Download IBC Risk Assessment Form_FINAL

University of Wisconsin Oshkosh
Office of Grants and Faculty Development
Institutional Biosafety Committee
Biological Risk Assessment
IBC Use Only
Submission Date:
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 [email protected]. 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. Class Determination
A. Check the appropriate section(s) below to determine which class the proposed work would fall under. Please
see definitions for each section under Appendix A: “Definitions for Class Determination”
III-A.
Experiments that Require IBC Approval, RAC review, and NIH Director Approval before Initiation
http://www4.od.nih.gov/oba/rac/guidelines_02/NIH_Guidelines_Apr_02.htm#_Toc7261560
Deliberate transfer of drug resistance strain to microorganism that are unknown to acquire the trait naturally,
if such acquisition could compromise the use of the drug to control disease agents in humans, veterinary
medicine or agriculture.
III-B.
Experiments that require NIH/ORDA and IBC Approval before Initiation
http://www4.od.nih.gov/oba/rac/guidelines_02/NIH_Guidelines_Apr_02.htm#_Toc7261562
Experiments Involving the Cloning of Toxin Molecules with LD50 of Less than 100 Nanograms per Kilogram
of Body Weight.
III-C.
Experiments that Require IBC and IRB Approvals and NIH/ORDA Registration Before Initiation
http://www4.od.nih.gov/oba/rac/guidelines_02/NIH_Guidelines_Apr_02.htm#_Toc7261564
Experiments Involving the Deliberate Transfer of Recombinant DNA or DNA or RNA Derived from rDNA into
one or more Human Subjects.
III-D.
Experiments that Require IBC Approval before Initiation
http://www4.od.nih.gov/oba/rac/guidelines_02/NIH_Guidelines_Apr_02.htm#_Toc7261566
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
III-E.
Research Experiments that Require IBC Registration Simultaneous with Initiation
http://www4.od.nih.gov/oba/rac/guidelines_02/NIH_Guidelines_Apr_02.htm#_Toc7261573
Experiments Involving the Formation of rDNA molecules Containing No More than Two-Thirds of the
Genome of Any Eukaryotic Virus.
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 utilizing biological infectious agents or biological toxins
III-F.
Research Experiments that are Exempt from the NIH Guidelines.
http://www4.od.nih.gov/oba/rac/guidelines_02/NIH_Guidelines_Apr_02.htm#_Toc7261577
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/viruses
when propagated only in 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.
2
University of Wisconsin Oshkosh
Office of Grants and Faculty Development
III. 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 B: “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 C: “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 D: “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
IV. Potential Risks
A. 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: __
_________________________
Explain any potential risks below:
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University of Wisconsin Oshkosh
Office of Grants and Faculty Development
V.
Location
A. 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.
VI. Recombinant or Synthetic Nucleic Acid Work
A. 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 C: “Definitions” below.
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Office of Grants and Faculty Development
VII. Work Utilizing Animals*
A. For in vivo use list host species and target organs or systems and describe the method of delivery:
*Any work involving live animals must receive initial approval by the campus IACUC. Contact [email protected]
B. For whole animals, could there be an adverse physiological impact?
C. For in vivo use, discuss the potential for shedding of the toxin or agent from the animal host:
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University of Wisconsin Oshkosh
Office of Grants and Faculty Development
FOR IBC USE ONLY:
Reviewer’s Recommendations:
Exempt (No further paperwork is necessary at this time. PI will be send an Exempt Determination Letter)
Non-Exempt (Complete the Recombinant DNA and Synthetic Nucleic Acid Molecules Protocol
Application for Non-Exempt Activities)
Exempt but Registration is Required:
Complete the Biological Agent Registration form
Complete the Biological Toxin Registration form
Notes:
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Office of Grants and Faculty Development
Appendix A: Definitions for Class Determination
III-A:
Definitions
Experiments that Require IBC Approval, RAC Review, and NIH Director Approval Prior to Initiation
(See page 16 of NIH Guidelines)
III-B:
Experiments that Require NIH/OBA and IBC Approval Prior to Initiation (See page 16 of NIH Guidelines)
Explanation: Experiments in this category cannot be initiated without submission of relevant information on the
proposed experiment to NIH/OBA. The containment conditions for such experiments will be determined by NIH/OBA
in consultation with ad hoc experts. Such experiments require IBC approval before initiation. Deliberate formation
of recombinant or synthetic nucleic acid molecules containing genes for the biosynthesis of toxin molecules
lethal for vertebrates at an LD50 of less than 100 nanograms per kilogram body weight (e.g., microbial toxins
such as the botulinum toxins, tetanus toxin, diphtheria toxin, and Shigella dysenteriae neurotoxin). Specific
approval has been given for the cloning in Escherichia coli K-12 of DNA containing genes coding for the
biosynthesis of toxic molecules which are lethal to vertebrates at 100 nanograms to 100 micrograms per
kilogram body weight.
