U.S. Consumer Product Safety Commission

This presentation was prepared by CPSC staff. It has not been reviewed or approved by the Commission and may not reflect its views.

How the CPSC Identifies and Manages Risks

Related to Consumer Products

John GoldenRegional Product Safety Attaché (Asia-

Pacific)U.S. Embassy, Beijing

How CPSC prevents injuries and deaths?

Product Standards

Identifies, monitors, analyzes trends

Conducts risk assessments

Conducts research

Educates on manufacturing for safety

Educates on safe use

Surveillance: retail,

Internet, ports

Investigations,

Recalls,Compliance

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Regulations

What are the circumstances that trigger CPSC involvement?

CPSC is a data-driven agency and performs analysis based on:

• Post-market incidents

• Reports of injuries, and incidents from multiple sources:

– CPSC databases – Public sources, including firms and

manufacturers– Shared information with domestic agencies– Shared information with international

partners3

What are the circumstances that

trigger CPSC involvement?

• Products that fail to comply with a technical regulation or ban administered by CPSC

• Products that contain a defect which could create a “substantial product hazard”

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What are the circumstances that

trigger CPSC involvement?

• Products that fail to comply with voluntary standards and present a “substantial product hazard”

• Products that create an “unreasonable risk” of serious injury or death

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Product Safety Concerns

“Substantial Product Hazard”1

A failure to comply with an applicable consumer product safety rule under [the CPSA] or similar rule, regulation, standard, or ban under any other Act enforced by the Commission which creates a substantial risk of injury to the public,…

1 Section 15 of the Consumer Product Safety Act (CPSA) 6

Product Safety Concerns

“Substantial Product Hazard”1

or a product defect which (because of the pattern of defect, the number of defective products distributed in commerce, the severity of the risk, or otherwise) creates a substantial risk of injury to the public.

1 Section 15 of the Consumer Product Safety Act (CPSA)

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Risk Management Process

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Risk Assessment

and Prioritization

Comparing Risk to

AcceptabilityCriteria

Actions to Reduce

Risk

What Actions Do We Take to

Manage That Risk?

Evaluate Results

Are Our Actions

Effective?

Data Collection

Hazard Identification

Probability ofHazard

Occurrence and

Consequence

Risk Analysis

Risk of that Hazard

Occurring that Often

With That

Consequence

Risk Assessment

Risk Management

Ensuring Compliance

How Do We Help

Ensure Compliance With Risk

Management

Strategy?

Data Collection

• National Electronic Injury Surveillance System (NEISS)

– Data collected from approximately 100 hospital emergency departments around the country

– Data weighted to provide consumer injury estimates nationwide

• Death Certificates collected from all states for codes that likely involve consumer product-related deaths 9

Data Collection

• Saferproducts.gov

• Hotline (800-638-CPSC)

• News clips

• In-depth investigations

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Data Collection

• Additional Surveillance Data from:

–National Burn Center Reporting System

–National Fire Incident Reporting System

–Poison Control Centers

• Collection of actual samples or a similar sample involved in an incident, purchased at a retailer or seized at a port

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Hazard Identification

An interdisciplinary team of subject matter experts reviews incidents to:

• Identify hazards described

• Examine chain of events

• Review circumstances of incident and other consequences that could have resulted

• Identify incident hazard patterns

• Screen for trends and emerging hazards

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For physical samples, an interdisciplinary team of subject matter experts evaluates the samples to:

• Identify hazards described

• Determine the modes of failure

• Determine compliance with existing safety standards or regulations

Hazard Identification

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Risk Analysis

Based on the evaluation of the data or physical sample, an interdisciplinary team of subject matter experts:

• Makes a qualitative evaluation of risk, based on how often the hazard may occur and how harmful the hazard is

• Captures all risk analysis in new internal database for longer-term pattern analysis

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Risk Assessment and Prioritization

Based on the results of the risk analysis, the CPSC compares the evaluated risk to the acceptable level of risk.

The criteria for acceptable level of risk is based on: • Nature of hazard (e.g. level of consumer

involvement, etc.)• Likelihood of occurrence• Severity of injury• Likely users of product

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Prioritization is based on the gap between the current risk posed by the product and the acceptability criteria, and it is influenced by the degree to which CPSC actions are estimated to mitigate the risk (addressability).

Risk Assessment and Prioritization

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Actions to Reduce Risk

Actions to reduce risk to acceptable levels:

• Participate in the improvement or creation of voluntary standards

• Improve or create technical regulations• Reach out to manufacturers,

distributors, and importers

• Educate the public

The result is a strategy aimed at first lowering and then maintaining risk at acceptable levels.

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Manufacturers, importers, and retailers have obligations that could include:

• Testing and certification• Third-party testing and certification• Follow CPSC regulations, voluntary

industry standards, and best manufacturing practices

Compliance With Risk Management Strategy

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Compliance With Risk Management Strategy

Actions by CPSC to monitor compliance with meeting safer CPSC requirements may include:

• Port surveillance• Market surveillance• CPSC internal testing

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Compliance actions are taken when a product does not meet CPSC requirements and/or contains a defect that presents a substantial product hazard.

Compliance actions may include:• Stop sale• Design change• Recall to consumer and/or at distribution

level• Repair, replacement, and/or refund

Compliance With Risk Management Strategy

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Evaluate Results

CPSC monitors and evaluates the hazards related to products to see if safety concerns are adequately addressed.

CPSC performs data-driven evaluations to answer:

• Are our actions effective?

• Are we reducing the likelihood of occurrence?

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CPSC performs data-driven evaluations to address the following:

• Are we reducing the severity of the injury?

• Are we reducing the risk and thus closing the gap between actual level and acceptable level of risk?

• Are manufacturers, importers, and retailers complying with CPSC requirements?

Evaluate Results

John GoldenRegional Product Safety Attaché (Asia-

Pacific)U.S. Embassy, Beijing

Phone: 86-10-8531-3318Fax: 86-10-8531-3652

E-mail: jgolden@cpsc.gov E-mail: goldenjx@state.gov