FEATURE
GM vs. Traditional Crops
How Do They Differ ?
K. V. Prabhu
G
enetically modified crops are
developed through the process
of genetic engineering by
incorporating a gene (or genes) foreign
to the crop species through procedures
different from natural pollination or sex-
ual reproduction. These are also known
popularly as Genetically Modified
Organisms (GMOs) or referred to as
Living Modified Organisms (LMO) or
transgenic organisms.
How are GM Crops produced as
against those bred traditionally?
A GM crop is produced principally by
introducing a gene sourced from any
foreign organism that does not naturally
hybridize with the crop species being
genetically engineered. The foreign gene
can also be a synthesized DNA sequence
for a product and the receiving crop is
known either not to produce it, or pro-
duce it in insufficient quantity. The intro-
duced gene also includes elements such
as promoters, termination sequences and
K. V. Prabhu Ph.D. is Head and Principal Scientist, Division of Genetics, Indian Agricultural Research Institute, New Delhi
(E-mail: kvinodprabhu@rediffmail.com)
APRIL, 2010
some times selection markers, all of
which are required for making the gene
express the protein it codes for and
enable its detection in the process of
genetic transformation. The whole com-
position is known as a “gene construct”.
For simplicity, the construct can be
referred to as “transgene”. The receiving
plant is transformed into a GM plant by
transferring the transgene construct
either directly into the genome of the
recipient organism through “ballistic
bombardment” or through a bacterium
known as Agrobacterium tumefaciens
which has the capacity to transfer the
gene construct into the recipient plant
through infection. When the latter pro-
cedure is adopted, the resulting GM crop
would have passed through the same
procedures that the tissue cultured prod-
uct passes through, known as the process
of regeneration for successful transfor-
mation.
In contrast to the transforma-
tion techniques used for developing the
GM crop, in the case of conventional
plant breeding, usually two or more geno-
types (known as parents) are hybridized
to recombine the genes from both the
parents desired to be brought together.
The genes are tracked in the
following generations through selection
to finally end up in a stable genotype
which is released as a “variety”. In this
process, a large number of genes recom-
bine from parental genotypes exchanging
large extent of genomic regions from the
involved parents, the best combinations
are selected consciously according to the
objectives of the breeding program to be
evaluated for performance and eventual
release as a new variety (see figure on
next page).
One of the exceptions to this
procedure are the hybrids where the
evolved hybrid would necessarily have
equal genomic regions from both par-
ents. The other exception is the process
of development of introgression line
(also known as near-isogenic line) that uu
BIOTECH NEWS 57
 GM vs. Traditional Crops

How Do They Differ ?

Chromosome level changes that occur during conventional plant

breeding and integration of a transgene during genetic engineering
A Schematic Representation

TRADITIONAL PLANT BREEDING

Chromosomes are made of DNA that comprise a series of genes, much like a strand
of pearls. Traditional piant breeding ends up binding together many genes at once from
both parents through the process of hybridization
Many Alleles are recombined between
the parents at their original positions on
Allele of the same gene with the same chromosome along with the
undesired expression desired gene
Desired allele of a gene

Identical Chromosome Chromosome carrying

Chromosome of
of another genotype of genes from both parents including
donor genotype
same species the desired gene in the new variety

GENETIC ENGINEERING
A transformation event adds only a single gene construct to the chromosome
A single gene construct gets integrated at
any random position in one or many copies
Desired Gene on any chromosome
Desired Gene
construct

Improved
Commercial Plant Commercial Plant
Variety Variety
Donor species (any
organism, plant, animal,
microbe or a synthetic gene)
u

u results from a specific breeding process
known as “backcross breeding” where
the focus is to transfer only one gene
from one parent (known as donor par-
ent) into another already established vari-
ety, known as the recurrent parent.
In general, once stabilized by the inte-
gration of the transgene anywhere in its
genome, the GM crop follows the same
series of survival procedures like any
other conventional variety of the crop.
The difference lies however, in the limit-
less potential of the GM crop both in the
way the new “transgene” integrates into
the native DNA of the crop and the loca-
tion on the chromosome where it inte-
grates. Once integrated, the transgene
can recombine like any gene when
crossed with another variety of the same has incorporated a foreign gene in its
crop. genome is as safe as its conventional
GM Crop and Farmer/Consumer counterpart. The rigorous testing the
product undergoes for establishing its
The GM crop variety (hybrid in terms of
safety vis-a-vis the environment, human
the farmer) and the commercial product
and animal health under the vigil of the
of the GM crop (such as leafy foliage,
regulatory processes in place, makes the
fruits, grains, oil or fibre from the view
GM crop a beneficial product to farmers
point of the consumer), will technically
and consumers. Depending on the gene
be substantially similar to its conven-
incorporated in the GM crop, its value in
tional counterpart. In terms of farmers,
differentiating it from its conventional
the GM crop will enable them to pro-
counter product differs. For example, if
duce more or better quality product
a insect resistance is the feature of a GM
while for the consumer it will add more
crop, this will be valuable to the farmer
value to the product for a better quality
in terms of reduced use of pesticides,
of life. Over the last two decades, the
reduced losses due to the insect pest and
technology of genetic engineering of
better market value through low or no
plants has undergone a series of refine-
damage caused to the commercial prod- uu
ments to ensure that the product which

58 BIOTECH NEWS VOLUME 5 | NO. 2

 GM vs. Traditional Crops

How Do They Differ ?

Genetically speaking…..
As a consequence of its random integration in the native genome anywhere in any chromo-
some and its being entirely new to the recipient genome, the transgene does not have its
alternate form “allele” in the recipient variety. In addition, since the transgene can find a
place in between any two functional genes, depending on its position, there may be varia-
tion in its own expression or that of the two genes it is flanked with. However, it should be
appreciated that if the latter is the case, the GM crop will be declared as not suitable for
commercialization and will never reach the farmer. This is enabled through a series of regu-
lations and tests the GM crop undergoes for its equivalence and similarity with the normal
crop. In contrast, in the conventional approach, since the location of every native gene is
fixed on specific chromosome, its segregation in its progeny is within the alleles of the char-
acter without disrupting other expressions (when the gene or its product is independent of
others). Therefore, the rules of genetic segregation will be different in the conventional
hybridization followed in plant breeding and that in the case of genetic transformation prod-
uct. In the case of conventional plant breeding, if the new gene being transferred from one
parent into another parent is, say, “R” present on a particular chromosome, then the hybrid-
ized product will be “Rr” where, the “r” is the alternate allele coming from the same chro-
mosome counterpart of the latter parent, whose expression is not desired. The progeny of
this hybridized product will segregate into, 1RR : 2Rr : 1rr. The RR and rr combinations
are called “homozygous” the Rr is called “heterozygous”. In contrast, because the
transgene is completely foreign, there will be no counterpart allele of the transgene in the
transformed product which will therefore be a combination “R-” and its progeny will segre-
gate accordingly into 1RR : 2R- : 1--, where the RR is homozygous for transgene, R- is
known as “hemizygous” and the individual is called “null” as this individual does not carry
any allele of the transgene. The fate of the progeny of the Bt hybrid cotton is as explained
above if one grows the seed produced on the Bt hybrid plant.

u uct by the insect pest. The consumer
would have the benefit of getting
undamaged product and residual pesti-
cides in the commercial product. The
conventional product in contrast will be
prone to have the insect pest or have pes-
ticide residues in the commercial prod-
uct to the disadvantage of both farmers
and consumers. If the GM crop is pro-
duced to add value to the commercial
product such as enhanced carotene con-
tent or minerals, the farmer will be able
to obtain better marketability while the
consumer will have healthful products
for consumption.
The farmers have to take care
that they do not use the seed of a GM
crop hybrid for raising another crop for
the reason explained in the box above. If
they do, then there will be 25% “null”
plants which will be non-GM plants.
Organic Crops vs GM Crops
Organic crops are any natural and non-
GM crop variety which is cultivated with-
out the use of chemical fertilizers, pesti-
cides and chemicals. The field where it is
grown has to be certified as organic field
having no traces of any chemical/ inor-
ganic fertilizer(s) or chemicals. The crop
cultivation, harvesting and packaging
has to be certified as done organically
without any use of chemicals. It is also
required that the seed used for producing
the crop is also produced organically. As
per the current definition and standards,
GM crops do not qualify for cultivation
as organic crops.
GM Crops: Common Misconceptions
GM crops are unsafe and harmful : The most
common misconception is that GM
crops are unsafe and harmful for human
beings, animals and environment. It
needs to be understood that GM crops
are rigorously evaluated and analyzed
for any risk they may pose to human
beings, animals and environment. Only
when it is confirmed safe through a stan-
dard set of investigations and protocols,
a GM crop is released in the environ-
ment for cultivation.
GM crops destroy natural genetic diversity: It is
often stated that GM crops erode genetic uu

APRIL, 2010 BIOTECH NEWS 59

 GM vs. Traditional Crops

How Do They Differ ?

u diversity of the crop. This misconception
is based on the perceived ability of the
GM crops themselves to become inva-
sive or pass the invasiveness to wild rela-
tives or native varieties through “gene
flow” or “pollen flow”. While it may so
happen that a successful GM variety
may get so popular that it may end up
replacing other varieties like many tradi-
tional varieties have done in the course
history, it does not mean that this will
cause erosion of genetic diversity. It only
ends up into the pattern of “mono-
culture” as may also happen in the case
of a popular single non-GM variety for a
crop. However, this is not likely to hap-
pen in India where large number of pri-
vate and public plant breeders and seed
producers invariably keep developing
and releasing GM, or non-GM varieties.
There are no possibilities of a gene like
insect resistance, salt tolerance or disease
resistance enabling a GM crop to be inva-
sive, or spread into varieties in the wild.
As such, in India, multiple crops are
grown each year in almost all parts and
there are wild relatives of few crops
which occupy large areas. Even if herbi-
cide tolerance genes are deployed and
they do move into wild types, these
plants are not provided with extra fitness
for them to produce more seeds. Thus,
like the established safety of every other
improved character from non-GM vari-
eties in the past history, the GM trait
also does not make the weed become
invasive in general. Herbicide tolerance
makes the variety of wild relative possi-
bly gain herbicide tolerance, only to the
targeted herbicide. Neither it becomes
fitter nor invasive by producing more
seeds than usual.
Issue of foreign bacterial or animal genes in tradi-
tional crops: Even if the transgene is taken
out from a bacterium, animal or other
plant species, the GM plant does not
become a bacterium or animal or
another plant species. The transgene
only produces the protein and not the
tissue or organ that belongs to the source
organism. It is notable that there are
thousands of genes common between
crops and animals. For example, there
are more than 10,000 common genes
between human beings and rice. The pro-
teins produced by these do not make rice
into a human organelle. The transgene is
only a chemical entity made up of com-
mon components existing in human
beings and plants or bacteria. As such
we everyday consume bacteria and
microorganisms through fresh vegeta-
bles, fruits and drinking water. The con-
sumer needs to understand this and
come to an informed judgement on the
issue.
GM crops increase yield and reduce soil fertility:
No GM crop has any additional yielding
ability over and above its original tradi-
tional counterpart variety or hybrid. If
the transgene makes the GM crop resis-
tant to diseases, pests or drought and
heat stresses, it helps it to achieve its full
productivity potential without any yield
loss due to the stresses. Thus, the GM
crop variety or hybrid only responds to
the genetic potential of the non-GM tra-
ditional counterpart and does not reduce
soil fertility additionally. Unless the
transgene itself is for yield increase, the
GM crop does not yield more than the
yield potential of the original crop vari-
ety. n

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60 BIOTECH NEWS VOLUME 5 | NO. 2

FEATURE
GM Crops in India
Beyond Bt Brinjal
G.Padmanaban
W
hile it is a disappointment
that a moratorium on the
introduction of Bt Brinjal
without specifying a time frame has been
imposed by the Ministry of Environment
and Forests (MoEF), I believe that it is
also an opportunity to objectively assess
the science and the ground reality in
respect of the relevance of genetically
modified (GM) crops as a whole for the
country. Nobody seems to be against a
technology based solution to stagnating
productivity in agriculture in the face of
projected increase in human population.
GM technology affords a unique
opportunity to tackle biotic as well as
abiotic stresses, besides improving the
nutritive quality of the feed stock.
Majority of the stake holders are not
against the technology as such, but the
standard concerns expressed are:
1. Environmental and health safety.
2. Regulatory regimes for approval.
There have been innumerable
arguments attesting to safety aspects with
G.PadmanabanPh.D. is Emeritus Professor and former Director, Indian Institute of Science, Bangalore.(E-mail: geepee@biochem.iisc.ernet.in)
64 BIOTECH NEWS
respect to the GM crops so far developed
and field-tested. It has to be conceded
that there would be vociferous diehards
who would not accept GM technology,
whatever may be the scientific validity.
The society and the government need to
evolve and accept the policy on GM-crop
cultivation based on scientific inputs and
a correct perception on the need for such
a technology. It would be in the interest
of the nation, if valid scientific
arguments are accepted so that one does
not throw out the baby with the bath
water. It is also the duty of the scientific
community, which believes in GM
technology, to address the concerns and
keep evolving newer strategies to make
the technology safe on the ground, as
well as in the minds of the public. But, if
vested interests dictate terms to dump the
technology, it would be a great loss. India
missed the industrial revolution as a
subjugate nation and is still paying a
price in terms of development. It would
be a great tragedy if it misses, as a free
nation, the GM revolution that can
address concerns of food security and
mass nutrition.
In this article I have made an
attempt to summarize the concerns of
the MoEF that have led it to the
imposition of the moratorium and to
analyze each of those concerns.
A: All the brinjal growing states have
expressed reservation on the
introduction of Bt brinjal
This is true. A couple of states had based
the decision on the lack of evidence in
terms of commercial benefits to the
farmer. However, the EC-II report clearly
mentions the significant decrease in
pesticide spray, increased marketable
yield and the projected economic gain to
the farmer, in quantitative terms based
on the trials conducted by the Indian
Institute of Vegetable Research Varanasi.
This, of course, needs to be replicated in
private farmers' fields. The inputs
available to at least some of the state uu
VOLUME 5 | NO. 2
 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
strong hold, loopholes in the regulatory
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
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
scientists, have not studied the issues
involved, but have offered comments Courtesy: ABSP II South Asia (2010)
without any hesitation. It does become
necessary to take decisions in the best absence of an accredited, dedicated of brinjal cultivated in different states, as
interest of the nation, guided by genuine public sector laboratory for GM studies, has been the case with Bt cotton. Even in
scientific inputs, rather than attempting a one has to accept the fact that GEAC has the case of non-transgenic crops, is it not
consensus. I am not sure, a consensus evaluated and accepted the data. I would a fact that farmers prefer only certain
can be ever reached in any part of the like to state that many seed companies varieties and hybrids? What happens to
world on this issue. Did India enter into and academia involved in GM research biodiversity in these cases? This is the
the nuclear deal based on a national have a perception that GEAC is one of price the society has to pay ever since
consensus? the toughest regulatory bodies and man started practicing agriculture,
demands data not required even by targeting specific varieties and hybrids.
C: All the tests on Bt brinjal were agencies ( FDA /EPA /USDA) in the Philosophically I have never understood
carried out by Mahyco USA. the issue of biodiversity with respect to
There were no independent tests transgenic crops carrying a couple of
validating the results. One can only state
D: The biodiversity issue is crucial, transgenes. This is in the context of
that public-funded institutions such as
since brinjal is 'Indian' horizontal and vertical transmission of
Tamil Nadu Agricultural University, The gene flow studies carried out are not genes taking place in nature all the time
Coimbatore and University of adequate. The trials should have been in evolutionary scale. How did the 2000
Agricultural Sciences, Dharwad as well carried out in different environmental varieties of brinjal evolve? Can any one
as Indian Council for Agricultural conditions. Bt brinjal may affect the rich define a pure, unadulterated line of rice
Research and Indian Institute of biodiversity of this vegetable. The in terms of the genome? How is the
Vegetable Research, Varanasi were example given is Bt cotton, which is biodiversity affected even if a couple of
involved in the field trials. One cannot dominating over non-Bt cotton in the transgenes were to reach an unintended
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
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 s weed. Although, I respect the regulatory uu

APRIL, 2010 BIOTECH NEWS 65

 GM Crops in India
Beyond Bt Brinjal
u protocols on gene flow demanded in
transgenic crop trials, deep inside I
believe that the biodiversity card is
overplayed. The government can create
biodiversity parks all over the country to
preserve rare varieties of selected plant
species.
E: Bt brinjal as a food crop cannot be
equated with Bt cotton
The chronic toxicity tests carried out in
experimental animals are not adequate.
There are suggestions that chronic
toxicity tests should be carried out during
the entire life cycle of the animal.
Solanaceae is a unique species and the
transgenes may bring the hidden toxins
to the surface. Brinjal is used in native
medicine without cooking and abundant
caution needs to be exercised in assessing
the health safety of Bt brinjal. As per EC-
II report, the developers have indeed
carried out a variety of mandatory
toxicity tests in a wide variety of
experimental and domesticated animals.
A 90 day chronic toxicity test has been
carried out. These tests have been
considered as adequate by GEAC. One
should also keep in mind that there is so
much published information already
available on the safety of Bt toxins to
humans and animals. More than this, Bt
corn is being consumed across the globe
for over a decade. Apart from being cattle
feed, the breakfast cereal in North
America, perhaps, contains Bt corn. We
cannot just discard the American
experience and state that it is not relevant
for our discussion. In my perception, the
greatest proof of safety of Bt gene is the
long term consumption of Bt corn in
many countries without any confirmed
and authenticated ill effects to the public.
Of course, scientifically it is well known
that Bt proteins get degraded in the
acidic stomach of the mammal, whereas
it gets activated under the alkaline
conditions of the gut in the pests. It gets
degraded during cooking. Its penetrance
in the soil and microflora is not of real
concern. In spite of all these arguments,
the chronic toxicity tests in rodents can
66 BIOTECH NEWS
be carried out for 6 months or even a
year, if that would satisfy the
requirement. I personally do not see the
logic in extended studies.
I also do not subscribe to the
addition of sophisticated tests such as
transcriptomic, proteomic and
metabolomic studies. A plant is a
dynamic entity and would respond even
to small changes in environment cues.
One can be reasonably certain that these
parameters would be different between
the different varieties of brinjal, or even
the same variety grown under different
geographical and environment
conditions. This does not mean that the
changes seen are detrimental.
F: Bt brinjal has been developed by
Mahyco in which Monsanto has a
stake of 26%
The gene belongs to Monsanto. Priority
needs to be given to the
commercialization of indigenously
developed transgenic products. China has
developed Bt rice indigenously and has
approved trials that would lead to
commercialization. First, the support for
indigenous development is definitely
welcome. There are atleast a few events,
both in the private and public sectors,
that are ready for trials towards
commercialization. But, one needs to
talk to the scientists concerned to
understand the trials and tribulations
they undergo to take their transgenics
forward.
On the one hand they have to
face the tough requirements of RCGM
and GEAC, constant interference by
activists directly or indirectly, Supreme
court ruling that actually allowed on
going trials (Mahyco), but clamped an
embargo on newer trials that were ready
(indigenous) and on the other, face an
uncertain future in terms of publications
and career advancement (public sector)
and survival (private company). Is this
the right environment for indigenous
development of commercial capabilities?
As regards China, it has followed a dual
policy. It has approved specific GM y in
products developed by MNCs (eg.GM
corn and Soya), while developing its own
Bt rice. As per a news item (November 4,
2009/PR news shire- First call),
Monsanto was opening its first research
center in Zhongguancum, Beijing.
Monsanto has made a commitment to
collaborate with Chinese scientists on
advanced biotech and breeding
technology. China is pragmatic. It wants
to get the best of both worlds. We are
driven by emotional activism. It is not as
if there is no opposition to GM
technology in China. But, it is able to
take decisions and move ahead. It is able
to keep the big picture in perspective,
namely food security to an over billion
population and an intense ambition to
become the world leader. I will not be
surprised if we will be importing Bt rice
from China at some point of time!
G: Resistance development is a
serious concern in monophagous
pests
By far this is the most serious issue,
which scientists should address as the
primary challenge. Two different
hypotheses are available to explain the
mode of action of Cry toxins. One is
based on generating pores (punching
holes) in the insect gut cell and the other
is based on killing mediated by signal
transduction. In both the models, the first
steps envisaged are similar. The ingested
toxin is cleaved by midgut protease and
the activated toxin binds to cadherin
receptor located in the microvilli of
midgut cells. The toxin oligomer then
binds to secondary receptors anchored to
the membrane such as aminopeptidase N
or alkaline phosphatase. The toxin
oligomer then inserts into lipid raft
membranes forming pores and causing
the cells to burst. In the second model,
the binding of toxin to cadherin receptor
is visualized to trigger a signal
transduction cascade, eventually leading
to oncotic cell death.
Mechanisms of resistance development
have been studied in different pests
induced to become resistant in the
laboratory. In general, the most m is due uu
VOLUME 5 | NO. 2

