Safety Standard for Infant Bouncer Seats, 43470-43482 [2017-19255]
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[Docket No. CPSC–2015–0028]
Safety Standard for Infant Bouncer
Seats
Consumer Product Safety
Commission.
ACTION: Final rule.
AGENCY:
The Danny Keysar Child
Product Safety Notification Act, section
104 of the Consumer Product Safety
Improvement Act of 2008 (CPSIA),
requires the United States Consumer
Product Safety Commission
(Commission or CPSC) to promulgate
consumer product safety standards for
durable infant or toddler products.
These standards are to be ‘‘substantially
the same as’’ applicable voluntary
standards or more stringent than the
voluntary standard, if the Commission
determines that more stringent
requirements would further reduce the
risk of injury associated with the
product. The Commission is issuing this
final rule establishing a safety standard
for infant bouncer seats (bouncer seats)
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SUMMARY:
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in response to the direction of section
104(b) of the CPSIA. Additionally, the
Commission is finalizing an amendment
to its regulations regarding third party
conformity assessment bodies to include
safety standard for bouncer seats in the
list of notice of requirements (NORs)
issued by the Commission.
DATES: This rule will become effective
March 19, 2018. The incorporation by
reference of the publication listed in
this rule is approved by the Director of
the Federal Register as of March 19,
2018.
FOR FURTHER INFORMATION CONTACT:
Keysha Walker, Compliance Officer,
U.S. Consumer Product Safety
Commission, 4330 East West Highway,
Bethesda, MD 20814; telephone: 301–
504–6820; email: kwalker@cpsc.gov.
SUPPLEMENTARY INFORMATION:
I. Background and Statutory Authority
The CPSIA 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. Standards issued under
section 104 are to be ‘‘substantially the
same as’’ the applicable voluntary
standards or more stringent than the
voluntary standard, if the Commission
determines 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,’’ and
the statute specifies twelve categories of
products that are included in the
definition, including walkers, carriers
and various types of children’s chairs.
When issuing a regulation governing
product registration under section 104,
the Commission determined that an
‘‘infant bouncer’’ falls within the
definition of a ‘‘durable infant or toddler
product.’’ 74 FR 68668 (Dec. 29, 2009);
16 CFR 1130.2(a)(15).
On October 19, 2015, the Commission
issued a notice of proposed rulemaking
(NPR) for infant bouncer seats. 80 FR
63168. The NPR proposed to
incorporate by reference the 2015
version of the voluntary standard,
ASTM F2167 Standard Consumer
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Safety Specification for Infant Bouncer
Seats (ASTM F2167), as a mandatory
consumer product safety rule with
several modifications to the content,
format, and placement of warning labels
and instructions, to strengthen the
standard.
In this document, the Commission is
issuing a mandatory consumer product
safety standard for bouncer seats. As
required by section 104(b)(1)(A), the
Commission consulted with
manufacturers, retailers, trade
organizations, laboratories, consumer
advocacy groups, consultants, and the
public to develop this rule, largely
through the ASTM process. Based on
revisions to the voluntary standard
since the NPR published, the final rule
incorporates by reference the most
recent voluntary standard for infant
bouncer seats, developed by ASTM
International, ASTM F2167–17, with
two modifications related to warning
label content and placement. These
modifications strengthen the standard
by requiring a more stringent warning to
caregivers to use the restraints, even if
an infant falls asleep in the bouncer,
and requires the fall hazard warning to
be placed on the upper seat back of the
bouncer seat, to ensure that caregivers
read and heed the warning. The
Commission’s more stringent
requirements are intended to further
reduce the risk of injury to infants that
fall from, and with, bouncer seats,
especially bouncer seats that are placed
on an elevated surface.
Additionally, the final rule amends
the list of NORs issued by the
Commission in 16 CFR part 1112 to
include the standard for infant bouncer
seats. Under section 14 of the CPSA, the
Commission promulgated 16 CFR part
1112 to establish requirements for
accreditation of third party conformity
assessment bodies (or testing
laboratories) to test for conformity with
a children’s product safety rule.
Amending part 1112 adds an NOR for
the infant bouncer seat standard to the
list of children’s product safety rules.
II. Product Description
A. Definition of ‘‘Bouncer Seats’’
Section 1.2 of ASTM F2167–17
defines an ‘‘infant bouncer seat’’ as: ‘‘a
freestanding product intended to
support an occupant in a reclined
position to facilitate bouncing by the
occupant, with the aid of a caregiver or
by other means.’’ Additionally, section
1.2 states that infant bouncer seats are
intended for ‘‘infants who have not
developed the ability to sit up
unassisted (approximately 0 to 6 months
of age).’’
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Bouncer seats vary widely in style
and complexity, but typically, bouncer
seats consist of a cloth cover stretched
over a wire or tubular frame. Wire frame
bouncers have two designs. The forward
bend design is constructed with the
seating area supported from the front
side of the product. The second wire
frame design is a rear bend design. In
the rear bend design, the seat is
supported from the rear side of the
product. Other bouncer designs are also
currently available, including, but not
limited to, products with individual
wire legs, solid bases, and spring
designs. These infant bouncer designs
use different methods to support the
seat and are intended for ‘‘bouncing,’’ as
defined in ASTM F2167.
All bouncer seats support the child in
an inclined position, and some brands
have adjustable seat backs. Various
bouncer seat models include a
‘‘soothing unit’’ that vibrates or bounces
the chair, and may play music or other
sounds. Most bouncer seats also feature
an accessory bar with attached toys that
are, or at some point will be, within the
child’s reach. Most of the bouncer seat
models examined by Commission staff
provide a 3-point restraint system,
consisting of wide cloth crotch
restraints and short adjustable waist
straps with plastic buckles. Only two
models of bouncer seats reviewed by
CPSC for the NPR employed upper body
restraints. Many bouncer seat brands
also include an ‘‘infant insert,’’ intended
for use to support smaller babies. Tabs
C and D, Staff Briefing Package: Infant
Bouncer Seats Notice of Proposed
Rulemaking, dated September 30, 2015
(Staff NPR Briefing Package), available
at: https://www.cpsc.gov/Global/
Newsroom/FOIA/CommissionBriefing
Packages/2015/ProposedRuleSafety
StandardforInfantBouncerSeat
September302.pdf.
B. Market Description
For the final rule, staff identified 23
firms supplying infant bouncer seats to
the U.S. market, with several firms
moving into or out of the market since
the NPR was published. The 23
identified firms primarily specialize in
the manufacture and/or distribution of
children’s products, including durable
nursery products. Eight of the 23 known
firms are domestic manufacturers and 8
are domestic importers. The remaining
seven firms are foreign (four
manufacturers, two importers, and one
retailer).1 Tab C, Staff Briefing Package:
Final Rule for Infant Bouncer Seats,
1 Staff
categorized each firm using information
from Dun & Bradstreet and ReferenceUSAGov, as
well as firm Web sites.
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dated August 23, 2017 (Staff Final Rule
Briefing Package), available at: https://
www.cpsc.gov/s3fs-public/Final-RuleSafety-Standard-for-Infant-BouncerSeats-August-23–2017.pdf?
ctmyMqMkYWQ1t3QN9
DUXCDKnJQ5rKCX6.
Staff expects that the infant bouncer
seats of 14 of these firms already comply
with ASTM F2167 because the firms
either: (1) Have their bouncers certified
by the Juvenile Products Manufacturers
Association (JPMA) (five firms); (2)
claim compliance with the voluntary
standard (eight firms); or (3) have been
tested to the ASTM standard by CPSC
staff (one firm).2
III. Incident Data
For the NPR, CPSC’s Directorate for
Epidemiology, Division of Hazard
Analysis, described 277 reported
incidents involving bouncer seats,
including 11 fatalities and 51 injuries,
occurring between January 1, 2006 and
February 2, 2015. The incidents
described in the NPR were based on
reports involving victims 12 months old
and younger in the Injury or Potential
Injury Incident (IPII), In-Depth
Investigation (INDP), and Death
Certificates (DTHS) databases
(collectively referred to as Consumer
Product Safety Risk Management
System data, or CPSRMS data). A
detailed discussion of the incidents and
hazard patterns developed for the NPR
can be found in Tab A of the Staff NPR
Briefing Package.
A. CPSRMS Data
For the final rule, CPSC staff reviewed
bouncer seat incident reports in
CPSRMS from February 2, 2015 through
July 6, 2016. CPSC staff found 70
incident reports in addition to those
discussed in the NPR, including one
fatality and three injuries. The fatality
involved a 4-month-old female who
died after suffering a fractured skull
injury when the infant bouncer she was
seated in fell from a table. Two of the
reported injuries were head contusions.
A 5-month-old male sustained a head
contusion when a bouncer seat bent
backward to the floor. A 6-month-old
male sustained a head contusion when
a bouncer cover came off of the wire
frame and the infant flipped forward,
striking his head on the battery
compartment. In another reported
incident, the victim suffered minor leg
2 JPMA typically allows six months for products
in their certification program to shift to a new
standard once it is published. Therefore, firms are
likely already complying with ASTM F2167–16,
which was published in May 2016. Firms are not
expected to comply with the recently published
ASTM F2167–17 until December 2017.
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burns from a hot metal bar under a
bouncer cover. Tab A, Staff Final Rule
Briefing Package.
Staff did not identify any hazards in
the updated incident data that were not
included in the hazard patterns
described in the NPR (product design,
structural integrity, toy bar-related,
stability, chemical/electric hazards,
restraints, hazardous environment),
which specifically identified product
design and structural integrity as the top
two product-related hazards (in terms of
frequency of occurrence). Staff found
that product design and structural
integrity continue to be the top two
product-related hazards (in terms of
frequency) for the updated CPSRMS
data. Of the 70 new incident reports
involving bouncer seats, 51 incident
reports described issues with product
design, and 13 incident reports
described issues with structural
integrity. Staff determined that almost
all of the issues with product design
were related to lopsided or low-riding
bouncer frames. Data for the final rule
can be found in Tab A of the Staff Final
Rule Briefing Package.
B. NEISS Data
For the NPR, CPSC staff found 672
bouncer-related incidents, including
two fatalities, reported in the National
Electronic Injury Surveillance System
(NEISS) records retrieved for bouncer
incidents from January 1, 2006 to
December 31, 2013, involving children
12 months old and younger. Staff found
that 385 cases, or an estimated 9,200
injuries, occurred in hazardous
environments (counters, tables, and
other elevated surfaces).
Staff updated information on bouncerrelated incidents from the NEISS
records for the final rule. From January
1, 2014 through December 31, 2015,
staff found 202 additional NEISS
records describing infant bouncer
incidents. Staff’s inspection of the
updated NEISS data revealed that 100
cases, or an estimated 2,800 injuries,
took place in hazardous environments.
The remaining 102 cases, or an
estimated 2,800 injuries, took place on
the floor or an unknown location. Staff
found no additional fatalities in the
NEISS data during this time frame. Staff
estimates that 4,700 (85%) bouncer
injuries involved the head and face.
ESTIMATED NEISS BOUNCER
INJURIES, 2006–2015
[age 0–1]
Year
2006 ..................
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Estimated
injuries
Cases
67
1,400
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ESTIMATED NEISS BOUNCER
INJURIES, 2006–2015—Continued
[age 0–1]
Year
2007
2008
2009
2010
2011
2012
2013
2014
2015
Cases
..................
..................
..................
..................
..................
..................
..................
..................
..................
2006–2015
Estimated
injuries
66
74
86
94
121
90
74
98
104
1,700
1,600
2,200
2,300
3,400
2,500
2,100
2,900
2,700
877
22,800
Based on the annual estimates provided
in the table, staff found a statistically
significant upward trend (p-value of
0.006) in the estimated emergency
department-treated injuries involving
bouncers for victims under 1-year-old
from 2006 to 2015.
IV. Product Recalls
The NPR described two recalls of
infant bouncer seats since January 2006,
involving two different firms, one recall
in April 2007 3 (involving breakage of a
tubular steel frame) and another recall
in July 2009 4 (involving small, sharp
metal objects that could protrude
through the bouncer fabric). No injuries
were associated with either product at
the time of the recall. See Tab E, Staff
NPR Briefing Package. For the final rule,
staff reports that no additional recalls
involving bouncer seats have occurred.
V. Overview and Assessment of ASTM
F2167
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A. Overview
The voluntary standard for infant
bouncer seats, ASTM F2167, Standard
Consumer Safety Specification for
Infant Bouncer Seats, is intended to
minimize the risk of injury or death to
infants in bouncer seats associated with
falls from elevated surfaces, product
disassembly or collapse, stability, and
suffocation. ASTM F2167 was first
approved in December 2001, and the
standard published in January 2002.
Since then, ASTM has revised the
standard 11 times. Tab C of the Staff
NPR Briefing Package includes a
description of these revisions through
2015.5
3 CPSC link to recalled product: https://
www.cpsc.gov/en/Recalls/2007/Infant-BouncerSeats-Recalled-Due-to-Frame-Failure/.
4 CPSC link to recalled product: https://
www.cpsc.gov/en/Recalls/2009/BabySwede-LLCRecalls-Bouncer-Chairs-Due-to-Laceration-Hazard/.
5 Prior to the NPR publishing in October 2015,
ASTM F2167 was revised several times as part of
the rulemaking consultation process. In February
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More recently, in May 2016, ASTM
revised the standard to add specific
developmental guidance for caregivers
about when to stop using the bouncer,
and ASTM removed a general
requirement for banned toys or other
articles because those requirements do
not apply to infant bouncer seats. As
discussed below, the standard was
subsequently revised in June of 2017 to
incorporate changes recommended by
ASTM’s Ad Hoc Task Group 6
concerning warning label formatting
requirements, and to add a requirement
that limits the maximum weight of an
occupant in an infant bouncer seat. The
June 2017 version of the voluntary
standard also removed a requirement for
manufacturers of bouncer seats to
change the model number whenever the
product underwent a significant
structural or design modification. We
agree with ASTM that although
changing the model number represents
a best practice, most ASTM standards
do not include the statement, and such
practice does not impact the safety of
the product.
B. Assessment of the Voluntary
Standard
For the NPR, CPSC staff examined the
relationship between the performance
requirements in ASTM F2167–15 and
each of the hazard patterns staff
identified in the incident data for
bouncer seats. Tab C, Staff NPR Briefing
Package. Based on staff’s assessment,
the Commission issued the NPR
proposing to incorporate ASTM F2167–
15 with the following modifications to
warnings content, placement, and
format:
• Revised content of the warnings,
markings, and instructions:
—Modify text in the warnings stating to
use the restraints ‘‘even if baby is
sleeping’’;
2014 (ASTM F2167–14) the standard was revised to
improve the sideward and rearward stability tests.
Additionally in 2014, ASTM F2167–14a included
changes to the stability test to make the ASTM
standard more strict, to address tip-over incidents,
and to add requirements and test procedures to
address incidents involving battery leakage,
corrosion, and overheating.
6 The Ad Hoc Task Group was formed by ASTM
and consists of members of the various voluntary
standards groups whose standards are affected by
the durable nursery product rules. The purpose of
the Ad Hoc Task Group is to harmonize the
wording and warning label format of durable infant
and toddler products. Ad Hoc Task Group
recommendations for warning statements were
originally published as a reference document titled,
‘‘Ad Hoc Wording—May 4, 2016,’’ as part of the F15
Committee Documents, and subsequently, the
recommendations were revised and published in
October 2016, with the title, ‘‘Ad Hoc Approved
Wording, Revision A—October 17, 2016’’ (Ad Hoc
Approved Wording).
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—change the text in the warnings to
read, ‘‘stop using when baby starts
trying to sit up’’; and
—change the developmental guidance
in the instructions, if stated, to read:
‘‘from birth (or ‘‘0’’) until baby starts
trying to sit up.’’
• Restricted the fall hazard label on
the front surface of the bouncer to be
adjacent to the area where the child’s
head would rest, and modified the
visibility test to reflect this requirement.
