BIOSAFETY.
BIORISK ASSESSMENT
Dr. Gabriel Ionescu
Cantacuzino Institute,
“Carol Davila” U.M.Ph. Bucharest
Biohazard definition
(adapted from ISO/IEC Guide 51:1999)
Potential source of harm caused by biological agents or toxins
translated into Romanian
PERICOL BIOLOGIC
NU
RISC BIOLOGIC
Biorisk definition
(adapted from ISO/IEC Guide 51:1999)
• 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
• NOTE The source of harm may be an unintentional exposure,
accidental release or loss, theft, misuse, diversion, unauthorized
access or intentional unauthorized release
Specific
guidelines
Available on www.cantacuzino.ro See Section “Biosiguranta – Biosecuritate”
Directives, guidelines, standards
•
•
EU DIRECTIVES
EU Directive 2000/54/EC of the European Parliament and of the Council of 18
September 2000 on the protection of workers from risks related to exposure to
biological agents at work - HG 1092/2006
EC Directive on the Contained Use of Genetically Modified Organisms – OU 77 and
78 / 2007
GUIDELINES
•
•
•
•
•
•
Laboratory Safety Manual - WHO
Biosafety in Microbiological and Biomedical Laboratories (BMBL) - CDC
The Laboratory Biosafety Guidelines - Health Canada
Guidelines for Research Involving Recombinant DNA Molecules EC - NIH
Biorisk management. Laboratory biosecurity guidance - WHO
Biosafety risk assessment methodologies – Sandia Report
STANDARDS
•
•
•
OHSAS 18001
ISO 15190:2003 - Medical laboratories - Requirements for safety
CWA 15793:2008 - Laboratory biorisk management standard
Biosafety definition
• All measures that prevent accidentally
exposure at biological agents (microorganisms and toxins) and infections and
their released in environment
See WHO Biosafety manual
biological agent (adapted from EU Directive 2000/54/EC)
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
2011 – The Year of Biosafety
• EBSA announced 2011 “Year of Biosafety in
Europe” as an initiative to support the newly
established International Federation of Biosafety
Associations (IFBA)
• The European Centre for Disease Prevention
and Control (ECDC) together with the European
Biosafety Association (EBSA), a special session
at 14th EBSA Annual Conference (April 13-15th,
Portugal) to bring together laboratory and
biosafety experts to discuss the development of
effective pan-European biosafety networks
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
practices)
concepts,
principles
and
ECDC
• EPIET
and
EUPHEM
training
programmes
special modules in biosafety practices
• exchange of biological materials
• testing methods
• training of laboratory staff
• ECDC BioRisk Initiative for Capacity
building
and
Knowledge
base
development (BRICK project)
Biorisk assessment definition
(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?.
Risk assessment
strategy
Characteristics
• risk assessment is CAREFUL judgment
• risk assessment is proactive rather than reactive
• assessments can be qualitative, semi-quantitative or
quantitative
• risk assessment methodology should be:
– identified
– implemented
– maintained
• risk assessment is first step to control (reduce or eliminate)
the hazards
• risk assessment will provide a guide for the selection of
appropriate
- biosafety levels needs
- microbiological practices
- safety equipment
- facility safeguards
Assess the capability of the
laboratory staff to control hazards
- training
- technical proficiency
- good habits of all members of the laboratory
- operational integrity of containment equipment
- facility safeguards
New risk assessment or
review of an existing one when:
• the introduction of new biological agents
• new work or changes to the programme of
work
• alterations to work flow or volume
• new construction / modifications to
laboratories, equipment or its operation
• introduction of altered and unplanned
staffing arrangements
New risk assessment or
review of an existing one when:
• significant
alterations
to
Standard
Operating Procedures (SOPs) or working
practices
(e.g.
disinfection/waste
management
methodologies,
PPE
provision / usage entry/exit protocols,
etc.);
• unexpected events that may have
relevance for the management of biorisks
are observed
New risk assessment or
review of an existing one when:
• actual or potential non-conformity with
internal / external rules and regulations is
identified
• as part of the existing management
system review process (e.g. annually or at
another appropriate and predetermined
frequency)
Biorisk definition
Biosafety risks are defined as a function of
the likelihood of infection by the agent and
the likelihood of exposure through an
infectious route based on the procedures and
work practices and the consequences of
disease assuming infection
Biosafety risks is a function of:
• likelihood of
– infection by the agent
– exposure through an infectious route
• consequences
4 scenarios
• Risk to individuals in the laboratory
• Risk to an individual outside the laboratory
(the human community)
• Risk to animals outside the laboratory (the
animal community)
• Risks to humans and animals resulting
from a secondary exposure
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)
• Does this agent or one of its by-products cause a carcinogenic or
mutagenic reaction in a human host?
