i

Jurisprudence Project

On

Genetically Modified Organisms and their impact on

Human health and Ecology : A Jurisprudential Analysis
with respect to liability of State under International Law

Submitted to:

Dr. Kaumudhi Challa

(Assistant Professor)

(Faculty of Jurisprudence II)

Submitted by:

Shantanu Vaishnav

Roll no. 142

Semester VI, Section B

B.A. LL.B. (Hons.)

Submitted on:

July 20, 2020

HIDAYATULLAH NATIONAL LAW UNIVERSITY

Uparwara Post, Abhanpur, Atal Nagar, Raipur (C.G.) - 492002
 ii

DECLARATION OF ORIGINALITY

I, Shantanu Vaishnav, have undergone research of the project work titled “Genetically
Modified Organisms and their impact on Human health and Ecology : A
Jurisprudential Analysis with respect to liability of State under International Law”, as a
student of Jurisprudence. I hereby declare that this Research Project has been prepared by the
student for academic purpose only, and is the outcome of the investigation and preparation
done by me under the guidance and supervision of Dr. Kaumudhi Challa, Assistant
Professor, Faculty of Jurisprudence II, Hidayatullah National Law University, Raipur. The
authors endorses certain views as his own and gives due credit to the jurists wherever
required.

Shantanu Vaishnav

Roll no. 142

Semester VI, Section B

 iii

CERTIFICATE OF ORIGINALITY

This is to certify that Ms. Shantanu Vaishnav, Roll Number 142, student of Semester VI,
Section B of B.A.LL.B.(Hons.), Hidayatullah National Law University, New Raipur
(Chhattisgarh) has undergone research of this project work titled “Genetically Modified
Organisms and their impact on Human health and Ecology : A Jurisprudential Analysis
with respect to liability of State under International Law”, in partial fulfillment of the
subject of Jurisprudence.

Place: Atal Nagar

Date: 20.07.2020 Dr. Kaumudhi Challa

Assistant Professor

(Faculty- Jurisprudence II)

Hidayatullah National Law University, Atal Nagar Chhattisgarh

 iv

ACKNOWLEDGEMENTS

I would like to sincerely thank the Faculty member of Jurisprudence Dr. Kaumudhi Challa
for giving me this project on the topic, “Genetically Modified Organisms and their impact
on Human health and Ecology : A Jurisprudential Analysis with respect to liability of
State under International Law” . This has widened my knowledge on the relevant topic.
Her guidance and support has been instrumental in the completion of this project.

I’d also like to thank all the honourable authors, writers, social workers and Academicians,
for their outstanding and remarkable works views, ideas, and articles that I have used for the
completion of my project.

My heartfelt gratitude also goes out to the staff and administration of HNLU for the
infrastructure in the form of our library and IT lab that was a source of great help in the
completion of this project. I thank my friends for their precious inputs which have been very
helpful in the completion of this project.

Shantanu Vaishnav

Roll no. 142

Semester VI, Section B

 v

TABLE OF CONTENT
Declaration of Originality....................................................................................................ii
Certificate of Originality .....................................................................................................iii
Acknowledgements..............................................................................................................iv
List of Abbreviations...........................................................................................................vi
Introduction…………………………………………………………………………….....1-2
Research Methodology……………………………………………………………………3-6
i)Problem of the Study
ii)Rationale
iii)Objective
iv)Review of Literature
v)Concepts and Variables
vi)Hypothesis
vii)Nature of the study
viii)Sources
ix)Chapterization
x)Time
xi)Limitation of the Study
xii)Contribution of the study
ix)Chapterization

Chapter 1: Production and History of Genetically Modified Organisms ……………..7-9

Chapter 2: Importance of Genetically Modified Organisms…………………………..10-11

Chapter 3: Impact of Genetically Modified Organisms on Human health and

Ecology…………………………………………………………………………………12-16

Chapter 4:Liability of the State to International law with respect to GMO……………17-23

Conclusion.......................................................................................................................24-25
References...........................................................................................................................26
 vi

LIST OF ABBREVIATIONS

 GMO Genetically Modified Organisms

 GM Genetically Modified

 US United States

 IOAS International Organic Accreditation Service

 IFOAM International Federation of Organic Agriculture Movements

 1

INTRODUCTION

A genetically modified organism (GMO) is any organism whose genetic material has been
altered using genetic engineering techniques. The exact definition of a genetically modified
organism and what constitutes genetic engineering varies, with the most common being an
organism altered in a way that "does not occur naturally by mating and/or natural
recombination". A wide variety of organisms have been genetically modified (GM), from
animals to plants and microorganisms. Genes have been transferred within the same species,
across species (creating transgenic organisms) and even across kingdoms. New genes can be
introduced, or endogenous genes can be enhanced, altered or knocked out.1

Creating a genetically modified organism is a multi-step process. Genetic engineers must

isolate the gene they wish to insert into the host organism and combine it with other genetic
elements, including a promoter and terminator region and often a selectable marker. A
number of techniques are available for inserting the isolated gene into the host genome.
Recent advancements using genome editing techniques, notably CRISPR, have made the
production of GMO's much simpler. Herbert Boyer and Stanley Cohen made the first
genetically modified organism in 1973, a bacteria resistant to the antibiotic kanamycin. The
first genetically modified animal, a mouse, was created in 1974 by Rudolf Jaenisch, and the
first plant was produced in 1983. In 1994 the Flavr Savr tomato was released, the first
commercialized genetically modified food. The first genetically modified animal to be
commercialized was the GloFish (2003) and the first genetically modified animal to be
approved for food use was the AquAdvantage salmon in 2015.