• Specified a standard format
(including black text on a white
background, table design, bullet points,
and black border) for the warnings on
the product and in the instructions.
The most recent version of the
voluntary standard for bouncer seats,
ASTM F2167–17, was approved on June
1, 2017, and published in June 2017.
ASTM F2167–17 includes modified and
new performance and labeling
requirements developed by ASTM in
conjunction with stakeholders and
CPSC staff on the ASTM subcommittee
task group, to address the hazards
associated with bouncer seats. ASTM
F2167–17 addresses several of the
hazards identified by the Commission in
the NPR. Accordingly, after reviewing
and considering comments received in
response to the NPR, as well as the work
of the Ad Hoc Task Group, the
Commission incorporates by reference
ASTM F2167–17, with two
modifications that were identified in the
NPR related to warning content and
warning placement, as the mandatory
safety standard for infant bouncer seats.
Below we assess ASTM F2167–17 and
explain how it differs from what the
Commission proposed.
1. Content of the Warnings, Markings,
and Instructions
The NPR proposed to incorporate by
reference ASTM F2167–15, with
modifications to warning, marking, and
instruction requirements. ASTM F2167–
15 advised caregivers: ‘‘Always use
restraints. Adjust to fit snugly.’’ Based
on the incident data that relate deaths
to suffocation among unrestrained
infants while they slept, and relate
serious head injuries to unrestrained
infants due to falls from bouncer seats
that are placed on elevated surfaces and
falls from bouncer seats that are being
carried by caregivers, the Commission
stated in the NPR that the voluntary
standard was inadequate to address the
risk of injury to infants from falls out of
bouncer seats, or the risk of suffocation
among unrestrained infants who are
sleeping. In the NPR, the Commission
proposed warning language stating:
‘‘Adjust to fit snugly, even if baby is
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sleeping.’’ Tab D, Staff NPR Briefing
Package.
The newest version of the voluntary
standard, ASTM F2167–17, still does
not require a warning statement that
caregivers should use the restraints,
even if an infant is asleep. We disagree
with this approach. We note that some
NPR commenters were concerned by the
addition of language to the product
warnings regarding sleep because such
language may suggest that bouncer seats
are intended to be used for long-term,
unattended, sleep. However, CPSC staff
advises that young infants, such as those
who are intended to use bouncer seats,
spend more time asleep than awake.7
Infants spending more than brief
periods in a bouncer seat will fall asleep
on occasion (and caregivers will place
infants to sleep in bouncer seats under
some circumstances), just as infants will
fall asleep in strollers, swings, and carseat carriers. It may be counterintuitive,
and therefore unlikely to occur to
consumers, that products made for
infants’ use, especially those that have
features intended to sooth and comfort
infants, would be unsafe places for
infants to sleep. In fact, despite claims
that bouncer seats are not intended for
children to sleep in, CPSC staff found
that some manufacturers’ marketing
suggests that bouncers are intended for
sleep as well as play. Moreover,
incident data and Health Sciences’
assessment demonstrate that the
severity of injury from a fall from a
bouncer seat increases for a child who
is unrestrained. Accordingly, in the
final rule, the Commission requires that
the fall hazard warning state that
caregivers should use the restraints,
even if baby falls asleep.
Based on staff’s recommendation and
the work of the Ad Hoc Task Group, the
final rule uses the phrase ‘‘falls asleep’’
instead of the phrase ‘‘is sleeping’’ that
the Commission had proposed in the
NPR. This change aligns with wording
approved by the Ad Hoc Task Group,
which is ‘‘Never leave child unattended,
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7 For example, see the American Academy of
Pediatrics Web site, https://
www.healthychildren.org/English/ages-stages/baby/
sleep/Pages/default.aspx.
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even if child falls asleep.’’ The Ad Hoc
Task Group intends for this warning to
be used on products for infants who are
likely to fall asleep in the product, but
which are not intended for periods of
unattended sleep (i.e. bouncers, swings,
infant rockers, and handheld carriers).8
The Commission notes that the final
rule does not preclude manufacturers
from including an additional statement
indicating that bouncers are not
intended for long term sleep.
Accordingly, the required fall and
suffocation warning label text regarding
use of restraints for the final rule is:
• Always use restraints and adjust to
fit snugly, even if baby falls asleep.
ASTM F2167–17 includes the other
modifications the Commission had
proposed for warning statement
requirements. Specifically, sections
8.5.2.1 and 9.2.1 Fig. 11 of ASTM
F2167–17 requires text in the warnings
to state: ‘‘stop using when baby starts
trying to sit up.’’ ASTM F2167–17
requires additional text in the
suffocation hazard warning label to
limit the maximum weight for an
occupant in an infant bouncer seat. The
rationale for ASTM’s change is based on
surveillance of the marketplace, which
demonstrated that some manufacturers
have weight limits that do not correlate
to the developmental milestones
contemplated in the current warnings.
Section 8.5.2.1 of ASTM F2167–17
requires text in the warnings to instruct
caregivers to: ‘‘STOP using bouncer
when baby starts trying to sit up or has
reached [insert manufacturer’s
recommended maximum weight, not to
exceed 20 lb], whichever comes first.’’
2. Warning Label Placement and
Visibility Test
The NPR proposed a modification to
ASTM F2167–15’s requirement for label
8 During the April 2017 ASTM meetings, several
Ad Hoc Task Group members requested the removal
of this sentence from the Ad Hoc recommendations
because no subcommittee had adopted the
sentence. In the discussions, some manufacturers
stated that these products are not appropriate for
sleep, stating that the language ‘‘even if baby falls
asleep,’’ may mislead caregivers. The Ad Hoc Group
balloted the removal of the sentence in June 2017;
however, the ballot received multiple negative votes
and did not pass.
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placement. ASTM F2167–15 required
that the fall hazard label be placed on
the front surface of the bouncer seat
back so that it is visible when a
newborn CAMI dummy is placed in the
bouncer seat. In the NPR, the
Commission assessed this provision of
the voluntary standard and found that it
did not adequately address the risk of
injury to infants falling from bouncer
seats placed on elevated surfaces, a
foreseeable misuse of infant bouncer
seats. Tab D, Staff NPR Briefing Package.
To strengthen the standard and further
reduce the risk of injury, the NPR
proposed that the fall hazard warning
label be on the front surface of the
bouncer seat, adjacent to where the
child’s head would rest, and the NPR
also modified the visibility test. ASTM
F2167–17 retains the fall hazard
warning placement and corresponding
visibility test from ASTM F2167–15.
Thus, the current voluntary standard
still does not address the Commission’s
concern about the visibility of the fall
hazard warning.
NPR Commenters expressed concern
that some products were designed with
insufficient space in the area adjacent to
the child’s head to accommodate the
necessary warning labels. Commenters
were also concerned about the
repeatability of the visibility test
proposed in the NPR. We note, however,
that staff’s research on the seat back
space, including models with narrow
seat backs, did not corroborate the
commenters’ concerns. Nevertheless, to
enhance test repeatability and to
address the comments regarding
insufficient seat back space for warning
labels, the final rule allows a larger area
for warning label placement than
proposed in the NPR and clarifies the
corresponding visibility test.
The visibility test in the final rule is
based on ASTM F2167–17. Using the
CAMI dummy, as shown in Figure 1
below, the allowable area for warning
label placement starts from a dotted line
that crosses the junctions of underarm
and both sides of the torso of the CAMI
dummy.
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This observable line expands the seat
back space allowed for warning labels
and clarifies the precision of the
visibility test, both of which address
commenter concerns.
3. Warning Label Format
The NPR proposed modifications to
the requirements in ASTM F2167–15
regarding the format of warning labels
noting that ASTM F2167–15 did not
provide for a consistent warning label
format across infant bouncer seats. Staff
evaluated the warnings format in the
voluntary standard and recommended
that the Commission establish minimum
requirements for presenting the hazard
information that are consistent with best
practices to attract and maintain
attention, as well as aid reading and
comprehension. Tab D, Staff NPR
Briefing Package. Accordingly, the NPR
proposed to specify a standard format
(including black text on a white
background, table design, bullet points,
and black border) for the warnings on
bouncer seats and in the instructions.
Since the NPR published in 2015,
ASTM’s Ad Hoc Task Group issued
recommendations regarding warnings
intended to apply across juvenile
products. These recommendations,
based on ANSI Z535.4, American
National Standard for Product Safety
Signs and Labels, have been
incorporated into ASTM F2167–17. The
Commission notes that Human Factors
staff regularly cites ANSI Z535.4 as a
baseline in developing warning
materials, including those proposed in
the bouncer seat NPR. The approved Ad
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Hoc Task Group recommendations are
very similar to the ANSI Z535.4, with
modifications to make the
recommendations more stringent. The
recommendations provide noticeable
and consistent warning labels on infant
bouncer seats and across juvenile
products. Accordingly, for the final rule,
the Commission incorporates by
reference ASTM F2167–17, without any
modifications to the formatting
provisions.
VI. Response to Comments
CPSC received six comments in
response to the NPR, including a joint
letter submitted by four consumer
advocacy groups. Three commenters
supported the changes proposed in the
NPR, and the remaining commenters
expressed concern over the
Commission’s proposed modifications.
We summarize and respond to the
commenters below.
A. Warning Label Location
Comment 1: One commenter stated
that the proposed requirement for the
fall hazard warning label to be adjacent
to an infant’s head would necessitate a
wider seat back to accommodate a
warning label in multiple languages,
which is desirable for international
sales. According to the same
commenter, the ASTM F15.21
Subcommittee had already evaluated
this location and concluded that other
locations above and below the infant’s
head were considered to be just as
visible as the locations adjacent to an
infant’s head. A second commenter
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stated that the proposed fall hazard
label visibility test procedure is not
specific and can be misinterpreted by
test labs. This commenter suggested
using the test protocol in the current
ASTM standard that uses the CAMI
newborn dummy.
Response 1: Based on the incident
data and research, the final rule requires
that the fall hazard warning label be
placed near the child’s face. This
location allows caregivers to notice the
label while making eye contact with the
infant, and potentially creates mental
images of the consequence (‘‘skull
fracture’’) of not complying with the
instructions because the warning label
would be placed next to the body part
at risk. Tab D, Staff NPR Briefing
Package.
Commenters claim that the area on
the infant bouncer adjacent to an
infant’s head could be severely limited
in some cases due to the design of the
seat back and allowance needed for
stitching tolerances. CPSC staff’s
research did not corroborate this claim.
Tab D, Staff NPR Briefing Package.
Accordingly, the NPR, 80 FR at 63179–
80, invited commenters to provide
information on costs and design changes
that would be required if the label were
required to be next to an infant’s head.
Staff reports that during the ASTM Ad
Hoc Task Group meetings held in
January and February 2016,
manufacturers provided several
examples of juvenile products,
including infant bouncer seats, to
demonstrate difficulties associated with
warning label placement in proposed
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locations. However, NPR commenters
provided neither cost estimates, nor
specific comments, other than stating
that the location would require a wider
seat back and would limit representing
multiple languages.
To resolve concerns about the amount
of space for warning label placement
and address the Commission’s concern
about an effective warning label, the
final rule states the test procedure
language in ASTM F2167–17, but
clarifies the allowable area for the fall
hazard warning label. The fall hazard
warning label must be visible when
placed above an imaginary horizontal
line that crosses through the junctions
of underarm and side of the torso
(armpits) on both left and right of the
CAMI, and not obscured by any part of
the dummy. A warning label located at
or around the infant’s shoulders can
address the visibility and caregiver
motivational concerns expressed in the
Human Factors staff memorandum for
the NPR (Tab D), and also provide
additional surface area to accommodate
the recommended warning label.
B. Warning Label Format
Comment 2: Two commenters
recommended against the proposed
formatting requirements. Commenters
specifically highlighted the following
proposed warning formatting
requirements:
• A heavy black border around the
label,
• Delineating message panels with
solid lines,
• Black text on white message panel,
• Bullet points preceding
precautionary statements,
• Choosing a background color for the
signal word panel based on a best
contrast against the product material,
and
• Using non-condensed style font.
Commenters stated that, in general,
ASTM standards provide flexibility to
manufacturers to pick colors and
formatting features that are most
appropriate for the product. One
commenter recommended delaying the
publication of the final rule for any and
all warnings requirements until the
warnings format and content revisions
proposed in the NPR can be reviewed by
ASTM Ad Hoc Task Group, balloted
through the ASTM process, and then
implemented into F2167. The same
commenter also indicated that the
formatting requirements in the bouncer
NPR and several other NPRs are
inconsistent with each other.
Response 2: Human Factors staff at
CPSC employs the ANSI Z535.4,
American National Standard for
Product Safety Signs and Labels as a
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baseline to develop warning materials.
Since the NPR was published, the
ASTM Ad Hoc Task Group met and
made recommendations for warning
label formatting across juvenile
products. The ASTM Ad Hoc Task
Group’s recommendations are based on
ANSI Z535.4 and are more stringent
than the ANSI Z535 series. ASTM 2167–
17 now incorporates recommendations
made by the Ad Hoc Task Group.
Accordingly, the final rule incorporates
by reference ASTM 2167–17 without
any modifications to warning label
format.
C. Warning Label Content
Comment 3: Two commenters
recommended against the proposed
addition of ‘‘even if baby is sleeping’’ to
the end of the precautionary statement:
‘‘Always use restraints. Adjust to fit
snugly.’’ One commenter believes that
this statement implies that sleeping in a
bouncer is acceptable and may
encourage caregivers to use the product
for extended periods of sleep. The
second commenter believes that this
statement contradicts the warning to
never leave children unattended.
Response 3: Incident data associated
with bouncer seats demonstrate that
unrestrained infants suffer serious head
injuries from falls and get into
compromised positions that may result
in suffocation. Tab A, Staff NPR Briefing
Package; Tab A, Staff Final Rule Briefing
Package. Young infants will sleep in
bouncers as they spend more time
asleep than awake. Tab D, Staff NPR
Briefing Package. Some bouncers in the
market include references to calming
and soothing features of a bouncer, as
well as appropriateness for short
periods of sleep in a bouncer, such as
‘‘Your child can also sleep for short
periods of time in the bouncer if he or
she is content doing so.’’ Based on
incident data, the final rule requires that
the warning statement reference sleep to
reflect this foreseeable product use
scenario and to address the risk of
injury from falls.
In October 2016, the ASTM Ad Hoc
Task Group approved a recommended
warning to address products likely to be
used for short-term sleep.9 The
Commission agrees with the Ad Hoc
Task Group’s language and has modified
the warning in the final rule to use the
phrase ‘‘even if child falls asleep’’ to
align with the Ad Hoc Task Group’s
9 The recommended wording is as follows:
‘‘Products likely to be used for infants who are
sleeping (i.e., bouncers, swings, infant rockers,
handheld carriers) that are not intended for periods
of unattended sleep, would benefit from this
warning about unattended use. Never leave child
unattended, even if child falls asleep.’’
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language. Manufacturers who produce
bouncers in which infants should not be
allowed to sleep may add language to
their warnings statements alerting
caregivers to this issue.
Comment 4: One commenter
recommended that the ASTM
subcommittee reach a consensus on the
need for the additional proposed
language: ‘‘Stop using bouncer when
baby starts trying to sit up.’’
Response 4: At the January 12, 2016
ASTM meeting, the F15.18
subcommittee on Infant Bouncer Seats
reviewed and agreed with the
Commission’s proposed language on
developmental guidance. ASTM
balloted and approved the proposed
language, and such language has been
included in ASTM F2167 since the 2016
version of the standard.
D. Other Warning Label Issues
Comment 5: Two commenters
recommended that the warning label be
attached on the product using
embroidery or stamping to increase its
permanency.
