Compliance and Enforcement Policy

4. Guiding Principles

The Branch's compliance and enforcement activities will be in accordance with:

1. The Department's Decision Making Framework, taking into consideration the risk to health and safety, enterprise compliance history, departmental priorities and available resources;
2. The principles of fairness, equity and transparency;
3. The powers set out in the relevant legislation that governs the non-compliance;
4. National consistency in the methods and approach of enforcement, to the maximum extent possible; and
5. Will be carried out by authorized and qualified personnel, professionally, in an unbiased and unprejudiced manner.

5. Responsibilities

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.

6. Definitions

Branch

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.

Compliance

The state of conformity of a regulated enterprise, individual or other legal entity, product or substance with a legislative requirement or voluntary agreement.

Enforcement

A range of actions that may be taken to induce, encourage or compel observance of a legislative requirement.

Enterprise

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.

Legislation

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.

Programme

A Branch subdivision.

Regulation

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.

7.4 Investigations

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.