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FEATURE

GM vs. Traditional Crops

How Do They Differ ?

K. V. Prabhu

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

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 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 crossed with another variety of the same has incorporated a foreign gene in its
known as “backcross breeding” where crop. genome is as safe as its conventional
the focus is to transfer only one gene GM Crop and Farmer/Consumer counterpart. The rigorous testing the
from one parent (known as donor par- product undergoes for establishing its
The GM crop variety (hybrid in terms of
ent) into another already established vari- safety vis-a-vis the environment, human
the farmer) and the commercial product
ety, known as the recurrent parent. and animal health under the vigil of the
of the GM crop (such as leafy foliage,
In general, once stabilized by the inte- regulatory processes in place, makes the
fruits, grains, oil or fibre from the view
gration of the transgene anywhere in its GM crop a beneficial product to farmers
point of the consumer), will technically
genome, the GM crop follows the same and consumers. Depending on the gene
be substantially similar to its conven-
series of survival procedures like any incorporated in the GM crop, its value in
tional counterpart. In terms of farmers,
other conventional variety of the crop. differentiating it from its conventional
the GM crop will enable them to pro-
The difference lies however, in the limit- counter product differs. For example, if
duce more or better quality product
less potential of the GM crop both in the a insect resistance is the feature of a GM
while for the consumer it will add more
way the new “transgene” integrates into crop, this will be valuable to the farmer
value to the product for a better quality
the native DNA of the crop and the loca- in terms of reduced use of pesticides,
of life. Over the last two decades, the
tion on the chromosome where it inte- reduced losses due to the insect pest and
technology of genetic engineering of
grates. Once integrated, the transgene better market value through low or no
plants has undergone a series of refine-
can recombine like any gene when 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 the reason explained in the box above. If GM crops do not qualify for cultivation
would have the benefit of getting they do, then there will be 25% “null” as organic crops.
undamaged product and residual pesti- plants which will be non-GM plants.
cides in the commercial product. The GM Crops: Common Misconceptions
conventional product in contrast will be Organic Crops vs GM Crops GM crops are unsafe and harmful : The most
prone to have the insect pest or have pes- Organic crops are any natural and non- common misconception is that GM
ticide residues in the commercial prod- GM crop variety which is cultivated with- crops are unsafe and harmful for human
uct to the disadvantage of both farmers out the use of chemical fertilizers, pesti- beings, animals and environment. It
and consumers. If the GM crop is pro- cides and chemicals. The field where it is needs to be understood that GM crops
duced to add value to the commercial grown has to be certified as organic field are rigorously evaluated and analyzed
product such as enhanced carotene con- having no traces of any chemical/ inor- for any risk they may pose to human
tent or minerals, the farmer will be able ganic fertilizer(s) or chemicals. The crop beings, animals and environment. Only
to obtain better marketability while the cultivation, harvesting and packaging when it is confirmed safe through a stan-
consumer will have healthful products has to be certified as done organically dard set of investigations and protocols,
for consumption. without any use of chemicals. It is also a GM crop is released in the environ-
The farmers have to take care required that the seed used for producing ment for cultivation.
that they do not use the seed of a GM the crop is also produced organically. As GM crops destroy natural genetic diversity: It is
crop hybrid for raising another crop for per the current definition and standards, 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 cide tolerance genes are deployed and into a human organelle. The transgene is
is based on the perceived ability of the they do move into wild types, these only a chemical entity made up of com-
GM crops themselves to become inva- plants are not provided with extra fitness mon components existing in human
sive or pass the invasiveness to wild rela- for them to produce more seeds. Thus, beings and plants or bacteria. As such
tives or native varieties through “gene like the established safety of every other we everyday consume bacteria and
flow” or “pollen flow”. While it may so improved character from non-GM vari- microorganisms through fresh vegeta-
happen that a successful GM variety eties in the past history, the GM trait bles, fruits and drinking water. The con-
may get so popular that it may end up also does not make the weed become sumer needs to understand this and
replacing other varieties like many tradi- invasive in general. Herbicide tolerance come to an informed judgement on the
tional varieties have done in the course makes the variety of wild relative possi- issue.
history, it does not mean that this will bly gain herbicide tolerance, only to the GM crops increase yield and reduce soil fertility:
cause erosion of genetic diversity. It only targeted herbicide. Neither it becomes No GM crop has any additional yielding
ends up into the pattern of “mono- fitter nor invasive by producing more ability over and above its original tradi-
culture” as may also happen in the case seeds than usual. tional counterpart variety or hybrid. If
of a popular single non-GM variety for a Issue of foreign bacterial or animal genes in tradi- the transgene makes the GM crop resis-
crop. However, this is not likely to hap- tional crops: Even if the transgene is taken tant to diseases, pests or drought and
pen in India where large number of pri- out from a bacterium, animal or other heat stresses, it helps it to achieve its full
vate and public plant breeders and seed plant species, the GM plant does not productivity potential without any yield
producers invariably keep developing become a bacterium or animal or loss due to the stresses. Thus, the GM
and releasing GM, or non-GM varieties. another plant species. The transgene crop variety or hybrid only responds to
There are no possibilities of a gene like only produces the protein and not the the genetic potential of the non-GM tra-
insect resistance, salt tolerance or disease tissue or organ that belongs to the source ditional counterpart and does not reduce
resistance enabling a GM crop to be inva- organism. It is notable that there are soil fertility additionally. Unless the
sive, or spread into varieties in the wild. thousands of genes common between transgene itself is for yield increase, the
As such, in India, multiple crops are crops and animals. For example, there GM crop does not yield more than the
grown each year in almost all parts and are more than 10,000 common genes yield potential of the original crop vari-
there are wild relatives of few crops between human beings and rice. The pro- ety. n
which occupy large areas. Even if herbi- teins produced by these do not make rice

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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 respect to the GM crops so far developed nation, the GM revolution that can
that a moratorium on the and field-tested. It has to be conceded address concerns of food security and
introduction of Bt Brinjal that there would be vociferous diehards mass nutrition.
without specifying a time frame has been who would not accept GM technology, In this article I have made an
imposed by the Ministry of Environment whatever may be the scientific validity. attempt to summarize the concerns of
and Forests (MoEF), I believe that it is The society and the government need to the MoEF that have led it to the
also an opportunity to objectively assess evolve and accept the policy on GM-crop imposition of the moratorium and to
the science and the ground reality in cultivation based on scientific inputs and analyze each of those concerns.
respect of the relevance of genetically a correct perception on the need for such
modified (GM) crops as a whole for the a technology. It would be in the interest A: All the brinjal growing states have
country. Nobody seems to be against a of the nation, if valid scientific expressed reservation on the
technology based solution to stagnating arguments are accepted so that one does introduction of Bt brinjal
productivity in agriculture in the face of not throw out the baby with the bath This is true. A couple of states had based
projected increase in human population. water. It is also the duty of the scientific the decision on the lack of evidence in
GM technology affords a unique community, which believes in GM terms of commercial benefits to the
opportunity to tackle biotic as well as technology, to address the concerns and farmer. However, the EC-II report clearly
abiotic stresses, besides improving the keep evolving newer strategies to make mentions the significant decrease in
nutritive quality of the feed stock. the technology safe on the ground, as pesticide spray, increased marketable
Majority of the stake holders are not well as in the minds of the public. But, if yield and the projected economic gain to
against the technology as such, but the vested interests dictate terms to dump the the farmer, in quantitative terms based
standard concerns expressed are: technology, it would be a great loss. India on the trials conducted by the Indian
1. Environmental and health safety. missed the industrial revolution as a Institute of Vegetable Research Varanasi.
2. Regulatory regimes for approval. subjugate nation and is still paying a This, of course, needs to be replicated in
There have been innumerable price in terms of development. It would private farmers' fields. The inputs
arguments attesting to safety aspects with be a great tragedy if it misses, as a free available to at least some of the state uu

G.PadmanabanPh.D. is Emeritus Professor and former Director, Indian Institute of Science, Bangalore.(E-mail: geepee@biochem.iisc.ernet.in)

64 BIOTECH NEWS 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 be carried out for 6 months or even a products developed by MNCs (eg.GM
transgenic crop trials, deep inside I year, if that would satisfy the corn and Soya), while developing its own
believe that the biodiversity card is requirement. I personally do not see the Bt rice. As per a news item (November 4,
overplayed. The government can create logic in extended studies. 2009/PR news shire- First call),
biodiversity parks all over the country to I also do not subscribe to the Monsanto was opening its first research
preserve rare varieties of selected plant addition of sophisticated tests such as center in Zhongguancum, Beijing.
species. transcriptomic, proteomic and Monsanto has made a commitment to
metabolomic studies. A plant is a collaborate with Chinese scientists on
E: Bt brinjal as a food crop cannot be dynamic entity and would respond even advanced biotech and breeding
equated with Bt cotton to small changes in environment cues. technology. China is pragmatic. It wants
The chronic toxicity tests carried out in One can be reasonably certain that these to get the best of both worlds. We are
experimental animals are not adequate. parameters would be different between driven by emotional activism. It is not as
There are suggestions that chronic the different varieties of brinjal, or even if there is no opposition to GM
toxicity tests should be carried out during the same variety grown under different technology in China. But, it is able to
the entire life cycle of the animal. geographical and environment take decisions and move ahead. It is able
Solanaceae is a unique species and the conditions. This does not mean that the to keep the big picture in perspective,
transgenes may bring the hidden toxins changes seen are detrimental. namely food security to an over billion
to the surface. Brinjal is used in native population and an intense ambition to
medicine without cooking and abundant F: Bt brinjal has been developed by become the world leader. I will not be
caution needs to be exercised in assessing Mahyco in which Monsanto has a surprised if we will be importing Bt rice
the health safety of Bt brinjal. As per EC- stake of 26% from China at some point of time!
II report, the developers have indeed The gene belongs to Monsanto. Priority
carried out a variety of mandatory needs to be given to the G: Resistance development is a
toxicity tests in a wide variety of commercialization of indigenously serious concern in monophagous
experimental and domesticated animals. developed transgenic products. China has pests
A 90 day chronic toxicity test has been developed Bt rice indigenously and has By far this is the most serious issue,
carried out. These tests have been approved trials that would lead to which scientists should address as the
considered as adequate by GEAC. One commercialization. First, the support for primary challenge. Two different
should also keep in mind that there is so indigenous development is definitely hypotheses are available to explain the
much published information already welcome. There are atleast a few events, mode of action of Cry toxins. One is
available on the safety of Bt toxins to both in the private and public sectors, based on generating pores (punching
humans and animals. More than this, Bt that are ready for trials towards holes) in the insect gut cell and the other
corn is being consumed across the globe commercialization. But, one needs to is based on killing mediated by signal
for over a decade. Apart from being cattle talk to the scientists concerned to transduction. In both the models, the first
feed, the breakfast cereal in North understand the trials and tribulations steps envisaged are similar. The ingested
America, perhaps, contains Bt corn. We they undergo to take their transgenics toxin is cleaved by midgut protease and
cannot just discard the American forward. the activated toxin binds to cadherin
experience and state that it is not relevant On the one hand they have to receptor located in the microvilli of
for our discussion. In my perception, the face the tough requirements of RCGM midgut cells. The toxin oligomer then
greatest proof of safety of Bt gene is the and GEAC, constant interference by binds to secondary receptors anchored to
long term consumption of Bt corn in activists directly or indirectly, Supreme the membrane such as aminopeptidase N
many countries without any confirmed court ruling that actually allowed on or alkaline phosphatase. The toxin
and authenticated ill effects to the public. going trials (Mahyco), but clamped an oligomer then inserts into lipid raft
Of course, scientifically it is well known embargo on newer trials that were ready membranes forming pores and causing
that Bt proteins get degraded in the (indigenous) and on the other, face an the cells to burst. In the second model,
acidic stomach of the mammal, whereas uncertain future in terms of publications the binding of toxin to cadherin receptor
it gets activated under the alkaline and career advancement (public sector) is visualized to trigger a signal
conditions of the gut in the pests. It gets and survival (private company). Is this transduction cascade, eventually leading
degraded during cooking. Its penetrance the right environment for indigenous to oncotic cell death.
in the soil and microflora is not of real development of commercial capabilities? Mechanisms of resistance development
concern. In spite of all these arguments, As regards China, it has followed a dual have been studied in different pests
the chronic toxicity tests in rodents can policy. It has approved specific GM y in induced to become resistant in the
laboratory. In general, the most m is due uu

66 BIOTECH NEWS VOLUME 5 | NO. 2


GM Crops in India

Beyond Bt Brinjal

u frequently observed mechanism is due to former function and give approval for the Bt toxin, it would avoid expression of
defects in receptor binding followed by commercialization. GEAC has evolved the toxin in all tissues of the plant.
resistance due to defects in protease over several years of experience and, Similarly, if the toxin is expressed only
production, elevated immune response, perhaps, it is not a good idea to disband during the stage of pest attack, its
enhanced esterase production etc. the same. It may need some more fine concentration will get diluted during
Strategies to overcome resistance include tuning. Thus, these two authorities can grain maturation and disappear from the
development of Bt plants with novel Cry be two arms of NBRA in the Agriculture final product. India has to give priority to
toxins (eg.VIP3 plants), Cry gene sector. The biggest challenge is to create develop transgenics to improve the
stacking (eg. Cry 1Ac with Cry 2Ab), independent and dedicated experimental nutritive quality of the grain and resist
modified Cry toxins that bypass primary facilities to monitor and evaluate GM abiotic stresses such as low rainfall and
receptor interaction (eg. Cry 1A Mod crops. Till such a facility comes into salinity in soils.
toxins), use of Cyt proteins from Bt i existence, the existing laboratories in Finally, none of these agenda
strain along with Cry toxins and use of different institutions have to be net- should delay the release of Bt brinjal.
cadherin fragments to counter resistance worked to provide independent After all, Bt corn and Bt cotton were
(Bravo, A and Soberon, M (2008). How experimental capabilities for NBRA. introduced with single Bt genes and
to cope with insect resistance to Bt R&D Efforts (Priority). Bt transgenics antibiotic markers and their safety in the
toxins? Trends in Biotechnology Vol.26, should only be developed with more than field is well established. Evolution
473-579). one gene. Those that have already been towards a better safety regime and
In addition, on the field use of developed should be given priority for introduction of NBRA cannot be reasons
refuge cropping has been shown to be commercialization. In fact, if we can for delaying the release of Bt brinjal. I do
effective. It is clear that in developed develop two different sets, one should be not believe that labeling of GM crops as
countries there is already a switch to the in reserve to be introduced as and when such should become an issue. It will only
use of Bt crops with stacked genes. signs of resistance are seen. Resistance is confuse the masses in a developing
Indigenous efforts should only be not a permanent character. It is well country like India. We are losing
towards developing Bt plants with known that when crops are rotated, the precious time in reaping the benefits of
stacked genes. Monsanto has already pressure on the insect to develop Bt gene and nearly 25 countries,
indicated of possible resistance resistance to a particular gene is eased. including some in Europe have gone in
development in Gujarat to pink boll The insect once again becomes sensitive. for this technology. More than all the
worm in Bt cotton and has Bt crops can ideally form part of valid scientific arguments, success in the
recommended the use of second Integrated Pest Management regime. field would convince the public of the
generation Bollguard with two stacked When major pests cannot thrive, minor importance of GM crops for food
genes. I wish there is an Indian authority pests can become the primary concern. security. The introduction and success of
which gives this advice based on a Therefore, transgenics to contain minor Bt cotton has convinced many farmers
constant monitoring of the GM crops in pests (eg. sucking pets) need to be and a segment of the public that GM
the field. developed simultaneously. I have earlier technology can lead to increased
listed many genes that can be used to productivity, decreased pesticide spray
H: India needs an independent combat resistance. Newer strategies such and increased revenue to the farmer. If Bt
authority to evaluate and approve the as the use of SiRNA to knock out brinjal succeeds, it would go a long way
trials as well as to monitor the specific gene expression need to be in convincing many that GM technology
performance of GM crops in the field pursued vigorously. Strategies are is safe and viable. I look for the day when
after commercialization available to remove antibiotic markers. India would have pest-resistant rice with
A unified National Biotechnology Even screening a large number of events improved nutritive quality ( balanced
Regulatory Authority (now rechristened can give the desired transgenic without protein and micro nutrients) that can go
Biotechnology Regulatory Authority of antibiotic selection. Fortunately, all these grow even under conditions of low
India, or BRAI) is under consideration. efforts are underway. Development of rainfall. Agriculture is not just about
The bill pending since 2005 is likely to be transgenic varieties would help farmers technology, since it embodies a culture
taken up in the parliament for debate. I to store the seeds. But, the seed and there are political and sociological
feel that the regulatory authority to companies can make money only if they over tones. It needs to be realized that
evaluate and monitor transgenic crops in sell hybrids. Technology developers need GM is only an innovative approach to
experimental fields and the one that to be compensated, while the farmers provide a technological solution, but it
performs a regulatory function after derive benefit. The future challenges are should not be made a scape goat if there
commercialization should be different. the development of tissue specific and is failure else where.n
GEAC can continue to perform the stage-specific promoters. In the case of

