Safety Standard for Soft Infant and Toddler Carriers, 17422-17433 [2014-06771]
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Federal Register / Vol. 79, No. 60 / Friday, March 28, 2014 / Rules and Regulations
(iv) Task 57–29–03–270–801–A–01, Gear Rib
Forward Lug Attachment for the Main Gear
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Nondestructive Testing Manual, Revision
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(v) Task 57–29–04–270–801–A–01, Gear Rib
Forward Lug Attachment for the Main Gear
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Forward and Aft Lug Attachment for the
Main Gear, of Chapter 57, Wings, of the
Airbus A318/A319/A320/A321
Nondestructive Testing Manual, Revision
89, dated August 1, 2011.
(4) The following service information was
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Revision 01, dated October 27, 2006.
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[FR Doc. 2014–04954 Filed 3–27–14; 8:45 am]
BILLING CODE 4910–13–P
CONSUMER PRODUCT SAFETY
COMMISSION
16 CFR Parts 1112 and 1226
[Docket No. CPSC–2013–0014]
Safety Standard for Soft Infant and
Toddler Carriers
Consumer Product Safety
Commission.
ACTION: Final rule.
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AGENCY:
The Danny Keysar Child
Product Safety Notification Act, section
104 of the Consumer Product Safety
Improvement Act of 2008 (CPSIA),
requires the United States Consumer
SUMMARY:
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Product Safety Commission
(Commission, CPSC, or we) to
promulgate consumer product safety
standards for durable infant or toddler
products. Durable infant and toddler
standards must 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 issuing this final rule
establishing a safety standard for soft
infant and toddler carriers in response
to the direction under section 104(b) of
the CPSIA.
DATES: The rule will become effective
September 29, 2014 and apply to
product manufactured or imported on or
after that date. The incorporation by
reference of the publication listed in
this rule is approved by the Director of
the Federal Register as of September 29,
2014.
FOR FURTHER INFORMATION CONTACT: Julio
A. Alvarado, Office of Compliance and
Field Operations, Consumer Product
Safety Commission, 4330 East West
Highway, Bethesda, MD 20814;
telephone: 301–504–7418; email:
jalvarado@cpsc.gov.
SUPPLEMENTARY INFORMATION:
I. Background and Statutory Authority
The Consumer Product Safety
Improvement Act of 2008 (CPSIA, Pub
L. 110–314) 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: (1) Examine and assess
the effectiveness of voluntary consumer
product safety standards for durable
infant or toddler products, in
consultation with representatives of
consumer groups, juvenile product
manufacturers, and independent child
product engineers and experts; and (2)
promulgate consumer product safety
standards for durable infant and toddler
products. Durable infant and toddler
standards must 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.’’
Section 104(f)(2)(H) of the CPSIA
specifically identifies ‘‘infant carriers’’
as durable infant or toddler products.
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The Commission has identified at least
four types of products that fall within
the product category of ‘‘infant
carriers,’’ including: Frame backpack
carriers, hand-held infant carriers,
slings, and soft infant and toddler
carriers.
On April 5, 2013, the Commission
issued a notice of proposed rulemaking
(NPR) for soft infant and toddler
carriers. 78 FR 20511. The NPR
proposed to adopt as a mandatory
standard the current voluntary standard
for soft infant and toddler carriers,
ASTM F2236–13, ‘‘Standard Consumer
Safety Specification for Soft Infant and
Toddler Carriers’’ (ASTM F2236–13),
without alteration.
The Commission is issuing a final
mandatory safety standard for soft infant
and toddler carriers. Pursuant to section
104(b)(1)(A) of the CPSIA, the
Commission consulted with
manufacturers, retailers, trade
organizations, laboratories, consumer
advocacy groups, consultants, and
members of the public to develop this
standard, largely through the ASTM
process. After publication of the NPR,
ASTM approved two revised versions of
F2236–13, F2236–13a, on November 1,
2013, and F2236–14, on January 1, 2014.
The revisions included in ASTM
F2236–14 clarify several issues raised in
the comments received on the NPR.
Furthermore, the Commission finds that
the revisions included in ASTM F2236–
14 adequately address the comments
received on the NPR. Section V of the
preamble below discusses clarifying
changes to the standard. The final rule
for soft infant and toddler carriers
incorporates ASTM F2236–14, by
reference, without alteration.
II. Product Description
A. Definition of a Soft Infant and
Toddler Carrier
ASTM F2236–14 defines a ‘‘soft infant
and toddler carrier’’ as ‘‘a product,
normally of sewn fabric construction,
which is designed to contain a full term
infant to a toddler, generally in an
upright position, in close proximity to
the caregiver.’’ Additionally, soft infant
and toddler carriers are generally
designed to carry a child ‘‘between 7
and 45 pounds.’’ ASTM F2236–14
explains that soft infant and toddler
carriers are ‘‘normally ‘worn’ by the
caregiver with a child positioned in the
carrier and the weight of the child and
carrier suspended from one or both
shoulders of the caregiver. These
products may be worn on the front, side,
or back of the caregiver’s body, with the
infant either facing towards or away
from the caregiver.’’ Typically, children
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are carried in soft infant and toddler
carriers on the front of a caregiver; but
some products on the market can be
configured to carry a child upright on a
caregiver’s front, back, or hip.
In the United States, soft infant and
toddler carriers are available in two
broad classes: Structured and
nonstructured. Structured soft infant
and toddler carriers contain straps and
waist belts that connect to the seat area
and other carrier components with
buckles, straps, and mechanical
fasteners. The straps, belts, and seating
area of these products are often stiffened
with padding and typically have a
heavy textile covering. Nonstructured
products consist of a flat, textile center
with waist straps and very long upper
straps (5 to 6 feet) that wrap around the
caregiver and are secured by typing the
ends of the straps, such as the mei-tai
design. ASTM F2236–14 does not
distinguish between products based on
whether they are structured or
nonstructured; therefore, requirements
apply equally to all types of soft infant
and toddler carriers.
ASTM F2236–14’s definition of a
‘‘soft infant and toddler carrier’’
distinguishes soft infant and toddler
carriers from other types of infant
carriers that are also worn by a caregiver
but that are not covered under ASTM F–
2236–14, specifically slings (including
wraps), and framed backpack carriers.
Soft infant and toddler carriers are
designed to carry a child in an upright
position. Slings are designed to carry a
child in a reclined position. However,
some slings may also be used to carry
a child upright. Thus, the primary
distinction between a sling and a soft
infant and toddler carrier is that a sling
allows for carrying a child in a reclined
position. Different hazard patterns arise
from carrying a child in a reclined
position. Accordingly, slings are not
covered by the standard for soft infant
and toddler carriers. Like soft infant and
toddler carriers, framed backpack
carriers are intended to carry a child in
an upright position. However, framed
backpack carriers are distinguishable
from soft infant and toddler carriers
because typically, backpack carriers are
constructed of sewn fabric over a rigid
frame and are intended solely for
carrying a child on the caregiver’s back.
III. Incident Data
The preamble to the NPR summarized
incident data involving soft infant and
toddler carriers reported to the
Commission from January 1, 1999 to
September 10, 2012. 78 FR 20513 (April
5, 2013). CPSC’s Directorate for
Epidemiology, Division of Hazard
Analysis updated this information for
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the final rule to include soft infant and
toddler carrier-related incident data
reported to the Commission from
September 11, 2012 through July 15,
2013. During the September 11, 2012 to
July 15, 2013 time frame, CPSC received
31 new incident reports related to soft
infant and toddler carriers. Two of the
incidents were fatal, and 29 were
nonfatal. Twenty-four of the 29 nonfatal
incidents involved injuries. The total
count of reported incidents includes
emergency department-treated injuries
(i.e., injuries reported through the
National Electronic Injury Surveillance
System (NEISS)).1 CPSC staff cannot
present national emergency departmenttreated injury estimates for the final rule
due to insufficient numbers of NEISS
incidents reported during the time
period. The number of incidents
occurring in 2012 and 2013 is subject to
change because the CPSC continues to
collect information about such
incidents.
A. Fatalities
Both reported fatalities involved
suffocation. One suffocation fatality
occurred in 2010. The decedent was a
17-day-old infant who was being carried
in a soft infant and toddler carrier—
facing the mother—while the mother
ran errands. The mother reportedly
breast fed the victim while walking. The
report is unclear about whether the
victim was out of the carrier or in the
carrier while being fed. The mother
found the child nonresponsive in the
carrier. The child was placed on life
support, which was later removed due
to the child’s poor prognosis. The
second suffocation fatality occurred in
2011. The decedent, a 4-month-old
female, was placed prone to sleep on a
bed while still in a soft infant carrier.2
B. Nonfatalities
Twenty-nine soft infant and toddler
carrier-related nonfatal incidents were
reported to the CPSC from September
11, 2012 to July 15, 2013. The incident
reports demonstrate that an injury
occurred in 24 of the 29 incidents. The
children’s age was unreported or
1 CPSC’s NEISS database is a national probability
sample of hospitals in the United States and its
territories. Patient information is collected from
each NEISS hospital for every emergency visit
involving an injury associated with consumer
products. From this sample, the total number of
product-related injuries treated in hospital
emergency rooms nationwide can be estimated.
2 According to CPSC Human Factors staff, this
scenario represents an unsafe sleep environment.
The prone sleep position is a known risk factor for
SIDS, and placing an infant to sleep face down on
top of a bed may increase the risk of suffocation.
Sleeping in the prone position on a bed with an
infant still inside a carrier may further increase the
suffocation risk.
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unknown in four of the 29 nonfatal
incidents. For the remaining 25
incidents, the ages provided in the
reports ranged from 1 month to 18
months, with 64 percent of the total
reports involving children 6 months of
age or younger.
Among the 24 nonfatal injuries
reported, four incidents required
hospitalization. Two of the four injuries
requiring hospitalization, a skull
fracture and a leg fracture, resulted from
infants falling out of a soft infant and
toddler carrier. The other two injuries
that required hospitalization were head
injuries to the infant resulting from the
caregiver falling. Other injuries
included contusions, abrasions, and
lacerations, mostly of the head and face.
Fourteen of the injuries resulted from
falls, either from the caregiver falling
while wearing the carrier or from the
infant falling out of the carrier.
The remaining five incident reports
stated problems with the product but
indicated that either no injury had
occurred or the report failed to provide
information about any injury.
C. Hazard Pattern Identification
CPSC identified hazard patterns
among the 31 new incident reports that
were similar to the hazard patterns
identified among the incidents
considered for the NPR. The primary
hazard associated with use of a soft
infant and toddler carrier continues to
be falling, either caregivers falling while
wearing the carrier and injuring the
child in the carrier, or children falling
or facing the risk of falling from the
carrier. Hazard patterns are grouped into
the following categories in order of
frequency of incident reports:
• Caregiver falls (11) 3;
• structure, fit, and position issues
(7);
• design and finish-related issues 4
(2), (which are also among the 7 in the
previous category);
• strap issues (2);
• issues with stitching/seams (1); and
• other issues (10).
Caregiver Falls: Eleven of the 31
incidents (35 percent) reported injuries
to the infant in the carrier, when the
caregiver slipped or tripped and fell. All
of these were emergency departmenttreated injury (NEISS data) reports.
Structure, fit, and position issues:
Seven of the 31 incidents (23 percent)
were related to aspects of the leg- and
torso-opening design, how the carrier
held the infant, and where the soft
3 All of the fall incidents were emergency
department-treated injury (NEISS data) reports.
4 Finish-related issues concern items such as
material smoothness and lead content.
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infant and toddler carrier was
positioned on the caregiver. Examples of
scenarios reported include: an infant
slipping far down into the carrier and
suffering an injury when the caregiver
bent over; an infant falling out of the
carrier when the caregiver bent forward;
and leg circulation-related injuries to
the infant. Three injuries were reported
in this category, including one
hospitalization.
Design-related issues: Two of the
reports included in the structure, fit,
and position category above stated
complaints about how the carrier fit on
the caregiver and that the infant got too
hot when the carrier was used with the
carrier insert. A carrier insert is
available with some soft infant and
toddler carriers to help support a young
infant’s head and neck. No one reported
injuries in this category.
Strap issues: Two of the 31 incidents
(six percent) reported issues with straps,
mostly regarding the adjuster breaking
or slipping. Both incidents resulted in
injuries, including one hospitalization
for a skull fracture stemming from a fall
when the strap came undone.
Issues with stitching/seams: One
incident report (three percent) stated
that stitching on a carrier component
came undone. However, the infant
sustained no injury.
Other issues: Ten incident reports (32
percent) involved non-product-related
issues or provided insufficient
information for CPSC staff to determine
definitively how the product
contributed to the incident. The two
fatalities are included in this category—
one case of an infant suffering
respiratory distress while being carried
facing inward, and the other case
involved an infant put to sleep in a
prone position on a bed while still in a
soft infant and toddler carrier. In each
case, CPSC staff concluded that
insufficient information was reported to
determine a predominant factor about
the product that contributed to the
death. Five reports were of incidental
injuries sustained by infants while being
carried around in a soft infant and
toddler carrier. Examples of such
incidents include an infant who hit a
pole after a bus in which the child was
riding suddenly accelerated and an
infant who got hurt while being put into
a carrier. The remaining three reports
involved infants who fell out of the
carrier, with no additional information
specified.
D. NEISS Data
The soft infant and toddler carrier
NPR presented a separate national
injury estimate for the 13-year period
from January 1999 through December
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2011. However, insufficient emergency
department-treated injuries associated
with soft infant and toddler carriers in
2012 prevent derivation of reportable
national estimates.5 In addition, until
NEISS data for 2013 are finalized in
spring 2014, partial estimates for 2013
are not available. Hence, injury
estimates are not presented separately in
this final rule. However, the emergency
department-treated injuries are included
in the total count of reported incidents
presented in section III.C above.
IV. Response to Comments
CPSC received five comments
regarding the NPR, including comments
from industry, consumer groups, trade
associations, and consumers. The
comments address eight separate issues
related to fastener strength testing
requirements, warning label revisions,
and the effective date of the final rule.
Two commenters generally supported
the rule. Comments submitted in
response to the NPR are available at:
www.regulations.gov, by searching
under the docket number of the
rulemaking, CPSC–2013–0014. The
Commission finds that revisions made
to the ASTM voluntary standard, which
are incorporated into ASTM F2236–14,
approved on January 1, 2014, and
published in January 2014, adequately
address comments received on the NPR.
Accordingly, the Commission will
incorporate by reference the most recent
version of the voluntary standard,
ASTM F2236–14, as the mandatory
standard for soft infant and toddler
carriers.
We summarize the comments
received on the NPR and CPSC’s
responses below. To make identification
of the comments and our responses
easier, we placed the word ‘‘Comment,’’
in parentheses, before the comment’s
description, and the word ‘‘Response,’’
in parentheses, before our response.
Additionally, we have numbered each
comment to help distinguish among
comments. The number assigned to each
comment is for organizational purposes
only and does not signify the comment’s
value or importance, or the order in
which we received the comment.
A. Fastener Strength
(Comment 1) Two commenters stated
that the specified fastener strength test
load of 80 pounds in section 7.7.2 of
ASTM F2236–13 is too high for soft
infant and toddler carriers whose
manufacturer-recommended maximum
occupant weight for the product is less
5 According to the NEISS publication criteria, an
estimate must be 1,200 or greater, the sample size
must be 20 or greater, and the coefficient of
variation must be 33 percent or smaller.
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than 45 pounds. The commenters
suggested using a sliding scale for the
test load that would adjust the test load
by 1 pound for every pound the carrier
is rated above or below 45 pounds. For
example, for soft infant and toddler
carriers designed for a maximum
occupant weight of 25 pounds,
commenters recommended a fastener
test load of 60 pounds (80 pounds
minus 20 pounds) instead of an 80pound force. One commenter stated that
for carriers designed for very small
occupants, it would be difficult for
every load-bearing fastener to be
designed to meet the 80-pound test load
because such fasteners tend to be large
and difficult to handle gently when
close to a small infant.
(Response 1) The Commission
disagrees with the commenters and
declines to modify the final rule based
on this comment. ASTM F2236–13
added requirements for fastener strength
testing. Each unique load-bearing
fastener, except load-bearing fasteners
used for a leg opening adjustment, must
not break or disengage when subjected
to a tensile load of 80-pound force for
5 seconds. The force is applied to the
straps or soft goods on either side of the
fastener. Leg opening adjustment
fasteners are tested to a 45-pound force.
