Volume 5 | No.

2 | April 2010

Volume 5 | No.1 | February 2010

Volume 4, No. 4 August, 2009

w w w. b i o t e c h n e w s . i n
N E W S

Bioimplants and Devices

aDDING COMFORT TO YEARS

Department of Biotechnology
Ministry of Science & Technology
Government of India

Genetically Modified Crops

Need for a meaningful dialogue
 To the Readers

CONTENTS
To the Readers Feature Genetically Modified Crops
Genetically Modified Crops India’s Biosafety System
55 88
Beyond the Din
S. Natesh
At Par With The World?
Morven A. McLean
Beyond the Din
Feature Feature
GM vs. Traditional Crops
57 Investments in GM Crops Research
How Do They Differ ?
K. V. Prabhu
92 Power of Partnerships
K. Vijayaraghavan
T he issue of Biotech News in your hands brings a special feature on genetically modified (GM) crops. The approval
of Bt brinjal (aubergine) by the Genetic Engineering Approval Committee on October 14, 2010 and the subsequent
indefinite moratorium imposed by the Ministry of Environment & Forests on February 10, 2010, brought the issue
of GM crops into the limelight. While the ensuing public debate on such an important subject was indeed welcome, its
SnapShot quality and tenor nevertheless have been very disappointing. The moratorium and the debate have cast doubts on the
60 Commercialized GM Crops Feature competence of our regulatory decision making process. A fair and objective analysis of the relative strengths and
Global Status Investments in GM Crops Research
96 Public Sector Priorities
weaknesses of our regulatory system is, therefore, called for. This is crucial because the quality of a decision is a direct
derivative of the elegance of the process. It is important to be correct in the judgement as a lot of selfless effort has gone
S.K. Sopory
into attaining the current levels of expertise in regulation. A decision by itself may or may not be important but the process
Feature of decision making serves as a benchmark for the future. How objective and truthful is the judgement passed on our
GM Crops in India
64 Beyond Bt Brinjal Feature
regulators and the regulatory system? How much of this view is the result of an ideological opposition to new technologies
including transgenics?
G.Padmanaban Genetically Modified Crops
100 Public Perceptions An open society demands that on issues of national relevance all stakeholders must be consulted. But
Satyajit Rath|Prabir Purkayastha consultations have to be conducted in a spirit of engagement and mutual trust between participants. Obviously, everyone
Feature sees issues differently depending on their own particular perspective but perspectives should not become impediments in
G M Technology
68 Responsible and Purposeful Use
consensus building. In our endeavour to foster an ecosystem of innovation in India's agriculture the last thing we need is
demoralizing and fatiguing each other. Today's India requires that those who do science and those who use science must
Cross Fire
R. P. Sharma
104 Suman Sahai |C Kameswara Rao|Imran Siddiqi
engage each other honestly and responsibly. Discussions that yield more heat than light do not produce clarity, but only
succeed in making issues murkier.

Feature Beyond the din, it is time we

G M Crops examined these and other questions
72 Feature
Human and Animal Safety Deployment of GM Crops dispassionately. Given our current
B. Sesikeran 112 Need For a Clear Cut Policy agricultural scenario, India cannot afford the
E.A. Siddiq luxury of foreclosing its option of deploying
transgenic technologies. We must, however,
Feature use them responsibly and purposefully. We
Ecological Consequences of GMOs
75 Ensuring Environmental Safety Horse’s Mouth
GM Crops in India
also need a predictable and enabling policy
environment, increased public- and private-
R. Uma Shaanker|K. N. Ganeshaiah 116 The Way Forward sector support for early translation and, of
M. K. Bhan course, a regulatory system in which every
stakeholder has trust. This will help in the
Feature global integration of the Indian biotech
India’s Agri-horticultural Diversity
78 Conserving Our Biological Heritage Profile sector.
S.K. Sharma|Pratibha Brahmi |Mukesh Kumar Rana
118 National Research Center for While the debate did not generate much
Plant Biotechnolgy positive energy, it did raise several important
issues:
Feature
Regulating GM Crops l How do we integrate GM technology as
84 Global Best Practices one of the important components of our
Shanthu Shantharam 122 News Desk agricultural system? How do we ensure
that transgenic technology is deployed
responsibly and purposefully?

54 BIOTECH NEWS VOLUME 5 | NO. 2 APRIL, 2010 BIOTECH NEWS 55

 FEATURE
l How do we secure the safety of human beings and environment?
l Who should have the final say on biosafety? And release of GM crops for commercial cultivation?
l What can India imbibe from the best global practices for regulation? How does our regulatory system compare with that of other
countries?
l How do we create a regulatory system that is professionally-led, science-based, independent, transparent and accountable?
l How can we make private sector R&D more in consonance to India's agricultural needs?
l How do we enhance the efficiency and productivity of our public-funded institutions, decisively nudging them towards innovation
and early translation?
GM vs. Traditional Crops
l How can we ensure effective and continuous communication with stakeholders to inspire public confidence?
l Where do we go from here? What should be our next steps?
We sought the help of a cross section of experts who have firsthand knowledge of the sector to help the readers of Biotech News
How Do They Differ ?
understand some of these issues. As you will see, we have assembled a galaxy of well-known contributors from India and abroad. We
also invited three of them to state their own position on GM crops. Several of the distinguished authors agreed to write at a short notice
in spite of other competing engagements. To all of them I convey our appreciation and thanks. We are also grateful to K N Ganeshaiah,
R Uma Shaanker (both from University of Agricultural Sciences, Bangalore), K S Charak, S R Rao, (both from DBT), Sudhanshu Vrati
(National Institute of Immunology), and Vibha Ahuja (Biotech Consortium India Ltd) who helped in various ways to enrich this issue.
The articles in this issue have been written in the spirit of promoting a meaningful dialogue on the issues surrounding GM
crops. This is the time to reconcile divergent views in an atmosphere of mutual respect and cordiality, based on facts, not opinions, with K. V. Prabhu
reason, not emotion, and with grace, not aggression.n

S. Natesh
Editor-in-Chief
E-mail: natesh.dbt@nic.in

G
enetically modified crops are
developed through the process
of genetic engineering by
incorporating a gene (or genes) foreign
Reader’s Mail to the crop species through procedures
different from natural pollination or sex-
It is a pleasure to read the February 2010 issue of Biotech News and I must congratulate you all for ual reproduction. These are also known
Volume 5 | No.1 | February 2010
some times selection markers, all of
which are required for making the gene
express the protein it codes for and
enable its detection in the process of
genetic transformation. The whole com-
position is known as a “gene construct”.
For simplicity, the construct can be
GM crop, in the case of conventional
plant breeding, usually two or more geno-
types (known as parents) are hybridized
to recombine the genes from both the
parents desired to be brought together.
The genes are tracked in the
following generations through selection

the extensive team-work required to come up with a publication Presently, when India is a emerging popularly as Genetically Modified referred to as “transgene”. The receiving to finally end up in a stable genotype
force at the frontiers of science, Biotech News is can play a pivotal role in bringing about awareness Organisms (GMOs) or referred to as plant is transformed into a GM plant by which is released as a “variety”. In this
towards new scientific approaches. The feature 'Reverse Swing' was very encouraging and promising, Living Modified Organisms (LMO) or transferring the transgene construct process, a large number of genes recom-
posing viable horizons for the Indian scientists abroad. Khorana Program for scholars is inspiring for transgenic organisms. either directly into the genome of the bine from parental genotypes exchanging
young researchers in pursuit of excellence. The detailed insights into the cover story 'Wellness, by recipient organism through “ballistic large extent of genomic regions from the
How are GM Crops produced as bombardment” or through a bacterium involved parents, the best combinations
design', very aptly portrayed the evolution of bio-implants and devices sector in the healthcare
industry. It is indeed encouraging to note that Indian Medical Technology stands at par with the West
against those bred traditionally? known as Agrobacterium tumefaciens are selected consciously according to the
Bioimplants and Devices A GM crop is produced principally by which has the capacity to transfer the objectives of the breeding program to be
aDDING COMFORT TO YEARS and has a plethora of products in pipeline with significant potential. I look forward to reading the
introducing a gene sourced from any gene construct into the recipient plant evaluated for performance and eventual
next issue of Biotech News!
foreign organism that does not naturally through infection. When the latter pro- release as a new variety (see figure on
Dr Kavita Shah, Associate Professor Biochemistry/Bioinformatics Division, MMV, Banaras Hindu hybridize with the crop species being
University, Varanasi 221 005 cedure is adopted, the resulting GM crop next page).
genetically engineered. The foreign gene would have passed through the same One of the exceptions to this
I was pleased to receive the February,2010 issue of Biotech News. Splendid in look, rich in content and diverse in special and can also be a synthesized DNA sequence procedures that the tissue cultured prod- procedure are the hybrids where the
current topics, Biotech News opens a new window in science publications. A section on recent Biotechnology books will be for a product and the receiving crop is uct passes through, known as the process evolved hybrid would necessarily have
welcome as it is in the Tuesday issue of the HINDU or Current Science. A snapshot on concluded projects funded by DBT, known either not to produce it, or pro- of regeneration for successful transfor- equal genomic regions from both par-
listing of top biotechnologists (with their contact details that enables young students to interact with them) and a brief profile of duce it in insufficient quantity. The intro- mation. ents. The other exception is the process
leading Biotechnology Labs in India will be desirable. duced gene also includes elements such In contrast to the transforma- of development of introgression line
Prof. KV Peter, Ph. D. Director, World Noni Research Foundations, World Wellness Open University Building, Rajiv Gandhi as promoters, termination sequences and tion techniques used for developing the (also known as near-isogenic line) that uu
Road, Old Mahabalipuram Road, Perungudi, Chennai.n
K. V. Prabhu Ph.D. is Head and Principal Scientist, Division of Genetics, Indian Agricultural Research Institute, New Delhi
(E-mail: kvinodprabhu@rediffmail.com)

56 BIOTECH NEWS VOLUME 5 | NO. 2 APRIL, 2010 BIOTECH NEWS 57

 GM vs. Traditional Crops
How Do They Differ ?
Chromosome level changes that occur during conventional plant
breeding and integration of a transgene during genetic engineering
TRADITIONAL PLANT BREEDING
Chromosomes are made of DNA that comprise a series of genes, much like a strand
of pearls. Traditional piant breeding ends up binding together many genes at once from
both parents through the process of hybridization
Desired allele of a gene
Chromosome of
donor genotype
GENETIC ENGINEERING
A transformation event adds only a single gene construct to the chromosome
Desired Gene
Desired Gene
Donor species (any
organism, plant, animal,
microbe or a synthetic gene)
u results from a specific breeding process
known as “backcross breeding” where
the focus is to transfer only one gene
from one parent (known as donor par-
ent) into another already established vari-
ety, known as the recurrent parent.
In general, once stabilized by the inte-
gration of the transgene anywhere in its
genome, the GM crop follows the same
series of survival procedures like any
other conventional variety of the crop.
The difference lies however, in the limit-
less potential of the GM crop both in the
way the new “transgene” integrates into
the native DNA of the crop and the loca-
tion on the chromosome where it inte-
grates. Once integrated, the transgene
can recombine like any gene when
58 BIOTECH NEWS
A Schematic Representation
Many Alleles are recombined between
the parents at their original positions on
Allele of the same gene with the same chromosome along with the
undesired expression desired gene
Identical Chromosome
of another genotype of
same species
A single gene construct gets integrated at
any random position in one or many copies
on any chromosome
construct
Commercial Plant
Variety
crossed with another variety of the same
crop.
GM Crop and Farmer/Consumer
The GM crop variety (hybrid in terms of
the farmer) and the commercial product
of the GM crop (such as leafy foliage,
fruits, grains, oil or fibre from the view
point of the consumer), will technically
be substantially similar to its conven-
tional counterpart. In terms of farmers,
the GM crop will enable them to pro-
duce more or better quality product
while for the consumer it will add more
value to the product for a better quality
of life. Over the last two decades, the
technology of genetic engineering of
plants has undergone a series of refine-
ments to ensure that the product which
Chromosome carrying
genes from both parents including
the desired gene in the new variety
Improved
Commercial Plant
Variety
u above if one grows the seed produced on the Bt hybrid plant.
has incorporated a foreign gene in its
genome is as safe as its conventional
counterpart. The rigorous testing the
product undergoes for establishing its
safety vis-a-vis the environment, human
and animal health under the vigil of the
regulatory processes in place, makes the
GM crop a beneficial product to farmers
and consumers. Depending on the gene
incorporated in the GM crop, its value in
differentiating it from its conventional
counter product differs. For example, if
a insect resistance is the feature of a GM
crop, this will be valuable to the farmer
in terms of reduced use of pesticides,
reduced losses due to the insect pest and
better market value through low or no
damage caused to the commercial prod- uu
VOLUME 5 | NO. 2
GM vs. Traditional Crops
How Do They Differ ?
Genetically speaking…..
As a consequence of its random integration in the native genome anywhere in any chromo-
some and its being entirely new to the recipient genome, the transgene does not have its
alternate form “allele” in the recipient variety. In addition, since the transgene can find a
place in between any two functional genes, depending on its position, there may be varia-
tion in its own expression or that of the two genes it is flanked with. However, it should be
appreciated that if the latter is the case, the GM crop will be declared as not suitable for
commercialization and will never reach the farmer. This is enabled through a series of regu-
lations and tests the GM crop undergoes for its equivalence and similarity with the normal
crop. In contrast, in the conventional approach, since the location of every native gene is
fixed on specific chromosome, its segregation in its progeny is within the alleles of the char-
acter without disrupting other expressions (when the gene or its product is independent of
others). Therefore, the rules of genetic segregation will be different in the conventional
hybridization followed in plant breeding and that in the case of genetic transformation prod-
uct. In the case of conventional plant breeding, if the new gene being transferred from one
parent into another parent is, say, “R” present on a particular chromosome, then the hybrid-
ized product will be “Rr” where, the “r” is the alternate allele coming from the same chro-
mosome counterpart of the latter parent, whose expression is not desired. The progeny of
this hybridized product will segregate into, 1RR : 2Rr : 1rr. The RR and rr combinations
are called “homozygous” the Rr is called “heterozygous”. In contrast, because the
transgene is completely foreign, there will be no counterpart allele of the transgene in the
transformed product which will therefore be a combination “R-” and its progeny will segre-
gate accordingly into 1RR : 2R- : 1--, where the RR is homozygous for transgene, R- is
known as “hemizygous” and the individual is called “null” as this individual does not carry
any allele of the transgene. The fate of the progeny of the Bt hybrid cotton is as explained
u uct by the insect pest. The consumer the reason explained in the box above. If GM crops do not qualify for cultivation
would have the benefit of getting they do, then there will be 25% “null” as organic crops.
undamaged product and residual pesti- plants which will be non-GM plants.
cides in the commercial product. The GM Crops: Common Misconceptions
Organic Crops vs GM Crops
conventional product in contrast will be GM crops are unsafe and harmful : The most
Organic crops are any natural and non-
prone to have the insect pest or have pes- common misconception is that GM
GM crop variety which is cultivated with-
ticide residues in the commercial prod- crops are unsafe and harmful for human
out the use of chemical fertilizers, pesti-
uct to the disadvantage of both farmers beings, animals and environment. It
cides and chemicals. The field where it is
and consumers. If the GM crop is pro- needs to be understood that GM crops
grown has to be certified as organic field
duced to add value to the commercial are rigorously evaluated and analyzed
having no traces of any chemical/ inor-
product such as enhanced carotene con- for any risk they may pose to human
ganic fertilizer(s) or chemicals. The crop
tent or minerals, the farmer will be able beings, animals and environment. Only
cultivation, harvesting and packaging
to obtain better marketability while the when it is confirmed safe through a stan-
has to be certified as done organically
consumer will have healthful products dard set of investigations and protocols,
without any use of chemicals. It is also
for consumption. a GM crop is released in the environ-
required that the seed used for producing
The farmers have to take care ment for cultivation.
the crop is also produced organically. As
that they do not use the seed of a GM GM crops destroy natural genetic diversity: It is
per the current definition and standards,
crop hybrid for raising another crop for often stated that GM crops erode genetic uu
APRIL, 2010 BIOTECH NEWS 59
 GM vs. Traditional Crops

How Do They Differ ?

u diversity of the crop. This misconception
is based on the perceived ability of the
GM crops themselves to become inva-
sive or pass the invasiveness to wild rela-
tives or native varieties through “gene
flow” or “pollen flow”. While it may so
cide tolerance genes are deployed and
they do move into wild types, these
plants are not provided with extra fitness
for them to produce more seeds. Thus,
like the established safety of every other
improved character from non-GM vari-
SNAPSHOT
into a human organelle. The transgene is
only a chemical entity made up of com-
mon components existing in human
beings and plants or bacteria. As such
we everyday consume bacteria and
microorganisms through fresh vegeta-

Commercialized GM Crops
happen that a successful GM variety eties in the past history, the GM trait bles, fruits and drinking water. The con-
may get so popular that it may end up also does not make the weed become sumer needs to understand this and
replacing other varieties like many tradi- invasive in general. Herbicide tolerance come to an informed judgement on the
tional varieties have done in the course makes the variety of wild relative possi- issue.
history, it does not mean that this will
cause erosion of genetic diversity. It only
bly gain herbicide tolerance, only to the
targeted herbicide. Neither it becomes
GM crops increase yield and reduce soil fertility:
No GM crop has any additional yielding
Global Status
Source: Global Status of Commercialized Biotech/GM Crops: 2009, Brief 41 International Service for the Acquisition of Agri-Biotech Application (ISAAA).
ends up into the pattern of “mono- fitter nor invasive by producing more ability over and above its original tradi-
culture” as may also happen in the case seeds than usual. tional counterpart variety or hybrid. If
of a popular single non-GM variety for a Issue of foreign bacterial or animal genes in tradi- the transgene makes the GM crop resis- The year 2009 saw increased commercialization of genetically modified biotech crops. During the year, 14 million
crop. However, this is not likely to hap- tional crops: Even if the transgene is taken tant to diseases, pests or drought and farmers (90 percent of whom were small and resource-poor farmers from developing countries) planted 134 million
pen in India where large number of pri- out from a bacterium, animal or other heat stresses, it helps it to achieve its full hectares of biotech crops in 25 countries. This is up from 13.3 million farmers and 125 million hectares (7 percent) in
vate and public plant breeders and seed plant species, the GM plant does not productivity potential without any yield 2008. Trait hectares or “virtual hectares” reached 180 million hectares, up 14 million hectares from 2008. Eight of
producers invariably keep developing become a bacterium or animal or loss due to the stresses. Thus, the GM
the 11 countries planting crops with stacked traits were developing nations. Brazil surpassed Argentina as the second
and releasing GM, or non-GM varieties. another plant species. The transgene crop variety or hybrid only responds to
There are no possibilities of a gene like the genetic potential of the non-GM tra-
largest grower of biotech crops globally.
only produces the protein and not the
insect resistance, salt tolerance or disease tissue or organ that belongs to the source ditional counterpart and does not reduce Bt cotton in India has revolutionized cotton production in the country with 5.6 million farmers planting 8.4
resistance enabling a GM crop to be inva- organism. It is notable that there are soil fertility additionally. Unless the million hectares in 2009, equivalent to a record 87 percent adoption rate. India gained US$1.8 billion from Bt cotton
sive, or spread into varieties in the wild. thousands of genes common between transgene itself is for yield increase, the in 2008 alone and reduced insecticide use by half.
As such, in India, multiple crops are crops and animals. For example, there GM crop does not yield more than the Biotech rice and the drought tolerant trait have been identified as the two most important drivers globally for
grown each year in almost all parts and are more than 10,000 common genes yield potential of the original crop vari- future biotech crop adoption. During 2009, China accorded biosafety clearance to insect-resistant rice. This is likely
there are wild relatives of few crops between human beings and rice. The pro- ety. n
to spur faster development of rice and other GM biotech crops in other developing countries. Meanwhile drought
which occupy large areas. Even if herbi- teins produced by these do not make rice
tolerant maize is expected to be deployed in the United States in 2012 and sub-Saharan Africa in 2017. Other key
highlights marking the beginning of the second wave of growth in 2009 include the approval of SmartStax, a novel
biotech maize containing eight different genes for insect and herbicide resistance and planting in the United States
and Canada of the first Roundup Ready 2 Yield soybeans the first product of a new class of technology that allows
more efficient, precise gene insertion to directly impact yields. Six European countries planted 94,750 hectares of
biotech crops in 2009. The top
DBT LAUNCHES WEBSITE FOR ONLINE SUBMISSION OF PROPOSALS eight countries, each growing
FOR CONFERENCES, TRAVEL, EXHIBITIONS AND POPULAR LECTURES more than 1 million hectares
were: Brazil (21.4 million ha.),
Argentina (21.3 mha), India (8.4
DBT has launched a new user friendly interactive website www.dbtctep.gov.in to facilitate online submission of mha), Canada (8.2 mha), China
proposals seeking financial assistance for organizing conferences, seminars, symposia & workshops; travel (3.7 mha), Paraguay (2.2 mha)
support for presenting research papers in the international conferences being held outside India, and for and South Africa (2.1 mha).
organizing scientific exhibitions & arranging popular lectures within India. The remaining countries
The objective of setting up this website is to expedite processing of proposals and release of grants in aid to included : Uruguay, Bolivia,
beneficiary institutions whose proposals are approved, enabling PI’s to track the status of their proposals, and Phillippines, Australia, Burkina
electronic disbursement of funds. Online submission of proposals is strongly encouraged by DBT. Faso, Spain, Mexico, Chile,
For more details please visit the new website. For any suggestions \ queries please contact Mr. K. Rajagopal, Colombia, Honduras, Czech
Manager, DBT CTEP Management Cell, The Energy and Resources Institute, IHC Complex, Lodhi Road, New Republic, Portugal, Romania,
Delhi 110 003 (Tel: 011 24682100, 41504900, E-mail: ctepcell@dbtctep.gov.in) or Dr. T. Madhan Mohan, Adviser, DBT Poland, Costa Rica, Egypt and
(Block 2, CGO Complex, Lodhi Road, New Delhi 110 003, Phone: 011 24361813, E-mail: madhan@dbt.nic.in) Slovakia.

60 BIOTECH NEWS VOLUME 5 | NO. 2 APRIL, 2010 BIOTECH NEWS 61

 GLOBAL AREA OF BIOTECH CROPS
Million Hectares ( 1996-2009 )
SNAPSHOT
200
25 Biotech Crop Countries
180

160 “Trait Hectares”

140 Total Hectares

Biotech Crop Countries and Mega-Countries*, 2009 120

100
Industrial
Developing

#5 #20 #14 #19 #25 #21 80

#22
Canada* Portugal Spain* Czech Republic Poland Slovakia Romania
<0.05 Million Ha. 0.1 Million Ha. <0.05 Million Ha. <0.05 Million Ha. <0.05 Million Ha. <0.05 Million Ha. 60
8.2 Million Ha.
Maize Maize Maize Maize Maize 40
Canola, Maize, Maize
Soybean, Sugarbeet 20
#6
China* 0
#1 3.7 Million Ha.
USA* 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009
64.0 Million Ha. Cotton, Tomato, Poplar, A record 14 million farmers, in 25 countries, planted 134 million hectares (330 million acres) in 2009, a significant increase of 7% or
Papaya, Sweet Pepper 9 million hectares (22 million acres) over 2008. Source: Clive James, 2009.
Soybean, Maize,
Cotton, Canola, #4
Squash, Papaya,
Alfalfa, Sugarbeet
India*
8.4 Million Ha.
Global Area of Biotech Crops
By Country (2009)
#15 Cotton
Mexico* Area
Rank Country Biotech Crops
0.1 Million Ha. #11 ( Million Hectares)
Philippines* 1* USA* 64.0 Soybean, Maize, Cotton, Canola, Squash, Papaya, Alfaalfa, Sugarbeet
Cotton, Soybean 0.5 Million Ha.
2* Brazil 21.4 Soybean, Maize, Cotton
Maize 3* Argentina 21.3 Soybean, Maize, Cotton
#18
Honduras #24 4* India 8.4 Cotton
<0.05 Million Ha. Egypt 5* Canada 8.2 Canola, Maize, Soybean, Sugarbeet
<0.05 Million Ha.
Maize 6* China 3.7 Cotton, Tomato, Poplar, Papaya, Sweet Pepper
Maize 7* Paraguay 2.2 Soybean
#23 8* South Africa 2.1 Maize, Cottton, Soybean
Costa Rica #12
<0.05 Million Ha. Australia* 9* Uruguay 0.8 Soybean, Maize
0.2 Million Ha.
10* Bolivia 0.8 Soybean
Cotton, Soybean Cotton, Canola 11* Philippines 0.5 Maize
#17 #13 12* Australia 0.2 Cotton, Canola
Colombia Burkina Faso 13* Burkina Faso 0.1 Cotton
<0.05 Million Ha. 0.1 Million Ha.
14* Spain 0.1 Maize
Cotton Cotton 15* Mexico 0.1 Cotton, Soybean
#10 #16 #3 #9 #7 #2 #8 16 Chile <0.1 Maize, Soybean, Canola
Bolivia* Chile Argentina* Uruguay* Paraguay* Brazil* South Africa* 17 Columbia <0.1 Cotton
0.8 Million Ha. <0.05 Million Ha. 21.3 Million Ha. 0.8 Million Ha. 2.2 Million Ha. 21.4 Million Ha. 2.1 Million Ha.
18 Honduras <0.1 Maize
Soybean Maize,Soybean,Canola Soybean,Maize,Cotton Soybean,Maize Soybean Soybean,Maize,Cotton Maize,Soybean,Cotton 19 Czech Republic <0.1 Maize
20 Portugal <0.1 Maize
* 15 biotech mega-countries growing 50,000 hectares, or more, of biotech crops.
Source: Global Status of Commercialized Biotech/GM Crops: 2009, Brief 41 International Service for the Acquisition of Agri-Biotech Application (ISAAA). 21 Romania <0.1 Maize
22 Poland <0.1 Maize
23 Costa Rica <0.1 Cotton, Soybean
24 Egypt <0.1 Maize
EU Clears GM Potato For Farming 25 Slovakia <0.1 Maize
*15 biotech mega-countries growing 50,000 hectares, or more, of biotech crops. Source: Clive James, 2009

In a landmark decision on March 2, 2010, the European Commission has cleared the way for a genetically modified Projections for the Decade 2006-2015
potato to be grown in the EU - only the second GM product it has allowed. 2006 2015

# of Biotech Countries 22 ~40

The starch of the Amflora potato can be utilised for industrial uses like making paper, and for animal feed - but not for
10.3 million ~20 million
human consumption. The Commission stated that its decision was based on a “considerable volume of sound science. # of Farmers Planting Biotech Crops

Global Biotech Area 102 million ha. ~200 million ha. Source: Clive James, 2007

62 BIOTECH NEWS VOLUME 5 | NO. 2 APRIL, 2010 BIOTECH NEWS 63

 GM Crops in India

Beyond Bt Brinjal
FEATURE
u governments were not scientifically
broad- based .