Response 5: The ASTM standard does
not require a certain type of attachment
for labels but requires the labels to be
tested per section 7.8 to determine the
labels’ permanency. A similar
permanency test procedure is used in
other ASTM standards. No data were
provided by the commenter, and the
Commission has no information
suggesting that these requirements are
ineffective. Accordingly, the
Commission incorporates by reference
ASTM F2167–17, without any
modification to section 7.8.
Comment 6: Three commenters
recommended using pictures to clarify
warning messages.
Response 6: The Commission
acknowledges that well-designed
graphics can be useful to increase the
noticeability of the warnings as they
help capture a user’s attention.
Pictograms are also helpful for users
with limited or no English literacy.
However, the design of effective
graphics can be difficult. To avoid
confusing consumers, a warning
pictogram should be developed with an
empirical study and well tested on the
target audience. Although the
Commission may take action in the
future if it believes graphic symbols are
needed to reduce the risk of injury
associated with bouncer seats, the rule
permits, but does not mandate, such
supporting graphics.
VII. Incorporation by Reference
Section 1229.2(a) of the final rule
provides that infant bouncer seats must
comply with applicable sections of
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ASTM F2167–17. The OFR has
regulations concerning incorporation by
reference. 1 CFR part 51. These
regulations require that, for a final rule,
agencies must discuss in the preamble
to the rule the way in which materials
that the agency incorporates by
reference are reasonably available to
interested persons, and how interested
parties can obtain the materials.
Additionally, the preamble to the rule
must summarize the material. 1 CFR
51.5(b).
In accordance with the OFR’s
requirements, the discussion in section
VIII of this preamble summarizes the
required provisions of ASTM F2167–17.
Interested persons may purchase a copy
of ASTM F2167–17 from ASTM, either
through ASTM’s Web site, or by mail at
the address provided in the rule. A copy
of the standard may also be inspected at
the CPSC’s Office of the Secretary, U.S.
Consumer Product Safety Commission,
as discussed above. Note that the
Commission and ASTM arranged for
commenters to have ‘‘read only’’ access
to ASTM F2167–15 during the NPR’s
comment period.
VIII. Description of the Final Rule
Section 1229.2(a) of the final rule for
infant bouncer seats incorporates by
reference ASTM F2167–17 with two
modifications, as stated in § 1229.2(b),
related to the content and placement of
warnings. Section 1229.2(a) includes the
following key provisions summarized
below: scope, terminology, general
requirements, performance
requirements, test methods, marking
and labeling, and instructional
literature. As described below,
§ 1229.2(b) includes modifications to
test methods (§ 1229.2(b)(1)), marking
and labeling (§ 1229.2(b)(2) and (3)), and
instructional literature (§ 1229.2(b)(4)).
Scope. Section 1 of ASTM F2167–17
states the scope of the standard,
detailing what constitutes an ‘‘infant
bouncer seat.’’ As stated in section II.A
of this preamble, the Scope section
defines an ‘‘infant bouncer seat’’ as ‘‘a
freestanding product intended to
support an occupant in a reclined
position to facilitate bouncing by the
occupant, with the aid of a caregiver or
by other means.’’ ASTM F2167–17
states that infant bouncer seats are
intended for ‘‘infants who have not
developed the ability to sit up
unassisted (approximately 0 to 6 months
of age).’’
Terminology. Section 3 of ASTM
F2167–17 provides definitions of terms
specific to this standard.
General Requirements. Section 5 of
ASTM F2167–17 addresses numerous
hazards with several general
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requirements, most of which are also
found in the other ASTM juvenile
product standards. Several requirements
reference an existing CPSC standard.
The following general requirements
apply to bouncer seats. Where the
ASTM standard relies on a CPSC
mandatory standard, the mandatory
standard is cited in parentheses next to
the requirement:
• Hazardous sharp points and edges
(16 CFR 1500.48 and 1500.49);
• Small parts (16 CFR part 1501);
• Lead in paint (16 CFR part 1303);
• Wood parts;
• Latching and locking mechanisms;
• Scissoring, shearing, and pinching;
• Openings;
• Exposed coil springs;
• Protective components;
• Permanency of labels and warnings;
and
• Toys (ASTM F963).
Performance Requirements and Test
Methods. Sections 6 and 7 of ASTM
F2167–17 contain performance
requirements specific to bouncer seats,
as well as test methods that must be
used to assess conformity with such
requirements. Accordingly, the final
rule includes performance requirements
for the following:
• Restraints;
• Stability (forward, sideward, and
rearward);
• Slip Resistance
• Structural Integrity;
• Dynamic and Static Load;
• Disassembly/Collapse;
• Drop Test;
• Toy Bar Attachment Integrity; and
• Battery Compartment.
Additionally, section 7 of ASTM
F2167–17 includes test procedures to
ensure the permanency of labels and
warnings, and a fall hazard visibility
test. The test procedure in § 1229.2(b)(1)
of the final rule replaces the fall hazard
visibility test in section 7.11.3.1 of
ASTM F2167–17, as described in
section V.B.2 of this preamble.
Marking and Labeling. Section 8 of
ASTM F2167–17 requires products to be
marked or labeled with manufacturing
information and relevant product
warnings. Warning label requirements
for bouncer seats in section 8.4.5 of
ASTM F2167–17 require two groups of
warning statements, a fall hazard
warning and a suffocation warning.
ASTM F2167–17 includes warning
language and formatting requirements
for both falls and suffocation warnings.
Section 8.4.7.1 requires the fall hazard
warning to be placed on the front
surface of the infant bouncer seat back,
so that it complies with the visibility
requirement in section 7.11.
Section 1229.2(b)(2) of the final rule
replaces the content of the fall hazard
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warning in section 8.5.1.1 of ASTM
F2167–17. Section 1229.3(b)(3) of the
final rule replaces the content of the
suffocation hazard warning in sections
8.5.2.1 and 8.5.3 in ASTM F2167–17.
Changes to warning content and the
visibility test for the placement of the
fall hazard warning are outlined in
section V.B.1–2 of this preamble.
Instructional Literature. Section 9 of
ASTM F2167–17 requires that
instructions be provided with bouncer
seats and be easy to read and
understand. Additionally, the section
contains requirements relating to
instructional literature contents,
including warnings.
Section 1229.2(b)(4) of the final rule
replaces the content of sections 9.2.1
and 9.2.2 of ASTM F2167–17. These
sections contain example warning labels
or references to example warning labels.
The content of the example warning
labels in § 1229.2(b)(4) reflects changes
to the content of the fall hazard warning
and suffocation hazard warning in
§ 1229.2(b)(2) and (3) of the final rule.
Changes to the instructional literature
that relate to warnings content are
outlined in section V.B.1–2 of this
preamble.
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). CPSC generally
considers 6 months to be sufficient time
for suppliers of durable infant and
toddler products to come into
compliance with a new standard under
section 104 of the CPSIA. Six months is
also the period that the Juvenile
Products Manufacturers Association
(JPMA) typically allows for products in
the JPMA certification program to
transition to a new standard once that
standard is published. The Commission
proposed a 6-month effective date in the
NPR for infant bouncer seats and we
received no comments on the proposed
effective date. Accordingly, the final
rule for bouncer seats, as well as the
amendment to part 1112, has a 6-month
effective date.
X. Regulatory Flexibility Act
A. Introduction
The Regulatory Flexibility Act (RFA),
5 U.S.C. 601–612, requires that agencies
review a proposed rule and a final rule
for the rule’s potential economic impact
on small entities, including small
businesses. Section 604 of the RFA
generally requires that agencies prepare
a final regulatory flexibility analysis
(FRFA) when promulgating final rules,
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unless the head of the agency certifies
that the rule will not have a significant
economic impact on a substantial
number of small entities. Staff prepared
a FRFA that is available at Tab C of the
Staff Final Rule Briefing Package. We
provide a summary of the FRFA below.
The final rule is unlikely to have a
significant economic impact on the five
domestic manufacturers of infant
bouncer seats. Of the six small
importers, a significant economic
impact cannot be ruled out for four of
the importers, either as a result of the
final rule requirements or the resulting
third party testing costs. Therefore, the
Commission cannot rule out a
significant economic impact for four of
the 11 firms (36 percent) operating in
the U.S. market for bouncers.
B. The Product
An infant bouncer seat is defined in
ASTM F2167–17, Standard Consumer
Safety Specification for Infant Bouncer
Seats, as ‘‘a freestanding product
intended to support an occupant in a
reclined position to facilitate bouncing
by the occupant, with the aid of a
caregiver or by other means.’’ These
products vary widely in price; they can
be purchased for as little as $20, but can
also easily cost more than $200.
C. The Market for Infant Bouncer Seats
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For the FRFA, the Commission
identified 23 firms supplying infant
bouncer seats to the U.S. market, with
several firms moving into or out of the
market since the NPR. These firms
primarily specialize in the manufacture
and/or distribution of children’s
products, including durable nursery
products. Eight of the 23 known firms
are domestic manufacturers and eight
are domestic importers. The remaining
seven firms are foreign (4
manufacturers, 2 importers, and 1
retailer).10 We expect that the infant
bouncer seats of 14 of these firms
already comply with ASTM F2167
because the firms either: (1) Have their
bouncers certified by JPMA (five firms);
(2) claim compliance with the voluntary
standard (eight firms); or (3) have been
tested to the ASTM standard by CPSC
staff (one firm).11
10 Staff categorized each firm using information
from Dun & Bradstreet and ReferenceUSAGov, as
well as firm Web sites.
11 JPMA typically allows six months for products
in their certification program to become compliant
with a new voluntary standard once it is published.
Therefore, firms are likely already complying with
ASTM F2167–16, which was published in May
2016. They are not expected to comply with the
recently published ASTM F2167–17 until December
2017.
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D. Impact on Small Businesses
The Commission is aware of
approximately 23 firms currently
marketing infant bouncer seats in the
United States, 16 of which are domestic.
Under U.S. Small Business
Administration (SBA) guidelines, a
manufacturer of infant bouncer seats is
categorized as small if it has 500 or
fewer employees, and importers and
wholesalers are considered small if they
have 100 or fewer employees. We have
limited our analysis to domestic firms
because SBA guidelines and definitions
pertain to U.S.-based entities. Based on
these guidelines, the Commission
determined that about 11 of the 23 firms
are small—five domestic manufacturers
and six domestic importers. Additional
unknown small domestic infant bouncer
seat suppliers may be operating in the
U.S. market.
1. Small Manufacturers
The economic impact of the final rule
for infant bouncer seats should be small
for the five small domestic
manufacturers. Each firm has an
established history of compliance with
the ASTM standard for infant bouncers
and is therefore expected to be
compliant with ASTM F2167–17, the
version of the voluntary standard upon
which the final rule is based, by the
time the mandatory standard becomes
final.
None of these firms includes more
than four languages in their warnings
and redesign is not expected. Based
upon staff’s inspection of their products,
we expect products to have more than
sufficient space for the required warning
labels under the modified warning label
for the final rule without the products
seeming cluttered.
Under section 14 of the CPSA, once
the new infant bouncer seat
requirements become effective, all
manufacturers will be subject to the
third party testing and certification
requirements under the CPSA and the
Testing and Labeling Pertaining to
Product Certification rule (16 CFR part
1107) (1107 rule). Third party testing
will include any physical and
mechanical test requirements specified
in the final infant bouncer seats rule.
Manufacturers and importers should
already be conducting required lead
testing for bouncer seats.
Third party testing costs are in
addition to the direct costs of meeting
the infant bouncer seats standard. The
Initial Regulatory Flexibility Analysis
(IRFA) prepared for the NPR concluded
that we could not rule out a significant
economic impact, given that we do not
know specifically how much the third
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party requirement adds to testing costs
or precisely how many models are
needed to meet the ‘‘high degree of
assurance’’ standard but that it was
unlikely to be economically significant
for most small manufacturers (i.e.,
testing costs would be less than 1
percent of gross revenue). Given that
these firms are already testing to the
voluntary standard and the Commission
received no public comments about
third party testing, the Commission
believes that it is unlikely that third
party testing would have a significant
economic impact on any of the five
small manufacturers.
2. Small Importers
a. Small Importers With Compliant
Infant Bouncer Seats
As noted in the IRFA, imported
bouncers tend to be produced to meet
the requirements for several trading
partners simultaneously, including their
different labeling requirements.
Producers for international markets
typically address labeling requirements
for their various trading partners by
simply providing a warning that covers
all required safety issues in multiple
languages. Specificity regarding warning
label location impacts the practicability
of replicating the warning label in
multiple languages. This could mean
that foreign producers will need to
design a product for the U.S. market or
reduce the number of languages used for
warnings on U.S.-bound bouncer seats.
The final rule provides additional
space for warning label placement than
that proposed in the NPR. With this
additional space, reducing on-product
warning languages should be a more
viable alternative for firms than it was
under the NPR proposal. Firms would
not need to reduce the number of
languages for their on-product warnings
for the final rule as significantly as that
required in the NPR. The additional
space addresses the location
requirement in the final rule, while
ensuring that the appearance of
bouncers remains comparable to firms’
competitor products (for which one to
three languages is typical).
Three small importers of infant
bouncer seats are currently in
compliance with the voluntary
standard; these firms likely would
continue compliance as new versions of
the voluntary standard are published.
One importer is unlikely to experience
a significant economic impact, even if
the importer opted to redesign its
bouncers to accommodate more than
eight warning label languages. The cost
estimate to redesign an infant bouncer
(based on information from several
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firms) is between $200,000 and
$300,000, which is less than 1 percent
of this firm’s revenue. The remaining
two small importers of compliant
bouncer seats might experience
significant economic costs, based on the
same comparison (i.e., $200,000 to
$300,000 could represent more than 1
percent of their annual revenue).
Although the Commission does not
expect that these firms would require
space for warning labels in more than
eight languages, we cannot rule out a
significant economic impact for one of
these two firms, given an extremely low
revenue level compared to estimated
costs for redesign. The second firm
appears to have the option of exiting the
bouncer market without experiencing a
significant impact.
b. Small Importers With Noncompliant
Infant Bouncer Seats
Three firms import bouncers that do
not comply with the voluntary standard.
The bouncers for these firms will
require changes to come into
compliance with the voluntary standard
as well as modifications to meet the
warning label requirements in the final
rule. In the absence of information on
precisely what changes would be
required to bring the bouncer seats
supplied by all three firms into
compliance with the final rule (as well
as information on sales revenue for all
three firms), the Commission cannot
rule out a significant economic impact
for any of these firms.
The magnitude of the economic
impact on the three firms with
noncompliant infant bouncer seats will
depend upon the cost of the changes
required and the degree to which their
supplying firms pass on any increases in
production costs associated with
changes to the product needed to meet
the mandatory standard (a redesign is
estimated to cost between $200,000 to
$300,000). Two of the firms are directly
tied to their foreign suppliers and
therefore, finding an alternate supply
source would not be a viable alternative.
However, given this close relationship,
it seems likely that their foreign
suppliers would have an incentive to
work with their U.S. subsidiaries to
maintain an American market presence.
One of those two firms likely would
only avoid a significant economic
impact if their supplier absorbed 100
percent of the cost of a redesign. The
third firm imports and wholesales a
wide variety of children’s products. We
do not know, however, how much of the
firm’s revenue is due to bouncer sales
and cannot determine what impact
discontinuing bouncer sales might have
on the third firm should the firm be
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unable to find a supplier of bouncers
that comply with the standard.
Based on the additional space
provided in the final rule for placement
of the fall hazard warning label, two of
these firms should not require
modifications to meet the requirement
in the final rule (although they would
have required modifications under the
NPR).
c. Third Party Testing Costs for Small
Importers
As with manufacturers, all importers
will be subject to third-party testing and
certification requirements, and
consequently, will be subject to costs
similar to those for manufacturers if
their supplying foreign firm(s) does not
perform third party testing. Half of the
bouncer seat importers (3 of 6) are
already testing their products to verify
compliance with the ASTM standard,
and any costs would be limited to the
incremental costs associated with third
party testing over the current testing
regime.
