[Federal Register Volume 73, Number 222 (Monday, November 17, 2008)]
[Notices]
[Pages 67838-67840]
From the Federal Register Online via the Government Publishing 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 [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 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