[Federal Register Volume 77, Number 237 (Monday, December 10, 2012)]
[Proposed Rules]
[Pages 73354-73366]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-29584]


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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Parts 1112 and 1225

[CPSC Docket No. CPSC-2012-0068]
RIN 3041-AD16


Safety Standard for Hand-Held Infant Carriers

AGENCY: Consumer Product Safety Commission.

ACTION: Notice of Proposed Rulemaking.

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SUMMARY: The Danny Keysar Child Product Safety Notification Act, 
Section 104(b) of the Consumer Product Safety Improvement Act of 2008 
(CPSIA) requires the United States Consumer Product Safety Commission 
(Commission, CPSC, or we) to promulgate consumer product safety 
standards for durable infant or toddler products. These standards are 
to be ``substantially the same as'' applicable voluntary standards or 
more stringent than the voluntary standard if the Commission concludes 
that more stringent requirements would further reduce the risk of 
injury associated with the product. The Commission is proposing a 
safety standard for handheld infant carriers in response to the 
direction under Section 104(b) of the CPSIA. The proposed rule would 
incorporate ASTM F2050-12 by reference, with two modifications.

DATES: Submit comments by February 25, 2013.

ADDRESSES: Comments related to the Paperwork Reduction Act aspects of 
the marking, labeling, and instructional literature of the proposed 
rule should be directed to the Office of Information and Regulatory 
Affairs, OMB, Attn: CPSC Desk Officer, Fax: 202-395-6974, or emailed to 
mailed to: [email protected].
    Other comments, identified by Docket No. CPSC-2012-0068, may be 
submitted electronically or in writing:
    Electronic Submissions: Submit electronic comments to the Federal 
eRulemaking Portal at: http://www.regulations.gov. Follow the 
instructions for submitting comments. To ensure timely processing of 
comments, the Commission is no longer

[[Page 73355]]

directly accepting comments submitted by electronic mail (email), 
except through www.regulations.gov. The Commission encourages you to 
submit electronic comments by using the Federal eRulemaking Portal, as 
described above.
    Written Submissions: Submit written submissions in the following 
way: Mail/Hand delivery/Courier (for paper, disk, or CD-ROM 
submissions), preferably in five copies, to: Office of the Secretary, 
Consumer Product Safety Commission, Room 820, 4330 East West Highway, 
Bethesda, MD 20814; telephone (301) 504-7923.
    Instructions: All submissions received must include the agency name 
and docket number for this rulemaking. All comments received may be 
posted without change, including any personal identifiers, contact 
information, or other personal information provided, to: http://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: http://www.regulations.gov, and insert the 
docket number, CPSC 2012-0068, into the ``Search'' box, and follow the 
prompts.

FOR FURTHER INFORMATION CONTACT:  Patricia L. Edwards, Project Manager, 
Directorate for Engineering Sciences, U.S. Consumer Product Safety 
Commission, 5 Research Place, Rockville, MD 20850; email: 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background and Statutory Authority

    The CPSIA was enacted on August 14, 2008. Section 104(b) of the 
CPSIA, part of the Danny Keysar Child Product Safety Notification Act, 
requires the Commission to promulgate consumer product safety standards 
for durable infant or toddler products. These standards are to be 
``substantially the same as'' applicable voluntary standards or more 
stringent than the voluntary standard if the Commission concludes that 
more stringent requirements would further reduce the risk of injury 
associated with the product. The term ``durable infant or toddler 
product'' is defined in section 104(f)(1) of the CPSIA as a durable 
product intended for use, or that may be reasonably expected to be 
used, by children under the age of 5 years. Infant carriers are one of 
the products specifically identified in section 104(f)(2)(F) as a 
durable infant or toddler product. At this time, the Commission has 
identified four types of products that could fall within the infant 
carrier product category, including: Frame backpack carriers, soft 
infant and toddler carriers, slings, and handheld infant carriers. This 
rule addresses hazards associated only with hand held infant carriers. 
Hazards associated with other types of carriers would be addressed in 
separate rulemaking proceedings.
    In this document, the Commission proposes a safety standard for 
hand held infant carriers. The proposed standard is based on the 
voluntary standard developed by ASTM International (formerly the 
American Society for Testing and Materials), ASTM F2050-12, ``Standard 
Consumer Safety Specification for Hand-Held Infant Carriers.'' The ASTM 
standard is copyrighted. However, by permission of ASTM, the standard 
can be viewed as a read-only document during the comment period on this 
proposal, at: http://www.astm.org.

II. The Product

A. Definition

    ASTM F2050-12 defines a ``hand held infant carrier'' as a 
``freestanding, rigid-sided product intended to carry an occupant whose 
torso is completely supported by the product to facilitate 
transportation by a caregiver by means of hand-holds or handles.'' The 
current ASTM voluntary standard references two types of hand held 
infant carriers: hand-held bassinets/cradles that incline 10 degrees or 
less from horizontal and sit directly on the floor, and hand-held 
carrier seats that incline more than 10 degrees from horizontal and are 
often also used as attachments to serve as infant car seats, strollers, 
or high chairs. The current ASTM voluntary standard defines ``hand-held 
carrier seat'' as a ``hand-held infant carrier having a seat back that 
is intended to be in a reclined position (more than 10[deg] from 
horizontal),'' and ``hand-held bassinet/cradle'' is defined as `` 
freestanding product, with a rest/support surface to facilitate sleep 
(intended to be flat or up to 10[deg] from horizontal), that sits 
directly on the floor, without legs or a stand, and has hand-holds or 
handle(s) intended to allow carrying an occupant whose torso is 
completely supported by the product.'' Some of the requirements in 
F2050-12 are different for hand-held bassinets/cradles and hand-held 
infant carriers because the intended position of the occupant (lying 
supine vs. sitting reclined) and the product designs used to 
accommodate the occupant can create different hazards. A Moses basket 
is considered to be a freestanding product with a rest/support surface 
to facilitate sleep and typically has hand-holds or handle(s) intended 
to allow carrying an occupant. Moses baskets typically have semi-rigid 
sides. The Commission seeks comments on whether Moses baskets are or 
should be covered by this safety standard. The Commission specifically 
seeks comments on (1) whether the definition of ``hand-held bassinet/
cradle'' in ASTM F2050-12 includes Moses baskets, and (2) if Moses 
baskets are not covered by the safety standard but should be, how the 
present definition should be amended to more clearly cover Moses 
baskets.

B. The Market

    Based on the 2005 survey conducted by American Baby Group titled, 
``2006 Baby Products Tracking Study,'' and annual birth data from the 
Centers for Disease Control and Prevention (CDC), we estimate that 
approximately 2.1 million infant car seats are sold in the United 
States each year. We do not know how many hand-held bassinets/cradles 
are sold annually. Hand-held carrier seats and hand-held bassinets/
cradles are typically produced and/or marketed by juvenile product 
manufacturers and distributors, except for Moses baskets, a unique type 
of hand-held bassinet/cradle that is often marketed by bedding 
manufacturers and distributors. We estimate there are currently at 
least 43 suppliers of both types of hand-held infant carriers to the 
U.S. market, 11 of which are domestic manufacturers and 10 of which are 
domestic importers. We estimate that 20 firms supply Moses basket-style 
hand-held bassinets/cradles only, but the source of these carriers is 
unknown. There are also two foreign firms--a foreign manufacturer and 
an importer that import products from foreign companies and distributes 
them in the United States.
    The products of 13 of the 43 hand-held infant carrier suppliers 
will likely be compliant with ASTM F2050-12 (6 are Juvenile Products 
Manufacturers Association (JPMA) certified to F2050-09; 3 claim 
compliance with F2050; and 4 have JPMA-certified strollers with hand-
held infant carrier attachments).\1\

[[Page 73356]]

 Of the remaining 30 firms supplying noncompliant hand-held infant 
carriers, the majority (25 firms) supply products that are newly 
covered due to the expanded scope of ASTM F2050-12 (20 supply Moses 
baskets; 3 supply bassinet attachments for strollers; and 2 supply 
other types of bassinet-style carriers) to include hand-held bassinets/
cradles.
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    \1\ JPMAs typically allows 6 months for products in their 
certification program to shift to a new standard once it is 
published. ASTM F2050-12, The voluntary standard upon which the 
proposed standard is based, will become effective for JPMA 
certification purposes in approximately March 2013. Firms that 
supply JPMA-certified strollers are expected to ensure that all of 
their attachments, including hand-held infant carriers, comply with 
all applicable ASTM standards as well.
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III. Incident Data

    The CPSC's Directorate for Epidemiology notes that there have been 
242 incidents, occurring between January 1, 2007 and June 7, 2012, 
reported to the Commission regarding hand-held infant carriers. Of the 
242 incidents, there were 36 fatalities, 60 nonfatal injuries, and 146 
incidents where no injury occurred or was reported.

