Revocation of Regulations Banning Certain Baby-Walkers, 35279-35282 [2010-14326]
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(ii) [Reserved]
Dated: June 9, 2010.
Todd Stevenson,
Secretary, U.S. Consumer Product Safety
Commission.
[FR Doc. 2010–14323 Filed 6–18–10; 8:45 am]
BILLING CODE 6355–01–P
CONSUMER PRODUCT SAFETY
COMMISSION
16 CFR Part 1500
RIN 3041–AC77
Revocation of Regulations Banning
Certain Baby-Walkers
AGENCY: Consumer Product Safety
Commission.
ACTION: Final rule.
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SUMMARY: In this document, the
Consumer Product Safety Commission
(‘‘CPSC’’ or ‘‘Commission’’) is revoking
its existing regulations pertaining to
baby-walkers because those regulations
are being replaced by a new and more
comprehensive safety standard
applicable to baby-walkers. The new
standard is being added by the
Commission in a separate document
published elsewhere in this issue of the
Federal Register.
DATES: Effective December 21, 2010.
FOR FURTHER INFORMATION CONTACT:
Carolyn Manley, Division of Regulatory
Enforcement, Office of Compliance,
Consumer Product Safety Commission,
4330 East West Highway, Bethesda, MD
20814, 301–504–7607,
cmanley@cpsc.gov.
SUPPLEMENTARY INFORMATION:
A. Background
1. The CPSC’s regulation for babywalkers. CPSC regulations at 16 CFR
1500.18(a)(6) and 1500.86(a)(4) ban any
‘‘baby-bouncer,’’ ‘‘walker-jumper,’’ ‘‘babywalker,’’ and ‘‘any other similar article’’
that does not meet specified safety
criteria. These regulations were issued
in 1971 by the Food and Drug
Administration (‘‘FDA’’) under the
Federal Hazardous Substances Act
(‘‘FHSA’’), 15 U.S.C. 1261–1278
(available at https://www.cpsc.gov/
businfo/fhsa.pdf). 36 FR 21809 (Nov. 16,
1971). On May 14, 1973, the functions
under the FHSA were transferred to the
then newly-created CPSC.
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Specifically, 16 CFR 1500.18(a)(6)
bans baby-walkers, baby-bouncers,
walker-jumpers and ‘‘any other similar
article’’ that is intended to support very
young children while ‘‘sitting walking,
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. The
regulation describes the hazardous
design features of such articles
warranting the ban as including, but not
being limited to, one or more of the
following:
• Areas about the point on each side
of the article where the frame
components are joined together to form
an X-shape capable of producing a
scissoring, shearing, or pinching effect;
• Other areas where two or more
parts are joined in such a manner as to
permit rotational movement capable of
exerting a scissoring, shearing, or
pinching effect;
• Exposed coil springs which may
expand sufficiently to allow an infant’s
finger, toe, or other body part to be
inserted, in whole or in part, and
injured by being caught between the
coils of the spring or between the spring
and another part of the article;
• Holes in plates or tubes which also
provide the possibility of insertion of a
finger, toe, or other part of the anatomy
that could then be injured by the
movement of another part of the article;
or
• A design and construction that
permits accidental collapse while in
use.
Exemptions to the ban are at 16 CFR
1500.86(a)(4). These include any babywalker (or the other subject products)
where:
• The frames are designed and
constructed in a manner to prevent
injury from any scissoring, shearing, or
pinching when the members of the
frame or other components rotate about
a common axis or fastening point or
otherwise move relative to one another;
and
• Any coil springs which expand
when the article is subjected to a force
that will extend the spring to its
maximum distance so that a space
between successive coils is greater than
one-eighth inch (0.125 inch) are covered
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35279
or otherwise designed to prevent
injuries; and
• All holes larger than one-eighth
inch (0.125 inch) in diameter, and slots,
cracks, or hinged components in any
portion of the article through which a
child could insert, in whole or in part,
a finger, toe, or any other part of the
anatomy, are guarded or otherwise
designed to prevent injuries; and
• The articles are designed and
constructed to prevent accidental
collapse while in use; and
• The articles are designed and
constructed in a manner that eliminates
from any portion of the article the
possibility of presenting a mechanical
hazard through pinching, bruising,
lacerating, crushing, breaking,
amputating, or otherwise injuring
portions of the human body when in
normal use or when subjected to
reasonably foreseeable damage or abuse;
and
• Any article which is introduced
into interstate commerce after the
effective date of [the regulation] is
labeled:
—With a conspicuous statement of
the name and address of the
manufacturer, packer, distributor, or
seller; and
—With a code mark on the article
itself and on the package containing the
article or on the shipping container, in
addition to the invoice(s) or shipping
document(s), which code mark will
permit future identification by the
manufacturer of any given model (the
manufacturer shall change the model
number whenever the article undergoes
a significant structural or design
modification);
and
• The manufacturer or importer of the
article shall make, keep, and maintain
for 3 years records of sale, distribution,
and results of inspections and tests
conducted in accordance with this
subparagraph and shall make such
records available at all reasonable hours
upon request by any officer or employee
of the Consumer Product Safety
Commission and shall permit such
officer or employee to inspect and copy
such records, to make such stock
inventories as such person deems
necessary, and to otherwise check the
correctness of such records.
