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2012 Safety Academy: Compliance Overview


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Acting Compliance Director provides overview of compliance operations for 2012

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2012 Safety Academy: Compliance Overview

  1. 1. U.S. Consumer Product Safety Commission Office of Compliance and Field Operations Safety Academy September 20, 2012 Marc J. Schoem Acting Director This presentation was prepared by CPSC staff, has not been reviewed or approved by, and may not reflect the views of the Commission.
  2. 2. Overview Office of Compliance and Field Operations Defect Regulatory FieldInvestigations Enforcement Investigations Division Division Division by Hazard by Hazard by City/State 2
  3. 3. Compliance Meeting CPSC Strategic Goals• Rigorous Hazard Identification • Retail Product Surveillance – Sample Collections • Internet Website Surveillance • Resale and Thrift Store Product Surveillance • In-Depth Investigations • Supporting Import Surveillance at Ports• Decisive Response • Establishment Inspections • Identification of Defective and Violative Products • Timely Investigations and Preliminary Determinations • Timely Referrals to OGC of Potential Section 15(b) Reporting Violations 3
  4. 4. Compliance Activities Defect Enforcement of CorrectiveInvestigations Rules and Bans Actions/Recalls Market Field ImportSurveillance Operations Surveillance Sanctions/ Penalties 4
  5. 5. Surveillance Databases IPII DTHS INDP NEISS National Injury and In-Depth Electronic DeathPotential Injury Investigations Injury Certificates Incident Data (IDIs) Surveillance System 5
  6. 6. In-Depth Investigations7,000 6,1786,000 5,513 5,277 5,036 5,057 4,984 4,8405,000 4,614 4,746 4,2954,000 3,8003,0002,0001,000 0 FY02 FY03 FY04 FY05 FY06 FY07 FY08 FY09 FY10 FY11 FY12 as of 9/18 6
  7. 7. Surveillance Activities • Program plan for regulated products; surveillance for defects Retail and other risks • Check for conformity with regulations and for recalledInternet products • Investigators at key ports of entryPorts and • Analysts identify most likely at- risk productsAirports 7
  8. 8. Reporting Under Section 15• When to report: • The manufacturer, importer, distributor, or retailer is required to report immediately upon obtaining information which reasonably supports the conclusion that a product: • Fails to meet a rule, regulation, standard, or ban under the CPSA or any other statute enforced by the CPSC; • Contains a defect which could create a substantial product hazard to consumers; or • Creates an unreasonable risk of serious injury or death. 8
  9. 9. Reporting Under Section 15 What to Provide When ReportingInitial Report• Details about product, stop sale date, potential defect and hazard, samples, and all available information Full Report• All information requested in 16 CFR §1115.13 with regard to manufacturer, product, defect, and injuries 9
  10. 10. Section 15 Reporting Trends 10
  11. 11. Overview of the Section 15 Defect/Hazard Process Contains DefectSection 15 Action Against Report/ the Product Sample PreliminaryPI/CA Case Determination No Action Against the Evaluation by Expert Staff Product Engineering, Human Factors, Health Sciences 11
  12. 12. Identifying Defect/Hazard• Pattern of Defect • Identification of defect, flaw, error and issues associated with design, engineering, quality control, labeling, use, assembly.• Number of Defective Products • Distributed into commerce• Severity of Risk • Severity of injury • Likelihood injury will occur • Vulnerable population affected 12
  13. 13. Overview of the Regulatory Process Banned Or Misbranded Product Testing for theRegulatory • standard 13 Corrective Case Action Plan Applicable No Action Regulation Against the Product 13
  14. 14. Implementing a Product Safety Recall Decision to Recall Stop Production Redesign? Stop Distribution Repair? Disposal? Stop Retail Sales Consumer Return for Incentives/ Repair/Replace Notification Refund Disposal 14
  15. 15. Fast Track Case Percentages of All Section 15 Reports100%90%80%70% 57% 56% 56%60% 54% 52% 52% 51% 48% 49% 48%50% 43%40%30%20%10% 0% FY 02 FY 03 FY 04 FY 05 FY 06 FY 07 FY 08 FY09 FY10 FY11 FY12 as of 9/18 15
  16. 16. Voluntary Recalls by Fiscal Year 16
  17. 17. Recalls and LOAs by Fiscal Year 2,1092000 1,907190018001700 1,627160015001400130012001100 1,0291000 915 900 800 681 704 700 618 600 473 478 498 476 500 413 422 400 300 200 100 0 FY06 FY07 FY08 FY09 FY10 FY11 FY12 as of 9/18 Recalls LOAs 17
  18. 18. Violations/Prohibited Acts Manufacturing, distributing, or importing any product that does not comply with a mandatory standard Failing to report information as required by CPSC statutes Selling a recalled product Exporting a recalled product for sale 18
  19. 19. Office of Compliance and Field Operations Priorities• Implementation of Field Investigative Enforcement Programs Cribs Mattresses VGB Pool Safety Act Bed Rails Fireworks Toddler Beds Toys Baby Walkers Children’s Sleepwear Bath Seats• Testing & Certification Requirements for Children’s and Non-Children’s Products. 19
  20. 20. Office of Compliance and Field Operations Priorities• Recall Effectiveness • Review Use of Product Registration Cards • Review Use of Social Media• Review of Internal Procedures • Review and Update of Defect and Regulatory • Procedures and Investigative Letters • Advance Section 6(b) Notice of Investigations • More Timely Response • Broader More Consistent Public Notification Through Voluntary Corrective Actions Plans and Letters of Advice 20
  21. 21. Office of Compliance and Field Operations Priorities Recall Monitoring Reverse Logistics• Reverse distribution or product return • how you get the product back from distribution• Reverse logistics plan should outline details such as: • how to quarantine the product • how to get the product returned • how to remove the product from shelves • how to repair, replace, or dispose of the product• Provide your reverse logistics plan to Compliance staff with your Corrective Action Plan (CAP) and Full Report. 21
  22. 22. Office of Compliance and Field Operations PrioritiesUse of Social Media in Consumer Notification 22
  23. 23. Industry Guidance•• “Business” section of website•• Monitor CPSC Activities through: • Frequently Visiting CPSC Website • Recall Announcement Subscriptions • Public Calendar Subscriptions • CPSC Electronic Reading Room Inquiries • CPSC Clearinghouse Letters • Seminar Attendance (Trade Shows/ICPHSO) • CPSC Public Database 23
  24. 24. Contact Information Marc J. Schoem Acting DirectorOffice of Compliance and Field OperationsU.S. Consumer Product Safety Commission 301-504-7520 – phone 240-638-6955 – mobile 24
  25. 25. Consumer Product Safety• CommissionMr. Dean W. Woodard U.S. CPSCDirector Office of Education, Global Outreach, and Small Business Ombudsman