SAN DIEGO STATE UNIVERSITY
BIOLOGICAL USE AUTHORIZATION APPLICATION
Instruction for completing the Biological Use Authorization Application shall be read prior to completing this application and
applicable attachments. Submit an electronic copy to ibc@mail.sdsu.edu. If more space is needed please attach a
separate sheet. If you need assistance in completing the form refer to or contact the Biosafety Officer (BSO) at (619) 5946965.
For research involving only human source materials (blood, tissue, cells, body fluids, etc.) complete the Human Source
Material Biological Use Authorization Application [DOC].
Upon approval of the BUA, Principal Investigators will complete an Annual BUA Continuation Form updating the committee
of the progress.
I.
CORE REGISTRATION INFORMATION
Name of Principal Investigator (PI)/Faculty:
Job Title:
Department:
Office Location:
Lab Location:
Office Phone:
Lab Phone:
Email Address:
Mail Code:
Co-Investigator or Faculty*:
Job Title:
Office Location:
Office Phone:
Email Address:
Cell Phone:
Fax:
Department:
Lab Location:
Lab Phone:
Mail Code:
Home Phone:
Fax:
*If more than one Co-Investigator, list in Section VI. Laboratory Personnel
Lab Supervisor/Manager:
Job Title:
Office Location:
Office Phone:
Email Address:
Department:
Lab Location:
Lab Phone:
Mail Code:
BUA Type (check one)
New
Renewal
Amendment
Fill out New BUA
Application
Fill out
Amendment Form
Home Phone:
Fax:
If Renewal
Applicable BUA/NIH Number & Approval Date
Original
Approval
NIH Recombinant
Risk
BUA#
Date
DNA Designation
Group
Type of Activity (Check One*):
*Submit a separate BUA application for research activities or teaching activities.
Research
General Project Title*:
*Covering all individual studies and projects within this BUA
Grant Title(s):
Granting
Agency(s):
Sponsor Award # or Project Period:
Fund #:
Non-Funded Project Titles:
Teaching
Course Name/Number:
Course Period:
Semester:
Administrative Use Only
EHS, SDSU
1/14
Rev 11/15
BUA Number
NIH Recombinant
DNA Designation
Biosafety
Level
Approval
Date
BUA#
II.
RESEARCH PROTOCOL
Describe the research objectives and experimental design involving the biohazardous materials
such as major goals, protocols, experiment technique and procedures, biohazardous agents and use of
animals. List all projects, whether or not the project is currently funded, with a project title and a short
description of each project. Provide a grant number for each funded project/study title. Provide
sufficient information for the IBC to evaluate work with research materials for the purpose of making a
biohazard risk assessment. (Do not attach Grant Application)
EHS, SDSU
2/14
Rev 11/15
III.
RESEARCH MATERIALS (Check all that apply; skip attachments that do not apply)
Project involves use of Recombinant DNA molecules and recombinant DNA-containing
organisms or cell cultures subject to the NIH Guidelines for Research Involving Recombinant
DNA Molecules. Requires completion and submission of Attachment A.
Project involves potential human, animal or plant pathogens or infectious agents. Requires
completion and submission of Attachment B.
Project involves human or non-human primate Organs, Tissues or Cell Cultures (OTCC) with
proven or potential hazard to humans. (All work with human blood, human blood products,
human body fluids, or other potentially infectious human materials such as brain, CNS tissues,
lymphoid tissues, gut, and bone marrow, and human cell cultures fall into this category.)
Requires completion and submission of Attachment C.
Project involves the collection and analysis of environmental samples. Requires completion
and submission of Attachment D.
Project involves the possession, use and/or transfer of biological toxins, regulated Select Agents
and toxins. Requires completion and submission of Attachment E.
Project involves the use of animals or derived products from animals that harbor zoonotic
agents (e.g. wild trap animals) or exotic or non-indigenous animals, plants. Requires
completion and submission of Attachment F.
Project involves the use of animals and/or plants in conjunction with materials described above
in Attachment A, B, C, D, E or F. Requires completion and submission of Attachment G
and Attachment A.
Project involves large scale production of cultures larger than 10 liter at any one time regardless
of Risk Group or Recombinant DNA material. Requires completion and submission of
Attachment H.
