About the BSL1 Biosafety Review Form
An initiative led by the CDC and the NIH has led to the acceptance and use of national
biosafety guidelines for research. As part of a commitment to providing a healthy and safe
learning and research environment, Franklin and Marshall College intends to be in compliance
with these guidelines. Noncompliance with these guidelines can result in funding difficulties
with the federal government that can affect all federally funded biological science research at
F&M.
The Biosafety Officer and the Institutional Biosafety Committee (IBC) have been charged to
review, approve, and maintain documentation on all protocols involving recombinant DNA and
other potentially hazardous biological materials including animal and plant pathogens, human
cell lines and tissues, toxins, viral vectors, carcinogens and the use of transgenic organisms.
Depending on the materials stored and used in a lab and how those materials are being used, labs
may be designated as Biosafety Level 1 (BSL1) or Biosafety Level 2 (BSL2).
This form contains 7 questions that will be used to determine how the NIH Guidelines
may be relevant to your research and the Biosafety containment and practices that are
required:
- If your research does not involve recombinant DNA, pathogens, human cells or tissues or
any potentially biohazardous materials and you answered “no” to every question, please
email the completed form to the Biosafety Officer (dfrielle@fandm.edu). You only need to
file the form one time, unless changes to your research projects would result in a “yes’
answer to any question on the form. In that case, you would need to update the form and
return it to the Biosafety Officer.
- If you answer “yes” to any of the questions, your research may require Biosafety Level 1 or
Biosafety Level 2 containment and practices, depending on what materials you are using
and what you intend to do with them. After completing the form, indicate whether you
believe your lab qualifies as BSL1 or BSL2 and email the completed form to the Biosafety
Officer (dfrielle@fandm.edu). The Biosafety Officer (and the IBC, if necessary) will
confirm that the Biosafety level that you intend to use is acceptable.
If your research activities are consistent with a BSL1 classification (exempt under the NIH
Guidelines), you must update and file this form annually. The annual filing is intended to
ensure compliance with the NIH Guidelines; often researchers alter their protocols and
begin to use non-exempt materials without realizing that the new protocols may require
enhanced biosafety containment.
- If it is determined that your research requires Biosafety Level 2 containment, you must
complete the BSL2 Biosafety Review form: this requires IBC review and approval. This
form is available at fandm.edu/biosafety.
These links may be helpful in determining the Risk Group of your research materials, the
appropriate Biosafety Level and whether your research is exempt under the NIH Guidelines. If
you have any questions about the form or the status of your lab, please contact the Biosafety
Officer.
http://oba.od.nih.gov/rdna/nih_guidelines_oba.html
http://www.cdc.gov/biosafety/publications/bmbl5/
http://www.aphis.usda.gov
http://www.selectagents.gov/select agents and Toxins list.html
BSL1 Biosafety Review Form
PI Name
Room no.
Date
1. Does your work involve any (non-recombinant) agents that are potentially infectious to
animals or plants, including viruses, bacteria, fungi or parasites?
Yes
No
If yes, complete this Table.
Infectious agent
Infectious Agents
Comments (e.g. strain, modifications)
Biosafety
level
Risk
Group
Add more rows to the table as needed or attach a copy of the table.
If this work requires Biosafety Level 2 or if any of the infectious agents are classified as Risk
Group 2 or above, the research is non-exempt. The BSL2 Biosafety Review form must be
completed for IBC review and approval. This form is available at fandm.edu/biosafety.
2a. Does this work involve recombinant DNA in infectious agents including viruses,
bacteria, fungi or parasites?
Yes
No
If yes, complete the Table.
Recombinant Infectious Agents
Nature/Source of
inserted DNA:
Examples: include
genus/species, potential for
increased drug resistance,
name of protein pathway or
function
Host(s)
Examples: E.coli K-12,
yeast, mammalian cells
Methods of gene
transfer/vector(s):
Intended Use of
rDNA:
Examples: virus; plasmid;
naked DNA; conjugation
Examples: cloning;
transgenic generation;
modification of natural
gene expression; new
protein expression
Add more rows to the table as needed or attach a copy of the table.
