1. Canada Consumer Product Safety Act An Overview Graham Stewart Health Canada

2. The Key Features of the Act Definitions (section 2): “consumer product” Includes components, parts and accessories. Attainable by individuals (not commercial products). “danger to human health or safety” Unreasonable hazards – existing or potential - during or as a result of normal/foreseeable use. Death or adverse effect on health (illness, injury, adverse reactions) including acute and chronic effects.

3. The Key Features of the Act (cont’d.) Definitions (cont’d): “manufacture” Produce, formulate, repackage and prepare. Includes recondition for sale. “sell” Offer, expose or have in possession for sale. With or without consideration. Includes lease / rent. Other definitions: “confidential business information”, “document”, “government”, etc.

4. The Key Features of the Act (cont’d.) Prohibitions (sections 5 – 11): No person shall manufacture, import, advertise or sell consumer products that are: – Prohibited as per Schedule 2; – Non-compliant with regulations; – General Prohibition on products that present “a danger to human health or safety”; – Recalled or the subject of corrective measures that have not been carried out; or, – That are the subject of false, misleading/deceptive claims (relating to health and safety) including false certification marks. For those advertising and selling only, the last 3 prohibitions must have been done “knowingly”.

5. The Key Features of the Act (cont’d.) Fines and Penalties: – Increased fines and penalties, including higher penalties where it can be proved the contravention was done knowingly or recklessly. – Administrative Monetary Penalties System (AMPs) for noncompliance with orders. Compliance and Enforcement: – Ability to enter and seize conveyances. – Suppliers can be required to move and store seized items at their own expense. – Removal of “automatic” forfeiture after seizure – previous provisions were deemed “unconstitutional”. – Suppliers can be required to pay for disposal upon forfeiture.

6. The Key Features of the Act (cont’d.) Minister (or her delegate) has the ability to require tests to verify compliance (section 12). Requirements to keep records of supplier and clients to allow traceability in the event of a recall, other record-keeping requirements can be added through regulation (section 13).

7. Mandatory Reporting (section 14) Purpose: Creates a post-market surveillance system, aimed at early detection of consumer product safety issues. The mandatory reporting process is triggered where there is an occurrence involving: A death or serious injury; Defect, or characteristic that could lead to a death or serious injury; Incorrect or insufficient information ; or, Recall or other measure that was initiated for human health or safety reasons by another jurisdiction (including foreign entity).

8. Mandatory Reporting…continued All levels of the supply chain would be responsible for reporting incidents to the Health Canada. All levels of the supply chain would be responsible for reporting incidents to the Health Canada. 2 types of reporting are outlined in the legislation: – Incident information may be received from all levels of the supply chain (retailer-distributors-manufacturers). – Further assessment of the risk would only be received from manufacturers and importers.

9. Mandatory Reporting…continued Upon receipt of incident information, HC can: – Take immediate action. – Begin internal assessment of risk. – Wait for assessment from importer/manufacturer before determining course of action. Failure to Report: – If a company fails to report, an inspectors’ order will be issued to order the company to provide information.

10. Inspectors’ Orders (sections 30 and 31) Current situation under HPA: – No authority to order a recall or take corrective actions. – Heavy reliance on advisories, warnings and voluntary compliance. Inspectors’ Orders under CCPSA will allow Health Canada to: – To order a company to recall and / or take corrective action. – Make it an offence for a company if they fail to take corrective action – Take action at the company’s expense. Step-wise Enforcement will still continue… – Information/education – Voluntary compliance – Mandatory compliance

11. Administrative Monetary Penalties Scheme (AMPS) (sections 46-61) What is an Administrative Monetary Penalty Scheme? – AMPS are civil penalties aimed at securing compliance with legislative and regulatory requirements. – AMPS are a flexible and responsive alternative to criminal prosecution for non-compliance. Triggers: – Non-compliance with an inspectors’ order will trigger the AMPS process – issuance of a Notice of Violation (NOV). Compliance Agreement: – Establishment has option to enter into a compliance agreement to take action to remedy the situation. Ministerial Review: request a review of the NOV on the grounds that: – an order has not been violated; – the penalty was not calculated properly.

12. Regulations (section 36) “True” prohibitions from Part I, Scheduled I of the HPA are listed in Schedule 2 any may be amended by regulation. Other prohibitions are rewritten as regulations - stand-alone or incorporated into existing – with the explicit authority to prohibit products in regulations. Allow exemptions. Product, class-specific or generic requirements for the manufacturing, etc of consumer products. Ability to designate or recognize certification organizations. Time and manner for providing documents. Recall, measures and review.

13. Bill C-6 vs. US CPSIA Recalls (preliminary determination) Mandatory Third Party Testing in Certain Children’s Products and Certificates Tracking labels Import Safety AMPS vs. US civil penalties Lead and Phthalates (current regulatory initiatives)

14. Questions?