The document summarizes new rules for third party testing of children's products that took effect in 2013. It outlines requirements for initial certification testing, component part testing, material change testing, and periodic testing for continued production. Manufacturers must have products tested by accredited laboratories, issue certificates of compliance, and maintain testing records. The rules aim to provide assurance that children's products meet safety standards for substances like lead and phthalates.
CPSC Toy Fair Presentation - Third Party Testing Rules for Children's Products Are Now Fully in Effect
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, 2013
VIEWS EXPRESSED IN THIS PRESENTATION ARE THOSE OF THE STAFF AND DO NOT NECESSARILY REPRESENT THE VIEWS OF THE COMMISSION.
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) – Toys
O
Y
and Child Care Articles (Sleeping & Feeding) Only
S
• Toy Safety Standard (ASTM F963-11)
2
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. 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
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. 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. 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. 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
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 for the rules potentially affected by the
material change; and
2. Issue a new Children’s Product Certificate
Mandatory; 16 CFR Part 1107
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, or
should know, could affect the product’s ability to
comply with applicable federal consumer
product safety laws and regulations.
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 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
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. 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. 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. 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
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 children's product safety rule.
16 CFR Part 1107
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. 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. 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. 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/testing
Archived www.cpsc.gov/periodic-testing Desktop Reference Guide
Presentations www.cpsc.gov/desktopguide
www.cpsc.gov/smallbiz
Slideshare Twitter
Downloadable Presentations Frequent Updates
www.SlideShare.net/USCPSC @CPSCSmallBiz
Editor's Notes
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.