The Consumer Product Safety Commission ("CPSC" or "Commission") has announced proposed rules regarding the requirements for a "reasonable testing program" and other certification testing  and the requirements for component part testing  pursuant to the Consumer Product Safety Improvement Act ("CPSIA"). Domestic manufacturers and importers of children's products and other products subject to a CPSC regulation or ban should track the development of the proposed rules and may consider incorporating some of the provisions now, in anticipation of a final rule.
The proposed rule on testing and labeling (referenced by the CPSC as the "15 Month Rule" because the rule was supposed to be issued 15 months after enactment of the CPSIA) would:
- Define the elements of a "reasonable testing program" for the testing and certification of products subject to a consumer product safety rule;
- Establish the protocols and standards for initial and continued testing of children's products; and
- Describe the label that manufacturers may place on a consumer product to show that the product complies with the certification requirements.
The proposed rule on component part testing would establish the conditions and requirements for testing of component parts of consumer products to demonstrate compliance with all applicable rules, bans, standards, and regulations:
- To support a general conformity certificate or a certificate for a children's product;
- As part of a reasonable testing program;
- As part of the standards and protocols for continued testing of children's products; or
- To meet the requirements of any other rule, ban, standard, guidance, policy, or protocol regarding consumer product testing that does not already directly address component part testing.
Comments to the proposed rules are due by August 3, 2010, and the Commission has proposed that any final rule would become effective 180 days after its publication. Please contact us if you are interested in preparing comments.
15 Month Rule
The Commission has proposed requirements for a "reasonable testing program" for a general conformity certificate ("GCC") for non-children's products as well as requirements to establish and maintain certification for children's products that must be tested by an accredited third-party lab.
"Reasonable Testing Program" for Non-Children's Products
Section 102 of the CPSIA requires every domestic manufacturer or importer of consumer products subject to any product safety rule under the CPSIA or similar rule, ban, standard, or regulation under any act enforced by the CPSC - and (1) imported for consumption and warehousing or (2) distributed in commerce - to issue certificates of conformity with the applicable standards. For non-children's products, these GCCs must be based either on individual tests of the product or on a "reasonable testing program."
A reasonable testing program must provide a high degree of assurance that the products will comply with all applicable rules, bans, standards, or regulations. To that end, the Commission has proposed that a reasonable testing program include the following five elements:
- Product specifications that describe the product and list the safety rules, bans, standards, or regulations, with which the product must comply. The specification would include a complete description of the product, and any other information, including, but not limited to, the materials and/or model names of items necessary for description and differentiation. The same specification may be used for different product sizes or other variations that do not affect the product's ability to comply with applicable rules, bans, standards, or regulations.
- Certification tests performed on samples of the product. Certification tests must be performed on samples that are identical to the finished product in all material respects. Products undergoing a material change after the initial certification testing would need to be retested. Manufacturers or importers can develop specific procedures, such as the number of samples to test, provided that the testing plan provides a "high degree of assurance that noncompliant products are not introduced into the stream of commerce."
- Production testing plan describing the tests that must be performed and testing intervals. The testing plan would need to exist for each manufacturing site and specify testing intervals short enough to ensure that if samples selected for testing comply with applicable rules, bans, etc., then there is a high degree of assurance that the untested products manufactured during that interval also comply. Companies may use recurring testing or process management techniques such as control charts, statistical process control programs, or failure modes and effects analysis.
- Remedial action plan. A remedial action plan would describe the steps to take whenever samples of a product or a component part fails a test or fail to comply with an applicable rule, ban standard, or regulation, including procedures to investigate and address failing test results. The remedial action may differ depending on the applicable rule, ban, standard, or regulation.
- Documentation of the reasonable testing program and how it was implemented. The required records would include: general conformity certificates for each product, product specification records, certification testing records including the identification of any third party conformity assessment body, testing plan records, and records of any remedial actions taken. The Commission proposes that the company maintain the records (except for test records) for as long as the product is in production or imported by the manufacturer, plus five years. Test records must be maintained for five years.
The Commission believes that these elements are present in most testing programs and can be accomplished with seemingly little efforts.
Third-Party Certification of Children's Products
The CPSIA requires every domestic manufacturer or importer of a children's product to issue a certificate, based on testing of sufficient samples by an accredited third-party laboratory, stating that the product complies with all applicable children's product safety rules. The proposed rule covers the requirements to establish the initial certification and to maintain ongoing certification.
To establish the initial certification, manufacturers must submit a sufficient number of samples of a children's product to a third party conformity assessment body for testing. The number of samples must "provide a high degree of assurance that the tests conducted for certification purposes accurately demonstrate the ability of the children's product to meet all applicable children's product safety rules." Fewer samples may be necessary if the manufacturing process consistently creates finished products that are uniform in composition and quality. Unless otherwise required, manufacturers may substitute component part testing for complete product testing, pursuant to the rule that will be codified at 16 C.F.R. pt. 1109, if the component part is sufficient to determine compliance for the entire product. If a product or component fails certification testing, the manufacturer must investigate the reasons for the failure and take remedial action.
