Genetic Modification of Crops

Submitted by:
GOURAV KEDIA - 16010324227
YASHRAJ DOKANIA- 16010324279

Division: “C”
Class: BBA. LLB
Symbiosis Law School, Hyderabad
Symbiosis International University, Pune.

In
October, 2018.

Under the guidance of

Prof. Shipra Chauhan
Symbiosis Law School, Hyderabad.
(A constituent of Symbiosis International University, Pune).
 CERTIFICATE

The Project entitled “Genetic Modification of Crops” submitted to the

Symbiosis Law School, Hyderabad for as part of internal assessment of
Environmental Law and is based on my original work carried out under the
guidance of Prof. Shipra Chauhan from June to October in 2018. The research
work has not been submitted elsewhere for award of any degree.

The material borrowed from other sources and incorporated in the thesis has
been duly acknowledged.

I understand that I myself could be held responsible and accountable for

plagiarism, if any, detected later on.

Signature of the candidate- Yashraj Dokania, Gourav Kedia

Date: 3rd October, 2018

 ACKNOWLEDGMENT
I would like to express my sincere gratitude and indebtedness to Prof. Shipra
Chauhan and my heartfelt appreciation for providing me the opportunity to
undertake a research project on the topic “Genetic Modification of crops” and
her enlightening lectures in the Interpretation of Statutes helped me to carry out
this research project. I would also like to thank Symbiosis Law School,
Hyderabad’s library for the wealth of information and for providing me with
excellent opportunities and facilities to help me complete this research project.

I would also like to thank my parents and classmates for helping me, in one-
way or the other, who have been constant pillars of support for the successful
completion of the research project

Yashraj Dokania
Gourav Kedia
BBA.LLB (3rd Year)
Symbiosis Law School, Hyderabad
Introduction
Genetic engineering, also called genetic modification or genetic manipulation, is the
direct manipulation of an organism's genesusing biotechnology. It is a set
of technologies used to change the genetic makeup of cells, including the transfer of genes
within and across species boundaries to produce improved or novel organisms. New DNA is
obtained by either isolating and copying the genetic material of interest using recombinant
DNA methods or by artificially synthesising the DNA. A construct is usually created and
used to insert this DNA into the host organism. The first recombinant DNA molecule was
made by Paul Berg in 1972 by combining DNA from the monkey virus SV40 with
the lambda virus. As well as inserting genes, the process can be used to remove, or "knock
out", genes. The new DNA can be inserted randomly, or targeted to a specific part of
the genome.
An organism that is generated through genetic engineering is considered to be genetically
modified (GM) and the resulting entity is a genetically modified organism (GMO). The first
GMO was a bacterium generated by Herbert Boyer and Stanley Cohen in 1973.Genetic
engineering has been applied in numerous fields including research, medicine, industrial
biotechnology and agriculture. In research GMOs are used to study gene function and
expression through loss of function, gain of function, tracking and expression experiments.
The rise of commercialised genetically modified crops has provided economic benefit to
farmers in many different countries, but has also been the source of most of
the controversy surrounding the technology. This has been present since its early use, the first
field trials were destroyed by anti-GM activists. Although there is a scientific consensus that
currently available food derived from GM crops poses no greater risk to human health than
conventional food, GM food safety is a leading concern with critics. Gene flow, impact on
non-target organisms, control of the food supply and intellectual property rights have also
been raised as potential issues. These concerns have led to the development of a regulatory
framework, which started in 1975. It has led to an international treaty, the Cartagena Protocol
on Biosafety, that was adopted in 2000. Individual countries have developed their own
regulatory systems regarding GMOs, with the most marked differences occurring between the
USA and Europe.
Application of Genetic Modification
Genetic engineering has applications in medicine, research, industry and agriculture
and can be used on a wide range of plants, animals and micro organisms. Plants have
been modified for insect protection, herbicide resistance, virus resistance, enhanced
nutrition, tolerance to environmental pressures and the production of edible vaccines.
Most commercialised GMOs are insect resistant or herbicide tolerant crop plants.

