[Federal Register Volume 73, Number 246 (Monday, December 22, 2008)]
[Notices]
[Pages 78331-78334]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-30255]


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CONSUMER PRODUCT SAFETY COMMISSION


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

[[Page 78332]]

metal jewelry established by the Consumer Product Safety Improvement 
Act of 2008.

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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 [email protected], 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 (301) 504-
0127.

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 [email protected].

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\
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    \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.
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    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.
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    \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.
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    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\
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    \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).
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    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\
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    \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.
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    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

[[Page 78333]]

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
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    \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.
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    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.
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    \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.
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    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.

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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.
[FR Doc. E8-30255 Filed 12-19-08; 8:45 am]
BILLING CODE 6355-01-P