E8-30255. Accreditation Requirements for Third Party Conformity Assessment Bodies To Test To the Requirements for Lead Content in Children's Metal Jewelry as Established by the Consumer Product Safety Improvement Act of 2008

AGENCY:

Consumer Product Safety Commission.

ACTION:

Notice of requirements for accreditation of third party conformity assessment bodies to assess conformity with the 600 parts per million (“ppm”) and 300 ppm lead content limits in metal and metal alloy parts of children's metal jewelry established by the Consumer Product Safety Improvement Act of 2008.

SUMMARY:

The U.S. Consumer Product Safety Commission (“CPSC” or “Commission”) today publishes requirements pursuant to the Consumer Product Safety Improvement Act of 2008 (“CPSIA”), Public Law 110-314, for accreditation of third party conformity assessment bodies to test to the 600 ppm and 300 ppm lead limits in metal and metal alloy parts of children's metal jewelry established by CPSIA. The Commission is not at this time addressing third party testing to the 100 ppm lead limit that may come into force three years after the date of enactment of CPSIA, depending on technological feasibility.

DATES:

Effective Date: These requirements for accreditation of laboratories to test to the 600 ppm and 300 ppm lead limits in children's metal jewelry are effective December 22, 2008.

Request for Comments: Please provide comments in response to this notice by January 21, 2009. Comments on this notice should be captioned “Laboratory Accreditation Process for Testing for Lead Content in Children's Metal Jewelry.” Comments should be submitted to the Office of the Secretary by e-mail at [e-mail], or mailed or delivered, preferably in five copies, to the Office of the Secretary, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, Maryland 20814. Comments may also be filed by facsimile to [phone].

FOR FURTHER INFORMATION CONTACT:

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 [e-mail].

SUPPLEMENTARY INFORMATION:

I. Introduction and Background

The Consumer Product Safety Act (“CPSA”), at section 14(a)(3)(B)(iv) as added by section 102(a)(2) of CPSIA, directs the Commission to publish this notice of requirements for accreditation of third party conformity assessment bodies (“third party laboratories”) to test children's metal jewelry for conformity with the 600 ppm and 300 ppm limits on lead content at section 101(a)(2) of CPSIA.^[1]

Under section 101(a)(2) of CPSIA, a limit of 600 ppm of lead in any part of a children's product, including an item of children's metal jewelry, becomes effective on February 10, 2009.^[2] Each importer or U.S. domestic manufacturer of such products manufactured on or after that date must issue a certificate of conformity with the 600 ppm limit.^[3] That certificate must be based on a test of each product or a representative testing program. Use of a third party laboratory whose accreditation has been accepted by the Commission is not yet required.

Subsequently, for children's metal jewelry products manufactured after March 23, 2009, each importer and domestic manufacturer must have metal and metal alloy parts of such products tested by a laboratory whose accreditation to do so has been accepted by the Commission in accordance with this notice and must issue a certificate of compliance with the 600 ppm lead limit for the metal and metal alloy parts of the jewelry based on that testing.^[4 5] When the 300 ppm limit of section 101(a)(2)(B) of CPSIA goes into force on August 14, 2009, each importer and domestic manufacturer of children's metal jewelry subject to that limit must have metal and metal alloy parts of such products tested by a laboratory whose accreditation to do so has been accepted by the Commission and must issue a certificate of compliance with the limit based on that testing.^[6]

This notice provides the criteria and process for Commission acceptance of accreditation of “third party” laboratories for testing to the 600 ppm and 300 ppm lead content limits (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 Federal Register and are exempted by CPSIA from the notice and comment rulemaking requirements of the Administrative Procedure Act, 5 U.S.C. 553.^[7]

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 for lead content in children's metal jewelry are effective upon their publication in the Federal Register, the Commission solicits comments on the accreditation procedures as they apply to that testing and on the accreditation approach in general, since the Commission must publish additional testing laboratory accreditation procedures over the coming months.

II. Accreditation Requirements

A. Baseline Third Party Laboratory Accreditation Requirements

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 lead content in metal and metal alloy parts of children's metal jewelry in accordance with the CPSC Standard Operating Procedure for Determining Total Lead (Pb) in Children's Metal Products (including Children's Metal Jewelry), CPSC-CH-E1001-08, available at http://www.cpsc.gov/​about/​cpsia/​CPSC-CH-E1001-08.pdf.^[8 9] A listing of ILAC-MRA signatory accrediting bodies is available on the Internet at http://ilac.org/​membersbycategory.html

A true copy in English of the accreditation and scope documents demonstrating compliance with these requirements must be registered with the Commission electronically. The additional requirements for accreditation of firewalled and governmental laboratories are described below in sections II.B and II.C.

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. Once the Commission adds a laboratory to that list, the laboratory may commence testing to support certification by the importer or domestic manufacturer of compliance with the 600 ppm and 300 ppm lead content limits on metal and metal alloy parts of children's metal jewelry based on third party testing.

B. Additional Accreditation Requirements for Firewalled Laboratories

In addition to the baseline accreditation requirements in section II.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 children's metal jewelry to be tested by the laboratory for conformity with lead content requirements to support certification owns a ten percent or greater interest. While the Commission is not addressing common parentage of a lab and a children's product manufacturer at this time, it will continue to 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.

C. Additional Accreditation Requirements for Governmental Laboratories

In addition to the baseline accreditation requirements of section II.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 afforded more favorable treatment than other laboratories in the same nation who have been accredited;
• 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 based on outcomes of the laboratory's conformity assessments.

