1. Implementation of the Proposed Canada Consumer Product Safety Act (Bill C-6) Mandatory Reporting Health Canada ICPHSO 2009, Toronto

2. 2 The Approach – Enhanced Targeted Oversight Modernized consumer product safety regime. Minimizing impact on industry by leveraging to the extent possible normal business practices and aiming for complementary and harmonized requirements where feasible. Supporting rapid response activities to address consumer product issues.

3. 3 Mandatory Reporting - Overview Mandatory reporting creates a post-market surveillance system, aimed at early detection of consumer product safety issues. All parts of the supply chain - particularly manufacturers and importers - will be responsible for ensuring that their products do not present an unreasonable danger to human health or safety. Key definitions: —consumer product; —import, manufacture, and sell; —danger to human health or safety.

4. 4 What is considered a reportable incident? 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).

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6. 6 Interpretation of Triggers - DRAFT DeathDeath occurs or product is suspected of contributing to death Serious injury (incl. illness, acute and chronic effects) Requires hospitalization Urgent care treatment (e.g. emergency room) Non-fatal threats to breathing (Actual or potential: choking, strangulation, suffocation, aspiration, other respiratory impairment) Permanent impairment of a body function or permanent damage to a body structure Property damage Loss or damage of another object as a result of using a consumer product (partial or total loss) 14(1)(a) Death or Serious Adverse Effect* *Initial report expected if the incident may reasonably have been expected to result in death or serious adverse effect

7. 7 Interpretation of Triggers - DRAFT 14(1)(b) Defect or Characteristic Definition: fault, flaw, or irregularity that causes weakness, failure or inadequacy in form or function that poses a danger to human health or safety Any non-compliance to the performance requirements of the regulations Not meeting certification requirements. Not meeting accepted Standard related to health and safety. Manufacturing or production error. Product design or materials used (contents, construction, finish, packaging).

8. 8 Interpretation of Triggers - DRAFT 14(1)(c) Incorrect/Insufficient Information Lacks precautionary/warning statements or labelling required by regulations. Information for assembly or use allows the product to pose a danger to human health or safety (even if otherwise safely designed or manufactured). Pictures or instructions that show or encourage unsafe use.

9. 9 Interpretation of Triggers - DRAFT 14(1)(d) Recall or Other Measure Upon becoming aware of a recall or measure being initiated by another jurisdiction (including foreign entity), report to Health Canada if: —it involves a product that is available in Canada; and, —the product poses a danger to human health or safety OR the reason for recall is also a Canadian requirement.

10. 10 WHO is responsible for reporting? All levels of the supply chain would be responsible for reporting incidents to their supplier and to Health Canada upon becoming aware of an incident. Health Canada may initiate the report by forwarding serious consumer complaints, incidents or trends. Upon becoming aware: interpretation of ‘responsible person’ —has the authority to report to Health Canada on behalf of the establishment; —has the authority to report to the supply chain on behalf of the establishment; and, —has the ability to be informed of the incident and act to correct it.

11. 11 WHEN and WHAT to report WHOWHATWHEN A person who MANUFACTURES, IMPORTS, or SELLS s. 14(2) report: All information in control of the company Minimum requirements: -your company information -where the product was from -product name/general category -reason for report 2 days after the day on which they become aware of the incident A person who MANUFACTURES or IMPORTS s. 14(3) report : All information on the smartform PDF -including proposed/taken measures or date for action plan 10 days after the day on which they become aware of the incident

12. 12 Option for Reporting Company Reporting Model Agreement between Health Canada and a company; Evidence of processes/procedures to support a ‘responsible person’; and, Weekly reporting of incidents (excluding deaths).

13. 13 HOW to report?

14. 14 WHAT HAPPENS to the report? Upon receipt of all reports, Health Canada will determine if the report: —is within the mandate; —is a reportable incident under section 14; and, —has complete mandatory information. Health Canada may at any time: —take immediate action. —begin internal assessment of risk. Failure to report: —an inspectors’ order will be issued to order the company to provide information or take measures. —Failure of an inspectors’ order is an automatic fine.

15. 15 Next Steps - Pathforward Multiple reporting in Ontario, North America – determine resolution. Launch of online report. Finalize policy/Launch formal industry consultation – anticipated November 2009. Industry information and training sessions. Coming into force (placeholder).

16. 16 More Information, Comments More information: http://www.hc-sc.gc.ca/cps-spc/legislation/acts-lois/bill_c6-loi-eng.php Bill Text: http://www2.parl.gc.ca/HousePublications/Publication.aspx?DocId=3986 468&Language=e&Mode=1 Please send comments to: ccpsa-lcspc@hc-sc.gc.ca