C-1124057-58Elizabeth II2009An Act to promote safety and security with respect to human pathogens and toxinsHuman Pathogens and Toxins ActHuman Pathogens and Toxins20264
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H-5.6724200990465PreambleWhereas the Parliament of Canada recognizes the objective of protecting the health, safety and security of the public;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;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;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;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;2009, c. 24, Preamble2026, c. 3, s. 400Now, therefore, Her Majesty, by and with the advice and consent of the Senate and House of Commons of Canada, enacts as follows:Short Title
Short titleThis Act may be cited as the Human Pathogens and Toxins Act.
Purpose of the Act
PurposeThe 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.2009, c. 24, s. 22026, c. 3, s. 401(E)
Interpretation and Application
DefinitionsThe following definitions apply in this Act.controlled activity, in respect of a human pathogen or toxin, means any of the following activities:possessing, handling or using it;producing it;storing it;permitting any person access to it;transferring it;importing or exporting it;releasing or otherwise abandoning it; ordisposing of it. (activité réglementée)conveyance means a vessel, aircraft, train, motor vehicle, trailer or other means of transportation, including a cargo container. (véhicule)disease includes intoxication. (maladie)human pathogen means a micro-organism, nucleic acid or protein thatis listed in the registry or in Part 2 of the schedule; oris 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)licence means a licence issued under section 18. (permis)Minister means the Minister of Health. (ministre)person means an individual or an organization as defined in section 2 of the Criminal Code. (personne)personal information has the same meaning as in section 3 of the Privacy Act. (renseignements personnels)possession has the same meaning as in subsection 4(3) of the Criminal Code. (possession)produce, in respect of a human pathogen or toxin, means to create it by any method or process, includingby manufacturing, cultivating, developing, reproducing or synthesizing it; orby 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)registry means the registry established under subsection 9(1). (registre)release means any discharge, anywhere, and includes leaking, spraying, depositing, dumping or vaporizing. (rejet)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)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)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)security clearance means a security clearance issued under section 34. (habilitation de sécurité)toxin means a substance that is produced by, or derived from, a micro-organism and thatmay or may not be listed in the registry and poses a moderate to high risk to the health of individuals;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); oris listed in Part 1 of the schedule. (toxine)IncludedFor the purposes of this Act, a human pathogen or toxin includesa substance that contains a human pathogen or toxin; andany synthetic form of the human pathogen or toxin.2009, c. 24, s. 32026, c. 3, s. 402
ExcludedThis Act does not apply toa 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 thatis in or on a human suffering from a disease caused by that human pathogen or toxin,has been expelled by a human suffering from a disease caused by that human pathogen or toxin, oris in or on a cadaver, a body part or other human remains; ora 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.[Repealed, 2012, c. 19, s. 752]2009, c. 24, s. 4; 2012, c. 19, s. 7522026, c. 3, s. 403
His Majesty
Act binding on His MajestyThis Act is binding on His Majesty in right of Canada or a province.2009, c. 24, s. 52026, c. 3, s. 404(E)
Obligation
Reasonable precautionsEvery 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.2009, c. 24, s. 62026, c. 3, s. 405(E)
Prohibitions
Controlled activitiesA person must not knowingly conduct any controlled activity unless a licence has been issued by the Minister that authorizes the activity.ExceptionsDespite the definition controlled activity in subsection 3(1), the following activities are not controlled activities:any activity to which the Transportation of Dangerous Goods Act, 1992 applies that involveshuman pathogens that fall into Risk Group 2,human pathogens that fall into Risk Group 3 and are not prescribed by regulation, ortoxins that are not prescribed by regulation;export authorized under the Export and Import Permits Act that involveshuman pathogens that fall into Risk Group 2,human pathogens that fall into Risk Group 3 and are not prescribed by regulation, ortoxins that are not prescribed by regulation;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:human pathogens that fall into Risk Group 3 and are prescribed by regulation,human pathogens that fall into Risk Group 4, ortoxins that are prescribed by regulation; andexport 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:human pathogens that fall into Risk Group 3 and are prescribed by regulation,human pathogens that fall into Risk Group 4, ortoxins that are prescribed by regulation.2009, c. 24, s. 72026, c. 3, s. 406
Human pathogens and toxins — scheduleDespite 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.2009, c. 24, s. 82026, c. 3, s. 406
Registry
RegistryThe Minister must establish and update a registry thatlists 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; andmay listany 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, orany 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.Minister’s obligationThe Minister must indicate in the registryin the case of a substance referred to in paragraph (1)(a), thatit 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, andthe minimum quantity at which, in the opinion of the Minister, it poses that risk; andin 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.Minimum quantityThe 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.Deletion of itemsThe 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).Amendments to the registryThe Minister must, in the registry,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;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);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); andamend 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).Amendment to the registry — nameThe Minister may amend the registry by modifying the name of a human pathogen or toxin listed in the registry.Accessibility of the registryThe Minister must make the registry accessible to the public by electronic means and by any other means that the Minister considers appropriate.DelegationThe 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).Non-applicationFor 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).Exemption from Statutory Instruments ActThe registry is exempt from sections 3, 5 and 11 of the Statutory Instruments Act.2009, c. 24, s. 92026, c. 3, s. 406
Advisory CommitteeAn 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.Request of MinisterThe Minister may at any time request the advisory committee to provide advice in respect of the registry.PublicationThe advisory committee must make available to the public the advice given to the Minister.2026, c. 3, s. 406
Schedule