Agriculture
One of the best-known and controversial applications of genetic engineering is the creation
and use of genetically modified crops or genetically modified livestock to produce genetically
modified food. Crops have been developed to increase production, increase tolerance
to abiotic stresses, alter the composition of the food, or to produce novel products.1 The first
crops to be realised commercially on a large scale provided protection from insect pests or
tolerance to herbicides. Fungal and virus resistant crops have also been developed or are in
development. This make the insect and weed management of crops easier and can indirectly
increase crop yield. GM crops that directly improve yield by accelerating growth or making
the plant more hardy (by improving salt, cold or drought tolerance) are also under
development. In 2016 Salmon have been genetically modified with growth hormones to
reach normal adult size much faster.2

GMOs have been developed that modify the quality of produce by increasing the nutritional
value or providing more industrially useful qualities or quantities.3 The Amflora potato
produces a more industrially useful blend of starches. Soybeans and canola have been
genetically modified to produce more healthy oils. The first commercialised GM food was
a tomato that had delayed ripening, increasing its shelf life.

Plants and animals have been engineered to produce materials they do not normally
make. Pharming uses crops and animals as bioreactors to produce vaccines, drug
intermediates, or the drugs themselves; the useful product is purified from the harvest and
then used in the standard pharmaceutical production process. Cows and goats have been
engineered to express drugs and other proteins in their milk, and in 2009 the FDA approved a
drug produced in goat milk.

1
Magaña-Gómez, JA; de la Barca, A.M. (2009). "Risk assessment of genetically modified crops for
nutrition and health". Nutr. Rev. 67 (1): 1–16. doi:10.1111/j.1753-4887.2008.00130.x. PMID 19146501
2
Pollack, Andrew (19 November 2015). "Genetically Engineered Salmon Approved for Consumption". The
New York Times. Retrieved 21 April2016.
3
Whitman, Deborah B. (2000). "Genetically Modified Foods: Harmful or Helpful?".
 Process Used to GM Crops
Generations can be defined by the advancements in science and technology. However,
communicating the science around these innovations can be one of the biggest challenges.
For example, popular culture has taken inspiration from innovations in genetic engineering
and created movies like Jurassic World, Xmen and Divergent. The problem is that these
stories don’t accurately portray the science of genetic modification and the benefits it can
have on society. In attempt to educate people about genetic modification, Layla Katiraee and
Karl Haro Mogel cleverly created an easy-to-read infographic to explain the six most
common crop modification techniques:

1. Cross Breeding: This technique has been used since the 1700s, it’s when you take two
sexually compatible crops and cross pollinate them to produce a hybrid. Some examples are
the plumcot (plum and apricot), tangelos (tangerine and grapefruit), the limequat (lime and
kumquat) and most famously the rabbage (cabbage and radish).
2. Mutagenesis: Mutations (muta) are genetic changes that can switch, add, or delete
nucleotides (those A,T,G and C bases), these genetic changes can sometimes lead to
new/enhanced traits which is why plant breeders sometimes induce (genesis) these genetic
changes using radiation or chemicals. Hermann Muller, Charlotte Auerbach and J. M. Robson
founded this technique in the first half of the 20th century. For example, radiation was used to
produce a deeper color in the red grapefruit.
3. Protoplast Fusion: Sounds scary right? It’s actually when you take two plant cells which
have their hard cell walls removed (Protoplasts) and you add a chemical called polyethylene
which allow the two cells to stick together. Once they are stuck together basic chemicals are
added to help the two cells combine and exchange genetic information to create a hybridized
plant cell (fusion). It’s much like cross breeding, except it’s done in a lab.
4. Polyploidy: We, humans, are diploid animals, which mean we have two sets of homologous
chromosomes. Polyploidy have more than one, and the induction of polyploidy is used by
plant breeders to control reproduction. Introducing polyploidy by soaking seeds in colchcine
can either make sterile crosses fertile, like the Triticale (hybrid of wheat and rye), or sterilizes
crops, like watermelon, to make seedless strains.
5. Genome Editing: This process has the ability to cut, replace or insert genes within the seed
cells using “molecular scissors” called nucleases—enzymes which have the ability to loosen,
remove and add nucleotides. These nucleases are artificially engineered to accurately place in
desired genes, or traits, into the genome of the crop. Herbicide tolerant canola was created
using this technique to help famers control weeds.
6. Transgenisis: When genes from one crop are incorporated into another crop. Since the
genetic code is readable by all living organisms, this means that the genes introduced will
code for the same proteins as it did before. There are many ways to introduce these new
genes, like using agrobacterium to carry it into the genome, or using electricity. I was even
learning how to transform yeast in my biology classes at school.
Genetically Modified Crops in India
The country has yet to approve commercial cultivation of a GM food crop. The only
genetically modified cash crop under commercial cultivation in India is cotton.