B: The wide public consultations in the

country brought several concerns to
the fore
The concerns are the standard ones:
biodiversity issues, health safety, MNC
GM Crops in India strong hold, loopholes in the regulatory

Beyond Bt Brinjal
regime. I have to state that the process of
consultation itself did not give much of
an opportunity to knowledgeable
scientists to effectively put across their
points of view, although in theory
nothing prevented their participation.
The meetings were by and large
dominated by crowds emotively
orchestrated by activists and
demonstrations in street corners. A more
G.Padmanaban effective interaction in each centre could
have been through having an intense
discussion with a limited group,
representing all stake holders. The fact
remains that a vast majority, including

W
hile it is a disappointment
that a moratorium on the
introduction of Bt Brinjal
without specifying a time frame has been
imposed by the Ministry of Environment
and Forests (MoEF), I believe that it is
also an opportunity to objectively assess
the science and the ground reality in
respect of the relevance of genetically
modified (GM) crops as a whole for the
country. Nobody seems to be against a
technology based solution to stagnating
productivity in agriculture in the face of
projected increase in human population.
GM technology affords a unique
opportunity to tackle biotic as well as
abiotic stresses, besides improving the
nutritive quality of the feed stock.
Majority of the stake holders are not
against the technology as such, but the
standard concerns expressed are:
1. Environmental and health safety.
2. Regulatory regimes for approval.
There have been innumerable
arguments attesting to safety aspects with
G.PadmanabanPh.D. is Emeritus Professor and former Director, Indian Institute of Science, Bangalore.(E-mail: geepee@biochem.iisc.ernet.in)
respect to the GM crops so far developed
and field-tested. It has to be conceded
that there would be vociferous diehards
who would not accept GM technology,
whatever may be the scientific validity.
The society and the government need to
evolve and accept the policy on GM-crop
cultivation based on scientific inputs and
a correct perception on the need for such
a technology. It would be in the interest
of the nation, if valid scientific
arguments are accepted so that one does
not throw out the baby with the bath
water. It is also the duty of the scientific
community, which believes in GM
technology, to address the concerns and
keep evolving newer strategies to make
the technology safe on the ground, as
well as in the minds of the public. But, if
vested interests dictate terms to dump the
technology, it would be a great loss. India
missed the industrial revolution as a
subjugate nation and is still paying a
price in terms of development. It would
be a great tragedy if it misses, as a free
nation, the GM revolution that can
address concerns of food security and
mass nutrition.
In this article I have made an
attempt to summarize the concerns of
the MoEF that have led it to the
imposition of the moratorium and to
analyze each of those concerns.
A: All the brinjal growing states have
expressed reservation on the
introduction of Bt brinjal
This is true. A couple of states had based
the decision on the lack of evidence in
terms of commercial benefits to the
farmer. However, the EC-II report clearly
mentions the significant decrease in
pesticide spray, increased marketable
yield and the projected economic gain to
the farmer, in quantitative terms based
on the trials conducted by the Indian
Institute of Vegetable Research Varanasi.
This, of course, needs to be replicated in
private farmers' fields. The inputs
available to at least some of the state uu
scientists, have not studied the issues
involved, but have offered comments
without any hesitation. It does become
necessary to take decisions in the best
interest of the nation, guided by genuine
scientific inputs, rather than attempting a
consensus. I am not sure, a consensus
can be ever reached in any part of the
world on this issue. Did India enter into
the nuclear deal based on a national
consensus?
C: All the tests on Bt brinjal were
carried out by Mahyco
There were no independent tests
validating the results. One can only state
that public-funded institutions such as
Tamil Nadu Agricultural University,
Coimbatore and University of
Agricultural Sciences, Dharwad as well
as Indian Council for Agricultural
Research and Indian Institute of
Vegetable Research, Varanasi were
involved in the field trials. One cannot
question the credibility of these public-
funded institutions, simply because they
received funds from USDA. Many of the
laboratory tests were outsourced. In the
absence of an accredited, dedicated
public sector laboratory for GM studies,
one has to accept the fact that GEAC has
evaluated and accepted the data. I would
like to state that many seed companies
and academia involved in GM research
have a perception that GEAC is one of
the toughest regulatory bodies and
demands data not required even by
agencies ( FDA /EPA /USDA) in the
USA.
D: The biodiversity issue is crucial,
since brinjal is 'Indian'
The gene flow studies carried out are not
adequate. The trials should have been
carried out in different environmental
conditions. Bt brinjal may affect the rich
biodiversity of this vegetable. The
example given is Bt cotton, which is
dominating over non-Bt cotton in the
country. I wonder as to why Bt brinjal
needs to be developed with all its
advantages, if it does not become a
popular choice. The approach would be
to introduce Bt in every popular variety
Courtesy: ABSP II South Asia (2010)
of brinjal cultivated in different states, as
has been the case with Bt cotton. Even in
the case of non-transgenic crops, is it not
a fact that farmers prefer only certain
varieties and hybrids? What happens to
biodiversity in these cases? This is the
price the society has to pay ever since
man started practicing agriculture,
targeting specific varieties and hybrids.
Philosophically I have never understood
the issue of biodiversity with respect to
transgenic crops carrying a couple of
transgenes. This is in the context of
horizontal and vertical transmission of
genes taking place in nature all the time
in evolutionary scale. How did the 2000
varieties of brinjal evolve? Can any one
define a pure, unadulterated line of rice
in terms of the genome? How is the
biodiversity affected even if a couple of
transgenes were to reach an unintended
target, unless the transgene is a killer.
The last two decades of experience
clearly shows that Bt genes are safe from
that perspective. Bt brinjal is not a killer
weed. Although, I respect the regulatory uu

64 BIOTECH NEWS VOLUME 5 | NO. 2 APRIL, 2010 BIOTECH NEWS 65

 GM Crops in India
Beyond Bt Brinjal
u protocols on gene flow demanded in
transgenic crop trials, deep inside I
believe that the biodiversity card is
overplayed. The government can create
biodiversity parks all over the country to
preserve rare varieties of selected plant
species.
E: Bt brinjal as a food crop cannot be
equated with Bt cotton
The chronic toxicity tests carried out in
experimental animals are not adequate.
There are suggestions that chronic
toxicity tests should be carried out during
the entire life cycle of the animal.
Solanaceae is a unique species and the
transgenes may bring the hidden toxins
to the surface. Brinjal is used in native
medicine without cooking and abundant
caution needs to be exercised in assessing
the health safety of Bt brinjal. As per EC-
II report, the developers have indeed
carried out a variety of mandatory
toxicity tests in a wide variety of
experimental and domesticated animals.
A 90 day chronic toxicity test has been
carried out. These tests have been
considered as adequate by GEAC. One
should also keep in mind that there is so
much published information already
available on the safety of Bt toxins to
humans and animals. More than this, Bt
corn is being consumed across the globe
for over a decade. Apart from being cattle
feed, the breakfast cereal in North
America, perhaps, contains Bt corn. We
cannot just discard the American
experience and state that it is not relevant
for our discussion. In my perception, the
greatest proof of safety of Bt gene is the
long term consumption of Bt corn in
many countries without any confirmed
and authenticated ill effects to the public.
Of course, scientifically it is well known
that Bt proteins get degraded in the
acidic stomach of the mammal, whereas
it gets activated under the alkaline
conditions of the gut in the pests. It gets
degraded during cooking. Its penetrance
in the soil and microflora is not of real
concern. In spite of all these arguments,
the chronic toxicity tests in rodents can
66 BIOTECH NEWS
be carried out for 6 months or even a
year, if that would satisfy the
requirement. I personally do not see the
logic in extended studies.
I also do not subscribe to the
addition of sophisticated tests such as
transcriptomic, proteomic and
metabolomic studies. A plant is a
dynamic entity and would respond even
to small changes in environment cues.
One can be reasonably certain that these
parameters would be different between
the different varieties of brinjal, or even
the same variety grown under different
geographical and environment
conditions. This does not mean that the
changes seen are detrimental.
F: Bt brinjal has been developed by
Mahyco in which Monsanto has a
stake of 26%
The gene belongs to Monsanto. Priority
needs to be given to the
commercialization of indigenously
developed transgenic products. China has
developed Bt rice indigenously and has
approved trials that would lead to
commercialization. First, the support for
indigenous development is definitely
welcome. There are atleast a few events,
both in the private and public sectors,
that are ready for trials towards
commercialization. But, one needs to
talk to the scientists concerned to
understand the trials and tribulations
they undergo to take their transgenics
forward.
On the one hand they have to
face the tough requirements of RCGM
and GEAC, constant interference by
activists directly or indirectly, Supreme
court ruling that actually allowed on
going trials (Mahyco), but clamped an
embargo on newer trials that were ready
(indigenous) and on the other, face an
uncertain future in terms of publications
and career advancement (public sector)
and survival (private company). Is this
the right environment for indigenous
development of commercial capabilities?
As regards China, it has followed a dual
policy. It has approved specific GM
products developed by MNCs (eg.GM
corn and Soya), while developing its own
Bt rice. As per a news item (November 4,
2009/PR news shire- First call),
Monsanto was opening its first research
center in Zhongguancum, Beijing.
Monsanto has made a commitment to
collaborate with Chinese scientists on
advanced biotech and breeding
technology. China is pragmatic. It wants
to get the best of both worlds. We are
driven by emotional activism. It is not as
if there is no opposition to GM
technology in China. But, it is able to
take decisions and move ahead. It is able
to keep the big picture in perspective,
namely food security to an over billion
population and an intense ambition to
become the world leader. I will not be
surprised if we will be importing Bt rice
from China at some point of time!
G: Resistance development is a
serious concern in monophagous
pests
By far this is the most serious issue,
which scientists should address as the
primary challenge. Two different
hypotheses are available to explain the
mode of action of Cry toxins. One is
based on generating pores (punching
holes) in the insect gut cell and the other
is based on killing mediated by signal
transduction. In both the models, the first
steps envisaged are similar. The ingested
toxin is cleaved by midgut protease and
the activated toxin binds to cadherin
receptor located in the microvilli of
midgut cells. The toxin oligomer then
binds to secondary receptors anchored to
the membrane such as aminopeptidase N
or alkaline phosphatase. The toxin
oligomer then inserts into lipid raft
membranes forming pores and causing
the cells to burst. In the second model,
the binding of toxin to cadherin receptor
is visualized to trigger a signal
transduction cascade, eventually leading
to oncotic cell death.
Mechanisms of resistance development
have been studied in different pests
induced to become resistant in the
laboratory. In general, the most uu
VOLUME 5 | NO. 2
u frequently observed mechanism is due to
defects in receptor binding followed by
resistance due to defects in protease
production, elevated immune response,
enhanced esterase production etc.
Strategies to overcome resistance include
development of Bt plants with novel Cry
toxins (eg.VIP3 plants), Cry gene
stacking (eg. Cry 1Ac with Cry 2Ab),
modified Cry toxins that bypass primary
receptor interaction (eg. Cry 1A Mod
toxins), use of Cyt proteins from Bt i
strain along with Cry toxins and use of
cadherin fragments to counter resistance
(Bravo, A and Soberon, M (2008). How
to cope with insect resistance to Bt
toxins? Trends in Biotechnology Vol.26,
473-579).
In addition, on the field use of
refuge cropping has been shown to be
effective. It is clear that in developed
countries there is already a switch to the
use of Bt crops with stacked genes.
Indigenous efforts should only be
towards developing Bt plants with
stacked genes. Monsanto has already
indicated of possible resistance
development in Gujarat to pink boll
worm in Bt cotton and has
recommended the use of second
generation Bollguard with two stacked
genes. I wish there is an Indian authority
which gives this advice based on a
constant monitoring of the GM crops in
the field.
H: India needs an independent
authority to evaluate and approve the
trials as well as to monitor the
performance of GM crops in the field
after commercialization
A unified National Biotechnology
Regulatory Authority (now rechristened
Biotechnology Regulatory Authority of
India, or BRAI) is under consideration.
The bill pending since 2005 is likely to be
taken up in the parliament for debate. I
feel that the regulatory authority to
evaluate and monitor transgenic crops in
experimental fields and the one that
performs a regulatory function after
commercialization should be different.
GEAC can continue to perform the
APRIL, 2010
former function and give approval for
commercialization. GEAC has evolved
over several years of experience and,
perhaps, it is not a good idea to disband
the same. It may need some more fine
tuning. Thus, these two authorities can
be two arms of NBRA in the Agriculture
sector. The biggest challenge is to create
independent and dedicated experimental
facilities to monitor and evaluate GM
crops. Till such a facility comes into
existence, the existing laboratories in
different institutions have to be net-
worked to provide independent
experimental capabilities for NBRA.
R&D Efforts (Priority). Bt transgenics
should only be developed with more than
one gene. Those that have already been
developed should be given priority for
commercialization. In fact, if we can
develop two different sets, one should be
in reserve to be introduced as and when
signs of resistance are seen. Resistance is
not a permanent character. It is well
known that when crops are rotated, the
pressure on the insect to develop
resistance to a particular gene is eased.
The insect once again becomes sensitive.
Bt crops can ideally form part of
Integrated Pest Management regime.
When major pests cannot thrive, minor
pests can become the primary concern.
Therefore, transgenics to contain minor
pests (eg. sucking pets) need to be
developed simultaneously. I have earlier
listed many genes that can be used to
combat resistance. Newer strategies such
as the use of SiRNA to knock out
specific gene expression need to be
pursued vigorously. Strategies are
available to remove antibiotic markers.
Even screening a large number of events
can give the desired transgenic without
antibiotic selection. Fortunately, all these
efforts are underway. Development of
transgenic varieties would help farmers
to store the seeds. But, the seed
companies can make money only if they
sell hybrids. Technology developers need
to be compensated, while the farmers
derive benefit. The future challenges are
the development of tissue specific and
stage-specific promoters. In the case of
GM Crops in India
Beyond Bt Brinjal
the Bt toxin, it would avoid expression of
the toxin in all tissues of the plant.
Similarly, if the toxin is expressed only
during the stage of pest attack, its
concentration will get diluted during
grain maturation and disappear from the
final product. India has to give priority to
develop transgenics to improve the
nutritive quality of the grain and resist
abiotic stresses such as low rainfall and
salinity in soils.
Finally, none of these agenda
should delay the release of Bt brinjal.
After all, Bt corn and Bt cotton were
introduced with single Bt genes and
antibiotic markers and their safety in the
field is well established. Evolution
towards a better safety regime and
introduction of NBRA cannot be reasons
for delaying the release of Bt brinjal. I do
not believe that labeling of GM crops as
such should become an issue. It will only
confuse the masses in a developing
country like India. We are losing
precious time in reaping the benefits of
Bt gene and nearly 25 countries,
including some in Europe have gone in
for this technology. More than all the
valid scientific arguments, success in the
field would convince the public of the
importance of GM crops for food
security. The introduction and success of
Bt cotton has convinced many farmers
and a segment of the public that GM
technology can lead to increased
productivity, decreased pesticide spray
and increased revenue to the farmer. If Bt
brinjal succeeds, it would go a long way
in convincing many that GM technology
is safe and viable. I look for the day when
India would have pest-resistant rice with
improved nutritive quality ( balanced
protein and micro nutrients) that can go
grow even under conditions of low
rainfall. Agriculture is not just about
technology, since it embodies a culture
and there are political and sociological
over tones. It needs to be realized that
GM is only an innovative approach to
provide a technological solution, but it
should not be made a scape goat if there
is failure else where.n
BIOTECH NEWS 67

FEATURE
G M Technology
Responsible and Purposeful Use
R. P. Sharma
G
enetic modification of crop
plants has been and continues
to be the basic feature of con-
ventional plant breeding wherein the
genetic traits of breeding value, and in
turn the genes governing those traits, are
brought together through the process of
hybridization, recombination and finally
selection of the promising genotypes.
The major difference between the con-
ventional approach and the recombinant
DNA based genetic modification is that
in the first approach genes being reshuf-
fled are “known” genes and are brought
together from sexually compatible rela-
tives whereas the recombinant DNA
based approach permits mobilization of
gene/s from unrelated species, genera
and even phyla and therefore, are 'un-
known' as far as their expression and
interaction in the alien genetic back-
ground to which they are brought are
concerned. Thus, in situations where the
required genetic traits are available in the
sexually compatible and therefore usable
RP Sharma Ph.D. is former Project Director & INSA Senior Scientist, National Research Centre on Plant Biotechnology, Indian Agricultural
Research Institute, New Delhi. (E-mail: rpsnrcpb@yahoo.co.in)
68 BIOTECH NEWS
germplasm, which is more often the
case, the conventional plant breeding
will remain the first option. However, for
those traits which are not available in
close relatives, or got lost due to natural
or manmade selections, mobilization of
genes through the recombinant DNA
technology based tools is the most desir-
able option for the plant breeders. It
should therefore be understood that
genetic modification or GM as we
understand it today, does help in borrow-
ing one or few genes from unrelated spe-
cies and is in no way a replacement of
conventional plant breeding. GM
approach is at best and at times indis-
pensable adjunct to conventional plant
breeding.
GM: A Brief History
Tracing the brief history of GM crops,
starting 1996, when the first GM crops
was released for commercial cultivation
in USA, most of the traits engineered in
plants so far are those which are not
available in the germplasm of the GM
modified crops. A brief analysis of the
world wide adoption of GM crops reveal
that only three major traits viz. insect
resistance, herbicide resistance and viral
resistance alone, or in combinations,
have been mobilized in only five major
crops viz. soybean, cotton, maize,
canola and papaya, covering more than
ninety percent of the area under GM
crops. These results clearly indicate that
so far the application of GM technology
has been highly need based and
restricted to only those traits which were
not amenable through conventional
methods of crop improvement.
In the Indian context, so far
only Bt cotton, engineered for insect
resistance has been commercialized. Bt
cotton, a highly successful example,
represents indispensability of GM
technology for a trait proving to be
recalcitrant to breed through
conventional plant breeding, primarily
because of the non-availability of uu
VOLUME 5 | NO. 2
u sources of resistance in the world cotton
germplasm against Helicoverpa armigera.
This insect was basically being managed
by repeated sprays of environment
polluting and health hazardous
pesticides. In fact, cotton crop received
almost 30% of the total pesticide used in
India. Following the release of Bt
cotton, the pesticide consumption in
India declined from 47,020 metric tones
in 2001 to 37,959 metric tones in 2006-
2007.
Lessons learnt from commercial
cultivation of Bt Cotton in India
l Time and again, first during “Green
Revolution” and now for adoption
of Bt-technology, Indian farmers
have demonstrated that they are
highly receptive to economically
viable technologies. Within seven
years of the release the area under
Bt-cotton increased from four acres
in 2002, to about 9.5 mha in 2009.
l Bt gene(s) provide tolerance to insect
damage only. The yield per se
depends on the overall genetic
background of the cultivars in which
APRIL, 2010
Responsible And Purposeful Use
Bt-gene has been engineered.
l The genetic background of the Bt
hybrids/varieties and not the “Bt-
transgenic event” is important for its
adaptability to diverse agro-
ecological situations.
l Science based technology, as in the
case of Bt-technology, requires
continuous awareness generation
among the farmers for its effective
implementation.
l Non-availability and high cost of
planting material can lead to
unethical trade practices.
l Reduction in pesticide usage led to
substantial savings in input cost and
reduced exposure of the farm
workers to environmental and health
hazardous pollutants.
Need Based Application of GM
Technology
Currently, Indian agriculture is passing
through a critical phase. Crop
production is static if not declining,
biotic and abiotic stresses are leading to
unpredictable crop losses and changing
G M Technology
environmental and soil dynamics are
challenging the sustainability of
agriculture. It is therefore of utmost
importance that countries like India
must develop, adopt and innovate new
and novel approaches for increasing
agricultural productivity in a sustainable
manner. It is in this context the GM
technology assumes much greater
significance and calls for its judicious
integration in the conventional
approaches being pursued for gene
management, nutrient management, pest
management, water management, soil
health management, and post harvest
management.
Obviously, the management of
each of the activities listed is going to be
crop specific and will demand thorough
planning in terms of trait to be improved
and the tool to be applied. For example
in a crop like rice, the varieties of
tomorrow must not only be high yielding
but fertilizer use efficient, tolerant to
existing and emerging biotic and abiotic
stresses and suited for upland conditions
of cultivations. For each of these traits
which are polygenic in nature uu
BIOTECH NEWS 69
 G M Technology
Responsible And Purposeful Use
u conventional plant breeding approaches
will no doubt help in assembling the
required gene combinations from the
existing germplasm, the recombinant
DNA tools applied judiciously will help
in mobilizing the monogenic traits not
available in the germplasm. The traits
which are attracting worldwide attention
for rice improvement are: bacterial,
fungal and viral diseases, insect
tolerance, herbicide tolerance, grain
quality parameters such as high protein,
high carotene (Vitamin-A), high
tocopherol (Vitamin-E), and high macro
& micro nutrients etc. As far as grain
yield is concerned, identification and
mobilization of major QTLs
(Quantitative Trait Loci) for hybrid vigor
and superior alleles of QTLs involved in
reducing the impact of negative
correlations among yield contributing
traits offer unique opportunity for
breaking the yield barriers. Water
scarcity and changing pattern of
monsoon are bound to alter the
agronomy of rice cultivation, forcing
development of varieties amenable to
drought and upland rice conditions.
Fortunately, the available rice germplasm
has enough genetic variability for
70 BIOTECH NEWS
breeding varieties for these traits.
However, upland rice conditions are very
favorable for the growth of weeds as
well. Managing weeds manually is not
only difficult but add to costs making
upland rice cultivation highly
uneconomical. It is being visualized that
in future upland rice cultivation with
“no till”, where rice seed is sown in the
unploughed fields, will emerge as a
highly desirable approach for sustaining
rice cultivation under changed agro-
ecological scenario. This would require
that the rice varieties meant for upland
and “no-till” conditions are genetically
modified for herbicide tolerance for
managing the weeds. On similar lines, as
outlined above for rice the desirable
specific traits in different crops can be
identified and introgressed into the high-
yielding varieties through GM
technology.
Responsible Deployment of GM
Technology
Given the biosafety concerns and the
costs associated with GM technology, it
is pertinent that a careful analysis
bordering indispensability, of the
application of genetic engineering for
the improvement of specific trait in a
crop of choice must be undertaken
before opting for this approach. As
stated earlier, the recombinant DNA
technology has virtually clubbed the
whole biological world into a “single
gene pool”, with the possibility of
isolating a gene of choice from a donor
and its integration in the genome of the
recipient plant. It is obvious that this
technology has given enormous power in
the hands of the scientists. In this whole
process, however, there are certain areas
where our existing knowledge is
inadequate and is a cause of concern.
This puts tremendous responsibility on
the users of this technology for its safe
application. The gap areas are:
l Since the genes and gene products
are known to interact intra-cellularly,
the behavior of a transgene in an
alien cellular environment of
transgenic plant can not be predicted
precisely in terms of allergenicity
and toxicity.
l The method of gene insertion in the
recipient DNA is random which
might lead to: (a) silencing of the
inserted gene itself or of the
surrounding genes at the site of uu
VOLUME 5 | NO. 2
u insertion; (b) genetic instabilities in
other genes of interest and (c)
activating some of evolutionary
silenced genes etc.
Keeping these uncertainties in view,
biosafety related issues of the transgenes
have emerged as major concerns
warranting categorization of transgenic
plants as regulated items.
Major Biosafety Concerns from the
Commercial Release of Transgenes
The major biosafety concerns from the
commercial release of the transgenic
plants and their negative impact on (i)
environment; (ii) human and animal
health and (iii) social and ethical issues
have been the subject of intensive
discussion worldwide. Incidentally,
during these discussions the importance
of transgenics in agriculture has been
accepted unequivocally. The note of
dissent, however, has been on the
adequacy of, and lack of transparency in
the biosafety protocols followed. The
potential risks to the environment being
envisaged are the development of : (a)
“superweeds” by the herbicide resistant
genes; (b) new viral strains by trans-
capsulation of virus resistant genes and
(c ) “superpests” by insect resistant
genes. Likewise, the potential risks to
human health include: (a) allergenicity;
(b) toxicity and (c ) acquired antibiotic
resistance by the human pathogens. The
ethical and social issues are varied and
are region and country specific. In the
Indian context these could be (a)
selective adoption of the technology
leading to further economic disparities
(b) monopolization of trade by rigid
intellectual property rights and restrictive
trade practices and (c) negative impact
on biodiversity by extensive cultivation
of transgenics.
A critical analysis of most of
the biosafety concerns enumerated above
would reveal that, in the long term,
many of these will turn out to be
inconsequential. The occurrence of
“superweeds” and “superpests” though a
remote possibility are addressable
APRIL, 2010
Responsible And Purposeful Use
through new molecules being discovered
for controlling of the weeds and insects.
Likewise, acquired resistance to
antibiotics by the human pathogens can
be made inconsequential if the
antibiotics used as selectable markers
during cellular selection of
transformants are those which have
outlived their therapeutic value. In recent
years, transformation protocols with
removable antibiotic resistant markers
have also been developed.
As far as negative impact on
biodiversity is concerned, the decline in
agro-biodiversity by extensive
application of high yielding varieties
during “green revolution” period has
been very well documented. Large scale
cultivation of transgenic varieties will
further add to this decline because
farmers will always prefer the varieties
ensuring high economic returns to them
over the poor yielding land races. Unless
and until farmer's interests are
safeguarded, the collection and
conservation of the biodiversity by crop
based institutions and Genetic Resources
Bureau is the only option available. As
far as Bt technology is concerned, the
major biosafety concern is the
development of resistance to the Bt-
protein in the target insects. Resistance
development is directly proportional to
the selection pressure imposed on the
insect and can certainly be delayed by
maintaining the appropriate refugia and
non-contiguity of large scale cultivation
of similar transgenic crops in the field.
The allergenicity and toxicity to human
and animal health are certainly major
biosafety concerns and the international
protocols addressing to these issue are
quite adequate and have been adopted
and followed rigorously in India.
Indian Biosafety Guidelines, in addition
to human and animal health and
environment, address the socio-
economic aspects of a transgenic plant
and therefore, in a sense, are unique.
These guidelines take into consideration
the field performance of a transgenic
crop before it is released for commercial
G M Technology
cultivation. The transgene “Insertion
Event” based release of GM crops,
practiced in some countries, are
exempted in India only from biosafety
tests but for field release, prescribed field
evaluations are mandatory. It is not only
the gene “insertion event” but the
genotype as a whole contributes to the
economic yield of the variety which
need to be ascertained before
commercial cultivation by the farmers.
The Indian Biosafety
Guidelines, evolved during the last two
decades do address most of the biosafety
concerns listed above. However, it is
time that a “National GM-Biosafety
Register” is developed, prescribing in
detail the crop and transgene specific
biosafety concerns, the tests to be
undertaken and the protocols that need
to be followed with a proviso of need
based expansion and modifications.
In order to ensure responsible
use of the GM technology, the
Government of India has been
modifying and updating the existing
biosafety protocols to make them more
effective and efficient. It is in process of
setting up of a Biotechnology
Regulatory Authority of India (BRAI),
which will be autonomous and statutory
agency to regulate the research,
transport, import, manufacture and use
of organisms and products of modern
biotechnology. The Department of
Biotechnology, Ministry of Science &
Technology has been entrusted to act as
the nodal agency and a consultative
group of experts has prepared a draft
Bill to establish Biotechnology
Regulatory Authority of India. The Bill
was prepared through a consultative
process involving interdisciplinary and
inter-ministerial experts, state
governments and stakeholders. It is
expected that once in place, BRAI will
address to the biosafety issues more
effectively and will bring in the required
impartiality and transparency in our
handling of the genetically modified
crop for sustainable development of
Indian agriculture.n
BIOTECH NEWS 71

