Regulation of Genetically Modified food in India- A critical analysis [Rutu Jethva]



Today, most of the foods we consume come from plants and animals that have been cultivated by humans for many thousands of years. Genetic changes over time are the result of carefully selecting plants or animals with the best characteristics for food and then breeding the next generation to improve upon them. In modern biotechnology, gene engineering, it is possible to transfer selected genes from one organism into another, even between species that are not closely related. Consequently, these organisms are termed genetically modified organisms (GMOs), i.e. organisms that contain genetic material that has been altered in a manner that does not occur naturally through mate-mating or natural recombination. GE organisms are also known as GE organisms, living modified organisms (LMOs) or transgenic organisms. When such products are produced or consumed, they are often referred to as genetically modified (GM) foods. Some of these GE plants are sold as food commodities (such as GM potatoes, GM maize, and GM papaya) and/or are further processed and formulated into food components. Presently, GM foods are obtained from plants that are derived from GE plants that have been genetically modified to improve their growth characteristics. The crop may be protected from pests or made herbicide-tolerant by, for example, enhancing its tolerance to pesticides. Plants have also been developed with GE characteristics related to disease resistance, modified nutritional properties, increased yields, etc. In 2017, 16 GE plants have been cultivated in 24 countries. Additionally, 43 countries have approved that these plants may also be used for food and feed. Since the introduction of GM foods into the food supply, many discussions have been held regarding their identity and safety. The following methodologies have thus been developed and biosafety regulations adopted by various countries. GMOs are plants that have been modified genetically using genetic engineering techniques. They are used in agriculture. The world's croplands are planted with GM crops on more than 10% of the areas. Plants are often bred to introduce new characteristics that do not occur naturally within the species, such as resistance to diseases, pests, or environmental conditions. Genetic engineering may also serve as an aid in increasing nutritional value, bioremediation, and for the production of pharmaceutical agents, biofuels, etc. The approach of genetic modification, involving copying and transferring genes from one species to another, is possible because the genetic code of all organisms is universal, meaning DNA1 is made up of the same building blocks and encoded in the same way. A copy of DNA sequence, or gene2, encoding certain traits can therefore be transferred into the cells of a different organism. Genes provide instructions to a cell regarding producing proteins that play a variety of roles within the cell. After a gene is inserted into the genome of a recipient plant, the resulting plant is considered to be genetically modified, and the new traits so encoded are passed on to subsequent generations. Generally, the desirable characteristics do not always exist in closely related species. Therefore, GE plants are developed by bringing together genes for improved plant varieties from a broad range of living sources.  

The Ministry of Environment, Forest and Climate Change (MoEFCC) is responsible for regulation of all GMOs, including GE plants, as per the Environment (Protection) Act, 1986. Guidelines and protocols have been established to assess the safety of GM foods. It also regulates GM foods in accordance with the Food Safety and Standards Act, 2006, which is the law in India governing food safety and standards. A range of capacity building initiatives have been undertaken by MoEFCC and other related ministries to raise awareness about GE plants and regulatory requirements among stakeholders. The Ministry of Environment, Forest, Climate Change and Climate Change as the nodal ministry for biosafety regulations has implemented the Phase II Capacity Building Project on Biosafety through the Global Environment Facility (GEF), funded by the United Nations Environment Program (UNEP) to improve biosafety management in India. The aim of this project is to increase public awareness of the biosafety regulatory framework through various fields, including 'enhancing public awareness'. Thus, several learning products have been developed as part of this project, and great efforts have been made to ensure outreach by utilizing a variety of tools, including: lectures, workshops, printed materials, as well as short videos. The Ministry of Environment and Forests, in association with Biotech Consortium India Limited (BCIL), has prepared booklets for various categories of stakeholders that focus on their unique information needs. 

  A GE plant must be developed in a step-by-step sequence, as follows:  

  • Identification of a gene: The first step in the process of discovering the gene responsible for a desired trait in an organism (plant, animal, microorganism) is to identify that gene by using molecular biology techniques.

  • A design for the insertion of gene: Once the gene has been isolated and cloned, it has to be supplemented with additional components (known as gene constructs) before it can be inserted into a plant. The addition of a promoter and a termination sequence to signal the initiation and termination of the gene sequence during experimental processes is one possibility. Another possibility is the addition of a marker gene for identifying GE cell/tissues during the experimental process.

  • Transformation: In this case, the gene construct will be transferred to the host plant via a genetic transformation involving a Gene Gun method or an Agrobacterium method. In plants, transformation refers to the process by which gene is incorporated into the host cell and established within the organism.   

