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Biosafety and Bloodborne Pathogens Training
To fulfill IBC minimum requirements, at least once at lab orientation. Principal Investigators and supervisors may have additional requirements. Also, the IBC may require additional training completion at the time of BUA approval or if significant changes occur at NC State University regarding biosafety. Maintain your training documentation carefully since granting agencies and regulatory bodies hold the University accountable for meeting official internal guidelines, policies and procedures.
OSHA requires Bloodborne Pathogens training to be completed prior to conducting duties listed in the Exposure Determination section of your Exposure Control Plan and also annually thereafter. EHS has developed online modules to supplement your review of the Exposure Control Plan, however this online training does not replace your annual review of your specific Exposure Control Plan with your supervisor.
Biological Use Authorization (BUA)
An approved BUA assures that an appraisal has been made of the potential impacts associated with the intended use of an organism. For a list of materials that require BUA submission prior to their acquisition and/or use, refer to page 4 of the NC State University Laboratory Biosafety Manual http://www.ncsu.edu/ncsu/ehs/www99/left/bioSafe/index.pdf. Federal, state, local, and university requirements and policies change over time requiring the BUA to be reevaluated and updated periodically. So BUAs must be submitted using the latest version of the form (available at http://www.ncsu.edu/ncsu/ehs/www99/left/bioSafe/bio_forms_index.htm ). Approval is valid only for the materials listed, the specified activities at the locations described in your application, and for the containment conditions specified. The BUA expires three years from the date of approval. Instructions to complete and submit the BUA are located on the form.
The Statement of Informed Consent is located within the BUA. Principal Investigators are directed to use it to communicate biohazard to laboratory workers, guide discussion of worker immunocompetence, and document completion of the online Laboratory Biosafety Training. Because Principal Investigators are required to add the names of new workers as they join the project, EH&S recommends maintaining the BUA, including the signed Statement of Informed Consent, with other lab safety and training documents such as the Safety Plan.
New BUAs are required when there is a change in the basic thrust of a project; i.e., a new goal. Amendments are required when the change may have safety or regulatory consequences but the basic thrust of the study stays the same. If the only change is addition or removal of personnel, an amendment is not required. Instead, add and remove personnel to the Statement of Informed Consent in your approved BUA. Refer to the table on the front of the Amendment form here http://www.ncsu.edu/ncsu/ehs/www99/left/bioSafe/index.pdf to determine the type of Amendment to submit. For questions regarding your amendment, contact the EH&S Biosafety Officer at 919-515-6858.
EH&S notifies the campus community by email as biosafety changes or concerns arise. These notifications are listed at EHS Biosafety notifications.
The IBC periodically reviews and updates the Laboratory Biosafety Manual. Changes incorporated into the latest version of the manual are accessible from within the manual itself at http://www.ncsu.edu/ncsu/ehs/www99/left/bioSafe/index.pdf
EH&S recommends the list of links located at the ABSA International website here https://www.absa.org/resbslinks.html. For more information contact EH&S at 919-515-6858.