Safety Standard for Soft Infant and Toddler Carriers, 20511-20522 [2013-07687]

Agencies

• Consumer Product Safety Commission

[Federal Register Volume 78, Number 66 (Friday, April 5, 2013)]
[Proposed Rules]
[Pages 20511-20522]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07687]


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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: Notice of proposed rulemaking.

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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 or CPSC) to promulgate consumer product safety standards 
for durable infant or toddler products. These standards are to be 
``substantially the same as'' applicable voluntary standards or more 
stringent than the voluntary standard if the Commission concludes that 
more stringent requirements would further reduce the risk of injury 
associated with the product. The Commission is proposing a safety 
standard for soft infant and toddler carriers in response to the 
direction under Section 104(b) of the CPSIA.\1\
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    \1\ The Commission voted 2-1 to approve publication of this 
proposed rule. Chairman Inez M. Tenenbaum and Commissioner Robert S. 
Adler voted to approve publication, and Commissioner Nancy A. Nord 
voted against publication. Commissioner's statements concerning this 
or any other Commission action may be viewed by clicking on a 
specific Commissioner's name and selecting ``Statements'' on the 
Commission's Web site at https://www.cpsc.gov/en/About-CPSC/Commissioners/, or obtained from the Commission's Office of the 
Secretary.

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DATES: Submit comments by June 19, 2013.

ADDRESSES: Comments related to the Paperwork Reduction Act aspects of 
the marking, labeling, and instructional literature of the proposed 
rule should be directed to the Office of Information and Regulatory 
Affairs, OMB, Attn: CPSC Desk Officer, FAX: 202-395-6974, or emailed to 
oira_submission@omb.eop.gov.
    Other comments, identified by Docket No. CPSC-2013-0014, may be 
submitted electronically or in writing:

[[Page 20512]]

    Electronic Submissions: Submit electronic comments to the Federal 
eRulemaking Portal at: https://www.regulations.gov. Follow the 
instructions for submitting comments. The Commission does not accept 
comments submitted by electronic mail (email), except through 
www.regulations.gov. The Commission encourages you to submit electronic 
comments by using the Federal eRulemaking Portal, as described above.
    Written Submissions: Submit written submissions in the following 
way: Mail/Hand delivery/Courier (for paper, disk, or CD-ROM 
submissions), preferably in five copies, to: Office of the Secretary, 
Consumer Product Safety Commission, Room 820, 4330 East West Highway, 
Bethesda, MD 20814; telephone (301) 504-7923.
    Instructions: All submissions received must include the agency name 
and docket number for this proposed rulemaking. All comments received 
may be posted without change, including any personal identifiers, 
contact information, or other personal information provided, to: https://www.regulations.gov. Do not submit confidential business information, 
trade secret information, or other sensitive or protected information 
that you do not want to be available to the public. If furnished at 
all, such information should be submitted in writing.
    Docket: For access to the docket to read background documents or 
comments received, go to: https://www.regulations.gov, and insert the 
docket number, CPSC-2013-0014, into the ``Search'' box, and follow the 
prompts.

FOR FURTHER INFORMATION CONTACT: Gregory K. Rea, Project Manager, 
Director, Division of Mechanical Engineering, Directorate for 
Laboratory Sciences, Consumer Product Safety Commission, 5 Research 
Place, Rockville, MD 20850; telephone: 301-987-2258; email: 
grea@cpsc.gov.

SUPPLEMENTARY INFORMATION: 

I. Background and Statutory Authority

    The Consumer Product Safety Improvement Act of 2008 (CPSIA, Pub Law 
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. These standards are 
to be ``substantially the same as'' applicable voluntary standards or 
more stringent than the voluntary standard if the Commission concludes 
that more stringent requirements would further reduce the risk of 
injury associated with the product. The term ``durable infant or 
toddler product'' is defined in section 104(f)(1) of the CPSIA as ``a 
durable product intended for use, or that may be reasonably expected to 
be used, by children under the age of 5 years.''
    In this document, the Commission is proposing a safety standard for 
soft infant and toddler carriers. ``Infant carriers'' are specifically 
identified in section 104(f)(2)(H) of the CPSIA 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, handheld infant carriers, slings, 
and soft infant and toddler carriers. This proposed rule addresses 
hazards associated only with soft infant and toddler carriers. 
Recently, the Commission issued a proposed rule on handheld infant 
carriers (77 FR 73354 (Dec. 10, 2012)). Hazards associated with frame 
backpack carriers and slings will be addressed separately in future 
rulemaking proceedings.
    Pursuant to Section 104(b)(1)(A), the Commission consulted with 
manufacturers, retailers, trade organizations, laboratories, consumer 
advocacy groups, consultants, and members of the public in the 
development of this proposed standard, largely through the ASTM 
process. The proposed rule is based on the voluntary standard developed 
by ASTM International (formerly the American Society for Testing and 
Materials), ASTM F2236-13, ``Standard Consumer Safety Specification for 
Soft Infant and Toddler Carriers'' (ASTM F2236-13), without alteration. 
The ASTM standard is copyrighted, but it can be viewed as a read-only 
document during the comment period on this proposal only, at: https://www.astm.org/cpsc.htm, by permission of ASTM.

II. Product Description

A. Definition of a Soft Infant and Toddler Carrier

    ASTM F2236-13 defines ``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 F2236-13 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 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.
    Two broad classes of soft infant and toddler carriers are available 
in the United States: Structured and nonstructured. Structured soft 
infant and toddler carriers contain straps and waist belts that 
connect, to the seat area of the carrier and each other, with buckles, 
straps, and other 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, such as the mei-
tai design, consist of a flat, textile center that acts as the seat 
area with waist straps and very long (5 to 6 feet) upper straps. The 
upper straps wrap over the caregiver's shoulders, cross in the back, 
and are brought around the waist to the front of the caregiver. The 
upper straps are then secured over the child's legs to form the leg 
openings and secure the child in an upright position. ASTM F2236-13 
does not distinguish between products based on whether they are 
structured or nonstructured; requirements apply equally to all types of 
soft infant and toddler carriers.
    The definition of a ``soft infant and toddler carrier'' is intended 
to distinguish it from other types of infant carriers that are also 
worn by a caregiver but that are not covered under ASTM F-2236-13, 
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; although 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 the sling's design that 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 included in the standard for soft infant and toddler carriers. 
Like soft infant and toddler carriers, framed backpack carriers are 
intended to carry

[[Page 20513]]

a child in an upright position, but are distinguishable because 
typically, they are constructed of sewn fabric over a rigid metal 
structure and are solely intended for carrying a child on the 
caregiver's back.