A. Fatalities

    From January 1, 2007 through early June, 2012, there were 36 
fatalities associated with hand-held infant carriers. The majority of 
the fatalities are attributed to the improper use or non-use of the 
carrier's restraint system.
    Five of the fatalities were caused by the infant carrier being 
placed in a hazardous environment, and therefore, these fatalities are 
considered to be non-product related. Two of these fatalities occurred 
when the infant carrier was placed atop a stove, which subsequently was 
ignited accidently. Another fatality was attributed to hyperthermia 
after an infant was left unattended in a carrier for an extended period 
of time, wrapped in multiple blankets, and left in a room with 
temperatures exceeding 90 degrees. In another of these five deaths, an 
infant in a carrier that was placed cross-wise inside a bassinet was 
able to tip the carrier into a reclined position, resulting in an 
asphyxiation death. The last of these five fatalities was the result of 
an infant suffocating on a blanket that was placed over his head while 
in the carrier. For an additional two fatalities, the evidence is 
insufficient to determine if there was any product involvement or the 
presence of any hazardous external circumstances.
    The remainder of the fatal incidents includes:
     Nine children were strangled by the carrier's harness 
chest clips or strap. In most of these incidents the infant was 
partially restrained in the seat with only the shoulder straps in 
place, with the crotch strap left unsecured, which allowed the infant 
to slide forward in the seat far enough to get caught at the throat by 
the chest clip that connects the two shoulder straps.
     In one incident, the restraint straps were too tight and 
impaired the infant's breathing, although no information regarding the 
placement of the straps was provided.
     Seven children were left unrestrained in the carrier and 
found in a prone position, face down on the seat, or on a blanket, 
covers, and/or pillow.
     Two children who had been left unrestrained in the carrier 
were found prone on the seat of the carrier, which had also tipped 
over.
     Three children were reported to have been trapped in an 
overturned seat, although no information was provided about the use of 
the restraints or how the seat overturned in these incidents.
     One fatality resulted from a fall from a carrier that was 
on a shopping cart but not equipped to attach to the cart.
     Six additional deaths were associated with hand-held 
carriers, but there was insufficient information to determine the 
circumstances.

B. Nonfatal Injuries

    From January 1, 2007 through early June 2012, 206 nonfatal 
incidents were reported. Of those, 60 incidents involved an injury, and 
2 of those required hospitalization due to serious head injuries 
suffered from a fall from a carrier that was on top of a shopping cart. 
Bumps, bruises, abrasions, lacerations, allergic reactions and near-
choking episodes are the most common injuries reported in the remaining 
58 injury reports. No age was reported for 28 percent of the injury 
incidents. For incidents where the age was reported, 1 child was 
reported to be 13 months old, 1 was reported to be 23 months old, and 
the rest were 12 months or younger. The remaining 146 incident reports 
indicate that no injury occurred or they fail to provide any 
information regarding injuries to the carrier occupant. However, many 
of the descriptions of the incidents suggest the potential for serious 
injury or death.

C. Recalls

    There have been a total of three consumer-level recalls involving 
hand-held carriers from January 1, 2007 through June 7, 2012.
    One recall, involving 450,000 car seats/carriers manufactured from 
December 2004 through September 2006, pertained to the carrier seat 
handle. The carrier handle could release unexpectedly, causing the seat 
to rotate forward in a manner that could result in the occupant of the 
carrier falling to the ground and suffering serious injuries. There 
were 679 incidents of the handle releasing unexpectedly, resulting in 
160 injuries reported to the CPSC and the manufacturer. The recall 
notice instructed consumers not to use the seat as a carrier until the 
repair kit offered by the manufacturer had been obtained and installed. 
(The modifications to the handle auto-lock test discussed in Section VI 
would address this hazard.)
    Another recall, conducted on December 18, 2009, involving 447,000 
infant car seat/carriers manufactured from January 6, 2008 to April 6, 
2009, also pertained to the carrier handle. The seat handle could 
loosen and fall off, posing a fall hazard to the infant occupant of the 
seat. There were 77 incidents of the child restraint handle fully or 
partially detaching from the car seat/carrier, resulting in three 
injuries, reported to the CPSC and the manufacturer. Consumers were 
instructed not to use the seat as a carrier until they had obtained and 
installed the repair kit offered by the manufacturer. (The carrying 
handle integrity test included in ASTM F2050-12, addresses this 
hazard).
    The third recall was conducted on November 4, 2010, and it involved 
23,000 infant car seats/carriers manufactured between April 2009 and 
May 2010. The harness chest clips could break, posing a fall hazard, 
and the broken pieces were small enough for an infant to swallow, which 
posed a choking hazard. There were four incidents of the chest clip 
breaking, resulting in three injuries reported to the CPSC and the 
manufacturer. The injuries that resulted from the clip breaking were 
minor lacerations and scratches to arms and a finger, and one report 
involved an infant placing the broken clip in his mouth. The recall 
notice instructed consumers to contact the manufacturer to request a 
free repair kit. (The restraint system test included in ASTM F2050-12 
addresses this hazard.)

IV. Hand-Held Carrier International Standards and the ASTM Voluntary 
Standard

    Section 104(b)(1)(A) of the CPSIA requires the Commission to 
consult representatives of ``consumer groups, juvenile product 
manufacturers, and independent child product engineers and experts'' to 
``examine and assess the effectiveness of any voluntary consumer 
product safety standards for durable infant or toddler products.'' As a 
result of incidents and recalls of hand-held infant carriers in the 
1990s, CPSC staff requested ASTM to develop voluntary requirements to 
address the hazards

[[Page 73357]]

related to handle breakage and handle lock failures. Through the ASTM 
process, we consulted with manufacturers, retailers, trade 
organizations, laboratories, consumer advocacy groups, consultants, and 
members of the public. The voluntary standard for hand-held infant 
carriers was first approved and published in August 2000, as ASTM 
F2050-00, Standard Consumer Safety Performance Specification for Hand-
Held Infant Carriers. It has been revised five times since then. The 
current version, ASTM F2050-12, was approved on July 1, 2012.
    In addition to reviewing the ASTM standard, we reviewed several 
international standards.

A. International Standards

    We identified one international standard, EN 12790, European/
British Standard for Child Care Articles--Reclined Cradles, which 
addresses hand-held infant carriers in a manner similar to ASTM F2050-
12. However, reclined cradles are designed and intended for unattended 
sleep, and the European standard includes requirements that also 
pertain to that use pattern. One difference between EN 12790 and ASTM 
F2050-12 is entrapment dimensions for holes and slot openings. The 
European standard permits dimensions for slot openings to be between 7 
mm and 12 mm, while ASTM F-2050-12 allows dimensions of 5 mm to 9.5 mm. 
We have concluded that the existing dimensions in the ASTM standard are 
anthropometrically appropriate and that there are no hazard patterns 
that would warrant modification of these dimensions. In addition, we 
concluded that the hazard patterns noted in the incidents do not 
warrant modification of the ASTM standard to address the requirements 
for flammability, surface chemicals, cords/ribbons, cradle angles, and 
cradle strength/durability that appear in EN 12790. Finally, we note 
that EN 12790 includes requirements for folding cradles, which is a use 
pattern outside the scope of ASTM F2050-12.
    We reviewed several other international standards and a National 
Highway Safety Transportation Administration (NHTSA) standard that 
address requirements for restraint systems of products when used in 
motor vehicles, and we concluded that these standards do not address 
the incident hazard patterns associated with hand-held infant carriers. 
These standards are: ECE 44 (European Provision for Restraining Devices 
for Child Occupants of Power-Driven Vehicles, JIS D 0401 (Japanese 
Standard for Automotive Accessories--Child Restraints), AS/NZS 
1754:2010 (Australian/New Zealand Standard for Child Restraint Systems 
for Use in Motor Vehicles), and FMVSS No. 213 (NHSTA Requirements for 
Child Restraint Systems Used in Motor Vehicles and Aircraft).

