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  2. 2. BIOSAFETY DEFINITION- In general, “BIOSAFETY” refers to the efforts that ensure safety in using, transporting, transferring, handling, releasing and disposing of biological organism including genetically modified organism which are capable of harming human, animals, plants or environment .
  3. 3. BIOLOGICAL RISK ASSESSMENT-  Genetically Modified Organism : It is operationally defined as an organism whose hereditary traits have been modified by human intervention using any method that results in the introduction, rearrangement or removal of genetic material from the genome of an organism.  Risk Assessment :It refers to assessment of the risks of introducing GMO into the environment, to human and natural or managed ecosystem.  Biosafety : It refers to the polices and procedures adapted to ensure the environmentally safe application of biological agents.
  4. 4.  DEFINITION OF HAZARDS- A hazard is the presence of an inherent characteristic that threatens human health. This characteristic may be attributed to an object (machine),chemical agent, biological agent ,to a process (movement, transport, chemical process, biotechnological processes) or to a situation (climate, storage). A hazard may have adverse effects on the product (quality), on the environment and on the health of workers (safety-health).  DEFINITION OF BIOHAZARD – is a hazard that originates from living organisms. These may be animals, microorganisms, materials that originate from animals (including humans) or plants.
  5. 5.  Biological Agents and Hazard Groups: Biological agents are classified under four hazard groups according to the severity of the harmful effects they may have on workers’ health. Consideration is given to: the ability of the biological agents to cause disease in “healthy” people; the mean severity of the disease; the likelihood of the biological agents causing epidemics, and the existence of effective treatments and suitable prophylactic measures.
  6. 6. HAZARDS GROUPS ARE DEFINED IN THE FOLLOWING MANNER:  Hazard group 1—Biological agent unlikely to cause disease in humans.  Hazard group 2—Biological agent that can cause a disease in human and could be a hazard to directly exposed workers. It is unlikely to spread to the community. Effective prophylaxis and treatment are usually available.  Hazard group 3—Biological agent that can cause severe human diseases and is a serious hazard to directly exposed workers. It may present a risk of spreading to the community. Effective prophylaxis and treatment are usually available.  Hazard group 4—Biological agent that can cause severe human diseases is a serious hazard to directly exposed workers. May present a risk of spreading to the community. Effective prophylaxis or treatment are usually not available.
  7. 7. CRITERIA IN BIOLOGICAL RISK ASSESSMENT:  Characterizing the biological agent and classifying it in one of the four hazard groups;  Identifying the potential immediate and delayed harmful effects for humans and the environment;  Defining the work situation and looking for procedures that favor the agent’s transmission;  Evaluating the probability of the occurrence of immediate harm in view of the work situation;  Evaluation of the potential consequences of each adverse effect if it occurs;  Evaluation of the likelihood of the occurrence of each identified potential adverse effect;  Estimation of risk posed by each identified characteristic of the GMO;  Application of management strategies for risks from the deliberate release or marketing of the GMO;  Determination of the overall risk of the GMO
  8. 8. GUIDELINES FOR CATEGORIZATION OF GENETICALLY MODIFIED PLANTS FOR FIELD TEST-  For experimental plants, considered to have a history of safe use in field work as follows; • A. Modified plants that result from conventional breeding practices (e.g. selective breeding, mutagenesis, protoplast fusion or embryo rescue) • B. Genetically modified plants, having inherent characteristics typical of modified plants from conventional breeding practices. • C. Plants, with genetic inserts that are known to be harmless and inoffensive to the environment. Let work proceed in accord with the basic standards appropriate to the particular plant.
  9. 9.  For field testing of experimental plants with a history of prior field work, a project notification or proposal form has to be submitted to the Institutional Biosafety Committee (IBC).  The IBC shall evaluate the proposed ambient working conditions through the accredited containment resources, in determining the sufficiency of biosafety provisions. Measures for the control and containment of field work should observe relevant past regulations and address the particular plant(s) under study.  Only after receiving IBC endorsement, work may begin. The IBC must forward all proposals and the committees, assessments thereof, to the National Biosafety Committee (NBC) for records and information.
