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Regulatory Enforcement: An Introduction & Refresher, with 2014 Updates

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2014 updates for durable infant and toddler products. How to locate CPSC data on regulatory non-compliance notices, which are also called "letters of advice" (LOAs). The referenced Excel table will be updated frequently with the names of the firm, the foreign manufacturer, and other information. Businesses may integrate this information into their compliance workflows to assist them in sourcing safe & compliant consumer products.

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Regulatory Enforcement: An Introduction & Refresher, with 2014 Updates

  1. 1. REGULATORY ENFORCEMENT: AN INTRODUCTION & REFRESHER, WITH 2014 UPDATES ICPHSO MINNEAPOLIS, MN SEPTEMBER 11, 2014 VIEWS EXPRESSED IN THIS PRESENTATION ARE THOSE OF THE STAFF AND DO NOT NECESSARILY REPRESENT THE VIEWS OF THE COMMISSION.
  2. 2. SECTION 104: NEW RULES 2014 Bassinets/Cradles 16 CFR 1218 Effective 4/26/14 Hand Held Infant Carriers 16 CFR 1225 Effective 6/6/14 Bedside Sleepers 16 CFR 1222 Effective 7/15/14 Soft Infant & Toddler Carriers 16 CFR 1226 Effective 9/29/14 Carriages & Strollers 16 CFR 1227 Effective 9/10/15
  3. 3. SECTION 104: PENDING RULES 2014 Recently Closed to Comment Frame Child Carriers 16 CFR 1230 Effective TBD Open for Comment Infant Sling Carriers 16 CFR 1228 Effective TBD Comment period closes October 6, 2014
  4. 4. • Identify requirements (physical, mechanical, chemical) • Conduct third party laboratory testing • Issue children’s product certificate (CPC) • Affix permanent tracking marks on product and packaging. • Durable infant and nursery products require product registration cards. 4 PREMARKET REQUIREMENTS (CHILDREN’S PRODUCTS)
  5. 5. 5 Full-size 2D Stroller 3D Umbrella Stroller Travel System Carriage Tandem Stroller Side-by-Side Stroller Multi-Occupant stroller Jogging stroller CASE STUDY: STROLLERS
  6. 6. 15 USC Part 1278a (Lead Content) 16 CFR Part 1303 (Lead in Paint and Surface Coatings) 6 PREMARKET REQUIREMENTS – CHEMICAL
  7. 7. 16 CFR Part 1227 (Strollers) (Effective 9/10/2015) Based on ASTM F833-13b with modifications 16 CFR Part 1501 (Small Parts) (Part of 16 CFR 1227 upon effective date.) 7 PREMARKET REQUIREMENTS – PHYSICAL & MECHANICAL
  8. 8. The following information must be permanently marked on the stroller and its packaging: (ASTM F833-13b) WARNING Never leave child unattended WARNING Avoid serious injury from falling or sliding out. Always use seat belt WARNING Child may slip into leg openings and strangle. Never use in reclined carriage position(s) unless (manufacturer to insert product specific instructions). This warning is not required on units that do not have openings or that automatically reduce the size of all openings Products with a removable-wheel fork assembly shall contain the warning statements and additional symbols (see ASTM F833-13b) WARNING : FALL HAZARD Wheel can detach and cause tip over. Pull on the wheel to assure it is securely attached (or manufacturer may insert another word(s) to describe product specific instructions). WARNING : FALL HAZARD from tip over Before running, jogging, or walking fast, LOCK the front wheel from swiveling (or manufacturer may insert another word(s) to describe product specific instructions). *This list is only a sample and it not comprehensive 8 PREMARKET REQUIREMENTS – STROLLER LABELING*
  9. 9. Permanent Tracking Information: The manufacturer must permanently affix distinguishing information (generally referred to as “tracking labels”) to the children’s product and its packaging Product Registration On-Product Marking: (Durable infant and toddler products only.) The manufacturer must permanently place the manufacturer name and contact information, model name and number, and the date of manufacture on each product. Information may be combined on a single label. 9 PREMARKET REQUIREMENTS – STROLLER LABELING
  10. 10. Initial Certification Testing: Children’s products must be tested for compliance at CPSC-accepted laboratories. Periodic Testing: Children’s products with continuing production must be retested and recertified at a minimum of once every year, except for those manufacturers conducting additional production testing. 16 CFR Part 1107. Material Change Testing: Material changes require a retest of the product or of the component part that was changed. 10 SALES REQUIREMENTS – TESTING
  11. 11. Manufacturers and importers must furnish a “Children’s Product Certificate” (CPC) to retailers or distributors. CPC’s must also accompany the applicable product or product shipment. (This can be a website URL or a document.) www.cpsc.gov/CPC 11 SALES REQUIREMENTS - CERTIFICATION
