Safety Standard for Bedside Sleepers, 73345-73354 [2012-29583]
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Federal Register / Vol. 77, No. 237 / Monday, December 10, 2012 / Proposed Rules
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[FR Doc. 2012–29710 Filed 12–7–12; 8:45 am]
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Issued in Renton, Washington, on
November 30, 2012.
Ali Bahrami,
Manager, Transport Airplane Directorate,
Aircraft Certification Service.
BILLING CODE 4910–13–P
CONSUMER PRODUCT SAFETY
COMMISSION
16 CFR Parts 1112 and 1222
[Docket No. CPSC–2012–0067]
Safety Standard for Bedside Sleepers
Consumer Product Safety
Commission.
ACTION: Notice of proposed rulemaking.
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
concludes that more stringent
requirements would further reduce the
risk of injury associated with the
product. The Commission is proposing
a safety standard for bedside sleepers in
response to the direction under Section
104(b) of the CPSIA.
DATES: Submit comments by February
25, 2013.
ADDRESSES: Comments related to the
Paperwork Reduction Act aspects of the
marking, labeling, and instructional
literature of the proposed rule should be
directed to the Office of Information and
Regulatory Affairs, OMB, Attn: CPSC
Desk Officer, FAX: 202–395–6974, or
emailed to
oira_submission@omb.eop.gov.
Other comments, identified by Docket
No. CPSC–2012–0067, may be
submitted electronically or in writing:
Electronic Submissions: Submit
electronic comments to the Federal
eRulemaking Portal at: https://
www.regulations.gov. Follow the
instructions for submitting comments.
To ensure timely processing of
comments, the Commission is no longer
directly accepting comments submitted
by electronic mail (email), except
SUMMARY:
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through www.regulations.gov. The
Commission encourages you to submit
electronic comments by using the
Federal eRulemaking Portal, as
described above.
Written Submissions: Submit written
submissions in the following way: Mail/
Hand delivery/Courier (for paper, disk,
or CD–ROM submissions), preferably in
five copies, to: Office of the Secretary,
Consumer Product Safety Commission,
Room 820, 4330 East West Highway,
Bethesda, MD 20814; telephone (301)
504–7923.
Instructions: All submissions received
must include the agency name and
docket number for this proposed
rulemaking. All comments received may
be posted without change, including
any personal identifiers, contact
information, or other personal
information provided, to https://
www.regulations.gov. Do not submit
confidential business information, trade
secret information, or other sensitive or
protected information that you do not
want to be available to the public. If
furnished at all, such information
should be submitted in writing.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov, and insert the
docket number, CPSC–2012–0067, into
the ‘‘Search’’ box and follow the
prompts.
FOR FURTHER INFORMATION CONTACT:
Douglas A. Lee, Project Manager,
Directorate for Engineering Sciences,
Consumer Product Safety Commission,
5 Research Place, Rockville, MD 20850;
telephone 301–987–2073; email
dlee@cpsc.gov.
SUPPLEMENTARY INFORMATION:
A. Background and Statutory Authority
The Consumer Product Safety
Improvement Act of 2008, (CPSIA, Pub.
L. 110–314), was enacted on August 14,
2008. Section 104(b) of the CPSIA, part
of the Danny Keysar Child Product
Safety Notification Act, requires the
Commission to: (1) Examine and assess
the effectiveness of voluntary consumer
product safety standards for durable
infant or toddler products, in
consultation with representatives of
consumer groups, juvenile product
manufacturers, and independent child
product engineers and experts, and (2)
promulgate consumer product safety
standards for durable infant and toddler
products. These standards are to be
‘‘substantially the same as’’ applicable
voluntary standards or more stringent
than the voluntary standard if the
Commission concludes that more
stringent requirements would further
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reduce the risk of injury associated with
the product. The term ‘‘durable infant or
toddler product’’ is defined in section
104(f)(1) of the CPSIA as a durable
product intended for use, or that may be
reasonably expected to be used, by
children under the age of 5 years.
In this document, the Commission is
proposing a safety standard for bedside
sleepers. Bassinets and cradles are
specifically identified in section
104(f)(2)(L) as durable infant or toddler
products. Bedside sleepers are similar to
bassinets, and many bedside sleepers
also function as bassinets. In addition,
some beside sleepers are accessories to
play yards/non-full-size baby cribs. On
October 3, 2012, the Commission
approved a notice of proposed
rulemaking (NPR) for a Safety Standard
for Bassinets and Cradles (https://
www.cpsc.gov/library/foia/foia12/brief/
bassinetnpr.pdf). The Commission has
issued a Safety Standard for Play Yards,
codified at 16 CFR part 1221. Recently
the Commission has proposed specific
language to address hazards due to
misassembly of play yard bassinet
accessories in a notice of proposed
rulemaking (77 FR 52272, August 29,
2012). This proposed rule, if finalized,
would amend the Safety Standard for
Play Yards. The proposed rule for
beside sleepers would adopt many of
the requirements in the proposed NPR
for bassinets, as well as address the
hazards associated with the use of
bassinet play yard accessories that can
be assembled with missing key
structural requirements for bedside
sleeper play yard accessories.
Pursuant to Section 104(b)(1)(A), the
Commission consulted with
manufacturers, retailers, trade
organizations, laboratories, consumer
advocacy groups, consultants, and
members of the public in the
development of this proposed standard,
largely through the ASTM process. The
proposed standard is based on the
voluntary standard developed by ASTM
International (formerly the American
Society for Testing and Materials),
ASTM F2906–12, ‘‘Standard Consumer
Safety Specification for Bedside
Sleepers’’ (ASTM F2906–12), with
additions to make the standard more
stringent. The ASTM standard is
copyrighted, but it can be viewed as a
read-only document, only during the
comment period on this proposal, at:
https://www.astm.org/cpsc.htm, by
permission of ASTM.
B. The Product
ASTM F2906–12 defines ‘‘bedside
sleeper’’ as ‘‘a rigid frame assembly that
may be combined with a fabric or mesh
assembly, or both, used to function as
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sides, ends, or floor or a combination
thereof, and that is intended to provide
a sleeping environment for infants and
is secured to an adult bed.’’ A ‘‘multimode product’’ is ‘‘a unit that is
designed and intended to be used in
more than one mode (for example, a
play yard, bassinet, changing table,
hand held carrier, or bedside sleeper).’’
A bedside sleeper is intended to be
secured to an adult bed that permits
newborns and infants to sleep close by
an adult without being in the adult bed.
In current products, the horizontal sleep
surface is typically 1 inch to 4 inches
below the level of the adult bed’s
mattress. The side of the bedside sleeper
that is adjacent to the adult bed can
usually be lowered, thereby
differentiating bedside sleepers from
bassinets, where all four sides of a
bassinet are the same height. Bedside
sleepers are intended for use with
children up to the developmental stage
where they can push up on hands and
knees (about 5 months). This is the same
developmental range for the intended
users of bassinets. Current bedside
sleepers range in size from about 35″ x
20″ to 40″ x 30.″ They may have rigid
sides, but they are most commonly
constructed with a tube frame covered
by mesh or fabric.
Freestanding bassinets are not
covered under the proposed standard
for bedside sleepers. They are covered
under ASTM F2194–12a, ‘‘Standard
Consumer Safety Specification for
Bassinets and Cradles.’’
Several manufacturers produce
multiuse (or multimode) bedside sleeper
products that convert into bassinets
and/or play yards. Most bedside sleeper
products can be converted into a
bassinet by raising the lowered side to
have four equal-height sides, and a few
also convert into a bassinet and play
yard. Some play yards include bedside
sleeper accessories which, when
attached, convert the play yard into a
bedside sleeper; and some bassinets
convert into bedside sleepers. All of the
tube-framed products that have been
evaluated by CPSC staff may be
collapsed for storage and transport. A
bedside sleeper that can be used in
additional modes would need to meet
each applicable standard. For example,
a bedside sleeper product that converts
into a play yard and a bassinet would
have to meet: ASTM F2906 bedside
sleeper requirements, ASTM F2194
bassinet requirements (except for height
of the fourth lowered side for bedside
sleepers) and sections of the ASTM
F406 play yard requirements applicable
to bassinets when in the bedside sleeper
mode; ASTM F406 play yard
requirements when in play yard use
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mode; and ASTM F2194 bassinet
requirements and applicable sections of
ASTM F406 play yard requirements
when in bassinet mode.
To ensure consistency with the
existing and proposed standards for
bassinets and play yards, the
Commission is proposing additions to
the scope and performance
requirements of a bedside sleeper, as
discussed below.
C. The Voluntary Standard—ASTM
F2906
ASTM first published a voluntary
standard for bedside sleepers, ASTM
F2906–11, in December 2011. It
required bedside sleepers to meet the
voluntary standard requirements of the
product upon which it was based, either
a play yard/non-full-size baby cribs,
ASTM F406 (play yard standard) or a
bassinet, ASTM F2194 (bassinet
standard). The standard also addressed
hazards specific to bedside sleeper
products. It addressed incidents
involving the creation of a hazardous
gap between the product and an adult
mattress, by requiring the successful
completion of three disengagement
tests. The tests ensured that the securing
components can withstand forces that
may be exerted on the product by either
the child or an adult, while sleeping.
The gap must be no more than 0.5 in.
when the product is installed to the
adult bed, per manufacturer’s
directions. When a 25-lb. horizontal
force is applied near the attachment
system or corners, the gap may not
exceed 1.0 in. And, to simulate an adult
rolling into a bedside sleeper while
sleeping, a gap greater than 1.0 in. may
not be created after the application and
release of a 50-lb. horizontal force to the
bedside sleeper’s corners. The inclusion
of these anti-gap requirements served to
mitigate the foreseeable head and neck
entrapment hazards posed by bedside
sleepers. The standard requires a
minimum 4-inch lowered side height
over which a child is unlikely to be able
to roll. In addition, latching and locking
devices are evaluated to prevent
unintentional movement of the side that
lowers and to ensure overall product
integrity.
In 2012, the standard for bedside
sleepers was changed from meeting
either ASTM F406 (play yard standard)
or ASTM F2194 (bassinet standard), to
require all products to meet ASTM
F2194 only. The bassinet minimum
side-height requirement (the upper
surface of the non-compressed mattress
of a bassinet/cradle must be at least 7.5
inches lower than the upper surface of
the lowest side in all intended bassinet/
cradle use positions) is also required for
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beside sleepers, with the exception of a
lowered side rail (the height of the side
rail in the lowest position shall be no
less than 4 inches when measured from
the top of the uncompressed bedside
sleeper mattress to the top of the
lowered side rail, when the mattress
support is in its highest position.)
Bedside sleepers and bassinets share a
significant number of hazard patterns
because they are used by children with
the same developmental abilities and for
the same purpose. Many bedside
sleepers also function as bassinets. By
requiring beside sleepers to be tested to
ASTM F2194 (bassinets) rather than to
ASTM F406 (play yards), ASTM made
the bedside sleeper standard more
stringent because there are bedside
sleeper hazards covered by the bassinet
standard but that are not covered by the
play yard standard. Additionally, ASTM
F406 requires a bassinet accessory on a
play yard structure to meet the
applicable sections of the play yard
voluntary standard. These changes were
incorporated into ASTM F2906–12,
‘‘Standard Consumer Safety
Specification for Bedside Sleepers,’’ in
July 2012.
CPSC staff also reviewed mandatory
and voluntary international standards in
Canada, the European Union, Australia,
and New Zealand. There are some
international standards governing safe
sleep products for infants; however,
there are no specific requirements that
address the hazards unique to bedside
sleeper products. Canada has a
mandatory standard for cribs, cradles,
and bassinets, SOR/2010–26; the
European Union uses EN 1130 Cribs
and Cradles and EN 12790 Child Care
Articles—Reclined Cradles to assess and
market various design elements and
structures in bedside sleeper products.
In Australia and New Zealand, several
standards exist for safe sleep products–
AS/NZS 2172:2003 Cots (full-size and
non-full-size cribs that do not fold); AS/
NZS 2195:1999 Folding Cots (play yards
and folding cribs of any size); AS/NZS
4385:1996 Infants’ Rocking Cradles
(cradles and bassinets that tilt.)
The Juvenile Products Manufacturers
Association (JPMA) has a certification
program for a variety of juvenile
products, including bassinets and play
yards. Manufacturers that voluntarily
obtain JPMA certification submit
products to an independent test
laboratory for conformance testing to the
most recent version of the voluntary
standard. Manufacturers have 6 months
after publication of a new or revised
standard to certify products to the new
requirements. Currently, JPMA does not
have a certification program for bedside
sleepers, and no firm claims to meet the
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ASTM voluntary standard, ASTM
F2906–12. However, three firms supply
multimode products, where one mode is
compliant with the associated ASTM
voluntary standard. Two firms claim
compliance with the ASTM standard for
bassinets; one firm is JPMA-certified as
compliant, and the other claims
compliance with the ASTM bassinet
standard. A third firm supplies play
yards that are JPMA-certified as
compliant with the ASTM play yard/
non-full-size crib standard.
D. Incident Data
CPSC staff identified 40 cases of
bedside sleeper-related incidents from
2001 to 2011. The CPSC databases
searched were the In-Depth
Investigation database, the Injury or
Potential Injury Incident database, and
the Death Certificate file. National
estimates of bedside sleeper productrelated injuries are not available because
the National Electronic Injury
Surveillance System (NEISS) data does
not allow for clear identification of
bedside sleepers. Therefore, the risk of
injury associated with the number of
products in use cannot be calculated.
CPSC staff is aware of four fatalities
and 36 nonfatal incidents (with and
without injuries) related to bedside
sleepers that were reported from January
2001 through December 2011. Bedside
sleepers have been on the market since
1997. During this time, there have been
two recalls for product defects that
created a substantial product hazard.
One recall involved four deaths, three
from head entrapment and one from
suffocation, and several complaints on
the same entrapment hazard from a
bedside sleeper with a bassinet base.
This recall involved 3-in-1 and 4-in-1
convertible bassinets that contained
metal bars covered by an adjustable
fabric flap, attached with Velcro,® that
folded down when the bassinet was
converted into a bedside sleeper. If the
Velcro® was not resecured properly
when the flap was adjusted, an infant
could slip through the opening and
become entrapped in the metal bars and
suffocate. Because of additional
incidents, this recall was re-announced
three times. There were 900,000 units
recalled. The second recall involved a
bedside sleeper with a play yard base.
