Instructions for Completing the Biosafety Application
Calvin College
Physical Plant 107
Environmental Health & Safety
(616) 526.8591
Please use the attached application for requesting a review and approval of activities involving biohazardous agents by
Calvin’s Institutional Biosafety Committee (IBC). This application should be used for all activities including research,
teaching, and testing. The IBC requests the information in accordance with its charge. This information is required by
the Occupational Safety and Health Administration's Occupational Exposure to Hazardous Chemicals in Laboratories
Standard, its Blood-Borne Pathogen Standard and/or the NIH Guidelines for Research Involving Recombinant or
Synthetic Nucleic Acid Molecules (rDNA or SNA).
Please allow the Biosafety Officer and/or IBC at least two weeks for review of application.
Submit completed application(s) to:
Heather Chapman
IBC Coordinator
Calvin College
Physical Plant 107
1475 Knollcrest Circle SE
Grand Rapids, MI 49546
(616) 526.8591
hlc5@calvin.edu
For additional information or assistance in completing this form, please contact the Heather Chapman, IBC Coordinator,
at 616.526.8591 or Lori Keen, Biosafety Officer, at 616.526.6080.
Biosafety Application (Rev5, 9/10/2014)
Page 1
Biosafety Application
Calvin College
☐
This application contains proprietary/confidential information (Please attach a justification statement and
any relevant documentation).
Project Title: Click here to enter text.
Principal Investigator Section
Principal Investigator Name/Title: Click here to enter text.
Department: Click here to enter text.
Address: Click here to enter text.
Phone: Click here to enter text.
Email: Click here to enter text.
Statement of Responsibility: I accept responsibility for the safe conduct of work with the agents described in this application. The
information in this application is accurate and complete.
Click here to enter text.
Signature of Principal Investigator
Date
Laboratory Personnel Section (use additional sheet if necessary)
The undersigned individual(s) are involved in this project and have read this application. Research students need not sign.
1. Name: Click here to enter text.
Signature:
Giving animal Injections?
Date: Click here to enter text.
Years of experience:
☐ Yes ☐ No
2. Name: Click here to enter text.
Signature:
Giving animal Injections?
Date: Click here to enter text.
☐ Yes ☐ No
3. Name: Click here to enter text.
Signature:
Giving animal Injections?
Date: Click here to enter text.
☐ Yes ☐ No
4. Name: Click here to enter text.
Signature:
Giving animal Injections?
Date: Click here to enter text.
☐ Yes ☐ No
5. Name: Click here to enter text.
Signature:
Giving animal Injections?
Date: Click here to enter text.
☐ Yes ☐ No
Title: Click here to enter text.
Contact: Click here to enter text.
Title: Click here to enter text.
Contact: Click here to enter text.
Years of experience:
Title: Click here to enter text.
Contact:
Years of experience:
Title: Click here to enter text.
Contact: Click here to enter text.
Years of experience:
Title: Click here to enter text.
Contact: Click here to enter text.
Years of experience:
*If any lab personnel are pregnant, nursing and/or immunocompromised, they are encouraged to discuss their work with their doctor.
Biosafety Application (Rev5, 9/10/2014)
Page 2
1. Project Location(s) (Room/Bldg): Click here to enter text.
2. Animal Use? ☐ Yes
☐ No
Date of IACUC approval, if already approved: Click here to enter text.
3. Human Subjects?
☐ Yes ☐ No
4. Select Agent Use? ☐ Yes ☐ No
If Yes, STOP here and contact the Institutional Biosafety Officer.
What’s a select agent? Check here: http://www.selectagents.gov/
5. Which of the following biological agents will be used? (check all that apply)
☐
Recombinant DNA (rDNA)
☐
Synthetic Nucleic Acid Molecules
☐
Toxins of Biological Origin
☐
Established Cell Line or Culture (if check, complete box 9)
☐
Microorganisms
☐
Human Blood/Tissue/Primary Cells (if checked, complete
box 10)
6. What level of biocontainment will be used?
☐
BSL-1
☐
BSL-2
☐
BSL-2+
7. Recombinant or Synthetic Nucleic Acid Molecule Section (If Not Applicable, check here ☐ & proceed to next section):
a. Are your activities exempt? ☐Yes ☐ No
Refer to: Section III F Exempt Experiments(note exceptions)
If Yes, list exemption category from drop down menu: Choose an item.
