Third Party Testing for Certain Children's Products; Infant Walkers: Requirements for Accreditation of Third Party Conformity Assessment Bodies, 35282-35285 [2010-14325]
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35282
Federal Register / Vol. 75, No. 118 / Monday, June 21, 2010 / Rules and Regulations
Regulation for Baby Bouncers, WalkerJumpers, and Baby-Walkers, 16 CFR
§ 1500.18(a)(6) and § 1500.86(a)(4),’’
dated August 14, 2009.
3. Snyder, R.G., Spencer, M.L.,
Owings, C.L. & Schneider, L.W. (1975),
Physical Characteristics of Children As
Related to Death and Injury for
Consumer Product Design and Use,
Prepared for the Consumer Product
Safety Commission (UM–HSRI–BI–75–5
Final Report Contract FDA–72–70 May
1975), Highway Safety Research
Institute, The University of Michigan,
May 31, 1975.
4. ASTM voluntary standard F 2012,
Standard Consumer Safety Performance
Specifications for Stationary Activity
Centers.
5. ASTM voluntary standard F 2167,
Standard Consumer Safety
Specification for Infant Bouncer Seats.
6. CPSC staff memorandum to
Jacqueline Elder, Assistant Executive
Director, Office of Hazard Identification
and Reduction, from Patricia Hackett,
Division of Mechanical Engineering,
‘‘Regulatory Review of CPSC Regulation
for Baby Bouncers, Walker-Jumpers, and
Baby-Walkers, 16 CFR §§ 1500.18(a)(6)
and 1500.86(a)(4),’’ dated April 24, 2007.
7. CPSC staff memorandum from
Mark E. Kumagai, Director, Division of
Mechanical Engineering, Directorate for
Engineering Sciences, ‘‘Staff Draft
Proposed Final Rule—Revocation of
CPSC Regulation for Baby-Walkers, 16
CFR 1500.18(a)(6) and 1500.86(a)(4),’’
May 5, 2010.
8. 36 FR 7255–56 (April 16, 1971).
9. 36 FR 21809–10 (Nov. 16, 1971).
10. 73 FR 68328 (Nov. 18, 2008).
11. 74 FR 6396 (Feb. 9, 2009).
12. 74 FR 68588 (Dec. 28, 2009).
§ 1500.18 Banned toys and other banned
articles intended for use by children.
Product Safety Act (CPSA) (15 U.S.C.
2063(a)(3)(B)(vi)).
(a) * * *
(6) Any article known as a ‘‘babybouncer’’ or ‘‘walker-jumper’’ and any
other similar article (referred to in this
paragraph as ‘‘article(s)’’), except an
infant walker subject to part 1216,
which is intended to support very
young children while sitting, bouncing,
jumping, and/or reclining, and which
because of its design has any exposed
parts capable of causing amputation,
crushing, lacerations, fractures,
hematomas, bruises, or other injuries to
fingers, toes, or other parts of the
anatomy of young children.
DATES: Effective Date: The requirements
for accreditation of third party
conformity assessment bodies to assess
conformity with 16 CFR part 1216 are
effective upon publication of this notice
in the Federal Register.
Comments in response to this notice
of requirements should be submitted by
July 21, 2010. Comments on this notice
should be captioned ‘‘Third Party
Testing for Certain Children’s Products;
Infant Walkers: Requirements for
Accreditation of Third Party Conformity
Assessment Bodies.’’
3. Amend § 1500.86 by revising
paragraph (a)(4) introductory text to
read as follows:
■
§ 1500.86 Exemptions from classification
as a banned toy or other banned article for
use by children.
(a) * * *
(4) Any article known as a ‘‘babybouncer’’ or ‘‘walker-jumper’’ and any
other similar article (referred to in this
paragraph as ‘‘article(s)’’), except an
infant walker subject to part 1216 of this
chapter, described in § 1500.18(a)(6)
provided:
*
*
*
*
*
Dated: June 9, 2010.
Todd Stevenson,
Secretary, U.S. Consumer Product Safety
Commission.
[FR Doc. 2010–14326 Filed 6–18–10; 8:45 am]
BILLING CODE 6355–01–P
CONSUMER PRODUCT SAFETY
COMMISSION
[CPSC Docket No. CPSC–2009–0066]
List of Subjects in 16 CFR Part 1500
16 CFR Part 1216
Baby walkers, Consumer protection,
Hazardous substances, Imports, Infants
and children, Labeling, Law
enforcement, Toys.
