Vol. 149, No. 5 — March 11, 2015

Registration

SI/2015-14 March 11, 2015

HUMAN PATHOGENS AND TOXINS ACT

Order Fixing December 1, 2015 as the Day on which Certain Provisions of the Act Come into Force

P.C. 2015-201 February 19, 2015

His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to section 72 of the Human Pathogens and Toxins Act, chapter 24 of the Statutes of Canada, 2009, fixes December 1, 2015 as the day on which section 7, subsections 11(1) and 12(1) and sections 13 to 16, 18 to 36, 38 and 56 of that Act come into force.

EXPLANATORY NOTE

(This note is not part of the Order.)

Proposal

Pursuant to section 72 the Human Pathogens and Toxins Act (HPTA), chapter 24 of the Statutes of Canada, 2009, which received royal assent on June 23, 2009, this Order fixes December 1, 2015, as the day on which sections 7, subsections 11(1) and 12(1), and sections 13 to 16, 18 to 36, 38 and 56 of the HPTA come into force.

Objective

The objective of this coming-into-force Order is to bring into force the remaining sections of the HPTA in order to further protect the Canadian public from the risks posed by human pathogens and toxins.

Background

In 2009, the HPTA received royal assent. The purpose of the HPTA is to establish a national safety and security regime to protect the health and safety of the public against the risks posed by human pathogens and toxins. As an initial measure, select sections of the HPTA were brought into force to establish basic biosafety requirements for persons conducting activities involving human pathogens or toxins in Canada. Key requirements are the registration of persons in possession of human pathogens and toxins (section 70), a general duty of care to take all reasonable precautions to protect the health and safety of the public when knowingly conducting activities with these agents (section 6), a smallpox ban (section 8) and an intentional release prohibition (section 58). In addition, most offence and penalty provisions are in force, as are inspection powers.

Concurrently with the coming into force of the Human Pathogens and Toxins Regulations, the remaining sections of the HPTA will come into full force, including the requirement to hold a licence to conduct controlled activities; the requirement to inform the Minister of Health of an inadvertent release of human pathogen or toxin, an accidental exposure, or a missing human pathogen or toxin; security clearance requirements for higher risk human pathogens or toxins; the requirement to designate a biological safety officer; and the requirement to provide the Minister of Health with certain information.

Implications

Human pathogens and toxins pose a risk to human health and public safety, whether through an accidental release from a laboratory, an infected worker or a deliberate release by way of an act of terrorism or other criminal activity. Bringing the HPTA fully into force by this Order and the proposed Human Pathogens and Toxins Regulations will fulfill its purpose to protect the Canadian public from the risks posed by human pathogens and toxins.

Consultation

Since September 2007, stakeholders have been given the opportunity to provide input into the development of the program and regulatory framework under the HPTA. The HPTA was tabled in the House of Commons in February 2009 and underwent rigorous examination by committees in both the House of Commons and the Senate before becoming law on June 23, 2009.

The Agency held several national consultations in person, online and bilaterally, to inform the development of the program and regulatory framework for the HPTA from 2010 to 2013. Stakeholders from academia, health care, and the private and public sectors participated in the consultations.

Departmental contact

Lisa Hogan
Office of Stakeholder Engagement and Regulatory Affairs
Centre for Biosecurity
Public Health Agency of Canada
Telephone: 613-769-5235
Email: lisa.hogan@hc-sc.gc.ca