III-C:
Experiments that Require IBC and Institutional Review Board (IRB) Approvals and RAC Review
Before Research Participant Enrollment (See page 17 of NIH Guidelines)
Explanation: Human gene transfer is the deliberate transfer into human research participants of either:
1. Recombinant nucleic acid molecules, or DNA or RNA derived from recombinant nucleic acid molecules,
or
2. Synthetic nucleic acid molecules, or DNA or RNA derived from synthetic nucleic acid molecules that meet
any one of the following criteria:
a. Contain more than 100 nucleotides; or
b. Possess biological properties that enable integration into the genome; or
c. Have the potential to replicate in a cell; or
d. Can be translated or transcribed
III-D:
Experiments that Require IBC Approval Before Initiation (See page 18 of NIH Guidelines)
Prior to the initiation of an experiment in this category, the PI must submit a registration document to the IBC
which contains the following information: (i) the source(s) of DNA; (ii) the nature of the inserted DNA
sequences; (iii) the host(s) and vector(s) to be used; (iv) if tan attempt will be made to obtain expression of a
foreign gene, and if so, indicate the protein that will be produced; and (v) the containment conditions that will
be implemented as specified in the NIH Guidelines. The Risk Group (RG1-4) of the work will define the
containment level (BSL 1-4).
III-E:
Experiments that Require IBC Notice Simultaneous with Initiation (See page 22 of NIH Guidelines)
All such experiments not listed in the above categories are considered part of this class. All such
experiments may be conducted at BSL-1 containment. A registration document shall be dated and signed
by the PI and filed with the Institutional Biosafety Committee at the time the experiments is initiated. The
IBC reviews and approves all such proposals but IBC review and approval prior to initiation of the
experiment is not required
III-F:
Exempt Experiments (See page 23 of NIH Guidelines)
These experiments are exempt from the NIH Guidelines. A registration document must be completed by the PI and
submitted to the IBC office at the time the experiment is initiated. The IBC reviews and approves all such proposals but
approval prior to initiation of the experiment is not required. Included in this group are any registrations for infectious
pathogens and toxins of biological origin
7
University of Wisconsin Oshkosh
Office of Grants and Faculty Development
Appendix B: 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 C: 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
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Office of Grants and Faculty Development
Appendix D:
Examples of Selected Microorganisms and Associated Risk Group
All work with biological agents at UW Oshkosh requires submission of a Biological Agent Registration form. If you intend to work with biological agents, even if not included on this list,
please contact the Institutional Biosafety Committee (IBC) at [email protected]
Selected
Microorganisms
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



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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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Appendix E:
Biological Toxins Requiring an IBC Protocol
All work with biological toxins at UW Oshkosh requires submission of a Biological Toxin Registration form. If you intend to work
with biological toxins, even if not included on this list, please contact the Institutional Biosafety Committee (IBC) at
[email protected]
Biological Toxin
LD50 (ug/kg)
Abrin*
0.7
Aerolysin
7
Botulinum toxin A* and B*
0.0012
Botulinum toxin C1*
0.0011
Botulinum toxin C2*
0.0012
Botulinum toxin D*
0.0004
Botulinum toxin E*
0.0011
Botulinum toxin F*
0.0025
b-bungarotoxin
14
Caeruleotoxin
53
Cereolysin
40-80
Cholera toxin
250
Clostridium difficile enterotoxin A
0.5
Clostridium perfringens lecithinase
3
Clostridium perfringens perfringolysin O
13-16
Clostridium perfringens delta toxin
5
Clostridium perfringens epsilon toxin
0.1
Conotoxin (only short, paralytic alpha conotoxins with specific
12-30
sequences are considered Select Agents)*
Crotoxin
12-30
Diacetoxyscirpenol*
1000-10,000
Diptheria toxin*
0.1
HT-2 toxin
5-10
Leucocidin
50
Listeriolysin
3-12
Modeccin
1-10
Nematocyst toxins
33-70
Notexin
25
Pertussis toxin
15
Pneumolysin
1.5
Pseudomonas aeruginosa toxin A
2.7
Ricin*
2.7
Saxitoxin*
8
Shiga toxin
0.25
Shigella dysenteriae neurotoxin
1.3
Staphyloccal aureus toxins*
2-25
Staphylococcus enterotoxin B*
25
Staphylococcus enterotoxin F
2-10
Staphylococcus enterotoxins A, C, D, and E*
20(A); <50(C)
Streptolysin O
8
Streptolysin S
25
T-2 toxin *
5,000-10,000
Taipoxin
2
Tetanus toxin
0.001
T-2 toxin*
5-10
Tetrodotoxin*
8
Volkensin toxin
1.4
Yersinia pestis murine toxin
10
This table was developed from those created by University of Florida Environmental Health and Safety Office and
Oregon Health & Science University
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* Toxins designated with an asterisk (*) are considered Select Agents by the Federal Government if kept by a PI at
or above the quantities listed in the table.
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