■ For the reasons stated in the preamble,
the Consumer Product Safety
Commission amends 16 CFR part 1500
as follows:
Third Party Testing for Certain
Children’s Products; Infant Walkers:
Requirements for Accreditation of
Third Party Conformity Assessment
Bodies
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PART 1500—HAZARDOUS
SUBSTANCES AND ARTICLES;
ADMINISTRATION AND
ENFORCEMENT REGULATIONS
1. The authority citation for 16 CFR
part 1500 continues to read as follows:
■
Authority: 15 U.S.C. 1261–1278.
2. Amend § 1500.18(a)(6) introductory
text by revising the first sentence to read
as follows:
■
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AGENCY: Consumer Product Safety
Commission.
ACTION: Notice of requirements.
SUMMARY: The Consumer Product Safety
Commission (CPSC or Commission) is
issuing a notice of requirements that
provides the criteria and process for
Commission acceptance of accreditation
of third party conformity assessment
bodies for testing pursuant to specific
CPSC regulations relating to infant
walkers. The Commission is issuing this
notice of requirements pursuant to
section 14(a)(3)(B)(vi) of the Consumer
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ADDRESSES: You may submit comments,
identified by Docket No. CPSC–2009–
0066, by any of the following methods:
Electronic Submissions: Submit
electronic comments in the following
way:
Federal eRulemaking Portal: https://
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
https://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 https://
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 https://
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; email rhowell@cpsc.gov.
SUPPLEMENTARY INFORMATION:
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I. Introduction
Section 14(a)(3)(B)(vi) of the CPSA, as
added by section 102(a)(2) of the
Consumer Product Safety Improvement
Act of 2008 (CPSIA), Public Law 110–
314, directs the CPSC to publish a
notice of requirements for accreditation
of third party conformity assessment
bodies to assess children’s products for
conformity with ‘‘other children’s
product safety rules.’’ Section 14(f)(1) of
the CPSA defines ‘‘children’s product
safety rule’’ as ‘‘a consumer product
safety rule under [the CPSA] or similar
rule, regulation, standard, or ban under
any other Act enforced by the
Commission, including a rule declaring
a consumer product to be a banned
hazardous product or substance.’’ Under
section 14(a)(2) of the CPSA, as added
by section 102(a)(2) of the CPSIA, every
manufacturer (and the private labeler, if
applicable) of a children’s product
subject to a children’s product safety
rule must have such product tested by
a third party conformity assessment
body accredited to do so, and must issue
a certificate of compliance with the
applicable regulations based on that
testing. Section 14(a)(2) of the CPSA
also requires that certification be based
on testing of sufficient samples of the
product, or samples that are identical in
all material respects to the product. The
Commission also emphasizes that,
irrespective of certification, the product
in question must comply with
applicable CPSC requirements (see, e.g.,
section 14(h) of the CPSA, as added by
section 102(b) of the CPSIA).
This notice provides the criteria and
process for Commission acceptance of
accreditation of third party conformity
assessment bodies for testing pursuant
to the safety standard for infant walkers
which appears elsewhere in this issue of
the Federal Register. The standard for
infant walkers will be codified at 16
CFR part 1216. The standard contains
the testing methods that conformity
assessment bodies will use to assess
infant walkers. The Commission is
recognizing limited circumstances in
which it will accept certifications based
on product testing conducted before the
infant walkers standard becomes
effective in six months. The details
regarding those limited circumstances
can be found in part IV of this document
below.
Although section 14(a)(3)(B)(vi) of the
CPSA directs the CPSC to publish a
notice of requirements for accreditation
of third party conformity assessment
bodies to assess conformity with ‘‘all
other children’s product safety rules,’’
this notice of requirements is limited to
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the standard identified immediately
above.
The CPSC also recognizes that section
14(a)(3)(B)(vi) of the CPSA is captioned
as ‘‘All Other Children’s Product Safety
Rules,’’ but the body of the statutory
requirement refers only to ‘‘other
children’s product safety rules.’’
