February 14, 2024

Responsibilities of the Human Pathogens and Toxins Act Security Clearance Holder
You need a valid security clearance issued under the Human Pathogens and Toxins Act (The Act) to access without escort any part of a facility where security sensitive biological agents are used to conduct controlled activities. These areas are called security sensitive biological agent zones. Before issuing a security clearance, the Public Health Agency of Canada (the Agency) verifies that the person won't pose a security risk if they are granted unescorted access to a security sensitive biological agent zone. The licence holder is responsible for ensuring that Human Pathogens and Toxins Act security clearance holders can fulfill their obligations.
As a Human Pathogens and Toxins Act security clearance holder, you:
- can only enter a security sensitive biological agent zone unescorted after you've verified that you've been endorsed for that particular security sensitive biological agent zone (Human Pathogens and Toxins Regulations 12(2)(m))
- must verify if you can enter a security sensitive biological agent zone unescorted by contacting your facility's delegated authority which may be your:
- licence holder or their representative
- biological safety officer or
- alternate biosafety contact
- must apply to renew your Human Pathogens and Toxins Act security clearance at least 80 days before your security clearance expires if you still need unescorted access to a security sensitive biological agent zone
- must notify the Agency at hpta.screening-filtrage.lapht@phac-aspc.gc.ca if you're convicted of a criminal offence in accordance with Human Pathogens and Toxins Regulations 19
- must not enter security sensitive biological agent zones unescorted if your Human Pathogens and Toxins Act security clearance has expired
Other obligations as a Human Pathogens and Toxins Act security clearance holder include:
- following all applicable biosecurity procedures when entering or exiting a security sensitive biological agent zone and follow all operational procedures that support your facility's biosecurity plan
- only performing controlled activities in a security sensitive biological agent zone if you have been authorized by your facility's delegated authority
- never conducting controlled activities:
- for non-peaceful purposes, and
- that may pose an unmitigated risk to public health, safety and security.
- verifying with your facility's delegated authority that you're allowed to supervise individuals without a Human Pathogens and Toxins Act security clearance in a security sensitive biological agent zone before doing so
- following and actively observing any individual under your supervision while in the security sensitive biological agent zone
- notifying your facility's delegated authority if you
- suspect loss, theft, misuse, diversion or intentional release of a security sensitive biological agent or related asset has occurred or may occur
- notice a security sensitive biological agent shipment has not been received within 24 hours of expected delivery, or
- are planning to prepare or schedule the transportation of a parcel containing a security sensitive biological agent
As a Human Pathogens and Toxins Act security clearance holder, you also have responsibilities related to sensitive information. You must:
- keep your access codes and account passwords private, including your Biosecurity Portal account information
- inform the appropriate authority of your facility immediately if you lose the access ID card or the key that gives you access to a security sensitive biological agent zone
- keep documentation about controlled activities confidential, following your facility's information management and security policies
As a Human Pathogens and Toxins Act security clearance holder, you must also comply with any other obligations developed by your facility.
For more information about your responsibilities and obligations, please consult:
- Human Pathogens and Toxins Act security clearance reminders
- Canadian Biosafety Standard, Third Edition
For questions about applying for a Human Pathogens and Toxins Act security clearance:
- Consult the Biosecurity frequently asked questions
- Contact hpta.screening-filtrage.lapht@phac-aspc.gc.ca