bIOSAFETY

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National academy science in 1974 made following recommendation – A. Certain types of experiment e.g. cloning of genes for bacterial toxin in prohibited. Use of caution in experiment linking animal DNA S to bacterial phase or plasmid DNA B. National institute of Health – Established the recombinant Advisory Committee in 1974 C. International meeting was convened in Alisomar , California 1975 D. In 1977 , NIH prepared environmental impact statement. E. 1981, most closing experiment in E. coli K -12 , certain strains of Bacillus subtilis and Saccharomyces cerevisiae were exampted

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Seminar On ADVANCES IN GENETIC ENGINEERING Topic : Biosafety Delivered by Jayanta Kumar Chamuah Division of Parasitology Roll No. 1199

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INTRODUCTION

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History A. National academy science in 1974 made following recommendation – Certain types of experiment e.g. cloning of genes for bacterial toxin in prohibited. Use of caution in experiment linking animal DNA S to bacterial phase or plasmid DNA B. National institute of Health – Established the recombinant Advisory Committee in 1974 C. International meeting was convened in Alisomar , California 1975 D. In 1977 , NIH prepared environmental impact statement. E. 1981, most closing experiment in E. coli K -12 , certain strains of Bacillus subtilis and Saccharomyces cerevisiae were exampted

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Objectives The biosafety guidelines are developed to contribute to ensuring an adequate level of protection in the fields of safe transfer, handling and use of living modified organizing resulting from modern biotechnology that may have adverse effects an conservation and sustainable use of biological diversity and reduce risk to human health The ultimate object is to regulate research and development activities using recombinant DNA technology should be to minimize risk from such activities and at the same time encourage these activities

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Risk Assessment Risk is a function of the level of hazard and probability of occurrence of hazard A hazard is any imaginable adverse effect that can be identified and measured Risk assessment involves determination of potential and anticipated adverse effect of recombinant DNA research Assessment of Risk during laboratory research : Initial Risk Assessment Comprehensive risk assessment

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Initial Risk Assessment The initial risk assessment is made by the investigator on the basis of risk to which the organism, on which he conduct experiment organism are classified into following risk groups based on their potential effect on a healthy human adult Risk group I Risk group II Risk group III Risk group IV

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Comprehensive risk assessment this assessment take into account the following : Organism factor Virulence Pathogenicity Infections dose Environmental stability Operation Availability of vaccine and treatment Type of manipulation

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Biosafety levels for various types of recombinant DNA research (NIH guidel) Biosafely Types of experiment BL-3 or BL-2 P Involving most exotic infectious agents with recognized potential for serious detrimental impact on ecosystem. BL-3-P Involving sequence encoding potent- vertebrate toxins introduced from plants or associated organism BL1-P Involving recombinant DNA Containing plants and plants associated microorgams. BL-2-P and BL1+ Plant modified by recombinant DNA that Biological Containment are noxious weeds or containment interbreed with noxious weed

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Risk assessment for planned in products Risk assessment should be done an the basis of following factors. Biological characteristics of the recipient or parental organism Taxonomic and relevant biological characteristics of the donor organism Characteristics of vector Intended use of GMO

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Process of risk assessment Identification of any novel genotypic and phenotypic feature of GMO that may have adverse effect an environment Evaluation of the likelihood of these adverse effect Consequence analysis Risk determination Risk evaluation

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Risk assessment of biotechnology products Assessment o risk from food obtained from transgenic varieties of crops takes into consideration The food crop that has been modified The potential for any introduced DNA to encode harmful substance The safety of proteins encoded by transgene

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Risk Regulation : Reactive regulation – Designed prevent the proven adverse effect shown by earlier work Proactive risk regulation developed to avoid potential harzards that are predicted in advance before there is any empinical endence for such hazards

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Containment Biological safety in labortories in achieved by combination of mechanism that are divided into Standard Laboratory practices Containment strategies Cantainment may be of - Physical Biological Physical Containment Special laboratory design Cantainment equipments Special laboratory operation. They are grouped in t BL1, BLL2, BL-3, and BL4

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Biological Containment Biological containment based on the vector plasmid, organelle or virus ) used for construction of recombinant DNA and most all into which vector is propagated in the laboratory. It is called host vector System

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Biosafety during industrial production 1. Many of the processes of Manufacture have the potential to generate biohazards 2. Inhalation appears to be the most significant mode of entry of microbes or microbial products into the body, while entry by ingestion or skin control 3. During extraction of intracellular enzymes, the greatest risk is posed by the processes of handling the large quantities of cell debris

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Biosafety guidelines in India In India, the ministry of environment and forest (MOEF) promulgated in December, 1989, the rules and procedure for the manufacture, impart, use, research and release of GMO products made from such organism, this is done environment protection Act, 1986 (EPA) 2. Indian Recombinant DNA safety guidelines and regulation have been prepared (initially in 1990, revised in 1994) by and are available an request recombinant DNA Advisary Committee (RDAC), DBT, New Delhi

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Thank You