Risk Assessment Components - CPSC.gov

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UNITED STATES OF AMERICACONSUMER PRODUCTSAFETY COMMISSIONCONSUMER PRODUCT SYSTEM SAFETYI DENTIFYING AND M ANAGING R ISKAUGUST 2015THIS PRESENTATION WAS PREPARED BY CPSC STAFF, HAS NOT BEEN REVIEWED OR APPROVED BY, AND MAY NOT REFLECT THE VIEWS OF, THE COMMISSION.

U.S. Consumer ProductSafety Commission An independent federal agency Established in May 1973 Responsible for consumer product safetyfunctions of the federal government Chairman and four Commissioners,appointed by the President andconfirmed by the Senate2

CPSC MISSIONProtecting the public against unreasonable risks ofinjury from consumer products througheducation, safety standards activities, regulation,and enforcement.

U.S. ESTIMATED ANNUAL LOSSES ASSOCIATED WITHCONSUMER PRODUCTS34,500Deaths36 MillionInjuries 1 Trillion inSocietal Costs4

Consumer Product“. . . any article, or component part thereof, produced ordistributed (i) for sale to a consumer for use in oraround a permanent or temporary household orresidence, a school, in recreation, or otherwise, or (ii)for the personal use, consumption or enjoyment of aconsumer in or around a permanent or temporaryhousehold or residence, a school, in recreation, or1otherwise ”1Section 3(a)(5) of the Consumer Product Safety Act, 15 U.S.C. § 2052 (a)(5)5

Consumer Products EXCLUDEDfrom CPSC Jurisdiction“ any article which is not customarily produced or distributed for sale to, oruse or consumption by, or enjoyment of, a consumer ”2Alcoholic beverages, tobacco, firearms and explosives (BATFE)Motor vehicles and equipment (NHTSA)Pesticides (EPA)Aircraft (FAA)Boats (Coast Guard)Food and drugs (USDA and FDA)Occupational products (OSHA)Fixed-site amusement park rides (State jurisdiction)2Section 3(a)(5)(A) of the Consumer Product Safety Act, 15 U.S.C. § 2052 (a)(5)(A)6

Laws that Give CPSC Authority Over ConsumerProducts, Foreign and Domestic Consumer Product Safety Act*Federal Hazardous Substances Act*Flammable Fabrics ActPoison Prevention Packaging ActVirginia Graeme Baker Pool and Spa Safety ActChildren’s Gasoline Burn Prevention ActRefrigerator Safety Act*Amended by the Consumer Product Safety Improvement Act of2008 and Public Law No. 112-28.7

Children’s Products and the ConsumerProduct Safety Improvement Act (CPSIA)Key process requirements for children’s productsprimarily intended for children 12 years old andyounger: Third party testing by CPSC-accepted labs Conformity certificates issued by importers &manufacturers (Children’s Product Certificate) Tracking labels8

Product Hazard Prevention StrategiesCPSC staffpromotes consumerproduct safety througha multi-prongedapproach} Engaging in product safety systemprocesses by supportingimprovements to voluntarystandards/codes Creating and enforcing technicalregulations and bans Identifying and removing productswith defects and hazards throughsurveillance activities and recalls Developing education programs forconsumers, importers, U.S. andforeign manufacturers, and retailers9

CPSC RISK MANAGEMENT ty ofHazardOccurrenceandConsequenceRisk AnalysisRisk of ThatHazardOccurring ThatOften PrioritizationComparingRisk toAcceptabilityCriteriaActions toReduce RiskEducationCorrectiveActionsStandards esultsMarket/PortSurveillanceTesting andCertificationCPSC TestingRISKTrendsDataAnalysisMANAGEMENT

DATA COLLECTION SYSTEMSIPIIInjury andPotentialInjuryIncident ationsNationalElectronicInjurySurveillanceSystem

INJURY AND POTENTIAL INJURY INCIDENT DATABASE (IPII)MedicalExaminersand CoronersNews Clips Hotline CallsAlertProgram(MECAP)InternetReportsFederal andComplianceState AgencyReportsReferralsOtherReports

DEATH CERTIFICATES DATABASE (DTHS) Contracts with 50 states Purchases approximately 8,000 per year Time lags Daily review Analytical use

IN DEPTH INVESTIGATIONS DATABASE (INDP) Field Investigations– On site– Local-level collaboration Medical examiner Police Fire– Sample collection opportunity Telephone Interviews

NATIONAL ELECTRONIC INJURY SURVEILLANCE SYSTEM (NEISS) National sample– Data collected from approximately 100 hospital emergencyrooms around the country– Data weighted to provide consumer injury estimates nationwide Multilevel system– About 395,000 consumer product-related injury reports annually– About 300,000 other incident reports annually Data submitted daily by hospital coders Data available from 1980 to present

MAP OF NEISS HOSPITAL LOCATIONSSan Juan

OTHER DATA SOURCES Additional Surveillance Data from:– National Burn Center Reporting System– National Fire Incident Reporting System Collection of actual samples or a similar sampleinvolved in an incident, purchased at a retaileror seized at a port

Risk Assessment Process

Integrated Teams ChemicalChildrenCombustionElectricalFireSeniors anceTeam LeaderLabSciencesHealthSciencesHazardAnalysis