• Does this agent have toxin or enzyme production which has a negative
impact in a healthy human host?
• Does this agent suppress a human host’s immune system? (E.g. cause
dramatic suppression which renders the host susceptible other infections)
• Does this agent have the ability to mutate once in a host or in the natural
environment to become infectious through new route or new hosts, or to
cause increased consequences?
• What is the duration of illness (the average length of time of clinical signs
of infection) in a normally healthy human host?
• What is the severity of illness (the average severity of illness, ranging from
no signs of illness to hospitalize in critical condition) in a normal health
human host?
• What is the duration of infection (the length of time the host is infected with
the organism) in a normal healthy human host?
Consequences of disease in
humans assuming infection (2)
• Does this disease cause any long-term conditions (sequelae) in a normal
healthy human host?
• What is the frequency of death in humans caused by this disease in a
defined population during a specified interval of time (Mortality Rate)?
• What level of national / international reporting is required for outbreaks of
this disease?
• Do effective diagnostic tests exist for humans?
• Do post exposure treatments (including immuno-globulin, vaccines and
antimicrobials) exist for humans?
• Do preventative measures (vaccines) exist for humans?
Consequences of disease in
animals assuming infection
• If the agent infects animals, what is the expected
morbidity rate to a naive but otherwise healthy animal
population?
• What level of national or international reporting is
required for outbreaks of this disease?
• What species of animals can this agent infect?
• Do effective diagnostic tests exist for animals?
• Do post exposure treatments (including immunoglobulin, vaccines and antimicrobials) exist for animals?
• o Do preventative measures (vaccines) exist for
animals?
The risk assessment should
categorize risks
• the use of a risk matrix identifying
likelihood and consequence categories
– e.g. high, moderate and low zones
• the acceptability of risk levels should be
defined
• the inherent risk from the biological agents
and toxins
– e.g. from risk grouping descriptions, material
safety data sheets etc.
Risk assessment
CAREFUL judgment
biosafety levels ≠ risk group
Ideally, a risk assessment should be conducted in
a manner which is standardized and systematic
allowing it to be repeatable and comparable.
A risk assessment will determine the degree of
correlation between an agent’s risk group
classification and biosafety level
Classification of infective
microorganisms by risk groups
• Risk Group 1 (no or very low individual and community risk)
A microorganism that is unlikely to cause human or animal disease
.
• 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,
Effective treatment and preventive measures are available and the risk of
spread of infection is limited.
• 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.
• 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.
Relation of risk groups to biosafety
levels, practices and equipment
Risk
group
Biosafety
level
1
Basic –
Biosafety Level 1
2
Basic –
Biosafety Level 2
3
Containment
Biosafety Level 3
4
Maximum
Biosafety Level 4
Laboratory
type
Laboratory
practices
Basic teaching, GMT
research
Safety
equipment
None; open
bench work
Primary health
services;diagn.
research
GMT plus protective Open bench plus
clothing, biohazard
BSC for potential
aerosols
sign
Special
diagnostic,
research
As Level 2 plus
special clothing,
controlled access,
directional air flow
BSC and/or
other primary
devices for
all activities
Dangerous
pathogens unit
As level 3 plus
airlock entry, shower
exit, special waste
disposal
Class III BSC
Positive presure
suit + BSC II
Double door
autoclave
Filtered air
Biorisk Assessment Sheet
Material Safety Data Sheet (MSDS)
FINAL REMARKS
Train and RETRAIN and RETRAIN and .. until good
microbiological techniques and safety precautions
become second nature
Inadequate training on :
- PPE use
- correct use and maintenance of equipment
FALSE sense of security