Canadian Market Surveillance Model on Consumer Product Safety

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1 OAS Management of Market Surveillance Systems on Consumer Product Safety May 23, 2012 Washington DC, USA Canadian Market Surveillance Model on Consumer Product Safety Keilee Meraw Consumer Product Safety Directorate Health Canada

2 Overview Health Canada s Consumer Product Safety Program Overview Mandate and Organizational Structure Food and Consumer Safety Action Plan Key Requirements under the: Canada Consumer Product Safety Act (CCPSA) (consumer products) Risk Assessment Incident Reporting Triage and Prioritization Hazard Analysis and Risk Assessment Surveillance and Monitoring Risk Management Compliance Promotion Enforcement

3 Consumer Product Safety Program The Consumer Product Safety Program helps to protect the Canadian public by researching, assessing and collaborating in the management of health risks and safety hazards associated with consumer products that Canadians use every day. CPSD works in partnership with industry (manufacturers, retailers and distributors) to ensure safer consumer products in the marketplace, and equips consumers with safety information that helps them make better decisions regarding the products they use.

TARGETED OVERSIGHT Mandatory Incident Reporting Standards Development

5 Food and Consumer Safety Action Plan - 3 Pillars ACTIVE PREVENTION Consumer Outreach Industry Compliance Promotion General Prohibition TARGETED OVERSIGHT Mandatory Incident Reporting Standards Development Risk Assessment RAPID RESPONSE Mandatory Recalls, communication of safety risks

6 Canada Consumer Product Act (CCPSA) Highlights New Authorities and Requirements: New General Prohibition. Record-keeping to allow traceability in the event of a recall. Ability to require tests and studies to verify compliance or prevent non-compliance. Mandatory reporting by industry incidents with their products (including nearmisses). Ability to order recall and other corrective measures. Sharing/disclosure of information. Increased fines and penalties including administrative monetary penalties (AMPs) Ability to order recall and other corrective actions

7 Legislation Consumer Products: Canada Consumer Product Safety Act (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]. Cosmetics: Food and Drugs Act Labeling, notification and safety of ingredients

8 Receiving Information Voluntary Reports Received from consumers, Coroners, Medical Professionals, etc. Mandatory Incident Reports 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.

9 Industry - 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: 1. Is this a consumer product that I sell, manufacture or import (including its components, parts or accessories)? 2. Is my product connected with the suspected incident? 3. Does it meet the criteria of an incident in 14(1) (a-d)? 4. Does it indicate an unreasonable hazard posed by the normal or foreseeable use of the product or the foreseeable misuse of the product?

10 H

11 Incident reporting When and to Whom

Industry - Incident Report Form http://www.hc-sc.

12 Industry - Incident Report Form

13 Process for Incident Reporting

14 Assessing Risk Under the CCPSA Assess Risk under the CCPSA Risk is assessed throughout the program and its activities. This includes a risk based approach in how we manage our work, recognizing that CPSD receives warrant action. With limited resources, there is a focus on prioritization of incidents to be acted upon, the measured response and monitoring for broader hazard analysis or injury trends. The assessment of risk: 1. Starts from the initial receipt of information from consumer or industry reports 2. Triage group reviews and prioritizes incidents 3. Re-routes to appropriate group within the organization is best placed to take action on the incident 4. Consider proposed mitigation measures if necessary. How are we developing and evaluating this work? Development of Risk Assessment Framework Peer review of Risk Assessment Methodologies Updating industry guidance on Incident Reporting

15 Triage

16 Prioritization

when trying to attach the car seat to the adaptors Product: Glass Bakeware Issue:

17 Case Studies to Demonstrate Prioritization Tool Case Study #1 Case Study #2 Product: Car seat adaptor Issue: reports received from industry and consumers about adaptors breaking when trying to attach the car seat to the adaptors Product: Glass Bakeware Issue: reports received from consumers about bakeware chipping and pieces ending up in the cooked food

