Abstract:
Genetic engineering has completely transformed the fields of agriculture, medicine, industry and environmental conservation. This research paper gives an insight about the history, applications, regulatory framework and future of genetic engineering. The introduction provides us with the meaning of genetic engineering and systematically explains evolution of modern biotechnology from the traditional methods. Certain pros and cons relating to gene engineering are herein mentioned.
Biotechnology and gene engineering is going to be the future of human civilization. All the fields would require a significant amount of input from biotechnology to carry on its operations. This paper provides us with potential future and related developments in this field. Our main focus was to explore more about the legal aspect of biotechnology and genetic engineering also get to know about the bodies regulating the functioning of institutions creating genetically modified organisms and products.
Keywords: Biotechnology, Genetic engineering, Regulator bodies, Genetically Modified Organisms (GMOs), CRISPR/Cas9
Introduction
Genetic Engineering is a process of alteration, modification and change in the genetic framework of organisms with the help of technology. In simple terms, advance equipment is used to add, delete or modify the DNA codes of organisms to improve their productivity, quality, life span or make them disease resistant. The bacterium was first genetically altered organism to be made in 1973. The same technique was used on mice in the year 1974 which made it possible to analyse how specific genes work in a model organism.
Agriculture, medicine, research are some of the fields in which genetic engineering is applicable. Improving and increasing the abilities of an organism beyond what is considered normal is the main goal of genetic engineering. There are various benefits of genetic engineering like faster and more efficient genetic modification as compared to traditional selective breeding practices, producing high quality and high yield crops. There are also several downsides like many people believe genetic modification creates interference in the nature and can potentially harm other normal organisms.
Environment (Protection) Act deals with and regulates genetic engineering and genetic modification of food in India. The Indian Government in the year 1989 made certain rules, regulations and guidelines regarding the development, export, use, import and storing of unsafe and dangerous Micro Organisms and Genetically Engineered Organisms.
Research Methodology
For this research paper, doctrinal research methodology is being used wherein secondary sources like books, journals, blogs and various other publications are taken into consideration to understand and interpret this topic.
Review of Literature
Kathy Wilson Peacock’s book tries to give us an extensive exploration about the applications, ethical implications and principles of genetic engineering. The book is a valuable resource for understanding the scientific advancements and social impacts of these technologies.
This literature review explores the historical development, its applications, regulatory framework and the future prospectus of genetic engineering.
History
Human mankind has adopted used from thousands of years various traditional methods like selective breeding and cross breeding of plants and animals, to produce high quality output from these organisms. Corn is a product that has risen out of selective breeding which was developed thousands of years ago in Southern part of Mexico. Currently, many countries around the globe have this grain as their staple food. But modifying plants and animals with the help of traditional breeding process is a time-consuming process after which making specific changes in it is more strenuous task. Hence, in the 1970s, biochemists Herbert Boyer and Stanley Cohen had created genetic engineering where they had to put DNA of one bacterium into another in less time.
In 1951, Jack Williamson published a science fiction novel named “Dragon’s Island” in which he was the first person to coin the term genetic engineering. However, it is also believed that in 1934 a Russian geneticist named Nikolay Timofeev-Ressovsky wrote a paper “The Experimental Production of Mutations”, in which he first used the term genetic engineering. The first Genetically Modified Organism (GMO): human insulin to treat diabetes was created in 1982 which then got accepted by the Food and Drug Administration. The first field trials of genetically engineered plants were made in France and USA. In these trials tobacco plants were engineered to be immune to herbicides. The World Health Organization (WHO) framed and implemented international guidelines and standards to determine the safety of GMO foods with the help of Food and Agriculture Organization (FAO) of the United Nations.
A combined of 11 transgenic crops were being cultivated in 25 countries, out of which a large area was grown in the US, Brazil, India, Canada, Argentina, Paraguay and South Africa. Jennifer Doudna and Emmanuelle Charpentier collaborated to develop the CRISPR/Cas9 system, a technique which can be used to easily and specifically modify the gene structure of almost any organism in 2012. The FDA had received an application for the first genetic alteration in an animal for use as food (a genetically engineered salmon) which they assented to in the year 2015.