Nevertheless, section 14(a)(3)(B)(vi) of
the CPSA could be construed as
requiring a notice of requirements for
‘‘all’’ other children’s product safety
rules, rather than a notice of
requirements for ‘‘some’’ or ‘‘certain’’
children’s product safety rules.
However, whether a particular rule
represents a ‘‘children’s product safety
rule’’ may be subject to interpretation,
and the Commission staff is continuing
to evaluate which rules, regulations,
standards, or bans are ‘‘children’s
product safety rules.’’ The CPSC intends
to issue additional notices of
requirements for other rules which the
Commission determines to be
‘‘children’s product safety rules.’’
This notice of requirements applies to
all third party conformity assessment
bodies as described in section 14(f)(2) of
the CPSA. Generally speaking, such
third party conformity assessment
bodies are: (1) Third party conformity
assessment bodies that are not owned,
managed, or controlled by a
manufacturer or private labeler of a
children’s product to be tested by the
third party conformity assessment body
for certification purposes; (2)
‘‘firewalled’’ conformity assessment
bodies (those that are owned, managed,
or controlled by a manufacturer or
private labeler of a children’s product to
be tested by the third party conformity
assessment body for certification
purposes and that seek accreditation
under the additional statutory criteria
for ‘‘firewalled’’ conformity assessment
bodies); and (3) third party conformity
assessment bodies owned or controlled,
in whole or in part, by a government.
The Commission requires baseline
accreditation of each category of third
party conformity assessment body to the
International Organization for
Standardization (ISO)/International
Electrotechnical Commission (IEC)
Standard 17025:2005, ‘‘General
Requirements for the Competence of
Testing and Calibration Laboratories.’’
The accreditation must be by an
accreditation body that is a signatory to
the International Laboratory
Accreditation Cooperation-Mutual
Recognition Arrangement (ILAC–MRA),
and the scope of the accreditation must
include testing for any of the test
methods identified earlier in part I of
this document for which the third party
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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 https://
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 https://www.cpsc.gov/
about/cpsia/labaccred.html.
The Commission stayed the
enforcement of certain provisions of
section 14(a) of the CPSA in a notice
published in the Federal Register on
February 9, 2009 (74 FR 6396); the stay
applied to testing and certification of
various products, including infant
walkers. On December 28, 2009, the
Commission published a notice in the
Federal Register (74 FR 68588) revising
the terms of the stay. One section of the
December 28, 2009, notice addressed
‘‘Consumer Products or Children’s
Products Where the Commission Is
Continuing the Stay of Enforcement
Until Further Notice,’’ due to factors
such as pending rulemaking
proceedings affecting the product or the
absence of a notice of requirements. The
infant walkers testing and certification
requirements were included in that
section of the December 28, 2009,
notice. As the factors preventing the
stay from being lifted in the December
28, 2009, notice with regard to testing
and certifications of infant walkers were
the absence of approved standards and
a notice of requirements, publication of
this notice, along with the final rule on
Safety Standard for Infant Walkers
which appears elsewhere in this issue of
the Federal Register, have the effect of
lifting the stay with regard to these
CPSC regulations for infant walkers.
This notice of requirements is
effective on June 21, 2010. The final rule
announcing the Safety Standard for
Infant Walkers is effective December 21,
2010. The effect of these twin
publications is that each manufacturer
(including the importer) or private
labeler of a product subject to 16 CFR
part 1216 must have any such product
manufactured on or after December 21,
2010 tested by a third party conformity
assessment body accredited to do so and
must issue a certificate of compliance
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with 16 CFR part 1216 based on that
testing.
This notice of requirements is exempt
from the notice and comment
rulemaking requirements of the
Administrative Procedure Act, 5 U.S.C.
553 (see section 14(a)(3)(G) of the CPSA,
as added by section 102(a)(2) of the
CPSIA (15 U.S.C. 2063(a)(3)(G))).
II. Accreditation Requirements
A. Baseline Third Party Conformity
Assessment Body Accreditation
Requirements
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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 https://
ilac.org/membersbycategory.html. The
accreditation must be to ISO Standard
ISO/IEC 17025:2005, ‘‘General
Requirements for the Competence of
Testing and Calibration Laboratories,’’
and the scope of the accreditation must
expressly include testing to the test
method for infant walkers included in
16 CFR part 1216, Safety Standard for
Infant Walkers. A true copy, in English,
of the accreditation and scope
documents demonstrating compliance
with these requirements must be
registered with the Commission
electronically. The additional
requirements for accreditation of
firewalled and governmental conformity
assessment bodies are described in parts
II.B and II.C of this document below.