B. Market Description

    Soft infant and toddler carriers are generally produced and/or 
marketed by juvenile product manufacturers and distributors. Several of 
these firms focus exclusively on soft infant and toddler carriers, as 
well as substitute products, such as slings. CPSC staff believes that 
at least 39 firms supply soft infant and toddler carriers to the U.S. 
market. Thirty-one domestic firms supply soft infant and toddler 
carriers to the U.S. market: 15 are domestic manufacturers; eight are 
domestic importers; and the supply sources of eight domestic firms are 
unknown. Five foreign firms supply soft infant and toddler carriers to 
the U.S. market: three are foreign manufacturers; one is a foreign 
importer; and one firm has an unknown supply source. Insufficient 
information is available on the remaining three firms to categorize 
them.
    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. Approximately 30 percent of soft infant 
and toddler carriers were handed down or purchased secondhand, meaning 
that about 70 percent of the products were acquired new. This suggests 
that approximately 1.5 million soft infant and toddler carriers are 
sold to households annually (.51 x .70 x 4.1 million births per year). 
Typically, 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. We estimate use into a child's second year under the 
assumption that approximately 25-50 percent of caregivers continue to 
use these products. Based on data from the 2006 Baby Products Tracking 
Study, approximately 2.1 million soft infant and toddler carriers are 
owned by new mothers. Thus, we estimate that approximately 2.6-3.2 
million households have soft infant and toddler carriers available for 
use annually.

III. Incident Data

    CPSC's Directorate for Epidemiology, Division of Hazard Analysis is 
aware of 93 incidents related to soft infant and toddler carriers--
reported over a period of nearly 13 years--beginning in January 1999 
through early September 2012. Two incidents involved a fatality, and 91 
incidents were nonfatal.

A. Fatalities

    Two suffocation fatalities were reported to CPSC from January 1999 
to September 2012. The first fatality involved a 5-week-old male who 
fell asleep in the soft infant and toddler carrier after a feeding. 
About 20 minutes after the feeding, he appeared unresponsive. The 
official cause of death was listed as positional asphyxia. The second 
fatal incident occurred when a 2-month-old female fell asleep in a soft 
infant and toddler carrier worn by her parent. The parent lay down on a 
couch to sleep for the night while still wearing the carrier with the 
infant inside. The parent awoke the next morning to find the child 
unresponsive with her face pressed into the parent's chest. Staff could 
not directly attribute the two reported fatalities to product design or 
mechanical failure of the soft infant and toddler carrier.

B. Nonfatalities

    Approximately 33 percent (30) of the 91 nonfatal incidents involved 
reports of an injury to an infant during use of a soft infant and 
toddler carrier. A majority of the injuries resulted from falls from 
the carrier. All of the injuries in which the age of the victim was 
available were reportedly sustained by infants who were 1 month to 13 
months old. However, most of the incidents involved infants 6 months 
and younger. Although the remaining 61 nonfatal incidents reported that 
no injury had occurred, many of the descriptions indicated the 
potential for a serious injury or death.
    Eight of the nonfatal incident reports involved skull fractures as 
a result of the childfalling out of the product. Five skull fracture 
injuries reportedly required hospitalization; the three remaining skull 
fracture injury reports did not mention any hospitalizations. Some of 
the remaining injuries reported included: Collarbone and limb 
fractures, contusions, abrasions, blisters, and scratches.

C. Hazard Pattern Identification

    The primary hazard associated with use of a soft infant and toddler 
carrier is 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 due to fastener problems, large 
leg openings, stitching or seam problems, or straps that slip. A 
majority of the reported incidents summarized in Table 1 below, and all 
seven of the recalls described in section III.E, involved an actual 
fall or potential risk of a child falling from a carrier.
    Staff classified the 93 reported incidents by the issues--product 
feature, design element, or failure--primarily responsible for the 
incident and summarized this data in Table 1, below. An explanation of 
the categories represented in Table 1 follows.
    Fastener problems: Twenty-five of the 93 incidents (27 percent) 
were related to fastener problems, such as snaps breaking/unexpectedly 
releasing, or buckles breaking/detaching/pinching/unexpectedly 
releasing. Six injuries, but no fatalities, were included among these 
reports.
    Structure, fit, and position issues: Fourteen of the 93 incidents 
(15 percent) were related to aspects of the leg- and torso-opening 
design, how the carrier held the infant, and where the carrier was 
positioned on the caregiver. Examples of scenarios reported include: An 
infant slipping down far into the carrier and suffering an injury when 
the caregiver went into a bent position; an infant falling out of the 
carrier when the caregiver bent forward; and leg circulation-related 
injuries. There were 10 injuries reported in this category. No reported 
fatalities were associated with this issue.
    Problems with large leg openings: Twelve of the 93 incidents (13 
percent) were related to leg openings that were too large and that 
allowed the infant to slip through completely and fall out of the 
carrier. While there were no fatalities among these reports, there were 
seven injuries; three involved infants who were hospitalized for skull 
fractures.
    Issues with stitching/seams: Ten reports (11 percent) were received 
about stitching on the carrier coming undone or seams ripping, 
resulting in other components, like straps, detaching and creating a 
fall hazard. One injury was included among these reports.
    Design and finish-related issues: Eight reports (nine percent) of 
inadequate back support, rough fabric, poor air flow in the carrier 
insert, and other design issues were received. No fatalities were 
noted, but two injuries were associated with these issues.
    Strap issues: Eight incidents (nine percent) reported issues with 
straps, mostly about the adjuster breaking or slipping. No injuries or 
fatalities were reported in this category.
    Other issues: Eleven reports (12 percent) were related to issues 
other than those described above. Two fatalities and four injuries, 
including two hospitalizations, were reported in this category. The two 
fatalities--one case of a parent falling asleep while

[[Page 20514]]

wearing the carrier with the infant inside, and the other case of an 
infant suffering respiratory distress while being carried around facing 
in--are included in this category. In each case, CPSC staff concluded 
that there were too many confounding factors reported to determine that 
a specific factor contributed predominantly to the deaths. The 
remaining reports were of unspecified falls, an nonspecific abrasion 
injury, and an incidental injury to the infant, due to a caregiver's 
fall.

