NATIONAL LAW UNIVERSITY

ORISSA

Impact of Genetically Modified

Organisms on Indian
Environment

BY:
Kushagra Gupta (2013 BA 022)

TABLE OF CONTENTS

TABLE OF CONTENTS...........................................................................................................1
INTRODUCTION......................................................................................................................2
HISTORICAL PERSPECTIVES:..............................................................................................4
RISK ASSESSMENT OF GENETICALLY MODIFIED FOODS:..........................................6
EFFECTS OF GENETICALLY MODIFIED FOODS ON ECOSYSTEM AND
ENVIRONMENT:......................................................................................................................8
CONFLICT BETWEEN WTO AND CARTAGENA..............................................................10
THE BIOSAFETY REGIME IN INDIA WITH RESPECT TO GM PRODUCTS.................11
INDIAN REGULATION IN LIGHT OF THE CARTAGENA-WTO CONFLICT................12
CONCLUSION........................................................................................................................13

INTRODUCTION

Last October, principal scientific adviser to the government of India R. Chidambaram sent a
letter to Prime Minister Narendra Modi about the use of genetically modified (GM) food
crops, in which he said: India... should not hesitate to be the first introducer of new
advanced technology, after convincing itself, of course, about its value to the users and the
nation, its economic viability, its safety and environment friendliness. It is an eminently
reasonable stance. But more often, its a lack of clarity that dogs the debate on GM crops in
Indiaas witnessed last Friday when a committee of government and independent experts
met inconclusively for the third time this year to evaluate field trial data on GM mustard.
The Indian GM crops saga is a convoluted one. Currently, it has the worlds fourth largest
GM crop acreage on the strength of Bt cotton, the only genetically modified crop allowed in
the country. But the introduction of Bt cotton has been both highly successful and
controversial. Cotton yield more than doubled in the first decade since its introduction in
2002, according to the Economic Survey 2011-12by which point it accounted for 90% of
cotton acreage. But it was also shadowed by controversy, with a tangle of pricing and
intellectual property rights (IPR) issues followed by government price interventions and
litigation.
GM food crops have fared worse. An agreement to develop Bt brinjal was signed in 2005
between MahycoAmerican agricultural biotech giant Monsantos Indian Bt cotton partner
and two Indian agricultural universities. Following the study of biosafety data and field
trials by two expert committees, Bt brinjal was cleared for commercialization by Indias top
biotech regulator, the Genetic Engineering Appraisal Committee, in 2009. But nothing came
of it, with moratoriums imposed by then Union environment minister Jairam Ramesh and his
successor Jayanthi Natarajan following opposition from civil society groups and brinjalgrowing states.
This split within the governmentVeerappa Moily subsequently reversed Natarajans
decision on field trials, and both Manmohan Singh at the time and Modi subsequently have
advocated GM cropsshows how fraught the issue is.

The benefits of GM crops include reduction of pesticide use, greater food security 1 and
enhanced nutritional quality of food.
Multiple studies have shown no human or ecological ill-effects, as well as increased yields
and resistance to pests among other benefits. Use of GM technology increased crop yields by
22%, reduced chemical pesticides by 37% and increased farmer profits by 68%, with better
results in developing countries than in developed ones.2
But the foundation of such studies has been questioned by opponents of GM cropsranging
from civil society groups to a minority within the scientific communitywho allege that
regulatory bodies and scientific publications are in bed with GM corporates. In India, Bt
cotton has been questionably blamed for economic distress and farmer suicides and raised
questions of biodiversity and horizontal gene transfer.
Both Singhs and Modis administrations must share the blame. GM crops have never been a
purely scientific issue. They are situated at a socioeconomic and political nexus, and involve
understandable fears about long-term human and environment safety, market monopolies in
seeds and food sovereignty. Politics involves managing perceptions; both governments have
failed here.
If the Modi government is to lay the ground for a measured, tested introduction of GM crops,
it must clean house. It can start with transparency; keeping biosafety data out of the public
domain, as has been done with GM mustard, will not help. Nor will the lacking regulatory
regime, rightly pointed out as being inadequate by the Supreme Court. Taking up the
proposed Biotechnology Regulatory Authority of India Bill again is a must. So is resolving
IPR issues that have again reared up with the Andhra Pradesh government seeking
compulsory licensing or revocation of the Bt cotton technology patent in its struggle with
Monsanto. Such interventions create regulatory uncertainty and deter the entry of competitors
that could check monopolistic conditions.