As noted in the NPR, CPSC staff
tested fasteners on 14 different soft
infant and toddler carriers, including
recalled carriers. The manufacturer’s
recommended maximum occupant
weight of the carriers tested ranged from
20 pounds to 45 pounds. CPSC staff
found that most of the tested fasteners
failed at loads well above the 80-pound
force used in the test, while some of the
fasteners on recalled products (which
were rated at 26-pound maximum
occupant weight) failed at 22 pounds to
55 pounds. The Commission agrees with
CPSC staff that lowering the test load to
a 60-pound force on a carrier rated at 25
pounds does not provide a sufficient
safety factor, considering that fasteners
from some recalled carriers failed at 55
pounds during testing. Based on the test
results, the Commission finds that an
80-pound test load is appropriate, even
for carriers with maximum occupant
weights below 45 pounds.
All of the buckle and strap fasteners
on the 14 carriers that CPSC staff tested
were made from plastic. CPSC staff
concluded that the characteristics of the
plastic used for the fasteners dictated
the fastener’s ability to withstand the
test load. The plastic material on the
fasteners that fractured at a lower load
was much less ductile, resulting in the
fastener fracturing instead of deforming.
Accordingly, CPSC staff found that
smaller fasteners were as capable as
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larger fasteners at meeting the 80-pound
test load. Staff concluded that fastener
strength was not necessarily
proportional to fastener size.
CPSC staff states that the 80-pound
test load for the fastener pull test is not
directly related to the maximum carrier
weight rating. Rather, the 80-pound test
load was established based on testing
the strength of fasteners on carriers
already on the market. Fasteners that
meet the required test load are robust
enough for expected use during the life
of the product. Moreover, CPSC staff
believes that it is reasonably foreseeable
that some caregivers may use soft infant
and toddler carriers with infants whose
weight exceeds the manufacturer’s
recommended occupant weight.
For the reasons discussed, the
Commission declines to modify the final
rule based on this comment.
B. Fasteners That Support the Head
(Comment 2) Two commenters stated
that fasteners that support the head
should be exempt from load testing.
Non-load-bearing fasteners intended to
retain items such as, but not limited to,
hoods, bibs, and toy rings are exempt
from load testing in ASTM F2236–13.
One of the commenters stated: ‘‘head
support for new born babies is critical,’’
but to achieve a good, adjustable head
support requires fasteners that are slim
and easy to use. The commenter designs
head support fasteners to carry a certain
load; however, the commenter stated
that these fasteners are not load bearing
and should be exempt from load testing
in section 6.4 of the standard.
(Response 2) ASTM balloted and
approved two clarifying changes to Note
1 in section 6.4 of the standard, which
have been incorporated into ASTM
F2236–14. These changes address the
commenters’ concern. Note 1 exempts
non-load-bearing fasteners from the
fastener strength tests in section 6.4 and
lists examples of non-load-bearing
fasteners that are exempt. We note that
the list in Note 1 is not exhaustive, but
merely illustrative, and that other
features attached to a soft infant and
toddler carrier by a non-load-bearing
fastener are also exempt from the
fastener strength tests in section 6.4.
ASTM F2236–13, the proposed
standard for adoption in the NPR, stated
that fasteners intended to retain items
such as ‘‘hoods, bibs and toy rings’’
were exempt from testing. The ASTM
subcommittee for soft infant and toddler
carriers was aware of a feature called a
‘‘sleeping hood’’ that is attached to a
soft infant and toddler carrier by nonload bearing fasteners. The ‘‘sleeping
hood’’ feature was intended to be
captured in ASTM F2236–13 Note 1
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with the phrase ‘‘hoods.’’ To clarify that
non-load-bearing fasteners used to
retain ‘‘sleeping hoods’’ are exempt
from testing, ASTM changed the word
‘‘hoods’’ in Note 1 to ‘‘sleeping hoods.’’
This revision was approved and
published in ASTM F2236–13a.
Subsequently, based on a
manufacturer’s concern that Note 1 was
still unclear about whether head
adjustment fasteners that were non-load
bearing had to be tested, ASTM balloted
and approved another modification to
Note 1. The second modification was
incorporated into ASTM F2236–14 and
added ‘‘head adjustment fasteners’’ to
the list of examples of fasteners exempt
from testing in Note 1. The Commission
agrees with the clarification and
believes that these revisions to the
voluntary standard address the
commenters’ concern.
To the extent that commenters are
suggesting that any potential loadbearing fastener that supports the head
should be excluded from the fastener
strength test in section 6.4 of the
standard, the Commission disagrees.
CPSC found that on the 14 carriers
tested, the uppermost fastener generally
supports the infant’s upper torso and
shoulders, as well as the head, and
therefore, the fastener is critical to
securing the infant in the carrier. Loadbearing fasteners that support the head,
upper torso, and shoulders are not
exempt from fastener-load testing
requirements. The commenter
apparently does not intend to exempt
this type of fastener from testing.
C. Fastener Strap Slip During Load
Testing
(Comment 3) One commenter stated
that the strap slippage requirement as
articulated in the standard (ASTM
F2236–13, paragraphs 6.4.1 and 6.4.2)
can result in a technical failure of an
otherwise safe product. The commenter
found that during product testing,
certain straps can slip more than 1 inch
but in a direction that makes the straps
become tighter, not looser. The
commenter asserted that this does not
compromise safety. The commenter
suggested that the language in paragraph
6.4.1 should be changed from ‘‘. . .
adjustable elements in straps shall not
slip more than 1 in. (2.5 cm) when
tested . . .’’ to ‘‘. . . adjustable
elements in straps shall not loosen more
than 1 in. (2.5 cm) when tested . . . .’’
(Response 3) The strap slippage
requirement in section 6.4.1 of ASTM
F2236–13, the standard referenced in
the NPR, prevents the fastener straps
from slipping an appreciable amount
through the buckles during fastener
strength testing. Significant slippage can
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result in a minimal load being held by
the fastener/strap and could result in
the strap pulling out of the fastener or
loosening to the point that the infant
could fall out of the carrier. The
commenter seeks to clarify that straps
that tighten during the test do not
constitute a test failure.
The Commission agrees that straps
that tighten during testing should not
fail the strap retention requirement in
the standard. However, based on the
CPSC staff’s assessment, the
Commission finds that use of the word
‘‘slip’’ in the standard is more accurate
than ‘‘loosen.’’ The amount of strap
‘‘slip’’ through a fastener can be
measured; whereas, CPSC staff is
uncertain how to measure strap
‘‘loosening.’’ Additionally, the
requirement for support/shoulder strap
slippage during the dynamic and static
load testing in paragraph 6.2 uses the
same wording, which states: ‘‘adjustable
sections of the support/shoulder straps
shall not slip more than 1 in. (25 mm)
per strap from their original adjusted
position . . .’’ Therefore, the
Commission will not replace the word
‘‘slip’’ with ‘‘loosen’’ in the final rule, as
suggested by the commenter.
After publication of the NPR, ASTM
balloted and approved a modification to
the voluntary standard that addresses
the commenter’s concern about straps
that tighten during testing. ASTM
F2236–14 incorporates a revision to
sections 6.2.2, 6.4.1, and 6.4.2 of the
voluntary standard to state: ‘‘straps shall
not slip, in a manner that loosens the
strap, by more than 1 inch.’’ This
modification was included in the
voluntary standard, beginning with
revision ASTM F2236–13a.
The Commission finds that the
revisions now incorporated into
sections 6.2.2, 6.4.1, and 6.4.2 of ASTM
F2236–14 addresses the commenter’s
concern and clarifies when fasteners
pass the fastener strength test
requirement without substantively
altering the test method.
D. Warning Text Format
(Comment 4) One commenter noted
that in ASTM F2236–13, the text height
requirement for the warnings provided
with product instructions specified in
section 9.2.2 needs to be modified to
match the text height requirement for
warning labels in section 8.3.1. The
commenter stated that if this
modification is not made, section 9.2.2
would require every letter of warning
text to be at least 0.1″ high, instead of
only the upper case letters, as is the case
in section 8.3.1.
(Response 4) The Commission agrees
that the text height requirement for
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commenter’s concern, ASTM balloted
and approved the following modified
text in section 9.2.2, as follows
(additions are shown by italics):
Section 9.2.2 of the voluntary
standard incorporates this revision,
beginning with ASTM F2236–13a. The
Commission believes that the revised
language addresses the commenter’s
concern.
children in this age group in a carrier on
the hip or back depending on the carrier
type. Given that infants from age 4
months and older have developed head
control and muscular strength and can
be placed in outward facing, hip, and
back carry positions, their face is less
likely to become pressed tightly into a
caretaker’s body. Therefore, the risk of
suffocation for these children is low.
The Commission has not received data
indicating that a risk of suffocation
exists for children 4 months and older.
Identifying explicitly children who
are most at risk does not suggest that
others are not at risk. However,
guidelines for warning labels
recommend focusing on the most likely
and most serious risks (Laughery and
Hammond, 1999; Wogalter, 2006).
Warnings about low-probability events
(i.e., older infants suffocating in soft
infant carriers) may reduce the
believability or arousal strength of
warnings that caution of more likely
risks (i.e., infants under 4 months
suffocating in soft infant carriers). The
Commission finds that the current
ASTM warning label about the
suffocation hazard is sufficient without
modification.
However, for the Commission to include
a warning statement about the greater
risk of instability and falls involving
products with higher weight limits, data
must be available to demonstrate that
carrying heavier children in soft infant
and toddler carriers presents a greater
risk of instability and falls. At this time,
the available data do not support this
position. Furthermore, the commenter
did not provide data demonstrating that
products with higher weight limits
present a greater risk of instability and
falls than carriers with a lower weight
limit. Therefore, at this time, the
Commission declines to modify the
warning label as suggested by the
commenter.
E. Suffocation Warning
(Comment 5) One commenter stated
that the required warning statement
should read: ‘‘Infants, especially those
under four months, can suffocate in this
product if face is pressed tight against
your body,’’ rather than the warning
statement in the proposed rule, as
provided in the ASTM standard:
‘‘Suffocation Hazard—Infants under 4
months can suffocate in this product if
face is pressed tight against your body.’’
The commenter said that this warning
language does not adequately warn the
user of the risk of suffocation for infants
over four months and that the suggested
warning statement will alert parents and
other caregivers to a risk to older babies
as well.
(Response 5) The Commission
disagrees that the proposed suffocation
warning, as provided in the ASTM
voluntary standard, does not adequately
warn users of the risk of suffocation.
The primary mechanism for suffocation
in a soft infant and toddler carrier is the
infant’s face being pressed tightly
against a caretaker’s body, obstructing
the nose and mouth and keeping the
infant’s head from moving. Infants
younger than 4 months old are mostly
at risk because they do not have the
head control or the muscle strength to
move their head away if their airway
becomes obstructed. By 4 months of age,
infants have increased neck strength
and can hold their heads up and explore
their surroundings while the caretaker is
walking. Infants who are 4 months old
can be carried in the outward-facing
position in soft infant and toddler
carriers that allow this carry position. At
around age 6 months, infants begin to sit
upright unassisted. Caretakers can carry
infants of this age in a soft infant and
toddler carrier on the hip or on the
caregiver’s back, depending on the
caretaker’s level of comfort. As children
reach toddlerhood, caregivers can carry
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F. Stability Warning
(Comment 6) One commenter stated:
‘‘we are concerned that raising the
upper weight limits, for the purpose of
ensuring that all soft infant and toddler
carriers on the market are covered by
the rule, brings in carriers that might
have a greater risk of instability and falls
due to the extra weight load relative to
the weight and strength of the caregiver.
We would urge the Commission to
include an adequate alert to this risk in
the required warnings and
instructions.’’
(Response 6) During the rulemaking,
CPSC staff identified soft infant and
toddler carriers on the market that have
a manufacturer-recommended upper
weight limit of 45 pounds. The
Commission believes that expanding the
scope of the standard to increase the
upper weight limit from 25 pounds to
45 pounds is necessary for the standard
to cover all products on the market.
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G. Product Marking
(Comment 7) One commenter
recommended that the CPSC require
that products manufactured after the
effective date of the final rule be marked
as compliant, so that consumers can
identify clearly products that meet the
new mandatory standard for soft infant
and toddler carriers.
(Response 7) The Commission finds
that sufficient incentive exists for
compliant producers to label their
products as compliant with the final
standard for soft infant and toddler
carriers. A final rule implementing
testing, certification, and labeling of
children’s products in section 14 of the
CPSA, as amended by the CPSIA,
Testing and Labeling Pertaining to
Product Certification, 16 CFR part 1107
(the 1107 rule), became effective on
February 13, 2013. Under the 1107 rule,
a manufacturer or importer may label a
certified compliant product as ‘‘Meets
CPSC Safety Requirements.’’ Because
producers are already allowed to label
compliant products as such under the
1107 rule, adding this option to the soft
infant and toddler carrier standard
would be redundant. The Commission
declines to change to the final rule
based on this comment.
H. Effective Date
(Comment 8) Two commenters
address the 6-month effective date
proposed in the NPR. One commenter,
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warnings should be consistent
throughout the standard. To address the
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representing several advocacy groups,
expressed support for the 6-month
effective date. Another commenter, a
soft infant and toddler carrier
manufacturer, recommended a 12month effective date, stating that the
manufacturing process can take up to 6
months, and the product may be stocked
in a warehouse for additional months,
depending on sales.
(Response 8) The final standard will
not be applied retroactively to products
manufactured prior to the effective date
of the final rule. Thus, any products
warehoused before the effective date
will not be affected by the standard.
Manufacturers should be able to comply
with the mandatory standard within 6
months of the final rule’s publication.
Manufacturers whose products do not
comply with the standard will require
some product modification. However,
product modification is expected to
involve minor changes, such as adding
or changing straps or fasteners.
Moreover, ASTM F2236–13 was
adopted by ASTM in March 2013, and
became effective in September 2013.
Although the Commission is adopting
ASTM F2236–14 as the mandatory
standard, no substantive changes have
been made to the voluntary standard
since ASTM F2236–13. Manufacturers
that comply with ASTM F2236–13 have
already made, or have begun to make,
the necessary modifications. The
Commission declines to change the
effective date of the final rule based on
this comment.
V. Summary of ASTM F2236–14
The Commission is issuing this final
rule for soft infant and toddler carriers
that incorporates by reference the most
recent voluntary standard for soft infant
and toddler carriers, ASTM F2236–14.
Together with the changes made in
ASTM F2236–12, ASTM F2236–13, and
ASTM F2236–13a, ASTM F2236–14
reflects the most significant revisions to
the standard to date. Revisions to the
voluntary standard include modified
and new requirements developed by
CPSC staff, working with stakeholders
on the ASTM subcommittee task group,
to address the hazards associated with
soft infant and toddler carriers. After the
comment period for the NPR closed, the
ASTM F15.21 Soft Infant and Toddler
Carrier subcommittee held a
teleconference on August 12, 2013, to
discuss comments submitted on the
NPR. The subcommittee discussed the
basis for each comment and reached a
consensus on revisions to be submitted
for ballot. The subcommittee chair
balloted the proposed revisions to
ASTM F2236–13 for concurrent ASTM
Main Committee F15 and Subcommittee
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F15.21 consideration on August 23,
2013, with a 1- month comment period.
The August 23, 2013 ballot contained
three revisions to the voluntary soft
infant and toddler carrier standard:
• Revisions to sections 6.2.2, 6.4.1,
and 6.4.2 to clarify that during the
dynamic load, static load, and fastener
strength tests, straps shall not slip, in a
manner that loosens the strap, more
than 1 inch.
• A revision to Note 1 in section 6.4
to clarify that ‘‘sleeping hoods’’ are an
example of non-load-bearing fasteners
that are exempt from fastener strength
testing.
• A revision to section 9.2.2 to clarify
that the text height requirements for the
warnings included with instructions in
section 9.2.2 are the same as the text
height requirements for warnings
required in section 8.3.1 of the
voluntary standard.
ASTM did not receive any negative
votes on the balloted revisions to ASTM
F2236–13. ASTM approved the balloted
revisions on November 1, 2013, and
subsequently published ASTM F2236–
13a in November 2013.
