2. • ‘Biosafety’ means the need to protect human
and animal health and environment from the
possible adverse effects of the products of
modern biotechnology.
• Biosafety defines the containment conditions
under which infectious agents can be safely
manipulated.
3. CONTAINMENT
• The safety measures which prevent the
escaping of GEOs from the laboratory are
called containment.
• They help to destroy harmful GEOs within the
laboratory itself. Hence there is no chance for
the microbes to come out of the laboratory
• In USA,the National Institute of Health(NIH)
set up the Recombinant DNA Advisory
Committee(RAC) in 1976.
4. • The RAC provide guidelines about safety
measures to keep hazardous organisms within
limits.
• These guidelines discuss about physical and
biological containments.
PHYSICAL CONTAINMENTS
• The physical methods being adopted inside the
laboratories to prevent escaping of GEOs to the
environment are called physical containment.
6. 1.Air filtration
• The exhaust air from the laboratory is filtered
through exhaust filters.
• It prevents the escaping of GEOs from the lab.
2.Sterilization lights
• Flurescent tube lights which emit UV light,are
fitted in the laboratory to sterilize the work areas
and exposed surfaces of the lab.
• This technique destroys microbial contaminent
inside the lab.
7. 3.Waste disposal
• All waste coming from the laboratory are
sterilized by autoclaving or by incinerating them
in an incinerator.
• This will prevent the escaping of contaminated
wastes from the lab.
8. 4.Protective handling
• Persons working in the laboratory must follow
certain techniques to avoid contamination and
to prevent escaping of microbes.
• The person must wear protective clothing
before entering the work area,it should not be
carried outside.
• Mouth pipetting should be avoided.
9. BIOLOGICAL CONTAINMENT
• The biological principles used in laboratories to
prevent the escape of GEOs or microbes are called
biological containment.
• Biological containment makes the organisms
unable to survive in the outside environment.
• It prevents the spreading of vector DNAs to the
organisms outside the laboratory by usual
conjugation,transformation or transduction.
10. • Bacteria which cannot grow outside unless
suitable nutrients have to be supplied are
used for gene manipulations.
• Such bacteria are made by inducing gene
mutation.This is a mutant bacterium that
survive only in the culture.
11. BIOSAFETY LEVEL
• Biosafety level is the level of the
biocontainment precautions required to
isolate dangerous biological agents in an
enclosed facility.
• The levels of containment range from the
lowest biosafety level 1 to the highest at level
4.
12. BIOSAFETY LEVEL 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
• It includes several kinds of bacteria and viruses
including canine hepatitis, non-pathogenic E.coli,
as well as some cell cultures and non-infectious
bacteria.
13. BIOSAFETY LEVEL 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 includes various bacteria and viruses that
cause only mild disease to humans, or are
difficult to contract via aerosol in a lab setting,
hepatitis A,B and C.
14. • Laboratory personnel have specific training in
handling pathogenic agents and are directed
by scientists with advanced training;
• Access to the laboratory is limited when work
is being conducted;
• Extreme precautions are taken with
contaminated sharp items.
15. BIOSAFETY LEVEL 3
• This level 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 after inhalation.
• It includes various bacteria, parasites and
viruses that can cause severe to fatal disease
in humans
16. • 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, specially designed
hoods, or other physical containment devices, or
by personnel wearing appropriate personal
protective clothing and equipment.
17. BIOSAFETY LEVEL 4
• This level is required for work with dangerous and
exotic agents that pose a high individual risk of
aerosol-transmitted laboratory infections, agents
which cause severe to fatal disease in humans for
which vaccines or other treatments
are not available, such as Bolivian and Argentine
hemorrhagic fevers,Marburg virus , Ebola virus,
and various other hemorrhagic diseases.
18. • This level is also used for work with agents
such as small pox that are considered
contagious enough to require the additional
safety measures, regardless of vaccination
availability
• When dealing with biological hazards at this
level the use of a positive pressure personnel
suit, with a segregated air supply is
mandatory.
