Consumer Product Safety Commission.
Notice of Requirements for Accreditation of Third Party Conformity Assessment Bodies to Assess Conformity with part 1501 of Title 16, Code of Federal Regulations.
The Commission is also recognizing limited circumstances in which testing performed by a laboratory on or after May 16, 2008, 90 days prior to the date of enactment of CPSIA (August 14, 2008), but prior to Commission acceptance of the laboratory's preexisting accreditation, provided that accreditation is accepted not later than January 20, 2009, may form the basis for the certificate of compliance with the small parts regulation required of the manufacturer or private labeler.
This notice provides the criteria and process for Commission acceptance of accreditation of “third party” laboratories for testing to the small parts regulations (laboratories that are not owned, managed, or controlled by a manufacturer or private labeler of a children's product to be tested by the laboratory for certification purposes), “firewalled” laboratories (those that are owned, managed, or controlled by a manufacturer or private labeler of a children's product to be tested by the laboratory for certification purposes and that seek accreditation under the additional statutory criteria for “firewalled” laboratories), and laboratories owned or controlled in whole or in part by a government.
The requirements of this notice are effective upon its publication in the
Baseline accreditation of each category of laboratory to the International Organization for Standardization (“ISO”) Standard ISO/IEC 17025:2005—General Requirements for the Competence of Testing and Calibration Laboratories—is required. The accreditation must be by an accreditation body that is a signatory to the International Laboratory Accreditation Cooperation—Mutual Recognition Arrangement (“ILAC–MRA”) and the scope of the accreditation must include testing for compliance with the small parts regulation at 16 CFR part 1501.
The Commission has established an electronic accreditation registration and listing system that can be accessed via its web site.
Although the accreditation requirements in this notice for testing to the small parts regulations are effective upon their publication in the
Robert “Jay” Howell, Acting Assistant Executive Director for Hazard Identification and Reduction, U.S. Consumer Product Safety Commission, 4330 East West Highway, Bethesda, Maryland 20814; e-mail
For a third party laboratory to be accredited to test children's products for conformity with the Commission's small parts regulations, it must be accredited by an ILAC–MRA signatory accrediting body and the accreditation must be registered with, and accepted by, the Commission. A listing of ILAC–MRA signatory accrediting bodies is available on the Internet at
The Commission will maintain on its web site an up-to-date listing of laboratories whose accreditations it has accepted and the scope of each accreditation. Subject to the limited provisions for acceptance of “retrospective” testing performed by other than firewalled laboratories noted in section III below, once the Commission adds a laboratory to that list, the laboratory may commence testing of children's products to support certification by the manufacturer or private labeler of compliance with the small parts regulations.
In addition to the baseline accreditation requirements in section I.A, firewalled laboratories seeking accredited status must submit to the Commission for review copies in English of their training documents showing how employees are trained to notify the Commission immediately and confidentially of any attempt by the manufacturer, private labeler or other interested party to hide or exert undue influence over the laboratory's test results. This additional requirement applies to any laboratory in which a manufacturer or private labeler of a children's product to be tested by the laboratory owns a ten percent or more interest. While the Commission is not addressing common parentage of a lab and a children's product manufacturer at this time, it will be vigilant to see if this issue needs to be dealt with in the future.
The Commission must formally accept, by order, the accreditation application of a laboratory before the laboratory can become an accredited firewalled laboratory.
In addition to the baseline accreditation requirements of section I.A, CPSIA permits accreditation of a laboratory owned or controlled in whole or in part by a government if:
• To the extent practicable, manufacturers or private labelers located in any nation are permitted to choose laboratories that are not owned or controlled by the government of that nation;
• The laboratory's testing results are not subject to undue influence by any other person, including another governmental entity;
• The laboratory is not accorded more favorable treatment than other laboratories in the same nation who have been accredited;
• The laboratory's testing results are accorded no greater weight by other governmental authorities than those of other accredited laboratories; and
• The laboratory does not exercise undue influence over other governmental authorities on matters affecting its operations or on decisions by other governmental authorities controlling distribution of products
The Commission will accept the accreditation of a governmental laboratory if it meets the baseline accreditation requirements of section I.A and meets the conditions stated here. To obtain this assurance, CPSC staff will engage the governmental entities relevant to the accreditation request.
The Commission has established an electronic accreditation acceptance and registration system accessed via the Commission's Internet site at
Subject to the limited provisions for acceptance of “retrospective” testing performed by other than accredited firewalled laboratories noted in section III. below, once the Commission adds a laboratory to the list, the laboratory may then commence testing of children's products to support certification of compliance with the small parts regulations by the manufacturer or private labeler.
The Commission will accept a certificate of compliance with the small parts requirements based on testing performed by an accredited third party or governmental laboratory on or after May 16, 2008 (90 days prior to August 14, 2008, the date on which CPSIA was enacted) and thus prior to the Commission's acceptance of the laboratory's accreditation if:
• The laboratory was ISO/IEC 17025 accredited by an C–MRA member at the time of the test;
• The accreditation scope in effect for the laboratory at that time expressly included testing to 16 CFR part 1501;
• The laboratory's accreditation application is accepted by the Commission under the procedures of this notice not later than January 20, 2009; and
• The laboratory's accreditation and inclusion of the small parts requirements in its scope remains in effect through the effective date for mandatory third party testing and manufacturer/private labeler certification for small parts.
Testing performed by a firewalled laboratory prior to Commission acceptance of its accreditation cannot be used as the basis for certification by a manufacturer or private labeler with a 10 percent or greater ownership interest in the laboratory pursuant to CPSA § 14(a)(3)(B)(ii) of compliance with the small parts regulations.