BIOSAFETY APPLICATION FORM
This application is designed to encompass the research activities of your laboratory in a comprehensive
manner. This is a laboratory registration, and is not intended to be limited to a specific grant or project.
Please complete and return the necessary forms by email to: IBC@ucdenver.edu
The form is locked so that the check boxes work. Type information in the indicated grey text boxes. To
expand tables with additional rows, please contact the Biosafety
Authorization #
Office, 303-724-0235, 4-7395, 4-5954.
Part I.
Administrative Information (This Part must be completed)
A. Protocol Title:
Principal Investigator (please only list name(s) of person(s)
Last Name, First Name
Employee ID Number
Email address
School/Dept/Division/Institute:
Mailstop:
Phone:
Fax:
B. Author (form completed by):
Last Name, First Name
Employee ID Number
Email address
C. Campus / Sites where laboratory activities/research will be conducted:
(Expand the table as necessary)
Anschutz Medical Campus
Downtown Campus
Laboratory Bldg & Space Number:
Room Type (Alcove, Module, Cold Room, Procedure Room)
Off-Site:
Complete Physical Address
D. Protocol Associates/ Lab/ Research Personnel (Do Not list personnel who are only performing
administrative, data management, statistical, etc. tasks): List each employee/graduate student/preor post-doc or student-worker, or volunteer/intern working in or assigned space in your laboratory.
(Expand this table as necessary by pressing return to move to the next line.)
Last Name, First Name
EHS BSF-001
Employee ID number
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Employee email address
1
I acknowledge all requirements and restrictions of the most current NIH Guidelines for the Biosafety
Level approved by the IBC. As the Principal Investigator I accept responsibility for the safe conduct of the
experiments conducted at the Biosafety Level approved by the IBC.
I understand that it is my responsibility to assure that all personnel working in my laboratory with any
hazardous materials are fully informed about their specific dangers, proper actions for safe use and
disposal, steps to take in case of accidents, and are provided with all necessary safety equipment and
instructions in its use.
I understand that it is my responsibility to assure that all personnel working in my laboratory with any of
these hazards are fully informed about their responsibility to report any spills, accidents, exposures, etc.
to the Biosafety Office/Dept. of Environmental Health & Safety and University Risk Management/Workers
Compensation Program as appropriate.
Date
Signature of Principal Investigator
PLEASE FILL OUT THE REST OF THIS FORM BY ANSWERING ALL SECTIONS APPLICABLE TO
YOUR RESEARCH ENDEAVORS.
The form is locked so that the check boxes work. Type information in the indicated grey text boxes. To
expand tables with additional rows, please contact the Biosafety Office, 303-724-0235, 4-7395, 4-5954.
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Part II.
Types of Experiments (This Part must be completed)
A. We will use the following research materials: complete all Parts for “Yes”
Experiments with Biological Materials or Infectious Agents Part of rDNA research:
1. Recombinant or synthetic nucleic acid molecules or organisms (includes plasmids, viral vectors)
If Yes, complete Part III of this form.
Yes
No
Experiments with Biological Materials or Infectious Agents NOT Part of rDNA research:
2. Human blood, body fluids (saliva, mucus, feces, urine, etc.), tissues, organs
Yes
If Yes, complete Part IV-A of this form.
No
3. Human Primary or immortalized cell cultures or cell lines
If Yes, complete Part IV-B of this form.
Yes
No
4. Non-Human Primate – tissue, cells, bodily fluids/excreta
If Yes, complete Part V of this form
Yes
No
5. Biological or Infectious Agents
If Yes, complete Part VI of this form.
Yes
No
Yes
No
7. Animal specimens, tissues or organs
If Yes, complete Part VII-B of this form.
Yes
No
8. Animal Primary or immortalized cell cultures or cell lines
If Yes, complete Part VII-C of this form.
