Safety Standard for Hand-Held Infant Carriers, 73415-73424 [2013-29061]
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[FR Doc. 2013–28886 Filed 12–5–13; 8:45 am]
BILLING CODE 8070–01–P
CONSUMER PRODUCT SAFETY
COMMISSION
16 CFR Parts 1112 and 1225
[CPSC Docket No. CPSC–2012–0068]
Safety Standard for Hand-Held Infant
Carriers
Consumer Product Safety
Commission.
ACTION: Final rule.
AGENCY:
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
SUMMARY:
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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 issuing
a safety standard for hand-held infant
carriers in response to the direction
under section 104(b) of the CPSIA. The
rule would incorporate ASTM F2050–
13a by reference, with one modification.
DATES: The rule will become effective
on June 6, 2014. The incorporation by
reference of the publication listed in
this rule is approved by the Director of
the Federal Register as of June 6, 2014.
FOR FURTHER INFORMATION CONTACT: Julio
Alvarado, Compliance Officer, Office of
Compliance and Field Operations, U.S.
Consumer Product Safety Commission,
4330 East-West Highway, Bethesda, MD
20814; email: jalvarado@cpsc.gov.
SUPPLEMENTARY INFORMATION:
I. Background and Statutory Authority
The CPSIA (Pub. L. 110–314) was
enacted on August 14, 2008. Section
104(b) of the CPSIA 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. Infant
carriers are one of the products
specifically identified in section
104(f)(2)(H) as a durable infant or
toddler product. 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 hand-held
infant carriers. This rule addresses
hazards associated only with hand-held
infant carriers. Hazards associated with
other types of carriers would be
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addressed in separate rulemaking
proceedings.
On December 10, 2012, the
Commission issued a notice of proposed
rulemaking (NPR) for hand-held infant
carriers. 77 FR 73354. The NPR
proposed to incorporate by reference the
then current voluntary standard, ASTM
F2050–12, Standard Consumer Safety
Specification for Hand-Held Infant
Carriers, with certain modifications to
strengthen the ASTM standard. One
proposed modification provided for a
change in the warning label to better
address suffocation and restraint-related
hazards. The other proposed
modification addressed the testing
procedures for the carry handle autolocking requirement and specified using
an aluminum cylinder as the surrogate
for the occupant of the carrier rather
than a CAMI Mark II 6-month infant
dummy (CAMI dummy).
Since the Commission published the
NPR, ASTM has revised ASTM F2050
twice. On July 1, 2013, ASTM approved
an updated version of the voluntary
standard, ASTM F2050–13, which
includes the warning label modification
proposed in the NPR. On September 1,
2013, ASTM approved another revision
of the voluntary standard, ASTM
F2050–13a, which includes a carry
handle auto-locking performance
requirement that is different than the
requirement proposed in the NPR. As
explained in section VII of this
preamble, the Commission agrees with
the auto-locking requirement in ASTM
F2050–13a. The draft final rule
incorporates by reference the most
recent version of the ASTM standard,
ASTM F2050–13a, with one
modification—a clarification of the
definition of ‘‘hand-held infant carrier,’’
to include a specific reference to both
‘‘rigid-sided’’ and ‘‘semi-rigid-sided’’
products.
II. The Product
ASTM F2050–13a 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 ASTM
voluntary standard published in August
2012, for the first time referenced two
types of hand-held infant carriers:
Hand-held bassinets/cradles and handheld carrier seats. 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° from horizontal),’’ and
‘‘hand-held bassinet/cradle’’ is defined
as ‘‘a freestanding product, with a rest/
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support surface to facilitate sleep
(intended to be flat or up to 10° 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.’’ Hand-held carrier seats often
are used as infant car seats, or as
attachments to strollers or high chairs
bases. Some of the requirements in
F2050–13a 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 a freestanding
product with a rest/support surface to
facilitate sleep and has hand-holds or
handles intended to allow carrying an
occupant. Some Moses baskets are rigidsided, but most have semi rigid sides. In
the NPR, the Commission sought
comment on whether Moses baskets are
or should be covered by this safety
standard. The Commission also asked:
(1) If Moses baskets should be included
in this safety standard, does the present
definition cover Moses baskets, and (2)
if the present definition does not cover
Moses baskets, how should the standard
be amended to cover Moses baskets?
The Commission received no comments
in response to these questions and will
clarify the definition of ‘‘hand-held
infant carrier’’ in the rule to specify that
the definition includes both ‘‘rigidsided’’ and ‘‘semi-rigid-sided’’ products.
III. Incident Data
The preamble to the NPR summarized
incident data involving bassinets and
cradles reported to the Commission as
of June 8, 2012. 77 FR 73354 (December
10, 2012). The NPR stated that,
according to reports to the CPSC, 242
incidents involving hand-held infant
carriers occurred between January 1,
2007 and June 7, 2012. Of the 242
incidents, there were 36 fatalities, 60
nonfatal injuries, and 146 incidents
where no injury occurred or was
reported. Staff attributed the majority of
the fatalities to the improper use or
nonuse of the carrier’s restraint system.
CPSC’s Directorate for Epidemiology,
Division of Hazard Analysis has
updated this information to include
hand-held infant carrier-related incident
data reported to the Commission from
June 8, 2012 through June 21, 2013. A
search of the CPSC epidemiological
databases showed that there were 10
new incidents related to hand-held
infant carriers reported during this time
frame. Seven of the 10 were fatal, and
three were nonfatal. None of the
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nonfatal incidents involved injuries. All
of the new incidents reportedly
occurred in late 2011 and 2012.
Reporting is ongoing, however, so the
incident totals are subject to change.
A. Fatalities Reported Since the NPR
Most of the more recently reported
seven fatalities involved a productrelated issue. The ages of the decedents
ranged from one month to 15 months.
Staff attributes the majority of the
fatalities to the improper use or nonuse
of the carrier’s restraint system. The
incident reports indicate the following
circumstances in these fatalities:
• Infant was unrestrained and found
in a prone position with the seat tipped
over;
• infant was unrestrained and found
with its face pressed into the side of the
seat;
• infant strangled to death when
restrained by the shoulder straps only
and moved forward in the seat and was
caught in the throat by the chest clip
that connects the shoulder straps;
• infant was strapped into a handheld infant carrier that was placed on a
bed and overturned;
• infant was reported to have become
entrapped in the carrier by other
unsupervised children; although
information on the exact manner of
entrapment was unavailable;
• insufficient information to identify
conclusively a hazard pattern but may
have been the result of misuse of the
product;
• insufficient information to identify
hazard pattern.
B. Nonfatal Incidents Reported Since
the NPR
There were three hand-held carrierrelated nonfatal incidents reported to
the Commission from June 8, 2012
through June 21, 2013. All of the
incidents occurred in 2012; none of
these involved an injury. Two of the
incident reports stated that the carrier
handle broke. The third report was a
complaint about the poor quality and
design of a Moses basket carrier.
C. Hazard Pattern Identification
Staff did not identify any new hazard
patterns among the 10 incident reports
that CPSC staff received since the
Commission published the hand-held
infant carrier NPR. In order of frequency
of incident reports, staff grouped the
hazard patterns of the incidents
reported since the NPR into the
following categories:
1. Restraint issues: Three of the
incidents—all fatalities—were
associated with the incorrect use or
nonuse of the harness straps. In two of
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these fatal incidents, the decedent was
not restrained in the carrier at all. The
decedents were found later to have
turned over to a prone position, face
down on a soft surface. One death
resulted when the infant was left in the
seat with only the shoulder straps
connected, but unrestrained at the
crotch strap, which allowed the infant
to slide forward in the seat, just enough
to get caught at the throat by the chest
clip and become strangled.
2. Handle problems: Two incident
reports state that the handle broke. One
of these incidents involved a product
that was already recalled for handle
problems. There were no injuries
reported in these incidents.
3. Issues with carrier design: There
was one fatality in this category, which
resulted when the occupied carrier was
left on a soft surface (i.e., a bed), tipped
upside down, and trapped the infant. In
addition, one noninjury report
complained about the poor and unsafe
design of a Moses basket carrier.
4. Hazardous environment: One
fatality resulted from an infant
becoming trapped in the hand-held
carrier by other unsupervised children.
Details of the manner in which the
entrapment occurred were unavailable.
5. Other product-related issue: One
fatality report indicated that misuse of
the product may have contributed to the
incident; however, not enough
information was available for CPSC staff
to identify conclusively the hazard
pattern involved.
6. Other/unknown issue: One fatality
was reported with an undetermined
official cause of death. There was
insufficient evidence of any product
involvement or the presence of any
hazardous external circumstances.
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IV. Overview of ASTM F2050
ASTM F2050, Standard Consumer
Safety Specification for Hand-Held
Infant Carriers, establishes safety
performance requirements, test
methods, and labeling requirements to
minimize the identified hazard patterns
associated with the use of hand-held
infant carriers. 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. ASTM has revised the standard
six times since then. ASTM F2050–13
was approved on July 1, 2013, and the
current version, ASTM F2050–13a, was
approved on September 1, 2013. The
more significant requirements of ASTM
F2050 include:
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• Scope—describes the types of
products intended to be covered under
the standard.
• Testing of the handle auto-locking
mechanism—is intended to prevent
unintentional rotation of the carrier and
resulting expulsion of the child when
the caregiver picks up the carrier by the
handle and the handle is not in a locked
position.
• Testing of the integrity of the
handle—is intended to prevent
unintentional separation of the handle
from the carrier while in use.
• Occupant restraints—are intended
to prevent incidents in which improper
use of restraints has resulted in the
entrapment and strangulation of
children.
• Slip-resistance requirement—is
intended to prevent the carrier from
sliding when placed on a slightly
inclined surface.
• Warning label—is intended to
address: (1) Improper use of restraints
(to prevent strangulation and other
injuries), and (2) improper placement of
the carrier on an elevated surface (to
prevent fall injuries).
The voluntary standard also includes:
(1) Torque and tension tests to prevent
components from being removed; (2)
requirements to prevent entrapment and
cuts (minimum and maximum opening
size, small parts, hazardous sharp edges
or points, and edges that can scissor,
shear, or pinch); (3) requirements for the
permanency and adhesion of labels; and
(4) requirements for instructional
literature.
V. The NPR and ASTM 2050–12
The NPR proposed to incorporate by
reference ASTM F2050–12 as a
consumer product safety standard, with
two modifications:
1. Warning Label: The NPR proposed
requiring 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 child’s head would rest.
Under the proposal, 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.
2. Handle Auto-Lock Test: The NPR
proposed a modification of the test
method for preventing the carrier from
rotating and spilling an unrestrained
infant when a caregiver picks up the
carrier and the handle is not locked in
the carry position. The test method in
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ASTM F2050–12 required the tester to
use a standard CAMI dummy as an
infant surrogate. The NPR proposed a
change that 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
testing had revealed that the CAMI
dummy could be wedged into the seat
padding or otherwise manipulated, so
that the CAMI dummy did not fall out
during the lift test when the CAMI
dummy otherwise should fall.