The Commission was able to obtain
revenue data for one of the small
importers with noncompliant bouncers.
For that importer, third party testing
costs, considered alone and apart from
any additional performance
requirements due to the final rule,
would not exceed one percent of gross
revenue unless around 12 units per
model required testing to provide the
‘‘high degree of assurance’’ required by
16 CFR part 1107. The Commission has
no basis for estimating the size of the
impact for the remaining two importers
of noncompliant bouncers.
E. Summary of Impacts
The Commission is aware of 11 small
firms, five domestic manufacturers and
six domestic importers, currently
marketing infant bouncer seats in the
United States. With regards to the five
domestic manufacturers, the
Commission considers it unlikely that
testing costs would have a significant
impact on any of these firms. Of the six
small importers, a significant economic
impact cannot be ruled out for four of
the importers either as a result of the
final rule requirements or the resulting
third party testing costs. Therefore, the
Commission cannot rule out a
significant economic impact for four of
the 11 firms (36 percent) operating in
the U.S. market for bouncers.
F. Alternatives
One of the alternatives to reduce the
impact on small entities discussed in
the NPR was to adopt the voluntary
standard with all of the modifications to
the on-product warning labels, except
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for the location specificity (i.e., next to
the child’s head). Based on comments
received, the requirements regarding onproduct warning label placement have
been modified in the final rule (i.e., up
from the child’s armpits on either side).
This modification provides additional
room and will reduce the economic
impact of the warning label location
specificity on small suppliers. The
Commission could further reduce the
economic impact on small entities by
eliminating the location requirement for
the fall hazard warning entirely.
However, this would reduce the
effectiveness of the fall hazard warning
label. The location for the fall hazard
warning ‘‘allows caregivers to notice the
label while making eye contact with the
infant, and potentially creates mental
images of the consequence (‘‘skull
fracture’’) of not complying with the
instructions . . .’’ Tab D, Staff NPR
Briefing Package; Tab B, Staff Final Rule
Briefing Package.
The Commission considered two
additional alternatives discussed in the
NPR that might minimize the economic
impact on small entities: (1) Adopt
ASTM F2167–17 with no modifications;
and (2) allow a later effective date.
Section 104 of the CPSIA requires that
the Commission promulgate a standard
that is either substantially the same as
the voluntary standard or more
stringent. Therefore, adopting ASTM
F2167–17 with no modifications is the
least stringent rule allowed by law. This
alternative would reduce the impact on
all of the known small businesses
supplying infant bouncers to the U.S.
market. If it were adopted, it should
eliminate any economic impact related
to warning label changes, but firms
would continue to be affected by third
party testing requirements. However,
adopting ASTM F2167–17 without
modification would not adequately
address the fall hazard scenario
identified in the incident data and
would reduce the effectiveness of the
fall hazard warning label.
Finally, the Commission could reduce
the final rule’s impact on small
businesses by setting a later effective
date. A later effective date would reduce
the economic impact on firms in two
ways. Firms would be less likely to
experience a lapse in production/
importation, which could result if they
are unable to comply and third party
test within the required timeframe.
Also, firms could spread costs over a
longer time period, thereby reducing
their annual costs, as well as the present
value of their total costs. However, the
Commission received no comments
asserting that firms would not have
sufficient time to comply with the
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proposed 6 month effective date.
Accordingly, the Commission declines
to extend the effective date of the final
rule.
G. Small Business Impacts of the
Accreditation Requirements for Testing
Laboratories
In accordance with section 14 of the
CPSA, all children’s products that are
subject to a children’s product safety
rule must be tested by a CPSC-accepted
third party conformity assessment body
(i.e., testing laboratory) for compliance
with applicable children’s product
safety rules. Testing laboratories that
want to conduct this testing must meet
the NOR pertaining to third party
conformity testing. NORs have been
codified for existing rules at 16 CFR part
1112. Consequently, the Commission
finalizes an amendment to 16 CFR part
1112 that establishes an NOR for those
testing laboratories that want to test for
compliance with the bouncers final rule.
This section assesses the impact of the
amendment on small laboratories.
A FRFA was conducted as part of the
promulgation of the original 1112 rule
(78 FR 15836, 15855–58) as required by
the RFA. Briefly, the FRFA concluded
that the accreditation requirements
would not have a significant adverse
impact on a substantial number of small
laboratories because no requirements
were imposed on laboratories that did
not intend to provide third party testing
services. The only laboratories that were
expected to provide such services were
those that anticipated receiving
sufficient revenue from the mandated
testing to justify accepting the
requirements as a business decision.
Based on similar reasoning, amending
the rule to include the NOR for the
bouncer standard will not have a
significant adverse impact on small
laboratories. Moreover, based upon the
number of laboratories in the United
States that have applied for CPSC
acceptance of the accreditation to test
for conformance to other juvenile
product standards, we expect that only
a few laboratories will seek CPSC
acceptance of their accreditation to test
for conformance with the infant bouncer
seat standard. 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
bouncer standard to their scope of
accreditation, a cost that test
laboratories have indicated is extremely
low when they are already accredited
for other section 104 rules. As a
consequence, the Commission certifies
that the NOR for the infant bouncer seat
standard will not have a significant
impact on a substantial number of small
entities.
XI. Environmental Considerations
The Commission’s regulations address
whether the agency is required to
prepare an environmental assessment or
an environmental impact statement.
Under these regulations, a rule that has
‘‘little or no potential for affecting the
human environment,’’ is categorically
exempt from this requirement. 16 CFR
1021.5(c)(1). The final rule for bouncer
seats falls within the categorical
exemption.
XII. Paperwork Reduction Act
The final rule for infant bouncer seats
contains information collection
requirements that are subject to public
comment and review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The preamble to
the proposed rule (80 FR at 63181–82)
discussed the information collection
burden of the proposed rule and
specifically requested comments on the
accuracy of our estimates. OMB has
assigned control number 3041–0174 to
this information collection. We did not
receive any comment regarding the
information collection burden of the
proposal. However, the final rule makes
modifications regarding the information
collection burden because the number
of estimated manufacturers subject to
the information collection burden is
now estimated at 23 manufacturers
rather than the 22 manufacturers
initially estimated in the proposed rule.
Accordingly, the estimated burden of
this collection of information is
modified as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
Number of
respondents
Frequency of
responses
Total annual
responses
Hours per
response
Total burden
hours
1229 .....................................................................................
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16 CFR Section
23
4
92
1
92
Our estimate is based on the
following:
Section 8.1 of ASTM F2167–17
requires that all infant bouncer seats
and their retail packaging be
permanently marked or labeled as
follows: The manufacturer, distributor,
or seller name, place of business (city,
state, mailing address, including zip
code), and telephone number; and a
code mark or other means that identifies
the date (month and year as a minimum)
of manufacture.
CPSC is aware of 23 firms that supply
bouncer seats in the U.S. market. For
PRA purposes, we assume that all 23
firms use labels on their products and
on their packaging already. All firms
will need to make some modifications to
their existing labels. We estimate that
the time required to make these
modifications is about 1 hour per
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16:23 Sep 15, 2017
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model. Each of the 23 firms supplies an
average of four different models of
bouncer seats. Therefore, we estimate
the burden hours associated with labels
to be 92 hours annually (1 hour × 23
firms × 4 models per firm = 92 hours
annually).
We estimate the hourly compensation
for the time required to create and
update labels is $33.58 (U.S. Bureau of
Labor Statistics, ‘‘Employer Costs for
Employee Compensation,’’ March 2017,
Table 9, total compensation for all sales
and office workers in goods-producing
private industries: https://www.bls.gov/
ncs/). Therefore, we estimate the annual
cost to industry associated with the
labeling requirements in the final rule to
be approximately $3,089 ($33.58 per
hour × 92 hours = $3,089.36). This
collection of information does not
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require operating, maintenance, or
capital costs.
In compliance with the Paperwork
Reduction Act of 1995 (44 U.S.C.
3507(d)), we have submitted the
information collection requirements of
this final rule to the OMB.
XIII. Preemption
Section 26(a) of the CPSA, 15 U.S.C.
2075(a), provides that when 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
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sradovich on DSKBBY8HB2PROD with RULES
certain circumstances. Section 104(b) of
the CPSIA refers to the rules to be
issued under that section as ‘‘consumer
product safety rules.’’ Therefore, the
preemption provision of section 26(a) of
the CPSA applies to this final rule
issued under section 104.
XIV. Amendment to 16 CFR Part 1112
To Include NOR for Bouncer Seat
Standard
The CPSA establishes certain
requirements for product certification
and testing. Products subject to a
consumer product safety rule under the
CPSA, or to a similar rule, ban, standard
or regulation under any other act
enforced by the Commission, must be
certified as complying with all
applicable CPSC-enforced requirements.
15 U.S.C. 2063(a). Certification of
children’s products subject to a
children’s product safety rule must be
based on testing conducted by a CPSCaccepted third party conformity
assessment body. Id. 2063(a)(2). The
Commission must publish an NOR for
the accreditation of third party
conformity assessment bodies to assess
conformity with a children’s product
safety rule to which a children’s product
is subject. Id. 2063(a)(3). The Safety
Standard for Infant Bouncer Seats, to be
codified at 16 CFR part 1229, is a
children’s product safety rule that
requires the issuance of an NOR.
The Commission published a final
rule, Requirements Pertaining to ThirdParty Conformity Assessment Bodies, 78
FR 15836 (March 12, 2013), which is
codified at 16 CFR part 1112 (referred to
here as part 1112). Part 1112 became
effective on June 10, 2013 and
establishes requirements for
accreditation of third-party conformity
assessment bodies (or laboratories) to
test for conformance with a children’s
product safety rule in accordance with
section 14(a)(2) of the CPSA. 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 standard for bouncer
seats, require the Commission to amend
part 1112. Accordingly, the Commission
is now amending part 1112 to include
the standard for infant bouncer seats in
the list of 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 infant bouncer
seats would be required to meet the
third-party conformity assessment body
accreditation requirements in 16 CFR
part 1112, Requirements Pertaining to
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Third-Party Conformity Assessment
Bodies. When a laboratory meets the
requirements as a CPSC-accepted thirdparty conformity assessment body, the
laboratory can apply to the CPSC to
have 16 CFR part 1229, Safety Standard
for Infant Bouncer Seats, included in its
scope of accreditation of CPSC safety
rules listed for the laboratory on the
CPSC Web site at: www.cpsc.gov/
labsearch.
As required by the RFA, staff
conducted a FRFA when the
Commission issued the part 1112 rule
(78 FR 15836, 15855–58). Briefly, the
FRFA concluded that the accreditation
requirements would not have a
significant adverse impact on a
substantial number of small test
laboratories because no requirements
were imposed on test laboratories that
did not intend to provide third-party
testing services. The only test
laboratories that were expected to
provide such services were those that
anticipated receiving sufficient revenue
from the mandated testing to justify
accepting the requirements as a business
decision. Moreover, a test laboratory
would only choose to provide such
services if it anticipated receiving
revenues sufficient to cover the costs of
the requirements.
Based on similar reasoning, amending
16 CFR part 1112 to include the NOR for
the infant bouncer seats standard will
not have a significant adverse impact on
small test laboratories. Moreover, based
upon the number of test laboratories in
the United States that have applied for
CPSC acceptance of accreditation to test
for conformance to other mandatory
juvenile product standards, we expect
that only a few test laboratories will
seek CPSC acceptance of their
accreditation to test for conformance
with the infant bouncer seats standard.
Most of these test laboratories will have
already been accredited to test for
conformity to other mandatory juvenile
product standards, and the only costs to
them would be the cost of adding the
infant bouncer seats standard to their
scope of accreditation. For these
reasons, the Commission certifies that
the NOR amending 16 CFR part 1112 to
include the infant bouncer seats
standard will not have a significant
impact on a substantial number of small
entities.
List of Subjects
16 CFR Part 1112
Administrative practice and
procedure, Audit, Consumer protection,
Incorporation by reference, Reporting
and recordkeeping requirements, Third
party conformity assessment body.
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16 CFR Part 1229
Bouncer seats, Chairs, Consumer
protection, Imports, Incorporation by
reference, Infants and children,
Labeling, Law enforcement, Seats, and
Toys.
For the reasons discussed in the
preamble, the Commission amends title
16 of the Code of Federal Regulations 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: 15 U.S.C. 2063; Pub. L. 110–
314, section 3, 122 Stat. 3016, 3017 (2008).
2. Amend § 1112.15 by adding
paragraph (b)(42) 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) * * *
(42) 16 CFR part 1229, Safety
Standard for Infant Bouncer Seats.
*
*
*
*
*
■ 3. Add part 1229 to read as follows:
PART 1229—SAFETY STANDARD FOR
INFANT BOUNCER SEATS
Sec.
1229.1 Scope.
1229.2 Requirements for infant bouncer
seats.
Authority: Sec. 104, Pub. L. 110–314, 122
Stat. 3016 (15 U.S.C. 2056a).
§ 1229.1
Scope.
This part establishes a consumer
product safety standard for infant
bouncer seats.
§ 1229.2
seats.
Requirements for infant bouncer
(a) Except as provided in paragraph
(b) of this section, each infant bouncer
seat must comply with all applicable
provisions of ASTM F2167–17,
Standard Consumer Safety Specification
for Infant Bouncer Seats, approved on
June 1, 2017. The Director of the Federal
Register approves this incorporation by
reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. You may
obtain a copy from ASTM International,
100 Bar Harbor Drive, P.O. Box 0700,
West Conshohocken, PA 19428; https://
www.astm.org/cpsc.htm. You may
inspect a copy at the Office of the
Secretary, U.S. Consumer Product
Safety Commission, Room 820, 4330
East West Highway, Bethesda, MD
20814, telephone 301–504–7923, or at
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43481
junctions of under arm and side of the
torso armpits on both left and right and
not obscured by any part of the dummy
(as shown in paragraph (b)(1)(ii), ‘‘Fig.
10’’).
(ii) Fig. 10: CAMI Dummy Restrained
in Seat; Allowable area for warning
label placement starts from the dotted
line that crosses the junctions of
underarm and both sides of the torso.
‘‘ALWAYS use restraints. Adjust to fit
snugly’’ with ‘‘ALWAYS use restraints
and adjust to fit snugly, even if baby
falls asleep.’’
(4) In section 8.5.3 of ASTM F2167–
17, replace the reference to ‘‘Figs. 10
and 11’’ with ‘‘Figs. 11 and 12.’’
(5) In section 9.2.1 of ASTM F2167–
17:
(i) Replace the reference to ‘‘Fig. 12’’
with ‘‘Fig. 13.’’
(ii) Replace Fig. 10 with paragraph
(b)(5)(iii), ‘‘Fig. 11’’.
(iii) Fig. 11: Fall Hazard Warning.
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ER18SE17.001
ER18SE17.002
(1) Instead of complying with section
7.11.3.1 of ASTM F2167–17, comply
with the following:
(i) 7.11.3.1 Visibility With CAMI
Dummy Restrained in Seat—While
standing in front of the product with the
Newborn CAMI dummy installed, verify
that the required warnings are visible
and placed above an imaginary
horizontal line that crosses through the
(2) In section 8.5.1.1 of ASTM F2167–
17, replace the warning statement
‘‘ALWAYS use restraints. Adjust to fit
snugly’’ with ‘‘ALWAYS use restraints
and adjust to fit snugly, even if baby
falls asleep.’’
(3) In section 8.5.2.1 of ASTM F2167–
17, replace the warning statement
sradovich on DSKBBY8HB2PROD with RULES
the National Archives and Records
Administration (NARA). For
information on the availability of this
material at NARA, call 202–741–6030,
or go to: www.archives.gov/federalregister/cfr/ibr-locations.html.
(b) Comply with ASTM F2167–17
with the following additions or
exclusions:
43482
Federal Register / Vol. 82, No. 179 / Monday, September 18, 2017 / Rules and Regulations
(v) Fig. 12: Suffocation Hazard
Warning.
