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  2. 2. • ‘Biosafety’ means the need to protect human and animal health and environment from the possible adverse effects of the products of modern biotechnology. • Biosafety defines the containment conditions under which infectious agents can be safely manipulated.
  3. 3. CONTAINMENT • The safety measures which prevent the escaping of GEOs from the laboratory are called containment. • They help to destroy harmful GEOs within the laboratory itself. Hence there is no chance for the microbes to come out of the laboratory • In USA,the National Institute of Health(NIH) set up the Recombinant DNA Advisory Committee(RAC) in 1976.
  4. 4. • The RAC provide guidelines about safety measures to keep hazardous organisms within limits. • These guidelines discuss about physical and biological containments. PHYSICAL CONTAINMENTS • The physical methods being adopted inside the laboratories to prevent escaping of GEOs to the environment are called physical containment.
  5. 5. • It include; 1.Air filtration 2.Sterilization lights 3.Waste disposal 4.Protective handling
  6. 6. 1.Air filtration • The exhaust air from the laboratory is filtered through exhaust filters. • It prevents the escaping of GEOs from the lab. 2.Sterilization lights • Flurescent tube lights which emit UV light,are fitted in the laboratory to sterilize the work areas and exposed surfaces of the lab. • This technique destroys microbial contaminent inside the lab.
  7. 7. 3.Waste disposal • All waste coming from the laboratory are sterilized by autoclaving or by incinerating them in an incinerator. • This will prevent the escaping of contaminated wastes from the lab.
  8. 8. 4.Protective handling • Persons working in the laboratory must follow certain techniques to avoid contamination and to prevent escaping of microbes. • The person must wear protective clothing before entering the work area,it should not be carried outside. • Mouth pipetting should be avoided.
  9. 9. BIOLOGICAL CONTAINMENT • The biological principles used in laboratories to prevent the escape of GEOs or microbes are called biological containment. • Biological containment makes the organisms unable to survive in the outside environment. • It prevents the spreading of vector DNAs to the organisms outside the laboratory by usual conjugation,transformation or transduction.
  10. 10. • Bacteria which cannot grow outside unless suitable nutrients have to be supplied are used for gene manipulations. • Such bacteria are made by inducing gene mutation.This is a mutant bacterium that survive only in the culture.
  11. 11. BIOSAFETY LEVEL • Biosafety level is the level of the biocontainment precautions required to isolate dangerous biological agents in an enclosed facility. • The levels of containment range from the lowest biosafety level 1 to the highest at level 4.
  12. 12. BIOSAFETY LEVEL 1 • Biosafety level 1 is suitable for work involving well characterized agents not known to consistently cause disease in healthy adult humans and of minimal potential hazard to laboratory personnel and the environment • It includes several kinds of bacteria and viruses including canine hepatitis, non-pathogenic E.coli, as well as some cell cultures and non-infectious bacteria.
  13. 13. BIOSAFETY LEVEL 2 • Biosafety level 2 is similar to Biosafety level 1 and is suitable for work involving agents of moderate potential hazard to personnel and the environment. • It includes various bacteria and viruses that cause only mild disease to humans, or are difficult to contract via aerosol in a lab setting, hepatitis A,B and C.
  14. 14. • Laboratory personnel have specific training in handling pathogenic agents and are directed by scientists with advanced training; • Access to the laboratory is limited when work is being conducted; • Extreme precautions are taken with contaminated sharp items.
  15. 15. BIOSAFETY LEVEL 3 • This level is applicable to clinical, diagnostic, teaching, research, or production facilities in which work is done with indigenous or exotic agents which may cause serious or potentially lethal disease after inhalation. • It includes various bacteria, parasites and viruses that can cause severe to fatal disease in humans
  16. 16. • Laboratory personnel have specific training in handling pathogenic and potentially lethal agents, and are supervised by competent scientists who are experienced in working with these agents. • All procedures involving the manipulation of infectious materials are conducted within biological safety cabinets, specially designed hoods, or other physical containment devices, or by personnel wearing appropriate personal protective clothing and equipment.
  17. 17. BIOSAFETY LEVEL 4 • This level is required for work with dangerous and exotic agents that pose a high individual risk of aerosol-transmitted laboratory infections, agents which cause severe to fatal disease in humans for which vaccines or other treatments are not available, such as Bolivian and Argentine hemorrhagic fevers,Marburg virus , Ebola virus, and various other hemorrhagic diseases.
