Canadian Market Surveillance Model on Consumer Product Safety
Keilee MerawConsumer Product Safety DirectorateHealth Canada
OAS – Management of Market Surveillance Systems on Consumer Product Safety
May 23, 2012Washington DC, USA
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
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.
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
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 near-misses).
•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
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
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.
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?
H
Incident reporting – When and to Whom
Industry - Incident Report Form
http://www.hc-sc.gc.ca/cps-spc/advisories-avis/incident/index-eng.php
Process for Incident Reporting
Assess Risk under the CCPSA
Assessing 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 incidents3. Re-routes to appropriate group within the organization is best placed to take action on the incident4. 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
Triage
Prioritization
Case Study #1
• Product: Car seat adaptor• Issue: reports received from
industry and consumers about adaptors breaking when trying to attach the car seat to the adaptors
Case Studies to Demonstrate Prioritization Tool
Case Study #2
• Product: Glass Bakeware• Issue: reports received from
consumers about bakeware chipping and pieces ending up in the cooked food
Risk Assessment
Case Study #1 – Car Seat Adaptor
Incidents Received 15 regarding defect; 3 falls, no injuries
Severity of Fall Hazard High
Likelihood of Car Seat Falling from the Adapter
Medium (due to flex points of latching posts)
Risk Medium to high
Assignment Risk Management
Enforcement Action Voluntary Recall
Case Study #2 Glass Storage Container
Incidents Received •1 received regarding glass chips causing cuts•other reports regarding glass shattering while in use
Likelihood of glass chipping and causing mouth lacerations
Only one report received regarding glass chips causing cuts
Risk undetermined
Assignment Surveillance Coordination – watch list monitoring (re-evaluate risk assessment with more information)
Enforcement Action None
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
Risk Management - Overview
Case Study #3
• Product: Various Toys• Hazard: small parts
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
Risk Management
Enforcement Activities
• Inspectors are designated under the Act.
• Inspections are carried out to verify compliance and prevent non-compliance.
• 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.
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
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
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.
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.
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.
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.
Thank you
Consumer Product Safety Directorate: www.healthcanada.gc.ca/productsafety
CCPSA General Enquires: [email protected]
Incident Reports: [email protected]
