REGULATIONS FOR SAFETY

IN BIOLOGICAL PLANTS

(in respect of biohazards and

biosecurity)

BY: ABDULRAHMAN MOHAMMED

(L-2012-V-21-D)

Contents

Definitions

Safety basics in biological plants

Biosafety in lab.

Personal biosafety

National regulations

International regulations

Definition

Biohazard: An agent of biological origin that has the capacity toproduce 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.

Safety basics in biological plants

Why biosafety practice in the facility?

Protection of:

Personnel

“products”

co-workers

lab support personnel

environment

Safety basics in biological

plants

Includes:

Biosafety in lab (production plant).

Personal biosafety

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.

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).

Relation of risk groups to biosafety levels, practices and

equipment

Risk

group

Biosafety

level (BSL)

Laboratory type Lab. practice Safety equipment

1Basic 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

3Containment

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

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.

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.

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

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

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.

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)

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.

Primary factors to consider in Risk Assessment:

1. Agent hazards (risk group)

2. Laboratory procedure hazards

3. Hazards associated with work practices.

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

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.

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.

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.

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!!

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

REGULATIONS AND LEGAL FRAMEWORK FOR BIOLOGICAL PLANT

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.

National Regulations (India)

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

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.

Constituted by an occupier or any person including

R&D institutions handling microbes.

Comprises Head of Institution, scientists doing relatedwork, medical experts and DBT nominee

Assists the occupier or any person including R&Dinstitution prepare an emergency plan as per guidelinesof RCGM

Copies of emergency plan to be made available toDistrict Level Committee/State BiotechnologyCoordination Committee and the Genetic EngineeringApproval Committee (GEAC)

INSTITUTIONAL BIOSAFETY COMMITTEE (IBSC)

INTERNATIONAL INSTITUTIONS AND

REGULATIONS

1. International Federation of Biosafety

Association.

2. ISO (international organization for standardization).

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

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)

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).

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)

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