Sei sulla pagina 1di 36

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

Bioimplants and Devices


Department of Biotechnology
Ministry of Science & Technology
Government of India

Genetically Modified Crops

Need for a meaningful dialogue
To the Readers

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
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?


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
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

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

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


GM vs. Traditional Crops GM vs. Traditional Crops

How Do They Differ ? How Do They Differ ?

Chromosome level changes that occur during conventional plant Genetically speaking…..
breeding and integration of a transgene during genetic engineering
A Schematic Representation 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
TRADITIONAL PLANT BREEDING 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-
Chromosomes are made of DNA that comprise a series of genes, much like a strand tion in its own expression or that of the two genes it is flanked with. However, it should be
of pearls. Traditional piant breeding ends up binding together many genes at once from
both parents through the process of hybridization appreciated that if the latter is the case, the GM crop will be declared as not suitable for
Many Alleles are recombined between commercialization and will never reach the farmer. This is enabled through a series of regu-
the parents at their original positions on
Allele of the same gene with the same chromosome along with the lations and tests the GM crop undergoes for its equivalence and similarity with the normal
undesired expression desired gene
Desired allele of a gene
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
Identical Chromosome Chromosome carrying others). Therefore, the rules of genetic segregation will be different in the conventional
Chromosome of
of another genotype of genes from both parents including
donor genotype
same species the desired gene in the new variety
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-
GENETIC ENGINEERING 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
A transformation event adds only a single gene construct to the chromosome
this hybridized product will segregate into, 1RR : 2Rr : 1rr. The RR and rr combinations
A single gene construct gets integrated at
any random position in one or many copies are called “homozygous” the Rr is called “heterozygous”. In contrast, because the
Desired Gene on any chromosome
Desired Gene 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
Commercial Plant Commercial Plant known as “hemizygous” and the individual is called “null” as this individual does not carry
Variety Variety
Donor species (any any allele of the transgene. The fate of the progeny of the Bt hybrid cotton is as explained
organism, plant, animal,
microbe or a synthetic gene)
u above if one grows the seed produced on the Bt hybrid plant.

u results from a specific breeding process crossed with another variety of the same has incorporated a foreign gene in its u uct by the insect pest. The consumer the reason explained in the box above. If GM crops do not qualify for cultivation
known as “backcross breeding” where crop. genome is as safe as its conventional would have the benefit of getting they do, then there will be 25% “null” as organic crops.
the focus is to transfer only one gene GM Crop and Farmer/Consumer counterpart. The rigorous testing the undamaged product and residual pesti- plants which will be non-GM plants.
from one parent (known as donor par- product undergoes for establishing its cides in the commercial product. The GM Crops: Common Misconceptions
The GM crop variety (hybrid in terms of Organic Crops vs GM Crops
ent) into another already established vari- safety vis-a-vis the environment, human conventional product in contrast will be GM crops are unsafe and harmful : The most
the farmer) and the commercial product Organic crops are any natural and non-
ety, known as the recurrent parent. and animal health under the vigil of the prone to have the insect pest or have pes- common misconception is that GM
of the GM crop (such as leafy foliage, GM crop variety which is cultivated with-
In general, once stabilized by the inte- regulatory processes in place, makes the ticide residues in the commercial prod- crops are unsafe and harmful for human
fruits, grains, oil or fibre from the view out the use of chemical fertilizers, pesti-
gration of the transgene anywhere in its GM crop a beneficial product to farmers uct to the disadvantage of both farmers beings, animals and environment. It
point of the consumer), will technically cides and chemicals. The field where it is
genome, the GM crop follows the same and consumers. Depending on the gene and consumers. If the GM crop is pro- needs to be understood that GM crops
be substantially similar to its conven- grown has to be certified as organic field
series of survival procedures like any incorporated in the GM crop, its value in duced to add value to the commercial are rigorously evaluated and analyzed
tional counterpart. In terms of farmers, having no traces of any chemical/ inor-
other conventional variety of the crop. differentiating it from its conventional product such as enhanced carotene con- for any risk they may pose to human
the GM crop will enable them to pro- ganic fertilizer(s) or chemicals. The crop
The difference lies however, in the limit- counter product differs. For example, if tent or minerals, the farmer will be able beings, animals and environment. Only
duce more or better quality product cultivation, harvesting and packaging
less potential of the GM crop both in the a insect resistance is the feature of a GM to obtain better marketability while the when it is confirmed safe through a stan-
while for the consumer it will add more has to be certified as done organically
way the new “transgene” integrates into crop, this will be valuable to the farmer consumer will have healthful products dard set of investigations and protocols,
value to the product for a better quality without any use of chemicals. It is also
the native DNA of the crop and the loca- in terms of reduced use of pesticides, for consumption. a GM crop is released in the environ-
of life. Over the last two decades, the required that the seed used for producing
tion on the chromosome where it inte- reduced losses due to the insect pest and The farmers have to take care ment for cultivation.
technology of genetic engineering of the crop is also produced organically. As
grates. Once integrated, the transgene better market value through low or no that they do not use the seed of a GM GM crops destroy natural genetic diversity: It is
plants has undergone a series of refine- per the current definition and standards,
can recombine like any gene when damage caused to the commercial prod- uu crop hybrid for raising another crop for often stated that GM crops erode genetic uu
ments to ensure that the product which


GM vs. Traditional Crops

How Do They Differ ?

u diversity of the crop. This misconception cide tolerance genes are deployed and into a human organelle. The transgene is
is based on the perceived ability of the they do move into wild types, these only a chemical entity made up of com-
GM crops themselves to become inva- plants are not provided with extra fitness mon components existing in human
sive or pass the invasiveness to wild rela- for them to produce more seeds. Thus, beings and plants or bacteria. As such
tives or native varieties through “gene like the established safety of every other we everyday consume bacteria and
flow” or “pollen flow”. While it may so improved character from non-GM vari- 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
were: Brazil (21.4 million ha.),
Argentina (21.3 mha), India (8.4
DBT has launched a new user friendly interactive website 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: 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: Slovakia.


Million Hectares ( 1996-2009 )
25 Biotech Crop Countries

160 “Trait Hectares”

140 Total Hectares

Biotech Crop Countries and Mega-Countries*, 2009 120


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

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
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
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
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


GM Crops in India

Beyond Bt Brinjal
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

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


GM Crops in India GM Crops in India

Beyond Bt Brinjal Beyond Bt Brinjal

u protocols on gene flow demanded in be carried out for 6 months or even a products developed by MNCs (eg.GM u frequently observed mechanism is due to former function and give approval for the Bt toxin, it would avoid expression of
transgenic crop trials, deep inside I year, if that would satisfy the corn and Soya), while developing its own defects in receptor binding followed by commercialization. GEAC has evolved the toxin in all tissues of the plant.
believe that the biodiversity card is requirement. I personally do not see the Bt rice. As per a news item (November 4, resistance due to defects in protease over several years of experience and, Similarly, if the toxin is expressed only
overplayed. The government can create logic in extended studies. 2009/PR news shire- First call), production, elevated immune response, perhaps, it is not a good idea to disband during the stage of pest attack, its
biodiversity parks all over the country to I also do not subscribe to the Monsanto was opening its first research enhanced esterase production etc. the same. It may need some more fine concentration will get diluted during
preserve rare varieties of selected plant addition of sophisticated tests such as center in Zhongguancum, Beijing. Strategies to overcome resistance include tuning. Thus, these two authorities can grain maturation and disappear from the
species. transcriptomic, proteomic and Monsanto has made a commitment to development of Bt plants with novel Cry be two arms of NBRA in the Agriculture final product. India has to give priority to
metabolomic studies. A plant is a collaborate with Chinese scientists on toxins (eg.VIP3 plants), Cry gene sector. The biggest challenge is to create develop transgenics to improve the
E: Bt brinjal as a food crop cannot be dynamic entity and would respond even advanced biotech and breeding stacking (eg. Cry 1Ac with Cry 2Ab), independent and dedicated experimental nutritive quality of the grain and resist
equated with Bt cotton to small changes in environment cues. technology. China is pragmatic. It wants modified Cry toxins that bypass primary facilities to monitor and evaluate GM abiotic stresses such as low rainfall and
The chronic toxicity tests carried out in One can be reasonably certain that these to get the best of both worlds. We are receptor interaction (eg. Cry 1A Mod crops. Till such a facility comes into salinity in soils.
experimental animals are not adequate. parameters would be different between driven by emotional activism. It is not as toxins), use of Cyt proteins from Bt i existence, the existing laboratories in Finally, none of these agenda
There are suggestions that chronic the different varieties of brinjal, or even if there is no opposition to GM strain along with Cry toxins and use of different institutions have to be net- should delay the release of Bt brinjal.
toxicity tests should be carried out during the same variety grown under different technology in China. But, it is able to cadherin fragments to counter resistance worked to provide independent After all, Bt corn and Bt cotton were
the entire life cycle of the animal. geographical and environment take decisions and move ahead. It is able (Bravo, A and Soberon, M (2008). How experimental capabilities for NBRA. introduced with single Bt genes and
Solanaceae is a unique species and the conditions. This does not mean that the to keep the big picture in perspective, to cope with insect resistance to Bt R&D Efforts (Priority). Bt transgenics antibiotic markers and their safety in the
transgenes may bring the hidden toxins changes seen are detrimental. namely food security to an over billion toxins? Trends in Biotechnology Vol.26, should only be developed with more than field is well established. Evolution
to the surface. Brinjal is used in native population and an intense ambition to 473-579). one gene. Those that have already been towards a better safety regime and
medicine without cooking and abundant F: Bt brinjal has been developed by become the world leader. I will not be In addition, on the field use of developed should be given priority for introduction of NBRA cannot be reasons
caution needs to be exercised in assessing Mahyco in which Monsanto has a surprised if we will be importing Bt rice refuge cropping has been shown to be commercialization. In fact, if we can for delaying the release of Bt brinjal. I do
the health safety of Bt brinjal. As per EC- stake of 26% from China at some point of time! effective. It is clear that in developed develop two different sets, one should be not believe that labeling of GM crops as
II report, the developers have indeed The gene belongs to Monsanto. Priority countries there is already a switch to the in reserve to be introduced as and when such should become an issue. It will only
carried out a variety of mandatory needs to be given to the G: Resistance development is a use of Bt crops with stacked genes. signs of resistance are seen. Resistance is confuse the masses in a developing
toxicity tests in a wide variety of commercialization of indigenously serious concern in monophagous Indigenous efforts should only be not a permanent character. It is well country like India. We are losing
experimental and domesticated animals. developed transgenic products. China has pests towards developing Bt plants with known that when crops are rotated, the precious time in reaping the benefits of
A 90 day chronic toxicity test has been developed Bt rice indigenously and has By far this is the most serious issue, stacked genes. Monsanto has already pressure on the insect to develop Bt gene and nearly 25 countries,
carried out. These tests have been approved trials that would lead to which scientists should address as the indicated of possible resistance resistance to a particular gene is eased. including some in Europe have gone in
considered as adequate by GEAC. One commercialization. First, the support for primary challenge. Two different development in Gujarat to pink boll The insect once again becomes sensitive. for this technology. More than all the
should also keep in mind that there is so indigenous development is definitely hypotheses are available to explain the worm in Bt cotton and has Bt crops can ideally form part of valid scientific arguments, success in the
much published information already welcome. There are atleast a few events, mode of action of Cry toxins. One is recommended the use of second Integrated Pest Management regime. field would convince the public of the
available on the safety of Bt toxins to both in the private and public sectors, based on generating pores (punching generation Bollguard with two stacked When major pests cannot thrive, minor importance of GM crops for food
humans and animals. More than this, Bt that are ready for trials towards holes) in the insect gut cell and the other genes. I wish there is an Indian authority pests can become the primary concern. security. The introduction and success of
corn is being consumed across the globe commercialization. But, one needs to is based on killing mediated by signal which gives this advice based on a Therefore, transgenics to contain minor Bt cotton has convinced many farmers
for over a decade. Apart from being cattle talk to the scientists concerned to transduction. In both the models, the first constant monitoring of the GM crops in pests (eg. sucking pets) need to be and a segment of the public that GM
feed, the breakfast cereal in North understand the trials and tribulations steps envisaged are similar. The ingested the field. developed simultaneously. I have earlier technology can lead to increased
America, perhaps, contains Bt corn. We they undergo to take their transgenics toxin is cleaved by midgut protease and listed many genes that can be used to productivity, decreased pesticide spray
cannot just discard the American forward. the activated toxin binds to cadherin H: India needs an independent combat resistance. Newer strategies such and increased revenue to the farmer. If Bt
experience and state that it is not relevant On the one hand they have to receptor located in the microvilli of authority to evaluate and approve the as the use of SiRNA to knock out brinjal succeeds, it would go a long way
for our discussion. In my perception, the face the tough requirements of RCGM midgut cells. The toxin oligomer then trials as well as to monitor the specific gene expression need to be in convincing many that GM technology
greatest proof of safety of Bt gene is the and GEAC, constant interference by binds to secondary receptors anchored to performance of GM crops in the field pursued vigorously. Strategies are is safe and viable. I look for the day when
long term consumption of Bt corn in activists directly or indirectly, Supreme the membrane such as aminopeptidase N after commercialization available to remove antibiotic markers. India would have pest-resistant rice with
many countries without any confirmed court ruling that actually allowed on or alkaline phosphatase. The toxin A unified National Biotechnology Even screening a large number of events improved nutritive quality ( balanced
and authenticated ill effects to the public. going trials (Mahyco), but clamped an oligomer then inserts into lipid raft Regulatory Authority (now rechristened can give the desired transgenic without protein and micro nutrients) that can go
Of course, scientifically it is well known embargo on newer trials that were ready membranes forming pores and causing Biotechnology Regulatory Authority of antibiotic selection. Fortunately, all these grow even under conditions of low
that Bt proteins get degraded in the (indigenous) and on the other, face an the cells to burst. In the second model, India, or BRAI) is under consideration. efforts are underway. Development of rainfall. Agriculture is not just about
acidic stomach of the mammal, whereas uncertain future in terms of publications the binding of toxin to cadherin receptor The bill pending since 2005 is likely to be transgenic varieties would help farmers technology, since it embodies a culture
it gets activated under the alkaline and career advancement (public sector) is visualized to trigger a signal taken up in the parliament for debate. I to store the seeds. But, the seed and there are political and sociological
conditions of the gut in the pests. It gets and survival (private company). Is this transduction cascade, eventually leading feel that the regulatory authority to companies can make money only if they over tones. It needs to be realized that
degraded during cooking. Its penetrance the right environment for indigenous to oncotic cell death. evaluate and monitor transgenic crops in sell hybrids. Technology developers need GM is only an innovative approach to
in the soil and microflora is not of real development of commercial capabilities? Mechanisms of resistance development experimental fields and the one that to be compensated, while the farmers provide a technological solution, but it
concern. In spite of all these arguments, As regards China, it has followed a dual have been studied in different pests performs a regulatory function after derive benefit. The future challenges are should not be made a scape goat if there
the chronic toxicity tests in rodents can policy. It has approved specific GM induced to become resistant in the commercialization should be different. the development of tissue specific and is failure else where.n
laboratory. In general, the most uu GEAC can continue to perform the stage-specific promoters. In the case of


G M Technology

Responsible And Purposeful Use


G M Technology

Responsible and Purposeful Use

R. P. Sharma

enetic modification of crop germplasm, which is more often the available in the germplasm of the GM u sources of resistance in the world cotton Bt-gene has been engineered. environmental and soil dynamics are
plants has been and continues case, the conventional plant breeding modified crops. A brief analysis of the germplasm against Helicoverpa armigera. l The genetic background of the Bt challenging the sustainability of
to be the basic feature of con- will remain the first option. However, for world wide adoption of GM crops reveal This insect was basically being managed hybrids/varieties and not the “Bt- agriculture. It is therefore of utmost
ventional plant breeding wherein the those traits which are not available in that only three major traits viz. insect by repeated sprays of environment transgenic event” is important for its importance that countries like India
genetic traits of breeding value, and in close relatives, or got lost due to natural resistance, herbicide resistance and viral polluting and health hazardous adaptability to diverse agro- must develop, adopt and innovate new
turn the genes governing those traits, are or manmade selections, mobilization of resistance alone, or in combinations, pesticides. In fact, cotton crop received ecological situations. and novel approaches for increasing
brought together through the process of genes through the recombinant DNA have been mobilized in only five major almost 30% of the total pesticide used in agricultural productivity in a sustainable
l Science based technology, as in the
hybridization, recombination and finally technology based tools is the most desir- crops viz. soybean, cotton, maize, India. Following the release of Bt manner. It is in this context the GM
case of Bt-technology, requires
selection of the promising genotypes. able option for the plant breeders. It canola and papaya, covering more than cotton, the pesticide consumption in technology assumes much greater
continuous awareness generation
The major difference between the con- should therefore be understood that ninety percent of the area under GM India declined from 47,020 metric tones significance and calls for its judicious
among the farmers for its effective
ventional approach and the recombinant genetic modification or GM as we crops. These results clearly indicate that in 2001 to 37,959 metric tones in 2006- integration in the conventional
DNA based genetic modification is that understand it today, does help in borrow- so far the application of GM technology 2007. approaches being pursued for gene
in the first approach genes being reshuf- ing one or few genes from unrelated spe- has been highly need based and l Non-availability and high cost of management, nutrient management, pest
fled are “known” genes and are brought cies and is in no way a replacement of restricted to only those traits which were Lessons learnt from commercial planting material can lead to management, water management, soil
together from sexually compatible rela- conventional plant breeding. GM not amenable through conventional cultivation of Bt Cotton in India unethical trade practices. health management, and post harvest
tives whereas the recombinant DNA approach is at best and at times indis- methods of crop improvement. l Time and again, first during “Green l Reduction in pesticide usage led to management.
based approach permits mobilization of pensable adjunct to conventional plant In the Indian context, so far Revolution” and now for adoption substantial savings in input cost and Obviously, the management of
gene/s from unrelated species, genera breeding. only Bt cotton, engineered for insect of Bt-technology, Indian farmers reduced exposure of the farm each of the activities listed is going to be
and even phyla and therefore, are 'un- resistance has been commercialized. Bt have demonstrated that they are workers to environmental and health crop specific and will demand thorough
known' as far as their expression and GM: A Brief History cotton, a highly successful example, highly receptive to economically planning in terms of trait to be improved
hazardous pollutants.
interaction in the alien genetic back- Tracing the brief history of GM crops, represents indispensability of GM viable technologies. Within seven and the tool to be applied. For example
ground to which they are brought are starting 1996, when the first GM crops technology for a trait proving to be years of the release the area under Need Based Application of GM in a crop like rice, the varieties of
concerned. Thus, in situations where the was released for commercial cultivation recalcitrant to breed through Bt-cotton increased from four acres Technology tomorrow must not only be high yielding
required genetic traits are available in the in USA, most of the traits engineered in conventional plant breeding, primarily in 2002, to about 9.5 mha in 2009. Currently, Indian agriculture is passing but fertilizer use efficient, tolerant to
sexually compatible and therefore usable plants so far are those which are not because of the non-availability of uu through a critical phase. Crop existing and emerging biotic and abiotic
l Bt gene(s) provide tolerance to insect
production is static if not declining, stresses and suited for upland conditions
damage only. The yield per se
biotic and abiotic stresses are leading to of cultivations. For each of these traits
RP Sharma Ph.D. is former Project Director & INSA Senior Scientist, National Research Centre on Plant Biotechnology, Indian Agricultural depends on the overall genetic
Research Institute, New Delhi. (E-mail: unpredictable crop losses and changing which are polygenic in nature uu
background of the cultivars in which


