[Federal Register Volume 74, Number 169 (Wednesday, September 2, 2009)]
[Notices]
[Pages 45428-45431]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-21134]


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CONSUMER PRODUCT SAFETY COMMISSION

[CPSC Docket No. CPSC-2009-0067]


Third Party Testing for Certain Children's Products; Notice of 
Requirements for Accreditation of Third Party Conformity Assessment 
Bodies to Assess Conformity With Parts 1203, 1510, 1512, and/or 1513 
and Section 1500.86(a)(7) and/or (a)(8) of Title 16, Code of Federal 
Regulations

AGENCY: Consumer Product Safety Commission.

ACTION: Notice of requirements.

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SUMMARY: The Consumer Product Safety Commission (``CPSC'' or 
``Commission'') is issuing a notice of requirements that provides the 
criteria and process for Commission acceptance of accreditation of 
third party conformity assessment bodies for testing pursuant to 
specific CPSC regulations relating to bicycle helmets, dive sticks and 
similar articles, rattles, bicycles, and bunk beds. The Commission is 
issuing this notice of requirements pursuant to section 14(a)(3)(B)(vi) 
of the Consumer Product Safety Act (15 U.S.C. 2063(a)(3)(B)(vi)).

DATES: Effective Date: The requirements for accreditation of third 
party conformity assessment bodies for testing to 16 CFR parts 1203, 
1510, 1512, and/or 1513; and/or 16 CFR 1500.86(a)(7) and (a)(8) are 
effective upon publication of this notice in the Federal Register.
    Comments in response to this notice of requirements should be 
submitted by October 2, 2009. Comments on this notice should be 
captioned ``Third Party Conformity Assessment Body Accreditation 
Process for 16 CFR parts 1203, 1510, 1512, and/or 1513; and/or 16 CFR 
1500.86(a)(7) and (a)(8).''

ADDRESSES: You may submit comments, identified by Docket No. CPSC-2009-
0067, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way: Federal 
eRulemaking Portal: http://www.regulations.gov. Follow the instructions 
for submitting comments.
    To ensure timely processing of comments, the Commission is no 
longer accepting comments submitted by electronic mail (e-mail) except 
through http://www.regulations.gov.

Written Submissions

    Submit written submissions in the following way: Mail/Hand 
delivery/Courier (for paper, disk, or CD-ROM submissions), preferably 
in five copies, to: Office of the Secretary, Consumer Product Safety 
Commission, Room 502, 4330 East-West Highway, Bethesda, MD 20814; 
telephone (301) 504-7923.
    Instructions: All submissions received must include the agency name 
and docket number for this notice of requirements. All comments 
received may be posted without change, including any personal 
identifiers, contact information, or other personal information 
provided, to http://www.regulations.gov. Do not submit confidential 
business information, trade secret information, or other sensitive or 
protected information electronically. Such information should be 
submitted in writing.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Robert ``Jay'' Howell, 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].

SUPPLEMENTARY INFORMATION: 

I. Introduction

    The Consumer Product Safety Act (``CPSA''), at section 
14(a)(3)(B)(vi), as added by section 102(a)(2) of the Consumer Product 
Safety Improvement Act of 2008 (``CPSIA''), Public Law 110-314, directs 
the CPSC to publish a notice of requirements for accreditation of third 
party conformity assessment bodies (also referred to as ``third party 
laboratories'') to assess children's products for conformity with 
``other children's product safety rules.'' Section 14(f)(1) of the CPSA 
defines ``children's product safety rule'' as ``a consumer product 
safety rule under [the CPSA] or similar rule, regulation, standard, or 
ban under any other Act enforced by the Commission, including a rule 
declaring a consumer product to be a banned hazardous product or 
substance.'' Under section 14(a)(3)(A) of the CPSA, each manufacturer 
(including the importer) or private labeler of products subject to 
those regulations must have products that are manufactured more than 90 
days after the Federal Register publication date of this notice tested 
by a third party conformity assessment body accredited to do so and 
must issue a certificate of compliance with the applicable regulations 
based on that testing. (The Commission notes, however, that in the 
Federal Register of February 9, 2009 (74 FR 6396), the Commission 
announced a stay of