18 Risk Assessment

19 Case Study #1 Car Seat Adaptor Incidents Received Severity of Fall Hazard 15 regarding defect; 3 falls, no injuries High Likelihood of Car Seat Falling from the Adapter Risk Medium (due to flex points of latching posts) Medium to high Assignment Risk Management Enforcement Action Voluntary Recall

20 Case Study #2 Glass Storage Container Incidents Received Likelihood of glass chipping and causing mouth lacerations Risk 1 received regarding glass chips causing cuts other reports regarding glass shattering while in use Only one report received regarding glass chips causing cuts undetermined Assignment Enforcement Action Surveillance Coordination watch list monitoring (re-evaluate risk assessment with more information) None

21 Surveillance and Monitoring Watch List Scanning of RADAR, US CPSC Public Database, RAPEX, ACCC for any activity on priority products/issues. Reports Weekly, Monthly reports on incident trends. Ad-hoc requests for trend analysis (e.g. appliances, chemicals, light bulbs). Special projects (e.g. Poisonings, Helmet Study). Environmental Scan Google alerts for watch list items and other priority issues

22 Risk Management - Overview Case Study #3 Product: Various Toys Hazard: small parts

education and guidance to industry Technical information e.

23 Risk Management Compliance Promotion Activities Communication & publication of information Information, education and guidance to industry Technical information e.g. Guidance documents outlining technical requirements for specific products

24 Risk Management Enforcement Activities Inspectors are designated under the Act. Inspections are carried out to verify compliance and prevent noncompliance. Inspectors visit all levels and sizes of trade, from manufacturers to retailers and also look at product at ports of entry into Canada. Inspectors may: Examine products and records, take samples, photographs and copies of documents. Start or stop any activity during the inspection. Quarantine product while verifying product. Seize product and other related-material and secure it on or off-site.

25 Risk Management Response to Non-Compliance Request voluntary measures Verify corrective measures Seize product/documents/materials Order recall and corrective measures Issue notices of violation (Administrative Monetary Penalties - pending) Carry out recalls/corrective measures Apply for injunction Investigate and prosecute

26 Risk Management Enforcement Considerations Risk to health and safety. Likelihood that the same problem will reoccur. Compliance history of the enterprise. Whether the enterprise acted with indifference or premeditation. Degree of cooperation offered by the enterprise. Deterrence

27 Case Study #3 Sampling and Evaluation program revealed that small parts of this toy may separate. Product non-compliant to a Regulation. High risk to health and safety choking hazard to young children. Negotiated voluntary recall and stop sale.

28 Path forward What is working well: Industry training continues; awareness is increasing. Instances of incidents are being reported through levels of trade and tracking is done through a common case number in RADAR. Challenges: Reporting from Industry are we seeing all the incidents? Incomplete information where they obtained the product. Incorrect identification of level of trade reporting as a retailer when they are directly importing. Insufficient information in s. 14(3) reports for Risk Management lack of proposed mitigation measures or action plan.

29 Importance of Standards The Food and Consumer Safety Action Plan recognizes the need to use and participate in standards, including assisting consumer and small medium enterprises (SME) participation. CPSD technical staff actively participate on standards development committees Product-specific standards Can be considered to help inform compliance with the CCPSA general prohibition and in regulations. International Standards Harmonization objective is driving standard convergence. ISO Guidance Standard on Product Safety. ISO Guidance Standard on Product Recall.

30 Continued Focus on Implementing the CCPSA Improving awareness of the Act and its authorities and requirements among stakeholders. Increased focus on consumer outreach. Reviewing and enabling decision making authorities. Putting in place regulations for Administrative Monetary Penalties and for certain Exemptions Further developing and streamlining policies and processes. Improving public release of documents to meet information needs of stakeholders, in keeping with the Government of Canada's Open Government initiative.

31 Thank you Consumer Product Safety Directorate: CCPSA General Enquires: Incident Reports:

Global Product Safety: Trends & Updates CANADA. Teresa Dufort December 4, 2012 McMillan LLP

Global Product Safety: Trends & Updates CANADA Teresa Dufort December 4, 2012 McMillan LLP What Hasn t Changed CCPSA Prohibitions Outline Mandatory Incident Reporting What Is New? New Guidance on Mandatory