Hyperlawhypertext legal database Human Pathogens and Toxins Act current to 2026-03-31

H-5.67 Human Pathogens and Toxins Act

Current to 2026-03-31 · last amended 2026-03-26

Contents
Provision — Preamble

Whereas the Parliament of Canada recognizes the objective of protecting the health, safety and security of the public;

Provision

Whereas the Parliament of Canada recognizes that human pathogens and toxins pose varying levels of risk to the health, safety and security of the public;

Provision

Whereas the Parliament of Canada recognizes that a lack of full scientific certainty regarding the risks posed by certain human pathogens and toxins is not to be used as a reason to postpone measures that protect the health, safety and security of the public;

Provision

Whereas the Parliament of Canada recognizes that human pathogens and toxins evolve and can be altered and that new human pathogens and toxins appear continually, therefore creating unique challenges in meeting the objective of protecting the health, safety and security of the public;

Provision

And whereas the Parliament of Canada recognizes that preventing the theft of sensitive information in relation to human pathogens and toxins contributes to the objective of protecting the health, safety and security of the public;

Provision

Now, therefore, Her Majesty, by and with the advice and consent of the Senate and House of Commons of Canada, enacts as follows:

Short Title

s. 1 — Short title

This Act may be cited as the Human Pathogens and Toxins Act.

Purpose of the Act

s. 2 — Purpose

The purpose of this Act is to establish a safety and security regime to protect the health, safety and security of the public against the risks posed by human pathogens and toxins.

Interpretation and Application

s. 3 — Definitions
s. 3(1)

The following definitions apply in this Act.

s. 3(1), definition “controlled activity”

controlled activity, in respect of a human pathogen or toxin, means any of the following activities:

s. 3(1), definition “controlled activity”, para (a)

possessing, handling or using it;

s. 3(1), definition “controlled activity”, para (b)

producing it;

s. 3(1), definition “controlled activity”, para (c)

storing it;

s. 3(1), definition “controlled activity”, para (d)

permitting any person access to it;

s. 3(1), definition “controlled activity”, para (e)

transferring it;

s. 3(1), definition “controlled activity”, para (f)

importing or exporting it;

s. 3(1), definition “controlled activity”, para (g)

releasing or otherwise abandoning it; or

s. 3(1), definition “controlled activity”, para (h)

disposing of it. (activité réglementée)

s. 3(1), definition “conveyance”

conveyance means a vessel, aircraft, train, motor vehicle, trailer or other means of transportation, including a cargo container. (véhicule)

s. 3(1), definition “disease”

disease includes intoxication. (maladie)

s. 3(1), definition “human pathogen”

human pathogen means a micro-organism, nucleic acid or protein that

s. 3(1), definition “human pathogen”, para (a)

is listed in the registry or in Part 2 of the schedule; or

s. 3(1), definition “human pathogen”, para (b)

is not listed in the registry or in Part 2 of the schedule but falls into Risk Group 2, Risk Group 3 or Risk Group 4. (agent pathogène humain)

s. 3(1), definition “licence”

licence means a licence issued under section 18. (permis)

s. 3(1), definition “minister”

Minister means the Minister of Health. (ministre)

s. 3(1), definition “person”

person means an individual or an organization as defined in section 2 of the Criminal Code. (personne)

s. 3(1), definition “personal information”

personal information has the same meaning as in section 3 of the Privacy Act. (renseignements personnels)

s. 3(1), definition “possession”

possession has the same meaning as in subsection 4(3) of the Criminal Code. (possession)

s. 3(1), definition “produce”

produce, in respect of a human pathogen or toxin, means to create it by any method or process, including

s. 3(1), definition “produce”, para (a)

by manufacturing, cultivating, developing, reproducing or synthesizing it; or

s. 3(1), definition “produce”, para (b)

by converting or refining a substance, micro-organism, nucleic acid or protein, or by using any other means of altering its physical or chemical properties. (production)

s. 3(1), definition “registry”

registry means the registry established under subsection 9(1). (registre)

s. 3(1), definition “release”

release means any discharge, anywhere, and includes leaking, spraying, depositing, dumping or vaporizing. (rejet)

s. 3(1), definition “risk group 2”

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 under Risk Group 2 in the registry. They are able to cause serious disease in a human but are unlikely to do so. Effective treatment and preventive measures are available and the risk of spread of disease caused by those pathogens is low. (groupe de risque 2)

s. 3(1), definition “risk group 3”

Risk Group 3 means a category of human pathogens that pose a high risk to the health of individuals and a low risk to public health and includes the human pathogens listed under Risk Group 3 in the registry. They are likely to cause serious disease in a human. Effective treatment and preventive measures are usually available and the risk of spread of disease caused by those pathogens is low. (groupe de risque 3)

s. 3(1), definition “risk group 4”

Risk Group 4 means a category of human pathogens that pose a high risk to the health of individuals and a high risk to public health and includes the human pathogens listed under Risk Group 4 in the registry. They are likely to cause serious disease in a human. Effective treatment and preventive measures are not usually available and the risk of spread of disease caused by those pathogens is high. (groupe de risque 4)

s. 3(1), definition “security clearance”

security clearance means a security clearance issued under section 34. (habilitation de sécurité)

s. 3(1), definition “toxin”

toxin means a substance that is produced by, or derived from, a micro-organism and that

s. 3(1), definition “toxin”, para (a)

may or may not be listed in the registry and poses a moderate to high risk to the health of individuals;

s. 3(1), definition “toxin”, para (b)

is listed in the registry and poses a moderate to high risk to the health, safety or security of the public due to a reasonable risk of intentional use as a biological weapon, with the risk and minimum quantity at which it poses that risk indicated in accordance with paragraph 9(2)(a); or

s. 3(1), definition “toxin”, para (c)

is listed in Part 1 of the schedule. (toxine)

s. 3(2) — Included

For the purposes of this Act, a human pathogen or toxin includes

s. 3(2)(a)

a substance that contains a human pathogen or toxin; and

s. 3(2)(b)

any synthetic form of the human pathogen or toxin.

s. 4 — Excluded

This Act does not apply to

s. 4(a)

a human pathogen or toxin that is in an environment in which it naturally occurs if it has not been cultivated or intentionally collected or extracted, including a human pathogen or toxin that

s. 4(a)(i)

is in or on a human suffering from a disease caused by that human pathogen or toxin,

s. 4(a)(ii)

has been expelled by a human suffering from a disease caused by that human pathogen or toxin, or

s. 4(a)(iii)

is in or on a cadaver, a body part or other human remains; or

s. 4(b)

a drug in dosage form or a device whose sale is permitted or otherwise authorized under the Food and Drugs Act or a human pathogen or toxin contained in such a drug or device.

s. 4(c)

[Repealed]

His Majesty

s. 5 — Act binding on His Majesty

This Act is binding on His Majesty in right of Canada or a province.

Obligation

s. 6 — Reasonable precautions

Every person who knowingly conducts any activity referred to in section 7 involving a human pathogen or toxin must take all reasonable precautions to protect the health, safety and security of the public against the risks posed by that activity.