Yes
No
Experiments with Whole Animals, Transgenic Animals, Tissues, or Cells
6. Whole Animals or Transgenic Animals (vertebrate or invertebrate animals)
If Yes, complete Part VII-A of this form and Appendix T (submit with this Form).
Experiments Involving Select Agent Pathogens and Toxins (includes Exempt Quantities)
9. Select Agent Pathogens: (http://www.selectagents.gov/index.html)
Yes
If Yes, contact the University Responsible Official and Institutional Biosafety Officer for further
instructions and to complete all necessary documents for IBC review and approval.
10. Select Agent Toxins: (http://www.selectagents.gov/index.html)
If Yes, complete SA Toxins Form, Appendix A and submit with this form.
Experiments Involving Plants
11. Recombinant or synthetic nucleic acids, infectious agents or microorganisms
affecting plants in conjunction with plants or plant materials.
If Yes, complete Part III and Appendix P, and submit with this form.
Field Research
12. Field studies.
If Yes, contact the Biosafety Officer at 724-0235 or via email at ibc@ucdenver.edu
Yes
No
Yes
No
Yes
No
The following Parts of this Application MUST be completed regardless of how the questions
above were answered:
Part II. B.
Part VIII.
Part IX.
Part X.
Part XI.
Research Narrative/Goals of Study
Risk Assessment and Containment
Dual Use Research
Shipping/Receiving Biological Materials
Required Trainings
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B. Research Narrative/Goals of Study (This Section must be completed)
Please describe the goals of your research, focusing on how biological materials, model organisms,
pathogens, rDNA, toxins, hazardous chemicals and/or radioactive materials will be used. Explain all
boxes checked “yes” in Part II. A.
Narrative:
Part III.
Use of Recombinant DNA (rDNA)
Use of rDNA materials is regulated by the NIH Office of Biotechnology Activities. The NIH defines
recombinant and synthetic nucleic acid molecules as:
(i) molecules that a) are constructed by joining nucleic acid molecules and b) can replicate in a living
cell (i.e. recombinant nucleic acids);
(ii) 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 (i.e. synthetic nucleic acids);OR
(iii) molecules that result from the replication of those described in (i) or (ii) above.
A. Recombinant DNA Research Narrative
Specifically describe the manner in which you are planning on using recombinant and/or synthetic
nucleic acids in sufficient detail to allow the comprehensive review and approval of your research
involving recombinant DNA or organisms containing recombinant nucleic acids. (Please do not paste
Grant Abstracts or Project Narratives into this section)
B. Recombinant DNA Research, NIH Guidelines
1. Use of nonpathogenic prokaryotic or lower eukaryotic organism(s)
Does your research involve the use of nonpathogenic prokaryotic or lower eukaryotic organism(s) as part
of a host-vector system (ex: E. coli K12 derivative, S. cerevisiae, B. subtilis)?
Yes
No
If Yes, please list the strain(s) of nonpathogenic prokaryotic or lower eukaryotic organism(s) in use. If
multiple organisms are used, you may attach a document or spreadsheet with this information using the
paperclip icon in the upper right hand side of this box.
2. Host of Recombinant or Synthetic Nucleic Acid Materials
Natural or synthetic recombinant DNA or RNA molecules will be used in the following:
NA
a. Bacteria, including Rickettsia – Complete Table
Pathogen
Name (Genus, Species)
NA
Is Vol. >10L Route of Exposure
for a Single
(inhalation,
Material
Risk
Vessel? contact, ingestion, is viable
Human Animal Plant Group
Y/N
vector borne)
(Y/N)
Do any Bacteria listed in the table above express antibiotic resistance?
