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.

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. 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. 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. • 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
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. 15 USC Part 1278a (Lead Content)
16 CFR Part 1303 (Lead in Paint and Surface
Coatings)
6
PREMARKET REQUIREMENTS – CHEMICAL

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. 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. 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. 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. 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. 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. 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. 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. 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. • 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. • 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. 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. 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. 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. CPSC LETTERS OF NONCOMPLIANCE
2,797
Violations
From October
2012 through
August 2014

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. 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. 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. 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. 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???