Furthermore, the Commission was
concerned that the ability to pass or fail
the test based on friction or placement
of the CAMI would affect the
consistency and repeatability of the test
results.
The NPR also asked for comments
regarding whether Moses baskets should
be included in this safety standard, and
if so, whether we should revise the
definition of ‘‘hand-held infant carrier’’
to cover Moses baskets.
VI. ASTM F2050–13a
ASTM approved the current voluntary
standard for hand-held infant carriers,
ASTM F2050–13a, on September 1,
2013. ASTM balloted the NPR’s
provisions concerning the warning label
requirement in 2013, and the provisions
are now included in the latest revision
of the voluntary standard, ASTM 2050–
13a.
Several comments received in
response to the NPR suggested that the
aluminum cylinder was not an
appropriate surrogate for use in the
handle auto-lock test and maintained
that other surrogates, including the
CAMI dummy, would produce more
repeatable and consistent test results if
properly placed in the carrier. After
considering these comments and the
results of additional testing performed
since the Commission published the
NPR, Commission staff determined that
using the CAMI dummy, with certain
modifications to the test procedure,
would produce more repeatable and
consistent test results. ASTM F2050–
13a retains the use of the CAMI dummy
as the surrogate occupant and clarifies
how the dummy should be situated in
the seat during testing. The revised
requirement also:
• Specifies using webbing instead of
hooks for lifting the carrier during the
test;
• specifies that a pneumatic cylinder
be used to provide the force needed for
the lift; and
• narrows the lift speed range.
VII. Responses to Comments
The Commission received five
comments on the NPR, including: one
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from a consumer’s group (Consumers
Union); one from the Juvenile Products
Manufacturers Association (JPMA); and
three from hand-held infant carrier
manufacturers. The comments raised
several issues, which resulted in ASTM
changing the handle auto-lock test
procedures and including guidance for
the placement of the CAMI dummy in
the seat during the handle-auto lock test
in ASTM F2050–13a. Several
commenters made general statements
supporting the overall purpose of the
proposed rule. All of the comments can
be viewed at: www.regulations.gov, by
searching under the docket number of
the rulemaking, CPSC–2012–0068.
Following is a summary of, and
responses to, the comments.
Handle Auto-Locking Test—CAMI
Dummy v. Aluminum Cylinder
Comment: Two commenters
supported the proposal to use the
aluminum cylinder surrogate instead of
the CAMI dummy during the handle
auto-locking test. The other three
commenters opposed using the
aluminum cylinder surrogate. Specific
concerns with the cylinder included: (1)
The cylinder is not the same shape as
a child and can roll from side to side
during testing; (2) the weight
distribution and center of gravity of the
cylinder are different for a child, and
the cylinder can tip forward in an
unrealistic manner during testing; and
(3) testing with the cylinder can be
dangerous because the cylinder can fall
out of the carrier during testing and
potentially injure a tester. The three
commenters who raised concerns about
using the cylinder as a surrogate in the
handle auto-locking test preferred using
the CAMI dummy as the surrogate for
this test. One commenter suggested that
whichever surrogate was specified,
more detail be provided for placing the
surrogate into the carrier before the lift
test. One commenter suggested that
CPSC should allow ASTM additional
time to develop a test procedure that
will provide more repeatable results.
Response: Since publication of the
NPR, Commission staff has reviewed the
comments, witnessed additional testing,
and participated in discussions at
ASTM hand-held infant carrier
subcommittee and task group meetings.
Based on this additional work, the
Commission agrees with the three
commenters who stated that using the
cylinder during testing would produce
unrepeatable results for some carriers.
The Commission believes that most of
the issues presented by use of the CAMI
dummy can be addressed with
clarifications and modifications to the
ASTM test procedure set forth in ASTM
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F2050–12 so that the test produces more
repeatable and reliable results. ASTM
revised the requirement in the most
recent version of F2050, and staff
believes the revision, as now stated in
ASTM F2050–13a, is adequate to
address the hazards associated with
unlocked carry handles. Therefore, the
final rule does not does not require any
changes to the carry handle auto-locking
requirement but incorporates by
reference the latest version of the
standard, ASTM F2050–13a.
Fall Hazard Warning
Comment: One commenter
recommended that the Commission
strengthen the warning regarding the
fall hazard to discourage more strongly
caregivers placing the carrier on
elevated surfaces. The language in
ASTM F2050–12 (the version in effect at
the time of the NPR) stated: ‘‘Fall
Hazard: Child’s movement can slide
carrier. NEVER place carrier near edges
of counter tops, tables, or other elevated
surfaces.’’
Response: The Commission agrees
with the commenter that the fall hazard
warning stated in ASTM F2050–12 was
not sufficiently strong. Leaving handheld carriers on elevated surfaces is a
foreseeable behavior, and the warning
language should highlight the
importance of not leaving the carriers on
elevated surfaces. ASTM F2050–13a
revises this warning. The warning
language in ASTM’s ‘13a version is
presented below:
8.3.2.5 Fall Hazard: Child’s activity
can move carrier. Never place carrier on
counter tops, tables, or any other
elevated surfaces.
The Commission agrees with the change
in the ASTM standard, and thus, no
further modifications are necessary in
response to this comment.
Location of the Strangulation Warning
Label
Comment: One commenter expressed
concern that the requirement that the
label be placed ‘‘in or adjacent to the
area where the child’s head would rest’’
does not specify sufficiently the proper
placement of the label, and therefore,
the label could be obscured when a
child is in the seat. The commenter
suggested requiring the label to be
placed ‘‘adjacent to where the infant’s
head or torso would rest with or without
the child installed in the seat.’’ The
commenter explained that this change
would permit the caregiver to see the
warning label at all times and allow the
manufacturer the space and flexibility to
place the label in a location that is
effective, without impacting NHTSA’s
airbag warning label.
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Response: The requirement in ASTM
F2050–13a specifying the location for
the warning label mirrors NHTSA’s
airbag warning label requirement. The
Commission believes the warning label
location requirement clearly describes
the proper location of the label and
further believes that adopting the
commenter’s suggestion may create
confusion regarding the placement of
the label and may reduce the warning’s
effectiveness if a manufacturer decides
to locate the label toward the lower end
of the infant carrier. The Commission
agrees with the current language in
ASTM F2050–13a and believes that the
warning label is more likely to be seen
if placed on the outer surface of the
cushion or padding, in or adjacent to
where child’s head rests, and also
believes that there is sufficient area in
that part of the seat to accommodate
both NHTSA’s and ASTM’s labels
independently. Therefore, the
Commission declines to make the
change suggested by the commenter.
Alert Mechanism
Comment: One commenter suggested
that the Commission look for feasible
means to bolster the protection against
the hazards posed by improper use of
the harness restraint system, by
requiring an alert mechanism that
would clearly signal or indicate whether
a harness restraint system is properly
secured.
Response: Although alerting the user
to the existence of improperly secured
or unsecured harnesses would be
beneficial, the Commission is uncertain
how to accomplish this. Visual
indicators are unlikely to get the
attention of the user, and an auditory
signal (similar to vehicle seat belt
reminders) would require a power
source that would energize the alert
mechanism when the carrier is inside
and outside of a vehicle. Adding a
power source to the child restraint
would require a redesign that may fall
under NHTSA’s jurisdiction.
Effective Date
Comment: One commenter supported
the proposed six-month effective date.
Another commenter requested an 18month effective date, assuming that the
final rule would reference the use of the
cylinder as the surrogate for the carry
handle auto-locking test. The
commenter seeking an 18-month
effective date expressed concern that
requiring the cylinder might necessitate
substantial design changes.
Response: Because the Commission
has determined that the CAMI dummy
will be used as a surrogate in the carry
handle auto-locking test, the
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commenter’s basis for requesting an 18month effective date no longer exists. A
six-month effective date should be
sufficient for manufacturers of handheld infant carriers to comply with the
rule.
Moses Baskets
We did not receive any comments
concerning Moses baskets. Despite the
lack of comments, the Commission has
determined that a revision to the
definition of ‘‘hand-held infant carrier’’
is warranted to clarify that Moses
baskets are subject to the standard. The
final rule modifies the definition of
‘‘hand-held infant carrier’’ as follows
(underline represents additional
wording): ‘‘Hand-held infant carrier—a
freestanding, rigid- or semi-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.’’
VIII. Assessment of Voluntary Standard
ASTM F2050–13a and Description of
Final Rule
Consistent with section 104(b) of the
CPSIA, this rule establishes new 16 CFR
part 1225, ‘‘Safety Standard for HandHeld Infant Carriers.’’ The new part
incorporates by reference the
requirements for hand-held infant
carriers in ASTM F2050–13a, with one
modification to clarify that semi-rigid
sided products, such as Moses baskets,
are included in the scope of the rule.
The following discussion describes the
final rule, the changes, and the
additions to the ASTM requirements.
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A. Scope (§ 1225.1)
The final rule states that part 1225
establishes a consumer product safety
standard for hand-held infant carriers
manufactured or imported on or after
the date that is six months after the date
of publication of a final rule in the
Federal Register.
B. Incorporation by Reference (§ 1225.2)
Section 1225.2(a) explains that,
except as provided in § 1225.2(b), each
hand-held infant carrier must comply
with all applicable provisions of ASTM
F2050–13a, ‘‘Standard Consumer Safety
Specification for Hand-Held Infant
Carriers,’’ which is incorporated by
reference. Section 1225.2(a) also
provides information on how to obtain
a copy of the ASTM standard or to
inspect a copy of the standard at the
CPSC. The Commission received no
comments on this provision in the NPR,
but the Commission is changing the
language in the incorporation in the
final rule to refer to ASTM F2050–13a,
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the current version of the ASTM
standard.
C. Changes to Requirements of ASTM
F2050–13a
The final rule modifies the definition
of ‘‘hand-held infant carrier’’ to clarify
that the definition includes products
with semi rigid sides, as well as
products that are rigid-sided. ASTM
revised the hand-held infant carrier
standard in 2012, to include a separate
definition for ‘‘hand-held bassinets/
cradles.’’ A Moses basket meets the
definition of a ‘‘hand-held bassinet’’
because a Moses basket is a freestanding
product with a rest/support surface that
is no more than 10° from horizontal,
that sits directly on the floor, without
legs or a stand, and has handles or
hand-holds intended to allow carrying
an occupant whose torso is completely
supported by the product. However,
because hand-held infant carriers (of
which hand-held bassinets/cradles are a
subset) are defined in part as ‘‘a rigidsided product’’ and many Moses baskets
have flexible sides, some manufacturers
and importers may have interpreted the
standard as excluding semi-rigid-sided
products such as Moses baskets.