Bt Cotton

For the time being, the only genetically modified crop that is under cultivation in India is Bt
cotton which is grown over 10.8 million hectares. Bt cotton was first used in India in 2002.

Bt Brinjal

The GEAC in 2007, recommended the commercial release of Bt Brinjal, which was
developed by Mahyco (Maharashtra Hybrid Seeds Company) in collaboration with the
Dharward University of Agricultural sciences and the Tamil Nadu Agricultural University.
But the initiative was blocked in 2010.

GM-mustard

Dhara Mustard Hybrid-11 or DMH-11 is a genetically modified variety of mustard developed

by the Delhi University’s Centre for Genetic Manipulation of Crop Plants. The researchers at
Delhi University have created hybridised mustard DMH-11 using “barnase / barstar”
technology for genetic modification. It is Herbicide Tolerant (HT) crop. If approved by the
Centre, this will be the second GM crop, after Bt Cotton, and the first transgenic food crop to
be allowed for cultivation in the country.

Concern Regarding GM Crops

Many believe that food on the market derived from GM crops poses no greater risk to human
health than conventional food. However, opponents have objected to GM crops on several
grounds, including environmental concerns, safety of GM foods, the business interests behind
GM crops, intellectual property laws etc.

Arguments in favour of GM Crops:

The proponents, argue that the GM technologies have been around for about 15 years and
they have been in use across the world including in countries such as Brazil and
China. During a visit to India in March 2005, Norman Borlaug – widely regarded as the
father of the Green Revolution – supported producing genetically modified (GM) food to
eradicate hunger from the world. “It is better to die eating GM food instead of dying of
hunger,” said the Nobel laureate, who passed away in 2009.

 Former prime minister, Manmohan Singh, saw biotechnology as key to food security
and warned against succumbing to “unscientific prejudices”.
 “The concerns over their (GM crops) perceived risks should be addressed by following
internationally accepted procedures for assessing safety parameters. ICAR, which is
involved in developing useful products and technologies in this field, must contribute to
the public discourse and provide clarity on this sensitive issue,” – President Pranab
Mukerjee.
 Indian intelligence agency names anti-GM groups such as Greenpeace India and Gene
Campaign as one of the many “anti-national” foreign-funded NGOs hampering
India’s economic progress.
 Agriculture scientists from research institutions including IARI, ICAR and various
Universities demanding “field trials” for GM crops, arguing that “confined field trials
are essential for the evaluation of productivity performance as well as food and
environmental safety assessment”.
 A group of prominent scientists had met under ‘father of green revolution’ MS
Swaminathan at National Academy of Agricultural Sciences ( NASA) and issued a 15-
point resolution in favour of GM crops.
 “A brinjal crop normally requires up to 30 sprays of insecticides. This goes into the
human consumption indirectly. If we grow and consume Bt brinjal, we will consume
some of the genes that have been built into the seeds to make the crop pest- and
herbicide-resistant. Ultimately, we have to see which of the two is less harmful for
consumption” – S.S. Gosal, Director of Research, Punjab Agriculture University.

Arguments against GM crops:

Organisations such as Greenpeace argue that the GM crops don’t yield better results, but push
the farmers into debt. They lose their sovereign right over seeds as they are forced to buy GM
seeds and technologies from multinational corporations. The increasing incidence of suicide
by farmers cultivating Bt cotton is cited as an example of the perils of GM crops in a country
such as India. Besides the suspect merits of GM crops, what the opponents also say is that
once they are released into the environment, it’s irreversible.
Regulatory mechanism in India
The top biotech regulator in India is Genetic Engineering Appraisal Committee (GEAC). The
committee functions as a statutory body under the Environment Protection Act 1986 of the
Ministry of Environment & Forests (MoEF). It was earlier known as Genetic Engineering
Approval Committee. Under the EPA 1986 “Rules for Manufacture, Use, Import, Export and
Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells 1989”,
GEAC is responsible for granting permits to conduct experimental and large-scale open field
trials and also grant approval for commercial release of biotech crops.

The Rules of 1989 also define five competent authorities i.e. the Institutional Biosafety
Committees (IBSC), Review Committee of Genetic Manipulation (RCGM), Genetic
Engineering Approval Committee (GEAC), State Biotechnology Coordination Committee
(SBCC) and District Level Committee (DLC) for handling of various aspects of the rules.

