Guidance on Mandatory Incident Reporting under the Canada Consumer Product Safety Act - Section 14 Duties in the Event of an Incident

June 2011

This document is an unofficial summary of, and guidance respecting, the requirements under section 14, Duties in the Event of an Incident. It is not intended to substitute for, supersede or limit the requirements under the CCPSA. In case of any discrepancy between this summary and the legislation, the legislation will prevail.

Table of Contents

• 1. Introduction
• 2. Definitions
  • 2.1. Consumer product
  • 2.2. Health Canada/Minister
  • 2.3. Importer
  • 2.4. Manufacturer
  • 2.5. Seller
• 3. Key Features
• 4. Receiving information on an event
• 5. Determination of an "incident"
  • 5.1. Does the event relate to a consumer product the person manufactures, imports or sells?
  • 5.2. Is the event an incident?
  • 5.3. Does the event indicate an unreasonable hazard posed by the normal or foreseeable use of the product?
  • 5.4. Provision of incident information
• 6. When and What to Provide
  • 6.1. Information regarding the "incident"
  • 6.2. Written report
• 7. How Information is to be provided to Health Canada
• 8. What Happens to the Information
  • 8.1. Overview of Health Canada process
  • 8.2. Confidential Business Information
  • 8.3. Personal Information
• 9. Failure to Provide Information
• 10. For More Information or Inquiries
• 11. Appendix A: Schedule I of the CCPSA
• 12. Appendix B: Types of "incidents"
  • 12.1. 14(1)(a) Death or Serious Adverse Effect
  • 12.2. 14(1)(b) Defect or Characteristic
  • 12.3. 14(1)(c) Incorrect or Insufficient Information
  • 12.4. 14(1)(d) Recall or Other Measure

1. Introduction

The Canada Consumer Product Safety Act (CCPSA) sets out duties in the event of an incident in relation to potential health or safety concerns with consumer products (section 14). Reportable incidents submitted by companies will help serve as an early warning and detection of health or safety issues with the purpose of reducing the number of unsafe or potentially unsafe consumer products on the Canadian market. This information can help Health Canada to work with industry to proactively and efficiently respond, where appropriate, to consumer product health and safety incidents.

It is the responsibility of a person (an individual or an organization -  see section 2 of the CCPSA) who manufactures, imports or sells consumer products in Canada for commercial purposes to ensure compliance with the CCPSA's mandatory reporting requirements.

Incident reports serve as a major source of information to help identify dangers posed by consumer products. By requiring that incidents be reported to Health Canada by all persons who manufacture, import or sell for commercial purposes, the Government of Canada can monitor the response to the danger. This information can be used to address unreasonable hazards and help prevent adverse human health effects.

Section 14 requires  persons who manufacture, import or sell consumer products in Canada for commercial purposes to provide information when they become aware that an incident has occurred that is related to a consumer product they supply in Canada. They have 2 days after the day on which they become aware to provide this information to Health Canada and to notify the person from whom they received the consumer product. Persons who manufacture or import have further obligations to provide Health Canada a written report with specific information within 10 days after the day on which they become aware of an incident.

This document is an unofficial summary of the requirements under section 14, Duties in the Event of an Incident. It is not intended to substitute for, supersede or limit the requirements under the CCPSA. In case of any discrepancy between this summary and the legislation, the legislation will prevail.

For further information, specific questions or clarification, contact a Consumer Product Safety Bureau and Regional Product Safety Offices: 1-866-662-0666.

2. Definitions

2.1. Consumer product

2.2. Health Canada/Minister

For the purposes of this guide any obligation under section 14 for providing information or reporting to the Minister is referenced as being provided to Health Canada.

2.3. Importer

2.4. Manufacturer

2.5. Seller

Note: A person who sells and imports a consumer product in Canada can report under  14(2) and 14(3) in its capacity as the importer. A person who sells and manufacturers a consumer product in Canada can report under 14(2) and 14(3) in its capacity as the manufacturer.

