[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]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

    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
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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