   Table 1--Distribution of Reported Incidents by Hazard Patterns Associated With Soft Infant and Toddler Carriers Reporting Period: January 1, 1999-
                                                                   September 10, 2012
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                                                                   Total reports                      Deaths                         Injuries
                         Issues                          -----------------------------------------------------------------------------------------------
                                                               Count        Percentage         Count        Percentage         Count        Percentage
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Mechanical Issues.......................................              77              83               0               0              26              87
    Fasteners...........................................              25              27               0               0               6              20
    Structure, fit, and position........................              14              15               0               0              10              33
    Large leg openings..................................              12              13               0               0           \1\ 7              23
    Stitching/seams.....................................              10              11               0               0               1               3
    Design and finish...................................               8               9               0               0               2               7
    Straps..............................................               8               9               0               0               0               0
Other...................................................              11              12               2             100           \2\ 4              13
Consumer Comments.......................................               5               5               0               0               0               0
                                                         -----------------------------------------------------------------------------------------------
        Total...........................................              93             100               2             100              30             100
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Source: U.S. Consumer Product Safety Commission's epidemiological databases IPII, INDP, and DTHS.
Note: The percentages have been rounded to the 2nearest integer. Subtotals do not necessarily add to heading totals.
\1\ (3 hosp.).
\2\ (2 hosp.).

D. NEISS Data

    In addition to the 93 incident reports received by the Commission, 
we estimated the number of injuries treated in U.S. hospital emergency 
departments using the CPSC's National Electronic Injury Surveillance 
System (NEISS). We estimate that over a 13-year-period, a total of 
1,400 injuries related to soft infant and toddler carriers were treated 
in U.S. hospital emergency departments from 1999 through 2011. Because 
CPSC's NEISS data for 2012 will be finalized in spring 2013, partial 
estimates for 2012 are not available. The injury estimates for 
individual years are based on very small samples and are not 
reportable. 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. Moreover, 
due to the unreliability of the yearly estimates, a trend analysis is 
not feasible.
    No fatalities were reported through NEISS. Although data extraction 
criteria included ages up to 4 years, all of the injured children were 
reported to be less than 2 years of age. A breakdown of the 
characteristics among the emergency department-treated injuries 
associated with soft infant and toddler carriers is presented in the 
bullets below.
     Hazard--Getting struck while in the carrier when caregiver 
fell (65%); falling out of the carrier (21%).
     Injured body part--Head (63%); face (11%).
     Injury type--Internal organ injury (48%); contusions/
abrasions (19%); and fractures (12%).
     Disposition--Treated and released (79%); hospitalized 
(10%); and treated and transferred (9%).

E. Product Recalls

    Seven product safety recalls, recalling 652,250 units, were 
announced between January 1, 1999 and June 17, 2010 that involved a 
fall hazard related to use of a soft infant and toddler carrier. These 
recalls related to 130 incident reports received by the CPSC. A 
breakdown of the specific product defect necessitating the recall, 
product units involved, and the number of incident reports received is 
presented in the chart below. At the time the products were recalled, 
nine infants had been injured significantly in incidents that ranged 
from bruises to skull fractures. Additional information on these 
recalls can be found on the Commission's Web sites at: www.cpsc.gov or 
www.saferproducts.gov.

                                                     Soft Infant and Toddler Carrier Recall Summary
                                                         [January 1, 1999 through June 17, 2010]
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                                                            Year                                               Incident
           Manufacturer                   Model           recalled    Units  recalled          Reason          reports            Injury reports
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Evenflo Company & Hufco-Delaware,  Model 070 & 080             1999  327,000..........  Infant shifts to              13  One--fractured skull; two--
 Inc..                              Snugli[supreg]                                       side & slips                      bruises.
                                    Front and Back                                       through leg
                                    PackTM.                                              opening, falls out.
Baby Swede, LLC..................  Baby Bjorn.........         1999  240,000 (Recall    Infants slip                   9  Six fractured skulls.
                                                                      to Repair).        through leg
                                                                                         openings--fall.
                                                                                         Infants < 2
                                                                                         months--highest
                                                                                         risk.
Baby Swede, LLC..................  Baby Bjorn Carrier          2004  49,000...........  Back support                  93  No injuries reported.
                                    Active.                                              buckles detach
                                                                                         from shoulder
                                                                                         straps--pose fall
                                                                                         hazard.

[[Page 20515]]

 
Playtex Products, Inc............  Playtex Hip Hammock         2005  32,000...........  Shoulder strap                 2  No injuries reported.
                                                                                         detaches from
                                                                                         Hammock, posing
                                                                                         fall hazard.
Beco Baby Carrier, Inc...........  Beco Baby Carrier           2008  2,000............  Shoulder strap                 8  No injuries reported.
                                    Butterfly.                                           buckles
                                                                                         unexpectedly
                                                                                         release tension--
                                                                                         straps slip
                                                                                         through--pose fall
                                                                                         hazard.
Optave, Inc......................  Action Baby Carrier         2008  250..............  Chest strap can                2  No injuries reported.
                                                                                         detach from
                                                                                         shoulder straps,
                                                                                         posing fall hazard
                                                                                         to infant.
Regal Lager, Inc.................  CYBEX 2. GO Infant          2010  2,700 U.S........  Shoulder strap                 3  No injuries reported.
                                    Carriers.                        400 Canada.......   slider buckle can
                                                                                         break, posing fall
                                                                                         hazard to infant.
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IV. Soft Infant and Toddler Carrier International Standard and ASTM 
Voluntary Standard

    Section 104(b)(1)(A) of the CPSIA requires the Commission to 
consult representatives of ``consumer groups, juvenile product 
manufacturers, and independent child product engineers and experts'' to 
``examine and assess the effectiveness of any voluntary consumer 
product safety standards for durable infant or toddler products.'' As a 
result of fall-related incidents and recalls of soft infant and toddler 
carriers, CPSC staff previously requested ASTM to develop voluntary 
requirements to address the hazards related to large leg openings. 
Through the ASTM process, we consulted with manufacturers, retailers, 
trade organizations, laboratories, consumer advocacy groups, 
consultants, and members of the public. The voluntary standard for soft 
infant carriers was first approved and published in April 2003, as ASTM 
F2236-03, Standard Consumer Safety Performance Specification for Soft 
Infant Carriers. It has been revised six times since then. The current 
version, ASTM F2236-13, renamed Standard Consumer Safety Performance 
Specification for Soft Infant and Toddler Carriers, was approved on 
March 1, 2013 and published in March 2013.
    In addition to reviewing the ASTM standard, we reviewed the only 
international standard for soft infant carriers of which we are aware, 
EN13209-2:2005 Child Use and Care Articles--Baby Carriers--Safety 
Requirements and Test Methods--Part 2: Soft Carrier.

