Brown University
Application for Biological Research Authorization
Please complete page 2 (and 3 if applicable) and only those sections below (I-V) that are relevant to the
laboratory’s use of biological materials (e.g.; microorganisms, cell lines, human materials, animals,
arthropods, toxins etc.).
PI NAME:______________________________________
One application per grant-funded, or University-funded project is NOT necessary. If one application can give
detail for multiple projects, please give the application a title fitting of the general work that will be done on
those projects. Completed applications must be signed electronically on page 13.
I.
II.
III.
IV.
V.
Recombinant or Synthetic Nucleic Acid Molecule Experiments
(p. 4) 
This section must be completed if the research involves the use of (i) molecules that a) are
constructed by joining nucleic acid molecules and b) that 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 (including nucleic
acids that integrate into the genome)
Microorganisms
(p.8) 
This section must be completed if the research involves the use of microbial agents including
bacteria, viruses and protozoa
Human/Non-Human Primate Materials including cell lines, blood, bodily fluids
(p.9) 
and tissues
This section must be completed for research using any of the above including screened/established
human/non-human primate blood, body fluid, cell lines, urine and saliva
Animals, Arthropods, Insects, Plants, Fungi or their tissues, fluids, cells
(p.10) 
This section must be completed if the research includes any of the above
Biological Toxins
(p.12) 
This section must be completed if the research includes any material from the select agents and
toxins list or other potential toxins
Renewal
Date of original application approval: __________________________________
Checking this box indicates that you are renewing a previously approved authorization. All renewal
applications must include original attachments (vector maps, descriptions of protocols and research scope).
They must also include an updated Exposure Control Plan. Please check the box below if you have
amended the authorization prior to renewal.
I have amended this application prior to its renewal. List amendment #’s: ___________________
Biological research that requires Institutional Biosafety Committee approval must not proceed until that approval has been
granted. Approvals are granted for three years however, if there are any changes in the approved protocol e.g., change of
agent (use of a new agent not already covered in the Biological Research Authorization), change of personnel, change of
location, please contact the Biological Safety Officer immediately as you may need to submit an amendment or update the
Exposure Control Plan.
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Application for Biological Research Authorization
Please contact with any
questions and return electronic
copy of the form to:
Biological Safety Officer
Office of Environmental Health & Safety
Box 1914
401-863-3087
IBC # __________ Date ____________
Action __________________________
Please refer to the IBC Policy at http://www.brown.edu/Administration/EHS/biological/
Principal Investigator (Last Name, First Name)
▲For EH&S Use Only ▲
Campus Box #:
Academic Title:
Email address:
Department:
Lab Location Building/Room: (list all Rooms):
Office Location:
List all spaces in which the biological materials for this project will be used e.g. shared lab, core facilities,
microscope room, animal housing etc. (list all shared spaces and responsible person for each):
Have the responsible parties for shared laboratory spaces/core facilities/housing/equipment rooms sent a copy of the letter of approval (page
3.) to the Biological Safety Officer?
 YES
 NO
List all personnel outside of your research group who may be impacted by the presence of your biological materials e.g. custodians in rooms
where rabies vector species are housed etc.
Office Phone #:
Lab Phone #:
Laboratory Supervisor (if not PI) Printed Name and Approval Signature:
Faculty Mentor/Experienced Collaborator (if applicable):
Project Title:
Project Start Date:
Project Duration:
Indicate Type of Laboratory:  Teaching Research Clinical Environmental
Biological Safety Cabinet or other enclosure?
Yes(location, type and certification date)______________________________  No
Highest Biosafety Level Required:  BSL-1  BSL-2  BSL-3  BSL-4
Repository Location (e.g. -80 Freezer): _________________________________
Please list all faculty, employees, and students involved in the project who will come in contact with these materials (Please note: A safety training
review will be conducted as part of the IBC review of this application. Please ensure all personnel are up-to-date on required safety training.)
Relevant Experience
(How many years? What kind of Relevant Experience?
Name and Title
Department
Telephone
Example: 4 years experience in tissue culture and
transfecting mammalian cells
Brown University Environmental Health and Safety
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Brown University
Application for Biological Research Authorization
This form letter must be electronically signed by the PI listed on page 2 with whom you share lab/storage space,
housing (when applicable) or equipment. Please send to all applicable PI’s. Once signed, this form must be
emailed to you (the Biological Research Authorization applicant) and forwarded to the Biological Safety Officer or
emailed directly to the Biological Safety Officer.
Dear Members of the Brown Institutional Biosafety Committee (IBC),
I have reviewed, evaluated and understand the project entitled: ___________________________________________
submitted to the IBC by: ______________________________________. I believe the information contained in this
application is accurate and complete. I agree to abide by the provisions of the application, the Exposure Control Plan
(where applicable to my space, equipment or personnel), current NIH Guidelines, the NIH Guide for Grants and Contracts,
Brown University policies and procedures, and local, state, and federal regulations.
If I feel that the procedures listed in the application or ECP are not being followed, I will address this issue with the
applicant PI and if necessary, the Biological Safety Officer.
I accept responsibility for the safe conduct of this work ONLY as it applies to my space, equipment or personnel. I will ensure that all
applicable personnel receive training in regard to proper safety practices and protective equipment needed for this work.
Electronic Signature (Principal Investigator) __________________________________________________
Brown University Environmental Health and Safety
Created: December 2012
Reviewed: February 2013
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I. SYNTHETIC/RECOMBINANT DNA EXPERIMENTS: (Indicate “yes or no” for each question per relevant part [I. and A-D] to determine the section of
the NIH Guidelines under which your research falls. Please note: inclusion in one section may exclude your work from another e.g., if your work can
best be categorized as fitting under section III-D-4-a of the Guidelines, it won’t likely also fall under sections in III-F). All researchers using
synthetic/recombinant nucleic acids must make this determination. )
http://oba.od.nih.gov/rdna/nih_guidelines_new.htm
YES NO

 The recombinant or synthetic nucleic acid molecules in your experiment can neither replicate nor generate nucleic acids that can
replicate in any living cell (e.g., oligonucleotides or other synthetic nucleic acids that do not contain an origin of replication or
contain elements known to interact with either DNA or RNA polymerase), and (2) are not designed to integrate into DNA, and (3)
do not produce a toxin that is lethal for vertebrates at an LD50 of less than 100 nanograms per kilogram body weight. If yes, the molecules
meet all 3 of the above criteria e.g., “they can neither replicate…” or “are not designed to integrate…” or “do not produce a
toxin…” , your research is categorized under section III-F-1 of the NIH Guidelines.


Are the recombinant or synthetic nucleic acid molecules in your experiment in organisms, cells , or viruses or have they been
modified or manipulated (e.g., encapsulated into synthetic or natural vehicles) to render them capable of penetrating cellular
membranes.? If no, your research is categorized under III-F-2 of the NIH Guidelines.


Do the recombinant or synthetic nucleic acid molecules in your experiment consist solely of the exact recombinant or synthetic
nucleic acid sequence from a single source that exists contemporaneously in nature? If yes, your research is categorized under
section III-F-3 of the NIH Guidelines.


Do the recombinant or synthetic nucleic acid molecules in your experiment 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? If yes, your research is categorized under III-F-4 of the NIH
Guidelines.


Do the recombinant or synthetic nucleic acid molecules in your experiment 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)? If yes, your research is categorized under III-F-5 of the NIH Guidelines.


Do the recombinant or synthetic nucleic acid molecules in your experiment 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, Exemptions Under Section III-F-6— Sublists of Natural Exchangers, for a list of natural exchangers
that are exempt from the NIH Guidelines. If yes, your research is categorized under III-F-6 of the NIH Guidelines.