PS: A Biotechnology Regulatory Authority was proposed, but the bill got lapsed due to the
dissolution of 15th Loksabha.

Genetic Engineering Appraisal Committee (GEAC)

1. The Committee shall function as a Statutory Body under the Ministry of Environment &
Forests for approval of activities involving large-scale use of hazardous living
microorganisms and recombinants in research and industrial production from the
environmental angle as per the provisions of rules 1989.
2. The Committee shall also be responsible for approval of proposal relating to release of
genetically engineered organisms and products into the environment including
experimental field trials as per the provisions of Rules, 1989.
3. The Committee shall be responsible for approval of proposals involving the use of
living modified organism falling in the risk category Ill and above in the
manufacture/import of recombinant Pharma products or where the end product of the
recombinant Pharma products per se is a living modified organism.
4. The Committee may co-opt other members/experts to the GEAC in accordance with the
provisions of Section 4, para 3 of the Rules, 1989 as necessary.
5. The Committee may also appoint subgroups/sub-committees/expert committee to
undertake specific activities related to compliance of biosafety.
6. One third members of the GEAC will constitute the quorum for convening the meeting.
7. The members of the GEAC will be required to sign a ‘Statement of Declaration of
Independence’ and ‘Statement of Confidentiality’ (as per enclosed proforma).
8. The Committee shall function for a period of three year from the date of issue of this
notification.
 9. With the approval of the Chairman GEAC, if required, representative of other Ministries
and other experts may be invited as ‘Special Invitees’ to participate in the meeting of the
GEAC depending on the issues to be discussed.
Major companies interested in Genetically Modified crops in India include Monsanto India,
Mahyco and BASF. The industry body — Association of Biotech Led Enterprises-
Agriculture Group (ABLE-AG) wants a progressive push to the march of GM technology in
India.

India consuming banned GM foods owing lack of regulation..4

Just last year the Food Safety and Standards Authority of India (FSSAI) had told the Supreme
Court that “GM (genetically modified) foods are not allowed in the country” and yet no
action has been taken against the GM foods flooding Indian markets.

The Coalition for a GM-free India has complained to the FSSAI with pictorial evidence
asking them to remove such products from the market and fix liability on those involved.

On December 29, Union Health Minister JP Nadda, in the Parliament, admitted that since
2007, GM soybean and canola oils are being imported in India without the approval of
FSSAI, which is tasked to regulate food to ensure that it is safe for human consumption.

This happened few months after the FSSAI told the SC, “Since regulation is yet to be framed,
it follows that GM food is not permitted to be sold in the country.”

In India, food safety regulations give the Centre the charge of regulating safety of imported
food, but the Ministry of Health and Family Welfare has passed the responsibility to ensure
these oils do not reach consumers on to the states.

“The regulatory system in the country is clearly in tatters. Incident after incident shows that
with the current regulatory regime in the country, citizens’ interests cannot be protected. If
the regulators had acted decisively in the past with severe deterrence, against illegal Bt cotton
and later, HT cotton cultivation and other illegal imports of GM foods, this situation could
have been prevented to a large extent. The government has to think of a serious overhaul of
the entire setup and significant improvements in the inter-agency coordination required for
ensuring that no illegal GM cultivation or sales take place in the country,” said the Coalition
in a statement issued last year after illegal GM soya cultivation was found in Gujarat.

The GM food imports require approvals under two laws: the Environment Protection Act of
1986 and the Food Safety and Standards Act of 2006. While the former covers environmental
impacts of the food products, the latter assesses the food’s impact on human health. Since no
regulation has been finalised for GM products, it is still banned in the country.

4
https://www.downtoearth.org.in/news/india-is-consuming-banned-gm-food-owing-to-lack-of-regulations-
59931
Genetically modified crops are cultivated from seeds that are genetically engineered to
increase yields or tolerance to pests.

Such crops help boost food production to meet the ever-increasing food demands of the
planet, say supporters. But whether it is safe for human consumption remains questionable as
scientists fear that biodiversity will be under threat if GM foods are mixed with non-GM
crops.

In response to this story, the FSSAI, in one of its tweets, said it is now in process of
prescribing guidelines for approval of such products.

