The Consumer Product Safety Improvement Act of 2008 (CPSIA or the Act) requires that the Commission establish requirements for accreditation of third‐party conformity assessment bodies (commonly known as third‐ party testing laboratories). The Act further requires manufacturers and importers to use third‐party laboratories that have been recognized as accredited under CPSC requirements to test children’s products for compliance with certain Commission product safety rules.
The Act defines a third‐party testing laboratory as one that is not owned, managed, or controlled by the manufacturer or private labeler of a product assessed by such testing laboratory.
The CPSIA provides that a laboratory that is owned, managed, or controlled by the manufacturer or private labeler may under certain specified conditions be recognized as accredited as a third‐party testing laboratory by the Commission. The Act calls such laboratories that comply with these conditions firewalled conformity assessment bodies (or firewalled laboratories).
All children’s products manufacturers or importers must comply with the CPSIA’s third‐party testing requirements. A manufacturer that owns its own laboratory may test products at that laboratory to support certifications of compliance with safety rules only if the Commission, by order, accredits the lab as a firewalled third‐party testing laboratory. These firewalled laboratories owned by the manufacturer must meet the high standards set for accreditation that are in place for regular third‐party laboratories and additional requirements in place to protect against undue influence as described below
Third‐party testing laboratories:
To be accepted by the Commission, third‐party testing laboratories must be independently accredited to ISO/IEC 17025:2005‐‐General Requirements for the Competence of Testing and Calibration Laboratories. The accreditation must be conducted by a full member of the International Laboratory Accreditation Cooperation‐‐Mutual Recognition Arrangement (“ILAC‐MRA'').
ISO 17025 accreditation of a laboratory includes an assessment to confirm the technical competence of the laboratory for certain testing methods and also includes an assessment of a laboratory’s management and organization to ensure safeguards against undue influence. The laboratory must have arrangements to ensure that its management and personnel are free from any undue internal and external commercial, financial and other pressures and influences that may adversely affect the quality of their work.
Firewalled third‐party testing laboratories:
The Commission may accredit a laboratory under the Act’s firewalled provision if the Commission finds by order that:
- accreditation of the laboratory would provide equal or greater consumer safety protection than the manufacturer’s or private labeler’s use of an independent third‐party conformity assessment body; and
- the laboratory has established procedures to ensure that –
- its test results are protected from undue influence by the manufacturer, private labeler or other interested party;
- the Commission is notified immediately of any attempt by the manufacturer, private labeler or other interested party to hide or exert undue influence over test results; and
- allegations of undue influence may be reported confidentially to the Commission.
To meet these criteria, firewalled third‐party testing laboratories must first meet the same ISO/IEC 17025 accreditation requirements as independent third‐party testing laboratories, including requirements for technical competence, standards for management and organization, and safeguards against undue influence.
In addition, an applicant firewalled laboratory must submit materials to the Commission that explain its safeguards against undue influence, including employee training on the process and means by which allegations of any attempt by the manufacturer or other interested party to hide or exert undue influence over test results can be immediately and confidentially reported to the Commission.
Firewalled laboratory applications are subjected to a vetting process involving agency career technical staff.
Section 102 of the Consumer Product Safety Improvement Act of 2008 (CPSIA) allows for the CPSC to accept laboratories that are 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 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 under this section;
- the laboratory’s testing results are accorded no greater weight by other governmental authorities than those of other laboratories accredited under this section; 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 based on outcomes of the laboratory’s conformity assessments.
The CPSC Requirements Pertaining to Third party Conformity Assessment Bodies (Laboratories) is codified in the rule at 16 CFR part 1112. This rule defines a governmental testing laboratory as a laboratory that is owned or controlled, in whole or in part, by a government. “Government” includes any unit of a national, territorial, provincial, regional, state, tribal, or local government, and a union or association of sovereign states. “Government” also includes domestic, as well as foreign entities. A laboratory is owned or controlled, in whole or in part, by a government if any one of the following characteristics applies:
- A governmental entity holds a 1 percent or greater ownership interest, whether direct or indirect, in the laboratory
- A governmental entity provides any direct financial investment or funding (other than fee for work);
- A governmental entity has the ability to appoint a majority of the third laboratory’s senior internal governing body (such as, but not limited to, a board of directors); the ability to appoint the presiding official of the laboratory's senior internal governing body (such as, but not limited to, chair or president); and/or the ability to hire, dismiss, or set the compensation level for laboratory personnel;
- Laboratory management or technical personnel include any government employees;
- The laboratory has a subordinate position to a governmental entity in its external organizational structure (not including its relationship as a regulated entity to a government regulator); or
- Apart from its role as regulator, the government can determine, establish, alter, or otherwise affect:
- The laboratory’s testing outcomes;
- The laboratory’s budget or financial decisions;
- Whether the laboratory may accept particular offers of work; or
- The laboratory's organizational structure or continued existence.