Project involves deliberate transfer of recombinant nucleic acid or synthetic nucleic acid into one
or more human research participants. Note: this would also include research involving ex-vivo
transduction of cells for human application. Requires completion and submission of
Attachment I and NIH Recombinant DNA Guideline Appendix MII-MV.
EHS, SDSU
3/14
Rev 11/15
IV.
A.
BIOSAFETY SUMMARY
Procedures and Work Practices performed which may result in the generation of aerosols,
splashed and or sprays of biological material and safety precautions that should be followed by
personnel performing these procedures are as follows:
i.
Procedures
Note: Biosafety procedures are agent or recombinant DNA material specific.
Procedures/Equipment
Agent(s)/Material(s)
Sample Collection
Microbiological
Growth
Gene
Insertion/Deletion
Introduction of
Vector
Cloning
Tissue Culture/ Cell
Culture
rDNA in vivo
Centrifugation
Ultracentrifugation
Sonication
Vortexing
Homogenization/
Blender
Opening vacuum
vials
Syringe filtration
Placing biological
material under
pressure
Fluorescence
activating cell
sorting
Fluorescence
activated cell
analysis
Pipetting/
Aliquoting
Vacuum
Needles/Blades/
Capillary Tubes
Finger Prick
Venipuncture
Bench Work
EHS, SDSU
rDNA:
Cell/Animal:
Containment
Personal Protective Equipment
Respirator/N95 mask
Sealed, Leak-proof primary containers
Biological Safety Cabinet
Non-glass collection container
Biological Safety Cabinet
Benchtop
Incubator
Sealed tube/vials
Other Containment Devices:
Biological Safety Cabinet
Benchtop
Incubator
Sealed tube/vials
Other Containment Devices:
Biological Safety Cabinet
Benchtop
Incubator
Sealed tube/vials
Other Containment Devices:
Biological Safety Cabinet
PCR Machine
Incubator
Sealed tube/vials
Other Containment Devices:
Biological Safety Cabinet
Incubator
Sealed tubes/vials
Other Containment Devices:
Biological Safety Cabinet
Other Containment Devices:
Biological Safety Cabinet
Sealed tubes/vials
Other Containment Devices:
Biological Safety Cabinet
Sealed tubes/vials
Other Containment Devices:
Biological Safety Cabinet
Sealed tubes/vials
Other Containment Devices:
Biological Safety Cabinet
Sealed tubes/vials
Other Containment Devices:
Biological Safety Cabinet
Sealed tubes/vials
Other Containment Devices:
Biological Safety Cabinet
Shield
Respirator/N95 Mask
Other Containment Devices:
Biological Safety Cabinet
Respirator/N95 Mask
Other Containment Devices:
Biological Safety Cabinet
Shield
Respirator/N95 Mask
Other Containment Devices:
Model:
Live cells?
Containment?
Model:
Live cells?
Containment?
Biological Safety Cabinet
Other Containment Devices:
Biological Safety Cabinet
Disinfectant trap
Disposable
Engineered Sharps
Disposable
Engineered Sharps
Designated area:
4/14
Shield
Respirator/N95
0.2u hydrophobic in-line filter
Reusable Sharps
Sharps Waste Container
Retractable Lancet Sharps
Sharps Waste Container
Rev 11/15
Other Containment Devices:
Biological Safety Cabinet
Laminar Flow Hood
Respirator/N95
mask
Other Containment Devices:
Biological Safety Cabinet
Respirator/N95 mask
Animal Behavioral
Sharp protection device:
Analysis
Other Containment Devices:
Biological Safety Cabinet
Respirator/N95 mask
Surgery or
Sharp protection device:
necropsy of
Other Containment Devices:
infected animals
Route:
IV
IP
IM
IN
Injection/Inoculation
Biological Safety Cabinet
Respirator/N95 mask
Other Containment Devices:
Specific SOP
Biological Safety Cabinet
Laminar Flow Hood
Husbandry
Respirator/N95 mask
Other Containment Devices:
Other, please specify procedure and describe containment:
Animal cage
changing
ii.