APRIL, 2010 BIOTECH NEWS 67


FEATURE

G M Technology

Responsible and Purposeful Use

R. P. Sharma

G
enetic modification of crop germplasm, which is more often the available in the germplasm of the GM
plants has been and continues case, the conventional plant breeding modified crops. A brief analysis of the
to be the basic feature of con- will remain the first option. However, for world wide adoption of GM crops reveal
ventional plant breeding wherein the those traits which are not available in that only three major traits viz. insect
genetic traits of breeding value, and in close relatives, or got lost due to natural resistance, herbicide resistance and viral
turn the genes governing those traits, are or manmade selections, mobilization of resistance alone, or in combinations,
brought together through the process of genes through the recombinant DNA have been mobilized in only five major
hybridization, recombination and finally technology based tools is the most desir- crops viz. soybean, cotton, maize,
selection of the promising genotypes. able option for the plant breeders. It canola and papaya, covering more than
The major difference between the con- should therefore be understood that ninety percent of the area under GM
ventional approach and the recombinant genetic modification or GM as we crops. These results clearly indicate that
DNA based genetic modification is that understand it today, does help in borrow- so far the application of GM technology
in the first approach genes being reshuf- ing one or few genes from unrelated spe- has been highly need based and
fled are “known” genes and are brought cies and is in no way a replacement of restricted to only those traits which were
together from sexually compatible rela- conventional plant breeding. GM not amenable through conventional
tives whereas the recombinant DNA approach is at best and at times indis- methods of crop improvement.
based approach permits mobilization of pensable adjunct to conventional plant In the Indian context, so far
gene/s from unrelated species, genera breeding. only Bt cotton, engineered for insect
and even phyla and therefore, are 'un- resistance has been commercialized. Bt
known' as far as their expression and GM: A Brief History cotton, a highly successful example,
interaction in the alien genetic back- Tracing the brief history of GM crops, represents indispensability of GM
ground to which they are brought are starting 1996, when the first GM crops technology for a trait proving to be
concerned. Thus, in situations where the was released for commercial cultivation recalcitrant to breed through
required genetic traits are available in the in USA, most of the traits engineered in conventional plant breeding, primarily
sexually compatible and therefore usable plants so far are those which are not because of the non-availability of uu

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 VOLUME 5 | NO. 2


G M Technology

Responsible And Purposeful Use

u sources of resistance in the world cotton l Bt-gene has been engineered. environmental and soil dynamics are
germplasm against Helicoverpa armigera. l The genetic background of the Bt challenging the sustainability of
This insect was basically being managed hybrids/varieties and not the “Bt- agriculture. It is therefore of utmost
by repeated sprays of environment transgenic event” is important for its importance that countries like India
polluting and health hazardous adaptability to diverse agro- must develop, adopt and innovate new
pesticides. In fact, cotton crop received ecological situations. and novel approaches for increasing
almost 30% of the total pesticide used in agricultural productivity in a sustainable
l Science based technology, as in the
India. Following the release of Bt manner. It is in this context the GM
case of Bt-technology, requires
cotton, the pesticide consumption in technology assumes much greater
continuous awareness generation
India declined from 47,020 metric tones significance and calls for its judicious
among the farmers for its effective
in 2001 to 37,959 metric tones in 2006- integration in the conventional
implementation.
2007. approaches being pursued for gene
l Non-availability and high cost of management, nutrient management, pest
Lessons learnt from commercial planting material can lead to management, water management, soil
cultivation of Bt Cotton in India unethical trade practices. health management, and post harvest
l Time and again, first during “Green l Reduction in pesticide usage led to management.
Revolution” and now for adoption substantial savings in input cost and Obviously, the management of
of Bt-technology, Indian farmers reduced exposure of the farm each of the activities listed is going to be
have demonstrated that they are workers to environmental and health crop specific and will demand thorough
highly receptive to economically hazardous pollutants. planning in terms of trait to be improved
viable technologies. Within seven and the tool to be applied. For example
years of the release the area under Need Based Application of GM in a crop like rice, the varieties of
Bt-cotton increased from four acres Technology tomorrow must not only be high yielding
in 2002, to about 9.5 mha in 2009. Currently, Indian agriculture is passing but fertilizer use efficient, tolerant to
through a critical phase. Crop existing and emerging biotic and abiotic
l Bt gene(s) provide tolerance to insect
production is static if not declining, stresses and suited for upland conditions
damage only. The yield per se
biotic and abiotic stresses are leading to of cultivations. For each of these traits
depends on the overall genetic
unpredictable crop losses and changing which are polygenic in nature uu
background of the cultivars in which

APRIL, 2010 BIOTECH NEWS 69


G M Technology

Responsible And Purposeful Use

u conventional plant breeding approaches breeding varieties for these traits. the improvement of specific trait in a
will no doubt help in assembling the However, upland rice conditions are very crop of choice must be undertaken
required gene combinations from the favorable for the growth of weeds as before opting for this approach. As
existing germplasm, the recombinant well. Managing weeds manually is not stated earlier, the recombinant DNA
DNA tools applied judiciously will help only difficult but add to costs making technology has virtually clubbed the
in mobilizing the monogenic traits not upland rice cultivation highly whole biological world into a “single
available in the germplasm. The traits uneconomical. It is being visualized that gene pool”, with the possibility of
which are attracting worldwide attention in future upland rice cultivation with isolating a gene of choice from a donor
for rice improvement are: bacterial, “no till”, where rice seed is sown in the and its integration in the genome of the
fungal and viral diseases, insect unploughed fields, will emerge as a recipient plant. It is obvious that this
tolerance, herbicide tolerance, grain highly desirable approach for sustaining technology has given enormous power in
quality parameters such as high protein, rice cultivation under changed agro- the hands of the scientists. In this whole
high carotene (Vitamin-A), high ecological scenario. This would require process, however, there are certain areas
tocopherol (Vitamin-E), and high macro that the rice varieties meant for upland where our existing knowledge is
& micro nutrients etc. As far as grain and “no-till” conditions are genetically inadequate and is a cause of concern.
yield is concerned, identification and modified for herbicide tolerance for This puts tremendous responsibility on
mobilization of major QTLs managing the weeds. On similar lines, as the users of this technology for its safe
(Quantitative Trait Loci) for hybrid vigor outlined above for rice the desirable application. The gap areas are:
and superior alleles of QTLs involved in specific traits in different crops can be l Since the genes and gene products
reducing the impact of negative identified and introgressed into the high- are known to interact intra-cellularly,
correlations among yield contributing yielding varieties through GM the behavior of a transgene in an
traits offer unique opportunity for technology. alien cellular environment of
breaking the yield barriers. Water transgenic plant can not be predicted
scarcity and changing pattern of Responsible Deployment of GM
precisely in terms of allergenicity
monsoon are bound to alter the Technology
and toxicity.
agronomy of rice cultivation, forcing Given the biosafety concerns and the
costs associated with GM technology, it l The method of gene insertion in the
development of varieties amenable to
is pertinent that a careful analysis recipient DNA is random which
drought and upland rice conditions.
bordering indispensability, of the might lead to: (a) silencing of the
Fortunately, the available rice germplasm
application of genetic engineering for inserted gene itself or of the
has enough genetic variability for uire
surrounding genes at the site of uu

70 BIOTECH NEWS VOLUME 5 | NO. 2


G M Technology

Responsible And Purposeful Use

l insertion; (b) genetic instabilities in


u through new molecules being discovered cultivation. The transgene “Insertion
other genes of interest and (c) for controlling of the weeds and insects. Event” based release of GM crops,
activating some of evolutionary Likewise, acquired resistance to practiced in some countries, are
silenced genes etc. antibiotics by the human pathogens can exempted in India only from biosafety
Keeping these uncertainties in view, be made inconsequential if the tests but for field release, prescribed field
biosafety related issues of the transgenes antibiotics used as selectable markers evaluations are mandatory. It is not only
have emerged as major concerns during cellular selection of the gene “insertion event” but the
warranting categorization of transgenic transformants are those which have genotype as a whole contributes to the
plants as regulated items. outlived their therapeutic value. In recent economic yield of the variety which
years, transformation protocols with need to be ascertained before
Major Biosafety Concerns from the removable antibiotic resistant markers commercial cultivation by the farmers.
Commercial Release of Transgenes have also been developed. The Indian Biosafety
The major biosafety concerns from the As far as negative impact on Guidelines, evolved during the last two
commercial release of the transgenic biodiversity is concerned, the decline in decades do address most of the biosafety
plants and their negative impact on (i) agro-biodiversity by extensive concerns listed above. However, it is
environment; (ii) human and animal application of high yielding varieties time that a “National GM-Biosafety
health and (iii) social and ethical issues during “green revolution” period has Register” is developed, prescribing in
have been the subject of intensive been very well documented. Large scale detail the crop and transgene specific
discussion worldwide. Incidentally, cultivation of transgenic varieties will biosafety concerns, the tests to be
during these discussions the importance further add to this decline because undertaken and the protocols that need
of transgenics in agriculture has been farmers will always prefer the varieties to be followed with a proviso of need
accepted unequivocally. The note of ensuring high economic returns to them based expansion and modifications.
dissent, however, has been on the over the poor yielding land races. Unless In order to ensure responsible
adequacy of, and lack of transparency in and until farmer's interests are use of the GM technology, the
the biosafety protocols followed. The safeguarded, the collection and Government of India has been
potential risks to the environment being conservation of the biodiversity by crop modifying and updating the existing
envisaged are the development of : (a) based institutions and Genetic Resources biosafety protocols to make them more
“superweeds” by the herbicide resistant Bureau is the only option available. As effective and efficient. It is in process of
genes; (b) new viral strains by trans- far as Bt technology is concerned, the setting up of a Biotechnology
capsulation of virus resistant genes and major biosafety concern is the Regulatory Authority of India (BRAI),
(c ) “superpests” by insect resistant development of resistance to the Bt- which will be autonomous and statutory
genes. Likewise, the potential risks to protein in the target insects. Resistance agency to regulate the research,
human health include: (a) allergenicity; development is directly proportional to transport, import, manufacture and use
(b) toxicity and (c ) acquired antibiotic the selection pressure imposed on the of organisms and products of modern
resistance by the human pathogens. The insect and can certainly be delayed by biotechnology. The Department of
ethical and social issues are varied and maintaining the appropriate refugia and Biotechnology, Ministry of Science &
are region and country specific. In the non-contiguity of large scale cultivation Technology has been entrusted to act as
Indian context these could be (a) of similar transgenic crops in the field. the nodal agency and a consultative
selective adoption of the technology The allergenicity and toxicity to human group of experts has prepared a draft
leading to further economic disparities and animal health are certainly major Bill to establish Biotechnology
(b) monopolization of trade by rigid biosafety concerns and the international Regulatory Authority of India. The Bill
intellectual property rights and restrictive protocols addressing to these issue are was prepared through a consultative
trade practices and (c) negative impact quite adequate and have been adopted process involving interdisciplinary and
on biodiversity by extensive cultivation and followed rigorously in India. inter-ministerial experts, state
of transgenics. Indian Biosafety Guidelines, in addition governments and stakeholders. It is
A critical analysis of most of to human and animal health and expected that once in place, BRAI will
the biosafety concerns enumerated above environment, address the socio- address to the biosafety issues more
would reveal that, in the long term, economic aspects of a transgenic plant effectively and will bring in the required
many of these will turn out to be and therefore, in a sense, are unique. impartiality and transparency in our
inconsequential. The occurrence of These guidelines take into consideration handling of the genetically modified
“superweeds” and “superpests” though a the field performance of a transgenic crop for sustainable development of
remote possibility are addressable crop before it is released for commercial Indian agriculture.n

APRIL, 2010 BIOTECH NEWS 71


FEATURE

G M Crops

Human and Animal Safety

B.Sesikeran

E
nsuring safety of any product accept the product after making sure that similar issues often get reviewed/
meant for human or animal use is the risk is very negligible and the benefits analyzed further. These can form fairly
paramount. This requires that are more, we need to equip ourselves with substantial evidence-based information
such a product has to go through certain strategies to manage the risk even if it that can be used for risk assessment.
regulatory processes laid out by the occurs. However, the most robust evidence of
respective government departments. Risk Communication: This process involves safety is a history of safe human use. It is
Regulation usually ensures that (1) the communicating such information to the for this reason that several traditional
product which is being approved is useful users so that they know what they are in foods and medicines are accepted because
i.e. efficacious and (2) that even after use for and feel reassured that the risk is far people have been using for years and
for varying periods of time, it is unlikely less than the benefits they are likely to there is no evidence of harm.
to cause any harm. Even if there is a derive. However, if a product is new or
potential risk, it is very unlikely to cause All the above processes are not in use in the country, the regulators
harm and that the immediate benefits far possible only if the harmful substances would want adequate data to be
outweigh such risk. The following are are known or identified. Risk assessment generated on its safety. This is possible
some of the steps involved in this process cannot be carried out if such harmful only through many test procedures which
Risk Assessment: This involves two very substances are unknown or exist only in are validated. Validation means that a set
important steps - identifying the risk our perception or imagination. Even in of procedures have been carried out on
(what is the harmful substance) and cases where there is no known or the potentially harmful substance and
quantifying the risk (how much is the identified risk, how does one look for confirmed that such procedures can
exposure to such a harmful substance). possible harmful substances? The answer detect the substance even at significantly
Risk-Benefit Analysis: Now that the extent of is simple. One has to rely on the available low levels. Employing validated
risk is made known to us, this step would scientific literature. Several researchers all procedures, if the test result turns out to
help us know whether the benefit is worth over the world are constantly generating be negative, one can be sure that there is
taking the risk. genuine research information, which gets no harm and if it happens to be positive
Risk Management: Although we decide to published and many such papers on then one can say with certainty that risk uu

B. Sesikeran MD is Director, National Institute of Nutrition, Hyderabad.(E-mail: dirnin_hyd@yahoo.co.in)

72 BIOTECH NEWS VOLUME 5 | NO. 2


G M Crops
Human and Animal Safety

u exists. Considering the fact that source that gives it a trait to protect itself toxic properties using the target insects.
laboratory animals are used primarily to from pests can be identified and inserted B. The next test is to feed the food
carry out such tests, appropriate animal into the food crop and a demonstrable containing the toxic protein to rats every
model (be it a rat or a rabbit or a goat etc benefit can be seen. The safety concern in day for a period of 90 days in order to
) needs to be chosen to predict the way a this case could be: assess long term effects of feeding the
human or other animals would behave if insect toxin. The rats are then studied in-
the same treatment were to be given. Rat  Will the product of the inserted gene, depth for their growth, sickness, activity,
which is an insect killing protein, also
is by far the best animal model because cause harm to humans? blood parameters and all biochemical
more than 95% of its metabolic pathways  Since, it is a protein which would not have indicators before they are finally
are similar to those of humans and many been eaten by humans earlier, is there any sacrificed at the end of the period. Their
likelihood of it causing allergy to those
other larger animals. Several decades of who consume? internal organs are examined thoroughly
data using rat as a model for drug or food  When this new gene was inserted into the and under the microscope for any
crop, did it disturb any other gene and
safety assessment has confirmed this. produce unintended effects? abnormal changes. These are also done in
Therefore, if no harm occurs in a rat fed comparison with animals fed with normal
with the test material, one can safely To address the first question two kinds food crop. If the difference is consistently
of safety tests can be done using rats.
assume that other mammals and humans observed then it is significant, otherwise,
A. Feed the animals the purified protein
would also behave in a similar way. one can be fairly certain that it is safe.
(insect toxin) in quantities many times
The key steps in biosafety testing The question is why only 90 days. The
more than what a human or animal is
therefore are short life span of 90 days in rats is almost
likely to consume. This is to be given as a
l Identify the risk similar to feeding humans from 6 months
l Have a validated test system single dose by gastric feeding and animals
to about 25 years of age. Added to these,
l Conduct the tests with should be observed for 14 days. If the
approved protocols the analysis of years of data and several
animals are fine, eating well and growing
l Review the scientific evidence studies indicated that no additional
l Assess the risk normally after the test period, it can be
information can be obtained even if they
Let us now apply these principles to assumed that even unrealistically larger
are fed beyond this period. Such longer
genetically modified or genetically consumption is safe. This is called as
duration animal studies spanning 180
engineered crops or foods. We develop acute toxicity test. Through this test, it
days or more are essential to assess the
such variety to quickly give an advantage can be confirmed that the toxin has effect
reproductive toxicity and the possibility
to the crop which we are unable to only on the insects and not on animals or
of occurrence of cancer.
manage efficiently due to many reasons. humans that are consuming it. But,
Bt proteins or for that matter
For instance, in case of a crop that gets before giving this pure protein to the
any protein cannot get into the cells as
eaten up by insects despite heavy use of animals it needs to be confirmed that the
such when consumed because they are uu
pesticides, a gene from even a non-food tested protein/ toxin has insect killing

APRIL, 2010 BIOTECH NEWS 73


G M Crops
Human and Animal Safety

u digested and converted into amino acids, to inject the test substance or a placebo their non-GM counterparts.
which we anyway eat through a variety under the skin of the patients with Concerns also exist regarding the possible
of foods. Proteins therefore are not allergy, under medical supervision, and transfer of antibiotic resistance selection
mutagenic and do not cause DNA look for allergic reactions. These tests marker gene or the promoter gene to the
damage and risk of cancers/tumors does would further reassure that the new gut bacteria. Scientific studies indicate
not arise. The 90 day studies as protein is not toxic to humans and other that the chances of any such transfer are
mentioned include detailed microscopic animals and is also unlikely to cause remote. In fact, we consume lots of DNA
examination where in the reproductive human allergy. through foods but they do not get
organs are examined and if there are any The final and by far the best incorporated into host or bacterial DNA.
abnormalities in these organs then surrogate evidence of safety is the extent Even if such an event takes place, those
reproductive toxicity studies should be of similarity between the non-genetically cells undergo repair or perish.
done. It is to be borne in mind that every modified food crop and the respective The above information would
test performed has to be validated and GM version. This is called as make it evident that GMOs are
merely performing studies without compositional analysis or establishing thoroughly tested for safety using
scientific basis will not give the answers substantial equivalence. Based on meaningful and validated tests. Hence,
we are looking for. As mentioned earlier, scientific data, we know the various known risks can be quantified. However,
if humans are already consuming for a components of the edible plant or plant there are no protocols to look for harmful
good length of time, then that is the best part like its water content, proteins, effects, which are based on paranoid
evidence of safety rather than any long carbohydrates, fats, minerals, vitamins, perceptions rather than science-based
term rat study. phytonutrients, anti nutrients and known reasons or evidence.
C. Assessing the possibility of allergens. When all components are All testing procedures have
allergenicity is again a complex process. similar between the two, we are fairly been prescribed based on scientific
Scientific evidence has shown that allergy sure that the GMO after the insertion of evidences and international best
causing substances have two major new gene has not changed anything in the practices. The following are the biosafety
characteristics - they are resistant to the plant. Worldwide, this is the single most guidelines which have been prescribed by
digestive juices as well as the acid in the robust test of safety. Even in traditional the Review Committee on Genetic
stomach and they do not get destroyed by plants there are normally variations Manipulation (RCGM) / Genetic
heat to a great extent and therefore persist between the crops within the same field Engineering Approval Committee
even in cooked food. Therefore, if the or between the crops from different soils / (GEAC):
new protein due to genetic modification different climates and sometimes within l Recombinant DNA Safety Guidelines,
1990 & 1994
can be digested by simulated gastric the same plant between different stages of
l Revised Guidelines for Research in
digestion and also breaks down on maturity. When comparisons are done, Transgenic Plants and Guidelines for
heating, then it is a strong enough these inherent variations are considered. Toxicity and Allergenicity Evaluation,
1998
evidence to say that it is unlikely to be an Newer techniques, which detect l Guidelines and SOPs for the conduct of
allergen. Thousands of possible allergens the minor components in the metabolic Confined Field Trials of Transgenic
have been identified from various sources pathways, which lead to the macro Plant, 2008
l Guidelines for the Safety Assessment of
and their amino acid composition, components like carbohydrates, vitamins GM Foods, 2008
sequence and tertiary structure are stored etc., are now available. However, until we l Protocol for Safety Assessment of
in large databases. The new GM proteins know what are all the variations as Genetically Engineered Plants / crops,
2008.
structure, sequence and amino acid mentioned above, such tests cannot be
It can be stated with confidence that no
composition is established. Using bio- used because any differences could be a
other food technology has gone through
informatics tools, they are compared or variation in the normal process and even
such vigorous safety testing procedures as
matched with the databases of known if no differences exist we still cannot
biotech derived crops. Let us recall the
allergens. If there is no match we are consider these as evidence. Such
statement of Pandit Jawaharlal Nehru :
further reassured that the new protein is techniques have to be standardized and
“It is science and science alone that can
not an allergy causing one. If there is a validated before they would be used for
solve the problem of hunger and poverty,
match then a more detailed testing should regulation/regulatory testing.
of insanitation and illiteracy, of
be done. The detailed testing would Studies on livestock like chicken, cattle,
superstition and deadening custom and
involve doing an ELISA test using the goats etc. need to be done in case any
tradition, of vast resources running
blood samples of patients with known part of the GM plant is likely to be used
waste, of a rich country inhabited by
allergies like asthma and mixing them as animal feed. These are not
starving people”.
with the test protein to see if they bind to toxicological studies but feeding studies
each other. The ultimate test, of course, is So give science a chance.n
to see if they are nutritionally similar to

74 BIOTECH NEWS VOLUME 5 | NO. 2


FEATURE

Ecological Consequences of GMOs

Ensuring Environmental Safety

R. Uma Shaanker K. N. Ganeshaiah

D
ebates on the ecological Thus the truth of the ecological assessing the ecological impact of the
consequences of GMOs fall consequences of GMOs lies somewhere GMOs.
into two extreme categories: in between! That it lies in between is also a) Pollen Transfer: Introgression
Those who feel that GMOs shall be the reason why the two opposite groups between the cultivated plants and their
treated as `Guilty until proven innocent' have been indulging in an unending tug wild relatives is a dominant evolutionary
and those who wish to treat transgenics of war over the issue. process and hence, it is argued, may not
as `Innocent until proven guilty' (Belt, be an exception for a transgenic cultivar
2003). While this polarization, even Ecological Impact of GMOs as well (Stewart Jr et al., 2003). In fact
among the professionals, is clearly due There are two major ways in which `most cultivated plants mate with one or
to their philosophical affiliation to the GMOs are suspected to affect the more wild relatives in some portion of
entities they are trying to protect ecosystem and the biological diversity. their geographic range.' (Snow, 2002).
(ecosystems and biodiversity in the first Consequently, it is feared that the
category), or promote (biotech products
Gene Flow
advantageous genes from the transgenics
The uncontrolled escape of transgenes
in the second), unfortunately, in the may be introgressed into the related wild
into non-target organisms especially into
public and in the media these debates species especially when the area under
the wild relatives is expected to affect the
have turned more emotional than GMOs increases.
local gene pool and also the ecological
rational; more decibel based than data- Obviously the probability and
balance. Transgenic genes may escape
based; and more prophetic than realistic. depth of such gene transfer is a function
from the source population in three
As a matter of fact, in a calm and of the extent to which wild relatives of a
ways: a) through pollen transfer, b) as
reasonably coordinated atmosphere, transgenic plant are distributed in the
seed escapes, and c) Horizontal gene
neither of the two categories would be area of cultivation. It is now known that
transfer through transformation and
able to completely defend their stand as world over there are a number of
transduction processes. The varied
the facts available are minimal and situations where the cultivated crops
probabilities and diverse consequences
where available, they are with neither of exchange gene pools with their wild
of these mechanisms are important in
the two extreme views. relatives (Ellstrand,1999) and some of uu

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 BIOTECH NEWS 75


Ecological Consequences of GMOs

Ensuring Environmental Safety

u the crops where this is most plausible are c). Horizontal Gene Transfer: Problems of negative reports
sorghum, sunflower, canola, wheat, Horizontal gene transfer is suggested to The debate on GMOs suffers from a
sugar beat and alfalfa (Stewart Jr et al., occur from the transgenic sources to peculiar habit of biased reporting that is
2003). All these situations are potential other related plant species through viral characteristic to science. It is important
grounds for the transgenes to escape as transduction or, to other microorganisms to realize that scientists in general
area under cultivation of transgenics through transformation (Pilson and exhibit a peculiar bias in their habit of
increases. The wild relatives thus Prendeville, 2004). The viruses that reporting results. For instance while
`transformed' may gain additional fitness infect the transgenics may encapsulate some of the instances cited above do
advantage owing to this gene rendering the specific gene and re-infect other plant reflect the negative impacts of GMOs on
itself the potentiality to be hazardous and release the gene in question or DNA the ecosystem, positive results, in this
weeds in the crop fields. While the logic of the transgenic plants entering the soil case demonstrating that GMOs have an
of this cannot be denied, we need to system may be taken up by the micro- impact, are almost always reported and
look at the facts of such consequences. organisms transforming them. However appreciated than those where the impact
Unfortunately, while only a horizontal gene transfer is among the is not detected. The authors, referees and
few examples of such pollen mediated least likely event because this requires even the editors do not find the negative
escape of the transgenic genes into wild high concentrations of viable DNA of results of such work as interesting and
relatives have been reported, as for the transgene to be accumulated in soils. worthy of publishing as those of the
example of transfer of the herbicide While there are reports of such DNA positive results and hence a lot of work
resistant gene from Brassica napus to B getting released into soil, it is very goes unreported making it difficult to
rapa, (Warwicket al., 2003, Steward Jr unlikely that such DNA fragments weigh the relative disadvantages of
etal., 2003) there are hardly any studies would be in viable and sufficient GMO over their advantages. Debates
on the fitness related spread of such quantities for the effective over GMOs always suffer from this bias
`transformed' wild relatives (Snow, transformation. To cite Dunfield and in science.
2002). In fact even in this case of Germida (20040), “studies have shown
Brassica, Warwick et al (2008) showed the possibility that transgenes can be Back to the future
that the hybrid lineages declined transferred to native soil microorganisms And this brings us back to the question
dramatically over time. For this reason, a … although there is not evidence of this that we began with: Should we treat
proper assessment of the impact of such occurring in the soil”. GMOs as `Guilty until proven innocent'
introgression has not been possible and or as `Innocent until proven guilty'.
if anything overestimated. Toxin Flow The answer to this lies in the future:
Pollen flow is likely to carry Addition of chemical products from
How would the future generation judge
the transgenes to the land races as well transgenes into the soil and environment
our decisions today in accepting or
and if this happens the `transformed' is argued to affect the biological systems.
rejecting the GMOs?
land races may in fact thrive well in the Perhaps by far the most well
Answer to this surprisingly may lie in the
nature and contribute to the crops wild documented and highly celebrated case
present and the past!! What does the
gene pool- an entity every breeder would is that of reduced fitness of the monarch
present generation think of our decisions
wish to have. In other words such butterflies feeding on the pollen from the
to go with Green Revolution during the
transfer of foreign genes may enhance Bt transgenics (Losey et al 1999).
second half of the 20th century?
the intra-specific genetic diversity of the Similarly there are a number of studies
We do not think that the younger
crops (Pilson and Prendeville, 2004). reporting that flow of toxins into the soil
generation of today considers the
b). Seed Escapes: This is an has affected the soil micro-flora towards
adoption of steps towards green
immediately possible consequence of the predominance of specific species or
revolution during 1960s and 70s as a
growing transgenic crops; the transgenic types in some cases and towards altered
curse on their generation. Rather the
seeds after the harvesting of the main microbial diversity in other cases
young generation today has sufficiently
crop may be left behind, escape and (Dunfield and Germida 2004). However
acknowledged that if our country had
survive as admixtures and hence may it is also important to realize that similar
not adopted steps towards green
enter into the chain of gene flow into effects are seen even with any two non-
revolution, their `present' would not
wild relatives (Dlugosch and Whitton, transgenic crops suggesting that the
have been as bright as it is. Though they
2008). There are a few examples of such minor changes in the soil flora is an
were not there to face the famines then,
escape of seeds and not surprisingly they ongoing process of farming per se and
they are aware of our begging bowl
survive well in the wild. need not be linked exclusively to the
situation. They are aware that they can uu
transgenes.

76 BIOTECH NEWS VOLUME 5 | NO. 2


Ecological Consequences of GMOs

Ensuring Environmental Safety

u raise their heads high in the world because they have

ENVIRONMENTAL SAFETY ASSESSMENT OF food and resources to live with. Unfortunately, it may
be difficult to extrapolate on the basis of this history
GENETICALLY MODIFIED CROPS to what could happen to our decisions on GMOs-
Environmental risk assessment is an integral component of not because GMOs would turn out to be bad but
biosafety evaluation of GM crops. The purpose of such because India is perhaps not in such dire states as it
assessments is to identify and evaluate the possible adverse was when green revolution occurred. But we need to
effects of genetically modified organisms on the conservation and take conscious and valued decisions such that we do
sustainable use of biological diversity. Known risk not again enter a state of begging bowl.
assessment techniques in different countries and guidelines
developed by relevant international organizations recognize
A message to the funding agencies
comparative risk assessment indicate that risks associated with We realize that there are very minimal datasets to
genetically modified organisms or products thereof, obtained systematically evaluate the impact of GMOs on the
through the use of modern biotechnology, should be considered ecosystem and crop genetic diversity. What exists is
in the context of the risks posed by the non-modified recipients or only indicative and at best inconclusive and there is a
parental organisms in the likely receiving environment. message here for the funding agencies such as
Department of Biotechnology, Ministry of
The following steps are important in such risk assessment Environment and Forest, Department of Science and
methodologies:
Technology and Indian Council of Agricultural
An identification of any novel genotypic or phenotypic traits Research. There is no point in blaming those who
that could have an adverse effect on biological diversity in the use their decibels than data sets to push their views in
receiving environment, including diverse impacts on human
health the public. We need to generate reliable information
An estimation of the likelihood of adverse effects being realized such that the policy maker take an informed decision
An evaluation of the consequences of any adverse effects, than temporally postponing the judgments on
should they be realized
An estimation of overall risk (based on the above) GMOs. Thus we need to facilitate certain areas of
A recommendation on the acceptability or not of identified research that demand immediate attention such that
risks, including risk mitigation strategies
And in cases where there remains uncertainty about the level of the professionals can find themselves on a solid
risk, additional research or risk mitigation measures or ground in drawing their conclusions and the public
monitoring of the LMO in the receiving environment may be
required. 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'.
Ecological impact of the Plant Physiology, 132: 1122-1126
introduced Trait(s)/gene(s) 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 Similarity to Blackwell Publishing Ltd.
proteins or conventional Dunfield K E, and J J Germida, 2004, Impact of genetically
traits in varieties modified crops on soil and plant mediated microbial communities. J
conventional Environ. Qual., 33: 806-815.
varieties 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.
Potential non-
target toxicity 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
Potential for crops and the escape of transgenes into wild populations. Ann Rev
resistance Potential Ecol Syst., 35: 149-174.
ecological Snow, A A, 2002, Transgenic Crops- Why gene flow matters. Nature
Outcrossing impacts Biotechnology, 20: 542
impacts 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
Each new event is carefully evaluated to ensure L., Raphanus sativus raphansitrum L., Sinapis arvesis L., and
Erucastrum gallicum(Wild.), O.E. Schultz, Theoretica and Applied
that there are no unintended side effects Genetics, 107: 528-539.
(Reference: Annexure III and Article 15 & 16 of Cartagena Protocol on Biosafety) Warwick S I, A Legere and M J Simard, , 2008, Do escaped
transgenes persist in nature? The case of a herbicide resistance
Compiled by: S. R. Rao, DBT transgene in a weed population of Brassica rapa. Molecular Ecology,
srrao.dbt@nic.in 17: 1387-1395.n