(vii) Fig. 13: Instruction Warning
Statements.
(6) In section 9.2.2 of ASTM F2167–
17, replace the reference to ‘‘Fig. 12’’
with ‘‘Fig. 13.’’
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Alberta E. Mills,
Acting Secretary, Consumer Product Safety
Commission.
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, and
558
[FR Doc. 2017–19255 Filed 9–15–17; 8:45 am]
[Docket No. FDA–2017–N–0002]
sradovich on DSKBBY8HB2PROD with RULES
BILLING CODE 6355–01–P
New Animal Drugs; Approval of New
Animal Drug Applications; Change of
Sponsor’s Address
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendments.
ACTION:
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16:23 Sep 15, 2017
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The Food and Drug
Administration (FDA or we) is
amending the animal drug regulations to
reflect application-related actions for a
new animal drug application (NADA)
and abbreviated new animal drug
applications (ANADAs) during March
and April 2017. FDA is also informing
the public of the availability of
summaries of the basis of approval and
of environmental review documents,
where applicable. The animal drug
regulations are also being amended to
reflect a change of a sponsor’s address
and to make technical amendments to
improve the accuracy of the regulations.
SUMMARY:
This rule is effective September
18, 2017.
DATES:
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ER18SE17.004
(vi) Replace Fig. 12 with paragraph
(b)(5)(vii), ‘‘Fig. 13’’.
ER18SE17.003
(iv) Replace Fig. 11 with paragraph
(b)(5)(v), ‘‘Fig. 12’’.
Agencies
[Federal Register Volume 82, Number 179 (Monday, September 18, 2017)]
[Rules and Regulations]
[Pages 43470-43482]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-19255]
-----------------------------------------------------------------------
CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Parts 1112 and 1229
[Docket No. CPSC-2015-0028]
Safety Standard for Infant Bouncer Seats
AGENCY: Consumer Product Safety Commission.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Danny Keysar Child Product Safety Notification Act,
section 104 of the Consumer Product Safety Improvement Act of 2008
(CPSIA), requires the United States Consumer Product Safety Commission
(Commission or CPSC) to promulgate consumer product safety standards
for durable infant or toddler products. These standards are to be
``substantially the same as'' applicable voluntary standards or more
stringent than the voluntary standard, if the Commission determines
that more stringent requirements would further reduce the risk of
injury associated with the product. The Commission is issuing this
final rule establishing a safety standard for infant bouncer seats
(bouncer seats) in response to the direction of section 104(b) of the
CPSIA. Additionally, the Commission is finalizing an amendment to its
regulations regarding third party conformity assessment bodies to
include safety standard for bouncer seats in the list of notice of
requirements (NORs) issued by the Commission.
DATES: This rule will become effective March 19, 2018. The
incorporation by reference of the publication listed in this rule is
approved by the Director of the Federal Register as of March 19, 2018.
FOR FURTHER INFORMATION CONTACT: Keysha Walker, Compliance Officer,
U.S. Consumer Product Safety Commission, 4330 East West Highway,
Bethesda, MD 20814; telephone: 301-504-6820; email: kwalker@cpsc.gov.
SUPPLEMENTARY INFORMATION:
I. Background and Statutory Authority
The CPSIA 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. Standards issued under section 104 are to be ``substantially
the same as'' the applicable voluntary standards or more stringent than
the voluntary standard, if the Commission determines 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,'' and the statute specifies twelve categories of
products that are included in the definition, including walkers,
carriers and various types of children's chairs. When issuing a
regulation governing product registration under section 104, the
Commission determined that an ``infant bouncer'' falls within the
definition of a ``durable infant or toddler product.'' 74 FR 68668
(Dec. 29, 2009); 16 CFR 1130.2(a)(15).
On October 19, 2015, the Commission issued a notice of proposed
rulemaking (NPR) for infant bouncer seats. 80 FR 63168. The NPR
proposed to incorporate by reference the 2015 version of the voluntary
standard, ASTM F2167 Standard Consumer Safety Specification for Infant
Bouncer Seats (ASTM F2167), as a mandatory consumer product safety rule
with several modifications to the content, format, and placement of
warning labels and instructions, to strengthen the standard.
In this document, the Commission is issuing a mandatory consumer
product safety standard for bouncer seats. As required by section
104(b)(1)(A), the Commission consulted with manufacturers, retailers,
trade organizations, laboratories, consumer advocacy groups,
consultants, and the public to develop this rule, largely through the
ASTM process. Based on revisions to the voluntary standard since the
NPR published, the final rule incorporates by reference the most recent
voluntary standard for infant bouncer seats, developed by ASTM
International, ASTM F2167-17, with two modifications related to warning
label content and placement. These modifications strengthen the
standard by requiring a more stringent warning to caregivers to use the
restraints, even if an infant falls asleep in the bouncer, and requires
the fall hazard warning to be placed on the upper seat back of the
bouncer seat, to ensure that caregivers read and heed the warning. The
Commission's more stringent requirements are intended to further reduce
the risk of injury to infants that fall from, and with, bouncer seats,
especially bouncer seats that are placed on an elevated surface.
Additionally, the final rule amends the list of NORs issued by the
Commission in 16 CFR part 1112 to include the standard for infant
bouncer seats. Under section 14 of the CPSA, the Commission promulgated
16 CFR part 1112 to establish requirements for accreditation of third
party conformity assessment bodies (or testing laboratories) to test
for conformity with a children's product safety rule. Amending part
1112 adds an NOR for the infant bouncer seat standard to the list of
children's product safety rules.
II. Product Description
A. Definition of ``Bouncer Seats''
Section 1.2 of ASTM F2167-17 defines an ``infant bouncer seat'' as:
``a freestanding product intended to support an occupant in a reclined
position to facilitate bouncing by the occupant, with the aid of a
caregiver or by other means.'' Additionally, section 1.2 states that
infant bouncer seats are intended for ``infants who have not developed
the ability to sit up unassisted (approximately 0 to 6 months of
age).''
[[Page 43471]]
Bouncer seats vary widely in style and complexity, but typically,
bouncer seats consist of a cloth cover stretched over a wire or tubular
frame. Wire frame bouncers have two designs. The forward bend design is
constructed with the seating area supported from the front side of the
product. The second wire frame design is a rear bend design. In the
rear bend design, the seat is supported from the rear side of the
product. Other bouncer designs are also currently available, including,
but not limited to, products with individual wire legs, solid bases,
and spring designs. These infant bouncer designs use different methods
to support the seat and are intended for ``bouncing,'' as defined in
ASTM F2167.
All bouncer seats support the child in an inclined position, and
some brands have adjustable seat backs. Various bouncer seat models
include a ``soothing unit'' that vibrates or bounces the chair, and may
play music or other sounds. Most bouncer seats also feature an
accessory bar with attached toys that are, or at some point will be,
within the child's reach. Most of the bouncer seat models examined by
Commission staff provide a 3-point restraint system, consisting of wide
cloth crotch restraints and short adjustable waist straps with plastic
buckles. Only two models of bouncer seats reviewed by CPSC for the NPR
employed upper body restraints. Many bouncer seat brands also include
an ``infant insert,'' intended for use to support smaller babies. Tabs
C and D, Staff Briefing Package: Infant Bouncer Seats Notice of
Proposed Rulemaking, dated September 30, 2015 (Staff NPR Briefing
Package), available at: https://www.cpsc.gov/Global/Newsroom/FOIA/CommissionBriefingPackages/2015/ProposedRuleSafetyStandardforInfantBouncerSeatSeptember302.pdf.
B. Market Description
For the final rule, staff identified 23 firms supplying infant
bouncer seats to the U.S. market, with several firms moving into or out
of the market since the NPR was published. The 23 identified firms
primarily specialize in the manufacture and/or distribution of
children's products, including durable nursery products. Eight of the
23 known firms are domestic manufacturers and 8 are domestic importers.
The remaining seven firms are foreign (four manufacturers, two
importers, and one retailer).\1\ Tab C, Staff Briefing Package: Final
Rule for Infant Bouncer Seats, dated August 23, 2017 (Staff Final Rule
Briefing Package), available at: https://www.cpsc.gov/s3fs-public/Final-Rule-Safety-Standard-for-Infant-Bouncer-Seats-August-23-2017.pdf?ctmyMqMkYWQ1t3QN9DUXCDKnJQ5rKCX6.
---------------------------------------------------------------------------
\1\ Staff categorized each firm using information from Dun &
Bradstreet and ReferenceUSAGov, as well as firm Web sites.
---------------------------------------------------------------------------
Staff expects that the infant bouncer seats of 14 of these firms
already comply with ASTM F2167 because the firms either: (1) Have their
bouncers certified by the Juvenile Products Manufacturers Association
(JPMA) (five firms); (2) claim compliance with the voluntary standard
(eight firms); or (3) have been tested to the ASTM standard by CPSC
staff (one firm).\2\
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\2\ JPMA typically allows six months for products in their
certification program to shift to a new standard once it is
published. Therefore, firms are likely already complying with ASTM
F2167-16, which was published in May 2016. Firms are not expected to
comply with the recently published ASTM F2167-17 until December
2017.
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III. Incident Data
For the NPR, CPSC's Directorate for Epidemiology, Division of
Hazard Analysis, described 277 reported incidents involving bouncer
seats, including 11 fatalities and 51 injuries, occurring between
January 1, 2006 and February 2, 2015. The incidents described in the
NPR were based on reports involving victims 12 months old and younger
in the Injury or Potential Injury Incident (IPII), In-Depth
Investigation (INDP), and Death Certificates (DTHS) databases
(collectively referred to as Consumer Product Safety Risk Management
System data, or CPSRMS data). A detailed discussion of the incidents
and hazard patterns developed for the NPR can be found in Tab A of the
Staff NPR Briefing Package.
A. CPSRMS Data
For the final rule, CPSC staff reviewed bouncer seat incident
reports in CPSRMS from February 2, 2015 through July 6, 2016. CPSC
staff found 70 incident reports in addition to those discussed in the
NPR, including one fatality and three injuries. The fatality involved a
4-month-old female who died after suffering a fractured skull injury
when the infant bouncer she was seated in fell from a table. Two of the
reported injuries were head contusions. A 5-month-old male sustained a
head contusion when a bouncer seat bent backward to the floor. A 6-
month-old male sustained a head contusion when a bouncer cover came off
of the wire frame and the infant flipped forward, striking his head on
the battery compartment. In another reported incident, the victim
suffered minor leg burns from a hot metal bar under a bouncer cover.
Tab A, Staff Final Rule Briefing Package.
Staff did not identify any hazards in the updated incident data
that were not included in the hazard patterns described in the NPR
(product design, structural integrity, toy bar-related, stability,
chemical/electric hazards, restraints, hazardous environment), which
specifically identified product design and structural integrity as the
top two product-related hazards (in terms of frequency of occurrence).
Staff found that product design and structural integrity continue to be
the top two product-related hazards (in terms of frequency) for the
updated CPSRMS data. Of the 70 new incident reports involving bouncer
seats, 51 incident reports described issues with product design, and 13
incident reports described issues with structural integrity. Staff
determined that almost all of the issues with product design were
related to lopsided or low-riding bouncer frames. Data for the final
rule can be found in Tab A of the Staff Final Rule Briefing Package.
B. NEISS Data
For the NPR, CPSC staff found 672 bouncer-related incidents,
including two fatalities, reported in the National Electronic Injury
Surveillance System (NEISS) records retrieved for bouncer incidents
from January 1, 2006 to December 31, 2013, involving children 12 months
old and younger. Staff found that 385 cases, or an estimated 9,200
injuries, occurred in hazardous environments (counters, tables, and
other elevated surfaces).
Staff updated information on bouncer-related incidents from the
NEISS records for the final rule. From January 1, 2014 through December
31, 2015, staff found 202 additional NEISS records describing infant
bouncer incidents. Staff's inspection of the updated NEISS data
revealed that 100 cases, or an estimated 2,800 injuries, took place in
hazardous environments. The remaining 102 cases, or an estimated 2,800
injuries, took place on the floor or an unknown location. Staff found
no additional fatalities in the NEISS data during this time frame.
Staff estimates that 4,700 (85%) bouncer injuries involved the head and
face.
Estimated NEISS Bouncer Injuries, 2006-2015
[age 0-1]
------------------------------------------------------------------------
Estimated
Year Cases injuries
------------------------------------------------------------------------
2006.......................................... 67 1,400
[[Page 43472]]
2007.......................................... 66 1,700
2008.......................................... 74 1,600
2009.......................................... 86 2,200
2010.......................................... 94 2,300
2011.......................................... 121 3,400
2012.......................................... 90 2,500
2013.......................................... 74 2,100
2014.......................................... 98 2,900
2015.......................................... 104 2,700
-------------------------
2006-2015................................. 877 22,800
------------------------------------------------------------------------
Based on the annual estimates provided in the table, staff found a
statistically significant upward trend (p-value of 0.006) in the
estimated emergency department-treated injuries involving bouncers for
victims under 1-year-old from 2006 to 2015.
IV. Product Recalls
The NPR described two recalls of infant bouncer seats since January
2006, involving two different firms, one recall in April 2007 \3\
(involving breakage of a tubular steel frame) and another recall in
July 2009 \4\ (involving small, sharp metal objects that could protrude
through the bouncer fabric). No injuries were associated with either
product at the time of the recall. See Tab E, Staff NPR Briefing
Package. For the final rule, staff reports that no additional recalls
involving bouncer seats have occurred.
---------------------------------------------------------------------------
\3\ CPSC link to recalled product: https://www.cpsc.gov/en/Recalls/2007/Infant-Bouncer-Seats-Recalled-Due-to-Frame-Failure/.
\4\ CPSC link to recalled product: https://www.cpsc.gov/en/Recalls/2009/BabySwede-LLC-Recalls-Bouncer-Chairs-Due-to-Laceration-Hazard/.
---------------------------------------------------------------------------
V. Overview and Assessment of ASTM F2167
A. Overview
The voluntary standard for infant bouncer seats, ASTM F2167,
Standard Consumer Safety Specification for Infant Bouncer Seats, is
intended to minimize the risk of injury or death to infants in bouncer
seats associated with falls from elevated surfaces, product disassembly
or collapse, stability, and suffocation. ASTM F2167 was first approved
in December 2001, and the standard published in January 2002. Since
then, ASTM has revised the standard 11 times. Tab C of the Staff NPR
Briefing Package includes a description of these revisions through
2015.\5\
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\5\ Prior to the NPR publishing in October 2015, ASTM F2167 was
revised several times as part of the rulemaking consultation
process. In February 2014 (ASTM F2167-14) the standard was revised
to improve the sideward and rearward stability tests. Additionally
in 2014, ASTM F2167-14a included changes to the stability test to
make the ASTM standard more strict, to address tip-over incidents,
and to add requirements and test procedures to address incidents
involving battery leakage, corrosion, and overheating.
---------------------------------------------------------------------------
More recently, in May 2016, ASTM revised the standard to add
specific developmental guidance for caregivers about when to stop using
the bouncer, and ASTM removed a general requirement for banned toys or
other articles because those requirements do not apply to infant
bouncer seats. As discussed below, the standard was subsequently
revised in June of 2017 to incorporate changes recommended by ASTM's Ad
Hoc Task Group \6\ concerning warning label formatting requirements,
and to add a requirement that limits the maximum weight of an occupant
in an infant bouncer seat. The June 2017 version of the voluntary
standard also removed a requirement for manufacturers of bouncer seats
to change the model number whenever the product underwent a significant
structural or design modification. We agree with ASTM that although
changing the model number represents a best practice, most ASTM
standards do not include the statement, and such practice does not
impact the safety of the product.
