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UNITED STATES OF AMERICA
                                                      CONSUMER PRODUCT
                                                      SAFETY COMMISSION

   E VERYTHING YOU E VER WANTED TO
   KNOW A BOUT THIRD PARTY TESTING
    C HILDREN’S PRODUCTS BUT WERE
             A FRAID TO A SK
                                       CPSC PANEL DISCUSSION
                AT INTERNATIONAL CONSUMER PRODUCT HEALTH AND SAFETY
                       ORGANIZATION (ICPHSO) - CRYSTAL CITY, VA
                                  FEBRUARY 28, 2013
VIEWS EXPRESSED IN THIS PRESENTATION ARE THOSE OF THE STAFF AND DO NOT NECESSARILY REPRESENT THE VIEWS OF THE COMMISSION.
THIRD PARTY TESTING
                FOR CHILDREN’S PRODUCTS

1. Initial Certification Testing
  – Enforced January 1, 2012 (most products)
2. Component Part Testing
  – Effective December 8, 2011
3. Material Change Testing
  – Effective February 8, 2013
4. Periodic Testing for Continued Production
  – Effective February 8, 2013
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
INITIAL CERTIFICATION TESTING
• 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
COMPONENT PART TESTING
• Voluntary; 16 CFR Part 1109
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.
• The concept of due care is flexible, and it will vary
  depending upon the circumstances and the industry in
  question.
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;
   –   spot checking a supplier’s test results;
   –   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
As of February 8, 2013…
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
MATERIAL CHANGE TESTING
If you – the manufacturer or importer – make a
material change to the children’s product after
initial certification, you must:
1. Re-test the affected component part or the
    product to the rules potentially affected by the
    material change; and
2. Issue a new Children’s Product Certificate

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 that product continues
  – and not just at the moment of initial testing
                 and certification.
            www.cpsc.gov/periodic-testing
                                            16 CFR Part 1107
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 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
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.
• 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.
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 period
• 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;
   – 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.
                                                      16 CFR Part 1107
EXAMPLE
EXAMPLE
EXAMPLE
EXAMPLE
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
   – records documenting the testing of representative
      samples, including the number of samples selected, the
      procedure used to select samples, and the basis for
      inferring compliance of the product based on the results of
      the tested samples.
• 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
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
RECORDKEEPING
                  COMPONENT PART TESTING
• For 5 years, each testing party and certifier
  must have access to the following records:
  – Test reports, including the test values, if any;
  – Identification of the party that conducted each
    test.
  – Identification of the:
     •   component part or the finished product tested;
     •   lot or batch tested;
     •   the applicable rules tested;
     •   testing method(s) and sampling protocol(s) used;
     •   date or date range when the component part or
         finished product was tested;
RECORDKEEPING
                COMPONENT PART TESTING
• For 5 years, each testing party and certifier
  must also have access to the following records
  and attestations:
  – Component part certificate(s) or finished product
    certificate(s), if any;
  – Records to support traceability to the party that had
    the component part or finished product tested;
  – Attestation by the party conducting testing that it was
    performed in compliance with section 14 of the CPSA,
    part 1107, or any more specific applicable rules; and

                                          16 CFR Part 1109
RECORDKEEPING
               COMPONENT PART TESTING
– Attestation by each certifier and testing party that
  while the component part or finished product was
  in its custody, it exercised due care to ensure:
    a.   proper management and control of raw materials,
         component parts, subassemblies, and finished
         products;
    b.   that the manufacturing process did not result in a
         prohibited level of a chemical from any source;
         and
    c.   that no action or inaction subsequent to testing
         and before distribution in commerce has occurred
         that would affect compliance.
                                         16 CFR Part 1109
UNDUE INFLUENCE TRAINING
• Manufacturers and their employees must not
  exert undue influence on testing laboratories to
  alter test methods or test results that serve as the
  basis for certifying a product’s compliance under
  federal law.
• Every appropriate staff member must receive
  training on avoiding undue influence and sign a
  statement evidencing the training.
   – Digital signatures are acceptable.
• Reports alleging undue influence can be filed
  confidentially with the CPSC Office of the
  Secretary.
Resources
Third Party Testing           Twitter @CPSCSmallBiz
www.cpsc.gov/testing
                              Slideshare
                               Downloadable Presentations
Desktop Reference Guide        www.SlideShare.net/USCPSC
www.cpsc.gov/desktopguide

                              Email list signup
CPSIA Resources                www.cpsc.gov/smallbiz
www.cpsc.gov/GettingStarted
EXAMPLE
Thank You
                       Panelists:

                       John Boja, PhD
                           Office of Compliance
                           jboja@cpsc.gov
Moderator:

Neal S. Cohen          Randy Butturini, PE
     Small Business        Office of Hazard Identification & Reduction
     Ombudsman             rbutturini@cpsc.gov
     ncohen@cpsc.gov   David DiMatteo
                            Office of General Counsel
                            ddimatteo@cpsc.gov
                       Mary House
                           Office of General Counsel
                           mhouse@cpsc.gov

