Implementation of Electrical Product Safety Regulation

in Ontario

International Consumer Product Health and Safety Organization

Sixth International Meeting and Training Symposium

“International Cooperation on Product Safety”

October 26,27,28

By: Peter Marcucci , VP Regulatory Affairs and Chief Engineer

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Overview of Topics

• Electrical Safety Authority (ESA)

• Electrical Product Safety Regulation

• Guideline Development Process

• Impact on Supply Chain and Others

• Next Steps

• Questions

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Electrical Safety Authority

• Established as a separate Corporation in April 1999

• One of the largest “Authorities Having Jurisdiction” (AHJ) in North America

• Private, not for profit, public safety organization

• Operates under the terms of an Administrative Agreement with the Ministry of Consumer Services

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Mandate

• Ontario-wide mandate for electrical safety and service delivery Bill 35, the Electricity Act, 1998

• Establish and enforce Ontario’s electrical safety regulations

Electrical wiring installations OESC (Reg 164/99)

Utility Regulations (Reg 22/04)

Electrical Contractor Licensing (Reg 570/05)

Product Safety (Reg 438/07)

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ESA’s Prior Role in Electrical Product Safety

ESA approved products based on rules in the Ontario Electrical Safety Code (OESC).

ESA had limited authority in the Act to deal with unsafe product issues ,had to rely on the Code which did not provide much.

ESA’s approach to unsafe products focused on:– responding to complaints/reports about product

safety, and– conducting investigations prior to issuing safety

alerts.

No mandatory reporting requirements regarding consumer electrical products.

Inadequate provisions to deal with unapproved, counterfeit and unsafe products.

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The Defining Case

• In 2005 ESA was alerted of suspected fires caused by defective refrigerators.

• The company did minimal public notification regarding the issue.

• A letter was sent to consumers alerting them of a ‘safety upgrade’.

• The Ontario Fire Marshal and ESA warn the public of safety issues associated with the refrigerators.

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CBC MARKETPLACE: YOUR HOME » DEFECTIVE PRODUCTS

Dangerous defects Broadcast: March 26, 2006

Do you have an affected LG fridge?

Latest notice from LG [PDF] (Ad appeared in major newspapers on March 24, 2006)The fridges were sold in Canada between June 2004 and April 2005.LG-branded models with serial numbers beginning with 405, 406, 407, 408, 409 and 410 are affected: 3-DOOR MODEL #LRFC 21760ST/SWLRFC25750SB/ST/SW/TT/WW2-DOOR MODEL #GR-729RNLRTX 18311WWLRTN 18320WWLRTX 18321BK/TT/WWConsumers with an affected refrigerator should contact LG immediately at 1-888-542-2623 or by email at retrofit@lge.com.

The result….

In Ontario , a loss in the confidence of the current product safety system

Identified gaps in ESA’s regulatory authority with respect to product safety

Increased demand for regulatory oversight by the Province of Ontario

Which led to…8

Bill 152 Legislative Amendments –Electricity Act, Part VIII

& Product Safety Regulation–

Ontario Regulation 438/07

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Product Safety Regulation 438/07

• After a public consultation process, Ontario Regulation 438/07 was finalized July 2007

• Filed August 1,2007 and printed in Ontario Gazette August 18, 2007

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Rationale / Intent of Ontario Reg. 438/07

The intent of the regulation is to address the 6 key areas in electrical product safety in Ontario and to:– Ensure that products do not present a serious product hazard;

– Ensure that electrical products are approved;

– Ensure accountability for the safety of products offered for sale;

– Ensure that the public is notified of unsafe products that pose a risk to consumers; and

– Ensure that appropriate corrective action is undertaken when an approved product is subsequently found to be unsafe.

ProductSafety

IncidentReporting

RiskAssessment

PublicNotification

CorrectiveAction

Enforcement

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Overview of Reg. 438/07 Reporting of Incidents/Accidents

• Mandatory reporting requirements came into effect on July 1, 2008

• ESA consulted on the development of guidelines for the reporting of incidents and accidents .

• Accident: An event that results in death, injury or property damage

• Incident: An event that could have resulted in death, injury or property damage.

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Overview of Regulation Risk Assessment

• ESA is committed to following a consistent and transparent risk assessment approach to determine the type of corrective action warranted.

• ESA consulted on the development of an enhanced risk assessment model based on best practices. This includes criteria for :

– Analysis of the risk;

– Risk being categorized as low, medium or high; and

– Risk category used to determine appropriate corrective action.