Timeline of Genetic Modified Food

 2002 – Bt cotton introduced in India.
 2006 – Activists filed a PIL against GM crops in the Supreme Court.
 2010 – The then environmental minister Jairam Ramesh blocked the release of Bt
Brinjal until further notice owing to a lack of consensus among scientists and opposition
from brinjal-growing states. No objection certificates from states were made mandatory
for field trials.
 2012 – Parliamentary standing committee on agriculture, in its 37th report asked for an
end to all GM field trials in the country.
 2013 July – New crop trials have been effectively on hold since late 2012, after a
supreme court-appointed expert panel recommended suspension for 10 years until
regulatory and monitoring systems could be strengthened. Though the SC panel
suggested moratorium on GM trails, there was no official verdict from the Supreme
Court on this issue.
 2013 July – Environment minister Jayanthi Natarajan put on hold all trials following SC
panel suggestions.
 2014 – Her successor, Veerappa Moili cleared the way for trails. (NB: Two of
Manmohan Singh’s own environment ministers had stalled GM trials earlier, but
Veerappa Moily took an opposite stand and the process of approving the one-acre field
trials restarted.)
 2014 March – GEAC (UPA government) approved field trials for 11 crops, including
maize, rice, sorghum, wheat, groundnut and cotton.
 2014 July – 21 new varities of genetically modified (GM) crops such as rice, wheat,
maize and cotton have been approved for field trials by the NDA government in July
2014. The Genetic Engineering Appraisal Committee (GEAC) — consisting mostly of
bio-technology supporters — rejected just one out of the 28 proposals up for
consideration. Six proposals were rejected for want of more information.
  2016: GEAC gave green signal to GM Mustard for field trial, but SC stayed the order
and sought public opinion on the same.
 There are as many as 20 GM crops already undergoing trails at various stages.

Conclusion
India has the world’s fifth largest cultivated area under genetically modified (GM) crops, at
11.4 million hectares (mh) in 2017. But unlike other big growers, its entire GM crop area is
under a single crop — cotton — incorporating genes from the Bacillus thuringiensis or Bt
soil bacterium coding for resistance against heliothis bollworm insect pests.
The country with the highest area under transgenic crops, at 75 mh, is the United States.
According to the International Service for the Acquisition of Agri-Biotech Applications
(ISAAA), the 75 mh GM acreage comprised 34.05 mh soyabean, 33.84 mh maize (corn),
4.58 mh cotton, 1.22 mh alfalfa, 0.876 mh canola, 0.458 mh sugar-beet, 3,000 hectares potato
and around 1,000 hectares each of apples, squash and papaya.
In India, the GM crops that are under regulatory consideration — apart from the already
commercialised Bt/insect-resistant cotton — include glyphosate-tolerant cotton and biotech
hybrid mustard. Both the Bollgard II-Roundup Ready Flex (BGII-RRF) cotton event of
Monsanto (incorporating Bt as well as glyphosate-tolerant genes) and transgenic mustard
developed by Delhi University’s Centre for Genetic Manipulation of Crop Plants (harbouring
three alien genes that enable higher yields through hybridisation) have undergone all the
mandated bio-safety research and open field trials. Their commercial release has, however,
been stuck due to opposition from environmental activists.

In the case of BG II-RRF cotton, the developer (Monsanto) itself has withdrawn its
regulatory applications, following disputes with the government over intellectual property
protection on GM technologies. But that has come even as a high-level expert panel
constituted by the Prime Minister’s Office has found 15 per cent of cotton area planted across
Andhra Pradesh, Telangana, Maharashtra and Gujarat in the 2017 season — and about five
per cent in Punjab — to be under hybrids containing the “unapproved” BG II-RRF event.
This is, of course, an indication of demand for GM technology among Indian farmers —
whether or not the government and green NGOs like it.
Bibliography
 https://www.foodnavigator-asia.com/Article/2017/06/20/FSSAI-Guidelines-for-GMO-
labelling-on-their-way
 https://www.clearias.com/genetically-modified-crops-and-regulations-in-india/
 https://indianexpress.com/article/india/indias-genetically-modified-crop-area-fifth-largest-
in-world-5255662/
 https://www.downtoearth.org.in/news/india-is-consuming-banned-gm-food-owing-to-lack-
of-regulations-59931
 http://www.biotech-now.org/food-and-agriculture/2015/07/6-different-processes-used-to-
genetically-modify-crops