u frequently observed mechanism is due to
defects in receptor binding followed by
resistance due to defects in protease
production, elevated immune response,
enhanced esterase production etc.
Strategies to overcome resistance include
development of Bt plants with novel Cry
toxins (eg.VIP3 plants), Cry gene
stacking (eg. Cry 1Ac with Cry 2Ab),
modified Cry toxins that bypass primary
receptor interaction (eg. Cry 1A Mod
toxins), use of Cyt proteins from Bt i
strain along with Cry toxins and use of
cadherin fragments to counter resistance
(Bravo, A and Soberon, M (2008). How
to cope with insect resistance to Bt
toxins? Trends in Biotechnology Vol.26,
473-579).
In addition, on the field use of
refuge cropping has been shown to be
effective. It is clear that in developed
countries there is already a switch to the
use of Bt crops with stacked genes.
Indigenous efforts should only be
towards developing Bt plants with
stacked genes. Monsanto has already
indicated of possible resistance
development in Gujarat to pink boll
worm in Bt cotton and has
recommended the use of second
generation Bollguard with two stacked
genes. I wish there is an Indian authority
which gives this advice based on a
constant monitoring of the GM crops in
the field.
H: India needs an independent
authority to evaluate and approve the
trials as well as to monitor the
performance of GM crops in the field
after commercialization
A unified National Biotechnology
Regulatory Authority (now rechristened
Biotechnology Regulatory Authority of
India, or BRAI) is under consideration.
The bill pending since 2005 is likely to be
taken up in the parliament for debate. I
feel that the regulatory authority to
evaluate and monitor transgenic crops in
experimental fields and the one that
performs a regulatory function after
commercialization should be different.
GEAC can continue to perform the
APRIL, 2010
former function and give approval for
commercialization. GEAC has evolved
over several years of experience and,
perhaps, it is not a good idea to disband
the same. It may need some more fine
tuning. Thus, these two authorities can
be two arms of NBRA in the Agriculture
sector. The biggest challenge is to create
independent and dedicated experimental
facilities to monitor and evaluate GM
crops. Till such a facility comes into
existence, the existing laboratories in
different institutions have to be net-
worked to provide independent
experimental capabilities for NBRA.
R&D Efforts (Priority). Bt transgenics
should only be developed with more than
one gene. Those that have already been
developed should be given priority for
commercialization. In fact, if we can
develop two different sets, one should be
in reserve to be introduced as and when
signs of resistance are seen. Resistance is
not a permanent character. It is well
known that when crops are rotated, the
pressure on the insect to develop
resistance to a particular gene is eased.
The insect once again becomes sensitive.
Bt crops can ideally form part of
Integrated Pest Management regime.
When major pests cannot thrive, minor
pests can become the primary concern.
Therefore, transgenics to contain minor
pests (eg. sucking pets) need to be
developed simultaneously. I have earlier
listed many genes that can be used to
combat resistance. Newer strategies such
as the use of SiRNA to knock out
specific gene expression need to be
pursued vigorously. Strategies are
available to remove antibiotic markers.
Even screening a large number of events
can give the desired transgenic without
antibiotic selection. Fortunately, all these
efforts are underway. Development of
transgenic varieties would help farmers
to store the seeds. But, the seed
companies can make money only if they
sell hybrids. Technology developers need
to be compensated, while the farmers
derive benefit. The future challenges are
the development of tissue specific and
stage-specific promoters. In the case of
GM Crops in India
Beyond Bt Brinjal
the Bt toxin, it would avoid expression of
the toxin in all tissues of the plant.
Similarly, if the toxin is expressed only
during the stage of pest attack, its
concentration will get diluted during
grain maturation and disappear from the
final product. India has to give priority to
develop transgenics to improve the
nutritive quality of the grain and resist
abiotic stresses such as low rainfall and
salinity in soils.
Finally, none of these agenda
should delay the release of Bt brinjal.
After all, Bt corn and Bt cotton were
introduced with single Bt genes and
antibiotic markers and their safety in the
field is well established. Evolution
towards a better safety regime and
introduction of NBRA cannot be reasons
for delaying the release of Bt brinjal. I do
not believe that labeling of GM crops as
such should become an issue. It will only
confuse the masses in a developing
country like India. We are losing
precious time in reaping the benefits of
Bt gene and nearly 25 countries,
including some in Europe have gone in
for this technology. More than all the
valid scientific arguments, success in the
field would convince the public of the
importance of GM crops for food
security. The introduction and success of
Bt cotton has convinced many farmers
and a segment of the public that GM
technology can lead to increased
productivity, decreased pesticide spray
and increased revenue to the farmer. If Bt
brinjal succeeds, it would go a long way
in convincing many that GM technology
is safe and viable. I look for the day when
India would have pest-resistant rice with
improved nutritive quality ( balanced
protein and micro nutrients) that can go
grow even under conditions of low
rainfall. Agriculture is not just about
technology, since it embodies a culture
and there are political and sociological
over tones. It needs to be realized that
GM is only an innovative approach to
provide a technological solution, but it
should not be made a scape goat if there
is failure else where.n
BIOTECH NEWS 67
FEATURE
G M Technology
Responsible and Purposeful Use
R. P. Sharma
G
enetic modification of crop
plants has been and continues
to be the basic feature of con-
ventional plant breeding wherein the
genetic traits of breeding value, and in
turn the genes governing those traits, are
brought together through the process of
hybridization, recombination and finally
selection of the promising genotypes.
The major difference between the con-
ventional approach and the recombinant
DNA based genetic modification is that
in the first approach genes being reshuf-
fled are “known” genes and are brought
together from sexually compatible rela-
tives whereas the recombinant DNA
based approach permits mobilization of
gene/s from unrelated species, genera
and even phyla and therefore, are 'un-
known' as far as their expression and
interaction in the alien genetic back-
ground to which they are brought are
concerned. Thus, in situations where the
required genetic traits are available in the
sexually compatible and therefore usable
RP Sharma Ph.D. is former Project Director & INSA Senior Scientist, National Research Centre on Plant Biotechnology, Indian Agricultural
Research Institute, New Delhi. (E-mail: rpsnrcpb@yahoo.co.in)
68 BIOTECH NEWS
germplasm, which is more often the
case, the conventional plant breeding
will remain the first option. However, for
those traits which are not available in
close relatives, or got lost due to natural
or manmade selections, mobilization of
genes through the recombinant DNA
technology based tools is the most desir-
able option for the plant breeders. It
should therefore be understood that
genetic modification or GM as we
understand it today, does help in borrow-
ing one or few genes from unrelated spe-
cies and is in no way a replacement of
conventional plant breeding. GM
approach is at best and at times indis-
pensable adjunct to conventional plant
breeding.
GM: A Brief History
Tracing the brief history of GM crops,
starting 1996, when the first GM crops
was released for commercial cultivation
in USA, most of the traits engineered in
plants so far are those which are not
available in the germplasm of the GM
modified crops. A brief analysis of the
world wide adoption of GM crops reveal
that only three major traits viz. insect
resistance, herbicide resistance and viral
resistance alone, or in combinations,
have been mobilized in only five major
crops viz. soybean, cotton, maize,
canola and papaya, covering more than
ninety percent of the area under GM
crops. These results clearly indicate that
so far the application of GM technology
has been highly need based and
restricted to only those traits which were
not amenable through conventional
methods of crop improvement.
In the Indian context, so far
only Bt cotton, engineered for insect
resistance has been commercialized. Bt
cotton, a highly successful example,
represents indispensability of GM
technology for a trait proving to be
recalcitrant to breed through
conventional plant breeding, primarily
because of the non-availability of uu
VOLUME 5 | NO. 2

u sources of resistance in the world cotton
germplasm against Helicoverpa armigera.
This insect was basically being managed
by repeated sprays of environment
polluting and health hazardous
pesticides. In fact, cotton crop received
almost 30% of the total pesticide used in
India. Following the release of Bt
cotton, the pesticide consumption in
India declined from 47,020 metric tones
in 2001 to 37,959 metric tones in 2006-
2007.
Lessons learnt from commercial
cultivation of Bt Cotton in India
l Time and again, first during “Green
Revolution” and now for adoption
of Bt-technology, Indian farmers
have demonstrated that they are
highly receptive to economically
viable technologies. Within seven
years of the release the area under
Bt-cotton increased from four acres
in 2002, to about 9.5 mha in 2009.
l Bt gene(s) provide tolerance to insect
damage only. The yield per se
depends on the overall genetic
background of the cultivars in which
APRIL, 2010
Responsible And Purposeful Use
l Bt-gene has been engineered.
l The genetic background of the Bt
hybrids/varieties and not the “Bt-
transgenic event” is important for its
adaptability to diverse agro-
ecological situations.
l Science based technology, as in the
case of Bt-technology, requires
continuous awareness generation
among the farmers for its effective
implementation.
l Non-availability and high cost of
planting material can lead to
unethical trade practices.
l Reduction in pesticide usage led to
substantial savings in input cost and
reduced exposure of the farm
workers to environmental and health
hazardous pollutants.
Need Based Application of GM
Technology
Currently, Indian agriculture is passing
through a critical phase. Crop
production is static if not declining,
biotic and abiotic stresses are leading to
unpredictable crop losses and changing
G M Technology
environmental and soil dynamics are
challenging the sustainability of
agriculture. It is therefore of utmost
importance that countries like India
must develop, adopt and innovate new
and novel approaches for increasing
agricultural productivity in a sustainable
manner. It is in this context the GM
technology assumes much greater
significance and calls for its judicious
integration in the conventional
approaches being pursued for gene
management, nutrient management, pest
management, water management, soil
health management, and post harvest
management.
Obviously, the management of
each of the activities listed is going to be
crop specific and will demand thorough
planning in terms of trait to be improved
and the tool to be applied. For example
in a crop like rice, the varieties of
tomorrow must not only be high yielding
but fertilizer use efficient, tolerant to
existing and emerging biotic and abiotic
stresses and suited for upland conditions
of cultivations. For each of these traits
which are polygenic in nature uu
BIOTECH NEWS 69
 G M Technology
Responsible And Purposeful Use
u conventional plant breeding approaches
will no doubt help in assembling the
required gene combinations from the
existing germplasm, the recombinant
DNA tools applied judiciously will help
in mobilizing the monogenic traits not
available in the germplasm. The traits
which are attracting worldwide attention
for rice improvement are: bacterial,
fungal and viral diseases, insect
tolerance, herbicide tolerance, grain
quality parameters such as high protein,
high carotene (Vitamin-A), high
tocopherol (Vitamin-E), and high macro
& micro nutrients etc. As far as grain
yield is concerned, identification and
mobilization of major QTLs
(Quantitative Trait Loci) for hybrid vigor
and superior alleles of QTLs involved in
reducing the impact of negative
correlations among yield contributing
traits offer unique opportunity for
breaking the yield barriers. Water
scarcity and changing pattern of
monsoon are bound to alter the
agronomy of rice cultivation, forcing
development of varieties amenable to
drought and upland rice conditions.
Fortunately, the available rice germplasm
has enough genetic variability for uire
70 BIOTECH NEWS
breeding varieties for these traits.
However, upland rice conditions are very
favorable for the growth of weeds as
well. Managing weeds manually is not
only difficult but add to costs making
upland rice cultivation highly
uneconomical. It is being visualized that
in future upland rice cultivation with
“no till”, where rice seed is sown in the
unploughed fields, will emerge as a
highly desirable approach for sustaining
rice cultivation under changed agro-
ecological scenario. This would require
that the rice varieties meant for upland
and “no-till” conditions are genetically
modified for herbicide tolerance for
managing the weeds. On similar lines, as
outlined above for rice the desirable
specific traits in different crops can be
identified and introgressed into the high-
yielding varieties through GM
technology.
Responsible Deployment of GM
Technology
Given the biosafety concerns and the
costs associated with GM technology, it
is pertinent that a careful analysis
bordering indispensability, of the
application of genetic engineering for
the improvement of specific trait in a
crop of choice must be undertaken
before opting for this approach. As
stated earlier, the recombinant DNA
technology has virtually clubbed the
whole biological world into a “single
gene pool”, with the possibility of
isolating a gene of choice from a donor
and its integration in the genome of the
recipient plant. It is obvious that this
technology has given enormous power in
the hands of the scientists. In this whole
process, however, there are certain areas
where our existing knowledge is
inadequate and is a cause of concern.
This puts tremendous responsibility on
the users of this technology for its safe
application. The gap areas are:
l Since the genes and gene products
are known to interact intra-cellularly,
the behavior of a transgene in an
alien cellular environment of
transgenic plant can not be predicted
precisely in terms of allergenicity
and toxicity.
l The method of gene insertion in the
recipient DNA is random which
might lead to: (a) silencing of the
inserted gene itself or of the
surrounding genes at the site of uu
VOLUME 5 | NO. 2

l insertion; (b) genetic instabilities in
u through new molecules being discovered
other genes of interest and (c)
activating some of evolutionary
silenced genes etc.
Keeping these uncertainties in view,
biosafety related issues of the transgenes
have emerged as major concerns
warranting categorization of transgenic
plants as regulated items.
Major Biosafety Concerns from the
Commercial Release of Transgenes
The major biosafety concerns from the
commercial release of the transgenic
plants and their negative impact on (i)
environment; (ii) human and animal
health and (iii) social and ethical issues
have been the subject of intensive
discussion worldwide. Incidentally,
during these discussions the importance
of transgenics in agriculture has been
accepted unequivocally. The note of
dissent, however, has been on the
adequacy of, and lack of transparency in
the biosafety protocols followed. The
potential risks to the environment being
envisaged are the development of : (a)
“superweeds” by the herbicide resistant
genes; (b) new viral strains by trans-
capsulation of virus resistant genes and
(c ) “superpests” by insect resistant
genes. Likewise, the potential risks to
human health include: (a) allergenicity;
(b) toxicity and (c ) acquired antibiotic
resistance by the human pathogens. The
ethical and social issues are varied and
are region and country specific. In the
Indian context these could be (a)
selective adoption of the technology
leading to further economic disparities
(b) monopolization of trade by rigid
intellectual property rights and restrictive
trade practices and (c) negative impact
on biodiversity by extensive cultivation
of transgenics.
A critical analysis of most of
the biosafety concerns enumerated above
would reveal that, in the long term,
many of these will turn out to be
inconsequential. The occurrence of
“superweeds” and “superpests” though a
remote possibility are addressable
APRIL, 2010
Responsible And Purposeful Use
for controlling of the weeds and insects.
Likewise, acquired resistance to
antibiotics by the human pathogens can
be made inconsequential if the
antibiotics used as selectable markers
during cellular selection of
transformants are those which have
outlived their therapeutic value. In recent
years, transformation protocols with
removable antibiotic resistant markers
have also been developed.
As far as negative impact on
biodiversity is concerned, the decline in
agro-biodiversity by extensive
application of high yielding varieties
during “green revolution” period has
been very well documented. Large scale
cultivation of transgenic varieties will
further add to this decline because
farmers will always prefer the varieties
ensuring high economic returns to them
over the poor yielding land races. Unless
and until farmer's interests are
safeguarded, the collection and
conservation of the biodiversity by crop
based institutions and Genetic Resources
Bureau is the only option available. As
far as Bt technology is concerned, the
major biosafety concern is the
development of resistance to the Bt-
protein in the target insects. Resistance
development is directly proportional to
the selection pressure imposed on the
insect and can certainly be delayed by
maintaining the appropriate refugia and
non-contiguity of large scale cultivation
of similar transgenic crops in the field.
The allergenicity and toxicity to human
and animal health are certainly major
biosafety concerns and the international
protocols addressing to these issue are
quite adequate and have been adopted
and followed rigorously in India.
Indian Biosafety Guidelines, in addition
to human and animal health and
environment, address the socio-
economic aspects of a transgenic plant
and therefore, in a sense, are unique.
These guidelines take into consideration
the field performance of a transgenic
crop before it is released for commercial
G M Technology
cultivation. The transgene “Insertion
Event” based release of GM crops,
practiced in some countries, are
exempted in India only from biosafety
tests but for field release, prescribed field
evaluations are mandatory. It is not only
the gene “insertion event” but the
genotype as a whole contributes to the
economic yield of the variety which
need to be ascertained before
commercial cultivation by the farmers.
The Indian Biosafety
Guidelines, evolved during the last two
decades do address most of the biosafety
concerns listed above. However, it is
time that a “National GM-Biosafety
Register” is developed, prescribing in
detail the crop and transgene specific
biosafety concerns, the tests to be
undertaken and the protocols that need
to be followed with a proviso of need
based expansion and modifications.
In order to ensure responsible
use of the GM technology, the
Government of India has been
modifying and updating the existing
biosafety protocols to make them more
effective and efficient. It is in process of
setting up of a Biotechnology
Regulatory Authority of India (BRAI),
which will be autonomous and statutory
agency to regulate the research,
transport, import, manufacture and use
of organisms and products of modern
biotechnology. The Department of
Biotechnology, Ministry of Science &
Technology has been entrusted to act as
the nodal agency and a consultative
group of experts has prepared a draft
Bill to establish Biotechnology
Regulatory Authority of India. The Bill
was prepared through a consultative
process involving interdisciplinary and
inter-ministerial experts, state
governments and stakeholders. It is
expected that once in place, BRAI will
address to the biosafety issues more
effectively and will bring in the required
impartiality and transparency in our
handling of the genetically modified
crop for sustainable development of
Indian agriculture.n
BIOTECH NEWS 71
FEATURE
G M Crops
Human and Animal Safety
B.Sesikeran
E
nsuring safety of any product
meant for human or animal use is
paramount. This requires that
such a product has to go through certain
regulatory processes laid out by the
respective government departments.
Regulation usually ensures that (1) the
product which is being approved is useful
i.e. efficacious and (2) that even after use
for varying periods of time, it is unlikely
to cause any harm. Even if there is a
potential risk, it is very unlikely to cause
harm and that the immediate benefits far
outweigh such risk. The following are
some of the steps involved in this process
Risk Assessment: This involves two very
important steps - identifying the risk
(what is the harmful substance) and
quantifying the risk (how much is the
exposure to such a harmful substance).
Risk-Benefit Analysis: Now that the extent of
risk is made known to us, this step would
help us know whether the benefit is worth
taking the risk.
Risk Management: Although we decide to
B. Sesikeran MD is Director, National Institute of Nutrition, Hyderabad.(E-mail: dirnin_hyd@yahoo.co.in)
72 BIOTECH NEWS
accept the product after making sure that
the risk is very negligible and the benefits
are more, we need to equip ourselves with
strategies to manage the risk even if it
occurs.
Risk Communication: This process involves
communicating such information to the
users so that they know what they are in
for and feel reassured that the risk is far
less than the benefits they are likely to
derive.
All the above processes are
possible only if the harmful substances
are known or identified. Risk assessment
cannot be carried out if such harmful
substances are unknown or exist only in
our perception or imagination. Even in
cases where there is no known or
identified risk, how does one look for
possible harmful substances? The answer
is simple. One has to rely on the available
scientific literature. Several researchers all
over the world are constantly generating
genuine research information, which gets
published and many such papers on
similar issues often get reviewed/
analyzed further. These can form fairly
substantial evidence-based information
that can be used for risk assessment.
However, the most robust evidence of
safety is a history of safe human use. It is
for this reason that several traditional
foods and medicines are accepted because
people have been using for years and
there is no evidence of harm.
However, if a product is new or
not in use in the country, the regulators
would want adequate data to be
generated on its safety. This is possible
only through many test procedures which
are validated. Validation means that a set
of procedures have been carried out on
the potentially harmful substance and
confirmed that such procedures can
detect the substance even at significantly
low levels. Employing validated
procedures, if the test result turns out to
be negative, one can be sure that there is
no harm and if it happens to be positive
then one can say with certainty that risk uu
VOLUME 5 | NO. 2