Because Moses baskets meet the
definition of ‘‘hand-held bassinet/
cradle,’’ and Moses baskets are not
subject to any other durable children’s
product standard (specifically ASTM
F2194–13, Standard Consumer Safety
Specification for Bassinets and Cradles),
the Commission has determined that
Moses baskets are within the scope of
the rule. The modification of the
definition of ‘‘hand-held infant carrier’’
to include semi rigid-sided products
clarifies that Moses baskets are covered
by the rule.
IX. 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 handheld carriers to come into compliance,
the final rule provides that the standard
will become effective 6 months after
publication in the Federal Register for
products manufactured or imported
after that date.
X. Regulatory Flexibility Act
A. Introduction
The Regulatory Flexibility Act (RFA),
5 U.S.C. 601–612, requires agencies to
consider the impact of rules on small
entities, including small businesses.
Section 604 of the RFA requires that
agencies prepare a final regulatory
flexibility analysis when the agency
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promulgates a final rule, unless the head
of the agency certifies that the rule will
not have a significant economic impact
on a substantial number of small
entities. The final regulatory flexibility
analysis must describe the impact of the
rule on small entities and identify any
alternatives that may reduce the impact.
Specifically, the final regulatory
analysis must contain:
• A succinct statement of the
objectives of, and legal basis for, the
rule;
• a summary of the significant issues
raised by public comments in response
to the initial regulatory flexibility
analysis, a summary of the assessment
of the agency of such issues, and a
statement of any changes made in the
proposed rule as a result of such
comments;
• a description of, and, where
feasible, an estimate of, the number of
small entities to which the rule will
apply;
• a description of the projected
reporting, recordkeeping, and other
compliance requirements of the rule,
including an estimate of the classes of
small entities subject to the
requirements and the type of
professional skills necessary for the
preparation of reports or records; and
• a description of the steps the agency
has taken to reduce the significant
economic impact on small entities,
consistent with the stated objectives of
applicable statutes, including a
statement of the factual, policy, and
legal reasons for selecting the alternative
adopted in the rule, and why each one
of the other significant alternatives to
the rule considered by the agency,
which affect the impact on small
entities, was rejected.
B. 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, which is often marketed
by bedding manufacturers and
distributors. The Commission estimates
that currently, there are at least 47
suppliers of hand-held infant carriers to
the U.S. market. Fifteen are domestic
manufacturers, 22 are domestic
importers, and 1 is a domestic firm with
an unknown supply source. In addition,
eight foreign firms distribute products
from outside of the United States (four
manufacturers, two importers, one
retailer, and one firm with an unknown
supply source). One firm, about which
the staff has little information, sells
hand-held infant carriers through an
online marketplace. An additional 24
domestic firms supply Moses basket
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bedding, along with Moses baskets. Staff
does not know the source of the Moses
baskets supplied by these 24 firms.
We expect that the products of 29 of
the 47 hand-held infant carrier suppliers
will be compliant with ASTM F2050–
13a (7 are JPMA certified to F2050; 6
claim compliance with F2050; and 16
have ASTM-compliant strollers with
hand-held infant carrier attachments).
We do not believe that any of the Moses
baskets currently on the market comply
with the voluntary standard; however,
the requirements that apply to Moses
baskets involve slip resistance, adding
warnings, and instructional literature.
Staff believes that the majority of Moses
baskets on the market would not require
adjustments to meet the slip resistance
requirement, and that adding warnings
and instructional literature would not
be costly.
The product ownership data available
is limited to infant car seats, which
represented nearly the entire hand-held
infant carrier market prior to the
publication of ASTM F2050–12, which
expanded the scope of the standard to
include hand-held bassinets and
cradles. 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 × .75 ×
4 million births per year). (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
2010,’’ National Vital Statistics Reports
Volume 61, Number 1 (August 28,
2012): Table I. Number of births in 2010
is rounded from 3,999,386.) These 2
million infant car seats represent the
minimum number of units sold per year
that might be affected by the hand-held
infant carrier standard. We do not know
how many Moses baskets and other
bassinet/cradle-style carriers are sold
annually.
C. Reason for Agency Action and Legal
Basis for 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
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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, F2050–13a,
upon which the rule is based.
The final rule modifies the definition
of ‘‘hand-held infant carrier’’ in ASTM
F2050–13a to clarify that the standard
includes products with semi rigid sides,
as well as products that are rigid-sided.
This modification resulted from the
Commission receiving no comments in
response to the NPR’s question whether
Moses baskets should be included
within the scope of this rule and the
Commission’s determination that Moses
baskets (which typically have semi rigid
as opposed to rigid sides) should be
covered by the rule.
D. Requirements of the Rule
The final rule adopts the voluntary
ASTM standard for hand-held infant
carriers (ASTM F2050–13a), with a
modification of the definition of ‘‘handheld infant carrier,’’ as discussed above.
Some of the more significant
requirements of the current voluntary
standard for hand-held infant carriers
are listed below:
• Carry handle integrity—a series of
endurance and durability tests is
intended to prevent rigid, adjustable
handles from breaking or unlocking
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).
• Marking and labeling
requirements—intended to provide
tracking information, as well as hazard
warnings.
The voluntary standard also includes:
(1) Torque and tension tests to prevent
components from being 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)
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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–
13a includes no reporting or
recordkeeping requirements.
The final rule does not alter ASTM
F2050–13a, except to clarify that the
definition of ‘‘hand-held infant carrier’’
includes products with semi rigid sides,
as well as products that are rigid-sided.
We do not expect this modification to
the final rule to have a negative
economic impact on firms because it is
a clarification of the intended scope,
rather than a change. In the 2012
version of the hand-held carrier
standard (F2050–12), ASTM changed
the standard to include a separate
definition for ‘‘bassinet-style carriers,’’
which may have been interpreted by
some manufacturers to include Moses
baskets. The Commission proposed the
same scope in the NPR but requested
comments on including Moses baskets.
In the absence of comments, the
Commission determined that Moses
baskets were intended to and should be
included in the scope and that the
definition of a ‘‘hand-held infant
carrier’’ should be modified to include
‘‘semi rigid-sided,’’ as well as ‘‘rigidsided’’ products, consistent with the
scope’s intent.
E. Other Federal or State Rules
Two federal rules would interact with
the hand-held infant carrier mandatory
standard: (1) 16 CFR part 1107, Testing
and Labeling Pertaining to Product
Certification (1107 rule or testing rule);
and (2) 16 CFR part 1112, Requirements
Pertaining to Third Party Conformity
Assessment Bodies (1112 rule).
The 1107 rule implementing sections
14(a)(2) and 14(i)(2) of the Consumer
Product Safety Act (CPSA), as amended
by the CPSIA, became effective on
February 13, 2013. Section 14(a)(2) of
the CPSA requires every manufacturer
of a children’s product that is subject to
a 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
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assessment body by a manufacturer or
private labeler.
Because hand-held infant carriers will
be subject to a mandatory children’s
product safety rule, the product will
also be subject to the third party testing
requirements of section 14(a)(2) of the
CPSA and the 1107 rule when the handheld infant carrier mandatory standard
and the notice of requirements (NORs)
become effective.
The 1112 rule, which became
effective on June 10, 2013, established
requirements for the accreditation of
third party conformity assessment
bodies 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 codified all of
the NORs that the CPSC had published,
to date. However, any new NORs
require an amendment to this rule.
Therefore, this rule amends 16 CFR part
1112 to establish the requirements for
accepting the accreditation of a
conformity assessment body to test for
compliance with the hand-held infant
carrier final rule.
F. Impact of the Rule on Small Business
There are at least 47 firms currently
known to be marketing hand-held infant
carriers in the United States, as well as
24 firms supplying Moses basket
bedding and Moses baskets whose
source is unknown. Under U.S. Small
Business Administration (SBA)
guidelines, a manufacturer of hand-held
infant carriers is small if the firm has
500 or fewer employees, and importers
and wholesalers are considered small, if
they have 100 or fewer employees.
Based on these guidelines, about 50 of
the firms known to be marketing handheld infant carriers in the United States
are small firms—10 domestic
manufacturers, 17 domestic importers, 1
domestic firm with an unknown supply
source, and 22 firms supplying Moses
basket/bedding suppliers. There may
also be additional small hand-held
infant carrier suppliers operating in the
U.S. market.
Small Manufacturers
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Direct Costs From the Rule
The expected impact on small
manufacturers of the standard will differ
based on whether the firm’s hand-held
infant carriers already comply with
F2050–12. Firms whose hand-held
infant carriers meet the requirements of
F2050–12 are likely to continue to
comply with the voluntary standard as
ASTM publishes new versions of the
ASTM standard. In addition, firms
currently in compliance are likely to
meet any new standard within six
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months after approval because six
months is the established amount of
time that JPMA allows for products in
JPMA’s certification program to shift to
a new standard. Compliance with the
voluntary standard in the six-month
time frame is part of an established
business practice. Additionally,
modifying warning labels and updating
instructional literature should not result
in significant expenditures for most
firms. As a result, the direct impact of
the rule on manufacturers whose
products are likely to meet the
requirements of ASTM F2050–13a (eight
of ten small domestic manufacturers) is
not likely to be significant. One or more
firms might have to modify their carry
handles to continue to pass the autolocking test, but staff believes that a
complete product redesign should not
be necessary. Thus, for manufacturers
whose products are likely to meet the
requirements of ASTM F2050–13a (eight
of ten firms), staff estimates little or no
incremental impact on the costs of
producing hand-held infant carriers.
For either or both of the hand-held
infant carrier suppliers staff believes do
not comply with the current version of
the voluntary standard, however,
meeting ASTM F2050–13a’s
requirements could necessitate product
redesign. A redesign would be minor if
most of the changes involve adding
straps and fasteners or using different
mesh or fabric; but 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 cost approximately
$500,000. Consequently, the final rule
could potentially have a significant
direct impact on small manufacturers
whose products currently do not
conform to the voluntary standard,
depending on the scope of the redesign
that ultimately is necessary. Where the
products need not be completely
redesigned, actual costs are likely to be
lower than the $500,000 level.
Even though the hand-held infant
carriers sold by two firms are neither
certified as compliant, nor claim
compliance with F2050–12, the
products may, in fact, comply with the
current standard. Staff 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
standard will be less significant than
described above.
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Indirect Costs From Testing and
Certification
In addition to the direct impact of the
standard described above, the rule will
have 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 NOR is in effect, all
manufacturers will be subject to the
additional costs associated with the
third party testing and certification
requirements. These costs will include
any physical and mechanical test
requirements specified in the final rule;
lead and phthalates testing is already
required, and hence, related costs are
not included here.
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 such testing 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 F2050–13a is unlikely
to be significant if only one hand-held
infant carrier sample per model is
necessary to comply with the third party
testing requirements. However, if more
than one sample would be needed to
meet the testing requirements, that third
party testing costs potentially could
have a significant impact on one or
more of the small manufacturers.
Small Importers
As with manufacturers of compliant
hand-held infant carriers, we do not
believe that the eight small importers of
hand-held infant carriers currently in
compliance with F2050–12 will
experience significant direct impacts as
a result of the final rule. In the absence
of regulation, these importing firms
would likely continue to their
established practice of complying with
the voluntary standard as the standard
evolves.
