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. 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.
4. Biosafety Guidelines for Laboratories
• Frequent hand wash is obligatory
• 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.
• 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.
5. 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
6. PHYSICAL CONTAINMENTS
• The physical methods being adopted inside the laboratories to prevent escaping of GEOs to
the environment are called physical containment.
• 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 - Florescent 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 contaminant inside the lab
• 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.
• 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.
7. 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.
• 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.
• 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.
8. 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.
9. 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.
• 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
10. 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
• 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.
11. 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.
• 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.
• The entrance and exit of a level four bio lab 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.
12. Environmental Impact
• Susceptibility of non-target organisms
• Change in use of chemicals in agriculture
• Unpredictable gene expression or transgene instability (gene silencing).
• Risks for agriculture:
• weeds or superweeds
• alteration of nutritional value (attractiveness of the organism to pests)
• unpredictable variation in active product availability
• General concerns:
• ethical issues (eg. labelling)
• public attitudes, perception; legislation monitoring
• socio-economics (eg. situation of poor farmers in developing countries)
13. Convention of Biodiversity (CBD) [1992]
• Focus: conservation and sustainable use of biodiversity
• Recognized the potential of modern biotechnology for human well being
• Took cognizance that modern biotechnology could have serious effects on
environment and health
• Article 8(g) emphasized the need to regulate the risks associated with the use of
LMOS.
• Article 19(3) set the stage for a legally binding international instrument about
biosafety.
14. Cartagena protocol (1993)
• Use of genetically modified organisms
• as a supplement to the convention on biological diversity
• seeks to protect biological diversity from the potential risks posed by genetically
modified organisms resulting from modern biotechnology
• ensuring an adequate level of protection in the field of the safe transfer (transboundary
movements), handling and use of GMOs
• adverse effects on the conservation and sustainable use of biological diversity, taking
also into account risks to human health
15. Two diametrically opposite trends of thought
US-Canada
• No new risks associated
with GM crops
• New regulations not
considered necessary
• Safety assessments
• ‘Product’ rather than
‘process’ base
EU
• GE crops considered new
and special
• Existing legislation not
considered sufficient
• Adoption of
‘Precautionary Principle’
as guide
• Safety assessment
• Process based
16. Environmental risks posed by GMOs
• Outcrossing between GMOs and pathogens
• Negative effects on populations of non target organisms GE technology carries
certain inherent unpredictability
• Isolation of a gene from its natural environment and integration into entirely
different organism
• Possible transgenic instability due to triggering of the inbuilt defense
mechanisms of the host organism leading to inactivation or silencing of foreign
genes.
17. • Hazard to human and animal health by transfer of toxins and allergens and by
creation of new toxins and allergenic compounds
• Development of aggressive weeds/ wild relatives by transfer of transgenic traits
• Erosion of land races/wild relatives by genetic pollution in centers of origin/
diversity
• Harm to the non-target organisms
• Development of pest resistance by prolonged use
![Convention of Biodiversity (CBD) [1992]
• Focus: conservation and sustainable use of biodiversity
• Recognized the potential of modern biotechnology for human well being
• Took cognizance that modern biotechnology could have serious effects on
environment and health
• Article 8(g) emphasized the need to regulate the risks associated with the use of
LMOS.
• Article 19(3) set the stage for a legally binding international instrument about
biosafety.](https://image.slidesharecdn.com/biosafetymeasures-250429082905-dd0d0889/85/Biosafety-guidelines-to-be-practiced-in-the-field-of-science-13-320.jpg)
