20BT2057 Bioethics, IPR and Biosafety - PDF

L T P C 20BT2057 BIOETHICS, IPR AND BIOSAFETY 3 0 0 3 Unit II Course Teacher Dr. R.S. David Paul Raj PhD Associate Professor...

L T P C 20BT2057 BIOETHICS, IPR AND BIOSAFETY 3 0 0 3 Unit II Course Teacher Dr. R.S. David Paul Raj PhD Associate Professor Department of Biotechnology School of Agriculture and Biosciences Karunya Institute of Technology and Sciences 1 Bio-safety and international agreements A Cartagena Protocol on Biosafety Convention on Biological Diversity (CBD), and the International Plant Protection Convention (IPPC) an international agreement deals with environmental aspects of GMOs. This international agreement establishes various procedures, and measures to ensure the safe handling, safe transfer and use of GMOs as a result of modern biotechnology that have adverse impact on biodiversity and human health. The Cartagena Protocol on Biosafety (CBD 2000) provides guidelines by adopting already existing and recognized techniques. The guidelines adopt with multidisciplinary approach of analyses methodologies and individual components to produce the GMOs (nature of organisms, vector, and inserted DNA), assessment of final total results such as characteristics of new organisms, with traits, intended use, nature of receiving environment. Approach also includes information like private and public research organizations and international agencies. Risk management process includes focusing on the economical and political components of the bio-safety issue of GMO. 2 The Cartagena Protocol on Biosafety to the Convention on Biological Diversity is an international treaty governing the movements of living modified organisms (LMOs) resulting from modern biotechnology from one country to another. It was adopted on 29 January 2000 as a supplementary agreement to the Convention on Biological Diversity and entered into force on 11 September 2003. What does the Cartagena Protocol do? Ensures the safe handling, transport, and use of LMOs Sets high standards for the import and export of LMOs Considers risks to human health and biological diversity Encourages cooperation on research and information exchange What does the Cartagena Protocol apply to? LMOs created through modern biotechnology, such as genetically modified (GM) farm commodities The import and export of LMOs between countries How does the Cartagena Protocol work? Requires operators to take appropriate response measures if damage is likely Allows competent authorities to implement response measures if operators fail to do so Encourages parties to consider socio-economic impacts, especially on local communities 3 Bio-safety regulations in India In India, Environment (Protection) Act 1986 and Rules 1989 regulates the Biosafety Research programme main emphasis and facilitate the implementation of biosafety procedures, rules and guidelines. It also regulates the use of Genetically Modified Organisms (GMOs) and products thereof in research and application to the users as well as to the environment. Three level mechanism comprising Institutional Biosafety Committees (IBSC) at the Institute/ company; the Review Committee on Genetic Manipulation (RCGM) in the Department of Biotechnology, Govt. of India and the Genetic Engineering Approval Committee (GEAC) in the Ministry of Environment & Forests (MoE&F) for approval for research and development activities on recombinant DNA products, environmental release of genetically engineered (GE) crops and monitoring and evaluation of research activities involving recombinant DNA technology. 4 Recombinant DNA Advisory Committee (RDAC) reviews the developments in biotechnology at national and international level and recommends suitable and appropriate safety regulations for India in r-DNA research, use and applications. Institutional Biosafety Committee (IBSC) play a role in examine and approve proposals involving r-DNA work, ensure adherence of r-DNA Safety Guidelines of Government, inspection of containment facilities at R&D and production units and to inform the RCGM about the facilities, prepare emergency plan according to guidelines, approve experiments utilizing the organisms and genetic elements from Risk Group-I and II organisms up to laboratory fermentation 20 ltrs capacity with intimation to RCGM. Review Committee on Genetic Manipulation (RCGM) mainly Monitor safety aspects of ongoing rDNA projects involving genetically Engineered (GE) organisms/hazardous microorganisms. The RCGM shall lay down procedures restricting or prohibiting production, sale, importation and use of such GE organisms or products thereof for research and applications as mentioned in the schedule of Rules, 1989. 5 6