One aspect of CPSC strategy, discussion of testing and certification

1. CPSC STRATEGY
IMPORT SURVEILLANCE &
PRODUCT TESTING
DEAN W. WOODARD, DIRECTOR, OFFICE OF EDUCATION, GLOBAL
OUTREACH AND SMALL BUSINESS OMBUDSMAN
NATIONAL RETAIL FEDERATION SUPPLY CHAIN SUMMIT
DALLAS, TEXAS
MAY 21, 2013
UNITED STATES OF AMERICA
CONSUMER PRODUCT
SAFETY COMMISSION
THESE COMMENTS ARE THOSE OF THE CPSC STAFF, HAVE NOT BEEN REVIEWED OR APPROVED BY,
AND MAY NOT NECESSARILY REFLECT THE VIEWS OF, THE COMMISSION

2. One CPSC Strategy to
Protect the Consumer
• Education and outreach
Domestic and international
• Import Surveillance
Loading, in transit, and dockside in USA
• Decisive Response
Recalls, letters of advice, civil penalties
2May 21, 2013

3. • Outreach/capacity building to ensure products meet
U.S. safety standards
• Close cooperation with other government product
safety agencies on requirements and common
concerns
• Extensive programs for engagement of regulatory
agencies by assisting them in effective product
surveillance strategies, testing programs, and safety
standards
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Global Outreach

4. Domestic Outreach
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University Outreach: establishing collaboration with
universities in Asia and United States with an emphasis
on manufacturing and the supply chain.
Small Business Ombudsman: Dedicated resource to
facilitate better understanding and compliance
Commitment to small business (sole proprietorship
upwards to small manufacturing plant less than 500
employees)

5. Education Outreach –
University Level
• Establishing collaboration with major U.S.
universities with a presence in Asia
• Expanding our network of engineering & scientific
departments at local universities
• Increasing the visibility of CPSC among the
academic community
• Establishing close ties with St. Louis University and
Duke University Kunshan
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6. • Dedicated resource to facilitate better
understanding and compliance
• Commitment to small business (sole
proprietorship upwards to small manufacturing
plant less than 500 employees)
• Identify the broader issues of concern to the small
business community
Office of Education, Global Outreach, and Small
Business Ombudsman (EXGO)
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Small Business Ombudsman

7. • Developing information and subject matter guidance
tailored to small business – new pages with realistic
FAQ’s written in plain English
• Developing partnerships with associations and
Alliances that represent small manufacturers, sole
proprietorships, and handcrafters
• Outreach includes webinars, presentations at trade
shows, and articles in publications
• Full use of social media
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Small Business Ombudsman

8. Global Outreach
• Enhance partnerships with foreign regulatory partners
through training exchanges
• Leadership positions in international organizations
ICPSC and OECD
• International Alignment Initiative
– Australia, Canada, EU, USA
– Seek consensus positions on hazards to children and
solutions
– Improve safety through closely aligned safety
requirements
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9. Import Surveillance
• Targeted Response
• CPSC Staff Co-Located at busiest ports
• Close scrutiny of import documentation for anomalies
• Inspection of containers
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10. Entry Review Process with
ITDS/RAM
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11. Why Focus on Education and
Import Surveillance?
(Where is the value added?)
• Raise level of quality/regulatory compliance at point
of manufacture—safer for consumers
• Interdicting noncompliant product at the ports levels
the playing field for compliant manufacturers
• World Class techniques such as TQM, 6 Sigma, ISO
31000 shift the emphasis from detection to
prevention
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12. Decisive Response
• Corrective Actions (Recalls)
― Refund, credit, replacement, repair
• Letters of Advice
― Corrective Actions, stop sales, seizure of goods
at the port
• Civil Penalty
― Penalties up to $15.15 million
― Criminal Penalties
― Injunctions
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13. Retail Surveillance
• Targeted blitzes focused on items of concern such as:
holiday toy safety, children’s products’ lead content,
and poor quality electrical products
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14. Retail Surveillance
• Includes in-store screening of products to ensure
products are properly labeled, are contained in proper
child-resistant packaging when required, and meet
generally regulatory requirements and accepted
industry voluntary standards. Includes on-site XRF
testing when feasible
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15. Retail Surveillance
• If there is a question of whether the product may pose
a hazard, official samples are collected for lab analysis
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16. PRIMER: CONSUMER PRODUCT
SAFETY IMPROVEMENT ACT (CPSIA)
OF 2008
Children’s products: designed or intended primarily
for children 12 years old and younger – children’s toys
are included.
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17. Key substantive requirements for children’s products:
Lead content in accessible components (100 ppm)
Lead in paint and surface coatings (90 ppm)
Phthalates (0.1% per banned phthalate) – Toys and
Child Care Articles (Sleeping & Feeding) Only
Toy Safety Standard (ASTM F963-11)
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T
O
Y
S
PRIMER: CPSIA

18. Key process requirements for children’s products
(including toys) primarily intended for children 12 years
old and younger:
• Third party testing by CPSC-accepted laboratories
• Conformity certificates issued by importers or
domestic manufacturers
(Children’s Product Certificate)
• Tracking labels
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PRIMER: CPSIA