Process, Technique and Application
The method of creating a Genetically Modified Organism (GMO) requires successful completion of many steps. But the researchers must first assess the objective for which the GMO is created and what features are to be inserted into it. Once these assessments are complete, following steps are to be undertaken:
- The first step is to identify an organism that possesses the desired trait and extracting its DNA successfully.
- After this, the gene which is responsible for controlling the desired trait is copied and cloned so that it can be altered for further modification.
- The gene is then modified in a specific way or pattern that will increase the efficiency and effectiveness of the target organism.
- The fourth step involves insertion of the modified gene into the target organism to receive the desired outcome.
- At the final stage, the modified gene is combined with the DNA of the superior organism to ensure the desired traits are properly expressed.
Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR/Cas9) technology has been carved out of modern biotechnology. It is a gene editing tool that is faster, cheaper and accurate as compared to traditional techniques of DNA editing.
Genetic engineering is applied across various fields. Some of these are:
Agriculture: Genetically modified crops are made with improved features like resistance to pests, diseases, chemicals etc. Also, genetic alterations are made to improve the quality, yield and the nutritional value of the crop.
Industry use: Scientists genetically engineer micro-organism to produce enzymes for using it in food processing and cleanser production. The Modified microbes are also used to make biodegradable plastics, prepare paper pulp and decomposing toxic wastes.
Nature and Biodiversity: Genetically modified organisms have an important part in protecting, conserving and restoring the endangered species and helps in controlling the effect of invasive species.
Medicine: Genetic engineering has revolutionized the field of medical science by making it possible to produce pharmaceutical drugs, vaccines and proteins through genetically altering organisms like yeast, bacteria etc. Influenza vaccines, cholera vaccine, insulin vaccines are some of the examples that are produced using gene editing tools.
Research: The concept of genetic engineering is ever-growing and a lot of research is still going on. Research has helped to develop unique technologies like CRISPR-Cas9 that has enabled the geneticists and medical professionals to modify and alter the genome in more efficient and effective manner as compared to traditional methods of selective breeding and cross breeding.
Legal Framework
In India, Genetically Modified Organisms (“GMOs”) and related products are under the control of “Rules for manufacture, use, import, export and storage of hazardous microorganisms, genetically engineered organisms or cells, 1989” notified under the Environment Protection Act, 1986 by the Government of India.
Rules, 1989
Applicability:
“These rules are applicable to manufacture, import and storage of microorganisms and gene-technological products.
There are various regulatory bodies that are established under this act:
Recombinant DNA Advisory Committee (RDAC) – The function of this committee is to review the developments in Biotechnology at national and international levels. It shall also recommend relevant and appropriate safety regulations in recombinant research, use and applications from time to time. This committee functions under the Department of Biotechnology.
Review Committee on Genetic Manipulation (RCGM) – The function of this body is to monitor the safety related aspects related to on-going research projects and activities involving genetically engineered organisms and hazardous microorganisms. This committee shall include representatives of: (i) Department of Biotechnology (ii) Indian Council of Medical Research (iii) Council of Scientific and Industrial Research (iv) Indian Council of Agriculture Research (v) Other experts in their individual capacity
These bodies shall make rules and procedures imposing restriction and prohibition on production, sale, importation and use of GMO of cells as given in the schedule.
Institutional Biosafety Committee (IBSC) – The main purpose and task of this committee is implementation of biosafety guidelines and rules in institutions that handle hazardous microorganisms, GMOs and recombinant DNA materials. This committee shall be constituted by an occupier or any person including research institution handling GMOs. This committee is made up of the head of the Institution Scientists who shall be engaged in DNA work, a medical expert and a nominee of the Department of Biotechnology.
Genetic Engineering Appraisal Committee (GEAC) – This committee was formed as Genetic Engineering Approval Committee and was renamed as Genetic Engineering Appraisal Committee in 2010. The function of this committee is appraisal of activities that involve the large-scale use of hazardous microbes and recombinants in research and industrial production. This committee is also responsible for assessing the applications and proposals regarding the release of genetically modified products and organisms into the nature. For using the genetically modified organism, prior approval of the GEAC is mandatorily required.
State Biotechnology Co-ordination Committee (SBCC) – This is a monitoring committee working at the state level. It has powers to investigate, inspect and to take strict actions in case of violations and breach of statutory provisions through State Pollution Control Board or the Directorate of Health. Periodical review of the safety and control measures established at various institutions and acting as agency at the state level to measure the damage caused by the introduction of GMOs released in the environment are some of the duties that need to be performed by the committee.