The existing regulations do not
include any requirements specifically
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pertaining to hazards associated with
falls down stairs, structural integrity,
occupant retention, or loading/stability
issues.
As discussed earlier in this part A.1
of this preamble, the regulations at 16
CFR 1500.18(a)(6) and 1500.86(a)(4)
apply to any ‘‘baby-bouncer,’’ ‘‘walkerjumper,’’ ‘‘baby-walker,’’ and ‘‘any other
similar article.’’ The regulations do not
define those terms, and when FDA
promulgated those regulations in 1971,
it expressly rejected comments that
sought a description of the regulated
articles [Ref. 9]. (Documents supporting
statements in this notice are identified
by [Ref. #], where # is the number of the
reference document as listed below in
section G of this notice.)
2. Recent statutory changes affecting
baby-walkers. The Consumer Product
Safety Improvement Act of 2008
(‘‘CPSIA’’), Pub. L. No. 110–314, 122
Stat. 3016 (available at https://
www.cpsc.gov/cpsia.pdf), was enacted
on August 14, 2008. Section 104 of the
CPSIA directs the Commission to take a
number of actions concerning ‘‘durable
infant or toddler products.’’ Section
104(f) of the CPSIA defines a durable
infant or toddler product as a durable
product intended for use, or that may be
reasonably expected to be used, by
children under the age of 5 years. This
includes cribs, toddler beds, high chairs,
booster chairs, hook-on chairs, bath
seats, gates and other enclosures for
confining a child, play yards, stationary
activity centers, infant carriers, strollers,
walkers, swings, bassinets, and cradles.
Section 104(b) of the CPSIA provides, in
part, that the Commission shall, in
consultation with representatives of
consumer groups, juvenile product
manufacturers, and independent child
product engineers and experts, examine
and assess the effectiveness of any
voluntary consumer product safety
standards for durable infant or toddler
products. The Commission also is
directed to promulgate consumer
product safety standards that are
substantially the same as such voluntary
standards or that are more stringent than
such voluntary standards if the
Commission determines that more
stringent standards would further
reduce the risk of injury associated with
the products.
Baby-walkers are one of the first two
products addressed in these
rulemakings. On September 3, 2009, the
Commission proposed a safety standard
for infant walkers. 74 FR 45704.
Elsewhere in this issue of the Federal
Register, the Commission is issuing a
new safety standard for infant walkers,
based largely on the provisions of the
current ASTM voluntary standard.
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Given the anticipated new safety
standard for infant walkers, the
Commission, on September 3, 2009,
proposed a rule to revoke 16 CFR
1500.18(a)(6) and 1500.86(a)(4). 74 FR
45714.
3. The voluntary standard for infant
walkers. The current voluntary standard
for Infant Walkers, The Standard
Consumer Safety Specification for
Infant Walkers (ASTM F977–07) [Ref. 1]
is published by the American Society
for Testing and Materials (now ASTM
International, or ASTM). The ASTM
voluntary standard defines an infant
walker as a mobile unit that enables a
child to move on a horizontal surface
when propelled by the child sitting or
standing within the walker, and that is
in the manufacturer’s recommended use
position. This standard has provisions
to address the following:
• Latching or Locking Mechanisms;
• Openings;
• Scissoring, Shearing, and Pinching;
• Exposed Coil Springs;
• Labeling;
• Protective Components;
• Stability;
• Structural Integrity;
• Occupant Retention; and
• Prevention of Falls Down Step(s).
ASTM F977–07 contains provisions
pertaining to scissoring, shearing,
pinching, and accidental collapse that
are stricter, or more conservative, than
the existing CPSC regulation. With
regard to exposed coil springs and
openings, the ASTM voluntary standard
differs somewhat from the existing
CPSC regulation.
The specifications in ASTM F977–07
for coil springs and openings (holes) are
similar in concept to those in the
mandatory regulation, but are less
restrictive as to allowable dimensions.