Prohibitions

s. 7 — Controlled activities
s. 7(1)

A person must not knowingly conduct any controlled activity unless a licence has been issued by the Minister that authorizes the activity.

s. 7(2) — Exceptions

Despite the definition controlled activity in subsection 3(1), the following activities are not controlled activities:

s. 7(2)(a)

any activity to which the Transportation of Dangerous Goods Act, 1992 applies that involves

s. 7(2)(a)(i)

human pathogens that fall into Risk Group 2,

s. 7(2)(a)(ii)

human pathogens that fall into Risk Group 3 and are not prescribed by regulation, or

s. 7(2)(a)(iii)

toxins that are not prescribed by regulation;

s. 7(2)(b)

export authorized under the Export and Import Permits Act that involves

s. 7(2)(b)(i)

human pathogens that fall into Risk Group 2,

s. 7(2)(b)(ii)

human pathogens that fall into Risk Group 3 and are not prescribed by regulation, or

s. 7(2)(b)(iii)

toxins that are not prescribed by regulation;

s. 7(2)(c)

any activity to which the Transportation of Dangerous Goods Act, 1992 applies that involves the following human pathogens or toxins, unless the person who conducts the activity also conducts controlled activities to which that Act does not apply:

s. 7(2)(c)(i)

human pathogens that fall into Risk Group 3 and are prescribed by regulation,

s. 7(2)(c)(ii)

human pathogens that fall into Risk Group 4, or

s. 7(2)(c)(iii)

toxins that are prescribed by regulation; and

s. 7(2)(d)

export authorized under the Export and Import Permits Act that involves the following human pathogens or toxins, unless the person who exports also conducts controlled activities to which that Act does not apply:

s. 7(2)(d)(i)

human pathogens that fall into Risk Group 3 and are prescribed by regulation,

s. 7(2)(d)(ii)

human pathogens that fall into Risk Group 4, or

s. 7(2)(d)(iii)

toxins that are prescribed by regulation.

s. 8 — Human pathogens and toxins — schedule

Despite section 7, a person must not conduct any activity referred to in that section in relation to a human pathogen or toxin listed in the schedule.

Registry

s. 9 — Registry
s. 9(1)

The Minister must establish and update a registry that

s. 9(1)(a)

lists any substance that, in the opinion of the Minister, is produced by, or derived from, a micro-organism and poses a moderate to high risk to the health, safety or security of the public due to a reasonable risk of intentional use as a biological weapon; and

s. 9(1)(b)

may list

s. 9(1)(b)(i)

any micro-organism, nucleic acid or protein if they are of the opinion that it falls into Risk Group 2, Risk Group 3 or Risk Group 4, or

s. 9(1)(b)(ii)

any substance if they are of the opinion that it is produced by, or derived from a micro-organism and it poses a moderate to high risk to the health of individuals.

s. 9(2) — Minister’s obligation

The Minister must indicate in the registry

s. 9(2)(a)

in the case of a substance referred to in paragraph (1)(a), that

s. 9(2)(a)(i)

it poses a moderate to high risk to the health, safety or security of the public due to a reasonable risk of intentional use as a biological weapon, and

s. 9(2)(a)(ii)

the minimum quantity at which, in the opinion of the Minister, it poses that risk; and

s. 9(2)(b)

in the case of a micro-organism, nucleic acid or protein referred to in subparagraph (1)(b)(i), the risk group into which, in the opinion of the Minister, it falls.

s. 9(3) — Minimum quantity

The Minister may, for any substance referred to in subparagraph (1)(b)(ii) that is listed in the registry, identify in the registry the minimum quantity at which, in the opinion of the Minister, the substance poses the risk referred to in that subparagraph.

s. 9(4) — Deletion of items

The Minister must delete from the registry a micro-organism, nucleic acid, protein or substance if the Governor in Council adds it to the schedule under subsection 10(1).

s. 9(5) — Amendments to the registry

The Minister must, in the registry,

s. 9(5)(a)

amend the risk group of a human pathogen if the Minister is of the opinion that it falls into a risk group that is different from the one under which it is listed in the registry;

s. 9(5)(b)

add the references referred to in paragraph (2)(a) if the Minister is of the opinion that the toxin that is listed in the registry poses a risk referred to in paragraph (1)(a);

s. 9(5)(c)

remove the references referred to in paragraph (2)(a) if the Minister is of the opinion that the toxin that is listed in the registry does not pose a risk referred to in paragraph (1)(a); and

s. 9(5)(d)

amend the minimum quantity that is listed for a toxin if the Minister is of the opinion that it is not the minimum quantity at which the toxin poses a risk referred to in paragraph (1)(a) or subparagraph (1)(b)(ii).

s. 9(6) — Amendment to the registry — name

The Minister may amend the registry by modifying the name of a human pathogen or toxin listed in the registry.

s. 9(7) — Accessibility of the registry

The Minister must make the registry accessible to the public by electronic means and by any other means that the Minister considers appropriate.

s. 9(8) — Delegation

The Minister may, subject to any terms and conditions that they specify, delegate to an officer or employee of the Public Health Agency of Canada established under section 3 of the Public Health Agency of Canada Act, any of the powers that the Minister is authorized to exercise or any of the duties and functions that they are authorized to perform under subsections (1) to (7).

s. 9(9) — Non-application

For greater certainty, section 5 of the Public Health Agency of Canada Act does not apply if the Minister delegates any of the powers they are authorized to exercise or any of the duties and functions that they are authorized to perform under subsection (8).

s. 9(10) — Exemption from Statutory Instruments Act

The registry is exempt from sections 3, 5 and 11 of the Statutory Instruments Act.

s. 9.1 — Advisory Committee
s. 9.1(1)

An advisory committee established under subsection 14(1) of the Public Health Agency of Canada Act is to, on a periodic basis, provide advice to the Minister in respect of the registry.

s. 9.1(2) — Request of Minister

The Minister may at any time request the advisory committee to provide advice in respect of the registry.

s. 9.1(3) — Publication

The advisory committee must make available to the public the advice given to the Minister.

Schedule

s. 10 — Addition of items
s. 10(1)

The Governor in Council may, by regulation, on the Minister’s recommendation,

s. 10(1)(a)

add a substance to Part 1 of the schedule if the Governor in Council is of the opinion that

s. 10(1)(a)(i)

it is produced by, or derived from, a micro-organism and poses a moderate to high risk to

s. 10(1)(a)(i)(A)

the health of individuals, or

s. 10(1)(a)(i)(B)

the health, safety or security of the public due to a reasonable risk of intentional use as a biological weapon, and

s. 10(1)(a)(ii)

all activities referred to in section 7 should be prohibited in relation to it; or

s. 10(1)(b)

add a micro-organism, nucleic acid or protein to Part 2 of the schedule if the Governor in Council is of the opinion that

s. 10(1)(b)(i)

it is able to cause disease in a human, and

s. 10(1)(b)(ii)

all activities referred to in section 7 should be prohibited in relation to it.

s. 10(1)(c)

[Repealed]

s. 10(2) — Deletion of items

The Governor in Council may, by regulation, on the Minister’s recommendation, delete a substance, micro-organism, nucleic acid or protein from the schedule if the Governor in Council is of the opinion that it is in the public interest to allow one or more of the activities referred to in section 7 to be authorized in relation to that substance, micro-organism, nucleic acid or protein.

s. 10(3) — Advisory Committee

The Minister shall consult an advisory committee established under subsection 14(1) of the Public Health Agency of Canada Act before making any recommendation under subsection (1) or (2).

s. 10(4) — Publication

The advisory committee shall make available to the public the advice given to the Minister.

