[Federal Register Volume 74, Number 208 (Thursday, October 29, 2009)]
[Notices]
[Pages 55820-55824]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-26073]


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CONSUMER PRODUCT SAFETY COMMISSION

[CPSC Docket No. CPSC-2009-0090]


Third Party Testing for Certain Children's Products; Notice of 
Requirements for Accreditation of Third Party Conformity Assessment 
Bodies to Assess Conformity with the Limits on Total Lead in Children's 
Products

AGENCY: Consumer Product Safety Commission.

ACTION: Notice of Requirements.

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SUMMARY: The Consumer Product Safety Commission (``CPSC'' or 
``Commission'')

[[Page 55821]]

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 the limits on 
total lead in children's products. 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 the limits on total 
lead in children's products are effective upon publication of this 
notice in the Federal Register.
    Comments in response to this notice of requirements should be 
submitted by November 30, 2009. Comments on this notice should be 
captioned ``Third Party Conformity Assessment Body Accreditation 
Process for the Limits on Total Lead in Children's Products.''

ADDRESSES: You may submit comments, identified by Docket No. CPSC-2009-
0090, 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 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 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. The details regarding those limited circumstances can be found 
in part IV of this document below.
    This notice provides the criteria and process for Commission 
acceptance of accreditation of third party conformity assessment bodies 
for testing pursuant to the following test methods:
     CPSC-CH-E1001-08, Standard Operating Procedure for 
Determining Total Lead (Pb) in Children's Metal Products (Including 
Children's Metal Jewelry \1\), issued December 4, 2008, and
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    \1\ Due to the Commission's stay of enforcement that appeared in 
the Federal Register on February 9, 2009 (74 FR 6396), at the time 
when the stay of enforcement was published, only accessible, 
metallic parts of children's metal jewelry were required to be 
tested. When the stay of enforcement is lifted, all accessible parts 
of children's metal jewelry, metals and non-metals, will need to 
comply with the applicable regulations.
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     CPSC-CH-E1002-08, Standard Operating Procedure for 
Determining Total Lead (Pb) in Non-Metal Children's Products, issued 
February 1, 2009.

For measuring total lead content of homogeneous polymeric materials 
(including natural and synthetic polymers or plastic materials in 
children's consumer products), the methods for using x-ray fluorescence 
spectrometry (XRF) described in CPSC-CH-E1002-08 may be used. Both 
methods may be freely downloaded from the CPSC Web site at http://www.cpsc.gov/about/cpsia/labaccred.html.
    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 test methods identified immediately above. The CPSC 
acknowledges that the test methods for determining total lead content 
are not, in themselves, rules, but we believe it is appropriate for the 
notice of requirements to apply to the CPSC test methods because 
section 101(g) of the CPSIA considers the lead content restrictions to 
be ``a regulation of the Commission'' under the Federal Hazardous 
Substances Act. Thus, the test methods would be used to assess 
conformity with the lead requirements.
    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

[[Page 55822]]

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.''
    The CPSC also advises interested parties that, with respect to the 
materials which the CPSC has determined not to exceed the lead content 
limits specified in section 101(a) of the CPSIA, testing by third party 
conformity assessment bodies is not required to support a finding that 
a particular material is within the determinations. In the Federal 
Register of August 26, 2009 (74 FR 43031), the CPSC issued a final rule 
identifying those materials which do not exceed the lead content limits 
specified in section 101(a) of the CPSIA (the ``determinations rule''). 
For example, the determinations rule includes natural fibers, such as 
cotton, in the determinations; this means that a cotton shirt would not 
need to be tested by a third party conformity assessment body for lead, 
and it also means that a third party conformity assessment body would 
not need to test the cotton shirt to show that it is, indeed, made out 
of cotton. The CPSC reminds interested parties that the obligation to 
have third party conformity assessment bodies test children's products 
exists in relation to ``children's product safety rules'' and that 
section 14(f)(1) of the Consumer Product Safety Act (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.'' Section 3(a)(6) of the 
CPSA, in turn, defines ``consumer product safety rule,'' in part, as a 
consumer product safety standard * * * or a rule * * * declaring a 
consumer product a banned hazardous product.'' The rule determining 
that certain materials do not exceed the lead limits in section 101(a) 
of the CPSIA is not a ``consumer product safety rule'' as defined by 
section 3(a)(6) of the CPSA and, therefore, also is not a ``children's 
product safety rule'' as defined by section 14(a)(1) of the CPSA. 
Consequently, to continue using the example of a cotton shirt, the 
cotton shirt manufacturer could decide, based on its own knowledge and 
expertise regarding the materials used in its product, that its cotton 
shirt is, indeed, made of cotton and within the determinations rule. 
The cotton shirt manufacturer would not need to submit samples of its 
cotton shirts to a third party conformity assessment body to determine 
whether the shirts were made of cotton.
    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 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 
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 October 29, 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 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 CPSC-CH-E1001-08, 
Standard Operating Procedure for Determining Total Lead (Pb) in 
Children's Metal Products (Including Children's Metal Jewelry), issued 
December 4, 2008, and/or CPSC-CH-E1002-08, Standard Operating Procedure 
for Determining Total Lead (Pb) in Non-Metal Children's Products, 
issued February 1, 2009. 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.