Addition of itemsThe Governor in Council may, by regulation, on the Minister’s recommendation,add a substance to Part 1 of the schedule if the Governor in Council is of the opinion thatit is produced by, or derived from, a micro-organism and poses a moderate to high risk tothe health of individuals, orthe health, safety or security of the public due to a reasonable risk of intentional use as a biological weapon, andall activities referred to in section 7 should be prohibited in relation to it; oradd a micro-organism, nucleic acid or protein to Part 2 of the schedule if the Governor in Council is of the opinion thatit is able to cause disease in a human, andall activities referred to in section 7 should be prohibited in relation to it.[Repealed, 2026, c. 3, s. 407]Deletion of itemsThe 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.Advisory CommitteeThe 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).PublicationThe advisory committee shall make available to the public the advice given to the Minister.2009, c. 24, s. 102026, c. 3, s. 407
Consequences of Updating the Registry or Schedule
Prohibited possession — updateWithin 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 mustdispose of it in accordance with the regulations, if any;transfer it to a facility where controlled activities in relation to it are authorized; orobtain from the Minister a licence, or a variation of the conditions of their existing licence, authorizing possession of it.Prohibited possession — scheduleWithin 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.No contraventionNo 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).DefenceIf 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,the registry with the human pathogen or toxin listed in it was reasonably accessible to the person;the human pathogen or toxin was listed in the registry; andthe registry indicated, in relation to the human pathogen or toxin,the risk group into which the human pathogen falls,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), orthe minimum quantity at which the toxin poses a moderate to high risk to the health of individuals, if any.2009, c. 24, s. 112026, c. 3, s. 409
Obligation to Inform Minister
Inadvertent releaseIf 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.Inadvertent productionIf 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 shallwithout 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; anddispose 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.InformationThe information that is to be provided under subsections (1) and (2) is the following:any information that supports the conclusion that a human pathogen or toxin has been released or produced;the name of the human pathogen or toxin released or produced;the quantity released or produced;the place and time of the release or production; andany other information relating to the release or production that the Minister may require.No contraventionNo 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.2009, c. 24, s. 122026, c. 3, s. 410
DiseaseIf 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:a description of the incident;the name of the human pathogen or toxin; andany other information relating to the incident that the Minister may require.2009, c. 24, s. 132026, c. 3, s. 411
Missing human pathogen or toxinIf 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.2009, c. 24, s. 142026, c. 3, s. 412
Person conducting controlled activitiesIf 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.2009, c. 24, s. 152026, c. 3, s. 412
Use of informationNo 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.2009, c. 24, s. 162026, c. 3, s. 412
False or misleading informationNo 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
IssuanceThe 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.ConditionsDespite subsection (1), the Minister may issue a licence only if,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; orin 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.Debts due to His MajestyIn 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.Licence applicationAn application for a licence must be filed with the Minister and made in the form and manner specified by the Minister.Refusal to issue licenceIf the Minister refuses to issue a licence, the Minister must notify the applicant in writing of the reasons for the refusal.ConditionsA 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.Conditions — transportationIf 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.Failure to consultThe 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.Other conditionsA licence must also set outthe licence holder’s name and, if applicable, the name of the individual who is designated as a representative for the licence holder;the biological safety officer’s name;the period during which the licence is in effect;a description of the facility in which controlled activities are authorized under it;a description of each part of the facility that is subject to section 33; andthe toxins, human pathogens, or the risk groups of the human pathogens, in respect of which controlled activities are authorized under it.Obligation of licence holderThe licence holder shall inform all persons conducting the controlled activities authorized by the licence of its conditions.Compliance with licence conditionsA licence holder and all persons conducting the controlled activities authorized by the licence shall comply with the licence conditions.Statutory Instruments ActA licence is not a statutory instrument within the meaning of the Statutory Instruments Act.2009, c. 24, s. 182026, c. 3, s. 415
Variation of licenceThe 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.ExceptionDespite 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.Time periodA 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.Debts owed to His MajestyIn 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.RepresentationsThe 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.Measures specified by MinisterIf 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.2009, c. 24, s. 192026, c. 3, s. 416
Suspension or revocationThe Minister may suspend or revoke a licence in any of the following situations: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;a licence holder who is an individual or the biological safety officer designated for the licence is not ordinarily resident in Canada; ora 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.Opportunity to make representationsThe Minister may suspend or revoke a licence only if the Minister first gives the licence holder a reasonable opportunity to make representations.Measures specified by MinisterIf 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.DisposalSubject 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,dispose of the human pathogen or toxin in accordance with the regulations, if any; ortransfer the human pathogen or toxin to a facility where controlled activities in relation to the human pathogen or toxin are authorized.2009, c. 24, s. 202026, c. 3, s. 417
Notice of decisionThe Minister shall notify a licence holder by registered mail of any decision made under section 19 or 20.Reasons for decisionThe 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.Effective dateSubject to subsection 23(2), the Minister’s decision takes effect 31 days after the day on which the notice is received.
Serious and imminent dangerIf 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.Effective dateThe 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.Opportunity to make representationsThe Minister is not required to give the licence holder an opportunity to make representations in respect of the decision.NoticeThe 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.2009, c. 24, s. 222026, c. 3, s. 418
Review of decisionWithin 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.SuspensionA 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).Measures specified by MinisterWhen 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.2009, c. 24, s. 232026, c. 3, s. 419(E)
Implementation of measuresA 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.No contraventionNo person contravenes subsection 7(1) or section 8 by reason only that they have implemented those measures.Statutory Instruments ActThe measures are not statutory instruments within the meaning of the Statutory Instruments Act.