On September 26, 2013, the ASTM
F15.21 Soft Infant and Toddler Carrier
subcommittee met to discuss results of
the items balloted on August 23, 2013.
One manufacturer wanted the voluntary
standard to further clarify that fasteners
used for adjusting the head portion of
the carrier were exempt from fastener
strength testing because such fasteners
are not load bearing. As a result, the
subcommittee chair developed a draft
ballot item that proposed to add ‘‘head
adjustment fasteners’’ to the list of
examples of fasteners that are exempt
from load testing listed in Note 1 of
section 6.4. The subcommittee chair
balloted the proposed revision to ASTM
F2236–13a for concurrent ASTM Main
Committee F15 and Subcommittee
F15.21 consideration on November 6,
2013, with a 1-month comment period.
ASTM did not receive any negative
votes on the balloted revision, and
approved the revised standard, ASTM
F2236–14, on January 1, 2014. ASTM
published ASTM F2236–14 in January
2014.
We summarize the provisions of
ASTM F2236–14 below. Each revision
to ASTM F2236–13 discussed above is
described below in more detail in the
relevant section of the standard where
the change appears. ASTM F2236–14
includes the following key provisions:
scope, terminology, general
requirements, performance
requirements, test methods, marking
and labeling, and instructional
literature.
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Scope. The scope of the voluntary
standard was broadened in December
2012 to include soft infant and toddler
carriers with an upper weight limit of
up to 45 pounds. Previously, it was
unclear whether carriers with upper
weight limits over 25 pounds fell within
the standard. Expanding the scope of
the standard clarifies that all soft infant
and toddler carrier products currently
on the market fall within the standard.
The name of the standard was changed
in 2012 to include the word ‘‘toddler,’’
to clarify that toddlers can also be
carried in these products. The scope of
the standard also distinguishes soft
infant and toddler carriers from other
wearable infant carrier products. The
scope provides that soft infant and
toddler carriers are ‘‘normally of sewn
fabric construction,’’ hold the child
‘‘generally in an upright position,’’ and
‘‘may be worn on the front, side, or back
of the caregiver’s body.’’ Finally, the
scope of the standard states that the
standard does not apply to infant slings.
Terminology. Section 3.1 of the
standard includes 14 definitions to help
explain general requirements and
performance requirements. Section 3.1.7
of the standard explains that a ‘‘leg
opening’’ is the ‘‘opening in the soft
carrier through which the occupant’s
legs extend when the product is used in
the manufacturer’s recommended use
position.’’ Sections 3.1.4 and 3.1.13 of
ASTM F2236–14, respectively, explain
that a ‘‘dynamic load’’ is the
‘‘application of impulsive force through
free fall of a weight,’’ and that a ‘‘static
load’’ is a ‘‘vertically downward force
applied by a calibrated force gage or by
dead weights.’’ Beginning in 2012, the
standard included a new definition for
‘‘carrying position’’ to clarify methods
for dynamic and static load testing in
section 7 of the standard. Finally, in
2013, the standard was updated to
include a new definition for ‘‘fastener’’
to aid in a new test for fastener strength
and strap retention.
General Requirements. ASTM F2236–
14 includes general requirements that
the products must meet, as well as
specified test methods to ensure
compliance with the general
requirements, which include:
• Restrictions on sharp points or
edges, as defined by 16 CFR §§ 1500.48
and .49;
• restrictions on small parts, as
defined by 16 CFR part 1501;
• restrictions on lead in paint, as set
forth in 16 CFR part 1303;
• requirements for locking and
latching devices;
• requirements for permanent
warning labels;
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• restrictions on flammability, as set
forth in 16 CFR part 1610;
• requirements for toy accessories, as
set forth in ASTM F 963.
The flammability requirement in
section 5.7 of the standard was changed,
beginning with ASTM F2236–13, from a
flammable solids requirement (16 CFR
1500.3(c)(6)(vi)), to meet the more
stringent flammability requirement for
wearing apparel (16 CFR part 1610).
Adopting the wearing apparel
flammability requirement in the soft
infant and toddler standard makes it
consistent with other wearable infant
carriers made of sewn fabric, such as
slings, to prevent a foreseeable fire
hazard in all wearable infant carriers.
Performance Requirements and Test
Methods. ASTM F2236–14 provides
performance requirements and test
methods that are designed to protect
against falls from the carrier due to large
leg openings, breaking fasteners or
seams, and straps that slip, including:
Leg Openings—Tested leg openings
must not permit passage of a test sphere
weighing 5 pounds that is 14.75 inches
in circumference.
Dynamic and Static Load—Beginning
with the 2012 version of ASTM F2236,
the dynamic load test was strengthened
from requiring a 25-pound shot bag to
be dropped, free fall, from 1 inch above
the seat area onto the carrier seat 1,000
times, to requiring testing with a 25pound shot bag, or a shot bag equal to
the manufacturer’s maximum occupant
weight limit, whichever is heavier.
Additionally, the static load test was
revised—from requiring a 75-pound
weight for testing—to requiring a 75pound weight, or a weight equal to three
times the manufacturer’s recommended
maximum occupant weight, whichever
is greater, to be placed in the seat area
of the carrier for 1 minute. Such
revisions to the dynamic and static load
tests strengthen the test requirements,
by requiring that products with a
maximum recommended weight of 45
pounds be tested to a 135-pound weight
instead of 75 pounds, which represents
an 80 percent increase in the severity of
the requirement.
ASTM F2236–14 requires that testing
conducted with the new required loads
must not result in a ‘‘hazardous
condition,’’ as defined in the general
requirements, or result in a structural
failure, such as fasteners breaking or
disengaging, or seams separating when
tested in accordance with the dynamic
and static load testing methods.
Additionally, the standard provides that
dynamic and static load testing must not
result in adjustable sections of support/
shoulder straps slipping more than 1
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inch per strap from their original
adjusted position after testing.
Section 6.2.2 of the standard on
Support/Shoulder Strap Slippage was
modified beginning with ASTM F2236–
13a. The modification clarifies what
constitutes passing or failing the strap
slippage test. Section 6.2.2 was
amended to state: ‘‘Adjustable sections
of support/shoulder straps shall not
slip, in a manner that loosens the strap,
more than 1 in. (25 mm) per strap from
their original adjusted position after
dynamic and static load testing is
performed in accordance with 7.2.1 and
7.2.2, respectively.’’ The amendment
allows straps to tighten during testing
but not loosen more than 1 inch, which
is the intent of the testing.
Fastener Strength and Strap
Retention—ASTM F2236–14 includes a
new component-level performance
requirement that was added to the
standard in 2013 to evaluate the
strength of fasteners and strap retention
to help prevent falls from a carrier.
Previously, soft infant and toddler
carriers were recalled due to an
occupant fall hazard caused by broken
fasteners that passed the static and
dynamic performance requirements in
the then existing standard, ASTM
F2236–10. Accordingly, the
performance requirement in section 6.4
of ASTM F2236–14 states that loadbearing fasteners at the shoulder and
waist of soft infant and toddler carriers,
such as buckles, loops, and snaps, may
not break or disengage; nor may their
straps slip more than 1 inch when
subjected to an 80-pound pull force.
Adjustable leg opening fasteners must
also be tested but are subjected to lower
loads, a 45-pound pull force, because
these fasteners do not carry the same
load as fasteners at the shoulders and
waist. ASTM F2236–14 requires that
when tested, fasteners must not break or
disengage, and adjustable elements must
not slip more than 1 inch.
Similar to the strap slip requirement
in the static and dynamic load testing
section of the standard, ASTM also
clarified the strap slip section of the
fastener strength test section in ASTM
F2236–13a. Sections 6.4.1 and 6.4.2
were amended to state: ‘‘Each unique
fastener, except for leg opening
adjustment fasteners as tested per 6.4.2,
shall not break or disengage, and
adjustable elements in straps shall not
slip, in a manner that loosens the strap,
more than 1 in. (2.5 cm) . . . .’’ This
amendment allows straps to tighten
during testing but not to loosen more
than 1 inch, which is the intent of the
testing.
Additionally, Note 1 to section 6.4 of
the standard provides that the fastener
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strength and strap retention testing
apply only to load-bearing fasteners.
ASTM F2236–13 stated: ‘‘Fasteners
intended to retain items such as, but not
limited to, hoods, bibs and toy rings, are
exempt from these requirements.’’
ASTM approved two changes to the
language in Note 1 to clarify that several
non-load-bearing features, ‘‘sleeping
hoods’’ and ‘‘head adjustment
fasteners,’’ are included in the list of
examples exempted from fastener
strength testing when such features are
non-load-bearing. Note 1 in section 6.4
of ASTM F2236–14 now provides that:
‘‘Fasteners intended to retain items such
as, but not limited to, sleeping hoods,
head adjustment fasteners, bibs and toy
rings, are exempt from these
requirements.’’
Unbounded Leg Opening—The
voluntary standard was updated in 2013
to clarify the unbounded leg opening
test procedure to improve test
repeatability. ASTM F2236–14 requires
that an unbounded leg opening must not
allow complete passage of a truncated
test cone that is 4.7 inches long, with a
major diameter of 4.7 inches and a
minor diameter of 3 inches. The
standard requires a test cone to be
pulled through the leg opening with a
5-pound force for 1 minute.
Marking, Labeling, and Instructional
Literature. ASTM F2236–14 requires
that each product and its retail package
be marked or labeled with certain
information and warnings. The warning
label requirement was updated in 2013
to address fall and suffocation hazards.
ASTM F2236–14 requires that the
warning label provide a fall hazard
statement addressing that infants can
fall through wide leg openings or out of
the carrier. The standard requires the
following fall-related precautionary
statements be addressed on the warning
label: Adjust leg openings to fit baby’s
legs snugly; before each use, make sure
all [fasteners/knots] are secure; take
special care when leaning or walking;
never bend at waist, bend at knees; only
use this carrier for children between _
lbs. and _ lbs. Additionally, ASTM
F2236–14 requires that a suffocation
hazard statement must address the fact
that infants under 4 months old can
suffocate in the carrier if the child’s face
is pressed tightly against the caregiver’s
body. The standard requires that the
warning label must also address the
following suffocation-related
precautionary statements: Do not strap
infant too tightly against your body;
allow room for head movement; keep
infant’s face free from obstructions at all
times. Products must also contain an
informational statement that a child
must face toward the caregiver until he
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or she can hold his or her head upright.
All products are required to come with
instructional literature on assembly,
use, maintenance, cleaning, and
required warnings.
ASTM F2236–14 includes an example
warning label that identifies more
clearly the hazards, the consequences of
ignoring the warning, and how to avoid
the hazards. The label format was
designed to communicate more
effectively these warnings to the
caregiver (Fig. 1). Manufacturers may
alter the rectangular shape of the label
to fit on shoulder straps, if the
Ii
17429
manufacturer chooses not to place label
in the occupant space. However, the
standard requires that the label be
placed in a prominent and conspicuous
location, where the caregiver will see
the label when placing the soft infant
and toddler carrier on their body.
WARNING
FALL AND SUFFOCATION HAZARD
FALL HAZARD - Infants can fall through a wide leg opening
or out of carrier.
• Adjust leg openings to fit baby's legs snugly.
• Before each use, make sure all ____ are secure.
• Take special care when leaning or walking.
• Never bend at waist; bend at knees.
• Only use this carrier for children between ___ lb. and ___ lb.
SUFFOCATION HAZARD - Infants under 4 months can suffocate in this
product if face is pressed tight against your body.
• Do not strap infant too tight against your body.
• Allow room for head movement.
• Keep infant's face free from obstructions at all times.
Figure 1. ASTM F2236-14 Example Warning Label.
ASTM F2236-14 includes a 2013 revision to section 9.2.2 of the standard on
Instructional Literature. Section 9.2.2 of the standard describes how the warning label is to be
conveyed in the instructional literature. The text height requirements in this section should
match the text height requirements for the on-product warning label in section 8.3.1, which was
overlooked when publishing ASTM F2236-13. To correct this issue, ASTM F2236-14 includes
the following revision to section 9.2.2, so that it is the same as 8.3.1: "In warning statements, the
symbol"&''' and the word WARNING shall be at least 0.2 in. (5 mm) high. The remainder of
The Administrative Procedure Act
(APA) generally requires that the
effective date of the rule be at least 30
days after publication of the final rule.
5 U.S.C. 553(d). The NPR proposed that
the final rule would become effective 6
months after publication of a final rule
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in the Federal Register. Although we
received one comment requesting a 12month effective date (comment 8 in
section IV.H), the Commission finds that
a 6-month effective date is sufficient
time to allow manufacturers to come
into compliance. Manufacturers whose
products are not compliant with the
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standard will require some product
modification; however, any necessary
product modification is expected to
involve minor changes, such as adding
or changing straps or fasteners.
Moreover, ASTM F2236–13 was
adopted by ASTM in March 2013, and
became effective in September 2013.
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VI. Effective Date
ER28MR14.034
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Although the Commission is adopting
ASTM F2236–14, this version of the
voluntary standard is substantially the
same as ASTM F2236–13.
Manufacturers that are compliant with
ASTM F2236–13 have already made or
have begun to make the necessary
modifications.
VII. Regulatory Flexibility Act
A. Introduction
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The Regulatory Flexibility Act (RFA)
requires that final rules be reviewed for
their potential economic impact on
small entities, including small
businesses. Section 604 of the RFA
requires that CPSC prepare a final
regulatory flexibility analysis (FRFA)
when the Commission promulgates a
final rule. The FRFA must describe the
impact of the rule on small entities and
identify any alternatives that may
reduce the impact. Specifically, the
FRFA must contain:
• A succinct statement of the
objectives of, and legal basis for, the
rule;
• a summary of the significant issues
raised by public comments in response
to the initial regulatory flexibility
analysis, a summary of the assessment
of the agency of such issues, and a
statement of any changes made in the
proposed rule as a result of such
comments;
• a description of, and, where
feasible, an estimate of, the number of
small entities to which the rule will
apply;
• a description of the projected
reporting, recordkeeping, and other
compliance requirements of the 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
• a description of the steps the agency
has taken to reduce the significant
economic impact on small entities,
consistent with the stated objectives of
applicable statutes, including a
statement of the factual, policy, and
legal reasons for selecting the alternative
adopted in the rule, and why each one
of the other significant alternatives to
the rule considered by the agency,
which affect the impact on small
entities, was rejected.
B. Market for Soft Infant and Toddler
Carriers
Soft infant and toddler carriers are
generally produced and/or marketed by
juvenile product manufacturers and
distributors. Several of these firms
primarily produce soft infant and
toddler carriers, as well as substitute
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products, such as slings. CPSC
Economic Analysis (EC) staff believes
that there are at least 54 suppliers of soft
infant and toddler carriers to the U.S.
market.6 Thirty-nine domestic firms
supply soft infant and toddler carriers to
the U.S. market: 23 are domestic
manufacturers; eight are domestic
importers; and eight firms have
unknown supply sources. In addition,
12 foreign firms supply soft infant and
toddler carriers to the U.S. market.
CPSC has insufficient information
available to categorize the remaining
three firms.7
According to a 2005 survey conducted
by the American Baby Group (2006
Baby Products Tracking Study), 51
percent of new mothers own soft infant
and toddler carriers.8 Approximately 30
percent of soft infant and toddler
carriers are handed down or purchased
secondhand.9 Thus, about 70 percent of
soft infant and toddler carriers are
acquired new. This estimate suggests
that approximately 1.5 million soft
infant and toddler carriers are sold to
households annually (0.51 x 0.70 x 4.1
million births per year).10
Many soft infant and toddler carriers
have expanded their maximum weight
limits in recent years to accommodate
older children. However, from the lack
of incident data involving children
older than 2 years, CPSC staff believes
that most caregivers would not be
comfortable carrying older, heavier
children in soft infant and toddler
carriers. Based on the incident data, it
appears that soft infant and toddler
carriers are used during a child’s first
year, with some caregivers continuing to
6 Staff conducted research to identify
manufacturers and importers of soft carriers. From
the time of the NPR to the final rule, several firms
entered the market, raising the number of suppliers
from 39 in the NPR to 54 presently.
7 CPSC staff made these determinations using
information from Dun & Bradstreet and
ReferenceUSAGov, as well as the firms’ Web sites.