There were 10 reports of infants falling
from the mattress into the bottom of a
bedside sleeper or becoming entrapped
between the edge of the mattress and the
side of the bedside sleeper. There were
76,000 units recalled. Details of the
recalls can be found on the cpsc.gov
Web site.
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1. Fatalities
All four reported fatalities involved
the same brand of recalled bedside
sleeper/bassinet. In all four cases, the
product was being used in the bassinet
mode, with the adjustable side raised at
the time of the incident. Three of the
deaths were due to entrapment and/or
hanging, which resulted after an infant’s
body, but not head, slipped through the
fabric covering and underlying
structural components of a particular
brand of bedside sleeper. In two of these
three fatalities involving a 4-month-old
and a 6-month-old decedent, the infant’s
head was entrapped between the lower
horizontal bars (of the adjustable side)
and the top of the mattress. The fabric
flap designed to cover the metal bars
was not in place. In the third fatality,
the fabric flap covering the adjustable
side was not secured to the permanent
fabric siding, and the horizontal bars of
the adjustable side were broken/
missing. As a result, the 6-month-old
decedent’s body slipped out through an
opening in the fabric siding, but her
chin/throat got caught on a lower
crossbar. The fourth death occurred
when an infant moved into a corner
where the fabric covering the adjustable
side was not secured by the Velcro®
strip and the bassinet was also missing
the lower rail. This created a pocket
between the side and bassinet floor. The
infant was found with their head in the
pocket and face against the side of the
bassinet, resulting in suffocation.
2. Nonfatal Incidents
Of the 36 nonfatal incidents, there
were three reported injuries involving
infants, none hospitalized, during the
use of a bedside sleeper. All of the
injured infants were under 5 months of
age, which is within the ASTM
recommended user age range. Two of
the infants suffered bruising when they
were entrapped between the metal rungs
of the same product that had caused
three of the fatalities described in the
previous section. The third injury
occurred when the infant rolled into a
position where his neck was
hyperextended into a non-breathable
corner of the product, and he suffered
respiratory difficulties. In all three
cases, the caregiver was nearby to
prevent any serious consequences.
The remaining 33 reports indicated
that no injury occurred or provided no
information about any injury. However,
many of the descriptions in the reports
indicated the potential for a serious
injury, or even death, in bedside
sleepers. In cases where victim age was
reported, six reported ages between 6
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months and 8 months old; the other
infants were under 5 months of age.
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3. Hazard Pattern Analysis
CPSC staff considered all 40 incident
reports to identify the hazard patterns
associated with bedside sleeper-related
incidents. The hazard scenarios in 24 of
the 40 incidents (60 percent) reported
were attributed to some sort of failure/
defect or a potential design flaw in the
product. This category includes the four
fatalities and three non-hospitalized
injuries. Listed below are the reported
problems, beginning with the most
frequently reported concerns:
• A problem with the adjustable
fabric cover over the horizontal metal
bars on the side that lowers in the
bedside sleeper mode was responsible
for nine of the reported incidents. These
included all four fatalities and two of
the injuries. All of these incidents
involved one particular manufacturer’s
bedside sleeper/convertible bassinet
product, which was recalled in 2008.
Two of the fatalities occurred before the
CPSC recall; the third, which involved
a secondhand product in poor
condition, occurred after the 2008
recall, but prior to the 2009 recall
(which was an expansion of the 2008
recall). Between the two injuries, one
occurred prior to the 2008 recall, while
the other occurred after that recall.
Neither of the post-recall incident
reports indicated whether the
consumers were aware of the recall.
• Issues with assembly instructions
were identified in six reported
incidents. In all of these reports, the
consumer had misassembled the
product but reported the product as
being faulty. None of the incidents
resulted in any injury or fatality. All but
one of these incidents involved one
particular manufacturer’s bedside
sleeper, which was recalled in 2011.
• Miscellaneous other product-related
issues, such as non-levelness of the
product (two reports), instability of leg
extensions (two reports), poor design
(two reports), broken component (one
report), failure of the attachment (to
adult bed) mechanism (one report), and
unclear age labeling (one report) were
reported in the remaining incident
reports. One incident reported an injury
associated with poor product design.
• In response to CPSC recall notices,
there were 16 non-incident reports of
concerns or complaints. In these reports,
the consumer either sought advice on
options regarding a bedside sleeper
product they owned that had been
recalled, or they inquired about whether
the product they owned was within the
scope of the recall.
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E. Proposed Changes to ASTM F2906–
12
CPSC staff identified 24 incidents due
to defect or potential design flaws in the
product. The hazards associated with
these incidents included: Issues with
the adjustable fabric cover over the
metal bars on the side that lowered in
the bedside sleeper mode (9 incidents);
poor assembly instruction (6 incidents);
and miscellaneous other product-related
issues (9 incidents). To address these
incidents, the Commission proposes to
adopt by reference, ASTM
International’s voluntary standard,
ASTM F2906–12, Standard Consumer
Safety Specification for Bedside
Sleepers, with a few additions to
strengthen the standard. Section 5
(Performance Requirements) of ASTM
F2906–12 requires that in addition to
the tests provided in ASTM F2906–12,
the bedside sleeper must be tested to the
bassinet standard (ASTM F2194).
Specifically, section 5.1 provides that:
Prior to or immediately after testing to this
consumer safety specification, the bedside
sleeper must be tested to Consumer Safety
Specification F2194. Multi-mode products
must also be tested to each applicable
standard. When testing to Consumer Safety
Specification F2194 the unit shall be free
standing, and not be secured to the test
platform as dictated elsewhere in this
standard.
Because bedside sleepers already are
required to be tested to the applicable
bassinet standard requirements, and
multimode products, to each applicable
standard, the Commission proposes in
this rule to add clarifying language to
ensure that the requirements that are not
yet included in an existing standard or
proposed in an NPR (i.e., ASTM F406–
12a (play yards) and ASTM F2194–12
(bassinets)) are also included in ASTM
F2906–12 (bedside sleepers).
1. Fabric-Sided Enclosed Openings
The current version of ASTM F2194–
12a (bassinets) contains a Fabric-Sided
Enclosed Openings’ performance
requirement for bassinets. This
requirement prohibits completely
bounded openings large enough to
permit passage of an infant’s torso. The
hazard scenarios addressed by this
requirement encompass the three
strangulation deaths described above
and a related, foreseeable suffocation
hazard. These hazards occur when a
child passes through an opening, either
becomes trapped between the liner and
mattress pad and suffocates, or becomes
suspended by the neck, and then
strangles. This hazard, associated with a
recall of 900,000 units, led to three of
the four fatalities on a bassinet that
converts to a bedside sleeper. The
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bassinet test procedure (ASTM F2194–
12a, section 7.8) attempts to push a
torso probe the size of a 5th percentile
infant through bounded openings with
20 lbs of force. The test is first
performed with product assembled per
the manufacturer’s instructions. If the
product has a removable cover, it is
performed a second time after all
fasteners or snaps are unfastened, but
the removable cover left in place. In
doing so, the test intentionally
replicates the incorrectly secured fabric
liner hazard scenario of the fatal
incidents.
A manufacturer’s bedside sleeper
accessory exhibited this hazard, which
led to its recall in 2011. The recall was
initiated in response to incident reports
in which the bedside sleeper accessory’s
removable cover (liner or shell) was
either not used, or was present but not
secured to the play yard frame. This
bedside sleeper accessory can also be
used as a play yard, or a bassinet
accessory to a play yard. When in the
bassinet accessory position, the front
side of the product can be lowered,
transforming it into the beside sleeper
mode. A 11⁄2 year-old unused sample of
this product was recently retested by
CPSC staff, confirming that it fails the
ASTM F2194 fabric-sided enclosed
opening requirement. However, a new
sample of a similar model from the same
manufacturer passed this test. Staff
identified two possible reasons for
testing variances. One explanation is
that the fit of the shell to the play yard
frame becomes looser with repeated
assembly and disassembly. The other
reason is that the seam joining the mesh
and fabric part of the liner may be in a
slightly different location on some
models. The seam may cause sufficient
friction on the torso test probe during
force testing on some models.
Accordingly, minor changes in materials
or construction may not be sufficient to
remedy the hazard presented by the
fabric-sided, bounded opening hazard.
Under section 6.7 of ASTM F2194–12,
for bassinets/cradles with fabric sides, a
completely bounded opening may not
be created that allows the complete
passage of the torso probe (based on a
torso diameter of a 5th percentile 0 to
2-month-old infant) when tested in
accordance with the fabric release test
methods for enclosed openings.
However, the test does not apply to play
yard bassinets or play yard accessories.
Bassinets accessories to play yards (that
cannot be converted to bedside sleepers)
are usually held in place by fasteners
that clip to the top of the play yard’s
railing. If the fasteners were left
unclipped, the bassinet would fall,
rendering the product untestable, due to
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the complete collapse of the bassinet
attachment; test labs would likely
consider that a failure. However, for
bassinets that convert to a bedside
sleeper with a lowered side, CPSC staff
determined that all bedside sleeper play
yard accessories should be subject to the
requirements of the ASTM F2194–12
bassinet standard’s section 6.7 FabricSided Enclosed Opening without the
exemption for bassinet play yard
accessories, given the demonstrated
hazards presented when a bedside
sleeper’s removable cover (liner or shell)
is either not used, or not secured
properly.
The Commission proposes additional
language for the ASTM F2906 bedside
sleeper standard to add a new definition
for ‘‘bedside sleeper accessory’’ and
eliminate the fabric-sided bounded
opening performance requirement
exemption currently granted to play
yard bassinet accessories. Unlike
bassinet play yard accessories, bedside
sleeper (or a bassinet that is converted
into a bedside sleeper) play yard
accessories could have fasteners left
unclipped (through the detachment of
snaps/Velcro) where the bedside sleeper
with the lowered side does not
completely collapse. Because the
bedside sleeper could still appear
functional, the Commission proposes to
add language under Section 3
(Terminology) of ASTM F2906–12. The
new proposed section 3.1.8 would state:
‘‘bedside sleeper accessory, n—an
elevated sleep surface that attaches to a
non-full-size crib or play yard, designed
to convert the product into a bedside
sleeper intended to have a horizontal
sleep surface while in a rest (nonrocking) position.’’ The Commission
also proposes to add a new proposed
section 5.7, stating: ‘‘a Bedside Sleeper
Accessory Fabric-Sided Enclosed
Openings—A bedside sleeper accessory
shall meet the F2194 performance
requirement ‘‘Fabric-Sided Enclosed
Openings.’’ Under new proposed
section 5.7.1, bedside sleeper
accessories would be exempt from this
requirement if either of the following
two conditions were met after
disengaging all fasteners between the
accessory and the non-full-size crib or
play yard base to which it is assembled:
(1) The bedside sleeper accessory
collapses under its own weight, such
that any part of the mattress pad
contacts the bottom floor of the non-fullsize crib or play yard (5.7.1.1); or (2) the
bedside sleeper accessory’s sleep
surface tilts by more 30 degrees
(5.7.1.2). These requirements are also
consistent with the proposed
requirements in the NPR for the Safety
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Standard for Play Yards for play yard
bassinet accessory misassembly
provisions, which require all key
structural elements to be attached
permanently to the bassinet shell. The
second method of compliance is to meet
a catastrophic failure test, where a
missing key structural element makes
the product collapse completely or tilt
more than 30 degrees. 77 FR 52273.
2. Consumer Misassembly With Missing
Components
The Commission proposed a
requirement to address consumer
misassembly of key structural elements
for bassinet accessories to play yards in
the NPR for the Safety Standard for Play
Yards, 77 FR 52272. However, the NPR
for play yards did not include specific
language for bedside sleeper play yard
accessories. Although section 5
(Performance Requirements) of ASTM
2906–12 provides that bedside sleepers
must be tested to ASTM F2194
(bassinets), and multimode products
must also be tested to each applicable
standard, the Commission proposes to
add language to ASTM 2906–12
(bedside sleepers) to make explicit that
the requirements for addressing
consumer misassembly of key structural
elements is required for bedside sleeper
play yard accessories in addition to
bassinet play yard accessories.
As described at length in the NPR for
the Safety Standard for Play Yards, 77
FR 52272, omission of key structural
elements of a bassinet assembly (such as
rods, tubes, bars, and hooks that keep
the sleep surface flat and level) could
result in a tilt in the sleeping surface
and put the infant in a position where
he or she is unable to breathe and is at
risk of suffocation. This hazard is
magnified should these misassembled
products be used as an unsupervised
sleep environment, another reasonably
foreseeable scenario. Similarly, a
misassembled bedside sleeper play yard
accessory may not be readily apparent
or obvious to the consumer. If the
misassembled accessory supports an
infant without a catastrophic and
obvious change to the sleep surface, a
consumer may continue to use the
misassembled accessory and
inadvertently place a child in danger.
Bedside sleeper accessories and bassinet
accessories incorporate very similar
designs and manufacturing processes
(because many bedside sleepers also
function as bassinets), and many of the
same performance requirements are
applicable to both products.
Accordingly, in order to ensure that all
of the hazards associated with bedside
sleeper play yard accessories and
bassinet play yard accessories that can
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be assembled missing key structural
elements are addressed, the Commission
proposes to add under section 5
(Performance Requirements) to ASTM
F2906–12, new proposed section 5.8
Bedside Sleeper Play Yard Accessories
Missing Key Structural Elements. The
new section 5.8 will provide: A bedside
sleeper accessory shall meet the F406
general requirement, ‘‘Bassinet/Cradle
Accessories Missing Key Structural
Elements.’’
3. New Requirements for Bassinets
ASTM F2906–12 already requires
bedside sleepers to meet the
requirements of the bassinet standard,
ASTM F2194 ‘‘Standard Consumer
Product Safety Specification for
Bassinets and Cradles,’’ with the
exception of the height of the lowered
fourth side. Most bedside sleepers also
function as bassinets. The intended
users are identical, and the majority of
the hazards are identical. The
Commission’s proposed modifications
to address bassinet hazards in ASTM
F2194–12 have been discussed in great
detail in the NPR and in the Bassinet
NPR staff briefing package. Specifically,
the Commission proposed four changes
to the ASTM bassinet standard. Three of
those proposed changes to the bassinet
standard would also be applicable to
bedside sleepers. The fourth proposed
change would update the scope and
corresponding terminology specific to
bassinets under ASTM F2194, and it is
not applicable to bedside sleepers.