Consequences of Updating the Registry or Schedule

s. 11 — Prohibited possession — update
s. 11(1)

Within 30 days after the date that an update to the registry under subsection 9(1) is publicly accessible, every person who, as a result of the update to the registry, no longer has lawful possession of a human pathogen or toxin must

s. 11(1)(a)

dispose of it in accordance with the regulations, if any;

s. 11(1)(b)

transfer it to a facility where controlled activities in relation to it are authorized; or

s. 11(1)(c)

obtain from the Minister a licence, or a variation of the conditions of their existing licence, authorizing possession of it.

s. 11(2) — Prohibited possession — schedule

Within 14 days after the date of publication of a regulation made under subsection 10(1), every person who, as a result of the regulation, no longer has lawful possession of a human pathogen or toxin must dispose of it in accordance with the regulations, if any.

s. 11(3) — No contravention

No person contravenes subsection 7(1) or section 8 by reason only that they possess a human pathogen or toxin in the circumstances described in subsection (1) or (2) if they transfer or dispose of it or obtain a licence or a variation of their existing licence authorizing possession of it, in accordance with subsection (1) or (2).

s. 11(4) — Defence

If a human pathogen or toxin is listed in the registry, then no person may be convicted of an offence — in relation to that human pathogen or toxin — for the contravention of this Act or the regulations unless it is proved that, at the time of the alleged contravention,

s. 11(4)(a)

the registry with the human pathogen or toxin listed in it was reasonably accessible to the person;

s. 11(4)(b)

the human pathogen or toxin was listed in the registry; and

s. 11(4)(c)

the registry indicated, in relation to the human pathogen or toxin,

s. 11(4)(c)(i)

the risk group into which the human pathogen falls,

s. 11(4)(c)(ii)

if the toxin poses a moderate to high risk to the health, safety or security of the public due to a reasonable risk of intentional use as a biological weapon, the references referred to in paragraph 9(2)(a), or

s. 11(4)(c)(iii)

the minimum quantity at which the toxin poses a moderate to high risk to the health of individuals, if any.

Obligation to Inform Minister

s. 12 — Inadvertent release
s. 12(1)

If a licence holder has reasonable grounds to suspect that a human pathogen or toxin has been released inadvertently from a facility in the course of a controlled activity authorized by the licence, the licence holder must, without delay, inform the Minister of the release and provide the Minister with the information referred to in subsection (3) that is under the licence holder’s control.

s. 12(2) — Inadvertent production

If a person is in possession of a human pathogen or toxin in contravention of subsection 7(1) or section 8 as a result of the inadvertent production of that human pathogen or toxin in the course of an activity that is otherwise lawful, the person shall

s. 12(2)(a)

without delay, inform the Minister of the inadvertent production and provide the Minister with the information referred to in subsection (3) that is under the person’s control; and

s. 12(2)(b)

dispose of the inadvertently produced human pathogen or toxin in accordance with the regulations, if any, or, if it is not listed in the schedule, transfer it to a facility where controlled activities in relation to that human pathogen or toxin are authorized.

s. 12(3) — Information

The information that is to be provided under subsections (1) and (2) is the following:

s. 12(3)(a)

any information that supports the conclusion that a human pathogen or toxin has been released or produced;

s. 12(3)(b)

the name of the human pathogen or toxin released or produced;

s. 12(3)(c)

the quantity released or produced;

s. 12(3)(d)

the place and time of the release or production; and

s. 12(3)(e)

any other information relating to the release or production that the Minister may require.

s. 12(4) — No contravention

No person contravenes subsection 7(1) or section 8 by reason only that they possess a human pathogen or toxin in the circumstances described in subsection (2) if they transfer or dispose of it in accordance with that subsection.

s. 13 — Disease

If a licence holder has reasonable grounds to suspect that an incident involving a human pathogen or toxin that is in their possession has, or may have, caused disease in an individual, the licence holder must, without delay, inform the Minister of the incident and provide the Minister with the following information that is under the licence holder’s control:

s. 13(a)

a description of the incident;

s. 13(b)

the name of the human pathogen or toxin; and

s. 13(c)

any other information relating to the incident that the Minister may require.

s. 14 — Missing human pathogen or toxin

If a licence holder has reasonable grounds to suspect that a human pathogen or toxin that was in their possession has been stolen or is otherwise missing, the licence holder must, without delay, inform the Minister and provide the Minister with any information relating to the incident that is under their control and that the Minister may require. The licence holder must also take reasonable measures to locate the missing human pathogen or toxin.

s. 15 — Person conducting controlled activities

If a person conducting controlled activities under the authority of a licence has reasonable grounds to suspect that any of the incidents described in subsection 12(1) or (2) or section 13 or 14 has occurred, the person must, without delay, inform the licence holder.

s. 16 — Use of information

No information provided under sections 12 to 15 by a licence holder or a person conducting controlled activities under the authority of a licence may be used or received against that person in any criminal proceedings that are subsequently instituted against them, other than with respect to a contravention of section 17 or in respect of an allegation that the licence holder or person conducting controlled activities has shown wanton or reckless disregard for the health, safety or security of other persons.

s. 17 — False or misleading information

No person shall knowingly communicate or cause to be communicated to the Minister false or misleading information in relation to a matter under this Act or the regulations.

Licences

s. 18 — Issuance
s. 18(1)

The Minister may, in accordance with the regulations, if any, issue a licence that authorizes any controlled activity in any facility if the Minister is of the opinion that the conduct of the controlled activity in the facility poses no undue risk to the health, safety or security of the public.

s. 18(1.1) — Conditions

Despite subsection (1), the Minister may issue a licence only if,

s. 18(1.1)(a)

in the case that the applicant is an individual, the applicant and the biological safety officer designated for the licence are ordinarily resident in Canada; or

s. 18(1.1)(b)

in the case that the applicant is an organization, the applicant is incorporated, formed or otherwise organized in Canada and its representative and the biological safety officer designated for the licence are ordinarily resident in Canada.

s. 18(1.2) — Debts due to His Majesty

In exercising the power conferred by subsection (1), the Minister may consider whether an applicant or any organization with which an applicant is or was affiliated owes an amount referred to in section 65.

s. 18(2) — Licence application

An application for a licence must be filed with the Minister and made in the form and manner specified by the Minister.

s. 18(3) — Refusal to issue licence

If the Minister refuses to issue a licence, the Minister must notify the applicant in writing of the reasons for the refusal.

s. 18(4) — Conditions

A licence authorizes the controlled activities that are specified in it and is subject to any conditions that the Minister considers appropriate to protect the health, safety and security of the public.

s. 18(4.1) — Conditions — transportation

If the Minister considers it appropriate to impose licence conditions for the conduct of controlled activities to which the Transportation of Dangerous Goods Act, 1992 applies, they must consult with the Minister of Transport and may consult with any other person the Minister considers appropriate.

s. 18(4.2) — Failure to consult

The failure of the Minister to comply with the requirement to consult under subsection (4.1) does not exempt the licence holder and all persons conducting the controlled activities authorized by the licence from the obligation to comply with the licence conditions.

s. 18(5) — Other conditions

A licence must also set out

s. 18(5)(a)

the licence holder’s name and, if applicable, the name of the individual who is designated as a representative for the licence holder;

s. 18(5)(a.1)

the biological safety officer’s name;

s. 18(5)(b)

the period during which the licence is in effect;

s. 18(5)(c)

a description of the facility in which controlled activities are authorized under it;

s. 18(5)(d)

a description of each part of the facility that is subject to section 33; and

s. 18(5)(e)

the toxins, human pathogens, or the risk groups of the human pathogens, in respect of which controlled activities are authorized under it.

s. 18(6) — Obligation of licence holder

The licence holder shall inform all persons conducting the controlled activities authorized by the licence of its conditions.

s. 18(7) — Compliance with licence conditions

A licence holder and all persons conducting the controlled activities authorized by the licence shall comply with the licence conditions.

s. 18(8) — Statutory Instruments Act

A licence is not a statutory instrument within the meaning of the Statutory Instruments Act.

s. 19 — Variation of licence
s. 19(1)

The Minister may, in accordance with the regulations, if any, on the Minister’s own initiative or on the application of a licence holder, vary a licence if the conditions referred to in subsections 18(1) and (1.1) are satisfied.

s. 19(1.1) — Exception

Despite subsection (1), the Minister may, if they are of the opinion that exigent circumstances exist, vary the licence even if the conditions referred to in subsection 18(1.1) are not satisfied.