8 The data collected for the Baby Products
Tracking Study does not represent an unbiased
statistical sample. The sample of 3,600 new and
expectant mothers is drawn from American Baby
magazine’s mailing lists. Also, because the most
recent survey information is from 2005, the
information may not reflect the current market.
9 The data on secondhand products for new
mothers was not available. Instead, data for new
mothers and experienced mothers were combined
and broken down into first-time mothers and
experienced mothers. Data for first-time mothers
and experienced mothers have been averaged to
calculate the approximate percentage of soft infant
and toddler carriers that were handed down or
purchased secondhand.
10 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. The number of live births in 2009 is
rounded from 4,130,665.
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use these products into the second year.
While we do not know the proportion
of caregivers who continue to use these
products into the second year, we
estimated the numbers of soft infant and
toddler carriers in use by assuming that
a portion of caregivers, e.g., 25–50
percent, will continue to use carriers in
the child’s second year. Based on data
from the 2006 Baby Products Tracking
Study, approximately 2.1 million soft
infant and toddler carriers are owned by
new mothers. Assuming that 25–50
percent of caregivers continue to use
soft infant and toddler carriers in the
second year, approximately 2.6 million
(2.1 million × 0.25 × 2.1 million) to 3.2
million (2.1 million × 0.50 × 2.1 million)
households have soft infant and toddler
carriers available for use annually.
Based on Directorate for Epidemiology
staff’s estimate of 1,400 injuries treated
nationally in emergency departments
from 1999 to 2011, an average of about
108 emergency department-treated
injuries involve soft infant and toddler
carriers annually.11 Therefore, about
0.34¥0.40 emergency departmenttreated injuries may occur annually for
every 10,000 soft infant and toddler
carriers available for use.
C. Reason for Agency Action and Legal
Basis for the Final Rule
The Danny Keysar Child Product
Safety Notification Act, section 104 of
the CPSIA, requires the CPSC to
promulgate mandatory standards for
nursery products that are substantially
the same as, or more stringent than, the
voluntary standard. Staff recommends
adopting the voluntary standard (ASTM
F2236–14), without modification.
D. Requirements of the Final Rule
The requirements of the final rule are
set forth above in section V of this
preamble, which describes ASTM
F2236–14.
E. Issues Raised by Public Comments
Section IV of this preamble contains
a summary of the five comments
received and the issues raised by the
comments.
11 Memorandum from Risana Chowdhury,
Directorate for Epidemiology, dated March 11,
2013, Subject: Soft Infant and Toddler CarrierRelated Deaths, Injuries, and Potential Injuries, and
NEISS Injury Estimates; 1999–September 10, 2012.
CPSC staff cannot present national emergency
department-treated injury estimates for 2012 due to
insufficient numbers of NEISS incidents reported
during the time period, and 2013 data is not yet
available. Memorandum from Risana Chowdhury,
Directorate for Epidemiology, dated September 23,
2013, Subject: Soft Infant and Toddler CarrierRelated Deaths, Injuries, and Potential Injuries
between September 11, 2012 and July 15, 2013.
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F. Other Federal Rules
Two federal rules interact with the
soft infant and toddler carrier
mandatory standard: (1) Testing and
Labeling Pertaining to Product
Certification (16 CFR part 1107); and (2)
Requirements Pertaining to Third Party
Conformity Assessment Bodies (16 CFR
part 1112). The regulation at 16 CFR
part 1107 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. Because soft infant and
toddler carriers will be subject to a
mandatory children’s product safety
rule, they will also be subject to the
third party testing requirements of 16
CFR part 1107 when the soft infant and
toddler carrier mandatory standard
becomes effective.
In addition, 16 CFR part 1107 requires
the third party testing of children’s
products to be conducted by CPSCaccredited laboratories. Section 14(a)(3)
of the CPSA required the Commission to
publish a notice of requirements (NOR)
for the accreditation of third party
conformity assessment bodies (i.e.,
testing laboratories) to test for
conformance with each children’s
product safety rule. The NORs for
existing rules are set forth in 16 CFR
part 1112. The Commission is finalizing
an amendment to 16 CFR part 1112 that
establishes the requirements for the
accreditation of testing laboratories to
test for compliance with the soft infant
and toddler carrier final rule.
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G. Impact on Small Businesses
The FRFA is limited to the 39
domestic firms known to be marketing
soft infant and toddler carriers in the
United States because U.S. Small
Business Administration (SBA)
guidelines and definitions pertain to
U.S.-based entities. Under SBA
guidelines, a manufacturer of soft infant
and toddler 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, 32 of the 39 domestic
firms supplying soft infant and toddler
carriers to the U.S. market are small
firms—18 manufacturers, six importers,
and eight firms—whose supply source is
unknown. Additional unknown small
soft infant and toddler carrier suppliers
may also operate in the U.S. market.
One purpose of the regulatory
flexibility analysis is to evaluate the
impact of a regulatory action and
determine whether the impact is
economically significant. While the SBA
gives considerable flexibility in defining
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‘‘economically significant,’’ CPSC staff
typically uses one percent of gross
revenue as the threshold for
determining ‘‘economic significance.’’
CPSC staff considers any impact that is
one percent or more of gross revenue is
considered economically significant.
SBA has accepted the one percent of
gross revenue threshold and this
threshold is also commonly used by
agencies in determining economic
significance.12
Small Manufacturers: The expected
impact of the final rule on small
manufacturers will differ, based on
whether manufacturers’ soft infant and
toddler carriers are already compliant
with F2236–13. Although F2236–14 was
published in January 2014, firms are
still likely to be testing to F2236–13.
However, because ASTM F2236–13,
ASTM F2236–13a, and ASTM F2236–14
do not contain material differences,
manufacturers in compliance with
ASTM F2236–13 are likely to continue
to comply with the voluntary standard.
The Juvenile Products Manufacturers
Association (JPMA), the major U.S.
trade association that represents
juvenile product manufacturers and
importers, has certified several soft
infant and toddler carriers as compliant
with the voluntary standard, and other
manufacturers have claimed compliance
with the voluntary standard. Based on
this information, 11 of 18 domestic
manufacturers comply with ASTM
F2236–13. These 11 firms should not
require any modifications to their
products and, as such, the firms should
not be impacted by incorporation of
ASTM F2236–14 as the final rule.
Meeting ASTM F2236–14’s
requirements could require some
modifications for seven of the 18
domestic manufacturers who are
believed not to be currently compliant
with ASTM F2236–13. Based upon past
discussions with firms and Engineering
Sciences staff, necessary modifications
would likely involve adding or changing
straps, fasteners, or fabrics and generally
would be less expensive to accomplish
than a complete product redesign.
Therefore, in most cases, the impact of
the final rule is not expected to have a
significant effect on products that do not
comply with ASTM F2236–13.
Under section 14 of the CPSA, soft
infant and toddler carriers are also
subject to third party testing and
certification requirements. Once the
12 U.S. Small Business Administration, Office of
Advocacy. A Guide for Government Agencies: How
to Comply with the Regulatory Flexibility Act and
Implementing the President’s Small Business
Agenda and Executive Order 13272. May 2012, pgs.
18–20. https://www.sba.gov/sites/default/files/
rfaguide_0512_0.pdf.
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new soft infant and toddler
requirements become effective, all
manufacturers will be subject to the
additional costs associated with the
third party testing and certification
requirements under the testing rule,
Testing and Labeling Pertaining to
Product Certification (16 CFR part
1107). Third party testing will pertain to
any physical and mechanical test
requirements specified in the soft infant
and toddler carrier final rule; lead and
phthalates testing is already required.
Third party testing costs are in addition
to the direct costs of meeting the soft
infant and toddler standard.
Based on information from the
durable nursery product industry and
confidential business information
supplied for the development of the
third party testing rule, CPSC staff
estimates that testing to a single ASTM
voluntary standard could cost around
$500–$600 per model sample. On
average, each small domestic
manufacturer supplies two different
models of soft infant and toddler
carriers to the U.S. market annually.
Therefore, if third party testing to the
requirements in the soft infant and
toddler standard is conducted every
year on a single sample for each model,
third party testing costs associated for
each manufacturer would be about
$1,000–$1,200 annually. Based on an
examination of estimates of firms’
revenues from recent Dun & Bradstreet
reports, the impact of third party testing
is not likely to be economically
significant if only one sample per model
is required. However, if more than one
sample is needed to meet the testing
requirements, third party testing costs
could have an economically significant
impact on some small manufacturers
(i.e., testing costs could be one percent
or more of gross revenue). CPSC staff
does not know exactly how many
samples each manufacturer will need to
test to meet the ‘‘high degree of
assurance’’ criterion required by 16 CFR
part 1107.
Small Importers: Most importers will
not experience significant impacts as a
result of the final rule. CPSC staff
believes that four of the six small
importers are compliant with the
voluntary standard. The remaining
importers may need to find an alternate
source of soft infant and toddler carriers
if their existing suppliers do not come
into compliance with the requirements
of the final rule. Alternatively, the firms
may discontinue importing soft infant
and toddler carriers altogether and
perhaps substitute another juvenile
product.
As is the case with manufacturers, all
importers will be subject to third party
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testing and certification requirements,
and consequently, they will experience
the associated costs, if their supplying
foreign firm(s) does not perform third
party testing. The resulting costs could
potentially have a significant impact on
a few small importers that must perform
the testing themselves, particularly if
more than one sample per model is
required.
Eight small firms have unknown
supply sources, three of which appear to
be compliant with ASTM F2236–13 and
should not be impacted by the
incorporation of ASTM F2236–14 as the
mandatory final rule. The remaining
five firms may need to make small
changes to their products to be
compliant with ASTM F2236–14. Due to
the nature of the product, the
modifications should be limited to
changes in straps or fasteners and
should not have a significant impact.
is generally considered sufficient time
for suppliers to come into compliance
with a durable infant and toddler
product rule. Setting a later effective
date would allow suppliers additional
time to modify and/or develop
compliant soft infant and toddler
carriers and spread the associated costs
over a longer period of time. However,
given that the changes to meet the
standard are not substantial, CPSC staff
believes that 6 months is sufficient.
H. Alternatives
VIII. Environmental Considerations
The Commission’s regulations address
whether we are required to prepare an
environmental assessment or an
environmental impact statement. If our
rule has ‘‘little or no potential for
affecting the human environment,’’ the
rule will be categorically exempted from
this requirement. 16 CFR 1021.5(c)(1).
The final rule for soft infant and toddler
carriers falls within the categorical
exemption.
One alternative would be to set an
effective date for the final rule later than
the staff-recommended 6 months, which
IX. Paperwork Reduction Act
This 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 (44 U.S.C. 3501–3520). The
preamble to the proposed rule (78 FR at
20520 through 20521) discussed the
information collection burden of the
proposed rule and specifically requested
comments on the accuracy of our
estimates. OMB has assigned control
number 3041–0162 to this information
collection. We did not receive any
comment regarding the information
collection burden of the proposal.
However, the final rule makes
modifications regarding the information
collection burden because the number
of estimated manufacturers subject to
the information collection burden is
now estimated at 54 manufacturers
rather than the 39 manufacturers
initially estimated in the proposed rule.
Accordingly, the estimated burden of
this collection of information is
modified as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
Number of
respondents
Frequency of
responses
Total annual
responses
Hours per
response
Total burden
hours
1226 .....................................................................................
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16 CFR section
54
2
108
1
108
Our estimate is based on the
following:
Section 8.1 of ASTM F2236–14
requires that all soft infant and toddler
carrier products and their retail
packaging be marked or labeled as
follows: the manufacturer, distributor,
or seller name, and either the place of
business (city, state, mailing address,
including zip code), or telephone
number, or both; and a code mark or
other means that identifies the date
(month and year as a minimum) of
manufacture.
CPSC is aware of 54 firms that supply
soft infant and toddler carriers in the
U.S. market. For PRA purposes, we
assume that all 54 firms use labels on
their products and on their packaging
already. However, firms might need to
make some modifications to their
existing labels. We estimate that the
time required to make these
modifications is about 1 hour per
model. Each of the 54 firms supplies an
average of two different models of soft
infant and toddler carriers. Therefore,
we estimate the burden hours associated
with labels to be 108 hours annually (1
hour × 54 firms × 2 models per firm =
108 hours annually).
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We estimate the hourly compensation
for the time required to create and
update labels is $27.71 (U.S. Bureau of
Labor Statistics, ‘‘Employer Costs for
Employee Compensation,’’ September
2013, Table 9, total compensation for all
sales and office workers in goodsproducing private industries: https://
www.bls.gov/ncs/). Therefore, we
estimate the annual cost to industry
associated with the labeling
requirements in the final rule to be
$2,992.68 ($27.71 per hour × 108 hours
= $2,992.68). This collection of
information does not require operating,
maintenance, or capital costs.
In compliance with the Paperwork
Reduction Act of 1995 (44 U.S.C.
3507(d)), we have submitted the
information collection requirements of
this final rule to the OMB.
X. 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
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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 applies to final
durable infant and toddler product final
rules. Therefore, the final rule issued
under section 104 of the CPSIA will
invoke the preemptive effect of section
26(a) of the CPSA when the final rule
becomes effective.
XI. Certification and Notice of
Requirements
Section 14(a) of the CPSA requires
that products subject to a consumer
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). Section 14(a)(2) of the CPSA
requires that certification of children’s
products subject to a children’s product
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Federal Register / Vol. 79, No. 60 / Friday, March 28, 2014 / Rules and Regulations
safety rule be based on testing
conducted by a CPSC-accepted third
party conformity assessment body.
Section 14(a)(3) of the CPSA requires
the Commission to publish a NOR for
the accreditation of third party
conformity assessment bodies (or
laboratories) to assess conformity with a
children’s product safety rule to which
a children’s product is subject. The final
rule for 16 CFR part 1226, ‘‘Safety
Standard for Soft Infant and Toddler
Carriers,’’ is a children’s product safety
rule that requires the issuance of a NOR.
Effective June 10, 2013, the
Commission published a final rule,
Requirements Pertaining to Third Party
Conformity Assessment Bodies, 78 FR
15836 (March 12, 2013), which codifies
16 CFR part 1112. Part 1112 establishes
requirements for accreditation of third
party conformity assessment bodies (or
laboratories) to test for conformance
with a children’s product safety rule in
accordance with Section14(a)(2) of the
CPSA. The final rule also codifies all of
the NORs that the CPSC has published,
to date. All new NORs, such as the soft
infant and toddler carrier standard,
require an amendment to part 1112.
Accordingly, the final rule amends part
1112 to include the soft infant and
toddler standard, along with the other
children’s product safety rules for
which the CPSC has issued NORs. The
final NOR is based on the CPSC’s
laboratory accreditation requirements
on the performance standard set forth in
the final rule for the safety standard for
soft infant and toddler carriers and the
test methods incorporated within this
standard.
Laboratories applying for acceptance
as a CPSC-accepted third party
conformity assessment body to test to
the new standard for soft infant and
toddler carriers are required to meet the
third party conformity assessment body
accreditation requirements in part 1112.
When a laboratory meets the
requirements as a CPSC-accepted third
party conformity assessment body, the
laboratory can apply to the CPSC to
have 16 CFR part 1226, Safety Standard
for Soft Infant and Toddler Carriers,
included in the laboratory’s scope of
accreditation of CPSC safety rules listed
for the laboratory on the CPSC Web site
at: www.cpsc.gov/labsearch.
A FRFA was conducted as part of the
promulgation of the original 16 CFR part
1112 (78 FR 15836, 15855–15858), as
required by the Regulatory Flexibility
Act. Briefly, the FRFA concluded that
the accreditation requirements would
not have a significant adverse impact on
a substantial number of small
laboratories because no requirements
were imposed on laboratories that did
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not intend to provide third party testing
services. The only laboratories expected
to provide such services are those that
anticipate receiving sufficient revenue
from the mandated testing to justify
accepting the requirements as a business
decision.
Based on similar reasoning, amending
the rule to include the NOR for the soft
infant and toddler carrier standard will
not have a significant adverse impact on
small laboratories. Moreover, based
upon the number of laboratories in the
United States that have applied for
CPSC acceptance of the accreditation to
test for conformance to other juvenile
product standards, we expect that only
a few laboratories will seek CPSC
acceptance of their accreditation to test
for conformance with the soft infant and
toddler carrier standard. Most of these
laboratories have already been
accredited to test for conformance to
other juvenile product standards, and
the only cost to them would be the cost
of adding the soft infant and toddler
standard to their scope of accreditation.