If category is III-F-6, list system from drop down menu: Choose an item.
b. Please select the NIH category for your recombinant or synthetic nucleic acid experiments.
Refer to: Section III Categories for complete details.
The descriptions in parentheses are provided only as a guide.
☐ Section III-A
(Transfer of drug resistance genes into microorganisms that are not
known to acquire the trait naturally)
☐ Section III-B
(Cloning of toxins with LD50 < 100 ng/kg body weight)
☐ Section III-C
(Transfer of rDNA, synthetic nucleic acid, DNA, or RNA derived from rDNA into human
subjects)
☐ Section III-D
(rDNA or SNA from Risk Group 2, 3, 4, or restricted agents as vector systems;
Infectious or defective DNA or RNA viruses; Whole animals and plants;
Large volumes)
☐ Section III-E
(rDNA or SNA involving < 2/3 of the genome of any eukaryotic virus in the
absence of helper virus or plasmids; Whole plants; Transgenic rodents)
Biosafety Application (Rev5, 9/10/2014)
Page 3
7. Recombinant or Synthetic Nucleic Acid Molecule Section (continued):
g. Complete table below using one column per construct (deletion or mutation series of a gene may be listed in one
column; use additional sheet if necessary).
Construct 1
Construct 2
Construct 3
Construct 4
Construct 5
Name and Provider
of Gene
Click here to
enter text.
Click here to
enter text.
Click here to
enter text.
Click here to
enter text.
Click here to
enter text.
Gene Function
Click here to
enter text.
Click here to Click here to Click here to Click here to
enter text.
enter text.
enter text.
enter text.
Example: marker
Vector Name
Click here to Click here to Click here to Click here to Click here to
enter text.
enter text.
enter text.
enter text.
enter text.
Example:
Vector Type /
Species and Strain
Expression control
elements
(promoters,
enhancers, etc)
Conc/titer of rDNA
(i.p./ml)
Host and Strain, if
applicable
Largest Production
Volume of Host
Host Range
(including any
genetic alterations
to host range)
Is recombinant
made in your lab? If
not, where?
If vector is a
genome, what %
has been deleted or
substituted?
Example
Example: green
fluorescent protein from
Clontech
pKH-WSU24
Click here to Click here to Click here to Click here to Click here to
Example: Viral /
enter text.
enter text.
enter text.
enter text.
enter text.
Adenovirus serotype 5
Click here to Click here to Click here to Click here to Click here to
enter text.
enter text.
enter text.
enter text.
enter text.
Example: CMV promoter
Click here to Click here to Click here to Click here to Click here to Example: 1 X 108 to 1
X1012 infectious
enter text.
enter text.
enter text.
enter text.
enter text.
particles/ml
Click here to Click here to Click here to Click here to Click here to
Example: E. coli, SureTM,
enter text.
enter text.
enter text.
enter text.
enter text.
Mouse heart cells, in vivo
Click here to Click here to Click here to Click here to Click here to
Example:
enter text.
enter text.
enter text.
enter text.
enter text.
1 liter
Click here to Click here to Click here to Click here to Click here to
Example: amphotropic,
enter text.
enter text.
enter text.
enter text.
enter text.
broad mammalian host
range
Click here to Click here to Click here to Click here to Click here to
Example:
enter text.
enter text.
enter text.
enter text.
enter text.
Vanderbilt Univ. Gene
Therapy Center
Click here to Click here to Click here to Click here to Click here to
enter text.
enter text.
enter text.
enter text.
enter text.
Biosafety Application (Rev5, 9/10/2014)
Example: 10%
Page 4
8. Toxins Section (If Not Applicable, check here ☐ & proceed to next section):
a. Are you handling toxins of biological origin? ☐ Yes ☐ No
If Yes, list the name and provider of toxin(s): Click here to enter text.