Three of the proposed requirements that
would apply to bedside sleepers
include: (1) Segmented Mattress
Flatness Requirement and Test Method;
(2) Removable Bassinet Bed Stability;
and (3) Stability Test Dummy. Because
bedside sleepers are already required to
be tested to the bassinet standard,
ASTM F2194, there is no need to add
language to the bedside sleeper standard
proposing these requirements and test
methods. Accordingly, if the proposed
changes to ASTM F2194 are finalized,
bedside sleepers will also be required to
meet the following requirements and
test methods in addition to all other
applicable requirements in ASTM
F2194. The following proposed changes
to the bassinet standard would also be
applicable to bedside sleepers:
A. Proposed Segmented Mattress
Flatness Requirement and Test Method
(Sections 6.9 and 7.10 of ASTM F2194–
12a)
In order to address the hazard of
suffocation/positional asphyxia due to
an excess mattress pad angle, the
Commission proposed performance
requirements and a test method for the
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minimum flatness of mattress surfaces.
This requirement would apply to
segmented mattresses, such as those
seen in a bassinet accessory to a play
yard. The Commission proposed that
the segmented mattresses commonly
used in play yards shall not create an
angle greater than 10 degrees when
tested using a 17-pound cylinder to
simulate the weight of a 6-month-old
infant. This performance requirement
and test method would also apply to a
segmented mattress used in a bedside
sleeper accessory to a play yard.
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B. Proposed New Performance
Requirement and Associated Definitions
To Address Hazards Associated With
the Stability of Removable Bassinet
Beds (Sections 3.1.3, 3.1.17, 3.1.18,
3.1.19, 3.1.20, 6.10, 7.11 of ASTM
F2194–12a)
In order to address hazards associated
with misassembly of removable bassinet
beds, the Commission proposed
performance requirements and a test
method for products that have bassinet
beds that attach to an elevated stand.
The requirements would apply to
removable bassinet beds that are
designed to separate from the stand/base
without the use of tools. The
Commission proposed that if a
removable bassinet bed is not properly
attached or assembled to its base, it
must meet one of the following
requirements:
• The base/stand shall not support
the bassinet (i.e., the bassinet bed falls
from the stand so that it is in contact
with the floor); or
• The lock/latch shall automatically
engage under the weight of the bassinet
bed (without any other force or action);
or
• The stand/base shall not be capable
of supporting the bassinet bed within 20
degrees of horizontal; or
• The bassinet shall contain a visual
indicator mechanism that shall be
visible on both sides of the product; or
• The bassinet bed shall not tip over
and shall retain the CAMI newborn
dummy when subjected to the stability
test outlined in the standard.
These requirements are equally
applicable to removable bedside
sleepers that are designed to separate
from the stand/base without the use of
tools.
C. Proposed Revised Test Procedure for
Bassinet Stability (Sections 2.3 and 7.4.4
of ASTM F2194–12a)
During evaluations of the test
methods for removable bassinet beds,
CPSC staff made comparisons of the
stability of products weighted with the
newborn CAMI dummy (7.45 lbs) as
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opposed to the infant CAMI dummy
(17.5 lbs). ASTM F 2194–12 contains a
stability requirement that uses the
heavier infant CAMI dummy. Use of the
newborn CAMI, which is readily
available to test labs and represents the
50th percentile newborn, would result
in a more conservative stability test. In
addition, bassinets are intended for use
with newborns. Accordingly, the
Commission proposed a revised test
procedure for bassinet stability that uses
a newborn CAMI instead of an infant
CAMI. This test procedure is equally
applicable to removable beside sleepers
that are designed to separate from the
stand/base without the use of tools
because they too are intended for use
with newborns.
F. Effective Date
The Administrative Procedure Act
(APA) generally requires that the
effective date of the rule be at least 30
days after publication of the final rule.
5 U.S.C. 553(d). To allow time for
bedside sleepers to come into
compliance, the Commission proposes
that the standard would become
effective 6 months after publication of a
final rule in the Federal Register. The
Commission invites comment on how
long it will take bedside sleeper
manufacturers to come into compliance
with the rule.
G. Regulatory Flexibility Act
1. Introduction
The Regulatory Flexibility Act (RFA),
5 U.S.C. 601–612, requires agencies to
consider the impact of proposed rules
on small entities, including small
businesses. Section 603 of the RFA
requires that the Commission prepare an
initial regulatory flexibility analysis and
make it available to the public for
comment when the notice of proposed
rulemaking is published. The initial
regulatory flexibility analysis must
describe the impact of the proposed rule
on small entities and identify any
alternatives that may reduce the impact.
Specifically, the initial regulatory
flexibility analysis must contain:
• A description of, and where
feasible, an estimate of the number of
small entities to which the proposed
rule will apply;
• A description of the reasons why
action by the agency is being
considered;
• A succinct statement of the
objectives of, and legal basis for, the
proposed rule;
• A description of the projected
reporting, recordkeeping, and other
compliance requirements of the
proposed rule, including an estimate of
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the classes of small entities subject to
the requirements and the type of
professional skills necessary for the
preparation of reports or records; and
• An identification, to the extent
possible, of all relevant federal rules
that may duplicate, overlap, or conflict
with the proposed rule.
In addition, the initial regulatory
flexibility analysis must contain a
description of any significant
alternatives to the proposed rule that
would accomplish the stated objectives
of the proposed rule and, at the same
time, reduce the economic impact on
small businesses.
2. The Market
Typically, bedside sleepers are
produced and/or marketed by juvenile
product manufacturers and distributors.
Currently, there are at least five known
manufacturers supplying bedside
sleepers to the U.S. market. Four are
domestic manufacturers, including one
manufacturer that dominates the
market. The fifth is a foreign
manufacturer who ships products
directly to the United States. There may
be additional unknown small
manufacturers and importers operating
in the U.S. market as well.
Under U.S. Small Business
Administration (SBA) guidelines, a
manufacturer of bedside sleepers is
small if it has 500 or fewer employees,
and an importer is considered small if
it has 100 or fewer employees. Based on
these guidelines, all four domestic
manufacturers known to be supplying
the U.S. market are small.
The Juvenile Products Manufacturers
Association (JPMA), the major U.S.
trade association that represents
juvenile product manufacturers and
importers, runs a voluntary Certification
Program for several juvenile products.
Under this program, products
voluntarily submitted by manufacturers
are tested against the appropriate ASTM
standard, and only passing products are
allowed to display JPMA’s Certification
Seal.
Currently, JPMA does not have a
Certification Program for bedside
sleepers, and no firm claims to meet the
ASTM bedside sleeper voluntary
standard. However, three firms supply
multimode products where one mode is
compliant with the associated ASTM
voluntary standard. Two firms claim
compliance with the ASTM standard for
bassinets; one firm is JPMA-certified as
compliant, and the other claims
compliance with the ASTM bassinet
standard. A third firm supplies play
yards that are JPMA-certified as
compliant with the ASTM play yard/
non-full-size crib standard.
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National estimates of bedside sleeper
product-related injuries are not
available because the National
Electronic Injury Surveillance System
(NEISS) data does not allow for clear
identification of bedside sleepers.
Therefore, the risk of injury associated
with the number of products in use
cannot be calculated.
3. Compliance Requirements of the
Proposed Rule
Although all bedside sleepers
currently on the market will require
some modification in order to meet the
voluntary standard, several of these
requirements would impose little to no
burden on manufacturers because firms
also must comply with similar
requirements in existing voluntary
standards.
Several modifications of the product
may be required. The lowered side of
the bedside sleeper must be 4 inches.
The height requirement for sides that
cannot be lowered is identical to that of
bassinets, 71⁄2 inches. This requirement
is not expected to pose a substantial cost
for firms. However, it is possible that a
few firms will need to modify their
product in order to comply. Some
products will need to add a permanent
fourth side, and some may need to raise
the fourth side so that it meets the
minimum 4-inch side height.
ASTM F2906–12 requires that the gap
between the bedside sleeper and adult
bed should not be more than a 1⁄2 inch
when the bedside sleeper is secured to
the bed. Firms may need to modify the
attachment system to meet the
minimum requirement by adjusting the
anchor and/or straps to reduce
stretching and to limit slippage.
Alternatively, firms may opt to redesign
their attachment system. Cost should be
minimal if no new materials are used.
Some products will require some
modification in order to meet the two
proposed bedside sleeper accessory
requirements. The Commission
proposes that the bedside sleeper
accessory would be required to meet the
(1) fabric sided opening requirement
and (2) consumer misassembly
requirement. In order to comply with
the fabric opening requirement, the
bedside sleeper accessory must pass the
torso probe test. Alternatively, when the
fabric-sided liner is unsecured, the
bedside sleeper accessory should either
collapse under its own weight or the
sleep surface should tilt by more than
30 degrees. The proposed consumer
misassembly requirement is identical to
the play yard bassinet misassembly
requirement proposed in the NPR for
the Safety Standard for Play Yards. The
Commission proposes that a bedside
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sleeper accessory that can be assembled
and attached to the play yard with any
of the key structural elements missing
must either: (1) Have all key structural
components permanently attached or (2)
be obviously unusable when attached to
the play yard with any key structural
element removed. The bedside sleeper
accessory, if misassembled, should
provide visual cues, such as the
mattress pad contacts the bottom floor
of the non-full-size crib or play yard, or
the sleep surface angle tilts by more
than 30 degrees to indicate
misassembly. The actual cost of meeting
these proposed requirements to
manufacturers is unknown, but it could
be minimal, primarily involving
additional stitching, rivets, and other
methods of attachment. However, if
product redesign is required, the costs
could be significant.
The proposed bassinet requirements
that are also applicable to bedside
sleepers—mattress and stability
requirements—are expected to have
little to no incremental impact on firms.
These requirements are identical to
requirements in the bassinet NPR for
Safety Standard for Bassinets and
Cradles and the cost of meeting those
requirements was accounted for in the
bassinet NPR. If these requirements are
finalized as proposed, a manufacturer
who produces a bedside sleeper and a
bassinet combination product would
already need to meet these requirements
and would have incurred the associated
costs under the bassinet standard. As a
consequence, meeting the same
requirements under a bedside sleeper
standard would impose no additional
burden. Most bedside sleeper
manufacturers produce such a
combination product. In addition, firms
would need to revise current warning
labels to include a description of correct
assembly and conversion modes. This
represents a minor modification.
4. Other Federal or State Rules
The Commission is in the process of
implementing sections 14(a)(2) and
14(i)(2) of the Consumer Product Safety
Act (CPSA), as amended by the CPSIA.
Section 14(a)(2) of the CPSA requires
every manufacturer of a children’s
product that is subject to a children’s
product safety rule to certify, based on
third party testing, that the product
complies with all applicable safety
rules. Section 14(i)(2) of the CPSA
requires the Commission to establish
protocols and standards (i) for ensuring
that a children’s product is tested
periodically and when there has been a
material change in the product, (ii) for
the testing of representative samples to
ensure continued compliance, (iii) for
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verifying that a product tested by a
conformity assessment body complies
with applicable safety rules, and (iv) for
safeguarding against the exercise of
undue influence on a conformity
assessment body by a manufacturer or
private labeler.
Because bedside sleepers will be
subject to a mandatory standard, they
will also be subject to the third party
testing requirements of section 14(a)(2)
of the CPSA when the mandatory
standard and the notice of requirements
become effective.
5. Impact on Small Businesses
There are five firms known to be
marketing bedside sleepers in the
United States. One is a foreign
manufacturer. The analysis applies to
the four domestic firms, all of which are
small. The impact of the standard on
manufacturers depends on two factors:
(1) Whether their products are multiuse
products and are already in compliance
with one or more existing voluntary (or
mandatory) standards; and (2) the
proportion of their total sales or revenue
that bedside sleepers constitute.
Three of the four domestic
manufacturers produce a multiuse
product, or a product that may be used
as a bedside sleeper, as well as a play
yard or bassinet. These multiuse
products are already in compliance with
an existing standard, and there is
significant overlap between standards. It
is likely that manufacturers will need to
make only slight, if any, modifications
to comply with the bedside sleeper
standard. The three producers of
multiuse products are unlikely to
experience a significant impact.
Two of the domestic manufactures
rely almost solely on the sales of
bedside sleepers as their revenue
source. One of the firms produces a
multiuse product that is in compliance
with an existing voluntary standard, as
described above, and should not
experience a significant impact. The
other firm, however, produces a product
that serves only as a bedside sleeper.
The costs of compliance for this firm are
unknown but could be significant if a
complete product redesign is required.
In addition, the impact could be
magnified because most of this firm’s
revenues are due to the sales of bedside
sleepers.
All manufacturers will need to modify
existing warning labels. A new warning
label poses a small burden because it
represents a minor modification. Costs
associated with the new warning label
would be low because no new materials
are used. Once the final rule and notice
of requirements are in effect, all
manufacturers will be subject to third
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party testing and certification
requirements.
proposed rule falls within the
categorical exemption.
6. Alternatives
I. Paperwork Reduction Act
This proposed rule contains
information collection requirements that
are subject to public comment and
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3521). In this document, pursuant to 44
U.S.C. 3507(a)(1)(D), we set forth:
• A title for the collection of
information;
• A summary of the collection of
information;
• A brief description of the need for
the information and the proposed use of
the information;
• A description of the likely
respondents and proposed frequency of
response to the collection of
information;
• An estimate of the burden that shall
result from the collection of
information; and
• Notice that comments may be
submitted to the OMB.
Title: Safety Standard for Bedside
Sleepers.
Description: The proposed rule would
require each bedside sleeper to comply
with ASTM F2906–12, Standard
Consumer Safety Specification for
Bedside Sleepers. Sections 7.1, 8.1, and
8.2 of ASTM F2906–12 contain
requirements for marking, labeling, and
instructional literature that are
disclosure requirements, thus falling
within the definition of ‘‘collections of
information’’ at 5 CFR 1320.3(c). Section
7.1 of ASTM F2906–12 requires that all
bedside sleeper products meet with the
Under the Danny Keysar Child
Product Safety Notification Act, section
104 of the CPSIA, one alternative that
would reduce the impact on small
entities is to make the voluntary
standard mandatory with no
modifications. Adopting the current
voluntary standard without any changes
potentially would reduce costs for
manufacturers. Three of the four small
manufacturers who are already
compliant with a voluntary standard
would have a reduced burden. However,
all firms still require some product
changes in order to meet the voluntary
standard. Because the staff’s proposed
changes add little to the overall burden,
adopting the voluntary standard with no
changes will not significantly offset the
burden.
