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BIOSAFETY &BIOETHICS
Guidelines & Levels
By
Dr. S.HIMALINI
MARY MATHA COLLEGE OF ARTS & SCIENCES
DEPARTMENT
OF
BIOTECHNOLOGY

 There are several local, state, and federal agencies
that either regulate or provide guidelines covering the
use of biological agents.
 Centers for Disease
Controls and
Prevention (CDC)
NationalInstitut
es of Health
(NIH):
Biosafety in
Microbiological
and Biomedical
Laboratories
(BMBL)

 1989 of Environment (Protection) Act 1986, laboratory
biosafety through appropriate containment has been
identified as the fundamental part of any biological research.
 In this direction, DBT had earlier published three guidelines
namely “Recombinant DNA safety guidelines, 1990” “Revised
Guidelines for Safety in Biotechnology, 1994” and “Revised
guidelines for research in transgenic plants, 1998”.

 Duringthelasttwodecades,rapidadvancementinbiologyandbiotec
hnologyresearch globally and in India, both in public and private
sector institutions, necessitated that the above guidelines are
reviewed, updated and harmonised with global best practices
and guidelines. Further, research on emerging and re-emerging
infections and potential risk associated in handling the
pathogenic organisms required to put in place stringent yet
practical regulations and guidelines for ensuring biosafety
measures for protection of public health and environment.

 guidelines for
microbiological safe work practices,
safety equipment, and
facilities that constitute the four established biosafety
levels.

 The BMBL is generally considered the standard for
biosafety and is the basis for this manual.
Compliance with the BMBL is a regulatory
requirement for work involving select agents and
toxins.

National Institutes of Health (NIH)
Guidelines for Research Involving Recombinant or
Synthetic Nucleic Acid Molecules (NIH Guidelines).
This document provides guidelines for constructing and
handling recombinant and synthetic nucleic acid
molecules, and organisms containing such nucleic acid.
Although these guidelines are not subject to regulatory
enforcement (with the exception of work involving select
agents and toxins), institutions that receive any NIH
funding for research involving recombinant or synthetic
nucleic acid molecules are required to comply with these
guidelines as a condition of funding.

This document requires that each institution
establish an Institutional Biosafety Committee with
the authority to approve proposed research involving
recombinant or synthetic nucleic acid molecules,
using the NIH Guidelines as a minimum standard.

Occupational Safety and Health Administration
(OSHA)
 Blood borne Pathogens.
This regulation covers occupational exposure to human
blood and other potentially infectious material, including
human tissue and cells. OSHA specifies a combination of
engineering controls, work practices, and training to
reduce the risk of infection. Personnel potentially
exposed to human blood and other potentially infectious
material must be offered immunization against the
Hepatitis B virus and receive annual training

Personnel who work with HIV or Hepatitis B virus in
a research laboratory must receive additional
training and demonstrate proficiency in working
with human pathogens

Department of Health and Human Services
(CDC) and Department of Agriculture (APHIS)
 Select Agent and Toxin Regulations.
These regulations cover the possession, use, and transfer
of biological agents and toxins that affect humans,
animals, and plants and which have been determined to
be potential bioterrorism agents (known as select
agents).
Entities and personnel who wish to work with select
agents must be registered with the CDC or APHIS before
acquiring or having access to select agents.

Individuals who require access to select agents
require a FBI background check and submittal of
fingerprints, and must be approved by the Select Agent
Program.
These regulations mandate strict requirements for
biosafety, emergency planning, and security of select
agents and toxins, and requires that laboratories that
possess select agents comply with the BMBL (see above)
and the OSHA Laboratory Standard

 if select agent toxins are used. Each transfer of a Select
Agent must have prior approval of the Select Agent
Program through completion of APHIS/CDC Form 2,
which requires signature by the Select Agent Responsible
Official (University Biosafety Officer) or designated
alternate. Accurate inventory records of Select Agents,
including transfers, must be maintained.

Biosafety of Recombinant DNA Research
Biocontainment 2017
Access doors to the laboratory should be self-closing and lockable.
An autoclave for decontamination of laboratory wastes should be available within the
laboratory
The work area must be maintained at an air pressure of at least 50 Pa below the
pressure of adjacent areas outside the facility when both doors of the airlock are closed
There should be a ventilation system that establishes a negative pressure into the
laboratory. Personnel must verify that proper direction air flow (into the laboratory)
is achieved.
If infectious wastes have to be removed to another area in the same building for
disinfection, they should hold and transported in a covered, leak-proof container

The facility must have an
emergency stop button
for the ventilation
system, which is easily
accessible in case of an
emergency.
The exhaust air from the facility
must pass through a HEPA filter
and must be tested by qualified
person.
Supply or replacement air to
the facility must have HEPA
filtered.
Refrigerators, freezers,
incubators, etc. that
contain biohazardous
materials for storage
must be labelled with a
biohazard symbol.

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