The Commission has also provided some flexibility for reliance on a certificate from a third party such as a vendor or foreign manufacturer. For example, the Commission's statement of basis and purpose for the proposed rule states:
While an importer is not required to commission testing itself and may, in certain cases, use component part test reports from the manufacturer, the importer is responsible for issuing the certificate for a children's product. The importer must also ensure that the proper testing was conducted (i.e., a third party conformity assessment body accredited for the correct test conducted the testing)....In those cases in which the importer has little or no control over the manufacturing process and is relying on the manufacturer's test data, the importer should take measures to understand the manufacturing and testing process.
Once establishing the initial certification, manufacturers must conduct periodic testing, at least annually, unless subject to an exception. If a manufacturer has implemented a reasonable testing program, it must submit samples to a third party conformity assessment body for periodic testing at least once every two years. If a manufacturer has not implemented a reasonable testing program, all periodic testing must be conducted by a third party conformity assessment body pursuant to a test plan and in intervals described in the proposed rule.
The proposed rule also addresses procedures for selecting random samples and safeguarding against the exercise of undue influence by a manufacturer on a third party conformity assessment body. If a children's product undergoes a material change in product design or manufacturing process, including the sourcing of component parts, that a domestic manufacturer or importer exercising due care knows or should know could affect compliance, the company must submit the materially changed product for testing by a third party conformity assessment body.
As with the reasonable testing program, a certification program for children's products must include a remedial action plan to investigate and address any failing test results. The proposed rule also specifies certain records that a manufacturer must maintain and make available for inspection by the CPSC upon request. The Commission proposes that the company maintain the records (except for test records) for as long as the product is in production or imported by the manufacturer, plus five years. Test records must be maintained for five years.
Component Parts Testing and Other Relief
In acknowledging the economic burden that businesses face as a result of required testing, the Commission has proposed a separate rule that would allow for the testing of component parts to support a general conformity certificate or a certificate for a children's product pursuant to section 14(a0 of the CPSA, as part of the reasonable testing program, as part of the standards and protocols for continued testing of children's products and/or to meet the requirements of any other rule, ban, standard, etc. regarding consumer product testing that does not already directly address component part testing. The Commission and staff had previously issued other guidance regarding component part testing. Any final rule arising from the proposed rule would supersede all previous guidance.
A company may certify compliance based on testing of a component part if the following requirements are met:
- Testing of the component part is required or sufficient to assess the consumer product's compliance. For example, testing a component part for lead may be sufficient in situations where only the component part is known to contain or may contain lead. On the other hand, testing a component part of a consumer product for compliance with the small parts requirements will, rarely, if ever, be appropriate, because the test generally requires that the entire product be tested to determine whether small parts can be detached during the use of the product. The component tested must be identical in all material respects to the component used in the finished consumer product and if there are any doubts as to whether the testing of one or more component parts can help to assess whether the entire product complies with applicable rules, the proposed rule dictates that the entire product should be tested.
- The component part tested is identical to the component parts used in the finished consumer product in all material respects.
- For content testing, the sample may be of a different size, shape, or finished condition as the component part of the finished product as long as the quantity is sufficient for testing purposes and in any form that has the same content as the component part of the finished product.
- A certifier must exercise due care to ensure that no change in the component parts after testing and before distribution has occurred that would affect compliance.
- Manufacturers of finished consumer products must exercise due care in the proper management and control of all raw materials, component parts, subassemblies, and finished goods for any factor that could affect compliance.
- A rule, ban, standard, or regulation does not require that the entire consumer product be tested.
- The certifiers and testing parties ensure that the test methods and sampling protocols comply with 16 C.F.R. pt. 1107 (described above) and any more specific requirements.
- Component parts are traceable.
- The testing party provides specified documentation to the certifier. All testing parties must maintain such documentation for five years. In addition, all certifiers must maintain records to support the traceability of component part suppliers for as long as the corresponding product is produced or imported and for an additional five years. The finished product certifier must make these records available for inspection by the CPSC upon request.
- The finished product certifier exercises due care in its reliance on a certificate for a component part, including taking the steps a prudent and competent person would take to conduct a reasonable review of a component part certificate and to address any concern over its validity.
Certifications issued in whole or in part based upon component part testing must identify the specified documentation required from the component part certifier or testing party and certify that no action subsequent to component part testing changed or degraded the consumer product such that it adversely affected the product's ability to comply with all applicable rules, bans, standards, and regulations.
The proposed rule also specifies conditions and requirements for specific consumer products, component parts, and chemicals such as paint, lead content, and phthalates.
Kelley Drye & Warren LLP
Kelley Drye & Warren's Consumer Product Safety practice group
is experienced in providing advice on the difficult issues of how and when potentially hazardous consumer products must be reported to the CPSC. If product recalls are necessary, we work with our clients and CPSC staff to quickly develop and implement cost-effective communications programs that satisfy product liability concerns and minimize potential penalties. When the CPSC threatens or brings enforcement actions, we advise our clients on appropriate strategies. For more information about this Client Advisory, please contact:
Christie Grymes Thompson