[Federal Register Volume 75, Number 107 (Friday, June 4, 2010)]
[Rules and Regulations]
[Pages 31688-31691]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-13080]
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CONSUMER PRODUCT SAFETY COMMISSION
[CPSC Docket No. CPSC-2009-0064]
16 CFR Part 1215
Third Party Testing for Certain Children's Products; Infant Bath
Seats: Requirements for Accreditation of Third Party Conformity
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 bath seats. 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 1215 are effective upon publication of this notice in the Federal
Register.
Comments in response to this notice of requirements should be
submitted by July 6, 2010. Comments on this notice should be captioned
``Notice of Requirements for Accreditation of Third Party Conformity
Assessment Bodies to Assess Conformity with Part 1215 of Title 16, Code
of Federal Regulations.''
ADDRESSES: You may submit comments, identified by Docket No. CPSC-2009-
0064 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:
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)(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 a notice of the requirements for
accreditation, 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, as
[[Page 31689]]
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).
This notice provides the criteria and process for Commission
acceptance of accreditation of third party conformity assessment bodies
for testing pursuant to safety standard for infant bath seats which
appears elsewhere in this issue of the Federal Register. The standard
for infant bath seats will be codified at 16 CFR part 1215. The
standard contains the testing methods that conformity assessment bodies
will use to assess infant bath seats. The Commission is recognizing
limited circumstances in which it will accept certifications based on
product testing conducted before the infant bath seat 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 test methods 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 bath seats. 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 bath seats 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 bath seats were the absence of approved standards and a notice
of requirements, publication of this notice along with today's Safety
Standard for Infant Bath Seats; Final Rule, have the effect of lifting
the stay with regard to these CPSC regulations.
This notice of requirements is effective on June 4, 2010. The final
rule announcing the Safety Standard for Infant Bath Seats is effective
December 1, 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 1215 must have any such product manufactured on
or after December 2, 2010, tested by a third party conformity
assessment body accredited to do so and must issue a certificate of
compliance with 16 CFR part 1215 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 bath seats included in 16 CFR part 1215, Safety Standard for
[[Page 31690]]
Infant Bath Seats. 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 bath seats 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 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 Bath Seats Prior to Their Effective Date
Elsewhere in this issue of the Federal Register, the Commission is
publishing a new safety standard for infant bath seats, which will be
codified at 16 CFR part 1215. 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 1215 must have
[[Page 31691]]
any such product manufactured on or after December 1, 2010 tested by a
third party conformity assessment body accredited to do so and must
issue a certificate of compliance with 16 CFR part 1215 based on that
testing.
To ease the transition to the new standard and avoid a
``bottlenecking'' of products at conformity assessment bodies at or
near the effective date of 16 CFR 1215, 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, at the time of the test.
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 1215; and
The test results show compliance with the test methods in
the new regulation (16 CFR part 1215).
Dated: May 25, 2010.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2010-13080 Filed 6-3-10; 8:45 am]
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