ORIGIN AND DEVELOPMENT OF BIOTECHNOLOGY BY - DHOBALE SANKET NARAYAN
ORIGIN
AND DEVELOPMENT OF BIOTECHNOLOGY
AUTHORED
BY - DHOBALE SANKET NARAYAN
Roll
no. - 04
Class -
LL.M 2nd Year
Division
- A
Progressive
Education Society
Modern
Law College, Pune
Savitribai
Phule Pune University, Pune
1) Abstract
Biotechnology
is multidisciplinary field which has major impact on our lives. The technology
is known since years which involve working with cells or cell-derived molecules
for various applications. It has wide range of uses and is termed “technology
of hope” which impact human health, well being of other life forms and our
environment. It has revolutionized diagnostics and therapeutics; however, the
major challenges to the human beings have been threats posed by deadly virus
infections as avian flu, Chikungunya, Ebola, Influenza A, SARS, West Nile, and
the latest Zika virus. Personalized medicine is increasingly recognized in healthcare
system. In this chapter, the readers would understand the applications of
biotechnology in human health care system. It has also impacted the environment
which is loaded by toxic compounds due to human industrialization and
urbanization. Bioremediation process utilizes use of natural or recombinant
organisms for the cleanup of environmental toxic pollutants. The development of
insect and pest resistant crops and herbicide tolerant crops has greatly
reduced the environmental load of toxic insecticides and pesticides. The
increase in crop productivity for solving world food and feed problem is
addressed in agricultural biotechnology. The technological advancements have
focused on development of alternate, renewable, and sustainable energy sources
for production of befouled. Marine biotechnology explores the products which
can be obtained from aquatic organisms. As with every research area, the field
of biotechnology is associated with many ethical issues and unseen fears. These
are important in defining laws governing the feasibility and approval for the
conduct of particular research.
2) Introduction
The
biotech sector market in India was $420 million during 2002-03. Nearly 70 per
cent of this was accounted for by the bio-Parma sector[1].
As far as the remaining components were concerned, 13 per cent was accounted
for by the bio-industrial sector, 7 per cent by the bio-services sector (which
covers clinical research and related contracted research programmes) and 6 per
cent by the agricultural sectors[2].
Bio-safety regulations in India comprise bio-safety rules and guidelines. The
existing legislative framework in India for bio-safety regulations has followed
a disaggregated approach with regulatory powers imposed in a top-down fashion.
The framework legislation for bio-safety regulations in India is the
Environment Protection Act. Three provisions of the EPA form the basis of the
bio-safety regulations. These are Sections 6, 8, and 25. India's bio-safety
rules apply to manufacture, import and storage of micro organisms and
gene-technology products and include products made of micro organisms that are
genetically engineered. The rules cover research and large-scale applications
of Genetically Modified Organisms (GMOs) and products. They also deal with
hazardous organisms that are not genetically modified. The rules encompass
manufacture, use, import, export, storage and research. Rule 8 requires
previous approval of the regulatory body for production and discharge of
genetically engineered organisms or cells into the environment. Rules 10 and 11
require permission and approval to be taken for substances, products and
foodstuffs and additives that contain genetically-engineered organisms or
cells. The most significant provision is Rule 9, which prohibits deliberate or
unintentional release of genetically-engineered organisms or cells covered
under the schedule for Experimental purposes, except when approved as a special
case by the regulatory body concerned. An interesting feature of the rules is
its Schedule, which categorizes animal and human pathogens in terms of their
risk profile.
The
Bio-safety rules have been supplemented by the Biotechnology Safety Guidelines
issued by the Department of Biotechnology (DBT). These Guidelines have been
issued in pursuance of Rule 4(2) of the Bio-safety Rules, which require manuals
of guidelines to be brought out by the Review Committee on Genetic
Manipulation, a component of the bio-safety decision- making apparatus that is
serviced by the DBT. The guidelines carry detailed analysis and assessment of
bio-safety levels. They also provide detailed guidance on rDNA research
activities, large-scale experiments, import and shipments and quality control
of products produced by rDNA technology. The guidelines were initially issued
by the DBT in January 1990 under the title Recombinant DNA Safety Guidelines.
