Incident Reporting Threshold Shift from “Reason to Believe” to “Reasonable Grounds to Suspect”

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Purpose

This guidance is intended to provide clarity regarding the new reporting threshold for notification requirements under the amended Human Pathogens and Toxins Act.

Additionally, the guidance provides important information to assist regulated parties including Licence Holders, Licence Holder Representatives, Biological Safety Officers, and persons conducting controlled activities with human pathogens or toxins under a Pathogen and Toxin licence with understanding:

  • What the new reporting threshold means under the Human Pathogens and Toxins Act
  • Which incidents must be reported
  • Factors to consider when assessing suspicion

Important: the following guidance is provided to assist regulated parties and is not a substitute for the Human Pathogens and Toxins Act; readers are recommended to consult the Human Pathogens and Toxins Act. In the event of any inconsistency between this guidance and the Human Pathogens and Toxins Act, the Human Pathogens and Toxins Act prevails. Examples are given for illustrative purposes only and do not guarantee a particular compliance and enforcement outcome.

Background

In 2026, the Human Pathogens and Toxins Act was amended to shift the reporting threshold for incidents from Reason to Believe to Reasonable Grounds to Suspect. The change reflects a proactive approach to risk management, emphasizing early detection and timely reporting of potential threats to public health, safety or security. This lower standard reduces uncertainty as to when reporting is required, particularly for incidents with ambiguous or developing consequences.

In accordance with sections 12 to 14 of the Human Pathogens and Toxins Act, Licence Holders and Licence Holder Representatives must inform the Minister without delay when they have reasonable grounds to suspect an incident with a human pathogen or toxin has occurred. Under section 15, individuals conducting controlled activities must inform the Licence Holder without delay when they have reasonable grounds to suspect the occurrence of any incident described in ss.12-14.

For clarity, this guidance refers to the version of section 15 that is currently in force; provisions related to section 14.1 and the amended version of section 15 associated with the administrative monetary penalties regime are not yet in force and are therefore not addressed in this document.

These reporting requirements generally apply to unexpected or unplanned incidents that can occur while conducting controlled activities authorized under a Pathogen and Toxin Licence, and are distinct from routine diagnostic activities conducted within the scope of a licence when those activities proceed as intended and do not result in an exposure, inadvertent production, release, or loss of a human pathogen or toxin. However, diagnostic activities are a common contact in which reporting obligations may arise, for example where exposure occurs or where a human pathogen or toxin is inadvertently produced and is not authorized under the licence, engaging subsection 12(2). This distinction will be explained in more detail below.

The shift from notifications based on the Reason to Believe threshold to the Reasonable Grounds to Suspect threshold strengthens the clarity and effectiveness of the incident‑reporting requirements under the Human Pathogens and Toxins Act, reducing ambiguity about when regulated parties must notify the Minister. Reasonable Grounds to Suspect requires a credible, fact‑based possibility that an incident may have occurred. It does not require the higher standard of probability required by “reason to believe,” but it must still be grounded in objective information rather than mere speculation. The Reasonable Grounds to Suspect threshold is better suited to the practical reality of how incidents typically present in laboratory and operational environments, wherein early signs or preliminary information may be available well before definitive evidence. This timely and informed risk management approach achieves a balance between reporting obligations and ensuring the health, safety and security of the public by keeping the Minister apprised of a subset of suspected incidents proportionate to their risk.

Note that incidents involving Risk Group 4 pathogens, Risk Group 3 Security Sensitive Biological Agents and prescribed toxins (which carry the greatest risk to public health, safety and security) warrant heightened attention, including well defined internal response and communication processes.

What Changed

Previous threshold (Reason to Believe)
Reporting was triggered when objective facts suggested that it was probable an incident had or may have occurred. This belief was supported by compelling and/or credible information.