APRIL, 2010 BIOTECH NEWS 77


FEATURE

India’s Agri-horticultural Diversity

Conserving Our Biological Heritage

S.K. Sharma Pratibha Brahmi Mukesh Kumar Rana

T
he conservation and sustainable linked to sustainable use. The concern cultivated plant species have their origin
management of natural today is incorporating greater in this region. It is an important Centre
resources is a primary global biodiversity within agricultural of origin and diversity of more than 20
concern today. Increasing population production systems. major agri- horticultural crops including
and rapid technological advances are There are 34 hot spots of rice, beans, cotton, sugarcane, citrus,
putting tremendous pressure on these biodiversity recognized globally and mango, banana, yams and several
resources. Plant genetic resources (PGR) three of these extend into India. These common vegetables and popular species
which encompass the agri-horticultural are the Himalayas, Western Ghats, Sri (see box on pg.79).
diversity are one of the essential Lanka and the Indo- Burma (covering India is also a homeland of
components that hold the key to the very the Eastern Himalayas) region. 167 cultivated species and 329 wild
foundation of agriculture as well as food India is blessed with rich agricultural relatives of crop plants and about 583
and nutritional security for the world. biodiversity including diversity in crop crops are cultivated in India (see box on
During the last four decades of this plants, wild crops relatives, livestock, pg.79). It has about 30,000-50,000
century, rapid progress in the field of aquatic resources, insects and microbes. landraces of rice, pigonpea, mango,
agriculture was witnessed along with the The Indian gene Centre is prominent turmeric, ginger, sugarcane, gooseberries
collection, conservation and sustainable among 12 mega gene Centres of the etc. and ranks seventh in terms of
utilization of PGR. Conservation of world. In addition, India has 26 contribution to world agriculture.
PGR has now become one of the most recognized endemic Centres that are Further, around 1,000 wild edible plant
widely discussed issues in the field of home to nearly one third of all the species are exploited by native tribes.
agriculture and environment. Because of flowering plants identified and described These include 145 species of roots and
high degree of human interventions in to date. Indian region too is a major tubers, 521 of leafy vegetable/greens,
management of genetic resources, center of domestication and diversity of 101 of buds and flowers, 647 of fruits
conservation in production system is crop plants. About 33 percent of the and 118 of seeds and nuts. In addition, uu

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

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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


India’s Agri-horticultural Biodiversity

Conserving Our Biological Heritage

Rice Diversity Collected at NBPGR. Brinjal Diversity Collected at NBPGR.

u which governs access to all genetic Indications of Goods (Registration and per se but a safeguard of material
resources of India and encompasses Protection) Act, 1999 were enacted and developed by a breeder through
provisions for equitable benefit sharing. suitable amendments made in other publication and documentation in public
The International Treaty on Plant existing IPR legislations, which have a domain. This germplasm registration
Genetic Resources for Food and bearing on the product, processes and can be used as evidence in documentary
Agricultural (ITPGRFA) is another technologies developed. The Indian or other forms to create and establish
legally binding treaty which has plant variety protection is unique in 'prior art'.
provisions for facilitated access to 64 providing equal rights to the farmers as Germplasm which can be
crops and forage species, under the breeder and conserver of genetic registered at NBPGR could be any good
Multilateral System (MS). This exchange resources of local importance. To performance material for specific and /
would be under the conditions of facilitate this activity with identification multiple traits (may not be yield
Standard Material Transfer Agreement of distinctiveness of newly developed superior), mutants or with a different
(SMTA). Being a single window system varieties, ICAR has provided the ploidy level than the normal, with
for exchange of small samples of plant requisite support to PPVFR by academic / scientific importance,
germplasm meant for research, NBPGR developing guidelines for distinctiveness, parental lines of inbreds, promising
has developed suitable Material Transfer uniformity and stability (DUS). To date, experimental material or landraces and
Agreement (MTA) for providing access DUS guidelines for 35 crops have been traditional varieties. The procedure and
to PGR both within and outside the developed and notified. Plant variety forms are available at NBPGR’s website
country. protection under the PPV&FR act (www.nbpgr.ernet.in). NBPGR has so
Also, under the GATT/ currently covers seventeen crops; others far registered 729 promising germplasm
WTO/ TRIPs regimes, restrictions have are to be notified soon. So far 1644 accessions of different agri-horticultural
been imposed on free trade in applications for registration in 19 crops. Efforts are being made to get
commodities, including agricultural notified crop species have been received more and more germplasm registered
products. Countries are required to by PPVFRA. Of these, 164 have been through this mechanism so as to
adopt patenting or enact effective sui issued certificates for plant variety enhance its utilization.
generis system or a combination of both, registration.
for the protection of Plant Breeders’ For germplasm registration Future Concerns
Rights. As a national obligation for the there is a system of plant germplasm Each country is interdependent on other
TRIPS Agreement of WTO, the new registration operating at the NBPGR. nations for its germplasm requirements
legislations, viz; the Protection of Plant This system is completely different from since it is not possible to acquire and
Varieties and Farmers Right Act registration of plant varieties of the conserve useful resources to satisfy its
(PPVFRA), 2001 and Geographical PPV&FR Act. This registration of research needs. It is therefore, imperative
germplasm is not a system of protection to collaborate at local, regional and uu

APRIL, 2010 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 Number of Accessions
Landraces Wild and weedy types Others Total
Rice 52615 1171 34895 88681
Sorghum 15429 236 4317 19982
Chickpea 6473 72 7447 13992
Groundnut 5995 217 6044 12256
Corn 5477 6 2003 7486
Cotton 1094 17 5178 6289
Brinjal 2782 530 1038 4350
Potato 148 110 2345 2603
Tomato 338 105 1427 1870
Cabbage 5 ---- 185 190
Cauliflower ---- 5 149 154

u international levels for the acquisition require substantial inputs and a diseases, insect-pests), quality of the
and conservation of the germplasm. It is decentralized evaluation network. With produce, better input-use efficiency and
also obligatory to obey the quarantine the development in information stability of performance. There is also a
and biosafety rules for the safe technology, the necessary tools for growing realization for a wider choice
movement of germplasm especially collation, retrieval and dissemination of and variety of horticultural and
where GM technologies are involved. information, documentation and agricultural products, for which diversity
There is a need to adopt complementary effective germplasm management can be in taste, color, nutritional values and
strategies for conservation of genetic done through sharing of information maturity character is highly valued by
resources involving both in situ and ex- following a network approach. the market. There is a need to modify
situ approaches. For in-situ conservation Further, application of targeted the descriptors for evaluation
due attention is required to be given to and precise molecular tools is required in accordingly, and make the search for the
genetically rich hotspots including the present day genomics driven crop desired characteristics in the database as
natural and protected habitats including improvement programs. The genomics quick and efficient as possible.
tribal belts to strengthen and expand the application calls for higher precision in Registration of genetics stocks
network of germplasm conservation characterization and evaluation of and elite germplasm needs to be
through involvement of all the genetic resource. Such intensive encouraged to promote germplasm
stakeholders, including the communities. evaluations could be practiced only if exchange and effective utilization.
It is to be ensured that a set of the the number of accessions to be evaluated Germplasm developed by public sector
available PGR with associated database is within the manageable limits. Hence, breeders have been freely available to
must be deposited as base collection there is now greater emphasis on the private sector breeders as well. In the
with the genebank, and one set identification of 'core sets' and 'mini changing global scenario under the new
maintained as active collection cores'. These core sets could then be IPR regimes, modalities for benefit
accessible for plant improvement. There subjected to rigorous characterizations sharing by both private and public
is an urgency to assess the germplasm and used for identification of useful sectors will also have to be worked out.
collection in the genebank to understand genes with the help of various 'allele This is urgent to ensure continuity of
the gaps and also identify the duplicates. mining' procedures. germplasm exchange and synergy
Characterization and The current emphasis in crop between the two sectors and models
evaluation are essential to promote the improvement programs is to develop need to be developed for sharing of
utilization of materials. A large number cultivars having genes for resistance / benefits with farmers and communities
of germplasm is yet to be properly tolerance to abiotic stress (such as who are the custodians of our agri-
characterized and evaluated. These tasks drought / cold) and biotic stress (such as horticultural diversity.n

82 BIOTECH NEWS VOLUME 5 | NO. 2


FEATURE

Regulating GM Crops

Global Best Practices

Shanthu Shantharam

I
n spite of the fact that GM crops are and many are not even at the starting agricultural systems, and those following
grown in more than 24 countries of line. Australia, Argentina, Brazil, China, the EU system are caught in endless
the world since 1996 to more than a India, and South Africa are some of the debates. International agencies like the
billion acres, and innumerable scientific other countries that have a working World Bank, Asian Development Bank,
reports and analyses of their safety have biotech regulatory system. Many OECD, UN-FAO, UN-WHO, UNDP,
been attested by world's leading scientific differences still persist between US UNESCO, and UNEP have spent
organizations and regulatory authorities, regulatory agencies and the EU, a sort of millions of dollars for regulatory
controversy regarding their regulatory permanent trans-Atlantic divide. It is capacity building with little progress.
oversight is fraught with endless important to note that there is really not Politicization of GM crops due
controversies surrounding their safety much of a difference of opinion on the the anti-GM activism is the root cause of
and utility. Efforts to internationally safety of GM crops between US and all the irreconcilable differences between
harmonize biosafety and environmental European scientific and regulatory regulators and the activists, and is also a
risk assessment standards have been organizations. The biggest difference major detriment to international
ongoing since the 1990s with mixed between the US and the EU is with harmonization of biosafety standards for
successes. As it always happens, regard to “Precautionary Principle”, a GM crops. This situation is best
pioneering regulatory agencies set the contentious philosophical point. exemplified by the Bt brinjal imbroglio in
early “standards”, and others end up as Developing countries of the world are India. Biosafety standards must be
followers. In case of Genetically caught in a dilemma as to which grounded in “common sense” and
Modified Organisms (GMOs), USA was regulatory system they have to follow. A “scientific consensus”. It is only when
and is the leader followed by Canada. plethora of biosafety and regulatory non-scientific issues related to trade,
EU is the hotbed of all controversies. capacity building programs from EU and intellectual property rights, socio-
Almost all controversies are fanned by USA have only added to the confusion. economic impacts, cultural and ethical
the EU policies that are heavily Those who follow the US regulatory issues are enjoined, endless debate
influenced (politicized) by the greens. system have made tremendous progress ensues. It is really unfortunate the even
The rest of the world has lagged behind, in adding GM crops into their matters of empirical science have been uu

Shanthu Shantharam,Ph.D is Executive Director, ABLE-SIGAB, New Delhi. (E-mail: shanthu.shantharam@ableindia.org)

84 BIOTECH NEWS VOLUME 5 | NO. 2


Regulating GM Crops
Global Best Practices

u politicized by some scientists just to environment. All other objectives are Regulatory trigger for GM crops: The
derail the technology. However, scientific secondary must be entrained to this goal. “Process” vs. “Product” Paradigm.
consensus are relatively easy to arrive by To achieve this goal, nations must use the
This has to do with as to why a GM crop
a group of national or international best possible scientific consensus,
must be regulated and what constitutes a
scientific experts, and that is the only practical guidelines and standard
GM crop. This is what is called the
way to assure proper regulatory oversight operating procedures.
regulatory trigger. As a priori, it is
on any technology so that benefits can
Basic Principles of Biotech assumed that GM crops are regulated
reach the public at the earliest. There are
Regulations because they are genetically engineered.
some excellent documents developed by
On the other hand, nobody seems to
leading regulatory agencies like USDA, Regulations are always a societal
have thought about why other kinds of
US-EPA and US-FDA, EC Biotech Risk construct. In any democratic society, the
GM crops developed using conventional
Assessment Grants Program, OECD, public demands guarantees for safety of
technologies are not regulated. It seems
UNESCO, UNDP, UN-FAO, UN-WHO, any product or technology that would
that in most parts of the world, modern
National Science academies of USA, directly affect their health and the
day GM crops are regulated because they
Brazil, India, Argentina, and the Royal environment. Therefore, regulations are
are “genetically engineered” using the
Societies of UK, Canada, Australia and developed to assure public and
modern gene-splicing technology. It
New Zealand. These reports and environmental safety. As a priority, for a
seems the technology by which a modern
documents developed by scientific rigorous and comprehensive scientific
day GM is developed is found guilty by
experts and serve as beacons for biosafety review and an environmental
default. The end product, namely the
developing a sound regulatory systems impact assessment are a must. It is
GM crop is not even considered. The
based on the best possible scientific imperative that regulators be
illogic of this trigger is that one can
knowledge. It should be relatively easy to scrupulously impartial and objective, and
develop any kind of product using
develop best regulatory practices for any do not present even a whiff of a conflict
conventional crop modification
country based on these documents and of interest while regulating the
techniques, and it would escape
reports to move the technology forward. technology. They should certainly not
regulatory scrutiny because there are
appear to be either promoters or
Goals and Objectives of Regulations: none. One can develop any “dangerous”
opponents of a technology, or a
or “uncertain” GM crop using
The only goal of any set of regulations is particular product.
conventional techniques, and no one will uu
to protect the safety of the public and the

