Canada Consumer Product Safety Act (CCPSA) Helen Ryan, Consumer Product Safety Directorate, Health Canada Presentation for CSA – June 11th – 12th, 2012 1 1

Health Canada has modernized our Product Safety legislation…. Came into force on June 20, 2011 and replaced Part 1 and Schedule 1 of the Hazardous Products Act. Governs a post market regime to address/prevent dangers to human health or safety that are posed by consumer products Defines consumer products as products (including components, parts, accessories, packaging) that may reasonably be expected to be obtained by an individual to be used for non-commercial purposes. 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. 2 2 2

CCPSA: New Authorities & Requirements Ability to order recall and other corrective measures. Record-keeping to allow traceability in the event of a recall. Mandatory reporting by industry “incidents” with 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”. 3 3 3 3

Documentation obligations for Industry… Retailers are required to prepare and maintain documents that record: The name and address of the person from whom the product was obtained The period in which the product was sold and the location of sale. All others (manufacturers, importers, etc) are required to prepare and maintain documents that record: The name and address of the person from whom the product was obtained, or To whom the product was sold, or both. 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. 4 4 4

Section 14: Incident 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? 5 5 5 5

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: Is this a consumer product that I sell, manufacture or import (including its components, parts or accessories)? Is my product connected with the suspected incident? Does it meet the criteria of an incident in 14(1) (a-d)? Section 14 (1)(a): Death or serious injury Section 14 (1)(b): Defect Section 14 (1)(c): Incorrect / Insufficient Information Section 14 (1)(d): Recall or other measure in another jurisdiction Does it indicate an unreasonable hazard posed by the normal or foreseeable use of the product or the foreseeable misuse of the product. 6 6 6

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Incident Reporting: When & to Whom 8 8 8 8

Assess Risk under the CCPSA Risk Assessment Process This process happens after the receipt of information Need to prioritize and assess the information Risk-based approach is ongoing in managing our work 2 case studies will be used to provide context to the RA processes. While presented in a linear fashion, risk assessment does not always come first in the process. Depending on the situation, RA may be involved at the beginning, middle or end, or not at all. Incidents can trigger a risk assessment, or an inspection based on risk management strategy could trigger an assessment. 9 9 9

Electrical Products (ESA) Overview of Risk Assessment Triage Administrative screening Prioritization Risk Assessment Initial Screening Full Risk Assessment Hazard Characterization Exposure Assessment Electrical Products (ESA) Industry CPSC Product Safety Lab Regional Inspector Other Sources Risk Management 10

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Prioritization Tool 12 12

Risk Assessment 13 Risk-based evaluations (Hazard / Exposure) Broad Scope: Mechanical/Physical, Electrical, Chemical, Microbial and Flammability Risk-based evaluations (Hazard / Exposure) Hazard identification: Product description and how it poses a hazard Likely users of the product Likely scenarios of product use Obviousness and severity of the hazard Exposure Assessment: Product users – special consideration for vulnerable sub-populations Foreseeable routes of exposure Frequency /duration of product use Lifespan of the product Identification of foreseeable scenarios or injury pathways 13 13 13

14 Incident Reporting – What we have seen to date The Number of Voluntary Reports and Industry Incident Reports Received by Health Canada June 20, 2011 - March 31, 2012 The number of Industry Incident Reports includes only the number of initial reports (CCPSA sub-section 14(2)). Updates (CCPSA, sub-section 14(3) and notifications of non-incidents) are not included in this graph. 14

The Number of Industry Incident Reports Received by Health Canada, by Fiscal Quarter (2011-12) The number of Industry Incident Reports includes only the number of initial reports, CCPSA sub-section 14 (2). Sub-section 14(3) reports and notifications of non-incidents are not included in this graph. Reports received between June 20-30, 2011 are included in Q2 for ease of reporting. 15

The Proportion of Industry Incident Reports Received by Health Canada, by Product Category June 20, 2011 – March 31, 2012 The number of Industry Incident Reports includes only the number of initial reports provided pursuant to CCPSA sub-section 14(2). Sub-section 14(3) updates and notifications of non-incidents are not included in this graph. 16

Incident Reporting Working Well Forms are uploading properly Instances of incident being reported up through levels of trade and tracking through a common case number. Industry is using the notification option on the form 17 17 17

Challenges 18 Reporting from industry – are we seeing all incidents? Inconsistencies in reporting Incomplete information (where they obtained product) In appropriate identification of level of trade (ie,. Denoted as a retailer when they directly import from out of country) Submitting incident as 14(3) report with proposed mitigation measure as “collecting further information” or request for more time, etc. Description of the incident and justification on corrective measures are often limited in detail Incomplete information about where products are acquired 18

Upcoming Activities 1 year retrospective report on the implementation of the CCPSA to be released in Fall 2012 Posting Incident Reporting Metrics on the Health Canada Website to be released Summer 2012 Risk Assessment and Mandatory Reporting Guidance Workshop in Fall 2012 Continued Industry and Consumer Outreach surrounding the CCPSA (updating materials as necessary, reaching out to targeted audiences i.e. small retailers) 19

Thank You Visit: www.healthcanada.gc.ca/productsafety for online resources such as: Mandatory Incident Reporting Guidance Document Retention Guidance FAQs Quick Reference Guide on the CCPSA To report an incident: www.healthcanada.gc.ca/reportaproduct CCPSA General Enquires: CCPSA-LCSPC@hc-sc.gc.ca 20