CPSC Toy Fair Presentation - Third Party Testing Rules for Children's Products Are Now Fully in Effect

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Overview of third party testing rules for children's products, including initial certification testing, material change testing, and periodic testing if you have continued production. Presentation also addresses optional component part testing. A review of mandatory recordkeeping requirements and undue influence training is also discussed. Pairs with video at http://www.youtube.com/watch?v=cR4RXQjmqC8

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  • As of 2013, CPSC has over 400 accepted laboratories around the world
  • Best practice is to know all of this at the design stage. Design in safety. (Importers are at a disadvantage here. Importers will likely find themselves in the position of having to test more frequently due to lack of knowledge/input/control about product’s design/manufacturing process/material composition and uncertainly about material substitutions and other changes to the product from batch to batch. Much will depend on the relationships and contractual provisions with suppliers, and the due care that an importer exercises in overseeing those relationships.)
  • Conformity certificates furnished to retailers and distributors and CPSC/CBP, upon request. Not required to furnish to consumers.
  • A party “exercising due care” must use the degree of care that a prudent and competent person engaged in the same line of business or endeavor would exercise under similar circumstances. At a minimum, due care requires taking some affirmative step to ensure the validity of the test report or certification being relied upon. Actions taken by a certifier to ensure the reliability of test reports from a supplier may differ depending on the nature of the component part supplied, the risk of noncompliance, the industry involved, and the nature of the relationship with the supplier. A long-term relationship with a trusted supplier that receives a large portion of its profits from one manufacturer may not require the same level of inquiry or monitoring as that of a new supplier that provides parts to many different manufacturers infrequently. Depending on the industry and the facts, a certifier may take various actions in order to know something about the validity of the test reports or certifications being relied upon.
  • 2 new pieces of the third party testing puzzle….
  • Bullet #2Meaning that if you do not have "continued production", a new CPC will be required the next time you produce the product.
  • Periodic testing plan means testing with a CPSC-accepted laboratory. A manufacturer is expected: (a) to know the best way to achieve compliance of its product, and (b) to use its knowledge of the product's design and manufacturing process to create a written periodic testing plan. Periodic testing should be conducted frequently enough to provide the manufacturer or importer a high degree of assurance that continuing production of the children's product complies with all applicable children's product safety rules. If a manufacturer is relying on a “periodic” testing plan, testing must be conducted no less than once per year, and it may need to be conducted more often than once per year. For example, the periodic testing rule states that in determining the frequency (by batch, lot, or other measurement) of testing ongoing production, a manufacturer may wish to consider various factors, such as: high variability in test results; measurements that are close to the allowable numerical limit for quantitative tests; known manufacturing process factors that could affect compliance with a rule; introduction of a new set of component parts into the manufacturing process; andthe potential for serious injury or death resulting from a noncompliant children's product, among other factors. Although not required, a manufacturer may wish to consider describing the rationale for the design of its periodic testing plan to memorialize the rationale and document the information available to the manufacturer at the time the plan was drafted. In the event that a health or safety problem with the product becomes evident later, retaining such information may provide the manufacturer and CPSC with an understanding of where and why the problem occurred.
  • Production testing means just that, first-party testing during production using a plan you’ve crafted and implemented to ensure a high degree of assurance for continued production . CPSC-accepted labs and methods are not required for production testing during 2-year interval periodEverything that a manufacturer does to control for potential variability in its production process (e.g., incoming inspection of raw materials, first party testing, in-factory QA/QC systems), in addition to periodic testing, should work together to provide the desired high degree of assurance.Mention but no details on ISO/IEC 17025:2005 laboratory
  • Everything that a manufacturer does to control for potential variability in its production process (e.g., incoming inspection of raw materials, first party testing, in-factory QA/QC systems), in addition to periodic testing, should work together to provide the desired high degree of assurance.3- year testing interval based on conduct continued testing using an accredited ISO/IEC 17025:2005 laboratory. See the regulation for greater detail. Not going to address ISO/IEC 17025:2005 laboratory here, although it is basically a production testing plan but using CPSC approved test methods with the ISO laboratory.
  • CPSC does not provide a model undue influence training course. Reports alleging undue influence can be filed confidentially with the CPSC Office of the Secretary.
  • The burden for demonstrating whether any material qualifies for a determination shall be on the submitter of the information requested in the RFI. Resources in the FY 2014 (Oct. 2013) to review, summarize, and respond.
  • CPSC Toy Fair Presentation - Third Party Testing Rules for Children's Products Are Now Fully in Effect

