Public Health Agency of Canada Regulatory Compliance and Enforcement Framework 

On this page

• Purpose
• General responsibilities of the Public Health Agency of Canada as a regulator
• Decision factors
• Public Health Agency of Canada's compliance and enforcement actions
• General responsibilities of regulated parties
• Enquiries

Purpose

This Framework:

• Explains the objectives and guiding principles of the Public Health Agency of Canada's (PHAC) regulatory compliance and enforcement activities within the scope of its areas of regulatory oversight, including biosecurity, migrant and traveller health screening, and the inspection of conveyances; and,
• Outlines PHAC's approach, principles and decision factors common to its compliance and enforcement activities.

This Framework builds on, and is informed by the Treasury Board Policy on Regulatory Transparency and Accountability, the Cabinet Directive on Regulation, PHAC's Policy on Providing Guidance on Regulatory Requirements, and PHAC's Regulatory Openness and Transparency Framework.

General responsibilities of the Public Health Agency of Canada as a regulator

PHAC is responsible for administering Acts and Regulations to promote and protect the health, safety and security of Canadians, and to conduct inspections and other compliance monitoring, verification and enforcement activities that follow applicable laws, regulations, policies, standards and guidance documents. PHAC staff have various roles and responsibilities, including trained and designated officers and inspectors, such as screening officers, biosafety inspectors, environmental health officers, and quarantine officers. More information is available on the acts and regulations PHAC administers.

PHAC engages with regulated parties, stakeholders, the public and other groups to raise awareness and enhance understanding of regulatory requirements, including the consequences associated with non-compliance. PHAC undertakes a range of compliance and enforcement actions, with an emphasis on early risk- and evidence-based interventions to proactively promote compliance, prevent non-compliance, and maintain compliance with the law. Where contraventions of legislation and/or regulation are identified, PHAC will undertake meaningful and appropriate compliance and enforcement actions in alignment with the guiding principles, decision factors and activities described below.

Decision factors

PHAC considers several decision factors in addition to the guiding principles to select the most appropriate compliance and enforcement action to support compliance and address non-compliance. These include:

• Risk-level of regulated activity: To determine the level of existing and potential risks, PHAC uses a risk-based approach and relies on an evaluation of many risk indicators, including the risk of existing and/or potential danger or harm. Risk analysis also considers the seriousness of harm or potential harm related to non-compliance. Activities of higher risk may face stronger enforcement actions to encourage correction and return to compliance without delay.
• Health impact: PHAC considers the potential and real consequences of the activity specifically on the health and safety of the people of Canada, including impacts on health care systems.
• Compliance history of the regulated party: PHAC reviews the compliance history of the regulated party, such as previous instances of non-compliance, previous efforts to achieve compliance and previous levels of cooperation with PHAC and other relevant regulators.
• Behaviour of the regulated party: PHAC considers the conduct and intentions of the regulated party with respect to the compliance issue, such as the deliberate or willful nature of an activity, as well as their willingness to comply with the law and cooperate with officials.

Public Health Agency of Canada's compliance and enforcement actions

Compliance promotion

Compliance promotion focusses on helping regulated parties be aware of, access, understand and comply with Acts and Regulations to avoid non-compliance, to minimize risks related to non-compliance, and/or to support a return to compliance. As part of compliance promotion, PHAC works to raise awareness and provide guidance, including:

• Providing regulatory and public health information and advice by developing and offering education, guidance and information to regulated parties, other stakeholders and the public to raise awareness and empower the people of Canada to improve their health, to prevent the introduction and spread of infectious disease and to protect the health and safety of the public against the risks posed by human pathogens and toxins; and,
• Developing standards, guidelines and other communications materials.

Compliance monitoring

Compliance monitoring focusses on verifying and maintaining compliance and identifying issues of non-compliance with the law. This is done through regularly scheduled and risk-based monitoring activities, as well as responding to enquiries and complaints. While engaged in monitoring activities, officials may also undertake promotion and verification activities, such as sharing information to support ongoing compliance or following-up on a matter of non-compliance. Compliance monitoring includes:

Screening

• Carrying out interviews and other assessments of regulated parties (e.g., travellers, conveyance operators, facility licence holders) to evaluate compliance with acts and regulations.

Reviewing documentation

• Recording, gathering, obtaining and/or analyzing information related to regulated parties and their activities.

Inspecting

• Carrying out inspections and identifying follow-up actions; and,
• Sampling and analysis to evaluate compliance and identify risks.

Enforcement

Enforcement focusses on preventing future non-compliance, stopping non-compliance, returning regulated parties to compliance, and/or imposing penalties on the regulated party for non-compliance.

Administrative enforcement actions

Administrative actions consist of notifications to regulated parties and control measures imposed on regulated parties. Notifications provide information to regulated parties to support a return to compliance and may include warning letters and notices of non-compliance.

PHAC may also impose control measures, such as: suspending, revoking or refusing to issue or renew a licence/certificate, restricting the conditions and/or terms of a licence/certificate, as well as refusing, suspending or revoking security clearance.

Control measures also include the issuance of orders, seizure of items, detention of individuals or items, and requiring the quarantine or isolation of travellers.

Penal

Penal enforcement will be considered in situations where other types of enforcement measures have proven ineffective or when contraventions pose a greater risk. Penal enforcement generally consists of two activities: investigation and prosecution.

Investigations involve the gathering of information and evidence relevant to suspected non-compliance to build a case that an offence has been committed and apply appropriate penalties under the law. When non-compliance has been identified, to which prosecution is an appropriate response, the official (may be an inspector, officer or a peace officer) will conduct an investigation to gather relevant and admissible evidence of the suspected offence.

PHAC makes recommendations for prosecution to the Public Prosecution Service of Canada (PPSC), which makes the final decision to prosecute or not based on a review of the evidence provided by the investigator. In some cases, PHAC may work directly with provincial/territorial prosecution authorities, such as the Directeur des poursuites criminelles et pénales in Quebec. The decision to prosecute will be made in consideration of specific criteria, including if there is a reasonable prospect of conviction, and if proceeding is in the public's interest.

General responsibilities of regulated parties

Regulated parties, (including travellers, conveyance operators and licenced facilities), are responsible for understanding their legal obligations, and proactively seeking to comply with all applicable statutory and regulatory requirements and respect the health, safety and security of the public. Specific requirements and responsibilities for regulated parties can be found within the respective Acts and Regulations and in associated authorization documents (e.g., licenses, permits). PHAC may also issue guidance documents to assist regulated parties in conducting their activities in compliance with the law.

During interactions with PHAC officials, a regulated party is required to provide all reasonable assistance and information necessary for the officer to perform their duties, including responding truthfully to questions and producing requested documentation. Wilfully or knowingly obstructing or hindering an officer who is carrying out their duties is an offence and may result in enforcement actions.

Enquiries

Responsibility for this Framework rests with PHAC.

Contact the Public Health Agency of Canada

Related links

• Public health data
• Border and travel health
• Biosafety and biosecurity
• Public health reference tool for cruise ship operators
• Health Canada on regulatory transparency and openness
• Canadian Food Inspection Agency on regulatory transparency and openness