Importers of hand-held infant carriers
would need to find an alternate supply
source if their existing supplier does not
comply with the requirements of the
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rule, which may be the case with all
four small importers of hand-held infant
carriers, whom we believe do not
comply with F2050–12. Some of these
importers could react to the rule by
discontinuing the import of
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 compliant handheld infant carriers. Deciding to import
an alternative product would be a
reasonable and realistic way to offset
any lost revenue. However, for some
importers, switching suppliers might
not be an option.
As is the case with manufacturers, all
importers will be subject to third party
testing and certification requirements,
and consequently, importers will incur
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 who
must perform the testing themselves, if
more than one sample per model is
required.
Moses Basket Suppliers
Staff also assessed the potential
impact of the rule on firms that supply
Moses baskets. There are 22 known
small firms supplying Moses baskets to
the U.S. market. Most of these firms also
supply bedding; some of them
manufacture the bedding, and others act
as importers. Because a separate
definition for ‘‘hand-held bassinets’’
was added to the standard relatively
recently in 2012, and some
manufacturers may be uncertain
whether Moses baskets (a type of handheld bassinet) are covered by the
standard because they are not rigidsided, Moses baskets currently on the
market may not have been designed to
comply with this standard.
Many Moses baskets on the market,
however, might be able to comply with
the standard with minimal
modifications. For example, although
Moses baskets would not be subject to
most of the hand-held carrier standard’s
performance requirements, Moses
baskets would likely have to meet the
slip-resistance requirement. Because
typical Moses baskets are fabricated
from textured materials, we believe that
these products likely would not require
modifications to meet the slip-resistance
requirement (that the product does not
slip on surface 10 degrees from
horizontal while facing forward,
sideways, and to the rear). Therefore,
the biggest changes might be to add
warnings and instructional literature,
actions that the staff expects would not
be costly.
Alternatively, Moses basket suppliers
could remove themselves from the
scope of the final rule by eliminating the
handles from their products. Because
most Moses baskets come with warnings
against carrying an infant in the basket,
eliminating handles would conform to
those instructions.
All Moses basket manufacturers
within the scope of the rule will be
subject to third party testing and
certification requirements. Importers of
Moses baskets could experience testing
costs if their supplying firm does not
perform third party testing. Because
Moses baskets would not be subject to
most of the mechanical tests in the
standard, we expect that third party
testing costs, at most, will be half the
amount of other types of hand-held
infant carriers, or approximately $250–
$500 per model sample. Review of each
firm’s product line reveals that most
firms use only one model of Moses
basket for their bedding; although some
firms have up to four variations of
Moses baskets. The resulting costs are
unlikely to have a significant impact on
firms that must perform the testing
themselves.
G. Alternatives
An alternative to the rule would be to
set an effective date later than six
months, which is generally considered
sufficient time for suppliers to come
into compliance with a rule. Setting a
later effective date would allow
suppliers additional time to develop
compliant hand-held infant carriers and
spread the associated costs over a longer
period of time.
XI. 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 rule falls within
the categorical exclusion.
XII. Paperwork Reduction Act
This rule contains information
collection requirements that are subject
to public comment and review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521). The preamble to the proposed
rule (77 FR at 73363 through 73364)
discussed the information collection
burden of the proposed rule and
specifically requested comments on the
accuracy of our estimates. Briefly,
sections 8 and 9 of ASTM F2050–13a
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).
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. OMB
has assigned control number 3041–0158
to this information collection. The
Commission did not receive any
comments regarding the information
collection burden of this proposal.
However, the final rule makes
modifications regarding the information
collection burden because the number
of estimated suppliers subject to the
information collection burden is now
estimated to be 71 firms, rather than the
43 firms initially estimated in the
proposed rule.
Accordingly, the estimated burden of
this collection of information is
modified as follows:
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TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
16 CFR Section
Number of
respondents
Frequency of
responses
Total annual
responses
Hours per
response
Total burden
hours
1221 .....................................................................................
71
2
142
1
142
Our estimates are based on the
following:
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Section 8.1 of ASTM F 2050–13a
requires that the name of the
manufacturer, distributor, or seller, and
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either the place of business (city, state,
and mailing address, including zip
code) or telephone number, or both, be
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marked clearly and legibly on each
product and its retail package. Section
8.2 of ASTM F 2050–13a requires a code
mark or other means that identifies the
date (month and year, as a minimum) of
manufacture.
There are 71 known entities
supplying hand-held infant carriers to
the U.S. market. All 71 firms are
assumed to use labels already on both
their products and their packaging, but
they might need to modify existing
labels. The estimated time required to
make these modifications is about 1
hour per model. Each entity supplies an
average of two different models of handheld infant carriers; therefore, the
estimated burden associated with labels
is 1 hour per model × 71 entities × 2
models per entity = 142 hours. We
estimate the hourly compensation for
the time required to create and update
labels is $27.44 (U.S. Bureau of Labor
Statistics, ‘‘Employer Costs for
Employee Compensation,’’ March 2013,
Table 9, total compensation for all sales
and office workers in goods-producing
private industries: https://www.bls.gov/
ncs/). Therefore, the estimated annual
cost to industry associated with the
labeling requirements is $3,896.48
($27.54 per hour × 142 hours =
$3,896.48). There are no operating,
maintenance, or capital costs associated
with the collection of information.
Section 9.1 of ASTM F2050–12
requires the supply of instructions with
the product. Hand-held infant carriers
often require installation or assembly,
and products sold without such
information would not be as attractive
to consumers as 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 that there are no burden hours
associated with section 9.1 of ASTM F
2050–12 because any burden associated
with supplying instructions with handheld infant carriers would be ‘‘usual and
customary’’ and not within the
definition of ‘‘burden’’ under the OMB’s
regulations.
XIII. Preemption
Section 26(a) of the CPSA, 15 U.S.C.
2075(a), provides that where a consumer
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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 the rule becomes effective.
XIV. Certification and Notice of
Requirements (NOR)
Section 14(a)(2) of the CPSA requires
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 handheld 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.
The Commission published a final
rule, Requirements Pertaining to Third
Party Conformity Assessment Bodies, 78
FR 15836 (March 12, 2013), which is
codified at 16 CFR part 1112 (referred to
here as part 1112). This rule became
effective on June 10, 2013. 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
PO 00000
Frm 00045
Fmt 4700
Sfmt 4700
73423
Section14(a)(2) of the CPSA. Part 1112
also codifies a list of all of the NORs
that the CPSC had published at the time
part 1112 was issued. All NORs issued
after the Commission published part
1112, such as the hand-held infant
carrier standard, require the
Commission to amend part 1112.
Accordingly, this rule amends part 1112
to include the hand-held infant carrier
standard in the list 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 are required to meet the third
party conformity assessment body
accreditation requirements in 16 CFR
part 1112. When a laboratory meets the
requirements as a CPSC-accepted third
party conformity assessment body, the
laboratory can apply to the CPSC to
have 16 CFR part 1225, Safety Standard
for Hand-Held Infant Carriers included
in the scope of accreditation of CPSC
safety rules listed for the laboratory on
the CPSC Web site at: www.cpsc.gov/
labsearch.
In connection with the part 1112
rulemaking, CPSC staff conducted an
analysis of the potential impacts on
small entities of the rule establishing
accreditation requirements, 78 FR
15836, 15855–58 (March 12, 2013), as
required by the Regulatory Flexibility
Act and prepared a Final Regulatory
Flexibility Analysis (FRFA). Briefly, the
FRFA concluded that the requirements
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 not likely pursue
accreditation for this purpose. Similarly,
amending the part 1112 rule to include
the NOR for the hand-held infant carrier
standard would not have a significant
adverse impact on small laboratories.
Most of these laboratories will have
already been accredited to test for
conformance to other juvenile product
standards, and the only costs to them
would be the cost of adding the handheld infant carrier standard to their
scope of accreditation. As a
consequence, the Commission certifies
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73424
Federal Register / Vol. 78, No. 235 / Friday, December 6, 2013 / Rules and Regulations
that the NOR for the hand-held infant
carrier standard will not have a
significant impact on a substantial
number of small entities.
To ease the transition to new third
party testing requirements for hand-held
infant carriers subject to the standard
and to avoid a ‘‘bottlenecking’’ of
products at laboratories at or near the
effective date of required third party
testing for hand-held infant carriers, the
Commission, under certain
circumstances, will accept certifications
based on testing that occurred before the
effective date for third party testing.
The Commission will accept
retrospective testing for 16 CFR part
1225, safety standard for hand-held
infant carriers, if the following
conditions are met:
• The children’s product was tested
by a third party conformity assessment
body accredited to ISO/IEC
17025:2005(E) by a signatory to the
ILAC–MRA at the time of the test. The
scope of the third party conformity body
accreditation must include testing in
accordance with 16 CFR part 1225. For
firewalled third party conformity
assessment bodies, the firewalled third
party conformity assessment body must
be one that the Commission, by order,
has accredited on or before the time that
the children’s product was tested, even
if the order did not include the tests
contained in the safety standard for
hand-held infant carriers at the time of
initial Commission acceptance. For
governmental third party conformity
assessment bodies, accreditation of the
body must be accepted by the
Commission, even if the scope of
accreditation did not include the tests
contained in the safety standard for
hand-held infant carriers at the time of
initial CPSC acceptance.
• The test results show compliance
with 16 CFR part 1225.
• The hand-held infant carrier was
tested on or after the date of publication
in the Federal Register of the final rule
for 16 CFR part 1225 and before June 6,
2014.
• The laboratory’s accreditation
remains in effect through June 6, 2014.
maindgalligan on DSK5TPTVN1PROD with RULES
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.
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16:51 Dec 05, 2013
Jkt 232001
Therefore, the Commission amends
Title 16 of the Code of Federal
Regulations by amending part 1112 and
adding a new part 1225 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 § 1112.15 by adding
paragraph (b)(34) to read as follows:
■
§ 1112.15 When can a third party
conformity assessment body apply for
CPSC acceptance for a particular CPSC rule
and/or test method?
*
*
*
*
(b)
(34) 16 CFR part 1225, Safety
Standard for Hand-Held Infant Carriers.
*
*
*
*
*
■ 3. Add part 1225 to read as follows:
federal_register/code_of_federal
regulations/ibr_locations.html.
(b) Instead of complying with section
3.1.3 of ASTM F2050–13a, comply with
the following:
(1) 3.1.3 hand-held infant carrier, n—
a freestanding, rigid- or semirigid-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.
(2) [Reserved]
Dated: December 2, 2013.
Todd A. Stevenson,
Secretary, Consumer Product Safety
Commission.
[FR Doc. 2013–29061 Filed 12–5–13; 8:45 am]
BILLING CODE 6355–01–P
*
DEPARTMENT OF ENERGY
Federal Energy Regulatory
Commission
18 CFR Part 40
PART 1225—SAFETY STANDARD FOR
HAND-HELD INFANT CARRIERS
[Docket No. RM13–8–000; Order No. 788]
Sec.