APRIL, 2010 BIOTECH NEWS 85


Regulating GM Crops
Global Best Practices

u question. This is a fundamental point Principles of Biosafety Review chronically maintained that GMOs by
that has been long lost in the present GM Substantial Equivalence, Principle of default are hazardous, and that the
debate. Familiarity and Generally Regarded as genetic engineering technology is
Safe (GRAS) are practical working inherently dangerous. Going beyond this
Biosafety Data Requirements: “Nice to contention, risk assessment can be either
principles simply based on common-
know” vs. “the Need to know” qualitative (descriptive) or quantitative
sense and past experiences. These
The scientific data required to carry out a requiring empirical data. In biological
principles have eminently served some of
rigorous biosafety review or risk systems, quantitative risk assessment can
the leading regulatory authorities to
assessment has to be determined by be arduous as the field based empirical
develop basic standards for scientific
scientific and technical experts alone. data are hard to gather. This is one of the
regulatory oversight of GMOs, and there
Most standard data requirements are contentions that haunt the trans-Atlantic
is no reason why these same principles
genetic stability data (Mendelian divide based on the precautionary
cannot be used in other countries. These
inheritance analysis), molecular data, principle. A practical thing to do is to
are not legal standards, but they are
and bio-chemical data. Plant take a precautionary approach which is
scientific standards for biosafety
morphology and reproduction biology basically dealt with by a regulatory
including food safety.
are also included. Such data review. This accomplishes the idea of
If a GM crop or a GMO, after genetic
requirements can change from time to stop, ask and decide. Using such a
engineering, is left 99% the same or
time as science and technology are precautionary approach, USA, Canada,
identical as its non-engineered
always progressing. It is not necessary Australia, New Zealand, Brazil, China,
counterpart, then such a GMO is
that each and every scientific paper India, Philippines, South Africa, and
considered substantially equivalent. If a
published on a day to day basis be many other countries of the world have
GM crop or a GMO is considered
incorporated into the review standards. commercialized GM crops without a
substantially equivalent, meaning no
There should be a scientific committee of single instance of causing human or
different from an organism that has been
experts who will review the progress in environmental harm in the thirteen year
in safe use for decades or centuries, then
science and technology on a biannual or history of GM crops commercialization.
such a GMO can be considered
annual basis to determine the scientific EA is a powerful decision making tool
“familiar”, and as such that GMO can be
consensus needed to establish the for regulators.
evaluated using the previous knowledge
regulatory standards of the day. For What is really critical in an
and experience of that particular
example, a set of 29 new tests for every Environmental Risk Assessment (ERA)
organism. Following these two
GM crop has been proposed in India is the nature of the organism and the
principles, one can classify a given GMO
which might take two or three decades environment into which it is being
as GRAS based on safe history of use of
based on all fanciful techniques that have introduced. Since the environment differs
the organism and the specific gene in
come to the fore recently (J. Biosci. from place to place and country to
question. Any specific genetic change
(34)2), June 2009, 1167-168). It is an country, an Environmental Assessment
that has been introduced, is all that one
egregious example of going overboard (EA) is a must. EA can be a simple and
needs to evaluate for biosafety.
with data requirements that fall neither direct method of determining the risk of
into the “need to know” or “nice to Risk Assessment introducing a GMO into a particular
know” category, and in no way informs Risk assessment of GMOs or any other environment. It must be remembered
the biosafety assessment. Leading technology product goods or services can that EA assesses not only the agricultural
regulatory authorities in US, Canada, be a dicey or tricky proposition. environment, but the neighboring
EU, Australia or New Zealand, who have Therefore, extreme care and environment as well. EA is mostly
more experience in commercializing GM consideration must be given to identify qualitative.
crops do not require this kind of data, the necessary criteria. Risk is nothing but Environmental Impact Study
and bears no resemblance to what is hazard X exposure, a classical formula of (EIS) is the most time consuming of all
recommended by the CODEX risk assessment. Hazard in this formula risk assessments that can take years. EIS
Alimentarius. Such data requirements assumes that GMO is a priori hazardous, needs lots of empirical data which will
create an uneven field where only which is unfortunate. By and in itself, the take years to develop. EIS is done when
companies with deep pockets will term hazard is a cause for great deal of an EA comes to a Finding of No
dominate. It is far more utilitarian to contention. People have been tired of Significant Impact (FONSI). There are
examine the experience of other arguing that GMO by default is not instances of certain environmental
regulatory authorities to develop hazardous, but anti-technology activists projects that have been delayed decades
standards for data requirements. and anti-GM campaigners have because of EIS. If a regulatory authority uu

86 BIOTECH NEWS VOLUME 5 | NO. 2


Regulating GM Crops
Global Best Practices

u takes the EIS route without proper test for a given GM food. All these tests public meeting to discuss the review, such
scientific cause, approving a GM crop must be decided by experts alone. meetings must be organized in different
will remain a pipedream. That is a sure locations to seek public input both
way of killing a technology. Moreover, Risk/Benefit Analysis verbally and in writing in an organized
EIS is the costliest way of regulating In the GM debate, one mostly hears fashion. Mob frenzy of the type
technology. At present the Supreme about the risks, and not enough about the witnessed in the recent Bt brinjal
Court of USA is hearing an EIS case on benefits. It is imperative that regulatory “consultations” must be avoided. All
herbicide resistant alfalfa whose EIS was authorities convince the public about information must also be posted on the
prepared by USDA, APHIS which took both risks and benefits in an impartial web site by indicating how points raised
over five years. If principles of way. Risk/benefit analysis is perhaps one by the public have been addressed. It is
substantial equivalence, familiarity and of the most important regulatory needs important to note that it must be made
GRAS are used, there should be no need to convince the public that in spite of extremely clear that not all points can
for EIS. It must be remembered that certain risks, the technology product is and will be incorporated into the review,
almost all GM crops are already more beneficial, and that risks can be and reasons for not incorporating must
established lines in commercial mitigated by oversight mechanisms. be spelled out.
production, and therefore, they all Risks of opportunity costs must be
eminently fit into the above principles. included in such an assessment. This Decision Making and Communication
For commercialization purposes, the way, one can assess the loss for not All decision making authority must be
most important data requirements are introducing the technology product. solely vested with the regulators who
the agronomic performance data under a have statutory responsibility for decision
variety of agro-climatic conditions so
Deregulation and Commercialization making. No member of the public must
Deregulation means declaring that a be allowed to participate in the decision
that its efficacy can be reasonably
regulated GM crop is determined to be making process. This is different from
assured in the farmer's hands. In fact,
no longer regulated, and allow it for seeking public input in consideration for
these things are carried out routinely for
commercialization. However, decision making. Using a decision
any new crop variety introduced to the
commercialization is done by the making tree will be extremely useful in
market. It is in the interest of purveyors
purveyors of the technology product, and this exercise. A statutory authority is like
of GM crops to make sure that their
not by the regulatory authority. But, the a court of law where litigants can only
product is a superior product and does its
authorities can or may impose conditions argue their case, but the judgment is
intended job in the field.
for commercialization. Deregulation is rendered by the judge. If the decision is
One can do an intelligent and
done after satisfying all conditions of in the negative, reasons for declining the
scientifically reasonable ex-ante EA
safety and environmental risks and the application must also be explained. It is
which would be sufficient for the
needed risk management mechanisms important to bear in mind that a
purposes of contained and confined field
are in place to mitigate such risks. statutory body's decision is subject to
tests and deregulation. An ERA may be
carried out post-commercialization. If judicial review when challenged.
Transparency and Accountability The decision must indicate the
post-commercialization monitoring is The entire process of regulatory
needed, post-ante analysis can be carried date on which it will come into effect and
oversight must be conducted in a
out from the empirical data gathered over how long it will be effective, just in case.
transparent way without compromising
several years. It should contain conditions that may be
legally permitted protection for
imposed on a case by case basis. The
confidential business information(CBI).
Food Safety decision must be signed by a competent
This is the only way to inspire public
Food safety tests like allergenicity, person in the authority and
confidence in the regulatory system. It is
toxicity, teratogenecity, and communicated in writing to the
best to use the worldwide web to the
carcinogenicity should always be carried applicant, and posted on the web site. In
maximum, but in a timely manner.
out according to the standards certain extraneous situations, it may be
Authorities must post a copy of the
established by the CODEX, a joint necessary to announce the decision
application immediately declaring that
standard setting body that draws through mass media.
the application is complete and accepted
scientific and technical expertise from
time to time. Long term chronic studies
for regulatory review. A draft of the Public Participation
biosafety review and EA/ERA must also Clear distinction must be made about
must be indicated by standardized
be posted on the web for public comment public input from that of public getting a
preliminary tests. There has to be a
giving a definite period of time. seat at the decision making table. It is
strong scientific indication for any other
In the event of a need for imperative to seek public comments and uu

APRIL, 2010 BIOTECH NEWS 87


Regulating GM Crops
Global Best Practices
(Contd. from page 87)

other inputs at the time of review and principles and guidelines must be assessment has a place in larger scheme
decision making, and address them all. developed to protect the CBI. If not, the of things, and must be encouraged, not
All irrelevant comments and inputs authority is likely to be challenged in the as a part of a biosafety regulatory review
should be pointed out as such. This is courts. process. This will have to be done from
best accomplished by through internet time to time as societal circumstances
based input. However, other forms of Cost of Regulations also change from time to time.
input must be allowed in writing. It is not Whatever be the regulations, there is
necessary that all inputs must be always a cost associated with it, both for Conclusions
incorporated, and reasons for not the regulatory authorities and the Regulations and regulatory standards are
incorporating must be spelled out. applicant. Unnecessary regulatory not etched in stone as science and
burden will increase costs of regulation technology keeps progressing all the
Statutory Time Limit and regulatory compliance which will in time. Regulations must keep pace with
Because time is money, all applications, turn make the technology costlier, and the technology development. Regulations
either for contained or confined or large even threaten to stop technology have always come after the development
scale/commercial release must be development. That is why it is important of technology, and have had a
reviewed within a statutory time period to carry out proper risk assessment and tremendous impact on technology
so that there is standardized period in regulate it scientifically as the identified development. Improper or undue
which the application will be disposed risks dictate. The most important goal of regulatory burden can hamper
of. This time limit must be fixed regulations must always be safe technology development and this must
depending upon a reasonable time deployment of GM crops based on not be allowed to happen in case of
required to complete the regulatory scientific risk assessment alone. modern biotechnology in Indian
review. However, the authority can Therefore, scientifically based regulations agriculture. Risk appropriate regulations
reserve the right to “stop the clock” to must be the standard bearer of any must be the corner stone of any sound
resolve a legal or scientific or technical regulatory system. Cost of regulations regulatory system, and therefore rigorous
issue relative to the application. This will can seriously hamper technology scientific standards alone must underpin
establish a level playing field for all development all over the world. the system.
applicants, and pave the way for planned A reliable, credible and
commercialization. Socio-Economic Impact Study confidence inspiring regulatory system is
Socio-economic impact study is dictated the order of the day. Regulations must
Confidential Business Information by the Cartagena Protocol on Biosafety not be allowed to be used to stifle
(CBI) and governs only the trans-boundary creativity and technological
In this competitive world, it is critically movement of GMOs. In other words, it development. Politicization and
important for the developers of is important for any developer of the ideological motivations must not be
technology to protect their CBI from technology or user of the technology to allowed to dictate either the regulatory
leaking out into the public domain determine risks, benefits of the framework or the regulatory policy.
through the regulatory process. In technology and its good services, and When a science based dynamic
accordance with the Right to how it might be accepted by the public in regulatory system is in place, there is no
Information Act (RTI) provisions, sound their societal context. Such an 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 introduced, and India is no exception to Agreement on the Application of
approved genetically engineered this practice. India's biosafety regulatory Sanitary and Phytosanitary Measures,
(GE) plants for cultivation or system has experienced a number of Agreement on Technical Barriers to
consumption (see table on pg 89). changes since the Rules for the Trade, Agreement on Trade-Related
Common to all of these countries was Manufacture, Use, Import, Export and Aspects of Intellectual Property Rights)
the establishment of a system to regulate Storage of Hazardous also affect regulatory approaches and
these products and particularly to ensure Microorganisms/Genetically decision-making. In order to be
their evaluation for human health and Engineered Organisms or Cells 1989 responsive, governments need to review
environmental safety prior to their (Rules, 1989) were first notified under and, when necessary, amend regulatory
commercial release. While there is no the Environment (Protection) Act, 1986, operations. Australia, for example, has
single best model for regulating GE including the elaboration of a series of formalized this in the Gene Technology
plants, the hallmarks of a functional guidance documents published by the Act, 2000, which required a statutory
biosafety regulatory system can be Department of Biotechnology (DBT) in review of the operations of the Act after
captured by the terms adaptability, 1990, 1998, 1999 and 2008. This kind of four years.
transparency, workability and clarity. flexibility is essential as a regulatory
This article examines each of these system must be able to adapt to the rapid Transparency
characteristics in the context of India's innovation in biotechnology research, The process by which regulatory
and other countries' national biosafety development and product deployment if changes are made is just as important as
regulatory systems. public confidence in the system is to be the changes themselves. Transparency,
maintained. Additionally, multilateral consultation and attention to meaningful
Adaptability negotiations related to environmental public participation and engagement are
Biosafety regulatory systems in all and human health safety (e.g., Cartagena very important in this regard. Again,
countries are dynamic. There is no Protocol on Biosafety, International Australia provides one of the best
example where the regulatory system Plant Protection Convention, Codex examples in terms of the measured
remains exactly as it was when first Alimentarius) and trade (e.g., process that was followed with the ult is uu

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 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?

Competent Regulatory Authorities for Food Safety


and GE Food Safety in Selected Countries
Country Competent Regulatory Authority
Food safety GE food safety
Argentina Servicio Nacional De Sanidad (SENASA) Servicio Nacional De Sanidad (SENASA)
Australia Food Standards Australia New Zealand Food Standards Australia New Zealand
China Ministry of Health Ministry of Health
Canada Health Canada Health Canada
European Union European Food Safety Authority European Food Safety Authority
India Ministry of Health & Family Welfare (Food Safety & Standards Authority of India) Ministry of Environment & Forests
Japan MoHL&W MoHL&W
South Africa Dept. of Health Dept. of Health
United States Food and Drug Administration Food and Drug Administration

u sector, and not within the government case-by-case assessment of products. regulatory system and other regulatory
bureaucracy itself. If the decision is Advisory committees can be used to systems within the government is
made to locate the risk assessment address specific issues of scientific understood by members of both the
function within the regulatory authority, uncertainty. For example, new risks that regulatory and regulated communities.
as has been done in the U.S., Canada may arise with advances in the genetic The regulation of GE foods in India
and in Australia's Office of the Gene engineering of plants and foods can be provides an example of how difficult this
Technology Regulator, then the proactively identified and product risk can be to achieve, although regulatory
government must be committed to assessment and management practices reforms are currently being pursued to
developing the appropriate expertise. changed if required. Such committees address this.
This is generally achieved through the can also be used to address limitations in In countries with mature
hiring, secondment and/or retraining of national scientific capacity by leveraging biosafety regulatory systems, the
scientific staff. Alternatively, and in an sub-regional or regional expertise with regulatory authority for GE foods is the
approach that has been utilized in the additional advantage that the same authority that is responsible for
countries such as Argentina and South committee's output may then have a administering food safety law(s) (Table
Africa, the regulatory authority may broader application. The use of in-house 2). This recognizes that the safety
appoint an expert advisory committee to scientists to assess products on a case-by- assessment of GE foods is part of, and
undertake risk assessments. If advisory case basis permits the development of not separate from, programs that address
committees are used, then appropriate considerable expertise within the the broader context of ensuring the
conflict of interest provisions must be in regulatory agency, provides for a degree safety of the foods that the public
place to ensure that the developers of of consistency not afforded by the ever- consumes. The “GE nature” of a food
GE plants do not end up in a position of changing membership of advisory derived from a GE crop or other GE
assessing their own products. In either committees, and can address the real or organism is not (and should not be) the
case, the regulatory agency/body should perceived conflicts of interest that arises solely defining characteristic of that food
have some foresight mechanism in place if product developers are also product as regards safety. Other, and arguably
to identify potential knowledge gaps, assessors. more important, food safety and food
and to promote and access training or quality considerations and associated
the recruitment of new knowledge. Clarity laws, regulations, standards and
The best approach may be to use Achieving clarity in a regulatory system guidance apply to GE and non-GE foods
elements of both as has been proposed is one of the most challenging tasks to alike, which is typically why GE food
for the Biotechnology Regulatory confront regulatory authorities. It safety assessment is positioned within
Authority of India: Expert Advisory requires that the scope and objectives of ministries of health and their associated
Committees that provide guidance for laws, regulations and guidance are food safety and standards agencies. India
the development of new policies, unambiguous, the division of has been a notable exception to this
coupled with in-house scientists who responsibilities between government practice as the authority to approve or
work as part of a multi-disciplinary ministries is clearly defined, and that the not approve a GE food has been vested
safety assessment team to conduct the interrelationship between the biosafety with MoEF under the Rules, 1989. This uu

90 BIOTECH NEWS 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
Indian GMO Research Information System (IGMORIS) is
Capacity Building Activities a database on activities involving the use of GMOs and
products thereof in India. The primary purpose of this New Set of Guidelines
Documents/Publications website is to make available objective and realistic
scientific information relating to GMOs and products Guidelines and Standard
Funding Organizations & thereof under research and commercial use to all Operating Procedures
Schemes stakeholders including scientists, regulators, industry and (SOPs) for Confined
the public in general. It is also expected to promote Field Trials of Genetically
R&D Funding/Biosaftey national and international collaborations. Engineered Plants
Proformas
Department of Biotechnology Guidelines for the Safety
Searching the Database Assessment of Foods Derived
Ministry of Science & Technology read more from Genetically
Government of India Engineered Plants
Other Important Links
Compiled by: Biotech Consortium India Limited Protocols for Food and
Feed Safety Assessment
Login Registration (Free) of GE Crops.

