Biosafety and Biosecurity

Biosafety and Biosecurity

  • Compliance with Human Pathogens and Toxins Act (HPTA) & Regulations
  • HPTA Licence Applications
  • Plan for Administrative Oversight (PAO) preparation
  • Biosecurity plans
  • Programs and manuals
  • Onsite training for users, Biosafety officers and management
  • Audits and program reviews

If your organization possesses, handles, uses, produces, stores, has access to, transfers, imports or exports, or disposes of RG 2 or 3 pathogens or toxins, you are to,

  •  Apply for a Licence with the Public Health Agency of Canada (PHAC)
      • Submit a Plan for Administrative Oversight (PAO)


Organizations have to prepare and submit a high level overview how biosafety and biosecurity risks are identified, assessed, managed and controlled in their organization. It is required to cover all work areas and individuals handling the specified biological material.

The process of risk identification and mitigation is called a risk assessment (RA) and KRMC experts can provide any type of biosafety risk assessment (RA) for scientists working with infectious material and toxins:

  • Overarching RA used to define an entire biosafety program
  • Specific RAs to analyze certain biosafety program elements such as biosecurity, medical surveillance, emergency response, etc.
  • Local RAs to specifically review one or more activities.

For more information about this process, please see the various presentations given by KRMC at the Canadian Biosafety Symposium.

2018:  Integrated Risk Approach to Overall Risk Assessment – PDF
2014: Rx Risk Assessing Risk in a less prescriptive environment – PDF

After completion of the RA, KRMC can also provide the corresponding program, manual, protocols or safe work practices with appropriate mitigation strategies, if desired. KRMC can offer training for all personnel involved.

KRMC can also help you with the continual improvement of programs required for optimal program management as described in their presentations  at the Canadian Biosafety Symposiums:

2015:  HPTA and HPTR Program Management – 1.5MB PDF

201 6:  You’ve-made-the-deadline_jn2016 – 6 MB PDF

Finally, KRMC can audit and review installations, infrastructures and biosafety programs to ensure compliance with internal and local external standards and guidelines.