In 1994 the Department issued the Revised Guidelines for Safety in
Biotechnology. In 1998 further revisions were affected. The 1998 amendments
were made in the light of enormous progress made since the 1990s in the fields
of recombinant DNA research and its applications namely, microbial strains,
cell lines and transgenic plants for commercial exploitation.
The
bio-safety rules are driven by multi-layered decision-making structures. These
structures carry their corresponding functions, details of which are described
below:
The
International Service for National Agricultural Research (ISNAR) and FAO has
identified four elements that are required to be considered when developing a
regulatory framework for biotechnology[3].
The first element is a legislative framework while the second element is
regarding the criteria for making a product subject to regulatory assessment.
The third element Concerns transparency and public involvement in decision-making
while the fourth element is on approaches to risk-assessment and
risk-management. India has fulfilled the first criteria by going for a
mandatory legislative framework. India's bio-safety regulations clearly deal
with both micro organisms and gene technology products. India has also factored
in the element of economic and social impacts in assessing risks arising from
GMOs and GM products. India has a decision-making system, which is well
structured but needs public involvement in decision making. It is this aspect
that has caused problems for India's bio-safety regulations.
Modern
technology involving the use of DNA technology has emerged as powerful tool for
improving both the quality and quantity of food supply and at the same time has
evoked controversial debates relating to the potential impact on human health,
environmental risks and also trade related issues[4].
3) THE RELATIONSHIP
BETWEEN ‘LAW’, ‘TECHNOLOGY’[5]
AND ‘SOCIETY’
There
are two approaches for examining the interface between these concepts:
·
The first approach is to evaluate how
technological developments are transforming the functioning of the legal
system. The most prominent aspect in this regard is the impact which
information and communication technologies are having on the administration of
courts, changes in procedure, approaches to research and in the functioning of
lawyers' offices, law firms as well as in legal education.
·
The second approach is to examine how laws try
to keep pace with technological changes. With the emergence of newer
technologies, uncertainties arise with regard to the application of existing
laws and occasionally there is a need to create new laws to regulate their use.
The
need for regulating new technologies is usually prompted by social and cultural
perceptions about the advantages of a particular technology or alternatively
the scope for its misuse. Such regulation could be in the form of
encouragement, restrictions or even prohibition on particular technologies. On
one hand, laws and policies can be structured to encourage innovation in
particular fields of technology, through means such as government subsidies,
tax concessions, protection of intellectual property rights and provision of
funds and research facilities among others. On the other hand, the growth and
use of certain technologies can be curtailed in different ways through means
like safety and health regulations, criminal sanctions for misuse, higher
taxation rates or even outright prohibitions. It is evident that
decision-making institutions such as legislatures, courts and regulatory
agencies are required to examine the constant interaction between the forces of
technological change t and social attitudes[6].
4) MEANING AND DEFINITION
Bio'
refers to life and 'technology' refers to the application of information for
practical use, i.e. the application of living organisms to create or improve a
product.
'Biotechnology
means any scientific application that uses biological systems, living organisms
or derivatives thereof, to produce or alter products or processes for
particular use’.
The
utilization of living organisms, systems or processes constitutes
biotechnology'.
Based
on the Collins English Dictionary definition, biotechnology is the
employment of living organisms, their parts or processes, to develop active and
useful products and to provide services e.g. waste treatment. The term
signifies a broad range of processes, from the use of earthworms as a source of
protein to the genetic modification of bacteria to offer human gene products,
e.g. growth hormones.
According
to the Golden Treasury of Science and Technology, biotechnology is a
discipline based on the harnessing of life processes which are controlled for
the bulk production of valuable substances.