The Commission will maintain on its
Web site an up-to-date listing of third
party conformity assessment bodies
whose accreditations it has accepted
and the scope of each accreditation.
Once the Commission adds a third party
conformity assessment body to that list,
the third party conformity assessment
body may commence testing of infant
walkers to support certification by the
manufacturer or private labeler of
compliance with the test methods
identified earlier in part I of this
document.
B. Additional Accreditation
Requirements for Firewalled Conformity
Assessment Bodies
In addition to the baseline
accreditation requirements in part II.A
of this document above, firewalled
conformity assessment bodies seeking
accredited status must submit to the
Commission copies, in English, of their
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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
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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 https://
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 https://
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
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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.
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IV. Acceptance of Children’s Product
Certifications Based on Third Party
Conformity Assessment Body Testing to
the New Safety Standard for Infant
Walkers Prior to Their Effective Date
Elsewhere in this issue of the Federal
Register, the Commission is publishing
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a new safety standard for infant walkers,
which will be codified at 16 CFR part
1216. The effect of this notice of
requirements and the final rule is that
each manufacturer (including the
importer) or private labeler of a product
subject to 16 CFR part 1216 must have
any such product manufactured on or
after December 21, 2010 tested by a
third party conformity assessment body
accredited to do so and must issue a
certificate of compliance with 16 CFR
part 1216 based on that testing.
To ease the transition to the new
standard and avoid a ‘‘bottleneck’’ of
products at conformity assessment
bodies at or near the effective date of 16
CFR 1216, the Commission will accept
certifications based on testing that
occurred prior to the effective date of
the new standard in certain prescribed
circumstances. However, any such
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testing must comport with all CPSC
requirements, including:
• At the time of product testing, the
product was tested by a third party
conformity assessment body that was
ISO/IEC 17025 accredited by an ILAC–
MRA member, and had been accepted
by the Commission;
• The accreditation scope in effect for
the third party conformity assessment
body at the time of testing expressly
included testing to the test method(s)
included in 16 CFR part 1216; and
• The test results show compliance
with the test methods in the new
regulation (16 CFR part 1216).
Dated: June 9, 2010.
Todd A. Stevenson,
Secretary, Consumer Product Safety
Commission.
[FR Doc. 2010–14325 Filed 6–18–10; 8:45 am]
BILLING CODE 6355–01–P
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]]>Agencies
[Federal Register Volume 75, Number 118 (Monday, June 21, 2010)]
[Rules and Regulations]
[Pages 35282-35285]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-14325]
-----------------------------------------------------------------------
CONSUMER PRODUCT SAFETY COMMISSION
[CPSC Docket No. CPSC-2009-0066]
16 CFR Part 1216
Third Party Testing for Certain Children's Products; Infant
Walkers: Requirements for Accreditation of Third Party Conformity
Assessment Bodies
AGENCY: Consumer Product Safety Commission.
ACTION: Notice of requirements.
-----------------------------------------------------------------------
SUMMARY: The Consumer Product Safety Commission (CPSC or Commission) is
issuing a notice of requirements that provides the criteria and process
for Commission acceptance of accreditation of third party conformity
assessment bodies for testing pursuant to specific CPSC regulations
relating to infant walkers. The Commission is issuing this notice of
requirements pursuant to section 14(a)(3)(B)(vi) of the Consumer
Product Safety Act (CPSA) (15 U.S.C. 2063(a)(3)(B)(vi)).
DATES: Effective Date: The requirements for accreditation of third
party conformity assessment bodies to assess conformity with 16 CFR
part 1216 are effective upon publication of this notice in the Federal
Register.
Comments in response to this notice of requirements should be
submitted by July 21, 2010. Comments on this notice should be captioned
``Third Party Testing for Certain Children's Products; Infant Walkers:
Requirements for Accreditation of Third Party Conformity Assessment
Bodies.''
