Laboratory Biosafety Training in REPORTER (Laboratory Biological Safety Training – EHPS-BS20) includes the Biosafety Orientation eLearning module which is intended to be a general overview of biosafety at NC State. The goal of this module is to help participants to understand what materials and/or research might trigger Institutional Biosafety Committee (IBC) approval and how to handle materials and/or research that do not.
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Biological Use Authorization (BUA) Form To register your biological materials, complete a BUA form and submit it according to instructions on the form. EHS will forward your form to the Institutional Biosafety Committee (IBC) for review and may contact you with questions or concerns about your proposal. The IBC reviews registrations at regularly scheduled meetings. Review the meeting schedule and submission deadlines for each meeting here. IBC approval can take as little as three weeks or as long as several months, depending upon how comprehensive the submission is initially, and/or the type of project. For amendments, use the BUA Amendments form. For duplicate Part D, use this form. The following biological materials require approval prior to the procurement of the materials necessary to initiate the project:
- recombinant/synthetic nucleic acid molecules in organisms (refer to the NCSU Recombinant and Synthetic Nucleic Acid Molecules Classification Guide) including their use in animals (including arthropods) and plants,
- human and other primate-derived substances (blood, blood products, cell lines or tissues),
- organisms or viruses infectious to humans, animals or plants (e.g., parasites, viruses, bacteria, fungi, prions, rickettsia) or biological materials that may contain these microorganisms;
- Select Agent or Toxins (human, animal, or plant) – refer to the list here http://www.selectagents.gov/SelectAgentsandToxinsList.html
- biologically active agents (e.g., venoms, toxins produced by living organisms) that may cause disease in other living organisms or cause significant impact if released into to the environment.
Investigators must procure all of the biological materials listed above through the MarketPlace online procurement process (this site contains the procurement process for suppliers not presently listed in the MarketPlace).
Laboratory Biosafety Manual The Laboratory Biosafety Manual provides a guide to common practices and requirements related to working with biological materials at NC State University in teaching, research, and diagnostic laboratories.
Safety Plan A Safety Plan is required for areas listed on the BUA. The Safety Plan approval process is separate from the BUA approval process.
Biowaste All treatment and disposal of biological waste must adhere to the requirements outlined in the NC State Laboratory Biosafety Manual. Review this EHS Biowaste website for a Q&A that will help you ensure your practices are in compliance.
Human blood, tissues, primary, or established human cell lines Any research, diagnostic, or teaching activity conducted with material derived from humans, including blood, OPIM, tissues, primary, or established cell lines requires the PI to complete and implement an Exposure Control Plan in addition to the BUA. The Laboratory Exposure Control Plan for Bloodborne Pathogens was designed to help Principal Investigators and Lab Managers understand and meet the provisions of OSHA regulation 1910.1030 for Bloodborne Pathogens in the workplace.
The BSL-2 Checklist The BSL-2 checklist is required to ensure that laboratory facilities meet basic requirements at the federal, state, and local levels for work at biosafety level 2 (BSL-2).
CDC Guidelines for Laboratory Biosafety Competency These guidelines outline the essential skills, knowledge, and abilities required of personnel working with biologic agents. See how you and your workers measure up on items like aseptic techniques, handling infectious agents, correct use of the biosafety cabinet, ability to respond to emergencies, and many others.