Animal Care / Use Application

Appendix D

Use of Hazardous Agents

Form completion instructions: To populate a box, click once on the box to show the “X.” To uncheck box, click on it once more to remove “X.” For narrative responses, click on the prompt text (“Click here to enter text”) and begin typing.

Protocol Title: Click here to enter text.

Principal Investigator: Name: Click here to enter text.Department: Click here to enter text.

  1. I have received IBC approval and my biosafety protocol specifically details the use of animals as indicated above as well as in this animal care/use application.

☐ Yes* ☐ No ☐ Pending

*If “YES”, provide the IBC approval # (e.g., 12-014): ______- ______OR

If approved by the IBC as BSL-1 and/or exempt rDNA check this box: ☐

If “No” see question #2.

NOTE: The IACUC will withhold approval of this application until IBC approval is granted.

2. Answer the following questions to determine the need for Institutional Biosafety Committee (IBC) approval.

Does this animal protocol involve:

  1. Introduction of rDNA by any means into animals including, but not limited to, transfer of genetically engineered cells (transfected by any means), cells that come from a transgenic animal, or using viral vectors? a. ☐ Yes ☐ No

Recombinant DNA (rDNA) is defined as the joining of naturally occurring or synthetic DNA sequences (insert) to host DNA such that the resulting joined sequences are capable of replicating in a host cell (vector).

  1. Use or cross-breeding of transgenic or knockout animals except for breeding one line of transgenic or knockout rodents for colony maintenance?

b. ☐ Yes☐ No

  1. Use of organisms or viruses known to be pathogenic to humans (e.g., parasites, viruses, bacteria, fungi, prions, rickettsia) or biological materials that may contain these microorganisms?

c. ☐ Yes☐ No

  1. Use of CDC/USDA regulated Select Agents or Toxins (human, animal, or plant)? Refer to the Select Agents website. d. ☐ Yes ☐ No
  2. Use of human or other primate tissues, blood or body fluids or materials derived from them, including established cell lines (e.g. HeLa, HEK 293, etc.)? e. ☐ Yes ☐ No
  3. Use of disease carrying vectors (such as arthropods) or other biologically active agents (e.g., toxins, venoms) that may cause disease in humans or cause significant impact if released to the environment

f. ☐ Yes☐ No

If “Yes” to ANY question above, IBC Approval is needed.

If “No” to ALL questions, IBC approval is not needed.

If unsure about ANY question above, contact the Biosafety Compliance Office at (704) 687-1872 to discuss.

For guidance on IBC forms and requirements, refer to the IBC website.

NOTE: The IACUC will withhold approval of this application until IBC approval is granted.

  1. Does this animal protocol involve use of radioisotopes/radiation producing devices? ☐ Yes☐ No

*If “Yes”, then the protocol must be reviewed and approved by EH&S. The use of radioisotopes/ionizing radiation producing devices also must follow the requirements outlined in the University’s Radiation Safety Handbook.

Have you obtained this approval from EH&S? ☐ Yes☐ No ☐ Pending

NOTE: The IACUC will withhold approval of this application until EH&S approval is granted.

  1. Does this animal protocol involve use of hazardous chemicals?☐ Yes☐ No

If “Yes”, Safety Data Sheets (SDS) for the chemical compounds must be provided to EH&S. The use of chemical compounds must follow the requirements outlined in the University’s Hygiene Plan.

5. Use of agents in animals: If you noted the use of any type of hazardous agents in the screening questions above please complete the table below.

Agent Name / Description / Type of Agent / Dose / Concentration / Route / Frequency of Administration / Anticipated Duration of Effect / Method of Waste Disposal
Click here to enter text. / ☐ Biological Hazard
☐Chemical Hazard
☐Radiation Hazard
☐Other
Specify: 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. / ☐ Biological Hazard
☐Chemical Hazard
☐Radiation Hazard
☐Other
Specify: 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.

Appendix D: Hazardous Agents

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