ADDRESSES: You may submit comments, identified by Docket No. CPSC-2009-
0066, by any of the following methods:
Electronic Submissions: Submit electronic comments in the following
way:
Federal eRulemaking Portal: https://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 https://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 https://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 https://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:
[[Page 35283]]
I. Introduction
Section 14(a)(3)(B)(vi) of the CPSA, as added by section 102(a)(2)
of the Consumer Product Safety Improvement Act of 2008 (CPSIA), Public
Law 110-314, directs the CPSC to publish a notice of requirements for
accreditation of third party conformity assessment bodies to assess
children's products for conformity with ``other children's product
safety rules.'' Section 14(f)(1) of the CPSA defines ``children's
product safety rule'' as ``a consumer product safety rule under [the
CPSA] or similar rule, regulation, standard, or ban under any other Act
enforced by the Commission, including a rule declaring a consumer
product to be a banned hazardous product or substance.'' Under section
14(a)(2) of the CPSA, as added by section 102(a)(2) of the CPSIA, every
manufacturer (and the private labeler, if applicable) of a children's
product subject to a children's product safety rule must have such
product tested by a third party conformity assessment body accredited
to do so, and must issue a certificate of compliance with the
applicable regulations based on that testing. Section 14(a)(2) of the
CPSA also requires that certification be based on testing of sufficient
samples of the product, or samples that are identical in all material
respects to the product. The Commission also emphasizes that,
irrespective of certification, the product in question must comply with
applicable CPSC requirements (see, e.g., section 14(h) of the CPSA, as
added by section 102(b) of the CPSIA).
This notice provides the criteria and process for Commission
acceptance of accreditation of third party conformity assessment bodies
for testing pursuant to the safety standard for infant walkers which
appears elsewhere in this issue of the Federal Register. The standard
for infant walkers will be codified at 16 CFR part 1216. The standard
contains the testing methods that conformity assessment bodies will use
to assess infant walkers. The Commission is recognizing limited
circumstances in which it will accept certifications based on product
testing conducted before the infant walkers standard becomes effective
in six months. The details regarding those limited circumstances can be
found in part IV of this document below.
Although section 14(a)(3)(B)(vi) of the CPSA directs the CPSC to
publish a notice of requirements for accreditation of third party
conformity assessment bodies to assess conformity with ``all other
children's product safety rules,'' this notice of requirements is
limited to the standard identified immediately above.
The CPSC also recognizes that section 14(a)(3)(B)(vi) of the CPSA
is captioned as ``All Other Children's Product Safety Rules,'' but the
body of the statutory requirement refers only to ``other children's
product safety rules.'' Nevertheless, section 14(a)(3)(B)(vi) of the
CPSA could be construed as requiring a notice of requirements for
``all'' other children's product safety rules, rather than a notice of
requirements for ``some'' or ``certain'' children's product safety
rules. However, whether a particular rule represents a ``children's
product safety rule'' may be subject to interpretation, and the
Commission staff is continuing to evaluate which rules, regulations,
standards, or bans are ``children's product safety rules.'' The CPSC
intends to issue additional notices of requirements for other rules
which the Commission determines to be ``children's product safety
rules.''
This notice of requirements applies to all third party conformity
assessment bodies as described in section 14(f)(2) of the CPSA.
Generally speaking, such third party conformity assessment bodies are:
(1) Third party conformity assessment bodies that are not owned,
managed, or controlled by a manufacturer or private labeler of a
children's product to be tested by the third party conformity
assessment body for certification purposes; (2) ``firewalled''
conformity assessment bodies (those that are owned, managed, or
controlled by a manufacturer or private labeler of a children's product
to be tested by the third party conformity assessment body for
certification purposes and that seek accreditation under the additional
statutory criteria for ``firewalled'' conformity assessment bodies);
and (3) third party conformity assessment bodies owned or controlled,
in whole or in part, by a government.
The Commission requires baseline accreditation of each category of
third party conformity assessment body to the International
Organization for Standardization (ISO)/International Electrotechnical
Commission (IEC) Standard 17025:2005, ``General Requirements for the
Competence of Testing and Calibration Laboratories.'' The accreditation
must be by an accreditation body that is a signatory to the
International Laboratory Accreditation Cooperation-Mutual Recognition
Arrangement (ILAC-MRA), and the scope of the accreditation must include
testing for any of the test methods identified earlier in part I of
this document for which the third party conformity assessment body
seeks to be accredited.