Work Practices – In each condition and experimental procedure indicated above, describe specific safe
work practice procedures that will be taken to prevent exposure to biohazardous materials.
Note: Biosafety procedures are agent or recombinant DNA material specific.
Procedure/Equipment
B.
Work Practices
Storage and access control of biohazardous materials include the following. Consider storage
in all locations, including freezers, cryotanks, and cold rooms.
Note: Biosafety storage and access are agent or recombinant DNA material specific.
Storage/Access
1. Biohazardous materials are contained inside well-labeled containers i.e. cups, tubes, vials.
2. Biohazard labels are clearly affixed on any biohazardous materials storage equipment clearly identifying the hazards
inside.
3. Storage refrigerators/freezers/cryotanks/incubators are in rooms whose access is limited or restricted to authorized
personnel.
4. Biohazardous materials are stored in locked facility or secure storage equipment.
5. Policies and procedures are in place whereby only persons who have been advised of the biohazardous material and
meet any specific entry requirements (e.g. immunization) are authorized to enter the laboratory or have access to agents.
6. Others (please specify)
C.
Biohazardous Waste Disinfection/Decontamination and Disposal (including viable agents,
recombinant DNA, infectious organisms, cultures, toxins or items which have come in contact
with these agents).
i.
Liquid Wastes (Check all that apply) If None Check Here
Note: Disinfection/Decontamination of liquid waste is agent or recombinant DNA material specific.
Final Disposal (after
Disinfection/Decontamination
Treatment
Agent(s)/Material(s)
disinfection indicated in left
Method
time (e.g.
column)
30 min)
Check all that apply. If “other”,
please specify below
As chemical waste
Into Sewer
None necessary
N/A
Other:
Into Sewer
As chemical waste
Autoclaving*
*County Permitted Autoclave Only
Other:
(Located in NLS 418C)
Chemical Methods:
Bleach (freshly diluted to final
Into Sewer
Other:
10% (v/v))
EHS, SDSU
5/14
As chemical waste
Rev 11/15
Other chlorine products
As chemical waste
Other:
As chemical waste
Other:
As chemical waste
Other:
As chemical waste
Other:
(Clidox®)
Iodine/iodophors (e.g.
Wescodyne®)
Alcohols (e.g. final 70% (v/v)
EtOH or Isopropyl Alcohol)
Phenolic agents (e.g.
Biozide®, Vesphene®)
Into Sewer
Other:
Quaternary Ammonium
Agents (e.g. Roccal®,
Coverage Plus®, Cavicide®,
Lysol®)
Aldehydes (ex. 2-4%
glutaraldehyde, 4%
formaldehyde, Cidex®)
Peroxygens (e.g. Virkon®)
As chemical waste
As chemical waste
Other:
As chemical waste
Other:
Other, please specify:
ii.
Solid Wastes (Plastic ware, glassware, sample containers, tissues)(Check all that apply)
If None Check Here
Note: Disinfection/Decontamination of solid waste is agent or recombinant DNA material specific.
Final Disposal (after disinfection
Disinfection/Decontamination
Treatment
Agent/Material
indicated in left column)
Method
time (e.g.
30 min)
Check all that apply. If “other”,
please specify below
None required
In Biohaz. bag
In Sharps container
N/A
Medical Solid Waste
Other:
Autoclaving*
In Biohaz. bag
In Sharps container
*County Permitted Autoclave Only
Other:
(Located in NLS 418C)
Chemical Methods
Bleach (freshly diluted to final
10% (v/v))
Aldehydes (e.g. fixation with
2-4% glutaraldehyde, 4%
formaldehyde)
Peroxygens (e.g. Virkon®)
In Biohaz. bag
Other:
In Biohaz. bag
Other:
In Sharps container
In Biohaz. bag
Other:
In Sharps container
In Sharps container
Other, please specify:
iii.
Animal Tissues/Carcass Waste (Check all that apply) If None Check Here
Note: Disinfection/Decontamination of Animal Tissues/Carcass waste is agent or recombinant DNA material
specific. All animal carcasses must be disposed of in red bags as biohazardous waste.
Final Disposal (after disinfection
Disinfection/Decontamination
Treatment
Agent/Material
indicated in left column)
Method
time (e.g.