Bacteria are the easiest organisms to engineer and have been used for research, food
production, industrial protein purification (including drugs), agriculture, and art. There is
potential to use them for environmental, purposes or as medicine. Fungi have been
engineered with much the same goals. Viruses play an important role as vectors for inserting
genetic information into other organisms. This use is especially relevant to human gene
therapy. There are proposals to remove the virulent genes from viruses to create vaccines.
Plants have been engineered for scientific research, to create new colors in plants, deliver
vaccines and to create enhanced crops. Genetically modified crops are publicly the most
controversial GMOs. The majority are engineered for herbicide tolerance or insect resistance.

1
https://en.wikipedia.org/wiki/Genetically_modified_organism
 2

Golden rice has been engineered with three genes that increase its nutritional value. Other
prospects for GM crops are as bioreactors for the production of biopharmaceuticals, biofuels
or medicines.

Animals are generally much harder to transform and the vast majority are still at the research
stage. Mammals are the best model organisms for humans, making ones genetically
engineered to resemble serious human diseases important to the discovery and development
of treatments. Human proteins expressed in mammals are more likely to be similar to their
natural counterparts than those expressed in plants or microorganisms. Livestock are
modified with the intention of improving economically important traits such as growth-rate,
quality of meat, milk composition, disease resistance and survival. Genetically modified fish
are used for scientific research, as pets and as a food source. Genetic engineering has been
proposed as a way to control mosquitos, a vector for many deadly diseases. Although human
gene therapy is still relatively new, it has been used to treat genetic disorders such as severe
combined immunodeficiency, and Leber's congenital amaurosis.

Many objections have been raised over the development of GMO's, particularly their
commercialization. Many of these involve GM crops and whether food produced from them
is safe and what impact growing them will have on the environment. Other concerns are the
objectivity and rigor of regulatory authorities, contamination of non-genetically modified
food, control of the food supply, patenting of life and the use of intellectual property rights.
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
issue with critics. Gene flow, impact on non-target organisms and escape are the major
environmental concerns. Countries have adopted regulatory measures to deal with these
concerns. There are differences in the regulation for the release of GMOs between countries,
with some of the most marked differences occurring between the US and Europe. Key issues
concerning regulators include whether GM food should be labeled and the status of gene
edited organisms.
 3

RESEARCH METHODOLOGY

The project has been carried out as doctrinal research. The research is descriptive in nature
and has been completed using articles, books, journal articles, and websites. International
documents and articles have also been referred.

i) Problem of the Study

Most of the genetically modified organisms are used as ‘models’ in laboratory researches to
study the function of specific genes. However, there are a lot of ethical issues related to
genetically modified organisms. Many objections have been raised over the development of
GMO's, particularly their commercialization. Many of these involve GM crops and whether
food produced from them is safe and what impact growing them will have on the
environment. Other concerns are the objectivity and rigor of regulatory authorities,
contamination of non-genetically modified food, control of the food supply, patenting of life
and the use of intellectual property rights. Key issues concerning regulators include whether
GM food should be labeled and the status of gene edited organisms.

ii) Rationale

There are many questions to be answered before genetically modified organisms can be
labeled “a good idea” or “a bad idea.” At this time, some questions are being investigated
from multiple discipline perspectives. Before any hard and fast conclusions can be made
about positive or negative impacts on human health, multidisciplinary research efforts must
address a multitude of questions that probably don’t have an answer. Before any policy
decisions are made, more conclusive research must be completed.

iii) Objective of the Study

 To know about Genetically Modified Organism and about its production and History.
 To study the importance of Genetically Modified Organisms and whether its safe for
Human Ecology and Environment.
 To study the impact (positive and negative) of Genetically Modified Organisms on
Human health and Ecology.
 4

 To analyse the liability of State to International Law in relation to Genetically

Modified Organisms.

iv) Review of Literature

 Genetically Modified Organisms, Open Access.2

A genetically changed organism (GMO) is any organism whose genetic material has been
altered mistreatment genetic engineering techniques. the precise definition of a
genetically changed organism and what constitutes recombinant DNA technology varies,
with the foremost common being an organism altered during a method that "does not
occur naturally by sexual union and/or natural recombination". a large kind of organisms
are genetically changed (GM), from animals to plants and microorganisms. Genes are
transferred among constant species, across species (creating transgenic organisms) and
even across kingdoms. New genes may be introduced, or endogenous genes may be
increased, altered or knocked out. Creating a genetically changed organism could be a
multi-step method. Genetic engineers should isolate the cistron they need to insert into the
host organism and mix it with alternative genetic parts, together with a promoter and
eradicator region and infrequently a selectable marker. Variety of techniques is obtainable
for inserting the isolated cistron into the host order. Recent advancements victimization
orders written material techniques, notably CRISPR, have created the assembly of GMO's
a lot of easier.

