National Biosafety Guidelines

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NATIONAL BIOSAFETY
GUIDELINES
"Biotechnology" is a collective term, encompassing a number of
technologies, some old,others new. Plant and animal breeding are
examples of traditional biotechnological methods.
Making of foods, such as, bread, cheese, and yogurt; and
medicines such as vaccines andhormones, are known products of
old biotechnological methodologies. The precise definitions of
"biotechnology" and of other terms such as "recombinant DNA"
are of extreme importance when used as part of biosafety
guidelines/regulations, particularly because they define the
bounds of guidelines/regulatory jurisdiction.
Modern Biotechnology has led to the development of new
products/processes which manifest distinct advantages for the
prevention and treatment of diseases. The list of biologically
active compounds which can be made by Genetically Modified
Organisms (GMOs) is increasing every day and it is believed that
in the next 15-20 years, we will be able to produce all biological
proteins by Genetically Modified Organisms. Through the use of
powerful gene cloning and molecular immunological techniques,
vaccines against malaria and hepatitis B have been prepared.
NEED FOR BIOSAFETY
GUIDELINES/REGULATIONS
A number of developed countries have prepared biosafety
guidelines for both laboratoryresearch and field applications of
GMO’s and their products. Such guidelines differ from onecountry
to another, however, the guiding principle is to ensure safety and
minimize all the riskswhich are likely to occur, encountered or
subsequently generated. Many developing countries have used
guidelines in developed countries as references and then modified
or amended in compliance with the relevant laws, regulations and
local conditions. At the international level, UNIDO, FAO, WHO,

UNEP, and other such agencies have prepared guidelines which
have helped developing countries to formulate their own
biosafety guidelines. The objective of these guidelines, prepared
by the National Biosafety Committee (NBC), is not to enforce
stringent regulations such that they will impair activities in the
research and development of recombinant DNA technology in the
country. At the same time, the objective is also not to be too
lenient to allow unintentional negligence leading to misuse and
irresponsibility by certain researchers or laboratories.
BASIS OF BIOSAFETY GUIDELINES
1)
All regulated works are classified according to level of
anticipated risk and safety, intothree categories:
A)
Work bearing minimal risk
B)
Work bearing low risk
C)
Work bearing considerable level of risk
2)
The proposed guidelines suggest three tiers for monitoring
and implementation.
A) Firstly, the Principal Investigator and researchers are
responsible to themselves and to thecommunity.
B) Secondly, a Technical Advisory Committee (TAC) which will
have the major
responsibility to ensure that the GMOs or any product under
consideration has gone through proper risk assessment under
these guidelines.
C) Thirdly, a National Biosafety Committee (NBC), will act as the
executive body for the overall monitoring, risk management and
commercial release of all regulated materials.
GUIDELINES FOR LABORATORY WORK
1) RISK CATEGORY 1 WORK:

1) Risk Category 1 work appears to convey minimal risk,
nevertheless, such work must be undertaken in compliance
with standard practices for conventional microbiological
laboratories.
2) Experiments involving pathogenic organisms should conform
to suitable containment and precautionary measures
including personnel training and instructions.
3) Laboratory staff should be familiar with all pathogenic
organisms under study and aware of the appropriate safety
procedures required.
2) RISK CATEGORY 2 WORK:
1) Risk Category 2 work may pose "low" levels of risks towards
laboratory personnel, the community or the environment.
2) Certain types of work however, may call for further safety
precautions or high levels of physical containment.
3) The project supervisor or head researcher has the primary
responsibility for identifying the nature of potential hazards
within the laboratory and for determining additional
precautions
3) RISK CATEGORY 3 WORK:
1) Risk Category 3 distinction is placed on work which may
pose a substantial level of risk to laboratory personnel, the
community or the environment.
2) Gene-therapy work and work for which the character and
degree of the risks are as yet uncertain fall under this
category.
3) Work is prohibited before consent is granted by the IBC/NBC
and only after both biosafety committees have inspected
and reviewed the project proposals, and advised the relevant
authorities on any measures that work should be allowed.

GENETICALLY MODIFIED MICROORGANISMS

GUIDELINES FOR FIELD WORK
Field work with genetically modified microorganisms must first
take into consideration the nature or character of the biological
system, as follows:
 For microorganisms, considered to have a history of safe
use in the field, work mayproceed in accordance with the
basic standards appropriate to the particular
microorganism.
 Those microorganisms,which are from a strain that has
been involved in previous documented fieldwork.
A)which perform the same functions as strains that have
been involved
in previousdocumented field work.
B)which remain confined to sites and surroundings that
resemble
previous fieldconditions, are considered to have a history
of safe use.
 For experimental microorganisms which do not meet the
above conditions, the work mayproceed under appropriate
containment levels as presented in Regulations
andContainment Section. The proposed measures of
containment must observe any one ormore of the
following conditions:
A)There is appropriate biological containment, where:
•Microorganisms are rendered non-reproducible before being field
tested; or
• Modifications are done to limit the survival of microorganisms
outside,
andto confine microorganisms within target areas.
B) Genetic inserts and constructs may be exchanged or
transferred to other
microorganisms only in a restricted area.

