Safety Standard for Hand-Held Infant Carriers, 73354-73366 [2012-29584]
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persons to submit comments on any
aspect of the proposed rule. Comments
should be submitted in accordance with
the instructions in the ADDRESSES
section at the beginning of this notice.
List of Subjects
16 CFR Part 1112
Administrative practice and
procedure, Audit, Consumer protection,
Reporting and recordkeeping
requirements, Third party conformity
assessment body.
16 CFR Part 1222
Consumer protection, Imports,
Incorporation by reference, Infants and
children, Labeling, Law enforcement,
and Toys.
For the reasons discussed in the
preamble, the Commission proposes to
amend Title 16 of the Code of Federal
Regulations as follows:
PART 1112—REQUIREMENTS
PERTAINING TO THIRD PARTY
CONFORMITY ASSESSMENT BODIES
1. The authority citation for part 1112
continues to read as follows:
Authority: Pub. L. 110–314, section 3, 122
Stat. 3016, 3017 (2008); 15 U.S.C. 2063.
2. Amend Part 1112.15 by adding
paragraph (b)(34) to read as follows:
§ 1112.15 When can a third party
conformity assessment body apply for
CPSC acceptance for a particular CPSC rule
and/or test method?
*
*
*
*
*
(b) The CPSC has published
previously, or in the cases of 16 CFR
parts 1221, 1223, and 1224, and ASTM
F 963–11 for the first time, the
requirements for accreditation for third
party conformity assessment bodies to
assess conformity with the following
CPSC rules and/or test methods:
*
*
*
*
*
(34) 16 CFR part 1222, Safety
Standard for Bedside Sleepers.
3. Add part 1222 to read as follows:
PART 1222—SAFETY STANDARD FOR
BEDSIDE SLEEPERS
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Sec.
1222.1
1222.2
Scope.
Requirements for Bedside Sleepers.
Authority: The Consumer Product Safety
Improvement Act of 2008, Pub. L. 110–314,
§ 104, 122 Stat. 3016 (August 14, 2008); Pub.
L. 112–28, 125 Stat. 273 (August 12, 2011).
§ 1222.1
Scope.
This part establishes a consumer
product safety standard for bedside
sleepers.
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§ 1222.2 Requirements for Bedside
Sleepers.
‘‘Bassinet/Cradle Accessories Missing
Key Structural Elements.’’
(a) Except as provided in paragraph
(b) of this section, each bedside sleeper
must comply with all applicable
provisions of ASTM F2906–12,
Standard Consumer Safety Specification
for Bedside Sleepers, approved on June
1, 2012. The Director of the Federal
Register approves this incorporation by
reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. You may
obtain a copy from ASTM International,
100 Bar Harbor Drive, P.O. Box 0700,
West Conshohocken, PA 19428; https://
www.astm.org/cpsc.htm. You may
inspect a copy at the Office of the
Secretary, U.S. Consumer Product
Safety Commission, Room 820, 4330
East West Highway, Bethesda, MD
20814, telephone 301–504–7923, or at
the National Archives and Records
Administration (NARA). For
information on the availability of this
material at NARA, call 202–741–6030,
or go to: https://www.archives.gov/
federal_register/
code_of_federalregulations/
ibr_locations.html.
(b) Comply with the ASTM F2906–12
standard with the following additions:
(1) In addition to complying with
section 3.1.7 of ASTM F2906–12,
comply with the following:
(i) 3.1.8 ‘‘bedside sleeper accessory,
n—an elevated sleep surface that
attaches to a non-full-size crib or play
yard, designed to convert the product
into a bedside sleeper intended to have
a horizontal sleep surface while in a rest
(non-rocking) position.’’
(ii) [Reserved]
(2) In addition to complying with
section 5.6 of ASTM F2906–12, comply
with the following:
(i) 5.7 Bedside Sleeper Accessory
Fabric-Sided Enclosed Openings—A
bedside sleeper accessory shall meet the
F2194 performance requirement,
‘‘Fabric-Sided Enclosed Openings.’’
(A) 5.7.1 Bedside sleeper accessories
are exempt from this requirement if
either of the following two conditions is
met after disengaging all fasteners
between the accessory and the non-fullsize crib or play yard base to which it
is assembled:
(B) 5.7.1.1 The bedside sleeper
accessory collapses under its own
weight, such that any part of the
mattress pad contacts the bottom floor
of the non-full-size crib or play yard.
(C) 5.7.1.2 The bedside sleeper
accessory’s sleep surface tilts by more
than 30 degrees.
(ii) 5.8 Bedside Sleeper Play Yard
Accessories Missing Key Structural
Elements: A bedside sleeper accessory
shall meet the F406 general requirement
Dated: December 3, 2012.
Todd A. Stevenson,
Secretary, Consumer Product Safety
Commission .
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[FR Doc. 2012–29583 Filed 12–7–12; 8:45 am]
BILLING CODE 6355–01–P
CONSUMER PRODUCT SAFETY
COMMISSION
16 CFR Parts 1112 and 1225
[CPSC Docket No. CPSC–2012–0068]
RIN 3041–AD16
Safety Standard for Hand-Held Infant
Carriers
Consumer Product Safety
Commission.
ACTION: Notice of Proposed Rulemaking.
AGENCY:
The Danny Keysar Child
Product Safety Notification Act, Section
104(b) of the Consumer Product Safety
Improvement Act of 2008 (CPSIA)
requires the United States Consumer
Product Safety Commission
(Commission, CPSC, or we) to
promulgate consumer product safety
standards for durable infant or toddler
products. These standards are to be
‘‘substantially the same as’’ applicable
voluntary standards or more stringent
than the voluntary standard if the
Commission concludes that more
stringent requirements would further
reduce the risk of injury associated with
the product. The Commission is
proposing a safety standard for
handheld infant carriers in response to
the direction under Section 104(b) of the
CPSIA. The proposed rule would
incorporate ASTM F2050–12 by
reference, with two modifications.
DATES: Submit comments by February
25, 2013.
ADDRESSES: Comments related to the
Paperwork Reduction Act aspects of the
marking, labeling, and instructional
literature of the proposed rule should be
directed to the Office of Information and
Regulatory Affairs, OMB, Attn: CPSC
Desk Officer, Fax: 202–395–6974, or
emailed to mailed to:
oira_submission@omb.eop.gov.
Other comments, identified by Docket
No. CPSC-2012-0068, may be submitted
electronically or in writing:
Electronic Submissions: Submit
electronic comments to the Federal
eRulemaking Portal at: https://
www.regulations.gov. Follow the
instructions for submitting comments.
To ensure timely processing of
comments, the Commission is no longer
SUMMARY:
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directly accepting comments submitted
by electronic mail (email), except
through www.regulations.gov. The
Commission encourages you to submit
electronic comments by using the
Federal eRulemaking Portal, as
described above.
Written Submissions: Submit written
submissions in the following way: Mail/
Hand delivery/Courier (for paper, disk,
or CD–ROM submissions), preferably in
five copies, to: Office of the Secretary,
Consumer Product Safety Commission,
Room 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 rulemaking. All
comments received may be posted
without change, including any personal
identifiers, contact information, or other
personal information provided, to:
https://www.regulations.gov. Do not
submit confidential business
information, trade secret information, or
other sensitive or protected information
that you do not want to be available to
the public. 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, and insert the
docket number, CPSC 2012–0068, into
the ‘‘Search’’ box, and follow the
prompts.
FOR FURTHER INFORMATION CONTACT:
Patricia L. Edwards, Project Manager,
Directorate for Engineering Sciences,
U.S. Consumer Product Safety
Commission, 5 Research Place,
Rockville, MD 20850; email:
pedwards@cpsc.gov.
SUPPLEMENTARY INFORMATION:
I. Background and Statutory Authority
The CPSIA was enacted on August 14,
2008. Section 104(b) of the CPSIA, part
of the Danny Keysar Child Product
Safety Notification Act, requires the
Commission to promulgate consumer
product safety standards for durable
infant or toddler products. These
standards are to be ‘‘substantially the
same as’’ applicable voluntary standards
or more stringent than the voluntary
standard if the Commission concludes
that more stringent requirements would
further reduce the risk of injury
associated with the product. The term
‘‘durable infant or toddler product’’ is
defined in section 104(f)(1) of the CPSIA
as a durable product intended for use,
or that may be reasonably expected to be
used, by children under the age of 5
years. Infant carriers are one of the
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products specifically identified in
section 104(f)(2)(F) as a durable infant
or toddler product. At this time, the
Commission has identified four types of
products that could fall within the
infant carrier product category,
including: Frame backpack carriers, soft
infant and toddler carriers, slings, and
handheld infant carriers. This rule
addresses hazards associated only with
hand held infant carriers. Hazards
associated with other types of carriers
would be addressed in separate
rulemaking proceedings.
In this document, the Commission
proposes a safety standard for hand held
infant carriers. The proposed standard is
based on the voluntary standard
developed by ASTM International
(formerly the American Society for
Testing and Materials), ASTM F2050–
12, ‘‘Standard Consumer Safety
Specification for Hand-Held Infant
Carriers.’’ The ASTM standard is
copyrighted. However, by permission of
ASTM, the standard can be viewed as a
read-only document during the
comment period on this proposal, at:
https://www.astm.org.
II. The Product
A. Definition
ASTM F2050–12 defines a ‘‘hand held
infant carrier’’ as a ‘‘freestanding, rigidsided product intended to carry an
occupant whose torso is completely
supported by the product to facilitate
transportation by a caregiver by means
of hand-holds or handles.’’ The current
ASTM voluntary standard references
two types of hand held infant carriers:
hand-held bassinets/cradles that incline
10 degrees or less from horizontal and
sit directly on the floor, and hand-held
carrier seats that incline more than 10
degrees from horizontal and are often
also used as attachments to serve as
infant car seats, strollers, or high chairs.
The current ASTM voluntary standard
defines ‘‘hand-held carrier seat’’ as a
‘‘hand-held infant carrier having a seat
back that is intended to be in a reclined
position (more than 10° from
horizontal),’’ and ‘‘hand-held bassinet/
cradle’’ is defined as ‘‘ freestanding
product, with a rest/support surface to
facilitate sleep (intended to be flat or up
to 10° from horizontal), that sits directly
on the floor, without legs or a stand, and
has hand-holds or handle(s) intended to
allow carrying an occupant whose torso
is completely supported by the
product.’’ Some of the requirements in
F2050–12 are different for hand-held
bassinets/cradles and hand-held infant
carriers because the intended position of
the occupant (lying supine vs. sitting
reclined) and the product designs used
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to accommodate the occupant can create
different hazards. A Moses basket is
considered to be a freestanding product
with a rest/support surface to facilitate
sleep and typically has hand-holds or
handle(s) intended to allow carrying an
occupant. Moses baskets typically have
semi-rigid sides. The Commission seeks
comments on whether Moses baskets are
or should be covered by this safety
standard. The Commission specifically
seeks comments on (1) whether the
definition of ‘‘hand-held bassinet/
cradle’’ in ASTM F2050–12 includes
Moses baskets, and (2) if Moses baskets
are not covered by the safety standard
but should be, how the present
definition should be amended to more
clearly cover Moses baskets.
B. The Market
Based on the 2005 survey conducted
by American Baby Group titled, ‘‘2006
Baby Products Tracking Study,’’ and
annual birth data from the Centers for
Disease Control and Prevention (CDC),
we estimate that approximately 2.1
million infant car seats are sold in the
United States each year. We do not
know how many hand-held bassinets/
cradles are sold annually. Hand-held
carrier seats and hand-held bassinets/
cradles are typically produced and/or
marketed by juvenile product
manufacturers and distributors, except
for Moses baskets, a unique type of
hand-held bassinet/cradle that is often
marketed by bedding manufacturers and
distributors. We estimate there are
currently at least 43 suppliers of both
types of hand-held infant carriers to the
U.S. market, 11 of which are domestic
manufacturers and 10 of which are
domestic importers. We estimate that 20
firms supply Moses basket-style handheld bassinets/cradles only, but the
source of these carriers is unknown.
There are also two foreign firms—a
foreign manufacturer and an importer
that import products from foreign
companies and distributes them in the
United States.
The products of 13 of the 43 handheld infant carrier suppliers will likely
be compliant with ASTM F2050–12 (6
are Juvenile Products Manufacturers
Association (JPMA) certified to F2050–
09; 3 claim compliance with F2050; and
4 have JPMA-certified strollers with
hand-held infant carrier attachments).1
1 JPMAs typically allows 6 months for products
in their certification program to shift to a new
standard once it is published. ASTM F2050–12, The
voluntary standard upon which the proposed
standard is based, will become effective for JPMA
certification purposes in approximately March
2013. Firms that supply JPMA-certified strollers are
expected to ensure that all of their attachments,
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Of the remaining 30 firms supplying
noncompliant hand-held infant carriers,
the majority (25 firms) supply products
that are newly covered due to the
expanded scope of ASTM F2050–12 (20
supply Moses baskets; 3 supply bassinet
attachments for strollers; and 2 supply
other types of bassinet-style carriers) to
include hand-held bassinets/cradles.
III.
Incident Data
The CPSC’s Directorate for
Epidemiology notes that there have been
242 incidents, occurring between
January 1, 2007 and June 7, 2012,
reported to the Commission regarding
hand-held infant carriers. Of the 242
incidents, there were 36 fatalities, 60
nonfatal injuries, and 146 incidents
where no injury occurred or was
reported.
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A. Fatalities
From January 1, 2007 through early
June, 2012, there were 36 fatalities
associated with hand-held infant
carriers. The majority of the fatalities are
attributed to the improper use or nonuse of the carrier’s restraint system.
Five of the fatalities were caused by
the infant carrier being placed in a
hazardous environment, and therefore,
these fatalities are considered to be nonproduct related. Two of these fatalities
occurred when the infant carrier was
placed atop a stove, which subsequently
was ignited accidently. Another fatality
was attributed to hyperthermia after an
infant was left unattended in a carrier
for an extended period of time, wrapped
in multiple blankets, and left in a room
with temperatures exceeding 90 degrees.
In another of these five deaths, an infant
in a carrier that was placed cross-wise
inside a bassinet was able to tip the
carrier into a reclined position, resulting
in an asphyxiation death. The last of
these five fatalities was the result of an
infant suffocating on a blanket that was
placed over his head while in the
carrier. For an additional two fatalities,
the evidence is insufficient to determine
if there was any product involvement or
the presence of any hazardous external
circumstances.
The remainder of the fatal incidents
includes:
• Nine children were strangled by the
carrier’s harness chest clips or strap. In
most of these incidents the infant was
partially restrained in the seat with only
the shoulder straps in place, with the
crotch strap left unsecured, which
allowed the infant to slide forward in
the seat far enough to get caught at the
including hand-held infant carriers, comply with all
applicable ASTM standards as well.
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throat by the chest clip that connects the
two shoulder straps.
• In one incident, the restraint straps
were too tight and impaired the infant’s
breathing, although no information
regarding the placement of the straps
was provided.
• Seven children were left
unrestrained in the carrier and found in
a prone position, face down on the seat,
or on a blanket, covers, and/or pillow.
• Two children who had been left
unrestrained in the carrier were found
prone on the seat of the carrier, which
had also tipped over.
• Three children were reported to
have been trapped in an overturned
seat, although no information was
provided about the use of the restraints
or how the seat overturned in these
incidents.
• One fatality resulted from a fall
from a carrier that was on a shopping
cart but not equipped to attach to the
cart.
• Six additional deaths were
associated with hand-held carriers, but
there was insufficient information to
determine the circumstances.
B. Nonfatal Injuries
From January 1, 2007 through early
June 2012, 206 nonfatal incidents were
reported. Of those, 60 incidents
involved an injury, and 2 of those
required hospitalization due to serious
head injuries suffered from a fall from
a carrier that was on top of a shopping
cart. Bumps, bruises, abrasions,
lacerations, allergic reactions and nearchoking episodes are the most common
injuries reported in the remaining 58
injury reports. No age was reported for
28 percent of the injury incidents. For
incidents where the age was reported, 1
child was reported to be 13 months old,
1 was reported to be 23 months old, and
the rest were 12 months or younger. The
remaining 146 incident reports indicate
that no injury occurred or they fail to
provide any information regarding
injuries to the carrier occupant.
However, many of the descriptions of
the incidents suggest the potential for
serious injury or death.
C. Recalls
There have been a total of three
consumer-level recalls involving handheld carriers from January 1, 2007
through June 7, 2012.
One recall, involving 450,000 car
seats/carriers manufactured from
December 2004 through September
2006, pertained to the carrier seat
handle. The carrier handle could release
unexpectedly, causing the seat to rotate
forward in a manner that could result in
the occupant of the carrier falling to the
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ground and suffering serious injuries.
There were 679 incidents of the handle
releasing unexpectedly, resulting in 160
injuries reported to the CPSC and the
manufacturer. The recall notice
instructed consumers not to use the seat
as a carrier until the repair kit offered
by the manufacturer had been obtained
and installed. (The modifications to the
handle auto-lock test discussed in
Section VI would address this hazard.)