u exists. Considering the fact that
laboratory animals are used primarily to
carry out such tests, appropriate animal
model (be it a rat or a rabbit or a goat etc
) needs to be chosen to predict the way a
human or other animals would behave if
the same treatment were to be given. Rat
is by far the best animal model because
more than 95% of its metabolic pathways
are similar to those of humans and many
other larger animals. Several decades of
data using rat as a model for drug or food
safety assessment has confirmed this.
Therefore, if no harm occurs in a rat fed
with the test material, one can safely
assume that other mammals and humans
would also behave in a similar way.
The key steps in biosafety testing
therefore are
l Identify the risk
l Have a validated test system
l Conduct the tests with
approved protocols
l Review the scientific evidence
l Assess the risk
Let us now apply these principles to
genetically modified or genetically
engineered crops or foods. We develop
such variety to quickly give an advantage
to the crop which we are unable to
manage efficiently due to many reasons.
For instance, in case of a crop that gets
eaten up by insects despite heavy use of
pesticides, a gene from even a non-food
APRIL, 2010
Human and Animal Safety
source that gives it a trait to protect itself
from pests can be identified and inserted
into the food crop and a demonstrable
benefit can be seen. The safety concern in
this case could be:
 Will the product of the inserted gene,
which is an insect killing protein, also
cause harm to humans?
 Since, it is a protein which would not have
been eaten by humans earlier, is there any
likelihood of it causing allergy to those
who consume?
 When this new gene was inserted into the
crop, did it disturb any other gene and
produce unintended effects?
To address the first question two kinds
of safety tests can be done using rats.
A. Feed the animals the purified protein
(insect toxin) in quantities many times
more than what a human or animal is
likely to consume. This is to be given as a
single dose by gastric feeding and animals
should be observed for 14 days. If the
animals are fine, eating well and growing
normally after the test period, it can be
assumed that even unrealistically larger
consumption is safe. This is called as
acute toxicity test. Through this test, it
can be confirmed that the toxin has effect
only on the insects and not on animals or
humans that are consuming it. But,
before giving this pure protein to the
animals it needs to be confirmed that the
tested protein/ toxin has insect killing
G M Crops
toxic properties using the target insects.
B. The next test is to feed the food
containing the toxic protein to rats every
day for a period of 90 days in order to
assess long term effects of feeding the
insect toxin. The rats are then studied in-
depth for their growth, sickness, activity,
blood parameters and all biochemical
indicators before they are finally
sacrificed at the end of the period. Their
internal organs are examined thoroughly
and under the microscope for any
abnormal changes. These are also done in
comparison with animals fed with normal
food crop. If the difference is consistently
observed then it is significant, otherwise,
one can be fairly certain that it is safe.
The question is why only 90 days. The
short life span of 90 days in rats is almost
similar to feeding humans from 6 months
to about 25 years of age. Added to these,
the analysis of years of data and several
studies indicated that no additional
information can be obtained even if they
are fed beyond this period. Such longer
duration animal studies spanning 180
days or more are essential to assess the
reproductive toxicity and the possibility
of occurrence of cancer.
Bt proteins or for that matter
any protein cannot get into the cells as
such when consumed because they are uu
BIOTECH NEWS 73
 G M Crops
Human and Animal Safety
u digested and converted into amino acids,
which we anyway eat through a variety
of foods. Proteins therefore are not
mutagenic and do not cause DNA
damage and risk of cancers/tumors does
not arise. The 90 day studies as
mentioned include detailed microscopic
examination where in the reproductive
organs are examined and if there are any
abnormalities in these organs then
reproductive toxicity studies should be
done. It is to be borne in mind that every
test performed has to be validated and
merely performing studies without
scientific basis will not give the answers
we are looking for. As mentioned earlier,
if humans are already consuming for a
good length of time, then that is the best
evidence of safety rather than any long
term rat study.
C. Assessing the possibility of
allergenicity is again a complex process.
Scientific evidence has shown that allergy
causing substances have two major
characteristics - they are resistant to the
digestive juices as well as the acid in the
stomach and they do not get destroyed by
heat to a great extent and therefore persist
even in cooked food. Therefore, if the
new protein due to genetic modification
can be digested by simulated gastric
digestion and also breaks down on
heating, then it is a strong enough
evidence to say that it is unlikely to be an
allergen. Thousands of possible allergens
have been identified from various sources
and their amino acid composition,
sequence and tertiary structure are stored
in large databases. The new GM proteins
structure, sequence and amino acid
composition is established. Using bio-
informatics tools, they are compared or
matched with the databases of known
allergens. If there is no match we are
further reassured that the new protein is
not an allergy causing one. If there is a
match then a more detailed testing should
be done. The detailed testing would
involve doing an ELISA test using the
blood samples of patients with known
allergies like asthma and mixing them
with the test protein to see if they bind to
each other. The ultimate test, of course, is
74 BIOTECH NEWS
to inject the test substance or a placebo
under the skin of the patients with
allergy, under medical supervision, and
look for allergic reactions. These tests
would further reassure that the new
protein is not toxic to humans and other
animals and is also unlikely to cause
human allergy.
The final and by far the best
surrogate evidence of safety is the extent
of similarity between the non-genetically
modified food crop and the respective
GM version. This is called as
compositional analysis or establishing
substantial equivalence. Based on
scientific data, we know the various
components of the edible plant or plant
part like its water content, proteins,
carbohydrates, fats, minerals, vitamins,
phytonutrients, anti nutrients and known
allergens. When all components are
similar between the two, we are fairly
sure that the GMO after the insertion of
new gene has not changed anything in the
plant. Worldwide, this is the single most
robust test of safety. Even in traditional
plants there are normally variations
between the crops within the same field
or between the crops from different soils /
different climates and sometimes within
the same plant between different stages of
maturity. When comparisons are done,
these inherent variations are considered.
Newer techniques, which detect
the minor components in the metabolic
pathways, which lead to the macro
components like carbohydrates, vitamins
etc., are now available. However, until we
know what are all the variations as
mentioned above, such tests cannot be
used because any differences could be a
variation in the normal process and even
if no differences exist we still cannot
consider these as evidence. Such
techniques have to be standardized and
validated before they would be used for
regulation/regulatory testing.
Studies on livestock like chicken, cattle,
goats etc. need to be done in case any
part of the GM plant is likely to be used
as animal feed. These are not
toxicological studies but feeding studies
to see if they are nutritionally similar to
their non-GM counterparts.
Concerns also exist regarding the possible
transfer of antibiotic resistance selection
marker gene or the promoter gene to the
gut bacteria. Scientific studies indicate
that the chances of any such transfer are
remote. In fact, we consume lots of DNA
through foods but they do not get
incorporated into host or bacterial DNA.
Even if such an event takes place, those
cells undergo repair or perish.
The above information would
make it evident that GMOs are
thoroughly tested for safety using
meaningful and validated tests. Hence,
known risks can be quantified. However,
there are no protocols to look for harmful
effects, which are based on paranoid
perceptions rather than science-based
reasons or evidence.
All testing procedures have
been prescribed based on scientific
evidences and international best
practices. The following are the biosafety
guidelines which have been prescribed by
the Review Committee on Genetic
Manipulation (RCGM) / Genetic
Engineering Approval Committee
(GEAC):
l Recombinant DNA Safety Guidelines,
1990 & 1994
l Revised Guidelines for Research in
Transgenic Plants and Guidelines for
Toxicity and Allergenicity Evaluation,
1998
l Guidelines and SOPs for the conduct of
Confined Field Trials of Transgenic
Plant, 2008
l Guidelines for the Safety Assessment of
GM Foods, 2008
l Protocol for Safety Assessment of
Genetically Engineered Plants / crops,
2008.
It can be stated with confidence that no
other food technology has gone through
such vigorous safety testing procedures as
biotech derived crops. Let us recall the
statement of Pandit Jawaharlal Nehru :
“It is science and science alone that can
solve the problem of hunger and poverty,
of insanitation and illiteracy, of
superstition and deadening custom and
tradition, of vast resources running
waste, of a rich country inhabited by
starving people”.
So give science a chance.n
VOLUME 5 | NO. 2
FEATURE
Ecological Consequences of GMOs
Ensuring Environmental Safety
R. Uma Shaanker
D
ebates on the ecological
consequences of GMOs fall
into two extreme categories:
Those who feel that GMOs shall be
treated as `Guilty until proven innocent'
and those who wish to treat transgenics
as `Innocent until proven guilty' (Belt,
2003). While this polarization, even
among the professionals, is clearly due
to their philosophical affiliation to the
entities they are trying to protect
(ecosystems and biodiversity in the first
category), or promote (biotech products
in the second), unfortunately, in the
public and in the media these debates
have turned more emotional than
rational; more decibel based than data-
based; and more prophetic than realistic.
As a matter of fact, in a calm and
reasonably coordinated atmosphere,
neither of the two categories would be
able to completely defend their stand as
the facts available are minimal and
where available, they are with neither of
the two extreme views.
Uma Shaanker and K. N. Ganeshaiah Ph.D. are with the School of Ecology and Conservation, University of Agricultural Sciences, GKVK
Bangalore. (E-mail: umashaanker@gmail.com | knganeshaiah@gmail.com)
APRIL, 2010
K. N. Ganeshaiah
Thus the truth of the ecological
consequences of GMOs lies somewhere
in between! That it lies in between is also
the reason why the two opposite groups
have been indulging in an unending tug
of war over the issue.
Ecological Impact of GMOs
There are two major ways in which
GMOs are suspected to affect the
ecosystem and the biological diversity.
Gene Flow
The uncontrolled escape of transgenes
into non-target organisms especially into
the wild relatives is expected to affect the
local gene pool and also the ecological
balance. Transgenic genes may escape
from the source population in three
ways: a) through pollen transfer, b) as
seed escapes, and c) Horizontal gene
transfer through transformation and
transduction processes. The varied
probabilities and diverse consequences
of these mechanisms are important in
assessing the ecological impact of the
GMOs.
a) Pollen Transfer: Introgression
between the cultivated plants and their
wild relatives is a dominant evolutionary
process and hence, it is argued, may not
be an exception for a transgenic cultivar
as well (Stewart Jr et al., 2003). In fact
`most cultivated plants mate with one or
more wild relatives in some portion of
their geographic range.' (Snow, 2002).
Consequently, it is feared that the
advantageous genes from the transgenics
may be introgressed into the related wild
species especially when the area under
GMOs increases.
Obviously the probability and
depth of such gene transfer is a function
of the extent to which wild relatives of a
transgenic plant are distributed in the
area of cultivation. It is now known that
world over there are a number of
situations where the cultivated crops
exchange gene pools with their wild
relatives (Ellstrand,1999) and some of uu
BIOTECH NEWS 75
 Ecological Consequences of GMOs
Ensuring Environmental Safety
u the crops where this is most plausible are
sorghum, sunflower, canola, wheat,
sugar beat and alfalfa (Stewart Jr et al.,
2003). All these situations are potential
grounds for the transgenes to escape as
area under cultivation of transgenics
increases. The wild relatives thus
`transformed' may gain additional fitness
advantage owing to this gene rendering
itself the potentiality to be hazardous
weeds in the crop fields. While the logic
of this cannot be denied, we need to
look at the facts of such consequences.
Unfortunately, while only a
few examples of such pollen mediated
escape of the transgenic genes into wild
relatives have been reported, as for
example of transfer of the herbicide
resistant gene from Brassica napus to B
rapa, (Warwicket al., 2003, Steward Jr
etal., 2003) there are hardly any studies
on the fitness related spread of such
`transformed' wild relatives (Snow,
2002). In fact even in this case of
Brassica, Warwick et al (2008) showed
that the hybrid lineages declined
dramatically over time. For this reason, a
proper assessment of the impact of such
introgression has not been possible and
if anything overestimated.
Pollen flow is likely to carry
the transgenes to the land races as well
and if this happens the `transformed'
land races may in fact thrive well in the
nature and contribute to the crops wild
gene pool- an entity every breeder would
wish to have. In other words such
transfer of foreign genes may enhance
the intra-specific genetic diversity of the
crops (Pilson and Prendeville, 2004).
b). Seed Escapes: This is an
immediately possible consequence of
growing transgenic crops; the transgenic
seeds after the harvesting of the main
crop may be left behind, escape and
survive as admixtures and hence may
enter into the chain of gene flow into
wild relatives (Dlugosch and Whitton,
2008). There are a few examples of such
escape of seeds and not surprisingly they
survive well in the wild.
76 BIOTECH NEWS
c). Horizontal Gene Transfer:
Horizontal gene transfer is suggested to
occur from the transgenic sources to
other related plant species through viral
transduction or, to other microorganisms
through transformation (Pilson and
Prendeville, 2004). The viruses that
infect the transgenics may encapsulate
the specific gene and re-infect other plant
and release the gene in question or DNA
of the transgenic plants entering the soil
system may be taken up by the micro-
organisms transforming them. However
horizontal gene transfer is among the
least likely event because this requires
high concentrations of viable DNA of
the transgene to be accumulated in soils.
While there are reports of such DNA
getting released into soil, it is very
unlikely that such DNA fragments
would be in viable and sufficient
quantities for the effective
transformation. To cite Dunfield and
Germida (20040), “studies have shown
the possibility that transgenes can be
transferred to native soil microorganisms
… although there is not evidence of this
occurring in the soil”.
Toxin Flow
Addition of chemical products from
transgenes into the soil and environment
is argued to affect the biological systems.
Perhaps by far the most well
documented and highly celebrated case
is that of reduced fitness of the monarch
butterflies feeding on the pollen from the
Bt transgenics (Losey et al 1999).
Similarly there are a number of studies
reporting that flow of toxins into the soil
has affected the soil micro-flora towards
the predominance of specific species or
types in some cases and towards altered
microbial diversity in other cases
(Dunfield and Germida 2004). However
it is also important to realize that similar
effects are seen even with any two non-
transgenic crops suggesting that the
minor changes in the soil flora is an
ongoing process of farming per se and
need not be linked exclusively to the
transgenes.
Problems of negative reports
The debate on GMOs suffers from a
peculiar habit of biased reporting that is
characteristic to science. It is important
to realize that scientists in general
exhibit a peculiar bias in their habit of
reporting results. For instance while
some of the instances cited above do
reflect the negative impacts of GMOs on
the ecosystem, positive results, in this
case demonstrating that GMOs have an
impact, are almost always reported and
appreciated than those where the impact
is not detected. The authors, referees and
even the editors do not find the negative
results of such work as interesting and
worthy of publishing as those of the
positive results and hence a lot of work
goes unreported making it difficult to
weigh the relative disadvantages of
GMO over their advantages. Debates
over GMOs always suffer from this bias
in science.
Back to the future
And this brings us back to the question
that we began with: Should we treat
GMOs as `Guilty until proven innocent'
or as `Innocent until proven guilty'.
The answer to this lies in the future:
How would the future generation judge
our decisions today in accepting or
rejecting the GMOs?
Answer to this surprisingly may lie in the
present and the past!! What does the
present generation think of our decisions
to go with Green Revolution during the
second half of the 20th century?
We do not think that the younger
generation of today considers the
adoption of steps towards green
revolution during 1960s and 70s as a
curse on their generation. Rather the
young generation today has sufficiently
acknowledged that if our country had
not adopted steps towards green
revolution, their `present' would not
have been as bright as it is. Though they
were not there to face the famines then,
they are aware of our begging bowl
situation. They are aware that they can uu
VOLUME 5 | NO. 2