If Yes, list Bacteria and its associated antibiotic resistance:
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No
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b. Virus – Complete Table
NA
Pathogen
Name (Genus, Species)
Is Vol. >10L Route of Exposure
for a Single
(inhalation,
Material
Risk
Vessel? contact, ingestion, is viable
Human Animal Plant Group
Y/N
vector borne)
(Y/N)
c. Yeast / Fungi – Complete Table
Name (Genus, Species)
Is Vol. >10L Route of Exposure
for a Single
(inhalation,
Material
Risk
Vessel? contact, ingestion, is viable
Human Animal Plant Group
Y/N
vector borne)
(Y/N)
d. Parasites – Complete Table
Name (Genus, Species)
NA
Pathogen
NA
Pathogen
Is Vol. >10L Route of Exposure
for a Single
(inhalation,
Material
Risk
Vessel? contact, ingestion, is viable
Human Animal Plant Group
Y/N
vector borne)
(Y/N)
e. Primary culture or cell lines - Complete Table
Cell Line
NA
Source:
Used with
*Embryonic
Replicate Used with
Viral
Origin:
(specify if stem
Risk
Virus
Plasmids Vectors
Human,
cell), *Placental, Group:
(Y/N)
(Y/N)
(Y/N)
Animal, Plant
*Fetal, Adult
1, 2, 3
*If Embryonic Stem Cell, are they listed on the NIH Stem Cell Registry?
Yes
No
*For Embryonic Stem Cell, Placental or Fetal, please list the specific source of each cell line listed above. You
must include Name, address, etc.
f.
Immortalized culture or cell lines - Complete Table
Cell Line
NA
Source:
Used with
*Embryonic
Replicate Used with
Viral
Origin:
(specify if stem
Risk
Virus
Plasmids Vectors
Human,
cell), *Placental, Group:
(Y/N)
(Y/N)
(Y/N)
Animal, Plant
*Fetal, Adult
1, 2, 3
*If Embryonic Stem Cell, are they listed on the NIH Stem Cell Registry?
Yes
No
*For Embryonic Stem Cell, Placental or Fetal, please list the specific source of each cell line listed above. You
must include Name, address, etc.
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g. Whole animals (vertebrate or invertebrate; transgenic or non-transgenic)
The material is
Viable
Non-viable
Complete Appendix T, and submit with this form
Yes
NA
h. Plants or plant pathogens or pests (transgenic or non-transgenic)
Complete Appendix P, and submit with this form.
Yes
NA
C. Nature of Vectors
1.
My vector(s) is/are plasmid-based.
Describe the plasmids and inserts or the nature of synthetic nucleic acid, using plasmid maps if
available. Provide source of plasmid material: (e.g. purchased from Vendor X, obtained from Dr. Y,
etc.)
2.
My vector(s) is/are viral in origin.
Complete the following section for each viral vector in use. If human or amphotropic vectors will be
used, please provide a detailed description including species-specificity, as applicable.
Strain,
vector
backbone:
Wild type
deletions:
(Name of
deleted
genes)
Replication
status:
Envelope
packaging
system(s):
Helper
Virus
required
(Y/N, if
Yes,
specify)
Source of vector
(made in lab X,
purchased from
Company Y, gift
from Dr. Z)
Adenovirus
Adeno
associated Virus
Alphavirus
(e.g. SFV, SIN)
Herpesvirus
Poxvirus (e.g.
Vaccinia)
Murine
Retrovirus
Human
Lentivirus (HIV)
Other:
3. Provide the following information concerning the nature of the insert(s):
a. What is the source of the DNA insert? Please include genus and species names of the organism(s)
from which the DNA is derived.
b. Please provide the full names and abbreviations of the gene(s), promoter(s) and/or transposable
elements to be studied, and a brief description of the biological function of the nucleic acid sequence.
(Indicate if this is cDNA, genomic DNA, or specific genes).
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c. If the DNA is from a eukaryotic virus and it is to be introduced into a eukaryotic host, provide the
percentage of the viral genome to be cloned.
%
d. If this is a mutated gene, please describe.
e. What do you know of the oncogenic potential of the genes of interest? If this is a known or suspected
oncogene, please describe sufficiently for IBC review.
f.
What do you know of the potential insertional mutagenesis of the vectors or the genes of interest?