 Consumer Perception of Genetically Modified Organisms and Sources of

Information, Shahla Wunderlich and Kelsey A Gatto, PMC US National Library
of Medicine National Institute of Health,2015.3

Genetically modified organisms (GMOs) have been available for commercial purchase
since the 1990s, allowing producers to increase crop yields through bioengineering that
creates herbicide-resistant and insect-resistant varieties. However, consumer knowledge
about GMOs has not increased at the same rate as the adoption of GMO crops.

2
Open Access. https://www.openaccessjournals.com/peer-reviewe
articles/geneticallymodifiedorganismjournals-review-articles-10113.html(last visited on 13/07/20)
3
PMC US National Library of Medicine National Institute of Health,
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4642419/ ( last visited on 13/07/20)
 5

Consumers worldwide are displaying limited understanding, misconceptions, and even

unfamiliarity with GMO food products. Many consumers report that they receive
information about GMO food products from the media, Internet, and other news sources.
These sources may be less reliable than scientific experts whom consumers trust more to
present the facts. Although many in the United States support mandatory GMO labeling
(similar to current European standards), consumer awareness of current GMO labeling is
low. A distinction must also be made between GMO familiarity and scientific
understanding, because those who are more familiar with it tend to be more resistant to
bioengineering, whereas those with higher scientific knowledge scores tend to have less
negative attitudes toward GMOs. This brings to question the relation between scientific
literacy, sources of information, and overall consumer knowledge and perception of
GMO foods.

v) Concpets and Variables

Through this project we are discussing the importance of Genetically Modified Organisms
with special reference to its impact on human health and ecology . It discusses various major
protocols for the liability of the state to International Law with respect to GMO .

vi) Hypothesis

It has been presumed that Genetically Modified Organisms are important in todays scenario
but before reaching to any particular conclusion regarding GMO that whether it’s good or bad
it is important to analyse the impact of GMO on Human health and ecology . And it is also
presumed that there are some protocols on international level which guide the liability of the
states to International law and protects the interest of public which acts as consumer for the
market of GMO products.

vii) Nature of the study

Given a study of this kind , a descriptive analytical method has been followed to carry out the
study. The present study based on the secondary sources of information for systemization ,
analyses and conclusions .
 6

viii) Sources

Secondary sources of data have been used to carry out the study. The data have been obtained
through Books, journals, Research papers, internet etc.

ix) Chapterization

The project has been divided into the following 4 chapters:

Chapter 1: Production and History of Genetically Modified Organisms

Chapter 2: Importance of Genetically Modified Organisms

Chapter 3: Impact of Genetically Modified Organisms on Human health and Ecology

Chapter 4:Liability of the State to International law with respect to GMO

x) Time

The average time taken to finish this project is around 10 days.

xi) Limitation of the study

The scope of project is limited to GMO’S effect on Human Health and Ecology and liability
of state to International Law but it is not focusing on the various GMO products and how
different countries have different principles regarding GMO which sometimes become
problematic.

xii) Contribution of the study

The contribution of the study is that it is focusing on the impact both positive and negative on
Human health and ecology which is important because some strongly believe that GMOs
would be harmful for human beings and the environment, but others believe that GMOs are a
positive because yield is increased, as well as food quality (increase of vitamins), and GMOs
have a positive economic impact, among other reasons. The GMO debate is a strong one, but
the positives offer more benefits than the perceived risks, which have yet to be proven to be
real.
 7

CHAPTER 1- PRODUCTION AND HISTORY OF

GENETICALLY MODIFIED ORGANISMS

 Production of Genetically Modified Organisms(GMO)4

Creating a genetically modified organism (GMO) is a multi-step process. Genetic engineers

must isolate the gene they wish to insert into the host organism. This gene can be taken from
a cell or artificially synthesized. If the chosen gene or the donor organism's genome has been
well studied it may already be accessible from a genetic library. The gene is then combined
with other genetic elements, including a promoter and terminator region and a selectable
marker.

A number of techniques are available for inserting the isolated gene into the host genome.
Bacteria can be induced to take up foreign DNA, usually by exposed heat shock or
electroporation.DNA is generally inserted into animal cells using microinjection, where it can
be injected through the cell's nuclear envelope directly into the nucleus, or through the use of
viral vectors. In plants the DNA is often inserted using Agrobacterium-mediated
recombination, biolistics or electroporation.

As only a single cell is transformed with genetic material, the organism must be regenerated
from that single cell. In plants this is accomplished through tissue culture.In animals it is
necessary to ensure that the inserted DNA is present in the embryonic stem cells.Further
testing using PCR, Southern hybridization, and DNA sequencing is conducted to confirm that
an organism contains the new gene.

Traditionally the new genetic material was inserted randomly within the host genome. Gene
targeting techniques, which creates double-stranded breaks and takes advantage on the cells
natural homologous recombination repair systems, have been developed to target insertion to
exact locations. Genome editing uses artificially engineered nucleases that create breaks at
specific points. There are four families of engineered nucleases: meganucleases, zinc finger

4
allianceforscience.cornell.edu/blog/2018/02/gmo-crops-increasing-yield-20-years-progress-ahead/
 8

nucleases, transcription activator-like effector nucleases (TALENs), and the Cas9-guideRNA

system (adapted from CRISPR). TALEN and CRISPR are the two most commonly used and
each has its own advantages. TALENs have greater target specificity, while CRISPR is easier
to design and more efficient.

