Analysis of Risk Group 3 Term Inspections

June 2019 marked the end of the first 3-year cycle of Risk Group 3 Licences term inspections. Between June 2016 and June 2019, the Centre for Biosecurity inspectors conducted 63 compliance monitoring and verification inspections. Out of this total:

•         26 (41%) were Containment Level 3 facilities with a Risk Group 3 licence
•         15 (24%) were Containment Level 2 facilities with a Risk Group 3 licence subject to the Biosafety Directive for Mycobacterium Tuberculosis Complex
•         20 (32%) were Containment Level 2 facilities with a Risk Group 3 licence subject to the Biosafety Directive for Human Immunodeficiency Virus, Human T-lymphotropic Virus, and Related Simian Retroviruses

The Centre for Biosecurity identified 404 deficiencies that required corrective action (395 minor and 9 major) with an average of 7 deficiencies per inspection. Many of the deficiencies were related to new regulatory requirements. In 6 risk group 3 facilities, no deficiencies were observed during their inspection.

The 3-year cycle analysis of the inspections also helped identify areas where further clarification and guidance would be beneficial. For example, Canadian Biosafety Standard requirement 4.4.7 was subject to various interpretations by regulated parties. To minimize misunderstanding, the Centre for Biosecurity has used the feedback to develop better guidance and clearer requirements in the upcoming editions of the standards.

Tips to achieve compliance:

•         keep all documentation related to your licence
•         reach out to the Centre for Biosecurity if you have any questions at biosafety.biosecurite@phac-aspc.gc.ca
•         check out the online training tools.