The committee shall be made up of:
1) Chief Secretary acting as a chairman
2) Secretary (Department of Environment) acting as a member secretary
3) Secretary (Department of Health) acting as a member
4) Secretary (Department of Agriculture) acting as a member
5) Secretary (Department of Industries and Commerce) acting a member
6) Secretary (Department of forest) acting as a member
7) Secretary (Department of Public Works/ Chief Engineer) acting as a member
8) State Microbiologists and Pathologists acting as a member
9) Chairman of State Pollution Control Board acting as a member
District Level Committee (DLC) – The function of this committee is to monitor and regulate the institutions engaged in the activities related to genetically modifying organisms and Hazardous microorganisms at district level. The persons authorized by the committee shall check, monitor and review the functioning of these institutions and shall prepare an off-site emergency plan.
The committee shall be made up of:
1) District collector acting as a chairman
2) Factory inspector acting as a member
3) Representative of the Pollution Control Board acting as a member
4) Chief Medical Officer (District Health Officer) acting as a member
5) District Agriculture Officer acting as a member
6) Representative of Public Health Engineering Department acting as a member
7) District Microbiologists/ Pathologists acting as a member
8) Commissioner of Municipal corporation acting as a member
The Cartagena Protocol on Biosafety
The Cartagena Protocol on Biosafety agreement is an addition made to the United Nations Environment Programme’s Convention on Biological Diversity (CBD).
Objective – The goal of the Cartagena Protocol is to make sure that sufficient level of protection in the field of safe handling, transportation and operation of Living Modified Organisms (LMOs) which can create harmful effects on the conservation and sustainability of the biodiversity.
Applicability – This protocol is applicable upon the transboundary movement, transit, handling LMOs which are considered to be utilized as food as well as to be released in the ecosystem. A total of 173, out of which 170 are United Nations members have ratified the protocol. On 17 January 2003, India ratified the protocol and on 11 September 2003 it came into force.
Summary – The protocol lays down guidelines and procedures to be followed by the signatory countries before dealing with Living Modified Organisms.
- The countries that are importing the LMOs have the right to be informed about the organisms exported to them.
- The countries are required to conduct risk assessments before making decisions to import and introduce these LMOs into their environment. The countries should share and exchange information amongst themselves about the LMOs.
- The protocol highlights the need for capacity building to ensure proper implementation of provisions takes place in those which countries which are still in developing phase or their economies are in transition.
- The protocol has also laid down the rules, regulations and procedures for compliance and enforcement of the provisions.
The Biotechnology Authority of India Bill, 2013
This particular bill was being introduced by the Ministry of Science and Technology in the Lok Sabha on 22nd April, 2013. Then it was passed on to the standing committee on 17th May, 2013.
Highlights:
- The Bill aims at setting up an independent authority, BRAI, to control those organisms that are made out of modern biotechnology.
- The authority will control the manufacturing, usage, conveyance, warehousing, release, cross border movements and research on the biotechnological products.
- The authority is vested with the authority to provide certification to those engineered products that are safe for to be used for the purpose it was been made.
- The Biotechnology Regulatory Appellate Tribunal is empowered to try civil cases that have biotechnology as main issue and hear appeals against judgements and orders provided by BRAI.
Committee shall be made up of: 1) Chairperson; 2) Two full time members; 3) Two part time members (for a period of three years).
They must hold scientific qualification which is specified and then selection would be done by a committee comprising of the Cabinet Secretary, Secretaries of relevant ministries and two eminent biotechnologists.
Functions:
- Authorizing and regulating the research, conveyance, cross border movement, warehousing, release, construction and usage of biotechnological products and organisms.
- Prior permissions would be required for conducting field trials.
- The Central Drugs Standard Control Organisation (CDSCO) would move ahead those applications dealing in drugs and vaccines with the contents of biotechnology, to get approved by the BRAI.
- The food items with contents of biotechnology need to get assented by the BRAI as fit for human consumption.
- The authority is being vested with the powers to call for information, initiate and undertake inquiries and provide directions for safeguarding the products and organisms.
Criticisms:
- As per some people, the bill was considered to be unconstitutional as the department of agriculture comes under the regulation of state governments.
