1. REGULATIONS FOR SAFETY
IN BIOLOGICAL PLANTS
(in respect of biohazards and
biosecurity)
BY: ABDULRAHMAN MOHAMMED
(L-2012-V-21-D)

2. Contents
 Definitions
 Safety basics in biological plants
 Biosafety in lab.
 Personal biosafety
 National regulations
 International regulations

3. Definition
 Biohazard: An agent of biological origin that has the capacity to
produce deleterious effects on humans, i.e. microorganisms, toxins
and allergens derived from those organisms; and allergens and
toxins derived from higher plants and animals.
 Biosecurity: Control of accidental and deliberate release of
biohazardous material.
 Biosafety: The containment principles, technologies and practices
that are implemented to prevent the unintentional exposure to
pathogens and toxins, or their accidental release.
 Biologicals: are medicinal preparations made from living organisms
and their products including serum, vaccines, antigens, antitoxins,
blood and other plasma derivatives etc.

4. Safety basics in biological plants
 Why biosafety practice in the facility?
Protection of:
Personnel
 “products”
co-workers
lab support personnel
environment

5. Safety basics in biological
plants
 Includes:
 Biosafety in lab (production plant).
 Personal biosafety

6. Biosafety in lab (production plant).
 There are three principal steps for biosecurity
 Physical Segregation: Prevent contamination.
 is the most important and effective step. It is the strongest form of
biosecurity and where effort should be placed if at all possible.
 Cleaning: Remove contamination.
 is the next most effective step. If all dirt is removed, there is little left
for the microbes to be carried by.
 Disinfection: Kill any remaining microbes.
 is important but is the least reliable step of biosecurity. Its
effectiveness depends on many factors, in particular the quality of
the cleaning process.

7. SEGREGATION
 Segregation: means keeping potentially infected persons and
animals and contaminated objects away from uninfected
animals and objects.
 This requires a barrier, either actual or conceptual.
 Nothing crosses the barrier unless it has to.
 The barrier can be:
 physical (fence),
 temporal (time between visits) or
 procedural (changing footwear and outer clothes)
 Perimeter is best marked by a fence, but this is not always possible
Limited and controlled access points (lock the gate).

8. Relation of risk groups to biosafety levels, practices and
equipment
Risk
group
Biosafety
level (BSL)
Laboratory type Lab. practice Safety equipment
1 Basic BSL- 1
Basic teaching
and research
Good microbiol.
techniques (GMT)
None, open bench work
2 Basic BSL- 2 Diagnostic
services and
research
GMT + protective
clothing biohazard
sign
Open bench plus bio –
safety cabinet (BSC) for
potential aerosols
3
Containment
BSL- 3
Special
diagnostic
services and
research
As BSL-2 plus
special clothing
controlled access
directional airflow
Biosafety cabinet and/or
other primary devices
for all activities
4 Maximum
Containment
BSL- 4
Dangerous
pathogen units
As BSL-3 plus
airlock entry,
shower exit and
special waist
disposal
Class-3 BSC or positive
pressure suites in
conjunction with class-2
BSCs, double ended
autoclave trough the
wall and filtered air

9. CLEANING
 Cleaning means that the surfaces of the object must be
visibly clean with no dirt left that is visible to the eye. This
cannot be done with a garden spray / knapsack sprayer.
 Cleaning needs effort.
 Scrubbing brushes for smaller items such as boots and high
pressure washers for bigger items such as vehicles High
pressure = 110-130 bar
 Cleaning with a detergent/disinfectant solution is OK, but it
must be CLEAN afterwards as well as disinfected.

10. DISINFECTION
 There are many disinfectants capable of
inactivating the microbes.
 The important elements are that they be used
at the correct concentration and be in
contact with the clean surface for long
enough to act.
 Time required depends on concentration up
to a certain limit, temperature and
contamination.
 Disinfection can be improved by DRYING, or
at least leaving the cleansed and disinfected
object overnight to dry itself.

