Biohazard Project Registration
The purpose of the Biohazard Project Registration process is to identify and assess risks associated with a project. Upon approval, the Biosafety Office and/or Institutional Biosafety Committee (IBC) will communicate specific guidance and requirements for the appropriate containment, procedures and practices needed to prevent accidental exposures or unintended releases of these materials. Registrations are project specific.
What constitutes a project is at the discretion of the PI. In general, a project covers a specific scope of work with specific aims. An “umbrella” registration for all the work done in the laboratory does not provide sufficient detail for a useful risk assessment, whereas registration of individual experiments requires too frequent upkeep of the registrations. Consult the Biosafety Office for guidance as needed.
As of March 2020, the Biosafety Office will no longer be accepting paper registration forms for project registrations (apart from Select Agent projects). All new project submissions, technical change amendments, administrative amendments, and 5-year renewals will be processed through the Gator TRACS Biohazard Project Registration module.
Biohazard Project Registration FAQs
Projects that involve:
- Culturing or propagating an unknown/uncharacterized pathogen.
- Analysis of samples known or suspected to be contaminated with an infectious biological agent.
- The use of infectious biological agents pathogenic to otherwise healthy humans.
- The use of primary human tumor cells.
- The use of cells immortalized with a virus (e.g. EBV, SV40).
- The use of toxins of biological origin that are either acute (LD50 < 100 µg/kg body weight) or export-controlled.
- Experiments using recombinant nucleic acids.
- Experiments using synthetic nucleic acids of any of the following: I. Designed to integrate in DNA; II. Replication competent; or III. Encode a toxin with an LD50 < 100 ng/kg body weight.
- The use of recombinant or synthetic nucleic acid molecules, or DNA or RNA derived from such molecules, in human research subjects.
- The requirement of federal or state permits (for possession, import, transport, or release).
1.Projects that include the use of rDNA/synthetic nucleic acid, projects that are non-exempt from NIH Guidelines, those that use CRISPR/Cas9 technology, are BSL-3 projects, or Select Agent projects require full Institutional Biosafety Committee (IBC) review and approval.
2.The IBC committee meets monthly and the registration form must be completed by 5 pm on the first Wednesday of each month in order to be considered for discussion at that month’s meeting. Projects that require extensive modification/revision may not be reviewed until the following month’s meeting. [IBC Meeting schedule]
1. IACUC protocols will not receive final approval until the Biosafety Office and/or IBC project approval is finalized. Biosafety Office staff advise IACUC staff of approved, denied or tabled projects.
2. The use of ANY primary human cells/tissues requires ABSL-2 practices and animal housing as stated in the IBC Guidelines for the Use of Human Cells and Tissues in Animals
1. Projects will expire 5 years after the project approval date.
2. Projects (including NIH-exempt projects) must be updated annually in Gator TRACS. PIs will receive reminders from Gator TRACS that their project will be expiring
- If your project is currently approved in Gator TRACS, you may amend the project under “Permit Amendments & Renewals” in the Biohazards Project Registration module.
- Please review the PI User Guide for further instructions.
- If your project was not approved in Gator TRACS, but in the “old” paper system, please submit a Biohazard Project Registration form in Gator TRACS and include the changes you are requesting.
- Include a summary of changes at the “Certification” step of the submission process.
- Upon approval, your project will have a 5-year expiration date from the date of approval in Gator TRACS.
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