A. International Standard

    CPSC evaluated requirements in ASTM F2236-13 and EN13209-2:2005 and 
determined that the requirements in ASTM F2236-13 are more stringent 
than EN13209-2:2005, and that they address the incidents seen in the 
data and reduce the risk of injury from these products. The few 
EN13209-2:2005 requirements without an ASTM F2236-13 counterpart 
address hazard patterns not found in the incident reports considered 
for this proposed rule.

B. Voluntary Standard--ASTM F2236

1. History of ASTM F2236
    Initially, ASTM F2236-03 addressed falls related to large leg 
openings. The standard's bounded leg opening performance requirement 
limited the size of the leg opening to prevent infants from falling 
through large adjustable leg openings. The standard also established 
requirements to address sharp points and edges, small parts, lead in 
paints, wood parts, locking and latching of fasteners, dynamic load 
testing, static load testing, and product labeling. The scope of the 
standard was based on the manufacturers' recommended use of the product 
with infants weighing 7 to 25 pounds.
    The next update of the voluntary standard was published in March 
2008. ASTM F2236-03 addressed fall issues with bounded leg openings 
that were too large but did not consider the ability of an unbounded 
leg opening to retain the occupant. An unbounded leg opening is created 
by placing the soft carrier on a caregiver's torso, with a leg opening 
circumference comprised of carrier materials and the caregiver's torso. 
Accordingly, to address additional fall hazards, an unbounded leg 
opening performance requirement was added to ASTM F2236-08. ASTM F2236-
08a was published in November 2008, to add general requirements 
included in other ASTM standards for durable children's products that 
address hazards associated with toy accessories and flammability.
    ASTM F2236-09 was published in April 2009. The statement that the 
child occupant must face the caregiver until the child can hold its 
head upright was moved in this version of the standard from the warning 
label to be an informational statement. ASTM F2236-10, published in 
December 2010, clarified further that the informational statement for a 
child to face the caregiver until the child can hold its head upright 
was unnecessary for soft infant carriers that have only one use 
position with the child facing the caregiver.
    ASTM F2236-12 was published in December 2012. Several sections of 
the voluntary standard were revised based on input from CPSC staff. The 
scope was expanded to increase the upper weight limit of products 
within the scope of the standard from 25 to 45 pounds and to include 
specifically in the title of the standard the word ``toddler.'' ASTM 
F2236-12 also included a new definition in the terminology section of 
the standard for ``carrying position,'' to clarify procedures for 
dynamic and static load testing. Finally, the test methods for dynamic 
Noand static load testing were modified to increase the weight load 
required for testing to ensure adequate testing of products that are 
designed to carry heavier children.

[[Page 20516]]

2. Description of the Current Voluntary Standard--ASTM F2236-13
    ASTM F2236-13 was published in March 2013. Together with the 
changes described in ASTM F2236-12, ASTM F2236-13 reflects the most 
significant revisions to the standard, to date. Revisions 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. ASTM F2236-13 
includes the following key provisions: Scope, terminology, general 
requirements, performance requirements, test methods, marking and 
labeling, and instructional literature.
    Scope. The scope of the standard was updated in December 2012, to 
broaden the upper weight limit from 25 to 45 pounds for products 
falling within the standard. Expanding the scope of the standard 
ensures that all soft infant and toddler carrier products currently on 
the market are covered by the standard. The name of the standard was 
altered at the same time 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, by describing 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 it does not apply to infant slings.
    Terminology. Section 3.1 of the standard includes 14 definitions 
that help to explain general 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 F2236-13, 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.'' 
A new definition for ``carrying position'' was added in ASTM F2236-12, 
to clarify methods for dynamic and static load testing in section 7 of 
the standard. Also, a new definition for ``fastener'' was included in 
ASTM F2236-13, to aid in a new test for fastener strength and strap 
retention.
    General Requirements. ASTM F2236-13 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;
     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 in 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). The flammability requirement 
was altered to be 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 F2236-13 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-lb. 
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-lb, shot 
bag, or a shot bag equal to the manufacturer's maximum occupant weight 
limit, whichever is heavier. Also, the static load test was altered 
from requiring a 75-lb. weight for testing, to requiring a 75-lb. 
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. This revision means that products 
with a maximum recommended weight of 45 pounds must be tested to a 135-
pound weight instead of 75 pounds, an 80 percent increase in the 
severity of the requirement.
    Testing 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, 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.
    Fastener Strength and Strap Retention--ASTM F2236-13 added a new 
component-level performance requirement to evaluate the strength of 
fasteners and strap retention to help prevent falls. Products recalled 
due to an occupant fall hazard were caused by broken fasteners that 
passed the static and dynamic performance requirements in ASTM F2236-
10. Accordingly, the new performance requirement, section 6.4 of ASTM 
F2236-13, 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. When tested, fasteners must not 
break or disengage, and adjustable elements must not slip more than 1 
inch.
    Unbounded Leg Opening--ASTM F2236-13 clarifies the unbounded leg 
opening test procedure to improve test repeatability. 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 test cone is pulled through the leg opening 
with a 5-pound force for 1 minute.
    Marking, Labeling, and Instructional Literature. ASTM F2236-13 
requires that each product and its retail package be marked or labeled 
with certain information and warnings. The warning label requirement 
was updated to address fall and suffocation hazards. The warning label 
must provide a fall hazard statement addressing that infants can fall 
through wide leg openings or out of the carrier. The following fall-
related warnings must 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, a suffocation 
hazard statement must

[[Page 20517]]

address 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 
warning label must also address the following suffocation-related 
warnings: 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 or she can hold his or 
her head upright. Instructional literature must be provided with all 
products that includes: assembly, use, maintenance and cleaning, and 
required warnings.
    Additionally, ASTM F2236-13 now includes an example warning label 
that identifies more clearly the hazards, the consequences of ignoring 
the warning, and what to do to avoid the hazards. The format of the 
label was designed to convey more effectively these warnings to the 
caregiver (Fig. 1). The rectangular shape of this label may be altered 
to fit on shoulder straps, if the manufacturer chooses not to place 
label in the occupant space; however, the label must be placed in a 
prominent and conspicuous location where the caregiver will see it when 
placing the soft infant and toddler carrier on their body.
[GRAPHIC] [TIFF OMITTED] TP05AP13.000

V. Assessment of Voluntary Standard ASTM F2236-13

    In this section of the preamble, we evaluate ASTM F2236-13 to 
determine whether adopting this voluntary standard as a mandatory 
standard will address the incidents described in section III of this 
preamble, or whether more stringent standards are required to reduce 
further the risk of injury associated with soft infant and toddler 
carriers.