4. Please provide details of the target/recipient cells or systems of the vector-DNA combination. What is
the target cell/system, animal or plant host(s)? Please provide detailed information about the host(s)
(e.g., E. coli K-12 system, Saccharomyces, insect cells, plant cells, live animals, whole plants, etc.)
5. List the specific foreign nucleic acids/proteins that will be expressed. Identify any known or potential
hazards associated with the expression of the foreign nucleic acids/proteins you will be working with.
D. Manipulations
1. Will you conduct Flow Cytometry or Cell Sorting or Laser Microdissection of any cells containing
recombinant DNA?
NA
List location for each.
Flow Cytometry, Location:
Cell Sorting, Location:
Laser Microdissection :
2. Will you use any of the following materials in combination with recombinant DNA?
a.
Radioisotopes
Isotope(s):
NA
Authorization Number:
b.
Select Agent Pathogens - contact the University Responsible Official and Institutional Biosafety
Officer for further instructions and to complete all necessary documents for IBC review and approval.
c.
Select Agent Toxins (including exempt quantities) - complete SA Toxins Form, Appendix A and
submit with this form.
E. Source and Nature of Introduced Nucleic Acid or Expressed Protein
My research involves: Please select any that apply to your construct(s)
1.
2.
3.
Extrachromosomal elements of a gram positive organism
Your research falls under NIH Guidelines Appendix C-VI
The inserted gene encodes 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).
Your research falls under NIH Guidelines Section III-B-1
The inserted gene encodes for a potential or known allergen
Your research falls under OSHA Act of 1970, General Duty Clause 5 (a) 1, 2
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4.
5.
The inserted gene confers a drug resistance trait to microorganisms that are not known to acquire the
trait naturally, if such acquisition could compromise the use of the drug to control disease in humans,
veterinary medicine or agriculture. Your research falls under NIH Guidelines Section III-A-1-a
If you check this box – explain the “drug resistance trait”
N/A
F. Source and Nature of Introduced Nucleic Acid or Expressed Proteins
My research involves: Please select any that apply to your experiment(s).
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
OPTION A: Synthetic nucleic acids that can neither replicate nor generate nucleic acids that can
replicate in any living cell (e.g., oligonucleotides or synthetic nucleic acids that do not contain an origin
of replication or contain elements known to interact with either DNA or RNA)
If OPTION A, B & C are all three checked, then your research falls under NIH Guidelines
Section III-F-1
OPTION B: Synthetic acids that are not designed to integrate in to DNA
If OPTION A, B & C are all three checked, then your research falls under NIH Guidelines
Section III-F-1
OPTION C: Synthetic acids that do not produce a toxin that is lethal for vertebrates at an LD50 of less
than 100ng/kg body weight
If OPTION A, B & C are all three checked, then your research falls under NIH Guidelines
Section III-F-1
Recombinant or synthetic acids that are not in organisms, cells, or viruses and that have not been
modified or manipulated (e.g., encapsulated into synthetic or natural vehicles) to render them capable
of penetrating cellular membranes
Your research falls under NIH Guidelines Section III-F-2
Recombinant or synthetic acids that consist solely of the exact recombinant or synthetic nucleic acid
sequence from a single source that exists contemporaneously in nature
Your research falls under NIH Guidelines Section III-F-3
Recombinant or synthetic acids that consist entirely of nucleic acids from a prokaryotic host, including
its indigenous plasmids or viruses when propagated only in that host (or a closely related strain of the
same species), or when transferred to another host by well-established physiological means
Your research falls under NIH Guidelines Section III-F-4
Recombinant or synthetic acids that consist entirely of nucleic acids from a eukaryotic host including
its chloroplasts, mitochondria, or plasmids (but excluding viruses) when propagated only in that host
(or a closely related strain of the same species)
Your research falls under NIH Guidelines Section III-F-5
Recombinant or synthetic acids that consist entirely of DNA segments from different species that
exchange DNA by known physiological processes, though one or more of the segments may be a
synthetic equivalent (See Appendices A-I through A-VI of the NIH Guidelines for a list of natural
exchangers)
Your research falls under NIH Guidelines Section III-F-6
Genomic DNA molecules that have acquired a transposable element, provided the transposable
element does not contain any recombinant and/or synthetic DNA
Your research falls under NIH Guidelines Section III-F-7
N/A
G. Risk Group 2 or 3 Agents as Host-Vector Systems
Does your research involve using Risk Group 2 or Risk Group 3 or Restricted Agents as HostVector Systems? Please select any that apply to your experiment(s).
