1. Biosafety
PPT Prepared by
Mr. Niladri Sekhar Roy
Asst. Professor
Department of Environmental Science
AKS University, Satna, M.P.
Email ID- nroy0111@gmail.com

2. Biosafety
Introduction
Biosafety Levels and hazards
•BSL-4 facilities for extraterrestrial samples
Microbes dealing by BSL 1, BSL 2, BSL 3 & BSL 4
category labs
BSL-4 facility LABs in India
Cartagena Biosafety Protocols - Fundamental
Guidelines in India

3. Introduction
Biosafety Safety from bio means organisms.
According to the Centre Of Disease Control and
Prevention (CDC), Biosafety is the application of
safety precautions that reduce a laboratorian’s risk of
exposure to a potentially infectious material and
limit contamination of the work environment and
ultimately the community.
Many labs work with contagious agents, that could lead
serious problems to lab worker, scientists,
biodiversity, human, ecology and the environment.
Biosafety guidelines is life saving for those personnel's,
humans and the environment.

4. Biosafety Levels and hazards
Biosafety Levels (BSL) are used to identify the protective
measures needed in a laboratory setting to protect
workers, the environment, and the public. The levels
are defined in Biosafety in Biomedical Laboratories
(the BMBL).
Risk assessments (जोखिम का आकलन) are conducted
by evaluating the way in which the infectious agents
or toxin is transmitted and its ability to cause disease,
the activities performed in the laboratory, the safety
equipment and design elements present in the
laboratory, the availability of preventive medical
countermeasures or treatment, and the health and
training of the laboratory worker.

5. • Activities and projects conducted in biological
laboratories are categorized by biosafety level. The four
biosafety levels are BSL-1, BSL-2, BSL-3, and BSL-4, with
BSL-4 being the highest (maximum) level of
containment. There are additional specific rules and
designations for animal research (ABSL), agricultural
research (BSL-Ag), and other types of research. These
other types of labs require their own specific set of
rules and regulationas, because they are dealing with
larger organisms, such as plants, animals, and insects.
• Investigations have shown that there are hundreds of
unreported biosafety accidents, with laboratories self-
policing the handling of biohazardous materials and
lack of reporting. Poor record keeping, improper
disposal, and mishandling biohazardous materials
result in increased risks of biochemical contamination
for both the public and environment.

6. Biosafety Level 1 (BSL-1)
Risk Group 1: (no or low individual and community
risk) A microorganism that is unlikely to cause
human or animal disease.
BSL-1 labs are used to study infectious agents or
toxins not known to consistently cause disease in
healthy adults. They follow basic safety procedures,
called Standard Microbiological Practices and
require no special equipment or design
features. Standard engineering controls in BSL-1
laboratories include easily cleaned surfaces that are
able to withstand the basic chemicals used in the
laboratory.

7. Biosafety Level 2 (BSL-2)
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.
BSL-2 laboratories are used to study moderate-risk infectious
agents or toxins that pose a risk if accidentally inhaled,
swallowed, or exposed to the skin. Design requirements for
BSL-2 laboratories include hand washing sinks, eye washing
stations in case of accidents, and doors that close
automatically and lock. BSL-2 labs must also have access to
equipment that can decontaminate laboratory waste,
including an incinerator, an autoclave, and/or another
method, depending on the biological risk assessment.

8. Biosafety Level 3 (BSL-3)
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.
• BSL-3 laboratories are used to study infectious agents or toxins
that may be transmitted through the air and cause potentially
lethal infection through inhalation exposure. Researchers perform
all experiments in biosafety cabinets that use carefully controlled
air flow or sealed enclosures to prevent infection. BSL-3
laboratories are designed to be easily decontaminated. These
laboratories must use controlled, or “directional,” air flow to
ensure that air flows from non-laboratory areas (such as the
hallway) into laboratory areas as an additional safety measure.
• Other engineered safety features include the use of two self-
closing, or interlocked, doors, sealed windows and wall surfaces,
and filtered ventilation systems. BSL-3 labs must also have access
to equipment that can decontaminate laboratory waste, including
an incinerator, an autoclave, and/or another method, depending
on the biological risk assessment.

9. Biosafety Cabinets

10. Biosafety Level 4 (BSL-4)
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.
BSL-4 laboratories are used to study infectious agents or
toxins that pose a high risk of aerosol-transmitted
laboratory infections and life-threatening disease for
which no vaccine or therapy is available. The
laboratories incorporate all BSL 3 features and occupy
safe, isolated zones within a larger building or may be
housed in a separate, dedicated building. Access to BSL-
4 laboratories is carefully controlled and requires
significant training.

11. There are two types of BSL-4 laboratories:
• Cabinet laboratory – all work with infectious agents
or toxins is done in a Class III Biosafety Cabinet​ with
very carefully designed procedures to contain any
potential contamination. In addition, the laboratory
space is designed to also prevent contamination of
other spaces.
• Suit laboratory – Laboratory personnel are required
to wear full-body, air-supplied suits, which are the
most sophisticated type of personal protective
equipment. All personnel shower before exiting the
laboratory and go through a series of procedures
designed to fully decontaminate them before
leaving.