Referral of decision to committeeOn 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.Designation of committee membersOne of the members of the committee is to be designated by the Minister and another by the person who requests the review.ChairpersonThe 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.RemunerationThe members of the committee may be paid for the carrying out of their functions any remuneration that the Governor in Council may determine.Travel, living and other expensesThe 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.
Factors to be consideredA committee to which a decision is referred shall considerthe reasons for the decision;the reasons stated by the person who requested the review; andany representations, information or material submitted to it by the Minister or the person who requested the review.
Protection of informationThe 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.
Committee’s reportWithin 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.
Final decisionWithin 60 days after receiving a committee’s report, the Minister shall, taking into account its findings and recommendations,reconsider the decision in respect of which the report was made; andsend the Minister’s final decision by registered mail to the person who requested the review.EffectThe Minister’s final decision takes effect on the day after the day on which it is received.
Duty to informA person whose licence is suspended or revoked shall, without delay, inform all persons conducting controlled activities authorized by it of its suspension or revocation.Return of revoked licenceA 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
List of authorized personsA 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.2009, c. 24, s. 312026, c. 3, s. 420
Obligation to inform MinisterIf 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
Access to facilitiesNo 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 unlessthey hold a security clearance for that part of the facility; orthey 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.
Issuance, suspension and revocationThe 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.AgreementThe 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.
Reconsideration of decisionIf 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.Request for reconsiderationThe request for reconsideration must set outthe decision that is the subject of the request;the reasons for the request, including any new information that the individual concerned wishes the Minister to consider; andany information prescribed by regulation.Opportunity to make representationsOn receipt of a request made in accordance with this section, the Minister shall give the individual concerned a reasonable opportunity to make representations.Confirmation or variation of decisionWithin 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.NoticeThe Minister shall notify the individual concerned in writing of the decision made following the reconsideration.
Biological Safety Officers
DesignationAn 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.Effective dateA 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.Powers, duties and functionsThe biological safety officer must exercise the powers and perform the duties and functions set out in the regulations.Designation — effectA designation does not have the effect of limiting the obligations of the licence holder or any other person under this Act.ReplacementIf 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.2009, c. 24, s. 362026, c. 3, s. 423
Licence Holder Representative
DesignationAn applicant that is an organization must, before a licence may be issued, designate an individual as its representative for the requested licence.Powers, duties and functionsThe 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.Designation — effectA designation does not have the effect of limiting the obligations of the licence holder or any other person under this Act.ReplacementIf 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.2026, c. 3, s. 423
Exemptions
Non-applicationSubsection 7(1) and section 8 do not apply toan inspector or analyst carrying out their functions under this Act;a peace officer carrying out their functions under any federal or provincial Act or a person providing assistance to that peace officer;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; orin exigent circumstances, any person carrying out their functions under any federal or provincial Act.
Information
Provision of information to MinisterThe 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.InformationThe information that is to be provided may include informationregarding the human pathogens or toxins in the possession of the applicant, licence holder or biological safety officer;regarding the persons having access to the human pathogens or toxins referred to in paragraph (a);regarding the facility in which the controlled activities are authorized or in respect of which an application for a licence has been submitted;regarding the controlled activities that are authorized by a licence or in respect of which an application for a licence has been submitted;that is necessary to enable Canada to fulfil its international obligations; andthat is necessary to enable Canada to submit Confidence-Building Measures in connection with the Biological and Toxin Weapons Convention.Obligation to provide informationAn 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.Excluded informationDespite 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.2009, c. 24, s. 382026, c. 3, s. 424
Disclosure by MinisterThe 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 ifthe disclosure is necessary for the administration or enforcement of this Act or the regulations;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;the disclosure is necessary to enable Canada to fulfil its international obligations; orthe disclosure is necessary to enable Canada to submit Confidence-Building Measures in connection with the Biological and Toxin Weapons Convention.Maintain confidentiality of informationExcept 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.2009, c. 24, s. 392026, c. 3, s. 425
Administration and Enforcement
Designation of inspectorsThe 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.Certificate to be producedThe 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.
Definition of documentIn sections 40.2 and 41, document includes any report, book and electronic data and any other thing containing information.2026, c. 3, s. 426
Provision of documents, information or materialAn 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.Duty to provideA person who is ordered by an inspector to provide a document, information or material must do so in the manner specified by the inspector.2026, c. 3, s. 426
Entry by inspectorSubject 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 thatan activity to which this Act or the regulations applies is conducted;any material, equipment or document relevant to the administration of this Act or the regulations is located; oran activity could be conducted under a licence for which an application is under consideration by the Minister.Individual accompanying inspectorAn 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.Inspector’s powersAn inspector who enters a place or conveyance may, for the purpose referred to in subsection (1),examine the place — including any building — or conveyance and any material or equipment found there;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;seize and detain for any time that may be necessary any material, equipment or document found there, or any conveyance;open and examine any receptacle or package found there;take, or require any person in the place or conveyance to produce, free of charge, a sample of any material found there;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;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;take photographs or make recordings or sketches;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;require any person in the place or conveyance to produce any document found there for examination or reproduction; andexamine, reproduce or cause to be reproduced, in whole or in part, any document found there and remove any reproductions.[Repealed, 2026, c. 3, s. 427][Repealed, 2026, c. 3, s. 427]Remote accessFor 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.Limitation — remote accessAn 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).ConveyanceFor 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.Duty to complyAn owner or person who, under subsection (3), is ordered to stop or move a conveyance, must stop or move it.Excluded informationDespite 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.Assistance to inspectorThe 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.Prohibition — obstruction and false statementsA 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).Entering private propertyAn 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.2009, c. 24, s. 412026, c. 3, s. 427
Warrant to enter dwelling-houseAn inspector may not enter a dwelling-house without the occupant’s consent, except under the authority of a warrant issued under subsection (2).Authority to issue warrantOn 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 thatthe dwelling-house is a place referred to in subsection 41(1);entry to the dwelling-house is necessary for a purpose referred to in subsection 41(1); andentry to the dwelling-house has been refused or there are reasonable grounds for believing that entry will be refused.Use of forceIn 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.Means of telecommunicationAn 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.2009, c. 24, s. 422022, c. 17, s. 70
MeasuresIf 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.ObligationA 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.Withdrawal of orderAn 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.Review by MinisterAn 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.Application of order not suspendedThe referral of a decision to the Minister for review does not suspend the application of the decision.Refusal to complyIf 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.Informing of actionAfter 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.Compliance not requiredNo 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.CostA 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.2009, c. 24, s. 432026, c. 3, s. 428
Storage and removalAn 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.InterferenceExcept with the inspector’s authority, no person shall remove, alter or interfere in any way with the seized thing.