[[Page 45429]]

enforcement of certain provisions of section 14(a) of the CPSA; the 
stay applies to the testing that would result from this notice of 
requirements.) Section 14(a)(2) of the CPSA, as added by section 
102(a)(2) of the 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. The Commission also emphasizes 
that, irrespective of certification, the product in question must 
comply with applicable CPSC requirements (see, e.g., section 14(h) of 
the CPSA, as added by section 102(b) of the CPSIA).
    The Commission also is recognizing limited circumstances in which 
it will accept certifications if the product was tested on or after May 
16, 2008 (90 days before the CPSIA's enactment) by a third party 
conformity assessment body that the CPSC accepts as being accredited by 
December 31, 2009 or 30 days before the Commission terminates the stay 
of enforcement that was originally announced in the Federal Register on 
February 9, 2009 (74 FR 6396), whichever date is later. This policy 
will apply to prior testing by independent third party conformity 
assessment bodies and by government-owned or government-controlled 
conformity assessment bodies, but not to ``firewalled'' conformity 
assessment bodies.
    This notice provides the criteria and process for Commission 
acceptance of accreditation of third party conformity assessment bodies 
for testing pursuant to the following regulations:
     16 CFR part 1203, Safety Standard for Bicycle Helmets 
(insofar as bicycle helmets that are ``children's products'' are 
concerned);
     16 CFR 1500.86(a)(7) and (a)(8), Exemptions from 
Classification as a Banned Toy or other Banned Article for use by 
Children. (The cited provisions pertain to dive sticks and ``similar 
articles.'');
     16 CFR part 1510, Requirements for Rattles;
     16 CFR part 1512, Requirements for Bicycles (insofar as 
bicycles that are ``children's products'' are concerned); and/or
     16 CFR part 1513, Requirements for Bunk Beds.
    Although section 14(a)(3)(B)(vi) of the CPSA directs the CPSC to 
publish a notice of requirements for accreditation of third party 
conformity assessment bodies to assess conformity with ``all other 
children's product safety rules,'' this notice of requirements is 
limited to the regulations identified immediately above.
    Section 14(a)(3)(B)(vi) of the CPSA is captioned as ``All Other 
Children's Product Safety Rules,'' but the body of the statutory 
requirement refers only to ``other children's product safety rules.'' 
Nevertheless, section 14(a)(3)(B)(vi) of the CPSA could be construed as 
requiring a notice of requirements for ``all'' other children's product 
safety rules, rather than a notice of requirements for ``some'' or 
``certain'' children's product safety rules. However, whether a 
particular rule represents a ``children's product safety rule'' may be 
subject to interpretation, and the Commission staff is continuing to 
evaluate which rules, regulations, standards, or bans are ``children's 
product safety rules.'' The CPSC intends to issue additional notices of 
requirements for other rules which the Commission determines to be 
``children's product safety rules.''
    This notice of requirements applies to all third party conformity 
assessment bodies as described in section 14(f)(2) of the CPSA. 
Generally speaking, such third party conformity assessment bodies are: 
(1) Third party conformity assessment bodies that are not owned, 
managed, or controlled by a manufacturer or private labeler of a 
children's product to be tested by the third party conformity 
assessment body for certification purposes; (2) ``firewalled'' 
conformity assessment bodies (those that are owned, managed, or 
controlled by a manufacturer or private labeler of a children's product 
to be tested by the third party conformity assessment body for 
certification purposes and that seek accreditation under the additional 
statutory criteria for ``firewalled'' conformity assessment bodies); 
and (3) third party conformity assessment bodies owned or controlled, 
in whole or in part, by a government.
    The Commission requires baseline accreditation of each category of 
third party conformity assessment body to the International 
Organization for Standardization (``ISO'') Standard ISO/IEC 17025:2005, 
``General Requirements for the Competence of Testing and Calibration 
Laboratories.'' 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 any of the 
regulations identified earlier in part I of this document for which the 
third party conformity assessment body seeks to be accredited.
    (A description of the history and content of the ILAC-MRA approach 
and of the requirements of the ISO/IEC 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),'' dated November 2008 and available on the CPSC's Web site 
at http://www.cpsc.gov/library/foia/foia09/brief/smallparts.pdf.)
    The Commission has established an electronic accreditation 
registration and listing system that can be accessed via its Web site.
    This notice of requirements is effective on September 2, 2009. 
However, the CPSC will stay its enforcement of this notice of 
requirements at least until February 10, 2010; the date reflects the 
stay of enforcement that the CPSC published in the Federal Register on 
February 9, 2009 (74 FR 6396). Nevertheless, the Commission invites 
comments on the accreditation procedures as they apply to that testing 
and on the accreditation approach in general.
    This notice of requirements is exempt from the notice and comment 
rulemaking requirements of the Administrative Procedure Act, 5 U.S.C. 
553 (see section 14(a)(3)(G) of the CPSA, as added by section 102(a)(2) 
of the CPSIA (15 U.S.C. 2063(a)(3)(G))).