1225.1 Scope.
1225.2 Requirements for hand-held infant
carriers.
Retirement of Requirements in
Reliability Standards
Authority: Pub. L. 110–314, sec. 104, 122
Stat. 3016 (August 14, 2008).
§ 1225.1
§ 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 2050–13a,
Standard Consumer Safety Specification
for Hand-Held Infant Carriers, approved
on September 1, 2013. The Director of
the Federal Register approves this
incorporation by reference in
accordance with 5 U.S.C. 552(a) and 1
CFR part 51. You may obtain a copy
from ASTM International, 100 Bar
Harbor Drive, P.O. Box 0700, West
Conshohocken, PA 19428; https://
www.astm.org. You may inspect a copy
at the Office of the Secretary, U.S.
Consumer Product Safety Commission,
Room 820, 4330 East West Highway,
Bethesda, MD 20814, telephone 301–
504–7923, or at the National Archives
and Records Administration (NARA).
For information on the availability of
this material at NARA, call 202–741–
6030, or go to: https://www.archives.gov/
Frm 00046
Fmt 4700
Pursuant to section 215 of the
Federal Power Act, the Commission
approves the retirement of 34
requirements within 19 Reliability
Standards identified by the North
American Electric Reliability
Corporation (NERC), the Commissioncertified Electric Reliability
Organization. The requirements
approved for retirement either: Provide
little protection for Bulk-Power System
reliability; or are redundant with other
aspects of the Reliability Standards. In
addition, the Commission withdraws 41
Commission directives that NERC
develop modifications to Reliability
Standards. This rule is part of the
Commission’s ongoing effort to review
its requirements and reduce
unnecessary burdens by eliminating
requirements that are not necessary to
the performance of the Commission’s
regulatory responsibilities.
DATES: Effective Date: This rule will
become effective January 21, 2014.
FOR FURTHER INFORMATION CONTACT:
Kevin Ryan (Legal Information), Office
of the General Counsel, Federal
Energy Regulatory Commission, 888
First Street NE., Washington, DC
20426, Telephone: (202) 502–6840
SUMMARY:
Scope.
This part establishes a consumer
product safety standard for hand-held
infant carriers.
PO 00000
Federal Energy Regulatory
Commission, DOE.
ACTION: Final rule.
AGENCY:
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Agencies
[Federal Register Volume 78, Number 235 (Friday, December 6, 2013)]
[Rules and Regulations]
[Pages 73415-73424]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-29061]
=======================================================================
-----------------------------------------------------------------------
CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Parts 1112 and 1225
[CPSC Docket No. CPSC-2012-0068]
Safety Standard for Hand-Held Infant Carriers
AGENCY: Consumer Product Safety Commission.
ACTION: Final rule.
-----------------------------------------------------------------------
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 issuing a safety
standard for hand-held infant carriers in response to the direction
under section 104(b) of the CPSIA. The rule would incorporate ASTM
F2050-13a by reference, with one modification.
DATES: The rule will become effective on June 6, 2014. The
incorporation by reference of the publication listed in this rule is
approved by the Director of the Federal Register as of June 6, 2014.
FOR FURTHER INFORMATION CONTACT: Julio Alvarado, Compliance Officer,
Office of Compliance and Field Operations, U.S. Consumer Product Safety
Commission, 4330 East-West Highway, Bethesda, MD 20814; email:
jalvarado@cpsc.gov.
SUPPLEMENTARY INFORMATION:
I. Background and Statutory Authority
The CPSIA (Pub. L. 110-314) was enacted on August 14, 2008. Section
104(b) of the CPSIA 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. Infant carriers are one of the products specifically
identified in section 104(f)(2)(H) as a durable infant or toddler
product. 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 hand-
held infant carriers. This rule addresses hazards associated only with
hand-held infant carriers. Hazards associated with other types of
carriers would be
[[Page 73416]]
addressed in separate rulemaking proceedings.
On December 10, 2012, the Commission issued a notice of proposed
rulemaking (NPR) for hand-held infant carriers. 77 FR 73354. The NPR
proposed to incorporate by reference the then current voluntary
standard, ASTM F2050-12, Standard Consumer Safety Specification for
Hand-Held Infant Carriers, with certain modifications to strengthen the
ASTM standard. One proposed modification provided for a change in the
warning label to better address suffocation and restraint-related
hazards. The other proposed modification addressed the testing
procedures for the carry handle auto-locking requirement and specified
using an aluminum cylinder as the surrogate for the occupant of the
carrier rather than a CAMI Mark II 6-month infant dummy (CAMI dummy).
Since the Commission published the NPR, ASTM has revised ASTM F2050
twice. On July 1, 2013, ASTM approved an updated version of the
voluntary standard, ASTM F2050-13, which includes the warning label
modification proposed in the NPR. On September 1, 2013, ASTM approved
another revision of the voluntary standard, ASTM F2050-13a, which
includes a carry handle auto-locking performance requirement that is
different than the requirement proposed in the NPR. As explained in
section VII of this preamble, the Commission agrees with the auto-
locking requirement in ASTM F2050-13a. The draft final rule
incorporates by reference the most recent version of the ASTM standard,
ASTM F2050-13a, with one modification--a clarification of the
definition of ``hand-held infant carrier,'' to include a specific
reference to both ``rigid-sided'' and ``semi-rigid-sided'' products.
II. The Product
ASTM F2050-13a 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
ASTM voluntary standard published in August 2012, for the first time
referenced two types of hand-held infant carriers: Hand-held bassinets/
cradles and hand-held carrier seats. 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 ``a 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.'' Hand-
held carrier seats often are used as infant car seats, or as
attachments to strollers or high chairs bases. Some of the requirements
in F2050-13a 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 a freestanding product with a rest/support
surface to facilitate sleep and has hand-holds or handles intended to
allow carrying an occupant. Some Moses baskets are rigid-sided, but
most have semi rigid sides. In the NPR, the Commission sought comment
on whether Moses baskets are or should be covered by this safety
standard. The Commission also asked: (1) If Moses baskets should be
included in this safety standard, does the present definition cover
Moses baskets, and (2) if the present definition does not cover Moses
baskets, how should the standard be amended to cover Moses baskets? The
Commission received no comments in response to these questions and will
clarify the definition of ``hand-held infant carrier'' in the rule to
specify that the definition includes both ``rigid-sided'' and ``semi-
rigid-sided'' products.
III. Incident Data
The preamble to the NPR summarized incident data involving
bassinets and cradles reported to the Commission as of June 8, 2012. 77
FR 73354 (December 10, 2012). The NPR stated that, according to reports
to the CPSC, 242 incidents involving hand-held infant carriers occurred
between January 1, 2007 and June 7, 2012. Of the 242 incidents, there
were 36 fatalities, 60 nonfatal injuries, and 146 incidents where no
injury occurred or was reported. Staff attributed the majority of the
fatalities to the improper use or nonuse of the carrier's restraint
system.
CPSC's Directorate for Epidemiology, Division of Hazard Analysis
has updated this information to include hand-held infant carrier-
related incident data reported to the Commission from June 8, 2012
through June 21, 2013. A search of the CPSC epidemiological databases
showed that there were 10 new incidents related to hand-held infant
carriers reported during this time frame. Seven of the 10 were fatal,
and three were nonfatal. None of the nonfatal incidents involved
injuries. All of the new incidents reportedly occurred in late 2011 and
2012. Reporting is ongoing, however, so the incident totals are subject
to change.
A. Fatalities Reported Since the NPR
Most of the more recently reported seven fatalities involved a
product-related issue. The ages of the decedents ranged from one month
to 15 months. Staff attributes the majority of the fatalities to the
improper use or nonuse of the carrier's restraint system. The incident
reports indicate the following circumstances in these fatalities:
Infant was unrestrained and found in a prone position with
the seat tipped over;
infant was unrestrained and found with its face pressed
into the side of the seat;
infant strangled to death when restrained by the shoulder
straps only and moved forward in the seat and was caught in the throat
by the chest clip that connects the shoulder straps;
infant was strapped into a hand-held infant carrier that
was placed on a bed and overturned;
infant was reported to have become entrapped in the
carrier by other unsupervised children; although information on the
exact manner of entrapment was unavailable;
insufficient information to identify conclusively a hazard
pattern but may have been the result of misuse of the product;
insufficient information to identify hazard pattern.
B. Nonfatal Incidents Reported Since the NPR
There were three hand-held carrier-related nonfatal incidents
reported to the Commission from June 8, 2012 through June 21, 2013. All
of the incidents occurred in 2012; none of these involved an injury.
Two of the incident reports stated that the carrier handle broke. The
third report was a complaint about the poor quality and design of a
Moses basket carrier.
C. Hazard Pattern Identification
Staff did not identify any new hazard patterns among the 10
incident reports that CPSC staff received since the Commission
published the hand-held infant carrier NPR. In order of frequency of
incident reports, staff grouped the hazard patterns of the incidents
reported since the NPR into the following categories:
1. Restraint issues: Three of the incidents--all fatalities--were
associated with the incorrect use or nonuse of the harness straps. In
two of
[[Page 73417]]
these fatal incidents, the decedent was not restrained in the carrier
at all. The decedents were found later to have turned over to a prone
position, face down on a soft surface. One death resulted when the
infant was left in the seat with only the shoulder straps connected,
but unrestrained at the crotch strap, which allowed the infant to slide
forward in the seat, just enough to get caught at the throat by the
chest clip and become strangled.
2. Handle problems: Two incident reports state that the handle
broke. One of these incidents involved a product that was already
recalled for handle problems. There were no injuries reported in these
incidents.
3. Issues with carrier design: There was one fatality in this
category, which resulted when the occupied carrier was left on a soft
surface (i.e., a bed), tipped upside down, and trapped the infant. In
addition, one noninjury report complained about the poor and unsafe
design of a Moses basket carrier.
4. Hazardous environment: One fatality resulted from an infant
becoming trapped in the hand-held carrier by other unsupervised
children. Details of the manner in which the entrapment occurred were
unavailable.
5. Other product-related issue: One fatality report indicated that
misuse of the product may have contributed to the incident; however,
not enough information was available for CPSC staff to identify
conclusively the hazard pattern involved.
6. Other/unknown issue: One fatality was reported with an
undetermined official cause of death. There was insufficient evidence
of any product involvement or the presence of any hazardous external
circumstances.
IV. Overview of ASTM F2050
ASTM F2050, Standard Consumer Safety Specification for Hand-Held
Infant Carriers, establishes safety performance requirements, test
methods, and labeling requirements to minimize the identified hazard
patterns associated with the use of hand-held infant carriers. 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. ASTM has
revised the standard six times since then. ASTM F2050-13 was approved
on July 1, 2013, and the current version, ASTM F2050-13a, was approved
on September 1, 2013. The more significant requirements of ASTM F2050
include:
Scope--describes the types of products intended to be
covered under the standard.