  10. 10.  For experimental plants that do not have history of safe use, the work should proceed under the appropriate containment level if any of the following conditions is met. • A. There is no cross-hybridization. • B. There are arrangements to contain the dispersal of plants and plant materials. • C. Introduced gene expression is stable, and does not fluctuate with changing environmental conditions.
  11. 11. Field testing experimental plants with no history of prior field work should proceed under the advice, counsel, and direction of the IBC and NBC. In both cases, committee recommendations and the command of work, shall be grounded on the biosafety concerns that may be gathered from the written proposals submitted. The project supervisor is prohibited from initiating work before consent is granted directly by the NBC.
  12. 12. REGULATORY FRAMEWORK FOR GMOS IN INDIA Ministry of Environment & Forests, Government of India notified the rules and procedures for the manufacture, import, use, research and release of GMOs as well as products made by the use of such organisms on December 5, 1989 under the Environment (Protection) Act, 1986 (EPA). These rules and regulations, commonly referred as Rules 1989 cover areas of research as well as large scale applications of GMOs and its products. These Rules are implemented by the Ministry of Environment & Forests and the Department of Biotechnology, Government of India.
  13. 13. Six Competent Authorities and their composition have been notified under this Rules which are as follows: i. Recombinant DNA Advisory Committee (RDAC) ii. Institutional Biosafety Committees (IBSC) iii. Review Committee on Genetic Manipulation (RCGM) iv. Genetic Engineering Appraisal Committee (GEAC) v. State Biosafety Coordination Committees (SBCC) vi. District Level Committees (DLC). While the RDAC is of advisory in function, the IBSC, RCGM, and GEAC are of regulatory function, SBCC and DLC are for monitoring purposes.
  14. 14. The approvals and prohibitions under Rules 1989 are summarized below-  No person shall import, export, transport, manufacture, process, use or sell any GMOs, substances or cells except with the approval of the GEAC.  Use of pathogenic organisms or GMOs or cells for research purpose shall be allowed under the Notification, 1989 of the EPA, 1986.  Any person operating or using GMOs for scale up or pilot operations shall have to obtain permission from GEAC.  For purpose of education, experiments on GMOs IBSC can look after, as per the guidelines of the Government of India.  Deliberate or unintentional release of GMOs not allowed.  Production in which GMOs are generated or used shall not be commenced except with the approval of GEAC  GEAC supervises the implementation of rules and guidelines.
  15. 15.  GEAC carries out supervision through SBCC, DLC or any authorized person.  If orders are not complied, SBCC/DLC may take suitable measures at the expenses of the person who is responsible.  In case of immediate interventions to prevent any damage, SBCC and DLC can take suitable measures and the expenses incurred will be recovered from the person responsible.  All approvals shall be for a period of 4 years at first instance renewable for 2 years at a time.  GEAC shall have powers to revoke approvals in case of: i. Any new information on harmful effects of GMOs. ii. GMOs cause such damage to the environment as could not be envisaged when approval was given. iii. Non-compliance of any conditions stipulated by GEAC.
  17. 17. • The following are some brief descriptions of Laboratory Biosafety Levels: BIOSAFETY LEVEL 1 (BS-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.  The laboratory is not necessarily separated from the general traffic patterns in the building. Work is generally conducted on open bench tops using standard microbiological practices. Special containment equipment or facility design is neither required nor generally used.  Laboratory personnel have specific training in the procedures conducted in the laboratory and are supervised by a scientist with general training in microbiology or a related science.
  18. 18. BIOSAFETY LEVEL 2 (BS-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 differs from BSL-1 in that  Laboratory personnel have specific training in handling pathogenic agents and are directed by competent scientists;  Access to the laboratory is limited when work is being conducted;  Extreme precautions are taken with contaminated sharp items; and  Certain procedures in which infectious aerosols or splashes may be created are conducted in biological safety cabinets or other physical containment equipment.