As a consequence, the Commission
certifies that the NOR for the soft infant
and toddler carrier standard will not
have a significant impact on a
substantial number of small entities.
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 1226
Consumer protection, Imports,
Incorporation by reference, Infants and
Children, Labeling, Law Enforcement,
and Toys.
For the reasons discussed in the
preamble, the Commission amends Title
16 of the Code of Federal Regulations by
amending part 1112 and adding a new
part 1226, 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: 15 U.S.C. 2063; Pub. L. No.
110–314, section 3, 122 Stat. 3016, 3017
(2008)
2. In § 1112.15 add paragraph (b)(37)
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?
*
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*
Frm 00047
*
Fmt 4700
(b) * * *
(37) 16 CFR part 1226, Safety
Standard for Soft Infant and Toddler
Carriers.
*
*
*
*
*
■
3. Add Part 1226 to read as follows:
PART 1226—SAFETY STANDARD FOR
SOFT INFANT AND TODDLER
CARRIERS
Sec.
1226.1 Scope.
1226.2 Requirements for soft infant and
toddler carriers.
Authority: The Consumer Product Safety
Improvement Act of 2008, Pub. L. 110–314,
Sec. 104, 122 Stat. 3016 (August 14, 2008);
Pub. L. 112–28, 125 Stat. 273 (August 12,
2011).
§ 1226.1
Scope.
This part establishes a consumer
product safety standard for soft infant
and toddler carriers.
§ 1226.2 Requirements for soft infant and
toddler carriers.
(a) Each soft infant and toddler carrier
must comply with all applicable
provisions of ASTM F2236–14,
Standard Consumer Safety Specification
for Soft Infant and Toddler Carriers,
approved on January 1, 2014. 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_federal
regulations/ibr_locations.html.
(b) [Reserved]
Dated: March 24, 2014.
Todd A. Stevenson,
Secretary, Consumer Product Safety
Commission.
[FR Doc. 2014–06771 Filed 3–27–14; 8:45 am]
BILLING CODE 6355–01–P
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Agencies
[Federal Register Volume 79, Number 60 (Friday, March 28, 2014)]
[Rules and Regulations]
[Pages 17422-17433]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-06771]
=======================================================================
-----------------------------------------------------------------------
CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Parts 1112 and 1226
[Docket No. CPSC-2013-0014]
Safety Standard for Soft Infant and Toddler Carriers
AGENCY: Consumer Product Safety Commission.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Danny Keysar Child Product Safety Notification Act,
section 104 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. Durable infant and
toddler standards must 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 issuing this final rule establishing a safety standard for soft
infant and toddler carriers in response to the direction under section
104(b) of the CPSIA.
DATES: The rule will become effective September 29, 2014 and apply to
product manufactured or imported on or after that date. The
incorporation by reference of the publication listed in this rule is
approved by the Director of the Federal Register as of September 29,
2014.
FOR FURTHER INFORMATION CONTACT: Julio A. Alvarado, Office of
Compliance and Field Operations, Consumer Product Safety Commission,
4330 East West Highway, Bethesda, MD 20814; telephone: 301-504-7418;
email: jalvarado@cpsc.gov.
SUPPLEMENTARY INFORMATION:
I. Background and Statutory Authority
The Consumer Product Safety Improvement Act of 2008 (CPSIA, Pub L.
110-314) 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: (1) Examine and assess the effectiveness of
voluntary consumer product safety standards for durable infant or
toddler products, in consultation with representatives of consumer
groups, juvenile product manufacturers, and independent child product
engineers and experts; and (2) promulgate consumer product safety
standards for durable infant and toddler products. Durable infant and
toddler standards must 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.'' Section 104(f)(2)(H) of the CPSIA specifically
identifies ``infant carriers'' as durable infant or toddler products.
The Commission has identified at least four types of products that fall
within the product category of ``infant carriers,'' including: Frame
backpack carriers, hand-held infant carriers, slings, and soft infant
and toddler carriers.
On April 5, 2013, the Commission issued a notice of proposed
rulemaking (NPR) for soft infant and toddler carriers. 78 FR 20511. The
NPR proposed to adopt as a mandatory standard the current voluntary
standard for soft infant and toddler carriers, ASTM F2236-13,
``Standard Consumer Safety Specification for Soft Infant and Toddler
Carriers'' (ASTM F2236-13), without alteration.
The Commission is issuing a final mandatory safety standard for
soft infant and toddler carriers. Pursuant to section 104(b)(1)(A) of
the CPSIA, the Commission consulted with manufacturers, retailers,
trade organizations, laboratories, consumer advocacy groups,
consultants, and members of the public to develop this standard,
largely through the ASTM process. After publication of the NPR, ASTM
approved two revised versions of F2236-13, F2236-13a, on November 1,
2013, and F2236-14, on January 1, 2014. The revisions included in ASTM
F2236-14 clarify several issues raised in the comments received on the
NPR. Furthermore, the Commission finds that the revisions included in
ASTM F2236-14 adequately address the comments received on the NPR.
Section V of the preamble below discusses clarifying changes to the
standard. The final rule for soft infant and toddler carriers
incorporates ASTM F2236-14, by reference, without alteration.
II. Product Description
A. Definition of a Soft Infant and Toddler Carrier
ASTM F2236-14 defines a ``soft infant and toddler carrier'' as ``a
product, normally of sewn fabric construction, which is designed to
contain a full term infant to a toddler, generally in an upright
position, in close proximity to the caregiver.'' Additionally, soft
infant and toddler carriers are generally designed to carry a child
``between 7 and 45 pounds.'' ASTM F2236-14 explains that soft infant
and toddler carriers are ``normally `worn' by the caregiver with a
child positioned in the carrier and the weight of the child and carrier
suspended from one or both shoulders of the caregiver. These products
may be worn on the front, side, or back of the caregiver's body, with
the infant either facing towards or away from the caregiver.''
Typically, children
[[Page 17423]]
are carried in soft infant and toddler carriers on the front of a
caregiver; but some products on the market can be configured to carry a
child upright on a caregiver's front, back, or hip.
In the United States, soft infant and toddler carriers are
available in two broad classes: Structured and nonstructured.
Structured soft infant and toddler carriers contain straps and waist
belts that connect to the seat area and other carrier components with
buckles, straps, and mechanical fasteners. The straps, belts, and
seating area of these products are often stiffened with padding and
typically have a heavy textile covering. Nonstructured products consist
of a flat, textile center with waist straps and very long upper straps
(5 to 6 feet) that wrap around the caregiver and are secured by typing
the ends of the straps, such as the mei-tai design. ASTM F2236-14 does
not distinguish between products based on whether they are structured
or nonstructured; therefore, requirements apply equally to all types of
soft infant and toddler carriers.
ASTM F2236-14's definition of a ``soft infant and toddler carrier''
distinguishes soft infant and toddler carriers from other types of
infant carriers that are also worn by a caregiver but that are not
covered under ASTM F-2236-14, specifically slings (including wraps),
and framed backpack carriers. Soft infant and toddler carriers are
designed to carry a child in an upright position. Slings are designed
to carry a child in a reclined position. However, some slings may also
be used to carry a child upright. Thus, the primary distinction between
a sling and a soft infant and toddler carrier is that a sling allows
for carrying a child in a reclined position. Different hazard patterns
arise from carrying a child in a reclined position. Accordingly, slings
are not covered by the standard for soft infant and toddler carriers.
Like soft infant and toddler carriers, framed backpack carriers are
intended to carry a child in an upright position. However, framed
backpack carriers are distinguishable from soft infant and toddler
carriers because typically, backpack carriers are constructed of sewn
fabric over a rigid frame and are intended solely for carrying a child
on the caregiver's back.
III. Incident Data
The preamble to the NPR summarized incident data involving soft
infant and toddler carriers reported to the Commission from January 1,
1999 to September 10, 2012. 78 FR 20513 (April 5, 2013). CPSC's
Directorate for Epidemiology, Division of Hazard Analysis updated this
information for the final rule to include soft infant and toddler
carrier-related incident data reported to the Commission from September
11, 2012 through July 15, 2013. During the September 11, 2012 to July
15, 2013 time frame, CPSC received 31 new incident reports related to
soft infant and toddler carriers. Two of the incidents were fatal, and
29 were nonfatal. Twenty-four of the 29 nonfatal incidents involved
injuries. The total count of reported incidents includes emergency
department-treated injuries (i.e., injuries reported through the
National Electronic Injury Surveillance System (NEISS)).\1\ CPSC staff
cannot present national emergency department-treated injury estimates
for the final rule due to insufficient numbers of NEISS incidents
reported during the time period. The number of incidents occurring in
2012 and 2013 is subject to change because the CPSC continues to
collect information about such incidents.
---------------------------------------------------------------------------
\1\ CPSC's NEISS database is a national probability sample of
hospitals in the United States and its territories. Patient
information is collected from each NEISS hospital for every
emergency visit involving an injury associated with consumer
products. From this sample, the total number of product-related
injuries treated in hospital emergency rooms nationwide can be
estimated.
---------------------------------------------------------------------------
A. Fatalities
Both reported fatalities involved suffocation. One suffocation
fatality occurred in 2010. The decedent was a 17-day-old infant who was
being carried in a soft infant and toddler carrier--facing the mother--
while the mother ran errands. The mother reportedly breast fed the
victim while walking. The report is unclear about whether the victim
was out of the carrier or in the carrier while being fed. The mother
found the child nonresponsive in the carrier. The child was placed on
life support, which was later removed due to the child's poor
prognosis. The second suffocation fatality occurred in 2011. The
decedent, a 4-month-old female, was placed prone to sleep on a bed
while still in a soft infant carrier.\2\
---------------------------------------------------------------------------
\2\ According to CPSC Human Factors staff, this scenario
represents an unsafe sleep environment. The prone sleep position is
a known risk factor for SIDS, and placing an infant to sleep face
down on top of a bed may increase the risk of suffocation. Sleeping
in the prone position on a bed with an infant still inside a carrier
may further increase the suffocation risk.
---------------------------------------------------------------------------
B. Nonfatalities
Twenty-nine soft infant and toddler carrier-related nonfatal
incidents were reported to the CPSC from September 11, 2012 to July 15,
2013. The incident reports demonstrate that an injury occurred in 24 of
the 29 incidents. The children's age was unreported or unknown in four
of the 29 nonfatal incidents. For the remaining 25 incidents, the ages
provided in the reports ranged from 1 month to 18 months, with 64
percent of the total reports involving children 6 months of age or
younger.
Among the 24 nonfatal injuries reported, four incidents required
hospitalization. Two of the four injuries requiring hospitalization, a
skull fracture and a leg fracture, resulted from infants falling out of
a soft infant and toddler carrier. The other two injuries that required
hospitalization were head injuries to the infant resulting from the
caregiver falling. Other injuries included contusions, abrasions, and
lacerations, mostly of the head and face. Fourteen of the injuries
resulted from falls, either from the caregiver falling while wearing
the carrier or from the infant falling out of the carrier.
The remaining five incident reports stated problems with the
product but indicated that either no injury had occurred or the report
failed to provide information about any injury.
C. Hazard Pattern Identification
CPSC identified hazard patterns among the 31 new incident reports
that were similar to the hazard patterns identified among the incidents
considered for the NPR. The primary hazard associated with use of a
soft infant and toddler carrier continues to be falling, either
caregivers falling while wearing the carrier and injuring the child in
the carrier, or children falling or facing the risk of falling from the
carrier. Hazard patterns are grouped into the following categories in
order of frequency of incident reports:
Caregiver falls (11) \3\;
---------------------------------------------------------------------------
\3\ All of the fall incidents were emergency department-treated
injury (NEISS data) reports.
---------------------------------------------------------------------------
structure, fit, and position issues (7);
design and finish-related issues \4\ (2), (which are also
among the 7 in the previous category);
---------------------------------------------------------------------------
\4\ Finish-related issues concern items such as material
smoothness and lead content.
---------------------------------------------------------------------------
strap issues (2);
issues with stitching/seams (1); and
other issues (10).
Caregiver Falls: Eleven of the 31 incidents (35 percent) reported
injuries to the infant in the carrier, when the caregiver slipped or
tripped and fell. All of these were emergency department-treated injury
(NEISS data) reports.
Structure, fit, and position issues: Seven of the 31 incidents (23
percent) were related to aspects of the leg- and torso-opening design,
how the carrier held the infant, and where the soft
[[Page 17424]]
infant and toddler carrier was positioned on the caregiver. Examples of
scenarios reported include: an infant slipping far down into the
carrier and suffering an injury when the caregiver bent over; an infant
falling out of the carrier when the caregiver bent forward; and leg
circulation-related injuries to the infant. Three injuries were
reported in this category, including one hospitalization.
Design-related issues: Two of the reports included in the
structure, fit, and position category above stated complaints about how
the carrier fit on the caregiver and that the infant got too hot when
the carrier was used with the carrier insert. A carrier insert is
available with some soft infant and toddler carriers to help support a
young infant's head and neck. No one reported injuries in this
category.
Strap issues: Two of the 31 incidents (six percent) reported issues
with straps, mostly regarding the adjuster breaking or slipping. Both
incidents resulted in injuries, including one hospitalization for a
skull fracture stemming from a fall when the strap came undone.
Issues with stitching/seams: One incident report (three percent)
stated that stitching on a carrier component came undone. However, the
infant sustained no injury.
Other issues: Ten incident reports (32 percent) involved non-
product-related issues or provided insufficient information for CPSC
staff to determine definitively how the product contributed to the
incident. The two fatalities are included in this category--one case of
an infant suffering respiratory distress while being carried facing
inward, and the other case involved an infant put to sleep in a prone
position on a bed while still in a soft infant and toddler carrier. In
each case, CPSC staff concluded that insufficient information was
reported to determine a predominant factor about the product that
contributed to the death. Five reports were of incidental injuries
sustained by infants while being carried around in a soft infant and
toddler carrier. Examples of such incidents include an infant who hit a
pole after a bus in which the child was riding suddenly accelerated and
an infant who got hurt while being put into a carrier. The remaining
three reports involved infants who fell out of the carrier, with no
additional information specified.
D. NEISS Data
The soft infant and toddler carrier NPR presented a separate
national injury estimate for the 13-year period from January 1999
through December 2011. However, insufficient emergency department-
treated injuries associated with soft infant and toddler carriers in
2012 prevent derivation of reportable national estimates.\5\ In
addition, until NEISS data for 2013 are finalized in spring 2014,
partial estimates for 2013 are not available. Hence, injury estimates
are not presented separately in this final rule. However, the emergency
department-treated injuries are included in the total count of reported
incidents presented in section III.C above.
---------------------------------------------------------------------------
\5\ According to the NEISS publication criteria, an estimate
must be 1,200 or greater, the sample size must be 20 or greater, and
the coefficient of variation must be 33 percent or smaller.
---------------------------------------------------------------------------
IV. Response to Comments
CPSC received five comments regarding the NPR, including comments
from industry, consumer groups, trade associations, and consumers. The
comments address eight separate issues related to fastener strength
testing requirements, warning label revisions, and the effective date
of the final rule. Two commenters generally supported the rule.
Comments submitted in response to the NPR are available at:
www.regulations.gov, by searching under the docket number of the
rulemaking, CPSC-2013-0014. The Commission finds that revisions made to
the ASTM voluntary standard, which are incorporated into ASTM F2236-14,
approved on January 1, 2014, and published in January 2014, adequately
address comments received on the NPR. Accordingly, the Commission will
incorporate by reference the most recent version of the voluntary
standard, ASTM F2236-14, as the mandatory standard for soft infant and
toddler carriers.
We summarize the comments received on the NPR and CPSC's responses
below. To make identification of the comments and our responses easier,
we placed the word ``Comment,'' in parentheses, before the comment's
description, and the word ``Response,'' in parentheses, before our
response. Additionally, we have numbered each comment to help
distinguish among comments. The number assigned to each comment is for
organizational purposes only and does not signify the comment's value
or importance, or the order in which we received the comment.