Return of seized thingAn 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.
Application for restorationOn 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.Order of restorationThe provincial court judge may order that the seized thing be restored immediately to the applicant if, on hearing the application, the judge is satisfied thatthe applicant is entitled to possession of it;it does not pose a serious and imminent danger to the health, safety or security of the public; andit will not be required as evidence in a prosecution for an offence that is subsequently instituted under this Act.Order of later restorationIf, 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 applicanton 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; oron the final conclusion of proceedings under this Act.ExceptionThe 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).2009, c. 24, s. 462026, c. 3, s. 429(E)
ForfeitureIf 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.Forfeiture with consentIf 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.DisposalSubject 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.2009, c. 24, s. 472026, c. 3, s. 430(E)
PreservationThe Minister shall make reasonable efforts to preserve any thing seized under this Act pending its disposition.
CostsThe 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.
Designation of analystThe Minister may designate any individual, or class of individuals, as an analyst for the administration and enforcement of this Act and the regulations.
Analysis and examinationAn inspector may submit to an analyst, for analysis or examination, any thing seized or taken by the inspector.Certificate or report of analystAn analyst who has made an analysis or examination may issue a certificate or report setting out the results of the analysis or examination.
AdmissibilityAn analyst’s certificate or report is admissible in evidence in any prosecution for an offence under this Act if itappears to be signed by the analyst;states that a thing has been analyzed or examined by the analyst; andstates 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.Attendance of analyst requiredThe 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.Notice of intention to produce certificate or reportNo 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
GeneralSubject to sections 54 to 58, every person who contravenes this Act or the regulations is guilty of an offence and liable,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;in all other cases,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, oron 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.2009, c. 24, s. 532026, c. 3, s. 432
Breach of dutyEvery 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.2009, c. 24, s. 542026, c. 3, s. 432
Wanton or reckless breach of dutyEvery 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.2009, c. 24, s. 552026, c. 3, s. 432
[Repealed, 2026, c. 3, s. 432]
Contravention of section 8 — knowinglyEvery 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.Contravention of section 8Every person who contravenes section 8 is guilty of an offence and liableon 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; oron 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.2009, c. 24, s. 572026, c. 3, s. 434
Intentional releaseEvery 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 imprisonmentfor life, if the result causes death or is likely to cause death to any individual;for a term of not more than 14 years, if the result creates a risk to the health, safety, or security of the public.2009, c. 24, s. 582026, c. 3, s. 435
DefenceNo 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 undersection 53, with respect to a contravention of subsection 7(1), section 17 and subsection 41(6);section 55;[Repealed, 2026, c. 3, s. 436]subsection 57(1); andsection 58.2009, c. 24, s. 592026, c. 3, s. 436
Place of trialA prosecution for an offence under this Act may be instituted, heard and determined in the place wherethe offence was committed or the subject matter of the prosecution arose;the accused was apprehended; orthe accused happens to be or is carrying on business.