Does your experiment involve the use of genomic DNA molecules that have acquired a transposable element, provided the
transposable element does not contain any recombinant and/or synthetic DNA? If yes, your research is categorized under III-F-7 of
the NIH Guidelines.


Do the recombinant or synthetic nucleic acid molecules in your experiment present a significant risk to health or the environment
(see Section IV-C-1-b- (1)-(c) as determined by the NIH Director, with the advice of the RAC, and following appropriate notice and
opportunity for public comment) NOR fall under any other sections of the NIH Guidelines? See Appendix C, Exemptions under Section III-F-8
for other classes of experiments which are exempt from the NIH Guidelines. If your experiment does not pose a significant risk to health
or the environment AS DETERMINED BY THE NIH DIRECTOR ETC., your research is categorized under III-F-8 of the NIH Guidelines
after approval from NIH/RAC. If your research does not pose a significant risk to health or the environment AND has NOT been
reviewed by the NIH Director, leave this question blank.


Does your research involve breeding two different transgenic rodents or a transgenic rodent and a non-transgenic rodent with the intent of
creating a new strain of transgenic rodent that can be housed at BL1 containment AND
(1) Both parental rodents can be housed under BL1 containment; and
(2) neither parental transgenic rodent contains the following genetic modifications: (i) incorporation of more than one-half of the genome of an
exogenous eukaryotic virus from a single family of viruses; or (ii) incorporation of a transgene that is under the control of a gammaretroviral
long terminal repeat (LTR); and
(3) the transgenic rodent that results from this breeding is not expected to contain more than one-half of an exogenous viral genome from a
single family of viruses?
If yes, this procedure is categorized under Appendix C-VIII of the NIH Guidelines.
A.
TISSUE CULTURE EXPERIMENTS INVOLVING SYNTHETIC/RECOMBINANT DNA
YES NO

 Do the recombinant or synthetic nucleic acid molecules in your experiment that are propagated and maintained in cells in
tissue culture contain less than one-half of any eukaryotic viral genome (all viruses from a single family being considered
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identical – see Appendix C-IX-E, Footnotes and References of Appendix C)? If yes, your research is categorized under
Appendix C-1 of the NIH Guidelines.


Do any recombinant or synthetic nucleic acid experiments involve Risk Groups 3, 4 or restricted organisms or nucleic acids
from Risk Groups 3, 4 or restricted organisms? If no, your research is categorized under Appendix C-1 of the NIH Guidelines.


Do any recombinant or synthetic nucleic acid experiments involve introduction of genes coding for molecules toxic for
vertebrates? If no, your research is categorized under Appendix C-1 of the NIH Guidelines.


Do any recombinant or synthetic nucleic acid experiments involve infectious viruses? If no, research is categorized under Appendix
C-1 of the NIH Guidelines


Do any recombinant or synthetic nucleic acid experiments involve defective viruses in the presence of helper viruses? If no,
your research is categorized under Appendix C-1 of the NIH Guidelines.


Do any recombinant or synthetic nucleic acid experiments involve whole plants regenerated from plant cells and tissue
cultures? If yes AND they remain axenic cultures even though they differentiate into embryonic tissue and regenerate
into plantlets, your research is categorized under Appendix C-1 of the NIH Guidelines.
B. EXPERIMENTS INVOLVING E.COLI K-12, YEAST, KLUYVEROMYCES LACTIS BACILLUS SUBTILIS/LICHENIFORMIS HOSTVECTOR SYSTEMS
YES NO

 Do any experiments involve Risk Groups 3, 4 or restricted organisms or nucleic acids from Risk Groups 3, 4 or restricted
organisms? If no, your research is categorized under Appendix C-II (for E. coli K-12) or Appendix C-III (for Saccharomyces
cerevisiae and Saccharomyces uvarum), Appendix C-IV (for Kluyveromyces lactis) or Appendix C-V (for Bacillus
subtilis/licheniformis).
.


Do any experiments involve introduction of genes coding for molecules toxic for vertebrates? If no, your research is categorized
under Appendix C- II (for E. coli K-12) or Appendix C-III (for Saccharomyces cerevisiae and Saccharomyces uvarum), Appendix
C-IV (for Kluyveromyces lactis or Appendix C-V (for Bacillus subtilis/licheniformis).


Will there be any large-scale experiments (more than 10 L of culture)? If no, your research is categorized under Appendix CII (for E. coli K-12) or Appendix C-III (for Saccharomyces cerevisiae and Saccharomyces uvarum), Appendix C-IV (for
Kluyveromyces lactis) or Appendix C-V (for Bacillus subtilis/licheniformis).


If using asporogenic Bacillus subtilis or asporogenic Bacillus licheniformis, are you using a strain which does not revert to a
spore-former with a frequency greater than 10-7? If yes, your research is categorized under Appendix C-V (for Bacillus
subtilis/licheniformis).
C. SYNTHETIC/RECOMBINANT DNA EXPERIMENTS THAT REQUIRE IBC APPROVAL AND DO NOT FALL INTO THE ABOVE SECTIONS
YES NO

 Is any human or animal pathogen (defined as a Risk Group 2, Risk Group 3, Risk Group 4, or Restricted Agents) used as
either the host organism or as a vector? If yes, your research is categorized under III-D-1 of the NIH Guidelines.
.


Is any recombinant or synthetic nucleic acid molecules from Risk Group 2, Risk Group 3, Risk Group 4 or restricted agents
cloned into nonpathogenic prokaryotic or lower eukaryotic host-vector systems? If yes, your research is categorized under
III-D-2 of the NIH Guideilnes.


Do recombinant or synthetic nucleic acid or RNA experiments involve the use of infectious DNA or RNA Viruses or Defective
DNA or RNA Viruses in the Presence of Helper Virus in Tissue Culture Systems? If yes, your research is categorized under
III-D-3 of the NIH Guidelines.


Do recombinant or synthetic nucleic acid or RNA experiments involve the use of defective animal or plant viruses in the
presence of helper virus in tissue culture systems? If yes, your research is categorized under III-D-3 of the NIH Guidelines.


Do recombinant or synthetic nucleic acid or RNA experiments involve whole animals (Section III-D-4) or plants (Section III-D5)? Indicate which________________ .


Do experiments involve more than 10 liters of culture? If yes, your research is categorized under III-D-6 of the NIH Guidelines.


Do experiments involve influenza viruses generated by recombinant or synthetic methods (e.g., generation by reverse
genetics of chimeric viruses with reassorted segments, introduction of specific mutations)? If yes, your research is categorized
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under III-D-7of the NIH Guidelines.


Do experiments NOT fall under sections III-A, III-B, III-C, III-D, III-F of the NIH Guidelines AND involve the formation of recombinant or
synthetic nucleic acid molecules containing no more than two-thirds of the genome of any eukaryotic virus? If yes, your research is
categorized under III-E-1 of the NIH Guidelines.


Do experiments NOT fall under sections III-A, III-B, III-C, III-D, III-F of the NIH Guidelines AND involve nucleic acid molecule-modified
whole plants, and/or experiments involving recombinant or synthetic nucleic acid molecule-modified organisms associated with whole
plants? If yes, your research is categorized under III-E-2 of the NIH Guidelines.