G M Technology G M Technology

Responsible And Purposeful Use Responsible And Purposeful Use

u insertion; (b) genetic instabilities in through new molecules being discovered cultivation. The transgene “Insertion
other genes of interest and (c) for controlling of the weeds and insects. Event” based release of GM crops,
activating some of evolutionary Likewise, acquired resistance to practiced in some countries, are
silenced genes etc. antibiotics by the human pathogens can exempted in India only from biosafety
Keeping these uncertainties in view, be made inconsequential if the tests but for field release, prescribed field
biosafety related issues of the transgenes antibiotics used as selectable markers evaluations are mandatory. It is not only
have emerged as major concerns during cellular selection of the gene “insertion event” but the
warranting categorization of transgenic transformants are those which have genotype as a whole contributes to the
plants as regulated items. outlived their therapeutic value. In recent economic yield of the variety which
years, transformation protocols with need to be ascertained before
Major Biosafety Concerns from the removable antibiotic resistant markers commercial cultivation by the farmers.
Commercial Release of Transgenes have also been developed. The Indian Biosafety
The major biosafety concerns from the As far as negative impact on Guidelines, evolved during the last two
commercial release of the transgenic biodiversity is concerned, the decline in decades do address most of the biosafety
plants and their negative impact on (i) agro-biodiversity by extensive concerns listed above. However, it is
environment; (ii) human and animal application of high yielding varieties time that a “National GM-Biosafety
health and (iii) social and ethical issues during “green revolution” period has Register” is developed, prescribing in
have been the subject of intensive been very well documented. Large scale detail the crop and transgene specific
discussion worldwide. Incidentally, cultivation of transgenic varieties will biosafety concerns, the tests to be
during these discussions the importance further add to this decline because undertaken and the protocols that need
of transgenics in agriculture has been farmers will always prefer the varieties to be followed with a proviso of need
accepted unequivocally. The note of ensuring high economic returns to them based expansion and modifications.
u conventional plant breeding approaches breeding varieties for these traits. the improvement of specific trait in a dissent, however, has been on the over the poor yielding land races. Unless In order to ensure responsible
will no doubt help in assembling the However, upland rice conditions are very crop of choice must be undertaken adequacy of, and lack of transparency in and until farmer's interests are use of the GM technology, the
required gene combinations from the favorable for the growth of weeds as before opting for this approach. As the biosafety protocols followed. The safeguarded, the collection and Government of India has been
existing germplasm, the recombinant well. Managing weeds manually is not stated earlier, the recombinant DNA potential risks to the environment being conservation of the biodiversity by crop modifying and updating the existing
DNA tools applied judiciously will help only difficult but add to costs making technology has virtually clubbed the envisaged are the development of : (a) based institutions and Genetic Resources biosafety protocols to make them more
in mobilizing the monogenic traits not upland rice cultivation highly whole biological world into a “single “superweeds” by the herbicide resistant Bureau is the only option available. As effective and efficient. It is in process of
available in the germplasm. The traits uneconomical. It is being visualized that gene pool”, with the possibility of genes; (b) new viral strains by trans- far as Bt technology is concerned, the setting up of a Biotechnology
which are attracting worldwide attention in future upland rice cultivation with isolating a gene of choice from a donor capsulation of virus resistant genes and major biosafety concern is the Regulatory Authority of India (BRAI),
for rice improvement are: bacterial, “no till”, where rice seed is sown in the and its integration in the genome of the (c ) “superpests” by insect resistant development of resistance to the Bt- which will be autonomous and statutory
fungal and viral diseases, insect unploughed fields, will emerge as a recipient plant. It is obvious that this genes. Likewise, the potential risks to protein in the target insects. Resistance agency to regulate the research,
tolerance, herbicide tolerance, grain highly desirable approach for sustaining technology has given enormous power in human health include: (a) allergenicity; development is directly proportional to transport, import, manufacture and use
quality parameters such as high protein, rice cultivation under changed agro- the hands of the scientists. In this whole (b) toxicity and (c ) acquired antibiotic the selection pressure imposed on the of organisms and products of modern
high carotene (Vitamin-A), high ecological scenario. This would require process, however, there are certain areas resistance by the human pathogens. The insect and can certainly be delayed by biotechnology. The Department of
tocopherol (Vitamin-E), and high macro that the rice varieties meant for upland where our existing knowledge is ethical and social issues are varied and maintaining the appropriate refugia and Biotechnology, Ministry of Science &
& micro nutrients etc. As far as grain and “no-till” conditions are genetically inadequate and is a cause of concern. are region and country specific. In the non-contiguity of large scale cultivation Technology has been entrusted to act as
yield is concerned, identification and modified for herbicide tolerance for This puts tremendous responsibility on Indian context these could be (a) of similar transgenic crops in the field. the nodal agency and a consultative
mobilization of major QTLs managing the weeds. On similar lines, as the users of this technology for its safe selective adoption of the technology The allergenicity and toxicity to human group of experts has prepared a draft
(Quantitative Trait Loci) for hybrid vigor outlined above for rice the desirable application. The gap areas are: leading to further economic disparities and animal health are certainly major Bill to establish Biotechnology
and superior alleles of QTLs involved in specific traits in different crops can be l Since the genes and gene products (b) monopolization of trade by rigid biosafety concerns and the international Regulatory Authority of India. The Bill
reducing the impact of negative identified and introgressed into the high- are known to interact intra-cellularly, intellectual property rights and restrictive protocols addressing to these issue are was prepared through a consultative
correlations among yield contributing yielding varieties through GM the behavior of a transgene in an trade practices and (c) negative impact quite adequate and have been adopted process involving interdisciplinary and
traits offer unique opportunity for technology. alien cellular environment of on biodiversity by extensive cultivation and followed rigorously in India. inter-ministerial experts, state
breaking the yield barriers. Water transgenic plant can not be predicted of transgenics.
scarcity and changing pattern of Responsible Deployment of GM Indian Biosafety Guidelines, in addition governments and stakeholders. It is
precisely in terms of allergenicity A critical analysis of most of
monsoon are bound to alter the Technology to human and animal health and expected that once in place, BRAI will
and toxicity. the biosafety concerns enumerated above environment, address the socio- address to the biosafety issues more
agronomy of rice cultivation, forcing Given the biosafety concerns and the
l The method of gene insertion in the would reveal that, in the long term, economic aspects of a transgenic plant effectively and will bring in the required
development of varieties amenable to costs associated with GM technology, it
recipient DNA is random which many of these will turn out to be and therefore, in a sense, are unique. impartiality and transparency in our
drought and upland rice conditions. is pertinent that a careful analysis
might lead to: (a) silencing of the inconsequential. The occurrence of These guidelines take into consideration handling of the genetically modified
Fortunately, the available rice germplasm bordering indispensability, of the
inserted gene itself or of the “superweeds” and “superpests” though a the field performance of a transgenic crop for sustainable development of
has enough genetic variability for application of genetic engineering for
surrounding genes at the site of uu remote possibility are addressable crop before it is released for commercial Indian agriculture.n


G M Crops
Human and Animal Safety

G M Crops

Human and Animal Safety


u exists. Considering the fact that source that gives it a trait to protect itself toxic properties using the target insects.
laboratory animals are used primarily to from pests can be identified and inserted B. The next test is to feed the food
carry out such tests, appropriate animal into the food crop and a demonstrable containing the toxic protein to rats every

nsuring safety of any product accept the product after making sure that similar issues often get reviewed/ model (be it a rat or a rabbit or a goat etc benefit can be seen. The safety concern in day for a period of 90 days in order to
meant for human or animal use is the risk is very negligible and the benefits analyzed further. These can form fairly ) needs to be chosen to predict the way a this case could be: assess long term effects of feeding the
paramount. This requires that are more, we need to equip ourselves with substantial evidence-based information human or other animals would behave if insect toxin. The rats are then studied in-
such a product has to go through certain strategies to manage the risk even if it that can be used for risk assessment. the same treatment were to be given. Rat  Will the product of the inserted gene, depth for their growth, sickness, activity,
which is an insect killing protein, also
regulatory processes laid out by the occurs. However, the most robust evidence of is by far the best animal model because cause harm to humans? blood parameters and all biochemical
respective government departments. Risk Communication: This process involves safety is a history of safe human use. It is more than 95% of its metabolic pathways  Since, it is a protein which would not have indicators before they are finally
Regulation usually ensures that (1) the communicating such information to the for this reason that several traditional are similar to those of humans and many been eaten by humans earlier, is there any sacrificed at the end of the period. Their
likelihood of it causing allergy to those
product which is being approved is useful users so that they know what they are in foods and medicines are accepted because other larger animals. Several decades of who consume? internal organs are examined thoroughly
i.e. efficacious and (2) that even after use for and feel reassured that the risk is far people have been using for years and data using rat as a model for drug or food  When this new gene was inserted into the and under the microscope for any
for varying periods of time, it is unlikely there is no evidence of harm. crop, did it disturb any other gene and
less than the benefits they are likely to safety assessment has confirmed this. produce unintended effects? abnormal changes. These are also done in
to cause any harm. Even if there is a derive. However, if a product is new or Therefore, if no harm occurs in a rat fed comparison with animals fed with normal
potential risk, it is very unlikely to cause not in use in the country, the regulators with the test material, one can safely To address the first question two kinds food crop. If the difference is consistently
All the above processes are
of safety tests can be done using rats.
harm and that the immediate benefits far possible only if the harmful substances would want adequate data to be assume that other mammals and humans observed then it is significant, otherwise,
A. Feed the animals the purified protein
outweigh such risk. The following are are known or identified. Risk assessment generated on its safety. This is possible would also behave in a similar way. one can be fairly certain that it is safe.
(insect toxin) in quantities many times
some of the steps involved in this process cannot be carried out if such harmful only through many test procedures which The question is why only 90 days. The
The key steps in biosafety testing more than what a human or animal is
Risk Assessment: This involves two very substances are unknown or exist only in are validated. Validation means that a set therefore are short life span of 90 days in rats is almost
likely to consume. This is to be given as a
important steps - identifying the risk our perception or imagination. Even in of procedures have been carried out on l Identify the risk similar to feeding humans from 6 months
l Have a validated test system single dose by gastric feeding and animals
(what is the harmful substance) and cases where there is no known or the potentially harmful substance and to about 25 years of age. Added to these,
l Conduct the tests with should be observed for 14 days. If the
quantifying the risk (how much is the identified risk, how does one look for confirmed that such procedures can approved protocols the analysis of years of data and several
animals are fine, eating well and growing
exposure to such a harmful substance). possible harmful substances? The answer detect the substance even at significantly l Review the scientific evidence studies indicated that no additional
l Assess the risk normally after the test period, it can be
Risk-Benefit Analysis: Now that the extent of is simple. One has to rely on the available low levels. Employing validated information can be obtained even if they
Let us now apply these principles to assumed that even unrealistically larger
risk is made known to us, this step would scientific literature. Several researchers all procedures, if the test result turns out to are fed beyond this period. Such longer
genetically modified or genetically consumption is safe. This is called as
help us know whether the benefit is worth over the world are constantly generating be negative, one can be sure that there is duration animal studies spanning 180
engineered crops or foods. We develop acute toxicity test. Through this test, it
taking the risk. genuine research information, which gets no harm and if it happens to be positive days or more are essential to assess the
such variety to quickly give an advantage can be confirmed that the toxin has effect
Risk Management: Although we decide to published and many such papers on then one can say with certainty that risk uu reproductive toxicity and the possibility
to the crop which we are unable to only on the insects and not on animals or
of occurrence of cancer.
manage efficiently due to many reasons. humans that are consuming it. But,
Bt proteins or for that matter
For instance, in case of a crop that gets before giving this pure protein to the
B. Sesikeran MD is Director, National Institute of Nutrition, Hyderabad.(E-mail: any protein cannot get into the cells as
eaten up by insects despite heavy use of animals it needs to be confirmed that the
such when consumed because they are uu
pesticides, a gene from even a non-food tested protein/ toxin has insect killing


G M Crops
Human and Animal Safety
u digested and converted into amino acids, to inject the test substance or a placebo their non-GM counterparts.
which we anyway eat through a variety under the skin of the patients with Concerns also exist regarding the possible
of foods. Proteins therefore are not allergy, under medical supervision, and transfer of antibiotic resistance selection
mutagenic and do not cause DNA look for allergic reactions. These tests marker gene or the promoter gene to the
damage and risk of cancers/tumors does would further reassure that the new gut bacteria. Scientific studies indicate
not arise. The 90 day studies as protein is not toxic to humans and other that the chances of any such transfer are
mentioned include detailed microscopic animals and is also unlikely to cause remote. In fact, we consume lots of DNA
examination where in the reproductive human allergy. through foods but they do not get
organs are examined and if there are any The final and by far the best incorporated into host or bacterial DNA.
Ecological Consequences of GMOs

Ensuring Environmental Safety

abnormalities in these organs then surrogate evidence of safety is the extent Even if such an event takes place, those
reproductive toxicity studies should be of similarity between the non-genetically cells undergo repair or perish.
done. It is to be borne in mind that every modified food crop and the respective The above information would
test performed has to be validated and GM version. This is called as make it evident that GMOs are
merely performing studies without compositional analysis or establishing thoroughly tested for safety using
scientific basis will not give the answers substantial equivalence. Based on meaningful and validated tests. Hence,
we are looking for. As mentioned earlier, scientific data, we know the various known risks can be quantified. However,
if humans are already consuming for a components of the edible plant or plant there are no protocols to look for harmful
good length of time, then that is the best part like its water content, proteins, effects, which are based on paranoid
evidence of safety rather than any long carbohydrates, fats, minerals, vitamins, perceptions rather than science-based
term rat study. phytonutrients, anti nutrients and known reasons or evidence.
R. Uma Shaanker K. N. Ganeshaiah
C. Assessing the possibility of allergens. When all components are All testing procedures have
allergenicity is again a complex process. similar between the two, we are fairly been prescribed based on scientific
Scientific evidence has shown that allergy sure that the GMO after the insertion of evidences and international best
causing substances have two major new gene has not changed anything in the practices. The following are the biosafety

characteristics - they are resistant to the plant. Worldwide, this is the single most guidelines which have been prescribed by ebates on the ecological Thus the truth of the ecological assessing the ecological impact of the
digestive juices as well as the acid in the robust test of safety. Even in traditional the Review Committee on Genetic consequences of GMOs fall consequences of GMOs lies somewhere GMOs.
stomach and they do not get destroyed by plants there are normally variations Manipulation (RCGM) / Genetic into two extreme categories: in between! That it lies in between is also a) Pollen Transfer: Introgression
heat to a great extent and therefore persist between the crops within the same field Engineering Approval Committee Those who feel that GMOs shall be the reason why the two opposite groups between the cultivated plants and their
even in cooked food. Therefore, if the or between the crops from different soils / (GEAC): treated as `Guilty until proven innocent' have been indulging in an unending tug wild relatives is a dominant evolutionary
new protein due to genetic modification different climates and sometimes within l Recombinant DNA Safety Guidelines, and those who wish to treat transgenics of war over the issue. process and hence, it is argued, may not
1990 & 1994
can be digested by simulated gastric the same plant between different stages of as `Innocent until proven guilty' (Belt, be an exception for a transgenic cultivar
l Revised Guidelines for Research in Ecological Impact of GMOs
digestion and also breaks down on maturity. When comparisons are done, Transgenic Plants and Guidelines for 2003). While this polarization, even as well (Stewart Jr et al., 2003). In fact
heating, then it is a strong enough these inherent variations are considered. Toxicity and Allergenicity Evaluation, among the professionals, is clearly due There are two major ways in which `most cultivated plants mate with one or
1998 GMOs are suspected to affect the
evidence to say that it is unlikely to be an Newer techniques, which detect l Guidelines and SOPs for the conduct of to their philosophical affiliation to the more wild relatives in some portion of
allergen. Thousands of possible allergens the minor components in the metabolic Confined Field Trials of Transgenic entities they are trying to protect ecosystem and the biological diversity. their geographic range.' (Snow, 2002).
have been identified from various sources pathways, which lead to the macro Plant, 2008
(ecosystems and biodiversity in the first Consequently, it is feared that the
and their amino acid composition, components like carbohydrates, vitamins
l Guidelines for the Safety Assessment of
category), or promote (biotech products
Gene Flow
GM Foods, 2008 advantageous genes from the transgenics
sequence and tertiary structure are stored etc., are now available. However, until we l Protocol for Safety Assessment of The uncontrolled escape of transgenes
in the second), unfortunately, in the may be introgressed into the related wild
in large databases. The new GM proteins know what are all the variations as Genetically Engineered Plants / crops, into non-target organisms especially into
2008. public and in the media these debates species especially when the area under
structure, sequence and amino acid mentioned above, such tests cannot be the wild relatives is expected to affect the
It can be stated with confidence that no have turned more emotional than GMOs increases.
composition is established. Using bio- used because any differences could be a local gene pool and also the ecological
other food technology has gone through rational; more decibel based than data- Obviously the probability and
informatics tools, they are compared or variation in the normal process and even balance. Transgenic genes may escape
such vigorous safety testing procedures as based; and more prophetic than realistic. depth of such gene transfer is a function
matched with the databases of known if no differences exist we still cannot from the source population in three
biotech derived crops. Let us recall the As a matter of fact, in a calm and of the extent to which wild relatives of a
allergens. If there is no match we are consider these as evidence. Such ways: a) through pollen transfer, b) as
statement of Pandit Jawaharlal Nehru : reasonably coordinated atmosphere, transgenic plant are distributed in the
further reassured that the new protein is techniques have to be standardized and seed escapes, and c) Horizontal gene
“It is science and science alone that can neither of the two categories would be area of cultivation. It is now known that
not an allergy causing one. If there is a validated before they would be used for transfer through transformation and
solve the problem of hunger and poverty, able to completely defend their stand as world over there are a number of
match then a more detailed testing should regulation/regulatory testing. transduction processes. The varied
of insanitation and illiteracy, of the facts available are minimal and situations where the cultivated crops
be done. The detailed testing would Studies on livestock like chicken, cattle, probabilities and diverse consequences
superstition and deadening custom and where available, they are with neither of exchange gene pools with their wild
involve doing an ELISA test using the goats etc. need to be done in case any of these mechanisms are important in
tradition, of vast resources running the two extreme views. relatives (Ellstrand,1999) and some of uu
blood samples of patients with known part of the GM plant is likely to be used
waste, of a rich country inhabited by
allergies like asthma and mixing them as animal feed. These are not
starving people”. Uma Shaanker and K. N. Ganeshaiah Ph.D. are with the School of Ecology and Conservation, University of Agricultural Sciences, GKVK
with the test protein to see if they bind to toxicological studies but feeding studies
So give science a chance.n Bangalore. (E-mail: |
each other. The ultimate test, of course, is to see if they are nutritionally similar to