FEATURE
G M Crops
Human and Animal Safety
B.Sesikeran
E
nsuring safety of any product
meant for human or animal use is
paramount. This requires that
such a product has to go through certain
regulatory processes laid out by the
respective government departments.
Regulation usually ensures that (1) the
product which is being approved is useful
i.e. efficacious and (2) that even after use
for varying periods of time, it is unlikely
to cause any harm. Even if there is a
potential risk, it is very unlikely to cause
harm and that the immediate benefits far
outweigh such risk. The following are
some of the steps involved in this process
Risk Assessment: This involves two very
important steps - identifying the risk
(what is the harmful substance) and
quantifying the risk (how much is the
exposure to such a harmful substance).
Risk-Benefit Analysis: Now that the extent of
risk is made known to us, this step would
help us know whether the benefit is worth
taking the risk.
Risk Management: Although we decide to
B. Sesikeran MD is Director, National Institute of Nutrition, Hyderabad.(E-mail: dirnin_hyd@yahoo.co.in)
72 BIOTECH NEWS
accept the product after making sure that
the risk is very negligible and the benefits
are more, we need to equip ourselves with
strategies to manage the risk even if it
occurs.
Risk Communication: This process involves
communicating such information to the
users so that they know what they are in
for and feel reassured that the risk is far
less than the benefits they are likely to
derive.
All the above processes are
possible only if the harmful substances
are known or identified. Risk assessment
cannot be carried out if such harmful
substances are unknown or exist only in
our perception or imagination. Even in
cases where there is no known or
identified risk, how does one look for
possible harmful substances? The answer
is simple. One has to rely on the available
scientific literature. Several researchers all
over the world are constantly generating
genuine research information, which gets
published and many such papers on
u exists. Considering the fact that
laboratory animals are used primarily to
carry out such tests, appropriate animal
similar issues often get reviewed/ model (be it a rat or a rabbit or a goat etc
analyzed further. These can form fairly ) needs to be chosen to predict the way a
substantial evidence-based information human or other animals would behave if
that can be used for risk assessment. the same treatment were to be given. Rat
However, the most robust evidence of is by far the best animal model because
safety is a history of safe human use. It is more than 95% of its metabolic pathways
for this reason that several traditional are similar to those of humans and many
foods and medicines are accepted because other larger animals. Several decades of
people have been using for years and data using rat as a model for drug or food
there is no evidence of harm.
safety assessment has confirmed this.
However, if a product is new or Therefore, if no harm occurs in a rat fed
not in use in the country, the regulators with the test material, one can safely
would want adequate data to be assume that other mammals and humans
generated on its safety. This is possible would also behave in a similar way.
only through many test procedures which
The key steps in biosafety testing
are validated. Validation means that a set therefore are
of procedures have been carried out on l Identify the risk
l Have a validated test system
the potentially harmful substance and
l Conduct the tests with
confirmed that such procedures can approved protocols
detect the substance even at significantly l Review the scientific evidence
l Assess the risk
low levels. Employing validated
Let us now apply these principles to
procedures, if the test result turns out to
genetically modified or genetically
be negative, one can be sure that there is
engineered crops or foods. We develop
no harm and if it happens to be positive
such variety to quickly give an advantage
then one can say with certainty that risk uu
to the crop which we are unable to
manage efficiently due to many reasons.
For instance, in case of a crop that gets
eaten up by insects despite heavy use of
pesticides, a gene from even a non-food
VOLUME 5 | NO. 2 APRIL, 2010
Human and Animal Safety
source that gives it a trait to protect itself
from pests can be identified and inserted
into the food crop and a demonstrable
benefit can be seen. The safety concern in
this case could be:
 Will the product of the inserted gene,
which is an insect killing protein, also
cause harm to humans?
 Since, it is a protein which would not have
been eaten by humans earlier, is there any
likelihood of it causing allergy to those
who consume?
 When this new gene was inserted into the
crop, did it disturb any other gene and
produce unintended effects?
To address the first question two kinds
of safety tests can be done using rats.
A. Feed the animals the purified protein
(insect toxin) in quantities many times
more than what a human or animal is
likely to consume. This is to be given as a
single dose by gastric feeding and animals
should be observed for 14 days. If the
animals are fine, eating well and growing
normally after the test period, it can be
assumed that even unrealistically larger
consumption is safe. This is called as
acute toxicity test. Through this test, it
can be confirmed that the toxin has effect
only on the insects and not on animals or
humans that are consuming it. But,
before giving this pure protein to the
animals it needs to be confirmed that the
tested protein/ toxin has insect killing
G M Crops
toxic properties using the target insects.
B. The next test is to feed the food
containing the toxic protein to rats every
day for a period of 90 days in order to
assess long term effects of feeding the
insect toxin. The rats are then studied in-
depth for their growth, sickness, activity,
blood parameters and all biochemical
indicators before they are finally
sacrificed at the end of the period. Their
internal organs are examined thoroughly
and under the microscope for any
abnormal changes. These are also done in
comparison with animals fed with normal
food crop. If the difference is consistently
observed then it is significant, otherwise,
one can be fairly certain that it is safe.
The question is why only 90 days. The
short life span of 90 days in rats is almost
similar to feeding humans from 6 months
to about 25 years of age. Added to these,
the analysis of years of data and several
studies indicated that no additional
information can be obtained even if they
are fed beyond this period. Such longer
duration animal studies spanning 180
days or more are essential to assess the
reproductive toxicity and the possibility
of occurrence of cancer.
Bt proteins or for that matter
any protein cannot get into the cells as
such when consumed because they are uu
BIOTECH NEWS 73
 G M Crops
Human and Animal Safety
u digested and converted into amino acids,
which we anyway eat through a variety
of foods. Proteins therefore are not
mutagenic and do not cause DNA
damage and risk of cancers/tumors does
not arise. The 90 day studies as
mentioned include detailed microscopic
examination where in the reproductive
organs are examined and if there are any
abnormalities in these organs then
reproductive toxicity studies should be
done. It is to be borne in mind that every
test performed has to be validated and
merely performing studies without
scientific basis will not give the answers
we are looking for. As mentioned earlier,
if humans are already consuming for a
good length of time, then that is the best
evidence of safety rather than any long
term rat study.
C. Assessing the possibility of
allergenicity is again a complex process.
Scientific evidence has shown that allergy
causing substances have two major
characteristics - they are resistant to the
digestive juices as well as the acid in the
stomach and they do not get destroyed by
heat to a great extent and therefore persist
even in cooked food. Therefore, if the
new protein due to genetic modification
can be digested by simulated gastric
digestion and also breaks down on
heating, then it is a strong enough
evidence to say that it is unlikely to be an
allergen. Thousands of possible allergens
have been identified from various sources
and their amino acid composition,
sequence and tertiary structure are stored
in large databases. The new GM proteins
structure, sequence and amino acid
composition is established. Using bio-
informatics tools, they are compared or
matched with the databases of known
allergens. If there is no match we are
further reassured that the new protein is
not an allergy causing one. If there is a
match then a more detailed testing should
be done. The detailed testing would
involve doing an ELISA test using the
blood samples of patients with known
allergies like asthma and mixing them
with the test protein to see if they bind to
each other. The ultimate test, of course, is
74 BIOTECH NEWS
to inject the test substance or a placebo
under the skin of the patients with
allergy, under medical supervision, and
look for allergic reactions. These tests
would further reassure that the new
protein is not toxic to humans and other
animals and is also unlikely to cause
human allergy.
The final and by far the best
surrogate evidence of safety is the extent
of similarity between the non-genetically
modified food crop and the respective
GM version. This is called as
compositional analysis or establishing
substantial equivalence. Based on
scientific data, we know the various
components of the edible plant or plant
part like its water content, proteins,
carbohydrates, fats, minerals, vitamins,
phytonutrients, anti nutrients and known
allergens. When all components are
similar between the two, we are fairly
sure that the GMO after the insertion of
new gene has not changed anything in the
plant. Worldwide, this is the single most
robust test of safety. Even in traditional
plants there are normally variations
between the crops within the same field
or between the crops from different soils /
different climates and sometimes within
the same plant between different stages of
maturity. When comparisons are done,
these inherent variations are considered.
Newer techniques, which detect
the minor components in the metabolic
pathways, which lead to the macro
components like carbohydrates, vitamins
etc., are now available. However, until we
know what are all the variations as
mentioned above, such tests cannot be
used because any differences could be a
variation in the normal process and even
if no differences exist we still cannot
consider these as evidence. Such
techniques have to be standardized and
validated before they would be used for
regulation/regulatory testing.
Studies on livestock like chicken, cattle,
goats etc. need to be done in case any
part of the GM plant is likely to be used
as animal feed. These are not
toxicological studies but feeding studies
to see if they are nutritionally similar to
FEATURE
their non-GM counterparts.
Concerns also exist regarding the possible
transfer of antibiotic resistance selection
marker gene or the promoter gene to the
gut bacteria. Scientific studies indicate
that the chances of any such transfer are
remote. In fact, we consume lots of DNA
through foods but they do not get
incorporated into host or bacterial DNA.
Even if such an event takes place, those
cells undergo repair or perish.
The above information would
make it evident that GMOs are
thoroughly tested for safety using
meaningful and validated tests. Hence,
known risks can be quantified. However,
there are no protocols to look for harmful
effects, which are based on paranoid
perceptions rather than science-based
reasons or evidence.
All testing procedures have
been prescribed based on scientific
evidences and international best
practices. The following are the biosafety
guidelines which have been prescribed by
the Review Committee on Genetic
Manipulation (RCGM) / Genetic
Engineering Approval Committee
(GEAC):
l Recombinant DNA Safety Guidelines,
1990 & 1994
l Revised Guidelines for Research in
Transgenic Plants and Guidelines for
Toxicity and Allergenicity Evaluation,
1998
l Guidelines and SOPs for the conduct of
Confined Field Trials of Transgenic
Plant, 2008
l Guidelines for the Safety Assessment of
GM Foods, 2008
l Protocol for Safety Assessment of
Genetically Engineered Plants / crops,
2008.
It can be stated with confidence that no
other food technology has gone through
such vigorous safety testing procedures as
biotech derived crops. Let us recall the
statement of Pandit Jawaharlal Nehru :
“It is science and science alone that can
solve the problem of hunger and poverty,
of insanitation and illiteracy, of
superstition and deadening custom and
tradition, of vast resources running
waste, of a rich country inhabited by
starving people”.
So give science a chance.n
VOLUME 5 | NO. 2
Ecological Consequences of GMOs
Ensuring Environmental Safety
R. Uma Shaanker
D
ebates on the ecological
consequences of GMOs fall
into two extreme categories:
Those who feel that GMOs shall be
treated as `Guilty until proven innocent'
and those who wish to treat transgenics
as `Innocent until proven guilty' (Belt,
2003). While this polarization, even
among the professionals, is clearly due
to their philosophical affiliation to the
entities they are trying to protect
(ecosystems and biodiversity in the first
category), or promote (biotech products
in the second), unfortunately, in the
public and in the media these debates
have turned more emotional than
rational; more decibel based than data-
based; and more prophetic than realistic.
As a matter of fact, in a calm and
reasonably coordinated atmosphere,
neither of the two categories would be
able to completely defend their stand as
the facts available are minimal and
where available, they are with neither of
the two extreme views.
Uma Shaanker and K. N. Ganeshaiah Ph.D. are with the School of Ecology and Conservation, University of Agricultural Sciences, GKVK
Bangalore. (E-mail: umashaanker@gmail.com | knganeshaiah@gmail.com)
APRIL, 2010
K. N. Ganeshaiah
Thus the truth of the ecological
consequences of GMOs lies somewhere
in between! That it lies in between is also
the reason why the two opposite groups
have been indulging in an unending tug
of war over the issue.
Ecological Impact of GMOs
There are two major ways in which
GMOs are suspected to affect the
ecosystem and the biological diversity.
Gene Flow
The uncontrolled escape of transgenes
into non-target organisms especially into
the wild relatives is expected to affect the
local gene pool and also the ecological
balance. Transgenic genes may escape
from the source population in three
ways: a) through pollen transfer, b) as
seed escapes, and c) Horizontal gene
transfer through transformation and
transduction processes. The varied
probabilities and diverse consequences
of these mechanisms are important in
assessing the ecological impact of the
GMOs.
a) Pollen Transfer: Introgression
between the cultivated plants and their
wild relatives is a dominant evolutionary
process and hence, it is argued, may not
be an exception for a transgenic cultivar
as well (Stewart Jr et al., 2003). In fact
`most cultivated plants mate with one or
more wild relatives in some portion of
their geographic range.' (Snow, 2002).
Consequently, it is feared that the
advantageous genes from the transgenics
may be introgressed into the related wild
species especially when the area under
GMOs increases.
Obviously the probability and
depth of such gene transfer is a function
of the extent to which wild relatives of a
transgenic plant are distributed in the
area of cultivation. It is now known that
world over there are a number of
situations where the cultivated crops
exchange gene pools with their wild
relatives (Ellstrand,1999) and some of uu
BIOTECH NEWS 75
 Ecological Consequences of GMOs
Ensuring Environmental Safety
u the crops where this is most plausible are
sorghum, sunflower, canola, wheat,
sugar beat and alfalfa (Stewart Jr et al.,
2003). All these situations are potential
grounds for the transgenes to escape as
area under cultivation of transgenics
increases. The wild relatives thus
`transformed' may gain additional fitness
advantage owing to this gene rendering
itself the potentiality to be hazardous
weeds in the crop fields. While the logic
of this cannot be denied, we need to
look at the facts of such consequences.
Unfortunately, while only a
few examples of such pollen mediated
escape of the transgenic genes into wild
relatives have been reported, as for
example of transfer of the herbicide
resistant gene from Brassica napus to B
rapa, (Warwicket al., 2003, Steward Jr
etal., 2003) there are hardly any studies
on the fitness related spread of such
`transformed' wild relatives (Snow,
2002). In fact even in this case of
Brassica, Warwick et al (2008) showed
that the hybrid lineages declined
dramatically over time. For this reason, a
proper assessment of the impact of such
introgression has not been possible and
if anything overestimated.
Pollen flow is likely to carry
the transgenes to the land races as well
and if this happens the `transformed'
land races may in fact thrive well in the
nature and contribute to the crops wild
gene pool- an entity every breeder would
wish to have. In other words such
transfer of foreign genes may enhance
the intra-specific genetic diversity of the
crops (Pilson and Prendeville, 2004).
b). Seed Escapes: This is an
immediately possible consequence of
growing transgenic crops; the transgenic
seeds after the harvesting of the main
crop may be left behind, escape and
survive as admixtures and hence may
enter into the chain of gene flow into
wild relatives (Dlugosch and Whitton,
2008). There are a few examples of such
escape of seeds and not surprisingly they
survive well in the wild.
76 BIOTECH NEWS
c). Horizontal Gene Transfer:
Horizontal gene transfer is suggested to
occur from the transgenic sources to
other related plant species through viral
transduction or, to other microorganisms
through transformation (Pilson and
Prendeville, 2004). The viruses that
infect the transgenics may encapsulate
the specific gene and re-infect other plant
and release the gene in question or DNA
of the transgenic plants entering the soil
system may be taken up by the micro-
organisms transforming them. However
horizontal gene transfer is among the
least likely event because this requires
high concentrations of viable DNA of
the transgene to be accumulated in soils.
While there are reports of such DNA
getting released into soil, it is very
unlikely that such DNA fragments
would be in viable and sufficient
quantities for the effective
transformation. To cite Dunfield and
Germida (20040), “studies have shown
the possibility that transgenes can be
transferred to native soil microorganisms
… although there is not evidence of this
occurring in the soil”.
Toxin Flow
Addition of chemical products from
transgenes into the soil and environment
is argued to affect the biological systems.
Perhaps by far the most well
documented and highly celebrated case
is that of reduced fitness of the monarch
butterflies feeding on the pollen from the
Bt transgenics (Losey et al 1999).
Similarly there are a number of studies
reporting that flow of toxins into the soil
has affected the soil micro-flora towards
the predominance of specific species or
types in some cases and towards altered
microbial diversity in other cases
(Dunfield and Germida 2004). However
it is also important to realize that similar
effects are seen even with any two non-
transgenic crops suggesting that the
minor changes in the soil flora is an
ongoing process of farming per se and
need not be linked exclusively to the
transgenes.
Problems of negative reports
The debate on GMOs suffers from a
peculiar habit of biased reporting that is
characteristic to science. It is important
to realize that scientists in general
exhibit a peculiar bias in their habit of
reporting results. For instance while
some of the instances cited above do
reflect the negative impacts of GMOs on
the ecosystem, positive results, in this
case demonstrating that GMOs have an
impact, are almost always reported and
appreciated than those where the impact
is not detected. The authors, referees and
even the editors do not find the negative
results of such work as interesting and
worthy of publishing as those of the
positive results and hence a lot of work
goes unreported making it difficult to
weigh the relative disadvantages of
GMO over their advantages. Debates
over GMOs always suffer from this bias
in science.
Back to the future
And this brings us back to the question
that we began with: Should we treat
GMOs as `Guilty until proven innocent'
or as `Innocent until proven guilty'.
The answer to this lies in the future:
How would the future generation judge
our decisions today in accepting or
rejecting the GMOs?
Answer to this surprisingly may lie in the
present and the past!! What does the
present generation think of our decisions
to go with Green Revolution during the
second half of the 20th century?
We do not think that the younger
generation of today considers the
adoption of steps towards green
revolution during 1960s and 70s as a
curse on their generation. Rather the
young generation today has sufficiently
acknowledged that if our country had
not adopted steps towards green
revolution, their `present' would not
have been as bright as it is. Though they
were not there to face the famines then,
they are aware of our begging bowl
situation. They are aware that they can uu
VOLUME 5 | NO. 2
ENVIRONMENTAL SAFETY ASSESSMENT OF
GENETICALLY MODIFIED CROPS
Environmental risk assessment is an integral component of
biosafety evaluation of GM crops. The purpose of such
assessments is to identify and evaluate the possible adverse
effects of genetically modified organisms on the conservation and
sustainable use of biological diversity. Known risk
assessment techniques in different countries and guidelines
developed by relevant international organizations recognize
comparative risk assessment indicate that risks associated with
genetically modified organisms or products thereof, obtained
through the use of modern biotechnology, should be considered
in the context of the risks posed by the non-modified recipients or
parental organisms in the likely receiving environment.
The following steps are important in such risk assessment
methodologies:
An identification of any novel genotypic or phenotypic traits
that could have an adverse effect on biological diversity in the
receiving environment, including diverse impacts on human
health
An estimation of the likelihood of adverse effects being realized
An evaluation of the consequences of any adverse effects,
should they be realized
An estimation of overall risk (based on the above)
A recommendation on the acceptability or not of identified
risks, including risk mitigation strategies
And in cases where there remains uncertainty about the level of
risk, additional research or risk mitigation measures or
monitoring of the LMO in the receiving environment may be
required.
Ecological impact of the
introduced Trait(s)/gene(s)
Similarity to
proteins or
traits in
conventional
varieties
Potential non-
target toxicity
Potential for
resistance
Outcrossing
impacts
Each new event is carefully evaluated to ensure
that there are no unintended side effects
(Reference: Annexure III and Article 15 & 16 of Cartagena Protocol on Biosafety)
Compiled by: S. R. Rao, DBT
APRIL, 2010
Ecological Consequences of GMOs
Ensuring Environmental Safety
u raise their heads high in the world because they have
food and resources to live with. Unfortunately, it may
be difficult to extrapolate on the basis of this history
to what could happen to our decisions on GMOs-
not because GMOs would turn out to be bad but
because India is perhaps not in such dire states as it
was when green revolution occurred. But we need to
take conscious and valued decisions such that we do
not again enter a state of begging bowl.
A message to the funding agencies
We realize that there are very minimal datasets to
systematically evaluate the impact of GMOs on the
ecosystem and crop genetic diversity. What exists is
only indicative and at best inconclusive and there is a
message here for the funding agencies such as
Department of Biotechnology, Ministry of
Environment and Forest, Department of Science and
Technology and Indian Council of Agricultural
Research. There is no point in blaming those who
use their decibels than data sets to push their views in
the public. We need to generate reliable information
such that the policy maker take an informed decision
than temporally postponing the judgments on
GMOs. Thus we need to facilitate certain areas of
research that demand immediate attention such that
the professionals can find themselves on a solid
ground in drawing their conclusions and the public
are fed with more substantiated policy statements.
References:
Belt, Henk van den, 2003, Debating the precautionary principle:
“Guilty until proven innocent” or `Innocent until proven guilty'.
Ecological impact of Plant Physiology, 132: 1122-1126
the modified plant Dlugosch K M and J Whitton, 2008, Can we stop transgenes from
taking a walk on the wild side?, Journal Compilation 2008,
Similarity to
Blackwell Publishing Ltd.
conventional Dunfield K E, and J J Germida, 2004, Impact of genetically
varieties
modified crops on soil and plant mediated microbial communities. J
Environ. Qual., 33: 806-815.
Potential Ellstrand, N C, H C Prentice, and J F Hancock, 1999, Geneflow and
weediness introgression from domesticated plants into their wild relatives. Ann
Rev. Ecol. Syst., 30:539-563.
Expression Losey, J.E., Rayor, L.S., and Carter, M.E. 1999, Transgenic pollen
harms monarch larvae. Nature 399:214
profile
Pilson, D and H R Prendeville, 2004, Ecological effects of transgenic
crops and the escape of transgenes into wild populations. Ann Rev
Potential
ecological Ecol Syst., 35: 149-174.
Snow, A A, 2002, Transgenic Crops- Why gene flow matters. Nature
impacts Biotechnology, 20: 542
Stewart, Jr C N, M D Halfhill, amd S I Warwick, Transgene
introgression from genetically modified crops to their wild relatives,
Nature Reviews/Genetics, 4: 806-817.
Warwick S I, M J Simard, and A Legere, 2003, Hybridization
between transgenic Brassica napus L. and its wild relatives: B. rapa
L., Raphanus sativus raphansitrum L., Sinapis arvesis L., and
Erucastrum gallicum(Wild.), O.E. Schultz, Theoretica and Applied
Genetics, 107: 528-539.
Warwick S I, A Legere and M J Simard, , 2008, Do escaped
transgenes persist in nature? The case of a herbicide resistance
transgene in a weed population of Brassica rapa. Molecular Ecology,
17: 1387-1395.n
srrao.dbt@nic.in
BIOTECH NEWS 77
 India’s Agri-horticultural Biodiversity

Conserving Our Biological Heritage

FEATURE
Important Agri-Horticultural Crop Species of Indian Origin
Crop groups Crops (Botanical name)
Cereals and millets Rice (Oryza sativa), little millet (Panicum sumatrense), kodo millet (Paspalum scrobiculatum)

Black gram (Vigna mungo), moth bean (V. aconitifolia), pigeon pea (Cajanus cajan), horse gram/kulthi (Macrotyloma uniflorum),
Grain legumes velvet bean (Mucuna utilis)

India’s Agri-horticultural Diversity Fruits

Mango (Mangifera indicia), banana (Musa spp.) jamun (Syzygium cumini), jackfruit (Artocarpus heterophyllus), Citrus group, lime and others,
karonda (Carissa congesta), khirni (Manilkara hexandra), phalsa (Grewia asiatica), bael (Aegle marmelos), wood apple (Feronia limonia),
kokam (Garcinia indica)

Conserving Our Biological Heritage Vegetables

Eggplant (Solanum melongena), ridged gourd, smooth gourd (Luffa spp.) round gourd/tinda (Praecitrullus fistulosus), pointed gourd/parval
(Trichosanthes dioica), taro/arbi (Colocasia esculenta), yam (Dioscorea spp.), jimikand (Amorphophallus campanulatus), kundri (Coccinia indica),
cucumber (Cucumis sativus), rat tailed radish/mungra (Raphanus caudatus)

Oilseeds Rai, sarson and toria types (Brassica spp.)

Fibres Jute (Corchorus capsularis), cotton (Gossypium arboreum), sunnhemp (Crotalaria juncea)

Medicinal and aromatic Rauvolfia serpentina, Saussurea lappa, Indian belladonna (Atropa acuminata),Indian barberry (Berberis aristata), Commiphora wightii

Turmeric (Curcuma domestica), ginger (Zingiber officinale), Cardamom (Elettaria cardamomum), Bengal/large cardamom (Amomum aromaticum),
Spices and condiments long pepper (Piper longum), black pepper (Piper nigrum), betel leaf (Piper betel) and cinnamon (Cinnamonum spp.)

S.K. Sharma Pratibha Brahmi Mukesh Kumar Rana Sugarcane (Saccharum officinarum), bamboos (Bambusa arundinacea, Dendrocalamus hamitoni, Sinocalamus giganteus),
Other crops Sesbania sesban and tea (Camellia sinensis)

u nearly 9,500 plant species of ethno- to habitat destruction, changing use of Wide genetic diversity provides stability

T
he conservation and sustainable
management of natural
resources is a primary global
concern today. Increasing population
and rapid technological advances are
putting tremendous pressure on these
resources. Plant genetic resources (PGR)
which encompass the agri-horticultural
diversity are one of the essential
components that hold the key to the very
foundation of agriculture as well as food
and nutritional security for the world.
During the last four decades of this
century, rapid progress in the field of
agriculture was witnessed along with the
collection, conservation and sustainable
utilization of PGR. Conservation of
PGR has now become one of the most
widely discussed issues in the field of
agriculture and environment. Because of
high degree of human interventions in
management of genetic resources,
conservation in production system is
S.K. Sharma Ph.D. is Director, National Bureau of Plant Genetic Resources (NBPGR), New Delhi (E-mail: director@nbpgr.ernet.in)
Pratibha Brahmi Ph.D. is Principal Scientist, NBPGR, New Delhi (E-mail:pratibha@nbpgr.ernet.in)
Mukesh Kumar Rana Ph.D. is Senior Scientist, NBPGR, New Delhi (E-mail: mkrana@nbpgr.ernet.in)
linked to sustainable use. The concern
today is incorporating greater
biodiversity within agricultural
production systems.
There are 34 hot spots of
biodiversity recognized globally and
three of these extend into India. These
are the Himalayas, Western Ghats, Sri
Lanka and the Indo- Burma (covering
the Eastern Himalayas) region.
India is blessed with rich agricultural
biodiversity including diversity in crop
plants, wild crops relatives, livestock,
aquatic resources, insects and microbes.
The Indian gene Centre is prominent
among 12 mega gene Centres of the
world. In addition, India has 26
recognized endemic Centres that are
home to nearly one third of all the
flowering plants identified and described
to date. Indian region too is a major
center of domestication and diversity of
crop plants. About 33 percent of the
cultivated plant species have their origin
biotanical use are reported from the
in this region. It is an important Centre
country of which around 7,500 are of
of origin and diversity of more than 20
ethno-medicinal importance and 3,900
major agri- horticultural crops including
are multipurpose edible species.
rice, beans, cotton, sugarcane, citrus,
mango, banana, yams and several Management of Agri-Hortcultural
common vegetables and popular species
Diversity in India
(see box on pg.79).
Genetic resources of actual or potential
India is also a homeland of
value of various agri-horticultural crops
167 cultivated species and 329 wild
are being lost at an alarming rate due
relatives of crop plants and about 583
crops are cultivated in India (see box on
pg.79). It has about 30,000-50,000
Crops Cultivated in India
landraces of rice, pigonpea, mango, Crop Group
turmeric, ginger, sugarcane, gooseberries Cereals and pseudocereals
etc. and ranks seventh in terms of Millets
contribution to world agriculture. Legumes
Further, around 1,000 wild edible plant
Oilseeds
species are exploited by native tribes.
Cash crops (sugar and fibre)
These include 145 species of roots and
Vegetable and tuber crops
tubers, 521 of leafy vegetable/greens,
101 of buds and flowers, 647 of fruits Fruits and plantation crops
and 118 of seeds and nuts. In addition, uu Forage crops
Spices and condiments
Medicinal plants
Aromatic plants
Dyes, narcotics and cottage industry plants
Total
land, degradation of soils, over- to farming systems and sustains
exploitation of water resources, faulty changing environmental conditions that
forestry practices, urban expansion, may occur in future.
changing social and cultural norms, and National Bureau of Plant
adoption of improved varieties/other Genetic Resources, New Delhi is the
technologies including cultivation of nodal institution at national level for
GM crops and adoption of intensive management of PGR in India, under the
agriculture by farmers. This erosion has umbrella of the Indian Council of
caused losses of several Agricultural Research, New Delhi. The
land races, primitive Bureau, after its creation in 1976, has
cultivars and farmer's developed a very strong Indian Plant
varieties with desirable Germplasm Management System which
and potentially useful operates in a collaborative and
No. of Species
genes, leading to threats partnership mode with other
12
to the basic food organizations. The system has
16 security. There are contributed immensely towards
17 conflicts between safeguarding the indigenous crop genetic
21 modern agriculture and resources and introducing useful PGR
16 traditional agriculture. from other countries for enhancing
97 However, these can be agricultural production and productivity
overcome with in the country. India being one of the
139
sustainable farming gene-rich countries of the world faces a
33
practices, supported by unique challenge of protecting its
27 natural heritage and evolving suitable
agricultural policies,
121 institutional mutually beneficial strategies for
63 mechanisms and germplasm exchange with other
21 scientific management countries. uu
583 of genetic diversity.

78 BIOTECH NEWS VOLUME 5 | NO. 2 APRIL, 2010 BIOTECH NEWS 79

 India’s Agri-horticultural Biodiversity
Conserving Our Biological Heritage
u Agro-Biodiversity Conservation in
National Network Mode
Over the years, India has developed
sound scientific management regimes for
ex-situ conservation and access to its
genetic resources. Groups of institutions,
scientific societies and non-
governmental organizations are
addressing the task with NBPGR as the
nodal agency for its coordination. It
aims at efficient management of plant
genetic resources by providing
convenience of access to the various
crop improvement programs. It also
houses the National Genebank Network,
which includes the National Genebank
at NBPGR which is primarily
responsible for conservation of
germplasm on long-term basis. The ten
regional stations of NBPGR in different
agro-climatic zones of the country and
57 National Active Germplasm Sites
(NAGS) are integral components of the
network. The NAGS are based at
premier institutes for specific crops or
crop groups and are entrusted with the
responsibility of multiplication,
evaluation, conservation of active
collections and their distribution to
users, both at national and international
levels. Various other national institutes,
all India coordinated crop research
projects, state agricultural universities
and other stakeholders are also linked to
the network. International Agricultural
Research Centres involved in
conservation and use of PGR are also
effectively linked to the network, Cryo-
genebank and the in-vitro genebank. The
ex-situ seed genebank at NBPGR
comprises of 12 long-term modules
maintained at -180 oC for housing the
base collections. The active collections
are distributed in 22 medium-term
modules maintained at 40 oC for storing
germplasm at active sites.
At present, the genebank holds
more than 3.8 lakh accessions including
crops where research in GM technology
interventions is being pursued (see table
on pg. 82). The cryo-bank facility in the
80 BIOTECH NEWS
National Genebank has accessions of
varied germplasm of orthodox,
intermediate and recalcitrant seed
species and also of pollen samples. The
in-vitro Genebank holds species which
do not produce seed or are difficult to
conserve by seeds. These include
tuberous and bulbous crops, tropical
fruits species, spices and industrial crops,
medicinal and aromatic plants species.
The cultures are maintained at
standardized temperatures and are sub-
cultured after 4 to 24 months' intervals.
The in-vitro genebank conserves various
priority crops which are maintained
under short to medium term storage
periods.
Some of the alternate strategies
of conservation of PGR often
complement each other and are driven
essentially by need and utility of
germplasm. The ex-situ collections and
maintenance of such a facility is limited
by financial and human resources
available and in addition these
collections are subjected to genetic drift.
The natural evolutionary forces often do
not influence their maintenance
processes. Hence, more dynamic,
sustainable and complementary plant
genetic resources management processes
are being adopted so that the system is
sustainable and meets the requirements
of the crop improvement programs.
The in-situ and on-farm conservation
strategies are being adopted on limited
scale for both vegetatively propagated
species such as citrus and seed
propagated crops such as Himalayan
barley, buckwheat and traditional
landraces of rice (see fig on pg. 81). The
outcome of these models is expected to
provide inputs for formulation of such in
situ and on-farm conservation projects
on a larger scale in the country.
PGR Conservation in the Context of
GM Crops
Introduction of GM crops is not going
to make much difference in the ex-situ
conservation strategies that are being
followed presently. There are
India’s Agri-horticultural Biodiversity
Conserving Our Biological Heritage
apprehensions for the loss of diversity in
view of the introduction of GM crops
e.g. brinjal (see fig on pg. 81),
particularly in the Centres of origin of
crop plants by introgression of
transgenes. Loss of diversity from gene
flow to wild and weedy species may
further jeopardise the potential for
further crop improvements. It is worth
noting that introgression is a very
complex process and depends on the
scale of introduction of transgenic
varieties, the genetics of associated
transgenes and the fitness that those
transgenes may confer on the population
they enter. However, a genebank
curator's worry would be to maintain the
genetic identity of conserved accessions
Rice Diversity Collected at NBPGR. Brinjal Diversity Collected at NBPGR.
in the context of GM crops. Strict
regeneration protocols need to be
u which governs access to all genetic Indications of Goods (Registration and per se but a safeguard of material
devised and followed, particularly in resources of India and encompasses Protection) Act, 1999 were enacted and developed by a breeder through
areas where GM crops are grown under provisions for equitable benefit sharing. suitable amendments made in other publication and documentation in public
conditions that generally favor gene flow. The International Treaty on Plant existing IPR legislations, which have a domain. This germplasm registration
In suspected introgressions, presence of Genetic Resources for Food and bearing on the product, processes and can be used as evidence in documentary
transgenes in regenerated germplasm Agricultural (ITPGRFA) is another technologies developed. The Indian or other forms to create and establish
and finding options for removing such legally binding treaty which has plant variety protection is unique in 'prior art'.
transgenes from collections need to be provisions for facilitated access to 64 providing equal rights to the farmers as Germplasm which can be
worked out. At NBPGR, detection crops and forage species, under the breeder and conserver of genetic registered at NBPGR could be any good
protocols have been developed for a Multilateral System (MS). This exchange resources of local importance. To performance material for specific and /
number of transgenes which would be would be under the conditions of facilitate this activity with identification multiple traits (may not be yield
useful, if such situations warrant the Standard Material Transfer Agreement of distinctiveness of newly developed superior), mutants or with a different
identity of accessions in near future. (SMTA). Being a single window system varieties, ICAR has provided the ploidy level than the normal, with
for exchange of small samples of plant requisite support to PPVFR by academic / scientific importance,
Regulatory and Protection
germplasm meant for research, NBPGR developing guidelines for distinctiveness, parental lines of inbreds, promising
Mechanisms for PGR
has developed suitable Material Transfer uniformity and stability (DUS). To date, experimental material or landraces and
Many international developments during
Agreement (MTA) for providing access DUS guidelines for 35 crops have been traditional varieties. The procedure and
the last two decades have directly or
to PGR both within and outside the developed and notified. Plant variety forms are available at NBPGR’s website
indirectly affected the genetic resource
country. protection under the PPV&FR act (www.nbpgr.ernet.in). NBPGR has so
management programs. Plant breeders
Also, under the GATT/ currently covers seventeen crops; others far registered 729 promising germplasm
have traditionally relied on open and free
WTO/ TRIPs regimes, restrictions have are to be notified soon. So far 1644 accessions of different agri-horticultural
access to PGR for developing new, high
been imposed on free trade in applications for registration in 19 crops. Efforts are being made to get
yielding crop varieties. With the
commodities, including agricultural notified crop species have been received more and more germplasm registered
adoption of the Convention on
products. Countries are required to by PPVFRA. Of these, 164 have been through this mechanism so as to
Biological Diversity (CBD), which
adopt patenting or enact effective sui issued certificates for plant variety enhance its utilization.
advocates national sovereignty over
generis system or a combination of both, registration.
biological resources, the authority for
for the protection of Plant Breeders’ For germplasm registration Future Concerns
access to genetic resources rests with the Each country is interdependent on other
Rights. As a national obligation for the there is a system of plant germplasm
national governments and this access is nations for its germplasm requirements
TRIPS Agreement of WTO, the new registration operating at the NBPGR.
subject to prior informed consent of the since it is not possible to acquire and
legislations, viz; the Protection of Plant This system is completely different from
providing country on mutually agreed conserve useful resources to satisfy its
Varieties and Farmers Right Act registration of plant varieties of the
terms. This led to enactment of research needs. It is therefore, imperative
(PPVFRA), 2001 and Geographical PPV&FR Act. This registration of
Biological Diversity Act (BDA) for India uu to collaborate at local, regional and uu
germplasm is not a system of protection
VOLUME 5 | NO. 2 APRIL, 2010 BIOTECH NEWS 81
 India’s Agri-horticultural Biodiversity

Conserving Our Biological Heritage

BioPharm 2020: UK-India

Current Holdings of Agri-Horticultural crops in the National Genebank where
Biotechnology Business Challenge
GM technologies are being pursued
Crop Number of Accessions
Landraces Wild and weedy types Others Total
Rice 52615 1171 34895 88681
Sorghum 15429 236 4317 19982 During the first round, teams
are required to complete a short
Chickpea 6473 72 7447 13992 business plan executive summary.
Groundnut 5995 217 6044 12256 The deadline for submission is
Corn 5477 6 2003 7486 Friday 14th May 2010.