Another recall, conducted on
December 18, 2009, involving 447,000
infant car seat/carriers manufactured
from January 6, 2008 to April 6, 2009,
also pertained to the carrier handle. The
seat handle could loosen and fall off,
posing a fall hazard to the infant
occupant of the seat. There were 77
incidents of the child restraint handle
fully or partially detaching from the car
seat/carrier, resulting in three injuries,
reported to the CPSC and the
manufacturer. Consumers were
instructed not to use the seat as a carrier
until they had obtained and installed
the repair kit offered by the
manufacturer. (The carrying handle
integrity test included in ASTM F2050–
12, addresses this hazard).
The third recall was conducted on
November 4, 2010, and it involved
23,000 infant car seats/carriers
manufactured between April 2009 and
May 2010. The harness chest clips could
break, posing a fall hazard, and the
broken pieces were small enough for an
infant to swallow, which posed a
choking hazard. There were four
incidents of the chest clip breaking,
resulting in three injuries reported to
the CPSC and the manufacturer. The
injuries that resulted from the clip
breaking were minor lacerations and
scratches to arms and a finger, and one
report involved an infant placing the
broken clip in his mouth. The recall
notice instructed consumers to contact
the manufacturer to request a free repair
kit. (The restraint system test included
in ASTM F2050–12 addresses this
hazard.)
IV. Hand-Held Carrier International
Standards and the ASTM Voluntary
Standard
Section 104(b)(1)(A) of the CPSIA
requires the Commission to consult
representatives of ‘‘consumer groups,
juvenile product manufacturers, and
independent child product engineers
and experts’’ to ‘‘examine and assess the
effectiveness of any voluntary consumer
product safety standards for durable
infant or toddler products.’’ As a result
of incidents and recalls of hand-held
infant carriers in the 1990s, CPSC staff
requested ASTM to develop voluntary
requirements to address the hazards
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related to handle breakage and handle
lock failures. Through the ASTM
process, we consulted with
manufacturers, retailers, trade
organizations, laboratories, consumer
advocacy groups, consultants, and
members of the public. The voluntary
standard for hand-held infant carriers
was first approved and published in
August 2000, as ASTM F2050–00,
Standard Consumer Safety Performance
Specification for Hand-Held Infant
Carriers. It has been revised five times
since then. The current version, ASTM
F2050–12, was approved on July 1,
2012.
In addition to reviewing the ASTM
standard, we reviewed several
international standards.
A. International Standards
We identified one international
standard, EN 12790, European/British
Standard for Child Care Articles—
Reclined Cradles, which addresses
hand-held infant carriers in a manner
similar to ASTM F2050–12. However,
reclined cradles are designed and
intended for unattended sleep, and the
European standard includes
requirements that also pertain to that
use pattern. One difference between EN
12790 and ASTM F2050–12 is
entrapment dimensions for holes and
slot openings. The European standard
permits dimensions for slot openings to
be between 7 mm and 12 mm, while
ASTM F–2050–12 allows dimensions of
5 mm to 9.5 mm. We have concluded
that the existing dimensions in the
ASTM standard are anthropometrically
appropriate and that there are no hazard
patterns that would warrant
modification of these dimensions. In
addition, we concluded that the hazard
patterns noted in the incidents do not
warrant modification of the ASTM
standard to address the requirements for
flammability, surface chemicals, cords/
ribbons, cradle angles, and cradle
strength/durability that appear in EN
12790. Finally, we note that EN 12790
includes requirements for folding
cradles, which is a use pattern outside
the scope of ASTM F2050–12.
We reviewed several other
international standards and a National
Highway Safety Transportation
Administration (NHTSA) standard that
address requirements for restraint
systems of products when used in motor
vehicles, and we concluded that these
standards do not address the incident
hazard patterns associated with handheld infant carriers. These standards
are: ECE 44 (European Provision for
Restraining Devices for Child Occupants
of Power-Driven Vehicles, JIS D 0401
(Japanese Standard for Automotive
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Accessories—Child Restraints), AS/NZS
1754:2010 (Australian/New Zealand
Standard for Child Restraint Systems for
Use in Motor Vehicles), and FMVSS No.
213 (NHSTA Requirements for Child
Restraint Systems Used in Motor
Vehicles and Aircraft).
B. The ASTM Voluntary Standard
In response to incidents and recalls of
hand-held infant carriers in the 1990s
related to handle breakage and handle
lock failures, CPSC requested ASTM to
develop voluntary requirements to
address the hazards. CPSC staff
participated in ASTM subcommittee
meetings and testing protocols in
developing draft requirements. ASTM F
2050, Standard Consumer Safety
Performance Specification for HandHeld Infant Carriers was first approved
and published in August 2000. ASTM
has revised the standard four times
since then, with the most current
version ASTM F 2050–12, approved on
July 1, 2012. Details regarding the
changes in the voluntary standard
through revisions in October, 2001,
November, 2003, December, 2008, and
October 2009, are provided at pages 30
and 31 of the November 7, 2012, Staff
Briefing Package.
ASTM F2050–12 addresses many of
the general hazards associated with
durable nursery products, such as lead
in paints, sharp edges/sharp points,
small parts, wood part splinters,
scissoring/shearing/pinching, openings/
entrapments, and toys. Specific
requirements for labeling, handle
integrity, handle auto-locking, and
restraint systems are also included.
The key provisions of the current
ASTM hand-held infant carrier standard
include: Definitions; general
requirements; performance
requirements; specific test methods; and
requirements for marking, labeling, and
instructional literature.
Definitions. ASTM F2050–12 defines
‘‘hand-held infant carrier’’ as a ‘‘free
standing, rigid-sided product intended
to carry an occupant whose torso is
completely supported by the product to
facilitate transportation by a caregiver
by means of hand-holds or handles.’’
The definition of ‘‘hand-held infant
carrier seat’’ is ‘‘a hand-held infant
carrier having a seat back that is
intended to be in a reclined position
(more than 10° from horizontal).’’ The
definition of ‘‘hand-held bassinet/
cradle’’ is a ‘‘freestanding product, with
a horizontal rest/support surface to
facilitate sleep (intended to be flat or up
to 10 from horizontal), which sits
directly on the floor, without legs or a
stand, and has hand-holds or handle(s)
intended to allow carrying an occupant
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whose torso is completely supported by
the product.’’
General Requirements. ASTM F2050–
12 contains general requirements that
the product must meet, as well as
mandated test methods that must be
used to ensure that the product meets
those requirements, including:
• Restrictions on sharp points, small
parts, lead paint, and wood parts;
• Specifications to prevent scissoring,
shearing, and pinching;
• Requirements for toy accessory
items, and the non-removal of protective
components;
• Specifications on openings
(intended to prevent finger and toe
entrapment), labeling (intended to
prevent labels from being removed and
ingested or aspirated on), and coil
springs; and
• Torque and tension tests for
protective components.
Performance Requirements and
Specific Test Methods. ASTM F2050–12
provides performance requirements that
the product must meet, as well as
mandated test methods that must be
used to ensure that the product meets
the performance requirement, including:
• A carry handle auto-locking
requirement (the carry handle must
move unaided into the designated carry
position or move unaided into a
position that is obvious to the caregiver
that the carry handle is not in the
designated carry position);
• A carry handle integrity
requirement (a rigid carry handle that
rotates in head-to-foot and foot-to-head
directions must not break or unlatch on
either or both sides when subject to the
handle endurance test);
• A restraint system requirement
(hand held carrier seats not intended for
use in motor vehicles must have a waist
and crotch restraint while hand-held
bassinets/cradles may not contain a
restraint system);
• Slip-resistance requirements;
Marking, Labeling, and Instructional
Literature. ASTM F2050–12 sets forth
requirements for marking, labeling, and
instructions that must accompany a
hand-held carrier, including warnings
regarding proper use of restraint straps,
placement of the carrier on soft or
elevated surfaces, and suffocation and
strangulation hazards that may arise if
restraint straps are not used properly
and suffocation hazards that can arise
when the carrier is placed on a soft
surface. The warning label also advises
caregivers never to leave a child
unattended in the carrier. The standard
also includes requirements and tests for
the permanency of labels and warnings.
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V. Assessment of Voluntary Standard
ASTM F2050–12
We considered the fatalities, injuries,
and noninjury incidents associated with
hand-held carriers, and we evaluated
the voluntary standard to determine
whether ASTM F2050–12 addresses the
incidents or whether more stringent
standards are required that would
further reduce the risk of injury
associated with these products. We
discuss our assessment in this section,
but our assessment does not include
deaths and injuries associated with
hand-held carriers where there was
insufficient evidence to determine the
circumstances.
1. Hazardous Surroundings
Five of the 36 fatalities reported, and
12 of the 242 incidents reported
involving a hand-held carrier were
attributable to unsafe environments
around the carrier. Two of the five
fatalities resulted when the carrier was
placed on top of a stove that later was
ignited. In another of the fatalities, the
infant died from hyperthermia after
being left unattended in a carrier,
wrapped in blankets, in a room where
temperatures exceeded 90 degrees. In
another fatality, the infant was placed in
the carrier cross-wise inside a bassinet
and asphyxiated when the carrier was
tipped into a reclined position trapping
the infant between the carrier and the
interior of the bassinet. The fifth fatality
was attributable to a suffocation in
which a blanket was placed over the
infants head while in the carrier. Risks
due to hazardous surroundings are not
attributable to the design or
construction of the hand-held carriers.
ASTM F 2050–12 includes product
warnings that address the dangers of
placing the product near the edges of
counter tops or on elevated surfaces,
and the warnings direct caregivers never
to leave a child unattended in a carrier.
We do not believe there are additional
requirements that can be put into place
in the standard to address this issue.
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2. Hazards Related to Accessories
Issues related to accessories, such as
toys, canopies, carrier seat covers, and
head and body support devices were
reported in 28 of the 242 (12 percent)
reported incidents. In 27 of these
incidents, the accessory was not
supplied with the carrier, but was
purchased separately by a caregiver. In
the remaining incident, the accessory
was an attached canopy. While there
were no fatalities involving accessories,
the incidents reported included:
Choking on a device designed to attach
a toy to the carrier handle; jamming an
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arm into the side of toy; breathing
obstruction from canopy drooping onto
childs face; and breaking and detaching
small pieces from a pacifier and a
pacifier holder. The current standard
precludes hazardous sharp edges or
points, as defined in 16 CFR 1500.48
and 1500.49 before and after testing to
the standard, and prohibits small parts,
as defined in 16 CFR part 1501, before
testing or liberated as a result of testing
to the standard. The standard also
requires that any toy accessories
attached to, removable from, or sold
with, an infant carrier, as well as their
means of attachment must meet the
applicable requirements of ASTM
Consumer Safety Specification F963
(now CPSC’s mandatory toy standard).
We believe that these requirements are
sufficient to address these hazards, and
therefore we are not proposing any
additional requirements at this time.
3. Design Issues
Twenty-eight of the 242 incident
reports (12 percent) are attributed to the
design of the carrier. Three of the
incidents reported in this category were
fatalities. Design issues are related to
instability, sharp surfaces, unsafe infant
posture when seated, and structural
integrity. Although the three reported
fatalities involve a child becoming
trapped under an overturned seat,
insufficient information was provided
in these reports to determine what
caused the seat to overturn. It is possible
these tip overs could be related to the
stability of the carrier when placed on
tables, sofas, or chairs. However, there
is insufficient incident data to support
a conclusion that design issues were the
cause of the fatalities or other incidents.
Additionally, many carriers are
designed to meet NHTSA requirements
for occupant crashworthiness, and
modification of the carrier to improve
stability when used outside the vehicle
might affect how the carrier integrates
into the carrier base in the vehicle. For
these reasons, we are not proposing any
changes to address stability-related
design issues at this time.
In addition to stability, this hazard
pattern includes occupant-positioning
incidents. Six consumer complaints
involve infant head slumping. However,
we received no reports of fatalities or
injuries resulting from infant head
slumping. Because we are aware of no
injuries resulting from this hazard, and
because a revision of the standard to
address angle of seat incline may
implicate issues within NHTSA’s
jurisdiction, we are not proposing any
changes to address angle of seat incline
at this time.
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Three consumer complaints state that
mothers do not always pay appropriate
attention to the way they swing carriers
while an infant is in the seat. The
complaints suggest that this movement
may place the infant at risk for shaken
baby syndrome. Because there are no
injuries reported in connection with this
scenario, and because no revision of the
standard would likely address any
potential risk of injury arising from the
way a caregiver swings the carrier, we
are not proposing any changes to
address this issue at this time.
4. Falls From Shopping Carts
Incidents included one reported
fatality and two reported injuries
involving children who fell from
shopping carts on which the carriers
had been placed. The two injured
children required hospitalization for
serious head injuries suffered when they
fell to the floor from a carrier that had
been placed on a shopping cart. The risk
associated with placing a child in a
hand-held carrier on a shopping cart is
addressed by ASTM 2372–11a,
Standard for Consumer Safety
Performance Specification for Shopping
Carts, which was developed to address
injuries to children associated with falls
from shopping carts. This standard
requires each shopping cart to have
warning statements instructing the user
not to use a personal infant carrier but
instead to use the seat in the cart and
to fasten the child securely into the seat.
In addition, the standard requires
retailers to provide additional safety
information in the form of warning
posters at the point of use. The warning
label pertaining to safe use recently was
revised and includes a pictogram
concerning the use of hand-held carriers
in the cart. This new label is included
in this latest version, which was
approved in January 2012. We do not
believe that there are additional
requirements that can be put in place in
either ASTM 2372–11a or ASTM
F2050–12 to address this issue.
5. Fabric Issues
In 15 of the 242 (6 percent) reported
incidents, the injury related to the
carrier fabric or padding. Incidents
related to fabric include: allergic
reactions to padding or items attached
to padding; bruising from fabric
stitching; and ingesting padding foam.
This hazard pattern is not specific to
this product. Because similar incidents
occur with other durable products and
are expected with any product with
fabric or padding, we are not proposing
any additional requirements to address
fabric issues at this time.
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6. Other Product-Related Concerns
In 10 of the 242 (4 percent) reported
incidents, we were unable to identify a
specific hazard pattern because
insufficient information regarding the
circumstances of the incident was
provided. Six of these incidents resulted
in fatalities. Most of these reports
indicate possible improper use of the
carrier or another contributing factor,
such as soft bedding. For example, one
case involves an infant sleeping in the
carrier with a blanket or covering that
may have resulted in suffocation.
However, because we are unable to
identify a specific hazard pattern in
incidents with insufficient information,
we are not proposing additional
requirements at this time.
7. Other Unknown Issues
Two fatalities could not be attributed
to design or performance of the handheld carrier. We are in the process of
investigating both deaths, and once
these investigations are complete,
further review by CPSC staff will be
warranted to determine if the design or
construction of the hand-held carrier
contributed to the deaths. If we
conclude that the design or construction
of the hand-held carrier contributed to
either of these deaths, we will
determine whether additional
requirements are necessary. Because the
involvement of the product in these
incidents is unclear, we cannot propose
additional requirements in the absence
of information supporting the
conclusion that these two incidents
were attributed to the design or
performance of the hand-held carrier.
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VI. Description of Proposed Changes to
ASTM Standard
The proposed rule would create a new
part 1225 titled, ‘‘Safety Standard for
Hand Held Carriers.’’ The proposed rule
would establish ASTM F2050–12,
‘‘Standard Consumer Safety
Specification for Hand-Held Infant
Carriers,’’ as a consumer product safety
standard, but with certain changes. We
are proposing two changes to ASTM
F2050–12. One change would add a
strangulation warning label to be affixed
to the outer surface of the cushion or
padding of a hand-held carrier seat in or
adjacent to the area where the childs
head would rest. The warning label for
hand-held carrier seats that are intended
to be used as restraints in motor
vehicles would include a pictogram,
while the warning label for hand-held
carrier seats not intended to be used as
restraints in motor vehicles would not
include the pictogram because these
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seats do not have the chest clips
depicted in the pictogram.
The other change would affect the test
method for ensuring that the carrier will
not rotate and spill an unrestrained
infant when a caregiver picks up the
carrier and the handle is not locked in
the carry position. The test method in
ASTM F2050–12 requires the tester to
use a standard CAMI, Mark II 6-month
infant dummy as an infant surrogate.
The proposed change would require the
tester to use an aluminum cylinder
designed as a surrogate for a 6-month
old infant, in lieu of the CAMI dummy,
because the CAMI dummy could be
wedged into the seat padding or
otherwise manipulated, such that it
does not fall out during the lift test
when it otherwise should fall. Further,
the ability to pass or fail the test based
on friction or placement of the CAMI
affects the consistency and repeatability
of the test results.
We describe these proposed changes
in the following section.
A. Improper Restraint Usage
Incorrect use or nonuse of the harness
straps were involved in 81 of the 242
reported incidents and resulted in 19 of
the 36 fatalities related to hand-held
carriers from January 1, 2007 to early
June 2012. Among these 19 fatalities,
nine strangulation incidents occurred
due to loose or partially buckled harness
straps. In six of the fatalities involving
nonuse or improper use of harness
straps, the child strangled on the chest
clips, while in two incidents children
strangled on loose straps. In seven
incidents, children who were not
restrained in the carrier moved
themselves into a compromising
position, resulting in asphyxia. Two
fatalities occurred when unrestrained
infants became trapped under an
overturned carrier. In one fatality, straps
that were too tight impaired the child’s
breathing while in the other, it is
unclear how the harness strap
contributed to the child’s death.