A. Large Leg Openings

    Twenty-three percent of the injuries (7 of 30), including three 
hospitalizations, were caused when a child fell out of a large leg 
opening. The last incident occurred in 2005, involving a product 
purchased initially in 2000. The prevalence of this hazard led to 
product recalls in 1999 (see section III.E above) and led to the 
creation of ASTM F2236, whose first performance requirement (6.1 and 
corresponding test 7.1) was developed to limit the size of a soft 
infant and toddler carrier leg opening. New reports involving the large 
leg opening hazard ceased within 2 years of the first version of ASTM 
F2236's publication in 2003. This, combined with CPSC detailed incident 
reviews, lead us to conclude that the current ASTM standard adequately 
addresses the large leg opening hazard scenario.

B. Structure, Fit, and Position

    Thirty-three percent of injuries reported to the CPSC (10 of 30) 
were related to the structure of the occupant seat area; fit of the 
occupant in the carrier; and the position of the soft infant and 
toddler carrier or the position of the wearer, or the position of the 
child in the seat area. These incidents occurred, for example, when an 
infant tucked down into the carrier and the caregiver bent at the waist 
breaking the child's leg; an infant fell out of the top of the carrier 
when the caregiver bent forward abrasions and/or blisters on infants 
from prolonged rubbing against the carrier while in use; and when 
infants suffered leg circulation-related injuries. New language in ASTM 
F2236-13 requires that warning labels address ensuring that fasteners 
and knots are secure before each use, taking special care when leaning 
or walking, and bending at the knees, not at the waist, while wearing 
the carrier. The standard also includes requirements on the format of 
the label to enhance the label's effectiveness (Fig. 1).
    Updated warning language on the product and in the instructional 
literature may address hazards arising from structure, fit, and 
position problems if consumers read, understand, and comply with the 
warnings. The diverse size of potential occupants, the broadrange of 
caregiver sizes and shapes, and numerous possible motions and 
activities that could lead to injury cannot be reliably replicated in a 
laboratory setting, making development of a repeatable test for 
structure, fit, and position types of injuries prohibitively difficult. 
A warning label would likely not address the hazard with circulation-
related injuries because that hazard may be due to a design issue. The 
Commission will

[[Page 20518]]

continue to study incoming reports of leg circulation-related injuries 
and determine whether any additional action is necessary.

C. Fasteners

    Twenty percent of the injuries (6 of 30) were caused by fastener 
failures when a fastener suddenly broke or separated and the child fell 
to the ground. Although no hospitalizations resulted from breaking 
fasteners, three children suffered fractured collarbones, along with 
contusions and abrasions to heads and faces. The caregiver in a 
majority of the incidents was able to catch the child and prevent a 
fall. Fastener failures led to four of the five voluntary product 
recalls conducted since 2005.
    ASTM F2236-13 addresses the hazards posed by fastener failures with 
a new performance requirement for fastener strength and strap 
retention, published in section 6.4 and a new test in section 7.7. New 
requirements state that all load-bearing fasteners, such as buckles, 
loops, and snaps may not break or disengage, nor may their straps slip 
more than 1 inch, when an 80-pound pull force is applied across the 
fasteners. An exception is made for adjustable leg opening fasteners, 
which must be subjected to a 45-pound pull force. Adjustable leg 
opening fasteners see substantially less load than other load-bearing 
fasteners during foreseeable use and abuse, such as fasteners securing 
shoulder and waist straps. The fastener strength and strap retention 
requirements do not apply to non-load-bearing fasteners that attach 
accessories, such as bibs, rain hoods, and toys to the soft infant and 
toddler carrier. The Commission believes that the inclusion of this new 
requirement in ASTM F2236-13 will adequately address the fall hazard 
related to fastener failures.

D. Design and Finish

    Seven percent of the soft infant and toddler injuries (2 of 30) are 
attributable to design and finish issues. Complaints include inadequate 
back support, rough fabric, poor air flow in the carrier insert, and 
one report of high lead levels in a zipper pull. The injuries consist 
of a pinched finger and a cut on the nose. ASTM F2236-13 includes 
language prohibiting sharp points and edges, but the standard does not 
specifically mention pinching. A pinching-shearing-scissoring hazard 
exists typically in products with rigid parts that move past one 
another; such a hazard does not generally exist with soft products. No 
changes to the voluntary standard for design and finish issues are 
recommended at this time. Section 101 of the CPSIA requires that 
children's products, such as soft infant and toddler carriers, not 
contain lead content in excess of 100 parts per million. Accordingly, 
such requirement does not need to be repeated in ASTM F2236-13.

E. Stitching/Seams

    Although only three percent of the injuries (1 of 30) involve 
stitching and seams, 11 percent of the total soft infant carrier 
reports (10 of 93) describe incidents in which stitching became undone 
or seams ripped, resulting in other components, like straps, becoming 
detached. One injury was reported when a seam failed, causing a 4-
month-old child to fall and receive minor contusions. The new fastener 
strength test, and the more stringent dynamic and static load tests in 
sections 7.7 and 7.2 of ASTM F2236-13, respectively, all apply loads to 
soft infant and toddler carrier seams and sewn attachment points. The 
Commission believes that incidents related to ripping seams are 
adequately addressed by these new requirements in the voluntary 
standard, and therefore, we are not proposing any additional changes at 
this time.

F. Straps

    Although there were no injuries related to soft infant carrier 
straps, nine percent of the reported incidents (8 of 93) involve issues 
with straps. The problems reported include broken strap length 
adjustment mechanisms and straps that permit unexpected slippage. The 
new fastener strength and strap retention requirements, and the more 
stringent dynamic and static load tests in sections 7.7 and 7.2 of ASTM 
F2236-13, respectively, all apply loads to soft infant and toddler 
carrier straps, and require that they not break or allow more than 1 
inch of slippage. Accordingly, the Commission believes that incidents 
related to breaking and slipping straps are adequately addressed by 
these new requirements in the voluntary standard and is not proposing 
any additional changes at this time.

