[Federal Register: September 2, 2009 (Volume 74, Number 169)]
[Notices]
[Page 45428-45431]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02se09-41]
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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 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
[[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