Click here to enter text.
b. In what form is the toxin(s) received? Click here to enter text.
c. Will you reconstitute the toxin(s)? ☐Yes ☐ No
If Yes, describe: Click here to enter text.
d. What is the highest concentration with which you will work or possess?
Click here to enter text.
e. What is the LD50 expressed in ng per kg body weight?
Click here to enter text.
f.
Do you agree to comply with Appendix I of BMBL, which includes maintaining an inventory system, secure
storage, and proper use of primary and secondary containment? (see BMBL Manual)
☐Yes ☐ No
9. Cell Culture Section (If Not Applicable, check here ☐ & proceed to next section):
Cells
Type
Source? (Lanza, ATCC, etc)
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
Use additional sheet, if necessary
Biosafety Application (Rev5, 9/10/2014)
Page 5
10. Human Blood and/or Tissue Section (If Not Applicable, check here ☐ & proceed to next section):
a. Are you handling human or nonhuman primate tissue or fluids? ☐Yes ☐ No
If Yes, list (include species):
Click here to enter text.
Click here to enter text.
b. What is the source and provider of the tissue(s)? Click here to enter text.
Click here to enter text.
c. Are the tissues known or suspected to be infected? ☐Yes ☐ No
If Yes, describe:
Click here to enter text.
Click here to enter text.
d. Has your staff taken the blood borne pathogen program? ☐Yes ☐ No
If Yes, list names and dates:
Click here to enter text.
Click here to enter text.
Click here to enter text.
11. Microorganism Section (If Not Applicable, check here ☐ & proceed to next section):
a. Which category of microorganism is being used? (check all that apply)
☐ Bacteria
☐ Archaea
☐ Fungi
☐ Unicellular Algae
☐ Protozoa
☐ Parasitic Worms
☐ Virus
b.
List each agent and its risk group, biosafety level, and provider (use additional sheet if necessary). Refer to ABSA
Risk Groups for details.
Risk Group
Agent (genus, species, strain)
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
Click here to enter text.
c. Are you producing or receiving vector virus? ☐Yes ☐ No
If yes, please describe any safety features that prevent the generation of recombinant virus and methods of
testing that have been performed or will be conducted:
Click here to enter text.
Click here to enter text.
Biosafety Application (Rev5, 9/10/2014)
safety
Page 6
12. Safety Procedures Section
a. Will you work with biohazardous agents in any of the following aerosol-producing devices or procedures?
☐Yes ☐ No (check all that apply)
☐ Aspirators
☐ Intranasal Inoculation
☐ Pressurized Vessels
☐ Blenders
☐ Centrifuges
☐ Large Volumes (
☐ Necropsy
☐ Shakers
☐ Sonicators
☐ Homogenizers
☐ Pipetting Infectious Liquids
☐ Vortexers
☐ Other, please list: Click here to enter text.
If Yes to any of the above, describe how you will contain the aerosol:
Click here to enter text.
If using sonicator, how will you provide hearing protection to all workers in the area?
Click here to enter text.
b. Do you concentrate the biohazardous agents? ☐Yes ☐ No (check all that apply)
☐ Centrifugation
☐ Filtration
☐ Other, please list: Click here to enter text.
If Yes, which agent is being concentrated? Click here to enter text.
☐ Precipitation
c. Are you using a vacuum supply with the biohazardous agents? ☐Yes ☐ No
If Yes, which agent is being used? Click here to enter text.
If Yes, indicate method for protecting the vacuum source:
d. At any time during the procedures, will biohazardous agents be moved from a higher safety level to a lower one
within the same facility? ☐Yes ☐ No
If Yes, provide a justification and describe method of inactivation for this step:
Click here to enter text.
e. How do you generally inactivate the biohazardous agents described in this application?
Click here to enter text.
Click here to enter text.
f.
How will you disinfect surfaces in the laboratory?
Click here to enter text.
Click here to enter text.
g. Will you need to work with or in any of the following? ☐Yes ☐ No (check all that apply)
☐ Biosafety Cabinet
☐ Fume Hood
☐ Autoclave
☐ Ventilated Cage Rack
☐ Filtered Cages (IVF cages)
☐ Any special equipment needed?