A. Fastener Strength
(Comment 1) Two commenters stated that the specified fastener
strength test load of 80 pounds in section 7.7.2 of ASTM F2236-13 is
too high for soft infant and toddler carriers whose manufacturer-
recommended maximum occupant weight for the product is less than 45
pounds. The commenters suggested using a sliding scale for the test
load that would adjust the test load by 1 pound for every pound the
carrier is rated above or below 45 pounds. For example, for soft infant
and toddler carriers designed for a maximum occupant weight of 25
pounds, commenters recommended a fastener test load of 60 pounds (80
pounds minus 20 pounds) instead of an 80-pound force. One commenter
stated that for carriers designed for very small occupants, it would be
difficult for every load-bearing fastener to be designed to meet the
80-pound test load because such fasteners tend to be large and
difficult to handle gently when close to a small infant.
(Response 1) The Commission disagrees with the commenters and
declines to modify the final rule based on this comment. ASTM F2236-13
added requirements for fastener strength testing. Each unique load-
bearing fastener, except load-bearing fasteners used for a leg opening
adjustment, must not break or disengage when subjected to a tensile
load of 80-pound force for 5 seconds. The force is applied to the
straps or soft goods on either side of the fastener. Leg opening
adjustment fasteners are tested to a 45-pound force.
As noted in the NPR, CPSC staff tested fasteners on 14 different
soft infant and toddler carriers, including recalled carriers. The
manufacturer's recommended maximum occupant weight of the carriers
tested ranged from 20 pounds to 45 pounds. CPSC staff found that most
of the tested fasteners failed at loads well above the 80-pound force
used in the test, while some of the fasteners on recalled products
(which were rated at 26-pound maximum occupant weight) failed at 22
pounds to 55 pounds. The Commission agrees with CPSC staff that
lowering the test load to a 60-pound force on a carrier rated at 25
pounds does not provide a sufficient safety factor, considering that
fasteners from some recalled carriers failed at 55 pounds during
testing. Based on the test results, the Commission finds that an 80-
pound test load is appropriate, even for carriers with maximum occupant
weights below 45 pounds.
All of the buckle and strap fasteners on the 14 carriers that CPSC
staff tested were made from plastic. CPSC staff concluded that the
characteristics of the plastic used for the fasteners dictated the
fastener's ability to withstand the test load. The plastic material on
the fasteners that fractured at a lower load was much less ductile,
resulting in the fastener fracturing instead of deforming. Accordingly,
CPSC staff found that smaller fasteners were as capable as
[[Page 17425]]
larger fasteners at meeting the 80-pound test load. Staff concluded
that fastener strength was not necessarily proportional to fastener
size.
CPSC staff states that the 80-pound test load for the fastener pull
test is not directly related to the maximum carrier weight rating.
Rather, the 80-pound test load was established based on testing the
strength of fasteners on carriers already on the market. Fasteners that
meet the required test load are robust enough for expected use during
the life of the product. Moreover, CPSC staff believes that it is
reasonably foreseeable that some caregivers may use soft infant and
toddler carriers with infants whose weight exceeds the manufacturer's
recommended occupant weight.
For the reasons discussed, the Commission declines to modify the
final rule based on this comment.
B. Fasteners That Support the Head
(Comment 2) Two commenters stated that fasteners that support the
head should be exempt from load testing. Non-load-bearing fasteners
intended to retain items such as, but not limited to, hoods, bibs, and
toy rings are exempt from load testing in ASTM F2236-13. One of the
commenters stated: ``head support for new born babies is critical,''
but to achieve a good, adjustable head support requires fasteners that
are slim and easy to use. The commenter designs head support fasteners
to carry a certain load; however, the commenter stated that these
fasteners are not load bearing and should be exempt from load testing
in section 6.4 of the standard.
(Response 2) ASTM balloted and approved two clarifying changes to
Note 1 in section 6.4 of the standard, which have been incorporated
into ASTM F2236-14. These changes address the commenters' concern. Note
1 exempts non-load-bearing fasteners from the fastener strength tests
in section 6.4 and lists examples of non-load-bearing fasteners that
are exempt. We note that the list in Note 1 is not exhaustive, but
merely illustrative, and that other features attached to a soft infant
and toddler carrier by a non-load-bearing fastener are also exempt from
the fastener strength tests in section 6.4.
ASTM F2236-13, the proposed standard for adoption in the NPR,
stated that fasteners intended to retain items such as ``hoods, bibs
and toy rings'' were exempt from testing. The ASTM subcommittee for
soft infant and toddler carriers was aware of a feature called a
``sleeping hood'' that is attached to a soft infant and toddler carrier
by non-load bearing fasteners. The ``sleeping hood'' feature was
intended to be captured in ASTM F2236-13 Note 1 with the phrase
``hoods.'' To clarify that non-load-bearing fasteners used to retain
``sleeping hoods'' are exempt from testing, ASTM changed the word
``hoods'' in Note 1 to ``sleeping hoods.'' This revision was approved
and published in ASTM F2236-13a.
Subsequently, based on a manufacturer's concern that Note 1 was
still unclear about whether head adjustment fasteners that were non-
load bearing had to be tested, ASTM balloted and approved another
modification to Note 1. The second modification was incorporated into
ASTM F2236-14 and added ``head adjustment fasteners'' to the list of
examples of fasteners exempt from testing in Note 1. The Commission
agrees with the clarification and believes that these revisions to the
voluntary standard address the commenters' concern.
To the extent that commenters are suggesting that any potential
load-bearing fastener that supports the head should be excluded from
the fastener strength test in section 6.4 of the standard, the
Commission disagrees. CPSC found that on the 14 carriers tested, the
uppermost fastener generally supports the infant's upper torso and
shoulders, as well as the head, and therefore, the fastener is critical
to securing the infant in the carrier. Load-bearing fasteners that
support the head, upper torso, and shoulders are not exempt from
fastener-load testing requirements. The commenter apparently does not
intend to exempt this type of fastener from testing.
C. Fastener Strap Slip During Load Testing
(Comment 3) One commenter stated that the strap slippage
requirement as articulated in the standard (ASTM F2236-13, paragraphs
6.4.1 and 6.4.2) can result in a technical failure of an otherwise safe
product. The commenter found that during product testing, certain
straps can slip more than 1 inch but in a direction that makes the
straps become tighter, not looser. The commenter asserted that this
does not compromise safety. The commenter suggested that the language
in paragraph 6.4.1 should be changed from ``. . . adjustable elements
in straps shall not slip more than 1 in. (2.5 cm) when tested . . .''
to ``. . . adjustable elements in straps shall not loosen more than 1
in. (2.5 cm) when tested . . . .''
(Response 3) The strap slippage requirement in section 6.4.1 of
ASTM F2236-13, the standard referenced in the NPR, prevents the
fastener straps from slipping an appreciable amount through the buckles
during fastener strength testing. Significant slippage can result in a
minimal load being held by the fastener/strap and could result in the
strap pulling out of the fastener or loosening to the point that the
infant could fall out of the carrier. The commenter seeks to clarify
that straps that tighten during the test do not constitute a test
failure.
The Commission agrees that straps that tighten during testing
should not fail the strap retention requirement in the standard.
However, based on the CPSC staff's assessment, the Commission finds
that use of the word ``slip'' in the standard is more accurate than
``loosen.'' The amount of strap ``slip'' through a fastener can be
measured; whereas, CPSC staff is uncertain how to measure strap
``loosening.'' Additionally, the requirement for support/shoulder strap
slippage during the dynamic and static load testing in paragraph 6.2
uses the same wording, which states: ``adjustable sections of the
support/shoulder straps shall not slip more than 1 in. (25 mm) per
strap from their original adjusted position . . .'' Therefore, the
Commission will not replace the word ``slip'' with ``loosen'' in the
final rule, as suggested by the commenter.
After publication of the NPR, ASTM balloted and approved a
modification to the voluntary standard that addresses the commenter's
concern about straps that tighten during testing. ASTM F2236-14
incorporates a revision to sections 6.2.2, 6.4.1, and 6.4.2 of the
voluntary standard to state: ``straps shall not slip, in a manner that
loosens the strap, by more than 1 inch.'' This modification was
included in the voluntary standard, beginning with revision ASTM F2236-
13a.
The Commission finds that the revisions now incorporated into
sections 6.2.2, 6.4.1, and 6.4.2 of ASTM F2236-14 addresses the
commenter's concern and clarifies when fasteners pass the fastener
strength test requirement without substantively altering the test
method.
D. Warning Text Format
(Comment 4) One commenter noted that in ASTM F2236-13, the text
height requirement for the warnings provided with product instructions
specified in section 9.2.2 needs to be modified to match the text
height requirement for warning labels in section 8.3.1. The commenter
stated that if this modification is not made, section 9.2.2 would
require every letter of warning text to be at least 0.1
high, instead of only the upper case letters, as is the case in section
8.3.1.
(Response 4) The Commission agrees that the text height requirement
for
[[Page 17426]]
warnings should be consistent throughout the standard. To address the
commenter's concern, ASTM balloted and approved the following modified
text in section 9.2.2, as follows (additions are shown by italics):
[GRAPHIC] [TIFF OMITTED] TR28MR14.035
Section 9.2.2 of the voluntary standard incorporates this revision,
beginning with ASTM F2236-13a. The Commission believes that the revised
language addresses the commenter's concern.
E. Suffocation Warning
(Comment 5) One commenter stated that the required warning
statement should read: ``Infants, especially those under four months,
can suffocate in this product if face is pressed tight against your
body,'' rather than the warning statement in the proposed rule, as
provided in the ASTM standard: ``Suffocation Hazard--Infants under 4
months can suffocate in this product if face is pressed tight against
your body.'' The commenter said that this warning language does not
adequately warn the user of the risk of suffocation for infants over
four months and that the suggested warning statement will alert parents
and other caregivers to a risk to older babies as well.
(Response 5) The Commission disagrees that the proposed suffocation
warning, as provided in the ASTM voluntary standard, does not
adequately warn users of the risk of suffocation. The primary mechanism
for suffocation in a soft infant and toddler carrier is the infant's
face being pressed tightly against a caretaker's body, obstructing the
nose and mouth and keeping the infant's head from moving. Infants
younger than 4 months old are mostly at risk because they do not have
the head control or the muscle strength to move their head away if
their airway becomes obstructed. By 4 months of age, infants have
increased neck strength and can hold their heads up and explore their
surroundings while the caretaker is walking. Infants who are 4 months
old can be carried in the outward-facing position in soft infant and
toddler carriers that allow this carry position. At around age 6
months, infants begin to sit upright unassisted. Caretakers can carry
infants of this age in a soft infant and toddler carrier on the hip or
on the caregiver's back, depending on the caretaker's level of comfort.
As children reach toddlerhood, caregivers can carry children in this
age group in a carrier on the hip or back depending on the carrier
type. Given that infants from age 4 months and older have developed
head control and muscular strength and can be placed in outward facing,
hip, and back carry positions, their face is less likely to become
pressed tightly into a caretaker's body. Therefore, the risk of
suffocation for these children is low. The Commission has not received
data indicating that a risk of suffocation exists for children 4 months
and older.
Identifying explicitly children who are most at risk does not
suggest that others are not at risk. However, guidelines for warning
labels recommend focusing on the most likely and most serious risks
(Laughery and Hammond, 1999; Wogalter, 2006). Warnings about low-
probability events (i.e., older infants suffocating in soft infant
carriers) may reduce the believability or arousal strength of warnings
that caution of more likely risks (i.e., infants under 4 months
suffocating in soft infant carriers). The Commission finds that the
current ASTM warning label about the suffocation hazard is sufficient
without modification.
F. Stability Warning
(Comment 6) One commenter stated: ``we are concerned that raising
the upper weight limits, for the purpose of ensuring that all soft
infant and toddler carriers on the market are covered by the rule,
brings in carriers that might have a greater risk of instability and
falls due to the extra weight load relative to the weight and strength
of the caregiver. We would urge the Commission to include an adequate
alert to this risk in the required warnings and instructions.''
(Response 6) During the rulemaking, CPSC staff identified soft
infant and toddler carriers on the market that have a manufacturer-
recommended upper weight limit of 45 pounds. The Commission believes
that expanding the scope of the standard to increase the upper weight
limit from 25 pounds to 45 pounds is necessary for the standard to
cover all products on the market. However, for the Commission to
include a warning statement about the greater risk of instability and
falls involving products with higher weight limits, data must be
available to demonstrate that carrying heavier children in soft infant
and toddler carriers presents a greater risk of instability and falls.
At this time, the available data do not support this position.
Furthermore, the commenter did not provide data demonstrating that
products with higher weight limits present a greater risk of
instability and falls than carriers with a lower weight limit.
Therefore, at this time, the Commission declines to modify the warning
label as suggested by the commenter.
G. Product Marking
(Comment 7) One commenter recommended that the CPSC require that
products manufactured after the effective date of the final rule be
marked as compliant, so that consumers can identify clearly products
that meet the new mandatory standard for soft infant and toddler
carriers.
(Response 7) The Commission finds that sufficient incentive exists
for compliant producers to label their products as compliant with the
final standard for soft infant and toddler carriers. A final rule
implementing testing, certification, and labeling of children's
products in section 14 of the CPSA, as amended by the CPSIA, Testing
and Labeling Pertaining to Product Certification, 16 CFR part 1107 (the
1107 rule), became effective on February 13, 2013. Under the 1107 rule,
a manufacturer or importer may label a certified compliant product as
``Meets CPSC Safety Requirements.'' Because producers are already
allowed to label compliant products as such under the 1107 rule, adding
this option to the soft infant and toddler carrier standard would be
redundant. The Commission declines to change to the final rule based on
this comment.
H. Effective Date
(Comment 8) Two commenters address the 6-month effective date
proposed in the NPR. One commenter,
[[Page 17427]]
representing several advocacy groups, expressed support for the 6-month
effective date. Another commenter, a soft infant and toddler carrier
manufacturer, recommended a 12-month effective date, stating that the
manufacturing process can take up to 6 months, and the product may be
stocked in a warehouse for additional months, depending on sales.
(Response 8) The final standard will not be applied retroactively
to products manufactured prior to the effective date of the final rule.
Thus, any products warehoused before the effective date will not be
affected by the standard. Manufacturers should be able to comply with
the mandatory standard within 6 months of the final rule's publication.
Manufacturers whose products do not comply with the standard will
require some product modification. However, product modification is
expected to involve minor changes, such as adding or changing straps or
fasteners. Moreover, ASTM F2236-13 was adopted by ASTM in March 2013,
and became effective in September 2013. Although the Commission is
adopting ASTM F2236-14 as the mandatory standard, no substantive
changes have been made to the voluntary standard since ASTM F2236-13.
Manufacturers that comply with ASTM F2236-13 have already made, or have
begun to make, the necessary modifications. The Commission declines to
change the effective date of the final rule based on this comment.
V. Summary of ASTM F2236-14
The Commission is issuing this final rule for soft infant and
toddler carriers that incorporates by reference the most recent
voluntary standard for soft infant and toddler carriers, ASTM F2236-14.
Together with the changes made in ASTM F2236-12, ASTM F2236-13, and
ASTM F2236-13a, ASTM F2236-14 reflects the most significant revisions
to the standard to date. Revisions to the voluntary standard include
modified and new requirements developed by CPSC staff, working with
stakeholders on the ASTM subcommittee task group, to address the
hazards associated with soft infant and toddler carriers. After the
comment period for the NPR closed, the ASTM F15.21 Soft Infant and
Toddler Carrier subcommittee held a teleconference on August 12, 2013,
to discuss comments submitted on the NPR. The subcommittee discussed
the basis for each comment and reached a consensus on revisions to be
submitted for ballot. The subcommittee chair balloted the proposed
revisions to ASTM F2236-13 for concurrent ASTM Main Committee F15 and
Subcommittee F15.21 consideration on August 23, 2013, with a 1- month
comment period. The August 23, 2013 ballot contained three revisions to
the voluntary soft infant and toddler carrier standard:
Revisions to sections 6.2.2, 6.4.1, and 6.4.2 to clarify
that during the dynamic load, static load, and fastener strength tests,
straps shall not slip, in a manner that loosens the strap, more than 1
inch.
A revision to Note 1 in section 6.4 to clarify that
``sleeping hoods'' are an example of non-load-bearing fasteners that
are exempt from fastener strength testing.
A revision to section 9.2.2 to clarify that the text
height requirements for the warnings included with instructions in
section 9.2.2 are the same as the text height requirements for warnings
required in section 8.3.1 of the voluntary standard.