Cotton 1094 17 5178 6289

Brinjal 2782 530 1038 4350
Potato 148 110 2345 2603
Tomato 338 105 1427 1870
Cabbage 5 ---- 185 190
Cauliflower ---- 5 149 154

u international levels for the acquisition
and conservation of the germplasm. It is
also obligatory to obey the quarantine
and biosafety rules for the safe
movement of germplasm especially
where GM technologies are involved.
There is a need to adopt complementary
strategies for conservation of genetic
resources involving both in situ and ex-
situ approaches. For in-situ conservation
due attention is required to be given to
genetically rich hotspots including
require substantial inputs and a
decentralized evaluation network. With
the development in information
technology, the necessary tools for
collation, retrieval and dissemination of
information, documentation and
effective germplasm management can be
done through sharing of information
following a network approach.
Further, application of targeted
and precise molecular tools is required in
the present day genomics driven crop
diseases, insect-pests), quality of the
To enter visit our website: biopharm2020.org/competition
produce, better input-use efficiency and
stability of performance. There is also a
growing realization for a wider choice
and variety of horticultural and
agricultural products, for which diversity
in taste, color, nutritional values and
maturity character is highly valued by
the market. There is a need to modify
the descriptors for evaluation
accordingly, and make the search for the CHANGED AD
desired characteristics in the database as DR
ES
S
quick and efficient as possible.

natural and protected habitats including
tribal belts to strengthen and expand the
network of germplasm conservation
through involvement of all the
Moving on !!!
improvement programs. The genomics
application calls for higher precision in Registration of genetics stocks CHANGED
characterization and evaluation of and elite germplasm needs to be ADDRE
SS
genetic resource. Such intensive encouraged to promote germplasm

As you move on, please

CHA
stakeholders, including the communities. evaluations could be practiced only if exchange and effective utilization. NGE
D ADDRESS
It is to be ensured that a set of the the number of accessions to be evaluated Germplasm developed by public sector

help us to keep track.

available PGR with associated database
must be deposited as base collection
with the genebank, and one set
maintained as active collection
accessible for plant improvement. There
is an urgency to assess the germplasm
collection in the genebank to understand
the gaps and also identify the duplicates.
Characterization and
evaluation are essential to promote the
utilization of materials. A large number
of germplasm is yet to be properly
characterized and evaluated. These tasks
is within the manageable limits. Hence,
there is now greater emphasis on the
identification of 'core sets' and 'mini
cores'. These core sets could then be
subjected to rigorous characterizations
and used for identification of useful
genes with the help of various 'allele
mining' procedures.
The current emphasis in crop
improvement programs is to develop
cultivars having genes for resistance /
tolerance to abiotic stress (such as
drought / cold) and biotic stress (such as
breeders have been freely available to
private sector breeders as well. In the
changing global scenario under the new
IPR regimes, modalities for benefit
sharing by both private and public
sectors will also have to be worked out.
This is urgent to ensure continuity of
germplasm exchange and synergy
between the two sectors and models
need to be developed for sharing of
benefits with farmers and communities
who are the custodians of our agri-
horticultural diversity.n
CH
AN
GE
D SSE
Please write to: The Circulation Manager (Biotech News)
Communication and Outreach Division
Aravali Foundation for Education
Aravali House, 431/D-22, Chhattarpur Hills, New Delhi-110 074
Email: info@biotechnews.in | Fax: +91-11-26301016

82 BIOTECH NEWS VOLUME 5 | NO. 2 APRIL, 2010 BIOTECH NEWS 83


FEATURE
Regulating GM Crops
Global Best Practices
Shanthu Shantharam
I
t is a fact that GM crops are now
grown in 25 countries covering more
than 130 million hectares of land
area across the world. Innumerable
scientific reports and analyses of their
safety have been attested by world's
leading scientific organizations and
regulatory authorities. Inspite of this,
commercial cultivation of GM crops is
subject of endless controversies
surrounding their safety, utility and
regulatory oversight. Efforts to
internationally harmonize biosafety and
environmental risk assessment standards
have been ongoing since the 1990s with
mixed successes. As it always happens,
pioneering regulatory agencies set the
early “standards”, and others end up as
followers. In case of Genetically
Modified Organisms (GMOs), USA was
and is the leader followed by Canada.
EU is the hotbed of all controversies.
Almost all controversies are fanned by
the EU policies that are heavily
influenced (politicized) by the greens.
Shanthu Shantharam,Ph.D is Executive Director, ABLE-SIGAB, New Delhi. (E-mail: shanthu.shantharam@ableindia.org)
84 BIOTECH NEWS
The rest of the world has lagged behind,
and many are not even at the starting
line. Australia, Argentina, Brazil, China,
India, and South Africa are some of the
other countries that have working biotech
regulatory systems. Many differences still
persist between US regulatory agencies
and the EU, a sort of permanent trans-
Atlantic divide. It is important to note
that there is really not much of a
difference of opinion on the safety of
GM crops between US and European
scientific and regulatory organizations.
The biggest difference between the US
and the EU is with regard to
“Precautionary Principle”, a contentious
philosophical point. Developing
countries of the world are caught in a
dilemma as to which regulatory system
they have to follow. A plethora of
biosafety and regulatory capacity
building programs from EU and USA
have only added to the confusion. Those
who follow the US regulatory system
have made tremendous progress in
u issues are enjoined, endless debate
adding GM crops into their agricultural
systems, and those following the EU
system are caught in endless debates.
International agencies like Rockefeller
Foundation, Bill & Melinda Gates
Foundation, World Bank, Asian
Development Bank, OECD, UN-FAO,
UN-WHO, UNDP, UNESCO, and
UNEP have spent millions of dollars for
regulatory capacity building with little
progress.
Politicization of GM crops due
the anti-GM activism is the root cause of
all the irreconcilable differences between
regulators and the activists, and is also a
major detriment to international
harmonization of biosafety standards for
GM crops. This situation is best
exemplified by the Bt brinjal imbroglio in
India. Biosafety standards must be
grounded in “common sense” and
“scientific consensus”. It is only when
non-scientific issues related to trade,
intellectual property rights, socio-
economic impacts, cultural and ethical uu
VOLUME 5 | NO. 2
ensues. It is really unfortunate the even
matters of empirical science have been
politicized by some scientists just to
derail the technology. However, scientific
consensus are relatively easy to arrive by
a group of national or international
scientific experts, and that is the only
way to assure proper regulatory oversight
on any technology so that benefits can
reach the public at the earliest. There are
some excellent documents developed by
leading regulatory agencies like USDA,
US-EPA and US-FDA, EC Biotech Risk
Assessment Grants Program, OECD,
UNESCO, UNDP, UN-FAO, UN-WHO,
National Science academies of USA,
Brazil, India, Argentina, and the Royal
Societies of UK, Canada, Australia and
New Zealand. These reports and
documents developed by scientific
experts and serve as beacons for
developing a sound regulatory systems
based on the best possible scientific
knowledge.
It should be relatively easy to
develop best regulatory practices for any
country based on these documents and
reports to move the technology forward.
APRIL, 2010
Regulating GM Crops
Global Best Practices
Goals and Objectives of Regulations: Regulatory trigger for GM crops: The
The only goal of any set of regulations is “Process” vs. “Product” Paradigm.
to protect the safety of the public and the
This has to do with as to why a GM crop
environment. All other objectives are
must be regulated and what constitutes a
secondary. To achieve this goal, nations
GM crop. This is what is called the
must use the best possible scientific
regulatory trigger. As a priori, it is
consensus, practical guidelines and
assumed that GM crops are regulated
standard operating procedures.
because they are genetically engineered.
On the other hand, nobody seems to
Basic Principles of Biotech have thought about why other kinds of
Regulations GM crops developed using conventional
Regulations are always a societal
technologies are not regulated. It seems
construct. In any democratic society, the
that in most parts of the world, modern
public demands guarantees for safety of
day GM crops are regulated because they
any product or technology that would
are “genetically engineered” using the
directly affect their health and the
modern gene-splicing technology. It
environment. Therefore, regulations are
seems the technology by which a modern
developed to assure public and
day GM is developed is found guilty by
environmental safety. As a priority, for a
default. The end product, namely the
rigorous and comprehensive scientific
GM crop is not even considered. The
biosafety review and an environmental
illogic of this trigger is that one can
impact assessment are a must. It is
develop any kind of product using
imperative that regulators be scrupu-
conventional crop modification
lously impartial and objective, and do not
techniques, and it would escape
present even a whiff of a conflict of
regulatory scrutiny because there are
interest while regulating the technology. none. One can develop any “dangerous”
They should certainly not appear to be or “uncertain” GM crop using
either promoters or opponents of a
conventional techniques, and no one will uu
technology, or a particular product.
BIOTECH NEWS 85
 Regulating GM Crops
Global Best Practices
u question. This is a fundamental point
that has been long lost in the present GM
debate.
Biosafety Data Requirements: “Nice to
know” vs. “the Need to know”
The scientific data required to carry out a
rigorous biosafety review or risk
assessment has to be determined by
scientific and technical experts alone.
Most standard data requirements are
genetic stability data (Mendelian
inheritance analysis), molecular data,
and bio-chemical data. Plant
morphology and reproduction biology
are also included. Such data
requirements can change from time to
time as science and technology are
always progressing. It is not necessary
that each and every scientific paper
published on a day to day basis be
incorporated into the review standards.
There should be a scientific committee of
experts who will review the progress in
science and technology on a biannual or
annual basis to determine the scientific
consensus needed to establish the
regulatory standards of the day. For
example, a set of 29 new tests for every
GM crop has been proposed in India
which might take two or three decades
based on all fanciful techniques that have
come to the fore recently (J. Biosci.
(34)2), June 2009, 1167-168). It is an
egregious example of going overboard
with data requirements that fall neither
into the “need to know” or “nice to
know” category, and in no way informs
the biosafety assessment. Leading
regulatory authorities in US, Canada,
EU, Australia or New Zealand, who have
more experience in commercializing GM
crops do not require this kind of data,
and bears no resemblance to what is
recommended by the CODEX
Alimentarius. Such data requirements
create an uneven field where only
companies with deep pockets will
dominate. It is far more utilitarian to
examine the experience of other
regulatory authorities to develop
standards for data requirements.
86 BIOTECH NEWS
Principles of Biosafety Review
Substantial Equivalence, Principle of
Familiarity and Generally Regarded as
Safe (GRAS) are practical working
principles simply based on common-
sense and past experiences. These
principles have eminently served some of
the leading regulatory authorities to
develop basic standards for scientific
regulatory oversight of GMOs, and there
is no reason why these same principles
cannot be used in other countries. These
are not legal standards, but they are
scientific standards for biosafety
including food safety.
If a GM crop or a GMO, after genetic
engineering, is left 99% the same or
identical as its non-engineered
counterpart, then such a GMO is
considered substantially equivalent. If a
GM crop or a GMO is considered
substantially equivalent, meaning no
different from an organism that has been
in safe use for decades or centuries, then
such a GMO can be considered
“familiar”, and as such that GMO can be
evaluated using the previous knowledge
and experience of that particular
organism. Following these two
principles, one can classify a given GMO
as GRAS based on safe history of use of
the organism and the specific gene in
question. Any specific genetic change
that has been introduced, is all that one
needs to evaluate for biosafety.
Risk Assessment
Risk assessment of GMOs or any other
technology product goods or services can
be a dicey or tricky proposition.
Therefore, extreme care and
consideration must be given to identify
the necessary criteria. Risk is nothing but
hazard X exposure, a classical formula of
risk assessment. Hazard in this formula
assumes that GMO is a priori hazardous,
which is unfortunate. By and in itself, the
term hazard is a cause for great deal of
contention. People have been tired of
arguing that GMO by default is not
hazardous, but anti-technology activists
and anti-GM campaigners have
chronically maintained that GMOs by
default are hazardous, and that the
genetic engineering technology is
inherently dangerous. Going beyond this
contention, risk assessment can be either
qualitative (descriptive) or quantitative
requiring empirical data. In biological
systems, quantitative risk assessment can
be arduous as the field based empirical
data are hard to gather. This is one of the
contentions that haunt the trans-Atlantic
divide based on the precautionary
principle. A practical thing to do is to
take a precautionary approach which is
basically dealt with by a regulatory
review. This accomplishes the idea of
stop, ask and decide. Using such a
precautionary approach, USA, Canada,
Australia, New Zealand, Brazil, China,
India, Philippines, South Africa, and
many other countries of the world have
commercialized GM crops without a
single instance of causing human or
environmental harm in the thirteen year
history of GM crops commercialization.
EA is a powerful decision making tool
for regulators.
What is really critical in an
Environmental Risk Assessment (ERA)
is the nature of the organism and the
environment into which it is being
introduced. Since the environment differs
from place to place and country to
country, an Environmental Assessment
(EA) is a must. EA can be a simple and
direct method of determining the risk of
introducing a GMO into a particular
environment. It must be remembered
that EA assesses not only the agricultural
environment, but the neighboring
environment as well. EA is mostly
qualitative.
Environmental Impact Study
(EIS) is the most time consuming of all
risk assessments that can take years. EIS
needs lots of empirical data which will
take years to develop. EIS is done when
an EA comes to a Finding of No
Significant Impact (FONSI). There are
instances of certain environmental
projects that have been delayed decades
because of EIS. If a regulatory authority uu
VOLUME 5 | NO. 2
u takes the EIS route without proper
scientific cause, approving a GM crop
will remain a pipedream. That is a sure
way of killing a technology. Moreover,
EIS is the costliest way of regulating
technology. At present the Supreme
Court of USA is hearing an EIS case on
herbicide resistant alfalfa whose EIS was
prepared by USDA, APHIS which took
over five years. If principles of
substantial equivalence, familiarity and
GRAS are used, there should be no need
for EIS. It must be remembered that
almost all GM crops are already
established lines in commercial
production, and therefore, they all
eminently fit into the above principles.
For commercialization purposes, the
most important data requirements are
the agronomic performance data under a
variety of agro-climatic conditions so
that its efficacy can be reasonably
assured in the farmer's hands. In fact,
these things are carried out routinely for
any new crop variety introduced to the
market. It is in the interest of purveyors
of GM crops to make sure that their
product is a superior product and does its
intended job in the field.
One can do an intelligent and
scientifically reasonable ex-ante EA
which would be sufficient for the
purposes of contained and confined field
tests and deregulation. An ERA may be
carried out post-commercialization. If
post-commercialization monitoring is
needed, post-ante analysis can be carried
out from the empirical data gathered over
several years.
Food Safety
Food safety tests like allergenicity,
toxicity, teratogenecity, and
carcinogenicity should always be carried
out according to the standards
established by the CODEX, a joint
standard setting body that draws
scientific and technical expertise from
time to time. Long term chronic studies
must be indicated by standardized
preliminary tests. There has to be a
strong scientific indication for any other
APRIL, 2010
test for a given GM food. All these tests
must be decided by experts alone.
Risk/Benefit Analysis
In the GM debate, one mostly hears
about the risks, and not enough about the
benefits. It is imperative that regulatory
authorities convince the public about
both risks and benefits in an impartial
way. Risk/benefit analysis is perhaps one
of the most important regulatory needs
to convince the public that in spite of
certain risks, the technology product is
more beneficial, and that risks can be
mitigated by oversight mechanisms.
Risks of opportunity costs must be
included in such an assessment. This
way, one can assess the loss for not
introducing the technology product.
Deregulation and Commercialization
Deregulation means declaring that a
regulated GM crop is determined to be
no longer regulated, and allow it for
commercialization. However,
commercialization is done by the
purveyors of the technology product, and
not by the regulatory authority. But, the
authorities can or may impose conditions
for commercialization. Deregulation is
done after satisfying all conditions of
safety and environmental risks and the
needed risk management mechanisms
are in place to mitigate such risks.
Transparency and Accountability
The entire process of regulatory
oversight must be conducted in a
transparent way without compromising
legally permitted protection for
confidential business information(CBI).
This is the only way to inspire public
confidence in the regulatory system. It is
best to use the worldwide web to the
maximum, but in a timely manner.
Authorities must post a copy of the
application immediately declaring that
the application is complete and accepted
for regulatory review. A draft of the
biosafety review and EA/ERA must also
be posted on the web for public comment
giving a definite period of time.
In the event of a need for
Regulating GM Crops
Global Best Practices
public meeting to discuss the review, such
meetings must be organized in different
locations to seek public input both
verbally and in writing in an organized
fashion. Mob frenzy of the type
witnessed in the recent Bt brinjal
“consultations” must be avoided. All
information must also be posted on the
web site by indicating how points raised
by the public have been addressed. It is
important to note that it must be made
extremely clear that not all points can
and will be incorporated into the review,
and reasons for not incorporating must
be spelled out.
Decision Making and Communication
All decision making authority must be
solely vested with the regulators who
have statutory responsibility for decision
making. No member of the public must
be allowed to participate in the decision
making process. This is different from
seeking public input in consideration for
decision making. Using a decision
making tree will be extremely useful in
this exercise. A statutory authority is like
a court of law where litigants can only
argue their case, but the judgment is
rendered by the judge. If the decision is
in the negative, reasons for declining the
application must also be explained. It is
important to bear in mind that a
statutory body's decision is subject to
judicial review when challenged.
The decision must indicate the
date on which it will come into effect and
how long it will be effective, just in case.
It should contain conditions that may be
imposed on a case by case basis. The
decision must be signed by a competent
person in the authority and
communicated in writing to the
applicant, and posted on the web site. In
certain extraneous situations, it may be
necessary to announce the decision
through mass media.
Public Participation
Clear distinction must be made about
public input from that of public getting a
seat at the decision making table. It is
imperative to seek public comments and uu
(Contd. on page 103)
BIOTECH NEWS 87
 India’s Biosafety System
At Par With The World?
FEATURE
Countries that have Approved to the guidance document were made however, and the European Union
One or More GE Plants or Their Derived and it was again circulated and posted to provides a notable example of how
Food Products the web. The final document was decision-making at the political level
Country Cultivation Food/feed use reviewed by Review Committee on routinely trumps the evidence-based,
Argentina v v Genetic Modification (RCGM) and scientific opinions published by the
Australia v v Genetic Engineering Approval European Food Safety Authority's GMO
Brazil v v Committee (GEAC) and finally Panel.
Burkina Faso v
India’s Biosafety System Canada v v
approved in 2008. The end result is a
guidance document that is consistent Workability
China v v

At Par With The World ? Colombia

Czech Republic
El Salvador
European Union
v

v
v
v
v
v
with internationally-accepted practices
for GE food safety assessment and was
developed through a transparent,
consultative and participatory process.
Different operational approaches can
and have been used to secure the
necessary scientific advice for
government decision-making. In
India v considering the risk assessment of
Japan Transparency also requires that the
v v
regulatory submission, assessment and biotechnology products, some countries,
Korea v v
Mexico decision-making process as applied to, such as India and South Africa, have
v v
Paraguay v v for example, the permitting of confined implemented a system of expert
Philippines v v field trials and pre-market product advisory committees, while others, such
Russia v evaluations, is clearly communicated. In as the United States and Canada have
Morven A. McLean South Africa v v relied primarily on a professional staff of
the case of confined field trials (e.g.,
Switzerland v
biosafety research level I and II trials), a in-house scientists that function as
Taiwan v
clear application process has been dedicated risk assessors. Other countries
United States v v
Uruguay established and detailed guidelines that such as Argentina, Australia and Japan
v v
have a combination of both.

C
urrently, 25 countries have
approved genetically engineered
(GE) plants for cultivation or
consumption (see table on pg 89).
Common to all of these countries was
the establishment of a system to regulate
these products and particularly to ensure
their evaluation for human health and
environmental safety prior to their
commercial release. While there is no
single best model for regulating GE
plants, the hallmarks of a functional
biosafety regulatory system can be
captured by the terms adaptability,
transparency, workability and clarity.
This article examines each of these
characteristics in the context of India's
and other countries' national biosafety
regulatory systems.
Adaptability
Biosafety regulatory systems in all
countries are dynamic. There is no
example where the regulatory system
remains exactly as it was when first
M.A. McLean,Ph.D is Director, Center for Environmental Risk Assessment, International Life Sciences Institute Research Foundation, Washington
D.C. (E-mail: mmclean@ilsi.org)
introduced, and India is no exception to
this practice. India's biosafety regulatory
system has experienced a number of
changes since the Rules for the
Manufacture, Use, Import, Export and
Storage of Hazardous
Microorganisms/Genetically
Engineered Organisms or Cells 1989
(Rules, 1989) were first notified under
the Environment (Protection) Act, 1986,
including the elaboration of a series of
guidance documents published by the
Department of Biotechnology (DBT) in
1990, 1998, 1999 and 2008. This kind of
flexibility is essential as a regulatory
system must be able to adapt to the rapid
innovation in biotechnology research,
development and product deployment if
public confidence in the system is to be
maintained. Additionally, multilateral
negotiations related to environmental
and human health safety (e.g., Cartagena
Protocol on Biosafety, International
Plant Protection Convention, Codex
Alimentarius) and trade (e.g.,
Agreement on the Application of
Sanitary and Phytosanitary Measures,
u establishment of the Office of the Gene
Agreement on Technical Barriers to
Trade, Agreement on Trade-Related
Aspects of Intellectual Property Rights)
also affect regulatory approaches and
decision-making. In order to be
responsive, governments need to review
and, when necessary, amend regulatory
operations. Australia, for example, has
formalized this in the Gene Technology
Act, 2000, which required a statutory
review of the operations of the Act after
four years.
Transparency
The process by which regulatory
changes are made is just as important as
the changes themselves. Transparency,
consultation and attention to meaningful
public participation and engagement are
very important in this regard. Again,
Australia provides one of the best
examples in terms of the measured
process that was followed with the uu
Source: CERA GM Crop Database (www.cera-gmc.org)
Technology Regulator and the
development of the Gene Technology
Act, 2000. Lately, India has adopted a
more participatory approach than was
historically the case to the development
and adoption of new regulatory
guidance. For example, the Guidelines
for the Safety Assessment of Foods
Derived from Genetically Engineered
Plants began with an Indian Council
Medical Research (ICMR) hosted multi-
sectoral stakeholder consultation in
2005, where consensus was achieved
that the safety assessment of GE foods
in India should be consistent with the
internationally accepted Guideline for
the Conduct of Food Safety Assessment
of Foods Derived from Recombinant-
DNA Plants adopted by the Codex
Alimentarius in 2003. ICMR then
drafted a guidance document for GE
food safety assessment that was
circulated to a broad array of
stakeholders and was posted to the web
for input from any interested party,
including the public at large. Revisions
stipulate the requirements for
conducting these trials are readily
available from DBT, Ministry of
Environment & Forests (MoEF) and on
the web. In the case of pre-market
product evaluations, the assessment and
approval process is not as transparently
communicated. While the 2008
Guidelines for the Safety Assessment of
Foods Derived from Genetically
Engineered Plants and associated
protocols provide clear information to
applicants as to what is expected in a
regulatory submission for a GE food
safety assessment, the same is not
available for environmental risk
assessment nor is there a clearly
elaborated application submission,
review and decision-making process for
either food safety or environmental risk
assessments. Improving this would
enhance predictability and consistency
of the system. Otherwise, this can lead
to the imposition of ad hoc information
and data requirements that are
arbitrarily applied, as well as decision-
making that is subject to political
influence. This is not unique to India,
Each approach has strengths and
weaknesses. While independent advisory
committees may have in place more
transparent accountability frameworks
than government departments, their
effectiveness can be limited by the fact
that their members are part-time and
cannot devote their full energies to risk
assessments. Out of necessity, such
committees may only meet monthly or
several times per year, and the
membership selection process, while
transparent, may not result in the best
combination of scientific expertise and
regulatory experience. In some cases,
members of advisory committees are
scientists who continue to work within
their fields of expertise and so may be in
a better position to maintain their
scientific currency than their
counterparts within government, but in
others they may be representatives of
line ministries and have little or no
technical or subject-matter expertise.
In many countries, including India, the
risk assessment expertise lies in
academic and other public sector
research institutions and the private uu

88 BIOTECH NEWS VOLUME 5 | NO. 2 APRIL, 2010 BIOTECH NEWS 89

 India’s Biosafety System
At Par With The World?
Country
Argentina
Australia
China
Canada
European Union
India Ministry of Health & Family Welfare (Food Safety & Standards Authority of India)
Japan
South Africa
United States
u sector, and not within the government
bureaucracy itself. If the decision is
made to locate the risk assessment
function within the regulatory authority,
as has been done in the U.S., Canada
and in Australia's Office of the Gene
Technology Regulator, then the
government must be committed to
developing the appropriate expertise.
This is generally achieved through the
hiring, secondment and/or retraining of
scientific staff. Alternatively, and in an
approach that has been utilized in
countries such as Argentina and South
Africa, the regulatory authority may
appoint an expert advisory committee to
undertake risk assessments. If advisory
committees are used, then appropriate
conflict of interest provisions must be in
place to ensure that the developers of
GE plants do not end up in a position of
assessing their own products. In either
case, the regulatory agency/body should
have some foresight mechanism in place
to identify potential knowledge gaps,
and to promote and access training or
the recruitment of new knowledge.
The best approach may be to use
elements of both as has been proposed
for the Biotechnology Regulatory
Authority of India: Expert Advisory
Committees that provide guidance for
the development of new policies,
coupled with in-house scientists who
work as part of a multi-disciplinary
safety assessment team to conduct the
90 BIOTECH NEWS
Competent Regulatory Authorities for Food Safety
and GE Food Safety in Selected Countries
Competent Regulatory Authority
Food safety
Servicio Nacional De Sanidad (SENASA)
Food Standards Australia New Zealand
Ministry of Health
Health Canada
European Food Safety Authority
MoHL&W
Dept. of Health
Food and Drug Administration
case-by-case assessment of products.
Advisory committees can be used to
address specific issues of scientific
uncertainty. For example, new risks that
may arise with advances in the genetic
engineering of plants and foods can be
proactively identified and product risk
assessment and management practices
changed if required. Such committees
can also be used to address limitations in
national scientific capacity by leveraging
sub-regional or regional expertise with
the additional advantage that the
committee's output may then have a
broader application. The use of in-house
scientists to assess products on a case-by-
case basis permits the development of
considerable expertise within the
regulatory agency, provides for a degree
of consistency not afforded by the ever-
changing membership of advisory
committees, and can address the real or
perceived conflicts of interest that arises
if product developers are also product
assessors.
Clarity
Achieving clarity in a regulatory system
is one of the most challenging tasks to
confront regulatory authorities. It
requires that the scope and objectives of
laws, regulations and guidance are
unambiguous, the division of
responsibilities between government
ministries is clearly defined, and that the
interrelationship between the biosafety
GE food safety
Servicio Nacional De Sanidad (SENASA)
Food Standards Australia New Zealand
Ministry of Health
Health Canada
European Food Safety Authority
Ministry of Environment & Forests
MoHL&W
Dept. of Health
Food and Drug Administration
regulatory system and other regulatory
systems within the government is
understood by members of both the
regulatory and regulated communities.
The regulation of GE foods in India
provides an example of how difficult this
can be to achieve, although regulatory
reforms are currently being pursued to
address this.
In countries with mature
biosafety regulatory systems, the
regulatory authority for GE foods is the
same authority that is responsible for
administering food safety law(s) (Table
2). This recognizes that the safety
assessment of GE foods is part of, and
not separate from, programs that address
the broader context of ensuring the
safety of the foods that the public
consumes. The “GE nature” of a food
derived from a GE crop or other GE
organism is not (and should not be) the
solely defining characteristic of that food
as regards safety. Other, and arguably
more important, food safety and food
quality considerations and associated
laws, regulations, standards and
guidance apply to GE and non-GE foods
alike, which is typically why GE food
safety assessment is positioned within
ministries of health and their associated
food safety and standards agencies. India
has been a notable exception to this
practice as the authority to approve or
not approve a GE food has been vested
with MoEF under the Rules, 1989. This uu
VOLUME 5 | NO. 2
Department of Biotechnology
Ministry of Science & Technology
Government of India
Compiled by: Biotech Consortium India Limited
u means that the regulation and associated
safety assessment of GE foods is
disconnected, programmatically and
operationally, from the food safety
regulatory system writ large. With the
promulgation of the Food Safety and
Standards Act, 2006 (FSSA, 2006),
which empowers the Food Safety and
Standards Authority of India to regulate
all GE foods, this situation is likely to
change. However, as of now and until
such time as rules and/or regulations for
GE foods are notified under the FSSA,
2006, notification S.O. 880(E) in the
Gazette of India allows for the
continued regulation of GE foods under
Rules, 1989. This means that the
decision to approve/not approve a GE
food remains with MoEF, through
GEAC, until S.O. 880(E) is kept in
abeyance.
In all countries, biosafety evaluations of
GE plants are but one part of a larger
regulatory scheme that may also include
laws, rules and regulations pertaining to
plant health and quarantine, plant
variety protection, variety registration
and seed certification. Inter-ministerial
coordination is essential to ensure that
the roles and responsibilities of the
various involved agencies are clearly
defined and that associated programs
work in unison to create as seamless a
APRIL, 2010
India’s Biosafety System
At Par With The World?
IGMORIS
INDIAN GMO RESEARCH INFORMATION SYSTEM
Overview
Organizations working with
GMOs
Groups of GMOs
Welcome to IGMORIS Whats New
Status of GMOs and Products
Field Trials of GM Crops Questionnaire for Institutions
Biosafety Data of Approved GM Questionnaire for Industry
Crop
Capacity Building Activities
Indian GMO Research Information System (IGMORIS) is
a database on activities involving the use of GMOs and
products thereof in India. The primary purpose of this New Set of Guidelines
Documents/Publications website is to make available objective and realistic
scientific information relating to GMOs and products Guidelines and Standard
Funding Organizations & thereof under research and commercial use to all Operating Procedures
Schemes stakeholders including scientists, regulators, industry and
the public in general. It is also expected to promote
(SOPs) for Confined
Field Trials of Genetically
R&D Funding/Biosaftey national and international collaborations. Engineered Plants
Proformas
Guidelines for the Safety
Searching the Database Assessment of Foods Derived
read more from Genetically
Other Important Links
Engineered Plants
Protocols for Food and
Feed Safety Assessment
Login Registration (Free) of GE Crops.
Logout
Send a Mail
Website of : INDIAN GMO RESEARCH INFORMATION SYSTEM
system as possible. For example, country, and biosafety regulatory
national biosafety regulatory systems are systems are no exception to this. The
responsible for the environmental risk Government of India has identified
assessment of GE plants and approvals biotechnology as a key driver of India's
are granted for the “event” defined as a economy in the 21st century and there
genotype produced from the have been significant investments in
transformation of a single plant species biotechnology research and development
using a specific genetic construct. This in both the public and private sectors. In
means that any lines, varieties or hybrids agricultural biotechnology, India has a
derived from an approved event through rich pipeline of GE plants under
conventional plant breeding are also development. Catalysts like agricultural
approved. These derived progeny are not adaptation to climate change, the food
submitted for further assessment within security crisis of 2007-08, and increasing
the biosafety regulatory system as demand for renewable energy have
biosafety has already been addressed. accelerated plant biotechnology research
Instead, they enter directly into the plant on a range of new traits and new plant
variety registration system where they species. Innovation in this sector requires
are evaluated for agronomic a biosafety regulatory system that
performance (e.g., yield, disease and supports research, development and
quality) in the same testing program as deployment of GE crops while ensuring
any other conventional variety or hybrid that environmental and human health
of that species. In this way, the mandate safety are appropriately considered and
to assess the environmental safety of a secured. This means that investments in
GE plant (which is a specific agricultural biotechnology should not be
requirement applied only the GE plants) limited to product development but also
is kept separate and distinct from the applied to ensuring that the regulatory
mandate to evaluate plant performance system is as robust as the community it
(which is applied equally to GE and regulates. Continuing to address
non-GE plants). adaptability, transparency, workability
and clarity within India's biosafety
Concluding Comments regulatory system is of benefit to all the
Regulatory systems necessarily reflect stakeholders it serves and, ultimately,
the social, economic, environmental, society at large.n
and related development objectives of a
BIOTECH NEWS 91