  • SelectionIn the following steps, plant tissues are transferred to a selective medium (for example, containing an antibiotic or herbicide), depending on the type of selectable marker. Selectable marker genes are present only in plants that possess the transgene of interest. A series of whole plants are produced using tissue culture methods for further study in labs and greenhouses. In making the evaluation, one must consider the activity and stable inheritance of the genes introduced as well as any unintended effects on plant growth and yield quality. 

  • Field Trials and Safety Assessment: The next step will be multi-location and multi-year efficacy trials in greenhouses and fields, in order to test the effects of the transgene and its overall effectiveness. In addition, this phase includes an evaluation of environmental effects and food safety. Prior to any environmental release or commercialization, data/information generated through the aforementioned experimental studies and trials is evaluated by regulatory authorities.

Regulations of GM foods in India

There are regulations in India for all activities related to GMOs and products thereof, referred to as "Rules for the Manufacture/Use/Import/Export and Storage of Hazardous Microorganisms, Genetically Engineered Organisms or Cells (1989)" (usually referred to simply as "Rules, 1989") under the Environment (Protection) Act, 1986. Rules 1989 are very broad in scope, covering almost all activities involving GMOs and their products, such as sale, storage, exportation, importation, and production. These rules are implemented by the MoEFCC, the Department of Biotechnology (DBT), the Ministry of Science & Technology of the Government of India, and the State Governments of India.

On a case-by-case basis, review committees on genetic manipulation (RCGM) and genetic engineering appraisal committees (GEAC) create sub-committees made up of experts from various disciplines drawn from public sector institutions to develop and review guidelines relevant to biosafety. As well, GE plants are regulated by Central Compliance Committees (CCC) for the purpose of monitoring certain confined field trials.  

Up until 2006, GEAC was the authority with respect to approving or disapproving the commercial distribution of GM foods. After the passage of the Food Safety and Standards Act (FSSA), 2006, GMO foods were included in the definition of food. Food Safety and Standards Authority of India (FSSAI) is responsible for regulating genetically engineered foods through the inclusion of genetically enhanced or engineered foods or foods containing such ingredients under the definition of food. It should be noted that, according to the FSSA, 2006, the FSSAI has a scientific panel that deals with genetically modified organisms (GMOs), and the effects of GMOs on human health. The organization has also developed guidelines regarding the evaluation of the safety of foods derived from genetically modified plants (2008), which have been updated since 2012.In addition, the guidelines have been adopted by the Genetic Engineering Advisory Committee. Based on the principles and regulations of the Codex Alimentarius Commission, the guidelines describe the steps involved in assessing the safety of foods derived from GE plants. We have also included a comprehensive summary of information and data requirements that must be provided to regulatory authorities to demonstrate the safety of foods derived from GE plants.  

Three appendices comprise the guidelines

  1. Checklist for preparing your dossier. 

  2. Codex Alimentarius Principles for the assessment of risk of foods produced using modern biotechnology.

  3. Codex Alimentarius Annex II & III regarding the assessment of safety of foods derived from genetically modified plants for their nutritional or health benefits and the assessment of food safety in situations where it is low levels of GE plant material in food.

Also in place is a series of protocols for the safe use of GE plants in food and feed, prepared by the DBT in 2008 to address the key elements of the safety assessment of foods and/or livestock feeds that may be derived from GE plants. Protocols covering the following topics have been prepared based on international best practices: 

  1. Evaluation of the acute oral safety limit in rats and mice

  2. An investigation of sub-chronic feeding in rodents

  3. Thermally stable proteins

  4. Digestibility test with pepsin

  5. Animal feed study

Detection of GMOs and GM Foods

The majority of GMOs are indistinguishable from non-GMOs using the naked eye. Processed GMOs or genetically modified foods are more difficult to identify novel genes than unprocessed foods. In most cases, GMOs and GM foods will require testing for a number of reasons. These reasons include screening for unapproved GMOs or the quantity of GM ingredients in the country. We need highly sensitive and specific tests that can detect genes engineered into particular organisms or proteins produced by introduced DNA. We will introduce the methods used to detect the presence of genetically modified organisms (GMOs), to identify which GMOs are present, and how to calculate the quantity of GMOs present in a sample in this section. GMOs are characterized by inserting a gene from one organism within the DNA of anotheororganism. This causesesng that organism to produce a protein that confers those characteristics desired by the creator.  

