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ISNAR
Introduction:
BIOSAFETY
is one term that is used to describe the policies procedures
adopted to ensure the environmentally safe application of modern
biotechnology.It is a term that is gaining wider currency as
more countries seek to benefit from the application of modern
science in agriculture, medicine, and the environment, without
endangering public health or environmental safety.
Egypt’s
national biosafety system was formally instituted by the
Ministry of Agriculture and Land Reclamation (MALR) in two
decrees issued early 1995. Ministerial Decree No. 85 (January
25,1995) establishes a National Biosafety Committee (NBC);
Ministerial Decree No. 136 (February 7,1995) adopted biosafety
regulations and guidelines for Egypt.
BIOSAFETY COMMITTEE
1. National
Biosafety Committee (NBC):
An Egyption
National Biosafety Committee is established, comprising policy
makers and designers,scientific experts in
Agricilture,Health,Industry and Environment from government and
academic research institutes as well as experts from private
sector.
1.1Roles And
Responsibilities Of (NBC):
The purpose
of the National Biosafety Committee is to establish policies and
procedures to govern the use of modern biotechnology in the
country.This includes publishing the National Biosafety
Committee guidelines(NBC Guidelines) to be followed at the
national level.The committee would also provide technical advice
to the regulatory authorities and the institutions responsible
for the development of the biotechnology in the country.
1.2 National
Biosafety Committee Members:
In order to
ensure the competence necessary to set biosafety policies at the
national level it is recommended that the NBC include:
Representative/s from the Ministry of Agriculture.
Representative/s from The Ministry of Education.
Representative/s from The Ministry of Industry.
Representative/s from The Ministry of Health.
Representative/s from The Sector of Environmental Affairs.
Representative/s from The Private Sector.
Policy makers and consultants knowledgeable in policies
And applicable laws.
Non-technical members who represent the interest of the
surrounding community with respect to the health and
Protection of the environment.
1.3 Activities
Of NBC:
a)
Formulate,implement and update safety codes.
b)
Risk assessment and license issuance.
c)
Coordination with international and national organizations.
d)
Provide training and technical advice.
e)
Report at least annually to governmental authorities.
1.4
Principal
Investigator (PI):
The
National Biosafety Committee would designate one or more
principal investigators.
2.
The Institutional
Biosafety Committee (IBC):
The
National Biosafety Committee should request that all
institutions conducting R-DNA research assemble an Institutional
Biosafety Committee.
2.1
Roles and
Responsibilities of IBC:
The IBC is
responsible for ensuring that the r-DNA research is carried out
in full conformity with the provisions of the NBC Guidelines.
As part of its general responsibilities for implementing the
NBC Guidelines,the IBC may establish additional procedures as
deemed
necessary
to govern the institution activities.
2.2
Institutional
Biosafety Committee Members:
In order to
ensure the competence necessary to review R-DNA research
activities,it is recommended that:
a)
The IBC include persons with expertise in R-DNA technology that
cover the research directions in the institute.
b) The
IBC include persons with expertise in biological safety and
physical containment.
c) The
IBC have available as consultant's persons knowledgeable in
institutional commitments, policies and applicable law.
d) IBC
designate a Biologic Safety Officer (BSO) that meets the
requirements set in section 1.4
2.3
Activities of
IBC:
a)
Assemble a comprehensive set of research and
containment oriented guidelines that are tailored to the
research activities of the institute and the comply
with the NBC Guidelines.
b)
Establish a program for inspection to ensure that the physical
containment facility continues to meet with the requirements.
c)
Assessment of the facilities procedures,practices,and of the
training and expertise of R-DNA personnel.
d)
Review periodically R-DNA research being conducted at the
institute to ensure that the requirements of the NBC Guidelines
are being fulfilled.
2.4
Biological Safety
Officer (BSO):
The
institute should appoint a Biological Safety Officer who should
be familiar with the biosafety requirements for the R-DNA work
and the facilities. His duties
include the
following:
a) Enforces
policies and regulations approved ensuring that
these regulations are not compromised by other considerations.
b) Ensure
through periodic inspections that laboratory standards are
rigorously followed.
c) Ensure
safety of laboratory work and prevent the accidental escape of
R-DNA modified organisms.
d) Maintain
a data base on all aspects of biosafety related to mandate
crops.
e) Checks
and gives advice on biosafety issues on a day to-day basis.
f) Monitor
worldwide biosafety requirements for R-DNA, also act as a member
of the biosafety committee,reporting all related issues.
BIOSAFETY GUIDELINES
1.RISK
ASSESSMENT:
Risk to the
health of workers and others in the immediate vicinity of the
work-place is one of the main concern in assessing the hazards
associated with the contained use of GMOs.These risks are
considered proportional to the scale of the operation and all
regulatory systems distinguish small-scale use for research and
development. As for large-scale use,the risk to health and
possible risks to environment in the event of escape of organism
from the production area must be evaluated and an appropriate
level of containment applied.Containment may be
physical,e.g.barriers limiting the escape of the organisms, or
biological, e.g. physiological limitations to the survival and
replication of the organism outside the process environment.