FEATURE
Investments in GM Crops Research
Power of Partnerships
K. Vijayaraghavan
G
lobal investment for crop yield
improvement during the period
1930-60 focused on agriculture
implements to increase farm productivity
resulting in an initial wave of patents in
the USA and Europe. During the next
thirty years, the research intensity moved
to development of new molecules for
agro-chemicals. Plant breeding efforts
continued during this period with the
father of the Green Revolution, Dr.
Norman Borlaug, providing vital
germplasm access for wheat to the
developing nations around the world,
including India. Significant research
investment for agro chemicals emanated
from the private sector, while the
research investment for plant breeding
vested with the public sector. This was
the era of successive release of improved
varieties by the public sector in major
agricultural regions. Germplasm moved
freely across the regions. A restrictive
regime for germplasm would have denied
India's access to high yielding wheat
K. Vijayaraghavan Ph.D is Chairman, Sathguru Management Consultants & Vice Chairman, Cornell-Sathguru Foundation for Development,
Hyderabad. (E-mail: vijay@sathguru.com)
92 BIOTECH NEWS
varieties from Mexico. From the early
90s genetic engineering created a
revolution in accelerating trait
development and crop yield
improvement. Over the last two decades,
the agro chemical industry lagged behind
in introducing new molecules due to
prohibitive costs involved in developing
them and the increasingly stringent
norms required to validate their safety
and efficacy. Similarly, breeding efforts
also declined because of the steep decline
in public investment for breeding
programs.
Research in Genetic Engineering
Turns Multi-Dimensional
The advent of genetic engineering
provided hope in a significant way to
stimulate productivity in agriculture.
Initial set of inventions in genetic
engineering resulted in inventors securing
patents for genes that were identified as a
distinct DNA sequence with a fixed
function. The trend continued during the
u In order to differentiate the claims,
90s, triggering an array of patents for
gene functions. However, subsequent
discoveries indicated that the
organization of the genome is much
more defined by quantitative synergies of
gene clusters (networks) than by the
function of a single gene. Inventors
preferred complex claims that aimed at
vertical integration of technologies by
disclosure of synergies of gene clusters.
The complex intellectual assets
governing genetically engineered crops
originated in this context. Patent claims
moved from isolated gene functions to
complex models of gene functions.
Claims were widened on role of an
isolated DNA sequence conferring gains
in a wide array of organisms. Multi-
functionality and the transfer of trait to
another organism triggered integration
efforts to gain access to a set of
biological materials (e.g. use of promoter
to enhance biological activity) that were
cumulatively responsible for
commercially delivering a trait value. uu
VOLUME 5 | NO. 2
TRADITIONAL RELATIONSHIP MODEL
Public Research
Investment
Public Research
Emerging relationships will drive consolidation of research investments
and research commercialization efforts.
improvement patents were filed with
modified gene sequences during the early
part of this decade. The result is that
every gene of interest that is perceived to
have value has been, in some way or
other, patented in developed countries. It
is true that the current IP regime in
countries such as USA are rethinking
their acceptance of broad claims for gene
patents. Future patents are likely to
recognize a limited coding sequence
rather than recognizing patents for the
whole sequence itself while limiting the
claims for the “Field of Use” factor.
Research Universities and private
enterprises in the USA led the
integration efforts in the last fifteen years,
with the public sector and the private
sector engaging collaboratively to
integrate functions of genes and further
integrate them in the genome of the
crops of interest to pyramid multiple
traits that were sought by the farmers.
Simultaneously the regulators
(Environment Protection Agency,
Federal Drug Agency and United States
Department of Agriculture) created a
vibrant and transparent regulatory
mechanism and the rapid advancement
of science coupled with public
communication and dissemination of
technology created the gene revolution
for the grain and oil seed crops in USA.
IP pooling efforts through “in-licensing”
of biological materials and technologies
APRIL, 2010
NEW RELATIONSHIP MODEL
(Converging investment and research efforts)
Market
Corporate Research
Public Research
provided rapid gains to the corporate
sector to bring out products by bundling
biomaterials and technologies. The
integration efforts provided further
opportunity for cross-country
partnerships through cross-country
licensing. The classic case is the
integration of trait gene for cotton in
Indian cotton hybrids during the early
years of the current decade.
Europe Lags Behind Due to Low Public
Confidence and Multiple Outbreaks of
Zoonotic Diseases
While these efforts were successful in
USA and parts of the South American
region (Brazil and Argentina), Europe
had faced the problem of the mad cow
disease in the 90s and was extremely
cautious about adopting new
technologies. Public confidence in
science was low and their trust in the
regulatory system was even lower. The
European Food Safety Authority (EFSA)
came into existence in this context.
However, public fear, lack of
understanding of emerging science at all
levels and successive outbreak of
zoonotic diseases did not revive public
confidence in novel foods. Most parts of
Europe experienced a sense of self denial
in accepting novel foods and the lack of
consensus within the European
community denied inventors the
opportunity to demonstrate successful
inventions in crop yield improvement
Investments in GM Crops Research
Power of Partnerships
Public & Private
Investors
Market
Corporate Research
and other trait factors.
Europe Continues to Invest in Genetic
Engineering Research
The European Union and the national
research systems within Europe,
however, continued to invest in research
for the development of genetically
engineered crops. Large European
companies have realized that they were
lagging behind and initiated efforts to
accelerate the research for new trait
development through genetic
modification. In a recent effort by the
EU researchers, this writer was engaged
in exploring application of inventions
that have originated within EU for
expeditious commercialization within
and outside the EU. Improved regulatory
consensus, recent approval of genetically
engineered potato, increasing acreage in
countries such as Spain and the pressure
of negotiations within WTO are
triggering a new paradigm shift in
European perspectives. There are over
400 effective patents filed in Europe that
are being explored at various stages of
commercialization by the public and
private sectors within Europe and
elsewhere in the world. European
companies have commercialized
genetically engineered crops in several
parts of the world including USA, Asia
Pacific and South America. European
research organizations have licensed
invaluable traits to entities in the public uu
BIOTECH NEWS 93
 Investments in GM Crops Research
Power of Partnerships
u and private research system for
commercial exploitation and are in
receipt of royalties from such
commercialization. Europe begins to
realize that innovations will flow to
markets and if such innovations are
denied access, it would only endanger
regional competitiveness.
Is There a Threat from the Narrow
Concentration of Patents for Genetic
Engineering Technologies in a Few
Hands?
This question is often brought up by
opponents of genetic engineering science
to argue that the concentration of patents
would create a near monopoly,
threatening the food security of many
nations. It is true that these inventions
were exploited by multinational
companies in large acreage crops such as
Cotton, Soybean, Corn and Canola in
the Americas. This was quite appropriate
in countries such as USA and Brazil
where large acreage farming is quite
common. Only 2% of Americans are
engaged in farming today and it made
perfect sense to adopt widely
disseminated technologies developed by
few sources for improving productivity
and gaining a competitive advantage for
the nation. These efforts have provided
USA with a significant global
competitive advantage for producing
high quality grain crops at the lowest
cost.
However, multinational companies have
not applied the same biomaterials and
technologies to develop traits for small
acreage crops. The low acreage of
vegetables grown by farmers in USA has
so far restrained large companies from
engaging in development efforts for such
crops. Some critics in India argue why
India should be the first country to
develop Bt brinjal. This is because brinjal
is not a crop of interest for Americans or
Europeans as much as it is for Asians.
Who else will focus on developing crops
that have predominant regional interests?
While the extent of adoption of
genetically modified crops is extensive in
94 BIOTECH NEWS
North America and South America, the
markets in these regions will tend
towards marginal growth. The key
market growth for seeds will emerge in
Southern and Eastern markets, more
specifically in China and India and in
countries such as Brazil, South Africa
and in a limited way, North Africa. The
advent of these growing markets will
drive technologies from hitherto
developed countries of the West to Asian
and other developing regions. Many of
these markets do not have a strong patent
regime. Will this deter the technology
owners to step into those markets? Not
really. In India, Monsanto introduced
their genes in cotton at a time when the
protection regime in the country was
virtually non-existent. A third of the
emerging markets that have potential for
high growth markets do not have
advanced regimes (in countries such as
Indonesia and Bangladesh not even a
basic one) for patent enforcement. This
will not deter research efforts in moving
into regions of high market growth.
Research efforts will move to the region
where the markets emerge. This is well
evidenced by the surge in research
investment for genetic engineering
research in China during the last five
years. China has committed over $ 1.5
billion for genetic engineering research
with further trenches of investment
forthcoming to accelerate this research
process. Lack of access to patents has not
deterred China in advancing their
research for new trait development.
China has adopted a judicious licensing
process for bio-material access
complimenting their huge resource
commitment for research. China has also
leveraged their initial low “in-country
capacity” with external research by
contracting leading American
Universities to engage in collaborative
research. Initial products or traits that are
brought to emerging markets in crops of
regional interest would primarily have
biomaterials that are currently de-
regulated elsewhere in advanced markets.
Most of these de-regulated products
introduced in emerging markets would
not be governed by in-country patent
restrictions, thereby creating free market
competition.
Where do Emerging Countries Gain
Access to Genes of Interest?
Gene exploration is dependent upon
understanding the functions of genes and
countries such as India or China have not
committed billions of dollars in
genomics and proteomics platforms the
way the Western world has invested
during the past two decades. Academic
researchers and large private entities in
countries such as USA, parts of Europe,
Australia and Canada are in a position to
generate significant leads for candidate
genes and pursue those candidates for
validating their functions and efficacy.
One successful candidate emerges out of
myriads of prospective genes of interest.
This multi billion dollar effort is
significantly limited to few nations and
within the nations to few players due to
the intensity of investment in upstream
research. However, this does not deter
entities engaged in crop improvement
research to access technologies. The
model is akin to the development of chip
technology. The world over, INTEL and
AMD invest in developing faster and
more reliable chips and rest of the
product developers integrate the
advanced chip technology in their
products. The “INTEL INSIDE”
concept is quite true for biological
research
and this is
precisely the
approach
that the
crop
improve-
ment
researchers
have taken
in
developing new traits in popular
cultivars to make them more relevant to
ensure continued adoption by farmers. uu
VOLUME 5 | NO. 2
u Technology
Access Models for
Emerging Countries
There are four possible models that
would emerge in this technology transfer
and product development process for
genetically modified crops in emerging
economies.
Technology Flow to Research Centers
Created by Ventures in Emerging
Economies
While multinational companies possess
the advantage of bringing currently de-
regulated products from other regions to
countries such as India, the limitation
exists in accessing cultivars of regional
interest. A successful event is made up of
proven functionality of the gene and the
genetic background in which the gene is
inserted. Companies with foresight
understand that the process of breeding
is a long drawn effort and some of them
have begun efforts in this area in right
earnest. However, many of the global
companies do not have an interest in
small acreage crops and therefore will
limit their breeding interest in large
acreage crops, more specifically grains
and oil seeds.
Technology Partnerships for Joint
Product Development
Joint venture partnerships have occurred
in the past in the agro chemical sector
and in sectors other than agriculture,
extensively in India. The seed sector will
not be an exception. Pooling of genes
and germplasm through joint ownership
will occur. However, valuation factors
and promising growth potential will turn
many companies to aspire for controlling
interest in ownership. Indian seed
companies are very possessive of their
controlling interest, just as Chinese
companies are.
Licensing of Technologies for
Commercial Exploitation
Licensing technologies for commercial
exploitation will drive the growth for new
product development. During the past
three years, there have been several
APRIL, 2010
licensing and sub-licensing of bio-
materials, know-how and research tools,
both to public and private research
systems within India. Sathguru has been
a large repository of bio-materials in
region and we have had a surge in
request for licensing bio-materials in the
recent years. China leads the world effort
today in licensing bio-materials and
technologies for genetic engineering of
crops. Gene technologies licensed by a
leading university such as Cornell to
Indian and Chinese partners at the same
time has attracted ten fold investments in
China as compared to Indian public
partnership efforts. China is ahead of the
rest of the world in developing traits for
biotic stress mitigation in rice (China had
just approved the event for commercial
seed multiplication when India imposed
moratorium on the Bt Brinjal).
Aggressive licensing efforts have also
commenced in other countries such as
Brazil, Argentina, South Africa (cotton,
potato, vegetable crops et al). Indian will
lag behind China, but we do hope that
the Indian enterprises and Indian public
entities will intensify their efforts, once
the Bt eggplant moratorium is resolved.
Licensing of Technologies for Pro-
bono Application in Orphan Crops and
Small Acreage Crops
This is a reality that would happen to
develop crops that are not very attractive
for large commercial entities to commit
their shareholders' funds. Donation of
technologies for public good advantage is
a reality. It is true in the case of Bt brinjal
that has been developed by public
partners in India (all the public partners
have the right to deliver technology to
resource poor farmers and have no
obligations whatsoever to Monsanto, as
claimed in many quarters). Bio-material
donations have taken place for the
development of late blight resistance in
potato, drought and salinity tolerance in
rice and virus resistance in crops. My
organization has provided access to
several vital genes of interest to public
research partners. These partnerships
thrive on mutual recognition of best
Investments in GM Crops Research
Power of Partnerships
practices in research, regulatory
validation and responsible product
dissemination. The donor expects the
recipient to engage in responsible
application and use of technology for the
public good. The public research
investment to encourage crop
development based on public good
donations of technologies will help to
address resource poor farmers gaining
access to technologies for low acreage
crops and crops of lesser commercial
interest. Otherwise, these crops tend to
become extinct from commercial
cultivation, threatening the vital bio
diversity of the country and nutritional
security. The public sector will play a
more predominant role in addressing
traits in plant varieties that are currently
under-researched by private entities. If
the three public partners (Tamil nadu
Agricultural University, Coimbatore;
University of Agricultural Sciences-
Dharwad; and the Indian Institute of
Vegetable Research, Varanasi) had not
engaged in the development and
validation of Bt brinjal, twenty two
popular varieties accessible to resource
poor farmers would not have been
possible.
In conclusion, public research at the
global level will increasingly be
integrated across the countries engaged
in progressive research at the upstream
level. Cross-country partnerships in
genomics platforms, SNP consortiums,
sharing of genetic resource database and
other efforts will increase among the
progressive nations. India has the
potential to play a key role in this regard.
At the mid-stream level, sharing of bio-
materials, research tools and
technologies for accelerated trait
integration will flow to regions that are
attractive with high market growth. At
the downstream level, technology
licensing will accelerate with corporate
entities and public research entities
engaged in integrating bio-materials for
trait integration and validation. Our
success in India will depend upon our
ability to nurture the co-existence of
these diverse forces for synergic gains.n
BIOTECH NEWS 95

FEATURE
Investments in GM Crops Research
Public Sector Priorities
S.K. Sopory
T
he pressure for the production
of more food for growing
population, especially in the
developing countries, and its availability
at an affordable price for the low income
consumers will always remain unless
and until the population load decreases
at this part of the planet. However, one
does not foresee this happening till next
50 years or more in the Indian
subcontinent. Therefore to produce
more food from the same arable area,
infact from decreasing cultivable land,
will be a major challenge for the
scientists, policy makers, farmers and
other stake holders. All of them will
have to work in unison, whether they
represent the public sector bodies or
private sector organizations, to remove
hunger and malnutrition, which are
some of the biggest challenges facing our
country. We feel that new technologies
like GM plants, other innovations,
farming practices, business models and
consumer awareness can come to our
S.K. Sopory Ph.D is Senior Scientist, International Centre for Genetic Engineering and Biotechnology (ICGEB), New Delhi.
(Email: sopory@icgeb.res.in)
96 BIOTECH NEWS
rescue once again. They can help us
reject the Malthusian hypothesis and
usher in a third generation agriculture
revolution supported by new
biotechnologies, in contrast to the first
green revolution which was propelled by
the use of dwarf varieties and, the
second revolution which was driven by
using hybrid vigor. More serious
deliberations are needed to find out how
to optimize the use of biotechnologies in
general and GM technology in
particular, to improve food and
nutritional security in our region.
While the above question may
be more global in nature, it has special
relevance for the Asia- Pacific region
where about 53% of its 3.6 billion people
are engaged in agriculture (& related
activities) and yet hunger and
malnutrition is widely prevalent here.
This region has high biodiversity but not
enough strengths in developing
knowledge based applications of
modern biotechnologies specifically in
u
the agri-sector. In this regard India and
China and a few other countries are an
exception in the sense that they have
technologies and expertise to utilize the
new biology paradigms, such as
production of GM crops, and
importantly these are available in the
public sector. However, their field- level
application has been hindered due to
exhaustive costs involved in the
experimentation for testing for biosafety
and environmental safety, and also due
to the scare raised in the minds of public
against GM crops. Recently, China
announced the approval of GM rice and
maize for commercial cultivation. The
public sector in India will, therefore,
have to further increase its inputs in the
agriculture biotechnology area and work
on many traits of agronomic
importance to enhance food production.
We suggest that the present support
towards this by DBT, CSIR, DST and
others should be continued or even
increased towards the development of uu
VOLUME 5 | NO. 2
GM crops, as their production will
overcome many constraints in achieving
higher productivity, despite the
controversy raised by the non-scientific
debates on GM brinjal.
Since the time mankind learnt
to domesticate plants for food and feed
and other daily needs, they have always
sought to incorporate new experience,
knowledge and tools to increase
productivity. The techniques of
developing new varieties and strains
through selection, hybridization, and
mutation, exploiting hybrid vigor and
overcoming crossability barriers between
cultivated and wild species, use of tissue
culture for multiplication, and anther
culture for haploid breeding and
dihaploid production have evolved with
time and have been applied with great
success in a number of plant species.
Though not obvious to farmers,
consumers or policy makers, the scientist
knew that the basis for developing
variability was infact the shuffling of the
APRIL, 2010
genetic material within and across
genotypes to obtain desirable
combinations. Creating new variations
from the existing ones was infact taught
to us by none other than a monk, Gregor
Mendel. Having come a long way from
phenotype based selection, which of
course is relevant even today, we have
assigned genes governing various
physiological and developmental traits
in plants. Using the same genetic
foundations laid down by Mendel and
his many successors and making use of
high-end technologies and genomic
approaches, it is possible to first identify
specific gene or genes controlling a trait
and in turn use them in a more surgeon-
like- precision and also in a predicable
way to modify the targeted characters in
the crops of interest. The GM
technology has enabled sourcing of
desirable traits across wide species
barriers, thus greatly expanding the
choice of genes available for crop
improvement. There may be, in certain
Investments in GM Crops Research
Public Sector Priorities
cases, some health and environmental
safety issues associated with adoption of
GM technology, these concerns need to
be addressed quickly. India is one of the
few countries in the developing world
that put the appropriate regulatory
systems in place to address these
concerns related to human, animal and
environmental safety. Infact, it is with
ever increasing demands from various
corners, justified or not, that the
biosafety regulations have become more
stringent which have made it almost
impossible for many public sector
organizations, for lack of increased
financial support and expertise, as
mentioned earlier, to convert their
discoveries in the laboratory to products
of immense use to the farmers and
consumers. The gap between discovery
and product is currently filled by private
companies. Initially, it was the domain
only of some multinationals but over the
years indigenous companies have also
come up with investments in this sector. uu
BIOTECH NEWS 97
 Investments in GM Crops Research Investments in GM Crops Research
Public Sector Priorities Public Sector Priorities

u species. Recent work in this area has mitigated using pesticides etc, yet it is The area on NUE has so far received
revealed that it is more often the important, from an environmental point less attention but cannot be ignored in
expression of genes, a quantitative of view, to reduce the use of pesticides future planning .
parameter, that is important to confer and develop organic farming practices by With ever decreasing levels of
stress tolerance, rather than bring in a developing GM plants that can fossil oil, the world over research has
GM Crop Varieties Under Development in Public-Funded Institutions totally new allele or gene from across withstand the pest, fungal, nematode been put on fast track mode to develop
diverse genera or even the kingdom. and bacterial attack. Work should also alternate sources of fuel. Research on
S.No. Crops Organization Traits/Gene Under such conditions, using the right be undertaken in using necessary bioethanol and biodiesel need special
Insect resistance/ cry1Aa and cry1Aabc promoter and adopting marker and technologies to stop post-harvest losses. attention. GM technology probably can
Brinjal Indian Agricultural Research Institute , New Delhi
1. cry1Ac
Tamilnadu Agricultural University, Coimbatore
cry1Ac
reporter free technology, it should be One of the area in this sector that has come handy to increase higher biomass.
Central Institute of Cotton Research, Nagpur possible to develop GM plants, which not yet got much attention is to develop The same plant, like sorgum, can be
2. Cotton Insect Resistance, herbicide tolerance
University of Agricultural Sciences-Dharwad cry 1Ac gene will be safe and stable. Genomics seeds that are tolerant to fungal infection used for both grain production and
International Crops Research Institute for the studies, which need more funding in and do not produce aflatoxins. higher vegetative mass for bio-fuel.
3. Groundnut Virus resistance/ Chitinase gene
Semi-Arid Tropics, Hyderabad future, have given us many new lessons Currently emphasis has been to While private sector would be more
International Crops Research Institute for the in gene functions. It is possible that either increase the productivity or interested in these areas, in a country
4. Chickpea Insect Resistance/ Pod borer, cry 1Ac
Semi-Arid Tropics, Hyderabad
many traits will be regulated by more decrease losses in the mainstream crops like India, the public sector should also
5. Mustard University of Delhi South Campus, New Delhi Hybrid seed, barnase/ barstar gene
than one gene. In this direction gene like rice, wheat, legumes and vegetables enhance its presence in research in the
International Crops Research Institute for the Pod borer and Fungal pathogen, cry 1Ac
6. Pigeonpea stacking is a possibility. Multi-gene etc. Support for work in these areas and area of bio-energy.
Semi-Arid Tropics, Hyderabad and chitinase
Central Potato Research Institute, Shimla, Ama1 and Rb gene derived from Solanum engineering thus should be supported crops , especially post-harvest losses in Besides shortage of food, the
7. Potato National Institute of Plant Genome Research, bulbocastanum in future research programs. In India, a vegetables, should be continued. The nutritional quality of the available food
New Delhi number of groups have identified many future programs should pay more is also a cause for concern. The
Cry1B-cry1Aa fusion gene
8. Tamilnadu Agricultural University, Coimbatore novel gene(s), which have been attention for value addition in the millets deficiency of proteins, vitamins and
Rice cry1Ac, cry2Ab
Rice chitinase (chi11) or tabacco osmotin gene functionally validated to confer stress and maize. A number of projects have minerals leads to anemia and blindness
9. Sorghum National Research Centre for Sorghum, Hyderabad Insect Resistance, Shoot borer tolerance. However, the proof of concept been supported in this area , however, in a large section of the population
Indian Agricultural Research Institute, New Delhi Antisense replicase gene of tomato leaf curl virus needs to be translated into products. the modern bio technologies have not especially the under privileged. The GM
10. Tomato National Institute of Plant Genome Research, cry1Ac The Govt. should thus fund more been fully utilized to harness the technology can play an important role in
New Delhi
projects in the public sector or under benefits of these plants which can be alleviating such shortcomings of the
Compiled by: K.S. Charak, DBT (Email: charak@dbt.nic.in)
public private partnerships to take the grown under harsh conditions and at main food items of the poor. Studies on
u This effort has now been further water, land and energy. Therefore one Selection can be even done under the leads obtained in different labs for field the same time are capable of producing availability of nutrients in the soil, like
catalyzed by Govt agencies like DBT will have to either look for genetic simulated conditions that may be testing, as mentioned earlier. high nutritive quality grains. iron, zinc and calcium, their uptake
who have initiated programs such as variability in the crop plants which will brought forth due to climate change and One foresees that water would The change in the food habits in the mechanisms, and bioavailability, can be
SIBRI and BIPP to support public be able to adapt to the above scenario or global warming. If the variability can be be a serious limitation for agriculture country from vegetarian diets to a non- the foundation on which future
private partnerships to convert ideas, one has to create new biotech crops obtained from the existing gene pool and growing plants like rice would seem vegetarian diet has wider implications in strategies for plant modifications can be
knowledge and technology to quickly capable of growing well under the above within the species or wild related a luxury. Though direct seeding for rice terms of food security. Investments will based .
take products from laboratory to constraints. species, one could then employ these in can be achieved to save water, this can have to be made in improving research The GM technology has great
farmers, which will yield high dividends One general area in which the the breeding programs. It has however be made possible only if one can take and applications in “ poultry and animal potential to improve crop productivity,
in terms of enhanced productivity with public sector should invest in is in the been seen that for many of the complex care of the problem of weeds. Hence, feed sector”. Alternate sources of feed , decrease yield losses due to various
minimal inputs. area of phenomics. Being a highly traits, which are governed by multiple weedicide resistant crops would be like modified marine algae , could also stress conditions, prepare plants for
Keeping the above points in biodiversity-rich country and having genes, the present breeding tools are not desirable for such agricultural practices be explored. adaptation to future environment
mind the question we address is many accessions of different crop plants, sufficient. Under this scenario, the best and for this GM technology can come The green revolution following climate change predictions,
whether to use GM technology or not, it would be worthwhile to undertake chance for of developing new variants is handy. In all these cases, irrespective of depended, in addition to the variety, on improve nutritional quality of food and
but what traits should one give such studies. In many other countries via GM technology and this can also be the traits one is looking at, gene high fertilizer inputs and irrigation. Both feed. It is time that we benefit from the
emphasis to while trying to overcome high- end equipment and other green deployed with in the existing breeding discovery to business models leading to these inputs have had their side effects. advancements made in the area of plant
the problem of shortage of food which house facilities have been created, e.g., programs. benefits for the farmers and consumers Ground water contamination by nitrate genomics, plant transformation, soil
is expected to increase under a global in Australia and networks developed in The other area in which more need to be developed. Further, as the and phosphorous has created lot of microbiology and agro-technologies and
climate change scenario? What are the Europe, to test for various parameters efforts are required is to develop GM plants growing under harsh hazards. It is therefore essential that in incorporate GM crops in the
key areas in which investment should be such as root growth, stomatal plants that are tolerant to cold environmental conditions may not yield future our agricultural practices should mainstream agricultural system, after
made from Govt funding? functions, overall yield etc, under stress (specifically for cold desert areas), high as much as expected, the seed policy depend on less of both. The GM these have been approved through the
and nutrient deficient conditions, to look temperature, drought, salinity tolerance. may also probably need to be addressed. technology will be most appropriate to biosafety screening system that is robust
Future agriculture will have to
deal with more of high temperature, for variants that will perform best under For many of these traits it is possible to While compared to abiotic develop high nitrogen and water use and transparent.
high salinity, high CO2 with less of specific environmental conditions. get the gene(s) of interest from a related stresses, most biotic stresses can be efficient ( NUE, WUE) crop plants. (The author is thankful to Dr Suresh Nair, ICGEB
for his help in the preparation of this article).n
uu

98 BIOTECH NEWS VOLUME 5 | NO. 2 APRIL, 2010 BIOTECH NEWS 99

 Genetically Modified Crops

Public Perceptions
FEATURE
u transfer is an 'unnatural' technology.
This is a rather strange argument. All
technologies are more or less unnatural
since they are human-made and do not
occur naturally. Any societal move away
from food gathering has always been
based on such 'unnatural' technologies.
Genetically Modified Crops In fact, this has been used by pro-GM
groups to claim that the products are

Public Perceptions there in nature and just transferring traits

from one set of organisms to another
does not constitute anything radically
new and potentially harmful.
Interestingly, they would also like to
create monopolies through patents
claiming these are novel products! The
fact is that, like any other technologies,
each GM product is a new product and
will need careful safety testing before
Satyajit Rath Prabir Purkayastha release.
This is an issue that scientists
have raised right from the beginning.
The Asilomar Conference on
Recombinant DNA in 1975 set out