Logout

Send a Mail
Website of : INDIAN GMO RESEARCH INFORMATION SYSTEM

u means that the regulation and associated system as possible. For example, country, and biosafety regulatory
safety assessment of GE foods is national biosafety regulatory systems are systems are no exception to this. The
disconnected, programmatically and responsible for the environmental risk Government of India has identified
operationally, from the food safety assessment of GE plants and approvals biotechnology as a key driver of India's
regulatory system writ large. With the are granted for the “event” defined as a economy in the 21st century and there
promulgation of the Food Safety and genotype produced from the have been significant investments in
Standards Act, 2006 (FSSA, 2006), transformation of a single plant species biotechnology research and development
which empowers the Food Safety and using a specific genetic construct. This in both the public and private sectors. In
Standards Authority of India to regulate means that any lines, varieties or hybrids agricultural biotechnology, India has a
all GE foods, this situation is likely to derived from an approved event through rich pipeline of GE plants under
change. However, as of now and until conventional plant breeding are also development. Catalysts like agricultural
such time as rules and/or regulations for approved. These derived progeny are not adaptation to climate change, the food
GE foods are notified under the FSSA, submitted for further assessment within security crisis of 2007-08, and increasing
2006, notification S.O. 880(E) in the the biosafety regulatory system as demand for renewable energy have
Gazette of India allows for the biosafety has already been addressed. accelerated plant biotechnology research
continued regulation of GE foods under Instead, they enter directly into the plant on a range of new traits and new plant
Rules, 1989. This means that the variety registration system where they species. Innovation in this sector requires
decision to approve/not approve a GE are evaluated for agronomic a biosafety regulatory system that
food remains with MoEF, through performance (e.g., yield, disease and supports research, development and
GEAC, until S.O. 880(E) is kept in quality) in the same testing program as deployment of GE crops while ensuring
abeyance. any other conventional variety or hybrid that environmental and human health
In all countries, biosafety evaluations of of that species. In this way, the mandate safety are appropriately considered and
GE plants are but one part of a larger to assess the environmental safety of a secured. This means that investments in
regulatory scheme that may also include GE plant (which is a specific agricultural biotechnology should not be
laws, rules and regulations pertaining to requirement applied only the GE plants) limited to product development but also
plant health and quarantine, plant is kept separate and distinct from the applied to ensuring that the regulatory
variety protection, variety registration mandate to evaluate plant performance system is as robust as the community it
and seed certification. Inter-ministerial (which is applied equally to GE and regulates. Continuing to address
coordination is essential to ensure that non-GE plants). adaptability, transparency, workability
the roles and responsibilities of the and clarity within India's biosafety
various involved agencies are clearly Concluding Comments regulatory system is of benefit to all the
defined and that associated programs Regulatory systems necessarily reflect stakeholders it serves and, ultimately,
work in unison to create as seamless a 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 varieties from Mexico. From the early 90s, triggering an array of patents for
improvement during the period 90s genetic engineering created a gene functions. However, subsequent
1930-60 focused on agriculture revolution in accelerating trait discoveries indicated that the
implements to increase farm productivity development and crop yield organization of the genome is much
resulting in an initial wave of patents in improvement. Over the last two decades, more defined by quantitative synergies of
the USA and Europe. During the next the agro chemical industry lagged behind gene clusters (networks) than by the
thirty years, the research intensity moved in introducing new molecules due to function of a single gene. Inventors
to development of new molecules for prohibitive costs involved in developing preferred complex claims that aimed at
agro-chemicals. Plant breeding efforts them and the increasingly stringent vertical integration of technologies by
continued during this period with the norms required to validate their safety disclosure of synergies of gene clusters.
father of the Green Revolution, Dr. and efficacy. Similarly, breeding efforts The complex intellectual assets
Norman Borlaug, providing vital also declined because of the steep decline governing genetically engineered crops
germplasm access for wheat to the in public investment for breeding originated in this context. Patent claims
developing nations around the world, programs. moved from isolated gene functions to
including India. Significant research complex models of gene functions.
investment for agro chemicals emanated Research in Genetic Engineering Claims were widened on role of an
from the private sector, while the Turns Multi-Dimensional isolated DNA sequence conferring gains
research investment for plant breeding The advent of genetic engineering in a wide array of organisms. Multi-
vested with the public sector. This was provided hope in a significant way to functionality and the transfer of trait to
the era of successive release of improved stimulate productivity in agriculture. another organism triggered integration
varieties by the public sector in major Initial set of inventions in genetic efforts to gain access to a set of
agricultural regions. Germplasm moved engineering resulted in inventors securing biological materials (e.g. use of promoter
freely across the regions. A restrictive patents for genes that were identified as a to enhance biological activity) that were
regime for germplasm would have denied distinct DNA sequence with a fixed cumulatively responsible for
India's access to high yielding wheat function. The trend continued during the commercially delivering a trait value. uu

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 VOLUME 5 | NO. 2


Investments in GM Crops Research

Power of Partnerships

TRADITIONAL RELATIONSHIP MODEL NEW RELATIONSHIP MODEL


(Converging investment and research efforts)
Public Research
Investment Market
Public & Private
Investors

Market
Public Research Corporate Research
Public Research Corporate Research

Emerging relationships will drive consolidation of research investments


and research commercialization efforts.

u In order to differentiate the claims, provided rapid gains to the corporate and other trait factors.
improvement patents were filed with sector to bring out products by bundling
modified gene sequences during the early biomaterials and technologies. The Europe Continues to Invest in Genetic
part of this decade. The result is that integration efforts provided further Engineering Research
every gene of interest that is perceived to opportunity for cross-country The European Union and the national
have value has been, in some way or partnerships through cross-country research systems within Europe,
other, patented in developed countries. It licensing. The classic case is the however, continued to invest in research
is true that the current IP regime in integration of trait gene for cotton in for the development of genetically
countries such as USA are rethinking Indian cotton hybrids during the early engineered crops. Large European
their acceptance of broad claims for gene years of the current decade. companies have realized that they were
patents. Future patents are likely to lagging behind and initiated efforts to
recognize a limited coding sequence Europe Lags Behind Due to Low Public accelerate the research for new trait
rather than recognizing patents for the Confidence and Multiple Outbreaks of development through genetic
whole sequence itself while limiting the Zoonotic Diseases modification. In a recent effort by the
claims for the “Field of Use” factor. While these efforts were successful in EU researchers, this writer was engaged
Research Universities and private USA and parts of the South American in exploring application of inventions
enterprises in the USA led the region (Brazil and Argentina), Europe that have originated within EU for
integration efforts in the last fifteen years, had faced the problem of the mad cow expeditious commercialization within
with the public sector and the private disease in the 90s and was extremely and outside the EU. Improved regulatory
sector engaging collaboratively to cautious about adopting new consensus, recent approval of genetically
integrate functions of genes and further technologies. Public confidence in engineered potato, increasing acreage in
integrate them in the genome of the science was low and their trust in the countries such as Spain and the pressure
crops of interest to pyramid multiple regulatory system was even lower. The of negotiations within WTO are
traits that were sought by the farmers. European Food Safety Authority (EFSA) triggering a new paradigm shift in
Simultaneously the regulators came into existence in this context. European perspectives. There are over
(Environment Protection Agency, However, public fear, lack of 400 effective patents filed in Europe that
Federal Drug Agency and United States understanding of emerging science at all are being explored at various stages of
Department of Agriculture) created a levels and successive outbreak of commercialization by the public and
vibrant and transparent regulatory zoonotic diseases did not revive public private sectors within Europe and
mechanism and the rapid advancement confidence in novel foods. Most parts of elsewhere in the world. European
of science coupled with public Europe experienced a sense of self denial companies have commercialized
communication and dissemination of in accepting novel foods and the lack of genetically engineered crops in several
technology created the gene revolution consensus within the European parts of the world including USA, Asia
for the grain and oil seed crops in USA. community denied inventors the Pacific and South America. European
IP pooling efforts through “in-licensing” opportunity to demonstrate successful research organizations have licensed
of biological materials and technologies inventions in crop yield improvement invaluable traits to entities in the public uu

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Investments in GM Crops Research

Power of Partnerships

u and private research system for North America and South America, the introduced in emerging markets would
commercial exploitation and are in markets in these regions will tend not be governed by in-country patent
receipt of royalties from such towards marginal growth. The key restrictions, thereby creating free market
commercialization. Europe begins to market growth for seeds will emerge in competition.
realize that innovations will flow to Southern and Eastern markets, more
markets and if such innovations are specifically in China and India and in Where do Emerging Countries Gain
denied access, it would only endanger countries such as Brazil, South Africa Access to Genes of Interest?
regional competitiveness. and in a limited way, North Africa. The Gene exploration is dependent upon
advent of these growing markets will understanding the functions of genes and
Is There a Threat from the Narrow drive technologies from hitherto countries such as India or China have not
Concentration of Patents for Genetic developed countries of the West to Asian committed billions of dollars in
Engineering Technologies in a Few and other developing regions. Many of genomics and proteomics platforms the
Hands? these markets do not have a strong patent way the Western world has invested
This question is often brought up by regime. Will this deter the technology during the past two decades. Academic
opponents of genetic engineering science owners to step into those markets? Not researchers and large private entities in
to argue that the concentration of patents really. In India, Monsanto introduced countries such as USA, parts of Europe,
would create a near monopoly, their genes in cotton at a time when the Australia and Canada are in a position to
threatening the food security of many protection regime in the country was generate significant leads for candidate
nations. It is true that these inventions virtually non-existent. A third of the genes and pursue those candidates for
were exploited by multinational emerging markets that have potential for validating their functions and efficacy.
companies in large acreage crops such as high growth markets do not have One successful candidate emerges out of
Cotton, Soybean, Corn and Canola in advanced regimes (in countries such as myriads of prospective genes of interest.
the Americas. This was quite appropriate Indonesia and Bangladesh not even a This multi billion dollar effort is
in countries such as USA and Brazil basic one) for patent enforcement. This significantly limited to few nations and
where large acreage farming is quite will not deter research efforts in moving within the nations to few players due to
common. Only 2% of Americans are into regions of high market growth. the intensity of investment in upstream
engaged in farming today and it made Research efforts will move to the region research. However, this does not deter
perfect sense to adopt widely where the markets emerge. This is well entities engaged in crop improvement
disseminated technologies developed by evidenced by the surge in research research to access technologies. The
few sources for improving productivity investment for genetic engineering model is akin to the development of chip
and gaining a competitive advantage for research in China during the last five technology. The world over, INTEL and
the nation. These efforts have provided years. China has committed over $ 1.5 AMD invest in developing faster and
USA with a significant global billion for genetic engineering research more reliable chips and rest of the
competitive advantage for producing with further trenches of investment product developers integrate the
high quality grain crops at the lowest forthcoming to accelerate this research advanced chip technology in their
cost. process. Lack of access to patents has not products. The “INTEL INSIDE”
However, multinational companies have deterred China in advancing their concept is quite true for biological
not applied the same biomaterials and research for new trait development. research
technologies to develop traits for small China has adopted a judicious licensing and this is
acreage crops. The low acreage of process for bio-material access precisely the
vegetables grown by farmers in USA has complimenting their huge resource approach
so far restrained large companies from commitment for research. China has also that the
engaging in development efforts for such leveraged their initial low “in-country crop
crops. Some critics in India argue why capacity” with external research by improve-
India should be the first country to contracting leading American ment
develop Bt brinjal. This is because brinjal Universities to engage in collaborative researchers
is not a crop of interest for Americans or research. Initial products or traits that are have taken
Europeans as much as it is for Asians. brought to emerging markets in crops of in
Who else will focus on developing crops regional interest would primarily have developing new traits in popular
that have predominant regional interests? biomaterials that are currently de- cultivars to make them more relevant to
While the extent of adoption of regulated elsewhere in advanced markets. ensure continued adoption by farmers. uu
genetically modified crops is extensive in Most of these de-regulated products

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Investments in GM Crops Research

Power of Partnerships

u Technology
Access Models for licensing and sub-licensing of bio- practices in research, regulatory
Emerging Countries materials, know-how and research tools, validation and responsible product
both to public and private research dissemination. The donor expects the
There are four possible models that
systems within India. Sathguru has been recipient to engage in responsible
would emerge in this technology transfer
a large repository of bio-materials in application and use of technology for the
and product development process for
region and we have had a surge in public good. The public research
genetically modified crops in emerging
request for licensing bio-materials in the investment to encourage crop
economies.
recent years. China leads the world effort development based on public good
Technology Flow to Research Centers today in licensing bio-materials and donations of technologies will help to
Created by Ventures in Emerging technologies for genetic engineering of address resource poor farmers gaining
Economies crops. Gene technologies licensed by a access to technologies for low acreage
While multinational companies possess leading university such as Cornell to crops and crops of lesser commercial
the advantage of bringing currently de- Indian and Chinese partners at the same interest. Otherwise, these crops tend to
regulated products from other regions to time has attracted ten fold investments in become extinct from commercial
countries such as India, the limitation China as compared to Indian public cultivation, threatening the vital bio
exists in accessing cultivars of regional partnership efforts. China is ahead of the diversity of the country and nutritional
interest. A successful event is made up of rest of the world in developing traits for security. The public sector will play a
proven functionality of the gene and the biotic stress mitigation in rice (China had more predominant role in addressing
genetic background in which the gene is just approved the event for commercial traits in plant varieties that are currently
inserted. Companies with foresight seed multiplication when India imposed under-researched by private entities. If
understand that the process of breeding moratorium on the Bt Brinjal). the three public partners (Tamil nadu
is a long drawn effort and some of them Aggressive licensing efforts have also Agricultural University, Coimbatore;
have begun efforts in this area in right commenced in other countries such as University of Agricultural Sciences-
earnest. However, many of the global Brazil, Argentina, South Africa (cotton, Dharwad; and the Indian Institute of
companies do not have an interest in potato, vegetable crops et al). Indian will Vegetable Research, Varanasi) had not
small acreage crops and therefore will lag behind China, but we do hope that engaged in the development and
limit their breeding interest in large the Indian enterprises and Indian public validation of Bt brinjal, twenty two
acreage crops, more specifically grains entities will intensify their efforts, once popular varieties accessible to resource
and oil seeds. the Bt eggplant moratorium is resolved. poor farmers would not have been
possible.
Technology Partnerships for Joint Licensing of Technologies for Pro- In conclusion, public research at the
Product Development bono Application in Orphan Crops and global level will increasingly be
Joint venture partnerships have occurred
Small Acreage Crops integrated across the countries engaged
in the past in the agro chemical sector This is a reality that would happen to in progressive research at the upstream
and in sectors other than agriculture, develop crops that are not very attractive level. Cross-country partnerships in
extensively in India. The seed sector will for large commercial entities to commit genomics platforms, SNP consortiums,
not be an exception. Pooling of genes their shareholders' funds. Donation of sharing of genetic resource database and
and germplasm through joint ownership technologies for public good advantage is other efforts will increase among the
will occur. However, valuation factors a reality. It is true in the case of Bt brinjal progressive nations. India has the
and promising growth potential will turn that has been developed by public potential to play a key role in this regard.
many companies to aspire for controlling partners in India (all the public partners At the mid-stream level, sharing of bio-
interest in ownership. Indian seed have the right to deliver technology to materials, research tools and
companies are very possessive of their resource poor farmers and have no technologies for accelerated trait
controlling interest, just as Chinese obligations whatsoever to Monsanto, as integration will flow to regions that are
companies are. claimed in many quarters). Bio-material attractive with high market growth. At
donations have taken place for the the downstream level, technology
Licensing of Technologies for development of late blight resistance in licensing will accelerate with corporate
Commercial Exploitation potato, drought and salinity tolerance in entities and public research entities
Licensing technologies for commercial rice and virus resistance in crops. My engaged in integrating bio-materials for
exploitation will drive the growth for new organization has provided access to trait integration and validation. Our
product development. During the past several vital genes of interest to public success in India will depend upon our
three years, there have been several research partners. These partnerships ability to nurture the co-existence of
thrive on mutual recognition of best these diverse forces for synergic gains.n

