About the Pathogen Regulation Directorate

Role of the Pathogen Regulation Directorate

The Pathogen Regulation Directorate administers and enforces the HPTA and the HPIR, and provides training and tools to promote safer biosafety practices and more secure laboratory environments. These responsibilities, outlined below, contribute to the Agency’s ongoing efforts to anticipate and respond to public health challenges and protect the health, safety and security of Canadians.

Regulatory Affairs

• Administering and enforcing the Human Pathogens and Toxins Act and the Human Pathogens Importation Regulations
• Developing regulations under the HPTA to promote biosafety and biosecurity
• Establishing an Advisory Committee for Human Pathogens and Toxins to provide expert science advice on the HPTA Schedules and other issues related to human pathogens and toxins

Biosafety Programs and Resources

• Providing technical assistance and training to domestic and international stakeholders to promote safe biosafety practices
• Providing Pathogen Safety Data Sheets (formerly Material Safety Data Sheets)
• Promoting the use of the Laboratory Biosafety Guidelines and the future Canadian Biosafety Standards and Guidelines (External link)
• Providing biosafety advisories and notifications

Outreach, Engagement and Consultation

• Conducting cross-Canada consultations for the Human Pathogens and Toxins Act program and regulatory framework
• In conjunction with the Canadian Food Inspection Agency (External link) , conducting national consultations on the harmonized Canadian Biosafety Standards and Guidelines
• Developing strong and sustainable relationships with stakeholders to promote shared knowledge of best practices

Registration, Permits and Inspection Operations

• Registrations under the Human Pathogens and Toxins Act
• Issuing permits to persons importing human pathogens or toxins and certifying facilities with higher risk human pathogens or toxins under the Human Pathogens Importation Regulations
• Inspections under the HPIR and HPTA

History of the Pathogen Regulation Directorate

The Office of Biosafety (OBS) was established within Health Canada in 1980. Its mission was to carry out effective, evidence-based biosafety interventions on a national basis through regulatory control, surveillance, applied research, and timely dissemination of information. In June 2000, the OBS was amalgamated into the Office of Laboratory Security (OLS) within the Centre for Emergency Preparedness and Response at Health Canada. Responsibility for the safety program of Health Canada’s laboratories, a network of 10 sites across the country providing specialized testing and research, was transferred to the OLS in November 2000.

To strengthen its ability to protect the health and safety of Canadians, in September 2004 the Government of Canada established a new Public Health Agency of Canada and appointed a Chief Public Health Officer, Dr. David Butler-Jones. The creation of the Agency and the subsequent establishment of the Pathogen Regulation Directorate marked the beginning of a new approach to federal leadership and collaboration with provinces and territories on public health and human pathogen regulation.

For more information about the work of the Public Health Agency of Canada and the Pathogen Regulation Directorate, please call (613) 957-1779 or send an e-mail to biosafety.biosecurite@phac-aspc.gc.ca.