Open Access Research Article
GENETIC ENGINEERING TECHNOLOGY - A BRIEF LEGAL PROBE, NATIONALLY AND INTERNATIONALLY
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GENETIC
ENGINEERING TECHNOLOGY - A BRIEF LEGAL PROBE, NATIONALLY AND INTERNATIONALLY
Authored By - Ganesh Reddy K
Abstract
This paper discusses the legal,
environmental, and ethical dilemmas involved with genetic engineering
technology. This paper aims to shed light upon the various regulations and
guidelines governing genetic engineering and scientific experimentation on plants
and animals, which also talks about certain ethical issues arising from genetic
engineering and scientific experiments. This paper further talks about the
institutes and statutes which help to regulate and govern these practices. This
paper looks into the regulations imposed on genetic engineering that vary
widely and compares the efficacies of these regulations in different countries.
It also tries to compare the international regulations and guidelines(mostly UK
and US) with those, which are in existence in India. The paper also deals with
the legalities of the human geneline modification scene.It briefly talks about
the role of different regulatory statutes present in India and how they
collaborate to develop a controlled environment that aids and promotes research
and tries to regulate and penalize any unethical and unnatural experiments. The
paper also talks about the negative implications of this technology and animal
experimentation on the environment and concludes on the author’s thoughts about
the future of the field.
Key Words:- Animal Experimentation,
Genetically Modified Organisms, Genetic Engineering, Genetic Modification,
International Guidelines Recombinant DNA (rDNA), Regulations
Introduction
Genetic
engineering is the manipulation of an organism’s genes using biotechnology.It involves
modifying genetic make up of cells , including the transfer of genes within
and across species boundaries to produce improved and novel
organisms.Since genetic engineering
forms an important part of our lives it is essential that we have proper
regulations in place to prevent the
misuse of such technology and as genetic engineering achieves new feet it is ever the more required that we
have proper regulations and institutions to govern it.
And also the fact that there is cruel experimentation on animals. These laws prevent
such atrocities and try to
punish and prevent such experimentation.
History of Genetic
Engineering:
Gene Editing
has a rather vast history,
which I tried
to touch on lines, through
this article.While having to comply with strict laws, this industry
indeed has grown from double helix
to the invention of CRISPR.The history of Genetic Engineering, beings only in
1950s, which is rather recent, which
happened, thanks to the discovery of the current day term ‘double helix’ which refers to the very shape/structure of DNA.This was a
result from the strenuous work from 3 professors, who laid foundation for even
modern day understanding of genes.In the late 1950s, Arthur Kornberg, a
nobel prize awardee for his work in the field of Genetic Engineering,
achieved another milestone in this field, by actually managing to create DNA in a test tube.The 1960s, mostly was
an experimentation period, with whatever information,
the 1950s provided to these engineers.The 1960s had little to very few discoveries A sudden boom is experienced in 1970s, where
successful cloning of DNA is first done in 1972.The 1980s was probably the
second most crucial phase, as genetic engineering was for the first time, being directly/indirectly put to use for
the public.The first ‘transgenic’ animal
was created, when a mouse was induced with the DNA of a rabbit.However, where the genetic engineering technology came to
public’s aid, was in the form of vaccines and
medicines, with synthetic Insulin being one of the first drugs of this
kind.It is in 1896, where for the
first time, a vaccine for humans, that owes its creation to genetic engineering
is approved.As mentioned earlier, with 1980s being the second most crucial
phase, the first place is bagged by
1990s, especially with the discovery of CRISPR in 1993.CRISPR stands for Clustered Regularly interspaced
palindromic repeats. In simplest words, CRISPR is a technology that is a driving force behind today’s genetic
engineering field and is capable of gene modification.Post, the invention of CRISPR technology, the genetic field has made huge advancements, being able to make
GMO(Genetic Modified Organisms), with
the field of
agriculture and food, being the most privileged.
I.
Indian
Scenario
The regulatory framework to biosafety in India
contains primarily of biosafety rules and guidelines, the central legislative authority with regard to biosafety guidelines is arguably The Environment Protection Act (1986), the
Sections 6,8 and 15 jointly form the preamble
through which all the biosafety regulations are formed in India.[1]
India has always had a structured and
systematic regulatory framework for genetic engineering evaluation. India was one of the first countries to have a
proper legal framework for the same purpose back in 1989, i.e., the "Rules for manufacture, use/import/export & storage of hazardous microorganisms/genetically engineered organisms or cells, 1989"[2], implemented by the Ministry
of Environment, Forest,
and Climate Change.
