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Basics of Biosafety
Working Safely with Biological Materials
Central Michigan University
College of Science and Technology
What is Biosafety?
Principles and practices employed to protect
laboratory personnel and the environment from
exposure or infection while working with living
organisms, biological materials, or agents.
Included
are any materials that may be potentially
infectious.
Includes recombinant DNA research
Agents and Risks
The “agent” is the what creates risk
Risks to the worker or environment are
often unknown
Determining “acceptable risk”?
Assessing Risk
There
The
is always risk!
risk must be identified
The risk is evaluated
The risk must be measured
Plan to minimize the risk
Who Determines Acceptable Risk?
Assessment is conducted by a Biosafety
Professional in partnership with and based
on information provided by the Principal
Investigator
The assessment is presented to the
Institutional Biosafety Committee (IBC) for
approval
Identifying Risk
Understand the biology of the agent
Susceptibility and transmission within the
host
Hazards associated with equipment and
procedures
Goal:
Provide
the highest practical protection and
the lowest practical exposure
Evaluating Risk Acceptability
Worst case scenario -What might happen?
Likelihood of an event
Seriousness of the incident
Actions needed to resolve the problems
What is Acceptable Risk?
Since there is no such thing as “no risk”
“Safe” means risk has been judged acceptable
Judging risk is a subjective- humans make
decisions
Measuring risk is objective- use available
guidelines, data, and documentation
Keep records of how determinations were made
due to subjective nature of the process
WHO-World Health Organization
Agents Assigned Risk Groups
RG-1 Unlikely to cause disease in humans or animals
RG-2 May cause disease but typically not serious
individual risk, low community risk, treatable
RG-3 May cause serious disease, usually treatable
low individual or community risk
High individual but low community risk, serious respiratory agents
RG-4 Serious or fatal, often not treatable,
Easy transmission, high individual and community risk
Biosafety Levels (BSL)
Different than the Risk Groups!!
Risk
groups used in risk assessment
BSL are used in risk management
BSL are ways to control the agent
facilities,
safety equipment, practices, PPE, etc.
Once risk is assessed then the appropriate BSL
is determined
BioSafety Level 1
Well characterized, non-pathogenic
organisms or agents
Open bench- no containment
Use good laboratory practices, waste
disposal, and aseptic techniques
Example: E. coli K-12 strains
BioSafety Level 2
Agents of moderate hazard to personnel
or environment
Basic lab, but restricted access, containment during
certain processes (i.e. aerosols, large volumes, etc.)
Autoclave and Biological Safety Cabinet desired
Use good laboratory practices, waste disposal, and
aseptic techniques
Example: most non-respiratory, non lethal, agents
BioSafety Level 3
Agents of high hazard to personnel or environment
Respiratory exotic or indigenous agents which are
easily transmissible causing serious or lethal disease
All work is contained, engineering controls and
controlled environments we currently do not have the
facilities to handle.
Example: Mycobacterium tuberculosis, SARS, etc.
BioSafety Level 4
FORGET ABOUT IT!!!
Hemorrhagic fever, deadly viruses, etc.
Total containment, airtight labs, “submarine”
doors, air pumps, water treatment, HEPA
filtration, etc.
Positive pressure “moonsuits”
Laboratory Acquired Infections (LAI)
Bacterial:
76% from clinical labs
8% from research labs
Exposure:
60% acquired from inhalation
Other exposures include:
digestion, sharps, splashes, direct and indirect contact
Laboratory Acquired Infections (LAI)
Viral
16% from clinical labs
70% from research labs
32%
from animal related activities
Biohazardous/Medical Waste
Waste
that is potentially infectious to
humans, animals or plants. It includes:
Medical
Waste according to MMWRA
Regulated Waste by MIOSHA
Regulated Waste by CDC/NIH
Michigan Medical Waste Regulatory Act
(MMWRA)
Defines “medical waste”
Requirements for waste handling and
disposal
Requires generators to register with
DEQ and implement a Medical Waste
Management Plan
Michigan Medical Waste Regulatory Act
(MMWRA)
Defines “medical waste”
Requirements for waste handling and
disposal
Requires generators to register with
DEQ and implement a Medical Waste
Management Plan
Biohazardous Waste Management Plan
Must outline how generating facility
complies with the MMWRA:
Types of wastes generated
Storage and disposal of wastes
Contingency plans
Training
Biohazardous Waste Categories
Cultures and stocks of infectious
agents and associated biologicals
laboratory
waste
biological production waste
discarded live and attenuated vaccines
culture dishes and related materials
contaminated PPE
Biohazardous Waste Categories
Liquid human and animal waste
liquid
or semi-liquid blood and blood
products and body fluids
contaminated
items that would release
blood or items that are caked with blood
or other potentially infectious materials;
NOT including urine or materials stained
with blood or body fluids
infectious
animal waste (research)
Biohazardous Waste Categories
Pathological waste
tissues
body
parts other than teeth
products of conception
fluids removed by trauma or during
surgery or autopsy/necropsy or other
medical procedure and not chemically
fixed.
