Compliance and enforcement policy for workplace hazardous products

Table of contents

• Disclaimer
• Introduction
• Purpose
• Scope
• Guiding principles
  • Primacy of occupational health and safety
  • Accountability
  • Fairness, consistency and impartiality
  • Transparency
  • Targeted and outcomes focused
  • Evidence based
• Roles and responsibilities
  • Health Canada
  • FPT OHS agencies
  • Regulated parties
• Compliance and enforcement activities
  • Compliance promotion
  • Compliance monitoring
  • Enforcement
    • Voluntary compliance measures
    • Measures initiated by Health Canada
    • Other enforcement responses: prosecution
• Glossary
  • Acronyms
  • Terms
• Contact us

Disclaimer

This policy does not constitute part of the Hazardous Products Act (HPA), the Hazardous Products Regulations (HPR), the Hazardous Materials Information Review Act (HMIRA), or the Hazardous Materials Information Review Regulations (HMIRR). In the event of any inconsistency or conflict between the HPA, the HPR, the HMIRA or the HMIRR and this policy, the HPA, the HPR, the HMIRA or the HMIRR take precedence.

This policy is an administrative guide that is intended to facilitate compliance by the regulated party with the HPA, the HPR, the HMIRA, the HMIRR and the applicable administrative policies. This policy is not intended to provide legal advice regarding the interpretation or application of the HPA, the HPR, the HMIRA or the HMIRR.

If a regulated party has questions about legal obligations or responsibilities under the HPA, the HPR, the HMIRA or the HMIRR, they should seek their own legal advice.

Introduction

The Workplace Hazardous Materials Information System (WHMIS) is Canada's national hazard communication standard for hazardous chemicals used in the workplace. The objective of this national program is to help protect workers in Canada from any adverse effects of hazardous products by providing relevant health and safety information. WHMIS is implemented through coordinated and interlocking federal, provincial and territorial (FPT) legislation, which ensures a consistent national system of hazard communication for all workers in Canada.

At the federal level, the HPA and the HPR regulate the sale and importation of hazardous products in Canada. The HPA and the HPR require suppliers of hazardous products to determine the appropriate classification of these products and communicate related hazard information through labels and safety data sheets (SDSs) when selling or importing these products intended for workplace use, handling or storage.

Health Canada administers the HPA and the HPR. Health Canada collaborates with FPT occupational health and safety (OHS) agencies to carry out compliance and enforcement activities to support the objectives of the HPA.

Health Canada also administers the HMIRA and the HMIRR. The HMIRA and the HMIRR allow for the protection of confidential business information (CBI) that would otherwise be required to be disclosed under the HPA (or the Canada Labour Code or the Accord Act).

Purpose

The purpose of this policy is to promote a consistent and transparent approach to compliance and enforcement for the sale and importation of hazardous products intended for use, handling or storage in a workplace in Canada under the HPA, and to claims for exemption and exemptions under the HMIRA, where applicable. In supporting suppliers to achieve compliance with the HPA and the HMIRA, this policy will enable workers to better protect themselves against the hazards posed by products that they use and handle in their workplaces.

Scope

This policy applies to Health Canada's compliance and enforcement activities in relation to the sale and importation of hazardous products intended for use, handling and storage in a workplace in Canada under the HPA, and claims for exemption and exemptions from disclosure of CBI under the HMIRA.

It is the responsibility of the regulated party to ensure they comply with all applicable requirements of the HPA, the HPR, the HMIRA or the HMIRR, as applicable.

In addition to the requirements of the HPA and the HMIRA, other legislation may apply to hazardous products, including but not limited to OHS legislation that is administered and enforced by FPT OHS agencies. It is the responsibility of the regulated parties to be aware of all applicable requirements.

Guiding principles

Health Canada's Compliance and enforcement policy framework identifies a number of principles that guide Health Canada in carrying out compliance and enforcement activities across all of its programs to protect the health and safety of Canadians. Health Canada emphasizes the following guiding principles, including some of the ones laid out in the Compliance and enforcement policy framework, in the administration of the HPA and the HMIRA.

Primacy of occupational health and safety

The main objective of WHMIS is to communicate hazard information that will reduce the risk of illness, injury or death to workers by providing relevant health and safety information on hazardous products intended for use, handling or storage in Canadian workplaces so that the necessary precautions can be taken. In carrying out compliance and enforcement activities under the HPA and the HMIRA, Health Canada follows the primary guiding principle to promote the communication of relevant and accurate information by suppliers to protect the health and safety of workers in Canada from the adverse effects of hazardous products.

Accountability

Health Canada is accountable to Parliament and to Canadians for all compliance and enforcement actions and decisions under this legislative framework. These actions and decisions must be consistent with:

• Health Canada's mandate, values, policies, legal and operational frameworks
• the public interest
• any applicable international requirements

Fairness, consistency and impartiality

Health Canada works to apply the HPA, the HPR, the HMIRA and the HMIRR in a fair, consistent and impartial manner. Qualified and authorized personnel carry out compliance and enforcement activities in ways that are reasonable, professional, unbiased and unprejudiced.