They cover all the activities and by-products involved in genetically modified organisms
(GMO's) under sections 8 and 25; this
includes the new gene technologies. This Act also laid down several provisions
to create few competent authorities
implemented by the Ministry of Environment, Forest and Climate Change.
The National Biodiversity Authority implemented the Biological Diversity Act, 2002, and it aims to regulate the methodology of genetic intervention
for improving livestock and crops.
In India, specific rules regulate Genetically Modified Organisms or GMOs;
notified under the Environmental
Protection Act, 1986. The specific Rules are "Rules for the manufacture,
use, import, export, and storage
of hazardous microorganisms, genetically engineered organisms
or cells," 1989. Various authorities such as the Ministry of Environment, Forestry
and Climate Change,
the Department of Biotechnology, and the State Governments are responsible
for implementing the said Rules.
India is a member of the Cartagena Protocol on Biosafety (CPB). However,
our national legislation has yet to include the CPB's newly revised definition of
genetic engineering. When it comes to legislating new rules in India,
it looks towards other countries and how they
are dealing with new technologies to understand better and implement the same.
These observations are backed by
constant research by leading institutes.
Per the Rules, 1989, the Ministry of Environment,
Forestry, and Climate Change (MoEFCC) exercises
its authority under Sections 8 and 25 of the Environment (Protection) Act,
1986, which talked about "Regulation of Genome Technologies in India" notified
the issuance of the Rules 1989 which tends to cover
the whole array of technologies related to genetic engineering, manufacturing and use of GMOs. Six competent authorities govern the implementation of these Rules:
1. rDNA Advisory Committee (RDAC)
2.
Institutional Biosafety Committee (IBSC)
3.
Review Committee on Genetic Manipulation (RCGM)
4. Genetic
Engineering Appraisal Committee
(GEAC)
5. State
Biotechnology Coordination Committee (SBCC)
6.
District Level Committee (DLC)[3]
In India Genetic Engineering Appraisal
Committee(GEAC) forms the apex institution to supervise and penalize any noncompliance by the parties.
Under the Rules 1989, GEAC supersedes in investigating import,
export, transfer or manufacture, produce
or sell any GMOs and implies
punitive actions on the acts that have occurred without its approval. Laid down
in the Rules 1989 are various prohibitions that allow for the safe conduct of
research and the violation of which
instigates penalties mentioned under the Environment Protection Act 1986. To mention a few prohibitions:
the research related to GMOs must be conducted
only in laboratories with the approval of GEAC, and in dealing with any
new technology concerning GMOs, the
researcher must obtain permission from GEAC and any deliberate and unsupervised release of GMOs into the
environment is punishable. GEAC can initiate its supervision through SBCC, DLC, or any authorized person as the
apex institute.
Not to mention, Rules, 1989, also provide for numerous prohibitions on
acts without the approval of the apex
body, which is, the GEAC.GEAC also holds a supervisor-like position and may carry it’s supervisory functions via the State-Level or the District
Level Committees.Rules, 1989
also authorize the GEAC to carry on it’s functions via any other person
it may deem fit.The GEAC is vested
with the power to penalize
offenders in this regard.No mention of handling
experiments on humans is given by the rules, although
microorganisms, animals and
plants have been adequately addressed.
On the other hand, it is important
to note that Foods that are a product
of genetically engineered crops, and
the safety tests for same are to be in compliance with the guidelines provided by the Indian Council of medical
research.The ICMR has devised a smart set of
rules and steps for assessing how safe GE Crops are.
It should come of as no surprise, when I say India’s regulations on GMOs
are rather quite solid, taking into
consideration the fact that India is an agricultural country, that widely uses genetically modified crops, with over 500
IBSCs that further strengthen the R&B scene in the country.
II.
International guidelines
When using agricultural technology, the
safety of our food, animal feed, and environmental protection remain essential factors for risk assessment. All agricultural
products destined for consumption and
use, including varieties created using traditional plant breeding methods, must meet these
standards. The classification of a new crop or plant product
as a "genetically modified
organism," or GMO, is one way that has evolved to trigger national rules
that include risk evaluations and
management plans.
