Canadian Consumer Product Safety - Risk Assessment - Prosafe

Canadian Consumer Product
Safety - Risk Assessment
Helen Ryan
Director Risk Assessment Bureau
Consumer Product Safety Directorate
Health Canada

Consumer Product Safety Program
New organizational structure established in
January 2011 to support new legislation.
Moved to functional model based on
requirements of new Act.
•Risk Assessment Bureau
• Surveillance & Information Division
• Product Safety Lab
• Risk Assessment Division
•Risk Management Bureau
• Risk Management Strategies
Division
• Compliance & Enforcement
Division
• Standards Development Unit
• Program Development Bureau
• External Relations Division
• Policy, Legislative and Regulatory
Affairs Division
• International and
Intergovernmental Affairs Division
Triage / Surveillance
Risk Communication
Policy
International / IGA
Risk Assessment
Risk Management
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Voluntary Reports
Receiving Information under CCPSA
• 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 or safety, enabling early
and proactive response to emerging hazards / trends; and
– Respond where appropriate to consumer product health and safety
incidents.
Surveillance and Data Monitoring
• Analyze reports and data from other sources
– Look for trends in reports received by industry and consumers
– Analyze incidents by type of product/country of origin
– Analyze injury by age range/treatment/type of product
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Assessing Risk under the CCPSA
What it is
• Defining and taking a consistent approach to priority setting and making
decisions about risk; developing clear processes for estimating the
level of risk to the Canadian public posed by a consumer product
Risk Assessment under the CCPSA
• CPSD receives new information on a daily basis through incident and
voluntary reports; surveillance activities
• General prohibition will drive many of the risk assessments
• Scope of products covered is broader (all products, including regulated
products, covered unless specifically exempted)
• Need consistent, risk-based approach to prioritize work
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Triage
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Risk Assessment
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Risk Assessment
• First Step - RA Level 1 Assessment:
• Review and preliminary evaluation of the reported information
available to date
• Goal to complete within approximately 1 week after assignment to
an officer
• RA Level 1 Findings/Recommendations (select one):
– Proceed to Further Assessment;
– Assign to Risk Management;
– Add to Surveillance ‘Watchlist’;
– RA Case Complete, and advise as applicable.
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Risk Assessment
‘Proceed to Further Assessment’: RA Level 2 Assessment
• More detailed review and assessment of risk
• Options for RA Level 2 Assessment:
• Regional Offices communicate with industry/company;
• Industry/company to supply further information and/or perform
product testing;
• Health Canada Product Safety Laboratory testing (when
appropriate/necessary):
– Product samples obtained from company
– Development of Test Methods:
• Relevant to the specific hazard
• Related to analogous product Standards, when appropriate
• Based on scientific research
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What it is
Managing Risk under the CCPSA
• Taking a risk-based approach to managing dangers to human
health or safety posed by consumer products
Risk Management under the CCPSA
• New enforcement powers: orders, prosecution, administrative
monetary penalty system (AMPS) where appropriate
• Standards development / regulation and policy-making with
broader mandate; General Prohibition
• Conduct inspections in response to incident reports
• Compliance, enforcement and education activities that predate
the Act, such as regular market surveys for regulated
products, compliance promotion, etc.
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Risk Management Options for CP Issues
CPS has variety of options for addressing issue in
immediate and longer term, including:
• Short-term
- Removal of product from market
• sale and distribution
• quarantine, correction (if possible), disposal
- As necessary, information to consumers
• advisory, recall
• Long-term
- Additional compliance and enforcement options with the company
– to address current and future non-compliance
- Standards, regulations, or other measures depending on the
circumstance and issue
– as guidance or voluntary requirement
– as regulatory (mandatory) requirements
- Public education
– appropriate where consumers need guidance on safe selection
and use of consumer products
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Risk Assessment Case Study – Cadmium in Children’s Jewelry
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Cadmium in Children's Jewelry – Assessing the Risk
• Cyclical enforcement in 2009/2010 revealed high levels of
lead and cadmium in children’s jewellery (up to 93% total
cadmium concentration)
• Concern that some manufacturers may be switching
from lead to cadmium as a source of inexpensive metal
• Advisories posted January 15 and May 17, 2010
• October 19, 2010, Health Canada calls on industry to
voluntarily stop production, importation and sale of
children's jewellery made with the intentional use of
cadmium or cadmium-containing materials

Guideline for Cadmium in Children’s
Jewellery
• July 25, 2011, draft guideline for consultation proposes
limits for total cadmium in children’s jewellery to 130 ppm
0.9516 mg (pMRL - < 4 yrs) = 130 ppm (0.013 %)
0.0073 kg (95 th percentile weight)
• Level set to protect small children from the risk of acute
toxicity following ingestion, and of chronic toxicity from daily
mouthing of jewellery.

Cadmium in Children's Jewelry – Managing the Risk
• Enforcement actions undertaken for levels above 130 ppm,
will be taken under section 7(a) or 8(a) of the Canada
Consumer Product Safety Act (CCPSA).
• Health Canada is considering regulation to address the risk
of cadmium exposure via children’s jewelry.
• CPSD will continue market surveillance of children’s jewelry
through Cyclical Enforcement.
• XRF technology being used to verify compliance of metallic
children’s jewelry.