1.
2.
3.
Yes, there will be introduction of recombinant or synthetic nucleic acids into Risk Group 2 agent(s).
Your research falls under NIH Guidelines Section III-D-1-a.
Yes, there will be introduction of recombinant or synthetic nucleic acids into Risk Group 3 agent(s).
Your research falls under NIH Guidelines Section III-D-1-b.
Yes, there will be introduction of recombinant or synthetic nucleic acids into Restricted Agents(s)
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4.
Your research falls under NIH Guidelines Section III-D-1-d. Your work may require an
USDA/APHIS permit and fall under NIH Guidelines V-G and/or V-M.
No
H. Risk Group 2 or 3 DNA into Non Pathogenic Host-Vector Systems
Does your research involve the transfer of genetic material from Risk Group 2, Risk Group 3, or
Restricted agents into a nonpathogenic prokaryotic or lower eukaryotic host-vector system?
Please select any that apply to your experiment(s).
1.
2.
3.
Yes, genetic material from RG2 or RG3 will be transferred.
Your research falls under NIH Guidelines Section III-D-2-a.
Yes, genetic material from a Restricted Agent will be transferred.
Your research falls under NIH Guidelines Section III-D-2-b. Your work may require a USDA
permit and fall under NIH Guidelines V-G and/or V-L.
No
I. Drug Resistance
Does your research involve the deliberate transfer of a drug resistance trait to microorganism(s) not
known to naturally possess this trait and therefore that could compromise the use of the drug to control
disease in humans, veterinary medicine or agriculture?
Yes (Your research falls under the NIH Guidelines Section III-A-1-a)
No
If Yes, please name the drug for which resistance is being introduced.
J. Cloning of Toxin Molecules
Does your research involve the cloning of toxin molecules?
Yes (Cloning of Toxins with an LD50 <100ng/kg body wt. falls under NIH Guidelines Section III-B-1)
No
If yes, please list (subunit, chimeras, holotoxin, etc.) and describe its purpose and LD50
Part IV.
Human Biological Materials, Specimens, Culture Materials NOT part of rDNA Research
Receiving and/or working with human specimens and/or human cell lines requires enrollment in the
Occupational Health Program. Contact 303-724-9145
A. Human Blood, Body Fluids, Tissues, or Organs
1. Will you collect, work with or bank human blood, body fluids, tissues, or organs?
Yes
No
If Yes, complete the following section - please check or list all that apply. Also, consult with the UCD
COMIRB regarding human subjects’ research application requirements.
2. Specimens collected or manipulated: check all that apply
Blood
Serum
Feces
Urine
Semen
Spinal fluid
Tissues/Organs
Other:
3. Types of manipulation(s): check all that apply
Centrifugation
Frozen Sections
Pipetting
Dissection
Blending/mixing
Sonication
Fixed/preserved in:
Flow Cytometry, Location:
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Cell Sorting, Location:
Other
4. Will the specimens be labeled with radioisotopes?
If yes,
Isotope(s):
Yes
No
Authorization Number:
B. Human Primary or Immortalized Cells in Culture NOT part of rDNA Research
a. Primary & Immortalized culture or cell lines - Complete Table
NA
Source:
1
Embryonic
List
List
(specify if stem
Biological
isotope(s)
Risk
Primary or
cell), 3Placental; 3Toxin used
used in
Group:
Cell Line
Immortalized Fetal, Adult; NA in culture; NA culture; NA 1, 2, 3
1
If Human Embryonic Stem Cell, are they listed on the NIH Stem Cell Registry?