European Union[4]
In 2003, the European Union implemented
regulatory legislation that may be the world's
most restrictive GMO regulations. All GMOs and irradiation food are
classified as "novel foods" and must be evaluated by the European
Food Safety Authority on a case-by-case basis (EFSA). The four basic types of authorisation criteria are "safety," "freedom of choice,"
"labelling," and "traceability."
The European Parliament's Committee on the Environment, Public Health, and Consumer Protection advocated for and
endorsed a "safety first" concept
in the case of GMOs, requiring that anybody responsible for any harmful health effects caused by GMOs is held
accountable. The Genetically Modified Food and Feed Regulation (EC) No 1829/2003 binds all 27 Member
States immediately and specifically concerns GM food and feed generated "from" a GMO4. The Regulation intends
to ensure that GM food and feed authorisation procedures provide a
high level of protection for human, animal, and environmental health[5].
In conjunction with Regulation 1830/2003 on GM product tracing and labelling, this Regulation applies
primarily to food and feed goods and their imports. On the other hand, the cultivation of GM crops is
a decision made by the Member States under Directive 2001/18/EC on the
deliberate release of genetically modified organisms into the environment (also known as the "Cultivation Directive"). This latter tool allows for growing genetically modified foods and plants
after a thorough examination of potential negative impacts on human health and the environment. It also states that
an organism must include foreign DNA in order to be classified as genetically
modified. Even if gene-editing was employed
to create the creature,
organisms that have had the foreign DNA removed (for example, via selective breeding) do not qualify as GMOs. While the European
Union used to have
rather severe controls on genetically modified foods, it now allows newer
varieties of modified maise and other
agricultural products. EU member states can utilize a safeguard clause' to
prohibit individual kinds if there are "justifiable reasons" to
believe the variety will harm
persons or the environment. After then, the member state must provide adequate
proof to show that this is the case.
[63] The Commission must look into these issues and either overturn the initial registrations or
suggest that the country remove the temporary limitation.
In the case of the UK, the draft of
Genetically Modified Organisms(amendment)(England) Regulations, 2022, is all set to ease restrictions on
Genetically modified crops for the food industries,
that is only if the bill is approved5.Nonetheless, this affirmative
move, has been quite a sigh to
scientists and pioneers in the Genetic Engineering fields, as their countless requests for the ease of extra-strict
restrictions have been heard for once.This proposed regulation, aims at removing a few additional procedure, capable
of halting or being a deadend to the
researchers and also allows for various kinds of plant breeding methods, that aren’t
quite accepted in the other parts
of the world, if not for the US.The
new set of regulations does so, without compromising the lowering of safety and
standards in the field.If passed,
this regulation could actually inspire a lot of other countries to ease their
own regulations and promote ethical
and safe advancements.
United States[6]
In contrast to Europe and the international
community, which have developed stringent premarket
approval processes, mandatory labelling, and moratoriums, the United States has not developed a regulatory scheme with
special GMO safeguards because the US government does not recognise biotechnology as posing special risks. As a
result, the Regulation of biotechnology
food items in the United States is similar to conventional food products. The United States reviews genetically
altered items using health and safety laws enacted before introducing contemporary biotechnology. So far, no new legislation covering these items has been introduced in the United States. The Coordinated Framework for Regulation
of Biotechnology governs US regulatory policies. There are three tenets to the
policy: "(1) US policy would
focus on the product of genetic modification (GM) techniques rather than the process
itself; (2) only regulation based
on verifiable scientific risks would be tolerated; and (3) GM products are on a continuum
with existing products, so existing statutes are sufficient to review the products." To be
approved for release in the United States, a genetically modified organism must be evaluated under the Plant Protection
Act by the USDA's Animal and Plant
Health Inspection Service (APHIS), as well as the Food and Drug Administration (FDA) and the Environmental Protection
Agency (EPA) depending on the organism's intended application. The United
States Department of Agriculture
assesses plants' propensity to become weeds. The FDA examines plants that could infiltrate
or affect the food chain. The EPA oversees pesticide-resistant genetically
engineered plants and agrochemical residues.
The Animal and Plant Health
Inspection Service withdrew a proposed rule in 2017 after receiving public
feedback. Agricultural stakeholders, in particular, believed it would have severely
limited genetic engineering and even new conventional plant breeding
approaches.