ENVIRONMENTAL SAFETY ASSESSMENT OF
GENETICALLY MODIFIED CROPS
Environmental risk assessment is an integral component of
biosafety evaluation of GM crops. The purpose of such
assessments is to identify and evaluate the possible adverse
effects of genetically modified organisms on the conservation and
sustainable use of biological diversity. Known risk
assessment techniques in different countries and guidelines
developed by relevant international organizations recognize
comparative risk assessment indicate that risks associated with
genetically modified organisms or products thereof, obtained
through the use of modern biotechnology, should be considered
in the context of the risks posed by the non-modified recipients or
parental organisms in the likely receiving environment.
The following steps are important in such risk assessment
methodologies:
An identification of any novel genotypic or phenotypic traits
that could have an adverse effect on biological diversity in the
receiving environment, including diverse impacts on human
health
An estimation of the likelihood of adverse effects being realized
An evaluation of the consequences of any adverse effects,
should they be realized
An estimation of overall risk (based on the above)
A recommendation on the acceptability or not of identified
risks, including risk mitigation strategies
And in cases where there remains uncertainty about the level of
risk, additional research or risk mitigation measures or
monitoring of the LMO in the receiving environment may be
required.
Ecological impact of the
introduced Trait(s)/gene(s)
Similarity to
proteins or
traits in
conventional
varieties
Potential non-
target toxicity
Potential for
resistance
Outcrossing
impacts
Each new event is carefully evaluated to ensure
that there are no unintended side effects
(Reference: Annexure III and Article 15 & 16 of Cartagena Protocol on Biosafety)
Compiled by: S. R. Rao, DBT
APRIL, 2010
Ecological Consequences of GMOs
Ensuring Environmental Safety
u raise their heads high in the world because they have
food and resources to live with. Unfortunately, it may
be difficult to extrapolate on the basis of this history
to what could happen to our decisions on GMOs-
not because GMOs would turn out to be bad but
because India is perhaps not in such dire states as it
was when green revolution occurred. But we need to
take conscious and valued decisions such that we do
not again enter a state of begging bowl.
A message to the funding agencies
We realize that there are very minimal datasets to
systematically evaluate the impact of GMOs on the
ecosystem and crop genetic diversity. What exists is
only indicative and at best inconclusive and there is a
message here for the funding agencies such as
Department of Biotechnology, Ministry of
Environment and Forest, Department of Science and
Technology and Indian Council of Agricultural
Research. There is no point in blaming those who
use their decibels than data sets to push their views in
the public. We need to generate reliable information
such that the policy maker take an informed decision
than temporally postponing the judgments on
GMOs. Thus we need to facilitate certain areas of
research that demand immediate attention such that
the professionals can find themselves on a solid
ground in drawing their conclusions and the public
are fed with more substantiated policy statements.
References:
Belt, Henk van den, 2003, Debating the precautionary principle:
Ecological impact of “Guilty until proven innocent” or `Innocent until proven guilty'.
Plant Physiology, 132: 1122-1126
the modified plant Dlugosch K M and J Whitton, 2008, Can we stop transgenes from
taking a walk on the wild side?, Journal Compilation 2008,
Similarity to Blackwell Publishing Ltd.
conventional Dunfield K E, and J J Germida, 2004, Impact of genetically
varieties modified crops on soil and plant mediated microbial communities. J
Environ. Qual., 33: 806-815.
Potential Ellstrand, N C, H C Prentice, and J F Hancock, 1999, Geneflow and
weediness introgression from domesticated plants into their wild relatives. Ann
Rev. Ecol. Syst., 30:539-563.
Expression Losey, J.E., Rayor, L.S., and Carter, M.E. 1999, Transgenic pollen
profile harms monarch larvae. Nature 399:214
Pilson, D and H R Prendeville, 2004, Ecological effects of transgenic
crops and the escape of transgenes into wild populations. Ann Rev
Potential Ecol Syst., 35: 149-174.
ecological Snow, A A, 2002, Transgenic Crops- Why gene flow matters. Nature
impacts Biotechnology, 20: 542
Stewart, Jr C N, M D Halfhill, amd S I Warwick, Transgene
introgression from genetically modified crops to their wild relatives,
Nature Reviews/Genetics, 4: 806-817.
Warwick S I, M J Simard, and A Legere, 2003, Hybridization
between transgenic Brassica napus L. and its wild relatives: B. rapa
L., Raphanus sativus raphansitrum L., Sinapis arvesis L., and
Erucastrum gallicum(Wild.), O.E. Schultz, Theoretica and Applied
Genetics, 107: 528-539.
Warwick S I, A Legere and M J Simard, , 2008, Do escaped
transgenes persist in nature? The case of a herbicide resistance
transgene in a weed population of Brassica rapa. Molecular Ecology,
srrao.dbt@nic.in 17: 1387-1395.n
BIOTECH NEWS 77
FEATURE
India’s Agri-horticultural Diversity
Conserving Our Biological Heritage
S.K. Sharma
T
he conservation and sustainable
management of natural
resources is a primary global
concern today. Increasing population
and rapid technological advances are
putting tremendous pressure on these
resources. Plant genetic resources (PGR)
which encompass the agri-horticultural
diversity are one of the essential
components that hold the key to the very
foundation of agriculture as well as food
and nutritional security for the world.
During the last four decades of this
century, rapid progress in the field of
agriculture was witnessed along with the
collection, conservation and sustainable
utilization of PGR. Conservation of
PGR has now become one of the most
widely discussed issues in the field of
agriculture and environment. Because of
high degree of human interventions in
management of genetic resources,
conservation in production system is
S.K. Sharma Ph.D. is Director, National Bureau of Plant Genetic Resources (NBPGR), New Delhi (E-mail: director@nbpgr.ernet.in)
Pratibha Brahmi Ph.D. is Principal Scientist, NBPGR, New Delhi (E-mail:pratibha@nbpgr.ernet.in)
Mukesh Kumar Rana Ph.D. is Senior Scientist, NBPGR, New Delhi (E-mail: mkrana@nbpgr.ernet.in)
78 BIOTECH NEWS
Pratibha Brahmi
linked to sustainable use. The concern
today is incorporating greater
biodiversity within agricultural
production systems.
There are 34 hot spots of
biodiversity recognized globally and
three of these extend into India. These
are the Himalayas, Western Ghats, Sri
Lanka and the Indo- Burma (covering
the Eastern Himalayas) region.
India is blessed with rich agricultural
biodiversity including diversity in crop
plants, wild crops relatives, livestock,
aquatic resources, insects and microbes.
The Indian gene Centre is prominent
among 12 mega gene Centres of the
world. In addition, India has 26
recognized endemic Centres that are
home to nearly one third of all the
flowering plants identified and described
to date. Indian region too is a major
center of domestication and diversity of
crop plants. About 33 percent of the
Mukesh Kumar Rana
cultivated plant species have their origin
in this region. It is an important Centre
of origin and diversity of more than 20
major agri- horticultural crops including
rice, beans, cotton, sugarcane, citrus,
mango, banana, yams and several
common vegetables and popular species
(see box on pg.79).
India is also a homeland of
167 cultivated species and 329 wild
relatives of crop plants and about 583
crops are cultivated in India (see box on
pg.79). It has about 30,000-50,000
landraces of rice, pigonpea, mango,
turmeric, ginger, sugarcane, gooseberries
etc. and ranks seventh in terms of
contribution to world agriculture.
Further, around 1,000 wild edible plant
species are exploited by native tribes.
These include 145 species of roots and
tubers, 521 of leafy vegetable/greens,
101 of buds and flowers, 647 of fruits
and 118 of seeds and nuts. In addition, uu
VOLUME 5 | NO. 2
 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)

Mango (Mangifera indicia), banana (Musa spp.) jamun (Syzygium cumini), jackfruit (Artocarpus heterophyllus), Citrus group, lime and others,
Fruits karonda (Carissa congesta), khirni (Manilkara hexandra), phalsa (Grewia asiatica), bael (Aegle marmelos), wood apple (Feronia limonia),
kokam (Garcinia indica)
Eggplant (Solanum melongena), ridged gourd, smooth gourd (Luffa spp.) round gourd/tinda (Praecitrullus fistulosus), pointed gourd/parval
Vegetables (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.)

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-
biotanical use are reported from the
country of which around 7,500 are of
ethno-medicinal importance and 3,900
are multipurpose edible species.
Management of Agri-Hortcultural
Diversity in India
Genetic resources of actual or potential
value of various agri-horticultural crops
are being lost at an alarming rate due
Crops Cultivated in India
Crop Group
Cereals and pseudocereals
Millets
Legumes
Oilseeds
Cash crops (sugar and fibre)
Vegetable and tuber crops
Fruits and plantation crops
Forage crops
Spices and condiments
Medicinal plants
Aromatic plants
Dyes, narcotics and cottage industry plants
Total
to habitat destruction, changing use of Wide genetic diversity provides stability
land, degradation of soils, over- to farming systems and sustains
exploitation of water resources, faulty changing environmental conditions that
forestry practices, urban expansion, may occur in future.
changing social and cultural norms, and National Bureau of Plant
adoption of improved varieties/other Genetic Resources, New Delhi is the
technologies including cultivation of nodal institution at national level for
GM crops and adoption of intensive management of PGR in India, under the
agriculture by farmers. This erosion has umbrella of the Indian Council of
caused losses of several land races, Agricultural Research, New Delhi. The
primitive cultivars and Bureau, after its creation in 1976, has
farmer's varieties with developed a very strong Indian Plant
desirable and potentially Germplasm Management System which
useful genes, leading to operates in a collaborative and
No. of Species
threats to the basic food partnership mode with other
12 security. There are organizations. The system has
16 conflicts between contributed immensely towards
17 modern agriculture and safeguarding the indigenous crop genetic
21 traditional agriculture. resources and introducing useful PGR
16 However, these can be from other countries for enhancing
overcome with agricultural production and productivity
97
sustainable farming in the country. India being one of the
139
practices, supported by gene-rich countries of the world faces a
33 agricultural policies, unique challenge of protecting its
27 institutional natural heritage and evolving suitable
121 mechanisms and mutually beneficial strategies for
63 scientific management germplasm exchange with other
21 of genetic diversity. countries. uu
583

APRIL, 2010 BIOTECH NEWS 79

 India’s Agri-horticultural Biodiversity

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
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
essentially by need and utility of devised and followed, particularly in
agro-climatic zones of the country and
germplasm. The ex-situ collections and areas where GM crops are grown under
57 National Active Germplasm Sites
maintenance of such a facility is limited conditions that generally favor gene flow.
(NAGS) are integral components of the
by financial and human resources In suspected introgressions, presence of
network. The NAGS are based at
available and in addition these transgenes in regenerated germplasm
premier institutes for specific crops or
collections are subjected to genetic drift. and finding options for removing such
crop groups and are entrusted with the
The natural evolutionary forces often do transgenes from collections need to be
responsibility of multiplication,
not influence their maintenance worked out. At NBPGR, detection
evaluation, conservation of active
processes. Hence, more dynamic, protocols have been developed for a
collections and their distribution to
sustainable and complementary plant number of transgenes which would be
users, both at national and international
genetic resources management processes useful, if such situations warrant the
levels. Various other national institutes,
are being adopted so that the system is identity of accessions in near future.
all India coordinated crop research
projects, state agricultural universities sustainable and meets the requirements
of the crop improvement programs. Regulatory and Protection
and other stakeholders are also linked to Mechanisms for PGR
the network. International Agricultural The in-situ and on-farm conservation
strategies are being adopted on limited Many international developments during
Research Centres involved in
scale for both vegetatively propagated the last two decades have directly or
conservation and use of PGR are also
species such as citrus and seed indirectly affected the genetic resource
effectively linked to the network, Cryo-
propagated crops such as Himalayan management programs. Plant breeders
genebank and the in-vitro genebank. The
barley, buckwheat and traditional have traditionally relied on open and free
ex-situ seed genebank at NBPGR
landraces of rice (see fig on pg. 81). The access to PGR for developing new, high
comprises of 12 long-term modules
outcome of these models is expected to yielding crop varieties. With the
maintained at -180 oC for housing the
provide inputs for formulation of such in adoption of the Convention on
base collections. The active collections
situ and on-farm conservation projects Biological Diversity (CBD), which
are distributed in 22 medium-term
on a larger scale in the country. advocates national sovereignty over
modules maintained at 40 oC for storing biological resources, the authority for
germplasm at active sites. PGR Conservation in the Context of access to genetic resources rests with the
At present, the genebank holds GM Crops national governments and this access is
more than 3.8 lakh accessions including subject to prior informed consent of the
Introduction of GM crops is not going
crops where research in GM technology providing country on mutually agreed
to make much difference in the ex-situ
interventions is being pursued (see table terms. This led to enactment of
conservation strategies that are being
on pg. 82). The cryo-bank facility in the Biological Diversity Act (BDA) for India uu
followed presently. There are

80 BIOTECH NEWS VOLUME 5 | NO. 2


Rice Diversity Collected at NBPGR.
u which governs access to all genetic
resources of India and encompasses
provisions for equitable benefit sharing.
The International Treaty on Plant
Genetic Resources for Food and
Agricultural (ITPGRFA) is another
legally binding treaty which has
provisions for facilitated access to 64
crops and forage species, under the
Multilateral System (MS). This exchange
would be under the conditions of
Standard Material Transfer Agreement
(SMTA). Being a single window system
for exchange of small samples of plant
germplasm meant for research, NBPGR
has developed suitable Material Transfer
Agreement (MTA) for providing access
to PGR both within and outside the
country.
Also, under the GATT/
WTO/ TRIPs regimes, restrictions have
been imposed on free trade in
commodities, including agricultural
products. Countries are required to
adopt patenting or enact effective sui
generis system or a combination of both,
for the protection of Plant Breeders’
Rights. As a national obligation for the
TRIPS Agreement of WTO, the new
legislations, viz; the Protection of Plant
Varieties and Farmers Right Act
(PPVFRA), 2001 and Geographical
APRIL, 2010
Conserving Our Biological Heritage
Brinjal Diversity Collected at NBPGR.
Indications of Goods (Registration and
Protection) Act, 1999 were enacted and
suitable amendments made in other
existing IPR legislations, which have a
bearing on the product, processes and
technologies developed. The Indian
plant variety protection is unique in
providing equal rights to the farmers as
breeder and conserver of genetic
resources of local importance. To
facilitate this activity with identification
of distinctiveness of newly developed
varieties, ICAR has provided the
requisite support to PPVFR by
developing guidelines for distinctiveness,
uniformity and stability (DUS). To date,
DUS guidelines for 35 crops have been
developed and notified. Plant variety
protection under the PPV&FR act
currently covers seventeen crops; others
are to be notified soon. So far 1644
applications for registration in 19
notified crop species have been received
by PPVFRA. Of these, 164 have been
issued certificates for plant variety
registration.
For germplasm registration
there is a system of plant germplasm
registration operating at the NBPGR.
This system is completely different from
registration of plant varieties of the
PPV&FR Act. This registration of
germplasm is not a system of protection
India’s Agri-horticultural Biodiversity
per se but a safeguard of material
developed by a breeder through
publication and documentation in public
domain. This germplasm registration
can be used as evidence in documentary
or other forms to create and establish
'prior art'.
Germplasm which can be
registered at NBPGR could be any good
performance material for specific and /
multiple traits (may not be yield
superior), mutants or with a different
ploidy level than the normal, with
academic / scientific importance,
parental lines of inbreds, promising
experimental material or landraces and
traditional varieties. The procedure and
forms are available at NBPGR’s website
(www.nbpgr.ernet.in). NBPGR has so
far registered 729 promising germplasm
accessions of different agri-horticultural
crops. Efforts are being made to get
more and more germplasm registered
through this mechanism so as to
enhance its utilization.
Future Concerns
Each country is interdependent on other
nations for its germplasm requirements
since it is not possible to acquire and
conserve useful resources to satisfy its
research needs. It is therefore, imperative
to collaborate at local, regional and uu
BIOTECH NEWS 81
 India’s Agri-horticultural Biodiversity
Conserving Our Biological Heritage
Current Holdings of Agri-Horticultural crops in the National Genebank where
GM technologies are being pursued
Crop
Landraces
Rice
Sorghum
Chickpea
Groundnut
Corn
Cotton
Brinjal
Potato
Tomato
Cabbage
Cauliflower
u international levels for the acquisition
and conservation of the germplasm. It is
also obligatory to obey the quarantine
and biosafety rules for the safe
movement of germplasm especially
where GM technologies are involved.
There is a need to adopt complementary
strategies for conservation of genetic
resources involving both in situ and ex-
situ approaches. For in-situ conservation
due attention is required to be given to
genetically rich hotspots including
natural and protected habitats including
tribal belts to strengthen and expand the
network of germplasm conservation
through involvement of all the
stakeholders, including the communities.
It is to be ensured that a set of the
available PGR with associated database
must be deposited as base collection
with the genebank, and one set
maintained as active collection
accessible for plant improvement. There
is an urgency to assess the germplasm
collection in the genebank to understand
the gaps and also identify the duplicates.
Characterization and
evaluation are essential to promote the
utilization of materials. A large number
of germplasm is yet to be properly
characterized and evaluated. These tasks
82 BIOTECH NEWS
Number of Accessions
Wild and weedy types
52615 1171
15429 236
6473 72
5995 217
5477 6 2003
1094 17
2782 530
148 110
338 105
5 ----
---- 5 149
require substantial inputs and a
decentralized evaluation network. With
the development in information
technology, the necessary tools for
collation, retrieval and dissemination of
information, documentation and
effective germplasm management can be
done through sharing of information
following a network approach.
Further, application of targeted
and precise molecular tools is required in
the present day genomics driven crop
improvement programs. The genomics
application calls for higher precision in
characterization and evaluation of
genetic resource. Such intensive
evaluations could be practiced only if
the number of accessions to be evaluated
is within the manageable limits. Hence,
there is now greater emphasis on the
identification of 'core sets' and 'mini
cores'. These core sets could then be
subjected to rigorous characterizations
and used for identification of useful
genes with the help of various 'allele
mining' procedures.
The current emphasis in crop
improvement programs is to develop
cultivars having genes for resistance /
tolerance to abiotic stress (such as
drought / cold) and biotic stress (such as
Others Total
34895 88681
4317 19982
7447 13992
6044 12256
7486
5178 6289
1038 4350
2345 2603
1427 1870
185 190
154
diseases, insect-pests), quality of the
produce, better input-use efficiency and
stability of performance. There is also a
growing realization for a wider choice
and variety of horticultural and
agricultural products, for which diversity
in taste, color, nutritional values and
maturity character is highly valued by
the market. There is a need to modify
the descriptors for evaluation
accordingly, and make the search for the
desired characteristics in the database as
quick and efficient as possible.
Registration of genetics stocks
and elite germplasm needs to be
encouraged to promote germplasm
exchange and effective utilization.
Germplasm developed by public sector
breeders have been freely available to
private sector breeders as well. In the
changing global scenario under the new
IPR regimes, modalities for benefit
sharing by both private and public
sectors will also have to be worked out.
This is urgent to ensure continuity of
germplasm exchange and synergy
between the two sectors and models
need to be developed for sharing of
benefits with farmers and communities
who are the custodians of our agri-
horticultural diversity.n
VOLUME 5 | NO. 2
FEATURE
Regulating GM Crops
Global Best Practices
Shanthu Shantharam
I
n spite of the fact that GM crops are
grown in more than 24 countries of
the world since 1996 to more than a
billion acres, and innumerable scientific
reports and analyses of their safety have
been attested by world's leading scientific
organizations and regulatory authorities,
controversy regarding their regulatory
oversight is fraught with endless
controversies surrounding their safety
and utility. Efforts to internationally
harmonize biosafety and environmental
risk assessment standards have been
ongoing since the 1990s with mixed
successes. As it always happens,
pioneering regulatory agencies set the
early “standards”, and others end up as
followers. In case of Genetically
Modified Organisms (GMOs), USA was
and is the leader followed by Canada.
EU is the hotbed of all controversies.
Almost all controversies are fanned by
the EU policies that are heavily
influenced (politicized) by the greens.
The rest of the world has lagged behind,
Shanthu Shantharam,Ph.D is Executive Director, ABLE-SIGAB, New Delhi. (E-mail: shanthu.shantharam@ableindia.org)
84 BIOTECH NEWS
and many are not even at the starting
line. Australia, Argentina, Brazil, China,
India, and South Africa are some of the
other countries that have a working
biotech regulatory system. Many
differences still persist between US
regulatory agencies and the EU, a sort of
permanent trans-Atlantic divide. It is
important to note that there is really not
much of a difference of opinion on the
safety of GM crops between US and
European scientific and regulatory
organizations. The biggest difference
between the US and the EU is with
regard to “Precautionary Principle”, a
contentious philosophical point.
Developing countries of the world are
caught in a dilemma as to which
regulatory system they have to follow. A
plethora of biosafety and regulatory
capacity building programs from EU and
USA have only added to the confusion.
Those who follow the US regulatory
system have made tremendous progress
in adding GM crops into their
agricultural systems, and those following
the EU system are caught in endless
debates. International agencies like the
World Bank, Asian Development Bank,
OECD, UN-FAO, UN-WHO, UNDP,
UNESCO, and UNEP have spent
millions of dollars for regulatory
capacity building with little progress.
Politicization of GM crops due
the anti-GM activism is the root cause of
all the irreconcilable differences between
regulators and the activists, and is also a
major detriment to international
harmonization of biosafety standards for
GM crops. This situation is best
exemplified by the Bt brinjal imbroglio in
India. Biosafety standards must be
grounded in “common sense” and
“scientific consensus”. It is only when
non-scientific issues related to trade,
intellectual property rights, socio-
economic impacts, cultural and ethical
issues are enjoined, endless debate
ensues. It is really unfortunate the even
matters of empirical science have been uu
VOLUME 5 | NO. 2

