Biosafety Issue

Biosafety
• ‘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.
 CONTAINMENT
• The safety measures which prevent the escaping of genetically
engineered organism (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.
 CONTAINMENT
• 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.

• It include;
• 1.Air filtration
• 2.Sterilization lights
• 3.Waste disposal
• 4.Protective handling
 PHYSICAL CONTAINMENTS
• 1.Air filtration

• The exhaust air from the laboratory is filtered

through exhaust filters.

• It prevents the escaping of GEOs from the lab.

 PHYSICAL CONTAINMENTS
• 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.

 PHYSICAL CONTAINMENTS
• 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.
 PHYSICAL CONTAINMENTS
• 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.

 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.
 BIOLOGICAL CONTAINMENT
• 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 Levels
 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.
 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.
 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.

 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
 BIOSAFETY LEVEL 3
• 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.
 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
 BIOSAFETY LEVEL 4
• 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 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.
 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.
 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.
• 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.
 Biosafety Guidelines for Laboratories
• The are many issues which 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)
 Risks for the Environment
• 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)

• change in cost of agriculture

• unpredictable variation in active product availability

• loss of changes in agricultural practice

 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)
 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.
 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.
 BCH
• 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”.
 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.

• 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.
 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.
• 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.
 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.

• 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).