For instance, the voluntary standard
prohibits any hole or slot between
0.210″ and 0.375″ in size that extends
entirely through a wall section of any
rigid material less than 0.375″ thick. The
existing regulation bans any babywalker that contains a hole larger than
0.125″ in diameter, and it does not
contain a depth requirement.
The rationale for the ASTM standard
was based on anthropometric data
developed for the CPSC by the
University of Michigan in 1975.
(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.)
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This data set sampled body
measurements of children from 2 weeks
to 13 years of age. The measurements
relevant here are the little finger
diameter and middle finger diameter.
The intent of the ASTM standard is to
prevent entrapments by making
openings either too small for the
smallest user to penetrate with their
smallest finger or larger than the largest
user’s biggest finger (thereby allowing
the finger to be withdrawn without
entrapment). The existing CPSC
regulations were never revised or
updated to take this data into
consideration. Thus, the requirements
in the CPSC regulations are outdated in
this respect. However, the CPSC
regulations also provide that hazards
presented by holes and by maximum
coil spring spacing are acceptable if they
are ‘‘otherwise designed to prevent
injuries.’’ This allows baby-walkers that
comply with the ASTM voluntary
standard to also comply with the CPSC
requirements.
B. Required Accredited Third Party
Testing and Certification of BabyWalkers
Section 14(a)(2) of the Consumer
Product Safety Act (‘‘CPSA’’), 15 U.S.C.
2063(a)(2) (available at https://
www.cpsc.gov/cpsia.pdf), as amended
by section 102 of the CPSIA, requires
manufacturers and private labelers of
children’s products (such as babywalkers) that are subject to a children’s
product safety rule to submit sufficient
samples of the children’s product, or
samples that are identical in all material
respects to the product, to a CPSCrecognized accredited third party
conformity assessment body (i.e., testing
laboratory) to be tested for compliance
with any applicable children’s product
safety rule. (The term ‘‘children’s
product safety rule’’ is defined at 15
U.S.C. 2063(f)(1). See also 15 U.S.C.
2052(a)(5), 2052(a)(6).) For the purposes
of the CPSA, the term ‘‘manufacturer’’
includes an importer. 15 U.S.C.
2052(a)(11).
The Commission has issued
regulations at 16 CFR 1110 concerning
the content of certificates of compliance
and limiting the parties who must issue
such certificates to the United States
importer and, in the case of
domestically produced products, the
United States manufacturer. Based on
such testing, the manufacturer and
private labeler must issue a certificate
stating that such children’s product
complies with the children’s product
safety rule based on the assessment of
a third party conformity assessment
body accredited to conduct such tests.
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Unless stayed by the Commission,
these requirements apply to any such
children’s product that is manufactured
more than 90 days after the Commission
has established and published a notice
of the requirements for accreditation of
third party conformity assessment
bodies to assess conformity with any
children’s product safety rule to which
such children’s product is subject.
Section 14(a)(3) of the CPSA, 15 U.S.C.
2063(a)(3). However, if the Commission
determines that an insufficient number
of third party conformity assessment
bodies have been accredited to permit
certification for a children’s product
safety rule, the Commission may extend
the deadline for certification to such
rule by not more than 60 days. Section
14(a)(3)(F) of the CPSA, 15 U.S.C.
2063(a)(3)(F).
Section 14(a)(3) of the CPSA also
provides a schedule for the dates by
which the Commission must publish the
notices of the requirements for
accreditation of third party conformity
assessment bodies for various children’s
products. For ‘‘baby bouncers, walkers,
and jumpers,’’ the statute specified that
the Commission publish a notice of the
requirements for accreditation of third
party conformity assessment bodies ‘‘to
assess conformity with parts
1500.18(a)(6) and 1500.86(a)’’ and that
such publication occur not later than
210 days after the date of enactment of
the CPSIA, or March 12, 2009. The
Commission did not issue that notice of
requirements because the proposed rule
to revoke 16 CFR 1500.18(a)(6) and
1500.86(a)(4) made it unproductive to
issue a notice of requirements that
referenced those regulations. As noted
above, elsewhere in this issue of the
Federal Register the Commission is
issuing a final safety standard for infant
walkers, 16 CFR part 1216, effective
December 21, 2010. Also, the
Commission is issuing a notice of
requirements for testing infant walkers
for certification to the new safety
standard for infant walkers. On a
schedule to be determined, the
Commission also will issue a notice of
requirements applicable to the current
requirements for baby-bouncers, walkerjumpers, and similar products.