 History of Genetically Modified Organisms5

Humans have domesticated plants and animals since around 12,000 BCE, using selective
breeding or artificial selection (as contrasted with natural selection). The process of selective
breeding, in which organisms with desired traits (and thus with the desired genes) are used to
breed the next generation and organisms lacking the trait are not bred, is a precursor to the
modern concept of genetic modification. Various advancements in genetics allowed humans
to directly alter the DNA and therefore genes of organisms. In 1972 Paul Berg created the
first recombinant DNA molecule when he combined DNA from a monkey virus with that of
the lambda virus.

Herbert Boyer and Stanley Cohen made the first genetically modified organism in 1973.They
took a gene from a bacterium that provided resistance to the antibiotic kanamycin, inserted it
into a plasmid and then induced other bacteria to incorporate the plasmid. The bacteria that
had successfully incorporated the plasmid was then able to survive in the presence of
kanamycin.Boyer and Cohen expressed other genes in bacteria.

In 1983 the first genetically engineered plant was developed by Michael W. Bevan, Richard
B. Flavell and Mary-Dell Chilton. They infected tobacco with Agrobacterium transformed
with an antibiotic resistance gene and through tissue culture techniques were able to grow a
new plant containing the resistance gene.

In 1976 Genentech, the first genetic engineering company was founded by Herbert Boyer and
Robert Swanson; a year later, the company produced a human protein (somatostatin).

5
https://geneticliteracyproject.org/2015/08/12/gmos-from-ancient-history-to-the-
future/text=Theearliestevidenceofartificiaselectionoplants,potentialramificationsonhumanhealtandEarthEecosyst
ems.
 9

Genentech announced the production of genetically engineered human insulin in 1978. The
insulin produced by bacteria, branded humulin, was approved for release by the Food and
Drug Administration in 1982. In 1988 the first human antibodies were produced in plants.In
1987, a strain of Pseudomonas syringaebecame the first genetically modified organism to be
released into the environment when a strawberry and potato field in California were sprayed
with it.

The first genetically modified crop, an antibiotic-resistant tobacco plant, was produced in
1982.China was the first country to commercialize transgenic plants, introducing a virus-
resistant tobacco in 1992.

In 1994 Calgene attained approval to commercially release the Flavr Savr tomato, the first
genetically modified food. Also in 1994, the European Union approved tobacco engineered to
be resistant to the herbicide bromoxynil, making it the first genetically engineered crop
commercialized in Europe. An insect resistant Potato was approved for release in the US in
1996, and by 1996 approval had been granted to commercially grow 8 transgenic crops and
one flower crop (carnation) in 6 countries plus the EU.

In 2010, scientists at the J. Craig Venter Institute announced that they had created the first
synthetic bacterial genome. They named it Synthia and it was the world's first synthetic life
form.

The first genetically modified animal to be commercialized was the GloFish, a Zebra fish
with a fluorescent gene added that allows it to glow in the dark under ultraviolet light. It was
released to the US market in 2003.

In 2015 AquAdvantage salmon became the first genetically modified animal to be approved
for food use. Approval is for fish raised in Panama and sold in the US.The salmon were
transformed with a growth hormone-regulating gene from a Pacific Chinook salmon and a
promoter from an ocean pout enabling it to grow year-round instead of only during spring
and summer.
 10

CHAPTER 2- IMPORTANCE OF GENETICALLY

MODIFIED ORGANISMS (GMO)

Genetically modified organisms (GMOs) are produced using scientific methods that include
recombinant DNA technology and reproductive cloning. In reproductive cloning, a nucleus is
extracted from a cell of the individual to be cloned and is inserted into the enucleated
cytoplasm of a host egg (an enucleated egg is an egg cell that has had its own nucleus
removed). The process results in the generation of an offspring that is genetically identical to
the donor individual. The first animal produced by means of this cloning technique with a
nucleus from an adult donor cell (as opposed to a donor embryo) was a sheep named Dolly,
born in 1996. Since then a number of other animals, including pigs, horses, and dogs, have
been generated by reproductive cloning technology. Recombinant DNA technology, on the
other hand, involves the insertion of one or more individual genes from an organism of one
species into the DNA (deoxyribonucleic acid) of another. Whole-genome replacement,
involving the transplantation of one bacterial genome into the “cell body,” or cytoplasm, of
another microorganism, has been reported, although this technology is still limited to basic
scientific applications.

Genetically modified organisms are produced using scientific methods that include
recombinant DNA technology.GMOs produced through genetic technologies have become a
part of everyday life, entering into society through agriculture, medicine, research, and
environmental management. However, while GMOs have benefited human society in many
ways, some disadvantages exist; therefore, the production of GMOs remains a highly
controversial topic in many parts of the world.

