Safety Standard for Bassinets and Cradles, 63019-63036 [2013-24203]
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Federal Register / Vol. 78, No. 205 / Wednesday, October 23, 2013 / Rules and Regulations
CONSUMER PRODUCT SAFETY
COMMISSION
16 CFR Parts 1112 and 1218
[Docket No. CPSC–2010–0028]
Safety Standard for Bassinets and
Cradles
Consumer Product Safety
Commission.
ACTION: Final rule.
AGENCY:
The Danny Keysar Child
Product Safety Notification Act, Section
104 of the Consumer Product Safety
Improvement Act of 2008 (CPSIA),
requires the United States Consumer
Product Safety Commission
(Commission or CPSC) to promulgate
consumer product safety standards for
durable infant or toddler products.
These standards are to be ‘‘substantially
the same as’’ applicable voluntary
standards or more stringent than the
voluntary standard if the Commission
concludes that more stringent
requirements would further reduce the
risk of injury associated with the
product. The Commission is issuing a
safety standard for bassinets and cradles
in response to the direction under
Section 104(b) of the CPSIA.
DATES: The rule will become effective
on April 23, 2014, with the exception of
§ 1218.2(b)(3)(i) through (iv), (b)(5), and
(b)(7), which will become effective on
April 23, 2015. The incorporation by
reference of the publication listed in
this rule is approved by the Director of
the Federal Register as of April 23,
2014.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
William Dewgard, Directorate for
Compliance, Consumer Product Safety
Commission, telephone: 301–504–7599;
email: WDewgard@cpsc.gov.
SUPPLEMENTARY INFORMATION:
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I. 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
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voluntary standards or more stringent
than the voluntary standard if the
Commission concludes that more
stringent requirements would further
reduce the risk of injury associated with
the product.
The term ‘‘durable infant or toddler
product’’ is defined in section 104(f)(1)
of the CPSIA as ‘‘a durable product
intended for use, or that may be
reasonably expected to be used, by
children under the age of 5 years.’’
Bassinets and cradles are specifically
identified in section 104(f)(2)(L) of the
CPSIA as a durable infant or toddler
product.
On April 28 2010, the Commission
issued a notice of proposed rulemaking
(NPR) for bassinets and cradles. 75 FR
22303. The NPR proposed to
incorporate by reference the voluntary
standard, ASTM F2194–07a ε1, Standard
Consumer Safety Specification for
Bassinets and Cradles, with certain
changes to provisions in the voluntary
standard to strengthen the ASTM
standard.
The Commission published a
supplemental notice of proposed
rulemaking (SNPR) on October 18, 2012.
77 FR 64055. The SNPR proposed to
incorporate the voluntary standard,
ASTM F2194–12, with: (1)
Modifications to sections pertaining to
scope and terminology and the stability
test procedure, and (2) the addition of
new provisions for a segmented mattress
flatness test and a removable bed
stability requirement.
In this document, the Commission is
issuing a safety standard for bassinets
and cradles. 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 standard, largely
through the ASTM process. The rule
incorporates the voluntary standard,
ASTM F2194–13, Standard Consumer
Safety Specification for Bassinets and
Cradles (ASTM F2194–13), by reference,
with the following modifications and
additions: a clarification to the scope of
the bassinet/cradle standard; a change to
the pass/fail criterion for the mattress
flatness test; an exemption from the
mattress flatness requirement for
bassinets that are less than 15 inches
across; the addition of a removable bed
stability requirement; and a change to
the stability test procedure requiring the
use of a newborn CAMI dummy rather
than an infant CAMI dummy.
II. The Product
ASTM F2194–13 defines ‘‘bassinet/
cradle’’ as a ‘‘small bed designed
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primarily to provide sleeping
accommodations for infants, supported
by free standing legs, a stationary frame/
stand, a wheeled base, a rocking base, or
which can swing relative to a stationary
base.’’ While in a rest position, a
bassinet/cradle is intended to have a
sleep surface less than or equal to 10°
from horizontal. The bassinet/cradle is
not intended to be used beyond the age
of approximately five months or when
a child is able to push up on his hands
and knees. Bassinet and cradle
attachments for non-full-size cribs or
play yards are considered part of the
bassinet/cradle category, as are bedside
sleepers that can be converted to foursided bassinets not attached to a bed.
Cribs, Moses baskets, and products
used in conjunction with an inclined
infant swing or stroller, and products
that are intended to provide only an
inclined sleep surface of greater than 10
degrees horizontal, are not included
under the category of ‘‘bassinets/
cradles.’’ (A Moses basket is a portable
cradle for a newborn or infant, often
made of straw or wicker, that can be
used with a variety of rocking and
stationary stands. As with other
bassinets and cradles, Moses baskets are
not intended for use after a child can
push up on its hands and knees.)
However, Moses baskets and carriage
accessories that can be converted to a
bassinet or cradle by attachment to a
separate base/stand would be
considered bassinets/cradles when used
with the base/stand. Similarly, products
that could be used at an incline of 10
degrees or less from horizontal, as well
as more than 10 degrees from
horizontal, would be considered
bassinets/cradles when in the flatter
configuration(s).
III. Incident Data
The preamble to the SNPR
summarized incident data involving
bassinets and cradles reported to the
Commission as of January 18, 2012. 77
FR 64055 (October 18, 2012). CPSC’s
Directorate for Epidemiology, Division
of Hazard Analysis has updated this
information to include bassinet- and
cradle-related incident data reported to
the Commission from January 18, 2012
through March 31, 2013. A search of the
CPSC epidemiological databases
showed that there were 71 new
incidents related to bassinets and
cradles reported during this time frame.