  18. 18. • This level is also used for work with agents such as small pox that are considered contagious enough to require the additional safety measures, regardless of vaccination availability • When dealing with biological hazards at this level the use of a positive pressure personnel suit, with a segregated air supply is mandatory.
  19. 19. • The entrance and exit of a level four biolab will contain multiple showers, a vacuum room, an ultraviolet light room, and other safety precautions designed to destroy all traces of the biohazard • All air and water service going to and coming from a biosafety level 4 lab will undergo similar decontamination procedures to eliminate the possibility of an accidental release.
  20. 20. Biosafety Guidelines Biosafety guidelines aiming at- • Regulating rDNA research with organisms that have least or no adverse effect. • Minimizing the possiblities of occasional release of GEOs from the lab. • Banning the release of GEOs if they are supposed to be causing potential risks in the environment.
  21. 21. Biosafety Guidelines for Laboratories • Food storage, eating, drinking and smoking are prohibited in lab. • Mouth pipetting is prohibited • Laboratory coats are obligatory and should be removed when exiting the lab. • Working surfaces must be decontaminated using soap and alcohol after each working day. • Waste products must be decontaminated by incineration or by autoclaving.
  22. 22. • Frequent hand wash is obligatory. • Avoid contact with GMO's and other exotic biological agents, disposable gloves should be worn when handling such items. • Laboratory door should be closed at all times. • Working with fume-producing chemicals must be under the laboratory hood. • Biohazard warning signs should be always posted in labs.
  23. 23. • Based upon ICGEB’s long-standing activities in biosafety, we have identified the main issues derived from the deliberate introduction of GM crops (and their derived products) into the environment or onto the market of concern today. These have been classified as: • Risks for animal and human health • toxicity & food quality/safety • allergies; • pathogen drug resistance (antibiotic resistance)
  24. 24. • Risks for the environment: • susceptibility of non-target organisms; • change in use of chemicals in agriculture • unpredictable gene expression or transgene instability (gene silencing).
  25. 25. • Risks for agriculture: • weeds or superweeds • alteration of nutritional value (attractiveness of the organism to pests) • change in cost of agriculture • unpredictable variation in active product availability • loss of changes in agricultural practise
  26. 26. • General concerns: • detection and analytical methods • ethical issues (eg. labelling) • public attitudes, perception; legislation monitoring • socio-economics (eg. situation of poor farmers in developing countries)
  27. 27. BIOSAFETY DATABASES • Several Websites offer useful entry-points to a diversity of biosafety data. • These "one-stop shops" contain huge collections or listings of relevant informatic tools and links to other sites, and can provide and exhaustive and comprehensive array of biosafety-related information.
  28. 28. BCH • The central portal of the Biosafety Clearing House (BCH), hosted by the CBD Secretariat, Montreal, Canada, is a major repository of biosafety information. • The portal is available in all official UN languages, and to date, a number of relevant national, regional and international databases are interoperable with the CBD-BCH, thus facilitating the searching over 8000 records from these combined databases through a unified search mechanism.
  29. 29. • Information is searchable under the following themes: biosafety information resources, national contacts, laws and regulations, decision and declaration information (including risk assessment documents) • The CBD-BCH also contains a sub-database of “National Biosafety Websites and Databases”.
  30. 30. ICGEB • The ICGEB webpages provides information on biosafety and risk assessment for the environmental release of GMOs with special regards to the need of the developing world.
  31. 31. • Notable resources include: • a Biosafety Bibliographic database • Risk Assessment Search Mechanism (RASM), database of past and current projects in GMO biosafety research, as well as the Collection of Biosafety Reviews and links to Internet biosafety resources offered by other organizations on its biosafety library webpages.
  32. 32. OECD(Organization for Economic Co-operation and Development) • The OECD created the BioTrack Online website to provide information on environmental, food and feed safety issues relating to modern biotechnology. • The home page focuses on the regulatory oversight of modern biotechnology products in OECD member countries.
  33. 33. • which includes information related to major legislative developments, documents, links to other related web sites, and online databases of modern biotechnology products, as well as field trials. • The information includes regulatory contacts, product database, field trials, and free documents.
  34. 34. BOTANICAL FILE BATABASE • The Botanical Files database provides data on the possibility of crop species out-crossing with wild and weedy relatives, and with conventional landraces and other varieties of the same crop plant.
  35. 35. • These files, developed for sugar beet and maize in Europe only, are based on maps that were established by local botanists using their national or regional flora and information from researchers (especially breeders).
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