The use of GMO crops has been seen as a necessary practice in today’s world. GMO crops
are allowing for more food production to feed the world’s population and creating a better
quality of food production and greater environmental protection. Producing more crops, at a
more efficient rate, is part of the objective of having GMOs in our food. Studies suggest that
without using GMOs, we will not be able to feed the extra 2-3 billion people that will be on
this planet by the year 2050. Not using GMOs actually puts us back 40-50 years in food
 11

production, while causing massive food shortages across the world over a very short
timeframe.

GMO foods have a longer shelf life which allows food to reach more remote areas so more
people can access to this food. It provides a sustainable way to feed the millions in countries
without access to nutrition-rich foods. This fact is of much greater importance to the
developing parts of the world than to us, but is still a significant benefit of GMO crops and
can be used to end world hunger—or at the very least reduce it. Additionally, GMO crops
allow food that would not usually be grown in certain areas, such as tomatoes in drought-
prone areas, to grow sustainably. Currently, we are not able to produce enough food to feed
some of the developing nations adequately and that is very unfortunate in itself. How dire the
situation would become without GMO crops is difficult to imagine. Until new technologies
are found to help dramatically increase our food production, GMOs are going to remain
essential to our lives.6

Nutrition and taste are two of the key quality decision points that we base our food
choices on. GMO crops have shown in studies to not only taste better but also be a better
quality product overall. This is not to say that non-GMO products do not taste good or are
low quality, but rather highlight the fact that GMO crops are of the same quality, if not better.
Not only is there the benefit of taste but researchers have created more nutritious crops that
contain more vitamins and minerals in each bite.

Protecting our environment and remaining sustainable is very important. Chemicals are a
required tool of modern agriculture to control pests and other problems that come up, but can
cause stress along with unwanted side effects on our environment. GMO crops are being
modified to become disease-resistant or insect-resistant. This allows our environment to take
less of a proverbial beating from all the pollution created with necessary farming practices.
GMO crops also require less soil to be tilled, resulting in less soil erosion by keeping the soil
in place. Maintaining our environment, and keeping it healthy will provide endless benefits
for future generations.

6
https://www.britannica.com/science/genetically-modified-organism.
 12

CHAPTER 3- IMPACT OF GENETICALLY

MODIFIED ORGANISMS ON HUMAN HEALTH

GMO stands for “Genetically Modified Organism,” and the phrase refers to plants or animals
that have been genetically engineered to produce a specific set of characteristics. This is not
to be confused with traditional breeding practices, where different breeds of the same species
are combined to produce favorable traits. With GMOs, DNA is taken from a completely
different species (like a virus or fish) and inserted into a crop (like a carrot) to transfer genetic
traits. These experimental combinations of genes do not occur in nature.7

 Benefits of Genetically Modified Organisms8

1. Crops
 Improvement of taste and quality;
 Reducing of vegetal growing;
 The growth of nutrient elements, of harvest and stress tolerance;
 Improve resistance to diseases, pests and herbicides;
 New products and growing techniques.

2. Animals
 Increased resistance, productivity and efficiency of feed conversion
 Improve efficiency in terms of meat, milk or eggs
 Improving diagnostic methods

3. Environment
 Bioherbicides and bioinsectycides friendly to environment
 Soil, water and energy preserving
 A better management of natural wastes
 Efficient processing

7
https://www.hindawi.com/journals/isrn/2011/369573/
8
http://animalsciencejournal.usamv.ro/pdf/2016/Art10.pdf
 13

4. Social
 Increasing food security for growing populations.

 Controversy related to Genetically Modified Organisms

1. Safety
 Potential impact on human health -allergens, transfer of antibiotic resistance genes,
unknown effects
 Potential environmental impact: unintended transfer of genes through cross-
pollination, unknown effects on other organisms, affecting biodiversity

2. Intellectual property
 The dominance of few companies on global food production
 Increased Independence developing countries of the industrialized

3. Ethics
 Damage to natural organisms values
 Interference with nature by "mixing" of genes between species
 Objections regarding the consumption of animal genes in plants and vice versa

4. Labeling
 It is not mandatory in some states

 Health concerns related to Genetically Modified Organisms(GMO)

1. Allergic reaction: there was no evidence of allergic effects related to GM food sold
so far.
 14

2. The transfer of genes from GM foods into the human body or to bacteria found in
the human gut: if possible, and if so, the genetic material transferred can affect
people's health?
This issue is particularly important for the genes which induce resistance to chemicals, in
this case, antibiotic, if the transfer of genes as possible. Although the likelihood of this
transfer is very small, experts -FAO Fund Food and Agriculture Organization and WHO
experts recommend not using the processes of gene transfer of antibiotic resistance to new
GMOs.

3. Natural transfer of mixing cultures and seeds from natural crops,

with the gene transfer would affect food safety. This risk is real and has been shown when
traces of rice approved to be used only for feed, was found in rice products for human
consumption, obtained from genetically modified crops that had not been voluntary in the
US. They have adopted national strategies to reduce mixing, separating clearly the perimeters
of crops (GMOs and conventional crops).Now put in place worldwide for details: monitoring
after the marketing of GMOs and GM food new, continuous monitoring of food safety
derived from GMOs.