3. Key Features

• Any person who manufactures, imports or sells consumer products in Canada for commercial purposes is responsible for understanding their obligations under the CCPSA.
• The CCPSA defines an incident, with respect to a consumer product, as:
  • An occurrence in Canada or elsewhere that resulted or may reasonably have been expected to result in an individual's death or in serious adverse effects on their health, including a serious injury;
  • A defect or characteristic that may reasonably be expected to result in an individual's death or in serious adverse effects on their health, including a serious injury;
  • Incorrect or insufficient information on a label or in instructions - or the lack of a label or instructions - that may reasonably be expected to result in an individual's death or in serious adverse effects on their health, including a serious injury; or
  • A recall or measure that is initiated for human health or safety reasons by
    1. A foreign entity,
    2. A provincial government,
    3. A public body that is established under an Act of the legislature of a province,
    4. An aboriginal government as defined in subsection 13(3) of the Access to Information Act, or
    5. An institution of an entity referred to in subparagraphs (ii) to (iv).
• Where a person who manufactures, imports or sells a consumer product for commercial purposes in Canada has become aware of an incident that is related to the product, they must provide information regarding the incident within 2 days to Health Canada and the person from whom they received the consumer product (refer to Figure 1 below).
• A person who manufactures or imports has reporting obligations in addition to providing information regarding the incident within 2 days to Health Canada and to the person from whom they received the consumer product. They must also provide a written report within 10 days after the day on which they become aware of an incident to Health Canada containing information about the incident, the consumer product involved, any consumer products that they manufacture or import that may be involved in a similar incident and any measure they have taken or propose to address the non-compliance (refer to Figure 1 below).
  
  
  Figure 1: An Example of Reporting an Incident
  
  
• The CCPSA, in conjunction with other federal laws, governs the disclosure of information provided to Health Canada. Sections 15 through 18 are the relevant provisions under the CCPSA regarding the disclosure of information. For further information see section 8.2 and 8.3 of this document.

4. Receiving information on an event

A person who manufactures, imports or sells a consumer product in Canada may receive information on an event through a variety of sources, for example:

• Direct notification by a consumer, through complaints or product liability lawsuits or claims;
• Direct notification by government (including Health Canada) or standards bodies;
• Direct notification by the person from whom they received the consumer product or to whom they sent the consumer product;
• Direct notification by a non-government organization;
• Receipt of reports from experts, test reports, scientific or epidemiological studies or other relevant information.

Establishing policies and procedures would be of help in determining if information received on an event constitutes an incident that must be reported under  section 14 of the CCPSA.

5. Determination of an "incident"

The CCPSA requires a person to determine whether an event is "related" to a consumer product that they manufacture, import or sell in Canada for commercial purposes and that the event meets one of the criteria set out in  paragraphs 14(1)(a) through (d).

It is only once a person has completed this determination and become "aware" of an incident that the 2 and 10 day timelines specified in the CCPSA commence.

The following questions can assist in the determination of whether an event is a reportable incident:

• Does the event relate to a consumer product that I sell, manufacture or import in Canada for commercial purposes (including its components, parts or accessories or packaging)?
• Does it meet the criteria of an incident in either one of paragraphs 14(1) (a) through (d)?
• Does it indicate an unreasonable hazard posed by the normal or foreseeable use of the product or the foreseeable misuse of the product?

5.1. Does the event relate to a consumer product the person manufactures, imports or sells?

When evaluating an event, the CCPSA requires a person to determine if the product involved (including its components, parts or accessories and its packaging) is related to a consumer product that they manufacture, import or sell in Canada for commercial purposes.

The event need not directly involve the same consumer product that is exactly identical to the product the person manufactures, imports or sells in Canada. This may be the case, for instance, if the consumer product the person supplies shares a component, accessory or part with the product involved in the incident.

For example:

• A recall of a consumer product is initiated for human health and safety reasons in another country. If the product manufactured by the person in Canada shares the same component as one that caused an event in the other country, this might be an event "related to" the consumer product.

An additional consideration for the aspect of "relate" requires a person to determine if the consumer product is connected with the event.

5.2. Is the event an incident?

An "incident" with respect to a consumer product is detailed under  paragraphs 14(1)(a) through 14(1)(d) of the CCPSA (refer to Appendix B for details on the interpretation of these paragraphs).

5.3. Does the event indicate an unreasonable hazard posed by the normal or foreseeable use of the product?

 Section 14 places the onus on the person who manufactures, imports or sells a consumer product for commercial purposes to determine whether to report an incident.

