CPSC STRATEGYIMPORT SURVEILLANCE &

PRODUCT TESTINGDEAN W. WOODARD, DIRECTOR, OFFICE OF EDUCATION,

GLOBAL OUTREACH AND SMALL BUSINESS OMBUDSMAN

NATIONAL RETAIL FEDERATION SUPPLY CHAIN SUMMITDALLAS, 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

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

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• 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

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 complianceCommitment to small business (sole proprietorship upwards to small manufacturing plant less than 500 employees)

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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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• 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)

Small Business Ombudsman

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• 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

Small Business Ombudsman

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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

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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Entry Review Process with ITDS/RAM

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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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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

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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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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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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PRIMER: CONSUMER PRODUCT SAFETY IMPROVEMENT ACT

(CPSIA) OF 2008Children’s products: designed or intended primarily for children 12 years old and younger – children’s toys are included.

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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) OnlyToy Safety Standard (ASTM F963-11)

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TOYS

PRIMER: CPSIA

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

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THIRD PARTY TESTINGFOR 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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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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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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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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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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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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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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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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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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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

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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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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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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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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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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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

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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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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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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RECORDKEEPINGPERIODIC/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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RECORDKEEPINGINITIAL 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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Desktop Reference Guidewww.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