ASTM did not receive any negative votes on the balloted revisions to
ASTM F2236-13. ASTM approved the balloted revisions on November 1,
2013, and subsequently published ASTM F2236-13a in November 2013.
On September 26, 2013, the ASTM F15.21 Soft Infant and Toddler
Carrier subcommittee met to discuss results of the items balloted on
August 23, 2013. One manufacturer wanted the voluntary standard to
further clarify that fasteners used for adjusting the head portion of
the carrier were exempt from fastener strength testing because such
fasteners are not load bearing. As a result, the subcommittee chair
developed a draft ballot item that proposed to add ``head adjustment
fasteners'' to the list of examples of fasteners that are exempt from
load testing listed in Note 1 of section 6.4. The subcommittee chair
balloted the proposed revision to ASTM F2236-13a for concurrent ASTM
Main Committee F15 and Subcommittee F15.21 consideration on November 6,
2013, with a 1-month comment period. ASTM did not receive any negative
votes on the balloted revision, and approved the revised standard, ASTM
F2236-14, on January 1, 2014. ASTM published ASTM F2236-14 in January
2014.
We summarize the provisions of ASTM F2236-14 below. Each revision
to ASTM F2236-13 discussed above is described below in more detail in
the relevant section of the standard where the change appears. ASTM
F2236-14 includes the following key provisions: scope, terminology,
general requirements, performance requirements, test methods, marking
and labeling, and instructional literature.
Scope. The scope of the voluntary standard was broadened in
December 2012 to include soft infant and toddler carriers with an upper
weight limit of up to 45 pounds. Previously, it was unclear whether
carriers with upper weight limits over 25 pounds fell within the
standard. Expanding the scope of the standard clarifies that all soft
infant and toddler carrier products currently on the market fall within
the standard. The name of the standard was changed in 2012 to include
the word ``toddler,'' to clarify that toddlers can also be carried in
these products. The scope of the standard also distinguishes soft
infant and toddler carriers from other wearable infant carrier
products. The scope provides that soft infant and toddler carriers are
``normally of sewn fabric construction,'' hold the child ``generally in
an upright position,'' and ``may be worn on the front, side, or back of
the caregiver's body.'' Finally, the scope of the standard states that
the standard does not apply to infant slings.
Terminology. Section 3.1 of the standard includes 14 definitions to
help explain general requirements and performance requirements. Section
3.1.7 of the standard explains that a ``leg opening'' is the ``opening
in the soft carrier through which the occupant's legs extend when the
product is used in the manufacturer's recommended use position.''
Sections 3.1.4 and 3.1.13 of ASTM F2236-14, respectively, explain that
a ``dynamic load'' is the ``application of impulsive force through free
fall of a weight,'' and that a ``static load'' is a ``vertically
downward force applied by a calibrated force gage or by dead weights.''
Beginning in 2012, the standard included a new definition for
``carrying position'' to clarify methods for dynamic and static load
testing in section 7 of the standard. Finally, in 2013, the standard
was updated to include a new definition for ``fastener'' to aid in a
new test for fastener strength and strap retention.
General Requirements. ASTM F2236-14 includes general requirements
that the products must meet, as well as specified test methods to
ensure compliance with the general requirements, which include:
Restrictions on sharp points or edges, as defined by 16
CFR Sec. Sec. 1500.48 and .49;
restrictions on small parts, as defined by 16 CFR part
1501;
restrictions on lead in paint, as set forth in 16 CFR part
1303;
requirements for locking and latching devices;
requirements for permanent warning labels;
[[Page 17428]]
restrictions on flammability, as set forth in 16 CFR part
1610;
requirements for toy accessories, as set forth in ASTM F
963.
The flammability requirement in section 5.7 of the standard was
changed, beginning with ASTM F2236-13, from a flammable solids
requirement (16 CFR 1500.3(c)(6)(vi)), to meet the more stringent
flammability requirement for wearing apparel (16 CFR part 1610).
Adopting the wearing apparel flammability requirement in the soft
infant and toddler standard makes it consistent with other wearable
infant carriers made of sewn fabric, such as slings, to prevent a
foreseeable fire hazard in all wearable infant carriers.
Performance Requirements and Test Methods. ASTM F2236-14 provides
performance requirements and test methods that are designed to protect
against falls from the carrier due to large leg openings, breaking
fasteners or seams, and straps that slip, including:
Leg Openings--Tested leg openings must not permit passage of a test
sphere weighing 5 pounds that is 14.75 inches in circumference.
Dynamic and Static Load--Beginning with the 2012 version of ASTM
F2236, the dynamic load test was strengthened from requiring a 25-pound
shot bag to be dropped, free fall, from 1 inch above the seat area onto
the carrier seat 1,000 times, to requiring testing with a 25-pound shot
bag, or a shot bag equal to the manufacturer's maximum occupant weight
limit, whichever is heavier. Additionally, the static load test was
revised--from requiring a 75-pound weight for testing--to requiring a
75-pound weight, or a weight equal to three times the manufacturer's
recommended maximum occupant weight, whichever is greater, to be placed
in the seat area of the carrier for 1 minute. Such revisions to the
dynamic and static load tests strengthen the test requirements, by
requiring that products with a maximum recommended weight of 45 pounds
be tested to a 135-pound weight instead of 75 pounds, which represents
an 80 percent increase in the severity of the requirement.
ASTM F2236-14 requires that testing conducted with the new required
loads must not result in a ``hazardous condition,'' as defined in the
general requirements, or result in a structural failure, such as
fasteners breaking or disengaging, or seams separating when tested in
accordance with the dynamic and static load testing methods.
Additionally, the standard provides that dynamic and static load
testing must not result in adjustable sections of support/shoulder
straps slipping more than 1 inch per strap from their original adjusted
position after testing.
Section 6.2.2 of the standard on Support/Shoulder Strap Slippage
was modified beginning with ASTM F2236-13a. The modification clarifies
what constitutes passing or failing the strap slippage test. Section
6.2.2 was amended to state: ``Adjustable sections of support/shoulder
straps shall not slip, in a manner that loosens the strap, more than 1
in. (25 mm) per strap from their original adjusted position after
dynamic and static load testing is performed in accordance with 7.2.1
and 7.2.2, respectively.'' The amendment allows straps to tighten
during testing but not loosen more than 1 inch, which is the intent of
the testing.
Fastener Strength and Strap Retention--ASTM F2236-14 includes a new
component-level performance requirement that was added to the standard
in 2013 to evaluate the strength of fasteners and strap retention to
help prevent falls from a carrier. Previously, soft infant and toddler
carriers were recalled due to an occupant fall hazard caused by broken
fasteners that passed the static and dynamic performance requirements
in the then existing standard, ASTM F2236-10. Accordingly, the
performance requirement in section 6.4 of ASTM F2236-14 states that
load-bearing fasteners at the shoulder and waist of soft infant and
toddler carriers, such as buckles, loops, and snaps, may not break or
disengage; nor may their straps slip more than 1 inch when subjected to
an 80-pound pull force. Adjustable leg opening fasteners must also be
tested but are subjected to lower loads, a 45-pound pull force, because
these fasteners do not carry the same load as fasteners at the
shoulders and waist. ASTM F2236-14 requires that when tested, fasteners
must not break or disengage, and adjustable elements must not slip more
than 1 inch.
Similar to the strap slip requirement in the static and dynamic
load testing section of the standard, ASTM also clarified the strap
slip section of the fastener strength test section in ASTM F2236-13a.
Sections 6.4.1 and 6.4.2 were amended to state: ``Each unique fastener,
except for leg opening adjustment fasteners as tested per 6.4.2, shall
not break or disengage, and adjustable elements in straps shall not
slip, in a manner that loosens the strap, more than 1 in. (2.5 cm) . .
. .'' This amendment allows straps to tighten during testing but not to
loosen more than 1 inch, which is the intent of the testing.
Additionally, Note 1 to section 6.4 of the standard provides that
the fastener strength and strap retention testing apply only to load-
bearing fasteners. ASTM F2236-13 stated: ``Fasteners intended to retain
items such as, but not limited to, hoods, bibs and toy rings, are
exempt from these requirements.'' ASTM approved two changes to the
language in Note 1 to clarify that several non-load-bearing features,
``sleeping hoods'' and ``head adjustment fasteners,'' are included in
the list of examples exempted from fastener strength testing when such
features are non-load-bearing. Note 1 in section 6.4 of ASTM F2236-14
now provides that: ``Fasteners intended to retain items such as, but
not limited to, sleeping hoods, head adjustment fasteners, bibs and toy
rings, are exempt from these requirements.''
Unbounded Leg Opening--The voluntary standard was updated in 2013
to clarify the unbounded leg opening test procedure to improve test
repeatability. ASTM F2236-14 requires that an unbounded leg opening
must not allow complete passage of a truncated test cone that is 4.7
inches long, with a major diameter of 4.7 inches and a minor diameter
of 3 inches. The standard requires a test cone to be pulled through the
leg opening with a 5-pound force for 1 minute.
Marking, Labeling, and Instructional Literature. ASTM F2236-14
requires that each product and its retail package be marked or labeled
with certain information and warnings. The warning label requirement
was updated in 2013 to address fall and suffocation hazards. ASTM
F2236-14 requires that the warning label provide a fall hazard
statement addressing that infants can fall through wide leg openings or
out of the carrier. The standard requires the following fall-related
precautionary statements be addressed on the warning label: Adjust leg
openings to fit baby's legs snugly; before each use, make sure all
[fasteners/knots] are secure; take special care when leaning or
walking; never bend at waist, bend at knees; only use this carrier for
children between -- lbs. and -- lbs. Additionally, ASTM F2236-14
requires that a suffocation hazard statement must address the fact that
infants under 4 months old can suffocate in the carrier if the child's
face is pressed tightly against the caregiver's body. The standard
requires that the warning label must also address the following
suffocation-related precautionary statements: Do not strap infant too
tightly against your body; allow room for head movement; keep infant's
face free from obstructions at all times. Products must also contain an
informational statement that a child must face toward the caregiver
until he
[[Page 17429]]
or she can hold his or her head upright. All products are required to
come with instructional literature on assembly, use, maintenance,
cleaning, and required warnings.
ASTM F2236-14 includes an example warning label that identifies
more clearly the hazards, the consequences of ignoring the warning, and
how to avoid the hazards. The label format was designed to communicate
more effectively these warnings to the caregiver (Fig. 1).
Manufacturers may alter the rectangular shape of the label to fit on
shoulder straps, if the manufacturer chooses not to place label in the
occupant space. However, the standard requires that the label be placed
in a prominent and conspicuous location, where the caregiver will see
the label when placing the soft infant and toddler carrier on their
body.
[GRAPHIC] [TIFF OMITTED] TR28MR14.033
[GRAPHIC] [TIFF OMITTED] TR28MR14.034
VI. Effective Date
The Administrative Procedure Act (APA) generally requires that the
effective date of the rule be at least 30 days after publication of the
final rule. 5 U.S.C. 553(d). The NPR proposed that the final rule would
become effective 6 months after publication of a final rule in the
Federal Register. Although we received one comment requesting a 12-
month effective date (comment 8 in section IV.H), the Commission finds
that a 6-month effective date is sufficient time to allow manufacturers
to come into compliance. Manufacturers whose products are not compliant
with the standard will require some product modification; however, any
necessary product modification is expected to involve minor changes,
such as adding or changing straps or fasteners. Moreover, ASTM F2236-13
was adopted by ASTM in March 2013, and became effective in September
2013.
[[Page 17430]]
Although the Commission is adopting ASTM F2236-14, this version of the
voluntary standard is substantially the same as ASTM F2236-13.
Manufacturers that are compliant with ASTM F2236-13 have already made
or have begun to make the necessary modifications.
VII. Regulatory Flexibility Act
A. Introduction
The Regulatory Flexibility Act (RFA) requires that final rules be
reviewed for their potential economic impact on small entities,
including small businesses. Section 604 of the RFA requires that CPSC
prepare a final regulatory flexibility analysis (FRFA) when the
Commission promulgates a final rule. The FRFA must describe the impact
of the rule on small entities and identify any alternatives that may
reduce the impact. Specifically, the FRFA must contain:
A succinct statement of the objectives of, and legal basis
for, the rule;
a summary of the significant issues raised by public
comments in response to the initial regulatory flexibility analysis, a
summary of the assessment of the agency of such issues, and a statement
of any changes made in the proposed rule as a result of such comments;
a description of, and, where feasible, an estimate of, the
number of small entities to which the rule will apply;
a description of the projected reporting, recordkeeping,
and other compliance requirements of the 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
a description of the steps the agency has taken to reduce
the significant economic impact on small entities, consistent with the
stated objectives of applicable statutes, including a statement of the
factual, policy, and legal reasons for selecting the alternative
adopted in the rule, and why each one of the other significant
alternatives to the rule considered by the agency, which affect the
impact on small entities, was rejected.
B. Market for Soft Infant and Toddler Carriers
Soft infant and toddler carriers are generally produced and/or
marketed by juvenile product manufacturers and distributors. Several of
these firms primarily produce soft infant and toddler carriers, as well
as substitute products, such as slings. CPSC Economic Analysis (EC)
staff believes that there are at least 54 suppliers of soft infant and
toddler carriers to the U.S. market.\6\ Thirty-nine domestic firms
supply soft infant and toddler carriers to the U.S. market: 23 are
domestic manufacturers; eight are domestic importers; and eight firms
have unknown supply sources. In addition, 12 foreign firms supply soft
infant and toddler carriers to the U.S. market. CPSC has insufficient
information available to categorize the remaining three firms.\7\
---------------------------------------------------------------------------
\6\ Staff conducted research to identify manufacturers and
importers of soft carriers. From the time of the NPR to the final
rule, several firms entered the market, raising the number of
suppliers from 39 in the NPR to 54 presently.
\7\ CPSC staff made these determinations using information from
Dun & Bradstreet and ReferenceUSAGov, as well as the firms' Web
sites.
---------------------------------------------------------------------------
According to a 2005 survey conducted by the American Baby Group
(2006 Baby Products Tracking Study), 51 percent of new mothers own soft
infant and toddler carriers.\8\ Approximately 30 percent of soft infant
and toddler carriers are handed down or purchased secondhand.\9\ Thus,
about 70 percent of soft infant and toddler carriers are acquired new.
This estimate suggests that approximately 1.5 million soft infant and
toddler carriers are sold to households annually (0.51 x 0.70 x 4.1
million births per year).\10\
---------------------------------------------------------------------------
\8\ The data collected for the Baby Products Tracking Study does
not represent an unbiased statistical sample. The sample of 3,600
new and expectant mothers is drawn from American Baby magazine's
mailing lists. Also, because the most recent survey information is
from 2005, the information may not reflect the current market.
\9\ The data on secondhand products for new mothers was not
available. Instead, data for new mothers and experienced mothers
were combined and broken down into first-time mothers and
experienced mothers. Data for first-time mothers and experienced
mothers have been averaged to calculate the approximate percentage
of soft infant and toddler carriers that were handed down or
purchased secondhand.
\10\ 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. The number of live births in 2009 is
rounded from 4,130,665.
---------------------------------------------------------------------------
Many soft infant and toddler carriers have expanded their maximum
weight limits in recent years to accommodate older children. However,
from the lack of incident data involving children older than 2 years,
CPSC staff believes that most caregivers would not be comfortable
carrying older, heavier children in soft infant and toddler carriers.
Based on the incident data, it appears that soft infant and toddler
carriers are used during a child's first year, with some caregivers
continuing to use these products into the second year. While we do not
know the proportion of caregivers who continue to use these products
into the second year, we estimated the numbers of soft infant and
toddler carriers in use by assuming that a portion of caregivers, e.g.,
25-50 percent, will continue to use carriers in the child's second
year. Based on data from the 2006 Baby Products Tracking Study,
approximately 2.1 million soft infant and toddler carriers are owned by
new mothers. Assuming that 25-50 percent of caregivers continue to use
soft infant and toddler carriers in the second year, approximately 2.6
million (2.1 million x 0.25 x 2.1 million) to 3.2 million (2.1 million
x 0.50 x 2.1 million) households have soft infant and toddler carriers
available for use annually. Based on Directorate for Epidemiology
staff's estimate of 1,400 injuries treated nationally in emergency
departments from 1999 to 2011, an average of about 108 emergency
department-treated injuries involve soft infant and toddler carriers
annually.\11\ Therefore, about 0.34-0.40 emergency department-treated
injuries may occur annually for every 10,000 soft infant and toddler
carriers available for use.