RISK FACTOR CATEGORIES RISK FACTORS Points

Low 10

High 0

High 5

Low 0

Yes 5

No or N/A 0

10

5

0

Yes 5

No or N/A 0

Enclosure made of flammable material 5

Heat producing product 5

5

Voltage Level, higher than 240V 510

High Energy emission 10

Fail safe 0

Product TypeProtection Device 10

20

50

High 5

Low or N/A 0

5

3

With Quality Control Programs e.g. ISO 9001 0

5

0

5No 3

Yes 0

0

10

10

10

10

Intensive

Retailer with safety culture

PERCEPTION OF RISK

An individual's perception of a Risk is amplified if the product incident is:

In the news

Catastrophic

Cause of child injury

In the Health care facility

History of non-compliance with approval requirements

Location/Environment

Possibility of unqualified or un-inspected installation

Minor/Minimal

DEFINITION

Proximity to large numbers of people, number of users etc.

Product Use in Tandem with other electrical devices

Manufacturer

Prevalence: product availability/usage rates

Amount of Personal Contact/interface

Exposure

Unknown

Negative Impact of Product failure on other connected equipment

Possibility of Shock/Fire

Medium

Decision Criteria for Unsafe Products

Failure Mode

Widely available

User Qualifications and Safety Culture: level of awareness and level of public education

Certified by other jurisdiction

PRODUCT SOURCE

From ESA Privileged list

Purchasing Restriction/Availability

PRODUCT DESIGN AND

CHARACTERISTICS

USER CHARACTERISTICS

AND HUMAN-DEVICE

INTERCONNECTION

Difficulty or ease of use, adequacy or appropriateness of design, adequacy or appropriateness of materials, components, or equipment, failure mode and application.

Retailer

Certified per Canadian standards

Limited number of manufacturers/distributors

Product certificationNot certified

History of non-compliance with approval requirements

Energy Consuming Equipment

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Overview of RegulationPublic Notification

• The regulation provides ESA the authority to ensure that people are informed of hazardous products by:

– Permitting ESA to identify when public notification is required;– Allowing ESA to require that a communication program is initiated;– Require that organizations/businesses give public notice;– Require that the organization/business communicate with ESA

regarding the program;– Provide for emergency communication measures by ESA when an

imminent hazard warrants them.

• To protect business information, the regulation requires that ESA notify a business of its intended communication and provide the company with an opportunity to review it.

• ESA consulted with stakeholders to establish guidelines for public notification based on best practices.

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Guideline DevelopmentProcess

• Stakeholders were invited to take part in the guideline development process.

• The first main stakeholder meeting took place on October 15, 2007.

• 5 seed documents (one per working group) were presented and circulated to stakeholders.

• Three external consultants were hired to produce the seed documents based on international best practices.

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Guideline Development Process Working Groups

Main Committee

All stakeholders

Working Group

1

Risk

Assessment

Methodology

Working Group

2

Accident & Incident

Reporting

Guidelines

Working Group

6

Funding Option

Development

Working Group

3/4

Corrective Action & Public Notification

Guidelines

Working Group

5

Revocation of

Approval &

Recognition Rules

Group 3 & 4 were combined because it was felt that notification of the public only one type of corrective action.

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Consultation Process Outcomes

• Agreement on Reporting thresholds, definitions and processes

• Increased communication and dialogue between affected stakeholders and ESA

• Development of “Industry Guidelines for the Management of Electrical Product Safety “published June 15,2008 and revised July 14,2008

• Industry guideline document can be found at :

http://www.esasafe.com/pdf/wg/Stakeholder_Findings_Final_Document.pdf

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Impact on Supply Chain

The Supply Chain: manufacturers, importers, brand owners, distributors, wholesalers, retailers.

– Reporting requirements• are required to submit a report to ESA about an incident,

accident or defect which meets the minimum reporting threshold

– Public Notification/Corrective Action• may be required by ESA to undertake public notification

or corrective action based on a risk assessment

– Assistance• may be requested by ESA to assist in an investigation

regarding an alleged incident, accident or defect

Impact on Certification Bodies and Field Evaluation Agencies

• CBs and FE agencies must report to ESA when they become aware of a serious electrical incident or accident or a defect of an electrical product or device it certified or evaluated that affects or is likely to affect the safety of any person or cause damage to property.

• CBs and FE agencies may be required to assist when requested by ESA.

• They may also provide input on the development of a corrective action when requested.

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Next Steps in Product Safety Activities

• Process improvement activities

• Implementation of prevention strategies

• Development of partnerships & strategic alliances (e.g. MOU with Health Canada)

• Detection and Response Activities

• Enforcement & Compliance Monitoring

Next Steps

• Phase I (Sept 2007 -November 2008)– Communicate with affected stakeholders– Complete guideline development process– Complete funding model consultations

• Phase II (November 2008 – December 2009)– Communicate new requirements to industry– Implement registration and funding model– Align business operations

• Phase III (at the earliest Jan 2010)– Initiate consumer awareness– Undertake prevention activities and market surveillance– Communicate with other provinces and other levels of government– Support Development of a National System.

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Operations Update2009 Projection

650+

Data until September 25th, 09

Distribution of Reports by Product TypeJuly 1, 2008 – August 25, 2009

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Questions??