(A description of the history and content of the ILAC-MRA approach
and of the requirements of the ISO/IEC 17025:2005 laboratory
accreditation standard is provided in the CPSC staff briefing
memorandum ``Third Party Conformity Assessment Body Accreditation
Requirements for Testing Compliance with 16 CFR part 1501 (Small Parts
Regulations),'' dated November 2008 and available on the CPSC's Web
site at https://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 https://www.cpsc.gov/about/cpsia/labaccred.html.
The Commission stayed the enforcement of certain provisions of
section 14(a) of the CPSA in a notice published in the Federal Register
on February 9, 2009 (74 FR 6396); the stay applied to testing and
certification of various products, including infant walkers. On
December 28, 2009, the Commission published a notice in the Federal
Register (74 FR 68588) revising the terms of the stay. One section of
the December 28, 2009, notice addressed ``Consumer Products or
Children's Products Where the Commission Is Continuing the Stay of
Enforcement Until Further Notice,'' due to factors such as pending
rulemaking proceedings affecting the product or the absence of a notice
of requirements. The infant walkers testing and certification
requirements were included in that section of the December 28, 2009,
notice. As the factors preventing the stay from being lifted in the
December 28, 2009, notice with regard to testing and certifications of
infant walkers were the absence of approved standards and a notice of
requirements, publication of this notice, along with the final rule on
Safety Standard for Infant Walkers which appears elsewhere in this
issue of the Federal Register, have the effect of lifting the stay with
regard to these CPSC regulations for infant walkers.
This notice of requirements is effective on June 21, 2010. The
final rule announcing the Safety Standard for Infant Walkers is
effective December 21, 2010. The effect of these twin publications is
that each manufacturer (including the importer) or private labeler of a
product subject to 16 CFR part 1216 must have any such product
manufactured on or after December 21, 2010 tested by a third party
conformity assessment body accredited to do so and must issue a
certificate of compliance
[[Page 35284]]
with 16 CFR part 1216 based on that testing.
This notice of requirements is exempt from the notice and comment
rulemaking requirements of the Administrative Procedure Act, 5 U.S.C.
553 (see section 14(a)(3)(G) of the CPSA, as added by section 102(a)(2)
of the CPSIA (15 U.S.C. 2063(a)(3)(G))).
II. Accreditation Requirements
A. Baseline Third Party Conformity Assessment Body Accreditation
Requirements
For a third party conformity assessment body to be accredited to
test children's products for conformity with the test methods
identified earlier in part I of this document, it must be accredited by
an ILAC-MRA signatory accrediting body, and the accreditation must be
registered with, and accepted by, the Commission. A listing of ILAC-MRA
signatory accrediting bodies is available on the Internet at https://ilac.org/membersbycategory.html. The accreditation must be to ISO
Standard ISO/IEC 17025:2005, ``General Requirements for the Competence
of Testing and Calibration Laboratories,'' and the scope of the
accreditation must expressly include testing to the test method for
infant walkers included in 16 CFR part 1216, Safety Standard for Infant
Walkers. A true copy, in English, of the accreditation and scope
documents demonstrating compliance with these requirements must be
registered with the Commission electronically. The additional
requirements for accreditation of firewalled and governmental
conformity assessment bodies are described in parts II.B and II.C of
this document below.
The Commission will maintain on its Web site an up-to-date listing
of third party conformity assessment bodies whose accreditations it has
accepted and the scope of each accreditation. Once the Commission adds
a third party conformity assessment body to that list, the third party
conformity assessment body may commence testing of infant walkers to
support certification by the manufacturer or private labeler of
compliance with the test methods identified earlier in part I of this
document.
B. Additional Accreditation Requirements for Firewalled Conformity
Assessment Bodies
In addition to the baseline accreditation requirements in part II.A
of this document above, firewalled conformity assessment bodies seeking
accredited status must submit to the Commission copies, in English, of
their training documents showing how employees are trained to notify
the Commission immediately and confidentially of any attempt by the
manufacturer, private labeler, or other interested party to hide or
exert undue influence over the third party conformity assessment body's
test results. This additional requirement applies to any third party
conformity assessment body in which a manufacturer or private labeler
of a children's product to be tested by the third party conformity
assessment body owns an interest of ten percent or more. While the
Commission is not addressing common parentage of a third party
conformity assessment body and a children's product manufacturer at
this time, it will be vigilant to see if this issue needs to be
addressed in the future.