Do experiments NOT fall under section III-D-4 and involve the generation of rodents in which the animal's genome has been altered by
stable introduction of recombinant or synthetic nucleic acid molecules, or nucleic acids derived therefrom, into the germ-line (transgenic
rodents)but can be conducted at BSL-1? If yes, your research is categorized under III-E-3-a of the NIH Guidelines.
D. EXPERIMENTS THAT REQUIRE IBC, RAC REVIEW AND NIH DIRECTOR APPROVAL BEFORE INITIATION (III-A), EXPERIMENTS
THAT REQUIRE NIH/OBA AND IBC APPROVAL BEFORE INITIATION (III-B), AND EXPERIMENTS THAT REQUIRE IRB AND IBC
APPROVAL AND NIH/OBA REGISTRATION BEFORE INITIATION APPROVAL BEFORE INITIATION (III-C)
YES NO

 Does the research involve the transfer of drug resistance trait to an organism that does not acquire it normally (if it could
compromise the use of the drug to control disease agents in humans, animal or agriculture) ? If yes, your research is categorized
under III-A-1 of the NIH Guidelines.
.


Does the experiment involve the formation of recombinant or synthetic nucleic acid containing genes coding for the synthesis
of molecules toxic for vertebrates? If yes, your research is categorized under III-B-1 of the NIH Guidelines.


Does the experiment involve human gene transfer experiments? If yes, your research is categorized under III-C-1 of the
NIH Guidelines.
E. Describe below, specific host(s), vector(s), DNA(s) and what proteins will be produced? (NOTE: Recombinant/synthetic nucleic acid
molecules work that falls under any of the III-F sections or Appendices CI-CVIII excluding excepted paragraphs A, need not be described here and
you may skip directly to part F of this section. Otherwise, please complete.)
Host Cells:_________________________________________________________________________________________________
__________________________________________________________________________________________________________
__________________________________________________________________________________________________________
Vector(s): _________________________________________________________________________________________________
__________________________________________________________________________________________________________
___________________________________________________________________________________________________________
Inserted DNA/Synthetic Nucleic Acid Molecule:
__________________________________________________________________________________________________________
__________________________________________________________________________________________________________
___________________________________________________________________________________________________________
___________________________________________________________________________________________________________
Protein produced (if applicable):________________________________________________________________________________
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________

THE EXPERIMENTS IN THIS AUTHORIZATION CAN BE CATEGORIZED UNDER NIH GUIDELINES SECTION(S)(list all that
apply):_____________________________________________________________________________________
F. Can your experiment or part of your experiment be listed under sections III-A, III-B, III-C, III-D, III-E-1 or III-E-2 of the NIH Guidelines?
 Yes If yes, complete parts G and H of this application. If your project includes experiments that fall under sections
III-A, III-B, III-C, III-D, III-E-1, III-E-2
III-F, III-E-3a or Appendices CI-CVIII OF NIH Guidelines, complete parts G
and H of this application.
No If no, a.) Describe why your research (or part of your research) fits into section III-F, III-E-3a or Appendices CI-CVIII of the NIH
Guidelines and provide a brief summary of your research.
b.) Describe key features of any key features cell line, virus or bacteria used in this project and if the experiments will
result in acquisition of new characteristics e.g., enhanced virulence, infectivity, drug resistance, or change in host
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range. Give references if appropriate.
c.) Describe the source of the DNA/synthetic nucleic acid molecules, the nature of the inserted DNA/synthetic nucleic acid
molecules sequences, the host(s) and vector(s) to be used, if an attempt will be made to obtain expression of a foreign
gene and what protein will be produced. Be sure to account for whether or not the genes involved or expressed have
potential: toxicity, allergenicity or other risk to research personnel
d.) Percent of the pathogen genome present in the vector (kilobases of the parent pathogen in the vector and packaging
cell combined).
e.) Outline the general procedures and techniques that will be employed e.g., cell culture, bacterial culture, DNA isolation.
f.) Complete a copy of the Exposure Control Plan (page 13).
____________________________________________________________________________________________________
_____________________________________________________________________________________________________
_____________________________________________________________________________________________________
______________________________________________________________ INCLUDE AS ATTACHMENT IF NECESSARY
G. If your experiment or part of your experiment can be listed under sections III-A, III-B, III-C, III-D, III-E-1 or III-E-2 of the NIH Guidelines,
please complete the following fields. In submitting this application, you agree to understand and comply with the Principal Investigator
responsibilities outlined in section IV-B-7 of the NIH Guidelines found here:
http://oba.od.nih.gov/oba/rac/Guidelines/NIH_Guidelines.htm#_Toc7261589
i.
Provide a brief summary of your research involving recombinant or synthetic nucleic acid molecules in non-technical language
INCLUDE AS ATTACHMENT IF NECESSARY:
________________________________________________________________________________________________________
________________________________________________________________________________________________________
________________________________________________________________________________________________________
________________________________________________________________________________________________________.
ii.
Will the experiment be carried out in E. coli or other prokaryotic host?
 Yes
 No
If yes, specify: _________________________________________________________________________________________
Host strains: ___________________________________________________________________________________________
Vectors: _______________________________________________________________________________________________
Inserted DNA/synthetic nucleic acid molecules (include names of genes and organisms from which they were cloned):
_______________________________________________________________________________________________________
Will whole virus or provirus be cloned?
 Yes
 No
NIH Guideline Section: _________________________ Recommended Biosafety Level: __________________________
iii. Will the experiment be carried out in eukaryotic cells?
 Yes
 No
If yes, specify: _________________________________________________________________________________________
Host strains: ___________________________________________________________________________________________
Vectors: _______________________________________________________________________________________________
Inserted DNA/synthetic nucleic acid molecules:
_______________________________________________________________________________________________________
Helper virus or packaging cells if used: ____________________________________________________________________
What fraction of a eukaryotic viral genome is contained in the recombinant DNA molecules (including vector and insert)?
 <1/2
 >1/2 but <2/3
 >2/3
NIH Guidelines Section: _________________________ Recommended Biosafety Level: __________________________
iv. Will the experiment be carried out using whole plants or animals as hosts?  Yes
 No
If yes, specify: _________________________________________________________________________________________
Host strains: ___________________________________________________________________________________________
Vectors: _______________________________________________________________________________________________
Inserted DNA/synthetic nucleic acid molecules: ______________________________________________________________
________________________________________________________________________________________________________
Helper virus or packaging cells if used: ____________________________________________________________________
What fraction of a eukaryotic viral genome is contained in the recombinant DNA/synthetic nucleic acid molecule?
 <2/3
 >2/3
NIH Guidelines Section: _________________________ Recommended Biosafety Level: __________________________
v. Will any of the sequences code for toxins?
 Yes (LD50)__________  No
vi. Will VSV-G be used for pseudotyping and are you aware that this can increase the risk of exposure through absorption and
inhalation along with injection and ingestion?
 Yes

 No
vii. If using adeno or lentivirus, will you be using third or fourth generation systems for safety? 
 Yes
 No
viii. If using oncogene inserts, a DNA sequencing library shall be kept. Indicate the location of these
records____________________________
H. SPECIFIC NUCLEIC ACID INFORMATION
a.) Describe the source of the DNA/synthetic nucleic acid molecules, the nature of the inserted DNA/synthetic nucleic acid
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molecules sequences, the host(s) and vector(s) to be used, if an attempt will be made to obtain expression of a foreign
gene and what protein will be produced. Be sure to account for whether or not the genes involved or expressed have potential:
toxicity, allergenicity or other risk to research personnel
b.) Attach vector maps
c.)Describe key features of the agent, virus or bacteria used in this project and if the experiments will result in acquisition
of new characteristics e.g., enhanced virulence, infectivity, drug resistance, or change in host range. Give references if
appropriate.
d.) Percent of the pathogen genome present in the vector (kilobases of the parent pathogen in thevector and packaging cell
combined).
e.) Will the research involve the use of antibiotic selection markers?  Yes  No If yes, list the markers and microbial agents used
(e.g. neomycin resistance marker in E. coli)
f.) Complete a copy of the Exposure Control Plan (page 13). INCLUDE AS ATTACHMENT IF NECESSARY
_________________________________________________________________________________________________________________
_________________________________________________________________________________________________________________
_________________________________________________________________________________________________________________
______________________________________________________________________________________________________________
II. MICROORGANISMS
NonPathogenic
Other
