C)There are physical arrangements to contain the dispersal of
Micro-organisms within the target areas or site of trial.
 In the case of those microorganisms which do not have a
history of safe use in field, thework may proceed with a
preliminary risk assessment to determine the full range
ofpossible environmental effects. Those Micro-organisms
recognized as "problematic" that have been engineered.
D)
Sustenance and nourishment of plant species, which may
therefore Provide nutrients in excess to disrupt the chemistry of
associated plants;
E) Destruction of toxic residues which may prompt secondary
ill-effects.
F)
Biological control of plant pests which may overwhelm
target species and
Thus produce toxic or pathogenic metabolites, spreading ill-health
in wild Population sat the trial site.
GENETICALLY MODIFIED PLANTS
Field work with genetically modified plants must first take into
consideration the natureor character of the biological systems, as
follows:
For experimental plants considered to have a history of safe use
in the field, the workmay proceed in accordance with the basic
standards appropriate to the particular plant.
Those plants are considered to have safe history that have been
modified by,
A)Conventional breeding practices (e.g. selective breeding,
mutagenesis, protoplast fusion or embryo rescue) and/or
having inherent characteristics typical of modified plants from
conventional breeding practices.
B)The introduction of genetic inserts that are known to be
harmless and
Non-hazardous to the environment.

 For experimental plants which do not meet the above
conditions, work may proceed under appropriate
containment level and criteria. The said measures of
containment must observe any one or more of the
following conditions:
C)There is no cross-hybridization.
D) There are arrangements to contain the dispersal of plants and
plant
materials.
E) Introduced gene expression is stable, and does not fluctuate
with
Changing environmental conditions.
 In the case of those plants which do not have a history of
safe use in the field, work mayproceed with a preliminary
risk assessment to determine:
F) Effects on the ecology of the trial site
 Increased resistance to diseases and pests.
 Propensity for weediness.
 Effects on other target and non-target organisms.
G) Effects on the ecology in the open environment
 Potential for cross-hybridization.
 Promotion of and stimulus for the growth and
development of weeds.
 Invasion of wild populations beyond the trial site
 Effects on other elements in the surroundings.
GENETICALLY MODIFIED ANIMALS:
Breeding of genetically modified animals should be conducted in
accordance with thefollowing:

A) Genetically modified animals should be bread in breeding
containers clearly distinguishable from other containers used for
breeding non -engineered animals.
Further, genetically engineered animals be individually
distinguished and housed,
however, if individual distinction becomes difficult, small
laboratory animals may
be managed according to breeding groups.
B)Wastes relating to genetically modified animals (including dead
bodies should
be disposed off after sterilization and
incineration as necessary.
C)In transporting genetically modified animals outside the work
area, containers possessing sufficient strength and structure to
prevent escape, should be used.
D) The word “Handle with Care” in “distinguishable ink” should
be clearly displayed on all containers that house genetically
modified animals.
E) Maintenance and management facilities and equipment etc
used for these studies should be performance – tested at the
time of installation and periodically and thereafter to maintain
original performance level.
F) A sign stating genetically modified animals should be posted
at each work area.
G)The work area should be kept clean.
H)

Working clothes should be worn in the work area only.

I) When transferring genetically modified animals to other
facilities and other personnel the person responsible must
notify receiving personnel of all the relevant information.

International Guidelines of
Biosafety
Classification of infective microorganisms by risk
group
Risk Group 1 (no or very low individual and community risk)
A microorganism that is unlikely to cause human or animal diseas

Risk Group 2 (moderate individual risk, low community risk)
A pathogen that can cause human or animal disease but is
unlikely to be a serious hazard to laboratory workers, the
community, livestock or the environment. Laboratory exposures
may cause serious infection, but effective treatment and
preventive measures are available and the risk of spread of
infection is limited.

Risk Group 3 (high individual risk, low community risk)
A pathogen that usually causes serious human or animal disease
but does not ordinarily spread from one infected individual to
another. Effective treatment and preventive measures are
available.

Risk Group 4 (high individual and community risk)
A pathogen that usually causes serious human or animal disease
and that can be readily transmitted from one individual to
another, directly or indirectly. Effective treatment and preventive
measures are not usually available.

Risk assessment
The backbone of the practice of biosafety is risk assessment. While
there are many tools available to assist in the assessment of risk for
a given procedure or experiment , the most important component is
professional judgement . Risk assessments should be performed by
the individuals most familiar with the specific characteristics of the
organisms being considered for use, the equipment and procedures
to be employed, animal models that may be used, and the
containment equipment and facilities available.
1) pathogenicity of the agent and infectious dose
2) consideration of the outcome of exposure
3) natural route of infection
4) other routes of infection, resulting from laboratory
manipulations (parenteral, airborne, ingestion)
5) stability of the agent in the environment
6) concentration of the agent and volume of concentrated
material to be manipulated presence of a suitable host (human
or animal)
7) local availability of effective prophylaxis or therapeutic
interventions.

Hazards associated with the
host/recipient
1) Pathogenicity of the host strain, including virulence,
infectivity, toxin production and modification of the host range
2) degree of immunity of the recipient and status of immune
system
3) seriousness of the consequences of exposure
4) susceptibility of the host

Hazards arising directly from the inserted
gene

1) toxins
2) cytokines
3) hormones
4) antibiotic resistance
5) allergens.
6) gene expression regulators
7) virulence factors or enhancers

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