Archive for category: CPSC

 

October 19,2011  The CSPC voted (3-2) to approve two testing rulemakings: “Testing and Labeling Pertaining to Product Certification” and“Conditions and Requirements for Relying on Component Part Testing or Certification, or Another Party’s Finished Product Testing or Certification, to Meet Testing and Certification Requirements.”  In addition, the CPSC approved (5-0) a request for comment on ways to reduce the cost of third party testing requirements.  The comments are due 75 days after publication in the federal register.  Contentions between the Commissioners demonstrated philosophical differences, with the minority believing the rules were not as flexible or practical as they could be.

Also, a point of interest, today was Commissioner Thomas Moore’s last Commission meeting.  The White House has not yet appointed a replacement for the democratic Commissioner.  Until a new Commissioner is approved, the Commission will very likely be deadlocked 2-2 on  divisive issues.

CPSC will be holding a hearing on October 26 at 10am EST on Alternative Requirements for Small Batch Manufacturers.  The hearing will be webcast live.

 

Testing and Labeling Pertaining to Product Certification

The following rule goes in effect 15 months after publication in the Federal Register.

The rulemaking lays out requirements for ensuring continued testing of children’s products periodically and when there has been a material change to the product.  Whether conducting periodic testing or testing because of a material change in the product, a manufacturer must submit a sufficient number of samples of a children’s product, or samples that are identical in all material respects to the children’s product, to a third party conformity assessment body for testing to support certification.  “Identical in all material respects” means there is no difference with respect to compliance between the sample tested and the finished product.  Component testing consistent with the “Component Part Testing Rule” (see below) may be used to support certification testing requirements of this section.

The number of samples selected must provide the manufacturer with a high degree of assurance that the testing accurately demonstrates the compliance of the children’s product.  “High degree of assurance” means, “an evidence-based demonstration of consistent performance of a product regarding compliance based on knowledge of a product and its manufacture.”  The number of samples submitted may depend on the manufacturing process, materials used, standard the product is being tested to, etc.

Any testing failure must be investigated and the manufacturer must take necessary steps to address the reasons for the failure.  This may involve retesting the product but only when the manufacturer has a high degree of assurance that the product complies can the manufacturer issue a certification.

 

Random Representative Sampling

HR 2715 (the CPSIA amendment) amended the testing requirements by requiring a manufacturer test “representative” samples in lieu of “random” samples.  This gives manufacturers broader discretion in choosing samples of products to be tested.  Manufacturers may still conduct “random” sampling so long as the sampling is “representative.”  The CPSC staff clarified this requirement stating that the procedure used to select representative product samples must provide a basis for inferring compliance about the population of untested products.  The manufacturer must document the procedure used to select the product samples for periodic testing and the basis for inferring compliance of the unmanufactured products.

This specific provision is subject to comments due 75 days after publication in the federal register notice.

 

Periodic Testing

Periodic testing must be done for all children’s products and conducted by a third party testing facility.  A manufacturer has three options but regardless of the option the manufacturer chooses, the time between tests (or testing intervals) must be short enough to ensure there is a high degree of assurance that the untested products comply with the product safety standard.   The manufacturer should consider various factors in choosing testing intervals including: high variability in test results, known manufacturing process factors that could affect compliance, consumer complaints, introduction of new components, number of products produced, similarity with other children’s products, etc.  The three options are as follows:

Without any additional testing (as the below two options), periodic testing must be conducted at least once a year.  Manufacturers must develop a separate periodic testing plan for each manufacturing site that gives a high degree of assurance of continued compliance.  The periodic testing plan must include: tests to be conducted, the number of samples tested, and intervals at which tests will be conducted.

If a manufacturer implements a production testing plan, periodic testing must be conducted at least once every two years.  A production testing plan includes the production management techniques and tests that must be performed to provide a high degree of assurance that the products manufactured after certification continue to meet all the applicable product safety regulations.  Control charts, statistical process control programs, failure modes and effects analyses, etc. can all be elements of a “production testing plan.”  The production test plan may be tailored to the manufacturer’s needs but cannot be solely based on mathematical methods.  The manufacturer must document the production test plan (process management techniques used, tests conducted, intervals selected, number of samples, basis for determining that the plan provides a high degree of assurance of product compliance).

Manufacturers conducting continued compliance testing with testing facilities accredited to ISO/IEC 17025:2005 only need to third party test once every three years. 

Test methods must be the same as those used for certification to the applicable children’s product safety rules.  Frequency of testing with the ISO/IEC 17025:2005 certified testing facility must provide a high degree of assurance that the untested children’s products are compliant.

 

Material Change

A manufacturer must conduct third party testing every time there is a material changeto the children’s product.  “Material change” is any change in the product’s design, manufacturing process, materials, or sourcing that a manufacturer exercising due care knows, or should know, could affect the product’s ability to comply with the underlying product safety regulation.  Third party testing is limited to the “materially changed” component.