A second alternative would be to set
an effective date later than the staffrecommended 6 months. This would
allow suppliers additional time to
modify and/or develop compliant
bedside sleepers and spread the
associated costs over a longer period of
time.
H. Environmental Considerations
The Commission’s regulations address
whether we are required to prepare an
environmental assessment or an
environmental impact statement. If our
rule has ‘‘little or no potential for
affecting the human environment,’’ it
will be categorically exempted from this
requirement. 16 CFR 1021.5(c)(1). The
marking and labeling instructions of
ASTM F2194, Standard Consumer
Safety Specification for Bassinets and
Cradles. Section 8.1 of ASTM F2194–12
requires:
• The name and the place of business
(city, state, mailing address including
Zip code) or telephone number of the
manufacturer, importer distributor, or
seller; and
• A code mark or other means that
identifies the date (month and year as a
minimum) of manufacture.
Section 8.1 of ASTM F2906–12
requires that all bedside sleeper
products comply with the instructional
literature requirements of ASTM F2194,
Standard Consumer Safety Specification
for Bassinets and Cradles. Section 9.1 of
ASTM F2194–12a requires all firms
supplying bedside sleepers to provide
easy-to-read and understand
instructions regarding assembly,
maintenance, cleaning, operating, and
adjustments, where applicable. Section
8 of ASTM F2906–12 also requires that
the instructions cover correct assembly
of product and use of attachment
system, and conversion, as well as alert
consumers that they should read all
instructions and keep the instructions
for future use. These requirements fall
within the definition of ‘‘collection of
information,’’ as defined in 44 U.S.C.
3502(3).
Description of Respondents: Persons
who manufacture or import bedside
sleepers.
Estimated Burden: We estimate the
burden of this collection of information
as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
Number of
respondents
Frequency of
responses
Total annual
responses
Hours per
response
Total burden
hours
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16 CFR Section
5
2
10
1
10
Our estimates are based on the
following:
There are five known firms supplying
bedside sleepers to the U.S. market. All
five firms are assumed to use labels on
both their products and their packaging
already, but they might need to make
some modifications to their existing
labels. The estimated time required to
make these modifications is about 1
hour per model. Each of these firms
supplies an average of two different
models of bedside sleepers; therefore,
the estimated burden hours associated
with labels is 1 hour × 5 firms × 2
models per firm = 10 annual hours.
Sections 8.1 and 8.2 of ASTM F2906–
12 require instructions to be supplied
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with the product. This is a practice that
is customary with bedside sleepers.
Bedside sleepers are products that
generally require some installation and
maintenance instructions, and any
products sold without such information
would not be able to compete
successfully with products that provide
this information. Therefore, because the
CPSC is unaware of bedside sleepers
that: (a) Generally require some
installation, but (b) lack any instructions
to the user about such installation, there
are no burden hours associated with the
instruction requirement in sections 8.1
and 8.2 because any burden associated
with supplying instructions with
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bedside sleepers would be ‘‘usual and
customary’’ and not within the
definition of ‘‘burden’’ under the OMB’s
regulations.
We estimate that hourly
compensation for the time required to
create and update labels is $27.64 (U.S.
Bureau of Labor Statistics, ‘‘Employer
Costs for Employee Compensation,’’
June 2012, Table 9, total compensation
for all sales and office workers in goodsproducing private industries: https://
www.bls.gov/ncs/). Therefore, the
estimated annual cost associated with
the proposed requirements is $276
($27.64 per hour × 10 hours = $276).
In compliance with the Paperwork
Reduction Act of 1995 (44 U.S.C.
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3507(d)), we have submitted the
information collection requirements of
this rule to the OMB for review.
Interested persons are requested to
submit comments regarding information
collection by January 9, 2013, to the
Office of Information and Regulatory
Affairs, OMB (see the ADDRESSES section
at the beginning of this notice).
Pursuant to 44 U.S.C. 3506(c)(2)(A),
we invite comments on:
• Whether the collection of
information is necessary for the proper
performance of the CPSC’s functions,
including whether the information will
have practical utility;
• The accuracy of the CPSC’s estimate
of the burden of the proposed collection
of information, including the validity of
the methodology and assumptions used;
• Ways to enhance the quality, utility,
and clarity of the information to be
collected;
• Ways to reduce the burden of the
collection of information on
respondents, including the use of
automated collection techniques, when
appropriate, and other forms of
information technology; and
• The estimated burden hours
associated with label modification,
including any alternative estimates.
mstockstill on DSK4VPTVN1PROD with
J. Preemption
Section 26(a) of the CPSA, 15 U.S.C.
2075(a), provides that where a consumer
product safety standard is in effect and
applies to a product, no state or political
subdivision of a state may either
establish or continue in effect a
requirement dealing with the same risk
of injury unless the state requirement is
identical to the federal standard. Section
26(c) of the CPSA also provides that
states or political subdivisions of states
may apply to the Commission for an
exemption from this preemption under
certain circumstances. Section 104(b) of
the CPSIA refers to the rules to be
issued under that section as ‘‘consumer
product safety rules,’’ thus implying
that the preemptive effect of section
26(a) of the CPSA would apply.
Therefore, a rule issued under section
104 of the CPSIA will invoke the
preemptive effect of section 26(a) of the
CPSA when it becomes effective.
K. Certification and Notice of
Requirements (NOR)
Section 14(a) of the CPSA imposes the
requirement that products subject to a
consumer product safety rule under the
CPSA, or to a similar rule, ban, standard
or regulation under any other act
enforced by the Commission, must be
certified as complying with all
applicable CPSC-enforced requirements.
15 U.S.C. 2063(a). Section 14(a)(2) of the
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CPSA requires that certification of
children’s products subject to a
children’s product safety rule be based
on testing conducted by a CPSCaccepted third party conformity
assessment body. Section 14(a)(3) of the
CPSA requires the Commission to
publish a notice of requirements (NOR)
for the accreditation of third party
conformity assessment bodies (or
laboratories) to assess conformity with a
children’s product safety rule to which
a children’s product is subject. The
proposed rule for 16 CFR part 1222,
‘‘Safety Standard for Bedside Sleepers,’’
when issued as a final rule, will be a
children’s product safety rule that
requires the issuance of an NOR.
On May 24, 2012, the Commission
published a proposed rule in the
Federal Register titled, ‘‘Requirements
Pertaining to Third Party Conformity
Assessment Bodies,’’ 77 FR 31086,
which, when finalized, would establish
the general requirements and criteria
concerning testing laboratories under 16
CFR part 1112. These include the
requirements and procedures for CPSC
acceptance of the accreditation of a
laboratory to test children’s products in
support of the certification required by
section 14(a)(2) of the CPSA. The
proposed rule lists the children’s
product safety rules for which the CPSC
has published NORs for laboratories. In
this document, the Commission is
proposing to amend the list in 16 CFR
part 1112, once that rule becomes final,
to include the bedside sleeper standard,
once finalized, along with the other
children’s product safety rules for
which the CPSC has issued NORs.
Laboratories applying for acceptance
as a CPSC-accepted third party
conformity assessment body to test to
the new standard for bedside sleepers
would be required to meet the third
party conformity assessment body
accreditation requirements in 16 CFR
part 1112, Requirements Pertaining to
Third Party Conformity Assessment
Bodies once that rule becomes final.
When a laboratory meets the
requirements as a CPSC-accepted third
party conformity assessment body, it
can apply to the CPSC to have 16 CFR
part 1222, Safety Standard for Bedside
Sleepers, included in its scope of
accreditation of CPSC safety rules listed
for the laboratory on the CPSC Web site
at: www.cpsc.gov/labsearch.
CPSC staff conducted an analysis of
the potential impacts on small entities
of the proposed rule establishing
accreditation requirements, as required
by the Regulatory Flexibility Act, and
prepared an Initial Regulatory
Flexibility Analysis (IRFA).
Requirements Pertaining to Third Party
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73353
Conformity Assessment Bodies. 77 FR
31086, 31123–26. The IRFA concluded
that the requirements would not have a
significant adverse impact on a
substantial number of small laboratories
because no requirements are imposed
on laboratories that do not intend to
provide third party testing services
under Section 14(a)(2) of the CPSA. The
only laboratories that are expected to
provide such services are those that
anticipate receiving sufficient revenue
from providing the mandated testing to
justify accepting the requirements as a
business decision. Laboratories that do
not expect to receive sufficient revenue
from these services to justify accepting
these requirements would likely not
pursue accreditation for this purpose.
Similarly, amending the rule to include
the NOR for the bedside sleeper
standard would 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,
perhaps fewer than 6, will seek CPSC
acceptance of their accreditation to test
for conformance with the bedside
sleeper standard. Most of these
laboratories already will have been
accredited to test for conformance to
other juvenile product standards, and
the only cost to them would be the cost
of adding the bedside sleeper standard
to their scope of accreditation. As a
consequence, the Commission could
certify that the proposed NOR for the
bedside sleeper standard will not have
a significant impact on a substantial
number of small entities.
The final NOR will base the CPSC
laboratory accreditation requirements
on the performance standard set forth in
the final rule for the safety standard for
bedside sleepers and the test methods
incorporated within that standard. The
Commission may recognize limited
circumstances in which it will accept
certification based on product testing
conducted before the Commission’s
acceptance of accreditation of
laboratories for testing bedside sleepers
(also known as retrospective testing) in
the final NOR. The Commission seeks
comments on any issues regarding the
testing requirements of the proposed
rule for bedside sleepers and the
accompanying proposed NOR.
L. Request for Comments
This proposed rule begins a
rulemaking proceeding under section
104(b) of the CPSIA to issue a consumer
product safety standard for bedside
sleepers. We invite all interested
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Federal Register / Vol. 77, No. 237 / Monday, December 10, 2012 / Proposed Rules
persons to submit comments on any
aspect of the proposed rule. Comments
should be submitted in accordance with
the instructions in the ADDRESSES
section at the beginning of this notice.
List of Subjects
16 CFR Part 1112
Administrative practice and
procedure, Audit, Consumer protection,
Reporting and recordkeeping
requirements, Third party conformity
assessment body.
16 CFR Part 1222
Consumer protection, Imports,
Incorporation by reference, Infants and
children, Labeling, Law enforcement,
and Toys.
For the reasons discussed in the
preamble, the Commission proposes to
amend Title 16 of the Code of Federal
Regulations as follows:
PART 1112—REQUIREMENTS
PERTAINING TO THIRD PARTY
CONFORMITY ASSESSMENT BODIES
1. The authority citation for part 1112
continues to read as follows:
Authority: Pub. L. 110–314, section 3, 122
Stat. 3016, 3017 (2008); 15 U.S.C. 2063.
2. Amend Part 1112.15 by adding
paragraph (b)(34) to read as follows:
§ 1112.15 When can a third party
conformity assessment body apply for
CPSC acceptance for a particular CPSC rule
and/or test method?
*
*
*
*
*
(b) The CPSC has published
previously, or in the cases of 16 CFR
parts 1221, 1223, and 1224, and ASTM
F 963–11 for the first time, the
requirements for accreditation for third
party conformity assessment bodies to
assess conformity with the following
CPSC rules and/or test methods:
*
*
*
*
*
(34) 16 CFR part 1222, Safety
Standard for Bedside Sleepers.
3. Add part 1222 to read as follows:
PART 1222—SAFETY STANDARD FOR
BEDSIDE SLEEPERS
mstockstill on DSK4VPTVN1PROD with
Sec.
1222.1
1222.2
Scope.
Requirements for Bedside Sleepers.
Authority: The Consumer Product Safety
Improvement Act of 2008, Pub. L. 110–314,
§ 104, 122 Stat. 3016 (August 14, 2008); Pub.
L. 112–28, 125 Stat. 273 (August 12, 2011).
§ 1222.1
Scope.
This part establishes a consumer
product safety standard for bedside
sleepers.
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§ 1222.2 Requirements for Bedside
Sleepers.
‘‘Bassinet/Cradle Accessories Missing
Key Structural Elements.’’
(a) Except as provided in paragraph
(b) of this section, each bedside sleeper
must comply with all applicable
provisions of ASTM F2906–12,
Standard Consumer Safety Specification
for Bedside Sleepers, approved on June
1, 2012. The Director of the Federal
Register approves this incorporation by
reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. You may
obtain a copy from ASTM International,
100 Bar Harbor Drive, P.O. Box 0700,
West Conshohocken, PA 19428; https://
www.astm.org/cpsc.htm. You may
inspect a copy at the Office of the
Secretary, U.S. Consumer Product
Safety Commission, Room 820, 4330
East West Highway, Bethesda, MD
20814, telephone 301–504–7923, or at
the National Archives and Records
Administration (NARA). For
information on the availability of this
material at NARA, call 202–741–6030,
or go to: https://www.archives.gov/
federal_register/
code_of_federalregulations/
ibr_locations.html.
(b) Comply with the ASTM F2906–12
standard with the following additions:
(1) In addition to complying with
section 3.1.7 of ASTM F2906–12,
comply with the following:
(i) 3.1.8 ‘‘bedside sleeper accessory,
n—an elevated sleep surface that
attaches to a non-full-size crib or play
yard, designed to convert the product
into a bedside sleeper intended to have
a horizontal sleep surface while in a rest
(non-rocking) position.’’
(ii) [Reserved]
(2) In addition to complying with
section 5.6 of ASTM F2906–12, comply
with the following:
(i) 5.7 Bedside Sleeper Accessory
Fabric-Sided Enclosed Openings—A
bedside sleeper accessory shall meet the
F2194 performance requirement,
‘‘Fabric-Sided Enclosed Openings.’’
(A) 5.7.1 Bedside sleeper accessories
are exempt from this requirement if
either of the following two conditions is
met after disengaging all fasteners
between the accessory and the non-fullsize crib or play yard base to which it
is assembled:
(B) 5.7.1.1 The bedside sleeper
accessory collapses under its own
weight, such that any part of the
mattress pad contacts the bottom floor
of the non-full-size crib or play yard.
(C) 5.7.1.2 The bedside sleeper
accessory’s sleep surface tilts by more
than 30 degrees.
(ii) 5.8 Bedside Sleeper Play Yard
Accessories Missing Key Structural
Elements: A bedside sleeper accessory
shall meet the F406 general requirement
Dated: December 3, 2012.