B. The ASTM Voluntary Standard

    In response to incidents and recalls of hand-held infant carriers 
in the 1990s related to handle breakage and handle lock failures, CPSC 
requested ASTM to develop voluntary requirements to address the 
hazards. CPSC staff participated in ASTM subcommittee meetings and 
testing protocols in developing draft requirements. ASTM F 2050, 
Standard Consumer Safety Performance Specification for Hand-Held Infant 
Carriers was first approved and published in August 2000. ASTM has 
revised the standard four times since then, with the most current 
version ASTM F 2050-12, approved on July 1, 2012. Details regarding the 
changes in the voluntary standard through revisions in October, 2001, 
November, 2003, December, 2008, and October 2009, are provided at pages 
30 and 31 of the November 7, 2012, Staff Briefing Package.
    ASTM F2050-12 addresses many of the general hazards associated with 
durable nursery products, such as lead in paints, sharp edges/sharp 
points, small parts, wood part splinters, scissoring/shearing/pinching, 
openings/entrapments, and toys. Specific requirements for labeling, 
handle integrity, handle auto-locking, and restraint systems are also 
included.
    The key provisions of the current ASTM hand-held infant carrier 
standard include: Definitions; general requirements; performance 
requirements; specific test methods; and requirements for marking, 
labeling, and instructional literature.
    Definitions. ASTM F2050-12 defines ``hand-held infant carrier'' as 
a ``free standing, rigid-sided product intended to carry an occupant 
whose torso is completely supported by the product to facilitate 
transportation by a caregiver by means of hand-holds or handles.'' The 
definition of ``hand-held infant carrier seat'' is ``a hand-held infant 
carrier having a seat back that is intended to be in a reclined 
position (more than 10[deg] from horizontal).'' The definition of 
``hand-held bassinet/cradle'' is a ``freestanding product, with a 
horizontal rest/support surface to facilitate sleep (intended to be 
flat or up to 10 from horizontal), which sits directly on the floor, 
without legs or a stand, and has hand-holds or handle(s) intended to 
allow carrying an occupant whose torso is completely supported by the 
product.''
    General Requirements. ASTM F2050-12 contains general requirements 
that the product must meet, as well as mandated test methods that must 
be used to ensure that the product meets those requirements, including:
     Restrictions on sharp points, small parts, lead paint, and 
wood parts;
     Specifications to prevent scissoring, shearing, and 
pinching;
     Requirements for toy accessory items, and the non-removal 
of protective components;
     Specifications on openings (intended to prevent finger and 
toe entrapment), labeling (intended to prevent labels from being 
removed and ingested or aspirated on), and coil springs; and
     Torque and tension tests for protective components.
    Performance Requirements and Specific Test Methods. ASTM F2050-12 
provides performance requirements that the product must meet, as well 
as mandated test methods that must be used to ensure that the product 
meets the performance requirement, including:
     A carry handle auto-locking requirement (the carry handle 
must move unaided into the designated carry position or move unaided 
into a position that is obvious to the caregiver that the carry handle 
is not in the designated carry position);
     A carry handle integrity requirement (a rigid carry handle 
that rotates in head-to-foot and foot-to-head directions must not break 
or unlatch on either or both sides when subject to the handle endurance 
test);
     A restraint system requirement (hand held carrier seats 
not intended for use in motor vehicles must have a waist and crotch 
restraint while hand-held bassinets/cradles may not contain a restraint 
system);
     Slip-resistance requirements;
    Marking, Labeling, and Instructional Literature. ASTM F2050-12 sets 
forth requirements for marking, labeling, and instructions that must 
accompany a hand-held carrier, including warnings regarding proper use 
of restraint straps, placement of the carrier on soft or elevated 
surfaces, and suffocation and strangulation hazards that may arise if 
restraint straps are not used properly and suffocation hazards that can 
arise when the carrier is placed on a soft surface. The warning label 
also advises caregivers never to leave a child unattended in the 
carrier. The standard also includes requirements and tests for the 
permanency of labels and warnings.

[[Page 73358]]

V. Assessment of Voluntary Standard ASTM F2050-12

    We considered the fatalities, injuries, and noninjury incidents 
associated with hand-held carriers, and we evaluated the voluntary 
standard to determine whether ASTM F2050-12 addresses the incidents or 
whether more stringent standards are required that would further reduce 
the risk of injury associated with these products. We discuss our 
assessment in this section, but our assessment does not include deaths 
and injuries associated with hand-held carriers where there was 
insufficient evidence to determine the circumstances.

1. Hazardous Surroundings

    Five of the 36 fatalities reported, and 12 of the 242 incidents 
reported involving a hand-held carrier were attributable to unsafe 
environments around the carrier. Two of the five fatalities resulted 
when the carrier was placed on top of a stove that later was ignited. 
In another of the fatalities, the infant died from hyperthermia after 
being left unattended in a carrier, wrapped in blankets, in a room 
where temperatures exceeded 90 degrees. In another fatality, the infant 
was placed in the carrier cross-wise inside a bassinet and asphyxiated 
when the carrier was tipped into a reclined position trapping the 
infant between the carrier and the interior of the bassinet. The fifth 
fatality was attributable to a suffocation in which a blanket was 
placed over the infants head while in the carrier. Risks due to 
hazardous surroundings are not attributable to the design or 
construction of the hand-held carriers. ASTM F 2050-12 includes product 
warnings that address the dangers of placing the product near the edges 
of counter tops or on elevated surfaces, and the warnings direct 
caregivers never to leave a child unattended in a carrier. We do not 
believe there are additional requirements that can be put into place in 
the standard to address this issue.

2. Hazards Related to Accessories

    Issues related to accessories, such as toys, canopies, carrier seat 
covers, and head and body support devices were reported in 28 of the 
242 (12 percent) reported incidents. In 27 of these incidents, the 
accessory was not supplied with the carrier, but was purchased 
separately by a caregiver. In the remaining incident, the accessory was 
an attached canopy. While there were no fatalities involving 
accessories, the incidents reported included: Choking on a device 
designed to attach a toy to the carrier handle; jamming an arm into the 
side of toy; breathing obstruction from canopy drooping onto childs 
face; and breaking and detaching small pieces from a pacifier and a 
pacifier holder. The current standard precludes hazardous sharp edges 
or points, as defined in 16 CFR 1500.48 and 1500.49 before and after 
testing to the standard, and prohibits small parts, as defined in 16 
CFR part 1501, before testing or liberated as a result of testing to 
the standard. The standard also requires that any toy accessories 
attached to, removable from, or sold with, an infant carrier, as well 
as their means of attachment must meet the applicable requirements of 
ASTM Consumer Safety Specification F963 (now CPSC's mandatory toy 
standard). We believe that these requirements are sufficient to address 
these hazards, and therefore we are not proposing any additional 
requirements at this time.

3. Design Issues

    Twenty-eight of the 242 incident reports (12 percent) are 
attributed to the design of the carrier. Three of the incidents 
reported in this category were fatalities. Design issues are related to 
instability, sharp surfaces, unsafe infant posture when seated, and 
structural integrity. Although the three reported fatalities involve a 
child becoming trapped under an overturned seat, insufficient 
information was provided in these reports to determine what caused the 
seat to overturn. It is possible these tip overs could be related to 
the stability of the carrier when placed on tables, sofas, or chairs. 
However, there is insufficient incident data to support a conclusion 
that design issues were the cause of the fatalities or other incidents. 
Additionally, many carriers are designed to meet NHTSA requirements for 
occupant crashworthiness, and modification of the carrier to improve 
stability when used outside the vehicle might affect how the carrier 
integrates into the carrier base in the vehicle. For these reasons, we 
are not proposing any changes to address stability-related design 
issues at this time.
    In addition to stability, this hazard pattern includes occupant-
positioning incidents. Six consumer complaints involve infant head 
slumping. However, we received no reports of fatalities or injuries 
resulting from infant head slumping. Because we are aware of no 
injuries resulting from this hazard, and because a revision of the 
standard to address angle of seat incline may implicate issues within 
NHTSA's jurisdiction, we are not proposing any changes to address angle 
of seat incline at this time.
    Three consumer complaints state that mothers do not always pay 
appropriate attention to the way they swing carriers while an infant is 
in the seat. The complaints suggest that this movement may place the 
infant at risk for shaken baby syndrome. Because there are no injuries 
reported in connection with this scenario, and because no revision of 
the standard would likely address any potential risk of injury arising 
from the way a caregiver swings the carrier, we are not proposing any 
changes to address this issue at this time.