While Health Canada strives for consistency in decision-making, the context and the circumstances applicable to a particular situation may lead to different compliance and enforcement responses to address issues of non-compliance and to hold a non-compliant party accountable.

Health Canada will act with the highest levels of integrity, as set out in the Values and Ethics Code for the Public Sector.

Transparency

Health Canada strives to make its compliance and enforcement actions and decision-making process clear and understandable to everyone. The department provides access to relevant, useful and timely information about compliance and enforcement while respecting privacy rights, where appropriate. For example, through the List of claims and exemptions under the Hazardous Materials Information Review Act, Health Canada makes available a summary of the claims for exemption from disclosure of CBI that have been submitted to Health Canada under the HMIRA.

Targeted and outcomes focused

Health Canada's compliance and enforcement actions are targeted to have the most positive impact on health and safety outcomes based on the effective use of resources. The most appropriate actions and tools are used, based on the impact of non-compliance for each situation.

Further information on the various factors considered by Health Canada when assessing non-compliance under the HPA, the HPR, the HMIRA and the HMIRR can be found in the Measures initiated by Health Canada section.

Evidence based

Health Canada's compliance and enforcement actions and decisions are based on the best available evidence, information and science.

Roles and responsibilities

Many parties have a role in advancing the objectives of the HPA and the HMIRA. The HPA, the HPR, the HMIRA and the HMIRR, where applicable, create responsibilities for Health Canada, FPT OHS agencies and regulated parties.

Health Canada

Health Canada is responsible for the administration of the HPA, the HPR, the HMIRA, and the HMIRR. Health Canada collaborates closely with FPT OHS agencies in the delivery of a national compliance and enforcement program for all hazardous products regulated under the HPA and provides the support and tools necessary to carry out compliance and enforcement activities. Health Canada also collaborates with other government organizations and international regulatory partners to harmonize regulations and help ensure the protection of health and safety of workers in Canada.

Health Canada provides support to regulated parties and other stakeholders to raise awareness of their responsibilities with respect to the HPA, the HPR, the HMIRA and the HMIRR. This support includes provision of compliance promotion tools to educate suppliers regarding the consequences associated with non-compliance.

FPT OHS agencies

Individuals from the FPT OHS agencies are designated as inspectors under the HPA and serve as regional contacts for compliance and enforcement activities conducted under the HPA and the HPR. The FPT OHS agencies work closely with Health Canada to carry out compliance promotion and monitoring, and take enforcement actions that follow applicable laws, policies and guidance documents.

Regulated parties

Regulated parties have mandatory responsibilities under the HPA, the HPR, the HMIRA and the HMIRR.

Regulated parties are expected to:

• understand relevant laws and their obligations
• ensure their products, activities and processes comply with the applicable laws
• assist inspectors during an inspection as required by law

Regulated parties may refer to the Technical Guidance on the Requirements of the Hazardous Products Act and the Hazardous Products Regulations for more information on the requirements of the HPA, the HPR, the HMIRA and the HMIRR.

Other legislation and regulations may also apply to hazardous products. It is the responsibility of the regulated party to be aware of all applicable requirements.

Compliance and enforcement activities

Health Canada manages the potential risk posed to worker health and safety by hazardous products through various types of compliance and enforcement activities. Health Canada chooses the actions and tools that are most appropriate for the situation, based on several factors. Some activities are designed to help regulated parties understand their responsibilities under the HPA, the HPR, the HMIRA and the HMIRR. Others are designed to induce or compel compliance with the law.

Health Canada uses actions and tools that fall under the following 3 main categories:

• compliance promotion
• compliance monitoring
• enforcement actions

Compliance promotion

Health Canada strives to support regulated parties in actively preventing problems from occurring in the first place. Compliance promotion focuses on raising awareness and educating regulated parties about their obligations under the HPA, the HPR, the HMIRA and the HMIRR. Health Canada encourages and promotes compliance through educational activities and information sharing on legislative and regulatory matters. This includes online tools, policies, and guidance documents intended to help regulated parties better understand their requirements and responsibilities.

Compliance monitoring

Health Canada, in collaboration with inspectors designated under the HPA, carries out compliance monitoring activities to proactively verify compliance, prevent non-compliance and to respond to suspected or known issues of non-compliance with the HPA, the HPR, the HMIRA and the HMIRR, as applicable. Compliance monitoring includes gathering and analyzing information, carrying out compliance verification activities where necessary, and collaborating with other regulatory agencies as appropriate.

As part of monitoring and verifying compliance, the HPA authorizes inspections to be conducted. Inspections may involve, but are not limited to, actions such as:

• visually examining a facility, inventories, labels and SDSs
• collecting and reviewing documents and records
• taking samples for laboratory analysis

The frequency, intensity and nature of compliance monitoring activities may vary according to the potential risks identified. Health Canada uses information from internal and external sources to identify possible risks to workers' health and safety. When Health Canada identifies a product or activity that may not be compliant with the HPA, the HPR, the HMIRA or the HMIRR, it applies the guiding principles in this policy to determine if further regulatory action is required.