Biotechnology
consists of 'the controlled employment of biological agents, e.g.
micro-organisms or cellular components, for favorable use'.
Biotechnology
has been defined as 'Janus-faced'. This means that there are two sides to it.
On one side, we know that the technology allows DNA to be modified so that
genes can be moved from one organism to another. On the other, it also entails
comparatively new techniques whose results are untested and should be met with
care.
Biotechnology
is 'the integrated use of microbiology, biochemistry and engineering sciences
in production or as service operation’.
5) HISTORY OF BIO
TECHNOLOGY[7]
What do stone-washed
jeans and home pregnancy tests have in common with bread, cheese and wine? They
are all examples of manipulating living organisms to create products or new
processes. They are all products of biotechnology.
Humans have
used biotechnology since the dawn of civilization. Egyptians used yeasts to
bake leavened bread, the Chinese developed fermentation techniques for brewing
and cheese making, and the Aztecs used Spirulina algae to make cakes. Today,
when most people think of biotechnology, they probably think of recombinant
DNA. Although much of modern biotechnology does deal with manipulating DNA,
classical biotechnology began long before we even knew about genes or chromosomes.
What began as recipes for production of food now includes technology to enhance
everything from farming to pharmaceuticals.
What we think of as
modern biotechnology began around the end of the nineteenth century. By then,
Mendel's work on genetics was completed and institutes for investigating
fermentation along with other microbial processes had been founded by Koch,
Pasteur, and Lister.
At the
beginning of the twentieth century, industry and agriculture started to
incorporate biotechnology. The growing automobile industry, for example, used
fermentation processes to produce acetone and paint solvents. By mid-century,
major advances in genetics dominated biotechnology research. The discovery that
DNA carries the genetic code and the structure of the "double helix"
were described by Watson and Crick. Soon, new techniques were developed to
allow manipulation of DNA. Genetically engineered plants, microbes, animals,
and products like insulin, highlight the future of biotechnology.
6) ORIGIN & DEVELOPMENT OF BIO TECHNOLOGY
THE most ancient biotechnological
art is fermentation - in the raising of dough, the brewing of alcohol, and the
production of tea, coffee, and cocoa (each of which requires a fermentation
step). But the new wave of biotechnology rests on two main techniques: genetic
manipulation and enzyme (or cell and cell organelle) immobilization. Genetic
manipulation is used by the biotechnologist to enhance the natural genetic
repertoire of a microorganism. The aim is usually to donate to the microorganism
a gene for an enzyme or a hormone in such a way that the product of that gene
is thenceforth synethesised by the microorganism. The successful development of
genetic manipulation has rested upon the discovery of new enzymes and the
improvement of old techniques by molecular biologists and microbiologists.
Crucial to the success has been the development of vectors for carrying foreign
genes into microorganisms. Also of great importance has been the acceleration
of DNA sequencing technology. The real cornerstone of genetic manipulation,
however, has been the discovery of enzymes that cut DNA at specific sites
(restriction enzymes), seal the cuts up (ligase) and copy DNA from messenger
RNA (reverse transcriptase). The first two of these are needed for the
insertion of foreign genes into the DNA of the vector. Reverse transcriptase
has become particularly important in the last two years since the revelation
that the genes of higher organisms are 'split' (the coding DNA being
interrupted by non-coding segments). In sharp contrast, bacteria do not have
split genes and cannot decode split genes that are transferred to them.
Therefore it is necessary to transfer an unsplit equivalent of the gene, which
is precisely what reverse transcriptase produces from messenger RNA.
Alternatively, due to recent advances in the technique of DNA synthesis, it is
also possible to make purely synthetic genes at least for small peptide
hormones. The use of enzymes is an older technique, applied in a number of
industries from baking to detergents. But purified enzymes are soluble
molecules and it is therefore not easy to separate them from the product of
their labour. Furthermore it is difficult to recycle the enzyme. These
difficulties have led to the development, in the late 1960s, of immobilised
enzymes. The enzyme is bound chemically to a solid matrix or entrapped in a
small pore gel. Immobilised enzymes have been successfully applied, for
example, to the production of semi-synthetic penicillin’s, to the large-scale
production of fructose from maize, and to a simple assay for blood cholesterol.