19. THIRD PARTY TESTING
FOR CHILDREN’S PRODUCTS
• Initial Certification Testing
– Enforced January 1, 2012 (most products)
• Component Part Testing
– Effective December 8, 2011
• Material Change Testing
– Effective February 8, 2013
• Periodic Testing for Continued Production
– Effective February 8, 2013
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20. INITIAL CERTIFICATION TESTING
• 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
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21. INITIAL CERTIFICATION TESTING
• Identify one (or more) CPSC-accepted
laboratories to conduct testing for identified
regulatory requirements
• Issue 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
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22. COMPONENT PART TESTING
• 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.
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23. COMPONENT PART TESTING
• The concept of due care is flexible, and it will vary
depending upon the circumstances and the industry
in question.
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24. COMPONENT PART TESTING
• For example, depending upon the industry and the
circumstances, the exercise of due care may include:
― asking questions about testing and sampling
procedures;
― requesting written test procedures;
― ensuring the supplier’s third party laboratory is
CPSC-accepted; or
― spot checking a supplier’s test results;
16 CFR Part 1109
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25. COMPONENT PART TESTING
• For example, depending upon the industry and the
circumstances, the exercise of due care may include:
― visiting a supplier’s factory or third party
laboratory; or
― agreeing contractually on testing and
recordkeeping.
• Document your “exercise of due care”
• Maintain records
16 CFR Part 1109
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26. MATERIAL CHANGE TESTING
A material change means any change in the product’s
design, manufacturing process, or sourcing of
component parts that a manufacturer exercising due
care knows, or should know, could affect the product’s
ability to comply with applicable federal consumer
product safety laws and regulations.
16 CFR Part 1107
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27. MATERIAL CHANGE TESTING
• If you – the manufacturer or importer – make a
material change to the children’s product after
initial certification, you must:
―Retest the affected component part or the
product for the rules potentially affected by
the material change; and
―Issue a new Children’s Product Certificate
• Mandatory; 16 CFR Part 1107
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28. PERIODIC TESTING
• If you – the manufacturer or importer – have
continued production of your children’s product, you
must periodically retest your product using a CPSC-
accepted laboratory
• Periodic testing only applies if you have continued
production
• Mandatory; 16 CFR Part 1107
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29. PERIODIC TESTING
Periodic testing helps provide a manufacturer with a
“high degree of assurance” that its children's product
continues to be compliant with the applicable
children's product safety rules while production of its
product continues – and not just at the moment of
initial testing and certification.
www.cpsc.gov/periodic-testing
16 CFR Part 1107
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30. PERIODIC TESTING
• Periodic testing must be conducted at a minimum of
1-, 2-, or 3-year intervals, depending upon whether
the manufacturer has:
― a periodic testing plan;
― a production testing plan; or
― plans to conduct production testing using an
accredited ISO/IEC 17025:2005 laboratory.
16 CFR Part 1107
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31. PERIODIC TESTING PLAN
• 1-year minimum testing interval – but may need to
be more frequent.
• A periodic testing plan must include:
―the tests to be conducted;
―the intervals at which the tests will be
conducted; and
―the number of representative samples tested.
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32. PERIODIC TESTING PLAN
• A “periodic testing plan” must be in writing, and no
particular format is required.
• Key: Know your product, your manufacturing
process, including strengths and vulnerabilities.
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33. PRODUCTION TESTING PLAN
• 2-year minimum testing interval using a CPSC-
accepted laboratory
• During 2-year period, first party testing (or other
means of assessing compliance) is acceptable
– CPSC-accepted labs and methods are not required
for production testing during 2-year interval
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34. PRODUCTION TESTING PLAN
• A “production testing plan” must be in writing, and
no particular format is required
• Key: Know your product, your manufacturing
process, including strengths and vulnerabilities
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35. PRODUCTION TESTING PLAN
• A production testing plan must describe:
– the quality assurance techniques used in the
manufacturing process
– the tests to be conducted, or the measurements
to be taken
16 CFR Part 1107
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36. PRODUCTION TESTING PLAN
• A production testing plan must describe:
– the intervals at which those tests or measurements
will be taken;
– the number of samples tested; and
– an explanation describing how these techniques and
tests provide a high degree of assurance of continued
compliance with the applicable regulations,
particularly if they are not the tests prescribed for
the applicable children's product safety rule.
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37. PRODUCTION TESTING PLAN
• 3-year minimum testing interval using a CPSC-
accepted laboratory
• During 3-year period, first party testing must be
conducted by an ISO/IEC 17025:2005-accredited
laboratory
• The tests conducted must use the methods in the
standard
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38. RECORDKEEPING
PERIODIC/PRODUCTION TESTING
• For 5 years, a manufacturer must maintain records of:
– its periodic or production testing plan;
– its periodic and/or production testing results; and
• Recommendation: Maintain documentation of the
other actions the manufacturer has taken to secure a
high degree of assurance that its products comply
with the applicable children's product safety rule.
16 CFR Part 1107
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39. RECORDKEEPING
INITIAL CERTIFICATION/MATERIAL CHANGE TESTING
• For 5 years, a manufacturer must also maintain
records of:
– all Children’s Product Certificates;
– all third party certification test results from initial
certification and material change testing;
– and all descriptions of material changes in a
product’s design, manufacturing process; and
sourcing of component parts during the continued
production of a product.
16 CFR Part 1107
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40. Twitter
Frequent Updates
@CPSCSmallBiz
Slideshare
Downloadable Presentations
www.SlideShare.net/USCPSC
Join the EXGO listserv for
regular updates. Just
send Dean an email.
Desktop Reference
Guide
www.cpsc.gov/desktopguide
Dean W. Woodard, Director, Office
of Education, Global Outreach, and
Small Business Ombudsman (EXGO)
dwoodard@cpsc.gov
(301) 504-7651
business@cpsc.gov
(301) 504-7999
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