About the BSL1 BiosafetyReview 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 theNIH 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 (). 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 (). 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 areconsistent 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.
agents and Toxins list.html
BSL1 Biosafety Review Form
PI Name / Room no. / Date1. Does your work involve any (non-recombinant) agents that are potentially infectious to animals or plants, including viruses, bacteria, fungior parasites?
Yes / NoIf yes, complete this Table.
Infectious AgentsInfectious agent / 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 / NoIf yes, complete the Table.
Recombinant Infectious AgentsNature/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):
Examples: virus; plasmid; naked DNA; conjugation / Intended Use of rDNA:
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 non-exempt. 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 / No3. Does this work involveany unfixed materials derived from humans or non-human primates? These materials include established cell lines, blood, other fluids, tissues, and primary cells.
Yes / NoIf “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 / NoIf “yes”, this workrequires 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 / NoToxins of Biological Origin
Toxin / Comments (include dose, LD50, route of administration,
safety precautions, etc.)
If yes, complete the table.
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 / NoIf yes, complete the table.
Biohazards in Animals or PlantsBiohazard/recombinant DNA / Animal /plant Specie(s) and description / Comments / Biosafety level
Add more rows to the table as needed or attach a copy of the table.
7. Will you be using or generating transgenic animals or plants?
Yes / NoIf yes, complete the table.
Genetically Manipulated Animals or PlantsGene 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 (). 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 () 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 Officerand the IBC of any changes to this research by promptly amending this form.
Signature of Principal Investigator Date