Biosafety Checklist for New Researchers

New PI Checklist for Work with Biohazards and Recombinant DNA
Office of Biosafety



1.    Texas A&M Institutional Biosafety Committee (IBC) approval is needed for all research, teaching or testing activities conducted by a member of the faculty or staff of Texas A&M University or a Texas A&M System component with a signed Memorandum of Understanding with Texas A&M IBC prior to initiation of the following work with:
a.    Pathogens and potential pathogens of humans, animals, or plants;
b.    Materials potentially containing human pathogens (human blood, tissue, and cell lines; non-human primate blood, tissues, and cell lines);
c.    Recombinant DNA (and RNA) including the creation or use of transgenic plants and animals;
d.    Biological toxins;
e.    Select Agents and Toxins, including strains and amounts exempted from the Select Agent Regulations; and
f.    Any material(s) requiring a CDC Import license or USDA permit.

2.    Registration with the IBC:
a.    The initial step for approval to work with biohazards is to submit a complete IBC permit application to the IBC.
b.    All applicable forms are available on-line (https://iris.tamu.edu)
c.    Instructions and assistance are available. (979.845.4969 or IBC@tamu.edu)

3.    IBC Training Requirements:
a.    Principal Investigators (PI) conducting research involving recombinant DNA molecules must complete NIH Guidelines training. This training is offered online via the CITI program and must be completed once every three years.
b.    All personnel who will be listed on a biosafety level two (BL2) permit must complete BL2 training, provided by the Office of Biosafety, before being permitted to work in the BL2 lab. Instructor led BL2 training is offered weekly and upon special request. BL2 Training is valid for three years and may be refreshed on-line via the CITI program.
c.    All personnel who will be listed on a biosafety level three (BL3) permit must complete BL3 training, provided by the Office of Biosafety, before being permitted to work in the BL3 lab.  Instructor led BL3 training is available upon request, as needed. Please contact the Office of Biosafety at 979.862.4549 or biosafety@tamu.edu for assistance. BL3 training must be renewed annually via classroom training.
d.    All personnel listed on either BL2 or BL3 IBC permits must also be provided lab/agent specific training by the PI. Documentation of this training must be provided to the IBC by the PI.  The Office of Biosafety can provide PIs with a template form to fulfill this requirement; the form  is included in the IBC Application.
e.    Bloodborne Pathogen (BBP) Training is required for all personnel at occupational risk of exposure to human and/or non-human primate blood, tissues, body fluids, and/or other potentially infectious materials. Annual retraining is mandatory. The first training must be completed in the classroom setting; instructor led classes are offered at least every 10 days. Thereafter, refresher training may be completed on-line via the CITI program.
f.    For personnel working in BL2 and BL3 labs a one-time TrainTraq training on the safe usage of a biosafety cabinet will also be assigned.

4.    Laboratory Inspection and Certification:
a.    As part of the IBC review and approval process, laboratories will be scheduled for inspection.
b.    The IBC permit cannot be approved until all lab space has been inspected and certified for the appropriate biosafety level.
c.    Example inspection checklists are available: (http://rcb.tamu.edu/biohazards/forms/bl2labinspections/view)

5.    IBC Approval:
a.    The IBC meets the third Wednesday of each month. IBC meetings are open to the public. To view a full schedule of Committee Meetings see the front page of RCB at http://rcb.tamu.edu.
b.    IBC applications describing rDNA studies which are not exempt of the NIH Guidelines must be reviewed by the full committee during a regularly convened meeting. NOTE: An application must be submitted at least 10 business days before the meeting date in order to be considered for review during the upcoming meeting.
c.    IBC applications describing non-recombinant work with biohazards, or recombinant work that is exempt of the NIH Guidelines, must still be registered with the IBC but can be approved by the IBC Chair on behalf of the IBC.

6.    Commencement of Work:
a.    Once the approval memo, signed by the IBC Chair, is received by the PI, approved experiments may commence.
b.    The IBC approval will detail the specific outline of the work permitted, including a list of approved agents, locations and assigned biosafety level(s).
c.    IBC approval is valid for three years; annual renewals are required as described below.
d.    A copy of the IBC approval letter will be provided to the PI, and the Department Head.

7.    Annual Requirements:
a.    A one-page annual renewal questionnaire must be submitted by the PI 60 days prior to the first and second anniversary of the IBC permit approval.
b.    Annual renewal forms are accessible on-line in the iRIS program.
c.    A laboratory inspection will be scheduled as part of the annual renewal.
d.    Personnel training requirements will be reviewed annually to ensure that all personnel are current with respect to required trainings.

8.    Amendments are required prior to implementing any changes to the existing IBC approval including changes in:
a.    Personnel: Any deletion or addition of laboratory personnel to BL2 and BL3 IBC permits must be submitted on-line in the iRIS program.
b.    Funding: Any addition of funding must be submitted for review by the IBC.
c.    Agents: Addition of agents, procedures, etc. must be submitted for review by the IBC
d.    Locations: Any changes in locations must be submitted to the IBC.
i.    The room being vacated must be decontaminated, chemical and biological agents properly disposed of (and/or secured for transport). The vacated lab will be inspected and decommissioned by Environmental Health and Safety and the Office of Biosafety.
ii.    The new lab must be inspected and certified before work in the new space may commence.
9.    Termination of IBC Permit:
a.    Investigators leaving the institution or ceasing all work with biohazardous materials should submit a termination request to the IBC.
b.    Requests for termination will initiate the laboratory decommission process described in 8.d.i.

Other Research Activities:
All research involving animals must be registered separately with the Institutional Animal Care and Use Committee (IACUC). IBC approval does not convey IACUC approval. Please see: http://rcb.tamu.edu/animals

All research involving human subjects must be reviewed by and may approval from  the Institutional Review Board (IRB). IBC approval does not convey IRB approval. Please see: http://rcb.tamu.edu/humansubjects

Any research that may be subject to Export Control regulations must be in compliance with Federal guidelines. Please see: http://vpr.tamu.edu/resources/export-controls

Research activities involving the use of other hazards are not the scope or oversight responsibility of the Office of Biosafety. For questions regarding general lab safety, laser safety and/or work with chemicals, radiation, etc., please contact Environmental Health and Safety: http://ehsd.tamu.edu/