This work may be exempt depending on what organisms and vectors are being used and what
genes are being inserted or manipulated. For example, the use of Escherichia coli K-12 and
Saccharomyces Host-Vector Systems is generally exempt. If this work requires Biosafety Level
2 or if any of the infectious agents are classified as Risk Group 2 or above, the research is nonexempt. The BSL2 Biosafety Review form must be completed for IBC review and approval. This
form is available at fandm.edu/biosafety.
2b. Does the construct contain viral DNA that represents more than ½ of any eukaryotic
viral genome?
Yes
No
3. Does this work involve any unfixed materials derived from humans or non-human
primates? These materials include established cell lines, blood, other fluids, tissues, and
primary cells.
Yes
No
If “yes”, this work requires Biosafety Level 2; the BSL2 Biosafety Review form must be
completed for IBC review and approval. This form is available at fandm.edu/biosafety.
4. Does this work involve human embryonic stem cells (hESC) and/or human induced
pluripotent stem cells (hiPSC)?
Yes
No
If “yes”, this work requires Biosafety Level 2; the BSL2 Biosafety Review form must be
completed for IBC review and approval. This form is available at fandm.edu/biosafety.
5. Does this work involve toxins of biological origin?
Yes
No
If yes, complete the table.
Toxins of Biological Origin
Toxin
Comments (include dose, LD50, route of administration,
safety precautions, etc.)
Add more rows to the table as needed or attach a copy of the table.
This work may be exempt depending on what toxins and concentrations are being used. If it is
not exempt, the BSL2 Biosafety Review form must be completed for IBC review and approval.
This form is available at fandm.edu/biosafety.
6. Will any of the recombinant DNA, infectious agents or biohazardous materials be used
with animals or plants?
Yes
No
If yes, complete the table.
Biohazards in Animals or Plants
Biohazard/recombinant DNA
Animal /plant
Specie(s) and
description
Comments
Add more rows to the table as needed or attach a copy of the table.
Biosafety
level
7. Will you be using or generating transgenic animals or plants?
Yes
No
If yes, complete the table.
Genetically Manipulated Animals or Plants
Gene altered;
Transgene (TG) or knockout (KO)
and Source
Species of
gene/marker
Species and
type of
genetically
altered animal
or plant
Biohazard (if used)
Does change
initiate or
promote
oncogenesis?
Yes/No
Biosafety
Level
Add more rows to the table as needed or attach a copy of the table.
This work may be exempt depending on what organisms and vectors are being used and what
genes are being inserted or manipulated. For example, use of Drosophila and Arabidopsis based
systems are generally exempt. If this work requires Biosafety Level 2 or if any of the infectious
agents are classified as Risk Group 2 or above, the research is non-exempt. The BSL2 Biosafety
Review form must be completed for IBC review and approval. This form is available at
fandm.edu/biosafety.
BIOSAFETY LEVEL ASSIGNMENT
If you answered “no” to all of the questions, please email the completed form to the Biosafety
Officer (dfrielle@fandm.edu). You only need to file the form one time, unless changes to your
research projects would result in a “yes’ answer to any question on the form. In that case, you
would need to update the form.
If you answered “yes” to any questions, what is the highest Biosafety Level that your research
requires?
Biosafety Level 1 (exempt) ______
Biosafety Level 2 ______
Please email the completed form to the Biosafety Officer (dfrielle@fandm.edu) for evaluation. If
your work is determined to be exempt under the NIH Guidelines, your research may be
conducted at Biosafety Level 1. You must update and file this form annually.
If it is not exempt, the BSL2 Biosafety Review form must be completed for IBC review and
approval.
Principal Investigator Assurance for Biosafety Level 1:
I agree to use at least Biosafety Level (BSL -1) containment practices with all exempt research
and teaching activities including work with rDNA and other potentially biohazardous materials.
I will notify the Biosafety Officer and the IBC of any changes to this research by promptly
amending this form.
Signature of Principal Investigator
Date
For F&M IBC use only
Version 5/2014
Date rec’d:
Date approved:
NIH exemption category: