[Federal Register Volume 73, Number 184 (Monday, September 22, 2008)]
[Notices]
[Pages 54564-54566]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-22167]
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CONSUMER PRODUCT SAFETY COMMISSION
Third Party Testing for Certain Children's Products; Notice of
Requirements for Accreditation of Third Party Conformity Assessment
Bodies To Assess Conformity With Part 1303 of Title 16, Code of Federal
Regulations
AGENCY: Consumer Product Safety Commission.
ACTION: Notice of Requirements for Accreditation of Third Party
Conformity Assessment Bodies to Assess Conformity with part 1303 of
Title 16, Code of Federal Regulations.
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Introduction: The Consumer Product Safety Act (``CPSA''), at Sec.
14(a)(3)(B)(i) as added by Sec. 102(a)(2) of the Consumer Product
Safety Improvement Act of 2008 (``CPSIA''), Public Law 110-314, directs
the U.S. Consumer Product Safety Commission (``CPSC'' or
``Commission'') to publish this notice of requirements for
accreditation of third party conformity assessment bodies (``third
party laboratories'') to test children's products for conformity with
the lead paint ban in the Commission's regulations at 16 CFR part 1303
(the ``lead paint ban''). Children's products are those designed or
intended for use primarily by children 12 years old and younger. Part
1303 bans paint and other surface coatings that contain more than 0.06
percent lead as well as toys, other consumer products intended for use
by children, and furniture bearing lead-containing paint.\1\ Each
manufacturer (including the importer) or private labeler of children's
products subject to the lead paint ban must have products manufactured
more than 90 days after this notice tested by a laboratory accredited
to do so and must issue a certificate of compliance with the lead paint
ban based on that testing.2 3
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\1\ On August 14, 2009, the 0.06 percent (600 ppm) lead limit is
reduced to 0.009 percent (90 ppm). CPSIA Sec. 101(a)(2)(B).
\2\ Section 14(a)(2) of the CPSA as added by Sec. 102(a)(2) of
CPSIA requires that certification be based on testing of sufficient
samples of the product, or samples that are identical in all
material respects to the product.
\3\ Of course, irrespective of certification, the children's
product in question must comply with applicable CPSC requirements.
See, e.g., CPSA Sec. 14(h) as added by CPSIA Sec. 102(b).
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The Commission is also recognizing limited circumstances in which
testing performed by a laboratory on or after May 16, 2008, 90 days
prior to the date of enactment of CPSIA (August 14, 2008), but prior to
Commission acceptance of the laboratory's preexisting accreditation,
provided that accreditation is accepted not later than November 26,
2008, may form the basis for the certificate of compliance with the
lead paint ban required of the manufacturer or private labeler.
This notice provides the criteria and process for Commission
acceptance of accreditation of ``third party'' laboratories for testing
to the lead paint ban (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.\4\
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\4\ CPSA Sec. 14(a)(3)(G) as added by Sec. 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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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
compliance with the lead paint ban.\5\ A laboratory owned or controlled
by a manufacturer or private labeler of products to be tested by the
laboratory is subject to additional requirements intended to assure
that the Commission is immediately and confidentially notified of any
attempt by the manufacturer, private labeler or other interested party
to hide or exert undue influence over the laboratory's test results. A
governmental laboratory may be accredited subject to additional
requirements concerning independence of its relationship with the host
government and freedom of manufacturers in the host country to elect to
use accredited non-government laboratories for certification testing
without suffering disadvantage.
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\5\ 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 Lead Paint Requirements of 16 CFR
Part 1303, September 2, 2008 available on the CPSC Web site at
http://cpsc.gov/library/foia/foia08/brief/thirdp.pdf.
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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 for testing to the lead
paint ban in this notice 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 accreditation procedures over the coming months.
DATES: Effective Date: The requirements for accreditation of
laboratories for testing to the lead paint ban are effective upon
publication of this notice in the Federal Register, that is September
22, 2008.
Request For Comments: Please provide comments in response to this
notice by October 22, 2008. Comments on this notice should be captioned
``Laboratory Accreditation Process for Lead Paint Ban Testing.''
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,
[[Page 54565]]
4330 East West Highway, Bethesda, Maryland 20814; e-mail
[email protected].
I. Accreditation Requirements
A. Baseline Third Party Laboratory Accreditation Requirements
For a third party laboratory to be accredited to test children's
products for conformity with the lead paint ban, it must be accredited
by an ILAC-MRA signatory accrediting body and the accreditation must be
registered with, and accepted by, the Commission. A listing of ILAC-MRA
signatory accrediting bodies is available on the Internet at http://ilac.org/membersbycategory.html. The accreditation must be to 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 requirements of 16 CFR part 1303.
A true copy 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 I.B and I.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. Subject to the limited provisions for acceptance of
``retrospective'' testing performed by other than firewalled
laboratories noted in Section III below, once the Commission adds a
laboratory to that list, the laboratory may commence testing of
children's products to support certification by the manufacturer or
private labeler of compliance with the lead paint ban.
B. Additional Accreditation Requirements for Firewalled Laboratories
In addition to the baseline accreditation requirements in section
I.A, firewalled laboratories seeking accredited status must submit to
the Commission copies 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 a children's product to be tested
by the laboratory owns a ten percent or more interest. While the
Commission is not addressing common parentage of a lab and a children's
product manufacturer at this time, it will 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
I.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 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 I.A and meets the conditions stated here. To obtain this
assurance, CPSC staff will engage the governmental entities relevant to
the accreditation request.
II. 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/businfo/labaccred.html. The
applicant provides 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, if relevant. Commission
staff reviews that information 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 Commission for consideration.\6\ 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.
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\6\ A laboratory that may ultimately seek acceptance as a
firewalled laboratory could initially request acceptance as a third
party laboratory accredited for testing of children's products other
than those of its owners.
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Subject to the limited provisions for acceptance of
``retrospective'' testing performed by other than accredited firewalled
laboratories noted in Section III. below, 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
lead paint ban by the manufacturer or private labeler.
III. 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 paint ban for a children's product based on 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 of enactment of
CPSIA) but 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 to 16 CFR part 1303;
The laboratory's accreditation application is accepted by
the Commission under the procedures of this notice not later than
November 26, 2008; and
[[Page 54566]]
The laboratory's accreditation and inclusion of part 1303
in its scope remains in effect through the effective date for mandatory
third party certification to the lead paint ban.
Testing performed by a firewalled laboratory prior to Commission
acceptance of its accreditation cannot be used as the basis for
certification pursuant to CPSA Sec. 14(a)(3)(B)(i) of compliance with
the lead paint ban by a manufacturer or private labeler with a 10
percent or greater ownership interest in the laboratory.
Dated: September 16, 2008.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. E8-22167 Filed 9-19-08; 8:45 am]
BILLING CODE 6355-01-P