Biosafety Program Risk Assessment Supplement
Effective Date: UPDATE – To Be Approved.
Mayo Clinic: Administrative Services - Research
Biosafety
Rochester, MN 55905
Biosafety Program Risk Assessment Information
Note: The lists included in this document are not all inclusive.
Biohazardous Material Definitions – IBC Purview
The categories and associated definitions below outline the areas of biosafety requiring review by the Mayo
Clinic IBC. Should a Mayo investigator wish to use one or more of the biological agents listed below, the
completion of a biosafety registration form and subsequent review must occur. Please contact the IBC or
Biosafety Coordinator with questions.
Biohazardous Categories
Biohazardous Agent
Risk Group 2 (and above)
Microorganisms
Viral vectors
Definitions
Any viable infectious, pathogenic, or toxin-producing agent, prion, toxin, or nucleic acid
construct including genetic locus, gene combination, gene, nucleic acid sequence, gene
vector, expressed foreign (recombinant-derived) protein, or transformed or otherwise
genetically manipulated host that has potential to affect the health of humans, animals,
plants, or ecosystems
Agents associated with human disease that is rarely serious or for which preventive or
therapeutic interventions are often available.
Examples: Entamoeba sp., Salmonella sp., Adenovirus, Herpesvirus, Helicobacter pylori
Modified viruses used to deliver genetic information to an cell or living organism.
Modifications commonly involve the deletion of a portion of the genome that allows for
viral replication.
Examples: Adenovirus, Vaccinia, Measles virus, Lentivirus
Recombinant DNA (rDNA)
As defined by the NIH Guidelines for Research Involving Recombinant DNA Molecules
(NIH Guidelines), recombinant DNA is
•
molecules that are constructed outside living cells by joining natural or synthetic
DNA segments to DNA molecules that can replicate in a living cell, or
•
molecules that result from the replication of those described in (i).
Infectious Agent
A viable biological agent that presents to human health. Infectious agents are ranked in
ascending order of biohazard so that agents that are considered to represent minimal risk
are usually grouped in Risk Group 1, and agents that represent the greatest hazard are in
Risk Group 4. Work with RG-4 agents is currently prohibited at the Mayo Clinic.
Oncogenic Virus
An oncogenic is a virus that can cause cancer. It refers to any virus with a DNA or RNA
genome causing cancer and is synonymous with "tumor virus" or "cancer virus"
Select Agents and Toxins
Specific microbial agents or toxins that could be "weaponized" and that represent serious
threat to human health or to agricultural commodities. See the complete select agent list
at the National Select Agent Registry (NSAR) website.
•
Select Agents and Toxins
–
biological agents and toxins that have been determined to have the
Master copies are retained online. Printed copies are considered current only on the date printed.
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potential to pose a severe threat to human health, to animal health, to
plant health, or to animal and plant products
•
Overlap Select Agents and Toxins
–
agents included on both the Health and Human Services list and the US
Department of Agriculture list
Toxins
A poisonous substance that is a specific product of the metabolic activities of a living
organism and is usually very unstable, notably toxic when introduced into the tissues, and
typically capable of inducing antibody formation
Prions
A disease-causing form of a normal protein called cellular prion protein (PRPc) that is
located primarily on the surface of central nervous system, resulting in transmissible
spongiform encephalopathies (TSE) which are neurodegenerative diseases in mammals.
Prions are neither bacterial nor fungal nor viral and contain no genetic material.
Common Biological Agents Found in Primary Human/Animal Samples
Specimen Type
Blood
Serum/Plasma
CSF
Saliva
Urine
Feces
Semen
Nasopharyngeal
Respiratory sites
Tissues
Gastric lavage
Wound/Skin lesion
exudates
Agents That Could Be Present
HBV, HCV, HIV, SARS, WNV, Brucella, N. meningitidis, Francisella, Enteric
pathogens, B. pertussis, Leptospira, other select agents such as B. anthracis, Y.
pestis, Burkholderia mallei and B. pseudomallei
WNV, Botulin toxin, HBV, HCV, HIV
HBV, WNV, HIV, Brucella, N. meningitidis, Francisella, M. tuberculosis, B.
anthracis, Y. pestis
N. meningitidis, HBV, HIV
HBV, HIV, SARS, Brucella, Francisella, Salmonella, STEC, M. tuberculosis, Y.
pestis, Leptospira, B. anthracis
Salmonella, Shigella, Campylobacter, Y. pestis, Vibrio species, H. pylori, STEC,
HBV, SARS, Polio virus, B. anthracis, Botulism toxin
Brucella, HBV, HIV
N. meningitidis, B. pertussis, C. diphtheriae, H. pylori, Polio virus, SARS, HBV
SARS, Brucella, B. anthracis, M. tuberculosis, B. pertussis, Legionella,
Francisella, Burkholderia mallei, B. pseudomallei, Y. pestis
SARS, Polio virus, WNV, Brucella, M. tuberculosis, Campylobacter, Leptospira,
B. mallei, B. pseudomallei
M. tuberculosis, H. pylori
Francisella, B. anthracis, Burkholderia mallei, Burkholderia mallei
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Biosafety Program Risk Assessment Supplement
Master copies are retained online. Printed copies are considered current only on the date printed.