s. 19(1.2) — Time period

A licence that has been varied under subsection (1.1) is valid for a period of up to 90 days after the day of the variance.

s. 19(1.3) — Debts owed to His Majesty

In exercising the power conferred by subsection (1), the Minister may consider whether the licence holder, any organization with which a licence holder is or was affiliated or a person conducting controlled activities under the authority of the licence owes an amount referred to in section 65.

s. 19(2) — Representations

The Minister may vary the licence on the Minister’s own initiative only if the Minister first gives the licence holder a reasonable opportunity to make representations.

s. 19(3) — Measures specified by Minister

If the Minister varies the licence, the Minister may specify in writing any measures to be taken to protect the health, safety and security of the public that the variation in conditions may necessitate.

s. 20 — Suspension or revocation
s. 20(1)

The Minister may suspend or revoke a licence in any of the following situations:

s. 20(1)(a)

the Minister is of the opinion that a controlled activity authorized by the licence is conducted in a manner that is contrary to this Act or the regulations or poses an undue risk to the health, safety or security of the public;

s. 20(1)(b)

a licence holder who is an individual or the biological safety officer designated for the licence is not ordinarily resident in Canada; or

s. 20(1)(c)

a licence holder that is an organization is incorporated, formed or otherwise organized outside Canada or that its representative or the biological safety officer designated for the licence is not ordinarily resident in Canada.

s. 20(2) — Opportunity to make representations

The Minister may suspend or revoke a licence only if the Minister first gives the licence holder a reasonable opportunity to make representations.

s. 20(3) — Measures specified by Minister

If the Minister suspends or revokes a licence, the Minister may specify in writing any measures to be taken to protect the health, safety and security of the public that the suspension or revocation may necessitate.

s. 20(4) — Disposal

Subject to the measures specified by the Minister, the licence holder shall, within five days after the day on which the Minister’s decision to suspend or revoke the licence takes effect,

s. 20(4)(a)

dispose of the human pathogen or toxin in accordance with the regulations, if any; or

s. 20(4)(b)

transfer the human pathogen or toxin to a facility where controlled activities in relation to the human pathogen or toxin are authorized.

s. 21 — Notice of decision
s. 21(1)

The Minister shall notify a licence holder by registered mail of any decision made under section 19 or 20.

s. 21(2) — Reasons for decision

The Minister shall give reasons for the decision in the notice and shall advise the licence holder of their right to request a review of the decision.

s. 21(3) — Effective date

Subject to subsection 23(2), the Minister’s decision takes effect 31 days after the day on which the notice is received.

s. 22 — Serious and imminent danger
s. 22(1)

If the Minister is of the opinion that there is a serious and imminent danger to the health, safety or security of the public, the Minister must notify the licence holder orally of the decision to suspend or revoke their licence.

s. 22(2) — Effective date

The decision takes effect at the time that the licence holder is notified of it and the licence holder is advised that it is effective immediately.

s. 22(3) — Opportunity to make representations

The Minister is not required to give the licence holder an opportunity to make representations in respect of the decision.

s. 22(4) — Notice

The Minister shall send the notice referred to in subsection 21(1) within five days after the day on which the licence holder is notified orally of the decision.

s. 23 — Review of decision
s. 23(1)

Within 30 days after the day on which the notice is received, the person whose licence is affected by the decision may request in writing, stating their reasons, that the Minister refer the decision to a committee for review.

s. 23(2) — Suspension

A request for a review suspends the application of the decision, unless the Minister notified the licence holder orally of the decision under the circumstances described in subsection 22(1).

s. 23(3) — Measures specified by Minister

When a request for a review is made, the Minister may specify in writing any measures to be taken to protect the health, safety and security of the public pending the Minister’s final decision.

s. 24 — Implementation of measures
s. 24(1)

A person whose licence is affected by the decision shall ensure that any measures specified by the Minister under subsection 19(3), 20(3) or 23(3) are implemented.

s. 24(2) — No contravention

No person contravenes subsection 7(1) or section 8 by reason only that they have implemented those measures.

s. 24(3) — Statutory Instruments Act

The measures are not statutory instruments within the meaning of the Statutory Instruments Act.

s. 25 — Referral of decision to committee
s. 25(1)

On receipt of a request for a review, the Minister shall, within a reasonable time, refer the decision to which the request relates to a committee that is to consist of three individuals who have expertise in the area of human pathogens or toxins.

s. 25(2) — Designation of committee members

One of the members of the committee is to be designated by the Minister and another by the person who requests the review.

s. 25(3) — Chairperson

The two members designated under subsection (2) shall designate a third member of the committee, who shall be its chairperson. If they are unable to designate the third member within a reasonable time, the Minister shall make the designation.

s. 25(4) — Remuneration

The members of the committee may be paid for the carrying out of their functions any remuneration that the Governor in Council may determine.

s. 25(5) — Travel, living and other expenses

The members of the committee are entitled to be paid, in accordance with Treasury Board directives, reasonable travel, living and other expenses incurred in the carrying out of their functions.

s. 26 — Factors to be considered

A committee to which a decision is referred shall consider

s. 26(a)

the reasons for the decision;

s. 26(b)

the reasons stated by the person who requested the review; and

s. 26(c)

any representations, information or material submitted to it by the Minister or the person who requested the review.

s. 27 — Protection of information

The committee members shall not disclose any information or material submitted to them as part of the review to any person other than the Minister unless the disclosure is authorized by the person to whom the information or material relates or is otherwise authorized or required by law.

s. 28 — Committee’s report

Within 60 days after the referral of a decision to a committee, or within any longer period that the Minister may allow, the committee shall report its findings and recommendations to the Minister and to the person who requested the review.

s. 29 — Final decision
s. 29(1)

Within 60 days after receiving a committee’s report, the Minister shall, taking into account its findings and recommendations,

s. 29(1)(a)

reconsider the decision in respect of which the report was made; and

s. 29(1)(b)

send the Minister’s final decision by registered mail to the person who requested the review.

s. 29(2) — Effect

The Minister’s final decision takes effect on the day after the day on which it is received.

s. 30 — Duty to inform
s. 30(1)

A person whose licence is suspended or revoked shall, without delay, inform all persons conducting controlled activities authorized by it of its suspension or revocation.

s. 30(2) — Return of revoked licence

A person whose licence is revoked shall return it by registered mail to the Minister as soon as feasible after the Minister’s decision takes effect or, if the decision is reviewed, as soon as feasible after the Minister’s final decision takes effect.

Access to Facility to Which Licence Applies

s. 31 — List of authorized persons

A licence holder must establish and maintain a list of all persons authorized by the licence holder to access the facility — including remote access by a means of telecommunication — to which the licence applies, including persons holding a security clearance for that facility and visitors. The licence holder must provide the Minister with that list if requested to do so.

s. 32 — Obligation to inform Minister

If a licence holder decides to prohibit the holder of a security clearance from having access to the facility to which the licence applies, the licence holder shall, without delay, inform the Minister in writing of their decision.