Immobilised cells or organelles have potential advantages when the
stabilization of an enzyme is difficult, or when a coenzyme or sequence of
enzymes is required for synthesis. Biotechnology may be dominated by microbial
and enzyme technology, but it is certainly not synonymous with them. Both
animal and plant cells have their place in the armory of the catholic
biotechnologist. Successful exploitation of animal cells has been achieved, for
example, by Welcome Research Laboratories in the production of interferon from
virus stimulated lymphoblastiod cells. A completely distinct exploitation of
animal cells lies behind the commercial production of high grade antibodies for
research, diagnostic and clinical use (for example for tissue typing prior to
transplantation). The key to that is the hybridomacell, an 'invention' of five
years ago. Natural antibody-secreting cells neither survive long enough in
culture nor produce pure enough antibodies to be a commercial source of
antibody. But a hybridoma cell, the result of fusing an antibody-producing cell
with a tumor cell, grows and divides continually. And all the cells from the
original hybridoma secrete the same, pure antibody. Work is also going ahead in
many countries on the problem of nitrogen fixation - attempting to extend the
range of associations of the nodule-forming, nitrogen-fixing, bacterium
Rhizobium to plants other than the Leguminosae (particularly cereals), or to
transfer the nitrogen fixing genes to plants - a distant prospect, given the
extreme oxygen sensitivity of the pathway. There is also the distant prospect,
through genetic manipulation, of a new source of controlled genetic variability
in plants to produce new high yielding or resistant varieties.
7)
Biotechnology and its Various Stages of Development[8]
There are various
stages in the development of biotechnology to meet the various needs of humans.
Its development was basically based on observations, and applications of these observations
to practical scenarios. The complexity of biotechnology is augmented due to
evolution of new technologies with time, as these are based on the employment
of improved technological advancements along with better understanding of
various principles of life-science. If, we systemically study the developments
of biotechnology up to its current stage, it can be divided into three
different stages or categories: (1) Ancient Biotechnology, (2) Classical
Biotechnology, and (3) Modern Biotechnology.
1)
Ancient Biotechnology (Pre-1800)
Most of the
developments in the ancient period i.e., before the year 1800, can be termed as
‘discoveries’ or ‘developments’. If we study all these developments, we can
conclude that all these inventions were based on common observations about
nature, which could be put to test for the betterment of human life at that
point in time.
Food, clothes, and
shelter are the most important basic needs of human beings irrespective of
whether they lived in the ancient period or the modern period. The only factor
that has changed is their types and origins. Food has been an inevitable need
since the existence of man as well as for continuous existence of human beings.
Early man used to eat raw meat, whenever they found a dead animal. However,
during harsh weather, there was a paucity of food, hence, as per the saying,
‘necessity is the mother of all inventions’, which led to the domestication of
food products, which is named as ‘agriculture’. In ancient times, humans
explored the possibilities of making food available by growing it near their
shelters, so that the basic need for food could be met easily. They brought
seeds of plants (mostly grains) and sowed them near to their shelters. They
understood the importance of water, light, and other requirements for the
optimal growth of food plants. Similar principles and needs also led them to
start domestication of different wild animals, which helped them to improve
their living conditions and to satisfy their hunger. The need to hunt for animal
was done away with it; as now animals were available to them at closer
proximity, and also they did not have to deal with the dangerous conditions of
hunting. Domestication of wild animals was the beginning of observation,
implications, and applications of animal breeding. Certainly, we can say that
this was the initial period of evolution of farming, which led to another needs
like the development of methods for food preservation and storage. They used
cold caves to preserve food for long-term storage. It also made the way for the
evolution of pots to store food products, in the form of leather bags, clay
jars, etc.