Todd A. Stevenson,
Secretary, Consumer Product Safety
Commission .
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[FR Doc. 2012–29583 Filed 12–7–12; 8:45 am]
BILLING CODE 6355–01–P
CONSUMER PRODUCT SAFETY
COMMISSION
16 CFR Parts 1112 and 1225
[CPSC Docket No. CPSC–2012–0068]
RIN 3041–AD16
Safety Standard for Hand-Held Infant
Carriers
Consumer Product Safety
Commission.
ACTION: Notice of Proposed Rulemaking.
AGENCY:
The Danny Keysar Child
Product Safety Notification Act, Section
104(b) of the Consumer Product Safety
Improvement Act of 2008 (CPSIA)
requires the United States Consumer
Product Safety Commission
(Commission, CPSC, or we) to
promulgate consumer product safety
standards for durable infant or toddler
products. These standards are to be
‘‘substantially the same as’’ applicable
voluntary standards or more stringent
than the voluntary standard if the
Commission concludes that more
stringent requirements would further
reduce the risk of injury associated with
the product. The Commission is
proposing a safety standard for
handheld infant carriers in response to
the direction under Section 104(b) of the
CPSIA. The proposed rule would
incorporate ASTM F2050–12 by
reference, with two modifications.
DATES: Submit comments by February
25, 2013.
ADDRESSES: Comments related to the
Paperwork Reduction Act aspects of the
marking, labeling, and instructional
literature of the proposed rule should be
directed to the Office of Information and
Regulatory Affairs, OMB, Attn: CPSC
Desk Officer, Fax: 202–395–6974, or
emailed to mailed to:
oira_submission@omb.eop.gov.
Other comments, identified by Docket
No. CPSC-2012-0068, may be submitted
electronically or in writing:
Electronic Submissions: Submit
electronic comments to the Federal
eRulemaking Portal at: https://
www.regulations.gov. Follow the
instructions for submitting comments.
To ensure timely processing of
comments, the Commission is no longer
SUMMARY:
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Agencies
[Federal Register Volume 77, Number 237 (Monday, December 10, 2012)]
[Proposed Rules]
[Pages 73345-73354]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-29583]
=======================================================================
-----------------------------------------------------------------------
CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Parts 1112 and 1222
[Docket No. CPSC-2012-0067]
Safety Standard for Bedside Sleepers
AGENCY: Consumer Product Safety Commission.
ACTION: Notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: The Danny Keysar Child Product Safety Notification Act,
Section 104 of the Consumer Product Safety Improvement Act of 2008
(CPSIA), requires the United States Consumer Product Safety Commission
(Commission or CPSC) to promulgate consumer product safety standards
for durable infant or toddler products. These standards are to be
``substantially the same as'' applicable voluntary standards or more
stringent than the voluntary standard if the Commission concludes that
more stringent requirements would further reduce the risk of injury
associated with the product. The Commission is proposing a safety
standard for bedside sleepers in response to the direction under
Section 104(b) of the CPSIA.
DATES: Submit comments by February 25, 2013.
ADDRESSES: Comments related to the Paperwork Reduction Act aspects of
the marking, labeling, and instructional literature of the proposed
rule should be directed to the Office of Information and Regulatory
Affairs, OMB, Attn: CPSC Desk Officer, FAX: 202-395-6974, or emailed to
oira_submission@omb.eop.gov.
Other comments, identified by Docket No. CPSC-2012-0067, may be
submitted electronically or in writing:
Electronic Submissions: Submit electronic comments to the Federal
eRulemaking Portal at: https://www.regulations.gov. Follow the
instructions for submitting comments. To ensure timely processing of
comments, the Commission is no longer directly accepting comments
submitted by electronic mail (email), except through
www.regulations.gov. The Commission encourages you to submit electronic
comments by using the Federal eRulemaking Portal, as described above.
Written Submissions: Submit written submissions in the following
way: Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions), preferably in five copies, to: Office of the Secretary,
Consumer Product Safety Commission, Room 820, 4330 East West Highway,
Bethesda, MD 20814; telephone (301) 504-7923.
Instructions: All submissions received must include the agency name
and docket number for this proposed rulemaking. All comments received
may be posted without change, including any personal identifiers,
contact information, or other personal information provided, to https://www.regulations.gov. Do not submit confidential business information,
trade secret information, or other sensitive or protected information
that you do not want to be available to the public. If furnished at
all, such information should be submitted in writing.
Docket: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov, and insert the
docket number, CPSC-2012-0067, into the ``Search'' box and follow the
prompts.
FOR FURTHER INFORMATION CONTACT: Douglas A. Lee, Project Manager,
Directorate for Engineering Sciences, Consumer Product Safety
Commission, 5 Research Place, Rockville, MD 20850; telephone 301-987-
2073; email cpsc.gov">dlee@cpsc.gov.
SUPPLEMENTARY INFORMATION:
A. Background and Statutory Authority
The Consumer Product Safety Improvement Act of 2008, (CPSIA, Pub.
L. 110-314), was enacted on August 14, 2008. Section 104(b) of the
CPSIA, part of the Danny Keysar Child Product Safety Notification Act,
requires the Commission to: (1) Examine and assess the effectiveness of
voluntary consumer product safety standards for durable infant or
toddler products, in consultation with representatives of consumer
groups, juvenile product manufacturers, and independent child product
engineers and experts, and (2) promulgate consumer product safety
standards for durable infant and toddler products. These standards are
to be ``substantially the same as'' applicable voluntary standards or
more stringent than the voluntary standard if the Commission concludes
that more stringent requirements would further
[[Page 73346]]
reduce the risk of injury associated with the product. The term
``durable infant or toddler product'' is defined in section 104(f)(1)
of the CPSIA as a durable product intended for use, or that may be
reasonably expected to be used, by children under the age of 5 years.
In this document, the Commission is proposing a safety standard for
bedside sleepers. Bassinets and cradles are specifically identified in
section 104(f)(2)(L) as durable infant or toddler products. Bedside
sleepers are similar to bassinets, and many bedside sleepers also
function as bassinets. In addition, some beside sleepers are
accessories to play yards/non-full-size baby cribs. On October 3, 2012,
the Commission approved a notice of proposed rulemaking (NPR) for a
Safety Standard for Bassinets and Cradles (https://www.cpsc.gov/library/foia/foia12/brief/bassinetnpr.pdf). The Commission has issued a Safety
Standard for Play Yards, codified at 16 CFR part 1221. Recently the
Commission has proposed specific language to address hazards due to
misassembly of play yard bassinet accessories in a notice of proposed
rulemaking (77 FR 52272, August 29, 2012). This proposed rule, if
finalized, would amend the Safety Standard for Play Yards. The proposed
rule for beside sleepers would adopt many of the requirements in the
proposed NPR for bassinets, as well as address the hazards associated
with the use of bassinet play yard accessories that can be assembled
with missing key structural requirements for bedside sleeper play yard
accessories.
Pursuant to Section 104(b)(1)(A), the Commission consulted with
manufacturers, retailers, trade organizations, laboratories, consumer
advocacy groups, consultants, and members of the public in the
development of this proposed standard, largely through the ASTM
process. The proposed standard is based on the voluntary standard
developed by ASTM International (formerly the American Society for
Testing and Materials), ASTM F2906-12, ``Standard Consumer Safety
Specification for Bedside Sleepers'' (ASTM F2906-12), with additions to
make the standard more stringent. The ASTM standard is copyrighted, but
it can be viewed as a read-only document, only during the comment
period on this proposal, at: https://www.astm.org/cpsc.htm, by
permission of ASTM.
B. The Product
ASTM F2906-12 defines ``bedside sleeper'' as ``a rigid frame
assembly that may be combined with a fabric or mesh assembly, or both,
used to function as sides, ends, or floor or a combination thereof, and
that is intended to provide a sleeping environment for infants and is
secured to an adult bed.'' A ``multi-mode product'' is ``a unit that is
designed and intended to be used in more than one mode (for example, a
play yard, bassinet, changing table, hand held carrier, or bedside
sleeper).'' A bedside sleeper is intended to be secured to an adult bed
that permits newborns and infants to sleep close by an adult without
being in the adult bed. In current products, the horizontal sleep
surface is typically 1 inch to 4 inches below the level of the adult
bed's mattress. The side of the bedside sleeper that is adjacent to the
adult bed can usually be lowered, thereby differentiating bedside
sleepers from bassinets, where all four sides of a bassinet are the
same height. Bedside sleepers are intended for use with children up to
the developmental stage where they can push up on hands and knees
(about 5 months). This is the same developmental range for the intended
users of bassinets. Current bedside sleepers range in size from about
35'' x 20'' to 40'' x 30.'' They may have rigid sides, but they are
most commonly constructed with a tube frame covered by mesh or fabric.
Freestanding bassinets are not covered under the proposed standard
for bedside sleepers. They are covered under ASTM F2194-12a, ``Standard
Consumer Safety Specification for Bassinets and Cradles.''
Several manufacturers produce multiuse (or multimode) bedside
sleeper products that convert into bassinets and/or play yards. Most
bedside sleeper products can be converted into a bassinet by raising
the lowered side to have four equal-height sides, and a few also
convert into a bassinet and play yard. Some play yards include bedside
sleeper accessories which, when attached, convert the play yard into a
bedside sleeper; and some bassinets convert into bedside sleepers. All
of the tube-framed products that have been evaluated by CPSC staff may
be collapsed for storage and transport. A bedside sleeper that can be
used in additional modes would need to meet each applicable standard.
For example, a bedside sleeper product that converts into a play yard
and a bassinet would have to meet: ASTM F2906 bedside sleeper
requirements, ASTM F2194 bassinet requirements (except for height of
the fourth lowered side for bedside sleepers) and sections of the ASTM
F406 play yard requirements applicable to bassinets when in the bedside
sleeper mode; ASTM F406 play yard requirements when in play yard use
mode; and ASTM F2194 bassinet requirements and applicable sections of
ASTM F406 play yard requirements when in bassinet mode.
To ensure consistency with the existing and proposed standards for
bassinets and play yards, the Commission is proposing additions to the
scope and performance requirements of a bedside sleeper, as discussed
below.
C. The Voluntary Standard--ASTM F2906
ASTM first published a voluntary standard for bedside sleepers,
ASTM F2906-11, in December 2011. It required bedside sleepers to meet
the voluntary standard requirements of the product upon which it was
based, either a play yard/non-full-size baby cribs, ASTM F406 (play
yard standard) or a bassinet, ASTM F2194 (bassinet standard). The
standard also addressed hazards specific to bedside sleeper products.
It addressed incidents involving the creation of a hazardous gap
between the product and an adult mattress, by requiring the successful
completion of three disengagement tests. The tests ensured that the
securing components can withstand forces that may be exerted on the
product by either the child or an adult, while sleeping. The gap must
be no more than 0.5 in. when the product is installed to the adult bed,
per manufacturer's directions. When a 25-lb. horizontal force is
applied near the attachment system or corners, the gap may not exceed
1.0 in. And, to simulate an adult rolling into a bedside sleeper while
sleeping, a gap greater than 1.0 in. may not be created after the
application and release of a 50-lb. horizontal force to the bedside
sleeper's corners. The inclusion of these anti-gap requirements served
to mitigate the foreseeable head and neck entrapment hazards posed by
bedside sleepers. The standard requires a minimum 4-inch lowered side
height over which a child is unlikely to be able to roll. In addition,
latching and locking devices are evaluated to prevent unintentional
movement of the side that lowers and to ensure overall product
integrity.
In 2012, the standard for bedside sleepers was changed from meeting
either ASTM F406 (play yard standard) or ASTM F2194 (bassinet
standard), to require all products to meet ASTM F2194 only. The
bassinet minimum side-height requirement (the upper surface of the non-
compressed mattress of a bassinet/cradle must be at least 7.5 inches
lower than the upper surface of the lowest side in all intended
bassinet/cradle use positions) is also required for
[[Page 73347]]
beside sleepers, with the exception of a lowered side rail (the height
of the side rail in the lowest position shall be no less than 4 inches
when measured from the top of the uncompressed bedside sleeper mattress
to the top of the lowered side rail, when the mattress support is in
its highest position.) Bedside sleepers and bassinets share a
significant number of hazard patterns because they are used by children
with the same developmental abilities and for the same purpose. Many
bedside sleepers also function as bassinets. By requiring beside
sleepers to be tested to ASTM F2194 (bassinets) rather than to ASTM
F406 (play yards), ASTM made the bedside sleeper standard more
stringent because there are bedside sleeper hazards covered by the
bassinet standard but that are not covered by the play yard standard.
Additionally, ASTM F406 requires a bassinet accessory on a play yard
structure to meet the applicable sections of the play yard voluntary
standard. These changes were incorporated into ASTM F2906-12,
``Standard Consumer Safety Specification for Bedside Sleepers,'' in
July 2012.
CPSC staff also reviewed mandatory and voluntary international
standards in Canada, the European Union, Australia, and New Zealand.
There are some international standards governing safe sleep products
for infants; however, there are no specific requirements that address
the hazards unique to bedside sleeper products. Canada has a mandatory
standard for cribs, cradles, and bassinets, SOR/2010-26; the European
Union uses EN 1130 Cribs and Cradles and EN 12790 Child Care Articles--
Reclined Cradles to assess and market various design elements and
structures in bedside sleeper products. In Australia and New Zealand,
several standards exist for safe sleep products- AS/NZS 2172:2003 Cots
(full-size and non-full-size cribs that do not fold); AS/NZS 2195:1999
Folding Cots (play yards and folding cribs of any size); AS/NZS
4385:1996 Infants' Rocking Cradles (cradles and bassinets that tilt.)
The Juvenile Products Manufacturers Association (JPMA) has a
certification program for a variety of juvenile products, including
bassinets and play yards. Manufacturers that voluntarily obtain JPMA
certification submit products to an independent test laboratory for
conformance testing to the most recent version of the voluntary
standard. Manufacturers have 6 months after publication of a new or
revised standard to certify products to the new requirements.
Currently, JPMA does not have a certification program for bedside
sleepers, and no firm claims to meet the ASTM voluntary standard, ASTM
F2906-12. However, three firms supply multimode products, where one
mode is compliant with the associated ASTM voluntary standard. Two
firms claim compliance with the ASTM standard for bassinets; one firm
is JPMA-certified as compliant, and the other claims compliance with
the ASTM bassinet standard. A third firm supplies play yards that are
JPMA-certified as compliant with the ASTM play yard/non-full-size crib
standard.