ASTM F2050–12 includes product
warnings that address the dangers of
leaving a child unattended in the
carrier, leaving a child in a carrier with
loose or unfastened harness straps, and
putting the carrier on a soft surface
where it can roll over and suffocate a
child. The warnings are required to be
‘conspicuous,’ i.e., visible when the
carrier is in the recommended use
position to a person standing near the
infant carrier in any one position
around the carrier but not necessarily
visible from all positions. This warning
statement attempts to address
suffocation, strangulation, and fall
hazards. However, a caregiver may not
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encounter the label during regular use of
the carrier.
We propose a new strangulation
warning label, placed where a caregiver
is expected to notice it during regular
interaction with the carrier and the
infant, which includes a pictogram
depicting proper and improper harness
use and that states: ‘WARNING–
Children have STRANGLED in loose or
partially buckled harness straps. Fully
restrain the child even when carrier is
used outside the vehicle.’ An ASTM
task group, with the assistance of CPSC
staff, developed several different
pictorial symbols that were presented to
an audience of 159 people. More than
95 percent of the participants who
reviewed the recommended pictogram
interpreted it correctly. We believe the
warning label with the pictogram will
improve noticeability and
comprehension of the risk.
B. Handle Issues
Handles breaking, detaching, or
failing to lock in the carry position were
reported in 55 of the 242 incidents.
Some of these incidents resulted in
injuries, such as a lacerated lip, bruises,
and a cranial hemorrhage, when the
carrier and/or the child fell to the
ground. We believe that many of the
incidents attributable to the failure of
the handle to lock are the result of the
handle appearing to be in a locked
position when the caregiver lifts the
carrier. We believe that the incidents in
which the handle itself breaks or
detaches from the carrier are attributable
to manufacturing or assembly errors.
The current voluntary standard
contains a handle preconditioning cycle
test, followed by a static hang test, to
assess handle lock stability and
integrity. The handle lock impact test is
designed to test the handle and handle
lock integrity to reduce the number of
fall injuries. This test is conducted at
the conclusion of the static hang test
and consists of dropping a hanging
weight at the end of the carrier. The
hanging weight simulates dynamic
loads placed on the handle and handle
lock while a caregiver walks with an
infant in the carrier.
The handle auto-lock test helps
ensure that when a caregiver picks up
the carrier with the handle out of the
locked position, the carrier will not
rotate and spill an unrestrained infant.
This is accomplished by requiring the
carrier handle to have an auto-lock
feature, or, when not locked in the carry
position, to fall to a position so it is
obvious to the caregiver that the handle
is not in the carry position. If neither
condition is met, then the handle must
lock into the carry position or another
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position, such that when the carrier is
lifted by the handle, the infant will not
fall out.
The existing handle auto-lock test
uses a standard CAMI, Mark II 6-month
infant dummy during the lift test. When
we tested one carrier, the CAMI became
wedged into the seat padding in such a
way that the CAMI did not fall out
during the lift test when an unrestrained
infant in this position likely would fall
from the carrier. We also found that
CAMI placement in the carrier could be
manipulated to achieve the desired
results. For example, placing a CAMI
with its back high in the seat makes the
carrier more likely to pass the test,
while placing a CAMI lower in the seat
may make the carrier more likely to fail.
Thus, friction or the placement of the
CAMI affects the consistency and
repeatability of the test.
To resolve these CAMI-related test
issues, we conducted the auto-lock test
using an aluminum cylinder designed as
a surrogate for a 6-month-old infant in
lieu of the CAMI dummy. This change
resulted in consistent test results
because the cylinder does not wedge
into the carrier padding like the CAMI
dummy, and placement of the cylinder
is less likely to affect the outcome of the
test.
We propose modifying ASTM F2050
to require conducting the auto-lock test
with the surrogate cylinder instead of
the infant CAMI dummy. The surrogate
cylinder is modeled from the torso of a
6-month-old child, and it is also used in
the bassinet segmented mattress test we
recently proposed in the NPR for
bassinets and cradles. 77 FR 64055.
Further, EN 12790 European/British
Standard for Child Care Articles—
Reclined Cradles, uses a similar
cylinder to conduct their tip test for the
same products.
VII. Effective Date
The Administrative Procedure Act
(APA) generally requires that the
effective date of a rule be at least 30
days after publication of the final rule.
5 U.S.C. 553(d). To allow time for handheld carriers to come into compliance,
we propose that the standard become
effective 6 months after publication of
the final rule in the Federal Register. We
invite comment on how long it will take
manufacturers to come into compliance.
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VIII. Regulatory Flexibility Act
A. Introduction
The Regulatory Flexibility Act (RFA),
5 U.S.C. 601-612, requires agencies to
consider the impact of proposed rules
on small entities, including small
businesses. Section 603 of the RFA
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requires that the Commission prepare an
initial regulatory flexibility analysis and
make it available to the public for
comment when the notice of proposed
rulemaking is published. The initial
regulatory flexibility analysis (IRFA)
must describe the impact of the
proposed rule on small entities and
identify any alternatives that may
reduce the impact. Specifically, the
IRFA must contain:
• A description of, and where
feasible, an estimate of the number of
small entities to which the proposed
rule will apply;
• A description of the reasons why
action by the agency is being
considered;
• A succinct statement of the
objectives of, and legal basis for, the
proposed rule;
• A description of the projected
reporting, recordkeeping, and other
compliance requirements of the
proposed rule, including an estimate of
the classes of small entities subject to
the requirements, and the type of
professional skills necessary for the
preparation of reports or records; and
• An identification, to the extent
possible, of all relevant federal rules
that may duplicate, overlap, or conflict
with the proposed rule.
B. The Market
The majority of hand-held infant
carriers are produced and/or marketed
by juvenile product manufacturers and
distributors. A potential exception is the
Moses basket (whose inclusion in the
scope as a type of hand-held bassinet or
cradle is under consideration by the
Commission), which are often marketed
by bedding manufacturers and
distributors. The Commission estimates
that currently, there are at least 43
suppliers of hand-held infant carriers to
the U.S. market. Eleven are domestic
manufacturers, and 10 are domestic
importers. There are also two foreign
firms—a foreign manufacturer and an
importer that imports products from
foreign companies and distributes them
from outside of the United States. An
additional 20 domestic firms supply
Moses basket bedding, along with Moses
baskets, whose source is unknown.
Hand-held infant carriers from six of
the 43 firms have been certified as
compliant with ASTM F2050 by the
JPMA, the major U.S. trade association
that represents juvenile product
manufacturers and importers. Three
firms claim compliance with F2050; and
four have JPMA-certified strollers with
hand-held infant carrier attachments. It
is assumed that the hand-held infant
carriers supplied by all 13 of these firms
will be in compliance with the
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voluntary standard. Of the remaining 30
firms supplying noncompliant handheld infant carriers, the majority (25
firms) supply products that are newly
covered due to the expanded scope of
ASTM F2050-12 (20 supply Moses
baskets, 3 supply bassinet attachments
for strollers, and 2 supply other types of
bassinet-style carriers).
The market data available is limited to
infant car seats, which represented
nearly the entire hand-held infant
carrier market under prior versions of
ASTM F2050. According to a 2005
survey conducted by the American Baby
Group (2006 Baby Products Tracking
Study), 68 percent of new mothers own
infant car seats. Approximately 25
percent of infant car seats were handed
down or purchased secondhand. Thus,
about 75 percent of infant car seats were
acquired new. This suggests annual
sales of about 2.1 million infant car
seats (.68 × .75 × 4.1 million births per
year).2 These 2.1 million infant car seats
represent the minimum number of units
sold per year that might be affected by
the proposed handheld infant carrier
standard. It is unknown how many
Moses baskets and other bassinet/
cradle-style carriers are sold annually.
C. Reason for Agency Action and Legal
Basis for Proposed Rule
The Danny Keysar Child Product
Safety Notification Act, section 104 of
the CPSIA, requires the CPSC to
promulgate a mandatory standard for
hand-held infant carriers that is
substantially the same as, or more
stringent than, the voluntary standard.
CPSC worked closely with ASTM to
develop the new requirements and test
procedures that have been added to the
voluntary standard since 2010. These
new requirements address several
known hazard patterns and will help to
reduce injuries and deaths in hand-held
carriers, and they have resulted in the
current voluntary standard, F2050-12,
upon which the proposed rule is based.
However, the Commission proposes
adding one new requirement to F205012, as well as modifying the
methodology for the existing handle
auto-lock test. The new requirement
would mandate a new warning label, as
described in Section VI (A), which
addresses strangulation and suffocation
hazards that have occurred as a result of
incorrect or nonuse of harness straps.
The modification proposed by the
2 U.S. Department of Health and Human Services,
Centers for Disease Control and Prevention (CDC),
National Center for Health Statistics, National Vital
Statistics System, ‘‘Births: Final Data for 2009,’’
National Vital Statistics Reports Volume 60,
Number 1 (November 2011): Table I. Number of
births in 2009 is rounded from 4,130,665.
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Commission is that an aluminum
cylinder, designed as a surrogate for a 6month old infant, be used in lieu of the
CAMI dummy in the handle auto-lock
test. This proposed change would result
in consistent test results because the
cylinder does not wedge into the carrier
padding like the CAMI dummy, and
placement of the cylinder is less likely
to affect the outcome of the test.
D. Requirements of the Proposed Rule
The Commission proposes adopting
the voluntary ASTM standard for handheld infant carriers (F2050-12), with a
new warning label requirement, and a
modification of the handle auto-lock
test. Some of the more significant
requirements of the current voluntary
standard for hand-held infant carriers
(ASTM F2050-12) are listed below:
• Carry handle integrity—a series of
endurance and durability tests are
intended to ensure that rigid, adjustable
handles do not break or unlock during
use.
• Carry handle auto-locking—
intended to address incidents that have
occurred when the rigid, adjustable
handles switched positions
unexpectedly.
• Restraints—intended to minimize
the fall hazard associated with inclined
hand-held carriers while simultaneously
minimizing the potential for injury or
death in flat bassinet/cradle products
where restraints can pose a
strangulation hazard.
• Slip resistance—intended to
prevent slipping when the hand-held
infant carrier is placed on a slightly
inclined surface (10 degrees).
The voluntary standard also includes:
(1) Torque and tension tests to ensure
that components cannot be removed; (2)
requirements for several hand-held
infant carrier features to prevent
entrapment and cuts (minimum and
maximum opening size, coverage of
exposed coil springs, small parts,
hazardous sharp edges or points,
smoothness of wood parts, and edges
that can scissor, shear, or pinch); (3)
marking and labeling requirements; (4)
requirements for the permanency and
adhesion of labels; (5) requirements for
instructional literature; and (6) toy
accessory requirements. ASTM F2050–
12 includes no reporting or
recordkeeping requirements. The
Commission proposes adding a new
warning label content and placement
requirement and using the more
appropriate cylinder surrogate for the
handle auto-lock testing.
The carry handle auto-locking
requirement applies only to hand-held
infant carriers that are rigid, adjustable,
rotate about a singular axis, and lock
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into the manufacturer’s designated carry
position; therefore, many suppliers,
most notably Moses basket suppliers,
would not be affected. Several models of
hand-held infant carriers with these
types of handles would be able to pass
the revised test without modifying their
product(s). The simplest and most
effective way to meet the requirement is
to add auto-lock positions close to the
one intended for use. This would
prevent the handle from moving so far
out of position and spilling the child
from the carrier. While redesign would
probably not be necessary, the hard
tools used to manufacture the handle’s
lock positions would need to be
modified. These hard tools are usually
modified by an outside firm, which
means that production would cease and,
unless the firm maintains an alternating
production schedule, could result in
significant downtime for the firm’s
production process.
The revised warning would change
the size, location, wording, and
presentation to highlight better the
dangers associated with only partially
buckling children into hand-held
carriers. A pictogram is included as part
of the modified warning for hand-held
carrier seats intended to be used as
restraints in motor vehicles. The
warning would be required on the
product itself, as well as within the
product’s instructional literature.
Changes to warning labels are not
expected to have a significant impact on
suppliers. Typically, warning labels that
are placed on fabric, such as the revised
strangulation warning, are less costly
than those used on plastic or metal.
E. Other Federal or State Rules
The Commission is in the process of
implementing sections 14(a)(2) and
14(i)(2) of the Consumer Product Safety
Act (CPSA), as amended by the CPSIA.
Section 14(a)(2) of the CPSA requires
every manufacturer of a children’s
product that is subject to a children’s
product safety rule to certify, based on
third party testing, that the product
complies with all applicable safety
rules. Section 14(i)(2) of the CPSA
requires the Commission to establish
protocols and standards (i) for ensuring
that a children’s product is tested
periodically and when there has been a
material change in the product, (ii) for
the testing of representative samples to
ensure continued compliance, (iii) for
verifying that a product tested by a
conformity assessment body complies
with applicable safety rules, and (iv) for
safeguarding against the exercise of
undue influence on a conformity
assessment body by a manufacturer or
private labeler.
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Because hand-held infant carriers will
be subject to a mandatory standard, they
will also be subject to the third party
testing requirements of section 14(a)(2)
of the CPSA when the mandatory
standard and the notice of requirements
become effective.
F. Impact of the Proposal on Small
Business
There are approximately 43 firms
currently known to be marketing handheld infant carriers in the United States.
Under U.S. Small Business
Administration (SBA) guidelines, a
manufacturer of hand-held infant
carriers is small if it has 500 or fewer
employees, and importers and
wholesalers are considered small if they
have 100 or fewer employees. Based on
these guidelines, 29 are small firms—6
domestic manufacturers, 4 domestic
importers, and 19 firms supplying
Moses baskets whose supply source is
unknown. The remaining firms are five
large domestic manufacturers, six large
domestic importers, one foreign
manufacturer, one foreign importer, and
one large firm supplying Moses baskets
from an unknown source. There may be
additional unknown small hand-held
infant carrier suppliers operating in the
U.S. market.
Small Manufacturers. The expected
impact on small manufacturers of the
proposed standard will differ based on
whether their hand-held infant carriers
are already compliant with F2050-09.
Firms whose hand-held infant carriers
meet the requirements of F2050–09 are
likely to continue to comply with the
voluntary standard as new versions are
published. In addition, they are likely to
meet any new standard within 6 months
of approval because this is the amount
of time JPMA allows for products in
their certification program to shift to a
new standard. Many of these firms are
active in the ASTM standard
development process, and compliance
with the voluntary standard is part of an
established business practice. Therefore,
it is likely that firms supplying handheld infant carriers that comply with
ASTM F2050–09 (which went into
effect for JPMA certification purposes in
April 2010) would also likely comply
with F2050–12 by March 2013, even in
the absence of a mandatory standard. It
should be noted, however, that because
the scope of F2050-09 is more limited
than the scope of F2050–12, only firms
supplying infant car seats would be
expected to have developed a pattern of
compliance. However, staff believes that
firms that manufacture JPMA-certified
strollers with attachments that can be
used separately as hand-held carriers
will also meet ASTM F2050–12 by
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March 2013; having developed a pattern
of compliance for strollers, they would
likely choose to meet any related ASTM
standards as well.
Given these considerations, it is
unlikely that the direct impact on
manufacturers whose products are
likely to meet the requirements of
ASTM F2050–12 (four of six small
domestic manufacturers) will be
significant. Modifying warning labels
and updating instructional literature is
a small cost for most firms. It is possible
that one or more firms might have to
modify their carry handles to continue
to pass the auto-locking test, but this
would most likely result in modifying
their hard tools to add locking positions,
rather than a complete product redesign.
Meeting ASTM F2050–12’s
requirements could necessitate product
redesign for at least some hand-held
infant carriers not believed to be
compliant with F2050–09 (two of six
small domestic manufacturers),
regardless of the proposed
modifications. A redesign would be
minor if most of the changes involve
adding straps and fasteners or using
different mesh or fabric, but the costs
could be more significant if changes to
the frame are required, including
changes to the handles. Some firms have
estimated product redesigns, including
engineering time, prototype
development, tooling, and other
incidental costs to reach approximately
$500,000. Consequently, the proposed
rule could potentially have a significant
direct impact on small manufacturers
whose products do not conform to
F2050–09. However, because most
products would probably not need to be
completely redesigned, actual costs are
likely to be lower than the $500,000
level, and any direct impact may be
mitigated if costs are treated as new
product expenses that can be amortized.
It is possible that one or both of the
firms whose hand-held infant carriers
are neither certified as compliant, nor
claim compliance with F2050–09, in
fact, are compliant with the standard.
The Commission has identified many
such cases with other products. To the
extent that some of these firms may
supply compliant hand-held infant
carriers and have developed a pattern of
compliance with the voluntary
standard, the direct impact of the
proposed standard will be less
significant than described above.