Security Clearances

s. 33 — Access to facilities

No person shall enter the part of a facility in which controlled activities are authorized in relation to human pathogens that fall into Risk Group 3 or Risk Group 4 and are prescribed by regulation or toxins prescribed by regulation unless

s. 33(a)

they hold a security clearance for that part of the facility; or

s. 33(b)

they are, in accordance with the regulations, if any, accompanied and supervised by a person who holds a security clearance for that part of the facility.

s. 34 — Issuance, suspension and revocation
s. 34(1)

The Minister may, in accordance with the regulations, issue a security clearance to any individual or suspend or revoke a security clearance. The Minister shall notify the individual concerned in writing of the decision.

s. 34(2) — Agreement

The Minister may, by way of an agreement, authorize any federal department or agency to issue, suspend or revoke security clearances and section 35 applies with any necessary modifications.

s. 35 — Reconsideration of decision
s. 35(1)

If the Minister refuses to issue a security clearance or suspends or revokes a security clearance, the individual concerned may, within 30 days after the day on which the notice is received, request in writing that the Minister reconsider the decision.

s. 35(2) — Request for reconsideration

The request for reconsideration must set out

s. 35(2)(a)

the decision that is the subject of the request;

s. 35(2)(b)

the reasons for the request, including any new information that the individual concerned wishes the Minister to consider; and

s. 35(2)(c)

any information prescribed by regulation.

s. 35(3) — Opportunity to make representations

On receipt of a request made in accordance with this section, the Minister shall give the individual concerned a reasonable opportunity to make representations.

s. 35(4) — Confirmation or variation of decision

Within a reasonable time after representations have been made or an opportunity to do so has been given, the Minister shall reconsider the decision, in accordance with the regulations, if any, and confirm or vary it.

s. 35(5) — Notice

The Minister shall notify the individual concerned in writing of the decision made following the reconsideration.

Biological Safety Officers

s. 36 — Designation
s. 36(1)

An applicant must, before a licence may be issued, designate as a biological safety officer for the requested licence, an individual who must have the qualifications set out in the regulations. The individual designated may also be the applicant.

s. 36(2) — Effective date

A designation takes effect on the day on which the designated individual provides the Minister with their written consent to the designation or the day on which the individual begins to act as a biological safety officer, whichever is earlier.

s. 36(3) — Powers, duties and functions

The biological safety officer must exercise the powers and perform the duties and functions set out in the regulations.

s. 36(4) — Designation — effect

A designation does not have the effect of limiting the obligations of the licence holder or any other person under this Act.

s. 36(5) — Replacement

If an individual ceases to act as a biological safety officer, the licence holder must, without delay, designate another individual and inform the Minister of the new designation.

Licence Holder Representative

s. 36.1 — Designation
s. 36.1(1)

An applicant that is an organization must, before a licence may be issued, designate an individual as its representative for the requested licence.

s. 36.1(2) — Powers, duties and functions

The representative is the point of contact for any matters in relation to the licence and may exercise any of the licence holder’s powers and perform any of their duties and functions under this Act or that are prescribed by regulations, if any.

s. 36.1(3) — Designation — effect

A designation does not have the effect of limiting the obligations of the licence holder or any other person under this Act.

s. 36.1(4) — Replacement

If an individual ceases to act as a representative, the licence holder must, without delay, designate another individual and inform the Minister of the new designation.

Exemptions

s. 37 — Non-application

Subsection 7(1) and section 8 do not apply to

s. 37(a)

an inspector or analyst carrying out their functions under this Act;

s. 37(b)

a peace officer carrying out their functions under any federal or provincial Act or a person providing assistance to that peace officer;

s. 37(c)

any person who, in the course of their employment, outside a facility in which controlled activities are authorized, collects a sample for the purpose of laboratory analysis or diagnostic testing; or

s. 37(d)

in exigent circumstances, any person carrying out their functions under any federal or provincial Act.

Information

s. 38 — Provision of information to Minister
s. 38(1)

The Minister may order an applicant, a licence holder or a biological safety officer to provide the Minister, in accordance with any conditions that the Minister may specify, with any information that is under that person’s control, including personal information and confidential business information, and that the Minister believes, on reasonable grounds, is relevant to the administration of this Act or the regulations.

s. 38(2) — Information

The information that is to be provided may include information

s. 38(2)(a)

regarding the human pathogens or toxins in the possession of the applicant, licence holder or biological safety officer;

s. 38(2)(b)

regarding the persons having access to the human pathogens or toxins referred to in paragraph (a);

s. 38(2)(c)

regarding the facility in which the controlled activities are authorized or in respect of which an application for a licence has been submitted;

s. 38(2)(d)

regarding the controlled activities that are authorized by a licence or in respect of which an application for a licence has been submitted;

s. 38(2)(e)

that is necessary to enable Canada to fulfil its international obligations; and

s. 38(2)(f)

that is necessary to enable Canada to submit Confidence-Building Measures in connection with the Biological and Toxin Weapons Convention.

s. 38(3) — Obligation to provide information

An applicant, a licence holder or a biological safety officer shall provide the Minister with the information, in accordance with any conditions that the Minister may specify.

s. 38(4) — Excluded information

Despite subsections (1) to (3), the Minister of National Defence may refuse to disclose any information the disclosure of which could reasonably be expected to be injurious to the defence or security of Canada or of a state allied or associated with Canada.

s. 39 — Disclosure by Minister
s. 39(1)

The Minister may, without the consent of the person to whom the information relates, disclose personal information and confidential business information obtained under this Act to a person from whom the Minister seeks advice, to a department or agency of the government of Canada or a province, to a foreign government or to an international organization if

s. 39(1)(a)

the disclosure is necessary for the administration or enforcement of this Act or the regulations;

s. 39(1)(b)

the Minister has reasonable grounds to believe that the disclosure is necessary to address a serious and imminent danger to the health, safety or security of the public;

s. 39(1)(c)

the disclosure is necessary to enable Canada to fulfil its international obligations; or

s. 39(1)(d)

the disclosure is necessary to enable Canada to submit Confidence-Building Measures in connection with the Biological and Toxin Weapons Convention.

s. 39(2) — Maintain confidentiality of information

Except in the circumstances described in paragraph (1)(b) or (d), before disclosing the information to any person other than His Majesty in right of Canada or an agent of His Majesty, the Minister must obtain the person’s written agreement that they will maintain the confidentiality of the information unless they are required by law to disclose it.

Administration and Enforcement

s. 40 — Designation of inspectors
s. 40(1)

The Minister may designate any individual, or class of individuals, as an inspector for the administration and enforcement of this Act and the regulations and may restrict in any manner that the Minister considers appropriate the powers that an inspector may exercise under this Act.

s. 40(2) — Certificate to be produced

The Minister shall provide an inspector with a certificate of designation and, on entering any place or conveyance under subsection 41(1), the inspector shall produce the certificate to the person in charge of that place or conveyance if requested to do so.

s. 40.1 — Definition of document

In sections 40.2 and 41, document includes any report, book and electronic data and any other thing containing information.

s. 40.2 — Provision of documents, information or material
s. 40.2(1)

An inspector may, for a purpose related to verifying compliance or preventing non-compliance with any provision of this Act or the regulations, order a person to provide, in the manner specified by the inspector, any document, information or material specified by the inspector.

s. 40.2(2) — Duty to provide

A person who is ordered by an inspector to provide a document, information or material must do so in the manner specified by the inspector.

s. 41 — Entry by inspector
s. 41(1)

Subject to section 42, an inspector may, for the purpose of verifying compliance or preventing non-compliance with any provision of this Act or the regulations, enter at any reasonable time any place or conveyance in which the inspector believes on reasonable grounds that

s. 41(1)(a)

an activity to which this Act or the regulations applies is conducted;

s. 41(1)(b)

any material, equipment or document relevant to the administration of this Act or the regulations is located; or

s. 41(1)(c)

an activity could be conducted under a licence for which an application is under consideration by the Minister.

s. 41(1.1) — Individual accompanying inspector

An inspector may be accompanied by any individual who the inspector believes is necessary to help them exercise their powers or perform their duties or functions under this section.