G. Other

    Thirteen percent of the injury reports (4 of 30), including two 
deaths, contain insufficient information for the CPSC to determine the 
exact nature of the product's contribution to the incident. This 
category includes two fatalities and four injuries, including two 
hospitalizations. The two fatalities discussed above in section III.A, 
both involving suffocation, are included in this category. In each 
case, CPSC staff concluded that there were too many confounding factors 
reported to determine that a specific factor contributed predominantly 
to the deaths. ASTM F2236-13 does, however, address in the warning 
label requirements a suffocation hazard arising from use of soft infant 
and toddler carriers. The new warning label requirements state that 
products must address the fact that infants under 4 months old can 
suffocate if their face is too tight against a caregiver's body, and 
the label also advises caregivers not to strap the infant too tightly 
against the body to allow room for head movement and to keep an 
infant's face free from obstruction at all times.

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). To allow time for manufacturers of soft 
infant and toddler products to come into compliance, the Commission 
proposes that the standard become effective 6 months after publication 
of a final rule in the Federal Register. The Commission invites comment 
on whether 6 months will be sufficient time for soft infant and toddler 
carrier manufacturers to come into compliance with the rule.

VII. Regulatory Flexibility Act

A. Introduction

    The Regulatory Flexibility Act (RFA) requires that proposed rules 
be reviewed for their potential economic impact on small entities, 
including small businesses. Section 603 of the RFA generally requires 
that CPSC staff prepare an initial regulatory flexibility analysis and 
make it available to the public for comment when the general notice of 
proposed rulemaking is published. The initial regulatory flexibility 
analysis must describe the impact of the proposed rule on small 
entities and identify any alternatives that may reduce the impact. 
Specifically, the initial regulatory flexibility analysis must contain:
     A description of, and where feasible, an estimate of the 
number of small entities to which the proposed rule will apply;
     a description of the reasons why action by the agency is 
being considered;
     a succinct statement of the objectives of, and legal basis 
for, the proposed rule;
     a description of the projected reporting, recordkeeping, 
and other compliance requirements of the proposed rule, including an 
estimate of the classes of small entities subject to

[[Page 20519]]

the requirements and the types of professional skills necessary for the 
preparation of reports or records; and
     identification, to the extent possible, of all relevant 
federal rules which may duplicate, overlap, or conflict with the 
proposed rule.

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 focus exclusively on soft infant and toddler carriers, as 
well as substitute products, such as slings. CPSC staff believes that 
there are at least 39 suppliers to the U.S. market. Thirty-one domestic 
firms supply soft infant and toddler carriers to the U.S. market: 15 
are domestic manufacturers; eight are domestic importers; and the 
supply sources of eight domestic firms are unknown. Five foreign firms 
supply soft infant and toddler carriers to the U.S. market: three are 
foreign manufacturers; one is a foreign importer; and one firm has an 
unknown supply source. Insufficient information is available to 
categorize the remaining three firms.\2\
---------------------------------------------------------------------------

    \2\ Staff made these determinations using information from Dun & 
Bradstreet and Reference USAGov, as well as firm 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.\3\ Approximately 30 percent of soft infant 
and toddler carriers were handed down or purchased secondhand.\4\ Thus, 
about 70 percent of soft infant and toddler carriers were acquired new. 
This suggests that approximately 1.5 million soft infant and toddler 
carriers are sold to households annually (.51 x .70 x 4.1 million 
births per year).\5\
---------------------------------------------------------------------------

    \3\ 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, it may not reflect the current market.
    \4\ 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.
    \5\ U.S. Department of Health and Human Services, Centers for 
Disease Control and Prevention (CDC), National Center for Health 
Statistics, National Vital Statistics System, ``Births: Final Data 
for 2009,'' National Vital Statistics Reports Volume 60, Number 1 
(November 2011): Table I. Number of 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. Staff 
believes, however, that most adult users would not be comfortable 
carrying older, heavier children in soft infant and toddler carriers. 
This belief is supported by a lack of incident data for children over 2 
years old. 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. We do not know the proportion who 
continues to use these products into the second year; accordingly, we 
estimate risk under the assumption that approximately 25-50 percent 
will do so. Based on data from the 2006 Baby Products Tracking Study, 
approximately 2.1 million soft infant and toddler carriers are owned by 
new mothers. Therefore, approximately 2.6-3.2 million households have 
soft infant and toddler carriers available for use annually. Based on 
Epidemiology staff's estimate of 1,400 injuries treated nationally in 
emergency departments from 1999 to 2011, it is estimated that an 
average of 108 emergency department-treated injuries involving children 
under age 2 related to soft infant and toddler carriers are treated 
annually. 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 in the households of new (and second year) 
mothers.

C. Reason for Agency Action and Legal Basis for the Draft Proposed Rule

    The Danny Keysar Child Product Safety Notification Act, section 104 
of the CPSIA, requires the CPSC to promulgate mandatory standards that 
are substantially the same as, or more stringent than, the voluntary 
standard for a durable infant or toddler product. CPSC staff worked 
closely with ASTM to develop the new requirements and test procedures 
that have been incorporated into ASTM F2236-13, which forms the basis 
of the proposed rule.

D. Requirements of the Proposed Rule

    The requirements of the proposed rule are set forth above in 
section IV.B.2 of this preamble, which describes ASTM F2236-13.

E. Other Federal Rules

    Section 14(a)(2) of the CPSA requires every manufacturer and 
private labeler of a children's product that is subject to a children's 
product safety rule to certify, based on third party testing conducted 
by a CPSC-accepted laboratory, that the product complies with all 
applicable children's product safety rules. Section 14(i)(2) of the 
CPSA requires the Commission to establish protocols and standards, by 
rule, for among other things, ensuring that a children's product is 
tested periodically and where there has been a material change in the 
product, and for safeguarding against the exercise of undue influence 
on a conformity assessment body by a manufacturer or private labeler. A 
final rule implementing sections 14(a)(2) and 14(i)(2) of CPSA, Testing 
and Labeling Pertaining to Product Certification, 16 CFR part 1107, 
became effective on February 13, 2013 (the 1107 rule).
    Soft infant and toddler carriers will be subject to a mandatory 
children's product safety rule, so they will also be subject to the 
third party testing requirements of section 14 of the CPSA and the 1107 
rule when the final rule and the notice of requirements become 
effective.