12. BSL-4 facilities for extraterrestrial samples
Sample-return missions that bring back to Earth samples
obtained from a Category V body must be curated at
facilities rated BSL-4. Because the existing BSL-4
facilities in the world do not have the complex
requirements to ensure the preservation and
protection of Earth and the sample simultaneously,
there are currently at least two proposals to build a
BSL-4 facility dedicated to curation of restricted
(potentially biohazardous) extraterrestrial materials.
The first is The European Sample Curation
Facility (ESCF), proposed to be built in Vienna, would
curate non-restricted samples as well as BSL-4
biocontainment of restricted material obtained
from Category V bodies such as Mars, Europa (Jupiter
II, smallest moon of Jupiter), Enceladus (6th Largest
moon of Saturn), etc.

13. Cabinet & Suit Laboratory
Cabinet Laboratory Suit Laboratory

14. BSL 1 Level Microbes
several kinds of microorganisms including non-pathogenic
of Escherichia coli strains and Staphylococcus, Bacillus
subtilis, Saccharomyces cerevisiae and other organisms
not suspected to contribute to human disease.
BSL 2 Level Microbes
Hepatitis A, B, and C viruses, human immunodeficiency
virus (HIV), pathogenic strains of Escherichia
coli and Staphylococcus, Salmonella, Plasmodium
falciparum, and Toxoplasma gondii

15. BSL 3 Level Microbes
Biosafety level 3 is commonly used for research and
diagnostic work involving various microbes which
can be transmitted by aerosols and/or cause severe
disease. These include Francisella
tularensis, Mycobacterium tuberculosis, Chlamydia
psittaci, Venezuelan equine encephalitis virus, Eastern
equine encephalitis virus, SARS-CoV-1, SARS-CoV-
2, MERS-CoV, Coxiella burnetii, Rift Valley fever
virus, Rickettsia rickettsii, several species
of Brucella, chikungunya, yellow fever virus, West Nile
virus, Yersinia pestis

16. BSL 4 Level Microbes
Biosafety level 4 laboratories are used for diagnostic work
and research on easily transmitted pathogens which
can cause fatal disease. These include a number of
viruses known to cause Viral Hemorrhagic Fever
(VHFs) such as Marburg virus, Ebola virus, Lassa virus,
and yellow fever virus. Other pathogens handled at
BSL-4 include Hendra virus, Nipah virus, and
some flaviviruses. Additionally, poorly characterized
pathogens which appear closely related to dangerous
pathogens are often handled at this level until sufficient
data are obtained either to confirm continued work at
this level, or to permit working with them at a lower
level. This level is also used for work with Variola virus

17. BSL-4 facility LABs in India
Name Location Date
Established
Description
High Security
Animal Disease
Laboratory (HSADL)
Bhopal, Madhya
Pradesh
1998 This facility deals
especially to zoonotic
organisms and emerging
infectious disease
threats.
Centre for Cellular
and Molecular
Biology
Hyderabad, Telanga
na
2009 National BSL-4
Containment Facility for
Human Infectious
Diseases
National Institute of
Virology
Pune, Maharashtra 2012 India's most advanced
BSL-4 category lab

18. Cartagena Biosafety Protocols
The full name of the treaty is Cartagena Protocol on
Biosafety to the Convention on Biological Diversity.
The Cartagena Protocol is an international treaty
governing the movements of Living Modified
Organisms (LMOs) from one country to another. The
treaty aims to ensure the safe handling, transport and
use of organisms that have been modified using
modern biotechnology. The treaty was adopted on 29
January 2000 as a supplementary agreement to the
Convention on Biological Diversity and entered into
force on 11 September 2003. The Protocol was signed
by 170 signatories including India.
Cont….

19. • It creates an Advanced Informed Agreement (AIA) procedure
that requires exporters to seek consent from importing
countries before the first shipment of LMOs meant to be
introduced into the environment (e.g. seeds for planting, fish
for release, and microorganisms for bioremediation)
• It establishes an internet-based “Biosafety Clearing-House” to
help countries exchange scientific, technical, environmental
and legal information about LMOs.
• It requires bulk shipments of LMO commodities, such as corn
or soybeans that are intended to be used as food, feed or for
processing, to be accompanied by documentation stating that
such shipments “may contain” LMOs and are “not intended
for intentional introduction into the environment”.
• The Protocol includes a clause that makes clear the Parties’
intent that the agreement does not alter the rights and
obligations of governments under the World Trade
Organization (WTO) or other existing international
agreements.

20. Guidelines in India
India is a signatory to the Cartagena Protocol on
Biosafety and ratified it on January 23, 2003. As per
Article 20 of the Cartagena Protocol on Biosafety,
requires set up of BCH in order to facilitate the
exchange of scientific, technical environmental and
legal information on living modified organisms
(LMOs). India has also set BCH, the following link
shall direct to India’s BCH
http://in.biosafetyclearinghouse.net/

21. Regulatory Framework in India
• GMO- EPA Act, 1986, regulation of
“environment pollutants”( Definition used by
MoEF to issue rules on GMOs)
• Rules for Manufacture, Use, Import, Export,
Storage of Hazardous Microorganisms, GEO or
cells”, 1989
• GMO placed in same category as hazardous
microorganisms
• 1989 Rules call for guidelines to be developed
on biosafety – Dept. of Biotechnology
guidelines, 1990(revised in 1994, 1998)

22. • 1990 Guidelines by Dept. of Biotechnology-
research involving GMO, genetic transformation
of green plants, large scale production and
accidental/deliberate release etc.
• 1989 Rules- Banned release, 1990 Guidelines
permit them (assessing and managing ecological
& health risk)
• 1990 and 1994 Guidelines covered agriculture
and pharmacy sectors, 1998 guidelines only for
transgenic use in agriculture.

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