Effective Date: UPDATE – To Be Approved.
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Biohazard Characteristics of Common Biological Agents
Biological Agent
Hepatitis B
Potential mode of transmission
Percutaneous or mucocutaneous
Recommended Containment
BSL-2 for handling body fluid and
tissue specimens
Hepatitis C
Infective Dose
Not known,
however, 1 mL of
infected blood may
contain from 102109 HBV particles
102-103 particles/ml
Percutaneous, rarely mucocutaneous
HIV
100-104 paticles/ml
Percutaneous or mucocutaneous
Influenza Viruses
Varies by strain
Inhalation of aerosols; mucocutaneous
BSL-2 for handling body fluid and
tissue specimens
BSL-2 for handling body fluid and
tissue specimens
H1N1: Splash protection if
performing rapid immunoassay;
biosafety cabinet if performing IFA,
DFA, culture or molecular assays
SARS-Corona virus
Unknown
Inhalation of aerosols
West Nile Virus
Unknown
Brucella species
Campylobacter
species
Coxiella burnetii
Escherichia coli
O157:H7
Francisella
tularensis
10 to 100 orgs
500 orgs or less
Inhalation of aerosols; percutaneous or
mucocutaneous
Inhalation of aerosols
Ingestion due to cross-contamination
10 orgs
10 to 100 orgs
Inhalation of aerosols
Ingestion due to cross-contamination
BSL-3 for manipulation of cultures
BSL-2
Aerosols: 5 to 10
orgs
Ingestion: 108 orgs
1 to 10 orgs
Inhalation of aerosols
BSL-3 for manipulation of cultures
Inhalation of aerosols
BSL-3 for manipulation of cultures
Not known
Inhalation of aerosols
Salmonella species
105 to 109 orgs
Ingestion due to cross-contamination
Shigella species
Staphylococcus
aureus
10 to 100 orgs
Virulence varies
greatly between
strains
Ingestion due to cross-contamination
Inhalation of aerosols; percutaneous or
mucocutaneous
Sterile sites isolates should be
manipulated in biological safety
cabinet
BSL-2 for non-typhi; BSL-3
recommended for manipulation of
Salmonella Typhi if aerosols are
likely
BSL-2
BSL-2
Mycobacterium
tuberculosis
Neisseria
meningtidis
Master copies are retained online. Printed copies are considered current only on the date printed.
HPAI: requires BSL-3 conditions
Untreated specimens processed in
biological safety cabinet
BSL-3 for manipulation of cultures
BSL-3 for manipulation of cultures
BSL-2
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Laboratory Activities Associated with Potential Exposures
Laboratory Activity
Causes
Aerosols
Splashes
Ingestion Due
to Splashes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Needle
Stick/Sharp
Injury
General Procedure Types
Centrifuging
Vortexing
Manual Pipetting
Aliquoting (Pouring)
Diluting
Shaking/Mixing
Capping/Uncapping
Blending
Homogenizing
Sonicating
Lyophilizing
Grinding
Microtoming/Cryostating
Cutting/Grossing
Sawing/Drilling
Harvesting of Tissues
Using Sharps – Glass/Blades
Using Sharps - Needles
Specific Procedure Types
Aspirating fluid from a sealed bottle
Withdrawing needles from stopper
Inoculating culture plates with fluid from a syringe
Disposal of contaminated syringes
Using a swab to make a bacterial suspension
Pouring or decanting fluids
Aspirating
Using autoinoculater for automated identification
systems
Inoculating identification cards using vacuum
systems
Inoculating suspension onto plate with swab
Opening plate to observe growth
“Sniffing” plate as part of bacterial identification
Flaming loop with bacterial growth on it
Cooling loop in culture plate
Manipulating bacterial growth with hot loop or
needle
Roughly discarding bacterial suspensions
Roughly discarding culture plates or specimens into
receptacle
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Master copies are retained online. Printed copies are considered current only on the date printed.
Yes
Yes
Yes
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Biosafety Program Risk Assessment Supplement
Effective Date
4/19/2012
Version
001
1/7/2012
002
Effective Date: UPDATE – To Be Approved.
Synopsis of Change
Created supplement including definitions of biohazardous material. Approved by IBC
on 6/21/2012.
Added Categories and Definitions for “Risk Group 2 (and above) Microorganisms” and
“Viral vectors”
Master copies are retained online. Printed copies are considered current only on the date printed.
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