Ecological Consequences of GMOs Ecological Consequences of GMOs

Ensuring Environmental Safety Ensuring Environmental Safety

u the crops where this is most plausible are c). Horizontal Gene Transfer: Problems of negative reports u raise their heads high in the world because they have
sorghum, sunflower, canola, wheat, Horizontal gene transfer is suggested to The debate on GMOs suffers from a ENVIRONMENTAL SAFETY ASSESSMENT OF food and resources to live with. Unfortunately, it may
sugar beat and alfalfa (Stewart Jr et al., occur from the transgenic sources to be difficult to extrapolate on the basis of this history
2003). All these situations are potential other related plant species through viral
peculiar habit of biased reporting that is
characteristic to science. It is important
GENETICALLY MODIFIED CROPS to what could happen to our decisions on GMOs-
grounds for the transgenes to escape as transduction or, to other microorganisms to realize that scientists in general Environmental risk assessment is an integral component of not because GMOs would turn out to be bad but
area under cultivation of transgenics through transformation (Pilson and exhibit a peculiar bias in their habit of biosafety evaluation of GM crops. The purpose of such because India is perhaps not in such dire states as it
increases. The wild relatives thus Prendeville, 2004). The viruses that reporting results. For instance while assessments is to identify and evaluate the possible adverse was when green revolution occurred. But we need to
`transformed' may gain additional fitness infect the transgenics may encapsulate some of the instances cited above do effects of genetically modified organisms on the conservation and take conscious and valued decisions such that we do
advantage owing to this gene rendering the specific gene and re-infect other plant reflect the negative impacts of GMOs on sustainable use of biological diversity. Known risk not again enter a state of begging bowl.
itself the potentiality to be hazardous and release the gene in question or DNA the ecosystem, positive results, in this assessment techniques in different countries and guidelines
weeds in the crop fields. While the logic of the transgenic plants entering the soil developed by relevant international organizations recognize
A message to the funding agencies
case demonstrating that GMOs have an
of this cannot be denied, we need to system may be taken up by the micro- comparative risk assessment indicate that risks associated with We realize that there are very minimal datasets to
impact, are almost always reported and
look at the facts of such consequences. organisms transforming them. However genetically modified organisms or products thereof, obtained systematically evaluate the impact of GMOs on the
appreciated than those where the impact
Unfortunately, while only a horizontal gene transfer is among the through the use of modern biotechnology, should be considered ecosystem and crop genetic diversity. What exists is
is not detected. The authors, referees and
few examples of such pollen mediated least likely event because this requires in the context of the risks posed by the non-modified recipients or only indicative and at best inconclusive and there is a
even the editors do not find the negative
escape of the transgenic genes into wild high concentrations of viable DNA of parental organisms in the likely receiving environment. message here for the funding agencies such as
results of such work as interesting and
relatives have been reported, as for the transgene to be accumulated in soils. Department of Biotechnology, Ministry of
worthy of publishing as those of the The following steps are important in such risk assessment
example of transfer of the herbicide While there are reports of such DNA Environment and Forest, Department of Science and
positive results and hence a lot of work methodologies:
resistant gene from Brassica napus to B getting released into soil, it is very Technology and Indian Council of Agricultural
goes unreported making it difficult to
rapa, (Warwicket al., 2003, Steward Jr unlikely that such DNA fragments An identification of any novel genotypic or phenotypic traits Research. There is no point in blaming those who
weigh the relative disadvantages of that could have an adverse effect on biological diversity in the
etal., 2003) there are hardly any studies would be in viable and sufficient use their decibels than data sets to push their views in
GMO over their advantages. Debates receiving environment, including diverse impacts on human
on the fitness related spread of such quantities for the effective health the public. We need to generate reliable information
over GMOs always suffer from this bias An estimation of the likelihood of adverse effects being realized
`transformed' wild relatives (Snow, transformation. To cite Dunfield and such that the policy maker take an informed decision
in science. An evaluation of the consequences of any adverse effects,
2002). In fact even in this case of Germida (20040), “studies have shown should they be realized than temporally postponing the judgments on
Brassica, Warwick et al (2008) showed the possibility that transgenes can be Back to the future An estimation of overall risk (based on the above) GMOs. Thus we need to facilitate certain areas of
that the hybrid lineages declined transferred to native soil microorganisms A recommendation on the acceptability or not of identified research that demand immediate attention such that
And this brings us back to the question risks, including risk mitigation strategies
dramatically over time. For this reason, a … although there is not evidence of this that we began with: Should we treat And in cases where there remains uncertainty about the level of the professionals can find themselves on a solid
proper assessment of the impact of such occurring in the soil”. risk, additional research or risk mitigation measures or ground in drawing their conclusions and the public
GMOs as `Guilty until proven innocent' monitoring of the LMO in the receiving environment may be
introgression has not been possible and or as `Innocent until proven guilty'. required. are fed with more substantiated policy statements.
if anything overestimated. Toxin Flow The answer to this lies in the future:
Addition of chemical products from References:
Pollen flow is likely to carry How would the future generation judge Belt, Henk van den, 2003, Debating the precautionary principle:
the transgenes to the land races as well transgenes into the soil and environment “Guilty until proven innocent” or `Innocent until proven guilty'.
our decisions today in accepting or Ecological impact of the Ecological impact of Plant Physiology, 132: 1122-1126
is argued to affect the biological systems. introduced Trait(s)/gene(s)
and if this happens the `transformed' rejecting the GMOs? the modified plant Dlugosch K M and J Whitton, 2008, Can we stop transgenes from
land races may in fact thrive well in the Perhaps by far the most well taking a walk on the wild side?, Journal Compilation 2008,
Answer to this surprisingly may lie in the Similarity to
nature and contribute to the crops wild documented and highly celebrated case Similarity to Blackwell Publishing Ltd.
present and the past!! What does the proteins or conventional Dunfield K E, and J J Germida, 2004, Impact of genetically
is that of reduced fitness of the monarch varieties
gene pool- an entity every breeder would present generation think of our decisions traits in modified crops on soil and plant mediated microbial communities. J
butterflies feeding on the pollen from the conventional Environ. Qual., 33: 806-815.
wish to have. In other words such to go with Green Revolution during the Potential Ellstrand, N C, H C Prentice, and J F Hancock, 1999, Geneflow and
Bt transgenics (Losey et al 1999). varieties
transfer of foreign genes may enhance second half of the 20th century? weediness introgression from domesticated plants into their wild relatives. Ann
the intra-specific genetic diversity of the Similarly there are a number of studies Potential non- Rev. Ecol. Syst., 30:539-563.
We do not think that the younger Expression Losey, J.E., Rayor, L.S., and Carter, M.E. 1999, Transgenic pollen
crops (Pilson and Prendeville, 2004). reporting that flow of toxins into the soil target toxicity harms monarch larvae. Nature 399:214
generation of today considers the profile
b). Seed Escapes: This is an has affected the soil micro-flora towards Pilson, D and H R Prendeville, 2004, Ecological effects of transgenic
adoption of steps towards green Potential for crops and the escape of transgenes into wild populations. Ann Rev
the predominance of specific species or resistance Potential
immediately possible consequence of revolution during 1960s and 70s as a ecological Ecol Syst., 35: 149-174.
types in some cases and towards altered Snow, A A, 2002, Transgenic Crops- Why gene flow matters. Nature
growing transgenic crops; the transgenic curse on their generation. Rather the Outcrossing impacts Biotechnology, 20: 542
microbial diversity in other cases
seeds after the harvesting of the main young generation today has sufficiently impacts Stewart, Jr C N, M D Halfhill, amd S I Warwick, Transgene
crop may be left behind, escape and (Dunfield and Germida 2004). However introgression from genetically modified crops to their wild relatives,
acknowledged that if our country had Nature Reviews/Genetics, 4: 806-817.
survive as admixtures and hence may it is also important to realize that similar Warwick S I, M J Simard, and A Legere, 2003, Hybridization
not adopted steps towards green
enter into the chain of gene flow into effects are seen even with any two non- between transgenic Brassica napus L. and its wild relatives: B. rapa
revolution, their `present' would not L., Raphanus sativus raphansitrum L., Sinapis arvesis L., and
wild relatives (Dlugosch and Whitton, transgenic crops suggesting that the Each new event is carefully evaluated to ensure
have been as bright as it is. Though they that there are no unintended side effects Erucastrum gallicum(Wild.), O.E. Schultz, Theoretica and Applied
2008). There are a few examples of such minor changes in the soil flora is an Genetics, 107: 528-539.
were not there to face the famines then, (Reference: Annexure III and Article 15 & 16 of Cartagena Protocol on Biosafety) Warwick S I, A Legere and M J Simard, , 2008, Do escaped
escape of seeds and not surprisingly they ongoing process of farming per se and
they are aware of our begging bowl transgenes persist in nature? The case of a herbicide resistance
survive well in the wild. need not be linked exclusively to the Compiled by: S. R. Rao, DBT transgene in a weed population of Brassica rapa. Molecular Ecology,
situation. They are aware that they can uu 17: 1387-1395.n


India’s Agri-horticultural Biodiversity

Conserving Our Biological Heritage

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

he conservation and sustainable linked to sustainable use. The concern cultivated plant species have their origin
biotanical use are reported from the land, degradation of soils, over- to farming systems and sustains
management of natural today is incorporating greater in this region. It is an important Centre
country of which around 7,500 are of exploitation of water resources, faulty changing environmental conditions that
resources is a primary global biodiversity within agricultural of origin and diversity of more than 20
ethno-medicinal importance and 3,900 forestry practices, urban expansion, may occur in future.
concern today. Increasing population production systems. major agri- horticultural crops including
are multipurpose edible species. changing social and cultural norms, and National Bureau of Plant
and rapid technological advances are There are 34 hot spots of rice, beans, cotton, sugarcane, citrus,
adoption of improved varieties/other Genetic Resources, New Delhi is the
putting tremendous pressure on these biodiversity recognized globally and mango, banana, yams and several Management of Agri-Hortcultural technologies including cultivation of nodal institution at national level for
resources. Plant genetic resources (PGR) three of these extend into India. These common vegetables and popular species
Diversity in India GM crops and adoption of intensive management of PGR in India, under the
which encompass the agri-horticultural are the Himalayas, Western Ghats, Sri (see box on pg.79).
Genetic resources of actual or potential agriculture by farmers. This erosion has umbrella of the Indian Council of
diversity are one of the essential Lanka and the Indo- Burma (covering India is also a homeland of
value of various agri-horticultural crops caused losses of several Agricultural Research, New Delhi. The
components that hold the key to the very the Eastern Himalayas) region. 167 cultivated species and 329 wild
are being lost at an alarming rate due land races, primitive Bureau, after its creation in 1976, has
foundation of agriculture as well as food India is blessed with rich agricultural relatives of crop plants and about 583
cultivars and farmer's developed a very strong Indian Plant
and nutritional security for the world. biodiversity including diversity in crop crops are cultivated in India (see box on
During the last four decades of this plants, wild crops relatives, livestock, pg.79). It has about 30,000-50,000
Crops Cultivated in India varieties with desirable Germplasm Management System which
and potentially useful operates in a collaborative and
century, rapid progress in the field of aquatic resources, insects and microbes. landraces of rice, pigonpea, mango, Crop Group No. of Species
genes, leading to threats partnership mode with other
agriculture was witnessed along with the The Indian gene Centre is prominent turmeric, ginger, sugarcane, gooseberries Cereals and pseudocereals 12
to the basic food organizations. The system has
collection, conservation and sustainable among 12 mega gene Centres of the etc. and ranks seventh in terms of Millets 16 security. There are contributed immensely towards
utilization of PGR. Conservation of world. In addition, India has 26 contribution to world agriculture. Legumes 17 conflicts between safeguarding the indigenous crop genetic
PGR has now become one of the most recognized endemic Centres that are Further, around 1,000 wild edible plant
Oilseeds 21 modern agriculture and resources and introducing useful PGR
widely discussed issues in the field of home to nearly one third of all the species are exploited by native tribes.
Cash crops (sugar and fibre) 16 traditional agriculture. from other countries for enhancing
agriculture and environment. Because of flowering plants identified and described These include 145 species of roots and
Vegetable and tuber crops 97 However, these can be agricultural production and productivity
high degree of human interventions in to date. Indian region too is a major tubers, 521 of leafy vegetable/greens,
overcome with in the country. India being one of the
management of genetic resources, center of domestication and diversity of 101 of buds and flowers, 647 of fruits Fruits and plantation crops 139
sustainable farming gene-rich countries of the world faces a
conservation in production system is crop plants. About 33 percent of the and 118 of seeds and nuts. In addition, uu Forage crops 33
practices, supported by unique challenge of protecting its
Spices and condiments 27 natural heritage and evolving suitable
agricultural policies,
Medicinal plants 121 institutional mutually beneficial strategies for
S.K. Sharma Ph.D. is Director, National Bureau of Plant Genetic Resources (NBPGR), New Delhi (E-mail: Aromatic plants
Pratibha Brahmi Ph.D. is Principal Scientist, NBPGR, New Delhi (
63 mechanisms and germplasm exchange with other
Mukesh Kumar Rana Ph.D. is Senior Scientist, NBPGR, New Delhi (E-mail: Dyes, narcotics and cottage industry plants 21 scientific management countries. uu
Total 583 of genetic diversity.


India’s Agri-horticultural Biodiversity India’s Agri-horticultural Biodiversity

Conserving Our Biological Heritage Conserving Our Biological Heritage

u Agro-Biodiversity Conservation in National Genebank has accessions of apprehensions for the loss of diversity in
National Network Mode varied germplasm of orthodox, view of the introduction of GM crops
intermediate and recalcitrant seed e.g. brinjal (see fig on pg. 81),
Over the years, India has developed
species and also of pollen samples. The particularly in the Centres of origin of
sound scientific management regimes for
in-vitro Genebank holds species which crop plants by introgression of
ex-situ conservation and access to its
do not produce seed or are difficult to transgenes. Loss of diversity from gene
genetic resources. Groups of institutions,
conserve by seeds. These include flow to wild and weedy species may
scientific societies and non-
tuberous and bulbous crops, tropical further jeopardise the potential for
governmental organizations are
fruits species, spices and industrial crops, further crop improvements. It is worth
addressing the task with NBPGR as the
medicinal and aromatic plants species. noting that introgression is a very
nodal agency for its coordination. It
The cultures are maintained at complex process and depends on the
aims at efficient management of plant
standardized temperatures and are sub- scale of introduction of transgenic
genetic resources by providing
cultured after 4 to 24 months' intervals. varieties, the genetics of associated
convenience of access to the various
The in-vitro genebank conserves various transgenes and the fitness that those
crop improvement programs. It also
priority crops which are maintained transgenes may confer on the population
houses the National Genebank Network,
under short to medium term storage they enter. However, a genebank
which includes the National Genebank
periods. curator's worry would be to maintain the
at NBPGR which is primarily
Some of the alternate strategies genetic identity of conserved accessions
responsible for conservation of Rice Diversity Collected at NBPGR. Brinjal Diversity Collected at NBPGR.
of conservation of PGR often in the context of GM crops. Strict
germplasm on long-term basis. The ten
complement each other and are driven regeneration protocols need to be
regional stations of NBPGR in different u which governs access to all genetic Indications of Goods (Registration and per se but a safeguard of material
essentially by need and utility of devised and followed, particularly in resources of India and encompasses Protection) Act, 1999 were enacted and developed by a breeder through
agro-climatic zones of the country and
germplasm. The ex-situ collections and areas where GM crops are grown under provisions for equitable benefit sharing. suitable amendments made in other publication and documentation in public
57 National Active Germplasm Sites
maintenance of such a facility is limited conditions that generally favor gene flow. The International Treaty on Plant existing IPR legislations, which have a domain. This germplasm registration
(NAGS) are integral components of the
by financial and human resources In suspected introgressions, presence of Genetic Resources for Food and bearing on the product, processes and can be used as evidence in documentary
network. The NAGS are based at
available and in addition these transgenes in regenerated germplasm Agricultural (ITPGRFA) is another technologies developed. The Indian or other forms to create and establish
premier institutes for specific crops or
collections are subjected to genetic drift. and finding options for removing such legally binding treaty which has plant variety protection is unique in 'prior art'.
crop groups and are entrusted with the
The natural evolutionary forces often do transgenes from collections need to be provisions for facilitated access to 64 providing equal rights to the farmers as Germplasm which can be
responsibility of multiplication,
not influence their maintenance worked out. At NBPGR, detection crops and forage species, under the breeder and conserver of genetic registered at NBPGR could be any good
evaluation, conservation of active
processes. Hence, more dynamic, protocols have been developed for a Multilateral System (MS). This exchange resources of local importance. To performance material for specific and /
collections and their distribution to
sustainable and complementary plant number of transgenes which would be would be under the conditions of facilitate this activity with identification multiple traits (may not be yield
users, both at national and international
genetic resources management processes useful, if such situations warrant the Standard Material Transfer Agreement of distinctiveness of newly developed superior), mutants or with a different
levels. Various other national institutes,
are being adopted so that the system is identity of accessions in near future. (SMTA). Being a single window system varieties, ICAR has provided the ploidy level than the normal, with
all India coordinated crop research
projects, state agricultural universities sustainable and meets the requirements for exchange of small samples of plant requisite support to PPVFR by academic / scientific importance,
of the crop improvement programs. Regulatory and Protection
and other stakeholders are also linked to germplasm meant for research, NBPGR developing guidelines for distinctiveness, parental lines of inbreds, promising
The in-situ and on-farm conservation Mechanisms for PGR
the network. International Agricultural has developed suitable Material Transfer uniformity and stability (DUS). To date, experimental material or landraces and
strategies are being adopted on limited Many international developments during
Research Centres involved in Agreement (MTA) for providing access DUS guidelines for 35 crops have been traditional varieties. The procedure and
scale for both vegetatively propagated the last two decades have directly or
conservation and use of PGR are also to PGR both within and outside the developed and notified. Plant variety forms are available at NBPGR’s website
species such as citrus and seed indirectly affected the genetic resource
effectively linked to the network, Cryo- country. protection under the PPV&FR act ( NBPGR has so
propagated crops such as Himalayan management programs. Plant breeders
genebank and the in-vitro genebank. The Also, under the GATT/ currently covers seventeen crops; others far registered 729 promising germplasm
barley, buckwheat and traditional have traditionally relied on open and free
ex-situ seed genebank at NBPGR WTO/ TRIPs regimes, restrictions have are to be notified soon. So far 1644 accessions of different agri-horticultural
landraces of rice (see fig on pg. 81). The access to PGR for developing new, high
comprises of 12 long-term modules been imposed on free trade in applications for registration in 19 crops. Efforts are being made to get
outcome of these models is expected to yielding crop varieties. With the
maintained at -180 oC for housing the commodities, including agricultural notified crop species have been received more and more germplasm registered
provide inputs for formulation of such in adoption of the Convention on
base collections. The active collections products. Countries are required to by PPVFRA. Of these, 164 have been through this mechanism so as to
situ and on-farm conservation projects Biological Diversity (CBD), which
are distributed in 22 medium-term adopt patenting or enact effective sui issued certificates for plant variety enhance its utilization.
on a larger scale in the country. advocates national sovereignty over
modules maintained at 40 oC for storing generis system or a combination of both, registration.
germplasm at active sites.
biological resources, the authority for
for the protection of Plant Breeders’ For germplasm registration Future Concerns
PGR Conservation in the Context of access to genetic resources rests with the Each country is interdependent on other
At present, the genebank holds Rights. As a national obligation for the there is a system of plant germplasm
GM Crops national governments and this access is nations for its germplasm requirements
more than 3.8 lakh accessions including TRIPS Agreement of WTO, the new registration operating at the NBPGR.
Introduction of GM crops is not going subject to prior informed consent of the since it is not possible to acquire and
crops where research in GM technology legislations, viz; the Protection of Plant This system is completely different from
to make much difference in the ex-situ providing country on mutually agreed conserve useful resources to satisfy its
interventions is being pursued (see table Varieties and Farmers Right Act registration of plant varieties of the
conservation strategies that are being terms. This led to enactment of research needs. It is therefore, imperative
on pg. 82). The cryo-bank facility in the (PPVFRA), 2001 and Geographical PPV&FR Act. This registration of
followed presently. There are Biological Diversity Act (BDA) for India uu to collaborate at local, regional and uu
germplasm is not a system of protection