30 min)
Check all that apply. If “other”,
please specify below
None necessary; transported to
In vivarium animal disposal freezer
N/A
In Biohaz. waste accumulation site freezer
vivarium as per protocol
Other:
described in Other.
Autoclave
In vivarium animal disposal freezer
In Biohaz. Waste accumulation site freezer
Other:
Other, please specify and describe final disposal:
D.
Work surface, instruments, equipment disinfection/decontamination. (Check all that apply)
If Not Applicable Check Here
Note: Work Surface, instruments, equipment disinfection/containment is agent or recombinant DNA material
specific.
EHS, SDSU
6/14
Rev 11/15
Disinfection/Decontamination
Method
Autoclaving
Contact
time
(e.g. 30’)
Chemical Methods:
Bleach (freshly
diluted to final 10%
(v/v))
Bleach (freshly
diluted to final 10%
(v/v)), + rinse with
70% Alcohol
Other chlorine
products (Clidox®)
Iodine/
iodophors (e.g.
Wescodyne®)
Alcohols (e.g. final
70% (v/v) EtOH or
Isopropyl Alcohol)
Phenolic agents
(e.g. Biozide®,
Vesphene®)
Quaternary
Ammonium
Agents (e.g.
Agent/Material
Work Surfaces (Check all
that apply)
Bench-tops
Stainless
Surfaces
N/A
N/A
Equipment/
Parts
Instruments/
Glassware/
Apparatus
Daily
After Use
Daily
After Use
After Spill
Daily
After Work
After Spill
Daily
After Work
After Spill
Daily
After Work
After Spill
Daily
After Work
After Spill
Daily
After Use
After Spill
Daily
After Use
After Spill
Daily
After Use
Daily
After Work
After Spill
Daily
After Work
After Spill
Daily
After Work
After Spill
Daily
After Work
After Spill
Daily
After Work
After Spill
Daily
After Work
After Spill
Daily
After Work
After Spill
Daily
After Work
After Spill
Daily
After Work
After Spill
Daily
After Work
After Spill
Daily
After Use
After Spill
Daily
After Use
After Spill
Daily
After Use
After Spill
Daily
After Use
After Spill
Daily
After Use
After Spill
Daily
After Use
Daily
After Work
After Spill
Daily
After Work
After Spill
Daily
After Use
After Spill
Daily
After Use
Daily
After Work
After Spill
N/A
Daily
After Work
After Spill
N/A
Daily
After Use
After Spill
Daily
After Use
After Spill
Daily
After Use
Daily
After Use
Daily
After Use
Daily
After Use
After Spill
Daily
After Use
Daily
After Use
Roccal®, Coverage
Plus®, Cavicide®,
Lysol®)
Aldehydes (e.g. 24% glutaraldehyde,
4% formaldehyde,
Cidex®)
Peroxygens (e.g.
Virkon®)
UV Light
Daily
After Use
Other, please specify and describe:
E.
Spill/Release Response
Describe laboratory specific protocol for spills or releases in your laboratory, shared
spaces or public areas.
Spill Kit Location:
F.
Protective Equipment which will be utilized to minimize exposure of personnel to agents while
in the laboratory:
Mandatory:
Appropriate Attire - close-toed shoes, long pants or skirt (no shorts, short skirts, sandals, etc.)
Lab Coat or Gown
EHS, SDSU
7/14
Rev 11/15
Safety Glasses or Goggles
Gloves (nitrile or latex)
☐ Other: List additional PPE used in the Lab.
Personal protective equipment is provided by the laboratory to all research personnel working in
the facility.
G.
Potential Environmental Impact
Please describe aspects of the protocol or agents which could have potential or deliberate
environmental impact. If you plan to conduct a field trial, include the location and size of environmental
release.
EHS, SDSU
8/14
Rev 11/15
V.
RESEARCH FACILITIES
A.
Authorized Lab Location, Room Usage, and Containment Equipment:
NOTE: The IBC requests prior notification, via submission of a BUA Amendment Application, regarding
any change in location of containment labs, or containment animal rooms.
i.