Determine Scope Entire product category vs. product specific– manufacturer, model, lot Hazard Scenarios Population at risk (Children, Seniors, Teens,General Population)

Hazard Identification and Characterization Integrated teams determine:––––––Product componentHazard/failure modeDesign vs. defectInjury severityPhysical/cognitive characteristics of usersEnvironmental factors

Injury Severity **Level of Injury4321ConsequenceInjury or consequence that is or could be fatal, includingbrain death; consequences that affect reproduction oroffspring; severe loss of limbs and/or function, leading tomore than approximately 10 % of disability.Injury or consequence that normally requireshospitalization and will affect functioning for more than 6months or lead to a permanent loss of function.Injury or consequence for which a visit to ER may benecessary, but in general, hospitalization is not required.Functioning may be affected for a limited period, notmore than about 6 months, and recovery is more or lesscomplete.Injury or consequence that after basic treatment (first aid,normally not by a doctor) does not substantially hamperfunctioning or cause excessive pain; usually theconsequences are completely reversible.** Guidelines for the Management of the Community Rapid Information System‘RAPEX’, Official Journal of the European Journal, Vol. 53, pp. 60-63.

Exposure Assessment Distribution quantityExposure time– Product life span – actual vs. recommended– Frequency/duration of useLikelihood of hazard manifestation– Product characteristics– User behavior– Environmental factors– Hidden hazardPath to injury

Risk Characterization Determine risk level based upon probabilityand severity

Risk Characterization Matrix **** Guidelines for the Management of the Community Rapid Information System‘RAPEX’, Official Journal of the European Journal, Vol. 53, p. 64.

ACTIONS TO REDUCE RISK26

Technical RegulationsRegulatory process can be started by vote of the Commissionor by a petition from an interested partyCPSC statutes specify thatvoluntary standards shouldbe relied upon. However, aregulation may be issued if:the current voluntarystandard does notadequately reducethe riskorthere is notsubstantialcompliance.27

CPSC Voluntary Standards MonitoringParticipate incommitteesProposestandardsdevelopment orrevisionsConduct testsand evaluationsto supportfindingsCPSC staff does not vote.Analyzeinjury/deathdata for hazardpatternsReviewstandards forinadequacies28

Consumer Education CPSC.gov SaferProducts.gov Press releases & blogs Neighborhood Safety Network Publications Social media29

ENSURING COMPLIANCE

Market Surveillance ActivitiesRetailInternetPorts andAirports Program plan for regulatedproducts; surveillance for defectsand other risks Check for conformity withregulations and for recalledproducts Investigators at key ports of entry Analysts identify most likely atrisk products31

Responsibility to Comply with VoluntaryStandards and Technical RegulationsAll equally lersImporters, although reliant on foreign producers, aredirectly responsible for the safety of products they bringinto the United States.32

Corrective ActionsThe CPSA provides for three remedies inthe case of the recall of a product thatcreates a substantial product hazard3: Repair Replacement Refund of purchase price315 U.S.C. § 2064(d).33

Testing and CertificationChildren’s Products: Third party testing by CPSC-accepted labs Conformity certificates issued by importers &manufacturers (Children’s Product Certificate) Tracking labels34

Testing and CertificationNon-children’s products: Testing: Any laboratory can perform thetesting for non-children’s products. Third partytesting is not required. Certification: A General Certification ofConformity (GCC) is required for all productssubject to a rule, ban, standard or regulationenforced by the CPSC35

CPSC Testing**Compliance Support Regulated Product Testing Age Grading – determining appropriate age range for product testing. Product Safety Assessments Conformance Assessments Customs SupportHazard Reduction Support Develop performance criteria and test methods for mandatory andvoluntary standards Conduct product evaluation/research projects(**Does not certify for sale or export.)36

CPSC National Product Testing & Evaluation CenterTesting AreasToy Test LabGeneral Product Test LabChildren’s Products LabPool and Spa Products LabImpact Lab (Bike Helmets)Outdoor Power Sports LabElectrical Products Test labChemistry LabCombustion Products Test Lab Modern Conference SpaceMachine ShopFlammability/Fire Test Lab

Evaluate Results

CPSRMS – System of IncidentsCPSRMS (CPS Risk Management System) Death certificatesfrom the states Based on ICD10 codesCentralized, Web-based searchable systemStandardized product codes and injury types applied to all incoming reportsDaily posting of incoming incidents to Integrated Teams (IT) for subject matterexperts’ review and status determinationAllows historic view of similar incidents for identification of emerging hazards39

HAZARD Analyses Triage of Incoming Incidents Referral to Subject Matter Expert Teams Expert Review Assign Keywords for Pattern Identification Recommend Sampling Frequency of Reporting – Product, Hazard, Severity, Age Product Safety Assessments Trend Analyses Risk Definition and Collaborative Mitigation Strategies

Integrated Teams – Process FlowIncident onRefer forcorrectiveactionComplianceRefer forstandardsdevelopmentHazardIdentificationRefer forpublic safetycampaignCommunication

Contact InformationJake MillerRegional Product Safety Attaché, Asia-PacificU.S. Embassy, BeijingE-mail: millerjj2@state.gov42

General Product Test Lab . Flammability/Fire Test Lab Electrical Products Test lab Chemistry Lab . Modern Conference Space . Pool and Spa Products Lab . Combustion Products Test Lab . Machine Shop Toy Test

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