T
he Bt brinjal debate has been
largely simplified as an
ideological disagreement
between camps either anti- or pro-
Genetically Modified (GM) crops, at
least in the public eye. There is no
denying that the vitriol of the debate is
in part due to ideological differences.
However, what is missing is the public
awareness that the disagreements fall
into two distinct categories, and that
conflating those is a grievous error in
determining public policy.
One disagreement is over the anti-GM
characterization of GM technologies as
intrinsically and catastrophically
harmful. A second disagreement is over
the nature of the GM crop technology
ownership and the effect of such
ownership on agriculture in India. Anti-
GM groups have sought to brand GM
technologies as intrinsically harmful and
to identify GM with rapacious
multinational corporations (MNCs).
This brings ideologically distinct groups
Satyajit Rath Ph.D. is Staff Scientist, National Institute of Immunology, New Delhi. (Email: Satyajit@nii.res.in)
Prabir Purkayastha Ph.D. works with Delhi Science Forum, New Delhi. (Email: prabirpurkayastha@yahoo.com)
together in uneasy and ill-fitting unity.
Thus, many socially progressive
movements find themselves in awkward
alliance with nativist and anti-modernity
opinion. On the other hand, pro-GM
argument in the public sphere has
portrayed GM technology with a
patronizing air of triumphalism making
the MNC ownership of GM
technologies a core component. This has
made the weak voice of the Indian
scientific community sound like a
handmaiden of an international
agribusiness juggernaut. It is essential to
separate the wheat from the chaff in all
this if we are to make public policy
about practical social good in
agriculture.
The issue of genetic
modification of crops and livestock is
undoubtedly complex and replete with
serious issues. The key questions are, is
it practically possible in India to evaluate
the risks and benefits of such
technologies, and to what extent are the
concerns specific to GM technologies?
Any significant technological advance
generally involves serious issues. Major
technological advances have always
come with attendant uncertainties and
risks. When we have no data to evaluate
risk, the situation is one of uncertainty,
and little reasonable prediction can be
made. But we do know enough to be
able to evaluate the risks of GM crops.
So long as we are not dealing with
catastrophic consequences, we can set a
'safety' threshold of a certain low
likelihood of adverse consequences in
order to permit the use of a given
technology. The weight of evidence
indicates that GM technology carries the
risk of non-catastrophic consequences
(as opposed to, say, nuclear weapons,
which carry the clear risk of catastrophic
consequences), and can therefore be
reasonably examined and used with
care.
One frequently heard criticism
of GM crops is that horizontal gene uu
voluntary guidelines on what could be
done consistent with safety. Till the
guidelines were formulated, they even
imposed a moratorium on further
research. However, things have changed
radically since then. At that time,
scientists were in the business of doing
science today a number are closely tied
to corporate interests. Scientists are no
longer just experts their personal
fortunes could also be riding on their
opinions. And while one could say that
scientific issues are best resolved by the
scientists, the introduction of a
technology into society is not a scientific
question but a policy problem embedded
within social and political issues.
More mundane safety related
issues of biotechnology arise from the
genetic material thus transferred. There
are health safety issues and
environmental safety issues. Some of
these arise from the imprecise insertion
of genes by this technology. A variant of
this concern is that the inserted gene, or
even the insertion process itself, may re-
engineer the biology of the plant and
generate poisons. While this possibility
certainly exists, it is not unique to GM
technology. Breeders of potatoes, for
example, know well the possibility that a
hybrid potato made from two good
varieties can generate high levels of toxic
material.
Another safety issue arises
from the possibility that genes and
proteins may behave differently in
contexts other than the one they were
taken from. This can give rise to the
generation of allergic reactions. A
brazilnut protein in GM soyabean and a
bean protein expressed in GM peas have,
for example, generated significant
allergic reactions. Similar studies with
many other GM crops, however, did not
find any allergogenicity. Once again,
food allergies are not unknown with
non-GM foods either.
Another issue that arises, and
sounds even more appropriate in cases
such as Bt brinjal, is the potential of the
introduced gene product, such as the Bt
toxin, to cause human/livestock harm.
While there is a fair amount of
understanding about the mechanisms by
which, say, the Bt toxin works, this, like
all other safety concerns, can only be
addressed case-by-case through pre-
release testing.
A key question is, for how long
is monitoring to be done in the pre-
release tests? There is no obvious
endpoint, since in theory, it could take
years or decades to make the ill-effects
of a poisonous substance manifest. But
in the absence of any evidence that GM
crop technology carries the risk of
catastrophic consequences, demands for
the unattainable absolute proof of safety
begin to sound like ploys to keep the
technology out of use no matter what
the evidence. Undoubtedly, there was
need for abundant caution and rigorous
testing when Bt was first introduced into uu

100 BIOTECH NEWS VOLUME 5 | NO. 2 APRIL, 2010 BIOTECH NEWS 101
 Genetically Modified Crops
Public Perceptions
u crops. While it was true that Bt in its
natural state in the bacteria has been
long used as a bio-pesticide, that by itself
does not mean that Bt is going to be safe
in its new form in a GM crop. However,
by now the world has experienced a fair
diversity of Bt crops, including food
crops. Bt Corn has now been accepted
for imports even in Europe. In this
context, while food crops require
particular attention, almost all crops
enter the food chain one way or another;
there is no impermeable barrier between
food and non-food crops. A case in point
is Bt cotton in India. Bt cotton stalks go
into cattle feed and milk products
obviously come from cattle. Cottonseed
oil also enters the food chain. While
case-by-case safety testing still remains
the correct norm, the argument that
there could still be a catastrophic danger
from the Bt protein in GM crops seems
less and less valid.
The issue of long-term toxicity
with GM crops has also been
particularly raised since, once a GM
crop is released, there is no effective call-
back. This is also the context in which
the potential threats of GM technology
for diversity in both crops and the
biosphere have been excitedly discussed,
since there is a possibility that the
introduced genetic modifications would
spread naturally both to other varieties
of the same species, and also to other
related species. How harmful is such
spread likely to be to crop diversity and
to biodiversity?
Most GM crops have one (or two) genes
introduced into them. These genes can
be easily bred into any variety of the
crop, as is done, for example, with Bt
cotton. This does not appear to lead a
'loss' of the variety in the sense of
flattening out the diversity landscape,
since the same number of varieties, with
differing trait profiles albeit with an
introduced gene, would still be available.
However, it is nonetheless true that GM
crop usage has led to a reduction in the
diversity of crop varieties being planted.
It is useful to note that this is not related
102 BIOTECH NEWS
to the 'GM' nature of the technology, but
to the imperatives of the marketplace
and to the fact that the technology is
owned and marketed by MNCs which,
in order to achieve the profit scales they
need, will aggressively drive high-volume
seed sales. Such corporate control of
agriculture is likely to promote the
process of monoculture that tends to
thin down biodiversity on the ground.
Thus, this is not an issue intrinsic to GM
technology, but to its ownership.
In essence, the issue is not
whether GM crops are without risks, but
whether the regulatory protocols
developed and used for testing them
sufficient for the purpose of evaluating
their safety. As noted above, GM crops
appear to carry risks of non-catastrophic
consequences of the kinds and scales
that society is familiar with. Therefore, it
is not unreasonable to suggest that
familiar safety-testing protocols will
serve societal needs well in this context
too. Protocols for testing GM crops have
been developed by international and
national bodies over time. They will
continue to be strengthened and
improved, but either-or positions vis-à-
vis GM crops are unlikely to contribute
to that process.
One major criticism of the
basis on which the Genetic Engineering
Approval Committee (GEAC) cleared Bt
Brinjal, has been the alleged unreliability
of the safety data. Safety data submitted
by the company, with a vested interest in
a favorable outcome, are deemed to be
suspect in this argument. And in this
context, the real issue that arises is a
question we are depressingly familiar
with: do we have strong implementation
of these regulatory processes and
protocols? The answer to that is likely to
tend to be more and more in the negative
the greater the involvement of powerful
interests, such as deep-pocketed MNCs.
This is as true of, say, drug approvals, as
of crop approvals. Again, who owns
GM technology appears to be far more
crucial an issue than its 'GM'ness.
These issues need to be seen in
the larger context of Indian agriculture
and food security. With a growing
population and with persistent problems
of poverty and malnutrition to address,
there is little doubt that increases in food
production would be immensely useful.
What is the possible role of GM crop
technologies in this context? The anti-
GM position is frequently apocalyptic
with regard to the risks of GM crop
technology, and therefore negates any
useful role for it. It is also frequently
allied with nativist anti-technology views
of agriculture, in which back-to-nature
approaches are seen as the most
appropriate solution. On the other hand,
the pro-GM position frequently sounds
as though GM crop technology by itself
can be a major solution.
As far as the evidence goes,
there is no reason to think that GM crop
technology carries catastrophic
consequences, and therefore it is indeed
proper to consider its possible
advantages for Indian agriculture and
food security seriously. However,
anybody who thinks that any one
category of approach, nativist or GM, is
going to be a common panacea for
India's food security is refusing to
acknowledge the sheer diversity and
complexity of agricultural practices and
needs across the country. For example,
anti-GM favorites such as the integrated
pest management system (IPMS) or the
system of rice intensification (SRI)
depend on their success on rigorous
practices and additional equipment, and
may be successful in some situations and
not in others. Thus, the use of GM crop
technology is going to be a part of our
food future, not because it is the sole
answer to the problems of Indian
agriculture, but because it can expand
the basket of choices available to a wide
variety of farming communities. While
GM is certainly not the only answer,
there is little doubt that it can very much
be a part of the answering strategies. It is
possible to grow more drought-resistant
or salinity-tolerant crops, or use less
pesticides, for example. Some of these uu
VOLUME 5 | NO. 2
u do not need transgenic technologies.
Molecular genetic marker-assisted
selective breeding is another tool that
can help in achieving some of these
aims. Achieving true breeding of hybrids
will also help in a different way. But all
of these tactics together would help to
expand the basket of choices available.
Regulating GM Crops
Global Best Practices
(Contd. from page 87)
other inputs at the time of review and
decision making, and address them all.
All irrelevant comments and inputs
should be pointed out as such. This is
best accomplished by through internet
based input. However, other forms of
input must be allowed in writing. It is not
necessary that all inputs must be
incorporated, and reasons for not
incorporating must be spelled out.
Statutory Time Limit
Because time is money, all applications,
either for contained or confined or large
scale/commercial release must be
reviewed within a statutory time period
so that there is standardized period in
which the application will be disposed
of. This time limit must be fixed
depending upon a reasonable time
required to complete the regulatory
review. However, the authority can
reserve the right to “stop the clock” to
resolve a legal or scientific or technical
issue relative to the application. This will
establish a level playing field for all
applicants, and pave the way for planned
commercialization.
Confidential Business Information
(CBI)
In this competitive world, it is critically
important for the developers of
technology to protect their CBI from
leaking out into the public domain
through the regulatory process. In
accordance with the Right to
Information Act (RTI) provisions, sound
APRIL, 2010
It is thus clear that, while there cannot
be a mere technological fix to the
problems of Indian agriculture,
technology will be part of the solutions.
The farm sector is also seeing a huge
squeeze on its income the prices of
inputs are rising faster than the output
prices. The increasing corporatisation of
principles and guidelines must be
developed to protect the CBI. If not, the
authority is likely to be challenged in the
courts.
Cost of Regulations
Whatever be the regulations, there is
always a cost associated with it, both for
the regulatory authorities and the
applicant. Unnecessary regulatory
burden will increase costs of regulation
and regulatory compliance which will in
turn make the technology costlier, and
even threaten to stop technology
development. That is why it is important
to carry out proper risk assessment and
regulate it scientifically as the identified
risks dictate. The most important goal of
regulations must always be safe
deployment of GM crops based on
scientific risk assessment alone.
Therefore, scientifically based regulations
must be the standard bearer of any
regulatory system. Cost of regulations
can seriously hamper technology
development all over the world.
Socio-Economic Impact Study
Socio-economic impact study is dictated
by the Cartagena Protocol on Biosafety
and governs only the trans-boundary
movement of GMOs. In other words, it
is important for any developer of the
technology or user of the technology to
determine risks, benefits of the
technology and its good services, and
how it might be accepted by the public in
their societal context. Such an
Genetically Modified Crops
Public Perceptions
inputs, as exemplified by the Monsanto-
driven Bt-crops, exacerbates this squeeze
further, and must be an issue of concern.
The technological worries relating to
GM crops appear relatively minor in
comparison, yet, sadly, it is these techno-
worries that hold centre-stage in the
ongoing debates.n
assessment has a place in larger scheme
of things, and must be encouraged, not
as a part of a biosafety regulatory review
process. This will have to be done from
time to time as societal circumstances
also change from time to time.
Conclusions
Regulations and regulatory standards are
not etched in stone as science and
technology keeps progressing all the
time. Regulations must keep pace with
the technology development. Regulations
have always come after the development
of technology, and have had a
tremendous impact on technology
development. Improper or undue
regulatory burden can hamper
technology development and this must
not be allowed to happen in case of
modern biotechnology in Indian
agriculture. Risk appropriate regulations
must be the corner stone of any sound
regulatory system, and therefore rigorous
scientific standards alone must underpin
the system.
A reliable, credible and
confidence inspiring regulatory system is
the order of the day. Regulations must
not be allowed to be used to stifle
creativity and technological
development. Politicization and
ideological motivations must not be
allowed to dictate either the regulatory
framework or the regulatory policy.
When a science based dynamic
regulatory system is in place, there is no
reason why GM crops cannot be
deployed safely for the benefit of all.n
BIOTECH NEWS 103
 CROSS FIRE CROSS FIRE
The recent approval of the Genetic Engineering Approval Committee for release of Bt brinjal for commercial cultivation in India and subsequent moratorium imposed by
the Ministry of Environment and Forests evoked strong and diametrically opposite views being expressed on GM crops in the media by a variety of individuals. Biotech
News contacted three prominent people and requested them to articulate their views and concerns for the benefit of our readers. As readers may notice the gap in
perceptions is still wide!
Suman Sahai Ph.D.
C Kameswara Rao Ph.D.
President, Gene Campaign, New Delhi. Executive Secretary, Foundation for Biotechnology Awareness and Education, Bangalore.
(E-mail: mail@genecampaign.org) (E-mail: pbtkrao@gmail.com)

A s a scientist, I am a believer in
science and the several benefits it
can bring to mankind. But after
stepping out of the ivory tower of the
genetics laboratory and allowing myself
to reflect on the applications of science, I
have come to understand that the purity
of science is often muddied when it is
translated into a technology. Science and
Technology can do a lot of good but if
incorrectly used, they can also do a lot of
bad.
As we face an era of
transformative technologies: genetic
engineering, synthetic biology,
nanotechnology, stem cell research and
others that have not even got names yet,
we realize the forces that these
technologies can unleash, both for good
and for not so good.
For me, a not insignificant cause
for concern in the field of science and its
application, is its privatization. When
science is in the public sector, it creates
public goods which serve the public
interest. Whatever the drawbacks of the
Green Revolution, it was a public sector
technology that brought a big jump in
food production. Farmers took the seed
and made it theirs, so the seed spread
where conditions were favorable. There
were no patents on the seed, no private
ownership. Increasing food production
rather than maximizing profits , was the
driving force of the Green Revolution.
When science and technology are in the
private sector, they are owned by the
companies. The patents make them the
owners of the seed, not the farmers. The
eye is on profit, not the public's needs.
Compromises are often made on the
safety of products as the many instances
in the pharma
sector have shown,
because there is
money riding on
M y support to genetically
engineered (GE) crops is based
on the ingenious science and
the strict regulatory regime that ensures
the efficacy and safety of the products and
consumption in India make it an urgent
need to raise crop productivity without
additional area of arable land or irrigation
facilities. We need to increase crop yields
institutions. Some varieties of Bt brinjal
were developed in a private-public
partnership. Indian seed companies, not
MNCs, are now conspicuous in the
biotech scene, because the public sector
the investments by a) enhancing tolerance to drought,
and profits must be the benefits that would accrue on their flood and salinity, and b) controlling the could not meet with the enormous
made yesterday, commercialization. pre-harvest losses due to weeds, diseases financial costs of the excessive biosecurity
not tomorrow. Global cultivation of GE crops and insects. GE has an enormous regulation.
This is as true of increased from 1.7 mill ha in 1996 to 134 potential in boosting crop productivity. In 14 years none of the scare
Agri- mill ha in 2009, in 16 developing and 9 This is not offered as a single silver bullet stories of the activists have materialized
biotechnology as developed countries, which is a testimony but has to be dove tailed with other plant and there is extensive literature proving
of pharma and to the benefits the technology offers. A breeding and modernized farming them wrong. Even the possibility of
other privatized quarter century of research experience, techniques and also put in place adverse effects on human health from the
S&T sectors. over 14 years of experience in biosecurity appropriate infrastructure and transfer of the two selectable Antibiotic
I have no regulation and commercial cultivation in management practices. Resistance Marker Genes (ARMGs),
ideological over 25 countries demonstrated that GE The excessive use of pesticides nptII and aadA, from GM plants to
position on crops are effective and safe. No by the farmers
Genetically conventional food product has a record of has built up
Engineered (GE) such prolonged and rigorous efficacy and resistance in the
crops and foods. safety evaluation. Over 350 million pests, harmed
As a scientist and Americans consumed biotech foods for 14 non-target
responsible citizen, years without untoward effects, the largest organisms, left
I would evaluate experiment ever on human food safety. residues in the
these crops and Indian farmers opted for Bt food and
foods for their cotton because it is profitable to them. Bt contaminated
safety and cotton (mostly Bollgard I with Cry 1 Ac soil and water.
relevance for the gene) cultivation increased between 2002 To contain these
small farmer and and 2009, from 0.5 mill ha to 8.5 mill ha. problems, Bt
for food security The farmer now prefers Bollgard II, with technology
the nature of stacked genes Cry 1 Ac and Cry 2 Ab, as would be an
safety tests that are it is more efficient than Bollgard I, in important
being conducted, controlling the bollworms. It is reported component of
the absence of post from China that a Bt crop also reduces Integrated Pest
release monitoring pests in the neighboring non-Bt crop Management.
mechanisms and fields. A technology needs a chance to About
other regulatory prove itself, which was denied to Bt 60 of 80
issues. It is here brinjal. transgenic traits
that I have grave The share of agriculture in in over 30 crops
solve the hunger problem is annoying. India's GDP has fallen to 16.6 per cent
doubts. being developed
Any intelligent person (and that includes from 46.3 per cent about six decades ago,
The ridiculous propaganda by in India are in
scientists and policy people in the public which does not reflect a successful policy.
both corporations and scientists in the the public or
and private sector) knows that GM crops Anticipated increase in population and
public sector that GE foods are needed to autonomous

104 BIOTECH NEWS VOLUME 5 | NO. 2 APRIL, 2010 BIOTECH NEWS 105

cannot solve the problem of hunger. What
will solve hunger is access to productive
assets to grow food and/or income to buy
food. Despite knowing better, the
mindless propaganda is pushed
aggressively to promote the technology.
GM technology may play a role in solving
one or the other problem that
conventional breeding has not been able
to but to promote it as the solution to all
problems is irresponsible and silly.
Using the Bt Gene
There is an unacceptable reliance on the Bt
gene in the current research program on
transgenic crops. According to data given
in a Current Science paper by Manju
Sharma, former Secretary of the
Department of Biotechnology, over 42
percent of the Ag biotechnology research
projects were using the Bt gene. Ranging
from cotton to potato, rice, brinjal,
tomato, okra, cauliflower, cabbage, coffee,
maize, even tobacco (!!) the Bt gene is
everywhere.
Assuming that the crops that are
being researched will reach the fields one
day, we would face a situation when a
wide range of crops growing in both the
Rabi and Kharif season will contain the
Bt gene. So throughout the year, there will
be standing crops containing the Bt
endotoxin. Not just that, in the same
season, there will be various Bt crops
juxtaposed with each other in small fields
when farmers grow a variety of different
crops, for example vegetables. When the
bollworm is exposed to the endotoxin,
constantly, season in and season out, the
bollworm is going to build up resistance
very fast. What can be the future of Bt
technology with this kind of deployment
of the Bt gene?
We need to question whether
the Bt approach is workable in a
developing country situation like ours
where the pest profile is diverse and the
pest density much larger than in colder
temperate regions. The decision to use the
Bt route to disease resistance should be
taken only after all the other factors that
would operate under Indian conditions,
are evaluated.
If the Bt strategy were indeed
selected as a viable path of disease
resistance, it cannot be used in thirty five
crops. Since cotton uses more pesticides
than any other crop, perhaps the use of
the Bt technology should be reserved
solely for the cotton crop, to be managed
with extensive farmer education and
monitoring of insect refuges. This could
106 BIOTECH NEWS
CROSS FIRE
allow the bollworm to remain susceptible
for a longer period. However, there other
concerns which pose a challenge to the
efficacy and applicability of this
technology for cotton farmers in India.
In India, apart from the
bollworm, sucking pests like mealy bug,
aphids and whitefly are serious pests and
wilt is a not uncommon disease. A strong
attack of either of these can wipe out the
cotton crop whether it contains the Bt
gene or not. In this situation, is the Bt
technology an effective and affordable
protection for the cotton farmer ? Would
it not be more profitable to adopt
Integrated Pest Management (IPM)? IPM
is not just affordable, it is also sustainable
and it is a technology which the Indian
farmer knows and can absorb well. There
are studies conducted by ICAR that show
IPM is the most effective approach to pest
control in India. There is no reason to
abandon this strategy . In addition to all
this is the fact that Indian farmers by and
large do not plant insect refuges to
manage resistance, so resistance
development and with it the collapse of
the Bt strategy is already scripted.
Much before Monsanto's
dramatic declaration in March 2010, that
Bt cotton was not resistant to the pink
bollworm, Gene Campaign had reported
as far back as 2003, that Bt cotton does
not offer protection against pink bollworm
(Pectinophora gossypiella). Pink bollworm
attack was found to be severe after 60 to
70 days. We reported that this was
supported by scientific literature. There
are reports that field populations of pink
bollworm harbor three genetic mutations
that confer resistance to Bt toxin. This
resistance is inherited as a recessive trait,
so caterpillars with two mutant versions
of the gene are resistant, but those with
one, or none, are susceptible.
Other studies study show that
the development of Bt.-resistant pink
bollworm larvae into adults takes longer
than the development of susceptible
larvae. This difference makes it more
likely that resistant bollworm moths
would mate with each other rather than
with susceptible individuals and all their
offspring would be resistant to the Bt.
cotton, as they would inherit two copies
of the resistance gene. So the Bt.
resistance trait would persist and spread in
the bollworm population. Pink bollworm
was already identified as a pest unaffected
by the Bt endotoxin, long before
Monsanto made its 'confession', to
prepare the ground for launching its
Bollgard II cotton with stacked genes.
Scientists confirm that the
incidence of pink bollworm is on the rise
and likely to get stronger every year.
Substantial savings in pesticide use could
not be expected in such a situation since
f GM plants to bacteria have not been
armers would have to continue to spray
to control pink bollworm and all the other
pests. It is for this reason that while
Indian cotton production is going up
because of superior genetic material
coming in the form of hybrids carrying
the Bt gene, expenditure on pesticides is
not coming down. This has been reported
by field studies, including those done by
TISS (Tata Institute of Social Sciences)
Mumbai, as well as Gene Campaign.
The Herbicide Tolerant Trait
Herbicide tolerant (HT) crops are
genetically engineered crops containing
genes that allow them to resist the
application of herbicides which are
chemicals that kill weeds as well as all
other plants except the ones that are
genetically engineered. The logic of
creating HT plants is to have crops that
will remain unharmed when chemicals
are applied for weed control. HT plants
can only be used together with the specific
herbicides that they are programmed for.
These are the company's proprietary
herbicides, so the farmer who buys HT
seeds from a company , also has to buy
the company's matched herbicide. Double
profits for the company but are there
benefits for the farmer? Does the rural
community benefit from crops that will
entail the killing of all the biodiversity in
the vicinity of fields with HT crops?
Controlling weeds by using
chemicals like herbicides becomes
necessary in the large land holding, labor
starved agricultural conditions in
industrial countries. In developing
countries like India weeds are controlled
manually. Farm operations like weeding,
sowing, harvesting, threshing and
winnowing are the key sources of rural
employment, especially for women. The
herbicide tolerance trait is essentially a
labor saving and hence a labor displacing
trait. In a labor surplus country like India,
it will have disastrous economic
implications. The Ag biotech Task Force
chaired by M. S. Swaminathan has
warned against introducing labor
displacing technologies like herbicide
tolerance.
The HT trait must be seen in the
context of how 'weeds' are perceived and
VOLUME 5 | NO. 2
bacteria, associated with the use of
ARMGs in GM plants, is recently ruled
out by the European Food
Safety Authority and the GMO and Bio-
hazard panels of the European Union. It
was noted that transfers of ARMGs from
shown to occur either in natural
conditions or in the laboratory, although
the two genes resistant to kanamycin,
neomycin and streptomycin are naturally
present in all environments.
In spite of the track record, GE
crops alone are segregated into an object
of politics and governance. Activist
groups trash the combined national and
global experience and wisdom on the
utility and safety of GE crops. They used
every trick to mold public opinion against
GE technology and to pressurize the
Indian Government to ban it and now
they partially succeeded with Bt brinjal.
Bt brinjal is a test case on both the sides of
the biotech divide, the hope that if it
succeeds other crops would have an easier
entry and the fear of the activists that they
would lose if it did, as they have already
lost on Bt cotton. During 2000-2009 Bt
brinjal involved some 200 scientists and
technologists from over 15 public and
private sector research institutions in
evaluating for performance and bio-
security, a process supervised by statutory
regulatory authorities and reviewed by
two Expert Committees. The second
Expert Committee considered Bt brinjal
as safe for consumption and that no
further tests are needed, basing on which
the Genetic Engineering Approval
Committee approved Bt brinjal for
commercialization, yet the Minister of
Environment and Forests (MoEF)
imposed a moratorium, creating
regulatory uncertainties that seriously
impact agri-biotech R&D.
In the absence of any
appreciable education, the public believed
the horror stories the activists publicized
with the help of the media which never
allow facts to interfere with a good story.
The public should be convinced that GE
technology is more precise than
conventional agricultural technology and
GE products undergo very rigorous
biosecurity testing before
commercialization.
As our major focus is transgenic Bt crops,
the following points would help in
enhancing public understanding of the
benefits and safety of the technology:
Bacillus thuringiensis (Bt) is a universal
APRIL, 2010
CROSS FIRE
soil bacterium which has been in the
food chain for ages, originating from
plant foods. Bt pro-teins were shown
to be harmless to most non-target
organisms, including mammals and
humans, even at high doses, by
ingestion, inhalation or injection.
Bt is one of the few pesticides
recommended for widespread aerial
application in North America and
was used to control forest pests and
urban moth infestations. No adverse
effects on human populations were
reported from the use of Bt in the
urban locations.
Reported death of farm animals and
birds in Andhra Pradesh was due to
causes other than consumption of Bt
cotton.
Several reports found no evidence for
Bt crop produce causing allergy.
Extensive data gathered by every
country's regulatory regime
convincingly demonstrated that non-
target organisms are safe from Bt
proteins.
Centuries of agricultural experience
does not indicate any alarming
possibilities of gene flow, which
depends upon breeding behavior and
genetic relationship of the species
involved, which GE does not change.
In a 10 year study of transgenic crops
in the UK, transgenics perished much
earlier than their non-GE
counterparts and did not become
super weeds to invade the
environment
GE crop varieties do not represent
any greater risk to crop genetic
diversity than the varieties of
conventional agriculture.
There is no scientific evidence that
presently commercialized GM crops
have caused any environmental
harm.
There is no terminator gene in any
crop anywhere in the world. The
technology is prevented from use in
any crop by international agreements
and/or governmental prohibitions.
Bt cotton was hardly the cause of
farmer suicides.
A country's science policy should be
framed by its scientific fraternity and
managed jointly by the relevant scientific
institutions and government departments.
In a democracy people's educated choice
must count but our policy is now being
dictated from the streets by vocal activists
to the benefit of the pesticide lobby,
organic lobby, and non-biotech seed
developers. Many activist groups are
MNCs, registered with the European
Union as political lobbyists to promote in
other countries through local NGOs, EU's
ideology based on political compulsions.
BIOTECHNOLOGY REGULATORY
AUTHORITY OF INDIA
The bill to go before the Parliament in
the Budget Session, 2010
Comments on Two Clauses in the BRAI
Being Contested by the Anti-Tech
Activists
I was member of the DBT's Committee,
chaired by Dr M S Swaminathan, that
met on February 3, 2007, to discus the
setting up of a National Biotechnology
Regulatory Authority. The move to set up
the NBRA (now Biotechnology
Regulatory Authority of India, BRAI)
came from the PMO and the Cabinet
Secretariat which directed the DBT to
constitute a Committee to shape the
proposal. The move did not come from
the Corporate Sector conspiring for a
diluted regulatory regime. Some NGOs
such as the Gene Campaign and the
South Asia Biosafety Program were on
this Committee besides those representing
the scientific community and the science
departments of the relevant ministries of
the GoI.
I have provided inputs in writing
to the DBT several times while the NBRA
document was in preparation and also
participated in the DBT consultative
meeting held in Bangalore on June 11,
2008. This meeting were disturbed by the
usual players of the Greenpeace and the
Environment Support Group objecting to
the very concept and need for the NBRA
(the din caused by them on February 6,
2010, at the Bt brinjal consultation
meeting was far less loud).
What I am conveying in this
note comes from my experience with the
development of the concept of the Indian
BRA and familiarity with bio-security
regulatory regimes of several countries.
For the time being, two clauses
in the BRAI which goes before the
Parliament soon, that relate to, a)
Confidential Commercial Information
and b) Punishment for propagating
misleading information, seem to have
become contentious, though rabble risers
are likely to pick some more else in course
of time.
BIOTECH NEWS 107