II. Accreditation Requirements

A. Baseline Third Party Conformity Assessment Body Accreditation 
Requirements

    For a third party conformity assessment body to be accredited to 
test children's products for conformity with the regulations identified 
earlier in part I of this document, 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 16 CFR parts 1203, 
1510, 1512, and/or 1513; and/or 16 CFR 1500.86(a)(7) and (a)(8). 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 conformity assessment

[[Page 45430]]

bodies are described in parts II.B and II.C of this document below.
    The Commission will maintain on its Web site an up-to-date listing 
of third party conformity assessment bodies 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 conformity assessment bodies noted in part IV 
below, once the Commission adds a third party conformity assessment 
body to that list, the third party conformity assessment body may 
commence testing of children's products to support certification by the 
manufacturer or private labeler of compliance with the regulations 
identified earlier in part I of this document.

B. Additional Accreditation Requirements for Firewalled Conformity 
Assessment Bodies

    In addition to the baseline accreditation requirements in part II.A 
of this document above, firewalled conformity assessment bodies seeking 
accredited status must submit to the Commission 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 third party conformity assessment body's 
test results. This additional requirement applies to any third party 
conformity assessment body in which a manufacturer or private labeler 
of a children's product to be tested by the third party conformity 
assessment body owns an interest of ten percent or more. While the 
Commission is not addressing common parentage of a third party 
conformity assessment body and a children's product manufacturer at 
this time, it will be vigilant to see if this issue needs to be 
addressed in the future.
    As required by section 14(f)(2)(D) of the CPSA, the Commission must 
formally accept, by order, the accreditation application of a third 
party conformity assessment body before the third party conformity 
assessment body can become an accredited firewalled conformity 
assessment body.

C. Additional Accreditation Requirements for Governmental Laboratories

    In addition to the baseline accreditation requirements of part II.A 
of this document above, the CPSIA permits accreditation of a third 
party conformity assessment body 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 conformity 
assessment bodies that are not owned or controlled by the government of 
that nation;
     The third party conformity assessment body's testing 
results are not subject to undue influence by any other person, 
including another governmental entity;
     The third party conformity assessment body is not accorded 
more favorable treatment than other third party conformity assessment 
bodies in the same nation who have been accredited;
     The third party conformity assessment body's testing 
results are accorded no greater weight by other governmental 
authorities than those of other accredited third party conformity 
assessment bodies; and
     The third party conformity assessment body 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 third party conformity assessment body's conformity assessments.
    The Commission will accept the accreditation of a governmental 
third party conformity assessment body if it meets the baseline 
accreditation requirements of part II.A of this document above and 
meets the additional conditions stated here. To obtain this assurance, 
CPSC staff will engage the governmental entities relevant to the 
accreditation request.