New threshold (Reasonable Grounds to Suspect)
Reporting is triggered when there are objective indicators suggesting the possibility an incident has or may have occurred, even if information is incomplete or still developing
This new standard does not require verification or confirmation of the incident before reporting.

Scope

If there are reasonable grounds to suspect that the following incidents occurred, notification to the Minister (ss.12-14) or internal notification to the Licence Holder (s.15) is required:

  • Human Pathogens and Toxins Act Section 12:
    • 12(1) an inadvertent release of a human pathogen or toxin from a facility that occurs in the course of a controlled activity.
    • 12(2) unintentional possession in contravention of subsection 7(1) or 8 as a result of the inadvertent production of a human pathogen or toxin in the course of an activity that is otherwise lawful due to unplanned, unexpected, or accidental production of a human pathogen or toxin, in the course of an activity that is otherwise lawful.
    • Clarification (diagnostic activities): Routine diagnostic isolation or identification performed deliberately and within the scope of the Pathogen and Toxin Licence is not, on its own, considered “inadvertent production” for the purpose of subsection 12(2). However, the isolation or identification of a human pathogen or toxin that is not authorized under the licence, including during routine diagnostic activities, constitutes inadvertent production for the purposes of subsection 12(2). Diagnostic laboratories are therefore a common context in which subsection12(2) obligations arise. Confirmation testing is not required before internal notification under section 15 or reporting under subsection 12(2) once reasonable ground to suspect are met.
  • Human Pathogens and Toxins Act Section 13:
    • Any incident involving a human pathogen or toxin in the Licence Holder’s possession that has caused or may cause disease in an individual. This includes incidents where there are reasonable grounds to suspect an exposure that is capable of resulting in disease, even if disease has not yet manifested.
    • For the purpose of section 13, “disease” is interpreted broadly under the Reasonable Grounds to Suspect threshold. Notification is required where objective information supports a credible possibility that an incident has caused disease or may cause disease, including through suspected exposure compatible with the characteristics and mode of transmission of the human pathogen or toxin involved, and the circumstances of exposure. Diagnostic confirmation of disease in the individual or confirmatory identification of the human pathogen or toxin is not required prior to notification.
  • Human Pathogens and Toxins Act Section 14:
    • Any missing, stolen, or lost human pathogen or toxin
  • Human Pathogens and Toxins Act section 14.1: Other incidents
    • This section is not yet in force and requires regulations to be developed and implemented. This section will require reporting of other incidents (delayed coming into force dependent upon regulations). Until it takes effect, reporting obligations apply only to ss. 12–14. Other incidents may be reported voluntarily.
  • Human Pathogens and Toxins Act Section 15: Mandatory Internal notification requirement
    • Individuals conducting controlled activities must notify the Licence Holder without delay when they have reasonable grounds to suspect the occurrence of any of the incidents described in ss.12-14.

Key Concepts

If you are unsure whether an incident meets the Reasonable Grounds to Suspect threshold after considering the available objective information, reporting is encouraged. It is better to report than to risk non-compliance with a reporting obligation.

Mandatory reporting to the Minister

Incidents that meet the Reasonable Grounds to Suspect threshold under Sections 12–14 of the Human Pathogens and Toxins Act. These involve objective indicators suggesting that an inadvertent release or production, suspected infection/intoxication, or a missing/stolen/lost human pathogen or toxin may have occurred.

Mandatory internal notification to the Licence Holder

Under section 15, individuals conducting controlled activities must notify the Licence Holder without delay when they have reasonable grounds to suspect any incident described in ss.12–14 has occurred.

Without delay

As soon as there is sufficient, objective information to form reasonable grounds to suspect an incident, the obligation to report applies immediately. Confirmation of infection or intoxication is not required prior to reporting, as there need only be reasonable grounds to suspect disease as a possible outcome.

Examples

Table 1: Examples of scenarios and whether they trigger the reporting requirement

Scenario

Reportable under Reasonable Grounds to Suspect?