1 David. J. Schiner, Genetically modified organisms and the Cartagena Protocol,

12 Fordham Envtl. L.J. 379
2 by Wilhelm Klumper and Matin Qaim of the University of Gottingen.

HISTORICAL PERSPECTIVES:

After 1900, by using Gregor Mendels genetic theory of crop species 3 improvement
developed through classic selection, a plant of one variety was crossed with a related plant to
produce desired characteristics. With the discovery of three-dimensional double helix
structure of DNA4 , scientists gained the possibility to identify and splice genes from one
kind of organism and transfer them into another. In 1973, Herbert Boyer and Stanley Cohen
combined their research to create the first successful DNA organism. 5 In 1982, US Food and
Drug Administration (FDA) approved the first genetically engineered drug, Genentechs
Humulin (a form of human insulin produced by bacteria). This was the first consumer
product developed through modern bioengineering.6 The first genetically modified plant was
produced in 1982 by using an antibiotic-resistant tobacco plant.7 The herbicide resistant
tobaccos were first applied in field in 1986 in France and the USA. The People s Republic of
China was the first country to allow commercialized transgenic plants by introducing a virusresistant tobacco in 1992. In 1994, the first genetically modified crop approved for sale in the
U.S. was a variety of tomato, which had a longer shelf life. In 1994, the European Union
approved genetically engineered tobacco which was resistant to the herbicide bromoxynil. It
the first commercially genetically engineered crop marketed in Europe. In 1995, the
Environmental Protection Agency approved Bt Potato to be safe for consumption. Gradually
other transgenic crops have also received marketing approval in the US including Bacillus
thuringiensis (Bt) corn and maize, cotton resistant to the herbicide bromoxynil, Bt cotton,
soybeans resistant to the herbicide glyphosate, virus-resistant squash, and other delayed
3 http://www.dnaftb.org/1/bio.html.
4 James Watson and Francis Crick in 1953.
5 S.N. Cohen, A.C. Chang, H.W. Boyer, R.B. Helling, Construction of biologically
functional bacterial plasmids in vitro, Proc Natl Acad Sci 70(11) (1973) 3240-3244
6 Biological and biomedical aspects of genetically modified food, Biomed.
Pharmacother. 59 (2005) 531 540.
7 R.T. Fraley, Expression of bacterial genes in plant cells, Proc. Natl. Acad. Sci. 80
(1983) 4803-4807.

ripening varieties of tomatoes. In 2000, with the production of golden rice, scientists
genetically modified food to increase its nutrient value for the first time. The largest share of
the GM crops planted globally is from seeds created by the multinational firm Monsanto of
US. Syngenta, Dupont and Bayer CropScience are also major GMO multinationals in the US
and Europe. In addition, a 2007 report from the European Joint Research Commission
predicts that by 2015, more than 40% of new GM plants entering the global marketplace will
have been developed in Asia. According to the International Service for the Acquisition of
Agri-Biotech Applications (ISAAA), in 2010 approximately 15 million farmers grew biotech
crops in 29 countries. 6.5 million farmers in China and 6.3 million small farmers in India
grew biotech crops in this period (mostly Bacillus thuringiensis cotton). 8 10 million resourcepoor farmers may have been secondary beneficiaries of Bt cotton in China.

8 International Service for the Acquisition of Agri-biotech Applications (ISAAA),

2011. Retrieved from http:/ / www. isaaa. org/ resources/publications/ briefs/ 43/
executivesummary/ default. asp

RISK ASSESSMENT OF GENETICALLY MODIFIED FOODS:

There is a growing concern that introducing foreign genes into edible plants may have an
unexpected and negative impact on human health. By inserting genes from organisms which
have never been eaten as food, new proteins with unexpected functions may introduce into
the human and animal food chains. The process of inserting the gene can damage the plants
own DNA. The foreign gene can integrate right in the middle of another gene and can cause it
to lose its function.9 Additionally, the tissue culture stages cause numerous changes to the rest
of the plant's DNA. A gene can behave in different ways in different locations, depending on
the regulatory elements it ends up next to. As genetic engineers cannot control where the
genes take its position in the plant DNA and do not know the effects of the different
locations, unpredicted effects can easily occur.10 A harmless protein in one organism can
become harmful if inserted into another organism, even if its sequence of amino acids
remains completely identical. The reason behind it is the molecular mechanism called posttranslation modification where, depending on the plant species and the type of cell, different
sugars, lipids or other molecules attach to the protein and modify its function [16]. The safety
testing of GM foods is based on the concept of substantial equivalence. The idea is if a
GM food can be shown to be substantially the same as a non GM food then it is considered
to be safe11. The comparison takes the agronomical, morphological, genetic and
compositional properties of the genetically modified foods and the traditionally produced
food, and establishes the degree of equivalence between the two counterparts. These
differences are further considered for toxicological, analytical and nutritional investigations.
Key nutrients like protein, carbohydrates, fats, fatty acids, vitamins and other nutritional /
antinutritional compounds are generally measured to find out the impact on nutritional value
9 M.W. Ho, Genetic engineering: Dream or nightmare? The brave new world of
bad science and big business, Third World Network, Malaysia, 2007
10 J.M. Smith, Genetic Roulette: the documented health risks of genetically
engineered foods. SAGE and Other India press, India, 2009.
11 H.A. Kuiper, G.A. Kleter, H.P.J.M. Noteborn, E.J. Kok, Assessment of the food
safety issues related to genetically modified foods, Plant J. 27(6) (2001) 503- 528

and safety of the organisms.12 It was developed because of the difficulties and cost of
performing traditional safety tests on GM foods. But it has been severely criticized by some
scientists because it is not clear what level of similarity can make the GM and non-GM food
substantially equivalent. The safety evaluation of GMFs addresses several specific issues:
1. Molecular characterizations of the host and donor organisms of the genes (specific
methods of transformation of the genes, analysis of the regulatory elements, number of
insertion sites, level and sites of expressions of the foreign genes etc.).
2. Stability of inserted recombinant DNA and expression of novel DNA in the new
organisms.
3. Potential toxicity profile of newly expressed proteins.
4. Toxicological and nutritional impact of alterations in composition of the new foods.
5. Potential allergenicity of newly expressed proteins and altered allergenicity of the whole
food.
6. Effects of processing and cooking on the compositional and toxicological changes in the
modified foods.
7. Potential intake and dietary impact of the modified foods.
8. Possibility of gene transfer from the genetically modified foods to microorganisms of the
human / animal gut flora and associated health impact.

12 H.A. Kuiper, G.A. Kleter, The scientific basis for risk assessment and regulation
of genetically modified foods. Trends Food Sci. Tech. 14 (2003) 277293.

EFFECTS OF GENETICALLY MODIFIED FOODS ON ECOSYSTEM AND

ENVIRONMENT:

A laboratory study was published in Nature which showed that pollen from BT corn caused
high mortality rates in monarch butterfly caterpillars. 13 Cowgill, showed that aphids feeding
on nematode-tolerant GM crops may damage various natural enemies of aphids. Nematode
proteinase inhibitors expressed in the GM crops can kill aphids and some natural enemies of
aphids.14 Decreased populations of aphids also will adversely affect the predators of aphids.
When highly tolerant crops are grown on a large scale, the abundance of some natural
enemies may also decline due to prey depletion. There is also a possibility of the transfer of
herbicide resistance genes from the genetically engineered crops into the weeds. These
"superweeds" would then be herbicide tolerant as well. Other introduced genes may cross
over into non modified crops planted next to GM crops. In environmental biosafety issues,
transgenic escape from a GM crop variety to its non-GM crop counterparts or wild relatives
has aroused tremendous debate worldwide. Transgenic escape of rice from its wild varieties
via pollenmediated gene flow has some unwanted ecological consequences. The quantity or
nutritional quality of non-prey foods such as vegetative tissue, seeds, pollen, floral and
extrafloral nectar, and honeydew may be influenced by transgenesis, and thus affect natural
enemies that rely upon these foods. For instance, nectar production and sugar content is
sometimes altered in GM crops from that observed in nonGM counterparts. 15 The quantity of
honeydew produced by hemipterans may be lowered, unaffected or increased on GM plants
compared with non-GM counterparts. Examples of new proteins expressed in GM crops are
the Cry proteins from Bacillus thuringiensis (Bt) strains that have insecticidal properties for
larvae of herbivoral insect species. The mechanism of action of Cry proteins is based on
13 . J.E. Losey, L.S. Rayor, M.E. Carter, Transgenic pollen harms monarch larvae,
Nature 399 (1999) 214.
14 Gene Flow and Agriculture, Relevance for TransgenicCrops. BCPC/University of
Keele, Staffordshire, 1999, 203 208.
15 Foraging behaviour of honey bees (Apis mellifera L.) on transgenic oilseed
rape (Brassica napus L. var. oleifera), Transgenic Res. 4 (1995) 270276.

