University of Wisconsin Oshkosh
Office of Grants and Faculty Development
Institutional Biosafety Committee
Biological Risk Assessment
IBC Use Only
Submission Date:
Require Registration? (Yes/No):
I. Cover Sheet: Project Identification, Personnel and Signatures
Principal Investigator/Instructor:
Department/Division:
Building/Lab Room #:
Phone No:
E-Mail:
Type of Review:
Initial
3 Year Risk Assessment Review
Risk Assessment Directions:
Investigators and/or instructors should complete the following questions based on their ongoing or future teaching or
research needs. Complete this risk assessment for each biological agent, toxin of biological origin, virus or
recombinant DNA project in your laboratory or classroom. Useful definitions can be found in Appendix B:
“Definitions”.
Submit completed form electronically to biosafety@uwosh.edu. Investigators should keep a copy in their records.
Useful Resources for PIs and Instructors:
Biosafety in Microbiological and Biomedical Laboratories (BMBL), 5th Edition
NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
American Biological Safety Association (ABSA) Risk Group Database
American Type Culture Collection (ATCC)
Principal Investigator or Instructor Certification:
By signing below I am agreeing that the information provided is true and accurate of the work currently performed
under my supervision as Principal Investigator or Instructor. I realize that any work utilizing biological materials,
even if such materials are considered exempt from NIH Guidelines, may still require registration with the UW
Oshkosh Institutional Biosafety Committee. I understand that I will also be required to complete biosafety training if
my research is registered with UW Oshkosh Institutional Biosafety Committee.
Signature of PI and/or Instructor:
Date:
Signature of Institutional Biosafety Chair:
Date:
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University of Wisconsin Oshkosh
Office of Grants and Faculty Development
II. Biological Materials
Identify the biological materials used in your teaching and/or research then complete the following questions for each
biological material identified. For additional rows, see Appendix A: “Additional Biological Materials”
Biological Material
(Agent, Pathogen,
Biotoxin, Fungi, Virus,
rDNA)
Include genus and species
as applicable
1.
Human
Pathogen/
Hazard
(Y/N)?
Animal
Pathogen/
Hazard
(Y/N)?
Plant
Pathogen/
Hazard
(Y/N)?
Risk Group
Classification*
Potential
Transmission/
Exposure
Route**
rDNA
Culture
volume >
10 liters?
(Y/N/NA)?
2.
3.
4.
5.
*Risk Group Information
See Appendix B: “Definitions” and the American Biological Safety Association (ABSA) website for a Risk Group
Database for Infectious Agents to determine the appropriate Risk Group Classification for your material(s). Additional
information on Risk Group Classification can be found in Appendix C: “Examples of Selected Microorganisms and
Associated Risk Group.”
** Modes of Infectious Transmission/Exposure
Select the potential routes of transmission for the materials or organisms you will be working with. Examples may
include:
 Inhalation
 Ingestion
 Skin absorption
 Contaminated blood/tissue/bodily fluids
 Fomites
 Vector transfer
III. Potential Risks
If risks exist for any of the biological materials listed on this form, please select all risks that apply and explain below:
Splash potential
Aerosol generation (cell culture, vortex, centrifuge, aerosol chamber, sonicator)
Needle stick/poke
Vector transfer
Other: __
_________________________
If risks are selected, please explain below:
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University of Wisconsin Oshkosh
Office of Grants and Faculty Development
IV.
Location
Explain where material use will occur. Include building and room/lab numbers and any satellite facilities.
Type of Room
Provide course
Provide classroom
number if work will be number if work will
(Classroom, Laboratory,
Building
Room No.
performed as part of a
be performed as
Procedure room, Animal
class activity
part of a class
Housing, Cold Room, etc.)
activity
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
V. Recombinant or Synthetic Nucleic Acid Work
If you plan to utilize recombinant or synthetic nucleic acid molecules as part of teaching, research and/or testing,
please provide a brief summary of that work below:
Please note: Any work utilizing recombinant and/or synthetic nucleic acids at UW Oshkosh must be disclosed,
regardless of the type of work conducted. Some work may be considered Exempt and some work may be considered
Non-Exempt according to federal regulations found within the NIH Guidelines for Research Involving Recombinant or
Synthetic Nucleic Acid Molecules (NIH Guidelines). Research considered Non-Exempt will require prior approval by the
UW Oshkosh Institutional Biosafety Committee (IBC) prior to initiation. Examples of work that would be considered
Exempt or Non-Exempt can be found in Appendix B: “Definitions” below.