Location
1. Laboratory Location
Note: Proposed Biosafety Level (BSL) can be obtained from the BMBL 5th Edition and should reflect the risk group of the agent/materials, practices
and facilities. The BSL is dictated by the highest BSL containment required by any agent utilized in that room.
Agent/
Materials
Sample
Collection
Location
Proposed
BSL
N/A
N/A
N/A
N/A
N/A
Shared
Room?
Yes
Yes
Yes
Yes
Yes
Storage
Location
Proposed
BSL
Shared
Room?
No
No
No
No
No
Yes
Yes
Yes
Yes
Yes
Handling
Location
Proposed
BSL
Shared
Room?
No
No
No
No
No
Yes
Yes
Yes
Yes
Yes
No
No
No
No
No
If Animal Housing or Handling is Not Applicable Check Here
Animal
Animal Housing
Location
Shared
Room?
Yes
Yes
Yes
Proposed
BSL
Animal Handling
Location
No
No
No
Shared
Room?
Yes
Yes
Yes
Proposed
BSL
No
No
No
If Growth of Plants is Not Applicable Check Here
Plant
Plant Growth Location
Stage of Growth (i.e.
seedling)
Shared Room?
Yes
Yes
Yes
Proposed
BSL
No
No
No
2. Field Location
Note: Proposed Biosafety Level (BSL) can be obtained from the BMBL 5th Edition and should reflect the risk group of the agent/materials, practices
and facilities. The BSL is dictated by the highest BSL containment required by any agent utilized in that room.
Agent/Material Sample Location
i.e. trapping
Handling
Location
i.e. analysis
Proposed
BSL
Shared
Facility?
Yes
Yes
Yes
Yes
Yes
Storage
Location
Proposed
BSL
No
No
No
No
No
Shared
Facility?
Yes
Yes
Yes
Yes
Yes
ii. Provide the following information for each Biosafety Cabinet: If Not Applicable Check Here
Make
Model
Serial
Location
UV Light?
Certification
Number
Expiration Date
Yes
No
Yes
No
Yes
No
iii.
Animal Housing Post Administration If Not Applicable Check Here
After delivery of agents, animals will be housed in (check all that applies):
Separate cages from other animals
Well-labeled cages indicating possible hazards to animal staff
Microisolator cages
Conventional/ABSL-1 facility
EHS, SDSU
9/14
Rev 11/15
No
No
No
No
No
ABSL-2 facility
ABSL-2 facility for 72 hours, then transferred to ABSL-1 facility
ABSL-3 facility
Live animals will not be returned to animal facilities after delivery
Other (please specify):
B.
Biohazard Signs and Labels
Are biohazard signs and labels posted?
Need signs and labels (Contact BSO at (619)
594-6965 to obtain the signs and labels)
Signs should be posted at the lab entrance and procedure rooms within the lab. Labels (stickers)
should be placed on refrigerators, freezers, biosafety cabinets, and incubators.
If Yes, where?
Lab Entrances and Procedure
Storage Areas (refrigerators, freezers)
Rooms
Work Areas (biosafety cabinet,
Other (please specify):
incubator)
Name the Biohazard identified on the Biohazard sign:
EHS, SDSU
Yes
10/14
Rev 11/15
VI.
LABORATORY PERSONNEL
A. Personnel
List all personnel involved with work covered under this biological use authorization, including lab
manager/supervisor, investigators, and students. If additional space is needed, attach a separate
sheet. The personnel indicated on the list who have not completed the IBC Biosafety Training will be
enrolled in the training and notified via email. Contact BSO for questions (619) 594-6965.
Last Name/First
Job Title Red ID # Email Address
Biosafety Training
Other Specified or
Name
Completion Date Special Training and
Date
B.
Health Status, Health Surveillance, and/or Immunization Program
Indicate if you are working with any of the agents listed below. You must consult with an Occupational
Medicine Physician to develop an appropriate health surveillance and/or immunization program for the
safe conduct of your protocol. Contact the Biosafety Officer at (619) 594-6965. Indicate if all
authorized personnel have completed the program.
Applicable
Agent
Program Details
Yes
No
Bloodborne
Pathogen
HBV vaccination or declination, post-exposure follow-up, treatment at no cost to employees, vaccination
record retention by PI, initial BBP training and annual retraining, and universal precautions.