Testing of the handle auto-locking mechanism--is intended
to prevent unintentional rotation of the carrier and resulting
expulsion of the child when the caregiver picks up the carrier by the
handle and the handle is not in a locked position.
Testing of the integrity of the handle--is intended to
prevent unintentional separation of the handle from the carrier while
in use.
Occupant restraints--are intended to prevent incidents in
which improper use of restraints has resulted in the entrapment and
strangulation of children.
Slip-resistance requirement--is intended to prevent the
carrier from sliding when placed on a slightly inclined surface.
Warning label--is intended to address: (1) Improper use of
restraints (to prevent strangulation and other injuries), and (2)
improper placement of the carrier on an elevated surface (to prevent
fall injuries).
The voluntary standard also includes: (1) Torque and tension tests
to prevent components from being removed; (2) requirements to prevent
entrapment and cuts (minimum and maximum opening size, small parts,
hazardous sharp edges or points, and edges that can scissor, shear, or
pinch); (3) requirements for the permanency and adhesion of labels; and
(4) requirements for instructional literature.
V. The NPR and ASTM 2050-12
The NPR proposed to incorporate by reference ASTM F2050-12 as a
consumer product safety standard, with two modifications:
1. Warning Label: The NPR proposed requiring 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 child's head would rest. Under the proposal, 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.
2. Handle Auto-Lock Test: The NPR proposed a modification of the
test method for preventing the carrier from rotating and spilling 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 required the tester to use a standard CAMI dummy as an infant
surrogate. The NPR proposed a change that 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 testing had revealed that
the CAMI dummy could be wedged into the seat padding or otherwise
manipulated, so that the CAMI dummy did not fall out during the lift
test when the CAMI dummy otherwise should fall. Furthermore, the
Commission was concerned that the ability to pass or fail the test
based on friction or placement of the CAMI would affect the consistency
and repeatability of the test results.
The NPR also asked for comments regarding whether Moses baskets
should be included in this safety standard, and if so, whether we
should revise the definition of ``hand-held infant carrier'' to cover
Moses baskets.
VI. ASTM F2050-13a
ASTM approved the current voluntary standard for hand-held infant
carriers, ASTM F2050-13a, on September 1, 2013. ASTM balloted the NPR's
provisions concerning the warning label requirement in 2013, and the
provisions are now included in the latest revision of the voluntary
standard, ASTM 2050-13a.
Several comments received in response to the NPR suggested that the
aluminum cylinder was not an appropriate surrogate for use in the
handle auto-lock test and maintained that other surrogates, including
the CAMI dummy, would produce more repeatable and consistent test
results if properly placed in the carrier. After considering these
comments and the results of additional testing performed since the
Commission published the NPR, Commission staff determined that using
the CAMI dummy, with certain modifications to the test procedure, would
produce more repeatable and consistent test results. ASTM F2050-13a
retains the use of the CAMI dummy as the surrogate occupant and
clarifies how the dummy should be situated in the seat during testing.
The revised requirement also:
Specifies using webbing instead of hooks for lifting the
carrier during the test;
specifies that a pneumatic cylinder be used to provide the
force needed for the lift; and
narrows the lift speed range.
VII. Responses to Comments
The Commission received five comments on the NPR, including: one
[[Page 73418]]
from a consumer's group (Consumers Union); one from the Juvenile
Products Manufacturers Association (JPMA); and three from hand-held
infant carrier manufacturers. The comments raised several issues, which
resulted in ASTM changing the handle auto-lock test procedures and
including guidance for the placement of the CAMI dummy in the seat
during the handle-auto lock test in ASTM F2050-13a. Several commenters
made general statements supporting the overall purpose of the proposed
rule. All of the comments can be viewed at: www.regulations.gov, by
searching under the docket number of the rulemaking, CPSC-2012-0068.
Following is a summary of, and responses to, the comments.
Handle Auto-Locking Test--CAMI Dummy v. Aluminum Cylinder
Comment: Two commenters supported the proposal to use the aluminum
cylinder surrogate instead of the CAMI dummy during the handle auto-
locking test. The other three commenters opposed using the aluminum
cylinder surrogate. Specific concerns with the cylinder included: (1)
The cylinder is not the same shape as a child and can roll from side to
side during testing; (2) the weight distribution and center of gravity
of the cylinder are different for a child, and the cylinder can tip
forward in an unrealistic manner during testing; and (3) testing with
the cylinder can be dangerous because the cylinder can fall out of the
carrier during testing and potentially injure a tester. The three
commenters who raised concerns about using the cylinder as a surrogate
in the handle auto-locking test preferred using the CAMI dummy as the
surrogate for this test. One commenter suggested that whichever
surrogate was specified, more detail be provided for placing the
surrogate into the carrier before the lift test. One commenter
suggested that CPSC should allow ASTM additional time to develop a test
procedure that will provide more repeatable results.
Response: Since publication of the NPR, Commission staff has
reviewed the comments, witnessed additional testing, and participated
in discussions at ASTM hand-held infant carrier subcommittee and task
group meetings. Based on this additional work, the Commission agrees
with the three commenters who stated that using the cylinder during
testing would produce unrepeatable results for some carriers. The
Commission believes that most of the issues presented by use of the
CAMI dummy can be addressed with clarifications and modifications to
the ASTM test procedure set forth in ASTM F2050-12 so that the test
produces more repeatable and reliable results. ASTM revised the
requirement in the most recent version of F2050, and staff believes the
revision, as now stated in ASTM F2050-13a, is adequate to address the
hazards associated with unlocked carry handles. Therefore, the final
rule does not does not require any changes to the carry handle auto-
locking requirement but incorporates by reference the latest version of
the standard, ASTM F2050-13a.
Fall Hazard Warning
Comment: One commenter recommended that the Commission strengthen
the warning regarding the fall hazard to discourage more strongly
caregivers placing the carrier on elevated surfaces. The language in
ASTM F2050-12 (the version in effect at the time of the NPR) stated:
``Fall Hazard: Child's movement can slide carrier. NEVER place carrier
near edges of counter tops, tables, or other elevated surfaces.''
Response: The Commission agrees with the commenter that the fall
hazard warning stated in ASTM F2050-12 was not sufficiently strong.
Leaving hand-held carriers on elevated surfaces is a foreseeable
behavior, and the warning language should highlight the importance of
not leaving the carriers on elevated surfaces. ASTM F2050-13a revises
this warning. The warning language in ASTM's `13a version is presented
below:
8.3.2.5 Fall Hazard: Child's activity can move carrier. Never place
carrier on counter tops, tables, or any other elevated surfaces.
The Commission agrees with the change in the ASTM standard, and thus,
no further modifications are necessary in response to this comment.
Location of the Strangulation Warning Label
Comment: One commenter expressed concern that the requirement that
the label be placed ``in or adjacent to the area where the child's head
would rest'' does not specify sufficiently the proper placement of the
label, and therefore, the label could be obscured when a child is in
the seat. The commenter suggested requiring the label to be placed
``adjacent to where the infant's head or torso would rest with or
without the child installed in the seat.'' The commenter explained that
this change would permit the caregiver to see the warning label at all
times and allow the manufacturer the space and flexibility to place the
label in a location that is effective, without impacting NHTSA's airbag
warning label.
Response: The requirement in ASTM F2050-13a specifying the location
for the warning label mirrors NHTSA's airbag warning label requirement.
The Commission believes the warning label location requirement clearly
describes the proper location of the label and further believes that
adopting the commenter's suggestion may create confusion regarding the
placement of the label and may reduce the warning's effectiveness if a
manufacturer decides to locate the label toward the lower end of the
infant carrier. The Commission agrees with the current language in ASTM
F2050-13a and believes that the warning label is more likely to be seen
if placed on the outer surface of the cushion or padding, in or
adjacent to where child's head rests, and also believes that there is
sufficient area in that part of the seat to accommodate both NHTSA's
and ASTM's labels independently. Therefore, the Commission declines to
make the change suggested by the commenter.
Alert Mechanism
Comment: One commenter suggested that the Commission look for
feasible means to bolster the protection against the hazards posed by
improper use of the harness restraint system, by requiring an alert
mechanism that would clearly signal or indicate whether a harness
restraint system is properly secured.
Response: Although alerting the user to the existence of improperly
secured or unsecured harnesses would be beneficial, the Commission is
uncertain how to accomplish this. Visual indicators are unlikely to get
the attention of the user, and an auditory signal (similar to vehicle
seat belt reminders) would require a power source that would energize
the alert mechanism when the carrier is inside and outside of a
vehicle. Adding a power source to the child restraint would require a
redesign that may fall under NHTSA's jurisdiction.
Effective Date
Comment: One commenter supported the proposed six-month effective
date. Another commenter requested an 18-month effective date, assuming
that the final rule would reference the use of the cylinder as the
surrogate for the carry handle auto-locking test. The commenter seeking
an 18-month effective date expressed concern that requiring the
cylinder might necessitate substantial design changes.
Response: Because the Commission has determined that the CAMI dummy
will be used as a surrogate in the carry handle auto-locking test, the
[[Page 73419]]
commenter's basis for requesting an 18-month effective date no longer
exists. A six-month effective date should be sufficient for
manufacturers of hand-held infant carriers to comply with the rule.
Moses Baskets
We did not receive any comments concerning Moses baskets. Despite
the lack of comments, the Commission has determined that a revision to
the definition of ``hand-held infant carrier'' is warranted to clarify
that Moses baskets are subject to the standard. The final rule modifies
the definition of ``hand-held infant carrier'' as follows (underline
represents additional wording): ``Hand-held infant carrier--a
freestanding, rigid- or semi-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.''
VIII. Assessment of Voluntary Standard ASTM F2050-13a and Description
of Final Rule
Consistent with section 104(b) of the CPSIA, this rule establishes
new 16 CFR part 1225, ``Safety Standard for Hand-Held Infant
Carriers.'' The new part incorporates by reference the requirements for
hand-held infant carriers in ASTM F2050-13a, with one modification to
clarify that semi-rigid sided products, such as Moses baskets, are
included in the scope of the rule. The following discussion describes
the final rule, the changes, and the additions to the ASTM
requirements.
A. Scope (Sec. 1225.1)
The final rule states that part 1225 establishes a consumer product
safety standard for hand-held infant carriers manufactured or imported
on or after the date that is six months after the date of publication
of a final rule in the Federal Register.
B. Incorporation by Reference (Sec. 1225.2)
Section 1225.2(a) explains that, except as provided in Sec.
1225.2(b), each hand-held infant carrier must comply with all
applicable provisions of ASTM F2050-13a, ``Standard Consumer Safety
Specification for Hand-Held Infant Carriers,'' which is incorporated by
reference. Section 1225.2(a) also provides information on how to obtain
a copy of the ASTM standard or to inspect a copy of the standard at the
CPSC. The Commission received no comments on this provision in the NPR,
but the Commission is changing the language in the incorporation in the
final rule to refer to ASTM F2050-13a, the current version of the ASTM
standard.