    1. 1. UNITED STATES OF AMERICA CONSUMER PRODUCT SAFETY COMMISSION A RE YOU R EADY? THIRD PARTY TESTING R ULES FOR C HILDREN’S PRODUCTS A RE NOW F ULLY I N E FFECT BY: NEAL S. COHEN, SMALL BUSINESS OMBUDSMAN NEW YORK INTERNATIONAL TOY FAIR FEBRUARY 12, 2013VIEWS EXPRESSED IN THIS PRESENTATION ARE THOSE OF THE STAFF AND DO NOT NECESSARILY REPRESENT THE VIEWS OF THE COMMISSION.
    2. 2. 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. • Key substantive requirements for children’s products: • Lead content in accessible components (100 ppm) • Lead in paint and surface coatings (90 ppm)T • Phthalates (0.1% per banned phthalate) – ToysOY and Child Care Articles (Sleeping & Feeding) OnlyS • Toy Safety Standard (ASTM F963-11) 2
    3. 3. • Key process requirements for children’s products (including toys) primarily intended for children 12 years old and younger: 1. Third party testing by CPSC-accepted labs 2. Conformity certificates issued by importers or manufacturers (Children’s Product Certificate) 3. Tracking labels 3
    4. 4. THIRD PARTY TESTING FOR CHILDREN’S PRODUCTS1. Initial Certification Testing – Enforced January 1, 2012 (most products)2. Component Part Testing – Effective December 8, 20113. Material Change Testing – Effective February 8, 20134. Periodic Testing for Continued Production – Effective February 8, 2013
    5. 5. 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
    6. 6. 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
    7. 7. 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.
    8. 8. 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
    9. 9. Beginning February 8, 2013…
    10. 10. MATERIAL CHANGE TESTINGIf you – the manufacturer or importer – make amaterial change to the children’s product afterinitial certification, you must:1. Re-test the affected component part or the product for the rules potentially affected by the material change; and2. Issue a new Children’s Product CertificateMandatory; 16 CFR Part 1107
    11. 11. 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, orshould know, could affect the product’s ability to comply with applicable federal consumer product safety laws and regulations. 16 CFR Part 1107
    12. 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. 13. PERIODIC TESTING Periodic testing helps provide a manufacturer with a “high degree of assurance” that its childrens product continues to be compliant with the applicable childrens product safetyrules 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
    14. 14. 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
    15. 15. 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.
    16. 16. 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.
    17. 17. 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 childrens product safety rule. 16 CFR Part 1107
    18. 18. 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 childrens product safety rule. 16 CFR Part 1107
    19. 19. 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
    20. 20. 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.
    21. 21. TOYS: POTENTIAL BURDEN REDUCTION• Existing determination for lead content – 16 CFR § 1500.91• Proposed “Requests For Information” (RFIs): – 8 Heavy Metals (Section 4.3.5.2 of ASTM F963-11) • Antimony, Arsenic, Barium, Cadmium, Chromium, Lead, Mercury, and Selenium – Prohibited Phthalates (Section 108 of CPSIA) – Adhesives in Manufactured Woods (Lead content; Sec. 101 of CPSIA) – Synthetic Food Additives (Lead content; Sec. 101 of CPSIA) 2013 CPSC Operating Plan
    22. 22. Neal S. Cohen Small Business Ombudsman Office of Education, Global Outreach, and Small Business Ombudsman ncohen@cpsc.gov (301) 504-7504 www.cpsc.gov/gettingstarted www.cpsc.gov/testingArchived www.cpsc.gov/periodic-testing Desktop Reference GuidePresentations www.cpsc.gov/desktopguidewww.cpsc.gov/smallbizSlideshare TwitterDownloadable Presentations Frequent Updateswww.SlideShare.net/USCPSC @CPSCSmallBiz

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