[Federal Register Volume 73, Number 222 (Monday, November 17, 2008)]
[Notices]
[Pages 67838-67840]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-27236]
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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 1501 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 1501 of
Title 16, Code of Federal Regulations.
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Introduction: The Consumer Product Safety Act (``CPSA''), at Sec.
14(a)(3)(B)(iii) 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 Commission's regulations at 16 CFR part 1501 for identifying toys
and other articles intended for use by children under three years of
age which present choking, aspiration, or ingestion hazards because of
small parts (the ``small parts rule'') \1\ Each manufacturer (including
the importer) or private labeler of products 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.2, 3
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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 and for testing to 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 for
pacifiers at 16 CFR part 1511. The requirements for accreditation
for testing to the lead paint ban were published in the Federal
Register on September 22, 2008. 73 FR 54,564-6. The requirements for
accreditation for testing to the crib and pacifier regulations were
published in the Federal Register on October 22, 2008. 73 FR 62,965-
7.
\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 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 January 20,
2009, may form the basis for the certificate of compliance with the
small parts regulation 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 small parts regulations (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
[[Page 67839]]
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 small parts regulation at 16 CFR part 1501.\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 Third Party Conformity Assessment Body Accreditation
Requirements for Testing Compliance with 16 CFR Part 1501 (Small
Parts Regulation), November 2008, available on the CPSC Web site at
http://www.cpsc.gov/library/foia/foia09/brief/smallparts.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 small parts 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 small parts regulations are effective
upon publication of this notice in the Federal Register, that is
November 17, 2008.
Request for Comments: Please provide comments in response to this
notice by December 17, 2008. Comments on this notice should be
captioned ``Laboratory Accreditation Process for Small Parts Testing.''
Comments should be submitted to the Office of the Secretary by e-mail
at smallpartsreqts@cpsc.gov, 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 rhowell@cpsc.gov.
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 small parts 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 1501. 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 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 small parts regulations.
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 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 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
[[Page 67840]]
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, 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/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. All information to support an
accreditation acceptance request must be provided in the English
language.
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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
small parts regulations 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
small parts 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 C-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 1501;
The laboratory's accreditation application is accepted by
the Commission under the procedures of this notice not later than
January 20, 2009; and
The laboratory's accreditation and inclusion of the small
parts requirements in its scope remains in effect through the effective
date for mandatory third party testing and manufacturer/private labeler
certification for small parts.
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 Sec.
14(a)(3)(B)(ii) of compliance with the small parts regulations.
Dated: November 12, 2008.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. E8-27236 Filed 11-14-08; 8:45 am]
BILLING CODE 6355-01-P