4. Falls From Shopping Carts

    Incidents included one reported fatality and two reported injuries 
involving children who fell from shopping carts on which the carriers 
had been placed. The two injured children required hospitalization for 
serious head injuries suffered when they fell to the floor from a 
carrier that had been placed on a shopping cart. The risk associated 
with placing a child in a hand-held carrier on a shopping cart is 
addressed by ASTM 2372-11a, Standard for Consumer Safety Performance 
Specification for Shopping Carts, which was developed to address 
injuries to children associated with falls from shopping carts. This 
standard requires each shopping cart to have warning statements 
instructing the user not to use a personal infant carrier but instead 
to use the seat in the cart and to fasten the child securely into the 
seat. In addition, the standard requires retailers to provide 
additional safety information in the form of warning posters at the 
point of use. The warning label pertaining to safe use recently was 
revised and includes a pictogram concerning the use of hand-held 
carriers in the cart. This new label is included in this latest 
version, which was approved in January 2012. We do not believe that 
there are additional requirements that can be put in place in either 
ASTM 2372-11a or ASTM F2050-12 to address this issue.

5. Fabric Issues

    In 15 of the 242 (6 percent) reported incidents, the injury related 
to the carrier fabric or padding. Incidents related to fabric include: 
allergic reactions to padding or items attached to padding; bruising 
from fabric stitching; and ingesting padding foam. This hazard pattern 
is not specific to this product. Because similar incidents occur with 
other durable products and are expected with any product with fabric or 
padding, we are not proposing any additional requirements to address 
fabric issues at this time.

[[Page 73359]]

6. Other Product-Related Concerns

    In 10 of the 242 (4 percent) reported incidents, we were unable to 
identify a specific hazard pattern because insufficient information 
regarding the circumstances of the incident was provided. Six of these 
incidents resulted in fatalities. Most of these reports indicate 
possible improper use of the carrier or another contributing factor, 
such as soft bedding. For example, one case involves an infant sleeping 
in the carrier with a blanket or covering that may have resulted in 
suffocation. However, because we are unable to identify a specific 
hazard pattern in incidents with insufficient information, we are not 
proposing additional requirements at this time.

7. Other Unknown Issues

    Two fatalities could not be attributed to design or performance of 
the hand-held carrier. We are in the process of investigating both 
deaths, and once these investigations are complete, further review by 
CPSC staff will be warranted to determine if the design or construction 
of the hand-held carrier contributed to the deaths. If we conclude that 
the design or construction of the hand-held carrier contributed to 
either of these deaths, we will determine whether additional 
requirements are necessary. Because the involvement of the product in 
these incidents is unclear, we cannot propose additional requirements 
in the absence of information supporting the conclusion that these two 
incidents were attributed to the design or performance of the hand-held 
carrier.

VI. Description of Proposed Changes to ASTM Standard

    The proposed rule would create a new part 1225 titled, ``Safety 
Standard for Hand Held Carriers.'' The proposed rule would establish 
ASTM F2050-12, ``Standard Consumer Safety Specification for Hand-Held 
Infant Carriers,'' as a consumer product safety standard, but with 
certain changes. We are proposing two changes to ASTM F2050-12. One 
change would add a strangulation warning label to be affixed to the 
outer surface of the cushion or padding of a hand-held carrier seat in 
or adjacent to the area where the childs head would rest. The warning 
label for hand-held carrier seats that are intended to be used as 
restraints in motor vehicles would include a pictogram, while the 
warning label for hand-held carrier seats not intended to be used as 
restraints in motor vehicles would not include the pictogram because 
these seats do not have the chest clips depicted in the pictogram.
    The other change would affect the test method for ensuring that the 
carrier will not rotate and spill an unrestrained infant when a 
caregiver picks up the carrier and the handle is not locked in the 
carry position. The test method in ASTM F2050-12 requires the tester to 
use a standard CAMI, Mark II 6-month infant dummy as an infant 
surrogate. The proposed change would require the tester to use an 
aluminum cylinder designed as a surrogate for a 6-month old infant, in 
lieu of the CAMI dummy, because the CAMI dummy could be wedged into the 
seat padding or otherwise manipulated, such that it does not fall out 
during the lift test when it otherwise should fall. Further, the 
ability to pass or fail the test based on friction or placement of the 
CAMI affects the consistency and repeatability of the test results.
    We describe these proposed changes in the following section.

A. Improper Restraint Usage

    Incorrect use or nonuse of the harness straps were involved in 81 
of the 242 reported incidents and resulted in 19 of the 36 fatalities 
related to hand-held carriers from January 1, 2007 to early June 2012. 
Among these 19 fatalities, nine strangulation incidents occurred due to 
loose or partially buckled harness straps. In six of the fatalities 
involving nonuse or improper use of harness straps, the child strangled 
on the chest clips, while in two incidents children strangled on loose 
straps. In seven incidents, children who were not restrained in the 
carrier moved themselves into a compromising position, resulting in 
asphyxia. Two fatalities occurred when unrestrained infants became 
trapped under an overturned carrier. In one fatality, straps that were 
too tight impaired the child's breathing while in the other, it is 
unclear how the harness strap contributed to the child's death.
    ASTM F2050-12 includes product warnings that address the dangers of 
leaving a child unattended in the carrier, leaving a child in a carrier 
with loose or unfastened harness straps, and putting the carrier on a 
soft surface where it can roll over and suffocate a child. The warnings 
are required to be `conspicuous,' i.e., visible when the carrier is in 
the recommended use position to a person standing near the infant 
carrier in any one position around the carrier but not necessarily 
visible from all positions. This warning statement attempts to address 
suffocation, strangulation, and fall hazards. However, a caregiver may 
not encounter the label during regular use of the carrier.
    We propose a new strangulation warning label, placed where a 
caregiver is expected to notice it during regular interaction with the 
carrier and the infant, which includes a pictogram depicting proper and 
improper harness use and that states: `WARNING- Children have STRANGLED 
in loose or partially buckled harness straps. Fully restrain the child 
even when carrier is used outside the vehicle.' An ASTM task group, 
with the assistance of CPSC staff, developed several different 
pictorial symbols that were presented to an audience of 159 people. 
More than 95 percent of the participants who reviewed the recommended 
pictogram interpreted it correctly. We believe the warning label with 
the pictogram will improve noticeability and comprehension of the risk.

B. Handle Issues

    Handles breaking, detaching, or failing to lock in the carry 
position were reported in 55 of the 242 incidents. Some of these 
incidents resulted in injuries, such as a lacerated lip, bruises, and a 
cranial hemorrhage, when the carrier and/or the child fell to the 
ground. We believe that many of the incidents attributable to the 
failure of the handle to lock are the result of the handle appearing to 
be in a locked position when the caregiver lifts the carrier. We 
believe that the incidents in which the handle itself breaks or 
detaches from the carrier are attributable to manufacturing or assembly 
errors.
    The current voluntary standard contains a handle preconditioning 
cycle test, followed by a static hang test, to assess handle lock 
stability and integrity. The handle lock impact test is designed to 
test the handle and handle lock integrity to reduce the number of fall 
injuries. This test is conducted at the conclusion of the static hang 
test and consists of dropping a hanging weight at the end of the 
carrier. The hanging weight simulates dynamic loads placed on the 
handle and handle lock while a caregiver walks with an infant in the 
carrier.
    The handle auto-lock test helps ensure that when a caregiver picks 
up the carrier with the handle out of the locked position, the carrier 
will not rotate and spill an unrestrained infant. This is accomplished 
by requiring the carrier handle to have an auto-lock feature, or, when 
not locked in the carry position, to fall to a position so it is 
obvious to the caregiver that the handle is not in the carry position. 
If neither condition is met, then the handle must lock into the carry 
position or another

[[Page 73360]]

position, such that when the carrier is lifted by the handle, the 
infant will not fall out.
    The existing handle auto-lock test uses a standard CAMI, Mark II 6-
month infant dummy during the lift test. When we tested one carrier, 
the CAMI became wedged into the seat padding in such a way that the 
CAMI did not fall out during the lift test when an unrestrained infant 
in this position likely would fall from the carrier. We also found that 
CAMI placement in the carrier could be manipulated to achieve the 
desired results. For example, placing a CAMI with its back high in the 
seat makes the carrier more likely to pass the test, while placing a 
CAMI lower in the seat may make the carrier more likely to fail. Thus, 
friction or the placement of the CAMI affects the consistency and 
repeatability of the test.
    To resolve these CAMI-related test issues, we conducted the auto-
lock test using an aluminum cylinder designed as a surrogate for a 6-
month-old infant in lieu of the CAMI dummy. This change resulted in 
consistent test results because the cylinder does not wedge into the 
carrier padding like the CAMI dummy, and placement of the cylinder is 
less likely to affect the outcome of the test.
    We propose modifying ASTM F2050 to require conducting the auto-lock 
test with the surrogate cylinder instead of the infant CAMI dummy. The 
surrogate cylinder is modeled from the torso of a 6-month-old child, 
and it is also used in the bassinet segmented mattress test we recently 
proposed in the NPR for bassinets and cradles. 77 FR 64055. Further, EN 
12790 European/British Standard for Child Care Articles--Reclined 
Cradles, uses a similar cylinder to conduct their tip test for the same 
products.