---------------------------------------------------------------------------
\6\ The Ad Hoc Task Group was formed by ASTM and consists of
members of the various voluntary standards groups whose standards
are affected by the durable nursery product rules. The purpose of
the Ad Hoc Task Group is to harmonize the wording and warning label
format of durable infant and toddler products. Ad Hoc Task Group
recommendations for warning statements were originally published as
a reference document titled, ``Ad Hoc Wording--May 4, 2016,'' as
part of the F15 Committee Documents, and subsequently, the
recommendations were revised and published in October 2016, with the
title, ``Ad Hoc Approved Wording, Revision A--October 17, 2016'' (Ad
Hoc Approved Wording).
---------------------------------------------------------------------------
B. Assessment of the Voluntary Standard
For the NPR, CPSC staff examined the relationship between the
performance requirements in ASTM F2167-15 and each of the hazard
patterns staff identified in the incident data for bouncer seats. Tab
C, Staff NPR Briefing Package. Based on staff's assessment, the
Commission issued the NPR proposing to incorporate ASTM F2167-15 with
the following modifications to warnings content, placement, and format:
Revised content of the warnings, markings, and
instructions:
--Modify text in the warnings stating to use the restraints ``even if
baby is sleeping'';
--change the text in the warnings to read, ``stop using when baby
starts trying to sit up''; and
--change the developmental guidance in the instructions, if stated, to
read: ``from birth (or ``0'') until baby starts trying to sit up.''
Restricted the fall hazard label on the front surface of
the bouncer to be adjacent to the area where the child's head would
rest, and modified the visibility test to reflect this requirement.
Specified a standard format (including black text on a
white background, table design, bullet points, and black border) for
the warnings on the product and in the instructions.
The most recent version of the voluntary standard for bouncer
seats, ASTM F2167-17, was approved on June 1, 2017, and published in
June 2017. ASTM F2167-17 includes modified and new performance and
labeling requirements developed by ASTM in conjunction with
stakeholders and CPSC staff on the ASTM subcommittee task group, to
address the hazards associated with bouncer seats. ASTM F2167-17
addresses several of the hazards identified by the Commission in the
NPR. Accordingly, after reviewing and considering comments received in
response to the NPR, as well as the work of the Ad Hoc Task Group, the
Commission incorporates by reference ASTM F2167-17, with two
modifications that were identified in the NPR related to warning
content and warning placement, as the mandatory safety standard for
infant bouncer seats. Below we assess ASTM F2167-17 and explain how it
differs from what the Commission proposed.
1. Content of the Warnings, Markings, and Instructions
The NPR proposed to incorporate by reference ASTM F2167-15, with
modifications to warning, marking, and instruction requirements. ASTM
F2167-15 advised caregivers: ``Always use restraints. Adjust to fit
snugly.'' Based on the incident data that relate deaths to suffocation
among unrestrained infants while they slept, and relate serious head
injuries to unrestrained infants due to falls from bouncer seats that
are placed on elevated surfaces and falls from bouncer seats that are
being carried by caregivers, the Commission stated in the NPR that the
voluntary standard was inadequate to address the risk of injury to
infants from falls out of bouncer seats, or the risk of suffocation
among unrestrained infants who are sleeping. In the NPR, the Commission
proposed warning language stating: ``Adjust to fit snugly, even if baby
is
[[Page 43473]]
sleeping.'' Tab D, Staff NPR Briefing Package.
The newest version of the voluntary standard, ASTM F2167-17, still
does not require a warning statement that caregivers should use the
restraints, even if an infant is asleep. We disagree with this
approach. We note that some NPR commenters were concerned by the
addition of language to the product warnings regarding sleep because
such language may suggest that bouncer seats are intended to be used
for long-term, unattended, sleep. However, CPSC staff advises that
young infants, such as those who are intended to use bouncer seats,
spend more time asleep than awake.\7\ Infants spending more than brief
periods in a bouncer seat will fall asleep on occasion (and caregivers
will place infants to sleep in bouncer seats under some circumstances),
just as infants will fall asleep in strollers, swings, and car-seat
carriers. It may be counterintuitive, and therefore unlikely to occur
to consumers, that products made for infants' use, especially those
that have features intended to sooth and comfort infants, would be
unsafe places for infants to sleep. In fact, despite claims that
bouncer seats are not intended for children to sleep in, CPSC staff
found that some manufacturers' marketing suggests that bouncers are
intended for sleep as well as play. Moreover, incident data and Health
Sciences' assessment demonstrate that the severity of injury from a
fall from a bouncer seat increases for a child who is unrestrained.
Accordingly, in the final rule, the Commission requires that the fall
hazard warning state that caregivers should use the restraints, even if
baby falls asleep.
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\7\ For example, see the American Academy of Pediatrics Web
site, https://www.healthychildren.org/English/ages-stages/baby/sleep/Pages/default.aspx.
---------------------------------------------------------------------------
Based on staff's recommendation and the work of the Ad Hoc Task
Group, the final rule uses the phrase ``falls asleep'' instead of the
phrase ``is sleeping'' that the Commission had proposed in the NPR.
This change aligns with wording approved by the Ad Hoc Task Group,
which is ``Never leave child unattended, even if child falls asleep.''
The Ad Hoc Task Group intends for this warning to be used on products
for infants who are likely to fall asleep in the product, but which are
not intended for periods of unattended sleep (i.e. bouncers, swings,
infant rockers, and handheld carriers).\8\ The Commission notes that
the final rule does not preclude manufacturers from including an
additional statement indicating that bouncers are not intended for long
term sleep. Accordingly, the required fall and suffocation warning
label text regarding use of restraints for the final rule is:
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\8\ During the April 2017 ASTM meetings, several Ad Hoc Task
Group members requested the removal of this sentence from the Ad Hoc
recommendations because no subcommittee had adopted the sentence. In
the discussions, some manufacturers stated that these products are
not appropriate for sleep, stating that the language ``even if baby
falls asleep,'' may mislead caregivers. The Ad Hoc Group balloted
the removal of the sentence in June 2017; however, the ballot
received multiple negative votes and did not pass.
---------------------------------------------------------------------------
Always use restraints and adjust to fit snugly, even if
baby falls asleep.
ASTM F2167-17 includes the other modifications the Commission had
proposed for warning statement requirements. Specifically, sections
8.5.2.1 and 9.2.1 Fig. 11 of ASTM F2167-17 requires text in the
warnings to state: ``stop using when baby starts trying to sit up.''
ASTM F2167-17 requires additional text in the suffocation hazard
warning label to limit the maximum weight for an occupant in an infant
bouncer seat. The rationale for ASTM's change is based on surveillance
of the marketplace, which demonstrated that some manufacturers have
weight limits that do not correlate to the developmental milestones
contemplated in the current warnings. Section 8.5.2.1 of ASTM F2167-17
requires text in the warnings to instruct caregivers to: ``STOP using
bouncer when baby starts trying to sit up or has reached [insert
manufacturer's recommended maximum weight, not to exceed 20 lb],
whichever comes first.''
2. Warning Label Placement and Visibility Test
The NPR proposed a modification to ASTM F2167-15's requirement for
label placement. ASTM F2167-15 required that the fall hazard label be
placed on the front surface of the bouncer seat back so that it is
visible when a newborn CAMI dummy is placed in the bouncer seat. In the
NPR, the Commission assessed this provision of the voluntary standard
and found that it did not adequately address the risk of injury to
infants falling from bouncer seats placed on elevated surfaces, a
foreseeable misuse of infant bouncer seats. Tab D, Staff NPR Briefing
Package. To strengthen the standard and further reduce the risk of
injury, the NPR proposed that the fall hazard warning label be on the
front surface of the bouncer seat, adjacent to where the child's head
would rest, and the NPR also modified the visibility test. ASTM F2167-
17 retains the fall hazard warning placement and corresponding
visibility test from ASTM F2167-15. Thus, the current voluntary
standard still does not address the Commission's concern about the
visibility of the fall hazard warning.
NPR Commenters expressed concern that some products were designed
with insufficient space in the area adjacent to the child's head to
accommodate the necessary warning labels. Commenters were also
concerned about the repeatability of the visibility test proposed in
the NPR. We note, however, that staff's research on the seat back
space, including models with narrow seat backs, did not corroborate the
commenters' concerns. Nevertheless, to enhance test repeatability and
to address the comments regarding insufficient seat back space for
warning labels, the final rule allows a larger area for warning label
placement than proposed in the NPR and clarifies the corresponding
visibility test.
The visibility test in the final rule is based on ASTM F2167-17.
Using the CAMI dummy, as shown in Figure 1 below, the allowable area
for warning label placement starts from a dotted line that crosses the
junctions of underarm and both sides of the torso of the CAMI dummy.
[[Page 43474]]
[GRAPHIC] [TIFF OMITTED] TR18SE17.000
This observable line expands the seat back space allowed for warning
labels and clarifies the precision of the visibility test, both of
which address commenter concerns.
3. Warning Label Format
The NPR proposed modifications to the requirements in ASTM F2167-15
regarding the format of warning labels noting that ASTM F2167-15 did
not provide for a consistent warning label format across infant bouncer
seats. Staff evaluated the warnings format in the voluntary standard
and recommended that the Commission establish minimum requirements for
presenting the hazard information that are consistent with best
practices to attract and maintain attention, as well as aid reading and
comprehension. Tab D, Staff NPR Briefing Package. Accordingly, the NPR
proposed to specify a standard format (including black text on a white
background, table design, bullet points, and black border) for the
warnings on bouncer seats and in the instructions.
Since the NPR published in 2015, ASTM's Ad Hoc Task Group issued
recommendations regarding warnings intended to apply across juvenile
products. These recommendations, based on ANSI Z535.4, American
National Standard for Product Safety Signs and Labels, have been
incorporated into ASTM F2167-17. The Commission notes that Human
Factors staff regularly cites ANSI Z535.4 as a baseline in developing
warning materials, including those proposed in the bouncer seat NPR.
The approved Ad Hoc Task Group recommendations are very similar to the
ANSI Z535.4, with modifications to make the recommendations more
stringent. The recommendations provide noticeable and consistent
warning labels on infant bouncer seats and across juvenile products.
Accordingly, for the final rule, the Commission incorporates by
reference ASTM F2167-17, without any modifications to the formatting
provisions.
VI. Response to Comments
CPSC received six comments in response to the NPR, including a
joint letter submitted by four consumer advocacy groups. Three
commenters supported the changes proposed in the NPR, and the remaining
commenters expressed concern over the Commission's proposed
modifications. We summarize and respond to the commenters below.
A. Warning Label Location
Comment 1: One commenter stated that the proposed requirement for
the fall hazard warning label to be adjacent to an infant's head would
necessitate a wider seat back to accommodate a warning label in
multiple languages, which is desirable for international sales.
According to the same commenter, the ASTM F15.21 Subcommittee had
already evaluated this location and concluded that other locations
above and below the infant's head were considered to be just as visible
as the locations adjacent to an infant's head. A second commenter
stated that the proposed fall hazard label visibility test procedure is
not specific and can be misinterpreted by test labs. This commenter
suggested using the test protocol in the current ASTM standard that
uses the CAMI newborn dummy.
Response 1: Based on the incident data and research, the final rule
requires that the fall hazard warning label be placed near the child's
face. This location allows caregivers to notice the label while making
eye contact with the infant, and potentially creates mental images of
the consequence (``skull fracture'') of not complying with the
instructions because the warning label would be placed next to the body
part at risk. Tab D, Staff NPR Briefing Package.
Commenters claim that the area on the infant bouncer adjacent to an
infant's head could be severely limited in some cases due to the design
of the seat back and allowance needed for stitching tolerances. CPSC
staff's research did not corroborate this claim. Tab D, Staff NPR
Briefing Package. Accordingly, the NPR, 80 FR at 63179-80, invited
commenters to provide information on costs and design changes that
would be required if the label were required to be next to an infant's
head. Staff reports that during the ASTM Ad Hoc Task Group meetings
held in January and February 2016, manufacturers provided several
examples of juvenile products, including infant bouncer seats, to
demonstrate difficulties associated with warning label placement in
proposed
[[Page 43475]]
locations. However, NPR commenters provided neither cost estimates, nor
specific comments, other than stating that the location would require a
wider seat back and would limit representing multiple languages.
To resolve concerns about the amount of space for warning label
placement and address the Commission's concern about an effective
warning label, the final rule states the test procedure language in
ASTM F2167-17, but clarifies the allowable area for the fall hazard
warning label. The fall hazard warning label must be visible when
placed above an imaginary horizontal line that crosses through the
junctions of underarm and side of the torso (armpits) on both left and
right of the CAMI, and not obscured by any part of the dummy. A warning
label located at or around the infant's shoulders can address the
visibility and caregiver motivational concerns expressed in the Human
Factors staff memorandum for the NPR (Tab D), and also provide
additional surface area to accommodate the recommended warning label.
B. Warning Label Format
Comment 2: Two commenters recommended against the proposed
formatting requirements. Commenters specifically highlighted the
following proposed warning formatting requirements:
A heavy black border around the label,
Delineating message panels with solid lines,
Black text on white message panel,
Bullet points preceding precautionary statements,
Choosing a background color for the signal word panel
based on a best contrast against the product material, and
Using non-condensed style font.
Commenters stated that, in general, ASTM standards provide
flexibility to manufacturers to pick colors and formatting features
that are most appropriate for the product. One commenter recommended
delaying the publication of the final rule for any and all warnings
requirements until the warnings format and content revisions proposed
in the NPR can be reviewed by ASTM Ad Hoc Task Group, balloted through
the ASTM process, and then implemented into F2167. The same commenter
also indicated that the formatting requirements in the bouncer NPR and
several other NPRs are inconsistent with each other.
Response 2: Human Factors staff at CPSC employs the ANSI Z535.4,
American National Standard for Product Safety Signs and Labels as a
baseline to develop warning materials. Since the NPR was published, the
ASTM Ad Hoc Task Group met and made recommendations for warning label
formatting across juvenile products. The ASTM Ad Hoc Task Group's
recommendations are based on ANSI Z535.4 and are more stringent than
the ANSI Z535 series. ASTM 2167-17 now incorporates recommendations
made by the Ad Hoc Task Group. Accordingly, the final rule incorporates
by reference ASTM 2167-17 without any modifications to warning label
format.
C. Warning Label Content
Comment 3: Two commenters recommended against the proposed addition
of ``even if baby is sleeping'' to the end of the precautionary
statement: ``Always use restraints. Adjust to fit snugly.'' One
commenter believes that this statement implies that sleeping in a
bouncer is acceptable and may encourage caregivers to use the product
for extended periods of sleep. The second commenter believes that this
statement contradicts the warning to never leave children unattended.
Response 3: Incident data associated with bouncer seats demonstrate
that unrestrained infants suffer serious head injuries from falls and
get into compromised positions that may result in suffocation. Tab A,
Staff NPR Briefing Package; Tab A, Staff Final Rule Briefing Package.
Young infants will sleep in bouncers as they spend more time asleep
than awake. Tab D, Staff NPR Briefing Package. Some bouncers in the
market include references to calming and soothing features of a
bouncer, as well as appropriateness for short periods of sleep in a
bouncer, such as ``Your child can also sleep for short periods of time
in the bouncer if he or she is content doing so.'' Based on incident
data, the final rule requires that the warning statement reference
sleep to reflect this foreseeable product use scenario and to address
the risk of injury from falls.
In October 2016, the ASTM Ad Hoc Task Group approved a recommended
warning to address products likely to be used for short-term sleep.\9\
The Commission agrees with the Ad Hoc Task Group's language and has
modified the warning in the final rule to use the phrase ``even if
child falls asleep'' to align with the Ad Hoc Task Group's language.
Manufacturers who produce bouncers in which infants should not be
allowed to sleep may add language to their warnings statements alerting
caregivers to this issue.
---------------------------------------------------------------------------
\9\ The recommended wording is as follows: ``Products likely to
be used for infants who are sleeping (i.e., bouncers, swings, infant
rockers, handheld carriers) that are not intended for periods of
unattended sleep, would benefit from this warning about unattended
use. Never leave child unattended, even if child falls asleep.''