Continuing offencesIf 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.2009, c. 24, s. 612026, c. 3, s. 437
Time limitSummary 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.Minister’s certificateA 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.2009, c. 24, s. 622026, c. 3, s. 438
Directors, officers and agents or mandatariesIf 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.2009, c. 24, s. 632026, c. 3, s. 439
Offences by employees or agents or mandatariesIn 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 thatthe offence was committed without the accused’s knowledge or consent; andthe accused exercised all due diligence to prevent its commission.2009, c. 24, s. 642026, c. 3, s. 440
Debts
Debts due to His MajestyThe following constitute debts due to His Majesty in right of Canada and may be recovered as such in any court of competent jurisdiction:an amount that a person is directed to pay under an order made by a court under this Act;the costs incurred in the seizure, storage, transfer, preservation or disposition under this Act of any human pathogen, toxin or other thing; andthe costs incurred in the carrying out of a measure under subsection 43(6).2009, c. 24, s. 652026, c. 3, s. 441(E)
Regulatory Powers
RegulationsThe Governor in Council may make regulations for carrying out the purposes of this Act, including regulationsdefining any term that is used but not defined in this Act;respecting the safety and security of activities to which this Act or the regulations made under it apply;respecting the conduct of controlled activities, including in relation tocontainment levels for human pathogens or toxins, andthe decontamination of material, equipment, places, conveyances and persons contaminated by human pathogens or toxins;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;respecting facilities in which controlled activities are authorized, includingthe location, design, construction, layout and upgrading of those facilities,the material and equipment at those facilities,heating, ventilation, air conditioning and air handling systems,biological safety cabinets, andsecurity requirements in relation to information technology;respecting access, including remote access by a means of telecommunication, to facilities in which controlled activities are authorized, includingthe conditions to be met by persons to obtain access to those facilities, andthe screening of persons accessing those facilities;prescribing the time when a document sent under this Act is to be considered to have been received;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;respecting security clearances required under section 33, includingthe conditions to be met by an applicant for a security clearance,the issuance of security clearances, as well as their suspension and revocation, andthe reconsideration of a decision to refuse, suspend or revoke a security clearance;respecting the accompaniment and supervision, within the part of a facility described in section 33, of persons who do not hold a security clearance;respecting the qualifications, powers, duties and functions of biological safety officers;specifying the powers, duties and functions of the representative for the purposes of subsection 36.1(2);respecting the establishment, content and maintenance of inventories of human pathogens and toxins, as well as the provision of reports on those inventories;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;respecting the provision of information to the Minister that is necessary for the administration of this Act and the regulations;respecting the collection, use and disclosure by the Minister of personal information and confidential business information;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; andprescribing any other matter that by this Act is to be prescribed.[Repealed, 2026, c. 3, s. 442]Levels of riskIn 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.DistinctionsA regulation may establish classes of persons, facilities, activities, human pathogens and toxins and distinguish among those classes.2009, c. 24, s. 662026, c. 3, s. 442
[Repealed, 2019, c. 29, s. 221]
[Repealed, 2019, c. 29, s. 221]
Interim ordersThe 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.DurationThe interim order has effect from the day on which it is made but ceases to have effect on the earliest of90 days after the day on which it is made, unless it is approved by the Governor in Council,the day on which it is repealed,the day on which a regulation made under section 66 that has the same effect as the interim order comes into force, andone year after the day on which it is made or any shorter period that it specifies.Exemption from Statutory Instruments ActAn interim order is exempt from the application of sections 3 and 9 of the Statutory Instruments Act.DeemingFor 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.Tabling of orderA copy of each interim order shall be tabled in each House of Parliament within 15 days after the day on which it is made.House not sittingIn order to comply with subsection (5), the interim order may be sent to the Clerk of the House if the House is not sitting.2009, c. 24, s. 672026, c. 3, s. 443
Incorporation by reference — limitation removedThe 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.Jointly produced documentsA 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.2009, c. 24, s. 682026, c. 3, s. 444
[Repealed, 2026, c. 3, s. 444]
Transitional Provisions
Activities already commencedEvery 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,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;advise the Minister of the location where the activity is conducted; anddesignate 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.Activities commencing before subsection 7(1) comes into forceEvery 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.Update of informationEvery 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.No effectSubsection (3) ceases to have effect on the day on which subsection 7(1) comes into force.
Possession of human pathogens or toxinsEvery person who, on the day on which section 8 comes into force, possesses a human pathogen or toxin listed in Schedule 5 shallinform the Minister of the human pathogen or toxin in their possession within 30 days after the day on which that section comes into force;provide the Minister with any information that the Minister may require with respect to it; anddispose of it in accordance with the Minister’s instructions.No contraventionNo 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
Order in councilSection 7, subsections 11(1) and 12(1), sections 13 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.]
(Subsection 3(1), section 8, subsections 9(4), 10(1) and 10(2) and paragraph 12(2)(b))Prohibited Human Pathogens and ToxinsToxinsHuman PathogensVariola virusVirus de la variole2009, c. 24, Sch.2026, c. 3, s. 445[Repealed, 2026, c. 3, s. 445][Repealed, 2026, c. 3, s. 445][Repealed, 2026, c. 3, s. 445][Repealed, 2026, c. 3, s. 445]RELATED PROVISIONS — 2022, c. 17, s. 76
Clarification — immediate applicationFor greater certainty, but subject to sections 77 and 78, the amendments made by this Act also apply with respect to proceedings that are ongoing on the day on which this Act comes into force.
 — 2022, c. 17, par. 77(2)(g)
Certain applications for warrantsEach of the following provisions, as it read immediately before the day on which this Act comes into force, continues to apply with respect to an application made for a warrant under the provision if the application is submitted, and no decision has been made in respect of the application, before that day:subsection 42(4) of the Human Pathogens and Toxins Act;
 — 2022, c. 17, s. 78.1
Impact of remote proceedingsThe Minister of Justice must, no later than three years after the day on which this Act receives royal assent, initiate one or more independent reviews on the use of remote proceedings in criminal justice matters that must include an assessment of whether remote proceedingsenhance, preserve or adversely affect access to justice;maintain fundamental principles of the administration of justice; andadequately address the rights and obligations of participants in the criminal justice system, including accused persons.ReportThe Minister of Justice must, no later than five years after the day on which a review is initiated, cause a report on the review — including any findings or recommendations resulting from it — to be laid before each House of Parliament.
 — 2022, c. 17, s. 78.2
Review by committeeAt the start of the fifth year after the day on which this Act receives royal assent, the provisions enacted or amended by this Act are to be referred to a committee of the Senate and a committee of the House of Commons that may be designated or established for the purpose of reviewing the provisions.ReportThe committees to which the provisions are referred are to review them and the use of remote proceedings in criminal justice matters and submit reports to the Houses of Parliament of which they are committees, including statements setting out any changes to the provisions that they recommend.