u politicized by some scientists just to
derail the technology. However, scientific
consensus are relatively easy to arrive by
a group of national or international
scientific experts, and that is the only
way to assure proper regulatory oversight
on any technology so that benefits can
reach the public at the earliest. There are
some excellent documents developed by
leading regulatory agencies like USDA,
US-EPA and US-FDA, EC Biotech Risk
Assessment Grants Program, OECD,
UNESCO, UNDP, UN-FAO, UN-WHO,
National Science academies of USA,
Brazil, India, Argentina, and the Royal
Societies of UK, Canada, Australia and
New Zealand. These reports and
documents developed by scientific
experts and serve as beacons for
developing a sound regulatory systems
based on the best possible scientific
knowledge. It should be relatively easy to
develop best regulatory practices for any
country based on these documents and
reports to move the technology forward.
Goals and Objectives of Regulations:
The only goal of any set of regulations is
to protect the safety of the public and the
APRIL, 2010
Regulating GM Crops
Global Best Practices
environment. All other objectives are Regulatory trigger for GM crops: The
secondary must be entrained to this goal. “Process” vs. “Product” Paradigm.
To achieve this goal, nations must use the
This has to do with as to why a GM crop
best possible scientific consensus,
must be regulated and what constitutes a
practical guidelines and standard
GM crop. This is what is called the
operating procedures.
regulatory trigger. As a priori, it is
Basic Principles of Biotech assumed that GM crops are regulated
Regulations because they are genetically engineered.
On the other hand, nobody seems to
Regulations are always a societal
have thought about why other kinds of
construct. In any democratic society, the
GM crops developed using conventional
public demands guarantees for safety of
technologies are not regulated. It seems
any product or technology that would
that in most parts of the world, modern
directly affect their health and the
day GM crops are regulated because they
environment. Therefore, regulations are
are “genetically engineered” using the
developed to assure public and
modern gene-splicing technology. It
environmental safety. As a priority, for a
seems the technology by which a modern
rigorous and comprehensive scientific
day GM is developed is found guilty by
biosafety review and an environmental
default. The end product, namely the
impact assessment are a must. It is
GM crop is not even considered. The
imperative that regulators be
illogic of this trigger is that one can
scrupulously impartial and objective, and
develop any kind of product using
do not present even a whiff of a conflict
conventional crop modification
of interest while regulating the
techniques, and it would escape
technology. They should certainly not
regulatory scrutiny because there are
appear to be either promoters or
none. One can develop any “dangerous”
opponents of a technology, or a
or “uncertain” GM crop using
particular product.
conventional techniques, and no one will uu
BIOTECH NEWS 85
 Regulating GM Crops
Global Best Practices
u question. This is a fundamental point
that has been long lost in the present GM
debate.
Biosafety Data Requirements: “Nice to
know” vs. “the Need to know”
The scientific data required to carry out a
rigorous biosafety review or risk
assessment has to be determined by
scientific and technical experts alone.
Most standard data requirements are
genetic stability data (Mendelian
inheritance analysis), molecular data,
and bio-chemical data. Plant
morphology and reproduction biology
are also included. Such data
requirements can change from time to
time as science and technology are
always progressing. It is not necessary
that each and every scientific paper
published on a day to day basis be
incorporated into the review standards.
There should be a scientific committee of
experts who will review the progress in
science and technology on a biannual or
annual basis to determine the scientific
consensus needed to establish the
regulatory standards of the day. For
example, a set of 29 new tests for every
GM crop has been proposed in India
which might take two or three decades
based on all fanciful techniques that have
come to the fore recently (J. Biosci.
(34)2), June 2009, 1167-168). It is an
egregious example of going overboard
with data requirements that fall neither
into the “need to know” or “nice to
know” category, and in no way informs
the biosafety assessment. Leading
regulatory authorities in US, Canada,
EU, Australia or New Zealand, who have
more experience in commercializing GM
crops do not require this kind of data,
and bears no resemblance to what is
recommended by the CODEX
Alimentarius. Such data requirements
create an uneven field where only
companies with deep pockets will
dominate. It is far more utilitarian to
examine the experience of other
regulatory authorities to develop
standards for data requirements.
86 BIOTECH NEWS
Principles of Biosafety Review
Substantial Equivalence, Principle of
Familiarity and Generally Regarded as
Safe (GRAS) are practical working
principles simply based on common-
sense and past experiences. These
principles have eminently served some of
the leading regulatory authorities to
develop basic standards for scientific
regulatory oversight of GMOs, and there
is no reason why these same principles
cannot be used in other countries. These
are not legal standards, but they are
scientific standards for biosafety
including food safety.
If a GM crop or a GMO, after genetic
engineering, is left 99% the same or
identical as its non-engineered
counterpart, then such a GMO is
considered substantially equivalent. If a
GM crop or a GMO is considered
substantially equivalent, meaning no
different from an organism that has been
in safe use for decades or centuries, then
such a GMO can be considered
“familiar”, and as such that GMO can be
evaluated using the previous knowledge
and experience of that particular
organism. Following these two
principles, one can classify a given GMO
as GRAS based on safe history of use of
the organism and the specific gene in
question. Any specific genetic change
that has been introduced, is all that one
needs to evaluate for biosafety.
Risk Assessment
Risk assessment of GMOs or any other
technology product goods or services can
be a dicey or tricky proposition.
Therefore, extreme care and
consideration must be given to identify
the necessary criteria. Risk is nothing but
hazard X exposure, a classical formula of
risk assessment. Hazard in this formula
assumes that GMO is a priori hazardous,
which is unfortunate. By and in itself, the
term hazard is a cause for great deal of
contention. People have been tired of
arguing that GMO by default is not
hazardous, but anti-technology activists
and anti-GM campaigners have
chronically maintained that GMOs by
default are hazardous, and that the
genetic engineering technology is
inherently dangerous. Going beyond this
contention, risk assessment can be either
qualitative (descriptive) or quantitative
requiring empirical data. In biological
systems, quantitative risk assessment can
be arduous as the field based empirical
data are hard to gather. This is one of the
contentions that haunt the trans-Atlantic
divide based on the precautionary
principle. A practical thing to do is to
take a precautionary approach which is
basically dealt with by a regulatory
review. This accomplishes the idea of
stop, ask and decide. Using such a
precautionary approach, USA, Canada,
Australia, New Zealand, Brazil, China,
India, Philippines, South Africa, and
many other countries of the world have
commercialized GM crops without a
single instance of causing human or
environmental harm in the thirteen year
history of GM crops commercialization.
EA is a powerful decision making tool
for regulators.
What is really critical in an
Environmental Risk Assessment (ERA)
is the nature of the organism and the
environment into which it is being
introduced. Since the environment differs
from place to place and country to
country, an Environmental Assessment
(EA) is a must. EA can be a simple and
direct method of determining the risk of
introducing a GMO into a particular
environment. It must be remembered
that EA assesses not only the agricultural
environment, but the neighboring
environment as well. EA is mostly
qualitative.
Environmental Impact Study
(EIS) is the most time consuming of all
risk assessments that can take years. EIS
needs lots of empirical data which will
take years to develop. EIS is done when
an EA comes to a Finding of No
Significant Impact (FONSI). There are
instances of certain environmental
projects that have been delayed decades
because of EIS. If a regulatory authority uu
VOLUME 5 | NO. 2

u takes the EIS route without proper
scientific cause, approving a GM crop
will remain a pipedream. That is a sure
way of killing a technology. Moreover,
EIS is the costliest way of regulating
technology. At present the Supreme
Court of USA is hearing an EIS case on
herbicide resistant alfalfa whose EIS was
prepared by USDA, APHIS which took
over five years. If principles of
substantial equivalence, familiarity and
GRAS are used, there should be no need
for EIS. It must be remembered that
almost all GM crops are already
established lines in commercial
production, and therefore, they all
eminently fit into the above principles.
For commercialization purposes, the
most important data requirements are
the agronomic performance data under a
variety of agro-climatic conditions so
that its efficacy can be reasonably
assured in the farmer's hands. In fact,
these things are carried out routinely for
any new crop variety introduced to the
market. It is in the interest of purveyors
of GM crops to make sure that their
product is a superior product and does its
intended job in the field.
One can do an intelligent and
scientifically reasonable ex-ante EA
which would be sufficient for the
purposes of contained and confined field
tests and deregulation. An ERA may be
carried out post-commercialization. If
post-commercialization monitoring is
needed, post-ante analysis can be carried
out from the empirical data gathered over
several years.
Food Safety
Food safety tests like allergenicity,
toxicity, teratogenecity, and
carcinogenicity should always be carried
out according to the standards
established by the CODEX, a joint
standard setting body that draws
scientific and technical expertise from
time to time. Long term chronic studies
must be indicated by standardized
preliminary tests. There has to be a
strong scientific indication for any other
APRIL, 2010
test for a given GM food. All these tests
must be decided by experts alone.
Risk/Benefit Analysis
In the GM debate, one mostly hears
about the risks, and not enough about the
benefits. It is imperative that regulatory
authorities convince the public about
both risks and benefits in an impartial
way. Risk/benefit analysis is perhaps one
of the most important regulatory needs
to convince the public that in spite of
certain risks, the technology product is
more beneficial, and that risks can be
mitigated by oversight mechanisms.
Risks of opportunity costs must be
included in such an assessment. This
way, one can assess the loss for not
introducing the technology product.
Deregulation and Commercialization
Deregulation means declaring that a
regulated GM crop is determined to be
no longer regulated, and allow it for
commercialization. However,
commercialization is done by the
purveyors of the technology product, and
not by the regulatory authority. But, the
authorities can or may impose conditions
for commercialization. Deregulation is
done after satisfying all conditions of
safety and environmental risks and the
needed risk management mechanisms
are in place to mitigate such risks.
Transparency and Accountability
The entire process of regulatory
oversight must be conducted in a
transparent way without compromising
legally permitted protection for
confidential business information(CBI).
This is the only way to inspire public
confidence in the regulatory system. It is
best to use the worldwide web to the
maximum, but in a timely manner.
Authorities must post a copy of the
application immediately declaring that
the application is complete and accepted
for regulatory review. A draft of the
biosafety review and EA/ERA must also
be posted on the web for public comment
giving a definite period of time.
In the event of a need for
Regulating GM Crops
Global Best Practices
public meeting to discuss the review, such
meetings must be organized in different
locations to seek public input both
verbally and in writing in an organized
fashion. Mob frenzy of the type
witnessed in the recent Bt brinjal
“consultations” must be avoided. All
information must also be posted on the
web site by indicating how points raised
by the public have been addressed. It is
important to note that it must be made
extremely clear that not all points can
and will be incorporated into the review,
and reasons for not incorporating must
be spelled out.
Decision Making and Communication
All decision making authority must be
solely vested with the regulators who
have statutory responsibility for decision
making. No member of the public must
be allowed to participate in the decision
making process. This is different from
seeking public input in consideration for
decision making. Using a decision
making tree will be extremely useful in
this exercise. A statutory authority is like
a court of law where litigants can only
argue their case, but the judgment is
rendered by the judge. If the decision is
in the negative, reasons for declining the
application must also be explained. It is
important to bear in mind that a
statutory body's decision is subject to
judicial review when challenged.
The decision must indicate the
date on which it will come into effect and
how long it will be effective, just in case.
It should contain conditions that may be
imposed on a case by case basis. The
decision must be signed by a competent
person in the authority and
communicated in writing to the
applicant, and posted on the web site. In
certain extraneous situations, it may be
necessary to announce the decision
through mass media.
Public Participation
Clear distinction must be made about
public input from that of public getting a
seat at the decision making table. It is
imperative to seek public comments and uu
BIOTECH NEWS 87
Regulating GM Crops
Global Best Practices
(Contd. from page 87)
other inputs at the time of review and
decision making, and address them all.
All irrelevant comments and inputs
should be pointed out as such. This is
best accomplished by through internet
based input. However, other forms of
input must be allowed in writing. It is not
necessary that all inputs must be
incorporated, and reasons for not
incorporating must be spelled out.
Statutory Time Limit
Because time is money, all applications,
either for contained or confined or large
scale/commercial release must be
reviewed within a statutory time period
so that there is standardized period in
which the application will be disposed
of. This time limit must be fixed
depending upon a reasonable time
required to complete the regulatory
review. However, the authority can
reserve the right to “stop the clock” to
resolve a legal or scientific or technical
issue relative to the application. This will
establish a level playing field for all
applicants, and pave the way for planned
commercialization.
Confidential Business Information
(CBI)
In this competitive world, it is critically
important for the developers of
technology to protect their CBI from
leaking out into the public domain
through the regulatory process. In
accordance with the Right to
Information Act (RTI) provisions, sound
principles and guidelines must be
developed to protect the CBI. If not, the
authority is likely to be challenged in the
courts.
Cost of Regulations
Whatever be the regulations, there is
always a cost associated with it, both for
the regulatory authorities and the
applicant. Unnecessary regulatory
burden will increase costs of regulation
and regulatory compliance which will in
turn make the technology costlier, and
even threaten to stop technology
development. That is why it is important
to carry out proper risk assessment and
regulate it scientifically as the identified
risks dictate. The most important goal of
regulations must always be safe
deployment of GM crops based on
scientific risk assessment alone.
Therefore, scientifically based regulations
must be the standard bearer of any
regulatory system. Cost of regulations
can seriously hamper technology
development all over the world.
Socio-Economic Impact Study
Socio-economic impact study is dictated
by the Cartagena Protocol on Biosafety
and governs only the trans-boundary
movement of GMOs. In other words, it
is important for any developer of the
technology or user of the technology to
determine risks, benefits of the
technology and its good services, and
how it might be accepted by the public in
their societal context. Such an
assessment has a place in larger scheme
of things, and must be encouraged, not
as a part of a biosafety regulatory review
process. This will have to be done from
time to time as societal circumstances
also change from time to time.
Conclusions
Regulations and regulatory standards are
not etched in stone as science and
technology keeps progressing all the
time. Regulations must keep pace with
the technology development. Regulations
have always come after the development
of technology, and have had a
tremendous impact on technology
development. Improper or undue
regulatory burden can hamper
technology development and this must
not be allowed to happen in case of
modern biotechnology in Indian
agriculture. Risk appropriate regulations
must be the corner stone of any sound
regulatory system, and therefore rigorous
scientific standards alone must underpin
the system.
A reliable, credible and
confidence inspiring regulatory system is
the order of the day. Regulations must
not be allowed to be used to stifle
creativity and technological
development. Politicization and
ideological motivations must not be
allowed to dictate either the regulatory
framework or the regulatory policy.
When a science based dynamic
regulatory system is in place, there is no
reason why GM crops cannot be
deployed safely for the benefit of all.n
FEATURE
India’s Biosafety System
At Par With The World ?
Morven A. McLean
C
urrently, 25 countries have
approved genetically engineered
(GE) plants for cultivation or
consumption (see table on pg 89).
Common to all of these countries was
the establishment of a system to regulate
these products and particularly to ensure
their evaluation for human health and
environmental safety prior to their
commercial release. While there is no
single best model for regulating GE
plants, the hallmarks of a functional
biosafety regulatory system can be
captured by the terms adaptability,
transparency, workability and clarity.
This article examines each of these
characteristics in the context of India's
and other countries' national biosafety
regulatory systems.
Adaptability
Biosafety regulatory systems in all
countries are dynamic. There is no
example where the regulatory system
remains exactly as it was when first
M.A. McLean,Ph.D is Director, Center for Environmental Risk Assessment, International Life Sciences Institute Research Foundation, Washington
D.C. (E-mail: mmclean@ilsi.org)
88 BIOTECH NEWS
introduced, and India is no exception to
this practice. India's biosafety regulatory
system has experienced a number of
changes since the Rules for the
Manufacture, Use, Import, Export and
Storage of Hazardous
Microorganisms/Genetically
Engineered Organisms or Cells 1989
(Rules, 1989) were first notified under
the Environment (Protection) Act, 1986,
including the elaboration of a series of
guidance documents published by the
Department of Biotechnology (DBT) in
1990, 1998, 1999 and 2008. This kind of
flexibility is essential as a regulatory
system must be able to adapt to the rapid
innovation in biotechnology research,
development and product deployment if
public confidence in the system is to be
maintained. Additionally, multilateral
negotiations related to environmental
and human health safety (e.g., Cartagena
Protocol on Biosafety, International
Plant Protection Convention, Codex
Alimentarius) and trade (e.g.,
Agreement on the Application of
Sanitary and Phytosanitary Measures,
Agreement on Technical Barriers to
Trade, Agreement on Trade-Related
Aspects of Intellectual Property Rights)
also affect regulatory approaches and
decision-making. In order to be
responsive, governments need to review
and, when necessary, amend regulatory
operations. Australia, for example, has
formalized this in the Gene Technology
Act, 2000, which required a statutory
review of the operations of the Act after
four years.
Transparency
The process by which regulatory
changes are made is just as important as
the changes themselves. Transparency,
consultation and attention to meaningful
public participation and engagement are
very important in this regard. Again,
Australia provides one of the best
examples in terms of the measured
process that was followed with the ult is uu
VOLUME 5 | NO. 2
 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 approved in 2008. The end result is a
Canada v v
China
guidance document that is consistent Workability
v v
Colombia with internationally-accepted practices Different operational approaches can
v v
Czech Republic v for GE food safety assessment and was and have been used to secure the
El Salvador v developed through a transparent, necessary scientific advice for
European Union v v consultative and participatory process. 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
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
Source: CERA GM Crop Database (www.cera-gmc.org) stipulate the requirements for have a combination of both.
conducting these trials are readily Each approach has strengths and
u establishment of the Office of the Gene
Technology Regulator and the available from DBT, Ministry of weaknesses. While independent advisory
development of the Gene Technology Environment & Forests (MoEF) and on committees may have in place more
Act, 2000. Lately, India has adopted a the web. In the case of pre-market transparent accountability frameworks
more participatory approach than was product evaluations, the assessment and than government departments, their
historically the case to the development approval process is not as transparently effectiveness can be limited by the fact
and adoption of new regulatory communicated. While the 2008 that their members are part-time and
guidance. For example, the Guidelines Guidelines for the Safety Assessment of cannot devote their full energies to risk
for the Safety Assessment of Foods Foods Derived from Genetically assessments. Out of necessity, such
Derived from Genetically Engineered Engineered Plants and associated committees may only meet monthly or
Plants began with an Indian Council protocols provide clear information to several times per year, and the
Medical Research (ICMR) hosted multi- applicants as to what is expected in a membership selection process, while
sectoral stakeholder consultation in regulatory submission for a GE food transparent, may not result in the best
2005, where consensus was achieved safety assessment, the same is not combination of scientific expertise and
that the safety assessment of GE foods available for environmental risk regulatory experience. In some cases,
in India should be consistent with the assessment nor is there a clearly members of advisory committees are
internationally accepted Guideline for elaborated application submission, scientists who continue to work within
the Conduct of Food Safety Assessment review and decision-making process for their fields of expertise and so may be in
of Foods Derived from Recombinant- either food safety or environmental risk a better position to maintain their
DNA Plants adopted by the Codex assessments. Improving this would scientific currency than their
Alimentarius in 2003. ICMR then enhance predictability and consistency counterparts within government, but in
drafted a guidance document for GE of the system. Otherwise, this can lead others they may be representatives of
food safety assessment that was to the imposition of ad hoc information line ministries and have little or no
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
including the public at large. Revisions influence. This is not unique to India, academic and other public sector
research institutions and the private uu