---------------------------------------------------------------------------
\11\ Memorandum from Risana Chowdhury, Directorate for
Epidemiology, dated March 11, 2013, Subject: Soft Infant and Toddler
Carrier-Related Deaths, Injuries, and Potential Injuries, and NEISS
Injury Estimates; 1999-September 10, 2012. CPSC staff cannot present
national emergency department-treated injury estimates for 2012 due
to insufficient numbers of NEISS incidents reported during the time
period, and 2013 data is not yet available. Memorandum from Risana
Chowdhury, Directorate for Epidemiology, dated September 23, 2013,
Subject: Soft Infant and Toddler Carrier-Related Deaths, Injuries,
and Potential Injuries between September 11, 2012 and July 15, 2013.
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C. Reason for Agency Action and Legal Basis for the Final Rule
The Danny Keysar Child Product Safety Notification Act, section 104
of the CPSIA, requires the CPSC to promulgate mandatory standards for
nursery products that are substantially the same as, or more stringent
than, the voluntary standard. Staff recommends adopting the voluntary
standard (ASTM F2236-14), without modification.
D. Requirements of the Final Rule
The requirements of the final rule are set forth above in section V
of this preamble, which describes ASTM F2236-14.
E. Issues Raised by Public Comments
Section IV of this preamble contains a summary of the five comments
received and the issues raised by the comments.
[[Page 17431]]
F. Other Federal Rules
Two federal rules interact with the soft infant and toddler carrier
mandatory standard: (1) Testing and Labeling Pertaining to Product
Certification (16 CFR part 1107); and (2) Requirements Pertaining to
Third Party Conformity Assessment Bodies (16 CFR part 1112). The
regulation at 16 CFR part 1107 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. Because soft infant and toddler
carriers will be subject to a mandatory children's product safety rule,
they will also be subject to the third party testing requirements of 16
CFR part 1107 when the soft infant and toddler carrier mandatory
standard becomes effective.
In addition, 16 CFR part 1107 requires the third party testing of
children's products to be conducted by CPSC-accredited laboratories.
Section 14(a)(3) of the CPSA required the Commission to publish a
notice of requirements (NOR) for the accreditation of third party
conformity assessment bodies (i.e., testing laboratories) to test for
conformance with each children's product safety rule. The NORs for
existing rules are set forth in 16 CFR part 1112. The Commission is
finalizing an amendment to 16 CFR part 1112 that establishes the
requirements for the accreditation of testing laboratories to test for
compliance with the soft infant and toddler carrier final rule.
G. Impact on Small Businesses
The FRFA is limited to the 39 domestic firms known to be marketing
soft infant and toddler carriers in the United States because U.S.
Small Business Administration (SBA) guidelines and definitions pertain
to U.S.-based entities. Under SBA guidelines, a manufacturer of soft
infant and toddler 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, 32 of the 39 domestic firms
supplying soft infant and toddler carriers to the U.S. market are small
firms--18 manufacturers, six importers, and eight firms--whose supply
source is unknown. Additional unknown small soft infant and toddler
carrier suppliers may also operate in the U.S. market.
One purpose of the regulatory flexibility analysis is to evaluate
the impact of a regulatory action and determine whether the impact is
economically significant. While the SBA gives considerable flexibility
in defining ``economically significant,'' CPSC staff typically uses one
percent of gross revenue as the threshold for determining ``economic
significance.'' CPSC staff considers any impact that is one percent or
more of gross revenue is considered economically significant. SBA has
accepted the one percent of gross revenue threshold and this threshold
is also commonly used by agencies in determining economic
significance.\12\
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\12\ U.S. Small Business Administration, Office of Advocacy. A
Guide for Government Agencies: How to Comply with the Regulatory
Flexibility Act and Implementing the President's Small Business
Agenda and Executive Order 13272. May 2012, pgs. 18-20. https://www.sba.gov/sites/default/files/rfaguide_0512_0.pdf.
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Small Manufacturers: The expected impact of the final rule on small
manufacturers will differ, based on whether manufacturers' soft infant
and toddler carriers are already compliant with F2236-13. Although
F2236-14 was published in January 2014, firms are still likely to be
testing to F2236-13. However, because ASTM F2236-13, ASTM F2236-13a,
and ASTM F2236-14 do not contain material differences, manufacturers in
compliance with ASTM F2236-13 are likely to continue to comply with the
voluntary standard.
The Juvenile Products Manufacturers Association (JPMA), the major
U.S. trade association that represents juvenile product manufacturers
and importers, has certified several soft infant and toddler carriers
as compliant with the voluntary standard, and other manufacturers have
claimed compliance with the voluntary standard. Based on this
information, 11 of 18 domestic manufacturers comply with ASTM F2236-13.
These 11 firms should not require any modifications to their products
and, as such, the firms should not be impacted by incorporation of ASTM
F2236-14 as the final rule.
Meeting ASTM F2236-14's requirements could require some
modifications for seven of the 18 domestic manufacturers who are
believed not to be currently compliant with ASTM F2236-13. Based upon
past discussions with firms and Engineering Sciences staff, necessary
modifications would likely involve adding or changing straps,
fasteners, or fabrics and generally would be less expensive to
accomplish than a complete product redesign. Therefore, in most cases,
the impact of the final rule is not expected to have a significant
effect on products that do not comply with ASTM F2236-13.
Under section 14 of the CPSA, soft infant and toddler carriers are
also subject to third party testing and certification requirements.
Once the new soft infant and toddler requirements become effective, all
manufacturers will be subject to the additional costs associated with
the third party testing and certification requirements under the
testing rule, Testing and Labeling Pertaining to Product Certification
(16 CFR part 1107). Third party testing will pertain to any physical
and mechanical test requirements specified in the soft infant and
toddler carrier final rule; lead and phthalates testing is already
required. Third party testing costs are in addition to the direct costs
of meeting the soft infant and toddler standard.
Based on information from the durable nursery product industry and
confidential business information supplied for the development of the
third party testing rule, CPSC staff estimates that testing to a single
ASTM voluntary standard could cost around $500-$600 per model sample.
On average, each small domestic manufacturer supplies two different
models of soft infant and toddler carriers to the U.S. market annually.
Therefore, if third party testing to the requirements in the soft
infant and toddler standard is conducted every year on a single sample
for each model, third party testing costs associated for each
manufacturer would be about $1,000-$1,200 annually. Based on an
examination of estimates of firms' revenues from recent Dun &
Bradstreet reports, the impact of third party testing is not likely to
be economically significant if only one sample per model is required.
However, if more than one sample is needed to meet the testing
requirements, third party testing costs could have an economically
significant impact on some small manufacturers (i.e., testing costs
could be one percent or more of gross revenue). CPSC staff does not
know exactly how many samples each manufacturer will need to test to
meet the ``high degree of assurance'' criterion required by 16 CFR part
1107.
Small Importers: Most importers will not experience significant
impacts as a result of the final rule. CPSC staff believes that four of
the six small importers are compliant with the voluntary standard. The
remaining importers may need to find an alternate source of soft infant
and toddler carriers if their existing suppliers do not come into
compliance with the requirements of the final rule. Alternatively, the
firms may discontinue importing soft infant and toddler carriers
altogether and perhaps substitute another juvenile product.
As is the case with manufacturers, all importers will be subject to
third party
[[Page 17432]]
testing and certification requirements, and consequently, they will
experience the associated costs, if their supplying foreign firm(s)
does not perform third party testing. The resulting costs could
potentially have a significant impact on a few small importers that
must perform the testing themselves, particularly if more than one
sample per model is required.
Eight small firms have unknown supply sources, three of which
appear to be compliant with ASTM F2236-13 and should not be impacted by
the incorporation of ASTM F2236-14 as the mandatory final rule. The
remaining five firms may need to make small changes to their products
to be compliant with ASTM F2236-14. Due to the nature of the product,
the modifications should be limited to changes in straps or fasteners
and should not have a significant impact.
H. Alternatives
One alternative would be to set an effective date for the final
rule later than the staff-recommended 6 months, which is generally
considered sufficient time for suppliers to come into compliance with a
durable infant and toddler product rule. Setting a later effective date
would allow suppliers additional time to modify and/or develop
compliant soft infant and toddler carriers and spread the associated
costs over a longer period of time. However, given that the changes to
meet the standard are not substantial, CPSC staff believes that 6
months is sufficient.
VIII. Environmental Considerations
The Commission's regulations address whether we are required to
prepare an environmental assessment or an environmental impact
statement. If our rule has ``little or no potential for affecting the
human environment,'' the rule will be categorically exempted from this
requirement. 16 CFR 1021.5(c)(1). The final rule for soft infant and
toddler carriers falls within the categorical exemption.
IX. Paperwork Reduction Act
This 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 (44 U.S.C. 3501-
3520). The preamble to the proposed rule (78 FR at 20520 through 20521)
discussed the information collection burden of the proposed rule and
specifically requested comments on the accuracy of our estimates. OMB
has assigned control number 3041-0162 to this information collection.
We did not receive any comment regarding the information collection
burden of the proposal. However, the final rule makes modifications
regarding the information collection burden because the number of
estimated manufacturers subject to the information collection burden is
now estimated at 54 manufacturers rather than the 39 manufacturers
initially estimated in the proposed rule.
Accordingly, the estimated burden of this collection of information
is modified 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
1226............................................................... 54 2 108 1 108
--------------------------------------------------------------------------------------------------------------------------------------------------------
Our estimate is based on the following:
Section 8.1 of ASTM F2236-14 requires that all soft infant and
toddler carrier products and their retail packaging be marked or
labeled as follows: the manufacturer, distributor, or seller name, and
either the place of business (city, state, mailing address, including
zip code), or telephone number, or both; and a code mark or other means
that identifies the date (month and year as a minimum) of manufacture.
CPSC is aware of 54 firms that supply soft infant and toddler
carriers in the U.S. market. For PRA purposes, we assume that all 54
firms use labels on their products and on their packaging already.
However, firms might need to make some modifications to their existing
labels. We estimate that the time required to make these modifications
is about 1 hour per model. Each of the 54 firms supplies an average of
two different models of soft infant and toddler carriers. Therefore, we
estimate the burden hours associated with labels to be 108 hours
annually (1 hour x 54 firms x 2 models per firm = 108 hours annually).
We estimate the hourly compensation for the time required to create
and update labels is $27.71 (U.S. Bureau of Labor Statistics,
``Employer Costs for Employee Compensation,'' September 2013, Table 9,
total compensation for all sales and office workers in goods-producing
private industries: https://www.bls.gov/ncs/). Therefore, we estimate
the annual cost to industry associated with the labeling requirements
in the final rule to be $2,992.68 ($27.71 per hour x 108 hours =
$2,992.68). This collection of information does not require operating,
maintenance, or capital costs.
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3507(d)), we have submitted the information collection requirements of
this final rule to the OMB.
X. 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 applies to final durable infant and toddler
product final rules. Therefore, the final rule issued under section 104
of the CPSIA will invoke the preemptive effect of section 26(a) of the
CPSA when the final rule becomes effective.
XI. Certification and Notice of Requirements
Section 14(a) of the CPSA requires that products subject to a
consumer 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). Section 14(a)(2) of the CPSA requires
that certification of children's products subject to a children's
product
[[Page 17433]]
safety rule be based on testing conducted by a CPSC-accepted third
party conformity assessment body. Section 14(a)(3) of the CPSA requires
the Commission to publish a NOR for the accreditation of third party
conformity assessment bodies (or laboratories) to assess conformity
with a children's product safety rule to which a children's product is
subject. The final rule for 16 CFR part 1226, ``Safety Standard for
Soft Infant and Toddler Carriers,'' is a children's product safety rule
that requires the issuance of a NOR.
Effective June 10, 2013, the Commission published a final rule,
Requirements Pertaining to Third Party Conformity Assessment Bodies, 78
FR 15836 (March 12, 2013), which codifies 16 CFR part 1112. Part 1112
establishes requirements for accreditation of third party conformity
assessment bodies (or laboratories) to test for conformance with a
children's product safety rule in accordance with Section14(a)(2) of
the CPSA. The final rule also codifies all of the NORs that the CPSC
has published, to date. All new NORs, such as the soft infant and
toddler carrier standard, require an amendment to part 1112.
Accordingly, the final rule amends part 1112 to include the soft infant
and toddler standard, along with the other children's product safety
rules for which the CPSC has issued NORs. The final NOR is based on the
CPSC's laboratory accreditation requirements on the performance
standard set forth in the final rule for the safety standard for soft
infant and toddler carriers and the test methods incorporated within
this standard.
Laboratories applying for acceptance as a CPSC-accepted third party
conformity assessment body to test to the new standard for soft infant
and toddler carriers are required to meet the third party conformity
assessment body accreditation requirements in part 1112. When a
laboratory meets the requirements as a CPSC-accepted third party
conformity assessment body, the laboratory can apply to the CPSC to
have 16 CFR part 1226, Safety Standard for Soft Infant and Toddler
Carriers, included in the laboratory's scope of accreditation of CPSC
safety rules listed for the laboratory on the CPSC Web site at:
www.cpsc.gov/labsearch.
A FRFA was conducted as part of the promulgation of the original 16
CFR part 1112 (78 FR 15836, 15855-15858), as required by the Regulatory
Flexibility Act. Briefly, the FRFA concluded that the accreditation
requirements would not have a significant adverse impact on a
substantial number of small laboratories because no requirements were
imposed on laboratories that did not intend to provide third party
testing services. The only laboratories expected to provide such
services are those that anticipate receiving sufficient revenue from
the mandated testing to justify accepting the requirements as a
business decision.
Based on similar reasoning, amending the rule to include the NOR
for the soft infant and toddler carrier standard will not have a
significant adverse impact on small laboratories. Moreover, based upon
the number of laboratories in the United States that have applied for
CPSC acceptance of the accreditation to test for conformance to other
juvenile product standards, we expect that only a few laboratories will
seek CPSC acceptance of their accreditation to test for conformance
with the soft infant and toddler carrier standard. Most of these
laboratories have already been accredited to test for conformance to
other juvenile product standards, and the only cost to them would be
the cost of adding the soft infant and toddler standard to their scope
of accreditation. As a consequence, the Commission certifies that the
NOR for the soft infant and toddler carrier standard will not have a
significant impact on a substantial number of small entities.
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 1226
Consumer protection, Imports, Incorporation by reference, Infants
and Children, Labeling, Law Enforcement, and Toys.
For the reasons discussed in the preamble, the Commission amends
Title 16 of the Code of Federal Regulations by amending part 1112 and
adding a new part 1226, as follows:
PART 1112--REQUIREMENTS PERTAINING TO THIRD PARTY CONFORMITY
ASSESSMENT BODIES
0
1. The authority citation for part 1112 continues to read as follows:
Authority: 15 U.S.C. 2063; Pub. L. No. 110-314, section 3, 122
Stat. 3016, 3017 (2008)
0
2. In Sec. 1112.15 add paragraph (b)(37) to read as follows:
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) * * *
(37) 16 CFR part 1226, Safety Standard for Soft Infant and Toddler
Carriers.
* * * * *
0
3. Add Part 1226 to read as follows:
PART 1226--SAFETY STANDARD FOR SOFT INFANT AND TODDLER CARRIERS
Sec.
1226.1 Scope.
1226.2 Requirements for soft infant and toddler carriers.
Authority: The Consumer Product Safety Improvement Act of 2008,
Pub. L. 110-314, Sec. 104, 122 Stat. 3016 (August 14, 2008); Pub. L.
112-28, 125 Stat. 273 (August 12, 2011).
Sec. 1226.1 Scope.
This part establishes a consumer product safety standard for soft
infant and toddler carriers.
Sec. 1226.2 Requirements for soft infant and toddler carriers.
(a) Each soft infant and toddler carrier must comply with all
applicable provisions of ASTM F2236-14, Standard Consumer Safety
Specification for Soft Infant and Toddler Carriers, approved on January
1, 2014. 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_federal regulations/ibr_
locations.html.
(b) [Reserved]
Dated: March 24, 2014.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2014-06771 Filed 3-27-14; 8:45 am]
BILLING CODE 6355-01-P