In view of the above, there are two basic approaches to test the GMOs:

  1. Protein based methods

  2. DNA based testing

1. Protein based methods: The testing should encompass the proteins produced by the gene that has been inserted into the GMO. In these tests, the strip test and ELISA based test may be used for screening (yes/no) and quantification (number of expressed proteins) in a GMO respectively.   

2. DNA based testing: It includes testing for the introduced gene itself. The DNA that is introduced into an organisms to create a GM crop consists of several components and is known as a gene construct.

Useful Information Resources

You can find additional information about GM foods by consulting several online databases. There are several useful websites that food safety officials and other stakeholders can access. 

  • FAO GM Foods Platform is an online platform that allows users to exchange information on food safety assessments of foods made from recombinant-DNA plants (GE) in accordance with CAC/GL 45-2003, Annex III, which was adopted in 2008 as a Codex guideline. Further, it summarizes the detailed safety assessment, detection methods, protocols, etc., provided by the approval authority.
  • Biosafety Clearing House (BCH) is a website that has been established in accordance with the provisions of Cartagena’s Protocol on Biosafety (CPB), Section 5: Useful Information Resources. The site facilitates the exchange of information on GMOs and LMOs between parties. Information taken from BCH is organized into a "National Record" that is submitted by Parties and a "Reference Record" that is submitted by BCH users. BCH's information system contains up-to-date information on GMOs and biosafety including Data on National Laws, Regulations, Guidelines, and Competent National Authorities. 
  • It provides information on biosafety regulations and GMO approvals in India. A website regarding the biosafety regulatory framework in India has been launched by the MoEFCC, the lead ministry in charge of implementing this framework.  

The future of genetically modified crops in India

In September 2012, a paper was published in the journal Food and Chemical Toxicology, which became one of its most popular discussions. The paper was from Gilles-Eric Seralini of the University of Caen in France, and it purported to demonstrate that a particular variety of genetically modified corn causes cancer in rats. This paper was the grist for the anti-GMO mill worldwide. It is illegal in some countries to grow genetically modified crops.

The Indian Minister of Environment, Jairam Ramesh, used this paper to advocate against GM crops, and a moratorium was placed on the commercialization of Brinjal. Similarly, the Supreme Court set up a committee to look into the issue and recommended temporarily halting GM crop trials. We are currently engaged in a process of expanding or modifying these first generation GMO crop plants. It has been reported that biotechnology companies are developing crops with 'stacked' traits (meaning that they have inserted multiple genes into target crops).Transformation of target crops with multiple genes). Occasionally, GMO lines express herbicide and insect resistance simultaneously, providing farmers with the option to combine these traits in their crops. This is one example of 'stacking'. Stacking is also used in order to combat genetic resistance in weeds and insect predators. In the US, the widespread adoption of GMOs that offer insect and weed resistance has inevitably resulted in the development of genetic resistance among the target organisms; weeds and insect predators. Companies involved in biotechnology are developing GMOs that express, for example, different variations of the gene that encodes the protein that attacks insects feeding on the plant. Plants can also serve as 'biofactories' for the production of important pharmaceuticals. In addition to this, other innovative applications of genetic engineering to plants are viewed by some as the next generation of GMO technology development. There is no clear indication of whether or to what extent this application of genetic engineering will be adopted. In this innovative area of biotechnology, there have been some successes as well as failures. The production of human proteins in plants by a pharmaceutical company was improperly monitored and controlled. The issue did not relate to human health risk, but rather to a company's failure to adhere to agreed-upon protocols for monitoring, containing, and reporting problems. As opposed to this, the experimental application of a monoclonal antibody produced in plants contributed to saving (relatively unknown) infected physicians from Ebola. By developing GMO crops, it has been demonstrated that people in underdeveloped countries are able to obtain an increased quantity of vitamin A precursor in their diet. The development of 'Golden Rice' that produces this nutrient can mitigate the impact of vitamin A deficiency on human health; therefore, preventing blindness and death among (some estimates indicate one million people every year) people who suffer from this condition. Innovative applications of plant GMOs may certainly be of interest in the future.

Conclusion

As a result, Genetically Modified Foods have tremendous potential to save money, eradicate poverty, reduce hunger and malnutrition, and promote innovative practices. Some people believe that GM foods have negative effects on the environment and human health; however, I believe that these concerns are de minimis and unfounded. While we must proceed with caution and undertake detailed research, technological advancements are constantly pushing the boundaries of what is possible. It is essential that consumers weigh the positives and negatives of this innovative process before accepting it in order to help one day rid the world of numerous problems.

 

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