Rationale

Respirator failure during work with a human pathogen that poses a known risk of inhalation based disease in human.

Yes
  • this is an example of a reportable incident under s. 13.
  • there is objective evidence of a control failure
  • the pathogen poses a known risk of inhalation‑based disease in a human
  • there is a credible possibility that an exposure which can cause a disease has occurred
  • verification of actual disease or symptoms not required before reporting

 

Needle stick with influenza virus

Yes
  • this is an example of a reportable incident under s. 13.
  • a needle stick is a verifiable, objective event, not subjective
  • Influenza is a human pathogen capable of causing disease in a human

 

A biosafety cabinet briefly alarms and resets, but airflow readings return to normal and no aerosol‑generating step was underway.

No
  • airflow returned to normal
  • no aerosol‑generating procedure was underway
  • workers remained within containment
  • no visible spill, splash, or breach
  • no evidence of missing or mishandled material
  • No plausible inhalation exposure pathway

 

Compliance and Enforcement

Reporting under the Human Pathogens and Toxins Act is intended to support biosafety and biosecurity oversight. Licence holders, Licence Holder Representatives, Biological Safety Officers, and all persons conducting controlled activities under the authority of a licence are responsible for reporting incidents, either to the Minister or the Licence Holder, as the case may be, that meet the Reasonable Grounds to Suspect threshold without delay.

Failing to report incidents that meet the requirements under sections 12-14, and failing to meet internal notification obligations under section 15, are offences under the Human Pathogens and Toxins Act and may result in compliance or enforcement actions. The Public Health Agency of Canada may take measures such as:

  • Issuing a Notice of Non-Compliance, which becomes part of your facility’s compliance record.
  • Varying the terms and conditions of a Pathogen and Toxin Licence to address compliance concerns.
  • Suspending or revoking a Pathogen and Toxin Licence in cases of significant risk or repeated non-compliance.
  • Seize and detain, as authorized under the Human Pathogens and Toxins Act.
  • Referring the matter for possible criminal prosecution under the Human Pathogens and Toxins Act.

Regulated parties remain responsible for implementing corrective actions and ensuring compliance with all requirements under the Human Pathogens and Toxins Act and Human Pathogens and Toxins Regulations.

Reporting an Incident

How to Report

Use your organization’s designated reporting process and prepare your submission online using either the Biosecurity Portal or a Biosecurity Incident Notification Report Form, depending on the nature of the incident.

Each relevant provision specifies the information that is required to be included in the submission, please refer to the Act to ensure all the correct information is submitted. Some examples of information include:

  • a description of the incident.
  • the name of the pathogen or toxin (if known).
  • any other information relating to the incident that the Minister may require.

Follow-Up Reporting

You may be asked to provide additional details or to conduct further analysis to identify the root-cause of an incident.

Challenges and Risk Mitigation

If uncertain, seek guidance

Reports should be based on objective indicators, not speculation alone. However, if you are uncertain whether the Reasonable Grounds to Suspect threshold applies, contact the Centre for Biosecurity at biosafety.biosecurity@phac-aspc.gc.ca for guidance.

Avoid Under-Reporting

Do not dismiss early signs of an incident. If you decide the Reasonable Grounds to Suspect threshold does not apply, record your observations and reasoning. Clear documentation helps demonstrate compliance and supports transparency during inspections or document reviews.

Avoid Bias

Reports must be factual, objective and free from personal assumptions or opinions.

Next Steps for Licence Holders

  • Review internal incident reporting procedures to align with the Reasonable Grounds to Suspect threshold
  • Train staff on identifying and documenting objective indicators that support Reasonable Grounds to Suspect suspicion
  • Contact the Public Health Agency of Canada at biosafety.biosecurite@phac-aspc.gc.ca or 1-613-957-1779 for support.

Effective Date

This guidance is effective immediately upon Royal Assent of the amended Human Pathogens and Toxins Act on March 26, 2026.