VII. Effective Date

    The Administrative Procedure Act (APA) generally requires that the 
effective date of a rule be at least 30 days after publication of the 
final rule. 5 U.S.C. 553(d). To allow time for hand-held carriers to 
come into compliance, we propose that the standard become effective 6 
months after publication of the final rule in the Federal Register. We 
invite comment on how long it will take manufacturers to come into 
compliance.

VIII. Regulatory Flexibility Act

A. Introduction

    The Regulatory Flexibility Act (RFA), 5 U.S.C. 601-612, requires 
agencies to consider the impact of proposed rules on small entities, 
including small businesses. Section 603 of the RFA requires that the 
Commission prepare an initial regulatory flexibility analysis and make 
it available to the public for comment when the notice of proposed 
rulemaking is published. The initial regulatory flexibility analysis 
(IRFA) must describe the impact of the proposed rule on small entities 
and identify any alternatives that may reduce the impact. Specifically, 
the IRFA must contain:
     A description of, and where feasible, an estimate of the 
number of small entities to which the proposed rule will apply;
     A description of the reasons why action by the agency is 
being considered;
     A succinct statement of the objectives of, and legal basis 
for, the proposed rule;
     A description of the projected reporting, recordkeeping, 
and other compliance requirements of the proposed rule, including an 
estimate of the classes of small entities subject to the requirements, 
and the type of professional skills necessary for the preparation of 
reports or records; and
     An identification, to the extent possible, of all relevant 
federal rules that may duplicate, overlap, or conflict with the 
proposed rule.

B. The Market

    The majority of hand-held infant carriers are produced and/or 
marketed by juvenile product manufacturers and distributors. A 
potential exception is the Moses basket (whose inclusion in the scope 
as a type of hand-held bassinet or cradle is under consideration by the 
Commission), which are often marketed by bedding manufacturers and 
distributors. The Commission estimates that currently, there are at 
least 43 suppliers of hand-held infant carriers to the U.S. market. 
Eleven are domestic manufacturers, and 10 are domestic importers. There 
are also two foreign firms--a foreign manufacturer and an importer that 
imports products from foreign companies and distributes them from 
outside of the United States. An additional 20 domestic firms supply 
Moses basket bedding, along with Moses baskets, whose source is 
unknown.
    Hand-held infant carriers from six of the 43 firms have been 
certified as compliant with ASTM F2050 by the JPMA, the major U.S. 
trade association that represents juvenile product manufacturers and 
importers. Three firms claim compliance with F2050; and four have JPMA-
certified strollers with hand-held infant carrier attachments. It is 
assumed that the hand-held infant carriers supplied by all 13 of these 
firms will be in compliance with the voluntary standard. Of the 
remaining 30 firms supplying noncompliant hand-held infant carriers, 
the majority (25 firms) supply products that are newly covered due to 
the expanded scope of ASTM F2050-12 (20 supply Moses baskets, 3 supply 
bassinet attachments for strollers, and 2 supply other types of 
bassinet-style carriers).
    The market data available is limited to infant car seats, which 
represented nearly the entire hand-held infant carrier market under 
prior versions of ASTM F2050. According to a 2005 survey conducted by 
the American Baby Group (2006 Baby Products Tracking Study), 68 percent 
of new mothers own infant car seats. Approximately 25 percent of infant 
car seats were handed down or purchased secondhand. Thus, about 75 
percent of infant car seats were acquired new. This suggests annual 
sales of about 2.1 million infant car seats (.68 x .75 x 4.1 million 
births per year).\2\ These 2.1 million infant car seats represent the 
minimum number of units sold per year that might be affected by the 
proposed handheld infant carrier standard. It is unknown how many Moses 
baskets and other bassinet/cradle-style carriers are sold annually.
---------------------------------------------------------------------------

    \2\ U.S. Department of Health and Human Services, Centers for 
Disease Control and Prevention (CDC), National Center for Health 
Statistics, National Vital Statistics System, ``Births: Final Data 
for 2009,'' National Vital Statistics Reports Volume 60, Number 1 
(November 2011): Table I. Number of births in 2009 is rounded from 
4,130,665.
---------------------------------------------------------------------------

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

    The Danny Keysar Child Product Safety Notification Act, section 104 
of the CPSIA, requires the CPSC to promulgate a mandatory standard for 
hand-held infant carriers that is substantially the same as, or more 
stringent than, the voluntary standard. CPSC worked closely with ASTM 
to develop the new requirements and test procedures that have been 
added to the voluntary standard since 2010. These new requirements 
address several known hazard patterns and will help to reduce injuries 
and deaths in hand-held carriers, and they have resulted in the current 
voluntary standard, F2050-12, upon which the proposed rule is based.
    However, the Commission proposes adding one new requirement to 
F2050-12, as well as modifying the methodology for the existing handle 
auto-lock test. The new requirement would mandate a new warning label, 
as described in Section VI (A), which addresses strangulation and 
suffocation hazards that have occurred as a result of incorrect or 
nonuse of harness straps. The modification proposed by the

[[Page 73361]]

Commission is that an aluminum cylinder, designed as a surrogate for a 
6-month old infant, be used in lieu of the CAMI dummy in the handle 
auto-lock test. This proposed change would result in consistent test 
results because the cylinder does not wedge into the carrier padding 
like the CAMI dummy, and placement of the cylinder is less likely to 
affect the outcome of the test.

D. Requirements of the Proposed Rule

    The Commission proposes adopting the voluntary ASTM standard for 
hand-held infant carriers (F2050-12), with a new warning label 
requirement, and a modification of the handle auto-lock test. Some of 
the more significant requirements of the current voluntary standard for 
hand-held infant carriers (ASTM F2050-12) are listed below:
     Carry handle integrity--a series of endurance and 
durability tests are intended to ensure that rigid, adjustable handles 
do not break or unlock during use.
     Carry handle auto-locking--intended to address incidents 
that have occurred when the rigid, adjustable handles switched 
positions unexpectedly.
     Restraints--intended to minimize the fall hazard 
associated with inclined hand-held carriers while simultaneously 
minimizing the potential for injury or death in flat bassinet/cradle 
products where restraints can pose a strangulation hazard.
     Slip resistance--intended to prevent slipping when the 
hand-held infant carrier is placed on a slightly inclined surface (10 
degrees).
    The voluntary standard also includes: (1) Torque and tension tests 
to ensure that components cannot be removed; (2) requirements for 
several hand-held infant carrier features to prevent entrapment and 
cuts (minimum and maximum opening size, coverage of exposed coil 
springs, small parts, hazardous sharp edges or points, smoothness of 
wood parts, and edges that can scissor, shear, or pinch); (3) marking 
and labeling requirements; (4) requirements for the permanency and 
adhesion of labels; (5) requirements for instructional literature; and 
(6) toy accessory requirements. ASTM F2050-12 includes no reporting or 
recordkeeping requirements. The Commission proposes adding a new 
warning label content and placement requirement and using the more 
appropriate cylinder surrogate for the handle auto-lock testing.
    The carry handle auto-locking requirement applies only to hand-held 
infant carriers that are rigid, adjustable, rotate about a singular 
axis, and lock into the manufacturer's designated carry position; 
therefore, many suppliers, most notably Moses basket suppliers, would 
not be affected. Several models of hand-held infant carriers with these 
types of handles would be able to pass the revised test without 
modifying their product(s). The simplest and most effective way to meet 
the requirement is to add auto-lock positions close to the one intended 
for use. This would prevent the handle from moving so far out of 
position and spilling the child from the carrier. While redesign would 
probably not be necessary, the hard tools used to manufacture the 
handle's lock positions would need to be modified. These hard tools are 
usually modified by an outside firm, which means that production would 
cease and, unless the firm maintains an alternating production 
schedule, could result in significant downtime for the firm's 
production process.
    The revised warning would change the size, location, wording, and 
presentation to highlight better the dangers associated with only 
partially buckling children into hand-held carriers. A pictogram is 
included as part of the modified warning for hand-held carrier seats 
intended to be used as restraints in motor vehicles. The warning would 
be required on the product itself, as well as within the product's 
instructional literature. Changes to warning labels are not expected to 
have a significant impact on suppliers. Typically, warning labels that 
are placed on fabric, such as the revised strangulation warning, are 
less costly than those used on plastic or metal.