s. 41(2) — Inspector’s powers

An inspector who enters a place or conveyance may, for the purpose referred to in subsection (1),

s. 41(2)(a)

examine the place — including any building — or conveyance and any material or equipment found there;

s. 41(2)(b)

require any person in the place or conveyance to produce, in the manner and form requested by the inspector, any material or equipment found there;

s. 41(2)(c)

seize and detain for any time that may be necessary any material, equipment or document found there, or any conveyance;

s. 41(2)(d)

open and examine any receptacle or package found there;

s. 41(2)(e)

take, or require any person in the place or conveyance to produce, free of charge, a sample of any material found there;

s. 41(2)(f)

direct the owner or the person having possession, care or control of any material, equipment or document found in the place or conveyance — or of the conveyance — to move it or, for any time that may be necessary, not to move it or to restrict its movement;

s. 41(2)(g)

conduct, or require any person in the place or conveyance to conduct, any test or analysis or take any measurement of any material or equipment found there;

s. 41(2)(h)

take photographs or make recordings or sketches;

s. 41(2)(i)

use or cause to be used any computer system, as defined in subsection 342.1(2) of the Criminal Code, or any means of telecommunication found there to examine electronic data that is contained in or available to the computer system or means of telecommunication;

s. 41(2)(j)

require any person in the place or conveyance to produce any document found there for examination or reproduction; and

s. 41(2)(k)

examine, reproduce or cause to be reproduced, in whole or in part, any document found there and remove any reproductions.

s. 41(2)(l)

[Repealed]

s. 41(2)(m)

[Repealed]

s. 41(2.1) — Remote access

For the purposes of subsection (1), an inspector is considered to have entered a place or conveyance when they remotely access it by a means of telecommunication.

s. 41(2.2) — Limitation — remote access

An inspector who enters — by remote access by a means of telecommunication — a place or conveyance that is not accessible to the public must do so with the knowledge of the owner or person in charge of the place or conveyance and only for the period necessary for the purpose referred to in subsection (1).

s. 41(3) — Conveyance

For the purpose of entering the conveyance, the inspector may order the owner or person having possession, care or control of the conveyance to stop it or move it to a place where the inspector can enter it.

s. 41(3.1) — Duty to comply

An owner or person who, under subsection (3), is ordered to stop or move a conveyance, must stop or move it.

s. 41(4) — Excluded information

Despite subsection (2), the Minister of National Defence may refuse to disclose any information the disclosure of which could reasonably be expected to be injurious to the defence or security of Canada or of a state allied or associated with Canada.

s. 41(5) — Assistance to inspector

The owner or person in charge of a place or conveyance that is entered by an inspector who is carrying out their functions and every individual in that place or conveyance must give the inspector and any individual referred to in subsection (1.1) all reasonable assistance and provide them with any information that the inspector may reasonably require.

s. 41(6) — Prohibition — obstruction and false statements

A person must not knowingly obstruct or hinder, or make a false or misleading statement either orally or in writing to, an inspector who is carrying out their functions or to any individual referred to in subsection (1.1).

s. 41(7) — Entering private property

An inspector who is carrying out their functions and any individual referred to in subsection (1.1) accompanying the inspector may enter on and pass through or over private property, and they are not liable for doing so.

s. 42 — Warrant to enter dwelling-house
s. 42(1)

An inspector may not enter a dwelling-house without the occupant’s consent, except under the authority of a warrant issued under subsection (2).

s. 42(2) — Authority to issue warrant

On ex parte application, a justice of the peace may issue a warrant authorizing the inspector named in it to enter a dwelling-house, subject to any conditions that may be specified in the warrant, if the justice of the peace is satisfied by information on oath that

s. 42(2)(a)

the dwelling-house is a place referred to in subsection 41(1);

s. 42(2)(b)

entry to the dwelling-house is necessary for a purpose referred to in subsection 41(1); and

s. 42(2)(c)

entry to the dwelling-house has been refused or there are reasonable grounds for believing that entry will be refused.

s. 42(3) — Use of force

In executing the warrant, the inspector named in it may not use force unless they are accompanied by a peace officer and the use of force is specifically authorized in the warrant.

s. 42(4) — Means of telecommunication

An application for a warrant may be submitted, and the warrant may be issued, by a means of telecommunication and section 487.1 of the Criminal Code applies for those purposes with any necessary modifications.

s. 43 — Measures
s. 43(1)

If an inspector has reasonable grounds to believe that a licence holder or any person in a place or conveyance where controlled activities are taking place is not compliant or is not likely to comply with one or more provisions of this Act or the regulations, the inspector may order the licence holder or person to carry out any measure that the inspector considers necessary to remedy or prevent the non-compliance.

s. 43(2) — Obligation

A licence holder or person who is ordered by an inspector to carry out such a measure must comply with the order and, in doing so, does not contravene this Act or the regulations.

s. 43(3) — Withdrawal of order

An inspector who orders a measure to be carried out must withdraw the order if they no longer have reasonable grounds to believe that the licence holder or person is not compliant or not likely to comply with this Act or the regulations.

s. 43(4) — Review by Minister

An inspector shall, without delay, refer any decision to make or withdraw an order to the Minister for review. After the review, the Minister may amend, replace or rescind the order if the Minister is of the opinion that it is necessary to do so.

s. 43(5) — Application of order not suspended

The referral of a decision to the Minister for review does not suspend the application of the decision.

s. 43(6) — Refusal to comply

If a licence holder or any other person who is ordered to carry out a measure fails to comply with the order, the inspector may carry out the measure or require another person to do so.

s. 43(7) — Informing of action

After the measure is carried out, the inspector shall, as soon as feasible, advise the person who failed to comply with the order that the measure was carried out.

s. 43(8) — Compliance not required

No person is required to carry out a measure ordered by an inspector if doing so would expose them to a danger, as defined in subsection 122(1) of the Canada Labour Code.

s. 43(9) — Cost

A licence holder, or if no licence has been issued in respect of the controlled activity, the person who is responsible for the conduct of the controlled activity, shall bear the cost of carrying out any measure ordered by an inspector.

s. 44 — Storage and removal
s. 44(1)

An inspector may order that a thing seized under this Act be kept or stored in the place where it was seized or be removed to any other appropriate place.

s. 44(2) — Interference

Except with the inspector’s authority, no person shall remove, alter or interfere in any way with the seized thing.

s. 45 — Return of seized thing

An inspector who seizes a thing under this Act shall release it if they are satisfied that the provisions of this Act and the regulations that apply to that thing have been complied with.

s. 46 — Application for restoration
s. 46(1)

On reasonable notice in writing to the Minister, the owner of a thing seized under this Act, or the person in possession of it at the time of its seizure, may, within 60 days after the day of its seizure, apply to a provincial court judge within whose jurisdiction the seizure was made for an order of restoration.

s. 46(2) — Order of restoration

The provincial court judge may order that the seized thing be restored immediately to the applicant if, on hearing the application, the judge is satisfied that

s. 46(2)(a)

the applicant is entitled to possession of it;

s. 46(2)(b)

it does not pose a serious and imminent danger to the health, safety or security of the public; and

s. 46(2)(c)

it will not be required as evidence in a prosecution for an offence that is subsequently instituted under this Act.

s. 46(3) — Order of later restoration

If, on hearing an application, the provincial court judge is satisfied that the applicant is entitled to possession of the seized thing and that it does not pose a serious and imminent danger to the health, safety or security of the public but is not satisfied with respect to paragraph (2)(c), the judge may order that the thing be restored to the applicant

s. 46(3)(a)

on the expiry of 180 days after the day of its seizure if no prosecution for an offence under this Act has been instituted before that day; or

s. 46(3)(b)

on the final conclusion of proceedings under this Act.

s. 46(4) — Exception

The provincial court judge may not make an order for the restoration of the seized thing if it has been forfeited by consent under subsection 47(2).

s. 47 — Forfeiture
s. 47(1)

