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rDNA Technology
Biosafety Regulations and Guidelines
Rahul Kumar
Biochemical Engineering
University School of chemical Tec...
INTRODUCTION
 Capability to manipulate genetic material present
tremendous potential to use in novel experiments and
appl...
Scope of the Guidelines
▪ Research
 Genetically Engineered organisms
 Genetically transformation of animals and Green pl...
Components of Guidelines
▪ Definition of recombinant DNA
▪ Classification of a pathogenic microorganisms
▪ Containment
▪ B...
What is rDNA Technology?
Recombinant DNA is the general name for taking a piece
of one DNA, and combining it with another ...
Classification of pathogenic microorganisms
Parametersonthebasis
ofrisk
Pathogenicity
Mode of transmission
Capability to c...
Containment
The term "Containment" is used in describing the safe methods for managing infectious agents in the laboratory...
Biosafety levels
It consists of a combination of laboratory practices and techniques, safety equipment and laboratory faci...
Guidelines for rDNA research activities:
Categories
Category-1
Which are exempt for the purpose of intimation and
approval...
Large Scale Experiments
▪ Large scale production of bio-molecules from genetically engineered microorganisms
▪ Experiments...
Release into the Environment
▪ Release or rDNA products and waste into the environment with assessment of
potential risks ...
Import and Shipment
▪ The import or receipt of etiologic agents and vectors of human and animal disease
or their carriers ...
Quality Control of rDNA products.
▪ A new license for the product or drug application would be required on products
made o...
Mechanism of Implementation of guidelines
▪ Recombinant DNA Advisory Committee (RDAC)
▪ Institutional Biosafety Committee ...
GOI - Government of India
DBT - Department of Biotechnology
RDAC - Recombinant DNA Advisory
Committee
IBSC - Institutional...
Recombinant DNA Advisory Committee (RDAC):
▪ Developments at national and international levels in Biotechnology
▪ Currentn...
Institutional Biosafety Committee (IBSC)
▪ Constituted in all centers engaged in genetic engineering research and producti...
Review Committee on Genetic Manipulation
(RCGM)
▪ To establish procedural guidance manual - procedure for regulatory proce...
Genetic Engineering Approval Committee
(GEAC)
▪ Body for review and approval of activities involving large scale use of ge...
rDNA Technology-Biosafety Regulations and Guidelines
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rDNA Technology-Biosafety Regulations and Guidelines

Biosafety regulations and guidelines on rDNA technology and the products of rDNA Technology.

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rDNA Technology-Biosafety Regulations and Guidelines