D. Incident Data
CPSC staff identified 40 cases of bedside sleeper-related incidents
from 2001 to 2011. The CPSC databases searched were the In-Depth
Investigation database, the Injury or Potential Injury Incident
database, and the Death Certificate file. National estimates of bedside
sleeper product-related injuries are not available because the National
Electronic Injury Surveillance System (NEISS) data does not allow for
clear identification of bedside sleepers. Therefore, the risk of injury
associated with the number of products in use cannot be calculated.
CPSC staff is aware of four fatalities and 36 nonfatal incidents
(with and without injuries) related to bedside sleepers that were
reported from January 2001 through December 2011. Bedside sleepers have
been on the market since 1997. During this time, there have been two
recalls for product defects that created a substantial product hazard.
One recall involved four deaths, three from head entrapment and one
from suffocation, and several complaints on the same entrapment hazard
from a bedside sleeper with a bassinet base. This recall involved 3-in-
1 and 4-in-1 convertible bassinets that contained metal bars covered by
an adjustable fabric flap, attached with Velcro,[supreg] that folded
down when the bassinet was converted into a bedside sleeper. If the
Velcro[supreg] was not resecured properly when the flap was adjusted,
an infant could slip through the opening and become entrapped in the
metal bars and suffocate. Because of additional incidents, this recall
was re-announced three times. There were 900,000 units recalled. The
second recall involved a bedside sleeper with a play yard base. There
were 10 reports of infants falling from the mattress into the bottom of
a bedside sleeper or becoming entrapped between the edge of the
mattress and the side of the bedside sleeper. There were 76,000 units
recalled. Details of the recalls can be found on the cpsc.gov Web site.
1. Fatalities
All four reported fatalities involved the same brand of recalled
bedside sleeper/bassinet. In all four cases, the product was being used
in the bassinet mode, with the adjustable side raised at the time of
the incident. Three of the deaths were due to entrapment and/or
hanging, which resulted after an infant's body, but not head, slipped
through the fabric covering and underlying structural components of a
particular brand of bedside sleeper. In two of these three fatalities
involving a 4-month-old and a 6-month-old decedent, the infant's head
was entrapped between the lower horizontal bars (of the adjustable
side) and the top of the mattress. The fabric flap designed to cover
the metal bars was not in place. In the third fatality, the fabric flap
covering the adjustable side was not secured to the permanent fabric
siding, and the horizontal bars of the adjustable side were broken/
missing. As a result, the 6-month-old decedent's body slipped out
through an opening in the fabric siding, but her chin/throat got caught
on a lower crossbar. The fourth death occurred when an infant moved
into a corner where the fabric covering the adjustable side was not
secured by the Velcro[supreg] strip and the bassinet was also missing
the lower rail. This created a pocket between the side and bassinet
floor. The infant was found with their head in the pocket and face
against the side of the bassinet, resulting in suffocation.
2. Nonfatal Incidents
Of the 36 nonfatal incidents, there were three reported injuries
involving infants, none hospitalized, during the use of a bedside
sleeper. All of the injured infants were under 5 months of age, which
is within the ASTM recommended user age range. Two of the infants
suffered bruising when they were entrapped between the metal rungs of
the same product that had caused three of the fatalities described in
the previous section. The third injury occurred when the infant rolled
into a position where his neck was hyperextended into a non-breathable
corner of the product, and he suffered respiratory difficulties. In all
three cases, the caregiver was nearby to prevent any serious
consequences.
The remaining 33 reports indicated that no injury occurred or
provided no information about any injury. However, many of the
descriptions in the reports indicated the potential for a serious
injury, or even death, in bedside sleepers. In cases where victim age
was reported, six reported ages between 6
[[Page 73348]]
months and 8 months old; the other infants were under 5 months of age.
3. Hazard Pattern Analysis
CPSC staff considered all 40 incident reports to identify the
hazard patterns associated with bedside sleeper-related incidents. The
hazard scenarios in 24 of the 40 incidents (60 percent) reported were
attributed to some sort of failure/defect or a potential design flaw in
the product. This category includes the four fatalities and three non-
hospitalized injuries. Listed below are the reported problems,
beginning with the most frequently reported concerns:
A problem with the adjustable fabric cover over the
horizontal metal bars on the side that lowers in the bedside sleeper
mode was responsible for nine of the reported incidents. These included
all four fatalities and two of the injuries. All of these incidents
involved one particular manufacturer's bedside sleeper/convertible
bassinet product, which was recalled in 2008. Two of the fatalities
occurred before the CPSC recall; the third, which involved a secondhand
product in poor condition, occurred after the 2008 recall, but prior to
the 2009 recall (which was an expansion of the 2008 recall). Between
the two injuries, one occurred prior to the 2008 recall, while the
other occurred after that recall. Neither of the post-recall incident
reports indicated whether the consumers were aware of the recall.
Issues with assembly instructions were identified in six
reported incidents. In all of these reports, the consumer had
misassembled the product but reported the product as being faulty. None
of the incidents resulted in any injury or fatality. All but one of
these incidents involved one particular manufacturer's bedside sleeper,
which was recalled in 2011.
Miscellaneous other product-related issues, such as non-
levelness of the product (two reports), instability of leg extensions
(two reports), poor design (two reports), broken component (one
report), failure of the attachment (to adult bed) mechanism (one
report), and unclear age labeling (one report) were reported in the
remaining incident reports. One incident reported an injury associated
with poor product design.
In response to CPSC recall notices, there were 16 non-
incident reports of concerns or complaints. In these reports, the
consumer either sought advice on options regarding a bedside sleeper
product they owned that had been recalled, or they inquired about
whether the product they owned was within the scope of the recall.
E. Proposed Changes to ASTM F2906-12
CPSC staff identified 24 incidents due to defect or potential
design flaws in the product. The hazards associated with these
incidents included: Issues with the adjustable fabric cover over the
metal bars on the side that lowered in the bedside sleeper mode (9
incidents); poor assembly instruction (6 incidents); and miscellaneous
other product-related issues (9 incidents). To address these incidents,
the Commission proposes to adopt by reference, ASTM International's
voluntary standard, ASTM F2906-12, Standard Consumer Safety
Specification for Bedside Sleepers, with a few additions to strengthen
the standard. Section 5 (Performance Requirements) of ASTM F2906-12
requires that in addition to the tests provided in ASTM F2906-12, the
bedside sleeper must be tested to the bassinet standard (ASTM F2194).
Specifically, section 5.1 provides that:
Prior to or immediately after testing to this consumer safety
specification, the bedside sleeper must be tested to Consumer Safety
Specification F2194. Multi-mode products must also be tested to each
applicable standard. When testing to Consumer Safety Specification
F2194 the unit shall be free standing, and not be secured to the
test platform as dictated elsewhere in this standard.
Because bedside sleepers already are required to be tested to the
applicable bassinet standard requirements, and multimode products, to
each applicable standard, the Commission proposes in this rule to add
clarifying language to ensure that the requirements that are not yet
included in an existing standard or proposed in an NPR (i.e., ASTM
F406-12a (play yards) and ASTM F2194-12 (bassinets)) are also included
in ASTM F2906-12 (bedside sleepers).
1. Fabric-Sided Enclosed Openings
The current version of ASTM F2194-12a (bassinets) contains a
Fabric-Sided Enclosed Openings' performance requirement for bassinets.
This requirement prohibits completely bounded openings large enough to
permit passage of an infant's torso. The hazard scenarios addressed by
this requirement encompass the three strangulation deaths described
above and a related, foreseeable suffocation hazard. These hazards
occur when a child passes through an opening, either becomes trapped
between the liner and mattress pad and suffocates, or becomes suspended
by the neck, and then strangles. This hazard, associated with a recall
of 900,000 units, led to three of the four fatalities on a bassinet
that converts to a bedside sleeper. The bassinet test procedure (ASTM
F2194-12a, section 7.8) attempts to push a torso probe the size of a
5th percentile infant through bounded openings with 20 lbs of force.
The test is first performed with product assembled per the
manufacturer's instructions. If the product has a removable cover, it
is performed a second time after all fasteners or snaps are unfastened,
but the removable cover left in place. In doing so, the test
intentionally replicates the incorrectly secured fabric liner hazard
scenario of the fatal incidents.
A manufacturer's bedside sleeper accessory exhibited this hazard,
which led to its recall in 2011. The recall was initiated in response
to incident reports in which the bedside sleeper accessory's removable
cover (liner or shell) was either not used, or was present but not
secured to the play yard frame. This bedside sleeper accessory can also
be used as a play yard, or a bassinet accessory to a play yard. When in
the bassinet accessory position, the front side of the product can be
lowered, transforming it into the beside sleeper mode. A 1\1/2\ year-
old unused sample of this product was recently retested by CPSC staff,
confirming that it fails the ASTM F2194 fabric-sided enclosed opening
requirement. However, a new sample of a similar model from the same
manufacturer passed this test. Staff identified two possible reasons
for testing variances. One explanation is that the fit of the shell to
the play yard frame becomes looser with repeated assembly and
disassembly. The other reason is that the seam joining the mesh and
fabric part of the liner may be in a slightly different location on
some models. The seam may cause sufficient friction on the torso test
probe during force testing on some models. Accordingly, minor changes
in materials or construction may not be sufficient to remedy the hazard
presented by the fabric-sided, bounded opening hazard.
Under section 6.7 of ASTM F2194-12, for bassinets/cradles with
fabric sides, a completely bounded opening may not be created that
allows the complete passage of the torso probe (based on a torso
diameter of a 5th percentile 0 to 2-month-old infant) when tested in
accordance with the fabric release test methods for enclosed openings.
However, the test does not apply to play yard bassinets or play yard
accessories. Bassinets accessories to play yards (that cannot be
converted to bedside sleepers) are usually held in place by fasteners
that clip to the top of the play yard's railing. If the fasteners were
left unclipped, the bassinet would fall, rendering the product
untestable, due to
[[Page 73349]]
the complete collapse of the bassinet attachment; test labs would
likely consider that a failure. However, for bassinets that convert to
a bedside sleeper with a lowered side, CPSC staff determined that all
bedside sleeper play yard accessories should be subject to the
requirements of the ASTM F2194-12 bassinet standard's section 6.7
Fabric-Sided Enclosed Opening without the exemption for bassinet play
yard accessories, given the demonstrated hazards presented when a
bedside sleeper's removable cover (liner or shell) is either not used,
or not secured properly.
The Commission proposes additional language for the ASTM F2906
bedside sleeper standard to add a new definition for ``bedside sleeper
accessory'' and eliminate the fabric-sided bounded opening performance
requirement exemption currently granted to play yard bassinet
accessories. Unlike bassinet play yard accessories, bedside sleeper (or
a bassinet that is converted into a bedside sleeper) play yard
accessories could have fasteners left unclipped (through the detachment
of snaps/Velcro) where the bedside sleeper with the lowered side does
not completely collapse. Because the bedside sleeper could still appear
functional, the Commission proposes to add language under Section 3
(Terminology) of ASTM F2906-12. The new proposed section 3.1.8 would
state: ``bedside sleeper accessory, n--an elevated sleep surface that
attaches to a non-full-size crib or play yard, designed to convert the
product into a bedside sleeper intended to have a horizontal sleep
surface while in a rest (non-rocking) position.'' The Commission also
proposes to add a new proposed section 5.7, stating: ``a Bedside
Sleeper Accessory Fabric-Sided Enclosed Openings--A bedside sleeper
accessory shall meet the F2194 performance requirement ``Fabric-Sided
Enclosed Openings.'' Under new proposed section 5.7.1, bedside sleeper
accessories would be exempt from this requirement if either of the
following two conditions were met after disengaging all fasteners
between the accessory and the non-full-size crib or play yard base to
which it is assembled: (1) The bedside sleeper accessory collapses
under its own weight, such that any part of the mattress pad contacts
the bottom floor of the non-full-size crib or play yard (5.7.1.1); or
(2) the bedside sleeper accessory's sleep surface tilts by more 30
degrees (5.7.1.2). These requirements are also consistent with the
proposed requirements in the NPR for the Safety Standard for Play Yards
for play yard bassinet accessory misassembly provisions, which require
all key structural elements to be attached permanently to the bassinet
shell. The second method of compliance is to meet a catastrophic
failure test, where a missing key structural element makes the product
collapse completely or tilt more than 30 degrees. 77 FR 52273.
2. Consumer Misassembly With Missing Components
The Commission proposed a requirement to address consumer
misassembly of key structural elements for bassinet accessories to play
yards in the NPR for the Safety Standard for Play Yards, 77 FR 52272.
However, the NPR for play yards did not include specific language for
bedside sleeper play yard accessories. Although section 5 (Performance
Requirements) of ASTM 2906-12 provides that bedside sleepers must be
tested to ASTM F2194 (bassinets), and multimode products must also be
tested to each applicable standard, the Commission proposes to add
language to ASTM 2906-12 (bedside sleepers) to make explicit that the
requirements for addressing consumer misassembly of key structural
elements is required for bedside sleeper play yard accessories in
addition to bassinet play yard accessories.
As described at length in the NPR for the Safety Standard for Play
Yards, 77 FR 52272, omission of key structural elements of a bassinet
assembly (such as rods, tubes, bars, and hooks that keep the sleep
surface flat and level) could result in a tilt in the sleeping surface
and put the infant in a position where he or she is unable to breathe
and is at risk of suffocation. This hazard is magnified should these
misassembled products be used as an unsupervised sleep environment,
another reasonably foreseeable scenario. Similarly, a misassembled
bedside sleeper play yard accessory may not be readily apparent or
obvious to the consumer. If the misassembled accessory supports an
infant without a catastrophic and obvious change to the sleep surface,
a consumer may continue to use the misassembled accessory and
inadvertently place a child in danger. Bedside sleeper accessories and
bassinet accessories incorporate very similar designs and manufacturing
processes (because many bedside sleepers also function as bassinets),
and many of the same performance requirements are applicable to both
products. Accordingly, in order to ensure that all of the hazards
associated with bedside sleeper play yard accessories and bassinet play
yard accessories that can be assembled missing key structural elements
are addressed, the Commission proposes to add under section 5
(Performance Requirements) to ASTM F2906-12, new proposed section 5.8
Bedside Sleeper Play Yard Accessories Missing Key Structural Elements.