---------------------------------------------------------------------------
Comment 4: One commenter recommended that the ASTM subcommittee
reach a consensus on the need for the additional proposed language:
``Stop using bouncer when baby starts trying to sit up.''
Response 4: At the January 12, 2016 ASTM meeting, the F15.18
subcommittee on Infant Bouncer Seats reviewed and agreed with the
Commission's proposed language on developmental guidance. ASTM balloted
and approved the proposed language, and such language has been included
in ASTM F2167 since the 2016 version of the standard.
D. Other Warning Label Issues
Comment 5: Two commenters recommended that the warning label be
attached on the product using embroidery or stamping to increase its
permanency.
Response 5: The ASTM standard does not require a certain type of
attachment for labels but requires the labels to be tested per section
7.8 to determine the labels' permanency. A similar permanency test
procedure is used in other ASTM standards. No data were provided by the
commenter, and the Commission has no information suggesting that these
requirements are ineffective. Accordingly, the Commission incorporates
by reference ASTM F2167-17, without any modification to section 7.8.
Comment 6: Three commenters recommended using pictures to clarify
warning messages.
Response 6: The Commission acknowledges that well-designed graphics
can be useful to increase the noticeability of the warnings as they
help capture a user's attention. Pictograms are also helpful for users
with limited or no English literacy. However, the design of effective
graphics can be difficult. To avoid confusing consumers, a warning
pictogram should be developed with an empirical study and well tested
on the target audience. Although the Commission may take action in the
future if it believes graphic symbols are needed to reduce the risk of
injury associated with bouncer seats, the rule permits, but does not
mandate, such supporting graphics.
VII. Incorporation by Reference
Section 1229.2(a) of the final rule provides that infant bouncer
seats must comply with applicable sections of
[[Page 43476]]
ASTM F2167-17. The OFR has regulations concerning incorporation by
reference. 1 CFR part 51. These regulations require that, for a final
rule, agencies must discuss in the preamble to the rule the way in
which materials that the agency incorporates by reference are
reasonably available to interested persons, and how interested parties
can obtain the materials. Additionally, the preamble to the rule must
summarize the material. 1 CFR 51.5(b).
In accordance with the OFR's requirements, the discussion in
section VIII of this preamble summarizes the required provisions of
ASTM F2167-17. Interested persons may purchase a copy of ASTM F2167-17
from ASTM, either through ASTM's Web site, or by mail at the address
provided in the rule. A copy of the standard may also be inspected at
the CPSC's Office of the Secretary, U.S. Consumer Product Safety
Commission, as discussed above. Note that the Commission and ASTM
arranged for commenters to have ``read only'' access to ASTM F2167-15
during the NPR's comment period.
VIII. Description of the Final Rule
Section 1229.2(a) of the final rule for infant bouncer seats
incorporates by reference ASTM F2167-17 with two modifications, as
stated in Sec. 1229.2(b), related to the content and placement of
warnings. Section 1229.2(a) includes the following key provisions
summarized below: scope, terminology, general requirements, performance
requirements, test methods, marking and labeling, and instructional
literature. As described below, Sec. 1229.2(b) includes modifications
to test methods (Sec. 1229.2(b)(1)), marking and labeling (Sec.
1229.2(b)(2) and (3)), and instructional literature (Sec.
1229.2(b)(4)).
Scope. Section 1 of ASTM F2167-17 states the scope of the standard,
detailing what constitutes an ``infant bouncer seat.'' As stated in
section II.A of this preamble, the Scope section defines an ``infant
bouncer seat'' as ``a freestanding product intended to support an
occupant in a reclined position to facilitate bouncing by the occupant,
with the aid of a caregiver or by other means.'' ASTM F2167-17 states
that infant bouncer seats are intended for ``infants who have not
developed the ability to sit up unassisted (approximately 0 to 6 months
of age).''
Terminology. Section 3 of ASTM F2167-17 provides definitions of
terms specific to this standard.
General Requirements. Section 5 of ASTM F2167-17 addresses numerous
hazards with several general requirements, most of which are also found
in the other ASTM juvenile product standards. Several requirements
reference an existing CPSC standard. The following general requirements
apply to bouncer seats. Where the ASTM standard relies on a CPSC
mandatory standard, the mandatory standard is cited in parentheses next
to the requirement:
Hazardous sharp points and edges (16 CFR 1500.48 and
1500.49);
Small parts (16 CFR part 1501);
Lead in paint (16 CFR part 1303);
Wood parts;
Latching and locking mechanisms;
Scissoring, shearing, and pinching;
Openings;
Exposed coil springs;
Protective components;
Permanency of labels and warnings; and
Toys (ASTM F963).
Performance Requirements and Test Methods. Sections 6 and 7 of ASTM
F2167-17 contain performance requirements specific to bouncer seats, as
well as test methods that must be used to assess conformity with such
requirements. Accordingly, the final rule includes performance
requirements for the following:
Restraints;
Stability (forward, sideward, and rearward);
Slip Resistance
Structural Integrity;
Dynamic and Static Load;
Disassembly/Collapse;
Drop Test;
Toy Bar Attachment Integrity; and
Battery Compartment.
Additionally, section 7 of ASTM F2167-17 includes test procedures
to ensure the permanency of labels and warnings, and a fall hazard
visibility test. The test procedure in Sec. 1229.2(b)(1) of the final
rule replaces the fall hazard visibility test in section 7.11.3.1 of
ASTM F2167-17, as described in section V.B.2 of this preamble.
Marking and Labeling. Section 8 of ASTM F2167-17 requires products
to be marked or labeled with manufacturing information and relevant
product warnings. Warning label requirements for bouncer seats in
section 8.4.5 of ASTM F2167-17 require two groups of warning
statements, a fall hazard warning and a suffocation warning. ASTM
F2167-17 includes warning language and formatting requirements for both
falls and suffocation warnings. Section 8.4.7.1 requires the fall
hazard warning to be placed on the front surface of the infant bouncer
seat back, so that it complies with the visibility requirement in
section 7.11.
Section 1229.2(b)(2) of the final rule replaces the content of the
fall hazard warning in section 8.5.1.1 of ASTM F2167-17. Section
1229.3(b)(3) of the final rule replaces the content of the suffocation
hazard warning in sections 8.5.2.1 and 8.5.3 in ASTM F2167-17. Changes
to warning content and the visibility test for the placement of the
fall hazard warning are outlined in section V.B.1-2 of this preamble.
Instructional Literature. Section 9 of ASTM F2167-17 requires that
instructions be provided with bouncer seats and be easy to read and
understand. Additionally, the section contains requirements relating to
instructional literature contents, including warnings.
Section 1229.2(b)(4) of the final rule replaces the content of
sections 9.2.1 and 9.2.2 of ASTM F2167-17. These sections contain
example warning labels or references to example warning labels. The
content of the example warning labels in Sec. 1229.2(b)(4) reflects
changes to the content of the fall hazard warning and suffocation
hazard warning in Sec. 1229.2(b)(2) and (3) of the final rule. Changes
to the instructional literature that relate to warnings content are
outlined in section V.B.1-2 of this preamble.
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). CPSC generally considers 6 months to be
sufficient time for suppliers of durable infant and toddler products to
come into compliance with a new standard under section 104 of the
CPSIA. Six months is also the period that the Juvenile Products
Manufacturers Association (JPMA) typically allows for products in the
JPMA certification program to transition to a new standard once that
standard is published. The Commission proposed a 6-month effective date
in the NPR for infant bouncer seats and we received no comments on the
proposed effective date. Accordingly, the final rule for bouncer seats,
as well as the amendment to part 1112, has a 6-month effective date.
X. Regulatory Flexibility Act
A. Introduction
The Regulatory Flexibility Act (RFA), 5 U.S.C. 601-612, requires
that agencies review a proposed rule and a final rule for the rule's
potential economic impact on small entities, including small
businesses. Section 604 of the RFA generally requires that agencies
prepare a final regulatory flexibility analysis (FRFA) when
promulgating final rules,
[[Page 43477]]
unless the head of the agency certifies that the rule will not have a
significant economic impact on a substantial number of small entities.
Staff prepared a FRFA that is available at Tab C of the Staff Final
Rule Briefing Package. We provide a summary of the FRFA below.
The final rule is unlikely to have a significant economic impact on
the five domestic manufacturers of infant bouncer seats. Of the six
small importers, a significant economic impact cannot be ruled out for
four of the importers, either as a result of the final rule
requirements or the resulting third party testing costs. Therefore, the
Commission cannot rule out a significant economic impact for four of
the 11 firms (36 percent) operating in the U.S. market for bouncers.
B. The Product
An infant bouncer seat is defined in ASTM F2167-17, Standard
Consumer Safety Specification for Infant Bouncer Seats, as ``a
freestanding product intended to support an occupant in a reclined
position to facilitate bouncing by the occupant, with the aid of a
caregiver or by other means.'' These products vary widely in price;
they can be purchased for as little as $20, but can also easily cost
more than $200.
C. The Market for Infant Bouncer Seats
For the FRFA, the Commission identified 23 firms supplying infant
bouncer seats to the U.S. market, with several firms moving into or out
of the market since the NPR. These firms primarily specialize in the
manufacture and/or distribution of children's products, including
durable nursery products. Eight of the 23 known firms are domestic
manufacturers and eight are domestic importers. The remaining seven
firms are foreign (4 manufacturers, 2 importers, and 1 retailer).\10\
We expect that the infant bouncer seats of 14 of these firms already
comply with ASTM F2167 because the firms either: (1) Have their
bouncers certified by JPMA (five firms); (2) claim compliance with the
voluntary standard (eight firms); or (3) have been tested to the ASTM
standard by CPSC staff (one firm).\11\
---------------------------------------------------------------------------
\10\ Staff categorized each firm using information from Dun &
Bradstreet and ReferenceUSAGov, as well as firm Web sites.
\11\ JPMA typically allows six months for products in their
certification program to become compliant with a new voluntary
standard once it is published. Therefore, firms are likely already
complying with ASTM F2167-16, which was published in May 2016. They
are not expected to comply with the recently published ASTM F2167-17
until December 2017.
---------------------------------------------------------------------------
D. Impact on Small Businesses
The Commission is aware of approximately 23 firms currently
marketing infant bouncer seats in the United States, 16 of which are
domestic. Under U.S. Small Business Administration (SBA) guidelines, a
manufacturer of infant bouncer seats is categorized as small if it has
500 or fewer employees, and importers and wholesalers are considered
small if they have 100 or fewer employees. We have limited our analysis
to domestic firms because SBA guidelines and definitions pertain to
U.S.-based entities. Based on these guidelines, the Commission
determined that about 11 of the 23 firms are small--five domestic
manufacturers and six domestic importers. Additional unknown small
domestic infant bouncer seat suppliers may be operating in the U.S.
market.
1. Small Manufacturers
The economic impact of the final rule for infant bouncer seats
should be small for the five small domestic manufacturers. Each firm
has an established history of compliance with the ASTM standard for
infant bouncers and is therefore expected to be compliant with ASTM
F2167-17, the version of the voluntary standard upon which the final
rule is based, by the time the mandatory standard becomes final.
None of these firms includes more than four languages in their
warnings and redesign is not expected. Based upon staff's inspection of
their products, we expect products to have more than sufficient space
for the required warning labels under the modified warning label for
the final rule without the products seeming cluttered.
Under section 14 of the CPSA, once the new infant bouncer seat
requirements become effective, all manufacturers will be subject to the
third party testing and certification requirements under the CPSA and
the Testing and Labeling Pertaining to Product Certification rule (16
CFR part 1107) (1107 rule). Third party testing will include any
physical and mechanical test requirements specified in the final infant
bouncer seats rule. Manufacturers and importers should already be
conducting required lead testing for bouncer seats.
Third party testing costs are in addition to the direct costs of
meeting the infant bouncer seats standard. The Initial Regulatory
Flexibility Analysis (IRFA) prepared for the NPR concluded that we
could not rule out a significant economic impact, given that we do not
know specifically how much the third party requirement adds to testing
costs or precisely how many models are needed to meet the ``high degree
of assurance'' standard but that it was unlikely to be economically
significant for most small manufacturers (i.e., testing costs would be
less than 1 percent of gross revenue). Given that these firms are
already testing to the voluntary standard and the Commission received
no public comments about third party testing, the Commission believes
that it is unlikely that third party testing would have a significant
economic impact on any of the five small manufacturers.
2. Small Importers
a. Small Importers With Compliant Infant Bouncer Seats
As noted in the IRFA, imported bouncers tend to be produced to meet
the requirements for several trading partners simultaneously, including
their different labeling requirements. Producers for international
markets typically address labeling requirements for their various
trading partners by simply providing a warning that covers all required
safety issues in multiple languages. Specificity regarding warning
label location impacts the practicability of replicating the warning
label in multiple languages. This could mean that foreign producers
will need to design a product for the U.S. market or reduce the number
of languages used for warnings on U.S.-bound bouncer seats.
The final rule provides additional space for warning label
placement than that proposed in the NPR. With this additional space,
reducing on-product warning languages should be a more viable
alternative for firms than it was under the NPR proposal. Firms would
not need to reduce the number of languages for their on-product
warnings for the final rule as significantly as that required in the
NPR. The additional space addresses the location requirement in the
final rule, while ensuring that the appearance of bouncers remains
comparable to firms' competitor products (for which one to three
languages is typical).
Three small importers of infant bouncer seats are currently in
compliance with the voluntary standard; these firms likely would
continue compliance as new versions of the voluntary standard are
published. One importer is unlikely to experience a significant
economic impact, even if the importer opted to redesign its bouncers to
accommodate more than eight warning label languages. The cost estimate
to redesign an infant bouncer (based on information from several
[[Page 43478]]
firms) is between $200,000 and $300,000, which is less than 1 percent
of this firm's revenue. The remaining two small importers of compliant
bouncer seats might experience significant economic costs, based on the
same comparison (i.e., $200,000 to $300,000 could represent more than 1
percent of their annual revenue). Although the Commission does not
expect that these firms would require space for warning labels in more
than eight languages, we cannot rule out a significant economic impact
for one of these two firms, given an extremely low revenue level
compared to estimated costs for redesign. The second firm appears to
have the option of exiting the bouncer market without experiencing a
significant impact.
b. Small Importers With Noncompliant Infant Bouncer Seats
Three firms import bouncers that do not comply with the voluntary
standard. The bouncers for these firms will require changes to come
into compliance with the voluntary standard as well as modifications to
meet the warning label requirements in the final rule. In the absence
of information on precisely what changes would be required to bring the
bouncer seats supplied by all three firms into compliance with the
final rule (as well as information on sales revenue for all three
firms), the Commission cannot rule out a significant economic impact
for any of these firms.
The magnitude of the economic impact on the three firms with
noncompliant infant bouncer seats will depend upon the cost of the
changes required and the degree to which their supplying firms pass on
any increases in production costs associated with changes to the
product needed to meet the mandatory standard (a redesign is estimated
to cost between $200,000 to $300,000). Two of the firms are directly
tied to their foreign suppliers and therefore, finding an alternate
supply source would not be a viable alternative. However, given this
close relationship, it seems likely that their foreign suppliers would
have an incentive to work with their U.S. subsidiaries to maintain an
American market presence. One of those two firms likely would only
avoid a significant economic impact if their supplier absorbed 100
percent of the cost of a redesign. The third firm imports and
wholesales a wide variety of children's products. We do not know,
however, how much of the firm's revenue is due to bouncer sales and
cannot determine what impact discontinuing bouncer sales might have on
the third firm should the firm be unable to find a supplier of bouncers
that comply with the standard.