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University of Wisconsin Oshkosh
Office of Grants and Faculty Development
Appendix A: Additional Biological Materials
Biological Material
(Agent, Pathogen,
Biotoxin, Fungi, Virus,
rDNA)
Include genus and species
as applicable
6.
Human
Pathogen/
Hazard
(Y/N)?
Animal
Pathogen/
Hazard
(Y/N)?
Plant
Pathogen/
Hazard
(Y/N)?
Risk Group
Classification*
Potential
Transmission/
Exposure
Route**
Culture
volume >
10 liters?
(Y/N)?
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
25.
26.
27.
28.
29.
30.
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University of Wisconsin Oshkosh
Office of Grants and Faculty Development
Appendix B: Definitions
Recombinant and synthetic nucleic acid molecules:
The NIH Guidelines define recombinant and synthetic nucleic acids as:
 Molecules that are
a). constructed by joining nucleic acid molecules and
b). that can replicate in a living cell
 Nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are
chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules
 Molecules that result from the replication of those described above.
Risk Assessment is a methodology used to organize and analyze scientific information in order to estimate the
probability and severity of an adverse effect. The adoption of this methodology leads to the implementation of an
appropriate set of measures in order to provide maximal protection of human health and the environment. Risk
assessment has the following subsequent steps:
 Identification of biological hazards
 Determination of the class of risk of the genetically modified or pathogenic organism (Risk Group
Classification)
 Consideration of the type of activity in terms of probability of exposure to potential biological hazards
 Assignment of a class of risk to the contained use activity (Biosafety Level)
 Implementation of recommended containment level
* Risk Groups:
 Risk Group 1 (RG1): Agents are not associated with disease in healthy adult humans. Biosafety Level 1 (BSL-1)
containment will be used following “NIH Guidelines for the Research Involving Recombinant or Synthetic Nucleic Acid
Molecules” and Biosafety in Microbiological and Biomedical Laboratories, 5th Edition
 Risk Group 2 (RG2): Agents are associated with human disease which is rarely serious and for which preventative or
therapeutic interventions are often available. Biosafety Level 2 (BSL-2) containment will be used following “NIH
Guidelines for the Research Involving Recombinant or Synthetic Nucleic Acid Molecules” and Biosafety in
Microbiological and Biomedical Laboratories, 5th Edition
 Risk Group 3 (RG3): Agents are associated with serious or lethal human disease for which preventative or therapeutic
interventions may be available. Biosafety Level 3 (BSL-3) containment will be used following “NIH Guidelines for the
Research Involving Recombinant or Synthetic Nucleic Acid Molecules” and Biosafety in Microbiological and
Biomedical Laboratories, 5th Edition. UW Oshkosh does not currently have facilities to support BSL3 work
 Risk Group 4 (RG4): Agents are likely to cause serious or lethal human disease for which preventative or therapeutic
interventions are not usually available. Significant containment is required using Biosafety Level 4 (BSL-4) containment.
UW Oshkosh does not currently have facilities to support BSL4 work
Examples of Exempt and Non-Exempt Research Utilizing Recombinant or Synthetic Nucleic Acid Molecules:
Examples of experiments that are considered Non-Exempt from NIH Guidelines
Note: These experiments will require submission and approval of an IBC protocol application
1.
2.
3.
4.
5.
Experiments using Risk Group 2, Risk Group 3, Risk Group 4 or Restricted Agents as Host-Vector systems.
Experiments in which DNA from Risk Group 2, Risk Group 3, Risk Group 4 or Restricted Agents is cloned into
nonpathogenic prokaryotic or lower eukaryotic host-vector systems.
Experiments involving the use of infectious DNA or RNA viruses or defective DNA or RNA viruses in the presence of
helper viruses in tissue culture systems.
Experiments involving whole animals in which the animals genome has been altered by stable introduction of rDNA into
the germ line or experiments involving viable rDNA-modified microorganisms tested on animals
Experiments involving more than 10 liters of culture for recombinant DNA work
Examples of experiments that require Registration with the IBC simultaneous with initiation
Note: These experiments will require submission of a registration form with the IBC (for notification purposes)
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University of Wisconsin Oshkosh
Office of Grants and Faculty Development
1.
2.