 — 2026, c. 3, s. 453
Words and expressionsThe words and expressions used in this section and sections 454 and 455 have the same meaning as in the Human Pathogens and Toxins Act.DutiesOn the day on which section 406 comes into force, any person who, under paragraph 7(2)(c) or (d) of the Human Pathogens or Toxins Act, conducts controlled activities that are not authorized by their licence, must, within 90 days after that day, either apply to the Minister to vary their licence to authorize those activities or stop conducting those activities.No contraventionA person referred to in subsection (2) does not contravene subsection 7(1) of the Human Pathogens or Toxins Act if they comply with subsection (2).
 — 2026, c. 3, s. 454
Licence holder representativeAfter the day on which section 423 comes into force, a licence holder that is an organization must, without delay, provide the Minister with the name of its representative.
 — 2026, c. 3, s. 455
Validity period — extensionThe validity period of a licence may be extended for a period of up to 60 days beginning on the day on which this Act receives royal assent ifthe validity period of the licence ends within 30 days after the day on which this Act receives royal assent; andon the day on which this Act receives royal assent, the licence holder, its representative, if any, or the biological safety officer designated for the licence do not meet the requirements referred to in subsection 18(1.1) of the Human Pathogen and Toxins Act.
AMENDMENTS NOT IN FORCE — 2026, c. 3, s. 402(3)
Subsection 3(1) of the Act is amended by adding the following in alphabetical order:foreign entity means a foreign economic entity, foreign entity, or foreign state as those terms are defined in subsection 2(1) of the Foreign Interference and Security of Information Act. (entité étrangère)terrorist group has the same meaning as in subsection 83.01(1) of the Criminal Code. (groupe terroriste)
 — 2026, c. 3, s. 409(4)
The portion of subsection 11(4) of the Act before paragraph (a) is replaced by the following:DefenceIf a human pathogen or toxin is listed in the registry, then no person may be convicted of an offence or subjected to an administrative monetary penalty — in relation to that human pathogen or toxin — for the contravention of any provision of this Act or the regulations unless it is proved that, at the time of the alleged contravention,
 — 2026, c. 3, s. 413
Section 15 of the Act is replaced by the following:
Other incidentsIf a licence holder has reasonable grounds to suspect that an incident meets all of the conditions below, the licence holder must inform the Minister of the incident and provide them, without delay, with the information related to the incident that the Minister requires that is under the licence holder’s control:the incident is not one referred to in subsection 12(1) or (2) or section 13 or 14;it involves human pathogens that fall into Risk Group 3 and are prescribed by regulation, human pathogens that fall into Risk Group 4 or toxins prescribed by regulation;it is specified in regulations.
Person conducting controlled activitiesIf 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, 14 or 14.1 has occurred, the person must, without delay, inform the licence holder.
 — 2026, c. 3, s. 414
Section 16 of the Act is replaced by the following:
Use of informationNo 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 the following proceedings that are subsequently instituted against them:proceedings in respect of a violation enforced by an administrative monetary penalty; orcriminal proceedings, 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.
 — 2026, c. 3, ss. 415(3), (8), (9)
Section 18 of the Act is amended by adding the following after subsection (2):InformationAn application for a licence to authorize controlled activities in relation to human pathogens that fall into Risk Group 3 and are prescribed by regulation, human pathogens that fall into Risk Group 4 or toxins that are prescribed by regulation must include the information prescribed by regulation and make reference, in accordance with the regulations, to the following:any contribution or other funding that originates from outside Canada that the applicant received or expects to receive in relation to their activities;if the applicant is an organization, any person or foreign entity that has or is seeking to have any direct or indirect ownership or influence over the organization that would result in control in fact of the organization; andif the applicant is an individual, any person or foreign entity that has or is seeking to have any direct or indirect influence over any activities of the applicant that are governed by this Act or the regulations.Subsection 18(5) of the Act is amended by adding the following after paragraph (d):a description of each part of the facility that is prescribed by the regulations made for the purposes of section 33.1;Section 18 of the Act is amended by adding the following after subsection (6):Obligation of the licence holder — informationIf a licence authorizes controlled activities in relation to human pathogens that fall into Risk Group 3 and are prescribed by regulation, human pathogens that fall into Risk Group 4 or toxins that are prescribed by regulation, the licence holder must provide the Minister with the information prescribed by regulation and inform them, in accordance with the regulations, of the following:any contribution or other funding that originates from outside Canada that the licence holder received or expects to receive in relation to their activities;if the licence holder is an organization, any person or foreign entity that has or is seeking to have any direct or indirect ownership or influence over the organization that would result in control in fact of the organization; andif the licence holder is an individual, any person or foreign entity that has or is seeking to have any direct or indirect influence over any activities of the licence holder that are governed by this Act or the regulations.
 — 2026, c. 3, s. 421
Section 33 of the Act is replaced by the following
Access to facilities — security clearanceAn individual must not enter — to conduct controlled activities — 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 in relation to toxins prescribed by regulation unless they hold a security clearance for that part of the facility.
Access — compliance with regulationsExcept in accordance with the regulations, any individual who does not conduct controlled activities authorized in relation to human pathogens that fall into Risk Group 3 or Risk Group 4 and are prescribed by regulation or in relation to toxins prescribed by regulation is prohibited fromentering a facility in which controlled activities are authorized in relation to those human pathogens or toxins;remotely accessing that facility by a means of telecommunication; oraccessing by any means, sensitive information, as defined by regulation, in relation to those human pathogens or toxins.Non-applicationParagraphs (1)(a) and (b) do not apply to an individual who holds a security clearance referred to in section 33 that authorizes entry to part of a facility referred to in paragraph (1)(a) 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 in relation to toxins prescribed by regulation.RestrictionMoreover, if an individual holds a security clearance that does not authorize them to enter certain parts of a facility referred to in paragraph (1)(a) 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 in relation to toxins prescribed by regulation, the individual may enter those parts or remotely access them by a means of telecommunication only if they do so in accordance with the regulations.