The new section 5.8 will provide: A bedside sleeper accessory shall
meet the F406 general requirement, ``Bassinet/Cradle Accessories
Missing Key Structural Elements.''
3. New Requirements for Bassinets
ASTM F2906-12 already requires bedside sleepers to meet the
requirements of the bassinet standard, ASTM F2194 ``Standard Consumer
Product Safety Specification for Bassinets and Cradles,'' with the
exception of the height of the lowered fourth side. Most bedside
sleepers also function as bassinets. The intended users are identical,
and the majority of the hazards are identical. The Commission's
proposed modifications to address bassinet hazards in ASTM F2194-12
have been discussed in great detail in the NPR and in the Bassinet NPR
staff briefing package. Specifically, the Commission proposed four
changes to the ASTM bassinet standard. Three of those proposed changes
to the bassinet standard would also be applicable to bedside sleepers.
The fourth proposed change would update the scope and corresponding
terminology specific to bassinets under ASTM F2194, and it is not
applicable to bedside sleepers. Three of the proposed requirements that
would apply to bedside sleepers include: (1) Segmented Mattress
Flatness Requirement and Test Method; (2) Removable Bassinet Bed
Stability; and (3) Stability Test Dummy. Because bedside sleepers are
already required to be tested to the bassinet standard, ASTM F2194,
there is no need to add language to the bedside sleeper standard
proposing these requirements and test methods. Accordingly, if the
proposed changes to ASTM F2194 are finalized, bedside sleepers will
also be required to meet the following requirements and test methods in
addition to all other applicable requirements in ASTM F2194. The
following proposed changes to the bassinet standard would also be
applicable to bedside sleepers:
A. Proposed Segmented Mattress Flatness Requirement and Test Method
(Sections 6.9 and 7.10 of ASTM F2194-12a)
In order to address the hazard of suffocation/positional asphyxia
due to an excess mattress pad angle, the Commission proposed
performance requirements and a test method for the
[[Page 73350]]
minimum flatness of mattress surfaces. This requirement would apply to
segmented mattresses, such as those seen in a bassinet accessory to a
play yard. The Commission proposed that the segmented mattresses
commonly used in play yards shall not create an angle greater than 10
degrees when tested using a 17-pound cylinder to simulate the weight of
a 6-month-old infant. This performance requirement and test method
would also apply to a segmented mattress used in a bedside sleeper
accessory to a play yard.
B. Proposed New Performance Requirement and Associated Definitions To
Address Hazards Associated With the Stability of Removable Bassinet
Beds (Sections 3.1.3, 3.1.17, 3.1.18, 3.1.19, 3.1.20, 6.10, 7.11 of
ASTM F2194-12a)
In order to address hazards associated with misassembly of
removable bassinet beds, the Commission proposed performance
requirements and a test method for products that have bassinet beds
that attach to an elevated stand. The requirements would apply to
removable bassinet beds that are designed to separate from the stand/
base without the use of tools. The Commission proposed that if a
removable bassinet bed is not properly attached or assembled to its
base, it must meet one of the following requirements:
The base/stand shall not support the bassinet (i.e., the
bassinet bed falls from the stand so that it is in contact with the
floor); or
The lock/latch shall automatically engage under the weight
of the bassinet bed (without any other force or action); or
The stand/base shall not be capable of supporting the
bassinet bed within 20 degrees of horizontal; or
The bassinet shall contain a visual indicator mechanism
that shall be visible on both sides of the product; or
The bassinet bed shall not tip over and shall retain the
CAMI newborn dummy when subjected to the stability test outlined in the
standard.
These requirements are equally applicable to removable bedside
sleepers that are designed to separate from the stand/base without the
use of tools.
C. Proposed Revised Test Procedure for Bassinet Stability (Sections 2.3
and 7.4.4 of ASTM F2194-12a)
During evaluations of the test methods for removable bassinet beds,
CPSC staff made comparisons of the stability of products weighted with
the newborn CAMI dummy (7.45 lbs) as opposed to the infant CAMI dummy
(17.5 lbs). ASTM F 2194-12 contains a stability requirement that uses
the heavier infant CAMI dummy. Use of the newborn CAMI, which is
readily available to test labs and represents the 50th percentile
newborn, would result in a more conservative stability test. In
addition, bassinets are intended for use with newborns. Accordingly,
the Commission proposed a revised test procedure for bassinet stability
that uses a newborn CAMI instead of an infant CAMI. This test procedure
is equally applicable to removable beside sleepers that are designed to
separate from the stand/base without the use of tools because they too
are intended for use with newborns.
F. Effective Date
The Administrative Procedure Act (APA) generally requires that the
effective date of the rule be at least 30 days after publication of the
final rule. 5 U.S.C. 553(d). To allow time for bedside sleepers to come
into compliance, the Commission proposes that the standard would become
effective 6 months after publication of a final rule in the Federal
Register. The Commission invites comment on how long it will take
bedside sleeper manufacturers to come into compliance with the rule.
G. Regulatory Flexibility Act
1. Introduction
The Regulatory Flexibility Act (RFA), 5 U.S.C. 601-612, requires
agencies to consider the impact of proposed rules on small entities,
including small businesses. Section 603 of the RFA requires that the
Commission prepare an initial regulatory flexibility analysis and make
it available to the public for comment when the notice of proposed
rulemaking is published. The initial regulatory flexibility analysis
must describe the impact of the proposed rule on small entities and
identify any alternatives that may reduce the impact. Specifically, the
initial regulatory flexibility analysis must contain:
A description of, and where feasible, an estimate of the
number of small entities to which the proposed rule will apply;
A description of the reasons why action by the agency is
being considered;
A succinct statement of the objectives of, and legal basis
for, the proposed rule;
A description of the projected reporting, recordkeeping,
and other compliance requirements of the proposed rule, including an
estimate of the classes of small entities subject to the requirements
and the type of professional skills necessary for the preparation of
reports or records; and
An identification, to the extent possible, of all relevant
federal rules that may duplicate, overlap, or conflict with the
proposed rule.
In addition, the initial regulatory flexibility analysis must
contain a description of any significant alternatives to the proposed
rule that would accomplish the stated objectives of the proposed rule
and, at the same time, reduce the economic impact on small businesses.
2. The Market
Typically, bedside sleepers are produced and/or marketed by
juvenile product manufacturers and distributors. Currently, there are
at least five known manufacturers supplying bedside sleepers to the
U.S. market. Four are domestic manufacturers, including one
manufacturer that dominates the market. The fifth is a foreign
manufacturer who ships products directly to the United States. There
may be additional unknown small manufacturers and importers operating
in the U.S. market as well.
Under U.S. Small Business Administration (SBA) guidelines, a
manufacturer of bedside sleepers is small if it has 500 or fewer
employees, and an importer is considered small if it has 100 or fewer
employees. Based on these guidelines, all four domestic manufacturers
known to be supplying the U.S. market are small.
The Juvenile Products Manufacturers Association (JPMA), the major
U.S. trade association that represents juvenile product manufacturers
and importers, runs a voluntary Certification Program for several
juvenile products. Under this program, products voluntarily submitted
by manufacturers are tested against the appropriate ASTM standard, and
only passing products are allowed to display JPMA's Certification Seal.
Currently, JPMA does not have a Certification Program for bedside
sleepers, and no firm claims to meet the ASTM bedside sleeper voluntary
standard. However, three firms supply multimode products where one mode
is compliant with the associated ASTM voluntary standard. Two firms
claim compliance with the ASTM standard for bassinets; one firm is
JPMA-certified as compliant, and the other claims compliance with the
ASTM bassinet standard. A third firm supplies play yards that are JPMA-
certified as compliant with the ASTM play yard/non-full-size crib
standard.
[[Page 73351]]
National estimates of bedside sleeper product-related injuries are
not available because the National Electronic Injury Surveillance
System (NEISS) data does not allow for clear identification of bedside
sleepers. Therefore, the risk of injury associated with the number of
products in use cannot be calculated.
3. Compliance Requirements of the Proposed Rule
Although all bedside sleepers currently on the market will require
some modification in order to meet the voluntary standard, several of
these requirements would impose little to no burden on manufacturers
because firms also must comply with similar requirements in existing
voluntary standards.
Several modifications of the product may be required. The lowered
side of the bedside sleeper must be 4 inches. The height requirement
for sides that cannot be lowered is identical to that of bassinets,
7\1/2\ inches. This requirement is not expected to pose a substantial
cost for firms. However, it is possible that a few firms will need to
modify their product in order to comply. Some products will need to add
a permanent fourth side, and some may need to raise the fourth side so
that it meets the minimum 4-inch side height.
ASTM F2906-12 requires that the gap between the bedside sleeper and
adult bed should not be more than a \1/2\ inch when the bedside sleeper
is secured to the bed. Firms may need to modify the attachment system
to meet the minimum requirement by adjusting the anchor and/or straps
to reduce stretching and to limit slippage. Alternatively, firms may
opt to redesign their attachment system. Cost should be minimal if no
new materials are used.
Some products will require some modification in order to meet the
two proposed bedside sleeper accessory requirements. The Commission
proposes that the bedside sleeper accessory would be required to meet
the (1) fabric sided opening requirement and (2) consumer misassembly
requirement. In order to comply with the fabric opening requirement,
the bedside sleeper accessory must pass the torso probe test.
Alternatively, when the fabric-sided liner is unsecured, the bedside
sleeper accessory should either collapse under its own weight or the
sleep surface should tilt by more than 30 degrees. The proposed
consumer misassembly requirement is identical to the play yard bassinet
misassembly requirement proposed in the NPR for the Safety Standard for
Play Yards. The Commission proposes that a bedside sleeper accessory
that can be assembled and attached to the play yard with any of the key
structural elements missing must either: (1) Have all key structural
components permanently attached or (2) be obviously unusable when
attached to the play yard with any key structural element removed. The
bedside sleeper accessory, if misassembled, should provide visual cues,
such as the mattress pad contacts the bottom floor of the non-full-size
crib or play yard, or the sleep surface angle tilts by more than 30
degrees to indicate misassembly. The actual cost of meeting these
proposed requirements to manufacturers is unknown, but it could be
minimal, primarily involving additional stitching, rivets, and other
methods of attachment. However, if product redesign is required, the
costs could be significant.
The proposed bassinet requirements that are also applicable to
bedside sleepers--mattress and stability requirements--are expected to
have little to no incremental impact on firms. These requirements are
identical to requirements in the bassinet NPR for Safety Standard for
Bassinets and Cradles and the cost of meeting those requirements was
accounted for in the bassinet NPR. If these requirements are finalized
as proposed, a manufacturer who produces a bedside sleeper and a
bassinet combination product would already need to meet these
requirements and would have incurred the associated costs under the
bassinet standard. As a consequence, meeting the same requirements
under a bedside sleeper standard would impose no additional burden.
Most bedside sleeper manufacturers produce such a combination product.
In addition, firms would need to revise current warning labels to
include a description of correct assembly and conversion modes. This
represents a minor modification.
4. Other Federal or State Rules
The Commission is in the process of implementing sections 14(a)(2)
and 14(i)(2) of the Consumer Product Safety Act (CPSA), as amended by
the CPSIA. Section 14(a)(2) of the CPSA requires every manufacturer of
a children's product that is subject to a children's product safety
rule to certify, based on third party testing, that the product
complies with all applicable safety rules. Section 14(i)(2) of the CPSA
requires the Commission to establish protocols and standards (i) for
ensuring that a children's product is tested periodically and when
there has been a material change in the product, (ii) for the testing
of representative samples to ensure continued compliance, (iii) for
verifying that a product tested by a conformity assessment body
complies with applicable safety rules, and (iv) for safeguarding
against the exercise of undue influence on a conformity assessment body
by a manufacturer or private labeler.
Because bedside sleepers will be subject to a mandatory standard,
they will also be subject to the third party testing requirements of
section 14(a)(2) of the CPSA when the mandatory standard and the notice
of requirements become effective.
5. Impact on Small Businesses
There are five firms known to be marketing bedside sleepers in the
United States. One is a foreign manufacturer. The analysis applies to
the four domestic firms, all of which are small. The impact of the
standard on manufacturers depends on two factors: (1) Whether their
products are multiuse products and are already in compliance with one
or more existing voluntary (or mandatory) standards; and (2) the
proportion of their total sales or revenue that bedside sleepers
constitute.
Three of the four domestic manufacturers produce a multiuse
product, or a product that may be used as a bedside sleeper, as well as
a play yard or bassinet. These multiuse products are already in
compliance with an existing standard, and there is significant overlap
between standards. It is likely that manufacturers will need to make
only slight, if any, modifications to comply with the bedside sleeper
standard. The three producers of multiuse products are unlikely to
experience a significant impact.
Two of the domestic manufactures rely almost solely on the sales of
bedside sleepers as their revenue source. One of the firms produces a
multiuse product that is in compliance with an existing voluntary
standard, as described above, and should not experience a significant
impact. The other firm, however, produces a product that serves only as
a bedside sleeper. The costs of compliance for this firm are unknown
but could be significant if a complete product redesign is required. In
addition, the impact could be magnified because most of this firm's
revenues are due to the sales of bedside sleepers.
All manufacturers will need to modify existing warning labels. A
new warning label poses a small burden because it represents a minor
modification. Costs associated with the new warning label would be low
because no new materials are used. Once the final rule and notice of
requirements are in effect, all manufacturers will be subject to third
[[Page 73352]]
party testing and certification requirements.
6. Alternatives
Under the Danny Keysar Child Product Safety Notification Act,
section 104 of the CPSIA, one alternative that would reduce the impact
on small entities is to make the voluntary standard mandatory with no
modifications. Adopting the current voluntary standard without any
changes potentially would reduce costs for manufacturers. Three of the
four small manufacturers who are already compliant with a voluntary
standard would have a reduced burden. However, all firms still require
some product changes in order to meet the voluntary standard. Because
the staff's proposed changes add little to the overall burden, adopting
the voluntary standard with no changes will not significantly offset
the burden.
A second alternative would be to set an effective date later than
the staff-recommended 6 months. This would allow suppliers additional
time to modify and/or develop compliant bedside sleepers and spread the
associated costs over a longer period of time.