BSL-1,2, 2+
Animal
Pathogen
Plant
Pathogen
Opportunis
tic Human
Pathogen
A.
Strain
Human
Pathogen
Agent (genus and species)
Building &
Room agent is
used or stored
(indicate which)
ex. SFH 229
stored
Biosafety
Cabinet
make,
model and
Certification
Date
Is there a baseline serological test, vaccine, therapeutic treatment or post-exposure prophylaxis/plan (PEP) available should someone
in the lab become exposed (If several microorganisms are indicated above, please list vaccine, therapeutic treatment, or PEP for each.
The details of the PEP should be included in the Exposure Control Plan document)?
___________________________________________________________________________________________________________________
___________________________________________________________________________________________________________________
__________________________________________________________________________________________.
Answer the questions below per microorganism if using multiple microorganisms.
 Yes (microorganism)_____________, largest volume _________ No
B.
Do you work with quantities greater than 1 liter?
C.
Do you inactivate the agent/material prior to other laboratory manipulations?  Yes (microorganism) ______________ No
If yes, select method:  Heat ______________  Chemical _____________  Radiation____________ Other_____________
D.
Do you concentrate the material?  Yes (microorganism) ______________  No
If yes, select method:  Centrifuge___________  Filtration ____________  Precipitation____________  Other_________
E.
Do you insert the agent into intact animals?  Yes, which microorganism/ animal species________________________  No
IACUC Approval?  Yes, number___________________
No
 Pending
F.
If agent inserted into animal is a virus or viral vector, indicate the shedding period (if multiple, specify shedding period for each).
________________________________________________________________________________________________
G.
Will this project at any time involve shipping biological materials over public thoroughfares or transporting between two Brown
University owned or affiliated facilities? No  Yes, explain _________________________________________________________
______________________________________________________________________________________________________________.
H.
Does the research involve human subjects or human products?  No  Yes  N/A Commercial Cell Lines
IRB Approval?  Yes, number___________________
No
 Pending  N/A
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I.
If you have not provided the following details from section I. Recombinant DNA Experiments, please complete the following:
Provide a brief summary of your research (nature and purpose):
 I have answered this question previously
___________________________________________________________________________________________________________________
___________________________________________________________________________________________________________________
___________________________________________________________________________________________________________________
_____________________________________________________________________________INCLUDE AS ATTACHMENT IF NECESSARY.
J.
If you have not provided the following details from section I. Recombinant DNA Experiments, please complete the following:
a.) Describe the nature of the host(s) and vector(s) to be used.
b.)Describe key features of the agent, virus or bacteria used in this project and if the experiments will result in acquisition
of new characteristics e.g., enhanced virulence, infectivity, drug resistance, or change in host range. Give references if
appropriate.
c.) Outline the general procedures and techniques that will be employed e.g., cell culture, bacterial culture, DNA isolation.
d.) Complete a copy of the Exposure Control Plan (page 13).
 I have answered this question previously
_____________________________________________________________________________________________________
_____________________________________________________________________________________________________
_____________________________________________________________________________________________________
_____________________________________________________________________________________________________
_______________________________________________________________ INCLUDE AS ATTACHMENT IF NECESSARY
III. HUMAN/NON-HUMAN PRIMATE MATERIALS
ALL Human/Non-Human Primate Materials require BSL-2 unless fixed or embedded.
A. Human Materials/NHP Materials
Human/NHP Material
Blood
Type and Source
All Buildings and Rooms where used/stored
Body Fluids
Organs
Tissues
B. Tissue Culture
Primary Cell Lines/ Continuous Cell Lines
(indicate which)
C. Transplantable tumors
Tumor/Description
Type and Source
D. Hybridoma
Carrier cell line
E.
In vivo/In vitro
Type and Source
All Buildings and Rooms where used/stored
Animal or Tissue Culture
All Buildings and Rooms where used/stored
Animal Used
All Buildings and Rooms where used/stored
Is there a baseline serological test, vaccine, therapeutic treatment or post-exposure prophylaxis/plan (PEP) available should someone
in the lab become exposed (If several microorganisms are indicated above, please list vaccine, therapeutic treatment, or PEP for each.
The details of the PEP should be included in the Exposure Control Plan document)?
Brown University Environmental Health and Safety
Created: December 2012
Reviewed: February 2013
BSO-1
Page
9
Brown University
Application for Biological Research Authorization
___________________________________________________________________________________________________________________
___________________________________________________________________________________________________________________
___________________________________________________________________________________________________________________
F.
G.
H.
I.
J.
K.
Do you work with quantities greater than 1 liter?  Yes (human material)_____________, largest volume ________ No
Do you concentrate the material?  Yes (microorganism) ______________  No
If yes, select method:  Centrifuge___________  Filtration ____________  Precipitation____________  Other_________
Do you insert the material into intact animals?  Yes, which microorganism/ animal species_____________________  No
IACUC Approval?  Yes, number___________________
No
 Pending
Will this project at any time involve shipping biological materials over public thoroughfares or transporting between two Brown
University owned or affiliated facilities? No  Yes, explain  I have answered this question previously
___________________________________________________________________________________________________________________
___________________________________________________________________________________________________________________
_____________________________________________________________________________________________________________
Does the research involve human subjects or human products?
 No
 Yes
 N/A Commercial Cell Line  I have answered this question previously
IRB Approval?  Yes, number___________________
L.
M.
No
 Pending  N/A
If you have not provided the following details from section I. Recombinant DNA Experiments, or section II. Microorganisms, please
complete the following:
Provide a brief summary of your research (nature and purpose):
 I have answered this question previously
___________________________________________________________________________________________________________________
___________________________________________________________________________________________________________________
___________________________________________________________________________________________________________________
___________________________________________________________________________ INCLUDE AS ATTACHMENT IF NECESSARY.
If you have not provided the following details from section I. Recombinant DNA Experiments, or section II. Microorganisms, please
complete the following:
a.) Describe the nature of the human material(s), host(s) and vector(s) to be used.
b.)Describe key features of the human material, virus or bacteria used in this project and if the experiments will result in
acquisition of new characteristics e.g., enhanced virulence, infectivity, drug resistance, or change in host range. Give
references if appropriate.
c.) Outline the general procedures and techniques that will be employed e.g., cell culture, bacterial culture, DNA isolation.
d.) Complete a copy of the Exposure Control Plan (page 13).
 I have answered this question previously
_____________________________________________________________________________________________________
_____________________________________________________________________________________________________
_______________________________________________________________ INCLUDE AS ATTACHMENT IF NECESSARY .
IV. ANIMALS, ARTHROPODS, INSECTS OR PLANTS
A.
Animal/Arthropod/Insect/Plant
Animal/Arthropod/Insect
/Plant (Genus species)
B.
Tissue Culture
Cell Line
USDA, USFW, CDC
Permit Applicable
only for
capture/transport
(indicate which)
Biosafety Level (BSL-#),
Animal Biosafety
Level(ABSL-#), Plant
Biosafety Level (BL#-P)
For containment
Type and Source
Biosafety Level
Brown University Environmental Health and Safety
Created: December 2012
Reviewed: February 2013
BSO-1
Transgenic or
Creating
Transgenic
If yes, please make
sure this is
represented in
section I of this
form
Screened
for
pathogens
prior to
arrival?
All Buildings
and Rooms
where
used/stored
All Buildings and Rooms where used/stored
Page
10
Brown University
Application for Biological Research Authorization
C.
Transplantable tumors
Tumor/Description
D.
Type and Source
Animal or Tissue Culture
Biosafety Level
All Buildings and Rooms
where used/stored
In vivo/In vitro
Animal Used
Biosafety Level
All Buildings and Rooms
where used/stored
Hybridoma
Carrier cell line
Do not complete the section below if you’ve already answered these questions for Non-Human Primates in section III.
E.
Is there a baseline serological test, vaccine, therapeutic treatment or post-exposure prophylaxis/plan (PEP) available should someone
in the lab become exposed (If several microorganisms are indicated above, please list vaccine, therapeutic treatment, or PEP for each.
The details of the PEP should be included in the Exposure Control Plan document, page 13)?
__________________________________________________________________________________________________________
___________________________________________________________________________________________________________________
___________________________________________________________________________________________________
Do you work with quantities greater than 1 liter?  Yes (material type)_____________, largest volume _____________ No
F.
Do you concentrate the material?  Yes (material type) ______________  No
G.
If yes, select method:  Centrifuge___________  Filtration ___________  Precipitation____________  Other_________
Do you insert the material into intact animals?
 Yes, which microorganism/ animal species_____________________  No
H.
I.
IACUC Approval?  Yes, number___________________
No
 Pending
Will this project at any time involve shipping biological materials over public thoroughfares or transporting between two Brown
University owned or affiliated facilities?
No  Yes, explain (You may skip this question if you have answered in a previous