APRIL, 2010 BIOTECH NEWS 95


FEATURE

Investments in GM Crops Research

Public Sector Priorities

S.K. Sopory

T
he pressure for the production rescue once again. They can help us the agri-sector. In this regard India and
of more food for growing reject the Malthusian hypothesis and China and a few other countries are an
population, especially in the usher in a third generation agriculture exception in the sense that they have
developing countries, and its availability revolution supported by new technologies and expertise to utilize the
at an affordable price for the low income biotechnologies, in contrast to the first new biology paradigms, such as
consumers will always remain unless green revolution which was propelled by production of GM crops, and
and until the population load decreases the use of dwarf varieties and, the importantly these are available in the
at this part of the planet. However, one second revolution which was driven by public sector. However, their field- level
does not foresee this happening till next using hybrid vigor. More serious application has been hindered due to
50 years or more in the Indian deliberations are needed to find out how exhaustive costs involved in the
subcontinent. Therefore to produce to optimize the use of biotechnologies in experimentation for testing for biosafety
more food from the same arable area, general and GM technology in and environmental safety, and also due
infact from decreasing cultivable land, particular, to improve food and to the scare raised in the minds of public
will be a major challenge for the nutritional security in our region. against GM crops. Recently, China
scientists, policy makers, farmers and While the above question may announced the approval of GM rice and
other stake holders. All of them will be more global in nature, it has special maize for commercial cultivation. The
have to work in unison, whether they relevance for the Asia- Pacific region public sector in India will, therefore,
represent the public sector bodies or where about 53% of its 3.6 billion people have to further increase its inputs in the
private sector organizations, to remove are engaged in agriculture (& related agriculture biotechnology area and work
hunger and malnutrition, which are activities) and yet hunger and on many traits of agronomic
some of the biggest challenges facing our malnutrition is widely prevalent here. importance to enhance food production.
country. We feel that new technologies This region has high biodiversity but not We suggest that the present support
like GM plants, other innovations, enough strengths in developing towards this by DBT, CSIR, DST and
farming practices, business models and knowledge based applications of others should be continued or even
consumer awareness can come to our modern biotechnologies specifically in increased towards the development of uu

S.K. Sopory Ph.D is Senior Scientist, International Centre for Genetic Engineering and Biotechnology (ICGEB), New Delhi.
(Email: sopory@icgeb.res.in)

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Public Sector Priorities

u GM crops, as their production will genetic material within and across cases, some health and environmental
overcome many constraints in achieving genotypes to obtain desirable safety issues associated with adoption of
higher productivity, despite the combinations. Creating new variations GM technology, these concerns need to
controversy raised by the non-scientific from the existing ones was infact taught be addressed quickly. India is one of the
debates on GM brinjal. to us by none other than a monk, Gregor few countries in the developing world
Since the time mankind learnt Mendel. Having come a long way from that put the appropriate regulatory
to domesticate plants for food and feed phenotype based selection, which of systems in place to address these
and other daily needs, they have always course is relevant even today, we have concerns related to human, animal and
sought to incorporate new experience, assigned genes governing various environmental safety. Infact, it is with
knowledge and tools to increase physiological and developmental traits ever increasing demands from various
productivity. The techniques of in plants. Using the same genetic corners, justified or not, that the
developing new varieties and strains foundations laid down by Mendel and biosafety regulations have become more
through selection, hybridization, and his many successors and making use of stringent which have made it almost
mutation, exploiting hybrid vigor and high-end technologies and genomic impossible for many public sector
overcoming crossability barriers between approaches, it is possible to first identify organizations, for lack of increased
cultivated and wild species, use of tissue specific gene or genes controlling a trait financial support and expertise, as
culture for multiplication, and anther and in turn use them in a more surgeon- mentioned earlier, to convert their
culture for haploid breeding and like- precision and also in a predicable discoveries in the laboratory to products
dihaploid production have evolved with way to modify the targeted characters in of immense use to the farmers and
time and have been applied with great the crops of interest. The GM consumers. The gap between discovery
success in a number of plant species. technology has enabled sourcing of and product is currently filled by private
Though not obvious to farmers, desirable traits across wide species companies. Initially, it was the domain
consumers or policy makers, the scientist barriers, thus greatly expanding the only of some multinationals but over the
knew that the basis for developing choice of genes available for crop years indigenous companies have also
variability was infact the shuffling of the improvement. There may be, in certain come up with investments in this sector. uu

APRIL, 2010 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 water, land and energy. Therefore one Selection can be even done under the
catalyzed by Govt agencies like DBT will have to either look for genetic simulated conditions that may be
who have initiated programs such as variability in the crop plants which will brought forth due to climate change and
SIBRI and BIPP to support public be able to adapt to the above scenario or global warming. If the variability can be
private partnerships to convert ideas, one has to create new biotech crops obtained from the existing gene pool
knowledge and technology to quickly capable of growing well under the above within the species or wild related
take products from laboratory to constraints. species, one could then employ these in
farmers, which will yield high dividends One general area in which the the breeding programs. It has however
in terms of enhanced productivity with public sector should invest in is in the been seen that for many of the complex
minimal inputs. area of phenomics. Being a highly traits, which are governed by multiple
Keeping the above points in biodiversity-rich country and having genes, the present breeding tools are not
mind the question we address is many accessions of different crop plants, sufficient. Under this scenario, the best
whether to use GM technology or not, it would be worthwhile to undertake chance for of developing new variants is
but what traits should one give such studies. In many other countries via GM technology and this can also be
emphasis to while trying to overcome high- end equipment and other green deployed with in the existing breeding
the problem of shortage of food which house facilities have been created, e.g., programs.
is expected to increase under a global in Australia and networks developed in The other area in which more
climate change scenario? What are the Europe, to test for various parameters efforts are required is to develop GM
key areas in which investment should be such as root growth, stomatal plants that are tolerant to cold
made from Govt funding? functions, overall yield etc, under stress (specifically for cold desert areas), high
Future agriculture will have to and nutrient deficient conditions, to look temperature, drought, salinity tolerance.
deal with more of high temperature, for variants that will perform best under For many of these traits it is possible to
high salinity, high CO2 with less of specific environmental conditions. get the gene(s) of interest from a related uu

98 BIOTECH NEWS VOLUME 5 | NO. 2


Investments in GM Crops Research
Public Sector Priorities

u species. Recent work in this area has mitigated using pesticides etc, yet it is The area on NUE has so far received
revealed that it is more often the important, from an environmental point less attention but cannot be ignored in
expression of genes, a quantitative of view, to reduce the use of pesticides future planning .
parameter, that is important to confer and develop organic farming practices by With ever decreasing levels of
stress tolerance, rather than bring in a developing GM plants that can fossil oil, the world over research has
totally new allele or gene from across withstand the pest, fungal, nematode been put on fast track mode to develop
diverse genera or even the kingdom. and bacterial attack. Work should also alternate sources of fuel. Research on
Under such conditions, using the right be undertaken in using necessary bioethanol and biodiesel need special
promoter and adopting marker and technologies to stop post-harvest losses. attention. GM technology probably can
reporter free technology, it should be One of the area in this sector that has come handy to increase higher biomass.
possible to develop GM plants, which not yet got much attention is to develop The same plant, like sorgum, can be
will be safe and stable. Genomics seeds that are tolerant to fungal infection used for both grain production and
studies, which need more funding in and do not produce aflatoxins. higher vegetative mass for bio-fuel.
future, have given us many new lessons Currently emphasis has been to While private sector would be more
in gene functions. It is possible that either increase the productivity or interested in these areas, in a country
many traits will be regulated by more decrease losses in the mainstream crops like India, the public sector should also
than one gene. In this direction gene like rice, wheat, legumes and vegetables enhance its presence in research in the
stacking is a possibility. Multi-gene etc. Support for work in these areas and area of bio-energy.
engineering thus should be supported crops , especially post-harvest losses in Besides shortage of food, the
in future research programs. In India, a vegetables, should be continued. The nutritional quality of the available food
number of groups have identified many future programs should pay more is also a cause for concern. The
novel gene(s), which have been attention for value addition in the millets deficiency of proteins, vitamins and
functionally validated to confer stress and maize. A number of projects have minerals leads to anemia and blindness
tolerance. However, the proof of concept been supported in this area , however, in a large section of the population
needs to be translated into products. the modern bio technologies have not especially the under privileged. The GM
The Govt. should thus fund more been fully utilized to harness the technology can play an important role in
projects in the public sector or under benefits of these plants which can be alleviating such shortcomings of the
public private partnerships to take the grown under harsh conditions and at main food items of the poor. Studies on
leads obtained in different labs for field the same time are capable of producing availability of nutrients in the soil, like
testing, as mentioned earlier. high nutritive quality grains. iron, zinc and calcium, their uptake
One foresees that water would The change in the food habits in the mechanisms, and bioavailability, can be
be a serious limitation for agriculture country from vegetarian diets to a non- the foundation on which future
and growing plants like rice would seem vegetarian diet has wider implications in strategies for plant modifications can be
a luxury. Though direct seeding for rice terms of food security. Investments will based .
can be achieved to save water, this can have to be made in improving research The GM technology has great
be made possible only if one can take and applications in “ poultry and animal potential to improve crop productivity,
care of the problem of weeds. Hence, feed sector”. Alternate sources of feed , decrease yield losses due to various
weedicide resistant crops would be like modified marine algae , could also stress conditions, prepare plants for
desirable for such agricultural practices be explored. adaptation to future environment
and for this GM technology can come The green revolution following climate change predictions,
handy. In all these cases, irrespective of depended, in addition to the variety, on improve nutritional quality of food and
the traits one is looking at, gene high fertilizer inputs and irrigation. Both feed. It is time that we benefit from the
discovery to business models leading to these inputs have had their side effects. advancements made in the area of plant
benefits for the farmers and consumers Ground water contamination by nitrate genomics, plant transformation, soil
need to be developed. Further, as the and phosphorous has created lot of microbiology and agro-technologies and
plants growing under harsh hazards. It is therefore essential that in incorporate GM crops in the
environmental conditions may not yield future our agricultural practices should mainstream agricultural system, after
as much as expected, the seed policy depend on less of both. The GM these have been approved through the
may also probably need to be addressed. technology will be most appropriate to biosafety screening system that is robust
While compared to abiotic develop high nitrogen and water use and transparent.
stresses, most biotic stresses can be efficient ( NUE, WUE) crop plants. (The author is thankful to Dr Suresh Nair, ICGEB
for his help in the preparation of this article).n

APRIL, 2010 BIOTECH NEWS 99


FEATURE

Genetically Modified Crops

Public Perceptions

Satyajit Rath Prabir Purkayastha

T
he Bt brinjal debate has been together in uneasy and ill-fitting unity. concerns specific to GM technologies?
largely simplified as an Thus, many socially progressive Any significant technological advance
ideological disagreement movements find themselves in awkward generally involves serious issues. Major
between camps either anti- or pro- alliance with nativist and anti-modernity technological advances have always
Genetically Modified (GM) crops, at opinion. On the other hand, pro-GM come with attendant uncertainties and
least in the public eye. There is no argument in the public sphere has risks. When we have no data to evaluate
denying that the vitriol of the debate is portrayed GM technology with a risk, the situation is one of uncertainty,
in part due to ideological differences. patronizing air of triumphalism making and little reasonable prediction can be
However, what is missing is the public the MNC ownership of GM made. But we do know enough to be
awareness that the disagreements fall technologies a core component. This has able to evaluate the risks of GM crops.
into two distinct categories, and that made the weak voice of the Indian So long as we are not dealing with
conflating those is a grievous error in scientific community sound like a catastrophic consequences, we can set a
determining public policy. handmaiden of an international 'safety' threshold of a certain low
One disagreement is over the anti-GM agribusiness juggernaut. It is essential to likelihood of adverse consequences in
characterization of GM technologies as separate the wheat from the chaff in all order to permit the use of a given
intrinsically and catastrophically this if we are to make public policy technology. The weight of evidence
harmful. A second disagreement is over about practical social good in indicates that GM technology carries the
the nature of the GM crop technology agriculture. risk of non-catastrophic consequences
ownership and the effect of such The issue of genetic (as opposed to, say, nuclear weapons,
ownership on agriculture in India. Anti- modification of crops and livestock is which carry the clear risk of catastrophic
GM groups have sought to brand GM undoubtedly complex and replete with consequences), and can therefore be
technologies as intrinsically harmful and serious issues. The key questions are, is reasonably examined and used with
to identify GM with rapacious it practically possible in India to evaluate care.
multinational corporations (MNCs). the risks and benefits of such One frequently heard criticism
This brings ideologically distinct groups technologies, and to what extent are the of GM crops is that horizontal gene een uu

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 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 to the 'GM' nature of the technology, but the larger context of Indian agriculture
natural state in the bacteria has been to the imperatives of the marketplace and food security. With a growing
long used as a bio-pesticide, that by itself and to the fact that the technology is population and with persistent problems
does not mean that Bt is going to be safe owned and marketed by MNCs which, of poverty and malnutrition to address,
in its new form in a GM crop. However, in order to achieve the profit scales they there is little doubt that increases in food
by now the world has experienced a fair need, will aggressively drive high-volume production would be immensely useful.
diversity of Bt crops, including food seed sales. Such corporate control of What is the possible role of GM crop
crops. Bt Corn has now been accepted agriculture is likely to promote the technologies in this context? The anti-
for imports even in Europe. In this process of monoculture that tends to GM position is frequently apocalyptic
context, while food crops require thin down biodiversity on the ground. with regard to the risks of GM crop
particular attention, almost all crops Thus, this is not an issue intrinsic to GM technology, and therefore negates any
enter the food chain one way or another; technology, but to its ownership. useful role for it. It is also frequently
there is no impermeable barrier between In essence, the issue is not allied with nativist anti-technology views
food and non-food crops. A case in point whether GM crops are without risks, but of agriculture, in which back-to-nature
is Bt cotton in India. Bt cotton stalks go whether the regulatory protocols approaches are seen as the most
into cattle feed and milk products developed and used for testing them appropriate solution. On the other hand,
obviously come from cattle. Cottonseed sufficient for the purpose of evaluating the pro-GM position frequently sounds
oil also enters the food chain. While their safety. As noted above, GM crops as though GM crop technology by itself
case-by-case safety testing still remains appear to carry risks of non-catastrophic can be a major solution.
the correct norm, the argument that consequences of the kinds and scales As far as the evidence goes,
there could still be a catastrophic danger that society is familiar with. Therefore, it there is no reason to think that GM crop
from the Bt protein in GM crops seems is not unreasonable to suggest that technology carries catastrophic
less and less valid. familiar safety-testing protocols will consequences, and therefore it is indeed
The issue of long-term toxicity serve societal needs well in this context proper to consider its possible
with GM crops has also been too. Protocols for testing GM crops have advantages for Indian agriculture and
particularly raised since, once a GM been developed by international and food security seriously. However,
crop is released, there is no effective call- national bodies over time. They will anybody who thinks that any one
back. This is also the context in which continue to be strengthened and category of approach, nativist or GM, is
the potential threats of GM technology improved, but either-or positions vis-à- going to be a common panacea for
for diversity in both crops and the vis GM crops are unlikely to contribute India's food security is refusing to
biosphere have been excitedly discussed, to that process. acknowledge the sheer diversity and
since there is a possibility that the One major criticism of the complexity of agricultural practices and
introduced genetic modifications would basis on which the Genetic Engineering needs across the country. For example,
spread naturally both to other varieties Approval Committee (GEAC) cleared Bt anti-GM favorites such as the integrated
of the same species, and also to other Brinjal, has been the alleged unreliability pest management system (IPMS) or the
related species. How harmful is such of the safety data. Safety data submitted system of rice intensification (SRI)
spread likely to be to crop diversity and by the company, with a vested interest in depend on their success on rigorous
to biodiversity? a favorable outcome, are deemed to be practices and additional equipment, and
Most GM crops have one (or two) genes suspect in this argument. And in this may be successful in some situations and
introduced into them. These genes can context, the real issue that arises is a not in others. Thus, the use of GM crop
be easily bred into any variety of the question we are depressingly familiar technology is going to be a part of our
crop, as is done, for example, with Bt with: do we have strong implementation food future, not because it is the sole
cotton. This does not appear to lead a of these regulatory processes and answer to the problems of Indian
'loss' of the variety in the sense of protocols? The answer to that is likely to agriculture, but because it can expand
flattening out the diversity landscape, tend to be more and more in the negative the basket of choices available to a wide
since the same number of varieties, with the greater the involvement of powerful variety of farming communities. While
differing trait profiles albeit with an interests, such as deep-pocketed MNCs. GM is certainly not the only answer,
introduced gene, would still be available. This is as true of, say, drug approvals, as there is little doubt that it can very much
However, it is nonetheless true that GM of crop approvals. Again, who owns be a part of the answering strategies. It is
crop usage has led to a reduction in the GM technology appears to be far more possible to grow more drought-resistant
diversity of crop varieties being planted. crucial an issue than its 'GM'ness. or salinity-tolerant crops, or use less
It is useful to note that this is not related These issues need to be seen in pesticides, for example. Some of these uu