F. Impact on Small Businesses

    Under U.S. Small Business Administration (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, 26 of 
the 31 domestic firms supplying soft infant and toddler carriers to the 
U.S. market are small firms--12 manufacturers, six importers, and eight 
firms whose supply source is unknown. Additional unknown small soft 
infant and toddler carrier suppliers may operate in the U.S. market as 
well.
    Small Manufacturers. The expected impact of the proposed rule on 
small manufacturers will differ, based on whether their soft infant and 
toddler carriers are already compliant with ASTM F2236-10. Although 
ASTM F2236-12 was published in December 2012, and ASTM F2236-13 was 
published in March 2013, new standards are not in effect until 6 months 
after publication. Accordingly, firms are likely to be still testing to 
ASTM F2236-10. In general, firms whose soft infant and toddler carriers 
meet the requirements of ASTM F2236-10 are likely to continue to comply 
with the voluntary standard as new versions are published. In addition, 
they are likely to meet any new standard within 6 months because this 
is the amount of time JPMA allows for products in its certification 
program to shift to a new standard. Many of these firms are active in 
the ASTM standard development process, and compliance with the 
voluntary standard is part of an established business practice.

[[Page 20520]]

    The impact on seven of 12 domestic manufacturers who comply with 
ASTM F2236-10 is expected to be small. Firms already in compliance with 
ASTM F2236-10 may require slight, if any, modifications, in order to 
bring their product(s) into compliance with the current voluntary 
standard. Any strap/fastener modifications are expected to incur 
minimal costs, as are changes to the warning label.
    Meeting ASTM F2236-13's requirements could necessitate some product 
redesign for five of the 12 domestic manufacturers who are not believed 
to be compliant with ASTM F2236-10. These redesigns would likely 
involve adding or changing straps, fasteners, or fabrics; and partial 
redesigns are generally less expensive than complete redesigns, based 
on past discussions with manufacturers. For the types of changes that 
might be required to be made to these products, staff does not believe 
that complete redesigns (e.g., engineering time, prototype development, 
and tooling) would be required for any known products. Therefore, in 
most cases, the impact of the proposed rule is not expected to have a 
significant effect on products that are not believed to be compliant 
with ASTM F2236-10.
    It is possible that some firms whose soft infant and toddler 
carriers are neither certified as compliant, nor claim compliance with 
ASTM F2236-10 (or a similar standard), in fact, are compliant with the 
standard. CPSC staff has identified many such cases with other infant 
and toddler products. To the extent that some of these firms may supply 
compliant soft infant and toddler carriers and have developed a pattern 
of compliance with the voluntary standard, the direct impact of the 
proposed rule will be less significant than described above.
    Eight small firms have unknown supply sources, three of which 
appear to be compliant with ASTM F2236-10. If these firms are 
manufacturers, they will be affected as described above. If these firms 
are distributers or wholesalers, the impact will be similar to the 
impact on importers, as discussed below.
    In addition to the direct impact of the proposed rule, indirect 
impacts exist. These impacts are considered indirect because they do 
not arise directly as a consequence of the proposed rule's 
requirements. Once the rule becomes final and the notice of 
requirements is in effect, all manufacturers will be subject to the 
additional costs associated with the third party testing and 
certification requirements. This will include any physical and 
mechanical test requirements specified in the final rule. Because lead 
and phthalates testing are already required for soft infant and toddler 
products, they are not included in this discussion.
    Staff estimates that testing to the ASTM voluntary standard could 
cost about $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 
is conducted every year on a single sample for each model, third party 
testing costs for each manufacturer would be about $1,000-$1,200 
annually. Based on a review of firms' revenues, the impact of third 
party testing to ASTM F2236-13--if only one soft carrier sample per 
model is required--is unlikely to be significant. However, these costs 
could be more significant if multiple models are needed for testing.
    Small Importers. Most importers would not experience significant 
impacts as a result of the proposed rule. Five of the six small 
importers are believed to be compliant with the voluntary standard. In 
the absence of regulation, these firms would likely continue to comply 
with the voluntary standard as it evolves and would likely comply with 
the final mandatory standard as well. The remaining importer might need 
to find an alternate source of soft infant and toddler carriers if its 
existing supplier does not come into compliance with the requirements 
of the proposed rule. Alternatively, the firm may discontinue importing 
soft infant and toddler carriers altogether and perhaps substitute 
another product.
    As is the case with manufacturers, all importers will be subject to 
third party 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 
have a significant impact on a few small importers who must perform the 
testing themselves if more than one sample per model is required. In 
addition, the impacts could be higher than those incurred by domestic 
manufacturers if importers have to test each batch imported in the case 
where the foreign manufacturer does not conduct testing.

G. Alternatives

    Under the Danny Keysar Child Product Safety Notification Act, 
section 104 of the CPSIA, one alternative would be to set an effective 
date later than the proposed 6 months, which is generally considered 
sufficient time for suppliers to come into compliance with a proposed 
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.

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,'' it will be categorically exempted from this 
requirement. 16 CFR 1021.5(c)(1). The proposed rule falls within the 
categorical exemption.

IX. Paperwork Reduction Act

    The proposed rule contains information collection requirements that 
are subject to public comment and review by the Office of Management 
and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501-3521). In this document, pursuant to 44 U.S.C. 3507(a)(1)(D), we 
set forth:
     A title for the collection of information;
     A summary of the collection of information;
     A brief description of the need for the information and 
the proposed use of the information;
     A description of the likely respondents and proposed 
frequency of response to the collection of information;
     An estimate of the burden that shall result from the 
collection of information; and
     Notice that comments may be submitted to the OMB.
    Title: Safety Standard for Soft Infant and Toddler Carriers
    Description: The proposed rule would require each soft infant and 
toddler carrier to comply with ASTM F2236-13, Standard Consumer Safety 
Specification for Soft Infant and Toddler Carriers. Sections 8.1 and 
9.1 of ASTM F2236-13 contain requirements for marking, labeling, and 
instructional literature that are disclosure requirements, thus falling 
within the definition of ``collections of information'' at 5 C.F.R. 
1320.3(c).
    Description of Respondents: Persons who manufacture or import soft 
infant and toddler carriers.
    Estimated Burden: We estimate the burden of this collection of 
information as follows:

[[Page 20521]]



                                                       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...............................................................              39                2               78                1               78
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Our estimate is based on the following:
    Section 8.1 of ASTM F2236-13 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 39 firms that supply soft infant and toddler 
carriers in the U.S. market. All 39 firms are assumed to use labels on 
their products and on their packaging already, but they might need to 
make some modifications to their existing labels. The estimated time 
required to make these modifications is about 1 hour per model. Each of 
these firms supplies an average of two different models of soft infant 
and toddler carrier; therefore, the estimated burden hours associated 
with labels is 1 hour x 39 firms x 2 models per firm = 78 hours 
annually.
    We estimate the hourly compensation for the time required to create 
and update labels is $27.92 (U.S. Bureau of Labor Statistics, 
``Employer Costs for Employee Compensation,'' September 2012, Table 9, 
total compensation for all sales and office workers in goods-producing 
private industries: https://www.bls.gov/ncs/). Therefore, the estimated 
annual cost to industry associated with the labeling requirements is 
$2,177.76 ($27.92 per hour x 78 hours = $2,177.76). No operating, 
maintenance, or capital costs are associated with the collection.
    Section 9.1 of ASTM F2236-13 requires that all soft infant and 
carrier products provide instructions that are easy to read and 
understand. Where applicable, instructions for assembly, use, 
maintenance and cleaning of the product, and warnings, must also be 
included. Soft infant and toddler carriers are products that do not 
generally require installation but require instruction for proper use, 
fit, and adjustment on a caregiver's body. Under the OMB's regulations 
(5 CFR 1320.3(b)(2)), the time, effort, and financial resources 
necessary to comply with a collection of information that would be 
incurred by persons in the ``normal course of their activities'' are 
excluded from a burden estimate, where an agency demonstrates that the 
disclosure activities required to comply are ``usual and customary.'' 
Therefore, because we are unaware of soft infant and toddler carriers 
that lack any instructions to the user about proper use, fit, and 
assembly, we estimate tentatively that there are no burden hours 
associated with section 9.1 of ASTM F 2236-13 because any burden 
associated with supplying instructions with soft infant and toddler 
carriers would be ``usual and customary'' and would not fit within the 
definition of ``burden'' under the OMB's regulations.
    In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 
3507(d)), we have submitted the information collection requirements of 
this rule to OMB for review. Interested persons are requested to submit 
comments regarding information collection by May 6, 2013, to the Office 
of Information and Regulatory Affairs, OMB (see the ADDRESSES section 
at the beginning of this notice).
    Pursuant to 44 U.S.C. 3506(c)(2)(A), we invite comments on:
     Whether the collection of information is necessary for the 
proper performance of the CPSC's functions, including whether the 
information will have practical utility;
     the accuracy of the CPSC's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used;
     ways to enhance the quality, utility, and clarity of the 
information to be collected;
     ways to reduce the burden of the collection of information 
on respondents, including the use of automated collection techniques, 
when appropriate, and other forms of information technology; and
     the estimated burden hours associated with label 
modification, including any alternative estimates.

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 would apply. Therefore, a rule issued under 
section 104 of the CPSIA will invoke the preemptive effect of section 
26(a) of the CPSA when it becomes effective.

XI. Certification and Notice of Requirements (NOR)

    Section 14(a) of the CPSA imposes the requirement 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 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 notice of requirements 
(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 proposed rule for 16 
CFR part 1226, ``Safety Standard for Soft Infant and Toddler 
Carriers,'' when issued as a final rule, will be a children's product 
safety rule that requires the issuance of an 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 Section 14(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,

[[Page 20522]]

require an amendment to part 1112. Accordingly, the proposed rule would 
amend 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.
    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 would be 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, it can apply to the CPSC to have 16 CFR 
part 1226, Safety Standard for Soft Infant and Toddler Carriers, 
included in its scope of accreditation of CPSC safety rules listed for 
the laboratory on the CPSC Web site at: www.cpsc.gov/labsearch.
    CPSC staff previously conducted an analysis of the potential 
impacts on small entities of the proposed rule for part 1112, and 
published an Initial Regulatory Flexibility Analysis (IRFA) in 77 FR 
31086, 31123-26 (May 24, 2012). The IRFA concluded that the 
requirements in part 1112 would not have a significant adverse impact 
on a substantial number of small laboratories because no requirements 
are imposed on laboratories that do not intend to provide third party 
testing services under Section 14(a)(2) of the CPSA. The only 
laboratories that are expected to provide such services are those that 
anticipate receiving sufficient revenue from providing the mandated 
testing to justify accepting the requirements as a business decision. 
Laboratories that do not expect to receive sufficient revenue from 
these services to justify accepting these requirements would likely not 
pursue accreditation for this purpose.
    Amending part 1112 to include the NOR for the soft infant and 
toddler standard would also not have a significant adverse impact on 
small laboratories. 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 
standard. Most of these laboratories already will have 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 could certify that the proposed NOR for the soft infant and 
toddler standard will not have a significant impact on a substantial 
number of small entities.
    The final NOR will base the CPSC laboratory accreditation 
requirements on the performance standard set forth in the final rule 
for the safety standard for soft infant and toddler carriers and the 
test methods incorporated within that standard. The Commission may 
recognize limited circumstances in which it will accept certification 
based on product testing conducted before the Commission's acceptance 
of accreditation of laboratories for testing soft infant and toddler 
carriers (also known as retrospective testing) in the final NOR. The 
Commission seeks comments on any issues regarding the testing 
requirements of the proposed rule for soft infant and toddler carriers 
and the accompanying proposed NOR.

XII. Request for Comments

    This proposed rule begins a rulemaking proceeding under section 
104(b) of the CPSIA to issue a consumer product safety standard for 
soft infant and toddler carriers. We invite all interested persons to 
submit comments on any aspect of the proposed rule. Comments should be 
submitted in accordance with the instructions in the ADDRESSES section 
at the beginning of this notice.

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 proposes 
to amend 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. 110-314, section 3, 122 
Stat. 3016, 3017 (2008)

0
2. In Sec.  1112.15 add paragraph (b)(36) 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) * * *
* * * * *
    (36) 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 F2236-13, Standard Consumer Safety 
Specification for Soft Infant and Toddler Carriers, approved on March 
1, 2013. 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 29, 2013.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2013-07687 Filed 4-4-13; 8:45 am]
BILLING CODE 6355-01-P