In addition to the direct impact of the
proposed standard described above,
there are indirect impacts. These
impacts are considered indirect because
they do not arise directly as a
consequence of the hand-held infant
carrier rule’s requirements. Nonetheless,
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they could be significant. Once the rule
becomes final and the notice of
requirements is in effect, all
manufacturers will be subject to the
additional costs associated with the
third party testing and certification
requirements. This will include any
physical and mechanical test
requirements specified in the final rule;
lead and phthalates testing is already
required, and hence, it is not included
here.3
Based on durable nursery product
industry input and confidential
business information supplied for the
development of the third party testing
rule, testing to the ASTM voluntary
standard could cost $500–$1,000 per
model sample. Testing overseas could
potentially reduce some testing costs,
but that may not always be practical.
On average, each small domestic
manufacturer supplies two different
models of hand-held infant carriers to
the U.S. market annually. Therefore, if
third party testing were conducted every
year on a single sample for each model,
third party testing costs for each
manufacturer would be about $1,000–
$2,000 annually. Based on a review of
firm revenues, the impact of third party
testing to ASTM F2050–12 is unlikely to
be significant if only one hand-held
infant carrier sample per model is
required. However, if more than one
sample would be needed to meet the
testing requirements, it is possible that
third party testing costs could have a
significant impact on one or more of the
small manufacturers.
Small Importers. Importers of handheld infant carriers would need to find
an alternate source if their existing
supplier does not come into compliance
with the requirements of the proposed
rule, which may be the case with all
four small importers of hand-held infant
carriers, none of which is believed to be
in compliance with F2050–09. Some
could respond to the rule by
discontinuing the import of their
noncomplying hand-held infant carriers,
possibly discontinuing the product line
altogether. However, the impact of such
a decision could be mitigated by
replacing the noncompliant hand-held
infant carriers with a compliant
alternative. Deciding to import an
alternative product would be a
reasonable and realistic way to offset
any lost revenue.
As is the case with manufacturers, all
importers will be subject to third party
testing and certification requirements,
3 Hand-held infant carrier suppliers already must
third party test their products to the lead and
phthalate requirements. Therefore, these costs are
left out of the analysis above.
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and consequently, will experience costs
similar to those for manufacturers if
their supplying foreign firm(s) does not
perform third party testing. The
resulting costs could have a significant
impact on a few small importers that
must perform the testing themselves if
more than one sample per model is
required.
Moses Basket Suppliers. There are 19
small firms supplying Moses baskets to
the U.S. market. Most of these firms also
supply bedding; some of them
manufacture the bedding, while others
act as importers. The Commission has
been unable to determine the source of
the Moses baskets themselves, although
it is likely that most sellers purchase
them from other suppliers, either
foreign or domestic. Because these
products are recent potential additions
to the scope of ASTM F2050, it is
unlikely that any of them has been
designed to comply with this standard.
However, it is possible that many might
be able to comply with the standard
with minimal modifications. Moses
baskets generally do not use restraints,
so the biggest changes might be the
addition of warnings and instructional
literature. Alternatively, Moses basket
suppliers could remove themselves from
the scope of the proposed rule by
removing the handles from their
products. Because most Moses baskets
come with warnings against carrying an
infant in the basket, this would be a
reasonable change for suppliers to make.
As with manufacturers and importers,
all Moses basket suppliers within the
scope of the proposed rule will be
subject to third party testing and
certification requirements, and
consequently, they could experience
testing costs if their supplying firm(s)
does not perform third party testing.
Because Moses baskets would not be
subject to most of the mechanical tests
in the proposed standard, it is expected
that third party testing costs, at most,
will be half that of other types of handheld infant carriers, or approximately
$250–$500 per model sample. The
resulting costs could have a significant
impact on a few small firms that must
perform the testing themselves, even if
only one sample per model is required.
G. Alternatives
Under the Danny Keysar Child
Product Safety Notification Act, one
alternative that would reduce the
impact on small entities is to make the
voluntary standard mandatory with no
modifications. Doing so would
eliminate the impact on the four small
manufacturers with compliant products.
However, because of the number and
severity of the incidents associated with
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falls and restraints, staff does not
recommend this alternative.
A second alternative would be to set
an effective date later than the proposed
6 months, which is generally considered
sufficient time for suppliers to come
into compliance with a proposed rule.
Setting a later effective date would
allow suppliers additional time to
modify and/or develop compliant handheld infant carriers and spread the
associated costs over a longer period of
time.
The Commission invites comments
describing the possible impact of this
rule on manufacturers and importers, as
well as comments containing other
information describing how this rule
will affect small businesses.
IX. Environmental Considerations
The Commission’s regulations address
whether we are required to prepare an
environmental assessment or an
environmental impact statement. These
regulations provide a categorical
exclusion for certain CPSC actions that
normally have ‘‘little or no potential for
affecting the human environment.’’
Among those actions are rules or safety
standards for consumer products. 16
CFR 1021.5(c)(1). The proposed rule
falls within the categorical exclusion.
X. Paperwork Reduction Act
This proposed rule contains
information collection requirements that
are subject to public comment and
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). In this document, pursuant
to 44 U.S.C. 3507(a)(1)(D), we set forth:
• A title for the collection of
information;
• A summary of the collection of
information;
• A brief description of the need for
the information and the proposed use of
the information;
• A description of the likely
respondents and proposed frequency of
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response to the collection of
information;
• An estimate of the burden that shall
result from the collection of
information; and
• Notice that comments may be
submitted to the OMB.
Title: Safety Standard for Hand-Held
Infant Carriers.
Description: The proposed rule would
require each hand-held infant carrier to
comply with ASTM F2050–12, Standard
Consumer Safety Specification for
Hand-Held Infant Carriers. Sections of
ASTM F2050–12 contain requirements
for marking, labeling, and instructional
literature. These requirements fall
within the definition of ‘‘collection of
information,’’ as defined in 44 U.S.C.
3502(3).
Description of Respondents: Persons
who manufacture or import hand-held
infant carriers.
Estimated Burden: We estimate the
burden of this collection of information
as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
Number of
respondents
Frequency of
responses
Total annual
responses
Hours per
response
Total burden
hours
1221 .....................................................................................
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16 CFR Section
43
4
172
1
172
Our estimates are based on the
following:
Section 8.1 of ASTM F 2050–12
requires that the name of the
manufacturer, distributor, or seller, and
either the place of business (city, state,
and mailing address, including zip
code) or telephone number, or both, to
be marked clearly and legibly on each
product and its retail package. Section
8.2 of ASTM F 2050–12 requires a code
mark or other means that identifies the
date (month and year, as a minimum) of
manufacture.
There are 43 known entities
supplying hand-held infant carriers to
the U.S. market. All 43 firms are
assumed to use labels already on both
their products and their packaging, but
they might need to make some
modifications to their existing labels.
The estimated time required to make
these modifications is about 1 hour per
model. Each entity supplies an average
of four different models of hand-held
infant carriers; therefore, the estimated
burden associated with labels is 1 hour
per model × 43 entities × 4 models per
entity = 172 hours. We estimate the
hourly compensation for the time
required to create and update labels is
$27.55 (U.S. Bureau of Labor Statistics,
‘‘Employer Costs for Employee
Compensation,’’ March 2012, Table 9,
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total compensation for all sales and
office workers in goods-producing
private industries: https://www.bls.gov/
ncs/). Therefore, the estimated annual
cost to industry associated with the
labeling requirements is $4,738.60
($27.55 per hour × 172 hours =
$4,738.60). There are no operating,
maintenance, or capital costs associated
with the collection.
Section 9.1 of ASTM F2050–12
requires instructions to be supplied
with the product. Hand-held infant
carriers are products that generally
require installation or assembly, and
products sold without such information
would not be able to compete
successfully with products supplying
this information. Under the OMB’s
regulations (5 CFR 1320.3(b)(2)), the
time, effort, and financial resources
necessary to comply with a collection of
information that would be incurred by
persons in the ‘‘normal course of their
activities’’ are excluded from a burden
estimate, where an agency demonstrates
that the disclosure activities required to
comply are ‘‘usual and customary.’’
Therefore, because we are unaware of
hand-held infant carriers that generally
require installation or some assembly
but lack any instructions to the user
about such installation or assembly, we
estimate tentatively that there are no
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burden hours associated with section
9.1 of ASTM F 2050–12 because any
burden associated with supplying
instructions with hand-held infant
carriers would be ‘‘usual and
customary’’ and not within the
definition of ‘‘burden’’ under the OMB’s
regulations.
Based on this analysis, the proposed
standard for hand-held infant carriers
would impose a burden to industry of
172 hours at a cost of $4,728.60
annually.
In compliance with the PRA (44
U.S.C. 3507(d)), we have submitted the
information collection requirements of
this rule to the OMB for review.
Interested persons are requested to
submit comments regarding information
collection by January 9, 2013, to the
Office of Information and Regulatory
Affairs, OMB (see the ADDRESSES section
at the beginning of this notice).
Pursuant to 44 U.S.C. 3506(c)(2)(A),
we invite comments on:
• Whether the collection of
information is necessary for the proper
performance of the CPSC’s functions,
including whether the information will
have practical utility;
• The accuracy of the CPSC’s estimate
of the burden of the proposed collection
of information, including the validity of
the methodology and assumptions used;
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• Ways to enhance the quality, utility,
and clarity of the information to be
collected;
• Ways to reduce the burden of the
collection of information on
respondents, including the use of
automated collection techniques, when
appropriate, and other forms of
information technology; and
• The estimated burden hours
associated with label modification,
including any alternative estimates.
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XI. Preemption
Section 26(a) of the CPSA, 15 U.S.C.
2075(a), provides that where a consumer
product safety standard is in effect and
applies to a product, no state or political
subdivision of a state may either
establish or continue in effect a
requirement dealing with the same risk
of injury unless the state requirement is
identical to the federal standard. Section
26(c) of the CPSA also provides that
states or political subdivisions of states
may apply to the Commission for an
exemption from this preemption under
certain circumstances. Section 104(b) of
the CPSIA refers to the rules to be
issued under that section as ‘‘consumer
product safety rules,’’ thus implying
that the preemptive effect of section
26(a) of the CPSA would apply.
Therefore, a rule issued under section
104 of the CPSIA will invoke the
preemptive effect of section 26(a) of the
CPSA when it becomes effective.
XII. Certification and Notice of
Requirements (NOR)
Section 14(a)(2) of the CPSA imposes
the requirement that children’s products
subject to a children’s product safety
rule under the CPSA, or to a similar
rule, ban, standard, or regulation under
any other act enforced by the
Commission, must be certified as
complying with all applicable CPSCenforced requirements. 15 U.S.C.
2063(a)(2). For children’s products, such
certification must be based on tests on
a sufficient number of samples by a
third party conformity assessment body
accredited by the Commission to test
according to the applicable
requirements. As discussed in section I
of this preamble, section 104(b)(1)(B) of
the CPSIA refers to standards issued
under this section as ‘‘consumer
product safety standards.’’ Accordingly,
a safety standard for hand-held infant
carriers issued under section 104 of the
CPSA is a consumer product safety rule
that is subject to the testing and
certification requirements of section 14
of the CPSA. Because hand-held infant
carriers are children’s products, they
must be tested by a third party
conformity assessment body whose
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accreditation has been accepted by the
CPSC. Notices of requirements (NORs)
provide the criteria and process for our
acceptance of accreditation of third
party conformity assessment bodies.
On May 24, 2012, the Commission
published in the Federal Register the
proposed rule, Requirements Pertaining
to Third Party Conformity Assessment
Bodies, 77 FR 331086, which, when
finalized, would establish the general
requirements and criteria concerning
testing laboratories. These include the
requirements and procedures for CPSC
acceptance of the accreditation of a
laboratory to test children’s products in
support of the certification required by
section 14(a)(2) of the CPSA. The
proposed rule, at 16 CFR part 1112,
Requirements Pertaining to Third Party
Conformity Assessment Bodies, lists the
children’s product safety rules for
which the CPSC has published NORs for
laboratories. In this document, the
Commission is proposing to amend the
list in 16 CFR part 1112, once that rule
becomes final, to include the hand-held
infant carrier standard, once finalized,
along with the other children’s product
safety rules for which the CPSC has
issued NORs.
Laboratories applying for acceptance
as a CPSC-accepted third party
conformity assessment body to test to
the new standard for hand-held infant
carriers would be required to meet the
third party conformity assessment body
accreditation requirements in 16 CFR
part 1112, Requirements Pertaining to
Third Party Conformity Assessment
Bodies, once that rule becomes final.
When a laboratory meets the
requirements as a CPSC-accepted third
party conformity assessment body, it
can apply to the CPSC to have 16 CFR
part 1225, Safety Standard for HandHeld Infant Carriers included in its
scope of accreditation of CPSC safety
rules listed for the laboratory on the
CPSC Web site at: https://www.cpsc.gov/
labsearch.
The final NOR will base the CPSC
laboratory accreditation requirements
on the performance standard set forth in
the final rule for the safety standard for
hand-held infant carriers and the test
methods incorporated within that
standard. The Commission may
recognize limited circumstances in
which the Commission will accept
certification based on product testing
conducted before the Commission’s
acceptance of accreditation of
laboratories for testing hand-held infant
carriers (also known as retrospective
testing) in the final NOR. The
Commission seeks comments on any
issues regarding the testing
requirements of the proposed rule for
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hand-held infant carriers and the
accompanying proposed NOR.
XIII. Request for Comments
This proposed rule begins a
rulemaking proceeding under section
104(b) of the CPSIA to issue a consumer
product safety standard for hand-held
carriers. We invite all interested persons
to submit comments on any aspect of
the proposed rule. Comments should be
submitted in accordance with the
instructions in the ADDRESSES section at
the beginning of this notice.
We specifically seek comments from
the public on whether Moses baskets
should be included in this safety
standard. If Moses baskets should be
included in this safety standard, does
the present definition cover Moses
baskets? And if the present definition
does not cover Moses baskets, how
should it be amended to cover them?
We also seek comment concerning the
surrogate used in the handle autolocking test. Specifically, the
Commission asks if the test cylinder
described in this preamble and in the
proposed rule is an appropriate
surrogate for a six-month old infant. Is
there another surrogate—in particular,
the infant hinge gauge—that is as likely
or more likely to identify those handheld infant carriers that pose the
hazards identified in the handle lock
test?
List of Subjects
16 CFR Part 1112
Administrative practice and
procedure, Audit, Consumer protection,
Reporting and recordkeeping
requirements, Third party conformity
assessment body.
16 CFR Part 1225
Consumer protection, Imports,
Incorporation by reference, Infants and
children, Labeling, Law enforcement,
and Toys.
Therefore, the Commission proposes
to amend Title 16 of the Code of Federal
Regulations to read as follows:
PART 1112—REQUIREMENTS
PERTAINING TO THIRD PARTY
CONFORMITY ASSESSMENT BODIES
1. The authority citation for part 1112
continues to read as follows:
Authority: Pub. L. 110–314, section 3, 122
Stat. 3016, 3017 (2008); 15 U.S.C. 2063.
2. Amend § 1112.15 by adding
paragraph (b)(35) to read as follows:
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§ 1112.15 When can a third party
conformity assessment body apply for
CPSC acceptance for a particular CPSC rule
and/or test method?
73365
(a) Except as provided in paragraph
(b) of this section, each hand-held infant
carrier must comply with all applicable
provisions of ASTM F 2050–12,
Standard Consumer Safety Specification
for Hand-Held Infant Carriers, approved
on July 1, 2012. The Director of the
Federal Register approves this
incorporation by reference in
accordance with 5 U.S.C. 552(a) and 1
CFR part 51. You may obtain a copy
from ASTM International, 100 Bar
Harbor Drive, P.O. Box 0700, West
Conshohocken, PA 19428; https://
www.astm.org. You may inspect a copy
at the Office of the Secretary, U.S.
Consumer Product Safety Commission,
Room 820, 4330 East West Highway,
Bethesda, MD 20814, telephone 301–
504–7923, or at the National Archives
and Records Administration (NARA).
For information on the availability of
this material at NARA, call 202–741–
6030, or go to: https://www.archives.gov/
federal_register/code_of_federal
regulations/ibr_locations.html.
(b) Comply with the ASTM F2050–12
standard with the following additions or
exclusions:
(1) In addition to complying with
section 2.3 Other References, comply
with the following:
(i) 2.3 Other References: Test
Cylinder A (see Fig. X)
(ii) [Reserved]
(2) Instead of complying with section
6.1.3 of ASTM F2050–12, comply with
the following:
(i) 6.1.3 The carry handle shall lock
in a position forward or rearward of the
manufacturer’s designated carry
position such that an unrestrained Test
Cylinder A (see Figure X) does not fall
out of the carrier when tested in
accordance with 7.1.2 through 7.1.4.
(ii) [Reserved]
(3) Instead of complying with section
7.1.1 of ASTM F2050–12, comply with
the following:
(i) 7.1.1 Without a dummy in the
carrier, secure the harness according to
the manufacturer’s instructions, and
adjusting so that the harness along its
entire exposed length contacts the
seating surface. Position Test Cylinder A
centrally against the backrest of the
carrier in such a way that the bottom
edge is in contact with the seat/back
junction line (see Figure Y).
(ii) [Reserved]
(4) Instead of complying with Section
8.3.2 of ASTM F2050–12, comply with
the following:
(i) 8.3.2 The warning statements
shall address the following except as
otherwise noted.
(ii) [Reserved]
(5) Instead of complying with section
8.3.2.3 of ASTM F2050–12, comply with
the following:
(i) 8.3.2.3 Strangulation Hazard:
(ii) 8.3.2.3.1 Carriers intended for
use as infant restraint devices in motor
vehicles shall contain the following
warning label. This label requires exact
language (including the use of bold font
and uppercase characters as depicted)
and a specific location:
(iii) 8.3.2.3.2 The area of the
pictogram is to be at least 1.09 in2 (706
mm2) while not exceeding the size of
the airbag warning pictogram in the
label required under FMVSS No. 213.
The message area in the label shall be
no less than 4.65 in2 (30 cm2), while not
exceeding the size of the airbag warning
message area in the label required under
FMVSS No. 213. The pictogram shall be
black with a red circle and slash on a
white background and green check
mark. The heading area shall be yellow
with the word ‘‘warning’’ and the alert
symbol in black. The warning label shall
be a separate and independent label
from the airbag warning label required
in FMVSS No. 213. The warning label
shall be permanently affixed to the outer
surface of the cushion or padding in or
adjacent to the area where a child’s head
would rest, so that the label is plainly
visible and easily readable.
(iv) 8.3.2.3.3 The following warning
is required only for carriers not
intended for use in a motor vehicle and
are not hand-held bassinets/cradles.
This warning requires exact language
(including the use of bold font and
uppercase characters as depicted):
*
*
*
*
*
(b)
(35) 16 CFR part 1225, Safety
Standard for Hand-Held Infant Carriers.
3. Add part 1225 to read as follows:
PART 1225—SAFETY STANDARD FOR
HAND-HELD INFANT CARRIERS
Sec.
1225.1 Scope.
1225.2 Requirements for hand-held infant
carriers.
Authority: The Consumer Product Safety
Improvement Act of 2008, Pub. L. 110–314,
§ 104, 122 Stat. 3016 (August 14, 2008).
§ 1225.1
Scope.
This part establishes a consumer
product safety standard for hand-held
infant carriers.
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§ 1225.2 Requirements for hand-held
infant carriers.
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included. In addition, the instructions
shall include the following statements:
(ii) [Reserved]
(7) In addition to Figure 2, use the
following:
Dated: December 3, 2012.
Todd A. Stevenson,
Secretary, Consumer Product Safety
Commission.
DEPARTMENT OF VETERANS
AFFAIRS
[FR Doc. 2012–29584 Filed 12–7–12; 8:45 am]
RIN 2900–AN89
adjudication regulations concerning
service-connection. This amendment is
necessary to act upon a report of the
National Academy of Sciences, Institute
of Medicine (IOM), Gulf War and
Health, Volume 7: Long-Term
Consequences of Traumatic Brain
Injury, regarding the association
between traumatic brain injury (TBI)
and five diagnosable illnesses. The
intended effect of this amendment is to
establish that if a veteran who has a
service-connected TBI also has one of
these diagnosable illnesses, then that
38 CFR Part 3
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BILLING CODE 6355–01–P
Secondary Service Connection for
Diagnosable Illnesses Associated With
Traumatic Brain Injury
Department of Veterans Affairs.
Proposed rule.
AGENCY:
ACTION:
The Department of Veterans
Affairs (VA) is amending its
SUMMARY:
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EP10DE12.008
warning statements in 8.3.2. For carriers
intended for use as infant restraint
devices in motor vehicles, the warning
statement contained in the warning
label depicted in 8.3.2.3 must also be
EP10DE12.007
(6) Instead of complying with section
9.1.1 of ASTM F2050–12, comply with
the following:
(i) 9.1.1 The instructions shall
contain statements, which address the
Agencies
[Federal Register Volume 77, Number 237 (Monday, December 10, 2012)]
[Proposed Rules]
[Pages 73354-73366]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-29584]
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Parts 1112 and 1225
[CPSC Docket No. CPSC-2012-0068]
RIN 3041-AD16
Safety Standard for Hand-Held Infant Carriers
AGENCY: Consumer Product Safety Commission.
ACTION: Notice of Proposed Rulemaking.
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SUMMARY: The Danny Keysar Child Product Safety Notification Act,
Section 104(b) of the Consumer Product Safety Improvement Act of 2008
(CPSIA) requires the United States Consumer Product Safety Commission
(Commission, CPSC, or we) to promulgate consumer product safety
standards for durable infant or toddler products. These standards are
to be ``substantially the same as'' applicable voluntary standards or
more stringent than the voluntary standard if the Commission concludes
that more stringent requirements would further reduce the risk of
injury associated with the product. The Commission is proposing a
safety standard for handheld infant carriers in response to the
direction under Section 104(b) of the CPSIA. The proposed rule would
incorporate ASTM F2050-12 by reference, with two modifications.
DATES: Submit comments by February 25, 2013.
ADDRESSES: Comments related to the Paperwork Reduction Act aspects of
the marking, labeling, and instructional literature of the proposed
rule should be directed to the Office of Information and Regulatory
Affairs, OMB, Attn: CPSC Desk Officer, Fax: 202-395-6974, or emailed to
mailed to: oira_submission@omb.eop.gov.
Other comments, identified by Docket No. CPSC-2012-0068, may be
submitted electronically or in writing:
Electronic Submissions: Submit electronic comments to the Federal
eRulemaking Portal at: https://www.regulations.gov. Follow the
instructions for submitting comments. To ensure timely processing of
comments, the Commission is no longer
[[Page 73355]]
directly accepting comments submitted by electronic mail (email),
except through www.regulations.gov. The Commission encourages you to
submit electronic comments by using the Federal eRulemaking Portal, as
described above.
Written Submissions: Submit written submissions in the following
way: Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions), preferably in five copies, to: Office of the Secretary,
Consumer Product Safety Commission, Room 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 rulemaking. All comments received may be
posted without change, including any personal identifiers, contact
information, or other personal information provided, to: https://www.regulations.gov. Do not submit confidential business information,
trade secret information, or other sensitive or protected information
that you do not want to be available to the public. 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, and insert the
docket number, CPSC 2012-0068, into the ``Search'' box, and follow the
prompts.
FOR FURTHER INFORMATION CONTACT: Patricia L. Edwards, Project Manager,
Directorate for Engineering Sciences, U.S. Consumer Product Safety
Commission, 5 Research Place, Rockville, MD 20850; email:
pedwards@cpsc.gov.
SUPPLEMENTARY INFORMATION:
I. Background and Statutory Authority
The CPSIA was enacted on August 14, 2008. Section 104(b) of the
CPSIA, part of the Danny Keysar Child Product Safety Notification Act,
requires the Commission to promulgate consumer product safety standards
for durable infant or toddler products. These standards are to be
``substantially the same as'' applicable voluntary standards or more
stringent than the voluntary standard if the Commission concludes that
more stringent requirements would further reduce the risk of injury
associated with the product. The term ``durable infant or toddler
product'' is defined in section 104(f)(1) of the CPSIA as a durable
product intended for use, or that may be reasonably expected to be
used, by children under the age of 5 years. Infant carriers are one of
the products specifically identified in section 104(f)(2)(F) as a
durable infant or toddler product. At this time, the Commission has
identified four types of products that could fall within the infant
carrier product category, including: Frame backpack carriers, soft
infant and toddler carriers, slings, and handheld infant carriers. This
rule addresses hazards associated only with hand held infant carriers.
Hazards associated with other types of carriers would be addressed in
separate rulemaking proceedings.
In this document, the Commission proposes a safety standard for
hand held infant carriers. The proposed standard is based on the
voluntary standard developed by ASTM International (formerly the
American Society for Testing and Materials), ASTM F2050-12, ``Standard
Consumer Safety Specification for Hand-Held Infant Carriers.'' The ASTM
standard is copyrighted. However, by permission of ASTM, the standard
can be viewed as a read-only document during the comment period on this
proposal, at: https://www.astm.org.
II. The Product
A. Definition
ASTM F2050-12 defines a ``hand held infant carrier'' as a
``freestanding, rigid-sided product intended to carry an occupant whose
torso is completely supported by the product to facilitate
transportation by a caregiver by means of hand-holds or handles.'' The
current ASTM voluntary standard references two types of hand held
infant carriers: hand-held bassinets/cradles that incline 10 degrees or
less from horizontal and sit directly on the floor, and hand-held
carrier seats that incline more than 10 degrees from horizontal and are
often also used as attachments to serve as infant car seats, strollers,
or high chairs. The current ASTM voluntary standard defines ``hand-held
carrier seat'' as a ``hand-held infant carrier having a seat back that
is intended to be in a reclined position (more than 10[deg] from
horizontal),'' and ``hand-held bassinet/cradle'' is defined as ``
freestanding product, with a rest/support surface to facilitate sleep
(intended to be flat or up to 10[deg] from horizontal), that sits
directly on the floor, without legs or a stand, and has hand-holds or
handle(s) intended to allow carrying an occupant whose torso is
completely supported by the product.'' Some of the requirements in
F2050-12 are different for hand-held bassinets/cradles and hand-held
infant carriers because the intended position of the occupant (lying
supine vs. sitting reclined) and the product designs used to
accommodate the occupant can create different hazards. A Moses basket
is considered to be a freestanding product with a rest/support surface
to facilitate sleep and typically has hand-holds or handle(s) intended
to allow carrying an occupant. Moses baskets typically have semi-rigid
sides. The Commission seeks comments on whether Moses baskets are or
should be covered by this safety standard. The Commission specifically
seeks comments on (1) whether the definition of ``hand-held bassinet/
cradle'' in ASTM F2050-12 includes Moses baskets, and (2) if Moses
baskets are not covered by the safety standard but should be, how the
present definition should be amended to more clearly cover Moses
baskets.
B. The Market
Based on the 2005 survey conducted by American Baby Group titled,
``2006 Baby Products Tracking Study,'' and annual birth data from the
Centers for Disease Control and Prevention (CDC), we estimate that
approximately 2.1 million infant car seats are sold in the United
States each year. We do not know how many hand-held bassinets/cradles
are sold annually. Hand-held carrier seats and hand-held bassinets/
cradles are typically produced and/or marketed by juvenile product
manufacturers and distributors, except for Moses baskets, a unique type
of hand-held bassinet/cradle that is often marketed by bedding
manufacturers and distributors. We estimate there are currently at
least 43 suppliers of both types of hand-held infant carriers to the
U.S. market, 11 of which are domestic manufacturers and 10 of which are
domestic importers. We estimate that 20 firms supply Moses basket-style
hand-held bassinets/cradles only, but the source of these carriers is
unknown. There are also two foreign firms--a foreign manufacturer and
an importer that import products from foreign companies and distributes
them in the United States.
The products of 13 of the 43 hand-held infant carrier suppliers
will likely be compliant with ASTM F2050-12 (6 are Juvenile Products
Manufacturers Association (JPMA) certified to F2050-09; 3 claim
compliance with F2050; and 4 have JPMA-certified strollers with hand-
held infant carrier attachments).\1\
[[Page 73356]]
Of the remaining 30 firms supplying noncompliant hand-held infant
carriers, the majority (25 firms) supply products that are newly
covered due to the expanded scope of ASTM F2050-12 (20 supply Moses
baskets; 3 supply bassinet attachments for strollers; and 2 supply
other types of bassinet-style carriers) to include hand-held bassinets/
cradles.
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\1\ JPMAs typically allows 6 months for products in their
certification program to shift to a new standard once it is
published. ASTM F2050-12, The voluntary standard upon which the
proposed standard is based, will become effective for JPMA
certification purposes in approximately March 2013. Firms that
supply JPMA-certified strollers are expected to ensure that all of
their attachments, including hand-held infant carriers, comply with
all applicable ASTM standards as well.
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III. Incident Data
The CPSC's Directorate for Epidemiology notes that there have been
242 incidents, occurring between January 1, 2007 and June 7, 2012,
reported to the Commission regarding hand-held infant carriers. Of the
242 incidents, there were 36 fatalities, 60 nonfatal injuries, and 146
incidents where no injury occurred or was reported.
A. Fatalities
From January 1, 2007 through early June, 2012, there were 36
fatalities associated with hand-held infant carriers. The majority of
the fatalities are attributed to the improper use or non-use of the
carrier's restraint system.
Five of the fatalities were caused by the infant carrier being
placed in a hazardous environment, and therefore, these fatalities are
considered to be non-product related. Two of these fatalities occurred
when the infant carrier was placed atop a stove, which subsequently was
ignited accidently. Another fatality was attributed to hyperthermia
after an infant was left unattended in a carrier for an extended period
of time, wrapped in multiple blankets, and left in a room with
temperatures exceeding 90 degrees. In another of these five deaths, an
infant in a carrier that was placed cross-wise inside a bassinet was
able to tip the carrier into a reclined position, resulting in an
asphyxiation death. The last of these five fatalities was the result of
an infant suffocating on a blanket that was placed over his head while
in the carrier. For an additional two fatalities, the evidence is
insufficient to determine if there was any product involvement or the
presence of any hazardous external circumstances.
The remainder of the fatal incidents includes:
Nine children were strangled by the carrier's harness
chest clips or strap. In most of these incidents the infant was
partially restrained in the seat with only the shoulder straps in
place, with the crotch strap left unsecured, which allowed the infant
to slide forward in the seat far enough to get caught at the throat by
the chest clip that connects the two shoulder straps.
In one incident, the restraint straps were too tight and
impaired the infant's breathing, although no information regarding the
placement of the straps was provided.
Seven children were left unrestrained in the carrier and
found in a prone position, face down on the seat, or on a blanket,
covers, and/or pillow.
Two children who had been left unrestrained in the carrier
were found prone on the seat of the carrier, which had also tipped
over.
Three children were reported to have been trapped in an
overturned seat, although no information was provided about the use of
the restraints or how the seat overturned in these incidents.
One fatality resulted from a fall from a carrier that was
on a shopping cart but not equipped to attach to the cart.
Six additional deaths were associated with hand-held
carriers, but there was insufficient information to determine the
circumstances.
B. Nonfatal Injuries
From January 1, 2007 through early June 2012, 206 nonfatal
incidents were reported. Of those, 60 incidents involved an injury, and
2 of those required hospitalization due to serious head injuries
suffered from a fall from a carrier that was on top of a shopping cart.
Bumps, bruises, abrasions, lacerations, allergic reactions and near-
choking episodes are the most common injuries reported in the remaining
58 injury reports. No age was reported for 28 percent of the injury
incidents. For incidents where the age was reported, 1 child was
reported to be 13 months old, 1 was reported to be 23 months old, and
the rest were 12 months or younger. The remaining 146 incident reports
indicate that no injury occurred or they fail to provide any
information regarding injuries to the carrier occupant. However, many
of the descriptions of the incidents suggest the potential for serious
injury or death.
C. Recalls
There have been a total of three consumer-level recalls involving
hand-held carriers from January 1, 2007 through June 7, 2012.
One recall, involving 450,000 car seats/carriers manufactured from
December 2004 through September 2006, pertained to the carrier seat
handle. The carrier handle could release unexpectedly, causing the seat
to rotate forward in a manner that could result in the occupant of the
carrier falling to the ground and suffering serious injuries. There
were 679 incidents of the handle releasing unexpectedly, resulting in
160 injuries reported to the CPSC and the manufacturer. The recall
notice instructed consumers not to use the seat as a carrier until the
repair kit offered by the manufacturer had been obtained and installed.
(The modifications to the handle auto-lock test discussed in Section VI
would address this hazard.)
Another recall, conducted on December 18, 2009, involving 447,000
infant car seat/carriers manufactured from January 6, 2008 to April 6,
2009, also pertained to the carrier handle. The seat handle could
loosen and fall off, posing a fall hazard to the infant occupant of the
seat. There were 77 incidents of the child restraint handle fully or
partially detaching from the car seat/carrier, resulting in three
injuries, reported to the CPSC and the manufacturer. Consumers were
instructed not to use the seat as a carrier until they had obtained and
installed the repair kit offered by the manufacturer. (The carrying
handle integrity test included in ASTM F2050-12, addresses this
hazard).
The third recall was conducted on November 4, 2010, and it involved
23,000 infant car seats/carriers manufactured between April 2009 and
May 2010. The harness chest clips could break, posing a fall hazard,
and the broken pieces were small enough for an infant to swallow, which
posed a choking hazard. There were four incidents of the chest clip
breaking, resulting in three injuries reported to the CPSC and the
manufacturer. The injuries that resulted from the clip breaking were
minor lacerations and scratches to arms and a finger, and one report
involved an infant placing the broken clip in his mouth. The recall
notice instructed consumers to contact the manufacturer to request a
free repair kit. (The restraint system test included in ASTM F2050-12
addresses this hazard.)
IV. Hand-Held Carrier International Standards and the ASTM Voluntary
Standard
Section 104(b)(1)(A) of the CPSIA requires the Commission to
consult representatives of ``consumer groups, juvenile product
manufacturers, and independent child product engineers and experts'' to
``examine and assess the effectiveness of any voluntary consumer
product safety standards for durable infant or toddler products.'' As a
result of incidents and recalls of hand-held infant carriers in the
1990s, CPSC staff requested ASTM to develop voluntary requirements to
address the hazards
[[Page 73357]]
related to handle breakage and handle lock failures. Through the ASTM
process, we consulted with manufacturers, retailers, trade
organizations, laboratories, consumer advocacy groups, consultants, and
members of the public. The voluntary standard for hand-held infant
carriers was first approved and published in August 2000, as ASTM
F2050-00, Standard Consumer Safety Performance Specification for Hand-
Held Infant Carriers. It has been revised five times since then. The
current version, ASTM F2050-12, was approved on July 1, 2012.
In addition to reviewing the ASTM standard, we reviewed several
international standards.
A. International Standards
We identified one international standard, EN 12790, European/
British Standard for Child Care Articles--Reclined Cradles, which
addresses hand-held infant carriers in a manner similar to ASTM F2050-
12. However, reclined cradles are designed and intended for unattended
sleep, and the European standard includes requirements that also
pertain to that use pattern. One difference between EN 12790 and ASTM
F2050-12 is entrapment dimensions for holes and slot openings. The
European standard permits dimensions for slot openings to be between 7
mm and 12 mm, while ASTM F-2050-12 allows dimensions of 5 mm to 9.5 mm.
We have concluded that the existing dimensions in the ASTM standard are
anthropometrically appropriate and that there are no hazard patterns
that would warrant modification of these dimensions. In addition, we
concluded that the hazard patterns noted in the incidents do not
warrant modification of the ASTM standard to address the requirements
for flammability, surface chemicals, cords/ribbons, cradle angles, and
cradle strength/durability that appear in EN 12790. Finally, we note
that EN 12790 includes requirements for folding cradles, which is a use
pattern outside the scope of ASTM F2050-12.
We reviewed several other international standards and a National
Highway Safety Transportation Administration (NHTSA) standard that
address requirements for restraint systems of products when used in
motor vehicles, and we concluded that these standards do not address
the incident hazard patterns associated with hand-held infant carriers.
These standards are: ECE 44 (European Provision for Restraining Devices
for Child Occupants of Power-Driven Vehicles, JIS D 0401 (Japanese
Standard for Automotive Accessories--Child Restraints), AS/NZS
1754:2010 (Australian/New Zealand Standard for Child Restraint Systems
for Use in Motor Vehicles), and FMVSS No. 213 (NHSTA Requirements for
Child Restraint Systems Used in Motor Vehicles and Aircraft).
B. The ASTM Voluntary Standard
In response to incidents and recalls of hand-held infant carriers
in the 1990s related to handle breakage and handle lock failures, CPSC
requested ASTM to develop voluntary requirements to address the
hazards. CPSC staff participated in ASTM subcommittee meetings and
testing protocols in developing draft requirements. ASTM F 2050,
Standard Consumer Safety Performance Specification for Hand-Held Infant
Carriers was first approved and published in August 2000. ASTM has
revised the standard four times since then, with the most current
version ASTM F 2050-12, approved on July 1, 2012. Details regarding the
changes in the voluntary standard through revisions in October, 2001,
November, 2003, December, 2008, and October 2009, are provided at pages
30 and 31 of the November 7, 2012, Staff Briefing Package.
ASTM F2050-12 addresses many of the general hazards associated with
durable nursery products, such as lead in paints, sharp edges/sharp
points, small parts, wood part splinters, scissoring/shearing/pinching,
openings/entrapments, and toys. Specific requirements for labeling,
handle integrity, handle auto-locking, and restraint systems are also
included.
The key provisions of the current ASTM hand-held infant carrier
standard include: Definitions; general requirements; performance
requirements; specific test methods; and requirements for marking,
labeling, and instructional literature.
Definitions. ASTM F2050-12 defines ``hand-held infant carrier'' as
a ``free standing, rigid-sided product intended to carry an occupant
whose torso is completely supported by the product to facilitate
transportation by a caregiver by means of hand-holds or handles.'' The
definition of ``hand-held infant carrier seat'' is ``a hand-held infant
carrier having a seat back that is intended to be in a reclined
position (more than 10[deg] from horizontal).'' The definition of
``hand-held bassinet/cradle'' is a ``freestanding product, with a
horizontal rest/support surface to facilitate sleep (intended to be
flat or up to 10 from horizontal), which sits directly on the floor,
without legs or a stand, and has hand-holds or handle(s) intended to
allow carrying an occupant whose torso is completely supported by the
product.''
General Requirements. ASTM F2050-12 contains general requirements
that the product must meet, as well as mandated test methods that must
be used to ensure that the product meets those requirements, including:
Restrictions on sharp points, small parts, lead paint, and
wood parts;
Specifications to prevent scissoring, shearing, and
pinching;
Requirements for toy accessory items, and the non-removal
of protective components;
Specifications on openings (intended to prevent finger and
toe entrapment), labeling (intended to prevent labels from being
removed and ingested or aspirated on), and coil springs; and
Torque and tension tests for protective components.
Performance Requirements and Specific Test Methods. ASTM F2050-12
provides performance requirements that the product must meet, as well
as mandated test methods that must be used to ensure that the product
meets the performance requirement, including:
A carry handle auto-locking requirement (the carry handle
must move unaided into the designated carry position or move unaided
into a position that is obvious to the caregiver that the carry handle
is not in the designated carry position);
A carry handle integrity requirement (a rigid carry handle
that rotates in head-to-foot and foot-to-head directions must not break
or unlatch on either or both sides when subject to the handle endurance
test);
A restraint system requirement (hand held carrier seats
not intended for use in motor vehicles must have a waist and crotch
restraint while hand-held bassinets/cradles may not contain a restraint
system);
Slip-resistance requirements;
Marking, Labeling, and Instructional Literature. ASTM F2050-12 sets
forth requirements for marking, labeling, and instructions that must
accompany a hand-held carrier, including warnings regarding proper use
of restraint straps, placement of the carrier on soft or elevated
surfaces, and suffocation and strangulation hazards that may arise if
restraint straps are not used properly and suffocation hazards that can
arise when the carrier is placed on a soft surface. The warning label
also advises caregivers never to leave a child unattended in the
carrier. The standard also includes requirements and tests for the
permanency of labels and warnings.
[[Page 73358]]
V. Assessment of Voluntary Standard ASTM F2050-12
We considered the fatalities, injuries, and noninjury incidents
associated with hand-held carriers, and we evaluated the voluntary
standard to determine whether ASTM F2050-12 addresses the incidents or
whether more stringent standards are required that would further reduce
the risk of injury associated with these products. We discuss our
assessment in this section, but our assessment does not include deaths
and injuries associated with hand-held carriers where there was
insufficient evidence to determine the circumstances.
1. Hazardous Surroundings
Five of the 36 fatalities reported, and 12 of the 242 incidents
reported involving a hand-held carrier were attributable to unsafe
environments around the carrier. Two of the five fatalities resulted
when the carrier was placed on top of a stove that later was ignited.
In another of the fatalities, the infant died from hyperthermia after
being left unattended in a carrier, wrapped in blankets, in a room
where temperatures exceeded 90 degrees. In another fatality, the infant
was placed in the carrier cross-wise inside a bassinet and asphyxiated
when the carrier was tipped into a reclined position trapping the
infant between the carrier and the interior of the bassinet. The fifth
fatality was attributable to a suffocation in which a blanket was
placed over the infants head while in the carrier. Risks due to
hazardous surroundings are not attributable to the design or
construction of the hand-held carriers. ASTM F 2050-12 includes product
warnings that address the dangers of placing the product near the edges
of counter tops or on elevated surfaces, and the warnings direct
caregivers never to leave a child unattended in a carrier. We do not
believe there are additional requirements that can be put into place in
the standard to address this issue.
2. Hazards Related to Accessories
Issues related to accessories, such as toys, canopies, carrier seat
covers, and head and body support devices were reported in 28 of the
242 (12 percent) reported incidents. In 27 of these incidents, the
accessory was not supplied with the carrier, but was purchased
separately by a caregiver. In the remaining incident, the accessory was
an attached canopy. While there were no fatalities involving
accessories, the incidents reported included: Choking on a device
designed to attach a toy to the carrier handle; jamming an arm into the
side of toy; breathing obstruction from canopy drooping onto childs
face; and breaking and detaching small pieces from a pacifier and a
pacifier holder. The current standard precludes hazardous sharp edges
or points, as defined in 16 CFR 1500.48 and 1500.49 before and after
testing to the standard, and prohibits small parts, as defined in 16
CFR part 1501, before testing or liberated as a result of testing to
the standard. The standard also requires that any toy accessories
attached to, removable from, or sold with, an infant carrier, as well
as their means of attachment must meet the applicable requirements of
ASTM Consumer Safety Specification F963 (now CPSC's mandatory toy
standard). We believe that these requirements are sufficient to address
these hazards, and therefore we are not proposing any additional
requirements at this time.
3. Design Issues
Twenty-eight of the 242 incident reports (12 percent) are
attributed to the design of the carrier. Three of the incidents
reported in this category were fatalities. Design issues are related to
instability, sharp surfaces, unsafe infant posture when seated, and
structural integrity. Although the three reported fatalities involve a
child becoming trapped under an overturned seat, insufficient
information was provided in these reports to determine what caused the
seat to overturn. It is possible these tip overs could be related to
the stability of the carrier when placed on tables, sofas, or chairs.
However, there is insufficient incident data to support a conclusion
that design issues were the cause of the fatalities or other incidents.
Additionally, many carriers are designed to meet NHTSA requirements for
occupant crashworthiness, and modification of the carrier to improve
stability when used outside the vehicle might affect how the carrier
integrates into the carrier base in the vehicle. For these reasons, we
are not proposing any changes to address stability-related design
issues at this time.
In addition to stability, this hazard pattern includes occupant-
positioning incidents. Six consumer complaints involve infant head
slumping. However, we received no reports of fatalities or injuries
resulting from infant head slumping. Because we are aware of no
injuries resulting from this hazard, and because a revision of the
standard to address angle of seat incline may implicate issues within
NHTSA's jurisdiction, we are not proposing any changes to address angle
of seat incline at this time.
Three consumer complaints state that mothers do not always pay
appropriate attention to the way they swing carriers while an infant is
in the seat. The complaints suggest that this movement may place the
infant at risk for shaken baby syndrome. Because there are no injuries
reported in connection with this scenario, and because no revision of
the standard would likely address any potential risk of injury arising
from the way a caregiver swings the carrier, we are not proposing any
changes to address this issue at this time.
4. Falls From Shopping Carts
Incidents included one reported fatality and two reported injuries
involving children who fell from shopping carts on which the carriers
had been placed. The two injured children required hospitalization for
serious head injuries suffered when they fell to the floor from a
carrier that had been placed on a shopping cart. The risk associated
with placing a child in a hand-held carrier on a shopping cart is
addressed by ASTM 2372-11a, Standard for Consumer Safety Performance
Specification for Shopping Carts, which was developed to address
injuries to children associated with falls from shopping carts. This
standard requires each shopping cart to have warning statements
instructing the user not to use a personal infant carrier but instead
to use the seat in the cart and to fasten the child securely into the
seat. In addition, the standard requires retailers to provide
additional safety information in the form of warning posters at the
point of use. The warning label pertaining to safe use recently was
revised and includes a pictogram concerning the use of hand-held
carriers in the cart. This new label is included in this latest
version, which was approved in January 2012. We do not believe that
there are additional requirements that can be put in place in either
ASTM 2372-11a or ASTM F2050-12 to address this issue.
5. Fabric Issues
In 15 of the 242 (6 percent) reported incidents, the injury related
to the carrier fabric or padding. Incidents related to fabric include:
allergic reactions to padding or items attached to padding; bruising
from fabric stitching; and ingesting padding foam. This hazard pattern
is not specific to this product. Because similar incidents occur with
other durable products and are expected with any product with fabric or
padding, we are not proposing any additional requirements to address
fabric issues at this time.
[[Page 73359]]
6. Other Product-Related Concerns
In 10 of the 242 (4 percent) reported incidents, we were unable to
identify a specific hazard pattern because insufficient information
regarding the circumstances of the incident was provided. Six of these
incidents resulted in fatalities. Most of these reports indicate
possible improper use of the carrier or another contributing factor,
such as soft bedding. For example, one case involves an infant sleeping
in the carrier with a blanket or covering that may have resulted in
suffocation. However, because we are unable to identify a specific
hazard pattern in incidents with insufficient information, we are not
proposing additional requirements at this time.
7. Other Unknown Issues
Two fatalities could not be attributed to design or performance of
the hand-held carrier. We are in the process of investigating both
deaths, and once these investigations are complete, further review by
CPSC staff will be warranted to determine if the design or construction
of the hand-held carrier contributed to the deaths. If we conclude that
the design or construction of the hand-held carrier contributed to
either of these deaths, we will determine whether additional
requirements are necessary. Because the involvement of the product in
these incidents is unclear, we cannot propose additional requirements
in the absence of information supporting the conclusion that these two
incidents were attributed to the design or performance of the hand-held
carrier.
VI. Description of Proposed Changes to ASTM Standard
The proposed rule would create a new part 1225 titled, ``Safety
Standard for Hand Held Carriers.'' The proposed rule would establish
ASTM F2050-12, ``Standard Consumer Safety Specification for Hand-Held
Infant Carriers,'' as a consumer product safety standard, but with
certain changes. We are proposing two changes to ASTM F2050-12. One
change would add a strangulation warning label to be affixed to the
outer surface of the cushion or padding of a hand-held carrier seat in
or adjacent to the area where the childs head would rest. The warning
label for hand-held carrier seats that are intended to be used as
restraints in motor vehicles would include a pictogram, while the
warning label for hand-held carrier seats not intended to be used as
restraints in motor vehicles would not include the pictogram because
these seats do not have the chest clips depicted in the pictogram.
The other change would affect the test method for ensuring that the
carrier will not rotate and spill an unrestrained infant when a
caregiver picks up the carrier and the handle is not locked in the
carry position. The test method in ASTM F2050-12 requires the tester to
use a standard CAMI, Mark II 6-month infant dummy as an infant
surrogate. The proposed change would require the tester to use an
aluminum cylinder designed as a surrogate for a 6-month old infant, in
lieu of the CAMI dummy, because the CAMI dummy could be wedged into the
seat padding or otherwise manipulated, such that it does not fall out
during the lift test when it otherwise should fall. Further, the
ability to pass or fail the test based on friction or placement of the
CAMI affects the consistency and repeatability of the test results.
We describe these proposed changes in the following section.
A. Improper Restraint Usage
Incorrect use or nonuse of the harness straps were involved in 81
of the 242 reported incidents and resulted in 19 of the 36 fatalities
related to hand-held carriers from January 1, 2007 to early June 2012.
Among these 19 fatalities, nine strangulation incidents occurred due to
loose or partially buckled harness straps. In six of the fatalities
involving nonuse or improper use of harness straps, the child strangled
on the chest clips, while in two incidents children strangled on loose
straps. In seven incidents, children who were not restrained in the
carrier moved themselves into a compromising position, resulting in
asphyxia. Two fatalities occurred when unrestrained infants became
trapped under an overturned carrier. In one fatality, straps that were
too tight impaired the child's breathing while in the other, it is
unclear how the harness strap contributed to the child's death.
ASTM F2050-12 includes product warnings that address the dangers of
leaving a child unattended in the carrier, leaving a child in a carrier
with loose or unfastened harness straps, and putting the carrier on a
soft surface where it can roll over and suffocate a child. The warnings
are required to be `conspicuous,' i.e., visible when the carrier is in
the recommended use position to a person standing near the infant
carrier in any one position around the carrier but not necessarily
visible from all positions. This warning statement attempts to address
suffocation, strangulation, and fall hazards. However, a caregiver may
not encounter the label during regular use of the carrier.
We propose a new strangulation warning label, placed where a
caregiver is expected to notice it during regular interaction with the
carrier and the infant, which includes a pictogram depicting proper and
improper harness use and that states: `WARNING- Children have STRANGLED
in loose or partially buckled harness straps. Fully restrain the child
even when carrier is used outside the vehicle.' An ASTM task group,
with the assistance of CPSC staff, developed several different
pictorial symbols that were presented to an audience of 159 people.
More than 95 percent of the participants who reviewed the recommended
pictogram interpreted it correctly. We believe the warning label with
the pictogram will improve noticeability and comprehension of the risk.
B. Handle Issues
Handles breaking, detaching, or failing to lock in the carry
position were reported in 55 of the 242 incidents. Some of these
incidents resulted in injuries, such as a lacerated lip, bruises, and a
cranial hemorrhage, when the carrier and/or the child fell to the
ground. We believe that many of the incidents attributable to the
failure of the handle to lock are the result of the handle appearing to
be in a locked position when the caregiver lifts the carrier. We
believe that the incidents in which the handle itself breaks or
detaches from the carrier are attributable to manufacturing or assembly
errors.