As required by section 14(f)(2)(D) of the CPSA, the Commission must
formally accept, by order, the accreditation application of a third
party conformity assessment body before the third party conformity
assessment body can become an accredited firewalled conformity
assessment body.
C. Additional Accreditation Requirements for Governmental Conformity
Assessment Bodies
In addition to the baseline accreditation requirements of part II.A
of this document above, the CPSIA permits accreditation of a third
party conformity assessment body owned or controlled, in whole or in
part, by a government if:
To the extent practicable, manufacturers or private
labelers located in any nation are permitted to choose conformity
assessment bodies that are not owned or controlled by the government of
that nation;
The third party conformity assessment body's testing
results are not subject to undue influence by any other person,
including another governmental entity;
The third party conformity assessment body is not accorded
more favorable treatment than other third party conformity assessment
bodies in the same nation who have been accredited;
The third party conformity assessment body's testing
results are accorded no greater weight by other governmental
authorities than those of other accredited third party conformity
assessment bodies; and
The third party conformity assessment body does not
exercise undue influence over other governmental authorities on matters
affecting its operations or on decisions by other governmental
authorities controlling distribution of products based on outcomes of
the third party conformity assessment body's conformity assessments.
The Commission will accept the accreditation of a governmental
third party conformity assessment body if it meets the baseline
accreditation requirements of part II.A of this document above and
meets the additional conditions stated here. To obtain this assurance,
CPSC staff will engage the governmental entities relevant to the
accreditation request.
III. How Does a Third Party Conformity Assessment Body Apply for
Acceptance of Its Accreditation?
The Commission has established an electronic accreditation
acceptance and registration system accessed via the Commission's
Internet site at https://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 https://www.cpsc.gov/about/cpsia/labaccred.html. In the case of a firewalled conformity assessment
body seeking accredited status, when the staff's review is complete,
the staff transmits its recommendation on accreditation to the
Commission for consideration. (A third party conformity assessment body
that may ultimately seek acceptance as a firewalled third party
conformity assessment body also can initially request acceptance as a
third party conformity assessment body accredited for testing of
children's products other than those of its owners.) If the Commission
accepts a staff recommendation to accredit a firewalled conformity
assessment body, the firewalled conformity assessment body will then be
added to the CPSC's list of accredited third party conformity
assessment bodies. In each case, the Commission will notify the third
party
[[Page 35285]]
conformity assessment body electronically of acceptance of its
accreditation. All information to support an accreditation acceptance
request must be provided in the English language.
Once the Commission adds a third party conformity assessment body
to the list, the third party conformity assessment body may then begin
testing of children's products to support certification of compliance
with the regulations identified earlier in part I of this document for
which it has been accredited.
IV. Acceptance of Children's Product Certifications Based on Third
Party Conformity Assessment Body Testing to the New Safety Standard for
Infant Walkers Prior to Their Effective Date
Elsewhere in this issue of the Federal Register, the Commission is
publishing a new safety standard for infant walkers, which will be
codified at 16 CFR part 1216. The effect of this notice of requirements
and the final rule is that each manufacturer (including the importer)
or private labeler of a product subject to 16 CFR part 1216 must have
any such product manufactured on or after December 21, 2010 tested by a
third party conformity assessment body accredited to do so and must
issue a certificate of compliance with 16 CFR part 1216 based on that
testing.
To ease the transition to the new standard and avoid a
``bottleneck'' of products at conformity assessment bodies at or near
the effective date of 16 CFR 1216, the Commission will accept
certifications based on testing that occurred prior to the effective
date of the new standard in certain prescribed circumstances. However,
any such testing must comport with all CPSC requirements, including:
At the time of product testing, the product was tested by
a third party conformity assessment body that was ISO/IEC 17025
accredited by an ILAC-MRA member, and had been accepted by the
Commission;
The accreditation scope in effect for the third party
conformity assessment body at the time of testing expressly included
testing to the test method(s) included in 16 CFR part 1216; and
The test results show compliance with the test methods in
the new regulation (16 CFR part 1216).
Dated: June 9, 2010.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2010-14325 Filed 6-18-10; 8:45 am]
BILLING CODE 6355-01-P
