Human Pathogens and Toxins Act Security Clearance Reminders for Licence Holders, Licence Holder Representatives, and Security Clearance holders

A Security Clearance issued under the Human Pathogens and Toxins Act (hereafter referred to as Security Clearance) is required for unescorted access to a part of a facility where controlled activities are taking place with security sensitive biological agents.

The Licence Holder or the Licence Holder Representative must maintain an up-to-date list of persons authorized to access any part of the facility where controlled activities are conducted and provide this list to the Public Health Agency of Canada upon request. To comply with this requirement, licence holders or licence holder representatives must:

• maintain a record of security clearance issuance and expiry dates for individuals endorsed under their licence;
• maintain an up-to-date list of persons who have authorized unescorted access to a part of a facility where a controlled activity is being conducted with security sensitive biological agents;
• maintain a record of all entries and exits of authorized persons where controlled activities with security sensitive biological agents are conducted;
• maintain a record of persons under one-to-one supervision where controlled activities with security sensitive biological agents are conducted within their licensed facilities
• withdraw endorsements when access to security sensitive biological agents is no longer required informing the Public Health Agency of Canada of the reason for the withdrawal

If a Security Clearance has expired, the Security Clearance holder must be escorted by a person who holds a valid Security Clearance to access any part of the facility where controlled activities with security sensitive biological agents are authorized.

The Human Pathogens and Toxins Act Security Clearance screening team recommends Security Clearance holders re-apply for a new Security Clearance at least 6 months before the valid Security Clearance expires to avoid disrupting access to security sensitive biological agents.

The Centre for Biosecurity reviews applications as quickly as possible and has an 80-day service delivery standard. The 80-day service delivery standard applies only if an application has no missing or potential adverse information. It is the responsibility of the licence holder to follow-up with the applicant to ensure that they have responded to requests from the Centre for Biosecurity and that their application is complete. The Centre of Biosecurity has noted that delays in issuing Security Clearances are often due to incomplete applications.

For a Security Clearance issued after April 2021:

• The Licence Holder or Licence Holder Representative can view the Security Clearance expiry date in the biosecurity portal
• Automatic reminders are sent regarding the expiry of the Security Clearance

For a Security Clearance issued before April 2021:

• The Licence Holder or Licence Holder Representative must consult the most recent Security Clearance issuance letter sent to the applicant and the Licence Holder for the expiry date
• There are no automatic reminders regarding the expiry of the Security Clearance

It’s the responsibility of the Security Clearance holder to re-apply for a Security Clearance before it expires. If you do not know when your Security Clearance is expiring, you can email the Human Pathogens and Toxins Act Security Clearance screening team at hpta.screening-filtrage.lapht@phac-aspc.gc.ca .

Note that you are non-compliant with the Human Pathogens and Toxins Act if your Security Clearance expires and you continue to access a part of a facility where controlled activities are being conducted with security sensitive biological agents without one-on-one supervision by an individual with a valid Security Clearance. Such non-compliance may result in enforcement actions that may impact your normal operations until the situation is resolved.

At least one person with a valid Security Clearance must work at a facility for a licence authorizing controlled activities with security sensitive biological agents to be issued. If it is found that no person within a facility holds a valid Security Clearance (e.g., Security Clearances of everyone at the facility have expired), the Public Health Agency of Canada may take enforcement actions such as:

• issue a notice of non-compliance
• seize and detain the security sensitive biological agents, and
• vary, suspend or revoke the facility’s licence.

Further, the Public Health Agency of Canada may require the Licence Holder and/or Licence Holder Representative to destroy all security sensitive biological agents in their possession or transfer them to a facility that is authorized to conduct controlled activities with these agents. The Agency may also request that internal processes be evaluated to identify possible failures in procedures or training.

For more information about Security Clearances:

• please refer to the Biosecurity web page.
• contact hpta.screening-filtrage.lapht@phac-aspc.gc.ca .