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                                        BIOSEFTY

 

  

 

 

INTRODUCTION-

   

    work in laboratory involves hazardus chemicals, carcinogens, inflammmble solvents, radioactiv compounds, liv and infectious microbs, proper disposal of contaminated animal materials and genitically modified corps. safety of the personal working in labortory involvesvarious esures to prevent axcidental damage to the workers and spread of contamination. primary contaminant the protection of personnel and the immediate lab environment from exposure to infections agent, is provided by both good microbiological technique and the use of approprite safety equipment the use of vaccines may provide an incresed levels of personal protection. at last we say  that Biosafety is the prevention of large-scale loss of biological integrity, focusing both on ecology and human health.

Biosafety is related to many several fields:

  • In ecology (referring to imported life forms from beyond ecoregion borders),
  • In agriculture (reducing the risk of  transgenic genes, genetic engineering or prions such as BSE/"MadCow", reducing the risk of food bacterial contamination)
  • In medicine (referring to organs or tissues from biological origin, or genetic therapy products, virus; levels of laboratory containment protocols measured as 1, 2, 3, 4 in rising order of danger),
  • In chemistry science (i.e., nitrates in water, PCB levels affecting fertility) and
  • In exobiology (i.e., NASA's policy for containing alien microbes that may exist on space samples - sometimes called "biosafety level 5"[citation needed]).

The international Cartagena Protocol on Biosafety deals primarily with the agricultural definition but many advocacy groups seek to expand it to include post-genetic threats: new molecules, artificial life forms, and even robots which may compete directly in the natural food chain.

Biosafety in agriculture, chemistry, medicine, exobiology and beyond will likely require application of the precautionary principle, and a new definition focused on the biological nature of the threatened organism rather than the nature of the threat.

When biological warfare, currently hypothetical, threats (i.e., robots, new artificial bacteria) are considered, biosafety precautions are generally not sufficient. The new field of biosecurity addresses these complex threats.

Biosafety level refers to the stringency of biocontainment precautions deemed necessary by the CDC ( Centers for Disease Control and Prevention )  for laboratory work with infectious materials.

Typically, points  that experiment with or create potentially harmful biological material will have a committee or board of supervisors that is in charge of the point biosafety. They create and monitor the biosafety standards that must be met by labs or laboratories in order to prevent the accidental release of potentially destructive biological material.

 

 

BIOSEFTY LEVELS-

 

     Biosefty levels are of four types, witch consist of combinations of labortory practise and techniques safety equipments and lab faclities. a biosafety level is the level of the biocontainment precautions required to isolate dangerous biological agents in an enclosed facility. each combination is specifically appropirate for the operations performed the documented or suspected routes of transmission of the infectious agents, and the lab function or activity. The levels of containment range from the lowest biosafety level 1 (BSL-1) to the highest at level 4 (BSL-4). In the United States, the Centers for Disease Control and Prevention (CDC) have specified these levels. In the European Union, the same biosafety levels are defined in a directive.

 

 

BIOSEFTY REGULATIONS-

 

     Genitically modified orgnaisms are regulated in india under perview of the 1986 infdian environment act (henceforth , the EP act). EP objective is the improvement and protection of environment . for this objective or aim the act calls for regulations of " any solid , liquid, or guseous substance present in such concentration as may be , or tend to be, injurious to environment " called environment pollutents.The Ministry of Environment and Forests (MoEF) has notified the Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells 1989 (known as ‘Rules, 1989’) under the Environment (Protection) Act, 1986. These rules and regulations cover the areas of research as well as large scale applications of Genetically Modified Organism (GMOs) and products made there from throughout India.  The rules also cover the application of hazardous microorganisms which may not be genetically modified.  Hazardous microorganisms include those which are pathogenic to animals as well as plants. 

