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BIOTECHNOLOGY AND BIOSAFETY Dec-22,23-2006
Prof. S. Kannaiyan - Chairman NBA
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Introduction:
Modern molecular biology and Biotechnology tools are increasingly used to produce GMOS with novel traits using genetic engineering, genetic modification or recombinant DNA technology. These involve isolation of nucleic acid molecules from one organism altering the genetic make up of the recipient permanently and allowing them to be inherited by offspring.
Genes are basically the instructions in the cell and contain all information concerning the form and function of all living cells that give characteristics to an organism. The full set of instructions is called a genome. All organisms have genomes of varying sizes, for instance, the human genome has an estimated 60 -1,00,000 genes, most plants have about 20,000 genes, a nematode has about 18,000 genes and bacterium, Escherichia coli just over 4000 genes. The genetic differences among different species as well as organisms within a species lie in the difference in number and sequence of these genes in DNA/genome. A gene is a segment of DNA (deoxyribonucleic acid) molecule that exists in the nucleus of each cell.
Genetic modification:
Genetic modification(GM) is the recent development which allow specific genes to be identified, isolated and inserted into plants with a high level of specificity. With the advent of new transgenic varieties, there is promise of food security and freedom from hunger and malnutrition, especially in developing countries, Genetically modified crop offer significant economic advantages to farmers compared with the commercial crops by providing resistance to biotic, abiotic stresses under field condition. Therefore, appropriately deployed genetically engineered crop plants have the potential to contribute to sustainable gains in agriculture productivity. In addition, genetic modification also provide opportunities to alter the composition of food to increase its nutritive value such as increase the mineral and vitamin content of grains.
Regulatory mechanism in India:
India has a well defined regulatory mechanism for development and evaluation of GMOs and the products thereof. The Department of Biotechnology (DBT) and the Ministry of Environment & Forest (MoEF) are the two apex regulatory bodies. Rules have been notified by MoEF in 1989 under Environment Protection Act, 1986 (EPA), as the production and preservation of the environment is vested upon the government. These rules cover procedures for the manufacture, import, use, research and release of GMOs as well as products made by the use of such organisms. The objective of the rule is to ensure that the use of such products or life forms is safe to the environment and beneficial to the human beings. The competent authorities and their composition for dealing with all aspects of GMOs and products thereof has also been defined.
* Inaugural address delivered during the workshop on Biosafety held on 22-23rd, December, 2006 organised by Ministry of Environment of Forests, Govt. of India, New Delhi in association with the Science and Technology Development initiative (STAD) and Indian Science Writers Association
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Guidelines for safety have been issued by the Department of Biotechnology (DBT) in 1990 covering research in biotechnology, field trials and commercial applications. DBT had also brought out separate guideline for research in transgenic plats in 1998 and for clinical products in 1999. Activities involving GMOs are also covered under other policies such as the Drugs and Cosmetics Act (8th Amendment), the Drug Policy, 2002, and the National Seed Policy, 2002.
Presently, there are six competent authorities for implementation of regulations and guidelines in the country:
- Recombinant DNA Advisory Committee (RDAC)
- Review Committee on Genetic Manipulation (RCGM)
- Genetic Engineering Approval Committee (GEAC),
- Institutional Biosafety Committee (IBSC) attached to every organization engaged in rDNA research
- State Biosafety Coordination Committees (SBCC) and
- District Level Committee (DLC)
Of the above committees, the IBSC is constituted by organizations involved in research with GMOs with the approval of DBT. The IBSC is the nodal point for interaction within the institution for implementation of the guidelines. (Every research project using GMOs has an identified investigator who is required to get the research project approved from safety angle and inform the IBSC about the status and results of the experiments being conducted). The functions of IBSC include to:
- Reviewing and giving clearance to project proposals falling under restricted category as per DBT guidelines
- Recommending Category III risk or above experiments to RCGM approval
- Tailoring biosafety programme to the level of risk assessment
- Training of personnel on biosafety
- Adopting emergency plans
The role of IBSC assumes major importance since it is the only Statutory committee, which operate from the premises of institution and hence is in a position to conduct onsite evaluation, assessment and monitoring of adherence to the biosafety guidelines.
The decisions taken by the next higher committee i.e Review Committee on Genetic Manipulation (RCGM), which operates from DBT are based on the applications submitted by the investigators with the approval of IBSC on the status of the project and its conformity with the regulatory guidelines.
The IBSC comprises head of the institution / nominee, three or more scientists engaged in DNA work or molecular biology, an outside expert in the relevant discipline, a member with medical qualifications and nominee of DBT. The DBT nominee to oversee the adherence to biosafety guideline and server as the link between the Department of Biotechnology and the respective IBSC.
There are approximately 225 IBSCs in various institutions and laboratories in industries in India overseeing a range of research projects including development of genetically modified microorganisms, transgenic plants, transgenic animal and recombinant products. DBT has substantially funded research and development in biotechnology in the country, s also agencies like CSIR, ICMR and ICSR, Several private companies have also initiated research either independently or in collaboration with Indian and foreign institutions/companies. As a result of these efforts, a few products are in advanced stages of development and are likely to e commercialized shortly. 18 recombinant therapeutic products are already in the market, out of which five therapeutic are being manufactured indigenously. In the area of agricultures, four varieties of Bt cotton have been approved for commercial cultivation in the country and several crops are in the approval pipeline.
Risk assessment and management
Risk is defined as the probability of harm. Risk analysis consists of steps.
- Risk assessment
- Risk management
- Risk communication
Risk assessment evaluates and compares the scientific evidence regarding the risks associated with alternative activities. Risk management develops strategies to prevent and control risks within acceptable limits and risk assessment. In addition to the scientific assessment, it also takes into takes into consideration various factors such s social values and economics. Risk communication involves an ongoing dialogue between regulators and the public about risk and options to manage risk so that appropriate decision can be made. Risk assessment should be carried out on case by case basis.
The concept of risk assessments quite complex and relies on both science and judgment. Therefore, the risk associated with any depends on three element viz; Risk = HazardxProbabilityxConsequences. A hazard is anything that might conceivably go wrong. A hazard does not in itself constitute a risk. The probability associated with a hazard also depends in part on the management strategy used to control it. Risk can be underestimated if some hazards are not identified and properly characterized if the probability of the hazards occurring is greater than expected or if its consequence are more server than expected.
It has been generally accepted that details of risk assessment procedures may vary from case to case but there are few logical steps that need to be following;
- Identification of potential adverse effects on human health or environment
- An estimation of livelihood of these adverse efforts
- An evaluation of identified risks
- Considerations of appropriate risk management strategies
- Assessment of overall potential environment impact and consequences
- A recommendation as to whether or not the risks are acceptance or manageable