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Everything You Ever Wanted to Know About Third Party Testing Children’s Products But Were Afraid to Ask

  • 1. UNITED STATES OF AMERICA CONSUMER PRODUCT SAFETY COMMISSION E VERYTHING YOU E VER WANTED TO KNOW A BOUT THIRD PARTY TESTING C HILDREN’S PRODUCTS BUT WERE A FRAID TO A SK CPSC PANEL DISCUSSION AT INTERNATIONAL CONSUMER PRODUCT HEALTH AND SAFETY ORGANIZATION (ICPHSO) - CRYSTAL CITY, VA FEBRUARY 28, 2013 VIEWS EXPRESSED IN THIS PRESENTATION ARE THOSE OF THE STAFF AND DO NOT NECESSARILY REPRESENT THE VIEWS OF THE COMMISSION.
  • 2. THIRD PARTY TESTING FOR CHILDREN’S PRODUCTS 1. Initial Certification Testing – Enforced January 1, 2012 (most products) 2. Component Part Testing – Effective December 8, 2011 3. Material Change Testing – Effective February 8, 2013 4. Periodic Testing for Continued Production – Effective February 8, 2013
  • 3. 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
  • 4. INITIAL CERTIFICATION TESTING • 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
  • 5. COMPONENT PART TESTING • Voluntary; 16 CFR Part 1109
  • 6. 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. • The concept of due care is flexible, and it will vary depending upon the circumstances and the industry in question.
  • 7. 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; – spot checking a supplier’s test results; – 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
  • 8. As of February 8, 2013…
  • 9. 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
  • 10. MATERIAL CHANGE TESTING If you – the manufacturer or importer – make a material change to the children’s product after initial certification, you must: 1. Re-test the affected component part or the product to the rules potentially affected by the material change; and 2. Issue a new Children’s Product Certificate Mandatory; 16 CFR Part 1107
  • 11. 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 that product continues – and not just at the moment of initial testing and certification. www.cpsc.gov/periodic-testing 16 CFR Part 1107
  • 12. 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
  • 13. 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
  • 14. 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. • 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.
  • 15. 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 period • 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.
  • 16. 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; – 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. 16 CFR Part 1107
  • 21. 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 – records documenting the testing of representative samples, including the number of samples selected, the procedure used to select samples, and the basis for inferring compliance of the product based on the results of the tested samples. • 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
  • 22. 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
  • 23. RECORDKEEPING COMPONENT PART TESTING • For 5 years, each testing party and certifier must have access to the following records: – Test reports, including the test values, if any; – Identification of the party that conducted each test. – Identification of the: • component part or the finished product tested; • lot or batch tested; • the applicable rules tested; • testing method(s) and sampling protocol(s) used; • date or date range when the component part or finished product was tested;
  • 24. RECORDKEEPING COMPONENT PART TESTING • For 5 years, each testing party and certifier must also have access to the following records and attestations: – Component part certificate(s) or finished product certificate(s), if any; – Records to support traceability to the party that had the component part or finished product tested; – Attestation by the party conducting testing that it was performed in compliance with section 14 of the CPSA, part 1107, or any more specific applicable rules; and 16 CFR Part 1109
  • 25. RECORDKEEPING COMPONENT PART TESTING – Attestation by each certifier and testing party that while the component part or finished product was in its custody, it exercised due care to ensure: a. proper management and control of raw materials, component parts, subassemblies, and finished products; b. that the manufacturing process did not result in a prohibited level of a chemical from any source; and c. that no action or inaction subsequent to testing and before distribution in commerce has occurred that would affect compliance. 16 CFR Part 1109
  • 26. UNDUE INFLUENCE TRAINING • Manufacturers and their employees must not exert undue influence on testing laboratories to alter test methods or test results that serve as the basis for certifying a product’s compliance under federal law. • Every appropriate staff member must receive training on avoiding undue influence and sign a statement evidencing the training. – Digital signatures are acceptable. • Reports alleging undue influence can be filed confidentially with the CPSC Office of the Secretary.
  • 27. Resources Third Party Testing Twitter @CPSCSmallBiz www.cpsc.gov/testing Slideshare Downloadable Presentations Desktop Reference Guide www.SlideShare.net/USCPSC www.cpsc.gov/desktopguide Email list signup CPSIA Resources www.cpsc.gov/smallbiz www.cpsc.gov/GettingStarted
  • 29. Thank You Panelists: John Boja, PhD Office of Compliance jboja@cpsc.gov Moderator: Neal S. Cohen Randy Butturini, PE Small Business Office of Hazard Identification & Reduction Ombudsman rbutturini@cpsc.gov ncohen@cpsc.gov David DiMatteo Office of General Counsel ddimatteo@cpsc.gov Mary House Office of General Counsel mhouse@cpsc.gov