APRIL, 2010 BIOTECH NEWS 89

 India’s Biosafety System
At Par With The World?
Country
Argentina
Australia
China
Canada
European Union
India Ministry of Health & Family Welfare (Food Safety & Standards Authority of India)
Japan
South Africa
United States
u sector, and not within the government
bureaucracy itself. If the decision is
made to locate the risk assessment
function within the regulatory authority,
as has been done in the U.S., Canada
and in Australia's Office of the Gene
Technology Regulator, then the
government must be committed to
developing the appropriate expertise.
This is generally achieved through the
hiring, secondment and/or retraining of
scientific staff. Alternatively, and in an
approach that has been utilized in
countries such as Argentina and South
Africa, the regulatory authority may
appoint an expert advisory committee to
undertake risk assessments. If advisory
committees are used, then appropriate
conflict of interest provisions must be in
place to ensure that the developers of
GE plants do not end up in a position of
assessing their own products. In either
case, the regulatory agency/body should
have some foresight mechanism in place
to identify potential knowledge gaps,
and to promote and access training or
the recruitment of new knowledge.
The best approach may be to use
elements of both as has been proposed
for the Biotechnology Regulatory
Authority of India: Expert Advisory
Committees that provide guidance for
the development of new policies,
coupled with in-house scientists who
work as part of a multi-disciplinary
safety assessment team to conduct the
90 BIOTECH NEWS
Competent Regulatory Authorities for Food Safety
and GE Food Safety in Selected Countries
Competent Regulatory Authority
Food safety
Servicio Nacional De Sanidad (SENASA)
Food Standards Australia New Zealand
Ministry of Health
Health Canada
European Food Safety Authority
MoHL&W
Dept. of Health
Food and Drug Administration
case-by-case assessment of products.
Advisory committees can be used to
address specific issues of scientific
uncertainty. For example, new risks that
may arise with advances in the genetic
engineering of plants and foods can be
proactively identified and product risk
assessment and management practices
changed if required. Such committees
can also be used to address limitations in
national scientific capacity by leveraging
sub-regional or regional expertise with
the additional advantage that the
committee's output may then have a
broader application. The use of in-house
scientists to assess products on a case-by-
case basis permits the development of
considerable expertise within the
regulatory agency, provides for a degree
of consistency not afforded by the ever-
changing membership of advisory
committees, and can address the real or
perceived conflicts of interest that arises
if product developers are also product
assessors.
Clarity
Achieving clarity in a regulatory system
is one of the most challenging tasks to
confront regulatory authorities. It
requires that the scope and objectives of
laws, regulations and guidance are
unambiguous, the division of
responsibilities between government
ministries is clearly defined, and that the
interrelationship between the biosafety
GE food safety
Servicio Nacional De Sanidad (SENASA)
Food Standards Australia New Zealand
Ministry of Health
Health Canada
European Food Safety Authority
Ministry of Environment & Forests
MoHL&W
Dept. of Health
Food and Drug Administration
regulatory system and other regulatory
systems within the government is
understood by members of both the
regulatory and regulated communities.
The regulation of GE foods in India
provides an example of how difficult this
can be to achieve, although regulatory
reforms are currently being pursued to
address this.
In countries with mature
biosafety regulatory systems, the
regulatory authority for GE foods is the
same authority that is responsible for
administering food safety law(s) (Table
2). This recognizes that the safety
assessment of GE foods is part of, and
not separate from, programs that address
the broader context of ensuring the
safety of the foods that the public
consumes. The “GE nature” of a food
derived from a GE crop or other GE
organism is not (and should not be) the
solely defining characteristic of that food
as regards safety. Other, and arguably
more important, food safety and food
quality considerations and associated
laws, regulations, standards and
guidance apply to GE and non-GE foods
alike, which is typically why GE food
safety assessment is positioned within
ministries of health and their associated
food safety and standards agencies. India
has been a notable exception to this
practice as the authority to approve or
not approve a GE food has been vested
with MoEF under the Rules, 1989. This uu
VOLUME 5 | NO. 2
 India’s Biosafety System
At Par With The World?

IGMORIS
INDIAN GMO RESEARCH INFORMATION SYSTEM

Overview
Organizations working with
GMOs
Groups of GMOs
Welcome to IGMORIS Whats New
Status of GMOs and Products

Field Trials of GM Crops Questionnaire for Institutions

Biosafety Data of Approved GM Questionnaire for Industry

Crop
Capacity Building Activities
Documents/Publications
Funding Organizations &
Schemes
R&D Funding/Biosaftey
Proformas
Department of Biotechnology
Searching the Database
Ministry of Science & Technology
Government of India
Other Important Links
Compiled by: Biotech Consortium India Limited
Login Registration (Free)
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
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scientific information relating to GMOs and products Guidelines and Standard
thereof under research and commercial use to all Operating Procedures
stakeholders including scientists, regulators, industry and (SOPs) for Confined
the public in general. It is also expected to promote Field Trials of Genetically
national and international collaborations. Engineered Plants
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read more from Genetically
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u means that the regulation and associated
safety assessment of GE foods is
disconnected, programmatically and
operationally, from the food safety
regulatory system writ large. With the
promulgation of the Food Safety and
Standards Act, 2006 (FSSA, 2006),
which empowers the Food Safety and
Standards Authority of India to regulate
all GE foods, this situation is likely to
change. However, as of now and until
such time as rules and/or regulations for
GE foods are notified under the FSSA,
2006, notification S.O. 880(E) in the
Gazette of India allows for the
continued regulation of GE foods under
Rules, 1989. This means that the
decision to approve/not approve a GE
food remains with MoEF, through
GEAC, until S.O. 880(E) is kept in
abeyance.
In all countries, biosafety evaluations of
GE plants are but one part of a larger
regulatory scheme that may also include
laws, rules and regulations pertaining to
plant health and quarantine, plant
variety protection, variety registration
and seed certification. Inter-ministerial
coordination is essential to ensure that
the roles and responsibilities of the
various involved agencies are clearly
defined and that associated programs
work in unison to create as seamless a
system as possible. For example, country, and biosafety regulatory
national biosafety regulatory systems are systems are no exception to this. The
responsible for the environmental risk Government of India has identified
assessment of GE plants and approvals biotechnology as a key driver of India's
are granted for the “event” defined as a economy in the 21st century and there
genotype produced from the have been significant investments in
transformation of a single plant species biotechnology research and development
using a specific genetic construct. This in both the public and private sectors. In
means that any lines, varieties or hybrids agricultural biotechnology, India has a
derived from an approved event through rich pipeline of GE plants under
conventional plant breeding are also development. Catalysts like agricultural
approved. These derived progeny are not adaptation to climate change, the food
submitted for further assessment within security crisis of 2007-08, and increasing
the biosafety regulatory system as demand for renewable energy have
biosafety has already been addressed. accelerated plant biotechnology research
Instead, they enter directly into the plant on a range of new traits and new plant
variety registration system where they species. Innovation in this sector requires
are evaluated for agronomic a biosafety regulatory system that
performance (e.g., yield, disease and supports research, development and
quality) in the same testing program as deployment of GE crops while ensuring
any other conventional variety or hybrid that environmental and human health
of that species. In this way, the mandate safety are appropriately considered and
to assess the environmental safety of a secured. This means that investments in
GE plant (which is a specific agricultural biotechnology should not be
requirement applied only the GE plants) limited to product development but also
is kept separate and distinct from the applied to ensuring that the regulatory
mandate to evaluate plant performance system is as robust as the community it
(which is applied equally to GE and regulates. Continuing to address
non-GE plants). adaptability, transparency, workability
and clarity within India's biosafety
Concluding Comments regulatory system is of benefit to all the
Regulatory systems necessarily reflect stakeholders it serves and, ultimately,
the social, economic, environmental, society at large.n
and related development objectives of a

APRIL, 2010 BIOTECH NEWS 91

FEATURE
Investments in GM Crops Research
Power of Partnerships
K. Vijayaraghavan
G
lobal investment for crop yield
improvement during the period
1930-60 focused on agriculture
implements to increase farm productivity
resulting in an initial wave of patents in
the USA and Europe. During the next
thirty years, the research intensity moved
to development of new molecules for
agro-chemicals. Plant breeding efforts
continued during this period with the
father of the Green Revolution, Dr.
Norman Borlaug, providing vital
germplasm access for wheat to the
developing nations around the world,
including India. Significant research
investment for agro chemicals emanated
from the private sector, while the
research investment for plant breeding
vested with the public sector. This was
the era of successive release of improved
varieties by the public sector in major
agricultural regions. Germplasm moved
freely across the regions. A restrictive
regime for germplasm would have denied
India's access to high yielding wheat
K. Vijayaraghavan Ph.D is Chairman, Sathguru Management Consultants & Vice Chairman, Cornell-Sathguru Foundation for Development,
Hyderabad. (E-mail: vijay@sathguru.com)
92 BIOTECH NEWS
varieties from Mexico. From the early
90s genetic engineering created a
revolution in accelerating trait
development and crop yield
improvement. Over the last two decades,
the agro chemical industry lagged behind
in introducing new molecules due to
prohibitive costs involved in developing
them and the increasingly stringent
norms required to validate their safety
and efficacy. Similarly, breeding efforts
also declined because of the steep decline
in public investment for breeding
programs.
Research in Genetic Engineering
Turns Multi-Dimensional
The advent of genetic engineering
provided hope in a significant way to
stimulate productivity in agriculture.
Initial set of inventions in genetic
engineering resulted in inventors securing
patents for genes that were identified as a
distinct DNA sequence with a fixed
function. The trend continued during the
90s, triggering an array of patents for
gene functions. However, subsequent
discoveries indicated that the
organization of the genome is much
more defined by quantitative synergies of
gene clusters (networks) than by the
function of a single gene. Inventors
preferred complex claims that aimed at
vertical integration of technologies by
disclosure of synergies of gene clusters.
The complex intellectual assets
governing genetically engineered crops
originated in this context. Patent claims
moved from isolated gene functions to
complex models of gene functions.
Claims were widened on role of an
isolated DNA sequence conferring gains
in a wide array of organisms. Multi-
functionality and the transfer of trait to
another organism triggered integration
efforts to gain access to a set of
biological materials (e.g. use of promoter
to enhance biological activity) that were
cumulatively responsible for
commercially delivering a trait value. uu
VOLUME 5 | NO. 2

TRADITIONAL RELATIONSHIP MODEL
Public Research
Investment
Public Research
Emerging relationships will drive consolidation of research investments
and research commercialization efforts.
u In order to differentiate the claims,
improvement patents were filed with
modified gene sequences during the early
part of this decade. The result is that
every gene of interest that is perceived to
have value has been, in some way or
other, patented in developed countries. It
is true that the current IP regime in
countries such as USA are rethinking
their acceptance of broad claims for gene
patents. Future patents are likely to
recognize a limited coding sequence
rather than recognizing patents for the
whole sequence itself while limiting the
claims for the “Field of Use” factor.
Research Universities and private
enterprises in the USA led the
integration efforts in the last fifteen years,
with the public sector and the private
sector engaging collaboratively to
integrate functions of genes and further
integrate them in the genome of the
crops of interest to pyramid multiple
traits that were sought by the farmers.
Simultaneously the regulators
(Environment Protection Agency,
Federal Drug Agency and United States
Department of Agriculture) created a
vibrant and transparent regulatory
mechanism and the rapid advancement
of science coupled with public
communication and dissemination of
technology created the gene revolution
for the grain and oil seed crops in USA.
IP pooling efforts through “in-licensing”
of biological materials and technologies
APRIL, 2010
NEW RELATIONSHIP MODEL
(Converging investment and research efforts)
Market
Corporate Research
Public Research
provided rapid gains to the corporate
sector to bring out products by bundling
biomaterials and technologies. The
integration efforts provided further
opportunity for cross-country
partnerships through cross-country
licensing. The classic case is the
integration of trait gene for cotton in
Indian cotton hybrids during the early
years of the current decade.
Europe Lags Behind Due to Low Public
Confidence and Multiple Outbreaks of
Zoonotic Diseases
While these efforts were successful in
USA and parts of the South American
region (Brazil and Argentina), Europe
had faced the problem of the mad cow
disease in the 90s and was extremely
cautious about adopting new
technologies. Public confidence in
science was low and their trust in the
regulatory system was even lower. The
European Food Safety Authority (EFSA)
came into existence in this context.
However, public fear, lack of
understanding of emerging science at all
levels and successive outbreak of
zoonotic diseases did not revive public
confidence in novel foods. Most parts of
Europe experienced a sense of self denial
in accepting novel foods and the lack of
consensus within the European
community denied inventors the
opportunity to demonstrate successful
inventions in crop yield improvement
Investments in GM Crops Research
Power of Partnerships
Public & Private
Investors
Market
Corporate Research
and other trait factors.
Europe Continues to Invest in Genetic
Engineering Research
The European Union and the national
research systems within Europe,
however, continued to invest in research
for the development of genetically
engineered crops. Large European
companies have realized that they were
lagging behind and initiated efforts to
accelerate the research for new trait
development through genetic
modification. In a recent effort by the
EU researchers, this writer was engaged
in exploring application of inventions
that have originated within EU for
expeditious commercialization within
and outside the EU. Improved regulatory
consensus, recent approval of genetically
engineered potato, increasing acreage in
countries such as Spain and the pressure
of negotiations within WTO are
triggering a new paradigm shift in
European perspectives. There are over
400 effective patents filed in Europe that
are being explored at various stages of
commercialization by the public and
private sectors within Europe and
elsewhere in the world. European
companies have commercialized
genetically engineered crops in several
parts of the world including USA, Asia
Pacific and South America. European
research organizations have licensed
invaluable traits to entities in the public uu
BIOTECH NEWS 93
 Investments in GM Crops Research
Power of Partnerships
u and private research system for
commercial exploitation and are in
receipt of royalties from such
commercialization. Europe begins to
realize that innovations will flow to
markets and if such innovations are
denied access, it would only endanger
regional competitiveness.
Is There a Threat from the Narrow
Concentration of Patents for Genetic
Engineering Technologies in a Few
Hands?
This question is often brought up by
opponents of genetic engineering science
to argue that the concentration of patents
would create a near monopoly,
threatening the food security of many
nations. It is true that these inventions
were exploited by multinational
companies in large acreage crops such as
Cotton, Soybean, Corn and Canola in
the Americas. This was quite appropriate
in countries such as USA and Brazil
where large acreage farming is quite
common. Only 2% of Americans are
engaged in farming today and it made
perfect sense to adopt widely
disseminated technologies developed by
few sources for improving productivity
and gaining a competitive advantage for
the nation. These efforts have provided
USA with a significant global
competitive advantage for producing
high quality grain crops at the lowest
cost.
However, multinational companies have
not applied the same biomaterials and
technologies to develop traits for small
acreage crops. The low acreage of
vegetables grown by farmers in USA has
so far restrained large companies from
engaging in development efforts for such
crops. Some critics in India argue why
India should be the first country to
develop Bt brinjal. This is because brinjal
is not a crop of interest for Americans or
Europeans as much as it is for Asians.
Who else will focus on developing crops
that have predominant regional interests?
While the extent of adoption of
genetically modified crops is extensive in
94 BIOTECH NEWS
North America and South America, the
markets in these regions will tend
towards marginal growth. The key
market growth for seeds will emerge in
Southern and Eastern markets, more
specifically in China and India and in
countries such as Brazil, South Africa
and in a limited way, North Africa. The
advent of these growing markets will
drive technologies from hitherto
developed countries of the West to Asian
and other developing regions. Many of
these markets do not have a strong patent
regime. Will this deter the technology
owners to step into those markets? Not
really. In India, Monsanto introduced
their genes in cotton at a time when the
protection regime in the country was
virtually non-existent. A third of the
emerging markets that have potential for
high growth markets do not have
advanced regimes (in countries such as
Indonesia and Bangladesh not even a
basic one) for patent enforcement. This
will not deter research efforts in moving
into regions of high market growth.
Research efforts will move to the region
where the markets emerge. This is well
evidenced by the surge in research
investment for genetic engineering
research in China during the last five
years. China has committed over $ 1.5
billion for genetic engineering research
with further trenches of investment
forthcoming to accelerate this research
process. Lack of access to patents has not
deterred China in advancing their
research for new trait development.
China has adopted a judicious licensing
process for bio-material access
complimenting their huge resource
commitment for research. China has also
leveraged their initial low “in-country
capacity” with external research by
contracting leading American
Universities to engage in collaborative
research. Initial products or traits that are
brought to emerging markets in crops of
regional interest would primarily have
biomaterials that are currently de-
regulated elsewhere in advanced markets.
Most of these de-regulated products
introduced in emerging markets would
not be governed by in-country patent
restrictions, thereby creating free market
competition.
Where do Emerging Countries Gain
Access to Genes of Interest?
Gene exploration is dependent upon
understanding the functions of genes and
countries such as India or China have not
committed billions of dollars in
genomics and proteomics platforms the
way the Western world has invested
during the past two decades. Academic
researchers and large private entities in
countries such as USA, parts of Europe,
Australia and Canada are in a position to
generate significant leads for candidate
genes and pursue those candidates for
validating their functions and efficacy.
One successful candidate emerges out of
myriads of prospective genes of interest.
This multi billion dollar effort is
significantly limited to few nations and
within the nations to few players due to
the intensity of investment in upstream
research. However, this does not deter
entities engaged in crop improvement
research to access technologies. The
model is akin to the development of chip
technology. The world over, INTEL and
AMD invest in developing faster and
more reliable chips and rest of the
product developers integrate the
advanced chip technology in their
products. The “INTEL INSIDE”
concept is quite true for biological
research
and this is
precisely the
approach
that the
crop
improve-
ment
researchers
have taken
in
developing new traits in popular
cultivars to make them more relevant to
ensure continued adoption by farmers. uu
VOLUME 5 | NO. 2