specific receptor binding, in susceptible insect larvae, in epithelial cells of the midgut, leading
to pore formation, cell lysis, disintegration of the epithelium lining in the midgut and,
eventually, to death of the larvae owing to starvation. The U.S. Centre for Disease Control
and Prevention recorded 51 reports of severe human illness including allergic reactions
because of the consumption of genetically modified StarLink corn which was engineered to
produce Bt (an effective Lepidopteran insect controlling agent). Cry protein might be
considered as a potential allergen because of:
(i)

Resistance to gastric proteolytic degradation and to heat and acid treatment,

(ii)

The capacity to induce a positive IgE response in the rodents,

(iii)

Bioavailability in the bloodstream of the rodents,

(iv)

Probable glycosylation and

(v)

Molecular weight of allergens.

CONFLICT BETWEEN WTO AND CARTAGENA

When compared as a whole the WTO measures place emphasis on free trade while the
Protocol seeks affirmative action from parties to regulate trade in GMOs.
a. Precautionary Principle: The precautionary principle lacks a clear definition and its
scope varies in different international agreements. The WTO Agreements and WTO decisions
prioritize free trade and contain the principle in its most limited form. In the recent WTO
ruling against EU ban on import of GM crops from America, the WTO reiterates its stand in
the EU Hormones case of using the principle in a narrow sense. SPS permits only provisional
precautionary measures. Even these measures have to be based on available information and
must be reviewed in a reasonable period of time. The Protocol allows indefinite restrictions in
cases of uncertainty based on even non-scientific criteria.16
b. International Standards: The SPS encourages members to base their measures on
international standards and recognizes three standard setting bodies- the Codex Alimentarius,
International Office of Epizootics (IOE) and International Plant Protection Convention
(IPPC) none of which relate to biosafety measures. This precludes the Protocol as an
international standard setter with relation to GMOs under the SPS. In the absence of set
standards, restrictions may be based solely on scientific justification again bringing into play
the conflicting precautionary principles.
c. Burden Of Proof: In the Japanese Apples case,17 it was ruled by the WTO that the burden
to justify restriction was on the country of import. In contrast by specifying detailed
notification requirements on the exporting country, burden under the Protocol is placed on the
country of export.18
16 Ian Sheldon, Food Principles: Regulating Genetically Modified Organisms after
the 2006 WTO Ruling, 14 Brown J. World Aff. 128 (2008).
17 Japan Measures Affecting the Importation of Apples, WT/DS245/R.
18 Patrick J. Valley, Tension between the Cartagena Protocol and the WTO: The
Significance of Recent WTO Developments in an Ongoing Debate, 5 Chi. J. Intl
373 (2004-2005).

d. Dispute Redressal: Given the absence of a Dispute Redressal Agency under the Protocol,
the WTO becomes forum to determine disputes with regard to GMO trade. The dominance of
the WTO in settling disputes is further compounded by the fact that all WTO members are
not signatories to the Protocol.