E. Other Federal or State Rules

    The Commission is in the process of implementing sections 14(a)(2) 
and 14(i)(2) of the Consumer Product Safety Act (CPSA), as amended by 
the CPSIA. Section 14(a)(2) of the CPSA requires every manufacturer of 
a children's product that is subject to a children's product safety 
rule to certify, based on third party testing, that the product 
complies with all applicable safety rules. Section 14(i)(2) of the CPSA 
requires the Commission to establish protocols and standards (i) for 
ensuring that a children's product is tested periodically and when 
there has been a material change in the product, (ii) for the testing 
of representative samples to ensure continued compliance, (iii) for 
verifying that a product tested by a conformity assessment body 
complies with applicable safety rules, and (iv) for safeguarding 
against the exercise of undue influence on a conformity assessment body 
by a manufacturer or private labeler.
    Because hand-held infant carriers will be subject to a mandatory 
standard, they will also be subject to the third party testing 
requirements of section 14(a)(2) of the CPSA when the mandatory 
standard and the notice of requirements become effective.

F. Impact of the Proposal on Small Business

    There are approximately 43 firms currently known to be marketing 
hand-held infant carriers in the United States. Under U.S. Small 
Business Administration (SBA) guidelines, a manufacturer of hand-held 
infant carriers is small if it has 500 or fewer employees, and 
importers and wholesalers are considered small if they have 100 or 
fewer employees. Based on these guidelines, 29 are small firms--6 
domestic manufacturers, 4 domestic importers, and 19 firms supplying 
Moses baskets whose supply source is unknown. The remaining firms are 
five large domestic manufacturers, six large domestic importers, one 
foreign manufacturer, one foreign importer, and one large firm 
supplying Moses baskets from an unknown source. There may be additional 
unknown small hand-held infant carrier suppliers operating in the U.S. 
market.
    Small Manufacturers. The expected impact on small manufacturers of 
the proposed standard will differ based on whether their hand-held 
infant carriers are already compliant with F2050-09. Firms whose hand-
held infant carriers meet the requirements of F2050-09 are likely to 
continue to comply with the voluntary standard as new versions are 
published. In addition, they are likely to meet any new standard within 
6 months of approval because this is the amount of time JPMA allows for 
products in their certification program to shift to a new standard. 
Many of these firms are active in the ASTM standard development 
process, and compliance with the voluntary standard is part of an 
established business practice. Therefore, it is likely that firms 
supplying hand-held infant carriers that comply with ASTM F2050-09 
(which went into effect for JPMA certification purposes in April 2010) 
would also likely comply with F2050-12 by March 2013, even in the 
absence of a mandatory standard. It should be noted, however, that 
because the scope of F2050-09 is more limited than the scope of F2050-
12, only firms supplying infant car seats would be expected to have 
developed a pattern of compliance. However, staff believes that firms 
that manufacture JPMA-certified strollers with attachments that can be 
used separately as hand-held carriers will also meet ASTM F2050-12 by

[[Page 73362]]

March 2013; having developed a pattern of compliance for strollers, 
they would likely choose to meet any related ASTM standards as well.
    Given these considerations, it is unlikely that the direct impact 
on manufacturers whose products are likely to meet the requirements of 
ASTM F2050-12 (four of six small domestic manufacturers) will be 
significant. Modifying warning labels and updating instructional 
literature is a small cost for most firms. It is possible that one or 
more firms might have to modify their carry handles to continue to pass 
the auto-locking test, but this would most likely result in modifying 
their hard tools to add locking positions, rather than a complete 
product redesign.
    Meeting ASTM F2050-12's requirements could necessitate product 
redesign for at least some hand-held infant carriers not believed to be 
compliant with F2050-09 (two of six small domestic manufacturers), 
regardless of the proposed modifications. A redesign would be minor if 
most of the changes involve adding straps and fasteners or using 
different mesh or fabric, but the costs could be more significant if 
changes to the frame are required, including changes to the handles. 
Some firms have estimated product redesigns, including engineering 
time, prototype development, tooling, and other incidental costs to 
reach approximately $500,000. Consequently, the proposed rule could 
potentially have a significant direct impact on small manufacturers 
whose products do not conform to F2050-09. However, because most 
products would probably not need to be completely redesigned, actual 
costs are likely to be lower than the $500,000 level, and any direct 
impact may be mitigated if costs are treated as new product expenses 
that can be amortized.
    It is possible that one or both of the firms whose hand-held infant 
carriers are neither certified as compliant, nor claim compliance with 
F2050-09, in fact, are compliant with the standard. The Commission has 
identified many such cases with other products. To the extent that some 
of these firms may supply compliant hand-held infant carriers and have 
developed a pattern of compliance with the voluntary standard, the 
direct impact of the proposed standard will be less significant than 
described above.
    In addition to the direct impact of the proposed standard described 
above, there are indirect impacts. These impacts are considered 
indirect because they do not arise directly as a consequence of the 
hand-held infant carrier rule's requirements. Nonetheless, they could 
be significant. Once the rule becomes final and the notice of 
requirements is in effect, all manufacturers will be subject to the 
additional costs associated with the third party testing and 
certification requirements. This will include any physical and 
mechanical test requirements specified in the final rule; lead and 
phthalates testing is already required, and hence, it is not included 
here.\3\
---------------------------------------------------------------------------

    \3\ Hand-held infant carrier suppliers already must third party 
test their products to the lead and phthalate requirements. 
Therefore, these costs are left out of the analysis above.
---------------------------------------------------------------------------

    Based on durable nursery product industry input and confidential 
business information supplied for the development of the third party 
testing rule, testing to the ASTM voluntary standard could cost $500-
$1,000 per model sample. Testing overseas could potentially reduce some 
testing costs, but that may not always be practical.
    On average, each small domestic manufacturer supplies two different 
models of hand-held infant carriers to the U.S. market annually. 
Therefore, if third party testing were conducted every year on a single 
sample for each model, third party testing costs for each manufacturer 
would be about $1,000-$2,000 annually. Based on a review of firm 
revenues, the impact of third party testing to ASTM F2050-12 is 
unlikely to be significant if only one hand-held infant carrier sample 
per model is required. However, if more than one sample would be needed 
to meet the testing requirements, it is possible that third party 
testing costs could have a significant impact on one or more of the 
small manufacturers.
    Small Importers. Importers of hand-held infant carriers would need 
to find an alternate source if their existing supplier does not come 
into compliance with the requirements of the proposed rule, which may 
be the case with all four small importers of hand-held infant carriers, 
none of which is believed to be in compliance with F2050-09. Some could 
respond to the rule by discontinuing the import of their noncomplying 
hand-held infant carriers, possibly discontinuing the product line 
altogether. However, the impact of such a decision could be mitigated 
by replacing the noncompliant hand-held infant carriers with a 
compliant alternative. Deciding to import an alternative product would 
be a reasonable and realistic way to offset any lost revenue.
    As is the case with manufacturers, all importers will be subject to 
third party testing and certification requirements, and consequently, 
will experience costs similar to those for manufacturers if their 
supplying foreign firm(s) does not perform third party testing. The 
resulting costs could have a significant impact on a few small 
importers that must perform the testing themselves if more than one 
sample per model is required.
    Moses Basket Suppliers. There are 19 small firms supplying Moses 
baskets to the U.S. market. Most of these firms also supply bedding; 
some of them manufacture the bedding, while others act as importers. 
The Commission has been unable to determine the source of the Moses 
baskets themselves, although it is likely that most sellers purchase 
them from other suppliers, either foreign or domestic. Because these 
products are recent potential additions to the scope of ASTM F2050, it 
is unlikely that any of them has been designed to comply with this 
standard. However, it is possible that many might be able to comply 
with the standard with minimal modifications. Moses baskets generally 
do not use restraints, so the biggest changes might be the addition of 
warnings and instructional literature. Alternatively, Moses basket 
suppliers could remove themselves from the scope of the proposed rule 
by removing the handles from their products. Because most Moses baskets 
come with warnings against carrying an infant in the basket, this would 
be a reasonable change for suppliers to make.
    As with manufacturers and importers, all Moses basket suppliers 
within the scope of the proposed rule will be subject to third party 
testing and certification requirements, and consequently, they could 
experience testing costs if their supplying firm(s) does not perform 
third party testing. Because Moses baskets would not be subject to most 
of the mechanical tests in the proposed standard, it is expected that 
third party testing costs, at most, will be half that of other types of 
hand-held infant carriers, or approximately $250-$500 per model sample. 
The resulting costs could have a significant impact on a few small 
firms that must perform the testing themselves, even if only one sample 
per model is required.