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

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

As you move on, please

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


Regulating GM Crops
Global Best Practices

Regulating GM Crops

Global Best Practices

Shanthu Shantharam

u issues are enjoined, endless debate

Goals and Objectives of Regulations: Regulatory trigger for GM crops: The

t is a fact that GM crops are now The rest of the world has lagged behind, adding GM crops into their agricultural ensues. It is really unfortunate the even
grown in 25 countries covering more and many are not even at the starting systems, and those following the EU The only goal of any set of regulations is “Process” vs. “Product” Paradigm.
matters of empirical science have been to protect the safety of the public and the
than 130 million hectares of land line. Australia, Argentina, Brazil, China, system are caught in endless debates. This has to do with as to why a GM crop
politicized by some scientists just to environment. All other objectives are
area across the world. Innumerable India, and South Africa are some of the International agencies like Rockefeller must be regulated and what constitutes a
derail the technology. However, scientific secondary. To achieve this goal, nations
scientific reports and analyses of their other countries that have working biotech Foundation, Bill & Melinda Gates GM crop. This is what is called the
consensus are relatively easy to arrive by must use the best possible scientific
safety have been attested by world's regulatory systems. Many differences still Foundation, World Bank, Asian regulatory trigger. As a priori, it is
a group of national or international consensus, practical guidelines and
leading scientific organizations and persist between US regulatory agencies Development Bank, OECD, UN-FAO, assumed that GM crops are regulated
scientific experts, and that is the only standard operating procedures.
regulatory authorities. Inspite of this, and the EU, a sort of permanent trans- UN-WHO, UNDP, UNESCO, and because they are genetically engineered.
way to assure proper regulatory oversight
commercial cultivation of GM crops is Atlantic divide. It is important to note UNEP have spent millions of dollars for On the other hand, nobody seems to
on any technology so that benefits can Basic Principles of Biotech have thought about why other kinds of
subject of endless controversies that there is really not much of a regulatory capacity building with little
surrounding their safety, utility and difference of opinion on the safety of progress.
reach the public at the earliest. There are Regulations GM crops developed using conventional
some excellent documents developed by Regulations are always a societal
regulatory oversight. Efforts to GM crops between US and European Politicization of GM crops due technologies are not regulated. It seems
leading regulatory agencies like USDA, construct. In any democratic society, the
internationally harmonize biosafety and scientific and regulatory organizations. the anti-GM activism is the root cause of that in most parts of the world, modern
US-EPA and US-FDA, EC Biotech Risk public demands guarantees for safety of
environmental risk assessment standards The biggest difference between the US all the irreconcilable differences between day GM crops are regulated because they
Assessment Grants Program, OECD, any product or technology that would
have been ongoing since the 1990s with and the EU is with regard to regulators and the activists, and is also a are “genetically engineered” using the
UNESCO, UNDP, UN-FAO, UN-WHO, directly affect their health and the
mixed successes. As it always happens, “Precautionary Principle”, a contentious major detriment to international modern gene-splicing technology. It
National Science academies of USA, environment. Therefore, regulations are
pioneering regulatory agencies set the philosophical point. Developing harmonization of biosafety standards for seems the technology by which a modern
Brazil, India, Argentina, and the Royal developed to assure public and
early “standards”, and others end up as countries of the world are caught in a GM crops. This situation is best day GM is developed is found guilty by
Societies of UK, Canada, Australia and environmental safety. As a priority, for a
followers. In case of Genetically dilemma as to which regulatory system exemplified by the Bt brinjal imbroglio in default. The end product, namely the
New Zealand. These reports and rigorous and comprehensive scientific
Modified Organisms (GMOs), USA was they have to follow. A plethora of India. Biosafety standards must be GM crop is not even considered. The
documents developed by scientific biosafety review and an environmental
and is the leader followed by Canada. biosafety and regulatory capacity grounded in “common sense” and illogic of this trigger is that one can
experts and serve as beacons for impact assessment are a must. It is
EU is the hotbed of all controversies. building programs from EU and USA “scientific consensus”. It is only when develop any kind of product using
developing a sound regulatory systems imperative that regulators be scrupu-
Almost all controversies are fanned by have only added to the confusion. Those non-scientific issues related to trade, conventional crop modification
based on the best possible scientific lously impartial and objective, and do not
the EU policies that are heavily who follow the US regulatory system intellectual property rights, socio- techniques, and it would escape
knowledge. present even a whiff of a conflict of
influenced (politicized) by the greens. have made tremendous progress in economic impacts, cultural and ethical uu regulatory scrutiny because there are
It should be relatively easy to interest while regulating the technology. none. One can develop any “dangerous”
develop best regulatory practices for any They should certainly not appear to be or “uncertain” GM crop using
country based on these documents and either promoters or opponents of a
Shanthu Shantharam,Ph.D is Executive Director, ABLE-SIGAB, New Delhi. (E-mail: conventional techniques, and no one will uu
reports to move the technology forward. technology, or a particular product.


Regulating GM Crops Regulating GM Crops
Global Best Practices Global Best Practices

u question. This is a fundamental point Principles of Biosafety Review chronically maintained that GMOs by u takes the EIS route without proper test for a given GM food. All these tests public meeting to discuss the review, such
that has been long lost in the present GM Substantial Equivalence, Principle of default are hazardous, and that the scientific cause, approving a GM crop must be decided by experts alone. meetings must be organized in different
debate. Familiarity and Generally Regarded as genetic engineering technology is will remain a pipedream. That is a sure locations to seek public input both
inherently dangerous. Going beyond this way of killing a technology. Moreover, Risk/Benefit Analysis verbally and in writing in an organized
Biosafety Data Requirements: “Nice to Safe (GRAS) are practical working
contention, risk assessment can be either EIS is the costliest way of regulating In the GM debate, one mostly hears fashion. Mob frenzy of the type
principles simply based on common-
know” vs. “the Need to know” qualitative (descriptive) or quantitative technology. At present the Supreme about the risks, and not enough about the witnessed in the recent Bt brinjal
sense and past experiences. These
The scientific data required to carry out a requiring empirical data. In biological Court of USA is hearing an EIS case on benefits. It is imperative that regulatory “consultations” must be avoided. All
principles have eminently served some of
rigorous biosafety review or risk systems, quantitative risk assessment can herbicide resistant alfalfa whose EIS was authorities convince the public about information must also be posted on the
the leading regulatory authorities to
assessment has to be determined by be arduous as the field based empirical prepared by USDA, APHIS which took both risks and benefits in an impartial web site by indicating how points raised
develop basic standards for scientific
scientific and technical experts alone. data are hard to gather. This is one of the over five years. If principles of way. Risk/benefit analysis is perhaps one by the public have been addressed. It is
regulatory oversight of GMOs, and there
Most standard data requirements are contentions that haunt the trans-Atlantic substantial equivalence, familiarity and of the most important regulatory needs important to note that it must be made
is no reason why these same principles
genetic stability data (Mendelian divide based on the precautionary GRAS are used, there should be no need to convince the public that in spite of extremely clear that not all points can
cannot be used in other countries. These
inheritance analysis), molecular data, principle. A practical thing to do is to for EIS. It must be remembered that certain risks, the technology product is and will be incorporated into the review,
are not legal standards, but they are
and bio-chemical data. Plant take a precautionary approach which is almost all GM crops are already more beneficial, and that risks can be and reasons for not incorporating must
scientific standards for biosafety
morphology and reproduction biology basically dealt with by a regulatory established lines in commercial mitigated by oversight mechanisms. be spelled out.
including food safety.
are also included. Such data review. This accomplishes the idea of production, and therefore, they all Risks of opportunity costs must be
If a GM crop or a GMO, after genetic Decision Making and Communication
requirements can change from time to stop, ask and decide. Using such a eminently fit into the above principles. included in such an assessment. This
engineering, is left 99% the same or
time as science and technology are precautionary approach, USA, Canada, For commercialization purposes, the way, one can assess the loss for not All decision making authority must be
identical as its non-engineered
always progressing. It is not necessary Australia, New Zealand, Brazil, China, most important data requirements are introducing the technology product. solely vested with the regulators who
counterpart, then such a GMO is
that each and every scientific paper India, Philippines, South Africa, and the agronomic performance data under a have statutory responsibility for decision
published on a day to day basis be
considered substantially equivalent. If a
many other countries of the world have variety of agro-climatic conditions so
Deregulation and Commercialization making. No member of the public must
GM crop or a GMO is considered Deregulation means declaring that a
incorporated into the review standards. commercialized GM crops without a that its efficacy can be reasonably be allowed to participate in the decision
substantially equivalent, meaning no regulated GM crop is determined to be
There should be a scientific committee of single instance of causing human or assured in the farmer's hands. In fact, making process. This is different from
different from an organism that has been no longer regulated, and allow it for
experts who will review the progress in environmental harm in the thirteen year these things are carried out routinely for seeking public input in consideration for
in safe use for decades or centuries, then commercialization. However,
science and technology on a biannual or history of GM crops commercialization. any new crop variety introduced to the decision making. Using a decision
such a GMO can be considered commercialization is done by the
annual basis to determine the scientific EA is a powerful decision making tool market. It is in the interest of purveyors making tree will be extremely useful in
“familiar”, and as such that GMO can be purveyors of the technology product, and
consensus needed to establish the for regulators. of GM crops to make sure that their this exercise. A statutory authority is like
evaluated using the previous knowledge not by the regulatory authority. But, the
regulatory standards of the day. For What is really critical in an product is a superior product and does its a court of law where litigants can only
and experience of that particular authorities can or may impose conditions
example, a set of 29 new tests for every Environmental Risk Assessment (ERA) intended job in the field. argue their case, but the judgment is
organism. Following these two for commercialization. Deregulation is
GM crop has been proposed in India is the nature of the organism and the One can do an intelligent and rendered by the judge. If the decision is
principles, one can classify a given GMO done after satisfying all conditions of
which might take two or three decades environment into which it is being scientifically reasonable ex-ante EA in the negative, reasons for declining the
as GRAS based on safe history of use of safety and environmental risks and the
based on all fanciful techniques that have introduced. Since the environment differs which would be sufficient for the application must also be explained. It is
the organism and the specific gene in needed risk management mechanisms
come to the fore recently (J. Biosci. from place to place and country to purposes of contained and confined field important to bear in mind that a
question. Any specific genetic change are in place to mitigate such risks.
(34)2), June 2009, 1167-168). It is an country, an Environmental Assessment tests and deregulation. An ERA may be statutory body's decision is subject to
that has been introduced, is all that one
egregious example of going overboard (EA) is a must. EA can be a simple and carried out post-commercialization. If judicial review when challenged.
needs to evaluate for biosafety. Transparency and Accountability The decision must indicate the
with data requirements that fall neither direct method of determining the risk of post-commercialization monitoring is The entire process of regulatory
into the “need to know” or “nice to Risk Assessment introducing a GMO into a particular needed, post-ante analysis can be carried date on which it will come into effect and
oversight must be conducted in a
know” category, and in no way informs Risk assessment of GMOs or any other environment. It must be remembered out from the empirical data gathered over how long it will be effective, just in case.
transparent way without compromising
the biosafety assessment. Leading technology product goods or services can that EA assesses not only the agricultural several years. It should contain conditions that may be
legally permitted protection for
regulatory authorities in US, Canada, be a dicey or tricky proposition. environment, but the neighboring imposed on a case by case basis. The
confidential business information(CBI).
EU, Australia or New Zealand, who have Therefore, extreme care and environment as well. EA is mostly Food Safety decision must be signed by a competent
This is the only way to inspire public
more experience in commercializing GM consideration must be given to identify qualitative. Food safety tests like allergenicity, person in the authority and
confidence in the regulatory system. It is
crops do not require this kind of data, the necessary criteria. Risk is nothing but Environmental Impact Study toxicity, teratogenecity, and communicated in writing to the
best to use the worldwide web to the
and bears no resemblance to what is hazard X exposure, a classical formula of (EIS) is the most time consuming of all carcinogenicity should always be carried applicant, and posted on the web site. In
maximum, but in a timely manner.
recommended by the CODEX risk assessment. Hazard in this formula risk assessments that can take years. EIS out according to the standards certain extraneous situations, it may be
Authorities must post a copy of the
Alimentarius. Such data requirements assumes that GMO is a priori hazardous, needs lots of empirical data which will established by the CODEX, a joint necessary to announce the decision
application immediately declaring that
create an uneven field where only which is unfortunate. By and in itself, the take years to develop. EIS is done when standard setting body that draws through mass media.
the application is complete and accepted
companies with deep pockets will term hazard is a cause for great deal of an EA comes to a Finding of No scientific and technical expertise from
dominate. It is far more utilitarian to Significant Impact (FONSI). There are time to time. Long term chronic studies
for regulatory review. A draft of the Public Participation
contention. People have been tired of biosafety review and EA/ERA must also
examine the experience of other must be indicated by standardized Clear distinction must be made about
arguing that GMO by default is not instances of certain environmental be posted on the web for public comment
regulatory authorities to develop preliminary tests. There has to be a public input from that of public getting a
hazardous, but anti-technology activists projects that have been delayed decades giving a definite period of time.
standards for data requirements. strong scientific indication for any other seat at the decision making table. It is
and anti-GM campaigners have because of EIS. If a regulatory authority uu
In the event of a need for imperative to seek public comments and uu
(Contd. on page 103)


India’s Biosafety System
At Par With The World?
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

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.

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


India’s Biosafety System India’s Biosafety System
At Par With The World? At Par With The World?

