University of Colorado Denver
Biosafety Authorization Form
Appendix A
For Research Involving Select Agent Toxins
Form Reviewed by:
This space is for Institutional Biosafety Committee Use Only
Date
IBC
#:
Biosafety Officer/RO
Reviewer 1
Reviewer 2
Full Committee Review
Approved
Section I
Deferred
Disapproved
Biosafety Level
undetermined
Administrative Information
A letter of support, from your Department Chair and/or Division Head, must
accompany this application, per UCD Select Agents Policy. A sample format of a letter
may be obtained from the Biosafety Office.
If your laboratory is sponsoring a potential employee for or has an employee holding
H-1B or O-1 status, you need to complete an Export License Review Worksheet, and
submit that to the Office of Regulatory Compliance, to determine if a license is required,
or if certain exemptions may apply in addition to the review and approval. Please contact
ORC at 303-724-1010 or reg.compliance@ucdenver.edu for additional information.
A. Principal Investigator
Last Name, First Name
Employee ID Number
Email address
Mailstop
Phone
Fax:
School/Dept/Division/Institute:
B. Co-Investigators: (expand this table as necessary)
Last Name, First Name
Employee ID Number
Email address
C. Campus /Site where laboratory activities/research will be conducted.
Anschutz Medical Campus
Building
Downtown Campus
Laboratory Room #
Off-Site
Complete Physical Address
EHS-BSF-002 (r4)
rev Sept. 2010
1
NOTE Disposal of all SA Toxin(s) must be in accordance with the federal regulations, through
the UCD Hazardous Chemical Waste section. All personnel must be current on all UCD
Hazardous Chemical Waste Generator Training before you will receive authorization by the IBC
for this material.
D. Lab/Research Personnel: List each employee/graduate student/pre- or post-doc or studentworker, or volunteer/intern working in or assigned space in your laboratory. (expand this table
as necessary)
Research/Lab Personnel
Employee ID Number
Email
E. Funding Source(s): Include department funds, as well as public & private funding. (expand
this table as necessary)
NIH/Grant
Agency
Grant Number
Grant Title
Period of Funding
(from/to)
PLEASE COMPLETE THE REST OF THIS FORM BY ANSWERING ALL SECTIONS
APPLICABLE TO THE PROJECT USING THIS SELECT AGENT MATERIAL.
Attach additional pages if necessary.
Section II Select Agent Toxin Information
A. Specific SA Toxins Requested
Complete this section for each Select Agent Toxin to be purchased/stored/used in your
laboratory. Please review the Permissible Toxin Amounts to complete this section. (expand
this table as necessary.)
Name of toxin(s)
Maximum amount on
hand in the laboratory
at any time
Maximum amount to
be ordered at any one
time
Use of the listed toxin(s) will be:
In vitro
In vivo
IACUC Protocol Number
& Approval Date
EHS-BSF-002 (rev5)
December 2010
2
B. Research/Project Specific Information
1. State the objectives of the work to be performed with the Select Agent Toxin. Include
sufficient information on methods and lab procedures for appropriate IBC review.
Specify if work will involve live organisms, animals, introduction of antibiotic resistance to
live organisms, and/or recombinant DNA experiments. Such research requires significant
review by Federal Agencies prior to IBC approval. Consult the Biosafety Officer/Responsible
Official if you have any questions.
2. Describe how personnel will demonstrate proficiency in laboratory procedures prior to
beginning work with SA Toxins. On the Job Training must be documented and on file for each
individual, in addition to all federally-required Security Risk Assessment (SRA) requirements.1
3. Describe your Standard Operating Procedures and Personal Protective Equipment, to
protect personnel from exposure to the named SA or Toxin during manipulation, preparation
and use in vivo or in vitro experiments. If you have plans to use SA microorganisms, indicate
the availability of an autoclave for disinfection/decontamination on-site.
4. Describe your Standard Operating Procedures for the distruction and disposal of Select
agent materials.
5. Describe your plan for Medical Surveillance, to detect and protect personnel from exposure
to the named SA or Toxin during manipulation, preparation and use in vivo or in vitro
experiments. Please consult with the UCD Occupational Health Program (303-724-4663) to
address this requirement.
Section III
Compliance with Federal Regulations
A. Export Control and “Deemed Exports”
Does your laboratory currently sponsor any employee holding H-1B or O-1 status?
Yes
No
If yes, you need to complete an Export License Review Worksheet, and submit that to the
Office of Regulatory Compliance, to determine if a license is required, or if certain
exemptions may apply in addition to the review and approval. Please contact ORC at
303-724-1010 or reg.compliance@ucdenver.edu for additional information.
1
May be required for any SA Toxin for compliance with Federal Regulations.
EHS-BSF-002 (rev5)
December 2010
3
B. Laboratory-Specific Information
Provide a floor plan for all laboratories where the SA/Toxins are to be stored and used.
A hand-drawn sketch is sufficient.
Indicate the locations of all: doors, windows, fume hoods, biosafety cabinets, sinks, eyewash
(if available), and supply and exhaust grills or devices.
If you need further assistance, please discuss with the Biosafety Office.
C. Security
1. Describe the security measures (dedicated lab, locking door(s), card-key access, proximity
card reader, etc) specific to the laboratory where the SA Toxin will be stored and manipulated.
Include information on locked incubators, refrigerators, freezers, etc as appropriate, as well
as laboratory security at doors. Provide details to assure individuals not directly involved in the
research will have not have access to the SA Toxin materials.
Indicate if non-laboratory personnel (to include visitors, janitors, maintenance personnel,
etc) will have access to the laboratory. If you have not already done so, please consult with the
Biosafety Office and/or the Director of Electronic Access and Security Control (University Police
Department) for assistance regarding appropriate security measures.
2. Describe your Standard Operating Procedures for inventory of all SA Toxins in accordance
with the federal regulations. If you have not already done so, please consult with the Biosafety
Office for assistance regarding appropriate inventory measures.
EHS-BSF-002 (rev5)
December 2010
4
D. Principal Investigator Acknowledgement of Roles and Responsibilities
I acknowledge that I must meet and adhere to all requirements and restrictions of the most
current Select Agents and Toxins Regulations , the University directives for H-1B and O-1 visas,
the University of Colorado Denver Select Agents Policy and any other applicable University
policies, for the proposed research, to be reviewed and approved by the Institutional Biosafety
Committee and potentially subject to the review and approval and registration with the
designated federal agencies, prior to obtaining these materials and initiating experiments with
these materials.2
I accept responsibility for the safe conduct of the experiments conducted at the assigned
Biosafety Level or other containment.
I understand that it is my responsibility to assure that all personnel working in my laboratory with
any of these hazards are fully informed about their specific hazards, proper actions for safe use,
steps to take in case of accidents, and are provided with all necessary safety equipment and
instructions in its use.
Signature of Principal Investigator
Reviewed by:
RO/ARO
Date
This space is for Dept. of Env. Health and Safety Use ONLY
Laboratory Physical Capacity
Date
Emergency Power Backup.
Autoclave available & on PM program for waste treatment.
Vacuum lines in lab are HEPA filtered.
Adequate hand-washing sinks.
HVAC--Confirm findings with Facilities Operations representative
Single Pass
Re-Circulated
Negative pressure to provide directional airflow
Dedicated Exhaust
Shared Exhaust
Alarm system for exhaust failure
Constant Volume
Variable Air volume
Redundant Exhaust Fans
BSC
Class/Type/Date of Certification
Fume Hood
Performance verification/Alarm verification
Approved
Deferred
Disapproved
2
DHHS-Centers for Disease Control & Prevention (CDC) and/or USDA Animal & Plant Health Inspection
Service (APHIS)
EHS-BSF-002 (rev5)
December 2010
5