[Federal Register: October 29, 2009 (Volume 74, Number 208)]
[Notices]
[Page 55820-55824]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29oc09-57]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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 rhowell@cpsc.gov.
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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