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It may be defined as the policies and procedures invariably adopted to ensure the environmentally safe applications of biotechnology”


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Submitted by Alok kr vishwakarma Mahendra singh Bipin katiyar Amit verma M.pharm(pharmaceutics) PSIT,kanpur BIOSAFETY


Definition “It may be defined as the policies and procedures invariably adopted to ensure the environmentally safe applications of biotechnology” Biosafety levels (BSL): It usually refers to a classification system used to indicate the safety precautions required for those investigating microorganisms ,especially viruses known to be dangerous or lethal to those exposed to them.

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To G.M.O. (genetically modified organisms) across the entire world the various international organization like UNIDO/WHO/FAO/UNEP has constituted an informal working group on biosafety. In 1991 this working group prepared the voluntary code of conduct for the release of organism into the environment Soon after the International for genetic engineering and biotechnology (ICGEB) was constituted ICGEB duly organize animal workshop on biosafety From September 1998, ICGEB has successfully provided an excellent world wide facilities via and on online bibliography database on biosafety National biosafety system that essential y builds upon the prevailing regulatory experience ,namely Plant Quarantine act Environmental protection act and Worker health and safety regulation

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Specific guidelines for institutional mechanism for implementing the essentially comprise of the following expects:- Recombinant DNA advisory committee, under DBT (dept. of biotech) Institutional biosafety committee Review committee on genetic manipulation under DBT

Quintessence of biosafety:

Quintessence of biosafety A plethora of bioscientists do strongly opine that genetically modified crop, plant may be cultivated with the possible scope of any adverse consequence to the existing global environment however there are certain valid expects such as:- Comprehensive knowledge of biological complexity neither possible nor available. Unpredictable fat of organism being incorporated into the environment. Extremely important and wise to evaluate possible consequence well in anticipation.

Topic of concern [website of ICGEB]:

Topic of concern [website of ICGEB] It may be broadly classified into five major categories that are prominently related to environmental release of the genetically modified organisms (GMO) as stated following: 1.Risk for human health : Toxicity Vs food quality/safety Allergies Pathogen’s drug resistance that is antibiotic resistance

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2. Risks for environment : Persistence of gene/transgene/transgene products Resistance of target organisms or susceptibility of non-target organisms. Increased usage of chemical in agriculture Transgene instability Unperdictable gene expression 3. Risks for agriculture : Weeds or superweeds Change in nutritional value Reduction of cultivars and loss of biodiversity

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4.Risks for interaction with non-target organisms : Genetic pollution via pollen or seed dispersal Horizontal gene transfer DNA uptake that is transfer of foreign gene to microorganisms Generation of new line viruses by recombinent DNA technology 5.General concerns : Higher cost of agriculture production Loss of familiarity Ethical issues

Guidelines and regulations :

Guidelines and regulations The several countries have adequately formulated the specific biosafety guidelines for rDNA manipulations with the following aims and objectives ,namely:- 1 .To reduce the usual probability of infrequent release of GMOs 2 .To prevent and check the intentional release of such GMOs into the prevailing environment . These guidelines are duly being implemented via the following three articulated mechanism, for example:- Institutional biosafety committees (IBSCs) –To monitor the ongoing research activity at institutional level Genetic engineering approval committee (GEAC) –To permit the large scale application of GMOs at the commercial level; and open the field trials of transgenic substance like agricultural crops and health care products Review committee on genetic manipulation (RCGM) – To allow the risky activities in the research lab. under the direct supervision of the DBT

Operation/function of biosafety guidelines and regulations :

Operation/function of biosafety guidelines and regulations The academic institutions and industrial organization actively involved in genetic engineering activities should have essentially the properly constituted Institutional Biosafety Committee (IBSCs) Some examples are stated as under:- A company imported the transgenic the mustard seed having the expression of Barstar and Barnase gene from Belgium to study and evaluate the extract performance of the said charteristic seeds upon the Indian soil and its environment Another company imported seeds of transgenic cotton essentially containing BT gene to carry out specific trails in the glass house by adopting the procedure of back-coating with Indian cotton lines, and also to evaluate resistance of the transgenic plant material to bollworms in India A pharmaceutical organization duly carried out intensive and extensive experimental trials for the production of recombinant hepatitis B vaccine and human alpha-interferon by employing yeast and E.Coli respectively

Development of herbicide resistant crops:

Development of herbicide resistant crops Biosafety shares the ultimate responsibly takes both the the potential or the plethora of undesirable consequences emanating from new technology advancement as well as the absolute requirement for appropriate measures to significantly minimize the consequences Example:- Genetic Engineering of crops is invariably claimed to have defended a host of the world’s genuine problems specially to meet the hunger .Therefore specific emphasis w.r.t the present day agricultural research is mainly focused towards development herbicide resistance crops .

Application of BIOSAFETY:

Application of BIOSAFETY Development of genetic engineering biotechnology:- Ex: Creation of first successful man –made human chromosomes in the body of mouse ,cloning mammal (sheep), various Genetic Engineering based drug (e.g., streptokinase, human insulin etc), and animals having better characteristic feature. 2)Transgenic organism :- The marker transgenic or genetically modified organism is undergoing a very rapid development across the globe. These T.O. in various fields such as medicine , production of food and beverages, and agricultural products. Ex: introduction of transgenic plant (1996-1997) : various transgenic plant like herbicide pest ,virus-resistant varieties of potatoes, tomatoes ,soybeans, cotton and like were duly introduced actually right into the agricultural field.

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