2.Determination
of the Level of Safety Concern (LSC):
The
Agriculture Biotechnology Research Advisory Committee
(ABRAC)
has recommended a step-wise process to the Assistant Secretary
for Science and Education for the evaluation of level of safety
concern of the Genetically Modified Organism into three levels.
Determining
the level of safety concern is of great importance for analyzing
the risks to human health and natural ecosystem for
GMOs.
Step
1:Determine the level of safety concern of parental
organism:
Depending
on two criteria:
i.
Whether the organism poses negligible risk to human health and
no unreasonable risk to managed or natural ecosystem.
ii. The
ability to manage or control the organism during its planned
introduction into the environment so that the research is
conducted in a safe manner.
Level 1 of safety Concern for
parental Organisms:
The
organism poses negligible risk to human health and no
unreasonable risk to managed or natural ecosystem. Those
organisms whose ecological attributes in the specified
accessible environment are understood.
Some
attributes in combination might indicate Level -1 organisms are:
a) No
history of adverse effects in the accessible environment.
b) Low
evolutionary potential to become harmful organism in the
accessible environment.
c) Low
probability of survival in the accessible environment.
Level 2 of
safety Concern for parental Organisms:
Organisms
whose ecological attributes in the accessible
environment may pose a risk to human health that is not
negligible or may pose an unreasonable risk to managed or
natural ecosystem, which can and must be managed or controlled
by appropriate confinement.
Level 3 of Safety Concern for
parental Organisms:
Organisms
whose ecological attributes in the accessible environment may
pose a risk to human health that is not negligible or may pose
an unreasonable risk to managed or natural ecosystem, and no
feasible confinement will ensure safe conduct of the research
outside contained facilities.
Some
attributes in combination might indicate Level-3 organisms are:
a) History
of adverse effect in the specified environment.
b) Ability
to survive and proliferate in the environment.
c) Non-indigenous
status in the environment.
d) High
frequency of exchange of genetic information with adverse
effect.
e) Lack
of effective techniques to minimize the escape of the organisms.
f) Lack
of adequate techniques to recapture or kill escaped occurs.
Step 2:
Determine the effect of the Genetic Modification on level
of safety Concern:
The genetic
modification should be evaluated in terms of its effect on the
attribute of the parental organism evaluated in
step-1.where the genetic modification may have no effect on
safety or increase or decrease safety.
The effect
of the genetic modification on safety must be evaluated with
reference to:
i.
Direct effect of the organism on human health or the
environment.
ii.
Indirect effect of the organism through the substances it
produces.
iii. Effects
of genetic exchange with other organisms.
In step-2
investigators should examine the method of genetic modification;
the molecular characterization and stability of the modified
genes; the expression, function, and effects of the modified
genes.
Type1:Genetic
modification that Decrease Safety Concern for the
Modified organism:
Modifications that delete or disrupt the expression of a gene or
genes, responsible for traits, such as,
pathogenicity,fertility,survival, or fitness in a way that
increase safety of the organism.
Type2:Genetic
Modification that Have No Effect on Safety Concern for
the Modified organism:
Sustainable
understanding of the molecular biology and other
information,including relevant experience, which shows that the
modification is well characterized and that the gene functions
and effects are adequately understood to predict safety.
Modifications include:
i.
Insertions of nucleic acid,deletions, or rearrangement that have
no phenotypic or genotypic consequences in the
environment.
ii.
Insertions of nucleic acid, deletions, or rearrangement that
have known or predictable phenotypic or genotypic
consequences
in the environment that unlikely may result in additional
adverse effect to human health and the environment.
Type 3:Genetic
Modification that Increase Safety Concern for the
Modified organism.
Modifications include:
i. Insertions
of nucleic acid, deletions, or rearrangement that affect the
expression of genes,but the functions or effects are not
sufficiently
understood to determine with certainly if the modified organism
poses greater risk than the parental organism.
ii. Insertions
of nucleic acid, deletions,or rearrangement that have known or
predictable phenotypic or genotypic consequences
in
the environment that likely result in additional adverse effect
on human health and the environment.
Step 3:
Determination of the level of Safety Concern for
Genetically Modified Organisms:
The
genetically modified organisms should be assigned to one of
three levels of safety concern by considering the effect of the
genetic modification on safety, and if any affected attributes
alter the level of safety concern for the modified organism
compared to the parental organism.
The level
of safety concern for the genetically modified organism is
dependent on the same criteria applied to the determination of
the level of Safety Concern for the parental organism.
Level-1 Parental
Organism:
i.
Level-1
of
Safety Concern for the Parental Organism with type-I
modification is considered as
LSC-1
for the genetically
modified organism.
ii. Level-1
of Safety Concern for the Parental Organism with
type-2
modification is considered as
LSC-1
for the genetically
modified organism.
iii.
Level-1
of Safety Concern for the Parental Organism with
type-3
modification results in
LSC-1,LSC-2,LSC-A
genetically
modified
organism, depending on the degree of safety concern
as follows:
i.