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Genetically Modified Crops

Public Perceptions

u do not need transgenic technologies. It is thus clear that, while there cannot inputs, as exemplified by the Monsanto-
Molecular genetic marker-assisted be a mere technological fix to the driven Bt-crops, exacerbates this squeeze
selective breeding is another tool that problems of Indian agriculture, further, and must be an issue of concern.
can help in achieving some of these technology will be part of the solutions. The technological worries relating to
aims. Achieving true breeding of hybrids The farm sector is also seeing a huge GM crops appear relatively minor in
will also help in a different way. But all squeeze on its income the prices of comparison, yet, sadly, it is these techno-
of these tactics together would help to inputs are rising faster than the output worries that hold centre-stage in the
expand the basket of choices available. prices. The increasing corporatisation of ongoing debates.n
FEATURE

Deployment of GM Crops

Need For a Clear Cut Policy

E.A. Siddiq

A
chieving minimum required growth of Green Revolution crops reservationists are fully aware that this is
growth on a sustainable basis is declined to levels far lower than what is the only strategy option to find solution
crucial for sustained food- required to sustain the present level of to problems that defy both conventional
nutrition security. India has made sufficiency and no yield breakthroughs and marker technology and for which
enviable progress in agriculture during as yet in rain fed crops that account for there is no donor source in the
the last 50 years culminating in self- over 65% of the arable area coupled with compatible germplasm and that finding
sufficiency in our food grain needs since shrinking natural resources, especially remedy would have major socio-
early 80s. Transformation of a water, energy and plant genetic economic impact.
chronically food deficit country into a resources, achieving future demands India, although late in
food sufficient and surplus one is the would be the most challenging task, if accessing and using recombinant DNA
most significant accomplishment of the we are to excessively depend on the technology, during the last 15 years it
post-independent India. Two landmark currently available crop improvement has strengthened itself with needed
developments viz., exploitation of technologies. Rapid advances in cellular knowledge and skills, state of the art
hybrid vigor in maize and millets since and molecular biology have provided research infrastructure and competitive
mid 50s and introduction of plant type two major genomic tools viz., molecular critical mass. It is in an enviable position
based high yielding varieties of wheat marker technology enabling genotype today to engineer crop plants with
and rice since mid 60s marking major based selection and recombinant DNA desired trait(s), given transgenics in as
yield breakthroughs have made this technology capable of moving genes of many as 10 different crops already on its
possible. Despite such an impressive interest across the barriers of sexual shelves awaiting clearance by the
feat, the fact that over 200 million people incompatibility. While there is no Regulatory Authority for commercial
remain undernourished and much larger resistance to the use of the former for planting and several at various stages of
population malnourished is of great crop improvement, there is strong evaluation for efficacy, stability and bio-
concern, no matter what could be reservation against alien gene based safety including human health and
attributable to this paradox. With the genetically modified (GM) crops and environment security. Also, potential
current pace of productivity/production GM food products, though the benefits of Bt cotton, the first ever uu

E.A. SiddiqPh.D is Chairman of the Centre for Finger Printing and Diagnostics (CFCD), Hyderabad. (Email: easiddiq@rediffmail.com)

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Deployment of GM Crops
Need For a Clear Cut Policy

u commercialized biotech crop in the consultative process involving concerned The above raised reservations
country have been experienced during stakeholders of given target against GM technology cannot be totally
the last eight years, when over 85% of area/community. dismissed as baseless. They can,
the cotton area were planted to Bt cotton Introduction is not based on however, be addressed by scientific
and productivity more than doubled field level evaluation done in the community and officials of concerned
ending the dependence on imported concerned state for efficacy, stability and ministries to the satisfaction of the
cotton. Significantly, this development biosafety apprehensive activists and reluctant
too was not without hassles in reaching Small and large scale field test data on farmers, quoting policy goals and related
out to farmers. When Bt brinjal, capable performance/biosafety furnished to the provisions in the Draft National Policy
of minimizing greatly yield losses due to regulatory authority are often from trials on Biotechnology prepared by the
fruit and shoot borer, was to be released conducted by the applicant organization Department of Biotechnology, Ministry
last year for commercial planting, the lRegulatory process is not sound enough. of Science and Technology through
experience in trying to reach out it to It lacks transparency in the process of consultative process involving relevant
farmers reflected reservation against GM development and testing for efficacy and ministries, national institutes and
crops, especially those that are directly in biosafety and stringency is left much to scientists. Awaiting formal approval of
the food chain of man to be still strong be desired the Policy Document, the DBT is
and persistant. The kind of objections lInconsistency in efficacy and instances already in the process of implementing
raised against Bt brinjal by anti-GM of biosafety related problems many of the policy goals/provisions
lobby, ineffective response to them by lUnsubstantiated claims on economic envisaged. The following responses, if
scientific community and reluctance of advantage and environment security. properly explained vis a vis the issues
seed industry and farmers to adopt and lExtensive cultivation of transgenic crops should help remove the apprehensions
lack of clear cut policy-directed monopolised by multinational on the system and its functioning.
companies would prove a threat to rich
interventions from the governments are
said to collectively contribute to our
biodiversity of the country. Establishment of the National
lTransgenic strategy in pest control Biotechnology Regulatory Authority
failure to benefit from such innovative
would lead to emergence of newer and the Regulatory Process for
technologies.
pests/more viruliferous forms of the
Reservations Against Biotech Crops same pest.
Safety Assessment of GM Crops/Food
Broadly aiming at (a) development and
Reservation against GM crops from lIncreasing monopoly of multinational
companies in seed trade is to the use of biotech tools to address the
activists and others are -
disadvantage of Indian companies and problems that affect the largest section
The technology being developed and
seed cost is not affordable by small of the society (b) providing of produce/
introduced is not based on prior
farmers. processed products there from at prices uu

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Deployment of GM Crops
Need For a Clear Cut Policy

u affordable by all sections of the society agronomic performance, decision taken due to (a) breakdown of resistance due
and (c) making the country food- on the basis of data and findings from to selection pressure or (b) unintended or
nutrition secure and globally competitive such sources would strengthen the faith deliberate admixture/adulteration (by
in the emerging bio-economy, the draft and confidence of all in the user end and unscrupulous elements in seed trade) of
Biotechnology Regulatory Authority has thereby willing reception to the seed of transgenic with that of
been conceived. Yet to be formally technology. nontransgenic. The latter possibility
established, the Authority ensures Many reservations against GM could be checked by regular
through the three-tier system, rigorous crops are largely because of the failure survey/monitoring of transgenic fields
and sound science based approval of of scientists to respond to and clear all and seed sale points for genetic purity.
GM Crops. Structurally and unfounded apprehensions on their This strategy would greatly help remove
functionally, the development, testing efficacy, stability, biosafety and the wrong notion on the stability of
and approval system though sound environment security. transgenics.
enough, scope does exist for making it As for efficacy and economic The view that transgenics
still more stringent and transparent. gain from transgenics over the resistant to a pest could facilitate
More realistic choice of crop, source of corresponding non-transgenics, debate emergence of newer pests is as well not
gene and transformation avoiding on far and against biotech crops is due to disputable, when the transgene in
selectable markers, especially antibiotic lack of understanding. For instance, question is pest-specific. Observed build
ones are insisted upon at development claims and counter claims on yield up of once not so serious pink bollworm
phase, while ensuring stringent and superiority of pest resistant transgenics (Pectinophora gossypiella) in cotton is one
transparent assessment of biotech crops like Bt cotton and Bt brinjal is one such such case, where the transgene effective
for biosafety including human and case of poor understanding of the trait against bollworm (Heliothes armigera)
animal health and other unintended effect on productivity. Genetic yield remains ineffective against other related
effects (toxicity, allergenicity, and other potential being inherent to a given species of the pest.
adverse health related problems) at variety, no matter it is transgenic or non- Many believe that transgenics
laboratory and on environment transgenic, observed yield difference could prove a serious threat to genetic
(weediness, invasiveness, pollen flow between them depends on the level of diversity, which is the bedrock
caused genetic contamination/erosion) yield loss they suffer due to the pest. In conventional plant breeders depend on
at field level. Large scale multi-location situations of high pest incidence, the for progressively improving crop
field trial conducted on the transgenic would yield far higher than varieties. The contention that extensive
recommendation of the RCGM is the corresponding non-transgenic and exploitation of a few transgenics would
monitored and evaluated by the Genetic when there is no or very low pest build amount to disappearance of thousands
Monitoring and Evaluation Committee. up, there will be hardly any yield of native germplasm, need not be wholly
Its report and recommendation of the difference between them. Therefore, it is true. Similar apprehension was there
special Appraisal Committee constituted wrong to conclude that transgenics have when hybrids of millets and high
of experts form ultimately the basis for higher yield potential or it is only on par yielding varieties of rice and wheat were
granting approval for seed increase and with the non-transgenic control, as the introduced. The fact that maximum of
commercial planting by the Genetic observed difference in yield depends on crop specific diversity available in the
Engineering Approval Committee the level of pest incidence and the level country has already been conserved by
(GEAC). Thus, the regulatory system of protection the transgenics and non ex situ and in situ approaches and more
and regulatory process are in order in transgenics provide against the pest. could be done in future too. Such
the absence of formally cleared National Stability of trait expression is anticipatory conservation measures
Policy on Biotechnology and yet another apprehension about biotech already on should convince all those,
establishment of National crops. Discouraging reports on the who entertain such concern that it
Biotechnology Regulatory Authority. declined efficacy of Bt gene in cotton, cannot be a justification against GM
Priority action plan in this regard would for instance, are no doubt based on crops.
help ward off the criticism that biosafety actual observation in some parts of the The objection that increasing
and efficacy/performance related data country. Such instances of instability are monopoly of multinational seed
are not reliable. If the system has its own not characteristic to transgenics alone, as companies would be at the cost of
laboratory facilities or duly accredited breakdown of resistance (ineffectiveness domestic seed industry and that no
public laboratories exclusively designed of resistance gene against the pest) is as control over seed price would go against
for risk analysis of GM crops and well the case with natural genes. What farmers' interest, is although under-
depends on SAU's generated data on has been observed in Bt cotton could be standable, it is inevitable as long as the uu

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Deployment of GM Crops
Need For a Clear Cut Policy

u technology is not ours. The issue could, constraint is not our technical l laboratory and field levels for biosafety.
however, be resolved by government in competence to engineer crop plants of Considering the high cost involved in
discussion with the seed industry interest, given the impressive array of meeting satisfactorily such
reminding governments' policy of transgenics already in pipeline. It is requirements, public-private
making GM technology easily accessible rather in reaching out the technology to partnership models now in place and
and affordable to all. the targeted user. Learning from the are being promoted by the Department
Disputes and criticisms on the efficacy experience of other sectors as well as our of Biotechnology could be used to take
and biosafety of biotech crops arising own in this regard, the following advantage of the private sectors'
from various quarters cannot be wished suggestions and strategies would ensure excellence in development and
effective deployment of biotech crops. management skills for extensive
away. Addressing them with scientific
commercialization.
study based facts and figures is the right l Convincing the target clientele with
facts and figures that gain from the l Clear policy and rational strategies for
strategy to counter them and thereby
given biotech crop outweighed the risks deployment of transgenic crops is vital
promote the technology. Even eight
is basic to its extensive adoption. for successfully sustaining and
years after the release of Bt cotton, for
benefitting from transgenic technology.
instance, we still face resistance to it on l Endorsement of the recommendations
These should be in keeping with the
grounds like instances of livestock death of the GEAC on biosafety of given
fact that (a) genetic uniformity is
due to grazing in Bt cotton fields, GM crop(s) and processed products
genetically vulnerable to sudden
degradation of soil health and quality there from by the apex agricultural
outbreaks of pests and (b) sexual
affecting seriously the performance of research organizations at national
compatibility with plant species around
subsequently planted crops, increased (ICAR) and state (State Agricultural
would lead to genetic contamination,
suicide cases in Bt cotton grown areas Universities) levels and other National
genetic erosion and other unintended
due to crop failure, no appreciable cost laboratories.
consequences. To ward off the problem
reduction on plant protection etc. Such l Organized and intensive awareness
of genetic vulnerability, either
creation among the target population
issues be thoroughly investigated by a diversification of trans-resistance genes
on the intended introduction of biotech
competent committee constituted of through varietal mosaics or pyramiding
crop(s) highlighting its relevance to
researchers, social scientists and of varieties with diverse trans-
their livelihood security and biosafety
economists for establishing what is resistance genes could be ideal
including human and animal health
rumoured is not true. Only with strategies. To contain genetic
and environment security.
scientific scrutiny-based facts and contamination, areas/regions rich with
l Active involvement of state agricultural
figures, such reports can be countered compatible wild/cultivar species be
departments in reaching out the
and restore thereby the trust and precluded for introduction of given
technology to the intended regions,
confidence of growers and consumers. transgenic crop/variety. There should
ecologies and communities. Training
Apprehensions on long term effect of be legal restriction to introduce
of extension personnel at all levels on
GMOs could be out of genuine concern transgenic crops in biodiversity rich
the benefits and associated risks of the
for human health. As there is no way out areas, centers of origin and centers of
technology and organizing large scale
to subject human beings for long term diversity of a species, areas earmarked
on farm demonstrations.
clinical tests special Standing Technical for export oriented crops (e.g.: basmati
l Labeling of transgenic produce and
Committee constituted of physicians, rice) and those for organic farming.
processed food products is about
social scientists and agricultural Innovative technologies are inevitable
consumer right. Though mandatory in
scientists should monitor long term given the limitations of the conventional
India, measures be found to address
effect of consumption of GM food/feed the practical problems that would be breeding/selection technologies vis a vis
on human/animal health. encountered in actual implementation magnitude and seriousness of problems
in the face of reluctance of private facing us today. Undoubtedly extra care
Policy Initiatives and Technology sector companies on the plea that it is necessary to rule out any serious
Transfer Strategies for Effective would introduce price discrimination impact of GM crops/GM food/feed on
Deployment of Biotech Crops and would be against the policy goal of human/animal health and environment.
In taking full advantage of advances ensuring inclusiveness. But reservations, undue delays in
being made in the area of crop l Many valuable transgenics developed exploiting the technologies of large
biotechnology, relevant enough to by the public institutions are still on the socio-economic impact would amount to
address the problems that impede the shelf because of lack of resource denying the large undernourished-
progress of envisaged support for them to go through the malnourished population the benefits of
production/productivity growth, the mandatory testing requirements at new bioscience.n

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