 Environmental concerns related to Genetically Modified

Organisms(GMO)9

In today’s growing society, the majority of a communities concern is focused on food and how to

provide a sufficient amount for ourselves. Genetically Modified Organisms also known as GMOs

help society’s dramatic increase in population. But does modifying organisms contribute to

everyone’s well being or are we ruining the environment by altering the way nature works?

Genetically Modified Foods were introduced commercially in 1996 and now dominate the

production of corn, soybeans, and cotton in the . But as time passes, people might wonder if

altering plants and other foods will take a negative effect on the environment. Not everyone who

9
https://gmosblogproject.blogspot.com/2012/04/gmos-affect-on
environment.html:=Consumersdonotunderstandthepossibleeffectsthat,resistancegenesfromthecropsntotheweeds.
 15

buys food from supermarkets is aware that some of the foods they are buying are GMOs.

Consumers do not understand the possible effects that GMOs cause on their health or the

environment.

A negative issue of GMOs that affect the environment is that “crop plants engineered for herbicide

tolerance and weeds will cross-breed, resulting in the transfer of the herbicide resistance genes

from the 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”.This is an

issue because if we continue to create Genetically Modified Organisms, pretty soon there will be

no organic foods left and all plants grown could become genetically modified. If scientists are not

limited to what they modify, there is a possibility that nature can be altered passed the point of no

return. If we continue modifying foods, future organic crops DNA may be contaminated and may

cause the reaction that the only foods available will be Genetically Engineered Foods.

Monsanto’s facility, is one of the first of its kind in agriculture and focuses on how to maintain or

increase crop productivity by maximizing the crop’s water use – and what are the tools farmers

need to do this,” . Although their goals are to provide seeds to farmers so they are able to grow

more crops, they mainly put farmers in debt or out of business. This has a negative effect on the

environment because the farmers have to obey theses companies rules and have continue to grow

genetically modified crops.

Although limiting scientists who engineer foods is a good idea, other people may disagree. To

them, GMO’s are important to help famers produce more crops especially during the seasons that

are not typically time to grow crops. Many people worry that because of our increase in
 16

population, we may not be able to continue to have enough foods. They believe that GMO’s are

perfect so that we don’t run out of food for everyone.

It is suggested that in the year 2050 the world’s population will reach 9 billion people. “However,

the French study suggested two possible routes to feeding the world. One involving unsustainable

improvements in crop yields which do not take into account the detrimental impact on the

environment,” .

Genetically Modified Organisms are an important part of society but it is important that we do not

expand our dependence on that that makes our need for organic food any less important. In

conclusion, Genetically Modified Organisms are important for our growing community but

can be very dangerous towards the environment.

 17

CHAPTER 4- LIABILITY OS STATE TO

INTERNATIONAL LAW WITH RESPECT TO
GMO

There are two major international protocols that address genetically modified organisms, the
Cartagena Protocol of 2000 and the Nagoya-Kuala Lumpur Supplementary Protocol of 2010.
They are attached to the Convention on Biological Diversity of 1993. They apply only to
transboundary actions; they do not apply to use or transit of GMOs within countries.10

 Cartagena Protocol

The major international instrument on genetically modified organisms (GMOs) is the

Cartagena Protocol on Biosafety (the Protocol) to the Convention on Biological Diversity.
The Protocol was adopted on January 29, 2000 and became effective on September 11, 2003.
It is designed to protect both biological diversity and human life from any adverse effects of
organisms modified by technology. There are at present 166 parties to the Protocol; the
United States is not a party.

Biosafety was one of the key issues addressed by the Convention on Biodiversity, which
stressed the need to protect human health and the environment from the possibility of
negative outcomes of modern biotechnology, while at the same time seeing the potential for
good results of innovation in such areas as improving food supplies through agricultural
development. In November 1995, the Conference of the Parties to the Convention, at its
second meeting, established a working group on biosafety. The goal of the working group
was to create a protocol on the topic that would focus on transboundary movement of GMOs,
when there may be an adverse impact on “the conservation and sustainable use of biological
diversity.” The Protocol was the result of several years of negotiations, including six
meetings held between July 1996 and February 1999, concluding in January 2000 at a
meeting on the Conference of Parties held in Montreal.

10
https://www.loc.gov/law/help/restrictions-on-gmos/international-protocols.php
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A. Purpose and Definitions

The Protocol “provides an international regulatory framework to reconcile the respective

needs of trade and environmental protection with respect to a rapidly growing global
industry, the biotechnology industry.”

The Protocol itself states that its objective is to contribute to ensuring an adequate level of
protection in the field of the safe transfer, handling and use of living modified organisms
resulting from modern biotechnology that may have adverse effects on the conservation and
sustainable use of biological diversity, taking also into account risks to human health, and
specifically focusing on transboundary movements.

The Protocol defines “living modified organism” as “any living organism that possesses a
novel combination of genetic material obtained through the use of modern biotechnology.”
“Modern biotechnology” is defined as:

the application of:

a. In vitro nucleic acid techniques, including recombinant deoxyribonucleic

acid (DNA) and direct injection of nucleic acid into cells or organelles, or

b. Fusion of cells beyond the taxonomic family,

that overcome natural physiological reproductive or recombination barriers and that are
not techniques used in traditional breeding and selection.

