Compliance and Enforcement Policy
Table of Contents
- Policy Objectives
- Guiding Principles
- Compliance Monitoring Activities
- Response to Non-Compliance
- 8.1. Enterprise Response
- 8.1.1. Voluntary Disposals
- 8.1.2. Voluntary Detention
- 8.1.3. Recalls
- 8.2. Government Responses
- 8.2.1. Negotiated Compliance
- 8.2.2. Warnings
- 8.2.3. Import Refusal
- 8.2.4. Public Alerts
- 8.2.5. Custom Alerts
- 8.2.6. Seizures
- 8.2.7. Ticketing
- 8.2.8. Prosecutions
- 8.2.9. Injunction
- 8.1. Enterprise Response
- Complaint Resolution
- Information on Compliance and Enforcement Activities
The mission of the Healthy Environments and Consumer Safety Branch is to help the people of Canada maintain and improve their health by promoting healthy living, working and recreational environments, and by reducing the harm caused by, controlled substances, environmental contaminants, tobacco and unsafe consumer and industrial products.
The Branch focuses on these goals by promoting healthy behaviours, developing and applying harm reduction and prevention methods, and enforcing health protection legislation. The Branch enforces legislation through its Programmes and through the Regional Offices of Health Canada.
This policy lists the legislation administered by the Branch, provides the compliance and enforcement objectives, sets out responsibilities and describes the range of responses to non-compliance that the Branch will use to secure adherence to legislative requirements.
Programmes may develop policies and procedures that address specific needs provided that such policies are consistent with the principles and requirements of this policy.
The responsibility for the administration of relevant legislation rests with the Minister of Health but is delegated and discharged on a day-to-day basis by the Branch. This policy applies to the compliance and enforcement of the provisions of the acts and regulations administered by the Branch. Essentially, the policy applies to those products and activities that are subject to the applicable legislation and to those persons or enterprises that market such products or are involved in such activities in Canada. Detailed requirements are set out in following acts and their associated regulations:
Food and Drugs Act
The Branch is responsible for administering the Cosmetics Regulations under the Food and Drugs Act.
Controlled Drugs and Substances Act
Governs the importing, exporting, producing, possession, trafficking, sale, provision and prescription of controlled drugs and substances in an effort to minimize the abuse and diversion of these drugs and substances while enabling legitimate scientific and industrial use.
Radiation Emitting Devices Act
Governs the sale, lease and importation of radiation emitting devices.
Hazardous Products Act
Governs the importation, sale or advertising of products, materials and substances which may be hazardous to consumers or in the workplace.
Governs the manufacturing, sale, labelling and promotion of tobacco products with the purpose of protecting young persons from inducement to use tobacco products and of restricting access to tobacco products.
Governs the advertising of drugs and cosmetics.
3. Policy Objectives
To help the people of Canada maintain and enhance their health and safety through the fair and consistent application of legislation.
To obtain and maintain compliance using the most effective means while ensuring a fair, consistent and transparent approach.
To communicate Programme responsibilities and authorities concerning enforcement.
4. Guiding Principles
The Branch's compliance and enforcement activities will be in accordance with:
- The Department's Decision Making Framework, taking into consideration the risk to health and safety, enterprise compliance history, departmental priorities and available resources;
- The principles of fairness, equity and transparency;
- The powers set out in the relevant legislation that governs the non-compliance;
- National consistency in the methods and approach of enforcement, to the maximum extent possible; and
- Will be carried out by authorized and qualified personnel, professionally, in an unbiased and unprejudiced manner.
The maintenance and enhancement of health and safety is a responsibility that is shared among manufacturers, importers, distributors, retailers, health professionals, consumers, workers, travellers and government agencies.
Enterprises have primary responsibility for the safety of any product they manufacture, import or distribute to the Canadian public or use in a manufacturing environment. Enterprises must comply with legislative requirements.
The public has a responsibility for the maintenance of their health and the safe use of marketed products. Consumers and workers should use products according to the manufacturer's instructions. In addition, consumers are asked to inform the Branch through the nearest regional office of Health Canada of any health and safety related problems that they encounter with consumer products, cosmetics, controlled drugs and substances, radiation emitting devices and tobacco.
Programmes have a responsibility to monitor compliance and enforce the legislation they administer. To facilitate Programmes in their monitoring and enforcement activities, analysts and inspectors are designated under specific legislation. The primary role of the analyst is to assist in compliance and enforcement activities by analyzing samples. The primary role of the inspector is to monitor compliance and to enforce the relevant legislative requirements.
- The Healthy Environments and Consumer Safety Branch, Health Canada. The word Branch is also used to refer to the collective of Programmes that comprise the Branch.
- The state of conformity of a regulated enterprise, individual or other legal entity, product or substance with a legislative requirement or voluntary agreement.
- A range of actions that may be taken to induce, encourage or compel observance of a legislative requirement.
- A proprietorship, partnership, company, individual or other legal entity involved in a business, commercial activity or other activity that is subject to legislation. An enterprise can be involved in one or more business functions such as manufacturing, importing, wholesaling, and retailing.
- A general term encompassing both acts of parliament and regulations. The legally binding rules that governments use to place requirements on enterprises, citizens and government itself.
- A Branch subdivision.
- As defined in the Statutory Instruments Act, any document this is expressly authorized under an act of Parliament and that lays down rules of conduct, has binding legal effect, and is of general application.
7. Compliance Monitoring Activities
7.1 Education and Information
Compliance is facilitated if the legislative requirements are clearly identified and accessible. These requirements may include health and safety standards, Good Manufacturing Practices and other safety specifications. Branch Programmes shall encourage industry and other stakeholders to fully participate in the development of health and safety standards.
Programmes shall make information available and encourage compliance through education. They shall also continue to provide information to the public and encourage their participation in maintaining their health and the safety.
7.2 Voluntary Compliance Programs
Programmes may negotiate formal and informal commitments with industry associations or enterprises as an alternative or a supplement to regulations.
7.3 Inspection, Sampling, Analysis and Audits
Programmes may monitor compliance through audits, product and process inspections and product sampling and analyses.
When notified of a potential problem, Programmes will take steps to determine whether non-compliance has occurred. Problems may be identified through complaints, referrals from other agencies or governments, or a Programme's compliance monitoring system.
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.
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.
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.
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.
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.
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.
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.
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