- People were of opinion that rather than creating a separate regulatory body existing regulatory bodies should be strengthened.
- The bill had no provision for mandatory labelling of genetically modified foods.
There are several other laws that regulate and govern matters related to biotechnology and genetic engineering, such as:
- The Wildlife (Protection) Act, 1972
- The Foods Safety and Standards Act, 2006
- The Drugs and Cosmetics Act, 1940 read along with rules, 1945
- The Protection of Plant Varieties and Farmers Rights Act, 2001
- The Environment Impact Assessment (EIA) Notification, 2006
- The Indian Patents Act, 1970 read along with the Patents (Amendment) Act, 2005
Criticism
The rampant use of genetic engineering and GMOs involve significant risks linked to it. Some of the potential harms associated with GMOs are as follows:
- Adverse effect on human health – Creation of GMOs through gene alteration raise potential concerns relating to introduction of new allergens into foods and can trigger existing allergic reactions. The GMOs are created using antibiotic resistance that can transfer these bacteria into humans and may reduce the effect of antibiotics in humans.
- Harm to the environment – Manipulation in natural genetics of organisms can harm their existing DNA structure leading to disturbance in ecosystem and depletion of biodiversity. GMOs can harm the natural organisms after identifying them as potential competitors and can also contaminate the soil health and microbial communities.
Future
Biotechnology and genetic engineering are a very recent concept. It has a lot a scope and holds immense potential of development across various fields. With rapid advancement in the field of AI and Technology, Biotechnology and gene engineering will get a huge boost. There are also various downsides to genetic engineering which if remain unchecked could potentially disrupt the ecosystem and create adverse and harmful effects on the natural organisms. To tackle such issues strict rules, regulations and policies need to be framed.
In the field of medicine, more techniques like CRISPR/Cas9 might be invented to make the process of gene editing and modification is a more cost efficient and time saving way. The scientists and doctors would be able to make drugs, medicines and vaccines that can cure diseases which today stands incurable.
In our country, the division which works in Biotechnology with the help of Ministry of Science and Technology has laid down certain goals and strategies to be achieved in future, namely:
- Making efforts to bring in and encourage investments for innovation and development of biotechnological tools for enhancing the efficiency and productivity of agriculture and medicine, and conservation of biodiversity.
- Creating Indian human resource incomparable by development of skilled workforce, capacity building and R&D facilities.
- A powerful infrastructure must be established for research purpose and new profit-oriented biotechnologies bodies must be created.
Suggestions
- Promoting research and development: Biotechnology and Genetic engineering holds immense potential. This is a key to unlock the answers for those questions which still remain unsolved. It can save lives of thousands of people who suffer due to fatal diseases. Cost effective techniques can be developed so that the poor can avail these medical facilities.
- Creating awareness and setting up workshops: The government can tackle the agricultural problems like low quality crops, less yield, pest infestations by educating and making the farmers aware about the products and organisms developed using latest technologies.
- Framing stringent laws: The government must take steps to ensure that rules, regulations, policies are framed and implemented to safeguard the natural environment and stop malicious people from creating and releasing the genetically modified organisms which are intended to cause harm to the ecosystem.
Conclusion
In conclusion, this study provides a brief overview about genetic engineering transforming over a period of time acting as boon as well as a threat to this natural environment. Techniques like CRISPR/Cas9 being developed which are time efficient and cost effective as compared to our traditional methods. From this research we also get to know about history of genetic engineering as well which is explained concisely. Legal aspect regarding genetic engineering can also be understood very easily through this research paper wherein all the applicable laws, rules and regulations are being systematically mentioned and explained.
Keeping in mind the rapid developing world, Biotechnology and genetic engineering is the future to ensure that the needs of the humans and the biodiversity are balanced and go hand in hand. Increasing pollution, rapidly growing population, exploitation of resources are some of the issues that require an immediate solution. Genetic engineering can save and protect our natural environment by inventing those technologies, techniques, products, organisms that can fulfil the demands of humans in a more efficient and effective manner. At the end, it is our duty that we don’t tamper, modify or alter the creation of nature to such an extent that the technology we are developing for our own benefit and well-being starts to backfire on us.
Name – Omkar Dattaraj Shirwadkar
College – Kishinchand Chellaram Law College, Mumbai