C. Issues Presented in the Proposal and
CPSC’s Responses
In the preamble to the proposed rule
(74 FR at 45718), the Commission noted
that there could be some question about
whether there are products that fall
within 16 CFR 1500.18(a)(6) and
1500.86(a)(4), but not within any ASTM
standard. A possible example of this
might be jumpers that affix to door
frames.
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The Commission specifically invited
comments on: (1) Whether there are
products that are covered by 16 CFR
1500.18(a)(6) and 1500.86(a)(4), but not
by any ASTM voluntary standard; (2)
whether retention of CPSC’s current
regulations for those specific products is
warranted; and (3) whether there are
specific requirements in 16 CFR
1500.18(a)(6) and 1500.86(a), but not in
any ASTM standard, that warrant
retention.
There were no comments filed in the
docket for the proposed revocation of 16
CFR 1500.18(a)(6) and 1500.86(a)(4)
(CPSC Docket No. CPSC–2009–0066).
However, in the companion proposal to
issue a new safety standard for infant
walkers based on ASTM F 977–07
(CPSC Docket No. CPSC–2009–0065),
one commenter argued that the old
regulations should still apply to the
products other than infant walkers.
Another commenter, although
apparently focusing on a potential time
gap between revoking the old
regulations and issuing the new
regulation for infant walkers, stated ‘‘we
cannot allow for some products to not
be covered by the safety standard
regulations possibly increasing the
number of injured children.’’
The Commission concludes that it is
not in the public interest to revoke the
existing requirements of 16 CFR
1500.18(a)(6) and 1500.86(a)(4) as they
apply to baby-bouncers, walkerjumpers, and any other similar article
except baby-walkers. Having these
requirements will make it easier to
obtain a recall or other corrective
actions if products that present a hazard
due to a failure to meet some existing
requirement. Any negative effect of
having particular dimensions specified
in these regulations that are based on
outdated anthropometric data is
neutralized by the provision in the
regulations that allows products that are
‘‘otherwise designed to prevent
injuries.’’ The Commission would
consider an effective requirement based
on current anthropometric data to be
designed to prevent injuries.
Accordingly, only the requirements in
16 CFR 1500.18(a)(6) and 1500.86(a)
that apply to baby-walkers are being
revoked.
D. Paperwork Reduction Act
This rule does not impose any
information collection requirements.
Accordingly, this rule is not subject to
the Paperwork Reduction Act, 44 U.S.C.
3501–3520.
E. Environmental Considerations
This rule falls within the scope of the
Commission’s environmental review
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regulation at 16 CFR 1021.5(c)(1), which
provides a categorical exclusion from
any requirement for the agency to
prepare an environmental assessment or
environmental impact statement for
rules that revoke product safety
standards. Accordingly, neither an
environmental assessment nor an
environmental impact statement is
required.
F. Effective Date
The preamble to the proposed rule
specified that the revocation of the
existing regulations would be effective
upon the date of termination of the stay
of testing and certification requirements
originally announced in the Federal
Register of February 9, 2009 (74 FR
6396), or upon the effective date of the
new mandatory standard, whichever
occurs first (see 74 FR at 45718). The
reason that the proposed revocation
could become effective upon the
termination of the stay of testing and
certification, even though the new
mandatory standard was not yet issued,
was to prevent firms from having to test
and certify infant walkers to a standard
that would shortly be replaced by a
newer, more comprehensive one.
After the proposal was published in
the Federal Register, the Commission
extended the stay for many children’s
products, including baby-walkers, babybouncers, walker-jumpers, and similar
products, to 90 days after the
Commission issues a notice of
requirements for the applicable
regulatory requirement [Ref. 12].
Because the Commission will not be
issuing a notice of requirements for
testing and certifying baby-walkers to
the standards in 16 CFR 1500.18(a)(6)
and 1500.86(a)(4), no testing or
certification to those standards will be
required. Accordingly, the revocation of
the provisions of those standards
applicable to baby-walkers can become
effective on the effective date of the new
mandatory standard for infant walkers
without requiring any testing under the
old standard. Testing and certification
to the requirements of 16 CFR
1500.18(a)(6) and 1500.86(a)(4) as they
apply to the products other than baby
walkers will be required 90 days after
the Commission publishes a notice of
requirements for those products at some
future date.
G. References
1. ASTM voluntary standard F 977–
07, Standard Consumer Safety
Specification for Infant Walkers.
2. Memorandum from P. Edwards,
Project Manager, to the Commission,
‘‘Notice of Proposed Rulemaking—
Recommending the Revocation of CPSC
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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:
E:\FR\FM\21JNR2.SGM
21JNR2
Agencies
[Federal Register Volume 75, Number 118 (Monday, June 21, 2010)]
[Rules and Regulations]
[Pages 35279-35282]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-14326]
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1500
RIN 3041-AC77
Revocation of Regulations Banning Certain Baby-Walkers
AGENCY: Consumer Product Safety Commission.