After domestication of
food crops and wild animals, man moved on to other new observations like
cheese, curd, etc. Certainly, cheese can be considered as one of the first
direct products (or by-product) of biotechnology, because it was prepared by
adding rennet (an enzyme found in the stomach of calves) to sour milk, which is
possible only by exposing milk to microbes (although this understanding was not
there, at that time). Yeast is one of the oldest microbes that have been
exploited by humans for their benefit. Yeast has been widely used to make
bread, vinegar production, and other fermentation products, which include
production of alcoholic beverages like whiskey, wine, beer, etc. Vinegar has a
significant importance because of its low pHs Vinegar is capable of preventing
growth of certain microbes, and therefore, vinegar can be used successfully for
food preservation. The discoveries and benefits of these observations led
people to work on further improvement of the process. Fermentation was a
powerful tool to improve their living conditions, even though they were
ignorant about the principle behind it.
One of the
oldest examples of crossbreeding for the benefit of humans is mule. Mule is an
offspring of a male donkey and a female horse. People started using mules for
transportation, carrying loads, and farming, when there were no tractors or
trucks. Mule is comparatively easier to obtain than Hinny (offspring of a male
horse and a female donkey). Mule and Hinny both have a chromosome number 63,
unlike horse (64) and donkey (62).
2)
Classical Biotechnology[9]
The second phase
of evolution and development of biotechnology can be called ‘Classical
Biotechnology’. This phase existed from 1800 to almost the middle of the
twentieth century. During this period various observations started pouring in,
with scientific evidences. They were all very helpful toward solving the
puzzle/s of biotechnology. Each and every contribution from different
individuals helped to solve the puzzle and pave the path for new discoveries.
The basics for the
transfer of genetic information are the core of biotechnology. This was, for
the first time, deciphered in plants, i.e., Pisum sativum, commonly known as
Pea plant. These observations were decoded by Gregor John Mendel (1822-1884),
an Austrian Augustinian Monk. Mendel at that time presented “Laws of
Inheritance” to the Natural Science Society in Brunn, Austria. Mendel proposed
that invisible internal units of information account for observable traits, and
that these ‘factors’ -later called as genes, which are passed from one
generation to the next. However, the sad part of the story is that Mendel
failed to get due recognition for his discovery for almost 34 years after his
death, when other scientists like Hugo de Varies, Erich Von Tschermak, and Carl
Correns validated Mendel's work in 1900. The reason why Mendel's study remained
unnoticed for such a long period of time was because at the same time Charles
Darwin's Theory of Evolution was so consuming that it shadowed the significance
of work done by Mendel.
Almost at the same
time Robert Brown had discovered nucleus in cells, while in 1868, Fredrich
Miescher, a Swiss biologist reported nuclein, a compound that consisted of
nucleic acid that he extracted from pus cells i.e., white blood cells (WBC).
These two discoveries became the basis of modern molecular biology, for the
discovery of DNA as a genetic material, and the role of DNA in transfer of
genetic information. 1n 1881, Robert Koch, a German physician described the
bacterial colonies growing on potato slices (First ever solid medium). Walter
Hesse, one of the co-workers in Koch's laboratory, discovered agar when he
asked his wife what kept the jelly solid even at high temperature of summer.
She told, it is agar agar, since then nutrient agar became the most acceptable
and useful medium to obtain pure microbial cultures as well as for their
identification. In 1888, Heinrich Wilhelm Gottfried Von Waldeyer-Hartz, a
German scientist coined the term ‘Chromosome’, which is considered as an organized
structure of DNA and protein present in cells or a single piece of coiled DNA
containing many genes, regulatory elements, and other nucleotide sequences.
Other important discoveries during this period were vaccination against small
pox and rabies developed by Edward Jenner a British Physician and Louis Pasteur
a French Biologist.
