REGULATORY ENFORCEMENT:

AN INTRODUCTION & REFRESHER, WITH 2014

UPDATESICPHSOMINNEAPOLIS, MNSEPTEMBER 11, 2014

VIEWS EXPRESSED IN THIS PRESENTATION ARE THOSE OF THE STAFF AND DO NOT NECESSARILY REPRESENT THE VIEWS OF THE COMMISSION.

SECTION 104: NEW RULES2014

Bassinets/Cradles16 CFR 1218Effective 4/26/14

Hand Held Infant Carriers16 CFR 1225Effective 6/6/14

Bedside Sleepers16 CFR 1222Effective 7/15/14

Soft Infant & Toddler Carriers16 CFR 1226Effective 9/29/14

Carriages & Strollers16 CFR 1227Effective 9/10/15

SECTION 104: PENDING RULES2014

Recently Closed to Comment

Frame Child Carriers16 CFR 1230Effective TBD

Open for Comment

Infant Sling Carriers16 CFR 1228Effective TBDComment period closes October 6, 2014

• 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.

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PREMARKET REQUIREMENTS (CHILDREN’S PRODUCTS)

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Full-size 2D Stroller 3D Umbrella Stroller Travel System Carriage

Tandem Stroller Side-by-Side Stroller

Multi-Occupant stroller Jogging stroller

CASE STUDY: STROLLERS

15 USC Part 1278a (Lead Content)

16 CFR Part 1303 (Lead in Paint and Surface Coatings)

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PREMARKET REQUIREMENTS – CHEMICAL

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.)

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PREMARKET REQUIREMENTS – PHYSICAL & MECHANICAL

The following information must be permanently marked on the stroller and its packaging: (ASTM F833-13b)

WARNING Never leave child unattendedWARNING Avoid serious injury from falling or sliding out. Always use seat beltWARNING 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 HAZARDWheel 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 overBefore 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

Add

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PREMARKET REQUIREMENTS – STROLLER LABELING*

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.

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PREMARKET REQUIREMENTS – STROLLER LABELING

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.

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SALES REQUIREMENTS – TESTING

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

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SALES REQUIREMENTS - CERTIFICATION

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.

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SALES REQUIREMENTS – REGISTRATION CARDS

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.

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POST-SALES REQUIREMENTS

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

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POST-SALES REQUIREMENTS – DUTY TO REPORT

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

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RECALLS

• 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 directors16

BEST PRACTICES: COMPLIANCE PROGRAMS

• 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

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BEST PRACTICES: COMPLIANCE PROGRAMS

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.

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

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

CPSC LETTERS OF NONCOMPLIANCE

2,797 Violations

From October 2012 through August 2014

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.

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

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

Desktop Reference Guidewww.cpsc.gov/desktopguide

CPSIA Resourceswww.cpsc.gov/GettingStarted

Twitter@CPSCSmallBiz

Slideshare Downloadable Presentationswww.SlideShare.net/USCPSC

RESOURCES

Email list signup www.cpsc.gov/email

Mary ToroDirector, Div. of Regulatory EnforcementOffice of Compliance and Field Operations

mtoro@cpsc.gov

Neal S. Cohen Small Business Ombudsman

ncohen@cpsc.gov

THANK YOU

Questions???