used in India. They are not considered
useless plants as in the west but have
several useful functions critical to the well
being of rural communities. Plants
collected as weeds fulfil two important
nutritional roles. They are largely
nutritious leafy greens, like Chaulai,
Bathua saag which are a valued, and free,
source of nutrition in the family's diet. A
typical rice field in India (or Bangladesh)
would yield at least twenty to thirty types
of leafy greens over the cropping season.
This access to free nutrition is one of the
reasons why nutritional status is better
among the rural poor than among the
urban poor who have to buy all their food.
Those plants that are not eaten by the
family, serve as fodder for the livestock
that rural families maintain as additional
income sources. India is a fodder starved
country and has a very large livestock
population. Free range grazing and fodder
from fields is a great support to
maintaining livestock. If rural families
had to buy all the fodder they needed to
maintain their animals, many would not
be able to afford livestock and would have
to forego the extra income.
Apart from this, using herbicide
tolerant crops would make it impossible
to plant crops on the field borders and the
raised bunds, as is done in many parts of
India and Asia for additional food and for
increasing farm incomes. Typically,
farmers will grow crops like yams, ginger
or vegetables on the bunds surrounding
rice fields. Thus two or three kinds of
produce are available from the field in the
same season. This advantage would be
lost if the package of herbicide tolerant
crop varieties and herbicide use would be
implemented. In addition, the practice of
inter-cropping and mixed farming would
suffer a setback. Traditionally farmers
plant more than one crop in the field.
Sugar cane for instance is interspersed
with lentils or mustard and it is not
uncommon to find farmers planting
mustard along with wheat, to be harvested
one after the other or linseed together
with lentils. Mixed cropping is widely
practiced, with differing combinations of
crops depending on the region.
In addition to the supple-
mentary food and fodder that they
provide, so called weeds are also the
medicinal plants that rural families
depend on for the health and veterinary
care needs of themselves and their
animals. The introduction of herbicide
tolerant crops with accompanying
108 BIOTECH NEWS
CROSS FIRE
herbicide use would kill the surrounding
vegetation and deprive rural communities
of the medicinal plants which form the
basis of indigenous healing traditions. It is
acknowledged by WHO that over 80% of
rural communities across the world are
dependent on medicinal plants and
indigenous systems of medicine.
Destroying the vegetation
around crop fields would deprive village
communities of crucial health care
opportunities especially in a situation
where the formal system does not
adequately address their health and
veterinary requirements.
Another serious outcome of
introducing the HT trait is the
development of new weeds because the
herbicide tolerance trait is known to shift
easily into other crops. In the case of
canola, all the kinds of HT genes that
have been used are found to have
migrated into other non-GM canola The
crop of concern in developing countries
though is rice. Several studies
have shown that the HT trait
shifts quickly to rice relatives,
specifically, from Oryza sativa,
the cultivated rice, to O.
rufipogon, a wild relative also
called red rice, which is a
commonly found weed in areas
where rice is cultivated. The
shift of the HT trait into a rice
weed like O. rufipogon will
have economic implications
because the red rice is a strong
competitor of the cultivated
rice and tends to take over rice
fields.
Regulation
The regulatory system has in
many ways been the lightning
rod for resistance to GE crops .
Because information was
impossible to get and
regulatory bodies treated the
public as adversaries rather
than concerned citizens, the
opportunity for dialogue was
never created. This has led to
animosity and distrust which
will not be resolved unless an
honest dialogue and debate is
fostered. I think this is very
important.
More than ever
before, with respect to the new
transformative technologies,
we need strong and transparent
regulation, a contemplative
framework of bioethics and till there is
uncertainty about the safety , a
precautionary approach.
It is imperative that a law on
liability and redress is in place before any
GE product is released into the market . A
system for implementing labeling must be
put in place before GE foods come into
the market. This must be accompanied by
a public education exercise that makes the
label intelligible to ordinary consumers
allowing them to make an informed
choice. However, any system of labeling
must acknowledge that contamination of
natural with GE food is bound to happen.
Consumers must therefore have a say in
whether GE foods should be released at
all. Simply insisting that scientists have
declared it safe has no meaning because
food is so strongly conditioned by culture
and religion. A vegetarian will not eat
chicken soup however safe the scientists
declare it nor will a Hindu touch beef for
the same reason.n
uu
VOLUME 5 | NO. 2
Both these clauses serve
important purposes and so are very much
needed.
1. Protection of confidential
commercial information (CCI, also
called Confidential Business
Information) overriding the Right to
Information Act (2005):
Confidential Commercial Information
mainly concerns the gene constructs and
not concern the testing protocols and
result evaluation. A gene construct
contains several genes; none of them per
se is protected under IPR, leaving the
native genes for any one to use. What is
patentable is the gene construct, which is
innovative and which did not exist in
nature earlier. Whether patented or not
this constitutes CCI. The gene constructs
are not in the public domain except in the
patent documents made public when the
patent is granted (as in the case of most
transgenic crops) or in research
publications, if the research team chooses
to publish (as in the case of Golden Rice).
The gene construct of the Indian Bt
cotton is not available in the public
domain, except by inference.
When the biosecurity dossier of
Bt brinjal was to be placed in the public
domain, Mahyco claimed some
information in the dossier was CCI and so
should be excluded. The GEAC, which
was already under pressure, did not agree
and ordered the whole dossier to be
placed in the public domain, on its
website (reference: Proceedings of the
relevant meeting of the GEAC). With the
result the graphic illustration of the
transformed plasmid in Bt brinjal (pMON
10518) is open knowledge.
In addition to the molecular
machinery needed to make the chosen
gene (such as Cry 1Ac) to function in the
new environment (cotton or brinjal), gene
constructs (including pMON 10518) may
also contain some non-coding sequences,
which do not affect the functioning of the
gene construct nor cause any harmful
effects, which is confirmed during
biosafety evaluations. If a crop on the
field is suspected to be illegal, analysis for
the concerned gene product (a protein)
will clarify the issue. On the other hand,
the non-coding sequences, which vary
from developer to developer, function as
molecular tags and provide information
leading to the original developer of the
gene construct. Although no one
admitted, the identity of the transgene in
APRIL, 2010
CROSS FIRE
the Illegal Bt cotton in Gujarat as that of
Monsanto was possible because of the
non-coding sequences. This certainly
constitutes CCI, as making it public is
against the commercial interests of
institutions that invest huge amounts of
money and spend decades developing the
product.
In the case of Bt brinjal, the
European Scientists drafted for support by
the Indian anti-tech activists have kicked
up dust on presence of non-coding
sequences in spite of evidence provided
on that they are of no consequence to the
efficacy and safety of Bt brinjal. It is also
forgotten that the same transformed
plasmid pMON 10518 is also in the
Indian Bt cotton that has been in
cultivation since 2002, and which has not
thrown up any adverse consequences nor
proved any horror stories of the anti-tech
activists. These scientists did not perform
any new analysis or generated new data;
they merely interpreted the official GEAC
dossier, picking issues that can be
distorted to suit their convenience. The
aroused controversy, that has put Bt
brinjal in bad light, could have been
avoided if the nucleotide sequences of the
gene construct were not made public.
Safety issues should relate to the product
and not the process.
The second aspect of CCI
relates to making public the sites of
approved open field trials. Even when
they were not made public, there were
several acts of vandalism on standing
crop, attacks on laboratories and the
research personnel, in many parts of the
world, including India (Bt cotton, Bt
brinjal and genetically engineered rice).
The offenders have not been booked for
these unlawful acts. Locations of
approved field trials should be excluded
from the purview of RtI. The
Government should include a clause in
the BRAI to punish unlawful acts as they
a) constitute the destruction of someone's
legal property, b) cause personal harm and
c) contravene one's legal right to pursue
research of choice, approved by the
relevant authority.
The BRAI should have the
authority to decide what information is of
public interest, before the RtI Act comes
into play. However, a transparent
functioning involves placing on its website
all information of public interest such as
the minutes of all meetings of the BRAI,
its constituent authorities and constituted
committees.
2. Punishment for spreading
misleading information on the safety
of genetically engineered organisms
(GEOs) and making baseless charges
on institutions and personnel
involved:
Obviously this applies to both proponents
and opponents of technology.
The scientists, product developers or the
public and private sector institutions that
are involved in the biosecurity evaluation
of GEOs, that express whether positive or
negative information, are supported by
experimental/documentary evidence on
which their recommendation is based. By
the time of completion of the regulatory
evaluation, some 200 scientists/experts
and about 15 institutions (at least 10 from
the public sector) are involved. There is
neither truth nor any substance, to the
allegation that the data are provided only
by the product developer and so are
suspect or that absurd charge that all those
who are involved in the process are
corrupt or have conflict of interest. There
is nothing for the scientists, product
developers and the regulators to worry
about this provision, so long as they are
above board and do not make unsub-
stantiated claims. More over, the clause
ensures that they keep themselves above
suspicion and be better than 'Ceaser's
wife'.
The whole anti-tech campaign
in India is overloaded with irresponsible
charges relating to both science and
personal integrity, implying that only the
anti-tech activists and the experts they
cherry picked to support their agenda are
above board.
There must be some provision
to punish perpetrators of irresponsible
and unproven charges against scientists,
product developers and those involved in
implementing the regulatory regime,
including the regulatory authority.
People who leak confidential
information cause havoc to any system.
Information submitted to the BRAI by the
applicants, the regulatory evaluation
dossiers and their review by competent
authorities, should all be considered
confidential till an appropriate authority
of the BRAI approves them for public
release. There should be a provision to
punish people who leak confidential
information for whatever reason.
We earnestly hope that at least
this time the shouting brigade will not run
away with a much needed Act.n
BIOTECH NEWS 109

Imran Siddiqi
Imran Siddiqi is a Researcher in Plant Molecular Genetics at the Centre for Cellular and Molecular Biology, Hyderabad.
(E-mail: imran@ccmb.res.in)
T he issue of GM crops has
attracted a great deal of attention
both worldwide and in India.
Proponents view GM technology as a
major tool for the development of crops
having improved traits such as greater
yield, disease and pest resistance,
drought tolerance, and shelf life, in
addition to reducing environmental and
health hazards such as those caused by
application of chemical pesticides.
Opponents raise a number of concerns,
starting from general and ethical
concerns about consuming food that has
been genetically altered by introducing
genes across the normal species barriers,
and the possible unforeseen
consequences this could have; concerns
about the potential risks arising from
specific genes such as antibiotic or
herbicide resistance genes that are
introduced into a species, escaping to
other organisms or species; as well as
concerns about the effects on societies in
developing countries which account for
the major population and food markets
of the world, of the spread of GM crops
since much of the capacity for and
control of GM technology (especially
the most advanced GM technology) is
often covered by intellectual property
(IP) that resides with large multinational
corporations (MNCs) the concern is that
MNCs would come to exercise undue
influence should agriculture in these
countries become overly dependent on
GM crops.
Non-GM agricultural
technology which is much less
controversial, relates to methods that do
not involve transfer of genes across
species, i.e. the use of transgenic
approaches. Plant (and animal) breeders
have for centuries relied on variation that
exists within the gene pool of a species
to breed varieties having features that are
suitable for specific purposes and
environments.
The development of
technologies over the last decade to fully
110 BIOTECH NEWS
CROSS FIRE
u been fairly controversial for a variety of
sequence whole genomes (a genome is
the entire set of genes present in an
individual member of a species) at costs
that are rapidly decreasing as technology
advances, is now providing information
genes that are present in the same
species. Hence if the genetic trait of
interest is present within the overall gene
pool of a species, it is possible to use
MAS to develop cultivars that
at an unprecedented level of the diversity
incorporate that trait. If however it is not
that exists within a species as well as
present, then MAS cannot be used and
differences between related species.
GM approaches can be considered.
These differences can be used to arrive at
Examples of traits which are not found
the basis of the heritable differences
in the native species are resistance to
between members of a species and
certain insect pests such as bollworm (a
identification of the genes responsible,
major pest of cotton) and yellow stem
including genes for agronomically
borer (a rice pest). The gene for Bt toxin
important traits. The challenge lies in
derived from a bacterial pathogen
correlating large amounts of genome
(Bacillus thuringiensis) of certain insects
sequence information and the sequence
has been used to engineer resistance
variation with the characterization of
against both these pests. Studies have
the plants at sufficient depth and
indicated that Bt toxin is specific to
accuracy so as to determine where the
certain insects and does not affect other
genes of interest are located in the
species. The Bt toxin acts by binding to a
genome and ultimately narrowing down
receptor molecule found in the cell
to the identity of the genes themselves.
membranes of the insect gut and
The classical approach has been to use
disrupting the membranes leading to
the minor differences in sequence
death of the larvae. Studies indicate that
between members of a species as
animals including all mammals, that
molecular tags or markers to identify
lack the receptors for Bt toxin are not
and follow genes (over successive
affected by Bt toxin.
generations) that are close to the tag
Bt-cotton hybrids were
(even though one does not know what
introduced in India in 2002 and one of
precisely the gene is one can still follow
the projected benefits was the reduction
it from one generation to the next by
in pesticide requirement this would have.
following the tag). This can now be done
Cotton accounts for a major amount of
more extensively so as to allow genes to
the pesticide usage in agriculture in
be identified and followed with greater
India and the use of Bt-cotton hybrids in
comprehensiveness in breeding
India has been associated with a
programs whose goal would be to come
significant reduction in pesticide usage
up with plants in which the desired
and increased output (Bennett et al.,
genes (several of them) are all present in
2004). The cost of hybrid Bt-cotton seed
the same individual which thereby
however, is much higher than that of
shows agronomically improved
non-Bt hybrids so the economic benefit
characters. This approach called marker
of Bt-cotton is supposed to come not so
assisted selection (MAS) has enormous
much from savings on pesticide usage
potential and is substantially free of
but higher output. The higher output of
proprietary technology. MAS generally
Bt-cotton hybrids also requires inputs
does not involve products that raise the
such as irrigation which is a limitation in
kind of safety concerns that arise from
many areas where cotton is grown and
GM because new combinations of genes
there have been reports of poor
are created from within the gene pool of
performance under these conditions
the species by conventional crossing.
(Bennett et al., 2004; Sahai, 2007). The
However MAS is limited to reshuffling
use of Bt-cotton hybrids in India has uu
VOLUME 5 | NO. 2
reasons, with both favorable and
negative reports coming out on the
performance and economics of Bt-
cotton. Following Bt-cotton, the next
crop incorporating Bt-technology to be
considered for release in India has been
brinjal. Since unlike cotton, brinjal is a
food for human consumption, the safety
needs to be more stringent and requires
close examination. A general concern
with GM methodologies has been on the
safety of the genes used as selection
markers for plant transformation that
allow selection of plant cells that carry
the transgene of interest. A brief
summary of some principles underlying
plant transformation is presented in the
next paragraph to clarify the context.
A commonly used process of
making transgenics involves inserting the
gene of interest into a small circular
DNA molecule called a plasmid which is
introduced and maintained in the
bacterium Agrobacterium tumefaciens
that infects plants. Maintenance of the
plasmid in bacteria requires that the
plasmid carries a gene for antibiotic
resistance that is active in bacteria so
that in the presence of the antibiotic only
bacteria carrying the plasmid will
survive and grow. The plasmid also
carries sequences for transfer into and
selection in plant cells. When A.
tumefaciens infects a plant, it transfers
part of the plasmid DNA (T-DNA) into
the plant cell starting from a point called
the T-DNA right border (TR) and
ending at a sequence called the T-DNA
left border (TL). The T-DNA enters into
the nucleus of the plant cell where it is
inserted at a random location in the
plant's genome. All genes that are
present in the T-DNA between left and
right borders are thus integrated into the
plant DNA. In order to select for plant
cells in which insertion has taken place,
the transferred T-DNA is engineered to
contain another antibiotic resistance
gene which is active in plants. Plant cells
resistant to this antibiotic would have the
T-DNA containing the gene of interest
integrated within their genome and be
able to grow on medium containing the
antibiotic whereas untransformed plant
cells would be sensitive to the antibiotic
and fail to grow. Hence plasmids
designed for introducing genes into
plants via Agrobacterium mediated
transformation commonly have an
APRIL, 2010
CROSS FIRE
antibiotic resistance gene for selection in
bacteria, and another antibiotic
resistance gene for selection in plants.
The plant selection gene is present
between the T-DNA borders so that it
gets transferred to plants whereas the
bacterial resistance gene is commonly
present outside the T-DNA borders and
does not get transferred to plants.
Whereas antibiotic markers are
very useful for making transgenics that
will be confined to the laboratory, when
it comes to making products that will be
deployed on a large scale in the field or
used for human consumption, there is a
safety concern that these antibiotic
resistance genes can be transferred to
other organisms. Hence different
methods have been developed over the
last 14 years (de Vetten et al., 2003) for
producing transgenic plants that do not
carry additional antibiotic markers.
These methods involve modifications of
standard transformation methodologies
and give marker free transgenics. Marker
free plant transformation technology
therefore represents the gold standard for
making transgenic crops.
The case of Bt-brinjal bears
examination in this regard. The plasmid
pMON10518 (US Pat 5500365) used for
making Bt-brinjal carries the cry1Ac
gene encoding Bt toxin inserted after the
right border (TR). cry1Ac is followed by
an antibiotic selection gene, aad which
confers streptomycin and spectinomycin
resistance in bacteria, and after aad
comes the plant selection marker gene
nptII which confers resistance to the
antibiotic kanamycin and has been
configured so as to express in plants. The
design of the construct is such that the
aad gene is flanked by cry1Ac and nptII
on either side. Hence, in requiring the
presence of cry1Ac and nptII in
transformed plants, one invariably
selects for the aad gene as well. The
plasmid also contains only a single T-
DNA border sequence (TR) so that
transfer initiates but doesn't stop until
the whole plasmid is transferred into the
plant cell. It may be noted however that
the presence of the aad gene in the DNA
that is transferred to the plant cell serves
no functional purpose in plants as it does
not contribute to selection of
transformed plant cells, which is
achieved only by the nptII gene. The
presence of the aad gene in Bt-brinjal is
therefore gratuitous and it can be asked
why is there an extra antibiotic
resistance gene present if it is not
required and does not need to be there?
This is a serious weakness in the design
of the transformation strategy, especially
since the product is proposed to be used
for human consumption directly as a
food. Plasmid molecules that contain
both TR and TL and where the bacterial
selection marker lies outside the T-DNA
have been in existence since as far back
as 1984 (Bevan, 1984) so it is hard to see
why the aad gene was not excluded from
the plant in making Bt-brinjal.
Incidentally, the aad gene is
also present in the MON 531 derived Bt-
cotton hybrids that were first approved
for release in India in 2002. The
transformation construct in Bt-brinjal is
essentially identical to that used to make
MON 531 (US Pat App 20080124724).
The later cotton transformation event
MON 15985 was carried out using a
different methodology that did not
involve the use of antibiotic resistance
markers. Concern about the presence of
the aad gene in cotton seed made by
Monsanto has been raised in a 1999
report to the Food Standards Agency,
UK by the Advisory Committee on
Novel Foods and Processes
(www.acnfp.gov.uk/acnfppapers/gmissu
es/cottonseed). The report considers the
possibility of a human pathogen such as
Neisseria gonorrhoeae acquiring the aad
gene from the plant. It accepts that “the
risk of such an event is small and cannot
be quantified” but the consequences
would be extremely serious and advises
that “… it is our opinion that it would be
very unwise to allow increased
opportunity for such an event to happen
by the introduction of plants containing
this resistance gene.”
Because of the revolutionary nature of
GM technology and the possibility of
gene transfer giving rise in an unforeseen
way to hazardous organisms that can
multiply and spread, it has attracted far
greater attention in terms of safety
concerns than for example chemical
pesticides where enormous
environmental damage has already been
done. Nevertheless because of the nature
of these safety concerns, GM technology
needs to be deployed with very close
scrutiny when it comes to assessments uu
(Contd. on page 121)
BIOTECH NEWS 111

FEATURE
Deployment of GM Crops
Need For a Clear Cut Policy
E.A. Siddiq
A
chieving minimum required
growth on a sustainable basis is
crucial for sustained food-
nutrition security. India has made
enviable progress in agriculture during
the last 50 years culminating in self-
sufficiency in our food grain needs since
early 80s. Transformation of a
chronically food deficit country into a
food sufficient and surplus one is the
most significant accomplishment of the
post-independent India. Two landmark
developments viz., exploitation of
hybrid vigor in maize and millets since
mid 50s and introduction of plant type
based high yielding varieties of wheat
and rice since mid 60s marking major
yield breakthroughs have made this
possible. Despite such an impressive
feat, the fact that over 200 million people
remain undernourished and much larger
population malnourished is of great
concern, no matter what could be
attributable to this paradox. With the
current pace of productivity/production
E.A. SiddiqPh.D is Chairman of the Centre for Finger Printing and Diagnostics (CFCD), Hyderabad. (Email: easiddiq@rediffmail.com)
112 BIOTECH NEWS
growth of Green Revolution crops
declined to levels far lower than what is
required to sustain the present level of
sufficiency and no yield breakthroughs
as yet in rain fed crops that account for
over 65% of the arable area coupled with
shrinking natural resources, especially
water, energy and plant genetic
resources, achieving future demands
would be the most challenging task, if
we are to excessively depend on the
currently available crop improvement
technologies. Rapid advances in cellular
and molecular biology have provided
two major genomic tools viz., molecular
marker technology enabling genotype
based selection and recombinant DNA
technology capable of moving genes of
interest across the barriers of sexual
incompatibility. While there is no
resistance to the use of the former for
crop improvement, there is strong
reservation against alien gene based
genetically modified (GM) crops and
GM food products, though the
u commercialized biotech crop in the
reservationists are fully aware that this is
the only strategy option to find solution
to problems that defy both conventional
and marker technology and for which
there is no donor source in the
compatible germplasm and that finding
remedy would have major socio-
economic impact.
India, although late in
accessing and using recombinant DNA
technology, during the last 15 years it
has strengthened itself with needed
knowledge and skills, state of the art
research infrastructure and competitive
critical mass. It is in an enviable position
today to engineer crop plants with
desired trait(s), given transgenics in as
many as 10 different crops already on its
shelves awaiting clearance by the
Regulatory Authority for commercial
planting and several at various stages of
evaluation for efficacy, stability and bio-
safety including human health and
environment security. Also, potential
benefits of Bt cotton, the first ever uu
VOLUME 5 | NO. 2
country have been experienced during
the last eight years, when over 85% of
the cotton area were planted to Bt cotton
and productivity more than doubled
ending the dependence on imported
cotton. Significantly, this development
too was not without hassles in reaching
out to farmers. When Bt brinjal, capable
of minimizing greatly yield losses due to
fruit and shoot borer, was to be released
last year for commercial planting, the
experience in trying to reach out it to
farmers reflected reservation against GM
crops, especially those that are directly in
the food chain of man to be still strong
and persistant. The kind of objections
raised against Bt brinjal by anti-GM
lobby, ineffective response to them by
scientific community and reluctance of
seed industry and farmers to adopt and
lack of clear cut policy-directed
interventions from the governments are
said to collectively contribute to our
failure to benefit from such innovative
technologies.
Reservations Against Biotech Crops
Reservation against GM crops from
activists and others are -
The technology being developed and
introduced is not based on prior
APRIL, 2010
Need For a Clear Cut Policy
consultative process involving concerned
stakeholders of given target
area/community.
Introduction is not based on
field level evaluation done in the
concerned state for efficacy, stability and
biosafety
Small and large scale field test data on
performance/biosafety furnished to the
regulatory authority are often from trials
conducted by the applicant organization
lRegulatory process is not sound enough.
It lacks transparency in the process of
development and testing for efficacy and
biosafety and stringency is left much to
be desired
lInconsistency in efficacy and instances
of biosafety related problems
lUnsubstantiated claims on economic
advantage and environment security.
lExtensive cultivation of transgenic crops
monopolised by multinational
companies would prove a threat to rich
biodiversity of the country.
lTransgenic strategy in pest control
would lead to emergence of newer
pests/more viruliferous forms of the
same pest.
lIncreasing monopoly of multinational
companies in seed trade is to the
disadvantage of Indian companies and
seed cost is not affordable by small
farmers.
Deployment of GM Crops
The above raised reservations
against GM technology cannot be totally
dismissed as baseless. They can,
however, be addressed by scientific
community and officials of concerned
ministries to the satisfaction of the
apprehensive activists and reluctant
farmers, quoting policy goals and related
provisions in the Draft National Policy
on Biotechnology prepared by the
Department of Biotechnology, Ministry
of Science and Technology through
consultative process involving relevant
ministries, national institutes and
scientists. Awaiting formal approval of
the Policy Document, the DBT is
already in the process of implementing
many of the policy goals/provisions
envisaged. The following responses, if
properly explained vis a vis the issues
should help remove the apprehensions
on the system and its functioning.
Establishment of the National
Biotechnology Regulatory Authority
and the Regulatory Process for
Safety Assessment of GM Crops/Food
Broadly aiming at (a) development and
use of biotech tools to address the
problems that affect the largest section
of the society (b) providing of produce/
processed products there from at prices uu
BIOTECH NEWS 113
 Deployment of GM Crops
Need For a Clear Cut Policy
u affordable by all sections of the society
and (c) making the country food-
nutrition secure and globally competitive
in the emerging bio-economy, the draft
Biotechnology Regulatory Authority has
been conceived. Yet to be formally
established, the Authority ensures
through the three-tier system, rigorous
and sound science based approval of
GM Crops. Structurally and
functionally, the development, testing
and approval system though sound
enough, scope does exist for making it
still more stringent and transparent.
More realistic choice of crop, source of
gene and transformation avoiding
selectable markers, especially antibiotic
ones are insisted upon at development
phase, while ensuring stringent and
transparent assessment of biotech crops
for biosafety including human and
animal health and other unintended
effects (toxicity, allergenicity, and other
adverse health related problems) at
laboratory and on environment
(weediness, invasiveness, pollen flow
caused genetic contamination/erosion)
at field level. Large scale multi-location
field trial conducted on the
recommendation of the RCGM is
monitored and evaluated by the Genetic
Monitoring and Evaluation Committee.
Its report and recommendation of the
special Appraisal Committee constituted
of experts form ultimately the basis for
granting approval for seed increase and
commercial planting by the Genetic
Engineering Approval Committee
(GEAC). Thus, the regulatory system
and regulatory process are in order in
the absence of formally cleared National
Policy on Biotechnology and
establishment of National
Biotechnology Regulatory Authority.
Priority action plan in this regard would
help ward off the criticism that biosafety
and efficacy/performance related data
are not reliable. If the system has its own
laboratory facilities or duly accredited
public laboratories exclusively designed
for risk analysis of GM crops and
depends on SAU's generated data on
114 BIOTECH NEWS
agronomic performance, decision taken
on the basis of data and findings from
such sources would strengthen the faith
and confidence of all in the user end and
thereby willing reception to the
technology.
Many reservations against GM
crops are largely because of the failure
of scientists to respond to and clear all
unfounded apprehensions on their
efficacy, stability, biosafety and
environment security.
As for efficacy and economic
gain from transgenics over the
corresponding non-transgenics, debate
on far and against biotech crops is due to
lack of understanding. For instance,
claims and counter claims on yield
superiority of pest resistant transgenics
like Bt cotton and Bt brinjal is one such
case of poor understanding of the trait
effect on productivity. Genetic yield
potential being inherent to a given
variety, no matter it is transgenic or non-
transgenic, observed yield difference
between them depends on the level of
yield loss they suffer due to the pest. In
situations of high pest incidence, the
transgenic would yield far higher than
the corresponding non-transgenic and
when there is no or very low pest build
up, there will be hardly any yield
difference between them. Therefore, it is
wrong to conclude that transgenics have
higher yield potential or it is only on par
with the non-transgenic control, as the
observed difference in yield depends on
the level of pest incidence and the level
of protection the transgenics and non
transgenics provide against the pest.
Stability of trait expression is
yet another apprehension about biotech
crops. Discouraging reports on the
declined efficacy of Bt gene in cotton,
for instance, are no doubt based on
actual observation in some parts of the
country. Such instances of instability are
not characteristic to transgenics alone, as
breakdown of resistance (ineffectiveness
of resistance gene against the pest) is as
well the case with natural genes. What
has been observed in Bt cotton could be
due to (a) breakdown of resistance due
to selection pressure or (b) unintended or
deliberate admixture/adulteration (by
unscrupulous elements in seed trade) of
seed of transgenic with that of
nontransgenic. The latter possibility
could be checked by regular
survey/monitoring of transgenic fields
and seed sale points for genetic purity.
This strategy would greatly help remove
the wrong notion on the stability of
transgenics.
The view that transgenics
resistant to a pest could facilitate
emergence of newer pests is as well not
disputable, when the transgene in
question is pest-specific. Observed build
up of once not so serious pink bollworm
(Pectinophora gossypiella) in cotton is one
such case, where the transgene effective
against bollworm (Heliothes armigera)
remains ineffective against other related
species of the pest.
Many believe that transgenics
could prove a serious threat to genetic
diversity, which is the bedrock
conventional plant breeders depend on
for progressively improving crop
varieties. The contention that extensive
exploitation of a few transgenics would
amount to disappearance of thousands
of native germplasm, need not be wholly
true. Similar apprehension was there
when hybrids of millets and high
yielding varieties of rice and wheat were
introduced. The fact that maximum of
crop specific diversity available in the
country has already been conserved by
ex situ and in situ approaches and more
could be done in future too. Such
anticipatory conservation measures
already on should convince all those,
who entertain such concern that it
cannot be a justification against GM
crops.
The objection that increasing
monopoly of multinational seed
companies would be at the cost of
domestic seed industry and that no
control over seed price would go against
farmers' interest, is although under-
standable, it is inevitable as long as the uu
VOLUME 5 | NO. 2
u technology is not ours. The issue could,
however, be resolved by government in
discussion with the seed industry
reminding governments' policy of
making GM technology easily accessible
and affordable to all.
Disputes and criticisms on the efficacy
and biosafety of biotech crops arising
from various quarters cannot be wished
away. Addressing them with scientific
study based facts and figures is the right
strategy to counter them and thereby
promote the technology. Even eight
years after the release of Bt cotton, for
instance, we still face resistance to it on
grounds like instances of livestock death
due to grazing in Bt cotton fields,
degradation of soil health and quality
affecting seriously the performance of
subsequently planted crops, increased
suicide cases in Bt cotton grown areas
due to crop failure, no appreciable cost
reduction on plant protection etc. Such
issues be thoroughly investigated by a
competent committee constituted of
researchers, social scientists and
economists for establishing what is
rumoured is not true. Only with
scientific scrutiny-based facts and
figures, such reports can be countered
and restore thereby the trust and
confidence of growers and consumers.
Apprehensions on long term effect of
GMOs could be out of genuine concern
for human health. As there is no way out
to subject human beings for long term
clinical tests special Standing Technical
Committee constituted of physicians,
social scientists and agricultural
scientists should monitor long term
effect of consumption of GM food/feed
on human/animal health.
Policy Initiatives and Technology
Transfer Strategies for Effective
Deployment of Biotech Crops
In taking full advantage of advances
being made in the area of crop
biotechnology, relevant enough to
address the problems that impede the
progress of envisaged
production/productivity growth, the
APRIL, 2010
Need For a Clear Cut Policy
constraint is not our technical
competence to engineer crop plants of
interest, given the impressive array of
transgenics already in pipeline. It is
rather in reaching out the technology to
the targeted user. Learning from the
experience of other sectors as well as our
own in this regard, the following
suggestions and strategies would ensure
effective deployment of biotech crops.
l Convincing the target clientele with
facts and figures that gain from the
given biotech crop outweighed the risks
is basic to its extensive adoption.
l Endorsement of the recommendations
of the GEAC on biosafety of given
GM crop(s) and processed products
there from by the apex agricultural
research organizations at national
(ICAR) and state (State Agricultural
Universities) levels and other National
laboratories.
l Organized and intensive awareness
creation among the target population
on the intended introduction of biotech
crop(s) highlighting its relevance to
their livelihood security and biosafety
including human and animal health
and environment security.
l Active involvement of state agricultural
departments in reaching out the
technology to the intended regions,
ecologies and communities. Training
of extension personnel at all levels on
the benefits and associated risks of the
technology and organizing large scale
on farm demonstrations.
l Labeling of transgenic produce and
processed food products is about
consumer right. Though mandatory in
India, measures be found to address
the practical problems that would be
encountered in actual implementation
in the face of reluctance of private
sector companies on the plea that it
would introduce price discrimination
and would be against the policy goal of
ensuring inclusiveness.
l Many valuable transgenics developed
by the public institutions are still on the
shelf because of lack of resource
support for them to go through the
mandatory testing requirements at
Deployment of GM Crops
laboratory and field levels for biosafety.
Considering the high cost involved in
meeting satisfactorily such
requirements, public-private
partnership models now in place and
are being promoted by the Department
of Biotechnology could be used to take
advantage of the private sectors'
excellence in development and
management skills for extensive
commercialization.
l Clear policy and rational strategies for
deployment of transgenic crops is vital
for successfully sustaining and
benefitting from transgenic technology.
These should be in keeping with the
fact that (a) genetic uniformity is
genetically vulnerable to sudden
outbreaks of pests and (b) sexual
compatibility with plant species around
would lead to genetic contamination,
genetic erosion and other unintended
consequences. To ward off the problem
of genetic vulnerability, either
diversification of trans-resistance genes
through varietal mosaics or pyramiding
of varieties with diverse trans-
resistance genes could be ideal
strategies. To contain genetic
contamination, areas/regions rich with
compatible wild/cultivar species be
precluded for introduction of given
transgenic crop/variety. There should
be legal restriction to introduce
transgenic crops in biodiversity rich
areas, centers of origin and centers of
diversity of a species, areas earmarked
for export oriented crops (e.g.: basmati
rice) and those for organic farming.
Innovative technologies are inevitable
given the limitations of the conventional
breeding/selection technologies vis a vis
magnitude and seriousness of problems
facing us today. Undoubtedly extra care
is necessary to rule out any serious
impact of GM crops/GM food/feed on
human/animal health and environment.
But reservations, undue delays in
exploiting the technologies of large
socio-economic impact would amount to
denying the large undernourished-
malnourished population the benefits of
new bioscience.n
BIOTECH NEWS 115
 GM Crops in India