section)_____________________________________________________________________________________________________________
_________________________________________________________________________________________________________
Does the research involve human subjects or human products?
 No
 Yes  N/A Commercial Cell Lines (You may skip this
question if you have answered in a previous section)
IRB Approval?  Yes, number___________________
No
 Pending
J.
If you have not provided the following details in section I. Recombinant DNA Experiments, section II. Microorganisms, or section III.
Human Materials please complete the following:
Provide a brief summary of your research (nature and purpose):
 I have answered this question previously
___________________________________________________________________________________________________________________
___________________________________________________________________________________________________________________
___________________________________________________________________________________________________________________
____________________________________________________________________________ INCLUDE AS ATTACHMENT IF NECESSARY.
K.
If you have not provided the following details in section I. Recombinant DNA Experiments, section II. Microorganisms, or section III.
Human Materials please complete the following:
a.) Describe the nature of the biological material(s), host(s) and vector(s) to be used.
b.) Describe key features of the biological material, virus or bacteria used in this project and if the experiments will result in
acquisition of new characteristics e.g., enhanced virulence, infectivity, drug resistance, or change in host range. Give
references if appropriate.
c.) Outline the general procedures and techniques that will be employed e.g., cell culture, bacterial culture, DNA isolation.
d.) Complete a copy of the Exposure Control Plan (page 13).
 I have answered this question previously
Brown University Environmental Health and Safety
Created: December 2012
Reviewed: February 2013
BSO-1
Page
11
Brown University
Application for Biological Research Authorization
_____________________________________________________________________________________________________________
_____________________________________________________________________________________________________________
_______________________________________________________________________ INCLUDE AS ATTACHMENT IF NECESSARY
V. Biological Toxins and Select Agents (For more information on the Select Agents and Toxins Program e.g., list of agents, regulatory limits etc.,
please visit the following URL: http://www.selectagents.gov/)
A.
Biological Toxins and Select Agents
Type of
Toxin/Select
Agent
Ex:Tetrodotoxin
Total Amount in
Lab/Supplier
Experimental
Concentration
2mg/ Sigma
0.05 m
Toxin LD50
Human
Animal
334g/kg
.334
mg/kg
Biosafety
Level
(BSL)
2
Inactivation
Protocol
Prepared?
Yes See
attachment
All Buildings and Rooms
where used/Stored
SFH 887
B.
Is there a baseline serological test, vaccine, therapeutic treatment or post-exposure prophylaxis/plan (PEP) available should someone
in the lab become exposed (If several agents/toxins are indicated above, please list vaccine, therapeutic treatment, or PEP for each.
The details of the PEP should be included in the Exposure Control Plan document)?
__________________________________________________________________________________________________________
___________________________________________________________________________________________________________________
___________________________________________________________________________________________________
B.
C.
Do you work with quantities greater than 1 liter?  Yes (material type)_____________, largest volume _______________ No
Do you concentrate the material?  Yes (material type) ______________  No
If yes, select method:  Centrifuge___________  Filtration ___________  Precipitation____________  Other_________
D.
Do you insert the material into intact animals?
 Yes, which microorganism/ animal species_____________________  No
IACUC Approval?  Yes, number___________________
No
 Pending
Will this project at any time involve shipping biological toxins/select agents over public thoroughfares or transporting between two
Brown University owned or affiliated facilities?
No  Yes, explain (You may skip this question if you have answered in a previous
section)____________________________________________________________________________________________________________
________________________________________________________________________________________________________
Does the research involve human subjects or human products?
 No
 Yes  N/A Commercial Cell Lines
 I have answered this question previously
IRB Approval?  Yes, number___________________
No
 Pending
E.
F.
G.
If you have not provided the following details in section I. Recombinant DNA Experiments, section II. Microorganisms, section III.
Human Materials or section IV. Animals, Arthropods, Insects or Plants please complete the following:
Provide a brief summary of your research (nature and purpose):
 I have answered this question previously
__________________________________________________________________________________________________________________
__________________________________________________________________________________________________________________
__________________________________________________________________________________________________________________
________________________________________________________________________________.
H.
If you have not provided the following details in section I. Recombinant DNA Experiments, section II. Microorganisms, section III.
Human Materials or section IV. Animals, Arthropods, Insects or Plants please complete the following:
a.) Describe the nature of the biological toxin(s)/select agent(s), host(s) and vector(s) to be used.
b.)Describe key features of the biological toxin/select agent, virus or bacteria used in this project and if the experiments will
result in acquisition of new characteristics e.g., enhanced virulence, infectivity, drug resistance, or change in host range.
Give references if appropriate.
c.) Outline the general procedures and techniques that will be employed e.g., cell culture, bacterial culture, DNA isolation.
d.) Complete a copy of the Exposure Control Plan ([age 13).
 I have answered this question previously
_____________________________________________________________________________________________________
_____________________________________________________________________________________________________
_____________________________________________________________________________________________________
________________________________________________________________INCLUDE AS ATTACHMENT IF NECESSARY .
Brown University Environmental Health and Safety
Created: December 2012
Reviewed: February 2013
BSO-1
Page
12
Brown University
Application for Biological Research Authorization
The application form (summary and any attachments) must provide sufficient detail for the Biological Safety Committee to understand
and evaluate components of the project in order to review the application. For attached published references, please highlight pertinent
paragraphs or sentences. Submissions that lack detail or are illegible will be deferred from action and returned for revision and
resubmission. Incomplete applications may be delayed.
Certification and Signature
The information contained in this application is accurate and complete. I am familiar with and agree to abide by the provisions of the
current NIH Guidelines, the NIH Guide for Grants and Contracts, Brown University policies and procedures, and local, state, and federal
regulations.
In addition, I agree to abide by the following requirements:
a. I will initiate no recombinant or synthetic nucleic acid molecule research subject to the NIH Guidelines until
that research has been reviewed by the Biological Safety Committee.
b. I will follow appropriate biosafety level laboratory techniques in the research.
c. I will comply with all shipping requirements for recombinant or synthetic nucleic acid materials.
d. I will make available to the laboratory staff copies of the approved protocols that describe the potential
biohazards and the precautions to be taken.
e. I will have a specific protocol in place for post-exposure prophylaxis and/or treatment and my laboratory
personnel will know it’s location and have access to this document at all times.
f. I will train the laboratory staff in good microbiological practices and techniques required to ensure safety for
this project, in the procedures for dealing with accidents, and in waste management procedures, prior to any
project work and at least annually thereafter.
g. I will ensure that all laboratory staff are listed with the Office of Environmental Health & Safety.
h. I will submit in writing a request for approval from the Biological Safety Committee for any significant
modifications to the study, facilities, or procedures.
i. I will supervise staff, and correct work errors and conditions that could result in breach of the NIH Guidelines
or Brown University policy.
j. I will submit to the Biosafety Officer, the Biological Safety Committee, and the Office of Recombinant DNA
Activities at NIH (if applicable), reports of any research related accident, exposure incident, release of
recombinant or synthetic nucleic acid molecules to the environment, problems pertaining to the
implementation of biological and physical containment procedures, or violations of the NIH Guidelines
k. I have read and understood the United States Government Policy for Oversight of Life Sciences Dual Use
Research of Concern (DURC)
http://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=2&ved=0CDQQFjAB&url=http%3A%2F
%2Foba.od.nih.gov%2Foba%2Fbiosecurity%2FPDF%2FUnited_States_Government_Policy_for_Oversight_o
f_DURC_FINAL_version_032812.pdf&ei=KkMzUuLAD8u4APYm4HgAw&usg=AFQjCNFjinfNI2PPtgpyrA4bKJ3rCgKCug&bvm=bv.52164340,d.dmg
I have notified the Institutional Biosafety Committee (IBC) and the Biological Safety Officer as to the
applicability of this program to my research.
Please identify either yourself or another individual who has significant and appropriate microbiological education and experience to conduct the work at
the biosafety level requested and with the biohazards identified.
Circle one:
Self
Other ____________________________________________
Name of Identified Individual
Signature _________________________________________
Electronic Signature of Identified Individual
As Principal Investigator, I accept responsibility for the safe conduct of work with this material. I will ensure that all personnel receive
training in regard to proper safety practices and protective equipment needed for this work.
Electronic Signature (Principal Investigator) __________________________________________________
Brown University Environmental Health and Safety
Created: December 2012
Reviewed: February 2013
BSO-1
Date: ___________
Page
13
Brown University
Application for Biological Research Authorization
Exposure Control Plan
Brown University’s Institutional Biosafety Committee, along with the Office of
Environmental Health and Safety, has developed a template Exposure Control Plan (ECP) for
all Biological Research Authorizations and Biological Safety Manuals.