  19. 19. • BIOSAFETY LEVEL 3 (BS-3)-  Biosafety Level 3 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 as a result of exposure by the inhalation route.  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 or other physical containment devices, or by personnel wearing appropriate personal protective clothing and equipment.  The laboratory has special engineering and design features
  20. 20. • BIOSAFETY LEVEL 4 (BS-4)-  Biosafety Level 4 is required for work with dangerous and exotic agents that pose a high individual risk of aerosol- transmitted laboratory infections and life-threatening disease.  Agents with a close or identical antigenic relationship to Biosafety Level 4 agents are handled at this level until sufficient data are obtained either to confirm continued work at this level, or to work with them at a lower level.  Members of the laboratory staff have specific and thorough training in handling extremely hazardous infectious agents and they understand the primary and secondary containment functions of the standard and special practices, the containment equipment, and the laboratory design characteristics.
  21. 21.  They are supervised by competent scientists who are trained and experienced in working with these agents. Access to the laboratory is strictly controlled by the laboratory director.  The facility is either in a separate building or in a controlled area within a building, which is completely isolated from all other areas of the building. A specific facility operations manual is prepared or adopted.  Within work areas of the facility, all activities are confined to Class III biological safety cabinets, or Class II biological safety cabinets used with one-piece positive pressure personnel suits ventilated by a life support system. The Biosafety Level 4 laboratory has special engineering and design features to prevent microorganisms from being disseminated into the environment.
  22. 22. SAFETY EQUIPMENT (PRIMARY BARRIERS): BIOLOGICAL SAFETY CABINETS (BSCS) Biological safety cabinets (BSCs) are designed to protect the operator, the laboratory environment and work materials from exposure to infectious aerosols and splashes that may be generated when manipulating materials containing infectious agents, such as primary cultures, stocks and diagnostic specimens. Aerosol particles are created by any activity that imparts energy into a liquid or semiliquid material, such as shaking, pouring, stirring or dropping liquid onto a surface or into another liquid.
  23. 23. Aerosol particles of less than 5 µm in diameter and small droplets of 5–100 µm in diameter are not visible to the naked eye. The laboratory worker is generally not aware that such particles are being generated and may be inhaled or may cross contaminate work surface materials. BSCs, when properly used, have been shown to be highly effective in reducing laboratory- acquired infections and cross-contaminations of cultures due to aerosol exposures. BSCs also protect the environment
  24. 24. CLASS I BIOLOGICAL SAFETY CABINET Room air is drawn in through the front opening at a minimum velocity of 0.38 m/s, it passes over the work surface and is discharged from the cabinet through the exhaust duct. The directional flow of air whisks aerosol particles that may be generated on the work surface away from the laboratory worker and into the exhaust duct.
  25. 25. CLASS II BIOLOGICAL SAFETY CABINETS  The Class II BSC was designed not only to provide personnel protection but also to protect work surface materials from contaminated room air. Class II BSCs, of which there are four types (A1, A2, B1 and B2), differ from Class I BSCs by allowing only air from a HEPA-filtered (sterile) supply to flow over the work surface. The Class II BSC can be used for working with infectious agents in Risk Groups 2 and 3.  Owing to the relative size of these filters, about 70% of the air recirculates through the supply HEPA filter back into the work zone; the remaining 30% passes through the exhaust filter into the room or to the outside.
  26. 26. CLASS III BIOLOGICAL SAFETY CABINET This type provides the highest level of personnel protection and is used for Risk Group 4 agents. All penetrations are sealed “gas tight”. Supply air is HEPA-filtered and exhaust air passes through two HEPA filters. The Class III cabinet may be connected to a double-door autoclave used to decontaminate all materials entering or exiting the cabinet. Several glove boxes can be joined together to extend the work surface. Class III BSCs are suitable for work in Biosafety Level 3 and 4 laboratories.