ACTION: Final rule.
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SUMMARY: In this document, the Consumer Product Safety Commission
(``CPSC'' or ``Commission'') is revoking its existing regulations
pertaining to baby-walkers because those regulations are being replaced
by a new and more comprehensive safety standard applicable to baby-
walkers. The new standard is being added by the Commission in a
separate document published elsewhere in this issue of the Federal
Register.
DATES: Effective December 21, 2010.
FOR FURTHER INFORMATION CONTACT: Carolyn Manley, Division of Regulatory
Enforcement, Office of Compliance, Consumer Product Safety Commission,
4330 East West Highway, Bethesda, MD 20814, 301-504-7607,
cmanley@cpsc.gov.
SUPPLEMENTARY INFORMATION:
A. Background
1. The CPSC's regulation for baby-walkers. CPSC regulations at 16
CFR 1500.18(a)(6) and 1500.86(a)(4) ban any ``baby-bouncer,'' ``walker-
jumper,'' ``baby-walker,'' and ``any other similar article'' that does
not meet specified safety criteria. These regulations were issued in
1971 by the Food and Drug Administration (``FDA'') under the Federal
Hazardous Substances Act (``FHSA''), 15 U.S.C. 1261-1278 (available at
https://www.cpsc.gov/businfo/fhsa.pdf). 36 FR 21809 (Nov. 16, 1971). On
May 14, 1973, the functions under the FHSA were transferred to the then
newly-created CPSC.
Specifically, 16 CFR 1500.18(a)(6) bans baby-walkers, baby-
bouncers, walker-jumpers and ``any other similar article'' that is
intended to support very young children while ``sitting walking,
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. The
regulation describes the hazardous design features of such articles
warranting the ban as including, but not being limited to, one or more
of the following:
Areas about the point on each side of the article where
the frame components are joined together to form an X-shape capable of
producing a scissoring, shearing, or pinching effect;
Other areas where two or more parts are joined in such a
manner as to permit rotational movement capable of exerting a
scissoring, shearing, or pinching effect;
Exposed coil springs which may expand sufficiently to
allow an infant's finger, toe, or other body part to be inserted, in
whole or in part, and injured by being caught between the coils of the
spring or between the spring and another part of the article;
Holes in plates or tubes which also provide the
possibility of insertion of a finger, toe, or other part of the anatomy
that could then be injured by the movement of another part of the
article; or
A design and construction that permits accidental collapse
while in use.
Exemptions to the ban are at 16 CFR 1500.86(a)(4). These include
any baby-walker (or the other subject products) where:
The frames are designed and constructed in a manner to
prevent injury from any scissoring, shearing, or pinching when the
members of the frame or other components rotate about a common axis or
fastening point or otherwise move relative to one another; and
Any coil springs which expand when the article is
subjected to a force that will extend the spring to its maximum
distance so that a space between successive coils is greater than one-
eighth inch (0.125 inch) are covered or otherwise designed to prevent
injuries; and
All holes larger than one-eighth inch (0.125 inch) in
diameter, and slots, cracks, or hinged components in any portion of the
article through which a child could insert, in whole or in part, a
finger, toe, or any other part of the anatomy, are guarded or otherwise
designed to prevent injuries; and
The articles are designed and constructed to prevent
accidental collapse while in use; and
The articles are designed and constructed in a manner that
eliminates from any portion of the article the possibility of
presenting a mechanical hazard through pinching, bruising, lacerating,
crushing, breaking, amputating, or otherwise injuring portions of the
human body when in normal use or when subjected to reasonably
foreseeable damage or abuse; and
Any article which is introduced into interstate commerce
after the effective date of [the regulation] is labeled:
--With a conspicuous statement of the name and address of the
manufacturer, packer, distributor, or seller; and
--With a code mark on the article itself and on the package
containing the article or on the shipping container, in addition to the
invoice(s) or shipping document(s), which code mark will permit future
identification by the manufacturer of any given model (the manufacturer
shall change the model number whenever the article undergoes a
significant structural or design modification);
and
The manufacturer or importer of the article shall make,
keep, and maintain for 3 years records of sale, distribution, and
results of inspections and tests conducted in accordance with this
subparagraph and shall make such records available at all reasonable
hours upon request by any officer or employee of the Consumer Product
Safety Commission and shall permit such officer or employee to inspect
and copy such records, to make such stock inventories as such person
deems necessary, and to otherwise check the correctness of such
records.