…And More Biohazardous
Waste Categories
Animal and plant pathogen waste
Recombinant DNA waste
Sharps
Biowaste vs. Trash
3 basic questions to differentiate:
1. Is it contaminated with viable
biological material?
2. Can blood or other regulated
body or biological fluids be
released?
3. Is it a sharps hazard?
#1
Is it contaminated with
viable biological
material?
Examples:
• Contaminated lab waste
• Personal protective equipment
used for handling potentially
infectious materials (including
handling infected animals or their
products)
• Wastes from infectious disease
research (carcasses, body
fluids…)
#2
Can blood or other
(regulated) body fluids or
viable biological materials be
released?
Some Examples…
Tubes of blood
Vacuum flasks containing body
fluids or cell line waste
Managing Liquid Biohazardous Waste
Storage:
Label and secure bulk vessels
if not disposed of immediately
Treatment:
Chemical disinfection OR
Autoclave
Disposal: THEN
Flush to sewer
Use proper PPE!
Disinfection
10% bleach solution
good for general disinfection
High organics use 20%
Needs to be made weekly
Test contact time
Ethanol
Use 70% solution (most effective)
Longer contact time and flammable
*Should research and know effectiveness and contact time for the
best disinfectant against your agent!
WRAPPERS/NONABSORBENT MATERIALS
CONTAMINATED WITH
BLOOD
BANDAGES/OTHER
ABSORBENTS
SATURATED OR CRUSTED
WITH BLOOD
STAINED?….
or SATURATED?
Managing Non-Sharp Biohazardous Waste
labeled
container
lined with a
biohazardous
waste bag
equipped with a
lid.
Managing Non-Sharp
Biohazardous Waste
Securely tie bags for
transport to
treatment/collection
site.
When moving wastes,
use secondary
containment; avoid
using public halls and
elevators.
“Breakable” Non-sharps Biowaste
Store in labeled containers
that are puncture-resistant,
closable and will capture
leakage, BUT….
…Do NOT use
SHARPS containers!
Effective Waste Autoclaving
Leave bag open during
autoclaving or loosely closed
Add water to bag prior to
autoclaving if primarily dry
materials
Steam must contact
materials
Place bag in autoclavable
tray with sides
Treated Waste Bag Disposal
Allow waste bag to cool
Use fume hood to reduce
odors
Securely tie bag shut
Place bag in a nontransparent black bag for
regular disposal
Remember: NO ORANGE
BAGS IN DUMPSTER!
#3
Is it a sharps hazard?
Examples:
–
–
–
–
needles
syringes
scalpels
all biologically contaminated objects that
can easily penetrate skin (Pasteur pipettes,
razor blades, etc.)
Place sharps in approved sharps container
for disposal!
…Syringes in research settings should
be disposed of as a sharp to avoid
public relations concerns!
Sharps Containers
Containers must be leak-proof,
puncture-resistant, closable & labeled
with the biohazard symbol.
Proper sharps containers
must be used for
both clinic and
field work.
Proper Use of Sharps Containers
Place tops on containers before use
on lab bench
Don’t forget to date the container
when first put into use
Remember: sharps
containers are a
one-way disposal
system
Proper Use of Sharps Containers
Use sharps containers for sharps ONLY!
•
No solid biohazardous waste (i.e.
gauze, un-broken pipettes, gloves)
•
No mercury
thermometers
What’s wrong with this picture?
Sharps Container Disposal
Containers must be permanently closed
and disposed of through the animal facility
manager:
Within
90 days
of first use
When
¾ full
Disposal methods:
Landfill
Incineration
We
use waste hauler
Safety Notes on Sharps Use
Do not re-cap sharps
Keep sharps container in
close proximity to point of
use (i.e. limit handling) for
easy disposal
Do not leave needles in
pockets of coveralls or
smocks
Carcasses and Body Parts
Human tissues
Unfixed
tissues are medical waste
Make waste unrecognizable!
Animal tissues, carcasses
When
generated in infectious disease or recombinant
DNA research, these are medical waste
These items must be stored in biolabeled,
leakproof containers for incineration.
Waste service- see Audrey Brown
Managing All That Other Waste…
Drain bottles of non-hazardous
materials before disposal in trash
<3% of volume is considered empty
Higher volumes must not be thrown
in the trash
Managing All That Other Waste…
Do NOT discard
medications in the
trash.
Return to source for
disposal or seek
assistance from
your campus waste
group.
See Jaime Stock!
Any Questions?
Thank You
for your attention!
Thanks to Carol Stevens at CMU & Robin Mecklem at MSU for their assistance with this presentation