This article is written by Aradhya Gupta, pursuing B.A. LL.B. (Hons.) from Teerthanker Mahaveer University. This article discusses all the concepts of Genetically Modified Organisms, its rules, regulations, and challenges.

Introduction

In recent times, the genetic modifications of organisms or the concept of genetic engineering have been developed, which has progressed at a high pace during the last decade. By using the biotechnological mechanism, Genetically Modified organisms are being produced by transferring the genes between the different organisms for getting the specific desired traits in them. Plants are also derived through this method which is called Genetically Modified Plants or Transgenic plants.

Genetically Modified Organisms 

Meaning

An organism whose genetic material is changed by genetic biotechnology engineering, commonly known as Recombinant DNA technology. It is done with the desire or to create such combinations of plants, animals and bacteria and viruses’ genes that generally are not present in nature or occur in it. Such organisms are known as or referred to as genetically modified organisms (GMO). The whole process of genetic engineering is done in the laboratory for the generation of the desired biological beings, the perfect definition of GMOs, and what constitutes genetic engineering varies in every experiment.

Definitions

• The U.S. Department of Agriculture considers GMOs to be as- the plants or animals with heritable changes introduced by genetic engineering, and GMO specifically refers to the organisms with genes eliminated, introduced or re-arranged using the modern Molecular Biology like Recombinant DNA techniques as transgenesis.
• Generating or producing a GMO is a multi-dimensional process. In this, the genetic engineer segregates the desired gene and inserts it into the host organism and then fuse or integrates it with the other certain genetic elements. Different techniques are present in the subject of biotechnology and also emerging with a good pace for the ways of inserting the isolated gene into host organisms. Even the recent developments like the use of genome editing techniques- CRISPR have notably led to the making of GMOs much simplified.
• The important examples of organisms that have been subject to genetic engineering are crops, plants, farm animals, and soil bacteria.

Need for Genetic Engineering

India had achieved the Green Revolution during the 1970s. But today, in the 21st century, the situation has changed due to the frequent changes occurring in the climatic conditions as well as due to the increasing ratio of population factors in the country. The problem of hunger and starvation is on the rise in the whole world and elimination of such issues of malnutrition in hunger will be very difficult in the coming years and hence, to cope up with such versioning situations there is a need to focus on sustainable agricultural patterns and the unified efforts of all the stakeholders worldwide like UNICEF, WHO, FAO, etc. is needed.

The conventional methods and technologies of agriculture in production are also not sufficient to fulfil the food and nutrition requirement and also to eliminate the biggest arising problems of hunger and malnutrition. The recent advancements in the field of Biologies like modern biotechnology and Molecular Biology provide many advantages in comparison to that of the traditional technique.

Development in Genetic Engineering

• The first Genetically modified organism was a bacteria that was resistant to the antibiotic kanamycin made by Herbert Boyerand and Stanly in 1973.
• The first genetically modified animal was a mouse which was created by Rudolf Jaenisch in 1974.
• In 1983, the first Plant was produced.
• The first genetically modified food was tomato.
• Bt. cotton is the only genetically modified crop approved in 2002 by the Genetic engineering committee of the Ministry of Environment, forest and climate change for commercial cultivation in the country. Genetically modified crops are publicly the most controversial GMOs.
• The first genetically modified animal which is used for commercial purpose was Glofish in 2003.
• The first genetically modified animal which was approved for consumption purpose was AquaAdvant Salmon in 2015.
• The GMOs which are produced through the Genetic technological methods today have become a part of our everyday life from agriculture to Medicine, Research, and environmental management.
• Today with the use of genetic engineering, we can assimilate genes of one species into another completely unrelated species either for optimizing agricultural performance or for production of Pharmaceutical substances, etc.

Controversies regarding adverse effects of genetically modified organisms

As the researchers and scientists, through these techniques, can take a single gene from any of a living organism and insert or assimilate it into another organism cell to get desired traits like producing a plant that is resistant to a specific pest or disease. Therefore, the people in regard to GMOs were worried and concerned about the prospective adverse effects of it on the environment and risk, moreover, particularly upon the biological diversity and the health of human beings from any sort of toxicity and allergy. The specific areas of apprehension also included the unintended changes in the toxicity or other changes in the targeted species. 

Thus, such techniques of genetic engineering for the production of GMOs would not only put humans at risk but imbalance the ecological system further promoting the spread of different diseases among both plants and animals.

The Bt Corn Case Controversy

A very famous example of public debate over the use of genetically modified plants was the case of BT cotton. It was claimed by many scientists that the use of BT Corn is very harmful in the fields as the text toxic it releases can cause an unintentional spread of Recombinant genes or lead to the exposure of non-target organisms to some new toxic compound in the environment. The scientists disputed its study. But later on after 2 years of Investigation and Research, the six-team of researchers from the government, Academia, investigated the issue and concluded that the risk of BT corn was very low.

Rules and Regulations for the genetically modified organism

Background

For the biosafety evaluation of genetically modified organisms and their products, India has a structured and systematic regulatory framework. India started its development work in the field of biosafety regulatory system for GMOs, way back in the year of 1989. The main rules for the regulations of all the activities related to GMOs are provided under the Environment Protection Act 1986. Apart from it, there are several other acts, rules, and policies which are used and applied in biosafety technology towards genetically modified organisms.

Regulatory framework in India and Important Provisions related to Genetically Modified Organisms

• In India, the rules and regulations of all the activities related to GMOs and products are governed under The Manufacture, Storage and Import of Hazardous Chemicals Rules, 1989 under the provisions of the Environment Protection Act 1986 through the Ministry of environment, forest and climate change (MoEF&CC).