G. Alternatives

    Under the Danny Keysar Child Product Safety Notification Act, one 
alternative that would reduce the impact on small entities is to make 
the voluntary standard mandatory with no modifications. Doing so would 
eliminate the impact on the four small manufacturers with compliant 
products. However, because of the number and severity of the incidents 
associated with

[[Page 73363]]

falls and restraints, staff does not recommend this alternative.
    A second alternative would be to set an effective date later than 
the proposed 6 months, which is generally considered sufficient time 
for suppliers to come into compliance with a proposed rule. Setting a 
later effective date would allow suppliers additional time to modify 
and/or develop compliant hand-held infant carriers and spread the 
associated costs over a longer period of time.
    The Commission invites comments describing the possible impact of 
this rule on manufacturers and importers, as well as comments 
containing other information describing how this rule will affect small 
businesses.

IX. Environmental Considerations

    The Commission's regulations address whether we are required to 
prepare an environmental assessment or an environmental impact 
statement. These regulations provide a categorical exclusion for 
certain CPSC actions that normally have ``little or no potential for 
affecting the human environment.'' Among those actions are rules or 
safety standards for consumer products. 16 CFR 1021.5(c)(1). The 
proposed rule falls within the categorical exclusion.

X. Paperwork Reduction Act

    This proposed rule contains information collection requirements 
that are subject to public comment and review by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3521). In this document, pursuant to 44 U.S.C. 
3507(a)(1)(D), we set forth:
     A title for the collection of information;
     A summary of the collection of information;
     A brief description of the need for the information and 
the proposed use of the information;
     A description of the likely respondents and proposed 
frequency of response to the collection of information;
     An estimate of the burden that shall result from the 
collection of information; and
     Notice that comments may be submitted to the OMB.
    Title: Safety Standard for Hand-Held Infant Carriers.
    Description: The proposed rule would require each hand-held infant 
carrier to comply with ASTM F2050-12, Standard Consumer Safety 
Specification for Hand-Held Infant Carriers. Sections of ASTM F2050-12 
contain requirements for marking, labeling, and instructional 
literature. These requirements fall within the definition of 
``collection of information,'' as defined in 44 U.S.C. 3502(3).
    Description of Respondents: Persons who manufacture or import hand-
held infant carriers.
    Estimated Burden: We estimate the burden of this collection of 
information as follows:

                                                       Table 1--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Number of       Frequency of     Total annual      Hours per       Total burden
                           16 CFR Section                              respondents       responses        responses         response          hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
1221...............................................................              43                4              172                1              172
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Our estimates are based on the following:
    Section 8.1 of ASTM F 2050-12 requires that the name of the 
manufacturer, distributor, or seller, and either the place of business 
(city, state, and mailing address, including zip code) or telephone 
number, or both, to be marked clearly and legibly on each product and 
its retail package. Section 8.2 of ASTM F 2050-12 requires a code mark 
or other means that identifies the date (month and year, as a minimum) 
of manufacture.
    There are 43 known entities supplying hand-held infant carriers to 
the U.S. market. All 43 firms are assumed to use labels already on both 
their products and their packaging, but they might need to make some 
modifications to their existing labels. The estimated time required to 
make these modifications is about 1 hour per model. Each entity 
supplies an average of four different models of hand-held infant 
carriers; therefore, the estimated burden associated with labels is 1 
hour per model x 43 entities x 4 models per entity = 172 hours. We 
estimate the hourly compensation for the time required to create and 
update labels is $27.55 (U.S. Bureau of Labor Statistics, ``Employer 
Costs for Employee Compensation,'' March 2012, Table 9, total 
compensation for all sales and office workers in goods-producing 
private industries: http://www.bls.gov/ncs/). Therefore, the estimated 
annual cost to industry associated with the labeling requirements is 
$4,738.60 ($27.55 per hour x 172 hours = $4,738.60). There are no 
operating, maintenance, or capital costs associated with the 
collection.
    Section 9.1 of ASTM F2050-12 requires instructions to be supplied 
with the product. Hand-held infant carriers are products that generally 
require installation or assembly, and products sold without such 
information would not be able to compete successfully with products 
supplying this information. Under the OMB's regulations (5 CFR 
1320.3(b)(2)), the time, effort, and financial resources necessary to 
comply with a collection of information that would be incurred by 
persons in the ``normal course of their activities'' are excluded from 
a burden estimate, where an agency demonstrates that the disclosure 
activities required to comply are ``usual and customary.'' Therefore, 
because we are unaware of hand-held infant carriers that generally 
require installation or some assembly but lack any instructions to the 
user about such installation or assembly, we estimate tentatively that 
there are no burden hours associated with section 9.1 of ASTM F 2050-12 
because any burden associated with supplying instructions with hand-
held infant carriers would be ``usual and customary'' and not within 
the definition of ``burden'' under the OMB's regulations.
    Based on this analysis, the proposed standard for hand-held infant 
carriers would impose a burden to industry of 172 hours at a cost of 
$4,728.60 annually.
    In compliance with the PRA (44 U.S.C. 3507(d)), we have submitted 
the information collection requirements of this rule to the OMB for 
review. Interested persons are requested to submit comments regarding 
information collection by January 9, 2013, to the Office of Information 
and Regulatory Affairs, OMB (see the ADDRESSES section at the beginning 
of this notice).
    Pursuant to 44 U.S.C. 3506(c)(2)(A), we invite comments on:
     Whether the collection of information is necessary for the 
proper performance of the CPSC's functions, including whether the 
information will have practical utility;
     The accuracy of the CPSC's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used;

[[Page 73364]]

     Ways to enhance the quality, utility, and clarity of the 
information to be collected;
     Ways to reduce the burden of the collection of information 
on respondents, including the use of automated collection techniques, 
when appropriate, and other forms of information technology; and
     The estimated burden hours associated with label 
modification, including any alternative estimates.

XI. Preemption

    Section 26(a) of the CPSA, 15 U.S.C. 2075(a), provides that where a 
consumer product safety standard is in effect and applies to a product, 
no state or political subdivision of a state may either establish or 
continue in effect a requirement dealing with the same risk of injury 
unless the state requirement is identical to the federal standard. 
Section 26(c) of the CPSA also provides that states or political 
subdivisions of states may apply to the Commission for an exemption 
from this preemption under certain circumstances. Section 104(b) of the 
CPSIA refers to the rules to be issued under that section as ``consumer 
product safety rules,'' thus implying that the preemptive effect of 
section 26(a) of the CPSA would apply. Therefore, a rule issued under 
section 104 of the CPSIA will invoke the preemptive effect of section 
26(a) of the CPSA when it becomes effective.

XII. Certification and Notice of Requirements (NOR)

    Section 14(a)(2) of the CPSA imposes the requirement that 
children's products subject to a children's product safety rule under 
the CPSA, or to a similar rule, ban, standard, or regulation under any 
other act enforced by the Commission, must be certified as complying 
with all applicable CPSC-enforced requirements. 15 U.S.C. 2063(a)(2). 
For children's products, such certification must be based on tests on a 
sufficient number of samples by a third party conformity assessment 
body accredited by the Commission to test according to the applicable 
requirements. As discussed in section I of this preamble, section 
104(b)(1)(B) of the CPSIA refers to standards issued under this section 
as ``consumer product safety standards.'' Accordingly, a safety 
standard for hand-held infant carriers issued under section 104 of the 
CPSA is a consumer product safety rule that is subject to the testing 
and certification requirements of section 14 of the CPSA. Because hand-
held infant carriers are children's products, they must be tested by a 
third party conformity assessment body whose accreditation has been 
accepted by the CPSC. Notices of requirements (NORs) provide the 
criteria and process for our acceptance of accreditation of third party 
conformity assessment bodies.
    On May 24, 2012, the Commission published in the Federal Register 
the proposed rule, Requirements Pertaining to Third Party Conformity 
Assessment Bodies, 77 FR 331086, which, when finalized, would establish 
the general requirements and criteria concerning testing laboratories. 
These include the requirements and procedures for CPSC acceptance of 
the accreditation of a laboratory to test children's products in 
support of the certification required by section 14(a)(2) of the CPSA. 
The proposed rule, at 16 CFR part 1112, Requirements Pertaining to 
Third Party Conformity Assessment Bodies, lists the children's product 
safety rules for which the CPSC has published NORs for laboratories. In 
this document, the Commission is proposing to amend the list in 16 CFR 
part 1112, once that rule becomes final, to include the hand-held 
infant carrier standard, once finalized, along with the other 
children's product safety rules for which the CPSC has issued NORs.
    Laboratories applying for acceptance as a CPSC-accepted third party 
conformity assessment body to test to the new standard for hand-held 
infant carriers would be required to meet the third party conformity 
assessment body accreditation requirements in 16 CFR part 1112, 
Requirements Pertaining to Third Party Conformity Assessment Bodies, 
once that rule becomes final. When a laboratory meets the requirements 
as a CPSC-accepted third party conformity assessment body, it can apply 
to the CPSC to have 16 CFR part 1225, Safety Standard for Hand-Held 
Infant Carriers included in its scope of accreditation of CPSC safety 
rules listed for the laboratory on the CPSC Web site at: http://www.cpsc.gov/labsearch.
    The final NOR will base the CPSC laboratory accreditation 
requirements on the performance standard set forth in the final rule 
for the safety standard for hand-held infant carriers and the test 
methods incorporated within that standard. The Commission may recognize 
limited circumstances in which the Commission will accept certification 
based on product testing conducted before the Commission's acceptance 
of accreditation of laboratories for testing hand-held infant carriers 
(also known as retrospective testing) in the final NOR. The Commission 
seeks comments on any issues regarding the testing requirements of the 
proposed rule for hand-held infant carriers and the accompanying 
proposed NOR.

