A brief study of safety measures taken In biotechnology study

1. REGULATORY GUIDELINES AND SAFETY CONSIDERATION FOR
GENETIC ENGINEERING
“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 .
BIOSAFETY GUIDELINES
Policy proposed opted by the Government to avoid the risks of GEOs on
environment and public health.
AIM OF BIOSAFETY GUIDELINES
 Regulating rDNA research with organisms that have least or no adverse
effect.
 Minimizing the possibilities of occasional release of GEOs from the
laboratory
 Banning the release of GEOs if they are supposed to be causing potential
risks in the environment
SCOPE OF THE GUIDELINES
BIOLOGICAL RISK ASSESSMENT-
 It refers to the polices and procedures adapted to ensure the environmentally safe
application of biological agents.
 Risk Assessment : It refers to assessment of the risks of introducing GMO into the
environment, to human and natural or managed ecosystem.
CRITERIA IN BIOLOGICAL RISK ASSESSMENT
 Determination of the overall risk of the GMO
 Application of management strategies for risks from the deliberate release or
marketing of the GMO;
 Estimation of risk posed by each identified characteristic of the GMO;

2.  Evaluation of the likelihood of the occurrence of each identified potential adverse
effect;
 Evaluation of the potential consequences of each adverse effect if it occurs;
 Evaluating the probability of the occurrence of immediate harm in view of the
work situation;
 Defining the work situation and looking for procedures that favor the agent’s
transmission;
 Identifying the potential immediate and delayed harmful effects for humans and
the environment;
 Characterizing the biological agent and classifying it in one of the four hazard
groups;
COMPONENT OF GUIDELINES
.
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.
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
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)
THE RDNA BIOSAFETY GUIDELINES OF INDIA

3.  In India, DBT has proposed “The recombinant DNA safety guidelines” in
1983 and amended in 1990.
 These guidelines deals with a set of rules for production, use, import, export
and storage of hazardous organisms.
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
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)
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.
Institutional Biosafety Committee (IBSC)
 Constituted in all centers engaged in genetic engineering research and
production activities.

4.  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.
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.
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.