For an event to be an incident, under paragraphs 14(1)(a) to (c), it may be determined that the event indicates an unreasonable hazard posed by the normal or foreseeable use of the product.

Foreseeable use would include not only the use of a consumer product for its primary, ordinary or intended purpose, but also the misuse of a product that is reasonably foreseeable. What constitutes normal or foreseeable use of a consumer product will depend on the particular product involved, and with the circumstances surrounding the event.

Upon consideration of these questions posed in 5.1, 5.2 and 5.3:

a person may then have information from which one may reasonably conclude that the event is a reportable incident. This constitutes awareness of an incident.

5.4. Provision of incident information

Once a person has information from which one may reasonably conclude that there is an incident related to a consumer product that they manufacture, import or sell in Canada for commercial purposes, they are considered "aware" of the incident. The CCPSA then requires that the person provide information to Health Canada and, if applicable, to the person from whom they received the consumer product.

6. When and What to Provide

6.1. Information regarding the "incident"

Once the manufacturer, importer or seller becomes aware of an incident, they are required by the CCPSA to:

The effect of this mechanism is to notify all persons in the supply chain of the incident, and increase the detail of information received by Health Canada from the manufacturer, importer or seller (refer to Figure 2).

As per the Interpretation Act, where the due date for providing information to Health Canada falls on a "holiday" (which includes a Sunday), the provision of information is due on the next day that is not a holiday (refer to Table 1). "Holiday" is defined in subsection 35(1) of the Interpretation Act to include a "Sunday" and other identified holidays.

Table 1: Calculation of due dates

The person who manufactures, imports or sells a consumer product becomes aware of an incident on:	Information provided to Health Canada under subsection 14(2) due by midnight of the next*:
Note 1: The report becomes overdue after midnight in the person's location (e.g. if the person is reporting from a city in British Columbia to Health Canada in Ottawa, Ontario, the report is overdue after midnight PT). Note 2: This table assumes that there are no "holidays" (other than Sunday) that week.
Friday	Monday
Saturday	Monday
Sunday	Tuesday
Monday	Wednesday
Tuesday	Thursday
Wednesday	Friday
Thursday	Saturday

6.2. Written report

In addition to submitting the  subsection 14(2) information, the manufacturer or importer is required to:

Not every  subsection 14(3) incident report will require that measures be proposed with respect to the consumer product. Following analysis a person may determine that no measures are required in response to the incident. Alternatively, based on the circumstances, they may recommend a range of measures to be taken to address the cause of the incident.

What happens if the person who manufactures or imports is not able to meet the 10 day deadline?

If the person who manufactures or imports anticipates that they will not be able to compile the required information within 10 days, they may wish to inform Health Canada as soon as possible. Upon review of the report submitted under  subsection 14(2), Health Canada may indicate, in writing, a timeline different than the 10 days in which the report required under  subsection 14(3) must be provided.

7. How Information is to be provided to Health Canada

A digital PDF form has been developed to aid in providing information regarding incidents to Health Canada.

This form can be automatically submitted online.

8. What Happens to the Information

8.1. Overview of Health Canada process

Upon receipt of information regarding the incident, Health Canada determines if the report has complete information.

Incident information will inform analysis on emerging hazards and trends and allow Health Canada to work with industry proactively and efficiently respond, where appropriate, to consumer product health and safety incidents.

8.2. Confidential Business Information

To be considered confidential business information (CBI) under the CCPSA, information respecting a person's business or affairs must meet all of the following criteria:

1. It is not publicly available;
2. It is information in respect to which the person has taken measures that are reasonable in the circumstances to ensure that it remains not publicly available; and
3. It has actual or potential economic value to the person or their competitors because it is not publicly available and its disclosure would result in a material financial loss to the person or a material financial gain to their competitors.

Sections 16 and 17 of the CCPSA provide authority for the Minister to disclose CBI in specific circumstances. Under section 16, the Minister may disclose CBI without the consent of, or notice to, the person whose business or affairs the information relates if certain conditions are met. The disclosure can only be in relation to a consumer product, and can only be made to a person or government that carries out functions relating to the protection of human health or safety or the environment. In addition, the person or government to whom the information is to be provided must agree in writing to maintain its confidentiality and to use it only for the purpose of carrying out functions relating to the protection of human health or safety or the environment.

