Updates to the Plan for Administrative Oversight

On November 22, 2024, licensed stakeholders were invited to respond to a questionnaire about proposed changes to the Plan for Administrative Oversight. Participants were asked to provide feedback on proposed changes to the Canadian Biosafety Standard, Third Edition:

• a proposed redefinition of the term “risk management plan”
• a new requirement proposed for Matrix 4.1-Biosafety Program Management
• suggested topics for guidance.

For organizations intending to conduct scientific research, the Human Pathogens and Toxins Regulations require a Plan for Administrative Oversight before a licence, under the Act, can be issued. Incorporating the Plan for Administrative Oversight into the Canadian Biosafety Standard, Third Edition would complement the regulations by describing the elements that must be included in the plan and establishing an obligation to maintain it and keep it up to date. This approach would also clarify the importance of the Plans for Administrative Oversight within the scope of the Centre for Biosecurity Compliance and Enforcement Policy.

What we heard

A total of 214 people responded to the questionnaire from across the country and many types of industries.

Proposed Glossary Term: A majority (88%) indicated the proposed definition was clear and understandable.

Proposed Canadian Biosafety Standard, Third Edition Requirement: A majority (86%) indicated the proposed requirement was clear and understandable.

Many respondents also provided written feedback on the proposed changes to the Canadian Biosafety Standard, Third Edition, as well as helpful suggestions for guidance. Over the next few months, we will work to incorporate what we heard. In the meantime, you may find answers to questions about scientific research, the Plan for Administrative Oversight, biosafety program management, risk assessments, and more, in the following resources:

• Scientific Research Policy for Human Pathogens and Toxins
• Plan for Administrative Oversight for Pathogens and Toxins in a Research Setting - Required Elements and Guidance
• Webinar on the Plan for Administrative Oversight March 21, 2024
• Canadian Biosafety Guideline - Biosafety Program Management
• Canadian Biosafety Guideline - Local Risk Assessment
• Canadian Biosafety Guideline - Conducting a Biosecurity Risk Assessment
• Canadian Biosafety Handbook, Second Edition

Managing risks associated with research may involve measures that extend beyond biosafety and biosecurity. For more information on research security, including tools for researchers, please visit Safeguarding Your Research.

We wish to remind you that the Public Health Agency of Canada will not issue a licence to any organization intending to conduct scientific research if they fail to submit a Plan for Administrative Oversight when applying for a licence under the Act.

We appreciate the participation from stakeholders to help guide updates to the regulatory oversight of pathogens and toxins. For questions or comments related to Plan for Administrative Oversight, contact us at biosafety-biosecurite@phac-aspc.gc.ca.