Yes
No
Q-Fever
Annual medical exams, serologic testing, vaccine use when available, respiratory protection and
training.
Yes
No
Orthopoxvirus
(vaccinia and
others)
Medical consultation, contraindication awareness, vaccination or declination, medical screening, and
training.
Yes
No
Prion Research
Training and special procedures for exposure reporting, decontamination and records handling.
Yes
No
Cercopithecine
herpesvirus-1
(Herpesvirus
simiae)
Post-exposure follow-up and treatment at no cost to employee as well as training.
Other. Please specify agent and program details:
EHS, SDSU
11/14
Rev 11/15
VII.
REGULATORY REQUIREMENTS
A.
Required Institutional Safety Approval
Additional protocol submission may be required if this research involves human or animal subjects,
please contact Graduate and Research Affairs at (619) 594-0905.
Does this research involve animal subjects
or tissues?
Yes
No
Protocol #
(IACUC Approval)
Expiration
Date
Does this research involve human
subjects or tissue?
Does this research involve regulated
select agents or toxins?
Does this research involve human gene
therapy?
Yes
No
Yes
No
Yes
No
Protocol #
(IRB Approval)
HHS/USDA #
(HHS/USDA Approval)
FDA IND #
(FDA Approval)
Expiration
Date
Expiration
Date
Expiration
Date
B.
DOT/IATA Infectious Substance & Specimen Shipping Regulations, Material Transfer
Agreements, and CDC/APHIS/DOC Import/Export Permit
The U.S. Department of Transportation and International Air Transport Association requires all
individuals involved in transporting biohazardous materials in commerce be trained to properly prepare
shipments and recognize and respond to risks posed by these materials to prevent the release of these
materials in transit. The SDSU Department of Environmental Health & Safety provides training to meet
the training requirement. Contact EH&S at (619) 594-6965. If applicable, contact Graduate and
Research Affairs at (619) 594-0905 for a Material Transfer Agreement. Federal Regulation requires
CDC/APHIS Import/Export Permits or Department of Commerce Export Permits prior to transfer of
biohazardous materials to ensure the possession of these agents is in the best interest of the public.
Principal Investigators are required to document all personnel, facilities, and justification of need to
obtain authorization prior to transfer by all applicable federal authority. Contact EH&S at (619) 5946965 for further information.
Note: SDSU Shipment of Biological Materials and SDSU Guide to Shipping with Dry Ice are included in the Biosafety Training 2008 revision version. The
documents are also available for reference on the EHS Website. (http://bfa.sdsu.edu/ehs/ )
Materials
Agent/Material
Transport Training
Import/Export Permit
Transported within campus labs
Biosafety Training
N/A
Yes
No
Transported to/from campus
Yes
No
Domestically (Locally, or
N/A
APHIS Import Permit #:
 SDSU Shipment of Biological
Intrastate or interstate)
N/A
APHIS Export Permit #:
Materials
N/A
CDC Import Permit #:
 SDSU DOT Grounds Transport
of Biological Materials
Internationally
SDSU Shipment of Biological
N/A
CDC Import Permit #:
Materials
N/A
APHIS Import Permit #:
N/A
APHIS Export Permit #:
N/A
Dept. of Commerce Export Permit #:
Transported in Dry Ice
SDSU Guide to Shipping with Dry
N/A
Yes
No
Ice
Transported in Ethanol
SDSU Shipment of Ethanol
N/A
Yes
No
Solutions
Transported in Formalin
SDSU Guidelines Shipment of
N/A
(Formaldehyde)
Formaldehyde by Air
Yes
No
EHS, SDSU
12/14
Rev 11/15
VIII.
ACKNOWLEDGEMENT OF RESPONSIBILITIES
Principal Investigator:
BUA #:
Project Title:
Date:
By signing and initialing each statement below, I certify that I have read the following statements and
agree that I and all listed participants will abide by those statements as well as all SDSU policies and
procedures governing the use of recombinant DNA, infectious agents and other biohazardous materials
as outlined in this application and in the SDSU Biosafety Manual. I:
Recognize that I have a responsibility for ensuring the information provided in this application
is complete, accurate and thorough by participating in the development of the BUA
application and conducting a review of the protocols.