______________________________
Biosafety Application (Rev5, 9/10/2014)
Page 7
13. Waste Generation Section
a. Are you generating biological waste? ☐Yes ☐ No
Contact the BSO if you are unsure or have any questions.
If Yes, specify type:
b. Are you generating mixed waste? ☐Yes ☐ No (check all that apply)
☐ Biological and Chemical Hazard
☐ Biological and Radiological Hazard
☐ Biological, Chemical, and Radiological Hazard
c. Have you notified the Department of Environmental Health and Safety? ☐Yes ☐ No
14. Transport and Transfer Section
a. Will you transport or transfer biohazardous agents? ☐Yes ☐ No
[Transport refers to packaging and shipping these agents by air, land, or sea via airplanes, motor vehicles, boats, or other
means. Transfer refers to exchanging these agents between laboratories, generally between rooms or buildings within a
facility or institute.] Transport involving sharps requires them to be contained in a leak-proof, puncture-proof container and
labeled with a biohazard label (if applicable).
If Yes, describe agents and method of transport or transfer: Click here to enter text.
Click here to enter text.
b. If transporting agents in my personal vehicle, I accept responsibility for the personal liability I may incur in the
event of an accident. ☐Yes ☐ No ☐ N/A
c. The transport and transfer of biological agents is governed by the Center for Disease Control (CDC) and the
Federal Government. Do you agree to comply with the CDC and Federal regulations?
☐Yes ☐ No ☐ N/A
Refer to BMBL Appendix C Transport of Infectious Substances
Refer to http://hazmat.dot.gov/ for Federal Hazardous Materials Transportation Law.
Refer to http://hazmat.dot.gov/training/rmgmt/InfectSubstances.pdf for helpful info.
15. Assurances Section. Please answer Yes or No.
☐Yes ☐No
☐Yes ☐No
☐Yes ☐No
☐Yes ☐No
☐Yes ☐No
☐Yes ☐No
☐Yes ☐No
☐Yes ☐No
☐Yes ☐No
The Principal Investigator is trained for the proposed studies.
All personnel will receive the appropriate training in regard to safety practices and protective equipment for
this work.
Written experimental procedures will be maintained in the laboratory.
Laboratory procedures will be in compliance with the Chemical Hygiene Plan, the Biosafety Manual, the
OSHA Laboratory Safety Standard, and other appropriate OSHA Standards.
Chemical fume hoods shall never be used to contain biohazards.
No employee or researcher will be asked to intentionally consume or otherwise be exposed to a biological
agent as part of a research protocol.
All biological waste will be properly disposed in compliance with Waste Management Guidelines
established by the Department of Environmental Health and Safety.
As applicable, employees will be offered the necessary vaccination.
Approval of this application is only for the biohazardous agents and procedures described herein. Any
changes to the protocol (e.g., change of organisms, vectors, procedures, personnel, project location, etc.)
must be approved by amendment prior to use or implementation.
Biosafety Application (Rev5, 9/10/2014)
Page 8
16. Project Summary Section.
Please provide a brief overview of the proposed research containing sufficient information to ensure adequate review of the
protocol to determine compliance with the Calvin College Biosafety Program and local, state, and federal regulations. DO
NOT cut and past the specific aims section from a grant application.
a.
b.
c.
d.
e.
Purpose of research (brief);
Assessment of risk to personnel working with the biological agent;
An outline of the procedures and techniques employed;
Description of the safe practices, equipment, and facilities used to protect personnel;
Describe any specific methods of inactivation or disposal of the agent not mentioned above.
Attach additional sheets as necessary.
Click here to enter text.
Biosafety Officer Section Only
I have reviewed this application and
☐ BSO approves; no further action required by IBC
☐ BSO approves for designated member review (special expertise may be required)
☐ BSO requires full committee review
Name: Click here to enter text.
Date:
(Signature of Biosafety Officer)
Biosafety Application (Rev5, 9/10/2014)
Page 9