THE BIOSAFETY REGIME IN INDIA WITH RESPECT TO GM

PRODUCTS

India is a prominent member of the WTO as well as a signatory to the Protocol, thus a review
of its domestic regulatory regime is worthwhile in light of the above discussion. Relevant
legislations include The Environment Protection Act, 1986 (EPA) in so far as it permits the
Central Government to regulate and restrict handling of hazardous substances. 19 Under Sec.
25 of the EPA the Rules for the Manufacture, Use/Import/Export and Storage of Hazardous
Micro organisms/ Genetically Engineered Organisms or Cells, 1989 (Rules) were formulated
which established a regulatory body to approve, prohibit and regulate GMOs even providing
for dispute resolution and penalties in cases of non-compliance. In order to supplement these
rules Guidelines were issued by the Department of Biotechnology (DBT). The guidelines
relate to research activities including confined field trial. 20 The Institutional Framework36
divides of authority between the DBT under the Ministry of Science and Technology (MoST)
and the Ministry of Environment and Forests (MoEF). A series of bodies are created under
the two ministries with no particular hierarchy. Under the DBT there exists The Review
Committee on Genetic Manipulation (RCGM) to ensure environmental safety in the areas of
GMO research including field experiments and the Monitoring and Evaluation Committee
(MEC) that assists the RCGM with monitoring of research bodies. The Genetic Engineering
Approval Committee (GEAC) on the other hand is under the MoEF, it is the apex body to
19 EPA, 1986, 2(e): Hazardous substance.
20 Guidelines and Standard Operating Procedures (SOPs) for Confined Field Trials
of Regulated, Genetically Engineered (GE) Plants - 2008, Guidelines for the
Safety Assessment of Foods Derived from Genetically Engineered Plants - 2008,
Protocols for Food and Feed Safety Assessment of GE crops - 2008.

authorize the commercial use (including imports) of GMOs and release into the environment.
There are three other bodies under the de-centralized framework as the Institutional Biosafety
Committee (IBSC) the State and District Level Committees (SBCC and DLC) the advisory
Recombinant DNA Advisory Committee (RDNA).21

21 A. Damodaran, Re-Engineering Biosafety Regulations In India: Towards a

Critique of Policy, Law and Prescriptions, Law, Environment and Development
Journal, (2005) at 3.

INDIAN REGULATION IN LIGHT OF THE CARTAGENA-WTO

CONFLICT

Given the fact that India is a member of the WTO as well as a signatory to the Protocol,
Indian laws reflect which side of the divide India is on. During negotiations to Cartagena,
India was part of the likeminded group that was heavily in favour of intense regulation
through the Protocol. A review of national laws hardly reflects this position. The mechanism
of regulation omits critical principles set out under the Protocol such as a precautionary
principle, socio-economic considerations and public participation indicating a tilt towards the
WTO however even the WTO provides for considering economic and region specific
considerations while enforcing measures. Although the failure to incorporate provisions of
the Protocol may suggest a tilt towards the WTO, the failure to enforce even WTO measures
negates such an impression.22

22 Mahim Pratap Singh, Activists Voice Concern over Biotech Regulatory

Authority Bill, (Bhopal, February 18, 2010), available at
http://beta.thehindu.com/news/national/article108821.ece (last visited on March
8, 2010).

CONCLUSION

Given the situations such as the moratorium on BtBrinjal imposed by the MoEF as result of
public opposition it is essential for a country like India to evolve a holistic regulatory
framework. In order to do so it is imperative to implement our international commitments,
including promoting public participation, adoption of the Precautionary Principle,
incorporating socio-economic interests, labeling requirements and the like. One step in this
direction would be a standalone Gene Technology Legislation inclusive of the
abovementioned features as well as a strong liability clause (along the lines of the polluter
pays principle), and dispute redressal mechanism. This need for a dispute redressal
mechanism is fortified by instances such as the filing of a PIL in the Supreme Court in 2005
seeking a better biosafety test protocol for GMOs, which is yet to be disposed of. 23
Infrastructure is another sphere which needs attention. The absence of independent publiclyfunded laboratories for conducting risk assessment tests results in these tests being conducted
in the private laboratories of the biotech companies, as it happened in the case of BtBrinjal by
Mahyco, which is a blatant conflict of interest.24 Further it may be prudent to incorporate
certain assessments, one being a performance assessment and the other a need assessment. 25
Given the nascent stage that gene technology is in, it may be wise to put in place a
performance assessment mechanism post commercial release. Furthermore, before
proceeding with the evaluation of any GM product, conducting a needs assessment would
make sense, an assessment of needs may be brought under the ambit of socio-economic
factors as provided in the Protocol.

23 Jairam Ramesh, Bt Brinjal: Note by Ministry of Environment and Forests, The

Hindu, (New Delhi, 9th February 2010), available at
http://www.hindu.com/nic/btbrinjal.htm
24 R. Ramachandran, The GM Debate, Frontline.
25 Suman Sahai, The BT. Brinjal Case: Overhauling the Regulatory System must
be the First Step.