Recognize that I have responsibilities for ensuring that anyone who enters my laboratory
practices appropriate biosafety precautions.
Recognize that I have responsibilities for ensuring that all listed participants conducting this
work have received or will receive appropriate training in safe laboratory practices and
procedures for this protocol before any work begins on this project. Also, I have a
responsibility for ensuring that anyone working in or having access to spaces where this
project is conducted must be instructed on the hazards associated with this project. The IBC
or EHS may review my records documenting the training or instruction and may enter my
laboratory at any time to review my operations.
Recognize that I have a responsibility to be informed (and ensure that all staff members are
similarly informed) that certain medical conditions might increase an individuals risk of
potential health problems when working with pathogenic microorganisms and/or animals.
These conditions can include: pregnancy, immunosuppression, animal related allergies and
chronic skin conditions. If any of these conditions applies, I will send the personnel to consult
with a personal physician/health care professional about the work. These conditions may
restrict someone from working with the biohazardous material. If an employee is restricted
from working with the biohazardous materials in my laboratory, I am responsible for ensuring
the restriction.
Recognize that I have a responsibility for complying with the requirements pertaining to the
shipment and transfer of biohazardous materials.
Shipping Biohazardous Materials: Initialize by statement.
By initialing, I certify that I will properly classify, identify, pack, mark, label and document
shipments for transport. Any special arrangements such as notifying the consignee
(receiver) of import permits for international shipments shall fall under my responsibility. I
shall ensure that the consignee has obtained all necessary import permits to facilitate the
safe and legal acceptance of the shipment. I am also responsible for notifying the courier
for whom the packaged should be directly delivered. I am responsible for ensuring the
package is delivered directly to the person and address indicated on the outer packaging.
Obtaining export permits is my responsibility. I certify that I or other authorized personnel
in the laboratory have been trained to properly package and ship the materials.
Receiving Biohazardous Materials: Initialize by statement.
By initialing, I certify that I will inspect the package and documents and close the
shipping loop by informing the shipper that the consignment has arrived. I am also
EHS, SDSU
13/14
Rev 11/15
responsible for reporting any leakage and, if required, obtaining any import permits. I
shall ensure special arrangements are in place for the courier to directly deliver the
package to the person named on the outer packaging.
Recognize that I have a responsibility for reporting to the Biosafety Officer immediately any
spill of biohazardous material, any containment equipment or facility failure, any permitted
decontamination of equipment, and/or any breakdown in procedures, which may result in
potential exposure of laboratory personnel and/or the public to the biohazardous material.
Recognize that I have a responsibility for reporting to the Biosafety Officer immediately
should an employee become ill and/or exhibit symptoms and signs consistent with an
infectious by an organism associated with my research.
Recognize that I have a responsibility for following all the applicable guidelines as approved
for this protocol.
Recognize that I have a responsibility for submitting in writing a request for approval from the
IBC of any significant modifications to the study, which could result in an increased level of
biohazard.
Recognize that I will not carry out the work described in this application including all revisions
until it has been approved by the IBC.
By initialing, I certify that I have read the following guidelines that are applicable and agree that I and
all listed personnel will adhere to the specifics of the guidelines. (http://bfa.sdsu.edu/ehs/biosafety.htm) Check box if
not applicable.
Guidelines for Working with Human Source Materials
N/A
Guidelines for Drawing Human Blood
N/A
Guidelines for Emergency Procedures and Contacts for Needlestick or Exposure to Blood,
Body Fluids, and Infectious Agents
N/A
Guidelines for Research with Lentivirus
N/A
Guidelines for Research with Adenovirus
N/A
Guidelines for Creation, Importation and/or Breeding of Transgenic Organisms
N/A
Guidelines for Biohazardous and Sharps Waste Disposal
N/A
Signatures
Signature of Principal Investigator who will be working on this project
Date
Signature of Co-Principal Investigator who will be working in this project
Date
Signature of Faculty Member to whom the laboratory space is assigned
Date
EHS, SDSU
14/14
Rev 11/15