The existing regulations do not include any requirements
specifically
[[Page 35280]]
pertaining to hazards associated with falls down stairs, structural
integrity, occupant retention, or loading/stability issues.
As discussed earlier in this part A.1 of this preamble, the
regulations at 16 CFR 1500.18(a)(6) and 1500.86(a)(4) apply to any
``baby-bouncer,'' ``walker-jumper,'' ``baby-walker,'' and ``any other
similar article.'' The regulations do not define those terms, and when
FDA promulgated those regulations in 1971, it expressly rejected
comments that sought a description of the regulated articles [Ref. 9].
(Documents supporting statements in this notice are identified by [Ref.
], where is the number of the reference document as
listed below in section G of this notice.)
2. Recent statutory changes affecting baby-walkers. The Consumer
Product Safety Improvement Act of 2008 (``CPSIA''), Pub. L. No. 110-
314, 122 Stat. 3016 (available at https://www.cpsc.gov/cpsia.pdf), was
enacted on August 14, 2008. Section 104 of the CPSIA directs the
Commission to take a number of actions concerning ``durable infant or
toddler products.'' Section 104(f) of the CPSIA defines a durable
infant or toddler product as a durable product intended for use, or
that may be reasonably expected to be used, by children under the age
of 5 years. This includes cribs, toddler beds, high chairs, booster
chairs, hook-on chairs, bath seats, gates and other enclosures for
confining a child, play yards, stationary activity centers, infant
carriers, strollers, walkers, swings, bassinets, and cradles. Section
104(b) of the CPSIA provides, in part, that the Commission shall, in
consultation with representatives of consumer groups, juvenile product
manufacturers, and independent child product engineers and experts,
examine and assess the effectiveness of any voluntary consumer product
safety standards for durable infant or toddler products. The Commission
also is directed to promulgate consumer product safety standards that
are substantially the same as such voluntary standards or that are more
stringent than such voluntary standards if the Commission determines
that more stringent standards would further reduce the risk of injury
associated with the products.
Baby-walkers are one of the first two products addressed in these
rulemakings. On September 3, 2009, the Commission proposed a safety
standard for infant walkers. 74 FR 45704. Elsewhere in this issue of
the Federal Register, the Commission is issuing a new safety standard
for infant walkers, based largely on the provisions of the current ASTM
voluntary standard. Given the anticipated new safety standard for
infant walkers, the Commission, on September 3, 2009, proposed a rule
to revoke 16 CFR 1500.18(a)(6) and 1500.86(a)(4). 74 FR 45714.
3. The voluntary standard for infant walkers. The current voluntary
standard for Infant Walkers, The Standard Consumer Safety Specification
for Infant Walkers (ASTM F977-07) [Ref. 1] is published by the American
Society for Testing and Materials (now ASTM International, or ASTM).
The ASTM voluntary standard defines an infant walker as a mobile unit
that enables a child to move on a horizontal surface when propelled by
the child sitting or standing within the walker, and that is in the
manufacturer's recommended use position. This standard has provisions
to address the following:
Latching or Locking Mechanisms;
Openings;
Scissoring, Shearing, and Pinching;
Exposed Coil Springs;
Labeling;
Protective Components;
Stability;
Structural Integrity;
Occupant Retention; and
Prevention of Falls Down Step(s).
ASTM F977-07 contains provisions pertaining to scissoring,
shearing, pinching, and accidental collapse that are stricter, or more
conservative, than the existing CPSC regulation. With regard to exposed
coil springs and openings, the ASTM voluntary standard differs somewhat
from the existing CPSC regulation.
The specifications in ASTM F977-07 for coil springs and openings
(holes) are similar in concept to those in the mandatory regulation,
but are less restrictive as to allowable dimensions. For instance, the
voluntary standard prohibits any hole or slot between 0.210'' and
0.375'' in size that extends entirely through a wall section of any
rigid material less than 0.375'' thick. The existing regulation bans
any baby-walker that contains a hole larger than 0.125'' in diameter,
and it does not contain a depth requirement.
The rationale for the ASTM standard was based on anthropometric
data developed for the CPSC by the University of Michigan in 1975.
(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.) This data set sampled body measurements of
children from 2 weeks to 13 years of age. The measurements relevant
here are the little finger diameter and middle finger diameter. The
intent of the ASTM standard is to prevent entrapments by making
openings either too small for the smallest user to penetrate with their
smallest finger or larger than the largest user's biggest finger
(thereby allowing the finger to be withdrawn without entrapment). The
existing CPSC regulations were never revised or updated to take this
data into consideration. Thus, the requirements in the CPSC regulations
are outdated in this respect. However, the CPSC regulations also
provide that hazards presented by holes and by maximum coil spring
spacing are acceptable if they are ``otherwise designed to prevent
injuries.'' This allows baby-walkers that comply with the ASTM
voluntary standard to also comply with the CPSC requirements.