Under section 17, the Minister may disclose CBI to the public, without the consent of the person to whose business or affairs the information relates and without notifying that person beforehand, about a consumer product that is a serious and imminent danger to human health or safety or the environment if the disclosure of the information is essential to address the danger. Subsection 17(2) requires that notification of the disclosure be provided to the person no later than the next business day following the disclosure.

If a person making an incident report under  section 14 believes that information provided to Health Canada in relation to an incident meets the criteria for CBI under the CCPSA or third party information under the Access to Information Act, then they can indicate this to Health Canada at the time they provide the information.

Health Canada will work with manufacturers, importers and sellers to mitigate safety concerns without releasing CBI where possible.

8.3. Personal Information

The disclosure of personal information under the control of Health Canada must comply with the disclosure provisions set out in section 8 of the Privacy Act. Disclosure without the consent of the individual to whom the information relates must be made in compliance with subsection 8(2) of the Privacy Act.

Subsection 8(2) sets out 13 instances where such disclosure may be made. In particular, paragraph 8(2)(b) states that personal information under the control of a government institution may be made "for any purpose in accordance with any Act of Parliament or any regulation made there under that authorizes its disclosure."

The Minister's authority to disclose personal information without the consent of the individual under the CCPSA is subject to two conditions:

1. The information may be disclosed only to a person or government that carries out functions relating to the protection of human health or safety; and
2. The disclosure must be necessary to identify or address a serious danger to human health or safety.

The ability to share personal information in those rare and serious circumstances helps enable rapid response to serious dangers to human health or safety. The other disclosure provisions contained in section 8 of the Privacy Act continue to apply.

9. Failure to Provide Information

Failure to provide the information required by  section 14 of the CCPSA constitutes an offence and is subject to enforcement action.

10. For More Information or Inquiries

Contact a Health Canada Product Safety Office: 1-866-662-0666.

11. Appendix A: Schedule I of the CCPSA

SCHEDULE 1
(Subsection 4(1) and paragraph 37(1)(c))

1. Explosives within the meaning of  section 2 of the Explosives Act.
2. Cosmetics within the meaning of  section 2 of the Food and Drugs Act.
3. Devices within the meaning of section 2 of the Food and Drugs Act.
4. Drugs within the meaning of section 2 of the Food and Drugs Act.
5. Food within the meaning of section 2 of the Food and Drugs Act.
6. Pest control products within the meaning of  subsection 2(1) of the Pest Control Products Act.
7. Vehicles within the meaning of  section 2 of the Motor Vehicle Safety Act and a part of a vehicle that is integral to it -- as it is assembled or altered before its sale to the first retail purchaser -- including a part of a vehicle that replaces or alters such a part.
8. Feeds within the meaning of  section 2 of the Feeds Act.
9. Fertilizers within the meaning of  section 2 of the Fertilizers Act.
10. Vessels within the meaning of  section 2 of the Canada Shipping Act, 2001.
11. Firearms within the meaning of  section 2 of the Criminal Code.
12. Ammunition within the meaning of  subsection 84(1) of the Criminal Code.
13. Cartridge magazines within the meaning of subsection 84(1) of the Criminal Code.
14. Cross-bows within the meaning of subsection 84(1) of the Criminal Code.
15. Prohibited devices within the meaning of paragraphs (a) to (d) of the definition prohibited device" in subsection 84(1) of the Criminal Code.
16. Plants within the meaning of  section 3 of the Plant Protection Act, except for Jequirity beans (abrus precatorius).
17. Seeds within the meaning of section 2 of the  Seeds Act, except for Jequirity beans (abrus precatorius).
18. Controlled substances within the meaning of  subsection 2(1) of the Controlled Drugs and Substances Act.
19. Aeronautical products within the meaning of  subsection 3(1) of the Aeronautics Act.
20. Animals within the meaning of  subsection 2(1) of the Health of Animals Act.

12. Appendix B: Types of "incidents"

The following appendix provides some considerations when evaluating information to determine if a consumer product was involved in an incident under  paragraphs 14(1)(a) through14(1)(d) of the CCPSA.

12.1. 14(1)(a) Death or Serious Adverse Effect

If it is determined that the occurrence related to the consumer product resulted or may reasonably have been expected to result in an individual's death or in serious adverse effects on their health, including serious injury, the CCPSA requires that information be reported to Health Canada and to the person from whom the consumer product was received.