The following list shows CPSC-accepted firewalled laboratories. These laboratories are included in the list of all CPSC-accepted third party laboratories displayed at Lab Search.
Section 14 of the CPSA, as amended by the Consumer Product Safety Improvement Act of 2008 (“CPSIA”), requires manufacturers and importers of children’s products subject to applicable children’s product safety rules, to use third party conformity assessment bodies (third party testing laboratories) that have been accredited under CPSC requirements to test children’s products for compliance with those children’s product safety rules. The CPSA defines a “third party conformity assessment body” as one that is not owned, managed, or controlled by the manufacturer or private labeler of a product assessed by such testing laboratory, except that a laboratory that is owned, managed, or controlled by the manufacturer or private labeler, under certain specified conditions, may be recognized as accredited by the Commission as a third party testing laboratory. Testing laboratories that comply with these specified conditions are said to be “firewalled” against the possibility of undue influence.
The Commission may accredit a laboratory under the CPSA’s firewalled provision if the Commission finds, by order, that:
- Accreditation of the laboratory would provide equal or greater consumer safety protection than the manufacturer or private labeler’s use of an independent third party conformity assessment body; and
- The laboratory has established procedures to ensure that –
- its test results are protected from undue influence by the manufacturer, private labeler, or other interested party;
- the Commission is notified immediately of any attempt by the manufacturer, private labeler, or other interested party to hide or exert undue influence over test results; and
- allegations of undue influence may be reported confidentially to the Commission.
The CPSC Requirements Pertaining to Third party Conformity Assessment Bodies (Laboratories) is codified in the rule at 16 CFR part 1112.
For a list of CPSC-accepted firewalled laboratories, email labaccred@cpsc.gov. All CPSC-accepted firewalled laboratories are included in the list of all CPSC-accepted third party laboratories displayed at Lab Search.
In December 2017, the International Organization for Standardization (ISO) published a new version of ISO/IEC 17025, “General Requirements for the Competence of Testing and Calibration Laboratories.” (ISO/IEC 17025:2017). Two Consumer Product Safety Commission (CPSC) rules regarding testing and certification and laboratory accreditation and acceptance (16 C.F.R. parts 1107 (testing and certification) and part 1112 (laboratory acceptance)) incorporate by reference ISO/IEC 17025:2005. Currently, under part 1112 CPSC requires that testing laboratories must be accredited to ISO/IEC 17025:2005 for CPSC to accept the laboratory for testing children’s products to CPSC children’s product safety rules. Additionally, under part 1107, manufacturers that have an ISO/IEC 17025:2005 accredited laboratory may extend the period between required third party periodic testing for children’s products.
The International Laboratory Accreditation Cooperation (ILAC) and ISO have issued a “Joint ILAC-ISO Communiqué on the recognition of ISO/IEC 17025 during a Three-Year Transition [1].” Each ILAC-MRA accreditation body is now establishing internal policies with their accredited laboratories to transition accreditation to ISO/IEC 17025:2017. To allow for the full transition of all laboratories within 3 years from the publication date of the standard, some laboratories will be assessed to the 2017 version of the standard starting this year.
CPSC is providing the following guidance regarding CPSC acceptance of accreditation to ISO/IEC 17025:2017 during this transition period. Similar to the ISO/IEC transition policy, CPSC will accept accreditation to either ISO/IEC 17025:2005 or ISO/IEC 17025:2017. For testing laboratories that apply for CPSC acceptance or CPSC renewed acceptance after the guidance issue date, the CPSC will accept either ISO/IEC 17025:2005 or ISO/IEC 17025:2017.
CPSC is reviewing options in the future to update the applicable CPSC rules to specify the 2017 edition
Search for a CPSC-Accepted Testing Lab
Lab Accreditation Resources
Rules Requiring Third-Party Testing and a Children's Product Certificate
Rules Requiring Testing and a General Certificate of Conformity
Frequently Asked Questions About Third-Party Testing
Federal Register Notices Related to Third-Party Testing
Lab Bulletins and Test Manuals
Rulemaking
Final Rule: 1112/1118 Requirements for Third Party Conformity Assessment Bodies
Apply with CPSC as an accredited laboratory to test children's products for conformity with CPSC's children's product safety rules.