The current voluntary standard contains a handle preconditioning
cycle test, followed by a static hang test, to assess handle lock
stability and integrity. The handle lock impact test is designed to
test the handle and handle lock integrity to reduce the number of fall
injuries. This test is conducted at the conclusion of the static hang
test and consists of dropping a hanging weight at the end of the
carrier. The hanging weight simulates dynamic loads placed on the
handle and handle lock while a caregiver walks with an infant in the
carrier.
The handle auto-lock test helps ensure that when a caregiver picks
up the carrier with the handle out of the locked position, the carrier
will not rotate and spill an unrestrained infant. This is accomplished
by requiring the carrier handle to have an auto-lock feature, or, when
not locked in the carry position, to fall to a position so it is
obvious to the caregiver that the handle is not in the carry position.
If neither condition is met, then the handle must lock into the carry
position or another
[[Page 73360]]
position, such that when the carrier is lifted by the handle, the
infant will not fall out.
The existing handle auto-lock test uses a standard CAMI, Mark II 6-
month infant dummy during the lift test. When we tested one carrier,
the CAMI became wedged into the seat padding in such a way that the
CAMI did not fall out during the lift test when an unrestrained infant
in this position likely would fall from the carrier. We also found that
CAMI placement in the carrier could be manipulated to achieve the
desired results. For example, placing a CAMI with its back high in the
seat makes the carrier more likely to pass the test, while placing a
CAMI lower in the seat may make the carrier more likely to fail. Thus,
friction or the placement of the CAMI affects the consistency and
repeatability of the test.
To resolve these CAMI-related test issues, we conducted the auto-
lock test using an aluminum cylinder designed as a surrogate for a 6-
month-old infant in lieu of the CAMI dummy. This change resulted in
consistent test results because the cylinder does not wedge into the
carrier padding like the CAMI dummy, and placement of the cylinder is
less likely to affect the outcome of the test.
We propose modifying ASTM F2050 to require conducting the auto-lock
test with the surrogate cylinder instead of the infant CAMI dummy. The
surrogate cylinder is modeled from the torso of a 6-month-old child,
and it is also used in the bassinet segmented mattress test we recently
proposed in the NPR for bassinets and cradles. 77 FR 64055. Further, EN
12790 European/British Standard for Child Care Articles--Reclined
Cradles, uses a similar cylinder to conduct their tip test for the same
products.
VII. Effective Date
The Administrative Procedure Act (APA) generally requires that the
effective date of a rule be at least 30 days after publication of the
final rule. 5 U.S.C. 553(d). To allow time for hand-held carriers to
come into compliance, we propose that the standard become effective 6
months after publication of the final rule in the Federal Register. We
invite comment on how long it will take manufacturers to come into
compliance.
VIII. Regulatory Flexibility Act
A. Introduction
The Regulatory Flexibility Act (RFA), 5 U.S.C. 601-612, requires
agencies to consider the impact of proposed rules on small entities,
including small businesses. Section 603 of the RFA requires that the
Commission prepare an initial regulatory flexibility analysis and make
it available to the public for comment when the notice of proposed
rulemaking is published. The initial regulatory flexibility analysis
(IRFA) must describe the impact of the proposed rule on small entities
and identify any alternatives that may reduce the impact. Specifically,
the IRFA must contain:
A description of, and where feasible, an estimate of the
number of small entities to which the proposed rule will apply;
A description of the reasons why action by the agency is
being considered;
A succinct statement of the objectives of, and legal basis
for, the proposed rule;
A description of the projected reporting, recordkeeping,
and other compliance requirements of the proposed rule, including an
estimate of the classes of small entities subject to the requirements,
and the type of professional skills necessary for the preparation of
reports or records; and
An identification, to the extent possible, of all relevant
federal rules that may duplicate, overlap, or conflict with the
proposed rule.
B. The Market
The majority of hand-held infant carriers are produced and/or
marketed by juvenile product manufacturers and distributors. A
potential exception is the Moses basket (whose inclusion in the scope
as a type of hand-held bassinet or cradle is under consideration by the
Commission), which are often marketed by bedding manufacturers and
distributors. The Commission estimates that currently, there are at
least 43 suppliers of hand-held infant carriers to the U.S. market.
Eleven are domestic manufacturers, and 10 are domestic importers. There
are also two foreign firms--a foreign manufacturer and an importer that
imports products from foreign companies and distributes them from
outside of the United States. An additional 20 domestic firms supply
Moses basket bedding, along with Moses baskets, whose source is
unknown.
Hand-held infant carriers from six of the 43 firms have been
certified as compliant with ASTM F2050 by the JPMA, the major U.S.
trade association that represents juvenile product manufacturers and
importers. Three firms claim compliance with F2050; and four have JPMA-
certified strollers with hand-held infant carrier attachments. It is
assumed that the hand-held infant carriers supplied by all 13 of these
firms will be in compliance with the voluntary standard. Of the
remaining 30 firms supplying noncompliant hand-held infant carriers,
the majority (25 firms) supply products that are newly covered due to
the expanded scope of ASTM F2050-12 (20 supply Moses baskets, 3 supply
bassinet attachments for strollers, and 2 supply other types of
bassinet-style carriers).
The market data available is limited to infant car seats, which
represented nearly the entire hand-held infant carrier market under
prior versions of ASTM F2050. According to a 2005 survey conducted by
the American Baby Group (2006 Baby Products Tracking Study), 68 percent
of new mothers own infant car seats. Approximately 25 percent of infant
car seats were handed down or purchased secondhand. Thus, about 75
percent of infant car seats were acquired new. This suggests annual
sales of about 2.1 million infant car seats (.68 x .75 x 4.1 million
births per year).\2\ These 2.1 million infant car seats represent the
minimum number of units sold per year that might be affected by the
proposed handheld infant carrier standard. It is unknown how many Moses
baskets and other bassinet/cradle-style carriers are sold annually.
---------------------------------------------------------------------------
\2\ U.S. Department of Health and Human Services, Centers for
Disease Control and Prevention (CDC), National Center for Health
Statistics, National Vital Statistics System, ``Births: Final Data
for 2009,'' National Vital Statistics Reports Volume 60, Number 1
(November 2011): Table I. Number of births in 2009 is rounded from
4,130,665.
---------------------------------------------------------------------------
C. Reason for Agency Action and Legal Basis for Proposed Rule
The Danny Keysar Child Product Safety Notification Act, section 104
of the CPSIA, requires the CPSC to promulgate a mandatory standard for
hand-held infant carriers that is substantially the same as, or more
stringent than, the voluntary standard. CPSC worked closely with ASTM
to develop the new requirements and test procedures that have been
added to the voluntary standard since 2010. These new requirements
address several known hazard patterns and will help to reduce injuries
and deaths in hand-held carriers, and they have resulted in the current
voluntary standard, F2050-12, upon which the proposed rule is based.
However, the Commission proposes adding one new requirement to
F2050-12, as well as modifying the methodology for the existing handle
auto-lock test. The new requirement would mandate a new warning label,
as described in Section VI (A), which addresses strangulation and
suffocation hazards that have occurred as a result of incorrect or
nonuse of harness straps. The modification proposed by the
[[Page 73361]]
Commission is that an aluminum cylinder, designed as a surrogate for a
6-month old infant, be used in lieu of the CAMI dummy in the handle
auto-lock test. This proposed change would result in consistent test
results because the cylinder does not wedge into the carrier padding
like the CAMI dummy, and placement of the cylinder is less likely to
affect the outcome of the test.
D. Requirements of the Proposed Rule
The Commission proposes adopting the voluntary ASTM standard for
hand-held infant carriers (F2050-12), with a new warning label
requirement, and a modification of the handle auto-lock test. Some of
the more significant requirements of the current voluntary standard for
hand-held infant carriers (ASTM F2050-12) are listed below:
Carry handle integrity--a series of endurance and
durability tests are intended to ensure that rigid, adjustable handles
do not break or unlock during use.
Carry handle auto-locking--intended to address incidents
that have occurred when the rigid, adjustable handles switched
positions unexpectedly.
Restraints--intended to minimize the fall hazard
associated with inclined hand-held carriers while simultaneously
minimizing the potential for injury or death in flat bassinet/cradle
products where restraints can pose a strangulation hazard.
Slip resistance--intended to prevent slipping when the
hand-held infant carrier is placed on a slightly inclined surface (10
degrees).
The voluntary standard also includes: (1) Torque and tension tests
to ensure that components cannot be removed; (2) requirements for
several hand-held infant carrier features to prevent entrapment and
cuts (minimum and maximum opening size, coverage of exposed coil
springs, small parts, hazardous sharp edges or points, smoothness of
wood parts, and edges that can scissor, shear, or pinch); (3) marking
and labeling requirements; (4) requirements for the permanency and
adhesion of labels; (5) requirements for instructional literature; and
(6) toy accessory requirements. ASTM F2050-12 includes no reporting or
recordkeeping requirements. The Commission proposes adding a new
warning label content and placement requirement and using the more
appropriate cylinder surrogate for the handle auto-lock testing.
The carry handle auto-locking requirement applies only to hand-held
infant carriers that are rigid, adjustable, rotate about a singular
axis, and lock into the manufacturer's designated carry position;
therefore, many suppliers, most notably Moses basket suppliers, would
not be affected. Several models of hand-held infant carriers with these
types of handles would be able to pass the revised test without
modifying their product(s). The simplest and most effective way to meet
the requirement is to add auto-lock positions close to the one intended
for use. This would prevent the handle from moving so far out of
position and spilling the child from the carrier. While redesign would
probably not be necessary, the hard tools used to manufacture the
handle's lock positions would need to be modified. These hard tools are
usually modified by an outside firm, which means that production would
cease and, unless the firm maintains an alternating production
schedule, could result in significant downtime for the firm's
production process.
The revised warning would change the size, location, wording, and
presentation to highlight better the dangers associated with only
partially buckling children into hand-held carriers. A pictogram is
included as part of the modified warning for hand-held carrier seats
intended to be used as restraints in motor vehicles. The warning would
be required on the product itself, as well as within the product's
instructional literature. Changes to warning labels are not expected to
have a significant impact on suppliers. Typically, warning labels that
are placed on fabric, such as the revised strangulation warning, are
less costly than those used on plastic or metal.
E. Other Federal or State Rules
The Commission is in the process of implementing sections 14(a)(2)
and 14(i)(2) of the Consumer Product Safety Act (CPSA), as amended by
the CPSIA. Section 14(a)(2) of the CPSA requires every manufacturer of
a children's product that is subject to a children's product safety
rule to certify, based on third party testing, that the product
complies with all applicable safety rules. Section 14(i)(2) of the CPSA
requires the Commission to establish protocols and standards (i) for
ensuring that a children's product is tested periodically and when
there has been a material change in the product, (ii) for the testing
of representative samples to ensure continued compliance, (iii) for
verifying that a product tested by a conformity assessment body
complies with applicable safety rules, and (iv) for safeguarding
against the exercise of undue influence on a conformity assessment body
by a manufacturer or private labeler.
Because hand-held infant carriers will be subject to a mandatory
standard, they will also be subject to the third party testing
requirements of section 14(a)(2) of the CPSA when the mandatory
standard and the notice of requirements become effective.
F. Impact of the Proposal on Small Business
There are approximately 43 firms currently known to be marketing
hand-held infant carriers in the United States. Under U.S. Small
Business Administration (SBA) guidelines, a manufacturer of hand-held
infant carriers is small if it has 500 or fewer employees, and
importers and wholesalers are considered small if they have 100 or
fewer employees. Based on these guidelines, 29 are small firms--6
domestic manufacturers, 4 domestic importers, and 19 firms supplying
Moses baskets whose supply source is unknown. The remaining firms are
five large domestic manufacturers, six large domestic importers, one
foreign manufacturer, one foreign importer, and one large firm
supplying Moses baskets from an unknown source. There may be additional
unknown small hand-held infant carrier suppliers operating in the U.S.
market.
Small Manufacturers. The expected impact on small manufacturers of
the proposed standard will differ based on whether their hand-held
infant carriers are already compliant with F2050-09. Firms whose hand-
held infant carriers meet the requirements of F2050-09 are likely to
continue to comply with the voluntary standard as new versions are
published. In addition, they are likely to meet any new standard within
6 months of approval because this is the amount of time JPMA allows for
products in their certification program to shift to a new standard.
Many of these firms are active in the ASTM standard development
process, and compliance with the voluntary standard is part of an
established business practice. Therefore, it is likely that firms
supplying hand-held infant carriers that comply with ASTM F2050-09
(which went into effect for JPMA certification purposes in April 2010)
would also likely comply with F2050-12 by March 2013, even in the
absence of a mandatory standard. It should be noted, however, that
because the scope of F2050-09 is more limited than the scope of F2050-
12, only firms supplying infant car seats would be expected to have
developed a pattern of compliance. However, staff believes that firms
that manufacture JPMA-certified strollers with attachments that can be
used separately as hand-held carriers will also meet ASTM F2050-12 by
[[Page 73362]]
March 2013; having developed a pattern of compliance for strollers,
they would likely choose to meet any related ASTM standards as well.
Given these considerations, it is unlikely that the direct impact
on manufacturers whose products are likely to meet the requirements of
ASTM F2050-12 (four of six small domestic manufacturers) will be
significant. Modifying warning labels and updating instructional
literature is a small cost for most firms. It is possible that one or
more firms might have to modify their carry handles to continue to pass
the auto-locking test, but this would most likely result in modifying
their hard tools to add locking positions, rather than a complete
product redesign.
Meeting ASTM F2050-12's requirements could necessitate product
redesign for at least some hand-held infant carriers not believed to be
compliant with F2050-09 (two of six small domestic manufacturers),
regardless of the proposed modifications. A redesign would be minor if
most of the changes involve adding straps and fasteners or using
different mesh or fabric, but the costs could be more significant if
changes to the frame are required, including changes to the handles.
Some firms have estimated product redesigns, including engineering
time, prototype development, tooling, and other incidental costs to
reach approximately $500,000. Consequently, the proposed rule could
potentially have a significant direct impact on small manufacturers
whose products do not conform to F2050-09. However, because most
products would probably not need to be completely redesigned, actual
costs are likely to be lower than the $500,000 level, and any direct
impact may be mitigated if costs are treated as new product expenses
that can be amortized.
It is possible that one or both of the firms whose hand-held infant
carriers are neither certified as compliant, nor claim compliance with
F2050-09, in fact, are compliant with the standard. The Commission has
identified many such cases with other products. To the extent that some
of these firms may supply compliant hand-held infant carriers and have
developed a pattern of compliance with the voluntary standard, the
direct impact of the proposed standard will be less significant than
described above.
In addition to the direct impact of the proposed standard described
above, there are indirect impacts. These impacts are considered
indirect because they do not arise directly as a consequence of the
hand-held infant carrier rule's requirements. Nonetheless, they could
be significant. Once the rule becomes final and the notice of
requirements is in effect, all manufacturers will be subject to the
additional costs associated with the third party testing and
certification requirements. This will include any physical and
mechanical test requirements specified in the final rule; lead and
phthalates testing is already required, and hence, it is not included
here.\3\
---------------------------------------------------------------------------
\3\ Hand-held infant carrier suppliers already must third party
test their products to the lead and phthalate requirements.
Therefore, these costs are left out of the analysis above.
---------------------------------------------------------------------------
Based on durable nursery product industry input and confidential
business information supplied for the development of the third party
testing rule, testing to the ASTM voluntary standard could cost $500-
$1,000 per model sample. Testing overseas could potentially reduce some
testing costs, but that may not always be practical.
On average, each small domestic manufacturer supplies two different
models of hand-held infant carriers to the U.S. market annually.
Therefore, if third party testing were conducted every year on a single
sample for each model, third party testing costs for each manufacturer
would be about $1,000-$2,000 annually. Based on a review of firm
revenues, the impact of third party testing to ASTM F2050-12 is
unlikely to be significant if only one hand-held infant carrier sample
per model is required. However, if more than one sample would be needed
to meet the testing requirements, it is possible that third party
testing costs could have a significant impact on one or more of the
small manufacturers.
Small Importers. Importers of hand-held infant carriers would need
to find an alternate source if their existing supplier does not come
into compliance with the requirements of the proposed rule, which may
be the case with all four small importers of hand-held infant carriers,
none of which is believed to be in compliance with F2050-09. Some could
respond to the rule by discontinuing the import of their noncomplying
hand-held infant carriers, possibly discontinuing the product line
altogether. However, the impact of such a decision could be mitigated
by replacing the noncompliant hand-held infant carriers with a
compliant alternative. Deciding to import an alternative product would
be a reasonable and realistic way to offset any lost revenue.
As is the case with manufacturers, all importers will be subject to
third party testing and certification requirements, and consequently,
will experience costs similar to those for manufacturers if their
supplying foreign firm(s) does not perform third party testing. The
resulting costs could have a significant impact on a few small
importers that must perform the testing themselves if more than one
sample per model is required.
Moses Basket Suppliers. There are 19 small firms supplying Moses
baskets to the U.S. market. Most of these firms also supply bedding;
some of them manufacture the bedding, while others act as importers.
