Bill C-11 · 40th Parliament · Stephen Harper
Human Pathogens and Toxins Act
An Act to promote safety and security with respect to human pathogens and toxins
Government bill. Became law.
- IntroducedFeb. 9, 2009
- Debated in principleFeb. 23, 2009
- Studied by a committeeDone
- Passed its first chamberMay 5, 2009
- Passed the second chamberJune 22, 2009
- Became lawJune 23, 2009
Leading supporters
Ranked by the part each played: who is responsible for the bill, who carried it, and who spoke for it most.
- Stephen HarperPrime Minister
- Nicole EatonSenate · Sponsor in the Senate
- Colin Carriethanks parties for co-operation and notes strong support for strengthening safety
- Kirsty Duncancalls bill important and significant for addressing infectious disease threats
- Réal MénardEmphasizes the bill's importance for safety in handling pathogens and toxins.
- Keith Martincalls it a pleasure to speak on this important public health issue
- Jerahmiel S. GrafsteinSenate · SenatorExplicitly stated support for the bill's purpose of promoting safety and security.
- Art EggletonSenate · SenatorAs committee chair, reported the bill without amendment and accepted the case for the legislation after reviewing concerns.
Who carries this bill
Arrows run from the person responsible to those who answer to them on this bill. The critic leads the Senate’s scrutiny and answers to no one on it.
What it set out to do
On 9 February 2009, the Minister of Health introduced Bill C-11, An Act to promote safety and security with respect to human pathogens and toxins, in the House of Commons and it was given first reading. The bill establishes a legislative regime that extends beyond the present importation regime. Among other things, it: • requires laboratories carrying out activities with Risk Groups 2, 3 or 4 human pathogens, or select toxins, have to register with the Public Health Agency of Canada’s (PHAC) Office of Laboratory Security; • subjects licensees with Risk Group 3 and 4 pathogens (and possibly select toxins) to stricter operating regulations; • requires an importation permit to import a human pathogen or toxin; • requires a transfer permit to send and receive any human pathogen or toxin between laboratories within Canada that are not part of the same facility; • requires the authorization from the Department of Foreign Affairs and International Trade Canada to export of agents on the Export Control List; and • requires licensees, as part of their annual or biannual updates of inventories, to notify PHAC of the nature of the disposal of human pathogens and toxins.
Summary by the Library of Parliament.
Where members stand
That Bill C-11 · 2009-04-27 · Passed
How it changed on the way
53% of the text as introduced was changed or removed by the time it became law (12,263 words introduced, 12,621 passed). A committee amended it.
substantial changeintent mostly kept
The bill kept its core licensing, permit and prohibition regime for human pathogens and toxins but added new parliamentary oversight for regulations and mandatory advisory committee review before schedule changes. The preamble was reworded and two new sections on proposed regulations were inserted.
- Preamble risk description was revised.
Before: “Whereas the Parliament of Canada recognizes that certain human pathogens and toxins pose risks to the health and safety of the public;”
After: “Whereas the Parliament of Canada recognizes that human pathogens and toxins pose varying levels of risk to the health and safety of the public;”
- New requirement to lay proposed regulations before Parliament was added.
After: “66.1 Proposed regulations to be laid before Parliament”
- Minister must consult advisory committee before adding or deleting schedule items.
After: “(4) The Minister shall consult an advisory committee established under subsection 14(1) of the Public Health Agency of Canada Act before making any regulation under subsection (1), (2) or (3).”
- Advisory committee advice must be published.
After: “(5) The advisory committee shall make available to the public the advice given to the Minister.”
How precisely it is written
mixedChallenging the law: ModerateDisputing a charge: Moderate
The Act supplies exact numerical penalties, defined terms such as 'produce' and 'release', and scheduled lists, yet repeatedly conditions coverage and enforcement on ministerial opinions, reasonable grounds beliefs and necessity judgments. This mix yields black-and-white rules for listed items and fines but open-ended discretion over what becomes regulated or prohibited.
Open to argument
“If the Minister is of the opinion that a substance is produced by, or derived from, a micro-organism and is able to cause disease in a human”
Addition or deletion of toxins rests on subjective ministerial judgment rather than fixed scientific criteria.“the Minister believes, on reasonable grounds, is relevant to the administration of this Act”
Compelled disclosure turns on an official's belief about relevance, inviting disputes over scope.“poses a serious and imminent danger to the health or safety of the public”
Inspection and seizure powers hinge on an inspector's assessment of danger, an inherently evaluative standard.“the Minister considers appropriate the powers that an inspector may exercise”
Designation of inspectors and limits on their powers are left to ministerial discretion without statutory boundaries.
Clear-cut
“Risk Group 2" means a category of human pathogens that pose a moderate risk to the health of individuals and a low risk to public health and includes the human pathogens listed in Schedule 2”
Risk groups are tied directly to enumerated schedules rather than open-ended descriptions.
Discretion. Broad authority is delegated to the Minister and Governor in Council to add or remove substances from schedules, issue compliance orders, designate inspectors, authorize disclosures and decide what information is required, all conditioned on opinions about risk, necessity or public interest.
Challenging the law itself. Repeated use of 'in the opinion of' and 'reasonable grounds' standards could ground a vagueness or overbreadth challenge under section 7 of the Charter by leaving the scope of regulated conduct uncertain.
Disputing a charge under it. An accused could contest whether a substance meets the disease-causing test or whether conduct created a 'risk to the health or safety of the public', because those elements rest on contested opinions and reasonable-grounds assessments.
Read by a language model from the royal assent text; every quoted phrase appears in the bill. A reading of the drafting, not legal advice.
Did it work?
partly effective
The 2022 PHAC evaluation of the HPTAR framework (full effect 2015) found early signs of success including high compliance, reduced release risks, and Canada's top global biosafety/biosecurity rankings, with regulated entities understanding requirements. However, it identified gaps in security clearances, inspections, and roles leading to 2026 amendments modernizing the Act.
- Evaluation of the Human Pathogens and Toxins Act and Regulations Framework 2015-16 to 2020-21evaluationThe HPTAR Program has shown early signs of success with regulated organizations complying and addressing risks, contributing to decreased accidental or deliberate release risks and Canada's #1 global biosafety ranking.
- Evaluation of the Human Pathogens and Toxins Act and Regulations Framework 2015-16 to 2020-21evaluationThe evaluation made three recommendations on security clearances, virtual inspections, and BSO/LH roles and responsibilities, prompting a legislative review and resulting 2026 amendments to the Act.
Who lobbied on it
No lobbying registration naming this bill is loaded.
Stages and dates from LEGISinfo.