 

            These rules also define the competent authorities and composition of such authorities for handling of various aspects of the rules.  Presently there are five competent authorities  that is , Institutional Biosafety Committees (IBSC), Review Committee of Genetic Manipulation (RCGM), Genetic Engineering Approval Committee (GEAC), State Biotechnology Coordination Committee (SBCC) and the District Level Committee (DLC). The RCGM established under the Department of Biotechnology (DBT) supervises research activities including small scale field trials, whereas approvals for large scale releases and commercialization of GMOs are given by the GEAC, established under the MoEF. The SBCCs andDLCs have a major role in monitoring. The Rules also mandate that every institution engaged in GMO research establish an IBSC to oversee such research and to interface with the RCGM in regulating it. The IBSC has a nominee of DBT on its Committee.

 

BIOSEFTY GUIDELINES-

 

     The Rules, 1989 are supported by the following bio-safety guidelines:

 

-                      Recombinant DNA Safety Guidelines, 1990 & 1994

-                      Revised Guidelines for Research in Transgenic Plants and Guidelines for Toxicity andAllergenicity Evaluation, 1998

-                      Guidelines and SOPs for the conduct of Confined Field Trials of Transgenic Plant, 2008

-                      Guidelines for the Safety Assessment of GM Foods, 2008

-                      Protocol for Safety Assessment of Genetically Engineered Plants / crops, 2008.

 

            These guidelines and protocols are being regularly updated through a consultative approach and following the international norms prescribed by the Organization for Economic Co-operation and Development (OECD), CODEX Alimentarius Commission and International Plant Protection Convention (IPPC).

 

         

 
 
 
BIOSEFTY PROTOCOL-
 
 
    The protocol on biosefty to the convention 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. The Cartagena Protocol on Biosafety is an international agreement on biosafety, as a supplement to theConvention on Biological Diversity. The Biosafety Protocol seeks to protect biological diversity from the potential risks posed by genetically modified organisms resulting from modern biotechnology.
 

The Biosafety Protocol makes clear that products from new technologies must be based on the precautionary principle and allow developing nations to balance public health against economic benefits. It will for example let countries ban imports of a genetically modified organisms if they feel there is not enough scientific evidence that the product is safe and requires exporters to label shipments containing genetically altered commodities such as corn or cotton.The required number of 50 instruments of accession/ratification/approval/acceptance by countries was reached in May 2003. In accordance with the provisions of its Article 37, the Protocol entered into force on 11 September 2003. Afghanistan became the 165th country to ratify the Protocol on 20 February 2013.[2] In addition to member countries, the European Union is a party to the Protocol, making the total number of parties 166.

 

 

BIOSEFTY CABINET-

 

    A biosafety cabinet (BSC), witch also called biological safety cabinet or microbiological safety cabinet, is an enclosed, ventilated laboratory workspace for safely working with materials contaminated with (or potentially contaminated with) pathogens requiring a defined biosafety level. Several different types of biosefty cabinet exist, differentiated by the degree of biocontainment required. these first became commercially available in 1950. Biosafety cabinets are used to provide primary containment in the laboratory when the investigator is using potentially infectious materials. There are three types of biological safety cabinets:

 

Class I: The Class I biological safety cabinet is an open-front negative pressure cabinet The exhaust air from the cabinet is filtered by a high-efficiency particulate air (HEPA) filter. The Class I biosafety cabinet will provide personnel and environmental protection, but not product protection.

 

Class II: The Class II vertical laminar-flow biological cabinet is an open-front, ventilated cabinet. This cabinet provides a HEPA-filtered, recirculated mass airflow within the work space. The exhaust air from the cabinet is also filtered by HEPA filters. Thus, the Class II biosafety cabinet will provide personnel, environment and product protection. While HEPA filters are effective for trapping particulates and infectious agents, these filters will not capture volatile chemicals or gases.

 

Class III: These are totally enclosed ventilated cabinet of gas-tight construction. Operations within this Class cabinet are conducted through attached rubber gloves. When in use, the Class III cabinet is maintained through negative air pressure of at least 0.5 inches water gauge. Supply air is drawn into the cabinet through HEPA filters. The cabinet exhaust air is filtered by two HEPA filters, installed in series, before discharge outside of the facility. The exhaust fan for this Class cabinet is generally separate from the exhaust fans of the facility's ventilation system.

 

 

 

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