BIOSAFETY

BIORISK
ASSESSMENT

 Biosafety
definition
All measures that prevent
accidentally exposure at
biological agents (micro-
organisms and toxins) and
infections and their released
in environment
Biological agent
Any microorganism
including those which have
been genetically modified,
cell cultures and
endoparasites, which may
be able to provoke any
infection, allergy or toxicity
in humans, animals or plants
Bio-risk definition
Combination of the
probability of occurrence of
harm and the severity of
that harm where the source
of harm is a biological agent
or toxin
 Potential source of harm caused by biological
agents or toxins

Biohazard definition
Potential source of harm caused by biological agents or toxins
The source of harm may be an unintentional exposure,
accidental release or loss, theft, misuse, diversion, unauthorized
access or intentional unauthorized release
Biorisk Assessment (adapted from OHSAS 18001:2007)
Process of evaluating the biorisk(s) arising from a biohazard(s),
taking into account the adequacy of any existing controls, and
deciding whether or not the biorisk(s) is acceptable

As defined by Kaplan and Garrick, risk analysis consists of answering

three specific questions:
what can happen?
what is the chance that it will happen?
if it happens, what are the consequences?.
Characteristics
Risk assessment is first step to control (reduce or eliminate) the
hazardsAssessments can be qualitative, semi-quantitative or quantitative
Risk assessment methodology should be:
-identified
-implemented
-maintained
Provide a guide for the selection of appropriate
- biosafety levels needs
- microbiological practices
- safety equipment
- facility safeguards
Biosafety risks is a function of:
Likelihood of
-infection by the agent
-exposure through an infectious route

Consequences
 Scenarios Risk to individuals in the
laboratory
Risk to an individual Risks to humans and animal
outside the laboratory resulting from a secondary
(the human community) Risk to animals outside exposure
the laboratory (the
animal community)
 Routes of exposure

-droplets or droplet nuclei (upper or

lower respiratory tract)
-compromised skin or direct injection
-into the blood stream
-the mucosal membranes
-the gastrointestinal tract
Consequences of disease in humans assuming infection (1)
Consequences of disease in humans assuming infection (2)
Consequences of disease in animals assuming infection
 The risk assessment should categorize risks

Use of a risk matrix identifying likelihood and consequence

categories
e.g. high, moderate and low zones
Acceptability of risk levels should be defined
Inherent risk from the biological agents and toxins
e.g. from risk grouping descriptions, material safety data
sheets etc.
 biosafety levels ≠ risk group
Risk assessment
CAREFUL judgment
biosafety levels ≠ risk group

A risk assessment should be conducted in a manner which is

standardized and systematic allowing it to be repeatable and
comparable.
Determine the degree of correlation between an agent’s risk
group classification and biosafety level
Classification of infective microorganisms by risk
groups
Classification of infective microorganisms by risk
groups
Relation of risk groups to biosafety levels, practices and
equipment
Risk assessment strategy
Biorisk Assessment Sheet
 Risk Characterization

The description of the nature and magnitude of

the human risk, including attendant uncertainty.
 Assessing the Risks Risk:
The likelihood that a specified undesired event will
occur due to the realisation of a hazard by, or
during work activities or by the products and
services created by work activities.Risk is a
measure of future uncertainties in achieving
program performance goals and objectives within
defined cost, schedule and performance
constraints.
 Quantitative risk assessment (QRA)
Assessing the Risks

Quantitative risk assessment (QRA)

Commonly used in the high technology industries

QRA tends to deal with the avoidance of low

probability events with serious consequences to
the human / animal/ plant and the surrounding
environment.
 Subjective risk assessment
Assessing the Risks

Subjective risk assessment

Qualitative risk assessment involves making a
formal judgement on the consequence and
probability using:

Risk = Severity x Likelihood

 Assessing the Risks Example:
The likely effect of a hazard may for example be
rated:
1. Major
Death or major injury or illness causing long term
disability
2. Serious
Injuries or illness causing short-term disability
3. Slight
All other injuries or illnesses
Assessing the Risks The likelihood of harm may be
rated 1. High
1. High
Where it is certain that harm will occur

2. Medium
Where harm will often occur

3. Low
Where harm will seldom occur
 Likelihood of occurrence

Assessing the Risks

Risk= Severity of Harm x Likelihood of occurrence

 Creating Risk Assessments
Steps
Identify the hazards
Assess the risks
(are they high, medium or low?)
Determine control measures
(how do you reduce high or medium to low)
Implement an action plan to reduce the risks
Monitor, maintain and review the plan
(e.g. check the plan after a suitable time to see if it is still OK
because circumstances may have changed)