If
type-3
modification results in minimal increase in safety concern so
that risk to human health remains negligible and risk to managed
or natural ecosystem remains reasonable without the need for
confinement measures, then the genetically modified organism
remains
LSC-1.
ii.
If
type-3
modification increases safety concern to the extent that risk to
human health is no longer negligible or risk to the the
environment is no longer reasonable, but feasible confinement
measures are available to conduct research with negligible risk
to human health and the environment, then the genetically
modified organism is
LSC-2.
iii.
If
type-3
modification increases safety concern to the extent that
introduction into the environment cannot be adequately managed
or controlled to achieve negligible risk to human health and no
unreasonable risk to the environment, then the genetically
modified is LSC-3.
Level -2 Parental
Organism:
1)
Level-2
of Safety
Concern for the Parental Organism with -1 modification results
in
LSC-1
or
LSC-2
genetically modified organism,depending on the degree of safety
concern
as follows:
i.
If
type-1
modification decreases the safety concern to the extent that the
organism poses negligible risk to human health and no
unreasonable risk to managed or natural ecosystems without the
need for confinement measures then the genetically modified
organism is
LSC-1.
ii.
If type-1
modification decreases the safety concern and risk to human
health is negligible and risk to managed or natural ecosystems
is reasonable only when managed by use of confinement measures,
then the genetically modified
organism is
LSC-2.
II) Level-2
of Safety Concern for the Parental Organism with
type-2
modifications,remains
LSC-2
genetically
modified organism.
Appropriate
confinement measures are necessary for planned introduction into
the environment.
III) Level-2
of Safety Concern for the Parental organism with
type-3
modifications results in
LSC-2
or
LSC-3
genetically modified organism, depending on the degree of
increase in safety concern
as follows:
i.
If
type-3
modification increase safety concern,but planned introduction
into the environment still can be managed or controlled by
appropriate confinement measures,then the genetically modified
organism is
LSC-2.
ii.
If
type-3
modification increases safety concern to the extent that there
is not reasonable certainly that planned introduction into the
environment can be managed or controlled,then the genetically
modified organism is
LSC-A,
Research
must remain under confinement measures until there is a
certainly that it could be controlled in a safe manner.
Level -3 Parental
Organism:
1) Level-3
of
Safety Concern for the Parental Organism with
type-1
modification results in
LSC-1,LSC-2,LSC-3
genetically modified organism, depending on the degree of
decrease in safety concern
as follows:
i. If
type -1
modification decreases safety concern to the extent that planned
introduction into the environment poses negligible risk to human
health and no unreasonable risk to managed or natural ecosystem
without confinement measures, then the genetically modified
organism is
LSC-1.
ii. If
type-1
modification decreases safety concern, but confinement measures
are necessary for the planned introduction into the environment
with negligible risk to human health and no unreasonable risk to
managed or natural ecosystem, then the genetically modified
organism is
LSC-2.
iii.If
type-1
modification decreases safety concern, but not to the extent
that planned introduction of the organism can be managed or
controlled to achieve negligible risk to human health and no
unreasonable risk to managed or natural ecosystem, then the
genetically modified organism is
LSC-3.
Research
must be conducted in a contained facility.
II)
Level-3
of Safety Concern for the Parental Organism with
type-2
or
type-3
modification results in
LSC-3
genetically modified organisms.
3. BIOSAFETY GUIDELINES
Biosafety
guidelines are designed to ensure that the products of
biotechnology will not have adverse effect on the environment
and agriculture,to prevent unintentional release of hazardous
organisms,and to protect the surrounding communities as well as
employees and researches involved.In the use of such products
from the research stage till commercialization.
3.1
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 incinerating or by
autoclaving.
•Frequent
hand wash is obligatory(at least one hand wash sink should be
available).
•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.
3.2 Biosafety
Guidelines For Containment Greenhouse:
•Greenhouse
should be locked at all times
•Biosafety
categories and safety codes should be posted at the greenhouse
entrance.
•Air
circulation system should not allow dispersal of pollen or
GMO's
from greenhouse.
•Non-living
plant material,parts or viable exotic biological agents should
leave the greenhouse expect for:
ـ
Disposal,were it has to be autoclaved before its disposal.
ـ
Storage in other facilities,in this case it should undergo
adequate containment before transport.
•The
outgoing water must be chemically treated before its drainage.
•Coats
should be worn at all times in the greenhouse,and autoclaved
before removal from the greenhouse for any reason.
•Hand
washing is required upon entering and exiting the greenhouse.
•A
disinfecting pad embedded with a decontaminating substance must
be located the greenhouse entrance.
•Daily
record all experiments carried out in the greenhouse.
3.3 Biosafety
Guidelines For Field Trials:
(Small-Scale
Field Testing):
•Field
experiments with exotic plant pest and pathogens are prohibited.
•Plants
must be prevented from spreading pollen by the removal of
flowers.
•If
flowers are needed for testing and further experimentation,the
inflorescence flowers must be covered before maturation.
•Suitable
plot isolation must be provided avoiding pollen transmission to
other near plots.
•Special
protective measures should be taken to ensure complete isolation
of harvested plant parts.
•Plots
must be protected from the entry of animals or insects using
bowered rows.
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