Competent Regulatory Authorities for Food Safety

and GE Food Safety in Selected Countries IGMORIS
Country Competent Regulatory Authority
Food safety GE food safety

Argentina Servicio Nacional De Sanidad (SENASA) Servicio Nacional De Sanidad (SENASA) Organizations working with
Groups of GMOs
Australia Food Standards Australia New Zealand Food Standards Australia New Zealand Welcome to IGMORIS Whats New
Status of GMOs and Products
China Ministry of Health Ministry of Health
Field Trials of GM Crops Questionnaire for Institutions

Canada Health Canada Health Canada Biosafety Data of Approved GM Questionnaire for Industry
European Union European Food Safety Authority European Food Safety Authority 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
India Ministry of Health & Family Welfare (Food Safety & Standards Authority of India) Ministry of Environment & Forests 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
Japan MoHL&W MoHL&W 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
South Africa Dept. of Health Dept. of Health Department of Biotechnology
Guidelines for the Safety
Searching the Database Assessment of Foods Derived
Ministry of Science & Technology read more from Genetically
United States Food and Drug Administration Food and Drug Administration Government of India
Other Important Links
Engineered Plants
Compiled by: Biotech Consortium India Limited Protocols for Food and
Feed Safety Assessment
Login Registration (Free) of GE Crops.

u sector, and not within the government case-by-case assessment of products. regulatory system and other regulatory
Send a Mail
bureaucracy itself. If the decision is Advisory committees can be used to systems within the government is
made to locate the risk assessment address specific issues of scientific understood by members of both the
uncertainty. For example, new risks that regulatory and regulated communities. u means that the regulation and associated system as possible. For example, country, and biosafety regulatory
function within the regulatory authority,
may arise with advances in the genetic The regulation of GE foods in India safety assessment of GE foods is national biosafety regulatory systems are systems are no exception to this. The
as has been done in the U.S., Canada
engineering of plants and foods can be provides an example of how difficult this disconnected, programmatically and responsible for the environmental risk Government of India has identified
and in Australia's Office of the Gene
proactively identified and product risk can be to achieve, although regulatory operationally, from the food safety assessment of GE plants and approvals biotechnology as a key driver of India's
Technology Regulator, then the
assessment and management practices reforms are currently being pursued to regulatory system writ large. With the are granted for the “event” defined as a economy in the 21st century and there
government must be committed to
changed if required. Such committees address this. promulgation of the Food Safety and genotype produced from the have been significant investments in
developing the appropriate expertise.
can also be used to address limitations in In countries with mature Standards Act, 2006 (FSSA, 2006), transformation of a single plant species biotechnology research and development
This is generally achieved through the
national scientific capacity by leveraging biosafety regulatory systems, the which empowers the Food Safety and using a specific genetic construct. This in both the public and private sectors. In
hiring, secondment and/or retraining of
sub-regional or regional expertise with regulatory authority for GE foods is the Standards Authority of India to regulate means that any lines, varieties or hybrids agricultural biotechnology, India has a
scientific staff. Alternatively, and in an
the additional advantage that the same authority that is responsible for all GE foods, this situation is likely to derived from an approved event through rich pipeline of GE plants under
approach that has been utilized in
committee's output may then have a administering food safety law(s) (Table change. However, as of now and until conventional plant breeding are also development. Catalysts like agricultural
countries such as Argentina and South
broader application. The use of in-house 2). This recognizes that the safety such time as rules and/or regulations for approved. These derived progeny are not adaptation to climate change, the food
Africa, the regulatory authority may
scientists to assess products on a case-by- assessment of GE foods is part of, and GE foods are notified under the FSSA, submitted for further assessment within security crisis of 2007-08, and increasing
appoint an expert advisory committee to
case basis permits the development of not separate from, programs that address 2006, notification S.O. 880(E) in the the biosafety regulatory system as demand for renewable energy have
undertake risk assessments. If advisory
considerable expertise within the the broader context of ensuring the Gazette of India allows for the biosafety has already been addressed. accelerated plant biotechnology research
committees are used, then appropriate
regulatory agency, provides for a degree safety of the foods that the public continued regulation of GE foods under Instead, they enter directly into the plant on a range of new traits and new plant
conflict of interest provisions must be in
of consistency not afforded by the ever- consumes. The “GE nature” of a food Rules, 1989. This means that the variety registration system where they species. Innovation in this sector requires
place to ensure that the developers of
changing membership of advisory derived from a GE crop or other GE decision to approve/not approve a GE are evaluated for agronomic a biosafety regulatory system that
GE plants do not end up in a position of
committees, and can address the real or organism is not (and should not be) the food remains with MoEF, through performance (e.g., yield, disease and supports research, development and
assessing their own products. In either
perceived conflicts of interest that arises solely defining characteristic of that food GEAC, until S.O. 880(E) is kept in quality) in the same testing program as deployment of GE crops while ensuring
case, the regulatory agency/body should
if product developers are also product as regards safety. Other, and arguably abeyance. any other conventional variety or hybrid that environmental and human health
have some foresight mechanism in place
assessors. more important, food safety and food In all countries, biosafety evaluations of of that species. In this way, the mandate safety are appropriately considered and
to identify potential knowledge gaps,
quality considerations and associated GE plants are but one part of a larger to assess the environmental safety of a secured. This means that investments in
and to promote and access training or
Clarity laws, regulations, standards and regulatory scheme that may also include GE plant (which is a specific agricultural biotechnology should not be
the recruitment of new knowledge.
guidance apply to GE and non-GE foods laws, rules and regulations pertaining to requirement applied only the GE plants) limited to product development but also
The best approach may be to use Achieving clarity in a regulatory system
alike, which is typically why GE food plant health and quarantine, plant is kept separate and distinct from the applied to ensuring that the regulatory
elements of both as has been proposed is one of the most challenging tasks to
safety assessment is positioned within variety protection, variety registration mandate to evaluate plant performance system is as robust as the community it
for the Biotechnology Regulatory confront regulatory authorities. It
ministries of health and their associated and seed certification. Inter-ministerial (which is applied equally to GE and regulates. Continuing to address
Authority of India: Expert Advisory requires that the scope and objectives of
food safety and standards agencies. India coordination is essential to ensure that non-GE plants). adaptability, transparency, workability
Committees that provide guidance for laws, regulations and guidance are
unambiguous, the division of has been a notable exception to this the roles and responsibilities of the and clarity within India's biosafety
the development of new policies,
responsibilities between government practice as the authority to approve or various involved agencies are clearly Concluding Comments regulatory system is of benefit to all the
coupled with in-house scientists who
ministries is clearly defined, and that the not approve a GE food has been vested defined and that associated programs Regulatory systems necessarily reflect stakeholders it serves and, ultimately,
work as part of a multi-disciplinary
interrelationship between the biosafety with MoEF under the Rules, 1989. This uu work in unison to create as seamless a the social, economic, environmental, society at large.n
safety assessment team to conduct the
and related development objectives of a


Investments in GM Crops Research

Power of Partnerships


(Converging investment and research efforts)
Public Research
Investment Market
Public & Private
Investments in GM Crops Research

Power of Partnerships Public Research Corporate Research

Public Research

Corporate Research

Emerging relationships will drive consolidation of research investments

and research commercialization efforts.

u In order to differentiate the claims, provided rapid gains to the corporate and other trait factors.
improvement patents were filed with sector to bring out products by bundling
modified gene sequences during the early biomaterials and technologies. The Europe Continues to Invest in Genetic
K. Vijayaraghavan Engineering Research
part of this decade. The result is that integration efforts provided further
every gene of interest that is perceived to opportunity for cross-country The European Union and the national
have value has been, in some way or partnerships through cross-country research systems within Europe,
other, patented in developed countries. It licensing. The classic case is the however, continued to invest in research

lobal investment for crop yield varieties from Mexico. From the early 90s, triggering an array of patents for is true that the current IP regime in integration of trait gene for cotton in for the development of genetically
improvement during the period 90s genetic engineering created a gene functions. However, subsequent countries such as USA are rethinking Indian cotton hybrids during the early engineered crops. Large European
1930-60 focused on agriculture revolution in accelerating trait discoveries indicated that the their acceptance of broad claims for gene years of the current decade. companies have realized that they were
implements to increase farm productivity development and crop yield organization of the genome is much patents. Future patents are likely to lagging behind and initiated efforts to
resulting in an initial wave of patents in improvement. Over the last two decades, more defined by quantitative synergies of recognize a limited coding sequence Europe Lags Behind Due to Low Public accelerate the research for new trait
the USA and Europe. During the next the agro chemical industry lagged behind gene clusters (networks) than by the rather than recognizing patents for the Confidence and Multiple Outbreaks of development through genetic
thirty years, the research intensity moved in introducing new molecules due to function of a single gene. Inventors whole sequence itself while limiting the Zoonotic Diseases modification. In a recent effort by the
to development of new molecules for prohibitive costs involved in developing preferred complex claims that aimed at claims for the “Field of Use” factor. While these efforts were successful in EU researchers, this writer was engaged
agro-chemicals. Plant breeding efforts them and the increasingly stringent vertical integration of technologies by Research Universities and private USA and parts of the South American in exploring application of inventions
continued during this period with the norms required to validate their safety disclosure of synergies of gene clusters. enterprises in the USA led the region (Brazil and Argentina), Europe that have originated within EU for
father of the Green Revolution, Dr. and efficacy. Similarly, breeding efforts The complex intellectual assets integration efforts in the last fifteen years, had faced the problem of the mad cow expeditious commercialization within
Norman Borlaug, providing vital also declined because of the steep decline governing genetically engineered crops with the public sector and the private disease in the 90s and was extremely and outside the EU. Improved regulatory
germplasm access for wheat to the in public investment for breeding originated in this context. Patent claims sector engaging collaboratively to cautious about adopting new consensus, recent approval of genetically
developing nations around the world, programs. moved from isolated gene functions to integrate functions of genes and further technologies. Public confidence in engineered potato, increasing acreage in
including India. Significant research complex models of gene functions. integrate them in the genome of the science was low and their trust in the countries such as Spain and the pressure
investment for agro chemicals emanated Research in Genetic Engineering Claims were widened on role of an crops of interest to pyramid multiple regulatory system was even lower. The of negotiations within WTO are
from the private sector, while the Turns Multi-Dimensional isolated DNA sequence conferring gains traits that were sought by the farmers. European Food Safety Authority (EFSA) triggering a new paradigm shift in
research investment for plant breeding The advent of genetic engineering in a wide array of organisms. Multi- Simultaneously the regulators came into existence in this context. European perspectives. There are over
vested with the public sector. This was provided hope in a significant way to functionality and the transfer of trait to (Environment Protection Agency, However, public fear, lack of 400 effective patents filed in Europe that
the era of successive release of improved stimulate productivity in agriculture. another organism triggered integration Federal Drug Agency and United States understanding of emerging science at all are being explored at various stages of
varieties by the public sector in major Initial set of inventions in genetic efforts to gain access to a set of Department of Agriculture) created a levels and successive outbreak of commercialization by the public and
agricultural regions. Germplasm moved engineering resulted in inventors securing biological materials (e.g. use of promoter vibrant and transparent regulatory zoonotic diseases did not revive public private sectors within Europe and
freely across the regions. A restrictive patents for genes that were identified as a to enhance biological activity) that were mechanism and the rapid advancement confidence in novel foods. Most parts of elsewhere in the world. European
regime for germplasm would have denied distinct DNA sequence with a fixed cumulatively responsible for of science coupled with public Europe experienced a sense of self denial companies have commercialized
India's access to high yielding wheat function. The trend continued during the commercially delivering a trait value. uu communication and dissemination of in accepting novel foods and the lack of genetically engineered crops in several
technology created the gene revolution consensus within the European parts of the world including USA, Asia
for the grain and oil seed crops in USA. community denied inventors the Pacific and South America. European
K. Vijayaraghavan Ph.D is Chairman, Sathguru Management Consultants & Vice Chairman, Cornell-Sathguru Foundation for Development, research organizations have licensed
IP pooling efforts through “in-licensing” opportunity to demonstrate successful
Hyderabad. (E-mail:
of biological materials and technologies inventions in crop yield improvement invaluable traits to entities in the public uu


Investments in GM Crops Research Investments in GM Crops Research

Power of Partnerships Power of Partnerships

u and private research system for North America and South America, the introduced in emerging markets would u Technology
Access Models for licensing and sub-licensing of bio- practices in research, regulatory
commercial exploitation and are in markets in these regions will tend not be governed by in-country patent Emerging Countries materials, know-how and research tools, validation and responsible product
receipt of royalties from such towards marginal growth. The key restrictions, thereby creating free market both to public and private research dissemination. The donor expects the
There are four possible models that
commercialization. Europe begins to market growth for seeds will emerge in competition. systems within India. Sathguru has been recipient to engage in responsible
would emerge in this technology transfer
realize that innovations will flow to Southern and Eastern markets, more a large repository of bio-materials in application and use of technology for the
and product development process for
markets and if such innovations are specifically in China and India and in Where do Emerging Countries Gain region and we have had a surge in public good. The public research
genetically modified crops in emerging
denied access, it would only endanger countries such as Brazil, South Africa Access to Genes of Interest? economies.
request for licensing bio-materials in the investment to encourage crop
regional competitiveness. and in a limited way, North Africa. The Gene exploration is dependent upon recent years. China leads the world effort development based on public good
advent of these growing markets will understanding the functions of genes and Technology Flow to Research Centers today in licensing bio-materials and donations of technologies will help to
Is There a Threat from the Narrow drive technologies from hitherto Created by Ventures in Emerging technologies for genetic engineering of address resource poor farmers gaining
countries such as India or China have not
Concentration of Patents for Genetic developed countries of the West to Asian Economies crops. Gene technologies licensed by a access to technologies for low acreage
committed billions of dollars in
Engineering Technologies in a Few and other developing regions. Many of genomics and proteomics platforms the leading university such as Cornell to crops and crops of lesser commercial
While multinational companies possess
Hands? these markets do not have a strong patent way the Western world has invested the advantage of bringing currently de- Indian and Chinese partners at the same interest. Otherwise, these crops tend to
This question is often brought up by regime. Will this deter the technology during the past two decades. Academic regulated products from other regions to time has attracted ten fold investments in become extinct from commercial
opponents of genetic engineering science owners to step into those markets? Not researchers and large private entities in countries such as India, the limitation China as compared to Indian public cultivation, threatening the vital bio
to argue that the concentration of patents really. In India, Monsanto introduced countries such as USA, parts of Europe, exists in accessing cultivars of regional partnership efforts. China is ahead of the diversity of the country and nutritional
would create a near monopoly, their genes in cotton at a time when the Australia and Canada are in a position to interest. A successful event is made up of rest of the world in developing traits for security. The public sector will play a
threatening the food security of many protection regime in the country was generate significant leads for candidate proven functionality of the gene and the biotic stress mitigation in rice (China had more predominant role in addressing
nations. It is true that these inventions virtually non-existent. A third of the genes and pursue those candidates for genetic background in which the gene is just approved the event for commercial traits in plant varieties that are currently
were exploited by multinational emerging markets that have potential for validating their functions and efficacy. inserted. Companies with foresight seed multiplication when India imposed under-researched by private entities. If
companies in large acreage crops such as high growth markets do not have One successful candidate emerges out of understand that the process of breeding moratorium on the Bt Brinjal). the three public partners (Tamil nadu
Cotton, Soybean, Corn and Canola in advanced regimes (in countries such as myriads of prospective genes of interest. is a long drawn effort and some of them Aggressive licensing efforts have also Agricultural University, Coimbatore;
the Americas. This was quite appropriate Indonesia and Bangladesh not even a This multi billion dollar effort is have begun efforts in this area in right commenced in other countries such as University of Agricultural Sciences-
in countries such as USA and Brazil basic one) for patent enforcement. This significantly limited to few nations and earnest. However, many of the global Brazil, Argentina, South Africa (cotton, Dharwad; and the Indian Institute of
where large acreage farming is quite will not deter research efforts in moving within the nations to few players due to companies do not have an interest in potato, vegetable crops et al). Indian will Vegetable Research, Varanasi) had not
common. Only 2% of Americans are into regions of high market growth. the intensity of investment in upstream small acreage crops and therefore will lag behind China, but we do hope that engaged in the development and
engaged in farming today and it made Research efforts will move to the region research. However, this does not deter limit their breeding interest in large the Indian enterprises and Indian public validation of Bt brinjal, twenty two
perfect sense to adopt widely where the markets emerge. This is well entities engaged in crop improvement acreage crops, more specifically grains entities will intensify their efforts, once popular varieties accessible to resource
disseminated technologies developed by evidenced by the surge in research research to access technologies. The and oil seeds. the Bt eggplant moratorium is resolved. poor farmers would not have been
few sources for improving productivity investment for genetic engineering model is akin to the development of chip possible.
and gaining a competitive advantage for research in China during the last five Technology Partnerships for Joint Licensing of Technologies for Pro- In conclusion, public research at the
technology. The world over, INTEL and
the nation. These efforts have provided years. China has committed over $ 1.5 Product Development bono Application in Orphan Crops and global level will increasingly be
AMD invest in developing faster and
USA with a significant global billion for genetic engineering research more reliable chips and rest of the Joint venture partnerships have occurred
Small Acreage Crops integrated across the countries engaged
competitive advantage for producing with further trenches of investment in the past in the agro chemical sector This is a reality that would happen to in progressive research at the upstream
product developers integrate the
high quality grain crops at the lowest forthcoming to accelerate this research and in sectors other than agriculture, develop crops that are not very attractive level. Cross-country partnerships in
advanced chip technology in their
cost. process. Lack of access to patents has not extensively in India. The seed sector will for large commercial entities to commit genomics platforms, SNP consortiums,
products. The “INTEL INSIDE”
However, multinational companies have deterred China in advancing their not be an exception. Pooling of genes their shareholders' funds. Donation of sharing of genetic resource database and
concept is quite true for biological
not applied the same biomaterials and research for new trait development. and germplasm through joint ownership technologies for public good advantage is other efforts will increase among the
technologies to develop traits for small China has adopted a judicious licensing will occur. However, valuation factors a reality. It is true in the case of Bt brinjal progressive nations. India has the
and this is
acreage crops. The low acreage of process for bio-material access and promising growth potential will turn that has been developed by public potential to play a key role in this regard.
precisely the
vegetables grown by farmers in USA has complimenting their huge resource many companies to aspire for controlling partners in India (all the public partners At the mid-stream level, sharing of bio-
so far restrained large companies from commitment for research. China has also interest in ownership. Indian seed have the right to deliver technology to materials, research tools and
that the
engaging in development efforts for such leveraged their initial low “in-country companies are very possessive of their resource poor farmers and have no technologies for accelerated trait
crops. Some critics in India argue why capacity” with external research by controlling interest, just as Chinese obligations whatsoever to Monsanto, as integration will flow to regions that are
India should be the first country to contracting leading American companies are. claimed in many quarters). Bio-material attractive with high market growth. At
develop Bt brinjal. This is because brinjal Universities to engage in collaborative donations have taken place for the the downstream level, technology
is not a crop of interest for Americans or research. Initial products or traits that are have taken Licensing of Technologies for development of late blight resistance in licensing will accelerate with corporate
Europeans as much as it is for Asians. brought to emerging markets in crops of in Commercial Exploitation potato, drought and salinity tolerance in entities and public research entities
Who else will focus on developing crops regional interest would primarily have Licensing technologies for commercial rice and virus resistance in crops. My engaged in integrating bio-materials for
developing new traits in popular
that have predominant regional interests? biomaterials that are currently de- exploitation will drive the growth for new organization has provided access to trait integration and validation. Our
cultivars to make them more relevant to
While the extent of adoption of regulated elsewhere in advanced markets. product development. During the past several vital genes of interest to public success in India will depend upon our
ensure continued adoption by farmers. uu
genetically modified crops is extensive in Most of these de-regulated products three years, there have been several research partners. These partnerships ability to nurture the co-existence of
thrive on mutual recognition of best these diverse forces for synergic gains.n