  12. 12. Durable infant & toddler products, like a crib, must have postage pre-paid product registration cards affixed to the product for the consumer. Manufacturers must maintain the consumers' contact information in a database reserved exclusively for product safety notifications and not sales and marketing. 12 SALES REQUIREMENTS – REGISTRATION CARDS
  13. 13. Ongoing Monitoring of Consumer Use Companies should use all available means to monitor their products for safety concerns, including 1-800 customer service data, retailer and e-tailer feedback, online reviews, social media comments, & SaferProducts.gov. All information sources inform the “duty to report” to CPSC. 13 POST-SALES REQUIREMENTS
  14. 14. Companies must fully and immediately report information re: (i) a product contains a defect which could create a substantial product hazard (not substantial risk of injury); (ii) a product that creates an unreasonable risk of serious injury or death; (iii) a product that fails to comply with an applicable consumer product safety rule; (iv) certain choking incidents; and (v) certain lawsuits. Unabridged language found at www.cpsc.gov/reporting www.SaferProducts.gov 14 POST-SALES REQUIREMENTS – DUTY TO REPORT
  15. 15. A typical corrective action plan (CAP) agreement outlines: • the remedy to be implemented (repair/replace/refund/ warn), • a communication plan (consumer notification), and • specifies a recall monitoring plan and specific steps to take to dispose of or repair the products. www.cpsc.gov/recallguidance 15 RECALLS
  16. 16. • Institute internal controls and procedures to capture appropriate data • Disclose required information to regulators • Update and review controls and procedures • Provide employees with written standards and policies, compliance training, and the mechanism to report issues • Encourage disclosure of weaknesses to executives • Document compliance with above in writing and make it available to executives & board of directors 16 BEST PRACTICES: COMPLIANCE PROGRAMS
  17. 17. • Returns from distribution chain • Parts orders • Consumer complaints, claims, lawsuits, online product reviews • Product life testing • Quality assurance/product improvement • Material changes • Retailer reports/feedback • Incidents reported to/posted on SaferProducts.gov 17 BEST PRACTICES: COMPLIANCE PROGRAMS
  18. 18. CPSC LETTERS OF ADVICE/ NONCOMPLIANCE • Sent to firms with a regulatory violation • Remedies vary : • Correct Future Production • Stop Sale and Correct Future Production • Distribution Level Recall • Retail Level Recall • Consumer Level Recall • May inform future inspections, both domestic and at import.
  19. 19. FINDING CPSC LETTERS OF NONCOMPLIANCE • Identify applicable regulatory requirements for your product • Based on: • Product/product class • Intended age audience & consumer use patterns • Product’s material composition 15 USC §2063; 16 CFR §1107.20
  20. 20. FINDING CPSC LETTERS OF NONCOMPLIANCE • Identify one (or more) CPSC-accepted laboratories to conduct testing for identified regulatory requirements. • Certify in a Children’s Product Certificate (CPC) based on passing test results. • Provide CPC to retailers and distributors and, upon request, to CPSC or Customs (CBP). 15 USC §2063; 16 CFR §1107.20; 16 CFR 1110
  21. 21. CPSC LETTERS OF NONCOMPLIANCE 2,797 Violations From October 2012 through August 2014
  22. 22. CPSC LETTERS OF NONCOMPLIANCE • Voluntary; 16 CFR Part 1109 • If a finished product manufacturer purchases a component from a supplier who voluntarily tests its product (e.g., a paint supplier), that manufacturer must “exercise due care” to rely upon the component part certificate or component part test results in drafting its own Children’s Product Certificate. • The concept of due care is flexible, and it will vary depending upon the circumstances and the industry in question.
  23. 23. CPSC LETTERS OF NONCOMPLIANCE Actions Requested by Office of Compliance:  Consumer Level Recall  Retail Level Recall  Distributor Level Recall  Stop Sale and Correct Future Production  Correct Future Production
  24. 24. CPSC LETTERS OF NONCOMPLIANCE Import: Actions Requested by CPSC at Ports of Entry  Seizure & Destruction  Destruction by CBP; Requested by CPSC  Conditionally Release & Recondition  CPSC Office of Import Surveillance and Office of Compliance & Field Operations; Release under Bond  Conditionally Release For Destruction  CPSC Office of Import Surveillance and Office of Compliance & Field Operations; Release under Bond  Export  Unconditional Release
  25. 25. Desktop Reference Guide www.cpsc.gov/desktopguide CPSIA Resources www.cpsc.gov/GettingStarted Twitter @CPSCSmallBiz Slideshare Downloadable Presentations www.SlideShare.net/USCPSC RESOURCES Email list signup www.cpsc.gov/email
  26. 26. Mary Toro Director, Div. of Regulatory Enforcement Office of Compliance and Field Operations mtoro@cpsc.gov Neal S. Cohen Small Business Ombudsman ncohen@cpsc.gov THANK YOU Questions???

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