• In 1990, the set of rDNA guidelines was issued which covers genetically engineered organisms from a genetic transformation of plants and animals, implementation of the mechanism of biosafety guidelines, etc.

• The rules regarding the manufacture, use, import-export and storage of genetically engineered organisms and cells came into force from 1993.

• The multi-tier regulatory framework to evaluate and implement the biosafety of genetically modified crops work under the MoEF&CC  and department of biotechnology (DBT) of Ministry of Science and Technology, Government of India through 6 qualified committees or authorities-

1. The Recombinant DNA  Advisory Committee (RDAC),
2. The Review Committee Genetic Manipulation (RCGM),
3. The Genetic Engineering Appraisal Committee (GEAC),
4. Institutional Biosafety Committees (IBSC),
5. State Biotechnology Committees(SBCC), and 
6. District Level Committees (DLC).

The functions and roles of all these committees have been provided in the Rules, 1989.

• Among all of the above committees, the Genetic Engineering Appraisal Committee (GEAC) is the highest body constituted/established in the MoEF & CC change under The Manufacture, Storage and Import of Hazardous Chemicals Rules, 1989 under the Environment Protection Act 1986.
• This committee acts as a statutory body in India for the review and approval of the use of GMOs and their products for research and development, industrial production, environmental and field application.

• Show the three important legislations which were enacted by our Parliament of India for the rules and regulations of genetically modified crops development environmental release and approval for commercialization purpose they are

1. The Environmental protection Act 1986 administered by MoEF&CC.
2.  The Seeds act 1966 and the seeds order by the Ministry of Agriculture.
3. The Food Safety and Standards Act 2006 under the Ministry of Health and Family Welfare.

• The Government of India is in process of establishing Biotechnology Regulatory Authority of India(BRAI)

Its bill was introduced in the Lok Sabha in 2003 to set up an independent regulatory authority for the rules and regulations of organisms and products of genetically modified organisms. This authority will be able to make a single Window system efficient for GMO research, safety, and regulatory measures. The BRAI will regulate the research, import, environmental release, manufacture, and use of all biotechnology products and all the approvals will be granted in this for GMOs assessment undertaken by scientific Experts.

• Keeping with the recent trends on genetically modified organisms of foods, suitable measures, and mechanisms are being awarded to label the same within the scope of Codex alimentary. Genetically Modified detection and analytical food safety Laboratories have been established to ease the recognition of scientific data.

Regulations of Genome Engineering technologies in India

In India, recent initiatives have been taken by certain research institutions, for recognising the worldwide advances in the fields of Genome Engineering Technologies. 

In 2014, the Department of Biotechnology established an exclusively devoted Task Force on “Genome engineering technologies and their Utilizations” to promote the innovations and stimulate the development or advancement of genome-wide analysis and engineering technologies with the objectives to make them accessible plus affordable for larger utilisation. It is also advanced to better build up the facilities on emerging Technology like Gene edition and other supportive Research projects.

Other relevant rules and policies

In addition to the Rules,1989, certain other acts and rules are also enforced for specific activities related to GMOs and products like- Plant Quarantine Order 2003, Biological diversity Act 2002, etc.

Guidelines for the safety assessment of GMOs

Many guidelines have been adopted under the Rules,1989 which are needed to be followed for the safety assessment measures at the different stages in making Genetically Modified organisms like research, field trials, food safety evaluation, environmental risk evaluation, etc. In 1990, the Recombinant DNA safety guidelines which mainly focus on GMOs and shipment, etc. for laboratory research were adopted. 

These guidelines guide containment measures which are to be followed for different categories of genetically modified organisms accordingly. The guidelines are also released from time to time for the design of greenhouse and safeguards to be applied in the field trials of GMOs. Indian Council of Medical Research prepared certain guidelines for the safety analysis of the foods derived from the genetically modified plants which were adopted in 2008. These guidelines provide suggestions on principles and steps on the food safety assessment of genetically modified plants.

Suggestions

• The regulatory policies related to genetically modified organisms provided by the provisions should be environment friendly.
• To address the concerns of both the public and private sectors, efforts should be made to formulate a single-window regulatory mechanism.
• There should be a proper structure that promotes the speedy commercialization of Recombinant products and processes related to genetic engineering.
• The complete system of regulation of GMOs making should be open and transparent with relevant precautions.
• Also very important, there should be enough expertise in technology and risk assessment of GMOs production for maintaining the safety of the environment as well as the health of animals and human beings.

Conclusion

The genetically modified organisms benefit and secures mankind and have a positive impact when it is used for increasing the availability and quality of food and medical care and also the same contributes to a healthy ecological or environmental balance. But there is still the need to strengthen the regulatory framework in our country in regards to GMOs’ rules and implementations for avoiding any sort of delay in commercialization etc.

So if this biotechnology of genetic engineering for GMO production is used judiciously then it can result in an improved economy and that could further widely aid in the alleviation of hunger, malnutrition, and other diseases worldwide.

References 

• https://en.m.wikipedia.org/wiki/Genetically_modified_organism
• https://bmcproc.biomedcentral.com/articles/10.1186/s12919-018-0106-0
• https://www.tandfonline.com/doi/full/10.1080/21645698.2018.1529518
• https://www.nature.com/scitable/topicpage/genetically-modified-organisms-gmos-transgenic-crops-and-732/
• https://www.britannica.com/science/genetically-modified-organism

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