B. Required Accredited Third Party Testing and Certification of Baby-
Walkers
Section 14(a)(2) of the Consumer Product Safety Act (``CPSA''), 15
U.S.C. 2063(a)(2) (available at https://www.cpsc.gov/cpsia.pdf), as
amended by section 102 of the CPSIA, requires manufacturers and private
labelers of children's products (such as baby-walkers) that are subject
to a children's product safety rule to submit sufficient samples of the
children's product, or samples that are identical in all material
respects to the product, to a CPSC-recognized accredited third party
conformity assessment body (i.e., testing laboratory) to be tested for
compliance with any applicable children's product safety rule. (The
term ``children's product safety rule'' is defined at 15 U.S.C.
2063(f)(1). See also 15 U.S.C. 2052(a)(5), 2052(a)(6).) For the
purposes of the CPSA, the term ``manufacturer'' includes an importer.
15 U.S.C. 2052(a)(11).
The Commission has issued regulations at 16 CFR 1110 concerning the
content of certificates of compliance and limiting the parties who must
issue such certificates to the United States importer and, in the case
of domestically produced products, the United States manufacturer.
Based on such testing, the manufacturer and private labeler must issue
a certificate stating that such children's product complies with the
children's product safety rule based on the assessment of a third party
conformity assessment body accredited to conduct such tests.
[[Page 35281]]
Unless stayed by the Commission, these requirements apply to any
such children's product that is manufactured more than 90 days after
the Commission has established and published a notice of the
requirements for accreditation of third party conformity assessment
bodies to assess conformity with any children's product safety rule to
which such children's product is subject. Section 14(a)(3) of the CPSA,
15 U.S.C. 2063(a)(3). However, if the Commission determines that an
insufficient number of third party conformity assessment bodies have
been accredited to permit certification for a children's product safety
rule, the Commission may extend the deadline for certification to such
rule by not more than 60 days. Section 14(a)(3)(F) of the CPSA, 15
U.S.C. 2063(a)(3)(F).
Section 14(a)(3) of the CPSA also provides a schedule for the dates
by which the Commission must publish the notices of the requirements
for accreditation of third party conformity assessment bodies for
various children's products. For ``baby bouncers, walkers, and
jumpers,'' the statute specified that the Commission publish a notice
of the requirements for accreditation of third party conformity
assessment bodies ``to assess conformity with parts 1500.18(a)(6) and
1500.86(a)'' and that such publication occur not later than 210 days
after the date of enactment of the CPSIA, or March 12, 2009. The
Commission did not issue that notice of requirements because the
proposed rule to revoke 16 CFR 1500.18(a)(6) and 1500.86(a)(4) made it
unproductive to issue a notice of requirements that referenced those
regulations. As noted above, elsewhere in this issue of the Federal
Register the Commission is issuing a final safety standard for infant
walkers, 16 CFR part 1216, effective December 21, 2010. Also, the
Commission is issuing a notice of requirements for testing infant
walkers for certification to the new safety standard for infant
walkers. On a schedule to be determined, the Commission also will issue
a notice of requirements applicable to the current requirements for
baby-bouncers, walker-jumpers, and similar products.
C. Issues Presented in the Proposal and CPSC's Responses
In the preamble to the proposed rule (74 FR at 45718), the
Commission noted that there could be some question about whether there
are products that fall within 16 CFR 1500.18(a)(6) and 1500.86(a)(4),
but not within any ASTM standard. A possible example of this might be
jumpers that affix to door frames.
The Commission specifically invited comments on: (1) Whether there
are products that are covered by 16 CFR 1500.18(a)(6) and
1500.86(a)(4), but not by any ASTM voluntary standard; (2) whether
retention of CPSC's current regulations for those specific products is
warranted; and (3) whether there are specific requirements in 16 CFR
1500.18(a)(6) and 1500.86(a), but not in any ASTM standard, that
warrant retention.
There were no comments filed in the docket for the proposed
revocation of 16 CFR 1500.18(a)(6) and 1500.86(a)(4) (CPSC Docket No.