Investments in GM Crops Research
Public Sector Priorities

Investments in GM Crops Research

Public Sector Priorities

S.K. Sopory

he pressure for the production rescue once again. They can help us the agri-sector. In this regard India and
of more food for growing reject the Malthusian hypothesis and China and a few other countries are an
population, especially in the usher in a third generation agriculture exception in the sense that they have
developing countries, and its availability revolution supported by new technologies and expertise to utilize the
at an affordable price for the low income biotechnologies, in contrast to the first new biology paradigms, such as GM crops, as their production will genetic material within and across cases, some health and environmental
consumers will always remain unless green revolution which was propelled by production of GM crops, and overcome many constraints in achieving genotypes to obtain desirable safety issues associated with adoption of
and until the population load decreases the use of dwarf varieties and, the importantly these are available in the higher productivity, despite the combinations. Creating new variations GM technology, these concerns need to
at this part of the planet. However, one second revolution which was driven by public sector. However, their field- level controversy raised by the non-scientific from the existing ones was infact taught be addressed quickly. India is one of the
does not foresee this happening till next using hybrid vigor. More serious application has been hindered due to debates on GM brinjal. to us by none other than a monk, Gregor few countries in the developing world
50 years or more in the Indian deliberations are needed to find out how exhaustive costs involved in the Since the time mankind learnt Mendel. Having come a long way from that put the appropriate regulatory
subcontinent. Therefore to produce to optimize the use of biotechnologies in experimentation for testing for biosafety to domesticate plants for food and feed phenotype based selection, which of systems in place to address these
more food from the same arable area, general and GM technology in and environmental safety, and also due and other daily needs, they have always course is relevant even today, we have concerns related to human, animal and
infact from decreasing cultivable land, particular, to improve food and to the scare raised in the minds of public sought to incorporate new experience, assigned genes governing various environmental safety. Infact, it is with
will be a major challenge for the nutritional security in our region. against GM crops. Recently, China knowledge and tools to increase physiological and developmental traits ever increasing demands from various
scientists, policy makers, farmers and While the above question may announced the approval of GM rice and productivity. The techniques of in plants. Using the same genetic corners, justified or not, that the
other stake holders. All of them will be more global in nature, it has special maize for commercial cultivation. The developing new varieties and strains foundations laid down by Mendel and biosafety regulations have become more
have to work in unison, whether they relevance for the Asia- Pacific region public sector in India will, therefore, through selection, hybridization, and his many successors and making use of stringent which have made it almost
represent the public sector bodies or where about 53% of its 3.6 billion people have to further increase its inputs in the mutation, exploiting hybrid vigor and high-end technologies and genomic impossible for many public sector
private sector organizations, to remove are engaged in agriculture (& related agriculture biotechnology area and work overcoming crossability barriers between approaches, it is possible to first identify organizations, for lack of increased
hunger and malnutrition, which are activities) and yet hunger and on many traits of agronomic cultivated and wild species, use of tissue specific gene or genes controlling a trait financial support and expertise, as
some of the biggest challenges facing our malnutrition is widely prevalent here. importance to enhance food production. culture for multiplication, and anther and in turn use them in a more surgeon- mentioned earlier, to convert their
country. We feel that new technologies This region has high biodiversity but not We suggest that the present support culture for haploid breeding and like- precision and also in a predicable discoveries in the laboratory to products
like GM plants, other innovations, enough strengths in developing towards this by DBT, CSIR, DST and dihaploid production have evolved with way to modify the targeted characters in of immense use to the farmers and
farming practices, business models and knowledge based applications of others should be continued or even time and have been applied with great the crops of interest. The GM consumers. The gap between discovery
consumer awareness can come to our modern biotechnologies specifically in increased towards the development of uu success in a number of plant species. technology has enabled sourcing of and product is currently filled by private
Though not obvious to farmers, desirable traits across wide species companies. Initially, it was the domain
consumers or policy makers, the scientist barriers, thus greatly expanding the only of some multinationals but over the
S.K. Sopory Ph.D is Senior Scientist, International Centre for Genetic Engineering and Biotechnology (ICGEB), New Delhi.
knew that the basis for developing choice of genes available for crop years indigenous companies have also
variability was infact the shuffling of the improvement. There may be, in certain come up with investments in this sector. uu


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
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:
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


Genetically Modified Crops

Public Perceptions
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

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

Genetically Modified Crops Genetically Modified Crops

Public Perceptions Public Perceptions

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

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: (E-mail:

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
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,
to reflect on the applications of science, I and profits must be the benefits that would accrue on their flood and salinity, and b) controlling the could not meet with the enormous
have come to understand that the purity made yesterday, commercialization. pre-harvest losses due to weeds, diseases financial costs of the excessive biosecurity
of science is often muddied when it is not tomorrow. Global cultivation of GE crops and insects. GE has an enormous regulation.
translated into a technology. Science and 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
Technology can do a lot of good but if 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
incorrectly used, they can also do a lot of biotechnology as developed countries, which is a testimony but has to be dove tailed with other plant and there is extensive literature proving
bad. of pharma and to the benefits the technology offers. A breeding and modernized farming them wrong. Even the possibility of
As we face an era of other privatized quarter century of research experience, techniques and also put in place adverse effects on human health from the
transformative technologies: genetic S&T sectors. over 14 years of experience in biosecurity appropriate infrastructure and transfer of the two selectable Antibiotic
engineering, synthetic biology, I have no regulation and commercial cultivation in management practices. Resistance Marker Genes (ARMGs),
nanotechnology, stem cell research and ideological over 25 countries demonstrated that GE The excessive use of pesticides nptII and aadA, from GM plants to
others that have not even got names yet, position on crops are effective and safe. No by the farmers
we realize the forces that these Genetically conventional food product has a record of has built up
technologies can unleash, both for good Engineered (GE) such prolonged and rigorous efficacy and resistance in the
and for not so good. crops and foods. safety evaluation. Over 350 million pests, harmed
For me, a not insignificant cause As a scientist and Americans consumed biotech foods for 14 non-target
for concern in the field of science and its responsible citizen, years without untoward effects, the largest organisms, left
application, is its privatization. When I would evaluate experiment ever on human food safety. residues in the
science is in the public sector, it creates these crops and Indian farmers opted for Bt food and
public goods which serve the public foods for their cotton because it is profitable to them. Bt contaminated
interest. Whatever the drawbacks of the safety and cotton (mostly Bollgard I with Cry 1 Ac soil and water.
Green Revolution, it was a public sector relevance for the gene) cultivation increased between 2002 To contain these
technology that brought a big jump in small farmer and and 2009, from 0.5 mill ha to 8.5 mill ha. problems, Bt
food production. Farmers took the seed for food security The farmer now prefers Bollgard II, with technology
and made it theirs, so the seed spread the nature of stacked genes Cry 1 Ac and Cry 2 Ab, as would be an
where conditions were favorable. There safety tests that are it is more efficient than Bollgard I, in important
were no patents on the seed, no private being conducted, controlling the bollworms. It is reported component of
ownership. Increasing food production the absence of post from China that a Bt crop also reduces Integrated Pest
rather than maximizing profits , was the release monitoring pests in the neighboring non-Bt crop Management.
driving force of the Green Revolution. mechanisms and fields. A technology needs a chance to About
When science and technology are in the other regulatory prove itself, which was denied to Bt 60 of 80
private sector, they are owned by the issues. It is here brinjal. transgenic traits
companies. The patents make them the that I have grave The share of agriculture in in over 30 crops
owners of the seed, not the farmers. The solve the hunger problem is annoying. India's GDP has fallen to 16.6 per cent
doubts. being developed
eye is on profit, not the public's needs. Any intelligent person (and that includes from 46.3 per cent about six decades ago,
The ridiculous propaganda by in India are in
Compromises are often made on the scientists and policy people in the public which does not reflect a successful policy.
both corporations and scientists in the the public or
safety of products as the many instances and private sector) knows that GM crops Anticipated increase in population and
public sector that GE foods are needed to autonomous

cannot solve the problem of hunger. What allow the bollworm to remain susceptible Bollgard II cotton with stacked genes. bacteria, associated with the use of soil bacterium which has been in the to the benefit of the pesticide lobby,
will solve hunger is access to productive for a longer period. However, there other Scientists confirm that the ARMGs in GM plants, is recently ruled food chain for ages, originating from organic lobby, and non-biotech seed
assets to grow food and/or income to buy concerns which pose a challenge to the incidence of pink bollworm is on the rise out by the European Food plant foods. Bt pro-teins were shown developers. Many activist groups are
food. Despite knowing better, the efficacy and applicability of this and likely to get stronger every year. Safety Authority and the GMO and Bio- to be harmless to most non-target MNCs, registered with the European
mindless propaganda is pushed technology for cotton farmers in India. Substantial savings in pesticide use could hazard panels of the European Union. It organisms, including mammals and Union as political lobbyists to promote in
aggressively to promote the technology. In India, apart from the not be expected in such a situation since was noted that transfers of ARMGs from humans, even at high doses, by other countries through local NGOs, EU's
GM technology may play a role in solving bollworm, sucking pests like mealy bug, f GM plants to bacteria have not been ingestion, inhalation or injection. ideology based on political compulsions.
one or the other problem that aphids and whitefly are serious pests and armers would have to continue to spray shown to occur either in natural Bt is one of the few pesticides
conventional breeding has not been able wilt is a not uncommon disease. A strong to control pink bollworm and all the other conditions or in the laboratory, although BIOTECHNOLOGY REGULATORY
recommended for widespread aerial
to but to promote it as the solution to all attack of either of these can wipe out the pests. It is for this reason that while the two genes resistant to kanamycin, application in North America and
problems is irresponsible and silly. cotton crop whether it contains the Bt Indian cotton production is going up neomycin and streptomycin are naturally was used to control forest pests and The bill to go before the Parliament in
gene or not. In this situation, is the Bt because of superior genetic material present in all environments. the Budget Session, 2010
Using the Bt Gene technology an effective and affordable coming in the form of hybrids carrying In spite of the track record, GE
urban moth infestations. No adverse
There is an unacceptable reliance on the Bt protection for the cotton farmer ? Would the Bt gene, expenditure on pesticides is crops alone are segregated into an object
effects on human populations were Comments on Two Clauses in the BRAI
gene in the current research program on reported from the use of Bt in the Being Contested by the Anti-Tech
it not be more profitable to adopt not coming down. This has been reported of politics and governance. Activist
transgenic crops. According to data given urban locations.
in a Current Science paper by Manju
Integrated Pest Management (IPM)? IPM by field studies, including those done by groups trash the combined national and
Reported death of farm animals and Activists
is not just affordable, it is also sustainable TISS (Tata Institute of Social Sciences) global experience and wisdom on the I was member of the DBT's Committee,
Sharma, former Secretary of the and it is a technology which the Indian Mumbai, as well as Gene Campaign. utility and safety of GE crops. They used birds in Andhra Pradesh was due to
chaired by Dr M S Swaminathan, that
Department of Biotechnology, over 42 farmer knows and can absorb well. There every trick to mold public opinion against causes other than consumption of Bt
met on February 3, 2007, to discus the
percent of the Ag biotechnology research are studies conducted by ICAR that show The Herbicide Tolerant Trait GE technology and to pressurize the cotton.
setting up of a National Biotechnology
projects were using the Bt gene. Ranging IPM is the most effective approach to pest Herbicide tolerant (HT) crops are Indian Government to ban it and now Several reports found no evidence for
Regulatory Authority. The move to set up
from cotton to potato, rice, brinjal, control in India. There is no reason to genetically engineered crops containing they partially succeeded with Bt brinjal. Bt crop produce causing allergy. the NBRA (now Biotechnology
tomato, okra, cauliflower, cabbage, coffee, abandon this strategy . In addition to all genes that allow them to resist the Bt brinjal is a test case on both the sides of Extensive data gathered by every Regulatory Authority of India, BRAI)
maize, even tobacco (!!) the Bt gene is this is the fact that Indian farmers by and application of herbicides which are the biotech divide, the hope that if it country's regulatory regime came from the PMO and the Cabinet
everywhere. large do not plant insect refuges to chemicals that kill weeds as well as all succeeds other crops would have an easier convincingly demonstrated that non- Secretariat which directed the DBT to
Assuming that the crops that are manage resistance, so resistance other plants except the ones that are entry and the fear of the activists that they target organisms are safe from Bt constitute a Committee to shape the
being researched will reach the fields one development and with it the collapse of genetically engineered. The logic of would lose if it did, as they have already proteins. proposal. The move did not come from
day, we would face a situation when a the Bt strategy is already scripted. creating HT plants is to have crops that lost on Bt cotton. During 2000-2009 Bt Centuries of agricultural experience the Corporate Sector conspiring for a
wide range of crops growing in both the Much before Monsanto's will remain unharmed when chemicals brinjal involved some 200 scientists and does not indicate any alarming diluted regulatory regime. Some NGOs
Rabi and Kharif season will contain the dramatic declaration in March 2010, that are applied for weed control. HT plants technologists from over 15 public and possibilities of gene flow, which such as the Gene Campaign and the
Bt gene. So throughout the year, there will Bt cotton was not resistant to the pink can only be used together with the specific private sector research institutions in depends upon breeding behavior and South Asia Biosafety Program were on
be standing crops containing the Bt bollworm, Gene Campaign had reported herbicides that they are programmed for. evaluating for performance and bio- genetic relationship of the species this Committee besides those representing
endotoxin. Not just that, in the same as far back as 2003, that Bt cotton does These are the company's proprietary security, a process supervised by statutory involved, which GE does not change. the scientific community and the science
season, there will be various Bt crops not offer protection against pink bollworm herbicides, so the farmer who buys HT regulatory authorities and reviewed by In a 10 year study of transgenic crops departments of the relevant ministries of
juxtaposed with each other in small fields (Pectinophora gossypiella). Pink bollworm seeds from a company , also has to buy two Expert Committees. The second in the UK, transgenics perished much the GoI.
when farmers grow a variety of different attack was found to be severe after 60 to the company's matched herbicide. Double Expert Committee considered Bt brinjal earlier than their non-GE I have provided inputs in writing
crops, for example vegetables. When the 70 days. We reported that this was profits for the company but are there as safe for consumption and that no counterparts and did not become to the DBT several times while the NBRA
bollworm is exposed to the endotoxin, supported by scientific literature. There benefits for the farmer? Does the rural further tests are needed, basing on which super weeds to invade the document was in preparation and also
constantly, season in and season out, the are reports that field populations of pink community benefit from crops that will the Genetic Engineering Approval environment participated in the DBT consultative
bollworm is going to build up resistance bollworm harbor three genetic mutations entail the killing of all the biodiversity in Committee approved Bt brinjal for GE crop varieties do not represent meeting held in Bangalore on June 11,
very fast. What can be the future of Bt that confer resistance to Bt toxin. This the vicinity of fields with HT crops? commercialization, yet the Minister of any greater risk to crop genetic 2008. This meeting were disturbed by the
technology with this kind of deployment resistance is inherited as a recessive trait, Controlling weeds by using Environment and Forests (MoEF) diversity than the varieties of usual players of the Greenpeace and the
of the Bt gene? so caterpillars with two mutant versions chemicals like herbicides becomes imposed a moratorium, creating
conventional agriculture. Environment Support Group objecting to
We need to question whether of the gene are resistant, but those with necessary in the large land holding, labor regulatory uncertainties that seriously
There is no scientific evidence that the very concept and need for the NBRA
the Bt approach is workable in a one, or none, are susceptible. starved agricultural conditions in impact agri-biotech R&D.
presently commercialized GM crops (the din caused by them on February 6,
developing country situation like ours Other studies study show that industrial countries. In developing In the absence of any
have caused any environmental 2010, at the Bt brinjal consultation
where the pest profile is diverse and the the development of Bt.-resistant pink countries like India weeds are controlled appreciable education, the public believed
harm. meeting was far less loud).
pest density much larger than in colder bollworm larvae into adults takes longer manually. Farm operations like weeding, the horror stories the activists publicized What I am conveying in this
temperate regions. The decision to use the than the development of susceptible sowing, harvesting, threshing and with the help of the media which never There is no terminator gene in any
note comes from my experience with the
Bt route to disease resistance should be larvae. This difference makes it more winnowing are the key sources of rural allow facts to interfere with a good story. crop anywhere in the world. The
development of the concept of the Indian
taken only after all the other factors that likely that resistant bollworm moths employment, especially for women. The The public should be convinced that GE technology is prevented from use in
BRA and familiarity with bio-security
would operate under Indian conditions, would mate with each other rather than herbicide tolerance trait is essentially a technology is more precise than any crop by international agreements regulatory regimes of several countries.
are evaluated. with susceptible individuals and all their labor saving and hence a labor displacing conventional agricultural technology and and/or governmental prohibitions. For the time being, two clauses
If the Bt strategy were indeed offspring would be resistant to the Bt. trait. In a labor surplus country like India, GE products undergo very rigorous Bt cotton was hardly the cause of in the BRAI which goes before the
selected as a viable path of disease cotton, as they would inherit two copies it will have disastrous economic biosecurity testing before farmer suicides. Parliament soon, that relate to, a)
resistance, it cannot be used in thirty five of the resistance gene. So the Bt. implications. The Ag biotech Task Force commercialization. A country's science policy should be Confidential Commercial Information
crops. Since cotton uses more pesticides resistance trait would persist and spread in chaired by M. S. Swaminathan has As our major focus is transgenic Bt crops, framed by its scientific fraternity and and b) Punishment for propagating
than any other crop, perhaps the use of the bollworm population. Pink bollworm warned against introducing labor the following points would help in managed jointly by the relevant scientific misleading information, seem to have
the Bt technology should be reserved was already identified as a pest unaffected displacing technologies like herbicide enhancing public understanding of the institutions and government departments. become contentious, though rabble risers
solely for the cotton crop, to be managed by the Bt endotoxin, long before tolerance. benefits and safety of the technology: In a democracy people's educated choice are likely to pick some more else in course
with extensive farmer education and Monsanto made its 'confession', to The HT trait must be seen in the Bacillus thuringiensis (Bt) is a universal must count but our policy is now being of time.
monitoring of insect refuges. This could prepare the ground for launching its context of how 'weeds' are perceived and dictated from the streets by vocal activists