[[Page 55823]]

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 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/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 to the total 
lead content limits established by the CPSIA for children's products 
and tested in accordance with CPSC-CH-E1001-08, Standard Operating 
Procedure for Determining Total Lead (Pb) in Children's Metal Products 
(Including Children's Metal Jewelry), issued December 4, 2008, and/or 
CPSC-CH-E1002-08, Standard Operating Procedure for Determining Total 
Lead (Pb) in Non-Metal Children's Products, issued February 1, 2009, 
based on testing performed by an accredited third party conformity 
assessment body (including a government-owned conformity assessment 
body, a government controlled conformity

[[Page 55824]]

assessment body, and a firewalled conformity assessment body) if:
     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 at the time of the test. For 
firewalled conformity assessment bodies, the firewalled conformity 
assessment body must be one that the Commission has accredited by order 
at or before the time the product was tested, even if the order did not 
include the test methods specified in this notice. If the third party 
conformity assessment body has not been accredited by a Commission 
order as a firewalled conformity assessment body, the Commission will 
not accept a certificate of compliance based on testing performed by 
the third party conformity assessment body before it is accredited, by 
Commission order, as a firewalled conformity assessment body.
     The third party conformity assessment body's application 
for testing for total lead content in children's products using the 
test methods identified in this document is accepted by the CPSC by 
December 31, 2009 or 30 days prior to the date the Commission 
terminates the stay of enforcement that was originally announced in the 
Federal Register on February 9, 2009 (74 FR 6396) (whichever is the 
later date);
     The product was tested on or after December 4, 2008 with 
respect to CPSC test method CPSC-CH-E1001-08, Standard Operating 
Procedure for Determining Total Lead (Pb) in Children's Metal Products 
(Including Children's Metal Jewelry) and/or was tested on or after 
February 1, 2009 with respect to CPSC test method CPSC-CH-E1002-08, 
Standard Operating Procedure for Determining Total Lead (Pb) in Non-
Metal Children's Products. For example, a children's product 
constructed completely from metal materials must be tested in 
accordance with CPSC-CH-E1001-08. A children's product constructed 
completely from non-metal materials must be tested in accordance with 
CPSC-CH-E1002-08. A children's product constructed from a combination 
of metal and non-metal materials must be tested in accordance with both 
test methods.
     The accreditation scope in effect for the third party 
conformity assessment body at that time expressly included testing to 
the test method(s) identified earlier in part I of this document;
     The test results show compliance with the applicable 
current standards and regulations (i.e., the total lead limits in 
effect on the day the certification is presented, rather than those in 
effect on the day that the testing was performed); and
     The third party conformity assessment body's accreditation 
and inclusion of the test method(s) for determining total lead content 
(identified earlier in part I of this document) in its scope remain in 
effect through the effective date for mandatory third party testing and 
manufacturer/private labeler certification for the total lead limit 
requirements for children's products.

    Dated: October 23, 2009.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. E9-26073 Filed 10-28-09; 8:45 am]
BILLING CODE 6355-01-P