 — 2026, c. 3, s. 422
The Act is amended by adding the following after section 35:
Minister’s power — individualDespite sections 33 and 33.1, the Minister may, on any conditions that they consider appropriate, exempt any individual from the requirement to hold a security clearance under section 33 or to comply with the regulations referred to in section 33.1 if the Minister is of the opinion that the exemptionposes no undue risk to the health, safety or security of the public; andis warranted by reason of exigent circumstances related to the health, safety or security of the public.Duration of orderAn exemption ceases to have effect on the earliest of the following days:the day that is specified by the Minister in the exemption;the day on which the Minister revokes the exemption; orthe day that is one year after the day on which the exemption takes effect.Report and review by committeeWithin 30 days of exercising the power to exempt under subsection (1), the Minister must cause a report of the exercise, including the Minister’s reasons for granting the exemption, to be referred for review to the standing committee of each House of Parliament that normally considers matters related to national security.‍
 — 2026, c. 3, s. 431
The Act is amended by adding the following after section 52:Administrative Monetary PenaltiesViolations
Administrative monetary penaltiesEvery person who contravenes a provision designated under paragraph (12)(a) commits a violation and is liable to an administrative monetary penalty of not more than $50,000 in the case of an individual and $250,000 in the case of any other person.Purpose of penaltyThe purpose of the penalty is to promote compliance with the provisions of this Act or the regulations and not to punish.Minister’s powers — notice of violationThe Minister mayestablish the form of notices of violations;designate individuals, or classes of individuals, who are authorized to issue notices of violations; andestablish, in respect of each violation, a short-form description to be used in notices of violation.Notice of violationIf an individual designated under subsection (3) has reasonable grounds to believe that a person has committed a violation, the designated individual may issue a notice of violation and cause it to be served on the person. The notice of violation must include the information prescribed by regulation.Continuing violationA violation that is committed or continued on more than one day constitutes a separate violation in respect of each day on which it is committed or continued.LimitationProceedings in respect of a violation may be instituted no later than two years after the day on which the subject matter of the proceedings becomes known to the Minister.PublicationAfter proceedings in respect of a violation are ended, the Minister may make public the nature of the violation, the name of the person who committed it and the amount of the penalty imposed.Directors, officers and agents or mandatriesIf a person other than an individual commits a violation 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 violation is a party to the violation, whether or not the person is proceeded against under this Act or the regulations.Employees, agents or mandatariesIn a proceeding for a violation under this Act or the regulations, it is sufficient proof of the violation to establish that it was committed by the employee of the person named in the notice of violation, who is acting within the scope of their employment, or the agent or mandatary of the person named in the notice of violation, who is acting within the scope of their authority, whether or not the employee, agent or mandatary is identified or proceeded against for the violation, unless the person named in the violation establishes thatthe violation was committed without the persons’s knowledge or consent; andthe person exercised all due diligence to prevent its commission.Violation or offenceIf any act or omission can be proceeded with as a violation or as an offence, the Minister may commence proceedings in respect of that act or omission as a violation or recommend that it be proceeded with as an offence, but proceeding with it as a violation precludes proceeding with it as an offence, and proceeding with it as an offence precludes proceeding with it as a violation.Violation not offencesFor greater certainty, a violation is not an offence and, accordingly, section 126 of the Criminal Code does not apply in respect of a violation.RegulationsThe Governor in Council may make regulations respecting an administrative monetary penalties scheme, including regulationsdesignating any of the following as violations:non-compliance with the requirements in subsection 12(1), paragraph 12(2)(a) or section 13, 14, 14.1 or 15 that are in respect of notification or the provision of information, as the case may be,the contravention of subsection 18(2.1), (6) or (6.1),the contravention of subsection 18(7) in relation to any licence conditions that are in respect of notification and the provision of information,the contravention of section 30, 31 or 32,the contravention of the requirement in subsection 36(1) to designate an individual who holds the qualifications set out in regulations, as a biological safety officer,the contravention of subsection 36(3) in relation to any powers, duties and functions that are in respect of notification and the provision of information,the contravention of subsection 36(5) or 36.1(4),the contravention of subsection 38(3),the contravention of subsection 40.2(2), 41(3.1) or (5) or 44(2),the contravention of a provision of a regulation made under paragraph 66(1)(k), andnon-compliance with any other requirements that are in respect of notification and the provision of information that are prescribed by regulation;respecting the classification of each violation;respecting the information referred to in subsection (4);respecting the proceedings in respect of a violation; andrespecting the penalties, including in relation tothe determination of, or the method of determining the penalty applicable for each violation, andthe payment of the penalty imposed.Right to request reviewAny regulation made under any of paragraphs (12)(a) to (e) must provide that a person named in the notice of violation has the right to request a review of the decision that the person has committed a violation or of the penalty imposed, or both.
Penalties
PaymentIf the person named in the notice of violation pays, in the time and manner specified in the notice, the amount of the penalty set out in the notice,they are deemed to have committed the violation in respect of which the amount is paid;the Minister must accept that amount as complete satisfaction of the penalty in respect of the violation; andthe proceedings commenced in respect of the violation are ended.AlternativesInstead of paying the amount of the penalty set out in the notice, the person may, in the time and manner specified in the notice,if the amount of the penalty set out in the notice is $5,000 or more, request to enter into a compliance agreement with the Minister that ensures the person’s compliance with the provision to which the violation relates; orrequest a review by the Minister, in accordance with the regulations, of the decision that the person has committed a violation or of the penalty imposed, or both.