Based on the additional space provided in the final rule for
placement of the fall hazard warning label, two of these firms should
not require modifications to meet the requirement in the final rule
(although they would have required modifications under the NPR).
c. Third Party Testing Costs for Small Importers
As with manufacturers, all importers will be subject to third-party
testing and certification requirements, and consequently, will be
subject to costs similar to those for manufacturers if their supplying
foreign firm(s) does not perform third party testing. Half of the
bouncer seat importers (3 of 6) are already testing their products to
verify compliance with the ASTM standard, and any costs would be
limited to the incremental costs associated with third party testing
over the current testing regime.
The Commission was able to obtain revenue data for one of the small
importers with noncompliant bouncers. For that importer, third party
testing costs, considered alone and apart from any additional
performance requirements due to the final rule, would not exceed one
percent of gross revenue unless around 12 units per model required
testing to provide the ``high degree of assurance'' required by 16 CFR
part 1107. The Commission has no basis for estimating the size of the
impact for the remaining two importers of noncompliant bouncers.
E. Summary of Impacts
The Commission is aware of 11 small firms, five domestic
manufacturers and six domestic importers, currently marketing infant
bouncer seats in the United States. With regards to the five domestic
manufacturers, the Commission considers it unlikely that testing costs
would have a significant impact on any of these firms. Of the six small
importers, a significant economic impact cannot be ruled out for four
of the importers either as a result of the final rule requirements or
the resulting third party testing costs. Therefore, the Commission
cannot rule out a significant economic impact for four of the 11 firms
(36 percent) operating in the U.S. market for bouncers.
F. Alternatives
One of the alternatives to reduce the impact on small entities
discussed in the NPR was to adopt the voluntary standard with all of
the modifications to the on-product warning labels, except for the
location specificity (i.e., next to the child's head). Based on
comments received, the requirements regarding on-product warning label
placement have been modified in the final rule (i.e., up from the
child's armpits on either side). This modification provides additional
room and will reduce the economic impact of the warning label location
specificity on small suppliers. The Commission could further reduce the
economic impact on small entities by eliminating the location
requirement for the fall hazard warning entirely. However, this would
reduce the effectiveness of the fall hazard warning label. The location
for the fall hazard warning ``allows caregivers to notice the label
while making eye contact with the infant, and potentially creates
mental images of the consequence (``skull fracture'') of not complying
with the instructions . . .'' Tab D, Staff NPR Briefing Package; Tab B,
Staff Final Rule Briefing Package.
The Commission considered two additional alternatives discussed in
the NPR that might minimize the economic impact on small entities: (1)
Adopt ASTM F2167-17 with no modifications; and (2) allow a later
effective date.
Section 104 of the CPSIA requires that the Commission promulgate a
standard that is either substantially the same as the voluntary
standard or more stringent. Therefore, adopting ASTM F2167-17 with no
modifications is the least stringent rule allowed by law. This
alternative would reduce the impact on all of the known small
businesses supplying infant bouncers to the U.S. market. If it were
adopted, it should eliminate any economic impact related to warning
label changes, but firms would continue to be affected by third party
testing requirements. However, adopting ASTM F2167-17 without
modification would not adequately address the fall hazard scenario
identified in the incident data and would reduce the effectiveness of
the fall hazard warning label.
Finally, the Commission could reduce the final rule's impact on
small businesses by setting a later effective date. A later effective
date would reduce the economic impact on firms in two ways. Firms would
be less likely to experience a lapse in production/importation, which
could result if they are unable to comply and third party test within
the required timeframe. Also, firms could spread costs over a longer
time period, thereby reducing their annual costs, as well as the
present value of their total costs. However, the Commission received no
comments asserting that firms would not have sufficient time to comply
with the
[[Page 43479]]
proposed 6 month effective date. Accordingly, the Commission declines
to extend the effective date of the final rule.
G. Small Business Impacts of the Accreditation Requirements for Testing
Laboratories
In accordance with section 14 of the CPSA, all children's products
that are subject to a children's product safety rule must be tested by
a CPSC-accepted third party conformity assessment body (i.e., testing
laboratory) for compliance with applicable children's product safety
rules. Testing laboratories that want to conduct this testing must meet
the NOR pertaining to third party conformity testing. NORs have been
codified for existing rules at 16 CFR part 1112. Consequently, the
Commission finalizes an amendment to 16 CFR part 1112 that establishes
an NOR for those testing laboratories that want to test for compliance
with the bouncers final rule. This section assesses the impact of the
amendment on small laboratories.
A FRFA was conducted as part of the promulgation of the original
1112 rule (78 FR 15836, 15855-58) as required by the RFA. Briefly, the
FRFA concluded that the accreditation requirements would not have a
significant adverse impact on a substantial number of small
laboratories because no requirements were imposed on laboratories that
did not intend to provide third party testing services. The only
laboratories that were expected to provide such services were those
that anticipated receiving sufficient revenue from the mandated testing
to justify accepting the requirements as a business decision.
Based on similar reasoning, amending the rule to include the NOR
for the bouncer standard will not have a significant adverse impact on
small laboratories. Moreover, based upon the number of laboratories in
the United States that have applied for CPSC acceptance of the
accreditation to test for conformance to other juvenile product
standards, we expect that only a few laboratories will seek CPSC
acceptance of their accreditation to test for conformance with the
infant bouncer seat standard. 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 bouncer standard to their scope of accreditation, a cost
that test laboratories have indicated is extremely low when they are
already accredited for other section 104 rules. As a consequence, the
Commission certifies that the NOR for the infant bouncer seat standard
will not have a significant impact on a substantial number of small
entities.
XI. Environmental Considerations
The Commission's regulations address whether the agency is required
to prepare an environmental assessment or an environmental impact
statement. Under these regulations, a rule that has ``little or no
potential for affecting the human environment,'' is categorically
exempt from this requirement. 16 CFR 1021.5(c)(1). The final rule for
bouncer seats falls within the categorical exemption.
XII. Paperwork Reduction Act
The final rule for infant bouncer seats contains information
collection requirements that are subject to public comment and review
by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3520). The preamble to the
proposed rule (80 FR at 63181-82) discussed the information collection
burden of the proposed rule and specifically requested comments on the
accuracy of our estimates. OMB has assigned control number 3041-0174 to
this information collection. We did not receive any comment regarding
the information collection burden of the proposal. However, the final
rule makes modifications regarding the information collection burden
because the number of estimated manufacturers subject to the
information collection burden is now estimated at 23 manufacturers
rather than the 22 manufacturers initially estimated in the proposed
rule.
Accordingly, the estimated burden of this collection of information
is modified as follows:
Table 1--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Frequency of Total annual Hours per Total burden
16 CFR Section respondents responses responses response hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
1229............................................................... 23 4 92 1 92
--------------------------------------------------------------------------------------------------------------------------------------------------------
Our estimate is based on the following:
Section 8.1 of ASTM F2167-17 requires that all infant bouncer seats
and their retail packaging be permanently marked or labeled as follows:
The manufacturer, distributor, or seller name, place of business (city,
state, mailing address, including zip code), and telephone number; and
a code mark or other means that identifies the date (month and year as
a minimum) of manufacture.
CPSC is aware of 23 firms that supply bouncer seats in the U.S.
market. For PRA purposes, we assume that all 23 firms use labels on
their products and on their packaging already. All firms will need to
make some modifications to their existing labels. We estimate that the
time required to make these modifications is about 1 hour per model.
Each of the 23 firms supplies an average of four different models of
bouncer seats. Therefore, we estimate the burden hours associated with
labels to be 92 hours annually (1 hour x 23 firms x 4 models per firm =
92 hours annually).
We estimate the hourly compensation for the time required to create
and update labels is $33.58 (U.S. Bureau of Labor Statistics,
``Employer Costs for Employee Compensation,'' March 2017, Table 9,
total compensation for all sales and office workers in goods-producing
private industries: https://www.bls.gov/ncs/). Therefore, we estimate
the annual cost to industry associated with the labeling requirements
in the final rule to be approximately $3,089 ($33.58 per hour x 92
hours = $3,089.36). This collection of information does not require
operating, maintenance, or capital costs.
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3507(d)), we have submitted the information collection requirements of
this final rule to the OMB.
XIII. Preemption
Section 26(a) of the CPSA, 15 U.S.C. 2075(a), provides that when 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
[[Page 43480]]
certain circumstances. Section 104(b) of the CPSIA refers to the rules
to be issued under that section as ``consumer product safety rules.''
Therefore, the preemption provision of section 26(a) of the CPSA
applies to this final rule issued under section 104.
XIV. Amendment to 16 CFR Part 1112 To Include NOR for Bouncer Seat
Standard
The CPSA establishes certain requirements for product certification
and testing. Products subject to a consumer product safety rule under
the CPSA, or to a similar rule, ban, standard or regulation under any
other act enforced by the Commission, must be certified as complying
with all applicable CPSC-enforced requirements. 15 U.S.C. 2063(a).
Certification of children's products subject to a children's product
safety rule must be based on testing conducted by a CPSC-accepted third
party conformity assessment body. Id. 2063(a)(2). The Commission must
publish an NOR for the accreditation of third party conformity
assessment bodies to assess conformity with a children's product safety
rule to which a children's product is subject. Id. 2063(a)(3). The
Safety Standard for Infant Bouncer Seats, to be codified at 16 CFR part
1229, is a children's product safety rule that requires the issuance of
an NOR.
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).
Part 1112 became effective on June 10, 2013 and establishes
requirements for accreditation of third-party conformity assessment
bodies (or laboratories) to test for conformance with a children's
product safety rule in accordance with section 14(a)(2) of the CPSA.
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 standard for bouncer seats,
require the Commission to amend part 1112. Accordingly, the Commission
is now amending part 1112 to include the standard for infant bouncer
seats in the list of 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 infant
bouncer seats would be required to meet the third-party conformity
assessment body accreditation requirements in 16 CFR part 1112,
Requirements Pertaining to Third-Party Conformity Assessment Bodies.
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 1229, Safety Standard for Infant Bouncer Seats,
included in its scope of accreditation of CPSC safety rules listed for
the laboratory on the CPSC Web site at: www.cpsc.gov/labsearch.
As required by the RFA, staff conducted a FRFA when the Commission
issued the part 1112 rule (78 FR 15836, 15855-58). Briefly, the FRFA
concluded that the accreditation requirements would not have a
significant adverse impact on a substantial number of small test
laboratories because no requirements were imposed on test laboratories
that did not intend to provide third-party testing services. The only
test laboratories that were expected to provide such services were
those that anticipated receiving sufficient revenue from the mandated
testing to justify accepting the requirements as a business decision.
Moreover, a test laboratory would only choose to provide such services
if it anticipated receiving revenues sufficient to cover the costs of
the requirements.
Based on similar reasoning, amending 16 CFR part 1112 to include
the NOR for the infant bouncer seats standard will not have a
significant adverse impact on small test laboratories. Moreover, based
upon the number of test laboratories in the United States that have
applied for CPSC acceptance of accreditation to test for conformance to
other mandatory juvenile product standards, we expect that only a few
test laboratories will seek CPSC acceptance of their accreditation to
test for conformance with the infant bouncer seats standard. Most of
these test laboratories will have already been accredited to test for
conformity to other mandatory juvenile product standards, and the only
costs to them would be the cost of adding the infant bouncer seats
standard to their scope of accreditation. For these reasons, the
Commission certifies that the NOR amending 16 CFR part 1112 to include
the infant bouncer seats standard will not have a significant impact on
a substantial number of small entities.
List of Subjects
16 CFR Part 1112
Administrative practice and procedure, Audit, Consumer protection,
Incorporation by reference, Reporting and recordkeeping requirements,
Third party conformity assessment body.
16 CFR Part 1229
Bouncer seats, Chairs, Consumer protection, Imports, Incorporation
by reference, Infants and children, Labeling, Law enforcement, Seats,
and Toys.
For the reasons discussed in the preamble, the Commission amends
title 16 of the Code of Federal Regulations as follows:
PART 1112--REQUIREMENTS PERTAINING TO THIRD PARTY CONFORMITY
ASSESSMENT BODIES
0
1. The authority citation for part 1112 continues to read as follows:
Authority: 15 U.S.C. 2063; Pub. L. 110-314, section 3, 122
Stat. 3016, 3017 (2008).
0
2. Amend Sec. 1112.15 by adding paragraph (b)(42) 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) * * *
(42) 16 CFR part 1229, Safety Standard for Infant Bouncer Seats.
* * * * *
0
3. Add part 1229 to read as follows:
PART 1229--SAFETY STANDARD FOR INFANT BOUNCER SEATS
Sec.
1229.1 Scope.
1229.2 Requirements for infant bouncer seats.
Authority: Sec. 104, Pub. L. 110-314, 122 Stat. 3016 (15 U.S.C.
2056a).
Sec. 1229.1 Scope.
This part establishes a consumer product safety standard for infant
bouncer seats.
Sec. 1229.2 Requirements for infant bouncer seats.
(a) Except as provided in paragraph (b) of this section, each
infant bouncer seat must comply with all applicable provisions of ASTM
F2167-17, Standard Consumer Safety Specification for Infant Bouncer
Seats, approved on June 1, 2017. The Director of the Federal Register
approves this incorporation by reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. You may obtain a copy from ASTM
International, 100 Bar Harbor Drive, P.O. Box 0700, West Conshohocken,
PA 19428; https://www.astm.org/cpsc.htm. You may inspect a copy at the
Office of the Secretary, U.S. Consumer Product Safety Commission, Room
820, 4330 East West Highway, Bethesda, MD 20814, telephone 301-504-
7923, or at
[[Page 43481]]
the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.
(b) Comply with ASTM F2167-17 with the following additions or
exclusions:
(1) Instead of complying with section 7.11.3.1 of ASTM F2167-17,
comply with the following:
(i) 7.11.3.1 Visibility With CAMI Dummy Restrained in Seat--While
standing in front of the product with the Newborn CAMI dummy installed,
verify that the required warnings are visible and placed above an
imaginary horizontal line that crosses through the junctions of under
arm and side of the torso armpits on both left and right and not
obscured by any part of the dummy (as shown in paragraph (b)(1)(ii),
``Fig. 10'').
(ii) Fig. 10: CAMI Dummy Restrained in Seat; Allowable area for
warning label placement starts from the dotted line that crosses the
junctions of underarm and both sides of the torso.
[GRAPHIC] [TIFF OMITTED] TR18SE17.001
(2) In section 8.5.1.1 of ASTM F2167-17, replace the warning
statement ``ALWAYS use restraints. Adjust to fit snugly'' with ``ALWAYS
use restraints and adjust to fit snugly, even if baby falls asleep.''
(3) In section 8.5.2.1 of ASTM F2167-17, replace the warning
statement ``ALWAYS use restraints. Adjust to fit snugly'' with ``ALWAYS
use restraints and adjust to fit snugly, even if baby falls asleep.''
(4) In section 8.5.3 of ASTM F2167-17, replace the reference to
``Figs. 10 and 11'' with ``Figs. 11 and 12.''
(5) In section 9.2.1 of ASTM F2167-17:
(i) Replace the reference to ``Fig. 12'' with ``Fig. 13.''
(ii) Replace Fig. 10 with paragraph (b)(5)(iii), ``Fig. 11''.
(iii) Fig. 11: Fall Hazard Warning.
[GRAPHIC] [TIFF OMITTED] TR18SE17.002
[[Page 43482]]
(iv) Replace Fig. 11 with paragraph (b)(5)(v), ``Fig. 12''.
(v) Fig. 12: Suffocation Hazard Warning.
[GRAPHIC] [TIFF OMITTED] TR18SE17.003
(vi) Replace Fig. 12 with paragraph (b)(5)(vii), ``Fig. 13''.
(vii) Fig. 13: Instruction Warning Statements.
[GRAPHIC] [TIFF OMITTED] TR18SE17.004
(6) In section 9.2.2 of ASTM F2167-17, replace the reference to
``Fig. 12'' with ``Fig. 13.''
Alberta E. Mills,
Acting Secretary, Consumer Product Safety Commission.
[FR Doc. 2017-19255 Filed 9-15-17; 8:45 am]
BILLING CODE 6355-01-P