[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
http://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 http://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 http://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