11. DISINFECTION
 Disinfection kills a percentage of microbes not an absolute
amount
 Has to get the microbial contamination level to below an
infectious dose to be fully effective
 Needs the right concentration for the right time at the right
temperature
 Needs disinfectant to not be inactivated by other
materials

12. Personal Biosecurity
 Inner layer:
 Tyvek suit underneath waterproof outer-wear
 Inner layer of gloves in case outer layer tears
 Outer layer:
 Latex/nitrile gloves
 Wellingtons with plastic over-boots to
reduce dirt on boots, facilitating cleaning
Water proof outer-wear
 Hat/hood

13. Personal Biosecurity
 Wear personal protective equipment
 Face mask:
 Goggles, face shield, or protective glasses
 Gloves(need not be sterile)
 Long-sleeve gown or overall (plastic apron if
splashing is foreseen.

14. Personal safety recommendations in lab
 1)Coverall
 2)Hair cover
 3)Plastic apron
 4)Boot covers
 5)Mask-fit the mask making sure it is secure around the face,
especially around your nose
 6)Goggles
 7)Finally put on your gloves
 8)Ideally wear two sets of gloves (making sure that the cuffs
of the outer gloves go up and over the cuffs of your
coverall)

15. Laboratory BIOSECURITY In Biological Plant
 Risk assessment
 An analysis of the probability and consequences of loss, theft, and
misuse of microorganisms and biological materials.
 Is a coordinated approach that enables the appropriate selection
of measures to ensure reasonable and adequate laboratory security
with out unduly affecting the scientific work.

16. Primary factors to consider in Risk Assessment:
 1. Agent hazards (risk group)
 2. Laboratory procedure hazards
 3. Hazards associated with work practices.

17. Pathogen risk assessment
 To analyze the biological risk, we must take into
account:
 Pathogenicity/infectivity
 Virulence/lethality
 Infective dose
 Therapy/Prophylaxes
 Epidemic potential
 Resistance
 Survival in the environment
 Geographic spread (endemic)
 Mode of transmission

18. Hazards associated with Work Practices, Safety
Equipment and Facility Safeguards
 1st line: Conscientious and proficient laboratory
staff reduce the inherent risks that attend work
with hazardous agents.
 2nd line: Safety equipment remove or minimize the
exposures to hazardous biological
materials(BSCs).
 3rd line: Suitable design and construction of the
facilities contribute to the laboratory workers‘
protection.

19. Biological waste
 In the lab, waste must be contained in a biohazard box with an
autoclavable biohazard bag (usually yellow).
 Inactivate liquids either chemically (e.g., with bleach) or autoclave.
 Sterilize solids by autoclaving, then transfer into a different bag (red
white) to indicate that the waste has been deactivated.
 Special treatment for radioactive waste and waste of a biosafety
level of 3 and higher.

20. Essential Building Principles
 Primary containment barrier is the first barrier between agent and
man (PPEs such as gloves, gowns, masks, biosafety cabinets,
respiratory protection etc.)
 Secondary containment barrier is the barrier between agents and
environment (airtight rooms, air handling and filtration, air locks,
showers, laundry, sewage treatment, waste disposal, sterilizers,
redundant services as well as equipment and material niches.
 Tertiary containment barrier represents an additional organizational
barrier with the physical operation with items such as walls, fences,
security, quarantine and animal exclusion zones.

21. Biosafety Principles
 Substitution (replace hazardous material)
 Technical safety measures (engineering controls)
 Facility design
 Directional airflow, ventilation
 Isolators for animals
 Organizational measures
 SOP
 Practices, procedures
 Training
 Access control
 Personal Protective Equipment
 Does not necessarily eliminates the hazard!!