If no application is made for the restoration of a thing seized under this Act within 60 days after the day of its seizure, or an application has been made but no order of restoration is made after the application has been heard, the seized thing is forfeited to His Majesty in right of Canada.

s. 47(2) — Forfeiture with consent

If an inspector has seized a thing and its owner, or the person in possession of it at the time of its seizure, consents in writing to its forfeiture, the thing is forfeited to His Majesty in right of Canada.

s. 47(3) — Disposal

Subject to section 48, the Minister may dispose of a seized thing that is forfeited to His Majesty in right of Canada in any manner that the Minister directs.

s. 48 — Preservation

The Minister shall make reasonable efforts to preserve any thing seized under this Act pending its disposition.

s. 49 — Costs

The owner of a thing seized under this Act, or the person in possession of it at the time of its seizure, shall bear any associated seizure, storage, transfer, preservation or disposition costs.

s. 50 — Designation of analyst

The Minister may designate any individual, or class of individuals, as an analyst for the administration and enforcement of this Act and the regulations.

s. 51 — Analysis and examination
s. 51(1)

An inspector may submit to an analyst, for analysis or examination, any thing seized or taken by the inspector.

s. 51(2) — Certificate or report of analyst

An analyst who has made an analysis or examination may issue a certificate or report setting out the results of the analysis or examination.

s. 52 — Admissibility
s. 52(1)

An analyst’s certificate or report is admissible in evidence in any prosecution for an offence under this Act if it

s. 52(1)(a)

appears to be signed by the analyst;

s. 52(1)(b)

states that a thing has been analyzed or examined by the analyst; and

s. 52(1)(c)

states the results of that analysis or examination.

In the absence of evidence to the contrary, the certificate or report is proof of the statements contained in it without proof of the signature or official character of the person appearing to have signed it.

s. 52(2) — Attendance of analyst required

The party against whom a certificate or report is produced may, with leave of the court, require the analyst’s attendance for the purpose of cross-examination.

s. 52(3) — Notice of intention to produce certificate or report

No certificate or report may be admitted in evidence unless, before the trial, the party intending to produce it has given reasonable notice of that intention, together with a copy of the certificate or report, to the party against whom it is intended to be produced.

Offences and Punishment

s. 53 — General

Subject to sections 54 to 58, every person who contravenes this Act or the regulations is guilty of an offence and liable,

s. 53(a)

in the case of a contravention with respect to a human pathogen that falls into Risk Group 2, on summary conviction, to a fine of not more than $250,000 or to imprisonment for a term of not more than six months, or to both;

s. 53(b)

in all other cases,

s. 53(b)(i)

on conviction on indictment, to a fine of not more than $1,000,000 or to imprisonment for a term of not more than five years, or to both, or

s. 53(b)(ii)

on summary conviction, to a fine of not more than $500,000 or to imprisonment for a term of not more than 18 months, or to both.

s. 54 — Breach of duty

Every person who contravenes section 6 and, as a result, creates a risk to the health, safety or security of the public is guilty of an indictable offence and liable to imprisonment for a term of not more than five years.

s. 55 — Wanton or reckless breach of duty

Every person who contravenes section 6 and who shows wanton or reckless disregard for the health, safety or security of other persons and, as a result, creates a risk to the health, safety or security of the public is guilty of an indictable offence and liable to imprisonment for a term of not more than 10 years.

s. 56

[Repealed]

s. 57 — Contravention of section 8 — knowingly
s. 57(1)

Every person who knowingly contravenes section 8 is guilty of an offence and liable on conviction by indictment to a fine of not more than $5,000,000 or to imprisonment for a term of not more than 14 years, or to both.

s. 57(2) — Contravention of section 8

Every person who contravenes section 8 is guilty of an offence and liable

s. 57(2)(a)

on conviction on indictment, to a fine of not more than $1,000,000 or to imprisonment for a term of not more than five years, or to both; or

s. 57(2)(b)

on summary conviction, to a fine of not more than $500,000 or to imprisonment for a term of not more than 18 months, or to both.

s. 58 — Intentional release

Every person who intentionally releases or otherwise abandons a human pathogen or toxin in contravention of this Act or the regulations is guilty of an indictable offence and is liable to imprisonment

s. 58(a)

for life, if the result causes death or is likely to cause death to any individual;

s. 58(b)

for a term of not more than 14 years, if the result creates a risk to the health, safety, or security of the public.

s. 59 — Defence

No person who establishes that they exercised all due diligence to prevent the contravention of this Act or the regulations may be convicted of that offence, except for an offence under

s. 59(a)

section 53, with respect to a contravention of subsection 7(1), section 17 and subsection 41(6);

s. 59(b)

section 55;

s. 59(c)

[Repealed]

s. 59(d)

subsection 57(1); and

s. 59(e)

section 58.

s. 60 — Place of trial

A prosecution for an offence under this Act may be instituted, heard and determined in the place where

s. 60(a)

the offence was committed or the subject matter of the prosecution arose;

s. 60(b)

the accused was apprehended; or

s. 60(c)

the accused happens to be or is carrying on business.

s. 61 — Continuing offences

If an offence under this Act or the regulations is committed or continued on more than one day, the person who committed the offence is liable to be convicted for a separate offence for each day on which it is committed or continued.

s. 62 — Time limit
s. 62(1)

Summary conviction proceedings for an offence under this Act or the regulations may be instituted no later than two years after the day on which the subject matter of the proceedings becomes known to the Minister.

s. 62(2) — Minister’s certificate

A document that appears to be issued by the Minister, certifying the day on which the subject matter of the proceedings became known to the Minister, is admissible in evidence without proof of the signature or official character of the person appearing to have signed it. In the absence of evidence to the contrary, it is proof of the matters asserted in it.

s. 63 — Directors, officers and agents or mandataries

If a person other than an individual commits an offence under this Act or the regulations, any of the person’s directors, officers or agents or mandataries who directed, authorized, assented to, acquiesced in or participated in the commission of the offence is a party to and guilty of the offence and is liable on conviction to the punishment provided for the offence, whether or not the person has been prosecuted or convicted.

s. 64 — Offences by employees or agents or mandataries

In a prosecution for an offence under this Act or the regulations, it is sufficient proof of the offence to establish that it was committed by the accused’s employee acting within the scope of their employment, or the accused’s agent or mandatary acting within the scope of their authority, whether or not the employee or agent or mandatary is identified or prosecuted for the offence, unless the accused establishes that

s. 64(a)

the offence was committed without the accused’s knowledge or consent; and

s. 64(b)

the accused exercised all due diligence to prevent its commission.

Debts

s. 65 — Debts due to His Majesty

The following constitute debts due to His Majesty in right of Canada and may be recovered as such in any court of competent jurisdiction:

s. 65(a)

an amount that a person is directed to pay under an order made by a court under this Act;

s. 65(b)

the costs incurred in the seizure, storage, transfer, preservation or disposition under this Act of any human pathogen, toxin or other thing; and

s. 65(c)

the costs incurred in the carrying out of a measure under subsection 43(6).