Compliance Agreements
Entering into compliance agreementsAfter considering a request by a person named in the notice of violation, the Minister may enter into a compliance agreement with that person on any terms and conditions that are satisfactory to the Minister. The terms and conditions mayinclude a provision for the deposit of reasonable security, in a form and amount satisfactory to the Minister, as a guarantee that the person will comply with the compliance agreement; andprovide for the reduction, in whole or in part, of the penalty for the violation.DeemingA person who enters into a compliance agreement with the Minister is, on doing so, deemed to have committed the violation in respect of which the compliance agreement was entered into.Notice of complianceA notice from the Minister that they are satisfied that a person who has entered into a compliance agreement has complied with it ends the proceedings commenced in respect of the violation. Any security given by the person under the compliance agreement must then be returned to the person.Notice of defaultIf the Minister is of the opinion that a person who has entered into a compliance agreement has not complied with it, the Minister must cause a notice of default to be provided to the person informing them thatinstead of being liable to pay the amount of the penalty set out in the compliance agreement, the person is liable to pay, in the time and manner specified in the notice of default, an amount that is twice the amount of the penalty set out in the notice of violation, and for greater certainty, subsection 52.1(1) does not apply in respect of that amount; orthe security is forfeited to His Majesty in right of Canada.Effect of notice of defaultOnce provided with the notice of default, the person may not deduct from the amount set out in the notice of default any amount they spent under the compliance agreement andthe person is liable to pay the amount set out in the notice of default in the time and manner specified in the notice of default; orif the notice provides for the forfeiture of the security given under the compliance agreement, that security is forfeited to His Majesty in right of Canada and the proceedings commenced in respect of the violation are ended.Effect of paymentIf the person pays the amount set out in the notice of default in the time and manner specified in the notice of default, the Minister must accept the amount as complete satisfaction of the amount owing in respect of the violation and the proceedings commenced in respect of the violation are ended.
Refusal to enter into compliance agreementIf the Minister refuses to enter into a compliance agreement is liable to pay, in the time and manner specified in the notice of violation, the amount of the penalty set out in the notice of violation.Effect of paymentIf a person pays the amount set out in the notice of violation in the specified time and manner,they are deemed to have committed the violation in respect of which the amount is paid;the Minister must accept the amount as complete satisfaction of the penalty in respect of the violation; andthe proceedings commenced in respect of the violation are ended.Default of paymentIf a person does not pay the amount set out in the notice of violation in the specified time and manner, they are deemed to have committed the violation identified in the notice of violation.
Rules About Violations
Due diligenceA person must not be found to be liable for a violation under this Act if they establish that they exercised due diligence to prevent its commission.Non-applicationDespite subsection (1), a person to whom the Minister causes a notice of default to be provided under subsection 52.3(4) does not have a defence by reason that the person exercised due diligence to comply with the compliance agreement.Common law principlesEvery rule and principle of the common law that renders any circumstance a justification or excuse in relation to a charge for an offence under this Act or the regulations applies in respect of a violation to the extent that it is not inconsistent with this Act and the regulations.
 — 2026, c. 3, s. 433
The Act is amended by adding the following after section 55:
Communicating sensitive informationEvery person who knowingly and without lawful authority communicates sensitive information as prescribed by regulation to a foreign entity or terrorist group is guilty of an indictable offence and liable to imprisonment for life.
 — 2026, c. 3, s. 436(3)
Section 59 of the Act is amended by adding the following after paragraph (b):section 56;
 — 2026, c. 3, s. 441(2)
Section 65 of the Act is amended by striking out “and” at the end of paragraph (b) and adding the following after paragraph (c):any administrative monetary penalty required to be paid under this Act;any amount that is required to be paid under a compliance agreement entered into under subsection 52.3(1);any amount set out in a notice referred to in paragraph 52.3(4)(a); andthe amount of any reasonable expenses incurred in attempting to recover an amount referred to in paragraph (d), (e) or (f).
 — 2026, c. 3, ss. 442(4), (6) to (9), (12) and (14)
Subsection 66(1) of the Act is amended by adding the following after paragraph (e):respecting incidents referred to in section 14.1;Paragraph 66(1)(f) of the Act is replaced by the following:specifying the human pathogen and toxins for the purposes of subparagraphs 7(2)(c)(i) and (iii) and (d)(i) and (iii), section 14.1, subsections 18(2.1) and (6.1) and sections 33 and 33.1;The portion of paragraph 66(1)(g) of the Act before subparagraph (i) is replaced by the following:respecting security clearances for the purposes of section 33 and regulations made under paragraph (g.1), includingSubsection 66(1) of the Act is amended by adding the following after paragraph (g):respecting, for the purposes of section 33.1, the conditions to be met, which could include requirements for a security clearance, toenter a facility in which controlled activities are authorized in relation to human pathogens or toxins that are referred to in paragraph 33.1(1)(a),remotely access a facility by a means of telecommunication, oraccess sensitive information referred to in paragraph 33.1(1)(c);respecting the management of any sensitive information;Paragraph 66(1)(h) of the Act is repealed.Subsection 66(1) of the Act is amended by adding the following after paragraph (i.1):respecting sensitive information for the purpose of section 56;Subsection 66(1) of the Act is amended by adding the following after paragraph (l):respecting information that is to be provided to the Minister under subsection 18(2.1) or (6.1);
2026, c. 32026-03-262022, c. 172023-01-142019, c. 292019-06-21