Undue Influence

Each manufacturer must establish procedures to safeguard against the exercise of undue influence by a manufacturer on a third party testing facility.  The procedures must include:

• Safeguards including a written policy statement from company officials that the exercise of undue influence is not acceptable and directing that every appropriate staff member receive training on avoiding undue influence, and sign a statement attesting to participation in such training;
• A requirement that retraining occur (as necessary) should the “undue influence” regulations change;
• A  requirement to notify the CPSC immediately of any attempt by the manufacturer to hide or exert undue influence over test results; and
•  A requirement to inform employees that allegations of undue influence may be reported confidentially to the CPSC and a description of how these reports may be made.

Recordkeeping

The following records must be maintained for five years and be made available to the CPSC upon request.  Records do not need to be maintained in English if they can be translated within 48 hours.

• The Children’s Product Certificate for each product,
•  Each third party certification test.  Each manufacturing site must have separate certification tests,
• Records of periodic tests which may include:
• Periodic test plan and periodic test results,
• A production testing plan, production test results and periodic test results, or
•  Testing results of test conducted by a testing facility accredited to ISO/IEC 17025:2005 and periodic test results,
•  Records documenting the testing of representative samples including the number of representative samples selected, the procedure used to select the samples and the basis for inferring compliance of the untested products from the results of the tested samples,
• Descriptions of all material changes and the certification tests, and
• Undue influence procedures (including training materials and employee training records).

Component Part Testing Rule

The following rule goes into effect 30 days after publication in the Federal Register.   The rule lays out the conditions and requirements whereby a final product General Conformity Certification (GCC) or Children’s Product Certification (CPC) may be based on:

• Passing component part test reports,
• Certification of component parts of consumer products, or
• Finished product testing or certification conducted by a foreign manufacturer.

The final product certification (or final GCC/CPC) must be issued by the finished product certifier or the importer or domestic manufacturer.  All other entities in the supply chain may test or certify components and/or finished products but are not required to do so.

 

Requirements for Component Part Certification

Component part certification can only be conducted if testing of the component part is required or sufficient to assess compliance.  The component part tested must be identical in all material respects to the component parts used in the finished consumer product (the same definition of “identical in all material respects” as above applies).

The certifier or testing party is responsible for exercising due care to ensure that while a component part or finished product is in its custody, proper quality control is maintained for any factor that could affect the finished product’s compliance.  Quality control includes material management, manufacturing process control and any other action/inaction that could affect compliance.  Any “known or knowable” problems should be resolved.   In addition, the certifier or testing party must ensure that testing is done in accordance to the “Testing and Labeling Pertaining to Product Certification” rulemaking (see above) and any other applicable requirements.

Component part testing must be traceable meaning that the final product certifier must be able to trace back to the testing parties (including the name and address of each testing party and any third party testing facility that conducted testing on the component part or finished product).  For example, if a toy’s screws are supplied by Supplier A, tested and assembled into the toy by Manufacturer B and Certified by Importer C, Importer C must be able to trace the screws back to Manufacturer B.  If Supplier A tests the screws, then Importer C must be able to trace the screws back to Supplier A.

 

Recordkeeping

The following records must be maintained for five years and be made available to the CPSC upon request.  Records do not need to be maintained in English if they can be translated within 48 hours.

• Identification of the component part or finished product tested,
• Identification of lot or batch number or other information to identify the component part/finished product to which the testing applies,
•  Identification of the applicable product safety standard(s),
• Identification of the testing method(s) and sampling protocol(s) used,
• Date/date range when the component part or finished product was tested,
• Test reports that provide the results and test values (must be numerical if applicable – not pass/fail),
• Identification of the third party testing facility that tested the component or finished product and an attestation by the testing facility that all testing of a component part or finished product by that party was performed in compliance with applicable requirements,
• Component part certificate(s) or finished product certificate(s), if any,
• Records to support traceability,
• An 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 compliance with the requirements in the regulation.

The finished product certifier must receive all documents before relying on another party’s certification or test report and exercise “due care.”  “Due care” means addressing any concern over the documents’ validity before relying on such documents to issue a final product certificate.

 

Component Part Testing for Lead Paint, Lead Substrate and Phthalates

Component part testing of lead paint is allowed provided:

• Unless using the ASTM F 2853-10 to test for lead in paint, the testing is performed on dry paint that is scraped off any substrate.
• The paint is identical in all material respects to the paint used in production of the consumer product.  The paint may be supplied in either liquid form or dried film on a surface.  (Note: if a paint color is made up of many base colors, and each base color is tested and found compliant with the lead content requirements, then the finished ink can be certified based on the testing of the base colors.)

The regulation also states that component part testing for phthalates and lead substrate are both allowed provided that the requirements in this regulation are met.

 

Composit testing (testing done on a combination of different paint samples or component parts) may be used for both paint and substrates.  “In composite testing, only the total amount or percentage of the target chemical is determined, not how much was in each individual paint or component part.  Therefore, to determine that each paint or component part is within the applicable limit, the entire amount of the target chemical in the compost is attributed to each paint or component part.”