Commercial Information Circulars

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Ref : EIC 111/2/21

18 November 2008

Dear Sirs,

Commercial Information Circular No. 575/2008

US : Requirements for Accreditation of Third Party Conformity Assessment Bodies for Small Parts Rule

The US Consumer Product Safety Commission (CPSC) published in the Federal Register (FR) notice of 17 November 2008 setting out the requirements for the accreditation of third party conformity assessment bodies to test children's products for conformity with the CPSC's regulations for identifying toys and other articles intended for use by children under three years of age which present choking, aspiration, or ingestion hazards because of small parts ("small parts rule") at Title 16, Code of Federal Regulations, Part 1501 (16 CFR Part 1501). These accreditation requirements are effective on 17 November 2008 and comments on them are due by 17 December 2008. A copy (pdf format) of the FR notice is appended to this circular for reference.

DETAILS

2. Children's products are those designed or intended for use primarily by children 12 years old and younger. Section 14(a)(3)(B)(iii) of the Consumer Product Safety Act (CPSA), as added by Section 102(a)(2) of the Consumer Product Safety Improvement Act of 2008 (CPSIA), requires each manufacturer (including the importer) or private labeller of products subject to those regulations must have products manufactured as from 16 February 2009 tested by a laboratory accredited to do so and must issue a certificate of compliance with the applicable regulations based on that testing.

Baseline third party laboratory accreditation requirements

3. According to the FR notice, for a third party laboratory to be accredited to test children's products for conformity with the CPSC's small parts regulations, it must be accredited by an International Laboratory Accreditation Cooperation - Mutual Recognition Arrangement (ILAC - MRA) signatory accrediting body and the accreditation must be registered with, and accepted by, the CPSC. A listing of ILAC - MRA signatory accrediting bodies is available on the Internet at http://ilac.org/membersbycategory.html. The accreditation must be to International Organization for Standardization (ISO) Standard ISO/IEC 17025:2005 — General Requirements for the Competence of Testing and Calibration Laboratories and the scope of the accreditation must expressly include testing to the regulations of 16 CFR Part 1501. A true copy in English of the accreditation and scope documents demonstrating compliance with these requirements must be registered with the CPSC electronically.

Additional accreditation requirements for firewalled laboratories

4. Firewalled laboratories seeking accredited status must submit to the CPSC for review copies in English of their training documents showing how employees are trained to notify the CPSC immediately and confidentially of any attempt by the manufacturer, private labeller 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 labeller of a children's product to be tested by the laboratory owns a 10 percent or more interest. The CPSC must formally accept, by order, the accreditation application of a laboratory before the laboratory can become an accredited firewalled laboratory.

Additional accreditation requirements for governmental laboratories

5. In addition to the baseline accreditation requirements, the 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 labellers 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 favourable 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 based on outcomes of the laboratory's conformity assessments.

The CPSC will accept the accreditation of a governmental laboratory if it meets the baseline accreditation requirements and meets the conditions stated above. To obtain this assurance, CPSC staff will engage the governmental entities relevant to the accreditation request.

Way for a laboratory applying for acceptance of its accreditation

6. The CPSC has established an electronic accreditation acceptance and registration system accessed via the CPSC's website at http://www.cpsc.gov/businfo/labaccred.html. The applicant provides, in English, basic identifying information concerning its location, the type of accreditation it is seeking, and electronic copies of its ILAC-MRA accreditation certificate and scope statement and firewalled laboratory training document(s), if relevant. CPSC staff reviews that submission for accuracy and completeness. In the case of baseline third party laboratory accreditation and accreditation of governmental laboratories, when that review and any necessary discussions with the applicant are satisfactorily completed, the laboratory in question is added to the CPSC listing of accredited laboratories at http://www.cpsc.gov/businfo/labaccred.html. In the case of a firewalled laboratory seeking accredited status, when the review is complete, the staff transmits its recommendation on accreditation to the CPSC for consideration. If the CPSC accepts a staff recommendation to accredit a firewalled laboratory, that laboratory will then be added to the CPSC list of accredited laboratories. In each case, the CPSC will electronically notify the laboratory of acceptance of its accreditation. All information to support an accreditation acceptance request must be provided in the English language. Once the CPSC 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 labeller.

Limited acceptance of children's product certifications based on third party laboratory testing prior to CPSC acceptance of accreditation

7. The CPSC 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 16 May 2008, 90 days prior to 14 August 2008 (the date of enactment of CPSIA) and thus prior to the CPSC's acceptance of the laboratory's accreditation if:

• The laboratory was ISO/IEC 17025 accredited by an ILAC-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 CPSC under the procedures of the FR notice not later than 20 January 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 labeller certification for small parts. 

Testing performed by a firewalled laboratory prior to CPSC acceptance of its accreditation cannot be used as the basis for certification by a manufacturer or private labeller with a 10 percent or greater ownership interest in the laboratory.

ENQUIRIES

8. For enquiries concerning the content of this circular, please contact the undersigned at 2398 5682.

Yours faithfully,

(Miss Bonny CHAO)

for Director-General of Trade and Industry