Yes
No
2
*If Placental Cell, please list the specific source of each cell line listed above. You must include Name, address,
etc.
3
If your toxin appears on the Select Agent List, you must complete and submit a Select Agent Toxin Application- Appendix A.
Part V.
Non-Human Primate (NHP) - Tissue, Cells, Bodily Fluids NOT part of rDNA Research
Receiving and/or working with unfixed NHP materials requires enrollment in the Occupational Health
Program. Contact 303-724-9145
1. Are you working with Non-Human Primate tissue, cells, or bodily fluids?
If Yes, please complete the following Table(s) for each “Genus” / “Species”:
Genus
Species
Source
Please check all that apply for NHP listed in Table above:
Tissue, specify
The material is
Viable
Cells
The material is
Viable
Bodily Fluid(s), specify
The material is
Viable
Genus
Species
No
Is Permit Required?
Yes
No
Non-viable
Non-viable
Non-viable
Source
Please check all that apply for NHP listed in Table above:
Tissue, specify
The material is
Viable
Cells
The material is
Viable
Bodily Fluid(s), specify
The material is
Viable
Yes
Is Permit Required?
Yes
No
Non-viable
Non-viable
Non-viable
2. List Approved and/or Pending Permits (APHIS, CITES, Country of Origin Export permit, etc.) and
specify material.
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Part VI.
Experiments with Other Biological or Infectious Agents NOT part of rDNA Research
Complete this section if you use microorganisms with the potential to infect animals, plants or humans,
not otherwise addressed above for Part III. Use of Recombinant DNA (rDNA).
Receiving and/or working with Infectious Agents requires enrollment in the Occupational Health Program.
Contact 303-724-9145
1. Does your research involve the use of any of the following microorganisms not otherwise covered in
Part III above?
Yes
No
If No, continue to Part VIII.
If Yes, complete this section for each of the microorganisms to be used in research.
Please check all that apply:
Bacteria, including Rickettsia
Virus
Yeast/Fungi
Parasites
List agent(s) by Genus, species (expand this table as necessary). Include all viruses, bacteria, yeast,
fungi, rickettsia or parasites. To determine the correct Risk Group, refer to NIH Guidelines, Appendix B,
the CDC BMBL Agent Summary Statements, or discuss with the Biosafety Office.
a. Bacteria, including Rickettsia – Complete Table
Pathogen
Name (Genus, Species)
NA
Route of Exposure
(inhalation, contact, Material
Risk
ingestion, vector
is viable
Human Animal Plant Group Volume
borne)
(Y/N)
Do any Bacteria listed in the table above express antibiotic resistance?
If Yes, list Bacteria and its associated antibiotic resistance:
b. Virus – Complete Table
Yes
No
NA
Pathogen
Name (Genus, Species)
Route of Exposure
(inhalation, contact, Material
Risk
ingestion, vector
is viable
Human Animal Plant Group Volume
borne)
(Y/N)
c. Yeast / Fungi – Complete Table
Name (Genus, Species)
Route of Exposure
(inhalation, contact, Material
Risk
ingestion, vector
is viable
Human Animal Plant Group Volume
borne)
(Y/N)
d. Parasites – Complete Table
Name (Genus, Species)
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Pathogen
NA
Pathogen
Route of Exposure
Risk
(inhalation, contact, Material
Group
ingestion, vector
is viable
Human Animal Plant 1, 2, 3 Volume
borne)
(Y/N)
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2. For any agent listed above that is a Pathogen to humans or animals, is there a vaccine available?
Yes
No
If Yes, please list the Pathogen and the vaccine available.
3. Are animal or human pathogens to be used in animals?
If Yes, please list each pathogen and IACUC information:
Pathogen
IACUC Protocol #
Yes
IACUC
Approval Date
No
Vivarium Facility
4. Will any Agent listed in the above Tables be capable of transducing or potentially infectious to
plants?