22. Good Manufacturing Practices
 The Good Manufacturing Practices (GMP) are part of quality
assurance that ensures that biological products
are produced consistently and controlled in accordance
with the appropriate quality standards.
 These standards depend on the intended use of the product
and the requirements issued by the health authorities (WHO,
MOH) or the product specification.GMP applies to both production
and quality control laboratory.
 Purpose
 To ensure that the product is safe and effective for the end user

23. REGULATIONS AND LEGAL FRAMEWORK FOR BIOLOGICAL PLANT
National Regulations (India)
 India ratified the Cartagena Protocol on Biosafety in January 2003.
 India ratified the Convention on Prohibition of the Development,
Production and Stockpiling of Bacteriological (Biological) and
Toxic Weapons and their Destruction in July, 1974.

24. Acts/Rules - Biosafety Regulation
 Rules for Manufacture, Use, Import, Export and Storage of
Hazardous Microorganisms (Genetically Engineered Organisms
or Cells, 1989 under the EPA (1986) known as ‘ Rules 1989’ by
MoEF.
 The Biological Diversity Act, 2002 by MoEF
 Plant Quarantine Order, 2004 by NBPGR under MoA
 Seed Policy, 2002 by MoA
 DGFT Notification Relating to Inclusion of GM Policy in Foreign Trade
Policy (2006-09) by MoC&I
 Food Standards and Safety Act, 2006 by MoH&FW
 Drugs and Cosmetics Amendment Act, 1972 by MoH&FW

27. National Institute of Biologicals
(India)
 Registered in January 1992 ( vide No. S-22590) under the Societies
Registration Act 1860.
 National Institute of Biologicals (NIB) strives to fulfill the national
requirement for assuring the quality of biologicals to safeguard
public health.
 The Institute is committed to comply with the requirements of
ISO/IEC 17025: 2005 to assure accurate and reliable results.
 NIB has established systems and procedures to review the quality
objectives from time to time thereby continually improving the
effectiveness of the quality management system.

28. INSTITUTIONAL BIOSAFETY COMMITTEE (IBSC)
Constituted by an occupier or any person including
R&D institutions handling microbes.
Comprises Head of Institution, scientists doing related
work, medical experts and DBT nominee
Assists the occupier or any person including R&D
institution prepare an emergency plan as per guidelines
of RCGM
Copies of emergency plan to be made available to
District Level Committee/State Biotechnology
Coordination Committee and the Genetic Engineering
Approval Committee (GEAC)

29. INTERNATIONAL INSTITUTIONS AND
REGULATIONS
 1. International Federation of Biosafety
Association.
 2. ISO (international organization for
standardization).

30. Declaration of International Federation of Biosafety
Association on Advancing Global Biosafety and
Biosecurity
2011, the year of building
international biosafety communities
Longer-term goals
• Promoting biosafety education,
particularly of the younger generation,
involving curriculum development
within a common framework and a
common methodology for evaluation.
• Supporting appropriate and practical
legislative framework development.
• Developing a strategy to obtain
funding for applied biosafety research
programs

31. Declaration of International Federation of Biosafety
Association on Advancing Global Biosafety and
Biosecurity
Short term goals
• Raising awareness from the political
and public perspectives, and
encouraging collaboration among the
human and animal health communities
• Developing sustainable biosafety
associations and mapping gaps and
needs
• Providing advice to the competent
national authorities and services for the
improvement of efficient waste
management (through disseminating
knowledge of appropriate systems, tools and
technologies for public and veterinary health
environments).
• Promoting human and laboratory
capacity building with proper
identification of gaps and needs (using
the best available concepts, principles and
practices)

32. ISO
 ISO (International Organization for Standardization) is the
world’s largest developer of voluntary International
Standards with a current portfolio of over 19 700 documents
providing benefits for business, government and society. ISO
is a network comprising the national standards institutes of
163 countries.
 The document relevant to biological plants standards is
ISO/IEC 17025:2005(E).

33. References
• ISO/IEC 17025, General requirements for the
competence of testing and calibration laboratories,
second edition.
• WHO/CDS/EPR/2006.6. Biorisk management
Laboratory biosecurity guidance.
• http://www.nib.gov.in (Indian institute of
biologicals).
• http://www.iahvb.co.in (Institute of animal health
and veterinary biologicals)

34. THANK YOU FOR LISTENING