Compliance and Enforcement Policy

8. Response to Non-Compliance

Where non-compliance has been identified, the primary objective is to have the responsible enterprise bring the product or process into compliance.

The Branch will consider all enforcement options to determine the appropriate action in response to non-compliance. In determining the nature and strength of enforcement action to be taken in response to non-compliance, the various circumstances of the case will be taken into account including the following:

• the risk to health and safety,
• the likelihood that the same problem will reoccur,
• the compliance history of the enterprise,
• whether the enterprise acted with indifference or premeditation,
• the degree of cooperation offered by the enterprise,
• Branch and Programme priorities and available resources,
• the chances of success of the enforcement action being contemplated, and
• the need to maintain public confidence.

8.1 Enterprise Response

Where non-compliance is brought to the attention of an enterprise by the Branch or otherwise, it is the enterprise's responsibility to take timely and appropriate action to comply with legislative requirements.

8.1.1 Voluntary Disposals

A voluntary disposal is a decision by an enterprise to destroy a non-compliant product. In considering whether to seek a voluntary disposal, Programmes shall consider the following factors:

• the degree of cooperation offered by an enterprise on prior occasions,
• that the product will be rendered non saleable/usable,
• that the disposal can be monitored, and
• compliance with environmental legislation.

8.1.2 Voluntary Detention

A voluntary detention is an agreement between an enterprise and a Programme to maintain control of a particular product. While some legislation provides authority for product seizure or detention, a voluntary detention may be appropriate if the Programme is confident that the enterprise will comply with the conditions of the agreement.

The Branch may negotiate a voluntary detention to maintain the identity of a non-compliant product while waiting for a health hazard evaluation or while the enterprise is determining an appropriate course of action (i.e., disposal, reconditioning, return to manufacturer).

The Branch will monitor the effectiveness of a detention and may take other enforcement actions as appropriate.

8.1.3 Recalls

A recall is an action by an enterprise to correct or to remove from the market a non-compliant product that may represent a risk to health or safety. In some instances, the Branch may ask an enterprise to initiate the recall of a non-compliant product but the enterprise is responsible for implementing the recall.

Programmes shall monitor the effectiveness of an enterprise's recall. Where an enterprise refuses to recall a product or the recall is deemed to be inadequate, the Branch may take other action as appropriate, particularly where there may be a significant risk to health and safety.

8.2 Government Responses

The Branch may use any of the enforcement options to achieve compliance. The objective is to achieve compliance using the most appropriate level of intervention.

When discussing non-compliance with an enterprise, Programmes shall explain what is necessary to achieve compliance. Except for specific legislative requirements, Programmes shall not dictate how compliance is to be achieved. It is the responsibility of the enterprise to identify and implement action to ensure compliance.

Other agencies such as the RCMP, Canada Customs and Revenue Agency and other law enforcement agencies assist the Branch in its compliance and enforcement activities.

8.2.1 Negotiated Compliance

When a Programme informs an enterprise of non-compliance of which the enterprise was not aware, and the enterprise is willing to comply with the requirement, the Programme shall negotiate with the enterprise to establish an appropriate timeframe for achieving compliance based on the following factors:

• the risk to health and safety,
• the compliance history of the enterprise, and
• the chances of success.

8.2.2 Warnings

Programmes may issue a warning to an enterprise when it is believed that non-compliance has occurred, or is continuing, and the risk to human health or safety does not warrant stronger enforcement action. Programmes shall consider the compliance history of the enterprise and any efforts to achieve compliance. Where a warning is ignored or disregarded, the Programme may escalate its enforcement activities.

8.2.3 Import Refusal

Programmes may recommend to customs officers that a product be refused entry into Canada on the basis of non-compliance with legislative requirements.

8.2.4 Public Alerts

When there is an imminent health hazard, and the product is present in the market place or the workplace, the Branch may inform the population at risk by means of a public alert.

8.2.5 Customs Alerts

When it is suspected that non-complying products might be imported, Programmes may issue an alert to regional offices of the Canada Customs and Revenue Agency.

8.2.6 Seizures

Administrative seizures or detentions are an immediate and effective enforcement tool for controlling non-compliance. Programmes may take control of non-compliant items (e.g., products or equipment, or a suspected carrier of an infectious or contagious disease or infestation) under the authority for administrative seizure or detention provided in the applicable legislation. When determining whether to implement an administrative seizure, Programmes shall consider the risk to health and safety as well as the reliability and compliance history of the enterprise.

Evidentiary seizures are used to gather evidence for prosecutions. Programmes may seize non-compliant items under the authority of a search warrant obtained pursuant to sections 487 or 489 of the Criminal Code as evidence.

8.2.7 Ticketing

The Contraventions Act deals with contraventions of federal legislation and provides a procedure for the prosecution of regulatory offences where ticketing and fines are administered as a penalty for an offence. Ticketing has been adopted in conjunction with Part VI - Offences and Punishment of the Tobacco Act.

8.2.8 Prosecutions

A prosecution is a legal proceeding in which the courts determine whether non-compliance contravenes the applicable legislation and, if so, the appropriate penalty. The Branch will consider laying charges if non-compliance:

• creates a significant health or safety risk;
• is continuing in nature;
• was premeditated, indifferent, reckless or a marked departure from a reasonable standard of care; or if
• other enforcement activities have proven unsuccessful.

Prosecutions may be undertaken in conjunction with other enforcement measures, such as seizures, recalls or public announcements, if the circumstances warrant it.

8.2.9 Injunction

An injunction is a judicial order prohibiting specific activities. The Branch will consider seeking any injunction where there is a significant and continuing situation of non-compliance, in particular, where an enterprise continues to be non compliant after a conviction by the court.

9. Complaint Resolution

Where an enterprise believes that Branch activity is not consistent with this policy, the enterprise should bring their concerns to the attention of nearest Regional Director of Health Canada.

10. Information on Compliance and Enforcement Activities

The Branch may make information on compliance and enforcement activities available, subject to the provisions of the Access To Information Act and the Privacy Act.