Canada Consumer Product Safety Act (CCPSA) 1

Overview Key Partners From existing Hazardous Products Act to the Canada Consumer Product Safety Act. Key New Industry Obligations: Section 14: Duties in the Event of an Incident (MR) Preparing and Maintaining Documents Recalls and other measures Confidential Business Information & Personal Information Administrative Monetary Penalties (AMPs) Implementation, Outreach & Engagement 2 2

Canada Consumer Product Safety Act (CCPSA) Came into force on June 20, 2011 Purpose (s.3): “to protect the public by addressing or preventing dangers to human health or safety that are posed by consumer products in Canada…” “Consumer Product” (s.2): “a product, including its components, parts or accessories, that may reasonably be expected to be obtained by an individual to be used for non-commercial purposes, … and includes its packaging”. “Danger to Human Health or Safety” (s.2): “any unreasonable hazard – existing or potential – that is posed by a consumer product during or as a result of its normal or foreseeable use and that may reasonably be expected to cause [death or adverse health effect]…”. 3 3

Key Partners in Consumer Product Safety Government: New authorities and tools to promote and enforce compliance and take action where necessary. Industry: New responsibilities and obligations. Consumers: Better informed. Overall Results: Safer consumer products. Greater consumer confidence in products on the market. Better protection of consumer health and safety. More level playing field for responsible Canadian businesses and greater clarity of industry’s obligations. More consistency and compatibility with international trading partners and competitors. 4 4 4 4

Hazardous Products Act (HPA) The HPA was introduced in an earlier era. It prohibits and restricts the advertising, sale and importation of hazardous products. The HPA is reactive and focuses only on consumer products that have been regulated or prohibited. Authority to require corrective action is limited. Needed to renew our legislation: close gaps with other jurisdictions, address unregulated products, early detection of issues, require corrective action. 5 5 5

CCPSA: New Authorities and Requirements Ability to order recall and other corrective measures. Record-keeping to allow traceability in the event of a recall. Mandatory reporting by industry of “incidents” related to their products (including near misses). Ability to require tests and studies to verify compliance or prevent non-compliance. Sharing/disclosure of information. Increased fines and penalties including an administrative monetary penalties scheme (AMPs). New “ General Prohibition”. 6 6 6

Transfer of Regulations 7 7

Consumer Product Safety Net The new authorities in the CCPSA will contribute to an improved and more comprehensive safety net through early warnings, surveillance, risk assessment and risk management. These authorities should be seen as a more comprehensive approach in the context of a post-market regime. Does not apply to certain products that are addressed by other legislation, such as: explosives, cosmetics, drugs, food, medical devices, ammunition, and natural health products. 8 8

Key Industry Responsibilities Mandatory reporting of health or safety related incidents with consumer products. Mandatory record keeping for traceability of products throughout the supply chain. Health Canada may request tests, studies and other information necessary to verify compliance or prevent non-compliance. New general prohibition. Compliance with regulations, prohibitions. 9 9

Mandatory Reporting Mandatory Reporting is the requirement for Industry to report any incident related to a consumer product they supply as outlined in Section 14 of the CCPSA: Duties in the Event of an Incident. Intent of Section 14: Provide better intelligence on the use of consumer products and the potential risks with respect to human health and safety, enabling early and proactive response to emerging hazards / trends; and respond where appropriate to consumer product health and safety incidents. The requirements for mandatory reporting are framed by 3 primary questions: 1. What is a reportable incident? 2. When do I need to report the incident? 3. How do I report the incident? 10 10 10

What is a Reportable Incident? Upon learning of an “event” that may involve a company’s product, it is expected that the company undertakes an evaluation to determine if it meets the requirement to be reported to Health Canada and if the product involved is a consumer product as defined in the legislation. This determination is undertaken prior to timelines commencing for the mandatory incident reports. The following questions can assist in the determination of 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? 11 11

Determining “Related” – “Is my product connected or involved?” 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 involve a 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. An additional consideration for the aspect of "relate" requires a person to determine if the consumer product is connected with the event. 12 12

Meeting CCPSA Section 14 (1)(a-d) Criteria 14 (1)(a) 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; 14 (1)(b) 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; 14 (1)(c) Incorrect or insufficient information on a label or package - 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 14 (1)(d) Recall or other measure that was initiated for human health or safety reasons by another jurisdiction (including foreign entity) (refer to subparagraphs 14(1)(d)(i) to (v)). 13 13

Normal / Foreseeable Use or Misuse For an event to be an incident, particularly for paragraphs 14 (a) to (c), it should be determined that the event indicates an unreasonable hazard posed by the normal or foreseeable use or misuse of the product. Experience and judgment need to guide whether the consumer product was being used as it was originally intended to be used but must also extend to foreseeable but unintended 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. 14 14