used in India. They are not considered herbicide use would kill the surrounding framework of bioethics and till there is Both these clauses serve the Illegal Bt cotton in Gujarat as that of 2. Punishment for spreading
useless plants as in the west but have vegetation and deprive rural communities uncertainty about the safety , a important purposes and so are very much Monsanto was possible because of the
several useful functions critical to the well of the medicinal plants which form the precautionary approach. needed. non-coding sequences. This certainly misleading information on the safety
being of rural communities. Plants basis of indigenous healing traditions. It is It is imperative that a law on 1. Protection of confidential constitutes CCI, as making it public is of genetically engineered organisms
collected as weeds fulfil two important acknowledged by WHO that over 80% of liability and redress is in place before any
commercial information (CCI, also
against the commercial interests of (GEOs) and making baseless charges
nutritional roles. They are largely rural communities across the world are GE product is released into the market . A institutions that invest huge amounts of on institutions and personnel
nutritious leafy greens, like Chaulai, dependent on medicinal plants and system for implementing labeling must be called Confidential Business money and spend decades developing the
Bathua saag which are a valued, and free, indigenous systems of medicine. put in place before GE foods come into Information) overriding the Right to product. involved:
source of nutrition in the family's diet. A the market. This must be accompanied by In the case of Bt brinjal, the Obviously this applies to both proponents
typical rice field in India (or Bangladesh)
Destroying the vegetation
a public education exercise that makes the
Information Act (2005): European Scientists drafted for support by and opponents of technology.
around crop fields would deprive village Confidential Commercial Information
would yield at least twenty to thirty types label intelligible to ordinary consumers the Indian anti-tech activists have kicked The scientists, product developers or the
communities of crucial health care mainly concerns the gene constructs and
of leafy greens over the cropping season. allowing them to make an informed up dust on presence of non-coding public and private sector institutions that
opportunities especially in a situation not concern the testing protocols and
This access to free nutrition is one of the choice. However, any system of labeling sequences in spite of evidence provided are involved in the biosecurity evaluation
where the formal system does not result evaluation. A gene construct
reasons why nutritional status is better must acknowledge that contamination of on that they are of no consequence to the of GEOs, that express whether positive or
adequately address their health and contains several genes; none of them per
among the rural poor than among the natural with GE food is bound to happen. efficacy and safety of Bt brinjal. It is also negative information, are supported by
veterinary requirements. se is protected under IPR, leaving the
urban poor who have to buy all their food. Consumers must therefore have a say in forgotten that the same transformed experimental/documentary evidence on
Another serious outcome of native genes for any one to use. What is
Those plants that are not eaten by the whether GE foods should be released at plasmid pMON 10518 is also in the which their recommendation is based. By
introducing the HT trait is the patentable is the gene construct, which is
family, serve as fodder for the livestock all. Simply insisting that scientists have Indian Bt cotton that has been in the time of completion of the regulatory
development of new weeds because the innovative and which did not exist in
that rural families maintain as additional declared it safe has no meaning because cultivation since 2002, and which has not evaluation, some 200 scientists/experts
herbicide tolerance trait is known to shift nature earlier. Whether patented or not
income sources. India is a fodder starved food is so strongly conditioned by culture thrown up any adverse consequences nor and about 15 institutions (at least 10 from
easily into other crops. In the case of this constitutes CCI. The gene constructs
country and has a very large livestock and religion. A vegetarian will not eat proved any horror stories of the anti-tech the public sector) are involved. There is
canola, all the kinds of HT genes that are not in the public domain except in the
population. Free range grazing and fodder chicken soup however safe the scientists activists. These scientists did not perform neither truth nor any substance, to the
have been used are found to have patent documents made public when the
from fields is a great support to declare it nor will a Hindu touch beef for any new analysis or generated new data; allegation that the data are provided only
migrated into other non-GM canola The patent is granted (as in the case of most
maintaining livestock. If rural families the same reason.n they merely interpreted the official GEAC by the product developer and so are
crop of concern in developing countries transgenic crops) or in research
had to buy all the fodder they needed to dossier, picking issues that can be suspect or that absurd charge that all those
though is rice. Several studies publications, if the research team chooses
maintain their animals, many would not distorted to suit their convenience. The who are involved in the process are
have shown that the HT trait to publish (as in the case of Golden Rice).
be able to afford livestock and would have aroused controversy, that has put Bt corrupt or have conflict of interest. There
shifts quickly to rice relatives, The gene construct of the Indian Bt
to forego the extra income. brinjal in bad light, could have been is nothing for the scientists, product
specifically, from Oryza sativa, cotton is not available in the public
Apart from this, using herbicide avoided if the nucleotide sequences of the developers and the regulators to worry
the cultivated rice, to O. domain, except by inference.
tolerant crops would make it impossible gene construct were not made public. about this provision, so long as they are
rufipogon, a wild relative also When the biosecurity dossier of
to plant crops on the field borders and the Safety issues should relate to the product above board and do not make unsub-
called red rice, which is a Bt brinjal was to be placed in the public
raised bunds, as is done in many parts of and not the process. stantiated claims. More over, the clause
commonly found weed in areas domain, Mahyco claimed some
India and Asia for additional food and for The second aspect of CCI ensures that they keep themselves above
where rice is cultivated. The information in the dossier was CCI and so
increasing farm incomes. Typically, relates to making public the sites of suspicion and be better than 'Ceaser's
shift of the HT trait into a rice should be excluded. The GEAC, which
farmers will grow crops like yams, ginger approved open field trials. Even when wife'.
weed like O. rufipogon will was already under pressure, did not agree
or vegetables on the bunds surrounding they were not made public, there were The whole anti-tech campaign
have economic implications and ordered the whole dossier to be
rice fields. Thus two or three kinds of several acts of vandalism on standing in India is overloaded with irresponsible
because the red rice is a strong placed in the public domain, on its
produce are available from the field in the crop, attacks on laboratories and the charges relating to both science and
competitor of the cultivated website (reference: Proceedings of the
same season. This advantage would be research personnel, in many parts of the personal integrity, implying that only the
rice and tends to take over rice relevant meeting of the GEAC). With the
lost if the package of herbicide tolerant world, including India (Bt cotton, Bt anti-tech activists and the experts they
fields. result the graphic illustration of the
crop varieties and herbicide use would be brinjal and genetically engineered rice). cherry picked to support their agenda are
Regulation transformed plasmid in Bt brinjal (pMON above board.
implemented. In addition, the practice of The offenders have not been booked for
The regulatory system has in 10518) is open knowledge. There must be some provision
inter-cropping and mixed farming would these unlawful acts. Locations of
many ways been the lightning In addition to the molecular to punish perpetrators of irresponsible
suffer a setback. Traditionally farmers approved field trials should be excluded
rod for resistance to GE crops . machinery needed to make the chosen and unproven charges against scientists,
plant more than one crop in the field. from the purview of RtI. The
Because information was gene (such as Cry 1Ac) to function in the product developers and those involved in
Sugar cane for instance is interspersed Government should include a clause in
impossible to get and new environment (cotton or brinjal), gene implementing the regulatory regime,
with lentils or mustard and it is not the BRAI to punish unlawful acts as they
regulatory bodies treated the constructs (including pMON 10518) may including the regulatory authority.
uncommon to find farmers planting a) constitute the destruction of someone's
public as adversaries rather also contain some non-coding sequences, People who leak confidential
mustard along with wheat, to be harvested legal property, b) cause personal harm and
than concerned citizens, the which do not affect the functioning of the information cause havoc to any system.
one after the other or linseed together c) contravene one's legal right to pursue
opportunity for dialogue was gene construct nor cause any harmful Information submitted to the BRAI by the
with lentils. Mixed cropping is widely research of choice, approved by the
never created. This has led to effects, which is confirmed during applicants, the regulatory evaluation
practiced, with differing combinations of relevant authority.
animosity and distrust which biosafety evaluations. If a crop on the dossiers and their review by competent
crops depending on the region. The BRAI should have the
will not be resolved unless an field is suspected to be illegal, analysis for authorities, should all be considered
In addition to the supple- authority to decide what information is of
honest dialogue and debate is the concerned gene product (a protein) confidential till an appropriate authority
mentary food and fodder that they public interest, before the RtI Act comes
fostered. I think this is very will clarify the issue. On the other hand, of the BRAI approves them for public
provide, so called weeds are also the into play. However, a transparent
important. the non-coding sequences, which vary release. There should be a provision to
medicinal plants that rural families functioning involves placing on its website
More than ever from developer to developer, function as punish people who leak confidential
depend on for the health and veterinary all information of public interest such as
before, with respect to the new molecular tags and provide information information for whatever reason.
care needs of themselves and their the minutes of all meetings of the BRAI,
transformative technologies, leading to the original developer of the We earnestly hope that at least
animals. The introduction of herbicide its constituent authorities and constituted
we need strong and transparent gene construct. Although no one this time the shouting brigade will not run
tolerant crops with accompanying committees.
regulation, a contemplative uu admitted, the identity of the transgene in away with a much needed Act.n

u been fairly controversial for a variety of antibiotic resistance gene for selection in why is there an extra antibiotic
reasons, with both favorable and bacteria, and another antibiotic resistance gene present if it is not
negative reports coming out on the resistance gene for selection in plants. required and does not need to be there?
Imran Siddiqi performance and economics of Bt- The plant selection gene is present This is a serious weakness in the design
cotton. Following Bt-cotton, the next between the T-DNA borders so that it of the transformation strategy, especially
Imran Siddiqi is a Researcher in Plant Molecular Genetics at the Centre for Cellular and Molecular Biology, Hyderabad. crop incorporating Bt-technology to be gets transferred to plants whereas the since the product is proposed to be used
(E-mail: considered for release in India has been bacterial resistance gene is commonly for human consumption directly as a
brinjal. Since unlike cotton, brinjal is a present outside the T-DNA borders and food. Plasmid molecules that contain
food for human consumption, the safety does not get transferred to plants. both TR and TL and where the bacterial
needs to be more stringent and requires Whereas antibiotic markers are selection marker lies outside the T-DNA

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
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
close examination. A general concern
with GM methodologies has been on the
safety of the genes used as selection
markers for plant transformation that
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
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.
MAS to develop cultivars that
having improved traits such as greater at an unprecedented level of the diversity allow selection of plant cells that carry used for human consumption, there is a Incidentally, the aad gene is
incorporate that trait. If however it is not
yield, disease and pest resistance, that exists within a species as well as the transgene of interest. A brief safety concern that these antibiotic also present in the MON 531 derived Bt-
present, then MAS cannot be used and
drought tolerance, and shelf life, in differences between related species. summary of some principles underlying resistance genes can be transferred to cotton hybrids that were first approved
GM approaches can be considered.
addition to reducing environmental and These differences can be used to arrive at plant transformation is presented in the other organisms. Hence different for release in India in 2002. The
Examples of traits which are not found
health hazards such as those caused by the basis of the heritable differences next paragraph to clarify the context. methods have been developed over the transformation construct in Bt-brinjal is
in the native species are resistance to
application of chemical pesticides. between members of a species and A commonly used process of last 14 years (de Vetten et al., 2003) for essentially identical to that used to make
certain insect pests such as bollworm (a
Opponents raise a number of concerns, identification of the genes responsible, making transgenics involves inserting the producing transgenic plants that do not MON 531 (US Pat App 20080124724).
major pest of cotton) and yellow stem
starting from general and ethical including genes for agronomically gene of interest into a small circular carry additional antibiotic markers. The later cotton transformation event
borer (a rice pest). The gene for Bt toxin
concerns about consuming food that has important traits. The challenge lies in DNA molecule called a plasmid which is These methods involve modifications of MON 15985 was carried out using a
derived from a bacterial pathogen
been genetically altered by introducing correlating large amounts of genome introduced and maintained in the standard transformation methodologies different methodology that did not
(Bacillus thuringiensis) of certain insects
genes across the normal species barriers, sequence information and the sequence bacterium Agrobacterium tumefaciens and give marker free transgenics. Marker involve the use of antibiotic resistance
has been used to engineer resistance
and the possible unforeseen variation with the characterization of that infects plants. Maintenance of the free plant transformation technology markers. Concern about the presence of
against both these pests. Studies have
consequences this could have; concerns the plants at sufficient depth and plasmid in bacteria requires that the therefore represents the gold standard for the aad gene in cotton seed made by
indicated that Bt toxin is specific to
about the potential risks arising from accuracy so as to determine where the plasmid carries a gene for antibiotic making transgenic crops. Monsanto has been raised in a 1999
certain insects and does not affect other
specific genes such as antibiotic or genes of interest are located in the resistance that is active in bacteria so The case of Bt-brinjal bears report to the Food Standards Agency,
species. The Bt toxin acts by binding to a
herbicide resistance genes that are genome and ultimately narrowing down that in the presence of the antibiotic only examination in this regard. The plasmid UK by the Advisory Committee on
receptor molecule found in the cell
introduced into a species, escaping to to the identity of the genes themselves. bacteria carrying the plasmid will pMON10518 (US Pat 5500365) used for Novel Foods and Processes
membranes of the insect gut and
other organisms or species; as well as The classical approach has been to use survive and grow. The plasmid also making Bt-brinjal carries the cry1Ac (
disrupting the membranes leading to
concerns about the effects on societies in the minor differences in sequence carries sequences for transfer into and gene encoding Bt toxin inserted after the es/cottonseed). The report considers the
death of the larvae. Studies indicate that
developing countries which account for between members of a species as selection in plant cells. When A. right border (TR). cry1Ac is followed by possibility of a human pathogen such as
animals including all mammals, that
the major population and food markets molecular tags or markers to identify tumefaciens infects a plant, it transfers an antibiotic selection gene, aad which Neisseria gonorrhoeae acquiring the aad
lack the receptors for Bt toxin are not
of the world, of the spread of GM crops and follow genes (over successive part of the plasmid DNA (T-DNA) into confers streptomycin and spectinomycin gene from the plant. It accepts that “the
affected by Bt toxin.
since much of the capacity for and generations) that are close to the tag the plant cell starting from a point called resistance in bacteria, and after aad risk of such an event is small and cannot
Bt-cotton hybrids were
control of GM technology (especially (even though one does not know what the T-DNA right border (TR) and comes the plant selection marker gene be quantified” but the consequences
introduced in India in 2002 and one of
the most advanced GM technology) is precisely the gene is one can still follow ending at a sequence called the T-DNA nptII which confers resistance to the would be extremely serious and advises
the projected benefits was the reduction
often covered by intellectual property it from one generation to the next by left border (TL). The T-DNA enters into antibiotic kanamycin and has been that “… it is our opinion that it would be
in pesticide requirement this would have.
(IP) that resides with large multinational following the tag). This can now be done the nucleus of the plant cell where it is configured so as to express in plants. The very unwise to allow increased
Cotton accounts for a major amount of
corporations (MNCs) the concern is that more extensively so as to allow genes to inserted at a random location in the design of the construct is such that the opportunity for such an event to happen
the pesticide usage in agriculture in
MNCs would come to exercise undue be identified and followed with greater plant's genome. All genes that are aad gene is flanked by cry1Ac and nptII by the introduction of plants containing
India and the use of Bt-cotton hybrids in
influence should agriculture in these comprehensiveness in breeding present in the T-DNA between left and on either side. Hence, in requiring the this resistance gene.”
India has been associated with a
countries become overly dependent on programs whose goal would be to come right borders are thus integrated into the presence of cry1Ac and nptII in Because of the revolutionary nature of
significant reduction in pesticide usage
GM crops. up with plants in which the desired plant DNA. In order to select for plant transformed plants, one invariably GM technology and the possibility of
and increased output (Bennett et al.,
Non-GM agricultural genes (several of them) are all present in cells in which insertion has taken place, selects for the aad gene as well. The
2004). The cost of hybrid Bt-cotton seed gene transfer giving rise in an unforeseen
technology which is much less the same individual which thereby the transferred T-DNA is engineered to plasmid also contains only a single T-
however, is much higher than that of way to hazardous organisms that can
controversial, relates to methods that do shows agronomically improved contain another antibiotic resistance DNA border sequence (TR) so that
non-Bt hybrids so the economic benefit multiply and spread, it has attracted far
not involve transfer of genes across characters. This approach called marker gene which is active in plants. Plant cells transfer initiates but doesn't stop until
of Bt-cotton is supposed to come not so
species, i.e. the use of transgenic assisted selection (MAS) has enormous resistant to this antibiotic would have the the whole plasmid is transferred into the greater attention in terms of safety
much from savings on pesticide usage
approaches. Plant (and animal) breeders potential and is substantially free of T-DNA containing the gene of interest plant cell. It may be noted however that concerns than for example chemical
but higher output. The higher output of
have for centuries relied on variation that proprietary technology. MAS generally integrated within their genome and be the presence of the aad gene in the DNA pesticides where enormous
Bt-cotton hybrids also requires inputs
exists within the gene pool of a species does not involve products that raise the able to grow on medium containing the that is transferred to the plant cell serves environmental damage has already been
such as irrigation which is a limitation in
to breed varieties having features that are kind of safety concerns that arise from antibiotic whereas untransformed plant no functional purpose in plants as it does
many areas where cotton is grown and done. Nevertheless because of the nature
suitable for specific purposes and GM because new combinations of genes cells would be sensitive to the antibiotic not contribute to selection of
there have been reports of poor of these safety concerns, GM technology
environments. are created from within the gene pool of and fail to grow. Hence plasmids transformed plant cells, which is
performance under these conditions needs to be deployed with very close
The development of the species by conventional crossing. designed for introducing genes into achieved only by the nptII gene. The
(Bennett et al., 2004; Sahai, 2007). The
technologies over the last decade to fully However MAS is limited to reshuffling plants via Agrobacterium mediated presence of the aad gene in Bt-brinjal is scrutiny when it comes to assessments uu
use of Bt-cotton hybrids in India has uu
transformation commonly have an therefore gratuitous and it can be asked
(Contd. on page 121)