u Technology
Access Models for
Emerging Countries
There are four possible models that
would emerge in this technology transfer
and product development process for
genetically modified crops in emerging
economies.
Technology Flow to Research Centers
Created by Ventures in Emerging
Economies
While multinational companies possess
the advantage of bringing currently de-
regulated products from other regions to
countries such as India, the limitation
exists in accessing cultivars of regional
interest. A successful event is made up of
proven functionality of the gene and the
genetic background in which the gene is
inserted. Companies with foresight
understand that the process of breeding
is a long drawn effort and some of them
have begun efforts in this area in right
earnest. However, many of the global
companies do not have an interest in
small acreage crops and therefore will
limit their breeding interest in large
acreage crops, more specifically grains
and oil seeds.
Technology Partnerships for Joint
Product Development
Joint venture partnerships have occurred
in the past in the agro chemical sector
and in sectors other than agriculture,
extensively in India. The seed sector will
not be an exception. Pooling of genes
and germplasm through joint ownership
will occur. However, valuation factors
and promising growth potential will turn
many companies to aspire for controlling
interest in ownership. Indian seed
companies are very possessive of their
controlling interest, just as Chinese
companies are.
Licensing of Technologies for
Commercial Exploitation
Licensing technologies for commercial
exploitation will drive the growth for new
product development. During the past
three years, there have been several
APRIL, 2010
licensing and sub-licensing of bio-
materials, know-how and research tools,
both to public and private research
systems within India. Sathguru has been
a large repository of bio-materials in
region and we have had a surge in
request for licensing bio-materials in the
recent years. China leads the world effort
today in licensing bio-materials and
technologies for genetic engineering of
crops. Gene technologies licensed by a
leading university such as Cornell to
Indian and Chinese partners at the same
time has attracted ten fold investments in
China as compared to Indian public
partnership efforts. China is ahead of the
rest of the world in developing traits for
biotic stress mitigation in rice (China had
just approved the event for commercial
seed multiplication when India imposed
moratorium on the Bt Brinjal).
Aggressive licensing efforts have also
commenced in other countries such as
Brazil, Argentina, South Africa (cotton,
potato, vegetable crops et al). Indian will
lag behind China, but we do hope that
the Indian enterprises and Indian public
entities will intensify their efforts, once
the Bt eggplant moratorium is resolved.
Licensing of Technologies for Pro-
bono Application in Orphan Crops and
Small Acreage Crops
This is a reality that would happen to
develop crops that are not very attractive
for large commercial entities to commit
their shareholders' funds. Donation of
technologies for public good advantage is
a reality. It is true in the case of Bt brinjal
that has been developed by public
partners in India (all the public partners
have the right to deliver technology to
resource poor farmers and have no
obligations whatsoever to Monsanto, as
claimed in many quarters). Bio-material
donations have taken place for the
development of late blight resistance in
potato, drought and salinity tolerance in
rice and virus resistance in crops. My
organization has provided access to
several vital genes of interest to public
research partners. These partnerships
thrive on mutual recognition of best
Investments in GM Crops Research
Power of Partnerships
practices in research, regulatory
validation and responsible product
dissemination. The donor expects the
recipient to engage in responsible
application and use of technology for the
public good. The public research
investment to encourage crop
development based on public good
donations of technologies will help to
address resource poor farmers gaining
access to technologies for low acreage
crops and crops of lesser commercial
interest. Otherwise, these crops tend to
become extinct from commercial
cultivation, threatening the vital bio
diversity of the country and nutritional
security. The public sector will play a
more predominant role in addressing
traits in plant varieties that are currently
under-researched by private entities. If
the three public partners (Tamil nadu
Agricultural University, Coimbatore;
University of Agricultural Sciences-
Dharwad; and the Indian Institute of
Vegetable Research, Varanasi) had not
engaged in the development and
validation of Bt brinjal, twenty two
popular varieties accessible to resource
poor farmers would not have been
possible.
In conclusion, public research at the
global level will increasingly be
integrated across the countries engaged
in progressive research at the upstream
level. Cross-country partnerships in
genomics platforms, SNP consortiums,
sharing of genetic resource database and
other efforts will increase among the
progressive nations. India has the
potential to play a key role in this regard.
At the mid-stream level, sharing of bio-
materials, research tools and
technologies for accelerated trait
integration will flow to regions that are
attractive with high market growth. At
the downstream level, technology
licensing will accelerate with corporate
entities and public research entities
engaged in integrating bio-materials for
trait integration and validation. Our
success in India will depend upon our
ability to nurture the co-existence of
these diverse forces for synergic gains.n
BIOTECH NEWS 95
FEATURE
Investments in GM Crops Research
Public Sector Priorities
S.K. Sopory
T
he pressure for the production
of more food for growing
population, especially in the
developing countries, and its availability
at an affordable price for the low income
consumers will always remain unless
and until the population load decreases
at this part of the planet. However, one
does not foresee this happening till next
50 years or more in the Indian
subcontinent. Therefore to produce
more food from the same arable area,
infact from decreasing cultivable land,
will be a major challenge for the
scientists, policy makers, farmers and
other stake holders. All of them will
have to work in unison, whether they
represent the public sector bodies or
private sector organizations, to remove
hunger and malnutrition, which are
some of the biggest challenges facing our
country. We feel that new technologies
like GM plants, other innovations,
farming practices, business models and
consumer awareness can come to our
S.K. Sopory Ph.D is Senior Scientist, International Centre for Genetic Engineering and Biotechnology (ICGEB), New Delhi.
(Email: sopory@icgeb.res.in)
96 BIOTECH NEWS
rescue once again. They can help us
reject the Malthusian hypothesis and
usher in a third generation agriculture
revolution supported by new
biotechnologies, in contrast to the first
green revolution which was propelled by
the use of dwarf varieties and, the
second revolution which was driven by
using hybrid vigor. More serious
deliberations are needed to find out how
to optimize the use of biotechnologies in
general and GM technology in
particular, to improve food and
nutritional security in our region.
While the above question may
be more global in nature, it has special
relevance for the Asia- Pacific region
where about 53% of its 3.6 billion people
are engaged in agriculture (& related
activities) and yet hunger and
malnutrition is widely prevalent here.
This region has high biodiversity but not
enough strengths in developing
knowledge based applications of
modern biotechnologies specifically in
the agri-sector. In this regard India and
China and a few other countries are an
exception in the sense that they have
technologies and expertise to utilize the
new biology paradigms, such as
production of GM crops, and
importantly these are available in the
public sector. However, their field- level
application has been hindered due to
exhaustive costs involved in the
experimentation for testing for biosafety
and environmental safety, and also due
to the scare raised in the minds of public
against GM crops. Recently, China
announced the approval of GM rice and
maize for commercial cultivation. The
public sector in India will, therefore,
have to further increase its inputs in the
agriculture biotechnology area and work
on many traits of agronomic
importance to enhance food production.
We suggest that the present support
towards this by DBT, CSIR, DST and
others should be continued or even
increased towards the development of uu
VOLUME 5 | NO. 2

u GM crops, as their production will
overcome many constraints in achieving
higher productivity, despite the
controversy raised by the non-scientific
debates on GM brinjal.
Since the time mankind learnt
to domesticate plants for food and feed
and other daily needs, they have always
sought to incorporate new experience,
knowledge and tools to increase
productivity. The techniques of
developing new varieties and strains
through selection, hybridization, and
mutation, exploiting hybrid vigor and
overcoming crossability barriers between
cultivated and wild species, use of tissue
culture for multiplication, and anther
culture for haploid breeding and
dihaploid production have evolved with
time and have been applied with great
success in a number of plant species.
Though not obvious to farmers,
consumers or policy makers, the scientist
knew that the basis for developing
variability was infact the shuffling of the
APRIL, 2010
genetic material within and across
genotypes to obtain desirable
combinations. Creating new variations
from the existing ones was infact taught
to us by none other than a monk, Gregor
Mendel. Having come a long way from
phenotype based selection, which of
course is relevant even today, we have
assigned genes governing various
physiological and developmental traits
in plants. Using the same genetic
foundations laid down by Mendel and
his many successors and making use of
high-end technologies and genomic
approaches, it is possible to first identify
specific gene or genes controlling a trait
and in turn use them in a more surgeon-
like- precision and also in a predicable
way to modify the targeted characters in
the crops of interest. The GM
technology has enabled sourcing of
desirable traits across wide species
barriers, thus greatly expanding the
choice of genes available for crop
improvement. There may be, in certain
Investments in GM Crops Research
Public Sector Priorities
cases, some health and environmental
safety issues associated with adoption of
GM technology, these concerns need to
be addressed quickly. India is one of the
few countries in the developing world
that put the appropriate regulatory
systems in place to address these
concerns related to human, animal and
environmental safety. Infact, it is with
ever increasing demands from various
corners, justified or not, that the
biosafety regulations have become more
stringent which have made it almost
impossible for many public sector
organizations, for lack of increased
financial support and expertise, as
mentioned earlier, to convert their
discoveries in the laboratory to products
of immense use to the farmers and
consumers. The gap between discovery
and product is currently filled by private
companies. Initially, it was the domain
only of some multinationals but over the
years indigenous companies have also
come up with investments in this sector. uu
BIOTECH NEWS 97
 Investments in GM Crops Research
Public Sector Priorities

GM Crop Varieties Under Development in Public-Funded Institutions

S.No. Crops Organization Traits/Gene
Insect resistance/ cry1Aa and cry1Aabc
Brinjal Indian Agricultural Research Institute , New Delhi
1. cry1Ac
Tamilnadu Agricultural University, Coimbatore
cry1Ac
Central Institute of Cotton Research, Nagpur Insect Resistance, herbicide tolerance
2. Cotton
University of Agricultural Sciences-Dharwad cry 1Ac gene
International Crops Research Institute for the
3. Groundnut Virus resistance/ Chitinase gene
Semi-Arid Tropics, Hyderabad
International Crops Research Institute for the
4. Chickpea Insect Resistance/ Pod borer, cry 1Ac
Semi-Arid Tropics, Hyderabad
5. Mustard University of Delhi South Campus, New Delhi Hybrid seed, barnase/ barstar gene
International Crops Research Institute for the Pod borer and Fungal pathogen, cry 1Ac
6. Pigeonpea
Semi-Arid Tropics, Hyderabad and chitinase
Central Potato Research Institute, Shimla, Ama1 and Rb gene derived from Solanum
7. Potato National Institute of Plant Genome Research, bulbocastanum
New Delhi
Cry1B-cry1Aa fusion gene
8. Rice Tamilnadu Agricultural University, Coimbatore cry1Ac, cry2Ab
Rice chitinase (chi11) or tabacco osmotin gene
9. Sorghum National Research Centre for Sorghum, Hyderabad Insect Resistance, Shoot borer
Indian Agricultural Research Institute, New Delhi Antisense replicase gene of tomato leaf curl virus
10. Tomato National Institute of Plant Genome Research, cry1Ac
New Delhi
Compiled by: K.S. Charak, DBT (Email: charak@dbt.nic.in)

u This effort has now been further
catalyzed by Govt agencies like DBT
who have initiated programs such as
SIBRI and BIPP to support public
private partnerships to convert ideas,
knowledge and technology to quickly
take products from laboratory to
farmers, which will yield high dividends
in terms of enhanced productivity with
minimal inputs.
Keeping the above points in
mind the question we address is
whether to use GM technology or not,
but what traits should one give
emphasis to while trying to overcome
the problem of shortage of food which
is expected to increase under a global
climate change scenario? What are the
key areas in which investment should be
made from Govt funding?
Future agriculture will have to
deal with more of high temperature,
high salinity, high CO2 with less of
water, land and energy. Therefore one
will have to either look for genetic
variability in the crop plants which will
be able to adapt to the above scenario or
one has to create new biotech crops
capable of growing well under the above
constraints.
One general area in which the
public sector should invest in is in the
area of phenomics. Being a highly
biodiversity-rich country and having
many accessions of different crop plants,
it would be worthwhile to undertake
such studies. In many other countries
high- end equipment and other green
house facilities have been created, e.g.,
in Australia and networks developed in
Europe, to test for various parameters
such as root growth, stomatal
functions, overall yield etc, under stress
and nutrient deficient conditions, to look
for variants that will perform best under
specific environmental conditions.
Selection can be even done under the
simulated conditions that may be
brought forth due to climate change and
global warming. If the variability can be
obtained from the existing gene pool
within the species or wild related
species, one could then employ these in
the breeding programs. It has however
been seen that for many of the complex
traits, which are governed by multiple
genes, the present breeding tools are not
sufficient. Under this scenario, the best
chance for of developing new variants is
via GM technology and this can also be
deployed with in the existing breeding
programs.
The other area in which more
efforts are required is to develop GM
plants that are tolerant to cold
(specifically for cold desert areas), high
temperature, drought, salinity tolerance.
For many of these traits it is possible to
get the gene(s) of interest from a related uu

98 BIOTECH NEWS VOLUME 5 | NO. 2


u species. Recent work in this area has
revealed that it is more often the
expression of genes, a quantitative
parameter, that is important to confer
stress tolerance, rather than bring in a
totally new allele or gene from across
diverse genera or even the kingdom.
Under such conditions, using the right
promoter and adopting marker and
reporter free technology, it should be
possible to develop GM plants, which
will be safe and stable. Genomics
studies, which need more funding in
future, have given us many new lessons
in gene functions. It is possible that
many traits will be regulated by more
than one gene. In this direction gene
stacking is a possibility. Multi-gene
engineering thus should be supported
in future research programs. In India, a
number of groups have identified many
novel gene(s), which have been
functionally validated to confer stress
tolerance. However, the proof of concept
needs to be translated into products.
The Govt. should thus fund more
projects in the public sector or under
public private partnerships to take the
leads obtained in different labs for field
testing, as mentioned earlier.
One foresees that water would
be a serious limitation for agriculture
and growing plants like rice would seem
a luxury. Though direct seeding for rice
can be achieved to save water, this can
be made possible only if one can take
care of the problem of weeds. Hence,
weedicide resistant crops would be
desirable for such agricultural practices
and for this GM technology can come
handy. In all these cases, irrespective of
the traits one is looking at, gene
discovery to business models leading to
benefits for the farmers and consumers
need to be developed. Further, as the
plants growing under harsh
environmental conditions may not yield
as much as expected, the seed policy
may also probably need to be addressed.
While compared to abiotic
stresses, most biotic stresses can be
APRIL, 2010
mitigated using pesticides etc, yet it is
important, from an environmental point
of view, to reduce the use of pesticides
and develop organic farming practices by
developing GM plants that can
withstand the pest, fungal, nematode
and bacterial attack. Work should also
be undertaken in using necessary
technologies to stop post-harvest losses.
One of the area in this sector that has
not yet got much attention is to develop
seeds that are tolerant to fungal infection
and do not produce aflatoxins.
Currently emphasis has been to
either increase the productivity or
decrease losses in the mainstream crops
like rice, wheat, legumes and vegetables
etc. Support for work in these areas and
crops , especially post-harvest losses in
vegetables, should be continued. The
future programs should pay more
attention for value addition in the millets
and maize. A number of projects have
been supported in this area , however,
the modern bio technologies have not
been fully utilized to harness the
benefits of these plants which can be
grown under harsh conditions and at
the same time are capable of producing
high nutritive quality grains.
The change in the food habits in the
country from vegetarian diets to a non-
vegetarian diet has wider implications in
terms of food security. Investments will
have to be made in improving research
and applications in “ poultry and animal
feed sector”. Alternate sources of feed ,
like modified marine algae , could also
be explored.
The green revolution
depended, in addition to the variety, on
high fertilizer inputs and irrigation. Both
these inputs have had their side effects.
Ground water contamination by nitrate
and phosphorous has created lot of
hazards. It is therefore essential that in
future our agricultural practices should
depend on less of both. The GM
technology will be most appropriate to
develop high nitrogen and water use
efficient ( NUE, WUE) crop plants.
Investments in GM Crops Research
Public Sector Priorities
The area on NUE has so far received
less attention but cannot be ignored in
future planning .
With ever decreasing levels of
fossil oil, the world over research has
been put on fast track mode to develop
alternate sources of fuel. Research on
bioethanol and biodiesel need special
attention. GM technology probably can
come handy to increase higher biomass.
The same plant, like sorgum, can be
used for both grain production and
higher vegetative mass for bio-fuel.
While private sector would be more
interested in these areas, in a country
like India, the public sector should also
enhance its presence in research in the
area of bio-energy.
Besides shortage of food, the
nutritional quality of the available food
is also a cause for concern. The
deficiency of proteins, vitamins and
minerals leads to anemia and blindness
in a large section of the population
especially the under privileged. The GM
technology can play an important role in
alleviating such shortcomings of the
main food items of the poor. Studies on
availability of nutrients in the soil, like
iron, zinc and calcium, their uptake
mechanisms, and bioavailability, can be
the foundation on which future
strategies for plant modifications can be
based .
The GM technology has great
potential to improve crop productivity,
decrease yield losses due to various
stress conditions, prepare plants for
adaptation to future environment
following climate change predictions,
improve nutritional quality of food and
feed. It is time that we benefit from the
advancements made in the area of plant
genomics, plant transformation, soil
microbiology and agro-technologies and
incorporate GM crops in the
mainstream agricultural system, after
these have been approved through the
biosafety screening system that is robust
and transparent.
(The author is thankful to Dr Suresh Nair, ICGEB
for his help in the preparation of this article).n
BIOTECH NEWS 99
FEATURE
Genetically Modified Crops
Public Perceptions
Satyajit Rath
T
he Bt brinjal debate has been
largely simplified as an
ideological disagreement
between camps either anti- or pro-
Genetically Modified (GM) crops, at
least in the public eye. There is no
denying that the vitriol of the debate is
in part due to ideological differences.
However, what is missing is the public
awareness that the disagreements fall
into two distinct categories, and that
conflating those is a grievous error in
determining public policy.
One disagreement is over the anti-GM
characterization of GM technologies as
intrinsically and catastrophically
harmful. A second disagreement is over
the nature of the GM crop technology
ownership and the effect of such
ownership on agriculture in India. Anti-
GM groups have sought to brand GM
technologies as intrinsically harmful and
to identify GM with rapacious
multinational corporations (MNCs).
This brings ideologically distinct groups
Satyajit Rath Ph.D. is Staff Scientist, National Institute of Immunology, New Delhi. (Email: Satyajit@nii.res.in)
Prabir Purkayastha Ph.D. works with Delhi Science Forum, New Delhi. (Email: prabirpurkayastha@yahoo.com)
100 BIOTECH NEWS
Prabir Purkayastha
together in uneasy and ill-fitting unity.
Thus, many socially progressive
movements find themselves in awkward
alliance with nativist and anti-modernity
opinion. On the other hand, pro-GM
argument in the public sphere has
portrayed GM technology with a
patronizing air of triumphalism making
the MNC ownership of GM
technologies a core component. This has
made the weak voice of the Indian
scientific community sound like a
handmaiden of an international
agribusiness juggernaut. It is essential to
separate the wheat from the chaff in all
this if we are to make public policy
about practical social good in
agriculture.
The issue of genetic
modification of crops and livestock is
undoubtedly complex and replete with
serious issues. The key questions are, is
it practically possible in India to evaluate
the risks and benefits of such
technologies, and to what extent are the
concerns specific to GM technologies?
Any significant technological advance
generally involves serious issues. Major
technological advances have always
come with attendant uncertainties and
risks. When we have no data to evaluate
risk, the situation is one of uncertainty,
and little reasonable prediction can be
made. But we do know enough to be
able to evaluate the risks of GM crops.
So long as we are not dealing with
catastrophic consequences, we can set a
'safety' threshold of a certain low
likelihood of adverse consequences in
order to permit the use of a given
technology. The weight of evidence
indicates that GM technology carries the
risk of non-catastrophic consequences
(as opposed to, say, nuclear weapons,
which carry the clear risk of catastrophic
consequences), and can therefore be
reasonably examined and used with
care.
One frequently heard criticism
of GM crops is that horizontal gene een uu
VOLUME 5 | NO. 2
 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.
In fact, this has been used by pro-GM
groups to claim that the products are
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
release.
This is an issue that scientists
have raised right from the beginning.
The Asilomar Conference on
Recombinant DNA in 1975 set out
voluntary guidelines on what could be
done consistent with safety. Till the
guidelines were formulated, they even
imposed a moratorium on further
research. However, things have changed
radically since then. At that time, certainly exists, it is not unique to GM introduced gene product, such as the Bt
scientists were in the business of doing technology. Breeders of potatoes, for toxin, to cause human/livestock harm.
science today a number are closely tied example, know well the possibility that a While there is a fair amount of
to corporate interests. Scientists are no hybrid potato made from two good understanding about the mechanisms by
longer just experts their personal varieties can generate high levels of toxic which, say, the Bt toxin works, this, like
fortunes could also be riding on their material. all other safety concerns, can only be
opinions. And while one could say that Another safety issue arises addressed case-by-case through pre-
scientific issues are best resolved by the from the possibility that genes and release testing.
scientists, the introduction of a proteins may behave differently in A key question is, for how long
technology into society is not a scientific contexts other than the one they were is monitoring to be done in the pre-
question but a policy problem embedded taken from. This can give rise to the release tests? There is no obvious
within social and political issues. generation of allergic reactions. A endpoint, since in theory, it could take
More mundane safety related brazilnut protein in GM soyabean and a years or decades to make the ill-effects
issues of biotechnology arise from the bean protein expressed in GM peas have, of a poisonous substance manifest. But
genetic material thus transferred. There for example, generated significant in the absence of any evidence that GM
are health safety issues and allergic reactions. Similar studies with crop technology carries the risk of
environmental safety issues. Some of many other GM crops, however, did not catastrophic consequences, demands for
these arise from the imprecise insertion find any allergogenicity. Once again, the unattainable absolute proof of safety
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
engineer the biology of the plant and sounds even more appropriate in cases need for abundant caution and rigorous
generate poisons. While this possibility such as Bt brinjal, is the potential of the testing when Bt was first introduced into uu