By this time the
development and growth of biological sciences seemed to be reaching to the
exponential phase. The principle of genetics in inheritance was redefined by T
H Morgan, who has shown inheritance and the role of chromosomes in inheritance
by using fruit flies, i.e., Drosophila melanogaster.
This landmark work of T H Morgan was named, ‘The theory of the Gene’ in 1926.
Before the publication of Morgan's work, in 1909, the term ‘Gene’ had already
been coined by Wilhelm Johannsen (1857-1927), who described ‘gene’ as carrier
of heredity. Johannsen coined the terms ‘genotype’ and ‘phenotype’. ‘Genotype’
was meant to describe the genetic constitution of an organism, while ‘Phenotype’
was meant to describe actual organism. By this time genetics started gaining
its importance, which led to the start of Eugenic Movement in USA, in 1924. As
a result of this, in 1924, the US Immigration Act was used to restrict the
influx of poorly educated immigrants from Southern and Eastern Europe, on the
grounds of their suspected genetic inferiority.
Almost at the
same time, in Britain, Alexander Fleming a physician discovered antibiotics,
when he observed that one microorganism can be used to kill another
microorganism, a true representation of the ‘divide and rule’ policy of humans.
Fleming noted that all bacteria (Staphylococci) died when a mold was growing in
a Petri-dish. Later he discovered ‘penicillin’ the antibacterial toxin from the
mold Penicillium
notatum, which could be used against many infectious diseases.
Fleming wrote, “When
I woke up just after dawn on September 28, 1928, I certainly didn’t plan to
revolutionize all medicine by discovering the world's first antibiotic, or bacteria
killer”. As a matter of
fact vaccines and antibiotics turned out to be the best saviors of humanity.
Can we attribute these two discoveries for the ever increasing population as
well the ever ageing population of the world?
3)
Modern Biotechnology[10]
The Second World
War became a major impediment in scientific discoveries. After the end of the
second world war some, very crucial discoveries were reported, which paved the
path for modern biotechnology and to its current status. In 1953, JD Watson and
FHC Crick for the first time cleared the mysteries around the DNA as a genetic
material, by giving a structural model of DNA, popularly known as, ‘Double
Helix Model of DNA’. This model was able to explain various phenomena related
to DNA replication, and its role in inheritance. Later, Jacob and Monad had
given the concept of Operon in 1961, while Kohler and Millstein in 1975, came
up with the concept of cytoplasm hybridization and produced the first ever
monoclonal antibodies, which has revolutionized the diagnostics.
By this time it seemed
like the world's scientific community had almost all the basic tools available
to them for their applications, along with majority of basic concepts had been
elucidated, which has fast forwarded the path for important scientific
discoveries. Dr. Hargobind Khorana was able to synthesize the DNA in test tube,
while Karl Mullis added value to Khorana's discovery by amplifying DNA in a
test tube, thousand times more than the original amount of DNA. Using this
technological advancement, other scientists were able to insert a foreign DNA
into another host and were even able to monitor the transfer of a foreign DNA
into the next generation. The advent of HIV / AIDS as a deadly disease has
helped tremendously to improve various tools employed by life-scientist for
discoveries and applications in various aspects of day-to-day life. In the mean
time Ian Wilmot an Irish scientist was successful to clone an adult animal,
using sheep as model, and he named the cloned sheep as ‘Dolly’. Craig Venter,
in 2000, was able to sequence the human genome; the first publically available
genome is from JD Watson and Craig Venter, himself. These discoveries have
unlimited implications and applications. In 2010, Craig Venter has been
successful in demonstrating that a synthetic genome could replicate
autonomously. Should that be considered as a new possibility for creating life
in a test tube, which could be planned and designed by human being using a pen,
pencil, computer, and bioinformatics as tools? In future, can we produce life
as per our imagination and whims?