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When & Who to Report to 16 16 16

How to Report 17 17

Document Retention Requirements RETAILER ALL OTHER PERSONS (Manufacture, import, advertise, sell or test products for commercial purposes) Shall prepare and maintain documents that indicate the name and address of the person from whom they obtained the product and the location where and the period during which they sold the product. Shall prepare and maintain the prescribed documents. Shall prepare and maintain documents that indicate the name and address of the person from whom they obtained the product or to whom they sold it, or both, as applicable. 18 18

Document Retention Requirements Period for Document Retention Persons are required to keep documents until the expiry of six years after the end of the year to which they relate, unless regulations specify another time period. Keeping Documents in Canada Documents must be kept at your place of business in Canada or at any place prescribed by regulation; the expectation is to facilitate access. The Minister may grant an exemption if he or she considers that keeping the documents in Canada is unnecessary or impractical. Providing Documents Inspectors may request access to documents that are required to be maintained under section 13 and its regulations. Health Canada may also make a written request for documents under section 12. The request will set out the time period for providing the documents (to be determined based on the circumstances). 19 19

Exemptions There may be cases of certain donated consumer products where requirements to prepare and maintain documents would do little to support product traceability. e.g.: When a donation is from a person other than a manufacturer, importer, distributor, or retailer. Health Canada is considering a regulatory proposal to allow for an exemption from the documentation related requirements in subsection 13(1) to apply to persons when they are the recipients of certain donations of consumer products. Preliminary consultations for the making of Exemption Regulations concluded in the fall of 2010. The department will proceed through the established consultative process. 20 20 20

Exemptions Proposed Exemption Regulations would also allow, under very specific conditions, the manufacture, importation, advertisement or sale of non-compliant consumer products solely for the purposes of: export; bringing the products into compliance; or for testing, research or exhibition. 21 21

Tests, Studies and other Information The Minister of Health may order manufacturers and importers to conduct tests or studies and compile other information necessary to verify compliance or prevent non-compliance with the CCPSA or its regulations. 22 22

Confidential Business Information & Personal Information Disclosure to a person or government carrying out functions relating to the protection of human health or safety without consent where it is necessary to identify or address a serious danger to human health or safety. Does not affect provisions of the Privacy Act. Confidential Business Information The CCPSA outlines two circumstances in which may disclose without consent: Disclosure to a person or government that carries out functions relating to the protection of human health or safety or the environment if have: agreement in writing to maintain confidentiality of the information and use it only for the protection of human health or safety or the environment Disclosure if essential to address a serious and imminent danger to human health or safety or the environment and essential to address the danger; person to whom the information relates must be notified does not affect provisions of the Access to Information Act. 23 23

Compliance and Enforcement Offences (s.41-48): Increased fines and penalties, including higher penalties where it can be proved that the contravention was done knowingly or recklessly. Administrative Monetary Penalties (AMPS) (s.49-66) Contravention of an order made under s. 31 or 32 may lead to issuance of a Notice of Violation (NoV) An NoV would state the monetary penalty to be paid by the company; amount of penalty depends on the risk associated with the product (low, medium, high) and the company’s history of violations (0, 1, >1). Majority of the authorities and requirements are in the CCPSA, but some requirements need to be implemented through regulations. Regulations for Administrative Monetary Penalties (Canada Gazette process) (early consultation completed November 26, 2010). 24 24

National Outreach Campaign Health Canada’s Consumer Product Safety Directorate has initiated a national outreach campaign to promote the new legislation which includes activities such as public notice ads, information sessions, printed materials, videos and webcasts. These initiatives will support industry and consumer awareness of requirements under the Canada Consumer Product Safety Act which came into force on June 20, 2011. After June 20, 2011, there will be continued outreach as we continue to maintain and further develop relationships with industry and other stakeholders throughout Canada. In addition to information sessions there will be webinars presented in the coming weeks. 25 25 25

Industry Engagement Health Canada has been providing industry information sessions on the implementation of the CCPSA across Canada. HC will also be posting recordings in both official languages of the information session and provide interactive webinars. 26 26

Partnerships with Stakeholders Build partnerships with key stakeholders to diffuse information to help industry understand and comply with the new legislation. Pursue outreach initiatives on multiple levels: Information and training sessions across Canada; Guidance documents, Fact Sheets and Reference Guides; Webcasts of Information Sessions posted on HC web site to inform those who cannot attend in person; Videos posted on HC web site, YouTube and on various stakeholders’ sites; Consumer Product Safety web site links posted on various stakeholders’ sites; Material for stakeholders’ web sites and their e-newsletters; International initiatives for exporters to Canada. 27 27 27 27