C. Changes to Requirements of ASTM F2050-13a
The final rule modifies the definition of ``hand-held infant
carrier'' to clarify that the definition includes products with semi
rigid sides, as well as products that are rigid-sided. ASTM revised the
hand-held infant carrier standard in 2012, to include a separate
definition for ``hand-held bassinets/cradles.'' A Moses basket meets
the definition of a ``hand-held bassinet'' because a Moses basket is a
freestanding product with a rest/support surface that is no more than
10[deg] from horizontal, that sits directly on the floor, without legs
or a stand, and has handles or hand-holds intended to allow carrying an
occupant whose torso is completely supported by the product. However,
because hand-held infant carriers (of which hand-held bassinets/cradles
are a subset) are defined in part as ``a rigid-sided product'' and many
Moses baskets have flexible sides, some manufacturers and importers may
have interpreted the standard as excluding semi-rigid-sided products
such as Moses baskets. Because Moses baskets meet the definition of
``hand-held bassinet/cradle,'' and Moses baskets are not subject to any
other durable children's product standard (specifically ASTM F2194-13,
Standard Consumer Safety Specification for Bassinets and Cradles), the
Commission has determined that Moses baskets are within the scope of
the rule. The modification of the definition of ``hand-held infant
carrier'' to include semi rigid-sided products clarifies that Moses
baskets are covered by the rule.
IX. 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, the final rule provides that the standard will
become effective 6 months after publication in the Federal Register for
products manufactured or imported after that date.
X. Regulatory Flexibility Act
A. Introduction
The Regulatory Flexibility Act (RFA), 5 U.S.C. 601-612, requires
agencies to consider the impact of rules on small entities, including
small businesses. Section 604 of the RFA requires that agencies prepare
a final regulatory flexibility analysis when the agency promulgates a
final rule, unless the head of the agency certifies that the rule will
not have a significant economic impact on a substantial number of small
entities. The final regulatory flexibility analysis must describe the
impact of the rule on small entities and identify any alternatives that
may reduce the impact. Specifically, the final regulatory analysis must
contain:
A succinct statement of the objectives of, and legal basis
for, the rule;
a summary of the significant issues raised by public
comments in response to the initial regulatory flexibility analysis, a
summary of the assessment of the agency of such issues, and a statement
of any changes made in the proposed rule as a result of such comments;
a description of, and, where feasible, an estimate of, the
number of small entities to which the rule will apply;
a description of the projected reporting, recordkeeping,
and other compliance requirements of the rule, including an estimate of
the classes of small entities subject to the requirements and the type
of professional skills necessary for the preparation of reports or
records; and
a description of the steps the agency has taken to reduce
the significant economic impact on small entities, consistent with the
stated objectives of applicable statutes, including a statement of the
factual, policy, and legal reasons for selecting the alternative
adopted in the rule, and why each one of the other significant
alternatives to the rule considered by the agency, which affect the
impact on small entities, was rejected.
B. 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, which is often marketed by
bedding manufacturers and distributors. The Commission estimates that
currently, there are at least 47 suppliers of hand-held infant carriers
to the U.S. market. Fifteen are domestic manufacturers, 22 are domestic
importers, and 1 is a domestic firm with an unknown supply source. In
addition, eight foreign firms distribute products from outside of the
United States (four manufacturers, two importers, one retailer, and one
firm with an unknown supply source). One firm, about which the staff
has little information, sells hand-held infant carriers through an
online marketplace. An additional 24 domestic firms supply Moses basket
[[Page 73420]]
bedding, along with Moses baskets. Staff does not know the source of
the Moses baskets supplied by these 24 firms.
We expect that the products of 29 of the 47 hand-held infant
carrier suppliers will be compliant with ASTM F2050-13a (7 are JPMA
certified to F2050; 6 claim compliance with F2050; and 16 have ASTM-
compliant strollers with hand-held infant carrier attachments). We do
not believe that any of the Moses baskets currently on the market
comply with the voluntary standard; however, the requirements that
apply to Moses baskets involve slip resistance, adding warnings, and
instructional literature. Staff believes that the majority of Moses
baskets on the market would not require adjustments to meet the slip
resistance requirement, and that adding warnings and instructional
literature would not be costly.
The product ownership data available is limited to infant car
seats, which represented nearly the entire hand-held infant carrier
market prior to the publication of ASTM F2050-12, which expanded the
scope of the standard to include hand-held bassinets and cradles.
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 million births per year). (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 2010,'' National Vital Statistics
Reports Volume 61, Number 1 (August 28, 2012): Table I. Number of
births in 2010 is rounded from 3,999,386.) These 2 million infant car
seats represent the minimum number of units sold per year that might be
affected by the hand-held infant carrier standard. We do not know how
many Moses baskets and other bassinet/cradle-style carriers are sold
annually.
C. Reason for Agency Action and Legal Basis for 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, F2050-13a, upon which the rule is based.
The final rule modifies the definition of ``hand-held infant
carrier'' in ASTM F2050-13a to clarify that the standard includes
products with semi rigid sides, as well as products that are rigid-
sided. This modification resulted from the Commission receiving no
comments in response to the NPR's question whether Moses baskets should
be included within the scope of this rule and the Commission's
determination that Moses baskets (which typically have semi rigid as
opposed to rigid sides) should be covered by the rule.
D. Requirements of the Rule
The final rule adopts the voluntary ASTM standard for hand-held
infant carriers (ASTM F2050-13a), with a modification of the definition
of ``hand-held infant carrier,'' as discussed above. Some of the more
significant requirements of the current voluntary standard for hand-
held infant carriers are listed below:
Carry handle integrity--a series of endurance and
durability tests is intended to prevent rigid, adjustable handles from
breaking or unlocking 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).
Marking and labeling requirements--intended to provide
tracking information, as well as hazard warnings.
The voluntary standard also includes: (1) Torque and tension tests
to prevent components from being 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 F2050-13a includes no reporting or
recordkeeping requirements.
The final rule does not alter ASTM F2050-13a, except to clarify
that the definition of ``hand-held infant carrier'' includes products
with semi rigid sides, as well as products that are rigid-sided. We do
not expect this modification to the final rule to have a negative
economic impact on firms because it is a clarification of the intended
scope, rather than a change. In the 2012 version of the hand-held
carrier standard (F2050-12), ASTM changed the standard to include a
separate definition for ``bassinet-style carriers,'' which may have
been interpreted by some manufacturers to include Moses baskets. The
Commission proposed the same scope in the NPR but requested comments on
including Moses baskets. In the absence of comments, the Commission
determined that Moses baskets were intended to and should be included
in the scope and that the definition of a ``hand-held infant carrier''
should be modified to include ``semi rigid-sided,'' as well as ``rigid-
sided'' products, consistent with the scope's intent.
E. Other Federal or State Rules
Two federal rules would interact with the hand-held infant carrier
mandatory standard: (1) 16 CFR part 1107, Testing and Labeling
Pertaining to Product Certification (1107 rule or testing rule); and
(2) 16 CFR part 1112, Requirements Pertaining to Third Party Conformity
Assessment Bodies (1112 rule).
The 1107 rule implementing sections 14(a)(2) and 14(i)(2) of the
Consumer Product Safety Act (CPSA), as amended by the CPSIA, became
effective on February 13, 2013. Section 14(a)(2) of the CPSA requires
every manufacturer of a children's product that is subject to a 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
[[Page 73421]]
assessment body by a manufacturer or private labeler.
Because hand-held infant carriers will be subject to a mandatory
children's product safety rule, the product will also be subject to the
third party testing requirements of section 14(a)(2) of the CPSA and
the 1107 rule when the hand-held infant carrier mandatory standard and
the notice of requirements (NORs) become effective.
The 1112 rule, which became effective on June 10, 2013, established
requirements for the accreditation of third party conformity assessment
bodies 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
codified all of the NORs that the CPSC had published, to date. However,
any new NORs require an amendment to this rule. Therefore, this rule
amends 16 CFR part 1112 to establish the requirements for accepting the
accreditation of a conformity assessment body to test for compliance
with the hand-held infant carrier final rule.
F. Impact of the Rule on Small Business
There are at least 47 firms currently known to be marketing hand-
held infant carriers in the United States, as well as 24 firms
supplying Moses basket bedding and Moses baskets whose source is
unknown. Under U.S. Small Business Administration (SBA) guidelines, a
manufacturer of hand-held infant carriers is small if the firm has 500
or fewer employees, and importers and wholesalers are considered small,
if they have 100 or fewer employees. Based on these guidelines, about
50 of the firms known to be marketing hand-held infant carriers in the
United States are small firms--10 domestic manufacturers, 17 domestic
importers, 1 domestic firm with an unknown supply source, and 22 firms
supplying Moses basket/bedding suppliers. There may also be additional
small hand-held infant carrier suppliers operating in the U.S. market.
Small Manufacturers
Direct Costs From the Rule
The expected impact on small manufacturers of the standard will
differ based on whether the firm's hand-held infant carriers already
comply with F2050-12. Firms whose hand-held infant carriers meet the
requirements of F2050-12 are likely to continue to comply with the
voluntary standard as ASTM publishes new versions of the ASTM standard.
In addition, firms currently in compliance are likely to meet any new
standard within six months after approval because six months is the
established amount of time that JPMA allows for products in JPMA's
certification program to shift to a new standard. Compliance with the
voluntary standard in the six-month time frame is part of an
established business practice. Additionally, modifying warning labels
and updating instructional literature should not result in significant
expenditures for most firms. As a result, the direct impact of the rule
on manufacturers whose products are likely to meet the requirements of
ASTM F2050-13a (eight of ten small domestic manufacturers) is not
likely to be significant. One or more firms might have to modify their
carry handles to continue to pass the auto-locking test, but staff
believes that a complete product redesign should not be necessary.
Thus, for manufacturers whose products are likely to meet the
requirements of ASTM F2050-13a (eight of ten firms), staff estimates
little or no incremental impact on the costs of producing hand-held
infant carriers.
For either or both of the hand-held infant carrier suppliers staff
believes do not comply with the current version of the voluntary
standard, however, meeting ASTM F2050-13a's requirements could
necessitate product redesign. A redesign would be minor if most of the
changes involve adding straps and fasteners or using different mesh or
fabric; but 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 cost approximately $500,000.
Consequently, the final rule could potentially have a significant
direct impact on small manufacturers whose products currently do not
conform to the voluntary standard, depending on the scope of the
redesign that ultimately is necessary. Where the products need not be
completely redesigned, actual costs are likely to be lower than the
$500,000 level.
Even though the hand-held infant carriers sold by two firms are
neither certified as compliant, nor claim compliance with F2050-12, the
products may, in fact, comply with the current standard. Staff 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 standard will be less significant than described
above.
Indirect Costs From Testing and Certification
In addition to the direct impact of the standard described above,
the rule will have 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 NOR is in effect,
all manufacturers will be subject to the additional costs associated
with the third party testing and certification requirements. These
costs will include any physical and mechanical test requirements
specified in the final rule; lead and phthalates testing is already
required, and hence, related costs are not included here.