APRIL, 2010 BIOTECH NEWS 101

 Genetically Modified Crops
Public Perceptions
u crops. While it was true that Bt in its
natural state in the bacteria has been
long used as a bio-pesticide, that by itself
does not mean that Bt is going to be safe
in its new form in a GM crop. However,
by now the world has experienced a fair
diversity of Bt crops, including food
crops. Bt Corn has now been accepted
for imports even in Europe. In this
context, while food crops require
particular attention, almost all crops
enter the food chain one way or another;
there is no impermeable barrier between
food and non-food crops. A case in point
is Bt cotton in India. Bt cotton stalks go
into cattle feed and milk products
obviously come from cattle. Cottonseed
oil also enters the food chain. While
case-by-case safety testing still remains
the correct norm, the argument that
there could still be a catastrophic danger
from the Bt protein in GM crops seems
less and less valid.
The issue of long-term toxicity
with GM crops has also been
particularly raised since, once a GM
crop is released, there is no effective call-
back. This is also the context in which
the potential threats of GM technology
for diversity in both crops and the
biosphere have been excitedly discussed,
since there is a possibility that the
introduced genetic modifications would
spread naturally both to other varieties
of the same species, and also to other
related species. How harmful is such
spread likely to be to crop diversity and
to biodiversity?
Most GM crops have one (or two) genes
introduced into them. These genes can
be easily bred into any variety of the
crop, as is done, for example, with Bt
cotton. This does not appear to lead a
'loss' of the variety in the sense of
flattening out the diversity landscape,
since the same number of varieties, with
differing trait profiles albeit with an
introduced gene, would still be available.
However, it is nonetheless true that GM
crop usage has led to a reduction in the
diversity of crop varieties being planted.
It is useful to note that this is not related
102 BIOTECH NEWS
to the 'GM' nature of the technology, but
to the imperatives of the marketplace
and to the fact that the technology is
owned and marketed by MNCs which,
in order to achieve the profit scales they
need, will aggressively drive high-volume
seed sales. Such corporate control of
agriculture is likely to promote the
process of monoculture that tends to
thin down biodiversity on the ground.
Thus, this is not an issue intrinsic to GM
technology, but to its ownership.
In essence, the issue is not
whether GM crops are without risks, but
whether the regulatory protocols
developed and used for testing them
sufficient for the purpose of evaluating
their safety. As noted above, GM crops
appear to carry risks of non-catastrophic
consequences of the kinds and scales
that society is familiar with. Therefore, it
is not unreasonable to suggest that
familiar safety-testing protocols will
serve societal needs well in this context
too. Protocols for testing GM crops have
been developed by international and
national bodies over time. They will
continue to be strengthened and
improved, but either-or positions vis-à-
vis GM crops are unlikely to contribute
to that process.
One major criticism of the
basis on which the Genetic Engineering
Approval Committee (GEAC) cleared Bt
Brinjal, has been the alleged unreliability
of the safety data. Safety data submitted
by the company, with a vested interest in
a favorable outcome, are deemed to be
suspect in this argument. And in this
context, the real issue that arises is a
question we are depressingly familiar
with: do we have strong implementation
of these regulatory processes and
protocols? The answer to that is likely to
tend to be more and more in the negative
the greater the involvement of powerful
interests, such as deep-pocketed MNCs.
This is as true of, say, drug approvals, as
of crop approvals. Again, who owns
GM technology appears to be far more
crucial an issue than its 'GM'ness.
These issues need to be seen in
the larger context of Indian agriculture
and food security. With a growing
population and with persistent problems
of poverty and malnutrition to address,
there is little doubt that increases in food
production would be immensely useful.
What is the possible role of GM crop
technologies in this context? The anti-
GM position is frequently apocalyptic
with regard to the risks of GM crop
technology, and therefore negates any
useful role for it. It is also frequently
allied with nativist anti-technology views
of agriculture, in which back-to-nature
approaches are seen as the most
appropriate solution. On the other hand,
the pro-GM position frequently sounds
as though GM crop technology by itself
can be a major solution.
As far as the evidence goes,
there is no reason to think that GM crop
technology carries catastrophic
consequences, and therefore it is indeed
proper to consider its possible
advantages for Indian agriculture and
food security seriously. However,
anybody who thinks that any one
category of approach, nativist or GM, is
going to be a common panacea for
India's food security is refusing to
acknowledge the sheer diversity and
complexity of agricultural practices and
needs across the country. For example,
anti-GM favorites such as the integrated
pest management system (IPMS) or the
system of rice intensification (SRI)
depend on their success on rigorous
practices and additional equipment, and
may be successful in some situations and
not in others. Thus, the use of GM crop
technology is going to be a part of our
food future, not because it is the sole
answer to the problems of Indian
agriculture, but because it can expand
the basket of choices available to a wide
variety of farming communities. While
GM is certainly not the only answer,
there is little doubt that it can very much
be a part of the answering strategies. It is
possible to grow more drought-resistant
or salinity-tolerant crops, or use less
pesticides, for example. Some of these uu
VOLUME 5 | NO. 2

u do not need transgenic technologies.
Molecular genetic marker-assisted
selective breeding is another tool that
can help in achieving some of these
aims. Achieving true breeding of hybrids
will also help in a different way. But all
of these tactics together would help to
expand the basket of choices available.
It is thus clear that, while there cannot
be a mere technological fix to the
problems of Indian agriculture,
technology will be part of the solutions.
The farm sector is also seeing a huge
squeeze on its income the prices of
inputs are rising faster than the output
prices. The increasing corporatisation of
Genetically Modified Crops
Public Perceptions
inputs, as exemplified by the Monsanto-
driven Bt-crops, exacerbates this squeeze
further, and must be an issue of concern.
The technological worries relating to
GM crops appear relatively minor in
comparison, yet, sadly, it is these techno-
worries that hold centre-stage in the
ongoing debates.n
FEATURE
Deployment of GM Crops
Need For a Clear Cut Policy
E.A. Siddiq
A
chieving minimum required
growth on a sustainable basis is
crucial for sustained food-
nutrition security. India has made
enviable progress in agriculture during
the last 50 years culminating in self-
sufficiency in our food grain needs since
early 80s. Transformation of a
chronically food deficit country into a
food sufficient and surplus one is the
most significant accomplishment of the
post-independent India. Two landmark
developments viz., exploitation of
hybrid vigor in maize and millets since
mid 50s and introduction of plant type
based high yielding varieties of wheat
and rice since mid 60s marking major
yield breakthroughs have made this
possible. Despite such an impressive
feat, the fact that over 200 million people
remain undernourished and much larger
population malnourished is of great
concern, no matter what could be
attributable to this paradox. With the
current pace of productivity/production
E.A. SiddiqPh.D is Chairman of the Centre for Finger Printing and Diagnostics (CFCD), Hyderabad. (Email: easiddiq@rediffmail.com)
112 BIOTECH NEWS
growth of Green Revolution crops
declined to levels far lower than what is
required to sustain the present level of
sufficiency and no yield breakthroughs
as yet in rain fed crops that account for
over 65% of the arable area coupled with
shrinking natural resources, especially
water, energy and plant genetic
resources, achieving future demands
would be the most challenging task, if
we are to excessively depend on the
currently available crop improvement
technologies. Rapid advances in cellular
and molecular biology have provided
two major genomic tools viz., molecular
marker technology enabling genotype
based selection and recombinant DNA
technology capable of moving genes of
interest across the barriers of sexual
incompatibility. While there is no
resistance to the use of the former for
crop improvement, there is strong
reservation against alien gene based
genetically modified (GM) crops and
GM food products, though the
reservationists are fully aware that this is
the only strategy option to find solution
to problems that defy both conventional
and marker technology and for which
there is no donor source in the
compatible germplasm and that finding
remedy would have major socio-
economic impact.
India, although late in
accessing and using recombinant DNA
technology, during the last 15 years it
has strengthened itself with needed
knowledge and skills, state of the art
research infrastructure and competitive
critical mass. It is in an enviable position
today to engineer crop plants with
desired trait(s), given transgenics in as
many as 10 different crops already on its
shelves awaiting clearance by the
Regulatory Authority for commercial
planting and several at various stages of
evaluation for efficacy, stability and bio-
safety including human health and
environment security. Also, potential
benefits of Bt cotton, the first ever uu
VOLUME 5 | NO. 2

u commercialized biotech crop in the
country have been experienced during
the last eight years, when over 85% of
the cotton area were planted to Bt cotton
and productivity more than doubled
ending the dependence on imported
cotton. Significantly, this development
too was not without hassles in reaching
out to farmers. When Bt brinjal, capable
of minimizing greatly yield losses due to
fruit and shoot borer, was to be released
last year for commercial planting, the
experience in trying to reach out it to
farmers reflected reservation against GM
crops, especially those that are directly in
the food chain of man to be still strong
and persistant. The kind of objections
raised against Bt brinjal by anti-GM
lobby, ineffective response to them by
scientific community and reluctance of
seed industry and farmers to adopt and
lack of clear cut policy-directed
interventions from the governments are
said to collectively contribute to our
failure to benefit from such innovative
technologies.
Reservations Against Biotech Crops
Reservation against GM crops from
activists and others are -
The technology being developed and
introduced is not based on prior
APRIL, 2010
Need For a Clear Cut Policy
consultative process involving concerned
stakeholders of given target
area/community.
Introduction is not based on
field level evaluation done in the
concerned state for efficacy, stability and
biosafety
Small and large scale field test data on
performance/biosafety furnished to the
regulatory authority are often from trials
conducted by the applicant organization
lRegulatory process is not sound enough.
It lacks transparency in the process of
development and testing for efficacy and
biosafety and stringency is left much to
be desired
lInconsistency in efficacy and instances
of biosafety related problems
lUnsubstantiated claims on economic
advantage and environment security.
lExtensive cultivation of transgenic crops
monopolised by multinational
companies would prove a threat to rich
biodiversity of the country.
lTransgenic strategy in pest control
would lead to emergence of newer
pests/more viruliferous forms of the
same pest.
lIncreasing monopoly of multinational
companies in seed trade is to the
disadvantage of Indian companies and
seed cost is not affordable by small
farmers.
Deployment of GM Crops
The above raised reservations
against GM technology cannot be totally
dismissed as baseless. They can,
however, be addressed by scientific
community and officials of concerned
ministries to the satisfaction of the
apprehensive activists and reluctant
farmers, quoting policy goals and related
provisions in the Draft National Policy
on Biotechnology prepared by the
Department of Biotechnology, Ministry
of Science and Technology through
consultative process involving relevant
ministries, national institutes and
scientists. Awaiting formal approval of
the Policy Document, the DBT is
already in the process of implementing
many of the policy goals/provisions
envisaged. The following responses, if
properly explained vis a vis the issues
should help remove the apprehensions
on the system and its functioning.
Establishment of the National
Biotechnology Regulatory Authority
and the Regulatory Process for
Safety Assessment of GM Crops/Food
Broadly aiming at (a) development and
use of biotech tools to address the
problems that affect the largest section
of the society (b) providing of produce/
processed products there from at prices uu
BIOTECH NEWS 113
 Deployment of GM Crops
Need For a Clear Cut Policy
u affordable by all sections of the society
and (c) making the country food-
nutrition secure and globally competitive
in the emerging bio-economy, the draft
Biotechnology Regulatory Authority has
been conceived. Yet to be formally
established, the Authority ensures
through the three-tier system, rigorous
and sound science based approval of
GM Crops. Structurally and
functionally, the development, testing
and approval system though sound
enough, scope does exist for making it
still more stringent and transparent.
More realistic choice of crop, source of
gene and transformation avoiding
selectable markers, especially antibiotic
ones are insisted upon at development
phase, while ensuring stringent and
transparent assessment of biotech crops
for biosafety including human and
animal health and other unintended
effects (toxicity, allergenicity, and other
adverse health related problems) at
laboratory and on environment
(weediness, invasiveness, pollen flow
caused genetic contamination/erosion)
at field level. Large scale multi-location
field trial conducted on the
recommendation of the RCGM is
monitored and evaluated by the Genetic
Monitoring and Evaluation Committee.
Its report and recommendation of the
special Appraisal Committee constituted
of experts form ultimately the basis for
granting approval for seed increase and
commercial planting by the Genetic
Engineering Approval Committee
(GEAC). Thus, the regulatory system
and regulatory process are in order in
the absence of formally cleared National
Policy on Biotechnology and
establishment of National
Biotechnology Regulatory Authority.
Priority action plan in this regard would
help ward off the criticism that biosafety
and efficacy/performance related data
are not reliable. If the system has its own
laboratory facilities or duly accredited
public laboratories exclusively designed
for risk analysis of GM crops and
depends on SAU's generated data on
114 BIOTECH NEWS
agronomic performance, decision taken
on the basis of data and findings from
such sources would strengthen the faith
and confidence of all in the user end and
thereby willing reception to the
technology.
Many reservations against GM
crops are largely because of the failure
of scientists to respond to and clear all
unfounded apprehensions on their
efficacy, stability, biosafety and
environment security.
As for efficacy and economic
gain from transgenics over the
corresponding non-transgenics, debate
on far and against biotech crops is due to
lack of understanding. For instance,
claims and counter claims on yield
superiority of pest resistant transgenics
like Bt cotton and Bt brinjal is one such
case of poor understanding of the trait
effect on productivity. Genetic yield
potential being inherent to a given
variety, no matter it is transgenic or non-
transgenic, observed yield difference
between them depends on the level of
yield loss they suffer due to the pest. In
situations of high pest incidence, the
transgenic would yield far higher than
the corresponding non-transgenic and
when there is no or very low pest build
up, there will be hardly any yield
difference between them. Therefore, it is
wrong to conclude that transgenics have
higher yield potential or it is only on par
with the non-transgenic control, as the
observed difference in yield depends on
the level of pest incidence and the level
of protection the transgenics and non
transgenics provide against the pest.
Stability of trait expression is
yet another apprehension about biotech
crops. Discouraging reports on the
declined efficacy of Bt gene in cotton,
for instance, are no doubt based on
actual observation in some parts of the
country. Such instances of instability are
not characteristic to transgenics alone, as
breakdown of resistance (ineffectiveness
of resistance gene against the pest) is as
well the case with natural genes. What
has been observed in Bt cotton could be
due to (a) breakdown of resistance due
to selection pressure or (b) unintended or
deliberate admixture/adulteration (by
unscrupulous elements in seed trade) of
seed of transgenic with that of
nontransgenic. The latter possibility
could be checked by regular
survey/monitoring of transgenic fields
and seed sale points for genetic purity.
This strategy would greatly help remove
the wrong notion on the stability of
transgenics.
The view that transgenics
resistant to a pest could facilitate
emergence of newer pests is as well not
disputable, when the transgene in
question is pest-specific. Observed build
up of once not so serious pink bollworm
(Pectinophora gossypiella) in cotton is one
such case, where the transgene effective
against bollworm (Heliothes armigera)
remains ineffective against other related
species of the pest.
Many believe that transgenics
could prove a serious threat to genetic
diversity, which is the bedrock
conventional plant breeders depend on
for progressively improving crop
varieties. The contention that extensive
exploitation of a few transgenics would
amount to disappearance of thousands
of native germplasm, need not be wholly
true. Similar apprehension was there
when hybrids of millets and high
yielding varieties of rice and wheat were
introduced. The fact that maximum of
crop specific diversity available in the
country has already been conserved by
ex situ and in situ approaches and more
could be done in future too. Such
anticipatory conservation measures
already on should convince all those,
who entertain such concern that it
cannot be a justification against GM
crops.
The objection that increasing
monopoly of multinational seed
companies would be at the cost of
domestic seed industry and that no
control over seed price would go against
farmers' interest, is although under-
standable, it is inevitable as long as the uu
VOLUME 5 | NO. 2

u technology is not ours. The issue could,
however, be resolved by government in
discussion with the seed industry
reminding governments' policy of
making GM technology easily accessible
and affordable to all.
Disputes and criticisms on the efficacy
and biosafety of biotech crops arising
from various quarters cannot be wished
away. Addressing them with scientific
study based facts and figures is the right
strategy to counter them and thereby
promote the technology. Even eight
years after the release of Bt cotton, for
instance, we still face resistance to it on
grounds like instances of livestock death
due to grazing in Bt cotton fields,
degradation of soil health and quality
affecting seriously the performance of
subsequently planted crops, increased
suicide cases in Bt cotton grown areas
due to crop failure, no appreciable cost
reduction on plant protection etc. Such
issues be thoroughly investigated by a
competent committee constituted of
researchers, social scientists and
economists for establishing what is
rumoured is not true. Only with
scientific scrutiny-based facts and
figures, such reports can be countered
and restore thereby the trust and
confidence of growers and consumers.
Apprehensions on long term effect of
GMOs could be out of genuine concern
for human health. As there is no way out
to subject human beings for long term
clinical tests special Standing Technical
Committee constituted of physicians,
social scientists and agricultural
scientists should monitor long term
effect of consumption of GM food/feed
on human/animal health.
Policy Initiatives and Technology
Transfer Strategies for Effective
Deployment of Biotech Crops
In taking full advantage of advances
being made in the area of crop
biotechnology, relevant enough to
address the problems that impede the
progress of envisaged
production/productivity growth, the
APRIL, 2010
Need For a Clear Cut Policy
constraint is not our technical
competence to engineer crop plants of
interest, given the impressive array of
transgenics already in pipeline. It is
rather in reaching out the technology to
the targeted user. Learning from the
experience of other sectors as well as our
own in this regard, the following
suggestions and strategies would ensure
effective deployment of biotech crops.
l Convincing the target clientele with
facts and figures that gain from the
given biotech crop outweighed the risks
is basic to its extensive adoption.
l Endorsement of the recommendations
of the GEAC on biosafety of given
GM crop(s) and processed products
there from by the apex agricultural
research organizations at national
(ICAR) and state (State Agricultural
Universities) levels and other National
laboratories.
l Organized and intensive awareness
creation among the target population
on the intended introduction of biotech
crop(s) highlighting its relevance to
their livelihood security and biosafety
including human and animal health
and environment security.
l Active involvement of state agricultural
departments in reaching out the
technology to the intended regions,
ecologies and communities. Training
of extension personnel at all levels on
the benefits and associated risks of the
technology and organizing large scale
on farm demonstrations.
l Labeling of transgenic produce and
processed food products is about
consumer right. Though mandatory in
India, measures be found to address
the practical problems that would be
encountered in actual implementation
in the face of reluctance of private
sector companies on the plea that it
would introduce price discrimination
and would be against the policy goal of
ensuring inclusiveness.
l Many valuable transgenics developed
by the public institutions are still on the
shelf because of lack of resource
support for them to go through the
mandatory testing requirements at
Deployment of GM Crops
l laboratory and field levels for biosafety.
Considering the high cost involved in
meeting satisfactorily such
requirements, public-private
partnership models now in place and
are being promoted by the Department
of Biotechnology could be used to take
advantage of the private sectors'
excellence in development and
management skills for extensive
commercialization.
l Clear policy and rational strategies for
deployment of transgenic crops is vital
for successfully sustaining and
benefitting from transgenic technology.
These should be in keeping with the
fact that (a) genetic uniformity is
genetically vulnerable to sudden
outbreaks of pests and (b) sexual
compatibility with plant species around
would lead to genetic contamination,
genetic erosion and other unintended
consequences. To ward off the problem
of genetic vulnerability, either
diversification of trans-resistance genes
through varietal mosaics or pyramiding
of varieties with diverse trans-
resistance genes could be ideal
strategies. To contain genetic
contamination, areas/regions rich with
compatible wild/cultivar species be
precluded for introduction of given
transgenic crop/variety. There should
be legal restriction to introduce
transgenic crops in biodiversity rich
areas, centers of origin and centers of
diversity of a species, areas earmarked
for export oriented crops (e.g.: basmati
rice) and those for organic farming.
Innovative technologies are inevitable
given the limitations of the conventional
breeding/selection technologies vis a vis
magnitude and seriousness of problems
facing us today. Undoubtedly extra care
is necessary to rule out any serious
impact of GM crops/GM food/feed on
human/animal health and environment.
But reservations, undue delays in
exploiting the technologies of large
socio-economic impact would amount to
denying the large undernourished-
malnourished population the benefits of
new bioscience.n
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