[Federal Register Volume 75, Number 118 (Monday, June 21, 2010)]
[Rules and Regulations]
[Pages 35282-35285]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-14325]


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CONSUMER PRODUCT SAFETY COMMISSION

[CPSC Docket No. CPSC-2009-0066]

16 CFR Part 1216


Third Party Testing for Certain Children's Products; Infant 
Walkers: Requirements for Accreditation of Third Party Conformity 
Assessment Bodies

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 infant walkers. The Commission is issuing this notice of 
requirements pursuant to section 14(a)(3)(B)(vi) of the Consumer 
Product Safety Act (CPSA) (15 U.S.C. 2063(a)(3)(B)(vi)).

DATES: Effective Date: The requirements for accreditation of third 
party conformity assessment bodies to assess conformity with 16 CFR 
part 1216 are effective upon publication of this notice in the Federal 
Register.
    Comments in response to this notice of requirements should be 
submitted by July 21, 2010. Comments on this notice should be captioned 
``Third Party Testing for Certain Children's Products; Infant Walkers: 
Requirements for Accreditation of Third Party Conformity Assessment 
Bodies.''

ADDRESSES: You may submit comments, identified by Docket No. CPSC-2009-
0066, 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 
ways:
    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 820, 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. All comments received may be posted 
without change to http://www.regulations.gov, including any personal 
information provided. Do not submit confidential business information, 
trade secret information, or other sensitive or protected information 
(such as a Social Security Number) electronically; if furnished at all, 
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:

[[Page 35283]]

I. Introduction

    Section 14(a)(3)(B)(vi) of the CPSA, 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 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)(2) of the CPSA, as added by section 102(a)(2) of the CPSIA, every 
manufacturer (and the private labeler, if applicable) of a children's 
product subject to a children's product safety rule must have such 
product 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. Section 14(a)(2) of the 
CPSA also 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).
    This notice provides the criteria and process for Commission 
acceptance of accreditation of third party conformity assessment bodies 
for testing pursuant to the safety standard for infant walkers which 
appears elsewhere in this issue of the Federal Register. The standard 
for infant walkers will be codified at 16 CFR part 1216. The standard 
contains the testing methods that conformity assessment bodies will use 
to assess infant walkers. The Commission is recognizing limited 
circumstances in which it will accept certifications based on product 
testing conducted before the infant walkers standard becomes effective 
in six months. The details regarding those limited circumstances can be 
found in part IV of this document below.
    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 standard identified immediately above.
    The CPSC also recognizes that 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)/International Electrotechnical 
Commission (IEC) Standard 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 test methods 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 
Regulations),'' 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 
at http://www.cpsc.gov/about/cpsia/labaccred.html.
    The Commission stayed the enforcement of certain provisions of 
section 14(a) of the CPSA in a notice published in the Federal Register 
on February 9, 2009 (74 FR 6396); the stay applied to testing and 
certification of various products, including infant walkers. On 
December 28, 2009, the Commission published a notice in the Federal 
Register (74 FR 68588) revising the terms of the stay. One section of 
the December 28, 2009, notice addressed ``Consumer Products or 
Children's Products Where the Commission Is Continuing the Stay of 
Enforcement Until Further Notice,'' due to factors such as pending 
rulemaking proceedings affecting the product or the absence of a notice 
of requirements. The infant walkers testing and certification 
requirements were included in that section of the December 28, 2009, 
notice. As the factors preventing the stay from being lifted in the 
December 28, 2009, notice with regard to testing and certifications of 
infant walkers were the absence of approved standards and a notice of 
requirements, publication of this notice, along with the final rule on 
Safety Standard for Infant Walkers which appears elsewhere in this 
issue of the Federal Register, have the effect of lifting the stay with 
regard to these CPSC regulations for infant walkers.
    This notice of requirements is effective on June 21, 2010. The 
final rule announcing the Safety Standard for Infant Walkers is 
effective December 21, 2010. The effect of these twin publications is 
that each manufacturer (including the importer) or private labeler of a 
product subject to 16 CFR part 1216 must have any such product 
manufactured on or after December 21, 2010 tested by a third party 
conformity assessment body accredited to do so and must issue a 
certificate of compliance

[[Page 35284]]

with 16 CFR part 1216 based on that testing.
    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 test methods 
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 the test method for 
infant walkers included in 16 CFR part 1216, Safety Standard for Infant 
Walkers. 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 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. Once the Commission adds 
a third party conformity assessment body to that list, the third party 
conformity assessment body may commence testing of infant walkers to 
support certification by the manufacturer or private labeler of 
compliance with the test methods 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 Conformity 
Assessment Bodies

    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/about/cpsia/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/about/cpsia/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

[[Page 35285]]

conformity assessment body electronically of acceptance of its 
accreditation. All information to support an accreditation acceptance 
request must be provided in the English language.
    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. Acceptance of Children's Product Certifications Based on Third 
Party Conformity Assessment Body Testing to the New Safety Standard for 
Infant Walkers Prior to Their Effective Date

    Elsewhere in this issue of the Federal Register, the Commission is 
publishing a new safety standard for infant walkers, which will be 
codified at 16 CFR part 1216. The effect of this notice of requirements 
and the final rule is that each manufacturer (including the importer) 
or private labeler of a product subject to 16 CFR part 1216 must have 
any such product manufactured on or after December 21, 2010 tested by a 
third party conformity assessment body accredited to do so and must 
issue a certificate of compliance with 16 CFR part 1216 based on that 
testing.
    To ease the transition to the new standard and avoid a 
``bottleneck'' of products at conformity assessment bodies at or near 
the effective date of 16 CFR 1216, the Commission will accept 
certifications based on testing that occurred prior to the effective 
date of the new standard in certain prescribed circumstances. However, 
any such testing must comport with all CPSC requirements, including:
     At the time of product testing, the product was tested by 
a third party conformity assessment body that was ISO/IEC 17025 
accredited by an ILAC-MRA member, and had been accepted by the 
Commission;
     The accreditation scope in effect for the third party 
conformity assessment body at the time of testing expressly included 
testing to the test method(s) included in 16 CFR part 1216; and
     The test results show compliance with the test methods in 
the new regulation (16 CFR part 1216).

    Dated: June 9, 2010.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2010-14325 Filed 6-18-10; 8:45 am]
BILLING CODE 6355-01-P