The Protocol’s scope includes the transboundary movement, transit, handling, and use of
GMOs, but it explicitly does not apply to the movement across borders of GMO
pharmaceuticals for human use that are covered in other international agreements or
addressed by international organizations. Nothing in the document, however, limits a party to
it from applying its own decisions on GMO pharmaceuticals. Furthermore, any party can
make its own assessment and decisions on import standards for GMOs for contained use
within the party’s own borders.
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When the Protocol was accepted, the decision was made to set up an “open-ended ad hoc
Intergovernmental Committee for the Cartagena Protocol on Biosafety (ICCP)” that would
organize the initial meetings of parties to the Protocol.

B. Basic Principles for Planned Transport of GMOs

One of the principles on which the Protocol is based is the precautionary principle, a way of
determining whether regulation should be used in uncertain circumstances. It was outlined in
the 1992 Rio Declaration on Environment and Development, which states that “[w]here there
are threats of serious or irreversible damage, lack of full scientific certainty shall not be used
as a reason for postponing cost-effective measures to prevent environmental degradation.This
principle, which favors imposing methods to prevent damage, so long as they are “cost-
effective,” has been applied to a number of environmental issues; it is considered a useful
way to balance the sometimes conflicting interests of protecting the environment while not
overly inhibiting scientific advances and international trade.

The wording of the precautionary principle in some parts of the Protocol was controversial,
and States have interpreted its meaning in various ways. While the document authorizes
nations to take precautionary decisions even when scientific evidence is unclear as to
potential harm from GMOs, there is still disagreement on how to apply this principle. Under
the World Trade Organization’s dispute mechanisms, a 2006 panel said that states could not
generally rely on nongovernmental organizations’ reports or peer-reviewed journal articles as
the basis for applying the precautionary principle in a way that restricted trade.

Under the Protocol, the basic mechanism for regulating transit of GMOs across borders is
advance informed agreement, which requires that when there is a plan to move such products
across a boundary, parties will be notified in advance. There is a 270-day period in which the
party can decide whether to allow the transit and what conditions to impose if permission is
granted. The decisions are based on assessment of risk under recognized
assessment techniques.

C. Unintended Transboundary Transmission and Information Sharing

The Protocol also contains provisions on accidental movement of GMOs across borders. It
specifies that if a party becomes aware that something has occurred that “leads, or may lead,
to an unintentional transboundary movement” of a living GMO and if that movement would
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“have significant adverse effects on the conservation and sustainable use of biological
diversity” that may include a risk to human health, then that party has the obligation to notify
any affected countries, relevant international organizations, and the Biosafety Clearing
House. The Protocol establishes the Biosafety Clearing House to facilitate the exchange of
all kinds of information about GMOs and to help parties to the Protocol implement its
provisions.The Protocol also states that each participating country should establish a
“national focal point” to be responsible for the administrative functions required by the
Protocol; information on the designated focal point is available to all parties through the
Biosafety Clearing House.

D. Handling and Labeling

The Protocol also specifies that measures must be taken such that GMOs being transported
are properly handled, packaged, and safely moved. In addition, documentation must
accompany all shipments of GMOs that states that the items may contain GMOs, as well as
indicating a contact point for information about the shipment.

E. Illegal Transboundary Transmissions

The Protocol does not include specific penalties for improper transmission of GMOs across
borders. Instead it states that parties “shall adopt appropriate domestic measures aimed at
preventing and, if appropriate, penalizing transboundary movements” of GMOs when done in
a manner that violates Protocol provisions. It also states that parties affected by illegal
transmissions may request that the party of origin bear the expense of disposal of such
illegally transmitted GMOs, either through repatriation or destruction as appropriate.
Furthermore, such cases must be reported to the Biosafety Clearing House.
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 Nagoya-Kuala Lumpur Supplementary Protocol

Following years of negotiations over the question of liability for GMO-produced damages, on
October 15, 2010, the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and
Redress to the Cartagena Protocol on Biosafety (the Supplementary Protocol) was adopted.
As of March 2013, only eleven parties to the Protocol had ratified the Supplementary
Protocol; it will enter into force ninety days after the fortieth country ratifies or otherwise
accepts it.

The Supplementary Protocol provides international rules and procedure on liability and
redress for damage to biodiversity resulting from living modified organisms.

A. Purpose and Definitions

The Supplementary Protocol states that its objective is to “contribute to the conservation and
sustainable use of biological diversity, taking also into account risks to human health, by
providing international rules and procedures in the field of liability and redress relating to
living modified organisms.” It applies to damage from GMOs that cross borders and defines
“damage” as an adverse effect on the conservation and sustainable use of biological diversity,
taking also into account risks to human health that:

(i) Is measurable or otherwise observable taking into account, wherever available,

scientifically-established [sic] baselines recognized by a competent authority that takes into
account any other human induced variation and natural variation; and

(ii) Is significant The Supplementary Protocol further states that whether an adverse effect is
significant is determined based on a number of factors, including whether it causes long-term
or permanent change, the extent of the qualitative or quantitative change that results, whether
it reduces the way in which natural diversity provides goods and services, and the scope of
any adverse impact on human health.

