containment systems or control systems, in order to determine the root cause(s). The Public Health Agency of Canada (PHAC) to be informed without delay via the submission of an exposure notification report following: 4.9.9 an exposure to a pathogen or toxin; or recognition of a disease that has or may have been caused by an exposure to a human pathogen or toxin. An exposure follow-up report documenting the completed investigation, to be submitted to the PHAC within: 15 days of the submission of an exposure notification report involving a security sensitive biological 4.9.10 agent (SSBA); or 30 days of the submission of an exposure notification report involving a human pathogen or toxin other than an SSBA. Records and Documentation Training and refresher training to be documented; records to 4.10.1 be kept on file. Inventory of pathogens, toxins, and other regulated infectious material in long-term storage to be 4.10.2 maintained, including location and risk group(s). Inventory to include pathogens, toxins, and other regulated infectious material stored outside of the containment zone. Records of regular inspections of the containment zone and 4.10.5 corrective actions to be kept on file. Records of building and equipment maintenance, repair, inspection, testing, or certification, including performance 4.10.6 verification and testing records, in accordance with containment zone function, to be kept on file. Equipment used for performance verification and testing of containment systems and essential biosafety equipment to 4.10.7 have a valid calibration certificate at the time of testing; calibration certificates to be kept on file. Records of validation and routine verification 4.10.9 of decontamination technologies and processes to be kept on file. Records and documentation pertaining to: licence activities involving human pathogens and toxins to be kept on file for a minimum of 5 years; and animal pathogen import permit requirements for animal 4.10.10 pathogens, toxins, and other regulated infectious material to be kept on file for a minimum of 2 years following the date of disposal, complete or transfer, inactivation of the imported material.
containment systems or control systems, in order to determine the root cause(s). 4.9.9 The Public Health Agency of Canada (PHAC) to be informed without delay via the submission of an exposure notification report following: an exposure to a pathogen or toxin; or recognition of a disease that has or may have been caused by an exposure to a human pathogen or toxin. 4.9.10 An exposure follow-up report documenting the completed investigation, to be submitted to the PHAC within: 15 days of the submission of an exposure notification report involving a security sensitive biological agent (SSBA); or 30 days of the submission of an exposure notification report involving a human pathogen or toxin other than an SSBA. Records and Documentation 4.10.1 Training and refresher training to be documented; records to be kept on file. 4.10.2 Inventory of pathogens, toxins, and other regulated infectious material in long-term storage to be maintained, including location and risk group(s). Inventory to include pathogens, toxins, and other regulated infectious material stored outside of the containment zone. 4.10.5 Records of regular inspections of the containment zone and corrective actions to be kept on file. 4.10.6 Records of building and equipment maintenance, repair, inspection, testing, or certification, including performance verification and testing records, in accordance with containment zone function, to be kept on file. 4.10.7 Equipment used for performance verification and testing of containment systems and essential biosafety equipment to have a valid calibration certificate at the time of testing; calibration certificates to be kept on file. 4.10.9 Records of validation and routine verification of decontamination technologies and processes to be kept on file. 4.10.10 Records and documentation pertaining to: licence activities involving human pathogens and toxins to be kept on file for a minimum of 5 years; and animal pathogen import permit requirements for animal pathogens, toxins, and other regulated infectious material to be kept on file for a minimum of 2 years following the date of disposal, complete transfer, or inactivation of the imported material.
cl2_checklist_-_mandatory_requirements.docx