implementation of the proposed canada consumer product safety act (bill c-6) mandatory reporting...

Implementation of the Proposed Canada Consumer Product

Safety Act (Bill C-6)

Mandatory Reporting

Health CanadaICPHSO 2009, Toronto

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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.

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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.

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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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Interpretation of Triggers - DRAFT

Death • Death 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

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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).

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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.

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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.

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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.

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WHEN and WHAT to reportWHO WHAT WHEN

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

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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) .

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HOW to report?

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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.

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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).

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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=3986468&Language=e&Mode=1

Please send comments to:

ccpsa-lcspc@hc-sc.gc.ca