National
& International Stand on:
Human
Geneline Editing
Legally, there is a ban altogether on any kind of genetic
engineering process that has
something to do with humans. In some regions, there is a moratorium, with no
specified end date. India, China,
Ireland and Japan can be said to be on the same page as they clearly place a ban in
this field[7] .In 2018,
a Chinese scientist, has surprised
the scientific world with his successful
project of creating two so called ‘CRISPR babies’. He managed to actually make human embryo and then infuse them into a
pregnant woman. As outstanding the feat might be, this news has attracted widespread contempt, with most legal
scholars claiming that the Chinese Scientist has broken several regulations,
and failed to comply with the minimum required
ethical standards. China, too, has always had complete ban on Human Gene editing.
This lead to the scientist
being penalized with imprisonment for 3 years[8].
This has lead to the Chinese authorities being more
stern with regulations and also alerted other countries and thereby
tightening regulatory framework. However, for a scientist point of view, this kind of
a reaction is quite a demotivation and such strict regulations actually do put
a bar on advancements/improvements/innovations in the field. It is sad to note
that, an experiment to use CRISPR
technology to treat blindness in humans, which was showing positive results was also called to halt, post this
incident.
The USA, which is widely regarded as the country that grants the most
comparative freedom for innovations
and experiments, in the field of genetic engineering, also places quite a few deadends to Human Geneline Modifications. It
is interesting to note that Human Geneline Engineering
isn’t directly or expressed banned, however, the kind of precautions that the regulations needs the engineers and
scientists to take, makes it impossible to conduct research in this field of genetic engineering.
Not to mention, US’s FDA has made it’s stand against human genetic modification and has made clear that, it’s stand
will remain the same for the foreseeable
future.
On the other hand, it is safe to say that the UK, is rather leading this
race, with the granting of expressed permission for a few processes under the broad umbrella of Human Genetic
Modification.Of course, this was a result of long term political
deliberations[9]. The
Oviedo Convention plays an important
role in allowing Human Gene Work, only for diagnosis and non-modification purposes in the rest of the EU.
However,
for the most part, Human GeneLine Editing is prohibited worldwide, be it
Indian, US, China or the UK. The
reason behind this, being the dread and taboo attached to the very concept of editing or playing around with
human genes or humans, in general. Nonetheless, it is clear that the CRISPR technology has promised so much good,
than bad, and it probably is time to
prudently ease restrictions in this arena, and get done with the dread
associated. This arena also suffers from the blur between
the terms ‘treatment’ and
‘enhancement’.
III. Advantages and Disadvantages of Genetic
Engineering
The
concept of genetic engineering has many advantages in the field of medicine,
research, industry and agriculture.They are :
-Bacteria can be modified
into plasmid DNA’s which codes for various
medicines. The same can also be used to code various enzymes
which have a role in food processing and similar industries.
-Various plants have also been modified
using genetic engineering into herbicidal agents,
to produce virus resistance,
to improve nutrition etc. This is very much used in modern day agriculture.
-Genetically
modified animals have been used for research, model animals and production of agricultural and pharmaceutical products.
-As
mentioned earlier, genetic engineering has a huge application in medicine,
especially in manufacturing drugs
and gene therapy. Most important among those is production of human insulin in bacteria, growth hormones,
follicle stimulating hormone (used in infertility), antihemophilic factors, and
most importantly vaccines. They have also been used in making monoclonal antibiotics which is very
important in modern day medicine.
-Gene
therapy, which basically means genetic engineering of humans, is used to treat
many diseases like SCID, chronic lymphocytic
leukemia and Parkinson's
disease.10
-Coming
to its advantages in research, it is a very important tool for natural
scientists, in the creation of transgenic organisms, one of the most important tools for analyzing gene function.
-Genetic
engineering has a very significant role in industries. Some of the important
products of genetic engineering
include biofuels, complex proteins, various biomaterials, synthetic consortia,
etc. Genetically modified virus is also used in making environment friendly lithium
ion battery.
-Modern
day agriculture depends on genetic engineering. Genetically modified crop and livestock are used to produce genetically
modified food. These crops have higher productivity.
Genetically modified fish has also been developed.
DISADVANTAGES-
-Practically
there are very minimal disadvantages of genetic engineering. However there are
a few ethical, ecological and economical
concerns. These controversies have led to litigations, international trade disputes, etc
-Few
critics have raised the issue of patenting of life, use of intellectual
property rights, accusations that
scientists are “playing god” have been raised.