Yes
If Yes, complete and submit Appendix P, with this form.
No
5. Does any Agent listed in the Tables above require a CDC or USDA-APHIS or other permit?
Yes
No
If Yes, please list the Agent and specify the permit(s). A copy of each Permit must be forwarded to
the Biosafety Office.
6. Will any Agent listed in the Tables above be labeled with a radioisotope?
Yes
No
If Yes, please list each Agent and Radiation Safety information:
Agent
Isotope(s)
Authorization #
Approval Date
7. Complete the following section for each Agent listed in the Tables above to be used in the lab.
a. Location(s), building and laboratory rooms, where agent(s) will be used/handled
Biological Agent:
Laboratory Bldg & Room Number:
Part VII. Experiments with Whole Animals, Transgenic Animals, Blood, Bodily Fluids, Tissues,
Specimens, Cells
A. Whole Animals or Transgenic Animals (in-vitro or in-vivo)
1. Will you work with Whole animals and/or Transgenic animals?
If Yes, Complete Appendix T, and submit with this form
Yes
No
B. Animal Blood, Bodily Fluids, or Tissues
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1. Will your experiments use any of the following:
Animal blood; Species
Body fluids, Species
Tissues; Species
2. Will the specimens be labeled with radioisotopes?
If yes,
Isotope(s):
Authorization Number:
Yes
No
C. Animal Primary or Immortalized Cells in Culture
a. Primary & Immortalized culture or cell lines - Complete Table
Cell Line
1
NA
Risk
Primary or List Biological 1Toxin
List isotope(s)
Group:
Immortalized used in culture; NA used in culture; NA 1, 2, 3
If your toxin appears on the Select Agent List, you must complete and submit a Select Agent Toxin Application- Appendix A.
Part VIII. Risk Assessment and Containment (This Part must be completed)
1. Is a Biological Safety Cabinet (tissue culture hood) available?
Yes
No
Biosafety Cabinet Information (expand this table as necessary)
BSC #
Manufacturer
Model
Class
Serial
Number
Type
Certification
Date
Bldg./Room #
2. Does this project constitute any other potential risk or hazards to human health or the environment
which are not described above?
Yes
No
If yes, explain. Use additional pages as necessary.
Part IX.
Dual Use Research (This Part must be completed)
Dual Use Research, as defined by the federal government, is under the oversight of the NIH, Office of
Biotechnology Activities (OBA), and National Science Advisory Board for Biosecurity (NSABB).
Are you are using one or more of the following agents or toxins (any quantity)?
Yes
No (this Part is now complete)
Agents and toxins
a) Avian influenza virus (highly pathogenic)
b) Bacillus anthracis
c) Botulinum neurotoxins
d) Burkholderia mallei
e) Burkholderia pseudomallei
f) Ebola virus
g) Foot-and-mouth disease virus
h) Francisella tularensis
i)
j)
k)
l)
m)
n)
o)
Marburg virus
Reconstructed 1918 Influenza virus
Rinderpest virus
Toxin-producing strains of Clostridium botulinum
Variola major virus
Variola minor virus
Yersinia pestis
If YES, check any categories of experiments below that apply to your research experiments or projects:
Enhances the harmful consequences of the agent or toxin
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Disrupts immunity or the effectiveness of an immunization against the agent or toxin without
clinical and/or agricultural justification
Confers to the agent or toxin resistance to clinically and/or agriculturally useful prophylactic or
therapeutic interventions against that agent or toxin or facilitates their ability to evade detection
methodologies
Increases the stability, transmissibility, or the ability to disseminate the agent or toxin
Alters the host range or tropism of the agent or toxin
Enhances the susceptibility of a host population to the agent or toxin
Generates or reconstitutes an eradicated or extinct agent or toxin listed above
Check here if none of the above applies
Part X. Shipping/Receiving
Step #1. The Office of Regulatory Compliance requires that all materials being shipped/Exported
outside of the United States be reviewed to determine what restrictions may apply.