Enforcement

Enforcement actions include any actions taken by Health Canada to compel or induce compliance to mitigate the risk identified by non-compliance with the HPA or the HMIRA. When Health Canada identifies a contravention of the HPA or HMIRA, there are a number of enforcement actions that Health Canada may take to prevent or address non-compliance. Where a regulated party chooses to comply voluntarily, no further enforcement action may be necessary.

Voluntary compliance measures

It is always the regulated party's responsibility to take timely and appropriate action to meet all requirements of the HPA, the HPR, the HMIRA, and the HMIRR. In cases of non-compliance, the regulated party may voluntarily undertake one or more interventions based on the level of potential risk to worker health and safety. These could include product disposal and stop-sale of a given product until it is brought into compliance with the HPA and the HPR.

Voluntary actions by a regulated party do not preclude Health Canada from initiating other measures if they are appropriate in the circumstances.

Measures initiated by Health Canada

When a regulated party is unable or unwilling to take action, Health Canada may take enforcement action to address non-compliance or mitigate potential risks to health or safety. Health Canada's actions are targeted to have the most positive impact on the health and safety outcome based on the effective use of resources. Health Canada uses the most appropriate actions and tools based on the potential impact of the non-compliance for each situation.

Health Canada and persons designated under the HPA, such as inspectors, may take a number of enforcement actions to address non-compliance or to address an issue of health or safety, depending on the circumstances. These include, but are not limited to:

• Issuing warning letters to non-compliant regulated parties
• Seizure, detention or disposal of the hazardous product
• Issuing a ministerial order, including an order to obtain information to verify compliance or assess the risks associated with a hazardous product, to comply with the HPA or remove specific information from the SDS and label or to stop the sale or importation of a hazardous product subject to the HPA
• Recommending the refusal of imports of hazardous products at the border
• Suspension or cancellation of an exemption under the HMIRA

Decision factors

When there is a non-compliance with the HPA, the HPR, the HMIRA or the HMIRR, Health Canada considers many factors to inform its compliance monitoring and enforcement activities and to determine the most appropriate level of intervention. This assessment takes into account the characteristics of the product or the activity that may pose a risk to the health of Canadians such as:

• the nature of the product
• the nature of the regulated activity
• the nature of any non-compliance
• potential consequences of non-compliance

In determining the most appropriate type of intervention, Health Canada also considers factors related to the conduct of the regulated party and the need to maintain public confidence in the overall integrity of the regulatory regime including the public's perception of risk. For example, Health Canada will take into consideration:

• the behaviours of the regulated party conducting the activity, such as whether the regulated party acted with indifference, recklessness or premeditation
• the degree of co-operation and responsiveness offered by the regulated party
• the compliance history of the regulated party and previous compliance issues, including the regulated party's past and recent actions to comply with the law
• the likelihood of repeat compliance issues by the regulated party
• the likelihood of the enforcement action being effective in bringing the party into compliance or in mitigating the potential risk

Depending on the specific compliance issue, additional factors may be taken into consideration.

Other enforcement responses: prosecution

Should Health Canada's regulatory enforcement responses not be appropriate or effective to achieve compliance, a recommendation for prosecution may be considered. A prosecution is a legal proceeding in which the courts determine whether non-compliance contravenes the applicable legislation and, if so, the appropriate penalty. Prosecution may be recommended when other enforcement activities have proven unsuccessful, or in response to a violation of the regulations that:

• creates a significant health, safety or security risk
• is continuing in nature
• was premeditated, negligent, reckless or a marked departure from a reasonable standard of care

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

Glossary

Acronyms

HPA:

Hazardous Products Act

HPR:

Hazardous Products Regulations

HMIRA:

Hazardous Materials Information Review Act

HMIRR:

Hazardous Materials Information Review Regulations

CBI:

Confidential business information

FPT:

Federal, provincial and territorial

OHS:

Occupational health and safety

SDS:

Safety data sheet

WHMIS:

Workplace Hazardous Materials Information System

Terms

These definitions explain how terms are used in this policy. If there is a conflict with a definition in the HPA, the HPR, the HMIRA or the HMIRR, these Acts and Regulations prevail.

Compliance:

The state of conformity of a regulated party (including a corporation, institution, individual or other legal entity) or a product with a legislative or regulatory requirement.

Compliance monitoring:

Monitoring and verifying that products, activities and processes comply with the law.

Compliance promotion:

Educating and promoting compliance with the law.

Enforcement:

Taking actions when and if products, activities and processes do not comply with the law.

Hazardous product:

Any product, mixture, material or substance that is classified in accordance with the HPR in a category or subcategory of a hazard class listed in Schedule 2 of the HPA.

Inspector:

An individual designated as an inspector under subsection 21(1) of the HPA.

Minister:

The Minister of Health.

Supplier:

A person who, in the course of business, sells or imports a hazardous product.

Contact us

For more information about this policy, email whmis-simdut@hc-sc.gc.ca.