  1. 1. rDNA Technology Biosafety Regulations and Guidelines Rahul Kumar Biochemical Engineering University School of chemical Technology-GGSIP University
  2. 2. INTRODUCTION  Capability to manipulate genetic material present tremendous potential to use in novel experiments and applications.  Concern among the scientists: how to safely research in this field.  Involves various micro-organisms and pathogens.  rDNA advisory committee(RDAC) was setup by dept. of biotechnology India  The document aims at: • Guidelines in research • Meet the regulatory requirements by those in production testing and use of Genetically modified organisms.
  3. 3. Scope of the Guidelines ▪ Research  Genetically Engineered organisms  Genetically transformation of animals and Green plants  rDNA technology in vaccine development  Based on the principle of GLP-Good Laboratory Practices. ▪ Large scale operations ▪ Use of GMO in large scale fermentation processes or application of it in the environment. ▪ Based on the principle of GLSP-Good Large Scale Practices. ▪ Involves-containment, quality control, Personnel Protection and Medical surveillance. ▪ Environmental Risks ▪ Release of Engineered organisms in Environment-serious Ecological Consequences. ▪ Guideline prescribed Criteria: assessment of ecological aspects on a case by case basis. ▪ Planned introduction of rDNA organisms into the Environment. ▪ Also covers quality control methods as: safety, purity and Efficacy of rDNA products.
  4. 4. Components of Guidelines ▪ Definition of recombinant DNA ▪ Classification of a pathogenic microorganisms ▪ Containment ▪ Bio-safety levels ▪ Guidelines for rDNA research activities ▪ Large scale experiments ▪ Release to the environment ▪ Import and shipment ▪ Quality control of biologicals produced by rDNA technology
  5. 5. What is rDNA Technology? Recombinant DNA is the general name for taking a piece of one DNA, and combining it with another strand of DNA. Recombinant deoxyribonucleic acid (rDNA) by definition involves in vitro introduction of different segments of DNA (one being the vector and the others normally unrelated DNA sequences) that are capable of replication in a host cell either autonomously or as an integral part of host's genome and maintenance of their continued propagation.
  6. 6. Classification of pathogenic microorganisms Parametersonthebasis ofrisk Pathogenicity Mode of transmission Capability to cause disease Available effective/preventive measures Onthebasisof experiments Access factor of the organism Expression factor of the DNA Damage factor of biologically active substance
  7. 7. Containment The term "Containment" is used in describing the safe methods for managing infectious agents in the laboratory environment where they are being handled or maintained. Purpose of containment To reduce exposure of laboratory workers, other persons, and outside environment to potentially hazardous agents. Types of containment Biological Physical Elements of Containment Laboratory Practice and Technique Safety Equipment(primary barriers) Design Facility(Secondary Barrier)
  8. 8. Biosafety levels It consists of a combination of laboratory practices and techniques, safety equipment and laboratory facilities appropriate for the operations performed and the hazard posed by the infectious agents. Biosafety levels Level-1 Level-2 Level-3 Level-4
  9. 9. Guidelines for rDNA research activities: Categories Category-1 Which are exempt for the purpose of intimation and approval of competent authority. Category-2 Those requiring prior intimation of competent authority Category-3 Those requiring review and approval of competent authority before commencement.
  10. 10. Large Scale Experiments ▪ Large scale production of bio-molecules from genetically engineered microorganisms ▪ Experiments beyond 20 liters capacity for research as well as industrial purposes are included in the category of large scale experimentation/operations. ▪ For such activities it is recommended that one should seek approval of the competent authority as described in Chapter-III. ▪ For approval: furnish Details to GEAC
  11. 11. Release into the Environment ▪ Release or rDNA products and waste into the environment with assessment of potential risks and Consequences. ▪ Treatment of pathogenic waste in order to destroy their pathogenic character. ▪ All must be done upon the basis of risk assessment criteria. ▪ Release of any strain for field testing should be done with the permission of Genetic Engineering Approval Committee (GEAC)
  12. 12. Import and Shipment ▪ The import or receipt of etiologic agents and vectors of human and animal disease or their carriers is subject to the quarantine regulations ▪ Specifying conditions under which the agent or vector is shipped, handled and used are issued by the Review Committee on Genetic Manipulation. ▪ Large scale imports for industrial use are regulated by Genetic Engineering Approval Committee ▪ Subject to applicable packaging, labeling and shipping requirements specified for etiologic agents.
  13. 13. Quality Control of rDNA products. ▪ A new license for the product or drug application would be required on products made of recombinant DNA technology. ▪ A recombinant DNA product demonstrated to be identical to normally occurring substance would not require toxicological and pharmacological data. ▪ Fresh clinical trial if found.
  14. 14. Mechanism of Implementation of guidelines ▪ Recombinant DNA Advisory Committee (RDAC) ▪ Institutional Biosafety Committee (IBSC) ▪ Review Committee on Genetic Manipulation (RCGM) ▪ Genetic Engineering Approval Committee (GEAC)
  15. 15. GOI - Government of India DBT - Department of Biotechnology RDAC - Recombinant DNA Advisory Committee IBSC - Institutional Biosafety Committee RCGM - Review Committee on Genetic Manipulation DOEn - Department of Environment GEAC - Genetic Engineering Approval Committee SBCC - State Biotechnology Coordination Committee PI - Principal Investigator (R&D/Industry/Others) FA - Funding Agency (Govt./Private & Public Institutions) Institutional mechanism for implementation of guidelines frame work for implementation
  16. 16. Recombinant DNA Advisory Committee (RDAC): ▪ Developments at national and international levels in Biotechnology ▪ Currentness of the safety regulation for India on recombinant research use and applications ▪ To evolve long term policy for research and development in Recombinant DNA research. ▪ To formulate the safety guidelines for Recombinant DNA Research to be followed in India. ▪ To recommended type of training programme for technicians and research fellows for making them adequately aware of hazards and risks involved in recombinant DNA research and methods of avoiding it.
  17. 17. Institutional Biosafety Committee (IBSC) ▪ Constituted in all centers engaged in genetic engineering research and production activities. ▪ The Institutional Biosafety Committee shall be the nodal point for interaction within institution for implementation of the guidelines. ▪ Any research project which is likely to have biohazard during the execution stage or which involve the production of either microorganisms or biologically active molecules that might cause bio- hazard should be notified to IBSC.
  18. 18. Review Committee on Genetic Manipulation (RCGM) ▪ To establish procedural guidance manual - procedure for regulatory process with respect to activity involving genetically engineered organisms in research, production and applications related to environmental safety. ▪ Recommend containment facility. ▪ To assist the Bureau of Indian Standards to evolve standards for biologics produced by rDNA technology. ▪ To advise on intellectual property rights with respect to rDNA technology on patents.
  19. 19. Genetic Engineering Approval Committee (GEAC) ▪ Body for review and approval of activities involving large scale use of genetically engineered organisms and their products in research and development, industrial production, environmental release and field applications. ▪ Import, export, transport, manufacture, process, selling of any microorganisms or genetically engineered substances ▪ Discharge of Genetically engineered/classified organisms/cells from Laboratory, hospitals and related areas into environment. ▪ Large scale use of genetically engineered organisms/classified microorganisms in industrial production and applications.

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