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

III. How Does a Laboratory Apply for Acceptance of Its Accreditation?

The Commission has established an electronic accreditation acceptance and registration system accessed via the Commission's Internet site at http://www.cpsc.gov/​about/​cpsia/​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. Commission 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/​about/​cpsia/​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 Commission for consideration.^[10] If the Commission 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 Commission 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 Commission adds a laboratory to the list, the laboratory may then commence testing of children's products to support certification of compliance with the requirements for lead content in metal and metal alloy parts of children's metal jewelry by the importer or U.S. domestic manufacturer.

IV. Limited Acceptance of Children's Product Certifications Based on Third Party Laboratory Testing Prior to Commission Acceptance of Accreditation

The Commission will accept a certificate of compliance with the lead content limits in metal and metal alloy parts of children's metal jewelry based on total lead content 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 ILAC-MRA member at the time of the test;
• The accreditation scope in effect for the laboratory at that time expressly included testing using the February 3, 2005 CPSC Laboratory SOP for Determining Total Lead Content in Children's Metal Jewelry at http://www.cpsc.gov/​businfo/​pbjeweltest.pdf and/or the 2008 CPSC Laboratory SOP for Determining Total Lead Content in Children's Metal Jewelry, CPSC-CH-E1001-08, available at http://www.cpsc.gov/​about/​cpsia/​CPSC-CH-E1001-08.pdf;​;
• Total lead testing was conducted and the analytical results of the testing for total lead do not exceed the 600 ppm or 300 ppm total lead limit, as applicable;
• The laboratory's accreditation application is accepted by the Commission under the procedures of this notice not later than February 20, 2009; and
• The laboratory's accreditation and inclusion of the reference to the 2005 and/or the 2008 CPSC Laboratory SOP for Determining Total Lead Content in Children's Metal Jewelry in its scope remains in effect through the effective date for mandatory third party testing and certification for limits on total lead content in children's metal jewelry as established by the CPSIA.

Testing performed by a firewalled laboratory prior to Commission acceptance of its accreditation cannot be used as the basis for certification pursuant to CPSA section 14(a)(3)(B)(iv) by an importer or U.S. domestic manufacturer with a 10 percent or greater ownership interest in the laboratory of compliance with the lead content limits in metal and metal alloy parts of children's metal jewelry.

Dated: December 16, 2008.

Todd A. Stevenson,

Secretary, Consumer Product Safety Commission.

Footnotes

1.  Section 102 of CPSIA also required the Commission to publish requirements for accreditation of laboratories for testing to the lead paint ban at 16 CFR part 1303, for testing to the Commission's regulations for full-size baby cribs at 16 CFR part 1508 and for non-full-size baby cribs at 16 CFR part 1509, for pacifiers at 16 CFR part 1511, and for small parts at 16 CFR part 1501. The requirements for accreditation for testing to the lead paint ban were published in the Federal Register on September 22, 2008. 73 FR 54564-6. The requirements for accreditation for testing to the crib and pacifier regulations were published in the Federal Register on October 22, 2008. 73 FR 62965-7. The requirements for accreditation to test to the small parts regulations were published in the Federal Register on November 17, 2008. 73 FR 76838-40.

2.  CPSIA defines a children's product as a consumer product designed or intended primarily for children 12 years of age or younger. CPSIA section 235(a) to be codified at CPSA section 3(a)(2).

3.  On November 18, 2008, the Commission published in the Federal Register an immediately final rule that limited the parties that must issue the certifications required by section 14 of the CPSA as amended by CPSIA to the importer and the domestic manufacturer, as applicable. See 73 FR 68 328-32 (to be codified as 16 CFR part 1110). Further information on the form and content of the required certificates is available at http://www.cpsc.gov/​about/​cpsia/​faq/​elecertfaq.pdf.

4.  Section 14(a)(2) of the CPSA as added by section 102(a)(2) of CPSIA mandates that the required third party testing be conducted on “sufficient samples” of the product, or “samples that are identical in all material respects” to the product.

5.  Commission technical staff is working to develop accurate and repeatable test methods for quantifying lead in non-metal parts of children's products, including children's metal jewelry. Those methods will be posted on the CPSC Web site as soon as that work is completed.

6.  Of course, irrespective of certification, the product in question must comply with applicable CPSC requirements. See e.g., CPSA section 14(h) as added by CPSIA section 102(b).

7.  CPSA section 14(a)(3)(G) as added by section 102(a)(2) of CPSIA exempts publication of this notice from the rulemaking requirements of the Administrative Procedure Act, 5 U.S.C. 553, and from the Regulatory Flexibility Act, 5 U.S.C. 601-612.

8.  A description of the history and content of the ILAC-MRA approach and of the requirements of the ISO 17025:2005 laboratory accreditation standard is provided in the CPSC staff briefing memorandum Accreditation Requirements for Third Party Conformity Assessment Bodies to Test to the Requirements for Lead Content in Children's Metal Jewelry as Established by the Consumer Product Safety Improvement Act of 2008, December 2008, available on the CPSC Web site at http://www.cpsc.gov/​library/​foia/​foia09/​brief/​leadjewelry.pdf.

9.  The Commission received comments recommending that, in addition to ILAC-MRA signatories, it consider accepting laboratory accreditations by accrediting bodies that are members of other organizations. The staff is assessing these comments. At this point, the staff continues to recommend acceptance of laboratory accreditations only by ILAC-MRA signatory accrediting bodies.

10.  A laboratory that may ultimately seek acceptance as a firewalled laboratory could initially request acceptance as a third party laboratory accredited for testing for lead content in children's metal jewelry other than for such products manufactured or private labeled by its owners.