SAN DIEGO STATE UNIVERSITY
BIOLOGICAL USE AUTHORIZATION
AMENDMENT APPLICATION
The purpose of this form is to record any changes to a previously approved Biological Use Authorization as well as provide
information to the IBC to conduct a thorough and accurate risk assessment. The primary use of this form is to amend an
existing BUA for the changes noted in this amendment application.
The National Institutes of Health (NIH) requires SDSU to review all experiments involving recombinant or synthetic nucleic
acid. Any changes or additions to experiments involving the generation or use of recombinant nucleic acid molecules
conducted under Sections III-A-1 through Section III-F-6 of the NIH Recombinant DNA Guidelines must be approved by
the IBC prior to the initiation of the changes described in this amendment application.
In addition, any changes to work involving Risk Group 1 through Risk Group 3 infectious agents and human source
materials that does not involve recombinant nucleic acids must also be reviewed and approved by the IBC.
Submit a signed hard copy of the completed application to Gateway Center 3519D, MC 1933 and 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 at (619) 594-6965.
I.
CORE REGISTRATION INFORMATION
A. Principal Investigator
Name of Principal Investigator (PI)/Faculty:
Job Title:
Office Location:
Office Phone:
Email Address:
Department:
Lab Location:
Lab Phone:
Mail Code:
Fax:
B. Approved BUA Information
Original BUA Title:
Expiration Date
BUA #:
Administrative Use Only
Biosafety Level(s)
NIH Classification
Amendment Review Type
Administrative
Full Committee
C. Amendment Type and Requirements
Type of Amendment (Check all that apply)
Addition of Grant
Complete all applicable Sections:
Additional funding source information (only when the processes,
procedures, experimental approaches, locations and materials to be
used in the new grant ARE already listed and outlined under the
approved parent BUA)
Additional funding source information when all or some of the
processes, procedures, experimental approaches, locations and
materials to be used in the new grant require BUA approval and ARE
NOT listed and outlined in an approved parent BUA.
Only Complete Sections II & VI.
Complete Section II and Additional
Sections as Directed Below.
Change in Material/Agent
Note: Check appropriate boxes when the changes entail potential biosafety concerns beyond those approved in the
parent BUA. These materials/agents changes can be indicated/listed on a currently approved BUA attachment and
the amended attachment submitted with this BUA Amendment Application.
Complete Sections III, VI, Attachment A,
Change in any recombinant or synthetic nucleic acid
& A-1.
Complete Section III, VI & Attachment B.
Change in Infectious Agent (human, animal, plant)
Complete Section III, VI & Attachment C.
Change in Human Blood, Blood Product, Unfixed Tissue, Cell Culture
Complete Section III, VI & Attachment C.
Change in Subject/Population
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Complete Section III, VI & Attachment D.
Change in Hazardous Chemical, Toxins or Carcinogens Administered
into Organisms, Tissues or Cells
Change in Animals/Plants (including transgenic animals)
Complete Section III, VI, & Attachment
G. (Attachment A & a-1 if transgenic)
Complete Section III, VI, & Attachment J.
Change in Environmental Samples.
Change in Experimental Procedure and/or Work Practice
Complete IV, & VI.
Additions or changes that potentially affect biosafety measures and/or
concerns.
Change in Research Facility/Sample Site
Change of Research Facility (Note: The research facility must be
inspected and commissioned for described work by the Biosafety
Officers prior to working in the facility);
Change of Sample Site Where Field Research Samples are Collected.
Complete Sections V, & VI.
Complete Sections V, VI and submit
Field Research Safety Plan.
Change in Research Personnel
Addition or Deletion of Personnel. Only add personnel not indicated in
approved BUA.
Complete Personnel Update Form.
II.
A
DDITION OF GRANT
Check here if no changes
Complete this section to add a grant to the current parent BUA.
Grant Title(s):
Granting Agency(s):
Sponsor Award # or Project Period:
Fund #:
If the above grants have processes, procedures, experiments, locations and materials that ARE NOT listed in the
approved parent BUA, continue to next section of this application.
Check Here if Applicable
Addition of grant only:
The above grants are funded for projects, teaching or studies that are covered on the current approved Biological Use
Authorization. All biohazardous material/agents listed or described in the grant are indicated in the approved parent
BUA. All personnel working with biohazardous materials funded by this grant are listed in the approved BUA and have
completed all applicable biosafety trainings and occupational health requirements.
III.
ADDITIO
OF BIOHAZARDOUS MATERIALS/AGENTS
Check here if no changes
Complete this section when a biohazardous material or agent needs to be added or deleted.
Briefly describe the objective and the use of the new biohazardous material/agent and any required changes in the
biosafety work practice and facility containment as they relate to the parent BUA. Provide sufficient information for
the IBC to evaluate work with research materials for the purpose of making a biohazard risk assessment for this
amendment. For deletion of materials/agents from a BUA, list the materials/agents to be removed.
IV.
ADDITIO
OF EXPERIMENTAL PROCEDURE
Check here if no changes
Complete this section if the Amendment is adding a new procedure.
Briefly describe the objective and new experimental procedure involving the biohazardous materials/agents and
any required changes in the biosafety work practice and facility containment (i.e. personal protective equipment,
engineering controls, disinfection, waste disposal, access, spill response, impact to the environment). Provide sufficient
information for the IBC to evaluate the new experimental design for the purpose of making a biohazard risk assessment for
this amendment.
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V.
REGUL
ORY COMPLIANCE
A.
Addition
protocol submission may be required if this research involves human or animal subjects.Check here if
changes
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
Check here if no changes
Note: SDSU Shipment of Biological Materials and SDSU Guide to Shipping with Dry Ice are included in the Biosafety Training. 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 between campus
Biosafety Training
N/A
labs
Yes Location:
Transported to/from campus
Yes
Domestically (Locally, or
N/A
APHIS Import Permit #:
 SDSU Shipment of Biological
Intrastate or interstate)
N/A
APHIS Export Permit #:
Materials
Location:
N/A
CDC Import Permit #:
 SDSU DOT Grounds Transport
of Biological Materials
Internationally
SDSU Shipment of Biological
N/A
CDC Import Permit #:
Location:
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
Ice
Transported in Ethanol
SDSU Shipment of Ethanol
N/A
Yes
Solutions
Transported in Formalin
SDSU Guidelines Shipment of
N/A
(Formaldehyde)
Formaldehyde by Air
Yes
VI.
PROPO
ED RESEARCH FACILITIES
Check here if no changes
Complete this section if there are any changes in the research facility location or field research site including animal and
plant rooms.
NOTE: The IBC requires containment facility inspection if there is any change in location from the parent BUA.
A.
Laboratory Location Check
here if no changes
Note: Proposed Biosafety Level (BSL) can be obtained from the BMBL 5 th 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.
Building
Action
Add
Delete
Room
Modify
Proposed
Use
(i.e. handling,
storage)
Biosafety
Level
(BSL-1,
BSL-2)
Shared
Room
Yes
Yes
B.
Provide the following information for each Biosafety Cabinet: (if different from original BUA)
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Make
Model
Serial
Number
Check here if no changes
Location
UV Light?
Yes
Yes
No
No
C.
F
ield Research Location
Check here if no changes
Attach a Field Research Safety Plan with this Amendment.
Action
Location
Increased Describe:
Add
Delete Modify
Hazard?
Yes
Yes
VII.
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
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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 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
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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
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