Regulatory Affairs

Regulation, in its broadest sense, is a principle, rule or condition that governs the behaviour of citizens and organizations. Governments use regulation in combination with other instruments to achieve public policy objectives. Regulations are a form of law - they have force of law and usually set out rules that apply generally, rather than to specific persons or situations.

Treasury Board of Canada Secretariat (External link)

The Public Health Agency of Canada (the Agency) is responsible for administering and enforcing both the Human Pathogens and Toxins Act (External link) (HPTA) and the Human Pathogens Importation Regulations (External link) (HPIR) which fall under the Department of Health Act (External link) . The regulations, guidelines and other tools available to the Agency are key in protecting the health, safety and socioeconomic well-being of Canadians, and the natural environment in which we live.

Human Pathogens Importation Regulations

The Human Pathogens Importation Regulations were established in 1994 and made the Laboratory Biosafety Guidelines (LBG) mandatory for all facilities importing human pathogens and toxins. According to the HPIR, every person importing a human pathogen in Risk Group 2, 3 or 4, or toxin must obtain an import permit.

Human Pathogens and Toxins Act

In 2009, Parliament passed the Human Pathogens and Toxins Act. The Agency is charged with enforcing the Act and developing a program and regulatory framework. HPTA regulations will move beyond the scope of importation controls in the HPIR and address safety and security risks associated with a wide range of activities involving human pathogens or toxins, whether imported or domestically acquired. Anyone responsible for activities involving human pathogens or toxins listed on Schedule 1 of the HPTA must register with the Agency.

Cabinet Directive on Streamlining Regulation

The Cabinet Directive on Streamlining Regulation (External link) (CDSR) applies to all departments and agencies involved in the federal regulatory process and should be followed through every stage of the regulatory lifecycle. The CDSR requires a comprehensive management approach to regulating with specific requirements for the development, implementation, evaluation and review of regulations. Among other things, it requires regulatory organizations, such as the Agency, to:

• Consult with Canadians extensively throughout the regulatory process; and
• Be inclusive, transparent, and cooperative.

Some steps in the lifecycle management approach to regulatory development are not new, such as planning for implementation and compliance, but the CDSR outlines steps to make their practice more robust. Other steps, such as regulatory performance measurement and evaluation, are new and serve to add another layer of government accountability for achieving desired results.