19. • The entrance and exit of a level four biolab will
contain multiple showers, a vacuum room, an
ultraviolet light room, and other safety
precautions designed to destroy all traces of the
biohazard
• All air and water service going to and coming
from a biosafety level 4 lab will undergo similar
decontamination procedures to eliminate the
possibility of an accidental release.
20. Biosafety Guidelines
Biosafety guidelines aiming at-
• Regulating rDNA research with organisms that
have least or no adverse effect.
• Minimizing the possiblities of occasional
release of GEOs from the lab.
• Banning the release of GEOs if they are
supposed to be causing potential risks in the
environment.
21. 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
incineration or by autoclaving.
22. • Frequent hand wash is obligatory.
• 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.
23. • Based upon ICGEB’s long-standing activities in
biosafety, we have identified the main issues
derived from the deliberate introduction of GM
crops (and their derived products) into the
environment or onto the market of concern
today. These have been classified as:
• Risks for animal and human health
• toxicity & food quality/safety
• allergies;
• pathogen drug resistance (antibiotic resistance)
24. • Risks for the environment:
• susceptibility of non-target organisms;
• change in use of chemicals in agriculture
• unpredictable gene expression or transgene
instability (gene silencing).
25. • Risks for agriculture:
• weeds or superweeds
• alteration of nutritional value (attractiveness
of the organism to pests)
• change in cost of agriculture
• unpredictable variation in active product
availability
• loss of changes in agricultural practise
26. • General concerns:
• detection and analytical methods
• ethical issues (eg. labelling)
• public attitudes, perception; legislation
monitoring
• socio-economics (eg. situation of
poor farmers in developing countries)
27. BIOSAFETY DATABASES
• Several Websites offer useful entry-points to a
diversity of biosafety data.
• These "one-stop shops" contain huge collections or
listings of relevant informatic tools and links to
other sites, and can provide and exhaustive and
comprehensive array of biosafety-related
information.
28. BCH
• The central portal of the Biosafety Clearing House
(BCH), hosted by the CBD Secretariat, Montreal,
Canada, is a major repository of biosafety information.
• The portal is available in all official UN languages, and
to date, a number of relevant national, regional and
international databases are interoperable with the
CBD-BCH, thus facilitating the searching over 8000
records from these combined databases through
a unified search mechanism.
29. • Information is searchable under the following
themes: biosafety information resources, national
contacts, laws and regulations, decision and
declaration information (including risk assessment
documents)
• The CBD-BCH also contains a sub-database of
“National Biosafety Websites and Databases”.
30. ICGEB
• The ICGEB webpages provides information on
biosafety and risk assessment for
the environmental release of GMOs with
special regards to the need of the developing
world.
31. • Notable resources include:
• a Biosafety Bibliographic database
• Risk Assessment Search Mechanism
(RASM), database of past and current projects
in GMO biosafety research, as well as the
Collection of Biosafety Reviews and links to
Internet biosafety resources offered by other
organizations on its biosafety library
webpages.
32. OECD(Organization for Economic Co-operation
and Development)
• The OECD created the BioTrack
Online website to provide information on
environmental, food and feed safety issues
relating to modern biotechnology.
• The home page focuses on the regulatory
oversight of modern biotechnology products
in OECD member countries.
33. • which includes information related to major
legislative developments, documents, links to
other related web sites, and online
databases of modern biotechnology products,
as well as field trials.
• The information includes regulatory
contacts, product database, field trials, and
free documents.
34. BOTANICAL FILE BATABASE
• The Botanical Files database provides data on
the possibility of crop species out-crossing with
wild and weedy relatives, and with
conventional landraces and other varieties of
the same crop plant.
35. • These files, developed for sugar beet and
maize in Europe only, are based on maps that
were established by local botanists using their
national or regional flora and information
from researchers (especially breeders).