The Way Forward

HORSE’S MOUTH

detrimental. Decisions on safety are
based on science and must be the
responsibility of Review Committee on
Genetic Modification (RCGM)/Genetic
Engineering Approval Committee
GM Crops in India (GEAC). No non-scientist, however well
intentioned, should be encouraged to
matter who produces the technology, or
licenses it to others. Other things that are
extremely important include:
Intensifying India's basic and
translational agricultural science in
public-funded institutions; strengthening
of R&D in Indian companies; building
for BRAI will be through a legally
empowered inter-ministerial Board,
represented at Secretary level in a pan-
government perspective.
BRAI membership has been increased
to 5 from 3, one each to represent
agriculture, health, environment,
molecular science besides a chair who is

The Way Forward

cite poor quality literature to challenge
GEAC or RCGM consensus decision.
Once declared safe, commercialization
decision should be dealt with under the
Seed Act or Seed Policy through an
Much has been said on GM Crops in the recent past, and the multiplicity of views and effective, transparent decision making
process. The Agriculture Ministries at
opinions expressed and interpretations in the media has, instead of clearing the air, the centre and states must administer
this aspect as per their jurisdiction.
only added to the confusion. Biotech News spoke to Dr. M K Bhan, Secretary, On the policy front, greater operational
Department of Biotech News (BTN): Recently,
clarity in the otherwise lucid
Swaminathan Report would help
more competition through multiple
licensing; and investment by government
in research and commercialization to
encourage innovation. Government
should also buy India-specific
technology licenses and make them
available to public Institutes and to
multiple Indian companies. Look at the
prices at which vaccines are available to
Indian government through push and
pull mechanisms. We in government
cannot sit on judgment but should
expected to have broad-based
knowledge.
There was a specific clause about false
disclosures, which was actually meant
for companies. Given the public
apprehension and, rightly so, we have
deleted it.
A unit of socio-economic analysis has
been added to BRAI.
There will be an Appellate Authority
for re-examination on request for safety
assessment.
I must emphasize that we have to
separate safety decisions based on
science from commercialization which

Biotechnology, genetically modified crops have provide a predictable ecosystem for engage with industry to promote requires other inputs. BRAI's focus
been in the news in India, it seems innovation for public sector and private innovation under social contract should be on safety assessment.
Govt. of India for for all the wrong reasons. What, in sector scientists. The purpose of systems. This is ever more effective than
your view, is the way forward? BTN: How is the new regulatory system
regulation is to make output of other forms of subsidies. Finally, Indian going to be different from the present
his definitive views M.K.Bhan (MKB): Technologies innovation safe and beneficial and, agribiotech research is progressing well, one? What is its USP?
that have transformative potential through that process, promote it. No and many of the solutions will be
on issues involved for social and economic impact society can adapt to future challenges by indigenous in future. Indian industry is MKB: The current regulatory system is
creating barriers for science and as much Indian as the public sector committee based. In some countries it is
and the path that take a little time to find
acceptance. Our requirements for innovation. On the other hand, institutions. We must be creative in based on in-house professionals to
ensure scientific expertise, professional
India should adopt future are: (i) a clearly articulated innovation systems that do not address
safety concern adequately are
making industry innovation socially
relevant and the government needs to processes and transparency. We have
policy; (ii) regulation for safety
combined these two approaches. By
to harness the full assessment; and (iii) decision unacceptable. The future cannot be
designed at the fringes, but through a
invest in this direction as much as the
industry. We have to work together for advancing internal professional
making process on
potential of GM commercialization. The way balanced, yet optimistic approach. We inclusive development. strength, documentation will be better
and we can prepare for advances in
forward is to reaffirm our need a long-term perspective. Policy
technology while must dictate what products are made, BTN: Many questions have been raised technology ahead of time. Such a BRAI
endorsement of Government
and not vice versa. Policy is the function about the new regulatory authority on can maintain quality testing
policy on biotechnology in
also safeguarding agriculture, taking Swaminathan of Government (not of any single the anvil. What is your response to the infrastructure, and synergise multiple
Report as the basis, and respect the ministry) that takes into account social queries raised? inputs and feedback from stakeholders
the interests of existing regulatory system, and economic aspects. On safety, the last MKB: The Department of Biotechnology effectively.
word is of the regulators. Most humbly, Other changes are (i) effective oversight
consumers as well strengthening it where necessary
until a new one is established. The in recent times we have tended to
was asked to create a legislation and an
organizational blueprint for of Institutional Biosafety Committees;
as farmers. current regulatory system has unfairly weaken our regulators who have
worked hard to create the current
Biotechnology Regulatory Authority of (ii) better organized State Biotechnology
Committees; (iii) assured availability of
considerable experience and skill India (BRAI). We have done that and
sets. Undermining its confidence expertise. This must be stopped. addressed the several concerns raised testing labs that will be funded and
and resolve is unwise, even u after the bill was made public. The accredited by BRAI; (iv) availability of
BTN: What lessons can one learn from specific modifications made until now socio-economic analysis capacity within
the Bt brinjal controversy? include the following: BRAI; (v) in house training centre for
M.K. Bhan M.D., Ph.D. is Secretary, Department of Biotechnology, Government of India. (Email: mkbhan.dbt@nic.in)
MKB: Availability of quality seeds at continuing education for its members
l The administrative and policy oversight and professionals; (vi) a responsible uu
affordable price is an important issue, no
(Contd. on page 121)

116 BIOTECH NEWS VOLUME 5 | NO. 2 APRIL, 2010 BIOTECH NEWS 117

PRO FILE
National Research Center
for Plant Biotechnology
I
t was in the year 1985, a new
Division named “Biotechnology
Centre” came into existence at the
premier Indian Agricultural Research
Institute (IARI), New Delhi to undertake
research and teaching in Plant Molecular
Biology and Biotechnology. Realizing its
importance and relevance in the National
Agricultural Research System (NARS) in
the country, the centre was upgraded to a
National Research Centre under the
umbrella of the Indian Council of
Agricultural Research (ICAR) in the year
1993.
The mandate of the Centre is to
design plant molecular biology and
biotechnology tools and techniques for
genetic enhancement of crops, and to
develop human resource in the frontier
areas of new biology through teaching
and training for meeting the needs of the
NARS.
Research and Development
In the initial years, the Centre was
involved in standardizing protocols for
plant regeneration and genetic
transformation of important crop species
such as rice, chickpea and Indian mustard
(Brassica juncea) for deployment of
recombinant DNA technology. An
outcome of this massive effort was a large
number of tissue culture-raised plants of
118 BIOTECH NEWS
rice and mustard, which showed a wide
range of phenotypic variation called
“somaclonal variation”. Following years
of selection, a highly promising line
named Bio-902 was identified in mustard
that was subsequently released as a new
variety named Pusa Jai Kisan after three
years of multilocation evaluation. Even
after 15 years of its release, the variety is
still preferred by the farmers for its bolder
seeds and higher yield potential over the
popular check variety Varuna. This
remains the first commercial mustard
product in the world developed through
tissue culture.
One of the options to further
enhance yield is to develop hybrids for
commercial exploitation of heterosis.
This however necessitates availability of a
robust and efficient pollination control
system for large-scale production of
hybrid seeds. The Centre carried out
somatic cell hybridization involving
Indian mustard and its wild relatives to
generate several different somatic cell
hybrids. By back-crossing the hybrids
with the mustard parent, the nucleus of
the cultivated Indian mustard could be
combined with the cytoplasm of a wild
relative to generate a number of
cytoplasmic male sterile (CMS) lines.
One of these CMS lines based on the
cytoplasm of wild relative Moricandia
arvensis and its cognate male fertility
restoration line developed by the Centre
were made available to the public as well
as private institutions that led to
commercial production of mustard
hybrids in the country (Coral 432 and
NRC Sankar Sarson).
Since late 1980s, the Centre has
been working in the area of design and
use of DNA based genetic markers for
the assessment of genetic diversity,
genome mapping, gene tagging, map-
based gene cloning and marker assisted
selection (MAS). The first set of
restriction fragment length polymorphism
(RFLP) markers was generated and used
to construct the genome map of mustard,
which is the first of its kind in the
country. This map was subsequently used
to tag genes for fatty acid content and
resistance to a devastating fungal disease
namely, white rust. Molecular genetic
diversity has been assessed in several
important crop species including rice,
wheat, Brassica, sugarcane, jute and
tobacco leading to the development of
DNA fingerprints of elite genotypes
including the commercially important
Basmati rice. Thousands of genetic and
genomic Simple Sequence Repeat (SSR)
markers were designed in rice, wheat,
maize, barley, Sorghum, sugarcane and
Brassica, which are in public domain for uu
VOLUME 5 | NO. 2
National Research Center for Plant Biotechnology, Lal Bahadur Shastri Building, IARI Pusa, New Delhi-110012, www.nrcpb.org
u unrestricted use. In rice, genes for a
number of traits such as Basmati quality,
tolerance to salinity, fertility restoration,
and resistance against the fungal disease
blast have been successfully tagged using
DNA markers. The gene for blast
resistance was recently cloned based on
its position on the linkage map. In a
collaborative effort with the mother
institution IARI, a new variety of
Basmati rice named Improved Pusa
Basmati 1 has been developed through
MAS. Two genes for bacterial leaf blight
(BLB) resistance were combined in this
variety with Basmati quality traits by a
novel approach that integrated
phenotyping with marker based genotypic
selection employing modified backcross
pedigree strategy. Improved Pusa Basmati
1 is the first to be developed through
MAS in rice in the country and currently
is the only donor of BLB resistance in
Basmati breeding.
India participated in the
multinational Rice Genome Sequencing
project. This Centre was involved in this
effort along with the Delhi University
South Campus to sequence the long arm
of rice chromosome 11. The scientists of
the Centre first participated in
construction of a bacterial artificial
chromosome (BAC) based physical map
of the assigned chromosome in
APRIL, 2010
National Research Center for Plant Biotechnolgy
collaboration with the USA group at the
University of Arizona leading to a
publication in the Plant Cell. A total of
8.17Mb high quality sequence of the long
arm was generated and integrated with
that of the whole rice genome, which was
published in Nature in the year 2005.
This effort led to understanding of the
structure and evolution of the rice
genome as well as organization of genes
including the ones for disease resistance.
Discovery of new genes and markers is
greatly facilitated with the availability of
high quality genome sequence of rice.
This effort has now been replicated for
sequencing of long arm of tomato
chromosome 5 as a partner of an
International consortium.
Research on the soil bacterium
Bacillus thuringiensis (Bt) and its
insecticidal genes was initiated at this
centre in the late 1980s that led to the
development of first Bt-Brinjal in the late
1990s in the country. More recently new
and effective events of Bt-brinjal carrying
cry1Fa1 gene have been developed and
licensed to private institutions.
Significantly, in a collaborative effort with
the Central Institute on Cotton Research,
Nagpur and University of Agricultural
Sciences, Dharwad, Bt-gene cry1AC has
been transferred to a cotton variety
Bikaneri Nerma, which has been released
as a variety for commercial cultivation
following the biosafety guidelines. This
variety can be repeatedly grown by the
farmers for years without seed
replacement as required for hybrids and
also be used as a parent of new cotton
hybrids. Besides, efforts are also being
made to engineer crop genotypes with
tolerance to abiotic stresses such as
drought and salinity in crops such as
mustard and tomato, and with improved
shelf life of fruits in tomato.
Success of transgenic
technology depends on the availability of
genes and promoters. Keeping this in
view, the Centre initiated a program on
cloning of novel genes and promoters. A
number of protease inhibitor genes have
been cloned from leguminous crops and
are currently being characterized.
Candidate genes for drought tolerance
have been isolated from tolerant
genotypes of wheat, rice and Brassica
species and being validated for their
function. To clone novel promoters, T-
DNA insertion mutants were generated in
the model plant species Arabidopsis
thaliana. Using these mutants, promoters
have been trapped, cloned and
characterized, which include the ones
that drive specific gene expression in
roots, trichomes and anthers. Recently, a
strong promoter giving constitutive uu
BIOTECH NEWS 119
 National Research Center for Plant Biotechnolgy

u expression of a reporter gene has been Iran, Egypt, Bangladesh and Vietnam. in Plant Biotechnology is well recognized GM Crops in India
cloned that can serve as an alternative to
the commonly used CaMV35s promoter
All the students are gainfully engaged,
many of them contributing to the
nationally as well as internationally. Tools
and techniques developed by the Centre
The Way Forward
in transgenic development. research and development in the frontier are benefitting the end users immensely. (Contd. from page 117)
Plant molecular biology and areas of biology. Besides, the Centre has National and international collaborative
biotechnology research and its successful trained more than 250 scientists/ efforts leading to successful generation of
communication system with a media system redesign is required to become connected with GM crops cannot be
resource centre; (vii) public review effective in basic and translational overstated. Is anything been done in this
application for genetic enhancement of researchers from many different public knowledge and products of commercial
mechanism before final decision sciences. Many more university scientists regard?
crops demand availability of a critical and private research organizations in the value are examples that encourage
making; (viii) investment in research must do discovery and early
mass of trained human resource in the country in the area of molecular biology initiation of many such efforts in future.
that will improve regulatory science and translational science and biotechnology MKB: Unfortunately, as a country we
country. Since its inception, the centre and plant genetic engineering. The The science of genomics is progressing respond to situations than prepare
tools; and (ix) a truly inter-ministerial and there must be a seamless
has been engaged in post-graduate available trained human resource is very fast. The Centre has the capability, proactively. Innovation requires a stable
rather than a single ministry-driven collaboration across universities and
teaching and training. So far 91 students catalyzing an accelerated development in expertise and infrastructure to capitalize policy environment. Scientists must be
on these developments in frontier areas of
effort in all aspects. This will ensure agricultural institutions. The instruments
have obtained their M.Sc. and 74 their biotechnology research and application. able to predict what the country wants. I
biology for reaping a rich harvest for the fairness, transparency, and availability of and processes for academia-industry
Ph.D. degrees in Molecular Biology and
Future prospects required expertise. interaction are still difficult and must believe the Report of the DoA&C Task
Biotechnology. This includes students benefits of the poor farmers and Force headed by Prof. MS Swaminathan
The leadership role played by the Centre become hassle free. Imaginative, social
coming from foreign countries such as consumers of the country.n
BTN: How should India strengthen its contract-based innovation funds must be had more or less articulated the basis for
public sector research in agri-biotech? made available on large scale, supported a policy on agricultural biotechnology,
but, now there seems to be uncertainty
MKB: In terms of research in public by novel IP-sharing mechanisms.
Agriculture science needs better funding, again. As a community of scientists and
system we have to have short-, mid- and
a strong pull for the best and brightest. It DBT as part of the government, we are
Dr. P Anand Kumar is a Ph.D. from the Indian Agricultural Research Institute, New Delhi. He long-term policy. The ultimate challenge
is one of the greatest challenges we face. very responsible citizens of the country.
received Post-Doctoral training as a Fellow of the prestigious Alexander von Humbolt Foundation is to achieve absolute yield increase
at the University of Hannover, Germany from 1991-92. We must create world class leaders. Our We must have a policy that is based on
without correspondingly increasing
Dr. Kumar's work is focused on isolation and characterization of novel Bt (Bacillus thuringiensis) systems are too rigid - we should be able science and takes into account the
inputs and this is going to require the
genes, protein engineering of ä-endotoxins in E. coli, expression in transgenic plant systems and to encourage the most brilliant, creative limitations of the sector as well. We
highest level of basic plant science. This
development of efficient plant transformation techniques. He was the first to develop Bt-Brinjal in people and provide them space and must have a policy that promotes science
the country. The Bt-brinjal variety Pusa Purple Long resistant to Fruit Borer developed by him has will require a renewed focus on
enabling circumstances to work. Too and innovation in agriculture. Finally,
been licensed to four seed companies under Public-Private Partnership. characterizing the photosynthetic
much top down governance of science in our policy must address the concerns of
Dr. Kumar has received several awards and honours for his significant research contributions pathways and learning how to increase
the name of accountability has not the marginalized. These can be
including INSA Young Scientist Award, ISCA Prof. Hiralal Chakraborty Award, DBT Bioscience their efficiency. The best of modern
Award and VASVIK Award. produced excellence anywhere. accomplished through serious
biology and science must be applied to
Intellectual freedom creates engagement and not by speaking at each
Dr. Kumar spoke to Biotech News about his vision and roadmap for NRCPB in the years to come. the plant system. Secondly, we must
responsibility and concern, not other from the fringes, using moral
promote capacity of early- and late-stage
bureaucratic accountability. overtones. Government has to be
translational research and regulatory
Biotech News (BTN): What are the three transformation of brinjal in encouraged to infuse imagination and sincere. Teaching and learning go hand
product evaluation to capitalize on
most important research findings at the 'Transgenic Research' (2010) is another innovation in their research
available knowledge. Some kind of
BTN: The importance of a well- in hand.n
landmark paper. Molecular basis of programmes so as to achieve quality. articulated policy on various issues
Institute during the last five years? CMS in mustard published in 'Plant Publication in high impact factor
P Ananda Kumar (PAK): During the last and Cell Physiology' (2008) is a journals is given priority. Patenting and
five years, NRCPB has made significant discovery. Mapping of QTL licensing of novel innovations are
commendable achievements in terms for Basmati Quality in 'Molecular encouraged.
of discovering novel genes and Breeding' (2008) is an important step
BTN: What measures is NRCPB taking to Cross Fire
promoters such as Pi-Kh gene in rice in understanding Basmati traits. (Contd. from page 111)
that confers resistance to blast disease, attract first-rate human resources?
a powerful constitutive promoter in BTN: Which technologies have been PAK: NRCPB attracts the best post- of risks, even when these appear very arrived at by non-GM methods, the mutating the target gene using recently
Arabidopsis and gene targeting transferred to industry/user agencies graduate students from all over the small and difficult to quantify as would latter could be preferred, not least developed methods for identifying
technique in brinjal. recently? country through a competitive often be the case. While all the answers because it would involve less cost and individual plants having mutations in
BTN: Which are the five best publications PAK: We have transferred and licensed examination conducted by Indian may not always be possible to get, both time for testing, and be more acceptable specific DNA sequences (Colbert et al.,
Bt brinjal Event 142 to six private Agricultural Research Institute.
during the last three years? companies, three codon-modified Bt Scientists are recruited by ASRB by a the producers as well as the regulators to the public. The use of transgenic 2001). The standards of safety should
PAK: A publication on the development genes to ten companies and CMS lines rigorous selection procedure. Young need to adopt and enforce the highest approaches to downregulate endogenous also increase as GM technology gets
of SSR markers in rice in the journal in mustard to one company. biotechnologists are imparted training considerations of safety. For instance genes in plants (such as for example a better. In the long run this is likely to
'BMC Genomics' (2009) attracted (short and long term) so as to identify given that marker free technologies have recent study from NIPGR, New Delhi increase public acceptance of the
viewership of more than 2000 in the BTN: How is NRCPB promoting innovation? and nurture the latent talent.
first few months. Publication on cotton been in existence for over a decade, there which identified genes involved in fruit technology, and reduce both time and
PAK: NRCPB emphasizes on PPPP Researchers working abroad choose to
genome sequencing in 'Plant work in NRCPB in positions such as is no reason why they should not be ripening leading to increased shelf life expense, as well as controversy in the
(products, patents, publications and
Physiology' (2007) has been cited processes). The scientists are DBT-Ramalingaswamy Fellow, adopted as standard. In those cases (Meli et al., 2010)) may be substituted by testing and evaluation process.n
extensively. Chloroplast Overseas Visiting Scientists etc. n where an equivalent solution can be

120 BIOTECH NEWS VOLUME 5 | NO. 2 APRIL, 2010 BIOTECH NEWS 121
 s N s w N w N s Ne s s
ws N
ws New s ws Ne s ew s
N
ws Ne s ws Ne s ws Ne s ew ew
s Ne ws e e w N e e e s w N s e w N
s N e N
w s Ne w N
e ws Ne s N ew N
e ws N ew
s
N
e ws Ne s
w N
N ew Ne s N ew N
w s New s
w s e s N w s w N w s e w s e s
ws
w
Ne s
N s Ne w ew
s Ne ws Ne s
w N
ew
s Ne s ew
s Ne ws w
Ne s N ews
w
Ne s
N
ws New s
e w N ew w s N s N e w N s e w N s e w w N e w
N
e ws Ne s
w N ew
s Ne
s N ew s e ws Ne s N ew N
w s N ew s N ews Ne s N ews Ne s ews Ne s
N s Ne w ew N w s Ne s ew N w w N ws New s
e ws Ne s ew s N e ws Ne s ew N s ews Ne s N e ws Ne s e

NEWS NEWS NEWS NEWS

w N s w N w w N
N s Ne s ew
s Ne w
s ew N
ws Ne s ew
s Ne ws ew N
ws
w
N e s N ews Ne ws ws New s
ws New s w N s e w N s N e w N s e N
ew
s N e w N e
ws New s
w s New Ne s
w N ew s N ws N ew
s e ws Ne s
w N e w s N ew s N s e ws Ne s N ews Ne s
w N e
e
s News Ne s N ew Ne s N ew N
e ws Ne s N ew
s
N
e ws N ew
s
N
e ws
w
Ne s N ews Ne s ews Ne w s
w w s w s w w N
Ne s e ws Ne ws N ew Ne s N ew N
e ws Ne ws N ew
s
N
e w s N ew
s
N
e ws
w
Ne w s
N
e ws Ne s e ws New s
w s w s w N
Ne s N ews Ne s
w N ew Ne s N ew N
e ws N e
w s N ew
s
N
e w s N ew
s
N
e ws Ne s N ews Ne s e ws New s
w s w s s w w N
Ne s N e ws Ne s
w N ew Ne s N ew N
N ew N e
w s N ew
s
N
e w s N ew
s
N
e ws Ne s N ews Ne s e ws New
w N s w s s w w N
N e ws s Ne s w e w
Ne ws w Ne s Ne s
w N s w
Ne ws
N s Ne s N e ws Ne s ew
s
s e N ew
s e w N e s N ew s e Ne s e w w N ew e N ew
s e w N ew N
N N w w N Ne s s s
w ws ew ws Ne s N ews N
ew
s Ne s ws Ne ws
w N
ws Ne s
w N
ew
s N ew N
ew
s
e ws Ne s N ews Ne s e w N N s e w Ne s N e w N e w N w s N
N
ws
w N
Ne sStanford Ne s
w N s w N s Ne s
w s
ew s N ews
e
ew
s Ne s ws e
Ne s w e
s
wBiodesign w N ew Ne s
w N ew w N N s e w Ne s N ews
N
Ne Tshe first e ws Ne s w N w N w
Ne s
w
w ws
eCompany N“ConSure
ws Medical” is being Ne s
w Ne s w Ne s ew
s Ne s ew
s Ne s N Department of Biotechnology
e N s e e e w N w N s w
Ne s
w N formed
ws by w fellowsNof Stanford India Biodesign
ethe N
w s Ne s
w N
e ws Ne s ew
s N e
s ew Ne Ministry of Science & Technology
e N s e w N w N s e w N s N E W S
s w
Ne s
N Programme
ws Ne w
implemented and supported by the DBT N
w s Ne ws e ws Ne s ew N
w s New w w w. b i o t e c h n e w s . c o . i n Government of India
e e N w N s e
ws
w N s
Ne s in collaboration with Stanford University, USA. The N
ws Ne s ew
s Ne s w N s
w N ew N e e w N s e w Ne s ew
w s N e team has developed a device that could provide a w s N w N s e w N
Ne s ws breakthrough in management of fecal incontinence, Ne s ws Ne s Ne s
w N s
e w Ne e w Ne s e w w N ew
N N w N s Ne s
ws a debilitating condition in which a patient loses
ew
s Ne s ew w
Patron: M. K. Bhan, Secretary
Ne control of basic bodily functions. The device is N s e w N s N e Department of Biotechnology
ew N
w s N ew Government of India
N e s
meant to be used on hospital patients, although the
e ws N
w s N e w Editor in Chief: S. Natesh
N Ne s
team is also working on a home-care version. It has
e ws w Senior Advisor & Scientist ‘H’
N Ne Designed, Produced and Circulated by:
already been tested on five patients in All India
e ws Department of Biotechnology
Communication & Outreach Division
Institute of Medical Sciences, New Delhi and will be N s
w Editorial Advisory Mohd. Aslam
tested on five more after undergoing alterations. It is Ne Committee: Alka Sharma
Aravali Foundation for Education
Anamika Gambhir Aravali House, 431/D-22
the first indigenously-developed device to be cleared Chattarpur Hills
M. S. Shashi Kumar
for clinical testing at AIIMS.n New Delhi-110074, India
Editor: Manoj Dabas
Alka Sharma, DBT
DTP Assistance: Arogya Swami
Editorial Assistance: Poonam Barmotha
Agency and Pediatric Biology Centre. Sonali Jha Chatterjee
India's Participation in International Inauguration of Interim Facility of
Cancer Genome Consortium On this occasion Dr. Barbara Alving also
THSTI delivered the inauguration lecture on
The third scientific workshop of The interim facility of Translational “Turning Discoveries into Treatments: Disclaimer: Views expressed in invited articles are those of the authors and not necessarily subscribed to, or endorsed by DBT or any other organisation associated with the publication of Biotech News.
International Cancer Genome Health Science & Technology Institute Strategies for Catalyzing Translational
Consortium (ICGC) program was (THSTI) was inaugurated by Prof. G. Research” at National Institute of
held during 21-23rd March, 2010 at Padmanaban, Distinguished Immunology followed by a panel
Madrid, Spain. The workshop was Biotechnologist, IISc., Bangalore at 496 , discussion by eminent scientists. The
attended by all stakeholders of the Udyog Vihar-III, Gurgaon in the
ICGC. Experts from about 11 presence of Dr. Barbara Alving, Director,
National Centre Research Resources,
same was attended by a large number of
experts, scientists, students and industry I'd love to subscribe to News
countries participated during the representatives.n
meeting and presented the status on NIH, USA on 29th March,2010. Dr. M.
T. S. Rao, DBT
implementation of country-specific K. Bhan, Secretary, DBT and Chairman,
projects. Indian representatives from
Governing Body- Name*: Mr./Ms./Dr. ...........................................................................................................................................................................................................
THSTI were also
National Institute of Biomedical
present among other Designation/Organisation.................................................................................................................................................................................................
Genomics, Kolkata and Advanced
distinguished scientists.
Centre for Treatment, Research and This facility has a Mailing Address:................................................................................................................................................................................................................
Education in Cancer, Mumbai rented space of
presented the implementation strategy approximately 25,000 .................................................................City: ............................................................State.............................................Pin
of India-specific project on oral cancer square feet space to
including sample collection and develop various Telephone: (O)............................................................ (R) ................................................................E-mail......................................................................
sequence facility. The DBT laboratories of THSTI
participated in the executive and its niche centres
committee to finalize the policy and such as Vaccine and
strategy to implement the consortium Infectious Disease
Research Centre, Signature of Subscriber
including funding.n
National Development Dr. M.K. Bhan lighting the lamp after Dr. G Padmanaban (right)
T. S. Rao, DBT at the inauguration of the interim facility of THSTI.
Clinical Services
Dr. Sudhanshu Vrati is also seen in the picture.

122 BIOTECH NEWS VOLUME 5 | NO. 2 APRIL, 2010 BIOTECH NEWS 123