XIII. Request for Comments

    This proposed rule begins a rulemaking proceeding under section 
104(b) of the CPSIA to issue a consumer product safety standard for 
hand-held carriers. We invite all interested persons to submit comments 
on any aspect of the proposed rule. Comments should be submitted in 
accordance with the instructions in the ADDRESSES section at the 
beginning of this notice.
    We specifically seek comments from the public on whether Moses 
baskets should be included in this safety standard. If Moses baskets 
should be included in this safety standard, does the present definition 
cover Moses baskets? And if the present definition does not cover Moses 
baskets, how should it be amended to cover them?
    We also seek comment concerning the surrogate used in the handle 
auto-locking test. Specifically, the Commission asks if the test 
cylinder described in this preamble and in the proposed rule is an 
appropriate surrogate for a six-month old infant. Is there another 
surrogate--in particular, the infant hinge gauge--that is as likely or 
more likely to identify those hand-held infant carriers that pose the 
hazards identified in the handle lock test?

List of Subjects

16 CFR Part 1112

    Administrative practice and procedure, Audit, Consumer protection, 
Reporting and recordkeeping requirements, Third party conformity 
assessment body.

16 CFR Part 1225

    Consumer protection, Imports, Incorporation by reference, Infants 
and children, Labeling, Law enforcement, and Toys.

    Therefore, the Commission proposes to amend Title 16 of the Code of 
Federal Regulations to read as follows:

PART 1112--REQUIREMENTS PERTAINING TO THIRD PARTY CONFORMITY 
ASSESSMENT BODIES

    1. The authority citation for part 1112 continues to read as 
follows:

    Authority: Pub. L. 110-314, section 3, 122 Stat. 3016, 3017 
(2008); 15 U.S.C. 2063.

    2. Amend Sec.  1112.15 by adding paragraph (b)(35) to read as 
follows:

[[Page 73365]]

Sec.  1112.15   When can a third party conformity assessment body apply 
for CPSC acceptance for a particular CPSC rule and/or test method?

* * * * *
    (b)
    (35) 16 CFR part 1225, Safety Standard for Hand-Held Infant 
Carriers.
    3. Add part 1225 to read as follows:

PART 1225--SAFETY STANDARD FOR HAND-HELD INFANT CARRIERS

Sec.
1225.1 Scope.
1225.2 Requirements for hand-held infant carriers.

    Authority: The Consumer Product Safety Improvement Act of 2008, 
Pub. L. 110-314, Sec.  104, 122 Stat. 3016 (August 14, 2008).


Sec.  1225.1   Scope.

    This part establishes a consumer product safety standard for hand-
held infant carriers.


Sec.  1225.2  Requirements for hand-held infant carriers.

    (a) Except as provided in paragraph (b) of this section, each hand-
held infant carrier must comply with all applicable provisions of ASTM 
F 2050-12, Standard Consumer Safety Specification for Hand-Held Infant 
Carriers, approved on July 1, 2012. The Director of the Federal 
Register approves this incorporation by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy from ASTM 
International, 100 Bar Harbor Drive, P.O. Box 0700, West Conshohocken, 
PA 19428; http://www.astm.org. You may inspect a copy at the Office of 
the Secretary, U.S. Consumer Product Safety Commission, Room 820, 4330 
East West Highway, Bethesda, MD 20814, telephone 301-504-7923, or at 
the National Archives and Records Administration (NARA). For 
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/code_of_federal regulations/ibr_locations.html.
    (b) Comply with the ASTM F2050-12 standard with the following 
additions or exclusions:
    (1) In addition to complying with section 2.3 Other References, 
comply with the following:
    (i) 2.3 Other References: Test Cylinder A (see Fig. X)
    (ii) [Reserved]
    (2) Instead of complying with section 6.1.3 of ASTM F2050-12, 
comply with the following:
    (i) 6.1.3 The carry handle shall lock in a position forward or 
rearward of the manufacturer's designated carry position such that an 
unrestrained Test Cylinder A (see Figure X) does not fall out of the 
carrier when tested in accordance with 7.1.2 through 7.1.4.
    (ii) [Reserved]
    (3) Instead of complying with section 7.1.1 of ASTM F2050-12, 
comply with the following:
    (i) 7.1.1 Without a dummy in the carrier, secure the harness 
according to the manufacturer's instructions, and adjusting so that the 
harness along its entire exposed length contacts the seating surface. 
Position Test Cylinder A centrally against the backrest of the carrier 
in such a way that the bottom edge is in contact with the seat/back 
junction line (see Figure Y).
    (ii) [Reserved]
    (4) Instead of complying with Section 8.3.2 of ASTM F2050-12, 
comply with the following:
    (i) 8.3.2 The warning statements shall address the following except 
as otherwise noted.
    (ii) [Reserved]
    (5) Instead of complying with section 8.3.2.3 of ASTM F2050-12, 
comply with the following:
    (i) 8.3.2.3 Strangulation Hazard:
    (ii) 8.3.2.3.1 Carriers intended for use as infant restraint 
devices in motor vehicles shall contain the following warning label. 
This label requires exact language (including the use of bold font and 
uppercase characters as depicted) and a specific location:
[GRAPHIC] [TIFF OMITTED] TP10DE12.005

    (iii) 8.3.2.3.2 The area of the pictogram is to be at least 1.09 
in\2\ (706 mm\2\) while not exceeding the size of the airbag warning 
pictogram in the label required under FMVSS No. 213. The message area 
in the label shall be no less than 4.65 in\2\ (30 cm\2\), while not 
exceeding the size of the airbag warning message area in the label 
required under FMVSS No. 213. The pictogram shall be black with a red 
circle and slash on a white background and green check mark. The 
heading area shall be yellow with the word ``warning'' and the alert 
symbol in black. The warning label shall be a separate and independent 
label from the airbag warning label required in FMVSS No. 213. The 
warning label shall be permanently affixed to the outer surface of the 
cushion or padding in or adjacent to the area where a child's head 
would rest, so that the label is plainly visible and easily readable.
    (iv) 8.3.2.3.3 The following warning is required only for carriers 
not intended for use in a motor vehicle and are not hand-held 
bassinets/cradles. This warning requires exact language (including the 
use of bold font and uppercase characters as depicted):
[GRAPHIC] [TIFF OMITTED] TP10DE12.006


[[Page 73366]]


    (6) Instead of complying with section 9.1.1 of ASTM F2050-12, 
comply with the following:
    (i) 9.1.1 The instructions shall contain statements, which address 
the warning statements in 8.3.2. For carriers intended for use as 
infant restraint devices in motor vehicles, the warning statement 
contained in the warning label depicted in 8.3.2.3 must also be 
included. In addition, the instructions shall include the following 
statements:
    (ii) [Reserved]
    (7) In addition to Figure 2, use the following:
    [GRAPHIC] [TIFF OMITTED] TP10DE12.007
    
    [GRAPHIC] [TIFF OMITTED] TP10DE12.008
    

    Dated: December 3, 2012.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
 [FR Doc. 2012-29584 Filed 12-7-12; 8:45 am]
BILLING CODE 6355-01-P