B. Basic Principles

The basic principle underlying the Supplementary Protocol is that the polluter must pay for
any damage caused. Lefeber notes that this principle has an economic origin, but, he argues,
it is not clear whether it applies only to the person or organization in control of the polluting
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activity or whether liability extends to the state in charge of the area in which the activity
occurred. While suggesting that liability of the state could be justified in international law,
he notes that it has not been directly supported by existing international instruments.In fact
the Supplementary Protocol explicitly provides that it does not affect “the rights and
obligations of States under the rules of general international law with respect to the
responsibility of States for internationally wrongful acts.

An additional basic principle is that, for the provisions to apply, a causal link must be
established between the damage incurred and the GMO in question.

C. Response Requirements

Under the Supplementary Protocol, parties must require those responsible for damages to
immediately inform the authorities, evaluate the damage, and take appropriate response
measures. The authorities must also evaluate the damage, as well as identifying the operator
that caused the damage and determining needed response measures. If there is a likelihood
that damage will occur without timely intervention, the operator of the organization involved
is required to take appropriate measures so that damage is avoided. An assessment as to
whether damage is likely must be based on available scientific information, including
information collected by the Biosafety Clearing House. Authorities may also directly
implement response measures when operators of businesses fail to do so. In such cases, the
authorities may recover costs from the operators. The decision by a government authority to
take action should be relayed to the operator. Response measures must be implemented in
accordance with domestic law.

D. Additional Applications of Domestic Law

The Supplementary Protocol allows parties to make specific provisions under their domestic
law. It permits exemptions from responsibility when there are acts of war or civil unrest, or
acts of God (force majeure), and parties may add other exemptions as they deem
appropriate.Domestic law can also be used to establish the time and financial limits of
liability for costs incurred in response to damaging GMO events.
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Domestic law is also the source for rules and procedures to address the civil liability from
damage caused by GMOs. It permits parties to either develop specific civil liability law for
GMOs or to apply their existing general laws to such liability.

E. Assessment and Review

Once the Supplementary Protocol has been in force for five years, and at five-year intervals
thereafter, the effectiveness of the agreement will be reviewed by the Conference of the
Parties. The Conference of the Parties serving as the meeting of the parties for the Cartagena
Protocol serves as the Conference of the Parties to the Supplementary Protocol.

The above mentioned two protocols are the two main instruments regulating the GMO’s trade
on international level and define the liability of state to International law wrt GMO.
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CONCLUSION

GMOs can represent an alternative to conventional food & feed in the context of permanent
growing of world population and the rapid developments in genetic engineering with
appliance in agriculture and medicine. We can underline here that the US and EU feed
industry (98% of GMO imports are used for feed) rely more and more on GMOs, fact that
leads to a certain dependency on GMOs in this industry.
Although the food & feed safety concerns are more and more scientifically assessed and no
real evidence of harmful effects is found, the issues of preserving the environment and
biodiversity is an important aspect that comes along with the debate on the coexistence
possibility.
Gene flow between GM crops and compatible plants, along with increased use of broad-
spectrum herbicides can increase the risk of herbicide resistant weed populations. Debate
over the extent and consequences of gene flow intensified in 2001 when a paper was
published showing transgenes had been found in landrace maize in Mexico, the crops center
of diversity.Gene flow from GM crops to other organisms has been found to generally be
lower than what would occur naturally. In order to address some of these concerns some
GMOs have been developed with traits to help control their spread. To prevent the
genetically modified salmon inadvertently breeding with wild salmon, all the fish raised for
food are females, triploid, 99% are reproductively sterile, and raised in areas where escaped
salmon could not survive.Bacteria have also been modified to depend on nutrients that cannot
be found in nature, and genetic use restriction technology has been developed, though not yet
marketed, that causes the second generation of GM plants to be sterile.

Meanwhile, science is moving ahead rapidly. Some of the concerns associated with the first
generation of transgenic crops have technical solutions. New techniques of genetic
transformation are eliminating the antibiotic marker genes and promoter genes that are of
concern to some. Varieties including two different Bt genes are reducing the likelihood that
pest resistance will develop. Management strategies and genetic techniques are evolving to
prevent gene flow.However, the lack of observed negative effects so far does not mean they
cannot occur, and scientists agree that our understanding of ecological and food safety
processes is incomplete. Much remains unknown. Complete safety can never be assured, and
regulatory systems and the people who manage them are not perfect.
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REFERENCES

 https://www.britannica.com/science/genetically-modified-organism

 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4642419/

 https://geneticliteracyproject.org/2015/08/12/gmos-from-ancient-history-to-the-future/

 http://kanat.jsc.vsc.edu/student/gilbert/main.htm

 https://www.nationalgeographic.org/encyclopedia/genetically-modified-organisms/

 https://abcofagri.com/impact-of-genetically-modified-organisms-gmos-on-health/

 https://www.essaycrackers.com/blog/effects-genetically-modified-organisms-human-

health-environment/

 https://www.loc.gov/law/help/restrictions-on-gmos/international-protocols.php

 https://www.greenfacts.org/en/gmo/2-genetically-modified-crops/99-conclusions.htm