Inside the New Public Database:Lifecycle of a Consumer Complaint

Cheryl A. Falvey, General CounselDeWane Ray, Deputy AED for Hazard Identification and Reduction

Marc Schoem, Deputy Director, Office of Compliance and Field OperationsMelissa Hampshire, Assistant General Counsel, Enforcement and Information

Scott Wolfson, Director, Office of Information and Public Affairs

This presentation has not been reviewed or approved by the Commission and may not reflect its views.

Background

2For Official Use Only

The Consumer Product Safety Improvement Act of 2008 required CPSC to establish a new product safety database not later than March 2011 that:

• Allows consumers to directly submit “reports of harm;”

• Enables manufacturers, importers and private labelers to respond in the database to reports of harm involving their products;

• Is publicly available and searchable; and

• Is accessible through the CPSC’s Web site: www.cpsc.gov

Presentation Roadmap

Overview of IT Systems Current StateFuture State

Incident Report PhasesIntakeTriageIntegrated Teams

Legal ConsiderationsEducation and Outreach

Data Inputs

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Historically, the CPSC has compiled incident reports from three major sources:1. National Electronic Injury Surveillance System

(NEISS);2. Death Certificates purchased from state

governments; and3. Injury or Potential Injury Incident (IPII) database

that includes: Complaints filed through the CPSC’s website,

telephone hotline or via email; Reports from medical examiners and coroners; News clips; Reports submitted by public safety entities; Reports submitted by other government agencies;

and Manufacturer/retailer reports.

The existing Early Warning System (EWS) only supports three product categories. Other products must be manually triaged, and frequently patterns are not detected immediately.

CPSC.govCPSC.gov

Consumers Manufacturers

EWSEWS

Epidemiology

A consumer is injured by a poorly designed product. The consumer enters an incident report on CPSC.gov.

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Field InvestigationsProduct Safety Assessments

Compliance

Constituents

CPSC

Current State – Outmoded Technology Fails to Adequately Protect Consumers

Legacy SystemsAnd Databases

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No automated case management to track the progress of an investigation throughout the Agency. Cannot easily determine current status of an investigation.

No searchable public database of product incident reports.

Multiple disconnected databases are not linked so investigations are not integrated and it is difficult to share information across the Agency.

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CPSC staff must manually respond to FOIA requests, which consume staff time that would be more productively used supporting the agency mission researching product safety issues.

FOIA Requests

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Because of manual data input, it may be up to six weeks before the report is reviewed.

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!No direct interface to manufacturers exists. Incidents are sent manually on a monthly basis.

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4 Denotes legacytechnology

PUBLIC DATABASEMandated by CPSIA to becompleted by March 2011

PublicPortal

PublicPortal

ManufacturerPortal

ManufacturerPortal

Consumers and others can search the public database to

look for prior safety issues for a specific product, reducing

dependence on the FOIA process.

Consumers

The product manufacturer is automatically sent a copy of the incident report and given the opportunity to comment.

In the Future – New Technology Protects Children and Families

DataWarehouse

DataWarehouse

Manufacturers

EWSVersion 2.0

EWSVersion 2.0

CaseManagement

CaseManagement

Epidemiology

Epidemiology reviews the incident report and is able to search and view all related incidents, which allows them to rapidly detect potential hazard patterns for all product categories. All incident reports are triaged within 5 days of receipt.

A consumer is injured by a poorly designed product. The consumer visits the public portal and enters an incident report into the public database. The report is instantly visible to CPSC staff.

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4Field InvestigationsProduct Safety Assessments

Compliance

DocumentManagement

DocumentManagement

Compliance, Field Investigations, and EXHR are able to coordinate all case-related activities in their effort to quickly investigate and respond to the incident. Management can instantly determine the status of a particular case.

The Data Warehouse and Document Management System provide a central repository for storing all CPSC data and documents to allow for easy searching and retrieval.

5

Denotes newtechnology

Constituents

CPSC

Reports of Harm

For Official Use Only

1. Consumer submits Report of Harm.

3. Manufacturer registers and may submit Comment.

4. CPSC staff reviews any Comment and then publishes the Report of Harm and any Comment into the Database.

2. CPSC Specialist verifies eight required fields…

aDescription of the consumer product aIdentity of the manufacturer or private labeler aDescription of the harm aIncident date (or approximate date) aCategory of submitter aContact information of the submitter aVerification of submitter

aConsent of submitter

… and transmits report of harm to the manufacturer.

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uir

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Report of Harm Publication Process in the Database.

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U.S. Consumer Product Safety Commission

3. Enforcement

4. Standards

2. Investigation and Analysis

0. Planning, Management, and Evaluation

6. Education and Awareness

5. Industry Relations

7. International / Government

Consumers

Industry

International

Consumers

Industry

Safety Professionals

Healthcare Providers

Medical Examiners

Fed/State/Local

Agencies

Congress

Administration

Fed/State/Local

Agencies

International

Customs and Border Patrol

Core Business Functions

1. Intake and Identification

Media

Customs and Border Patrol

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U.S. Consumer Product Safety Commission

3. Enforcement

4. Standards

2. Investigation and Analysis

0. Planning, Management, and Evaluation

6. Education and Awareness

5. Industry Relations

7. International / Government

Consumers

Industry

International

Consumers

Industry

Safety Professionals

Healthcare Providers

Medical Examiners

Fed/State/Local

Agencies

Congress

Administration

Fed/State/Local

Agencies

International

Customs and Border Patrol

Integrated Team Approach

1. Intake and Identification

Data IntakeTriage/ EpidemiologyImport Surveillance

OmbudsmanClearinghouse

Public AffairsOffice of Education

Intergovernmental Affairs

CommissionExecutive Director / AEDs

Media

Customs and Border Patrol

INTEGRATED TEAMS

ComplianceFieldEngineeringLabHealth SciencesEconomic Factors

Business Input at SaferProducts.gov

12For Official Use Only

Manufacturers and Private Labelers

Commenting on reports of harm and correcting inaccurate and/or confidential information submitted by consumers to the CPSC database

Once a manufacturer or private labeler receives a report of harm from CPSC, the company may take a number of actions specific to the database:

1. Register with the database and make a comment for publication;

2. Claim the report of harm contains confidential business information, triggering CPSC review of the claim;

3. Claim the report of harm contains materially inaccurate information (e.g., that it is not the manufacturer or private labeler of the product), triggering CPSC review of the claim.