Will you be shipping/exporting any biological materials?
If Yes, please go to the Export Control web site and complete the Shipping Worksheet
Yes
No
http://www.ucdenver.edu/academics/research/AboutUs/regcomp/exportcontrol/Pages/ExportControl.aspx
Step #2. Please contact EHS Biosafety Program at Biosafety.Program@ucdenver.edu for assistance
in Shipping and/or Receiving biological materials. You must have completed the CU:
Shipping of Biological Materials (C20003) course within the past 2 years to meet the
regulatory requirements for shipping biological materials.
Part XI.
Required Trainings
All of the lab personnel listed in this Biosafety Application form have required trainings to complete.
This Application cannot be approved until all required trainings have been completed by lab personnel
All trainings are available on the SkillSoft web site:
http://www.ucdenver.edu/academics/research/AboutUs/health-safety/training/Pages/skillsoft.aspx
Required Courses
CU: Blood Borne Pathogens/Exposure Control Training
CU: Lab Safety Training
CU: Chemical Waste Management
CU: NIH Guidelines for rDNA (if this Protocol uses rDNA)
CU: Regulated Medical Waste Management
CU: Shipping of Biological Materials (if you are shipping/receiving
biological materials)
Radiation Safety (if you are using Radioactive Materials)
EHS BSF-001
Revision 13 (January 2016)
Course #
U00069
U00050
U00068
U00132
U00089
Frequency
Annually
Within 45 days of Hire
Annually
Once
Once
C20003
Every 2 Years
See EHS web site
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This space is for IBC and Biosafety Office Use
Authorization #:
Approval Date:
New
Expiration Date:
Amendment
Renewal
Biosafety Office Pre-review: Date
Personnel registered in EHS-A
Personnel training verified in EHS-A
HepB Vaccine Status Needs To Be Reviewed by OH
Lab Personnel and Training Status Letter to PI
Medical Surveillance / OH Review Needed for (list agent(s):
Pre-review Status:
No rDNA Research
Exempt rDNA Research
NIH Sections:
Requires IBC Review
N/A
Select Agents and Toxins:
Infectious Agents:
Human Tissue, Cells, Fluids
Biosafety Level:
BSL-1
Animal Biosafety Level:
Non-Human Primate Tissue, Cells, Fluids
BSL-2
ABSL-1
Animal Tissue, Cells, Fluids
BSL-3
ABSL-2
ABSL-3
Animal Species
Protocol Review Sheet Routed to IBC
No Review Comments
Pre-Review Comments:
Training Required:
Full Committee Review: Review Date
Approval Date
Expiry Date
Authorization Memo Date
NIH Sections:
N/A
Approved
Modifications Required
Deferred
Denied
Medical Surveillance / OH Review Needed
Biosafety Level:
BSL-1
Animal Biosafety Level:
BSL-2
ABSL-1
BSL-3
ABSL-2
ABSL-3
Animal Species
EHS BSF-001
Revision 13 (January 2016)
15
Information for IBC Minutes
Agent characteristics (e.g.
virulence, pathogenicity,
environmental stability)
Types of manipulations planned
Source(s) of the nucleic
sequences (e.g., species)
Nature of the nucleic acid
sequences (e.g., structural gene,
oncogene)
Host(s) and vector(s) to be used
Whether and attempt will be
made to obtain expression of a
foreign gene, and if so, the
protein that will be produced
EHS BSF-001
Comments
Part II, III (1, 2 & 3) & IV
List of what materials handled:
human, animal, cell lines, toxins,
transgenic animals,
microorganisms/RG, pathogens
in animals
Part IV-A-1 & Part III-C-6:
manipulations
PART III-C-3-a
Part III-C-3-b
Part III-C-4
Part III-C-5
Revision 13 (January 2016)
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