[Federal Register Volume 78, Number 66 (Friday, April 5, 2013)]
[Proposed Rules]
[Pages 20511-20522]
From the Federal Register Online via the Government Publishing 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 http://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
[email protected].
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: http://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: 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-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:
[email protected].
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: http://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
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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: http://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; http://www.astm.org/cpsc.htm. You may inspect a copy at the Office of the Secretary, U.S.
Consumer Product Safety Commission, Room 820, 4330 East West Highway,
Bethesda, MD 20814, telephone 301-504-7923, or at the National Archives
and Records Administration (NARA). For information on the availability
of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal regulations/ibr_
locations.html.
(b) Reserved
Dated: March 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