III. How Does a Third Party Conformity Assessment Body 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 third party conformity assessment body 
training document(s), if relevant.
    Commission staff will review the submission for accuracy and 
completeness. In the case of baseline third party conformity assessment 
bodies and government-owned or government-operated conformity 
assessment bodies, when that review and any necessary discussions with 
the applicant are satisfactorily completed, the third party conformity 
assessment body in question is added to the CPSC's list of accredited 
third party conformity assessment bodies at http://www.cpsc.gov/businfo/labaccred.html. In the case of a firewalled conformity 
assessment body seeking accredited status, when the staff's review is 
complete, the staff transmits its recommendation on accreditation to 
the Commission for consideration. (A third party conformity assessment 
body that may ultimately seek acceptance as a firewalled third party 
conformity assessment body also can initially request acceptance as a 
third party conformity assessment body accredited for testing of 
children's products other than those of its owners.) If the Commission 
accepts a staff recommendation to accredit a firewalled conformity 
assessment body, the firewalled conformity assessment body will then be 
added to the CPSC's list of accredited third party conformity 
assessment bodies. In each case, the Commission will notify the third 
party conformity assessment body electronically of acceptance of its 
accreditation. All information to support an accreditation acceptance 
request must be provided in the English language.
    Subject to the limited provisions for acceptance of 
``retrospective'' testing performed by other than accredited firewalled 
conformity assessment bodies noted in part IV of this document below, 
once the Commission adds a third party conformity assessment body to 
the list, the third party conformity assessment body may then begin 
testing of children's products to support certification of compliance 
with the regulations identified earlier in part I of this document for 
which it has been accredited.

IV. Limited Acceptance of Children's Product Certifications Based on 
Third Party Conformity Assessment Body Testing Prior to the 
Commission's Acceptance of Accreditation

    The Commission will accept a certificate of compliance with 16 CFR 
Parts 1203, 1510, 1512, and/or 1513; and/or 16 CFR 1500.86(a)(7) and 
(a)(8) based on testing performed by an accredited third party or 
governmental third party conformity assessment body:
     On or after May 16, 2008 (90 days before the CPSIA's 
enactment) and through the expiration of the stay of enforcement 
announced in the Federal

[[Page 45431]]

Register on February 9, 2009 (74 FR 6396), and
     Before the Commission's acceptance of the third party 
conformity assessment body's preexisting accreditation,

provided that accreditation is accepted by December 31, 2009 or 30 days 
before the Commission terminates the stay of enforcement that was 
originally announced in the Federal Register on February 9, 2009 (74 FR 
6396), whichever date is later, if:

     The third party conformity assessment body was ISO/IEC 
17025 accredited by an ILAC-MRA member at the time of the test;
     The accreditation scope in effect for the third party 
conformity assessment body at that time expressly included testing to 
the regulations identified earlier in part I of this document;
     The third party conformity assessment body's accreditation 
application is received by the Commission under the procedures of this 
notice by November 2, 2009; and
     The third party conformity assessment body's accreditation 
and inclusion of the regulations identified earlier in part I of this 
document in its scope remains in effect through the effective date for 
mandatory third party testing and manufacturer/private labeler 
certification for the relevant rule identified in this document.
    Testing performed by a firewalled conformity assessment body before 
the Commission's acceptance of its accreditation cannot be used as the 
basis for certification by a manufacturer or private labeler having a 
ten percent or greater ownership interest in the third party conformity 
assessment body.

    Dated: August 27, 2009.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. E9-21134 Filed 9-1-09; 8:45 am]
BILLING CODE 6355-01-P