Abstract
From 1994 to 2009, federal oversight of human pathogens and toxins was limited to facilities importing human pathogens and toxins into Canada under the Human Pathogens Importation Regulations (HPIR). This narrow focus of authority restricted the Government of Canada's ability to regulate and monitor a full range of activities, including those involving human pathogens and toxins acquired from domestic sources. In 2009, the Human Pathogens and Toxins Act (the Act) received Royal Assent to establish a national safety and security regime and expand oversight through a national, standardized process to verify safe and secure use of human pathogens and toxins in Canada. The Act and the Human Pathogens and Toxins Regulations (the Regulations), in full force since December 1, 2015, provides legislative and statutory requirements for the comprehensive oversight of the control of human pathogens and toxins in Canada. Expanded regulation and monitoring program activities aim to reduce the risks posed by human pathogens and toxins and strengthen biosafety management systems that serve to protect the health of Canadians.
Highlights
Since 2001, there have been numerous high profile national and international laboratory accidents and incidents including exposures, laboratory-acquired infections and deliberate crimes that involve human pathogens and toxins
Expanded regulation and monitoring program activities aim to reduce the risks posed by human pathogens and toxins and strengthen biosafety management systems that serve to protect the health of Canadians
In October 2001, letters containing anthrax were mailed to various individuals in the United States (US), resulting in five deaths (1)
Summary
Since 2001, there have been numerous high profile national and international laboratory accidents and incidents including exposures, laboratory-acquired infections and deliberate crimes that involve human pathogens and toxins. Laboratories and other regulated parties need to apply for a licence to conduct controlled activities, such as possessing, handling, using, producing, storing, permitting any person access, transferring, importing, exporting, releasing, abandoning and disposing of a human pathogen or toxin This is a risk-based licensing framework designed to improve federal oversight of human pathogens and toxins in Canada; establish national requirements for the safe and secure handling of human pathogens and toxins that apply to all facilities that conduct controlled activities with these agents; and provide assurance that individuals who have access to a prescribed list of security-sensitive human pathogens and toxins (known as Security Sensitive Biological Agents [SSBA]) have been assessed as trustworthy and reliable. Licence holders are required to inform the Agency if they have reason to believe that an incident involving a human pathogen or toxin in their possession has, or may have caused disease in an individual This requirement in the Act aims to increase the timeliness, accuracy and usefulness of information on laboratory exposures and laboratory-acquired infection that occur in licensed facilities across Canada. As such these data will contribute to evidencebased decision-making to guide current and future biocontainment and biosafety practices
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