Deployment of GM Crops
Need For a Clear Cut Policy

Deployment of GM Crops

Need For a Clear Cut Policy

E.A. Siddiq
u commercialized biotech crop in the consultative process involving concerned The above raised reservations
country have been experienced during stakeholders of given target against GM technology cannot be totally
the last eight years, when over 85% of area/community. dismissed as baseless. They can,
the cotton area were planted to Bt cotton Introduction is not based on however, be addressed by scientific

chieving minimum required growth of Green Revolution crops reservationists are fully aware that this is
growth on a sustainable basis is declined to levels far lower than what is the only strategy option to find solution and productivity more than doubled field level evaluation done in the community and officials of concerned
crucial for sustained food- required to sustain the present level of to problems that defy both conventional ending the dependence on imported concerned state for efficacy, stability and ministries to the satisfaction of the
nutrition security. India has made sufficiency and no yield breakthroughs and marker technology and for which cotton. Significantly, this development biosafety apprehensive activists and reluctant
enviable progress in agriculture during as yet in rain fed crops that account for there is no donor source in the too was not without hassles in reaching Small and large scale field test data on farmers, quoting policy goals and related
the last 50 years culminating in self- over 65% of the arable area coupled with compatible germplasm and that finding out to farmers. When Bt brinjal, capable performance/biosafety furnished to the provisions in the Draft National Policy
sufficiency in our food grain needs since shrinking natural resources, especially remedy would have major socio- of minimizing greatly yield losses due to regulatory authority are often from trials on Biotechnology prepared by the
early 80s. Transformation of a water, energy and plant genetic economic impact. fruit and shoot borer, was to be released conducted by the applicant organization Department of Biotechnology, Ministry
chronically food deficit country into a resources, achieving future demands India, although late in last year for commercial planting, the lRegulatory process is not sound enough. of Science and Technology through
food sufficient and surplus one is the would be the most challenging task, if accessing and using recombinant DNA experience in trying to reach out it to It lacks transparency in the process of consultative process involving relevant
most significant accomplishment of the we are to excessively depend on the technology, during the last 15 years it farmers reflected reservation against GM development and testing for efficacy and ministries, national institutes and
crops, especially those that are directly in biosafety and stringency is left much to scientists. Awaiting formal approval of
post-independent India. Two landmark currently available crop improvement has strengthened itself with needed
the food chain of man to be still strong be desired the Policy Document, the DBT is
developments viz., exploitation of technologies. Rapid advances in cellular knowledge and skills, state of the art
and persistant. The kind of objections lInconsistency in efficacy and instances already in the process of implementing
hybrid vigor in maize and millets since and molecular biology have provided research infrastructure and competitive
raised against Bt brinjal by anti-GM of biosafety related problems many of the policy goals/provisions
mid 50s and introduction of plant type two major genomic tools viz., molecular critical mass. It is in an enviable position
lobby, ineffective response to them by lUnsubstantiated claims on economic envisaged. The following responses, if
based high yielding varieties of wheat marker technology enabling genotype today to engineer crop plants with
scientific community and reluctance of advantage and environment security. properly explained vis a vis the issues
and rice since mid 60s marking major based selection and recombinant DNA desired trait(s), given transgenics in as
seed industry and farmers to adopt and lExtensive cultivation of transgenic crops should help remove the apprehensions
yield breakthroughs have made this technology capable of moving genes of many as 10 different crops already on its monopolised by multinational
possible. Despite such an impressive interest across the barriers of sexual shelves awaiting clearance by the lack of clear cut policy-directed on the system and its functioning.
companies would prove a threat to rich
feat, the fact that over 200 million people incompatibility. While there is no Regulatory Authority for commercial interventions from the governments are
said to collectively contribute to our
biodiversity of the country. Establishment of the National
remain undernourished and much larger resistance to the use of the former for planting and several at various stages of lTransgenic strategy in pest control
failure to benefit from such innovative Biotechnology Regulatory Authority
population malnourished is of great crop improvement, there is strong evaluation for efficacy, stability and bio- would lead to emergence of newer
concern, no matter what could be reservation against alien gene based technologies. and the Regulatory Process for
safety including human health and pests/more viruliferous forms of the
attributable to this paradox. With the genetically modified (GM) crops and environment security. Also, potential Reservations Against Biotech Crops same pest.
Safety Assessment of GM Crops/Food
current pace of productivity/production GM food products, though the Broadly aiming at (a) development and
benefits of Bt cotton, the first ever uu Reservation against GM crops from lIncreasing monopoly of multinational
companies in seed trade is to the use of biotech tools to address the
activists and others are -
disadvantage of Indian companies and problems that affect the largest section
The technology being developed and
E.A. SiddiqPh.D is Chairman of the Centre for Finger Printing and Diagnostics (CFCD), Hyderabad. (Email: seed cost is not affordable by small of the society (b) providing of produce/
introduced is not based on prior
farmers. processed products there from at prices uu

Deployment of GM Crops Deployment of GM Crops
Need For a Clear Cut Policy Need For a Clear Cut Policy

u affordable by all sections of the society agronomic performance, decision taken due to (a) breakdown of resistance due u technology is not ours. The issue could, constraint is not our technical laboratory and field levels for biosafety.
and (c) making the country food- on the basis of data and findings from to selection pressure or (b) unintended or however, be resolved by government in competence to engineer crop plants of Considering the high cost involved in
nutrition secure and globally competitive such sources would strengthen the faith deliberate admixture/adulteration (by discussion with the seed industry interest, given the impressive array of meeting satisfactorily such
in the emerging bio-economy, the draft and confidence of all in the user end and unscrupulous elements in seed trade) of reminding governments' policy of transgenics already in pipeline. It is requirements, public-private
Biotechnology Regulatory Authority has thereby willing reception to the seed of transgenic with that of making GM technology easily accessible rather in reaching out the technology to partnership models now in place and
been conceived. Yet to be formally technology. nontransgenic. The latter possibility and affordable to all. the targeted user. Learning from the are being promoted by the Department
established, the Authority ensures Many reservations against GM could be checked by regular Disputes and criticisms on the efficacy experience of other sectors as well as our of Biotechnology could be used to take
through the three-tier system, rigorous crops are largely because of the failure survey/monitoring of transgenic fields and biosafety of biotech crops arising own in this regard, the following advantage of the private sectors'
and sound science based approval of of scientists to respond to and clear all and seed sale points for genetic purity. from various quarters cannot be wished suggestions and strategies would ensure excellence in development and
GM Crops. Structurally and This strategy would greatly help remove effective deployment of biotech crops. management skills for extensive
unfounded apprehensions on their away. Addressing them with scientific
functionally, the development, testing efficacy, stability, biosafety and the wrong notion on the stability of study based facts and figures is the right l Convincing the target clientele with
and approval system though sound transgenics. facts and figures that gain from the l Clear policy and rational strategies for
environment security. strategy to counter them and thereby
given biotech crop outweighed the risks deployment of transgenic crops is vital
enough, scope does exist for making it As for efficacy and economic The view that transgenics promote the technology. Even eight
is basic to its extensive adoption. for successfully sustaining and
still more stringent and transparent. gain from transgenics over the resistant to a pest could facilitate years after the release of Bt cotton, for
benefitting from transgenic technology.
More realistic choice of crop, source of corresponding non-transgenics, debate emergence of newer pests is as well not instance, we still face resistance to it on l Endorsement of the recommendations
These should be in keeping with the
gene and transformation avoiding on far and against biotech crops is due to disputable, when the transgene in grounds like instances of livestock death of the GEAC on biosafety of given
fact that (a) genetic uniformity is
selectable markers, especially antibiotic lack of understanding. For instance, question is pest-specific. Observed build due to grazing in Bt cotton fields, GM crop(s) and processed products
genetically vulnerable to sudden
ones are insisted upon at development claims and counter claims on yield up of once not so serious pink bollworm degradation of soil health and quality there from by the apex agricultural
outbreaks of pests and (b) sexual
phase, while ensuring stringent and superiority of pest resistant transgenics (Pectinophora gossypiella) in cotton is one affecting seriously the performance of research organizations at national
compatibility with plant species around
transparent assessment of biotech crops like Bt cotton and Bt brinjal is one such such case, where the transgene effective subsequently planted crops, increased (ICAR) and state (State Agricultural
would lead to genetic contamination,
for biosafety including human and case of poor understanding of the trait against bollworm (Heliothes armigera) suicide cases in Bt cotton grown areas Universities) levels and other National
genetic erosion and other unintended
animal health and other unintended due to crop failure, no appreciable cost laboratories.
effect on productivity. Genetic yield remains ineffective against other related consequences. To ward off the problem
effects (toxicity, allergenicity, and other reduction on plant protection etc. Such l Organized and intensive awareness
potential being inherent to a given species of the pest. of genetic vulnerability, either
adverse health related problems) at creation among the target population
variety, no matter it is transgenic or non- Many believe that transgenics issues be thoroughly investigated by a diversification of trans-resistance genes
on the intended introduction of biotech
laboratory and on environment transgenic, observed yield difference could prove a serious threat to genetic competent committee constituted of through varietal mosaics or pyramiding
crop(s) highlighting its relevance to
(weediness, invasiveness, pollen flow between them depends on the level of diversity, which is the bedrock researchers, social scientists and of varieties with diverse trans-
their livelihood security and biosafety
caused genetic contamination/erosion) yield loss they suffer due to the pest. In conventional plant breeders depend on economists for establishing what is resistance genes could be ideal
including human and animal health
at field level. Large scale multi-location situations of high pest incidence, the for progressively improving crop rumoured is not true. Only with strategies. To contain genetic
and environment security.
field trial conducted on the transgenic would yield far higher than varieties. The contention that extensive scientific scrutiny-based facts and contamination, areas/regions rich with
l Active involvement of state agricultural
recommendation of the RCGM is the corresponding non-transgenic and exploitation of a few transgenics would figures, such reports can be countered compatible wild/cultivar species be
departments in reaching out the
monitored and evaluated by the Genetic when there is no or very low pest build amount to disappearance of thousands and restore thereby the trust and precluded for introduction of given
technology to the intended regions,
Monitoring and Evaluation Committee. up, there will be hardly any yield of native germplasm, need not be wholly confidence of growers and consumers. transgenic crop/variety. There should
ecologies and communities. Training
Its report and recommendation of the difference between them. Therefore, it is true. Similar apprehension was there Apprehensions on long term effect of be legal restriction to introduce
of extension personnel at all levels on
special Appraisal Committee constituted wrong to conclude that transgenics have when hybrids of millets and high GMOs could be out of genuine concern transgenic crops in biodiversity rich
the benefits and associated risks of the
of experts form ultimately the basis for higher yield potential or it is only on par yielding varieties of rice and wheat were for human health. As there is no way out areas, centers of origin and centers of
technology and organizing large scale
granting approval for seed increase and with the non-transgenic control, as the introduced. The fact that maximum of to subject human beings for long term diversity of a species, areas earmarked
on farm demonstrations.
commercial planting by the Genetic observed difference in yield depends on crop specific diversity available in the clinical tests special Standing Technical for export oriented crops (e.g.: basmati
l Labeling of transgenic produce and
Engineering Approval Committee the level of pest incidence and the level Committee constituted of physicians, rice) and those for organic farming.
country has already been conserved by processed food products is about
(GEAC). Thus, the regulatory system of protection the transgenics and non ex situ and in situ approaches and more social scientists and agricultural Innovative technologies are inevitable
consumer right. Though mandatory in
and regulatory process are in order in transgenics provide against the pest. could be done in future too. Such scientists should monitor long term given the limitations of the conventional
India, measures be found to address
the absence of formally cleared National Stability of trait expression is anticipatory conservation measures effect of consumption of GM food/feed the practical problems that would be breeding/selection technologies vis a vis
Policy on Biotechnology and yet another apprehension about biotech already on should convince all those, on human/animal health. encountered in actual implementation magnitude and seriousness of problems
establishment of National crops. Discouraging reports on the who entertain such concern that it in the face of reluctance of private facing us today. Undoubtedly extra care
Biotechnology Regulatory Authority. declined efficacy of Bt gene in cotton, cannot be a justification against GM Policy Initiatives and Technology sector companies on the plea that it is necessary to rule out any serious
Priority action plan in this regard would for instance, are no doubt based on crops. Transfer Strategies for Effective would introduce price discrimination impact of GM crops/GM food/feed on
help ward off the criticism that biosafety actual observation in some parts of the The objection that increasing Deployment of Biotech Crops and would be against the policy goal of human/animal health and environment.
and efficacy/performance related data country. Such instances of instability are In taking full advantage of advances ensuring inclusiveness. But reservations, undue delays in
monopoly of multinational seed
are not reliable. If the system has its own not characteristic to transgenics alone, as being made in the area of crop l Many valuable transgenics developed exploiting the technologies of large
companies would be at the cost of
laboratory facilities or duly accredited breakdown of resistance (ineffectiveness biotechnology, relevant enough to by the public institutions are still on the socio-economic impact would amount to
domestic seed industry and that no
public laboratories exclusively designed of resistance gene against the pest) is as address the problems that impede the shelf because of lack of resource denying the large undernourished-
control over seed price would go against
for risk analysis of GM crops and well the case with natural genes. What progress of envisaged support for them to go through the malnourished population the benefits of
farmers' interest, is although under-
depends on SAU's generated data on has been observed in Bt cotton could be production/productivity growth, the mandatory testing requirements at new bioscience.n
standable, it is inevitable as long as the uu

GM Crops in India

The Way Forward


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

The Way Forward

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

National Research Center for Plant Biotechnolgy

National Research Center

for Plant Biotechnology
National Research Center for Plant Biotechnology, Lal Bahadur Shastri Building, IARI Pusa, New Delhi-110012,

t was in the year 1985, a new rice and mustard, which showed a wide arvensis and its cognate male fertility u unrestricted use. In rice, genes for a collaboration with the USA group at the as a variety for commercial cultivation
Division named “Biotechnology range of phenotypic variation called restoration line developed by the Centre number of traits such as Basmati quality, University of Arizona leading to a following the biosafety guidelines. This
Centre” came into existence at the “somaclonal variation”. Following years were made available to the public as well tolerance to salinity, fertility restoration, publication in the Plant Cell. A total of variety can be repeatedly grown by the
premier Indian Agricultural Research of selection, a highly promising line as private institutions that led to and resistance against the fungal disease 8.17Mb high quality sequence of the long farmers for years without seed
Institute (IARI), New Delhi to undertake named Bio-902 was identified in mustard commercial production of mustard blast have been successfully tagged using arm was generated and integrated with replacement as required for hybrids and
research and teaching in Plant Molecular that was subsequently released as a new hybrids in the country (Coral 432 and DNA markers. The gene for blast that of the whole rice genome, which was also be used as a parent of new cotton
Biology and Biotechnology. Realizing its variety named Pusa Jai Kisan after three NRC Sankar Sarson). resistance was recently cloned based on published in Nature in the year 2005. hybrids. Besides, efforts are also being
importance and relevance in the National years of multilocation evaluation. Even Since late 1980s, the Centre has its position on the linkage map. In a This effort led to understanding of the made to engineer crop genotypes with
Agricultural Research System (NARS) in after 15 years of its release, the variety is been working in the area of design and collaborative effort with the mother structure and evolution of the rice tolerance to abiotic stresses such as
the country, the centre was upgraded to a still preferred by the farmers for its bolder use of DNA based genetic markers for institution IARI, a new variety of genome as well as organization of genes drought and salinity in crops such as
National Research Centre under the seeds and higher yield potential over the the assessment of genetic diversity, Basmati rice named Improved Pusa including the ones for disease resistance. mustard and tomato, and with improved
umbrella of the Indian Council of popular check variety Varuna. This genome mapping, gene tagging, map- Basmati 1 has been developed through Discovery of new genes and markers is shelf life of fruits in tomato.
Agricultural Research (ICAR) in the year remains the first commercial mustard based gene cloning and marker assisted MAS. Two genes for bacterial leaf blight greatly facilitated with the availability of Success of transgenic
1993. product in the world developed through selection (MAS). The first set of (BLB) resistance were combined in this high quality genome sequence of rice. technology depends on the availability of
The mandate of the Centre is to tissue culture. restriction fragment length polymorphism variety with Basmati quality traits by a This effort has now been replicated for genes and promoters. Keeping this in
design plant molecular biology and One of the options to further (RFLP) markers was generated and used novel approach that integrated sequencing of long arm of tomato view, the Centre initiated a program on
biotechnology tools and techniques for enhance yield is to develop hybrids for to construct the genome map of mustard, phenotyping with marker based genotypic chromosome 5 as a partner of an cloning of novel genes and promoters. A
genetic enhancement of crops, and to commercial exploitation of heterosis. which is the first of its kind in the selection employing modified backcross International consortium. number of protease inhibitor genes have
develop human resource in the frontier This however necessitates availability of a country. This map was subsequently used pedigree strategy. Improved Pusa Basmati Research on the soil bacterium been cloned from leguminous crops and
areas of new biology through teaching robust and efficient pollination control to tag genes for fatty acid content and 1 is the first to be developed through Bacillus thuringiensis (Bt) and its are currently being characterized.
and training for meeting the needs of the system for large-scale production of resistance to a devastating fungal disease MAS in rice in the country and currently insecticidal genes was initiated at this Candidate genes for drought tolerance
NARS. hybrid seeds. The Centre carried out namely, white rust. Molecular genetic is the only donor of BLB resistance in centre in the late 1980s that led to the have been isolated from tolerant
somatic cell hybridization involving diversity has been assessed in several Basmati breeding. development of first Bt-Brinjal in the late genotypes of wheat, rice and Brassica
Research and Development Indian mustard and its wild relatives to important crop species including rice, India participated in the 1990s in the country. More recently new species and being validated for their
In the initial years, the Centre was generate several different somatic cell wheat, Brassica, sugarcane, jute and multinational Rice Genome Sequencing and effective events of Bt-brinjal carrying function. To clone novel promoters, T-
involved in standardizing protocols for hybrids. By back-crossing the hybrids tobacco leading to the development of project. This Centre was involved in this cry1Fa1 gene have been developed and DNA insertion mutants were generated in
plant regeneration and genetic with the mustard parent, the nucleus of DNA fingerprints of elite genotypes effort along with the Delhi University licensed to private institutions. the model plant species Arabidopsis
transformation of important crop species the cultivated Indian mustard could be including the commercially important South Campus to sequence the long arm Significantly, in a collaborative effort with thaliana. Using these mutants, promoters
such as rice, chickpea and Indian mustard combined with the cytoplasm of a wild Basmati rice. Thousands of genetic and of rice chromosome 11. The scientists of the Central Institute on Cotton Research, have been trapped, cloned and
(Brassica juncea) for deployment of relative to generate a number of genomic Simple Sequence Repeat (SSR) the Centre first participated in Nagpur and University of Agricultural characterized, which include the ones
recombinant DNA technology. An cytoplasmic male sterile (CMS) lines. markers were designed in rice, wheat, construction of a bacterial artificial Sciences, Dharwad, Bt-gene cry1AC has that drive specific gene expression in
outcome of this massive effort was a large One of these CMS lines based on the maize, barley, Sorghum, sugarcane and chromosome (BAC) based physical map been transferred to a cotton variety roots, trichomes and anthers. Recently, a
number of tissue culture-raised plants of cytoplasm of wild relative Moricandia Brassica, which are in public domain for uu of the assigned chromosome in Bikaneri Nerma, which has been released strong promoter giving constitutive uu

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

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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.