-Few drawbacks of genetically modified food
include allergies and minor ailments.
-One
of the major drawbacks of genetic engineering is the cost. It is a very
expensive field .
-Lack
of trained professionals in this field is one the main hindrance in India Overall, leaving
a few drawbacks, genetic engineering has a lot of benefits. There have been a few articles which say the future
of medicine and research is genetic engineering.
Conclusion
Bioengineering
technologies, a key for cloning animal and creating whole new species of plants
and animals alike,
promises a lot of victory,
however, it faces the problems
in the form of uncertainty
and other backlashes. The only major arguments of the advocates of the technology
is that it would one day help with the potential grievous problems of
extinction, starvation, diseases and other environmental issues. A larger group
of critics believe that it brings
with itself, a greater number of problems, than the problems it currently is
solving. This would mean that the
genetic engineering space requires extremely capable regulations and an efficient
legal framework. Nonetheless, amongst all this Criticisms, it is clear
that genetic engineering technology will still triumph it’s way, evident from
the incorporation of the technology in various fields,
by the hour. However, the current
regulations are a little too stern and outdated, tending to unknowingly
curb advancements in the field.
As for the Indian Scenario,
unlike what a layman or anyone who’s not had his/her touch with this
topic would think, Indian
Law’s on GE are very
much on par with the
laws around the world, if not better.
The practical framework in our country is actually better
off , when compared to the regulatory mechanisms in the developed
nations. Not to mention, India being a
huge user of GMCs, it should be no surprise. Just because Indian legislations
in this space aren’t slacking behind it’s counterparts, it doesn’t mean the legislations are sufficient. Genetic Engineering laws, in general, need some looking into, be it national or
internationally. The last notable
international conference/ convention on this was in 2003, followed by ignored proposals, mostly. Bio Engineers, lawyers
and legal scholars have constantly expressed their dissatisfaction with the current outdated laws, not because the
laws don’t deal with new technologies but because these laws do not promote new advancements. Hence, there’s
a worldwide need for genetic engineering regulations to undergo
a reform, to enhance progress
in a field that shows-off unlimited possibilities, whilst still ensuring that the regulations are capable enough,
to prevent legal and ethical breaches.
[1] Bhuvan Bhaskar Jha & Ashutosh
Shankar, EVALUATING THE LAW
ON
REGULATION OF GENETICALLY MODIFIED CROPS IN INDIA, 2 Jamia Law Journal, 1, 2-3 (2017)
[3]
Ahuja. V, “Regulation of emerging
gene technologies in India”. BMC Proc 12, 14 (2018).
https://doi.org/10.1186/s12919-018-0106-0
[4] Crystal
Turnbull, Morten Lillemo and Trine A. K. Hvoslef-Eide, Global Regulation of Genetically Modified Crops Amid the Gene Edited
Crop Boom – A Review,FRONTIERS
IN PLANT SCIENCE,
February 24, 2021 https://www.frontiersin.org/articles/10.3389/fpls.2021.630396/full
[5] Department
for Environment, Food and Rural Affairs, ‘ New Legislation reduces time and
cost of gene editing trails for researchers’, 21 January, 2022
[6] Debra M. Strauss, The International Regulation of Genetically
Modified Organisms: Importing Caution into
the U.S. Food Supply, BUSINESS
FACULTY PUBLICATIONS FAIRFIELD UNIVERSITY, 2006 https://core.ac.uk/download/pdf/268549743.pdf
[7] Motoko A, Tetsuya I. International regulatory landscape and integration of
corrective genome editing into in vitro fertilization.
[8] Ian Sample, ‘Chinese scientist who edited babies’ genes jailed
for three years’, Guardian, Dec. 31, 2019,
[9] Rowena Mason & Hannah Devlin, MPs Vote in Favour of ‘Three-Person Embryo’
Law , Guardian, Feb. 3, 2015.
Article Information
GENETIC ENGINEERING TECHNOLOGY - A BRIEF LEGAL PROBE, NATIONALLY AND INTERNATIONALLY
Authors: Ganesh Reddy K
- Journal IJLRA
- ISSN 2582-6433
- Published 2023/07/13
- Issue 7
About Journal
International Journal for Legal Research and Analysis
- Abbreviation IJLRA
- ISSN 2582-6433
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