3.
4.
Experiments involving the formation of rDNA molecules containing no more than two-thirds of the genome of any
eukaryotic virus (BSL1 containment)
Experiments involving rDNA modified whole plants and/or experiments involving rDNA modified organisms associated
with whole plants.
Experiments involving transgenic rodents (BSL1 containment only)
Experiments using biological toxins or biological agents that are Exempt from NIH Guidelines
Examples of experiments that are Exempt from the NIH Guidelines.
Note: These experiments will not require registration or protocol application submission to the IBC, however, completion of this
Biological Risk Assessment Supplement is still required.
1.
2.
3.
4.
5.
6.
Experiments that are not in organisms or viruses (e.g., DNA sequencing, PCR)
Experiments that consist entirely of DNA segments from a single non-chromosomal or viral DNA source.
Experiments that consist entirely of DNA from a prokaryotic host including its indigenous plasmids or viruses when
propagated only in the host or when transferred to another host by well-established physiological means.
Experiments that consist entirely of DNA from a eukaryotic host including its chloroplasts, mitochondria, or plasmids
when propagated only in the host.
Experiments that consist entirely of DNA segments from different species that exchange DNA by known physiological
processes.
Experiments that don’t present a significant risk to health or the environment as determined by the NIH Director.
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University of Wisconsin Oshkosh
Office of Grants and Faculty Development
Appendix C:
Examples of Selected Microorganisms and Associated Risk Group
Microorganisms
Selected
Microorganisms
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Risk Group 1
Acanthocheilonema viteae
Alcaligenes faecalis
Bacillus megaterium
Bacillus subtitlis
Clostridium sporogenes
Enterobacter aerogenes
Enterobacter cloacae
Escherichia coli (except toxigenic virotypes)
Kocuria rosea (Micrococcus roseus)
Lactobacillus spp.
Leuconostoc spp.
Micrococcus luteus
Mycobacterium smegmatis
Neisseria sicca
Neisseria subflava
Pseudomonas fluorescens
Pseudomonas putida
Serratia marcescens
Staphylococcus epidermidis
Streptococcus bovis
Risk Group 2
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Adenovirus, all types
Babesia spp.
Bacillus cereus
Bordetella spp.
Brugia spp.
Burkholderia spp. (other than mallei or pseudomallei)
Chlamydia spp.
Clostridium spp. (other than botulinum) (other than sporogenes)
Coxsackie virus
Cryptosporidium spp.
Dirofilaria immitis
Ehrlichia spp.
Enterobacter spp. (other than above)
Enterococcus faecalis
Escherichia coli O157:H7
Escherichia coli (toxigenic other than above)
Haemophilus spp.
Helicobacter spp.
Herpes simplex virus (I and II)
Human Immunodeficiency virus
Influenza virus
Klebsiella spp.
Listeria monocytogenes
Mycobacterium avium
Mycobacterium, BCG
Mycobacterium leprae
Mycobacterium spp (other than those above and M. tuberculosis)
Neisseria gonorrhoeae
Neisseria meningitidis
Pasteurella spp.
Proteus spp.
Pseudomonas aeruginosa
Salmonella spp.
Shigella spp.
Sindbis virus
Staphylococcus aureus
Streptococcus pneumoniae
Streptococcus pyogenes
Trichuris spp.
Vaccinia virus
Varicella-zoster virus
West Nile Virus
Yersinia spp. (other than pestis)
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Risk Group 3
Bacillus anthracis
Brucella spp.
Burkholderia mallei
Burkholderia pseudomallei
Clostridium botulinum
Coccidioides immitis
Coxiella burnettii
Francisella tularensis
Hantavirus
Mycobacterium bovis (except BCG)
Mycobacteria tuberculosis
Rickettsia prowazekii
Rickettsia rickettsii
Yersinia pestis
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University of Wisconsin Oshkosh
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Appendix D:
Examples of Toxins of Biological Origin
Selected Toxins
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Toxins of Biological Origin
Abrin
Aflatoxins
Anatoxin
Botulinum toxins
Clostridium perfringens epsilon toxin
Cholera toxin
Conotoxins
Diacetoxyscirpenol
Diphtheria toxin
Microcystin
Pertussis toxin
Ricin
Saxitoxin
Shigatoxin
Staphylococcal enterotoxins
Streptococcal toxins
Tetrodotoxin
T-2 Toxin
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