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 such testing 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 F2050-13a is
unlikely to be significant if only one hand-held infant carrier sample
per model is necessary to comply with the third party testing
requirements. However, if more than one sample would be needed to meet
the testing requirements, that third party testing costs potentially
could have a significant impact on one or more of the small
manufacturers.
Small Importers
As with manufacturers of compliant hand-held infant carriers, we do
not believe that the eight small importers of hand-held infant carriers
currently in compliance with F2050-12 will experience significant
direct impacts as a result of the final rule. In the absence of
regulation, these importing firms would likely continue to their
established practice of complying with the voluntary standard as the
standard evolves.
Importers of hand-held infant carriers would need to find an
alternate supply source if their existing supplier does not comply with
the requirements of the
[[Page 73422]]
rule, which may be the case with all four small importers of hand-held
infant carriers, whom we believe do not comply with F2050-12. Some of
these importers could react to the rule by discontinuing the import of
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 compliant hand-held infant carriers. Deciding to import an
alternative product would be a reasonable and realistic way to offset
any lost revenue. However, for some importers, switching suppliers
might not be an option.
As is the case with manufacturers, all importers will be subject to
third party testing and certification requirements, and consequently,
importers will incur 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 who must perform the testing themselves, if more than one
sample per model is required.
Moses Basket Suppliers
Staff also assessed the potential impact of the rule on firms that
supply Moses baskets. There are 22 known small firms supplying Moses
baskets to the U.S. market. Most of these firms also supply bedding;
some of them manufacture the bedding, and others act as importers.
Because a separate definition for ``hand-held bassinets'' was added to
the standard relatively recently in 2012, and some manufacturers may be
uncertain whether Moses baskets (a type of hand-held bassinet) are
covered by the standard because they are not rigid-sided, Moses baskets
currently on the market may not have been designed to comply with this
standard.
Many Moses baskets on the market, however, might be able to comply
with the standard with minimal modifications. For example, although
Moses baskets would not be subject to most of the hand-held carrier
standard's performance requirements, Moses baskets would likely have to
meet the slip-resistance requirement. Because typical Moses baskets are
fabricated from textured materials, we believe that these products
likely would not require modifications to meet the slip-resistance
requirement (that the product does not slip on surface 10 degrees from
horizontal while facing forward, sideways, and to the rear). Therefore,
the biggest changes might be to add warnings and instructional
literature, actions that the staff expects would not be costly.
Alternatively, Moses basket suppliers could remove themselves from
the scope of the final rule by eliminating the handles from their
products. Because most Moses baskets come with warnings against
carrying an infant in the basket, eliminating handles would conform to
those instructions.
All Moses basket manufacturers within the scope of the rule will be
subject to third party testing and certification requirements.
Importers of Moses baskets could experience testing costs if their
supplying firm does not perform third party testing. Because Moses
baskets would not be subject to most of the mechanical tests in the
standard, we expect that third party testing costs, at most, will be
half the amount of other types of hand-held infant carriers, or
approximately $250-$500 per model sample. Review of each firm's product
line reveals that most firms use only one model of Moses basket for
their bedding; although some firms have up to four variations of Moses
baskets. The resulting costs are unlikely to have a significant impact
on firms that must perform the testing themselves.
G. Alternatives
An alternative to the rule would be to set an effective date later
than six months, which is generally considered sufficient time for
suppliers to come into compliance with a rule. Setting a later
effective date would allow suppliers additional time to develop
compliant hand-held infant carriers and spread the associated costs
over a longer period of time.
XI. 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 rule
falls within the categorical exclusion.
XII. Paperwork Reduction Act
This rule contains information collection requirements that are
subject to public comment and review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C.
3501-3521). The preamble to the proposed rule (77 FR at 73363 through
73364) discussed the information collection burden of the proposed rule
and specifically requested comments on the accuracy of our estimates.
Briefly, sections 8 and 9 of ASTM F2050-13a 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).
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. OMB has assigned control number 3041-0158 to this information
collection. The Commission did not receive any comments regarding the
information collection burden of this proposal. However, the final rule
makes modifications regarding the information collection burden because
the number of estimated suppliers subject to the information collection
burden is now estimated to be 71 firms, rather than the 43 firms
initially estimated in the proposed rule.
Accordingly, the estimated burden of this collection of information
is modified as follows:
Table 1--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Frequency of Total annual Hours per Total burden
16 CFR Section respondents responses responses response hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
1221............................................................... 71 2 142 1 142
--------------------------------------------------------------------------------------------------------------------------------------------------------
Our estimates are based on the following:
Section 8.1 of ASTM F 2050-13a 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, be
[[Page 73423]]
marked clearly and legibly on each product and its retail package.
Section 8.2 of ASTM F 2050-13a requires a code mark or other means that
identifies the date (month and year, as a minimum) of manufacture.
There are 71 known entities supplying hand-held infant carriers to
the U.S. market. All 71 firms are assumed to use labels already on both
their products and their packaging, but they might need to modify
existing labels. The estimated time required to make these
modifications is about 1 hour per model. Each entity supplies an
average of two different models of hand-held infant carriers;
therefore, the estimated burden associated with labels is 1 hour per
model x 71 entities x 2 models per entity = 142 hours. We estimate the
hourly compensation for the time required to create and update labels
is $27.44 (U.S. Bureau of Labor Statistics, ``Employer Costs for
Employee Compensation,'' March 2013, Table 9, total compensation for
all sales and office workers in goods-producing private industries:
https://www.bls.gov/ncs/). Therefore, the estimated annual cost to
industry associated with the labeling requirements is $3,896.48 ($27.54
per hour x 142 hours = $3,896.48). There are no operating, maintenance,
or capital costs associated with the collection of information.
Section 9.1 of ASTM F2050-12 requires the supply of instructions
with the product. Hand-held infant carriers often require installation
or assembly, and products sold without such information would not be as
attractive to consumers as 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 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.
XIII. 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 the rule becomes effective.
XIV. Certification and Notice of Requirements (NOR)
Section 14(a)(2) of the CPSA requires 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.
The Commission published a final rule, Requirements Pertaining to
Third Party Conformity Assessment Bodies, 78 FR 15836 (March 12, 2013),
which is codified at 16 CFR part 1112 (referred to here as part 1112).
This rule became effective on June 10, 2013. Part 1112 establishes
requirements for accreditation of third party conformity assessment
bodies (or laboratories) to test for conformance with a children's
product safety rule in accordance with Section14(a)(2) of the CPSA.
Part 1112 also codifies a list of all of the NORs that the CPSC had
published at the time part 1112 was issued. All NORs issued after the
Commission published part 1112, such as the hand-held infant carrier
standard, require the Commission to amend part 1112. Accordingly, this
rule amends part 1112 to include the hand-held infant carrier standard
in the list 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 are required to meet the third party conformity
assessment body accreditation requirements in 16 CFR part 1112. When a
laboratory meets the requirements as a CPSC-accepted third party
conformity assessment body, the laboratory can apply to the CPSC to
have 16 CFR part 1225, Safety Standard for Hand-Held Infant Carriers
included in the scope of accreditation of CPSC safety rules listed for
the laboratory on the CPSC Web site at: www.cpsc.gov/labsearch.
In connection with the part 1112 rulemaking, CPSC staff conducted
an analysis of the potential impacts on small entities of the rule
establishing accreditation requirements, 78 FR 15836, 15855-58 (March
12, 2013), as required by the Regulatory Flexibility Act and prepared a
Final Regulatory Flexibility Analysis (FRFA). Briefly, the FRFA
concluded that the requirements 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 not
likely pursue accreditation for this purpose. Similarly, amending the
part 1112 rule to include the NOR for the hand-held infant carrier
standard would not have a significant adverse impact on small
laboratories. Most of these laboratories will have already been
accredited to test for conformance to other juvenile product standards,
and the only costs to them would be the cost of adding the hand-held
infant carrier standard to their scope of accreditation. As a
consequence, the Commission certifies
[[Page 73424]]
that the NOR for the hand-held infant carrier standard will not have a
significant impact on a substantial number of small entities.
To ease the transition to new third party testing requirements for
hand-held infant carriers subject to the standard and to avoid a
``bottlenecking'' of products at laboratories at or near the effective
date of required third party testing for hand-held infant carriers, the
Commission, under certain circumstances, will accept certifications
based on testing that occurred before the effective date for third
party testing.
The Commission will accept retrospective testing for 16 CFR part
1225, safety standard for hand-held infant carriers, if the following
conditions are met:
The children's product was tested by a third party
conformity assessment body accredited to ISO/IEC 17025:2005(E) by a
signatory to the ILAC-MRA at the time of the test. The scope of the
third party conformity body accreditation must include testing in
accordance with 16 CFR part 1225. For firewalled third party conformity
assessment bodies, the firewalled third party conformity assessment
body must be one that the Commission, by order, has accredited on or
before the time that the children's product was tested, even if the
order did not include the tests contained in the safety standard for
hand-held infant carriers at the time of initial Commission acceptance.
For governmental third party conformity assessment bodies,
accreditation of the body must be accepted by the Commission, even if
the scope of accreditation did not include the tests contained in the
safety standard for hand-held infant carriers at the time of initial
CPSC acceptance.
The test results show compliance with 16 CFR part 1225.
The hand-held infant carrier was tested on or after the
date of publication in the Federal Register of the final rule for 16
CFR part 1225 and before June 6, 2014.
The laboratory's accreditation remains in effect through
June 6, 2014.
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 amends Title 16 of the Code of Federal
Regulations by amending part 1112 and adding a new part 1225 to read 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: Pub. L. 110-314, section 3, 122 Stat. 3016, 3017
(2008); 15 U.S.C. 2063.
0
2. Amend Sec. 1112.15 by adding paragraph (b)(34) 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)
(34) 16 CFR part 1225, Safety Standard for Hand-Held Infant
Carriers.
* * * * *
0
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: 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 2050-13a, Standard Consumer Safety Specification for Hand-Held Infant
Carriers, approved on September 1, 2013. The Director of the Federal
Register approves this incorporation by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy from ASTM
International, 100 Bar Harbor Drive, P.O. Box 0700, West Conshohocken,
PA 19428; https://www.astm.org. You may inspect a copy at the Office of
the Secretary, U.S. Consumer Product Safety Commission, Room 820, 4330
East West Highway, Bethesda, MD 20814, telephone 301-504-7923, or at
the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: https://www.archives.gov/federal_register/code_of_federal regulations/ibr_locations.html.
(b) Instead of complying with section 3.1.3 of ASTM F2050-13a,
comply with the following:
(1) 3.1.3 hand-held infant carrier, n--a freestanding, rigid- or
semirigid-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.
(2) [Reserved]
Dated: December 2, 2013.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2013-29061 Filed 12-5-13; 8:45 am]
BILLING CODE 6355-01-P