A person who manufactures, imports or sells is required to report an occurrence whether or not an actual injury or other health effect has occurred or whether or not the actual injury or other health effect was itself serious if the occurrence may reasonably have been expected to result in such harm. The potential for death or serious adverse health effects, including a serious injury, may be an indicator that the consumer product poses a danger to health and safety.

Examples of incidents under  paragraph 14(1)(a) are illustrated below:

Table 2: Examples of Incidents under paragraph 14(1)(a)

Event	Example
Death	Consumer product resulting in death or suspected of contributing to a death.
Any serious adverse health effects (illness, injury)	Acute physical injury or illness requiring medical or surgical treatment by, or under the supervision of a qualified doctor or nurse. Medical or surgical treatment can be provided in a hospital or clinic or in a similar place such as a regional or rural clinic where hospitalization may not always be possible. External physical injury (e.g. burn, laceration); Internal injury (e.g. internal bleeding, injury to an organ, fracture); Acute illness (poisoning); and/or Allergic reaction (anaphylaxis) Loss of consciousness Convulsions Sensory impairment (sight, hearing, etc.)
Non-fatal threats to breathing	Choking, strangulation, suffocation, asphyxiation, aspiration, or other respiratory impairment.
Property damage that could reasonably have been expected to result in an individual's death or serious adverse effect on health (illness, injury)	A consumer product repeatedly sparked, and the entire house caught fire, and without prompt evacuation there would have been deaths or serious adverse effects on health (serious burns).

12.2. 14(1)(b) Defect or Characteristic

If it is determined that a defect or characteristic may reasonably be expected to result in an individual's death or in serious adverse effects on their health, including a serious injury, the CCPSA requires that information be reported to Health Canada and to the person from whom the consumer product was received.

A defect or characteristic may include a fault, flaw, or irregularity - in any step from conception, design, manufacturing and packaging to handling and delivery to the customer - that causes weakness, failure or inadequacy in form or function that may reasonably be expected to result in an individual's death or in serious adverse effects on their health.

This may be apparent in the description of the reasons behind consumer complaints and returns, emerging trends of incidents with the product or through quality assurance processes or other checks used to identify any health and safety issues with a product.

An injury does not have to have occurred to trigger this reporting requirement. For example, an incident may involve:

• Non-compliance with regulations, certification requirements or standards related to health and safety;
• A manufacturing or production error; and/or,
• A flaw in product design or materials used (contents, construction, finish, packaging).

12.3. 14(1)(c) Incorrect or Insufficient Information

If incorrect or insufficient information on a label or in instructions - or the lack of a label or instructions - may reasonably be expected to result in an individual's death or in serious adverse effects on their health, including serious injury, the CCPSA requires that information be reported to Health Canada and to the person from whom the consumer product was received.

Incorrect information on a label or in instructions would include information that was not in accordance with fact, that was erroneous, or was inaccurate.

Insufficient information on a label or in instructions would include information that was deficient in force, quality or amount or was otherwise inadequate.

For example, where there are:

• Inadequate precautionary or warning statements;
• Pictures that show or encourage unsafe use contrary to instructions or written statements; and/or,
• Inadequate instructions, in any language, for assembly that could result in the consumer assembling the product incorrectly and potentially creating a hazard with the product (for example, inaccurate instructions even in a language other than an official language of Canada may lead to an incident which must be reported).

An injury does not have to have occurred to trigger this requirement.

12.4. 14(1)(d) Recall or Other Measure

The CCPSA requires that information be provided if a recall or measure was initiated for human health or safety reasons by:

1. A foreign entity (includes foreign corporations as well as foreign governments and public bodies);
2. A provincial government;
3. A public body that is an establishment under an Act of the legislature of a province;
4. An aboriginal government as defined in subsection 13(3) of the Access to Information Act, or
5. An institution of an entity referred to in subparagraphs (ii) to (iv) above.

Upon becoming aware of such a recall or measure initiated by another jurisdiction, the manufacturer, importer or seller is responsible for reporting to Health Canada and to the person from whom they received the consumer product.

For example: if the product hazard posed by the consumer product recalled in another country is due to a feature that was not included in the consumer product in Canada, information does not have to be provided to Health Canada.