The Laboratory Supervisor must read the ECP template and carefully fill out key
components specific to the protocol in which it belongs. In some cases one ECP may be
thorough enough to be used for more than one protocol however, ALL ECP’s involving
the use of human/non-human primate blood, cells, tissues, or bodily fluid must be
reviewed and updated annually. All other ECP’s must be reviewed and updated when
necessary (i.e., a change of agent, procedure, location, or staff). It is the responsibility of
the PI to ensure that all personnel who will be working on the protocol are listed on the
application and in the ECP and that they complete all of the required Brown University
EHS safety training.
Please contact Brown University’s Biological Safety Officer for assistance at 401-863-3353.
Brown University Environmental Health and Safety
Created: December 2012
Reviewed: February 2013
BSO-1
Page
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Brown University
Application for Biological Research Authorization
Exposure Control Plan (ECP)
POLICY
Brown University is committed to providing a safe and healthful work environment for faculty, students, and staff. In
pursuit of this goal, the following Exposure Control Plan (ECP) is provided to assist researchers in developing procedures
to eliminate or minimize occupational exposure to biological hazards and bloodborne pathogens in accordance with the
Institutional Biosafety Committee (IBC) and OSHA standards. This ECP includes:


Determination of researcher exposure
Implementation of various methods of exposure control, including:









Universal precautions
Engineering and administrative controls
Personal protective equipment
Hepatitis B vaccination
Disinfection/sterilization
Housekeeping
Post-exposure evaluation and follow-up
Recordkeeping
Communication of hazards to visitors/contractors and training
Implementation methods for these elements of the standard are discussed in the subsequent pages of this ECP.
Please Note: Where biological research is conducted with hazardous chemicals, the Chemical Hygiene Plan, Chemical
Safety Protocols and Lab Safety Manual shall be used according to the policies discussed in Laboratory Safety Training.
PROGRAM ADMINISTRATION
The Laboratory Supervisor (listed below) is responsible for implementation of the ECP in location(s) covered by the plan,
will maintain, review and update the ECP at least annually, and whenever necessary to include new or modified tasks and
procedures.
Laboratory Supervisor Name/Research Location:
Title of the protocol covered by this ECP:
IBC Authorization number of the protocol covered by
this ECP:
Contact Number (include area code):
24-Hour Contact Number (mobile/home):
RESEARCHER EXPOSURE DETERMINATION
The following is a list of all laboratory personnel who perform tasks and procedures in which occupational exposure may
occur and who must comply with all provisions outlined in this Exposure Control Plan.
Brown University Environmental Health and Safety
Created: December 2012
Reviewed: February 2013
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Brown University
Application for Biological Research Authorization
Name/Job Title (example: John Smith,
Research Asst.)
Department/Laboratory Location
(example: MCB/BMC 864)
Task/Procedure where occupational
exposure may occur (example: Cell
injection in live mice)
METHODS OF IMPLEMENTATION AND CONTROL
Universal Precautions
Universal Precautions is an approach to infection control. According to the concept of Universal Precautions, all human
blood and other potentially infectious material (OPIM) such as certain human body fluids are treated as if known to be
infectious for HIV, HBV, and other bloodborne pathogens.
Even when working with biological substances believed not to be infectious, researchers shall use universal precautions.
Exposure Control Plan Training
In addition to completion of Brown University EHS Biological Safety Training and Bloodborne Pathogen (BBP)
Training, researchers shall read and understand the specific ECP for the protocol on which they are assigned.
Engineering Controls and Administrative Controls
Engineering controls and administrative controls will be used to prevent or minimize exposure to biological materials and
bloodborne pathogens. Whenever possible, select and utilize engineering controls and administrative controls that mitigate
exposure such as, but not limited to:
 Appropriate Biosafety Cabinets
 Non-glass capillary tubes
 Sharps with Engineered Sharps Injury Protections (SESIP’s)
 Needleless systems
 Personal protective equipment
Administrative controls are defined as: controlling workplace hazards through methods such as training, written operating
procedures, work permits, safe work practices, exposure time limitations, alarms, signs, and warnings.
The specific engineering controls and administrative controls used as part of this research protocol are listed below:
Engineering Controls (example: Biosafety Cabinet)
Brown University Environmental Health and Safety
Created: December 2012
Reviewed: February 2013
BSO-1
Administrative Controls (example: food and drink
prohibited in lab)
Page
16
Brown University
Application for Biological Research Authorization
Sharps containers shall be replaced before they become overfilled to prevent needle sticks. Sharps must fit completely
into the selected sharps container (i.e., not to exceed the manufacturers marked "full" line). Do not bend, break, re-cap, or
re-sheath any needle. Do not force or push any item into a sharps container. When the fill line is reached, sharps
containers must be closed and locked (all sharps containers come with a locking mechanism). Requests for full sharp
container pick-up and replacement containers supplied by Environmental Health and Safety can be made through the
Container Request form located at the following URL:
http://brown.edu/Administration/EHS/container_disposal/
Personal Protective Equipment (PPE)
Describe below, the appropriate PPE that will be used for specific tasks or procedures. (Examples: Nitrile gloves shall be
used for handling specimens preserved in formaldehyde, splash goggles will be worn while performing blood draws on
mice etc.) Remember, a minimum level of PPE must be worn in the lab at all times i.e., safety glasses and appropriate
clothing.
PPE (example: splash goggles)
Task/Procedure (example: worn when pouring liquid
nitrogen)
All researchers using PPE must observe the following precautions:




Remove gloves carefully to avoid spraying or spatter
Wash hands immediately or as soon as feasible after removing gloves or other PPE.
Remove PPE after it becomes contaminated and before leaving the work area
For proper disposal of PPE please refer to the Brown University Biological Waste Program found at the following
URL:
http://brown.edu/Administration/EHS/policies/biological_waste_program.pdf





Wear appropriate gloves when it is reasonably anticipated that there may be hand contact with blood or OPIM,
and when handling or touching contaminated items or surfaces; replace gloves if torn, punctured or contaminated,
or if their ability to function as a barrier is compromised
Never wash or decontaminate disposable gloves for reuse.
Wear appropriate face and eye protection when splashes, sprays, spatters, or droplets of blood or OPIM pose a
hazard to the eye, nose, or mouth
Remove immediately or as soon as feasible any garment contaminated by blood or OPIM, in such a way as to
avoid contact with the outer surface
If utility gloves are being used, dispose if contaminated
Brown University Environmental Health and Safety
Created: December 2012
Reviewed: February 2013
BSO-1
Page
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Brown University
Application for Biological Research Authorization
Vaccination/Screening Program
Are there any non-routine measures such as special vaccinations or additional health screening techniques that would
potentially benefit research staff participating in or supporting this project?
___ No.
___ Yes. If yes, describe_____________________________________________________________________
__________________________________________________________________________________________________
_________________________________________________________________________________.
Please indicate a Post Exposure prophylaxis or treatment if applicable: (e.g., anti-viral medication for certain viral
exposures), or if specific procedures are required, describe the Post Exposure Plan (PEP) here:
__________________________________________________________________________________________________
__________________________________________________________________________________________________
.
Disinfection and Sterilization
Disinfection and sterilization is important for any biological research or biological waste disposal. To choose an
appropriate disinfectant, the identity of the micro-organisms, their concentration and the degree of inactivation desired
should be considered. Physical factors such as whether a space or surface is to be decontaminated, the type of surface, and
any interaction between the material and potential disinfectants should also be factored in the selection. Time available for
disinfection and the time required for particular disinfectants to be effective need to be considered. For clarification,
“disinfection” is not sporicidal. A few disinfectants will kill spores with prolonged exposure times (3-12 hours) and are
called “chemical sterilants.”
Factors that may affect the efficacy of chemical disinfectants include the following:







Organic and inorganic load present
Type and level of microbial contamination
Concentration of and exposure time to the germicide
Physical nature of the object (e.g., crevices, hinges etc.)
Presence of biofilms
Temperature and pH of the disinfection process
In some cases, relative humidity of the sterilization process
Most disinfectant solutions need to be regularly prepared as fresh solutions to avoid growth of micro-organisms in the
solution and to ensure optimum activity of the disinfectant chemical.
Remember to don proper PPE including chemically resistant gloves while performing disinfection.
If using commercial disinfectants, Federal law requires all applicable label instructions on EPA-registered products to be
followed (e.g., use-dilution, shelf life, storage, material compatibility, safe use, and disposal). If the user selects exposure
conditions (e.g., exposure time) that differ from those on the EPA-registered products label, the user assumes liability for
any injuries resulting from off-label use and is potentially subject to enforcement action under Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) 65.
Brown University Environmental Health and Safety
Created: December 2012
Reviewed: February 2013
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Brown University
Application for Biological Research Authorization
Disinfection Tool (Table 1):
All University researchers, staff and students listed in this Exposure Control Plan must reference this chart before
engaging in a protocol, disposing of, storing, or transporting within a building biological materials in order to understand
the specific disinfectants that must be used in the authorization.
Using the Disinfection Tool (Table 1):
For all biological materials, and biological wastes encountered, the users of an Exposure Control Plan must indicate which
disinfectant or sterilant they intend to use along with the recommended dilution, contact time, pH and temperature. A
reference in which this disinfectant was recommended must be included in the column labeled “REFERENCE.” If using
an EPA-registered or commercial product for disinfection/sterilization please also indicate the name of this product along
with its recommended dilution, contact time, pH and temperature (in the disinfection table provided). If utilizing steam
sterilization, indicate the settings used i.e., time, temperature and pressure. A good resource for this information is the
“Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008” from the Centers for Disease Control (CDC).
To obtain a list of Selected EPA-registered Disinfectants visit:
http://www.epa.gov/oppad001/chemregindex.htm
Attachments to this table may be included.
Spaces within the table that are shaded and marked “NR” refer to disinfectants that were specifically Not Recommended
for certain biological materials/wastes by either the CDC, World Health Organization (WHO) and/or the Brown
University Institutional Biosafety Committee. For example, the prions category marked with many “NR’s” were shown to
have a high innate resistance to many chemical germicides. In fact, proper chemical decontamination for prions as
recommended by the WHO include a combination heat and NaOH or for surfaces, by flooding for one hour, with NaOH
or sodium hypochlorite, followed by water rinses.
If in the course of your research you find conflicting support for disinfectants/sterilants that have been automatically
labeled as “NR” in the Disinfection Tool, please include a reference that indicates your selected disinfectant is effective. It
is possible that a product listed as “NR” might be sufficient for the type of disinfection/sterilization you require.
Additionally, when using this tool please consider the exceptions and restrictions listed below.
Exceptions and Restrictions:







Ethanol is not recommended for surface contamination due to the low contact time before evaporation
Bleach dilutions made be made fresh daily as the efficacy only last 24 hours
Formaldehyde is not a recommended disinfectant due to its carcinogenic properties and its Short Term Exposure
Limit (STEL) of 2ppm as set by OSHA.
Hydrogen peroxide can cause cosmetic and functional changes in equipment
UV radiation has several potential applications, but unfortunately its germicidal effectiveness and use is
influenced by organic matter; wavelength; type of suspension; temperature; type of microorganism; and UV
intensity, which is affected by distance. UV radiation is not recommended to disinfect surfaces because of lack of
penetration
The level of biocidal activity of Ortho-phthalaladehyde(OPA) was directly related to the temperature. 0.5% OPA
was not sporicidal with 270 minutes of exposure
Paracetic Acid and Hydrogen Peroxide can cause cosmetic and functional changes in equipment
Brown University Environmental Health and Safety
Created: December 2012
Reviewed: February 2013
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Page
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Brown University
Application for Biological Research Authorization
Table 1.
Steam Sterilization
(specify temp, time, and
pressure setting)
Gaseous Disinfectants
(ETO etc.)
Commercial
Disinfectant/Sterilizer
Alcohols
REFERENCE
NR
NR
NR
Glutaraldehyde
Paracetic Acid and
Hydrogen Peroxide
Phenolics
Quaternary Ammonium
Compounds
Ultraviolet (UV) Radiation
Wastes
NR
NR
NR
NR
Chlorine and Chlorine
Compounds
Formaldehyde
Hydrogen Peroxide
Iodophores
Ortho-phthalaldehyde
Paracetic Acid
Protozoa
Bloodborne
Pathogens
Prions
Cells
DNA
Lipid or
Medium-size
Viruses
Vegetative
bacteria
Fungi
Nonlipid or
Small Viruses
Gram (+)
bacteria
Gram (-)
bacteria
Micro-Organisms/Biologically Active Substances and Wastes
Spores
Sterilizer/Disinfectant
NR
NR
NR
NR
NR
NR
Fungal ascospores
NR
Some mycobacteria
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
C.parvum
NR
C.parvum
Cryptosporidium
NR
C.parvum
Cryptosporidium
NR
NR
NR
C.parvum
NR
NR
NR
NR
NR
NR
NR
NR
NR
mycobacteria
NR
NR
C.parvum
NR
= Not Recommended
Brown University Environmental Health and Safety
Created: December 2012
Reviewed: February 2013
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Brown University
Application for Biological Research Authorization
Housekeeping
An organized, clean laboratory is imperative for safety and good research. Maintenance of safety equipment (i.e.,
emergency eyewashes) is also an important factor in keeping a safe laboratory environment. Routine cleaning
and disinfection of all surfaces must be employed. Ensure that only cleanable, non-porous surfaces are used (i.e.,
fabric chairs shall not be used in the lab).
Below, is a list of the routine cleaning/disinfection/maintenance procedures the lab will follow and their
frequency:
Cleaning/Disinfection/Maintenance
(Example: 10% Bleach dilution/contact
time 15 minutes)
Task/Procedure (Example:
sprayed on bench tops)
Frequency (Example: nightly)
For a full description of disposal requirements for Biological Waste refer to:
http://brown.edu/Administration/EHS/policies/biological_waste_program.pdf
Laundry
At Brown University cotton or fire-resistant lab coats are required. Synthetic lab coats are a risk for injury when
working with open flames or pyrophoric chemicals because synthetic fibers burn, melt and stick to the skin at a
higher rate than natural fibers.
Laboratory coats must be kept in the laboratory when not in use and should never be brought home for
laundering. Laboratory coats that have been heavily contaminated with biological agents, infectious substances, or
hazardous chemicals shall be replaced. Routine laundering of laboratory coats may be conducted in-house (if
available) or by a professional laundering service and approved vendor. Contact Falvey Linen and Uniform
Supply at 401-942-8900 for information about laundering lab coats or your purchasing representative to order
disposable lab coats from approved vendors.
List the types of items specific to this lab or this protocol that may require laundering or replacement when
contaminated:
Item (Example: Disposable lab coats)
Replacement/Disposal/Laundering Frequency
(Example: after contamination, autoclaved, disposed of
in garbage and replaced)
In addition, the following general laundering requirements must be met:
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Handle potentially contaminated laundry as little as possible, with minimal agitation
Place wet laundry in leak-proof and appropriately labeled containers before transport
Wear appropriate PPE when handling and/or sorting laundry
Labels and Door Signs
Any equipment or container contaminated with biological materials, bloodborne pathogens or OPIM must display
the universal Biohazard symbol i.e., biological sharps containers, vacuum flasks etc.
To be NIH compliant, this symbol must also appear on any door where Biosafety Level 1 or 2 (BSL 1 or 2) work
occurs or biological waste is held. Also required for a BSL-1 sign:
 Biosafety Level
 Name of agent(s) in use
 Name and phone number of lab supervisor
Required for a BSL-2 sign:
 Biosafety level
 Laboratory supervisor’s name and telephone number
 required procedures for entering and exiting the laboratory
The standard CEMS emergency contact door sign posted on every laboratory door should reflect this information.
If your current sign does not, contact EHS at 401-863-3353.
EMERGENCIES
In general, Brown University employees and students must not engage in spill response for hazardous substances
such as chemical, biological, and radioactive materials. However, in some situations, such as clean up of
incidental spills (i.e., a few drops), it is appropriate for the person who caused the incidental spill to clean up the
material but only if they have been properly trained and have the appropriate equipment. All other spills must be
reported to Brown University Public Safety at 863-4111 so that the Environmental Health & Safety Emergency
Response Team may be activated.
In the event of a hazardous substance emergency or spill, the following action should be taken:

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Immediately alert all personnel to evacuate the room.
Once everyone is out, close the door behind you.
Find a nearby phone and contact Brown University Public Safety at 863-4111.
Tend to injured or contaminated personnel.
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Stay in the general area, at a safe distance away, and wait for emergency responders.
Introduce yourself to emergency responders as they arrive. Emergency responders want to ensure that the
information they have is accurate and that conditions have not changed since the initial phone call was
made.
POST-EXPOSURE EVALUATION AND FOLLOW-UP
There are several types of exposure that could lead to injury or illness in faculty, staff and students:

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Parenteral-puncture from a sharp, animal bites/scratches
Mucous Membrane- contact through eyes, nose, mouth, inhalation
Non-intact Skin-cut/scrape, rash, cold sore, acne, hang nail
Should an exposure incident occur:
•
•
•
•
•
Immediately wash area with soap and water, or in case of an eye exposure flush with copious amounts of
water use an emergency eyewash if available
Notify your supervisor
Contact public safety at 401-863-4111
-if minor/low risk exposure, report to EHS as an alternative to calling public safety
Seek first aid/medical treatment and always consult with a physician i.e., health services, your doctor etc.
**If the exposure involves recombinant or synthetic nucleic acid molecules, the PI along with the
Biological Safety Officer will likely have to report it to NIH. A document explaining when this is
necessary and how to file a report can be found here:
http://oba.od.nih.gov/oba/ibc/FAQs/FAQs_about_Incident_Reporting.pdf
For proper reporting use the forms found here:
http://www.brown.edu/Administration/EHS/lab/PDFs/accident_form.pdf
http://www.brown.edu/Administration/Office_of_Insurance_and_Risk/documents/Injury%20AR%20Form%20Re
v.6%2706.doc.pdf
RESEARCHER TRAINING
All researchers who have reasonably anticipated occupational exposure to biological materials, bloodborne
pathogens, or OPIM, or potentially dangerous equipment, should receive task-specific/equipment-specific training
conducted by the Laboratory Supervisor or designee. The Laboratory Supervisor shall also ensure that taskspecific/equipment-specific training is appropriately documented. The expectation is that this table will be used
to declare any task-specific training you intend to document.
Provide below tasks/procedures for which laboratory researchers will receive task-specific/equipment-specific
training:
(Examples: Cardiac puncture blood-draw on mouse, centrifuge training)
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Application for Biological Research Authorization
RECORDKEEPING
Training Records
Training for task-specific/equipment-specific training shall be documented. These documents will be kept
(Insert location of records here____________) for the duration of the Biological Research Authorization and any
associated Renewals/Amendments.
The following training form template shall be used to document laboratory/equipment specific training:
http://www.brown.edu/Administration/EHS/restricted/supervisors_training_template.pdf
The training records include:

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Dates of the training sessions
Contents or a summary of the training sessions
Names and qualifications of persons conducting the training
Names and job titles of all persons attending the training sessions
Communication of Hazards
Informing Other Employers/Contractors
It is the responsibility of the Laboratory Supervisor to provide other employees and contractors with information
about hazardous chemicals, biological materials, bloodborne pathogens, and OPIM that employees may be
exposed to on a job site along with suggested precautions and PPE.
Before scheduling service with an outside contractor, the equipment to be serviced must be decontaminated unless
that piece of equipment is being decontaminated by said outside contractor. In all events contractors or employees
should use Universal Precaution while servicing equipment in a Brown University Laboratory.
Laboratory Moving/Closeout Policy
The purpose of the Brown University Closeout Policy is to ensure that all Research Laboratories and Research
Support Areas are properly cleaned and decontaminated prior to decommissioning. Decommissioning of a
laboratory or research support area may be necessary when a Laboratory Supervisor leaves the University,
transfers to another space, or when a laboratory is prepared for demolition/renovation.
There are several resources available to assist Laboratory Supervisors and Departments with tasks related to the
proper decommissioning of research space. Some of these resources include, but are not limited to, the following:
• Office of Environmental Health & Safety at 401-863-3353
• Purchasing Department at 401-863-2206
• Facilities Management at 401-863-7800
More information on this policy can be located at the following URL:
http://www.brown.edu/Administration/EHS/restricted/lab_closeout.pdf
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