The Commission has been unable to determine the source of the Moses
baskets themselves, although it is likely that most sellers purchase
them from other suppliers, either foreign or domestic. Because these
products are recent potential additions to the scope of ASTM F2050, it
is unlikely that any of them has been designed to comply with this
standard. However, it is possible that many might be able to comply
with the standard with minimal modifications. Moses baskets generally
do not use restraints, so the biggest changes might be the addition of
warnings and instructional literature. Alternatively, Moses basket
suppliers could remove themselves from the scope of the proposed rule
by removing the handles from their products. Because most Moses baskets
come with warnings against carrying an infant in the basket, this would
be a reasonable change for suppliers to make.
As with manufacturers and importers, all Moses basket suppliers
within the scope of the proposed rule will be subject to third party
testing and certification requirements, and consequently, they could
experience testing costs if their supplying firm(s) does not perform
third party testing. Because Moses baskets would not be subject to most
of the mechanical tests in the proposed standard, it is expected that
third party testing costs, at most, will be half that of other types of
hand-held infant carriers, or approximately $250-$500 per model sample.
The resulting costs could have a significant impact on a few small
firms that must perform the testing themselves, even if only one sample
per model is required.
G. Alternatives
Under the Danny Keysar Child Product Safety Notification Act, one
alternative that would reduce the impact on small entities is to make
the voluntary standard mandatory with no modifications. Doing so would
eliminate the impact on the four small manufacturers with compliant
products. However, because of the number and severity of the incidents
associated with
[[Page 73363]]
falls and restraints, staff does not recommend this alternative.
A second alternative would be to set an effective date later than
the proposed 6 months, which is generally considered sufficient time
for suppliers to come into compliance with a proposed rule. Setting a
later effective date would allow suppliers additional time to modify
and/or develop compliant hand-held infant carriers and spread the
associated costs over a longer period of time.
The Commission invites comments describing the possible impact of
this rule on manufacturers and importers, as well as comments
containing other information describing how this rule will affect small
businesses.
IX. Environmental Considerations
The Commission's regulations address whether we are required to
prepare an environmental assessment or an environmental impact
statement. These regulations provide a categorical exclusion for
certain CPSC actions that normally have ``little or no potential for
affecting the human environment.'' Among those actions are rules or
safety standards for consumer products. 16 CFR 1021.5(c)(1). The
proposed rule falls within the categorical exclusion.
X. Paperwork Reduction Act
This proposed rule contains information collection requirements
that are subject to public comment and review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3521). In this document, pursuant to 44 U.S.C.
3507(a)(1)(D), we set forth:
A title for the collection of information;
A summary of the collection of information;
A brief description of the need for the information and
the proposed use of the information;
A description of the likely respondents and proposed
frequency of response to the collection of information;
An estimate of the burden that shall result from the
collection of information; and
Notice that comments may be submitted to the OMB.
Title: Safety Standard for Hand-Held Infant Carriers.
Description: The proposed rule would require each hand-held infant
carrier to comply with ASTM F2050-12, Standard Consumer Safety
Specification for Hand-Held Infant Carriers. Sections of ASTM F2050-12
contain requirements for marking, labeling, and instructional
literature. These requirements fall within the definition of
``collection of information,'' as defined in 44 U.S.C. 3502(3).
Description of Respondents: Persons who manufacture or import hand-
held infant carriers.
Estimated Burden: We estimate the burden of this collection of
information as follows:
Table 1--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Frequency of Total annual Hours per Total burden
16 CFR Section respondents responses responses response hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
1221............................................................... 43 4 172 1 172
--------------------------------------------------------------------------------------------------------------------------------------------------------
Our estimates are based on the following:
Section 8.1 of ASTM F 2050-12 requires that the name of the
manufacturer, distributor, or seller, and either the place of business
(city, state, and mailing address, including zip code) or telephone
number, or both, to be marked clearly and legibly on each product and
its retail package. Section 8.2 of ASTM F 2050-12 requires a code mark
or other means that identifies the date (month and year, as a minimum)
of manufacture.
There are 43 known entities supplying hand-held infant carriers to
the U.S. market. All 43 firms are assumed to use labels already on both
their products and their packaging, but they might need to make some
modifications to their existing labels. The estimated time required to
make these modifications is about 1 hour per model. Each entity
supplies an average of four different models of hand-held infant
carriers; therefore, the estimated burden associated with labels is 1
hour per model x 43 entities x 4 models per entity = 172 hours. We
estimate the hourly compensation for the time required to create and
update labels is $27.55 (U.S. Bureau of Labor Statistics, ``Employer
Costs for Employee Compensation,'' March 2012, Table 9, total
compensation for all sales and office workers in goods-producing
private industries: https://www.bls.gov/ncs/). Therefore, the estimated
annual cost to industry associated with the labeling requirements is
$4,738.60 ($27.55 per hour x 172 hours = $4,738.60). There are no
operating, maintenance, or capital costs associated with the
collection.
Section 9.1 of ASTM F2050-12 requires instructions to be supplied
with the product. Hand-held infant carriers are products that generally
require installation or assembly, and products sold without such
information would not be able to compete successfully with products
supplying this information. Under the OMB's regulations (5 CFR
1320.3(b)(2)), the time, effort, and financial resources necessary to
comply with a collection of information that would be incurred by
persons in the ``normal course of their activities'' are excluded from
a burden estimate, where an agency demonstrates that the disclosure
activities required to comply are ``usual and customary.'' Therefore,
because we are unaware of hand-held infant carriers that generally
require installation or some assembly but lack any instructions to the
user about such installation or assembly, we estimate tentatively that
there are no burden hours associated with section 9.1 of ASTM F 2050-12
because any burden associated with supplying instructions with hand-
held infant carriers would be ``usual and customary'' and not within
the definition of ``burden'' under the OMB's regulations.
Based on this analysis, the proposed standard for hand-held infant
carriers would impose a burden to industry of 172 hours at a cost of
$4,728.60 annually.
In compliance with the PRA (44 U.S.C. 3507(d)), we have submitted
the information collection requirements of this rule to the OMB for
review. Interested persons are requested to submit comments regarding
information collection by January 9, 2013, to the Office of Information
and Regulatory Affairs, OMB (see the ADDRESSES section at the beginning
of this notice).
Pursuant to 44 U.S.C. 3506(c)(2)(A), we invite comments on:
Whether the collection of information is necessary for the
proper performance of the CPSC's functions, including whether the
information will have practical utility;
The accuracy of the CPSC's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used;
[[Page 73364]]
Ways to enhance the quality, utility, and clarity of the
information to be collected;
Ways to reduce the burden of the collection of information
on respondents, including the use of automated collection techniques,
when appropriate, and other forms of information technology; and
The estimated burden hours associated with label
modification, including any alternative estimates.
XI. Preemption
Section 26(a) of the CPSA, 15 U.S.C. 2075(a), provides that where a
consumer product safety standard is in effect and applies to a product,
no state or political subdivision of a state may either establish or
continue in effect a requirement dealing with the same risk of injury
unless the state requirement is identical to the federal standard.
Section 26(c) of the CPSA also provides that states or political
subdivisions of states may apply to the Commission for an exemption
from this preemption under certain circumstances. Section 104(b) of the
CPSIA refers to the rules to be issued under that section as ``consumer
product safety rules,'' thus implying that the preemptive effect of
section 26(a) of the CPSA would apply. Therefore, a rule issued under
section 104 of the CPSIA will invoke the preemptive effect of section
26(a) of the CPSA when it becomes effective.
XII. Certification and Notice of Requirements (NOR)
Section 14(a)(2) of the CPSA imposes the requirement that
children's products subject to a children's product safety rule under
the CPSA, or to a similar rule, ban, standard, or regulation under any
other act enforced by the Commission, must be certified as complying
with all applicable CPSC-enforced requirements. 15 U.S.C. 2063(a)(2).
For children's products, such certification must be based on tests on a
sufficient number of samples by a third party conformity assessment
body accredited by the Commission to test according to the applicable
requirements. As discussed in section I of this preamble, section
104(b)(1)(B) of the CPSIA refers to standards issued under this section
as ``consumer product safety standards.'' Accordingly, a safety
standard for hand-held infant carriers issued under section 104 of the
CPSA is a consumer product safety rule that is subject to the testing
and certification requirements of section 14 of the CPSA. Because hand-
held infant carriers are children's products, they must be tested by a
third party conformity assessment body whose accreditation has been
accepted by the CPSC. Notices of requirements (NORs) provide the
criteria and process for our acceptance of accreditation of third party
conformity assessment bodies.
On May 24, 2012, the Commission published in the Federal Register
the proposed rule, Requirements Pertaining to Third Party Conformity
Assessment Bodies, 77 FR 331086, which, when finalized, would establish
the general requirements and criteria concerning testing laboratories.
These include the requirements and procedures for CPSC acceptance of
the accreditation of a laboratory to test children's products in
support of the certification required by section 14(a)(2) of the CPSA.
The proposed rule, at 16 CFR part 1112, Requirements Pertaining to
Third Party Conformity Assessment Bodies, lists the children's product
safety rules for which the CPSC has published NORs for laboratories. In
this document, the Commission is proposing to amend the list in 16 CFR
part 1112, once that rule becomes final, to include the hand-held
infant carrier standard, once finalized, along with the other
children's product safety rules for which the CPSC has issued NORs.
Laboratories applying for acceptance as a CPSC-accepted third party
conformity assessment body to test to the new standard for hand-held
infant carriers would be required to meet the third party conformity
assessment body accreditation requirements in 16 CFR part 1112,
Requirements Pertaining to Third Party Conformity Assessment Bodies,
once that rule becomes final. When a laboratory meets the requirements
as a CPSC-accepted third party conformity assessment body, it can apply
to the CPSC to have 16 CFR part 1225, Safety Standard for Hand-Held
Infant Carriers included in its scope of accreditation of CPSC safety
rules listed for the laboratory on the CPSC Web site at: https://www.cpsc.gov/labsearch.
The final NOR will base the CPSC laboratory accreditation
requirements on the performance standard set forth in the final rule
for the safety standard for hand-held infant carriers and the test
methods incorporated within that standard. The Commission may recognize
limited circumstances in which the Commission will accept certification
based on product testing conducted before the Commission's acceptance
of accreditation of laboratories for testing hand-held infant carriers
(also known as retrospective testing) in the final NOR. The Commission
seeks comments on any issues regarding the testing requirements of the
proposed rule for hand-held infant carriers and the accompanying
proposed NOR.
XIII. Request for Comments
This proposed rule begins a rulemaking proceeding under section
104(b) of the CPSIA to issue a consumer product safety standard for
hand-held carriers. We invite all interested persons to submit comments
on any aspect of the proposed rule. Comments should be submitted in
accordance with the instructions in the ADDRESSES section at the
beginning of this notice.
We specifically seek comments from the public on whether Moses
baskets should be included in this safety standard. If Moses baskets
should be included in this safety standard, does the present definition
cover Moses baskets? And if the present definition does not cover Moses
baskets, how should it be amended to cover them?
We also seek comment concerning the surrogate used in the handle
auto-locking test. Specifically, the Commission asks if the test
cylinder described in this preamble and in the proposed rule is an
appropriate surrogate for a six-month old infant. Is there another
surrogate--in particular, the infant hinge gauge--that is as likely or
more likely to identify those hand-held infant carriers that pose the
hazards identified in the handle lock test?
List of Subjects
16 CFR Part 1112
Administrative practice and procedure, Audit, Consumer protection,
Reporting and recordkeeping requirements, Third party conformity
assessment body.
16 CFR Part 1225
Consumer protection, Imports, Incorporation by reference, Infants
and children, Labeling, Law enforcement, and Toys.
Therefore, the Commission proposes to amend Title 16 of the Code of
Federal Regulations to read as follows:
PART 1112--REQUIREMENTS PERTAINING TO THIRD PARTY CONFORMITY
ASSESSMENT BODIES
1. The authority citation for part 1112 continues to read as
follows:
Authority: Pub. L. 110-314, section 3, 122 Stat. 3016, 3017
(2008); 15 U.S.C. 2063.
2. Amend Sec. 1112.15 by adding paragraph (b)(35) to read as
follows:
[[Page 73365]]
Sec. 1112.15 When can a third party conformity assessment body apply
for CPSC acceptance for a particular CPSC rule and/or test method?
* * * * *
(b)
(35) 16 CFR part 1225, Safety Standard for Hand-Held Infant
Carriers.
3. Add part 1225 to read as follows:
PART 1225--SAFETY STANDARD FOR HAND-HELD INFANT CARRIERS
Sec.
1225.1 Scope.
1225.2 Requirements for hand-held infant carriers.
Authority: The Consumer Product Safety Improvement Act of 2008,
Pub. L. 110-314, Sec. 104, 122 Stat. 3016 (August 14, 2008).
Sec. 1225.1 Scope.
This part establishes a consumer product safety standard for hand-
held infant carriers.
Sec. 1225.2 Requirements for hand-held infant carriers.
(a) Except as provided in paragraph (b) of this section, each hand-
held infant carrier must comply with all applicable provisions of ASTM
F 2050-12, Standard Consumer Safety Specification for Hand-Held Infant
Carriers, approved on July 1, 2012. The Director of the Federal
Register approves this incorporation by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy from ASTM
International, 100 Bar Harbor Drive, P.O. Box 0700, West Conshohocken,
PA 19428; https://www.astm.org. You may inspect a copy at the Office of
the Secretary, U.S. Consumer Product Safety Commission, Room 820, 4330
East West Highway, Bethesda, MD 20814, telephone 301-504-7923, or at
the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: https://www.archives.gov/federal_register/code_of_federal regulations/ibr_locations.html.
(b) Comply with the ASTM F2050-12 standard with the following
additions or exclusions:
(1) In addition to complying with section 2.3 Other References,
comply with the following:
(i) 2.3 Other References: Test Cylinder A (see Fig. X)
(ii) [Reserved]
(2) Instead of complying with section 6.1.3 of ASTM F2050-12,
comply with the following:
(i) 6.1.3 The carry handle shall lock in a position forward or
rearward of the manufacturer's designated carry position such that an
unrestrained Test Cylinder A (see Figure X) does not fall out of the
carrier when tested in accordance with 7.1.2 through 7.1.4.
(ii) [Reserved]
(3) Instead of complying with section 7.1.1 of ASTM F2050-12,
comply with the following:
(i) 7.1.1 Without a dummy in the carrier, secure the harness
according to the manufacturer's instructions, and adjusting so that the
harness along its entire exposed length contacts the seating surface.
Position Test Cylinder A centrally against the backrest of the carrier
in such a way that the bottom edge is in contact with the seat/back
junction line (see Figure Y).
(ii) [Reserved]
(4) Instead of complying with Section 8.3.2 of ASTM F2050-12,
comply with the following:
(i) 8.3.2 The warning statements shall address the following except
as otherwise noted.
(ii) [Reserved]
(5) Instead of complying with section 8.3.2.3 of ASTM F2050-12,
comply with the following:
(i) 8.3.2.3 Strangulation Hazard:
(ii) 8.3.2.3.1 Carriers intended for use as infant restraint
devices in motor vehicles shall contain the following warning label.
This label requires exact language (including the use of bold font and
uppercase characters as depicted) and a specific location:
[GRAPHIC] [TIFF OMITTED] TP10DE12.005
(iii) 8.3.2.3.2 The area of the pictogram is to be at least 1.09
in\2\ (706 mm\2\) while not exceeding the size of the airbag warning
pictogram in the label required under FMVSS No. 213. The message area
in the label shall be no less than 4.65 in\2\ (30 cm\2\), while not
exceeding the size of the airbag warning message area in the label
required under FMVSS No. 213. The pictogram shall be black with a red
circle and slash on a white background and green check mark. The
heading area shall be yellow with the word ``warning'' and the alert
symbol in black. The warning label shall be a separate and independent
label from the airbag warning label required in FMVSS No. 213. The
warning label shall be permanently affixed to the outer surface of the
cushion or padding in or adjacent to the area where a child's head
would rest, so that the label is plainly visible and easily readable.
(iv) 8.3.2.3.3 The following warning is required only for carriers
not intended for use in a motor vehicle and are not hand-held
bassinets/cradles. This warning requires exact language (including the
use of bold font and uppercase characters as depicted):
[GRAPHIC] [TIFF OMITTED] TP10DE12.006
[[Page 73366]]
(6) Instead of complying with section 9.1.1 of ASTM F2050-12,
comply with the following:
(i) 9.1.1 The instructions shall contain statements, which address
the warning statements in 8.3.2. For carriers intended for use as
infant restraint devices in motor vehicles, the warning statement
contained in the warning label depicted in 8.3.2.3 must also be
included. In addition, the instructions shall include the following
statements:
(ii) [Reserved]
(7) In addition to Figure 2, use the following:
[GRAPHIC] [TIFF OMITTED] TP10DE12.007
[GRAPHIC] [TIFF OMITTED] TP10DE12.008
Dated: December 3, 2012.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2012-29584 Filed 12-7-12; 8:45 am]
BILLING CODE 6355-01-P