Biotechnology
has brought humanity to this level of comfort; the next question is, where will
it take us? Biotechnology has both beneficial and destructive potentials. It
is, WE who should decide how to use this technology to help humanity rather
than to destroy it.
8) CASE LAWS
Understanding Basmati Biopiracy[11]
Vandana Shiva makes it
clear, that yes "[w]e have won the Basmati biopiracy battle, though the
war for defence of farmers' rights, indigenous knowledge and biodiversity still
needs to be won". Although the battle for Basmati rice is in relative
terms, over, there remains a great amount of uncertainty as to how such a
blatant act of piracy could occur with minimal opposition from officials.
Beyond biopiracy, Rice Tec’s Basmati patent is a case of resource piracy as a
natural resource (Basmati rice) was taken from a specific country without any
sort of granted permission or public recognition. It is a case of economic
piracy as Rice Tec used the term "Basmati', to advertise their hybrid
rice, in the hopes of appealing to customers looking for an aromatic product
similar to the original Basmati. Finally, it was a case of both intellectual
and cultural piracy as Rice Tec through its acquisition of Basmati, patented a
key heritage piece of rice producing rural communities without permission.
The severity of Rice
Tec’s biopiracy cannot be underestimated, as the conglomerate was claiming to
have invented the physical characteristics of Basmati such as the plant height
and grain length. By claiming ownership of the rice plant itself, Rice Tec was
directly threatening rural farming communities. Throughout centuries of
development, Indian farmers have produced some 200,000 varieties of rice.
9) CONCLUSION
By using the techniques developed by
biotechnology researchers can scientist can alter the life cycle of species by
inserting a gene of wholly unrelated species and enhance disease/ stress
resistance in that specie. The techniques like development of DNA vaccines and
genetically altered bacteria and other transformation of life through
biotechnology have been pursued for the sake of the social benefits which
biotechnologist’s promises. Cheaper and more effective medicines are possible
when produced through biological rather than chemicals means. But appropriate
balance of environmental and health concerns against economic benefits is
essential for the use of biotechnological applications. People should be given
awareness about both the benefits and risk of a product. They also be aware
that whether the benefits justify the risks, who reaps the benefits and who
bears the risk. If the risk and benefits are disproportionately distributed to
different groups, the practice may be unjust which may effect the community.
[1] A. Damodaran: Implications of
Competition Policy on Biotechnology Industry in India', in P.S. Mehta ed.,
Towards a Functional Competition Policy for India 239, 246 (New Delhi Academic
Foundation, 2005).
[2] Ibid.
[3] 9. Food and Agricultural
Organization, Regulating GMOs in Developing and Transition Countries,
Background Document to Conference 9, Electronic Forum on Biotechnology in Food
and Agriculture (2003), available at http://www.fao.org/biotech/C9doc.htm.
[4] Opponents of bio-technology are
skeptical about the role of bio-technology in increasing the food security;
they point to the threats that it poses to sustainable development to
agricultural and environmental bio-diversity and to public health, they counsel
caution about the not yet well known risks of gene technology. Floma Macmillan,
WTO and Environment, Sweet and Maxwell, London, 2007 quoted from 36 Nalsar Law
Review
[vol. 3: no. 1].
[5] A definition of 'Technology'
proposed by Donald Schon reads as: 'Any tool or technique, any product or
process, any physical equipment or method of doing or making, by which human
capability is extended'.
[6] Gregory N. Mandel, 'History
Lessons for a General Theory of Law and Technology', 8 Minnesota Journals of
Law, Science and Technology, 551-570 (2007).
[7]
https://www.lonestar.edu/history-of-biotechnology.htm
[8] Dr. Lily Srivastava, Law Relating
to Science & Technology (First Edition).
[9] Dr. Lily Srivastava, Law Relating
to Science & Technology (First Edition).
[10] Dr. Lily Srivastava, Law Relating
to Science & Technology (First Edition).
[11] Dr. Lily Srivastava, Law Relating
to Science & Technology (First Edition).