H. Environmental Considerations
The Commission's regulations address whether we are required to
prepare an environmental assessment or an environmental impact
statement. If our rule has ``little or no potential for affecting the
human environment,'' it will be categorically exempted from this
requirement. 16 CFR 1021.5(c)(1). The proposed rule falls within the
categorical exemption.
I. Paperwork Reduction Act
This proposed rule contains information collection requirements
that are subject to public comment and review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3521). In this document, pursuant to 44 U.S.C.
3507(a)(1)(D), we set forth:
A title for the collection of information;
A summary of the collection of information;
A brief description of the need for the information and
the proposed use of the information;
A description of the likely respondents and proposed
frequency of response to the collection of information;
An estimate of the burden that shall result from the
collection of information; and
Notice that comments may be submitted to the OMB.
Title: Safety Standard for Bedside Sleepers.
Description: The proposed rule would require each bedside sleeper
to comply with ASTM F2906-12, Standard Consumer Safety Specification
for Bedside Sleepers. Sections 7.1, 8.1, and 8.2 of ASTM F2906-12
contain requirements for marking, labeling, and instructional
literature that are disclosure requirements, thus falling within the
definition of ``collections of information'' at 5 CFR 1320.3(c).
Section 7.1 of ASTM F2906-12 requires that all bedside sleeper products
meet with the marking and labeling instructions of ASTM F2194, Standard
Consumer Safety Specification for Bassinets and Cradles. Section 8.1 of
ASTM F2194-12 requires:
The name and the place of business (city, state, mailing
address including Zip code) or telephone number of the manufacturer,
importer distributor, or seller; and
A code mark or other means that identifies the date (month
and year as a minimum) of manufacture.
Section 8.1 of ASTM F2906-12 requires that all bedside sleeper
products comply with the instructional literature requirements of ASTM
F2194, Standard Consumer Safety Specification for Bassinets and
Cradles. Section 9.1 of ASTM F2194-12a requires all firms supplying
bedside sleepers to provide easy-to-read and understand instructions
regarding assembly, maintenance, cleaning, operating, and adjustments,
where applicable. Section 8 of ASTM F2906-12 also requires that the
instructions cover correct assembly of product and use of attachment
system, and conversion, as well as alert consumers that they should
read all instructions and keep the instructions for future use. These
requirements fall within the definition of ``collection of
information,'' as defined in 44 U.S.C. 3502(3).
Description of Respondents: Persons who manufacture or import
bedside sleepers.
Estimated Burden: We estimate the burden of this collection of
information as follows:
Table 1--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Frequency of Total annual Hours per Total burden
16 CFR Section respondents responses responses response hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
1222............................................................... 5 2 10 1 10
--------------------------------------------------------------------------------------------------------------------------------------------------------
Our estimates are based on the following:
There are five known firms supplying bedside sleepers to the U.S.
market. All five firms are assumed to use labels on both their products
and their packaging already, but they might need to make some
modifications to their existing labels. The estimated time required to
make these modifications is about 1 hour per model. Each of these firms
supplies an average of two different models of bedside sleepers;
therefore, the estimated burden hours associated with labels is 1 hour
x 5 firms x 2 models per firm = 10 annual hours.
Sections 8.1 and 8.2 of ASTM F2906-12 require instructions to be
supplied with the product. This is a practice that is customary with
bedside sleepers. Bedside sleepers are products that generally require
some installation and maintenance instructions, and any products sold
without such information would not be able to compete successfully with
products that provide this information. Therefore, because the CPSC is
unaware of bedside sleepers that: (a) Generally require some
installation, but (b) lack any instructions to the user about such
installation, there are no burden hours associated with the instruction
requirement in sections 8.1 and 8.2 because any burden associated with
supplying instructions with bedside sleepers would be ``usual and
customary'' and not within the definition of ``burden'' under the OMB's
regulations.
We estimate that hourly compensation for the time required to
create and update labels is $27.64 (U.S. Bureau of Labor Statistics,
``Employer Costs for Employee Compensation,'' June 2012, Table 9, total
compensation for all sales and office workers in goods-producing
private industries: https://www.bls.gov/ncs/). Therefore, the estimated
annual cost associated with the proposed requirements is $276 ($27.64
per hour x 10 hours = $276).
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C.
[[Page 73353]]
3507(d)), we have submitted the information collection requirements of
this rule to the OMB for review. Interested persons are requested to
submit comments regarding information collection by January 9, 2013, to
the Office of Information and Regulatory Affairs, OMB (see the
ADDRESSES section at the beginning of this notice).
Pursuant to 44 U.S.C. 3506(c)(2)(A), we invite comments on:
Whether the collection of information is necessary for the
proper performance of the CPSC's functions, including whether the
information will have practical utility;
The accuracy of the CPSC's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used;
Ways to enhance the quality, utility, and clarity of the
information to be collected;
Ways to reduce the burden of the collection of information
on respondents, including the use of automated collection techniques,
when appropriate, and other forms of information technology; and
The estimated burden hours associated with label
modification, including any alternative estimates.
J. Preemption
Section 26(a) of the CPSA, 15 U.S.C. 2075(a), provides that where a
consumer product safety standard is in effect and applies to a product,
no state or political subdivision of a state may either establish or
continue in effect a requirement dealing with the same risk of injury
unless the state requirement is identical to the federal standard.
Section 26(c) of the CPSA also provides that states or political
subdivisions of states may apply to the Commission for an exemption
from this preemption under certain circumstances. Section 104(b) of the
CPSIA refers to the rules to be issued under that section as ``consumer
product safety rules,'' thus implying that the preemptive effect of
section 26(a) of the CPSA would apply. Therefore, a rule issued under
section 104 of the CPSIA will invoke the preemptive effect of section
26(a) of the CPSA when it becomes effective.
K. Certification and Notice of Requirements (NOR)
Section 14(a) of the CPSA imposes the requirement that products
subject to a consumer product safety rule under the CPSA, or to a
similar rule, ban, standard or regulation under any other act enforced
by the Commission, must be certified as complying with all applicable
CPSC-enforced requirements. 15 U.S.C. 2063(a). Section 14(a)(2) of the
CPSA requires that certification of children's products subject to a
children's product safety rule be based on testing conducted by a CPSC-
accepted third party conformity assessment body. Section 14(a)(3) of
the CPSA requires the Commission to publish a notice of requirements
(NOR) for the accreditation of third party conformity assessment bodies
(or laboratories) to assess conformity with a children's product safety
rule to which a children's product is subject. The proposed rule for 16
CFR part 1222, ``Safety Standard for Bedside Sleepers,'' when issued as
a final rule, will be a children's product safety rule that requires
the issuance of an NOR.
On May 24, 2012, the Commission published a proposed rule in the
Federal Register titled, ``Requirements Pertaining to Third Party
Conformity Assessment Bodies,'' 77 FR 31086, which, when finalized,
would establish the general requirements and criteria concerning
testing laboratories under 16 CFR part 1112. These include the
requirements and procedures for CPSC acceptance of the accreditation of
a laboratory to test children's products in support of the
certification required by section 14(a)(2) of the CPSA. The proposed
rule lists the children's product safety rules for which the CPSC has
published NORs for laboratories. In this document, the Commission is
proposing to amend the list in 16 CFR part 1112, once that rule becomes
final, to include the bedside sleeper standard, once finalized, along
with the other children's product safety rules for which the CPSC has
issued NORs.
Laboratories applying for acceptance as a CPSC-accepted third party
conformity assessment body to test to the new standard for bedside
sleepers would be required to meet the third party conformity
assessment body accreditation requirements in 16 CFR part 1112,
Requirements Pertaining to Third Party Conformity Assessment Bodies
once that rule becomes final. When a laboratory meets the requirements
as a CPSC-accepted third party conformity assessment body, it can apply
to the CPSC to have 16 CFR part 1222, Safety Standard for Bedside
Sleepers, included in its scope of accreditation of CPSC safety rules
listed for the laboratory on the CPSC Web site at: www.cpsc.gov/labsearch.
CPSC staff conducted an analysis of the potential impacts on small
entities of the proposed rule establishing accreditation requirements,
as required by the Regulatory Flexibility Act, and prepared an Initial
Regulatory Flexibility Analysis (IRFA). Requirements Pertaining to
Third Party Conformity Assessment Bodies. 77 FR 31086, 31123-26. The
IRFA concluded that the requirements would not have a significant
adverse impact on a substantial number of small laboratories because no
requirements are imposed on laboratories that do not intend to provide
third party testing services under Section 14(a)(2) of the CPSA. The
only laboratories that are expected to provide such services are those
that anticipate receiving sufficient revenue from providing the
mandated testing to justify accepting the requirements as a business
decision. Laboratories that do not expect to receive sufficient revenue
from these services to justify accepting these requirements would
likely not pursue accreditation for this purpose. Similarly, amending
the rule to include the NOR for the bedside sleeper standard would 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, perhaps fewer than 6, will seek CPSC acceptance of
their accreditation to test for conformance with the bedside sleeper
standard. Most of these laboratories already will have been accredited
to test for conformance to other juvenile product standards, and the
only cost to them would be the cost of adding the bedside sleeper
standard to their scope of accreditation. As a consequence, the
Commission could certify that the proposed NOR for the bedside sleeper
standard will not have a significant impact on a substantial number of
small entities.
The final NOR will base the CPSC laboratory accreditation
requirements on the performance standard set forth in the final rule
for the safety standard for bedside sleepers and the test methods
incorporated within that standard. The Commission may recognize limited
circumstances in which it will accept certification based on product
testing conducted before the Commission's acceptance of accreditation
of laboratories for testing bedside sleepers (also known as
retrospective testing) in the final NOR. The Commission seeks comments
on any issues regarding the testing requirements of the proposed rule
for bedside sleepers and the accompanying proposed NOR.
L. Request for Comments
This proposed rule begins a rulemaking proceeding under section
104(b) of the CPSIA to issue a consumer product safety standard for
bedside sleepers. We invite all interested
[[Page 73354]]
persons to submit comments on any aspect of the proposed rule. Comments
should be submitted in accordance with the instructions in the
ADDRESSES section at the beginning of this notice.
List of Subjects
16 CFR Part 1112
Administrative practice and procedure, Audit, Consumer protection,
Reporting and recordkeeping requirements, Third party conformity
assessment body.
16 CFR Part 1222
Consumer protection, Imports, Incorporation by reference, Infants
and children, Labeling, Law enforcement, and Toys.
For the reasons discussed in the preamble, the Commission proposes
to amend Title 16 of the Code of Federal Regulations as follows:
PART 1112--REQUIREMENTS PERTAINING TO THIRD PARTY CONFORMITY
ASSESSMENT BODIES
1. The authority citation for part 1112 continues to read as
follows:
Authority: Pub. L. 110-314, section 3, 122 Stat. 3016, 3017
(2008); 15 U.S.C. 2063.
2. Amend Part 1112.15 by adding paragraph (b)(34) to read as
follows:
Sec. 1112.15 When can a third party conformity assessment body apply
for CPSC acceptance for a particular CPSC rule and/or test method?
* * * * *
(b) The CPSC has published previously, or in the cases of 16 CFR
parts 1221, 1223, and 1224, and ASTM F 963-11 for the first time, the
requirements for accreditation for third party conformity assessment
bodies to assess conformity with the following CPSC rules and/or test
methods:
* * * * *
(34) 16 CFR part 1222, Safety Standard for Bedside Sleepers.
3. Add part 1222 to read as follows:
PART 1222--SAFETY STANDARD FOR BEDSIDE SLEEPERS
Sec.
1222.1 Scope.
1222.2 Requirements for Bedside Sleepers.
Authority: The Consumer Product Safety Improvement Act of 2008,
Pub. L. 110-314, Sec. 104, 122 Stat. 3016 (August 14, 2008); Pub.
L. 112-28, 125 Stat. 273 (August 12, 2011).
Sec. 1222.1 Scope.
This part establishes a consumer product safety standard for
bedside sleepers.
Sec. 1222.2 Requirements for Bedside Sleepers.
(a) Except as provided in paragraph (b) of this section, each
bedside sleeper must comply with all applicable provisions of ASTM
F2906-12, Standard Consumer Safety Specification for Bedside Sleepers,
approved on June 1, 2012. The Director of the Federal Register approves
this incorporation by reference in accordance with 5 U.S.C. 552(a) and
1 CFR part 51. You may obtain a copy from ASTM International, 100 Bar
Harbor Drive, P.O. Box 0700, West Conshohocken, PA 19428; https://www.astm.org/cpsc.htm. You may inspect a copy at the Office of the
Secretary, U.S. Consumer Product Safety Commission, Room 820, 4330 East
West Highway, Bethesda, MD 20814, telephone 301-504-7923, or at the
National Archives and Records Administration (NARA). For information on
the availability of this material at NARA, call 202-741-6030, or go to:
https://www.archives.gov/federal_register/code_of_federalregulations/ibr_locations.html.
(b) Comply with the ASTM F2906-12 standard with the following
additions:
(1) In addition to complying with section 3.1.7 of ASTM F2906-12,
comply with the following:
(i) 3.1.8 ``bedside sleeper accessory, n--an elevated sleep surface
that attaches to a non-full-size crib or play yard, designed to convert
the product into a bedside sleeper intended to have a horizontal sleep
surface while in a rest (non-rocking) position.''
(ii) [Reserved]
(2) In addition to complying with section 5.6 of ASTM F2906-12,
comply with the following:
(i) 5.7 Bedside Sleeper Accessory Fabric-Sided Enclosed Openings--A
bedside sleeper accessory shall meet the F2194 performance requirement,
``Fabric-Sided Enclosed Openings.''
(A) 5.7.1 Bedside sleeper accessories are exempt from this
requirement if either of the following two conditions is met after
disengaging all fasteners between the accessory and the non-full-size
crib or play yard base to which it is assembled:
(B) 5.7.1.1 The bedside sleeper accessory collapses under its own
weight, such that any part of the mattress pad contacts the bottom
floor of the non-full-size crib or play yard.
(C) 5.7.1.2 The bedside sleeper accessory's sleep surface tilts by
more than 30 degrees.
(ii) 5.8 Bedside Sleeper Play Yard Accessories Missing Key
Structural Elements: A bedside sleeper accessory shall meet the F406
general requirement ``Bassinet/Cradle Accessories Missing Key
Structural Elements.''
Dated: December 3, 2012.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission .
[FR Doc. 2012-29583 Filed 12-7-12; 8:45 am]
BILLING CODE 6355-01-P