When does the manufacturer's duty to report arise?

ISSUE DATABASE CPSA – 6(b)

Reports of Harm Statutory requirements for publication including consent and verification required. Manufacturer identified.

Consumer complaints confirmed pursuant to regulation are disclosed.

Time for notice Report available in the database not later than 10th business day after transmission by Commission to manufacturer

Notified by CPSC and given 10 days to comment on the Report. Extensions of time granted. Generally, CPSC may not publicly disclose information in less than 15 days.

Comments Any comment provided will be published with manufacturer’s consent. Comments published, to the extent practicable, at the same time or soon thereafter.

Manufacturer may provide comments on whether the Commission has taken “reasonable steps” to assure the accuracy of the information, that disclosure is fair in the circumstances and reasonably related to effectuating the purposes of the CPSA. Manufacturers may request that they be kept confidential. Comments must be specific.

ConfidentialInformation

Manufacturer may review Report for confidential information and request that portions of the Report identified as confidential be so designated. If Commission determines confidential it must redact portion from Database. If Commission determines not confidential it must notify manufacturer that information is not confidential and include the information in the Database. Burden of proof requirement in regulation.

All information reported to or otherwise obtained by the Commission or its representatives under this Act which information contains or relates to a trade secret or other matter referred to in section 1905 of title 18 shall be considered confidential and shall not be disclosed. If Commission determines information marked is not confidential Commission must notify that intends to disclose such document not less than 10 days after the date of receipt of notification. Burden of proof requirement in regulation.

Inaccurate Information Anyone can claim a Report contains materially inaccurate information. Regulations define how a claim for materially inaccurate information may be made. Specific requirements for claiming materially inaccurate information. Burden of proof requirement.

If the Commission has not taken reasonable steps to assure the accuracy of a complaint – because It has not been confirmed by a submitter and does not meet the regulatory criteria – it will not be publicly released.

Publication Commission will publish Reports that meet the minimum requirements for publication.

Commission must take reasonable steps to assure, prior to public disclosure that manufacturer specific information is accurate, and that such disclosure is fair in the circumstances and reasonably related to effectuating the purposes of the CPSA.

Correction Decline to add the materially inaccurate information to the Database;

Correct the materially inaccurate information; and, if the minimum requirements for publication are met, publish the Report in the Database; or

Add information to the Report to correct the materially inaccurate information; and, if the minimum requirements for publication are met, publish the Report in the Database.

Section 6(b)(7) and Commission regulations provide retraction procedure for the public disclosure or inaccurate or misleading information

ISSUE DATABASE CPSA – 6(b)

Consumer Name and Contact Information

Never published in the Database Provided with a FOIA release if consent provided

Section 15 Report Information

Excluded from Database Processed pursuant to FOIA

Voluntary Retailer Reporting

Excluded from Database Processed pursuant to FOIA

Disclaimer The Commission does not guarantee the accuracy, completeness or adequacy of information submitted by persons outside of the CPSC. The Database will contain a notice to this effect that will be prominently and conspicuously displayed on the Database and on any documents that are printed from the Database.

The Commission includes a statement that it has neither investigated the incident nor conducted or obtained any evaluations of the products that corroborate the substance of the information contained in the complaint or incident.

ISSUE DATABASE CPSA – 6(b)

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U.S. Consumer Product Safety Commission

3. Enforcement

4. Standards

2. Investigation and Analysis

0. Planning, Management, and Evaluation

6. Education and Awareness

5. Industry Relations

7. International / Government

Consumers

Industry

International

Consumers

Industry

Safety Professionals

Healthcare Providers

Medical Examiners

Fed/State/Local

Agencies

Congress

Administration

Fed/State/Local

Agencies

International

Customs and Border Patrol

Integrated Team Approach

1. Intake and Identification

Data IntakeTriage/ EpidemiologyImport Surveillance

OmbudsmanClearinghouse

Public AffairsOffice of Education

Intergovernmental Affairs

CommissionExecutive Director / AEDs

Media

Customs and Border Patrol

INTEGRATED TEAMS

ComplianceFieldEngineeringLabHealth SciencesEconomic Factors

An Informed Consumer Is An Empowered Consumer

Calling For Manufacturers To Connect With CPSC• Promoting the Business Portal

• FAQs and Tutorial Videos on Business Registration & Business

Response

Calling For Consumers To Connect With CPSC• We know how to do this; it is what we

have done for decades

• Moving more consumers to online incident reporting vs. Hotline, e-mail and mail

Twitter Conversation

Blogging – OnSafety, Partners

Calling For Consumers To Connect With CPSC• Tutorial Video On “How To File A Report”;

Coming Soon: “How to Search”

• FAQs aimed at promoting accurate reporting

• March: Promoting the Launch

• April: Touting The Search Function

CPSC Stands for Safety