Regulatory Powers

s. 66 — Regulations
s. 66(1)

The Governor in Council may make regulations for carrying out the purposes of this Act, including regulations

s. 66(1)(a)

defining any term that is used but not defined in this Act;

s. 66(1)(a.1)

respecting the safety and security of activities to which this Act or the regulations made under it apply;

s. 66(1)(a.2)

respecting the conduct of controlled activities, including in relation to

s. 66(1)(a.2)(i)

containment levels for human pathogens or toxins, and

s. 66(1)(a.2)(ii)

the decontamination of material, equipment, places, conveyances and persons contaminated by human pathogens or toxins;

s. 66(1)(b)

respecting licensing, including the conditions that must be met for a licence to be issued, the conditions that must be complied with under a licence, the renewal, suspension and revocation of a licence and the variation of an existing licence;

s. 66(1)(c)

respecting facilities in which controlled activities are authorized, including

s. 66(1)(c)(i)

the location, design, construction, layout and upgrading of those facilities,

s. 66(1)(c)(ii)

the material and equipment at those facilities,

s. 66(1)(c)(iii)

heating, ventilation, air conditioning and air handling systems,

s. 66(1)(c)(iv)

biological safety cabinets, and

s. 66(1)(c)(v)

security requirements in relation to information technology;

s. 66(1)(d)

respecting access, including remote access by a means of telecommunication, to facilities in which controlled activities are authorized, including

s. 66(1)(d)(i)

the conditions to be met by persons to obtain access to those facilities, and

s. 66(1)(d)(ii)

the screening of persons accessing those facilities;

s. 66(1)(e)

prescribing the time when a document sent under this Act is to be considered to have been received;

s. 66(1)(f)

specifying the human pathogens and toxins for the purposes of subparagraphs 7(2)(c)(i) and (iii) and (d)(i) and (iii) and section 33;

s. 66(1)(g)

respecting security clearances required under section 33, including

s. 66(1)(g)(i)

the conditions to be met by an applicant for a security clearance,

s. 66(1)(g)(ii)

the issuance of security clearances, as well as their suspension and revocation, and

s. 66(1)(g)(iii)

the reconsideration of a decision to refuse, suspend or revoke a security clearance;

s. 66(1)(h)

respecting the accompaniment and supervision, within the part of a facility described in section 33, of persons who do not hold a security clearance;

s. 66(1)(i)

respecting the qualifications, powers, duties and functions of biological safety officers;

s. 66(1)(i.1)

specifying the powers, duties and functions of the representative for the purposes of subsection 36.1(2);

s. 66(1)(j)

respecting the establishment, content and maintenance of inventories of human pathogens and toxins, as well as the provision of reports on those inventories;

s. 66(1)(k)

respecting the preparation, content and maintenance of any documents necessary for the administration of this Act and the regulations, as well as the provision of those documents to the Minister;

s. 66(1)(l)

respecting the provision of information to the Minister that is necessary for the administration of this Act and the regulations;

s. 66(1)(m)

respecting the collection, use and disclosure by the Minister of personal information and confidential business information;

s. 66(1)(n)

exempting, on any conditions that the Governor in Council deems appropriate, any person or class of persons, any activity or any human pathogen or toxin from the application of any provision of this Act or the regulations if the Governor in Council is of the opinion that the exemption is in the public interest and poses no undue risk to the health, safety or security of the public; and

s. 66(1)(o)

prescribing any other matter that by this Act is to be prescribed.

s. 66(1)(p)

[Repealed]

s. 66(1.1) — Levels of risk

In making regulations, the Governor in Council shall take into account the varying levels of risk posed by human pathogens — determined by whether they fall into Risk Group 2, Risk Group 3 or Risk Group 4 — and those posed by toxins.

s. 66(2) — Distinctions

A regulation may establish classes of persons, facilities, activities, human pathogens and toxins and distinguish among those classes.

s. 66.1

[Repealed]

s. 66.2

[Repealed]

s. 67 — Interim orders
s. 67(1)

The Minister may make an interim order containing any provision that may be contained in a regulation made under section 66 if the Minister is of the opinion that prompt measures are required to address a serious or imminent danger to the health, safety or security of the public.

s. 67(2) — Duration

The interim order has effect from the day on which it is made but ceases to have effect on the earliest of

s. 67(2)(a)

90 days after the day on which it is made, unless it is approved by the Governor in Council,

s. 67(2)(b)

the day on which it is repealed,

s. 67(2)(c)

the day on which a regulation made under section 66 that has the same effect as the interim order comes into force, and

s. 67(2)(d)

one year after the day on which it is made or any shorter period that it specifies.

s. 67(3) — Exemption from Statutory Instruments Act

An interim order is exempt from the application of sections 3 and 9 of the Statutory Instruments Act.

s. 67(4) — Deeming

For the purpose of any provision of this Act other than this section, any reference to regulations made under this Act is deemed to include interim orders, and a reference to a regulation made under a specified provision of this Act is deemed to include a reference to the portion of an interim order containing any provision that may be contained in a regulation made under the specified provision.

s. 67(5) — Tabling of order

A copy of each interim order shall be tabled in each House of Parliament within 15 days after the day on which it is made.

s. 67(6) — House not sitting

In order to comply with subsection (5), the interim order may be sent to the Clerk of the House if the House is not sitting.

s. 68 — Incorporation by reference — limitation removed
s. 68(1)

The limitation set out in paragraph 18.1(2)(a) of the Statutory Instruments Act to the effect that a document must be incorporated as it exists on a particular date does not apply to any power to make regulations under this Act.

s. 68(2) — Jointly produced documents

A regulation may incorporate by reference documents — as they exist on a particular date or as they are amended from time to time — that the Minister produces jointly with another government for the purpose of harmonizing the regulation with other laws.

s. 69

[Repealed]

Transitional Provisions

s. 70 — Activities already commenced
s. 70(1)

Every person who, on the day on which this section comes into force, is responsible for activities involving human pathogens or toxins shall, in the form and manner specified by the Minister, not later than 90 days after that coming into force,

s. 70(1)(a)

advise the Minister that they are responsible for human pathogens or toxins and inform the Minister of the risk groups to which the human pathogens belong;

s. 70(1)(b)

advise the Minister of the location where the activity is conducted; and

s. 70(1)(c)

designate an individual with the appropriate safety training in the area of human pathogens and toxins or relevant work experience as the contact person for the Minister and advise the Minister of that individual’s name.

s. 70(2) — Activities commencing before subsection 7(1) comes into force

Every person who is responsible for activities involving human pathogens or toxins and who commences those activities after the day on which this section comes into force but before the day on which subsection 7(1) comes into force shall, in the form and manner specified by the Minister, provide the Minister with the information referred to in subsection (1) not later than 30 days after the day on which the activities commence.

s. 70(3) — Update of information

Every person who is required to provide the Minister with information under subsection (1) or (2) shall provide the Minister with updated information annually. If a new individual is designated under paragraph (1)(c), the person shall advise the Minister of the designation without delay.

s. 70(4) — No effect

Subsection (3) ceases to have effect on the day on which subsection 7(1) comes into force.

s. 71 — Possession of human pathogens or toxins
s. 71(1)

Every person who, on the day on which section 8 comes into force, possesses a human pathogen or toxin listed in Schedule 5 shall

s. 71(1)(a)

inform the Minister of the human pathogen or toxin in their possession within 30 days after the day on which that section comes into force;

s. 71(1)(b)

provide the Minister with any information that the Minister may require with respect to it; and

s. 71(1)(c)

dispose of it in accordance with the Minister’s instructions.

s. 71(2) — No contravention

No person contravenes section 8 by reason only that they possess a human pathogen or toxin in the circumstances described in subsection (1) if they comply with that subsection.

Coming into Force

*72 — Order in council

Section 7, subsections 11(1) and 12(1), sections 1 3 to 16, 18 to 36, 38 and 56 come into force on a day or days to be fixed by order of the Governor in Council.[Note: Section 7, subsections 11(1) and 12(1), sections 13 to 16, 18 to 36, 38 and 56 in force December 1, 2015, see SI/2015-14.]

Schedule

Toxins Human Pathogens

SCHEDULE

Prohibited Human Pathogens and Toxins

Provision

Variola virus Virus de la variole

Schedule

[Repealed]

SCHEDULE 2
Schedule

[Repealed]

SCHEDULE 3
Schedule

[Repealed]

SCHEDULE 4
Schedule

[Repealed]

SCHEDULE 5