[Federal Register Volume 73, Number 205 (Wednesday, October 22, 2008)]
[Notices]
[Pages 62965-62967]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-25096]
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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 1508, Part 1509, and/or Part 1511
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 1508, Part
1509, and/or Part 1511 of Title 16, Code of Federal Regulations.
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Introduction: The Consumer Product Safety Act (``CPSA''), at
section 14(a)(3)(B)(ii) as added by section 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 Commission's regulations for full-size baby cribs at 16 CFR part
1508, for non-full-size baby cribs at 16 CFR part 1509, and/or for
pacifiers at 16 CFR part 1511.1 2 Each manufacturer
(including the importer) or private labeler of cribs and/or pacifiers
subject to those regulations must have products manufactured more than
90 days after the Federal Register publication date of this notice
tested by a laboratory accredited to do so and must issue a certificate
of compliance with the applicable regulations based on that
testing.3 4
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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. Those requirements were
published in the Federal Register on September 22, 2008. 73 FR
54564-6.
\2\ Children's products are those designed or intended for use
primarily by children 12 years old and younger.
\3\ 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.
\4\ 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 December 26,
2008, may form the basis for the certificate of compliance with the
crib and/or pacifier regulations 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 regulations for cribs and/or pacifiers (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.\5\
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\5\ 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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[[Page 62966]]
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 crib regulations of 16 CFR part 1508 and/or part
1509 and/or the pacifier regulations of part 1511.\6\ 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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\6\ 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 Third Party Conformity Assessment Body Accreditation
Requirements for Testing Compliance with 16 CFR Part 1508, Part
1509, and Part 1511 (Cribs and Pacifiers) as Required by the
Consumer Product Safety Improvement Act of 2008, October 2008,
available on the CPSC Web site at http://cpsc.gov/library/foia/foia09/brief/tpacp.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 in this notice for testing
to the crib and/or pacifier regulations 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.
DATES: Effective Date: The requirements for accreditation of
laboratories for testing to the crib and/or pacifier regulations are
effective upon publication of this notice in the Federal Register, that
is October 22, 2008.
Request for Comments: Please provide comments in response to this
notice by November 21, 2008. Comments on this notice should be
captioned ``Laboratory Accreditation Process for Crib and Pacifier
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, 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 Commission's crib and/or pacifier
regulations, 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 regulations of 16 CFR part 1508, 1509, and/or 1511 as applicable to
the product(s) to be tested.\7\ 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.
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\7\ A laboratory may seek Commission acceptance of accreditation
to test only full-size cribs, only non-full-size cribs, or only
pacifiers, or some combination thereof. However, required
manufacturer certifications may only be based on testing by a
laboratory accredited to test the specific product in question.
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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 crib and/or pacifier
regulations, as applicable.
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 for review 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
[[Page 62967]]
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(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/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.\8\ 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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\8\ 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
crib and/or pacifier regulations, as applicable, 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
crib and/or pacifier requirements 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 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 to 16 CFR part 1508, or part 1509,
or part 1511, as applicable;
The laboratory's accreditation application is accepted by
the Commission under the procedures of this notice not later than
December 26, 2008; and
The laboratory's accreditation and inclusion of the crib
and/or pacifier requirements in its scope remains in effect through the
effective date for mandatory third party testing and manufacturer/
private labeler certification for cribs and pacifiers.
Testing performed by a firewalled laboratory prior to Commission
acceptance of its accreditation cannot be used as the basis for
certification by a manufacturer or private labeler with a 10 percent or
greater ownership interest in the laboratory pursuant to CPSA section
14(a)(3)(B)(ii) of compliance with the crib and/or pacifier
regulations.
Dated: October 15, 2008.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. E8-25096 Filed 10-21-08; 8:45 am]
BILLING CODE 6355-01-P