[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]


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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.

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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.
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    \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.
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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\
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    \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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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\;
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    \3\ All of the fall incidents were emergency department-treated 
injury (NEISS data) reports.
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     structure, fit, and position issues (7);
     design and finish-related issues \4\ (2), (which are also 
among the 7 in the previous category);
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    \4\ Finish-related issues concern items such as material 
smoothness and lead content.
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     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.
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    \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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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.
---------------------------------------------------------------------------

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\
---------------------------------------------------------------------------

    \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. http://www.sba.gov/sites/default/files/rfaguide_0512_0.pdf.
---------------------------------------------------------------------------

    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: http://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; http://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: http://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