[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.
[[Page 78334]]
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