CPSC-2009-0066). However, in the companion proposal to issue a new
safety standard for infant walkers based on ASTM F 977-07 (CPSC Docket
No. CPSC-2009-0065), one commenter argued that the old regulations
should still apply to the products other than infant walkers. Another
commenter, although apparently focusing on a potential time gap between
revoking the old regulations and issuing the new regulation for infant
walkers, stated ``we cannot allow for some products to not be covered
by the safety standard regulations possibly increasing the number of
injured children.''
The Commission concludes that it is not in the public interest to
revoke the existing requirements of 16 CFR 1500.18(a)(6) and
1500.86(a)(4) as they apply to baby-bouncers, walker-jumpers, and any
other similar article except baby-walkers. Having these requirements
will make it easier to obtain a recall or other corrective actions if
products that present a hazard due to a failure to meet some existing
requirement. Any negative effect of having particular dimensions
specified in these regulations that are based on outdated
anthropometric data is neutralized by the provision in the regulations
that allows products that are ``otherwise designed to prevent
injuries.'' The Commission would consider an effective requirement
based on current anthropometric data to be designed to prevent
injuries. Accordingly, only the requirements in 16 CFR 1500.18(a)(6)
and 1500.86(a) that apply to baby-walkers are being revoked.
D. Paperwork Reduction Act
This rule does not impose any information collection requirements.
Accordingly, this rule is not subject to the Paperwork Reduction Act,
44 U.S.C. 3501-3520.
E. Environmental Considerations
This rule falls within the scope of the Commission's environmental
review regulation at 16 CFR 1021.5(c)(1), which provides a categorical
exclusion from any requirement for the agency to prepare an
environmental assessment or environmental impact statement for rules
that revoke product safety standards. Accordingly, neither an
environmental assessment nor an environmental impact statement is
required.
F. Effective Date
The preamble to the proposed rule specified that the revocation of
the existing regulations would be effective upon the date of
termination of the stay of testing and certification requirements
originally announced in the Federal Register of February 9, 2009 (74 FR
6396), or upon the effective date of the new mandatory standard,
whichever occurs first (see 74 FR at 45718). The reason that the
proposed revocation could become effective upon the termination of the
stay of testing and certification, even though the new mandatory
standard was not yet issued, was to prevent firms from having to test
and certify infant walkers to a standard that would shortly be replaced
by a newer, more comprehensive one.
After the proposal was published in the Federal Register, the
Commission extended the stay for many children's products, including
baby-walkers, baby-bouncers, walker-jumpers, and similar products, to
90 days after the Commission issues a notice of requirements for the
applicable regulatory requirement [Ref. 12]. Because the Commission
will not be issuing a notice of requirements for testing and certifying
baby-walkers to the standards in 16 CFR 1500.18(a)(6) and
1500.86(a)(4), no testing or certification to those standards will be
required. Accordingly, the revocation of the provisions of those
standards applicable to baby-walkers can become effective on the
effective date of the new mandatory standard for infant walkers without
requiring any testing under the old standard. Testing and certification
to the requirements of 16 CFR 1500.18(a)(6) and 1500.86(a)(4) as they
apply to the products other than baby walkers will be required 90 days
after the Commission publishes a notice of requirements for those
products at some future date.
G. References
1. ASTM voluntary standard F 977-07, Standard Consumer Safety
Specification for Infant Walkers.
2. Memorandum from P. Edwards, Project Manager, to the Commission,
``Notice of Proposed Rulemaking--Recommending the Revocation of CPSC
[[Page 35282]]
Regulation for Baby Bouncers, Walker-Jumpers, and Baby-Walkers, 16 CFR
Sec. 1500.18(a)(6) and Sec. 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 Sec. Sec. 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).
List of Subjects in 16 CFR Part 1500
Baby walkers, Consumer protection, Hazardous substances, Imports,
Infants and children, Labeling, Law enforcement, Toys.
0
For the reasons stated in the preamble, the Consumer Product Safety
Commission amends 16 CFR part 1500 as follows:
PART 1500--HAZARDOUS SUBSTANCES AND ARTICLES; ADMINISTRATION AND
ENFORCEMENT REGULATIONS
0
1. The authority citation for 16 CFR part 1500 continues to read as
follows:
Authority: 15 U.S.C. 1261-1278.
0
2. Amend Sec. 1500.18(a)(6) introductory text by revising the first
sentence to read as follows:
Sec. 1500.18 Banned toys and other banned articles intended for use
by children.
(a) * * *
(6) Any article known as a ``baby-bouncer'' 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.
0
3. Amend Sec. 1500.86 by revising paragraph (a)(4) introductory text
to read as follows:
Sec. 1500.86 Exemptions from classification as a banned toy or other
banned article for use by children.
(a) * * *
(4) Any article known as a ``baby-bouncer'' 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 Sec. 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