Thirty-eight of the 71 were fatal, and 33
were nonfatal. Sixteen of the nonfatal
incidents involved injuries. Almost all
of the new incidents reportedly
occurred between 2010 and 2012.
Reporting is ongoing, however, so the
incident totals are subject to change.
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A. Fatalities
The majority of the deaths (32 out of
38) were asphyxiations due to the
presence of soft or extra bedding in the
bassinet, prone placement of the infant,
and/or the infant getting wedged
between the side of the bassinet and
additional bedding. All but four of the
38 decedents were five months or less
in age, the ASTM-recommended age
range for bassinet use; three of the
decedents were six months old and
another was an eight-month-old.
Two of the 38 deaths were associated
with design aspects of the product. One
of these was a suffocation death in a
corner of the bassinet whose rocking
feature contributed to its non-level
resting position; the other fatality
occurred when the bassinet was
knocked over by an older sibling.
There were three fatalities with
insufficient information and one fatality
with confounding information
preventing CPSC from determining the
hazard scenario.
B. Nonfatal Incidents
A total of 33 bassinet-related nonfatal
incidents were reported from January
18, 2012 through March 31, 2013. Of
these, 16 reports indicated an injury to
an infant using the bassinet or cradle at
the time of the incident. The majority of
these injuries (11 out of 16, or 69
percent) were due to falls out of the
bassinets. All 11 fall injuries were
reported through NEISS, with little or
no circumstantial information on how
the fall occurred. However, the reports
do indicate that 55 percent of the
injured infants who fell out of bassinets
were older than the ASTMrecommended maximum age limit of
five months. All of the falls resulted in
head injuries. Among the remaining five
nonfatal injuries, mostly head injuries,
no hospitalizations were reported. All
but six of the injured were five months
or less in age.
The remaining 17 incident reports
indicated that no injury had occurred or
provided no information about any
injury. However, many of the
descriptions indicated the potential for
a serious injury or even death.
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C. Hazard Pattern Identification
The hazard patterns identified in the
71 new incident reports were similar to
the hazard patterns that were identified
in the incidents considered for the
SNPR and are grouped in the following
categories (in descending order of
frequency of incidents):
1. Non-product-related issues: Thirtyfour of the 71 reports (48 percent)
concerned incidents that involved no
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product defect or failure. This category
consisted of 32 fatalities that were
associated with the use of soft/extra
bedding, prone positioning, and/or the
infant getting wedged between the side
of the bassinet and additional bedding.
In addition, there were two nonfatal
injury incidents that did not involve any
product-related issues.
2. Product-related issues: The hazard
scenarios in 25 of the 71 reported
incidents (35 percent) were attributed to
a failure/defect or a potential design
flaw in the product. This category
includes one fatality and 13 injuries.
Listed below are the reported problems,
beginning with the most frequently
reported concerns:
• Reports of infants falling or
climbing out of bassinets/cradles
accounted for a total of 13 incidents, all
of which were received from emergency
departments around the United States.
Eleven of the incidents reported a
nonfatal injury; the remaining two
infants were reported to be uninjured.
• Lack of structural integrity, which
includes issues such as instability, loose
hardware, and product collapse, among
others, was reported in nine incidents—
one with a fatality and two with
nonfatal injuries.
• Problems with accessories (such as
the stand or sheets), which were sold
with the bassinets, were reported in two
incidents. However, no injuries were
reported.
• One other product-related problem,
involving the battery compartment of an
older product, was reported in one noninjury incident.
3. Recalled product-related issues:
There were six reports (eight percent)
that were associated with three different
recalled product-related issues. (Two of
the recalls were published since the
incident data for the SNPR briefing
package was presented; at the time,
these issues were classified under the
‘‘structural integrity’’ and ‘‘rocking’’
categories.) Although there were no
injuries, there was a fatality included
among the six incident reports. In the
fatal incident, it is reported that the
tilting of the bassinet caused the
decedent to roll and press up against the
side and suffocate.
4. Miscellaneous other issues: The
remaining six incident reports (eight
percent) were related to other
unspecified issues. The reports
described the incidents with insufficient
specificity or provided confounding
information, preventing CPSC staff from
identifying the hazard scenario. There
were four fatalities, one nonfatal injury,
and one non-injury incident reported in
this category.
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IV. Overview of ASTM F2194
ASTM F2194, Standard Consumer
Safety Specification for Bassinets and
Cradles, establishes safety performance
requirements, test methods, and labeling
requirements to minimize the identified
hazard patterns associated with the use
of bassinets/cradles. ASTM first
published a consumer product safety
standard for bassinets and cradles in
2002. The standard was revised several
times over the next 11 years. The
current version of the standard is ASTM
F2194–13. The more significant
requirements of ASTM F2194 include:
• Scope—describes the types of
products intended to be covered under
the standard.
• Spacing of rigid side components—
is intended to prevent child entrapment
between both uniformly and nonuniformly spaced components, such as
slats.
• Openings for mesh/fabric—is
intended to prevent the entrapment of
children’s fingers and toes, as well as
button ensnarement.
• Static load test—is intended to
ensure structural integrity even when a
child three times the recommended (or
95th percentile) weight uses the
product.
• Stability requirements—is intended
to ensure that the product does not tip
over when pulled on by a two-year-old
male.
• Sleeping pad thickness and
dimensions—is intended to minimize
gaps and the possibility of suffocation
due to excessive padding.
• Tests of locking and latching
mechanisms—is intended to prevent
unintentional folding while in use.
• Suffocation warning label—is
intended to help prevent soft bedding
incidents.
• Fabric-sided openings test—is
intended to prevent entrapments.
• Rock/swing angle requirement—is
intended to address suffocation hazards
that can occur when latch/lock
problems and excessive rocking or
swinging angles press children into the
side of the bassinet/cradle.
• Occupant restraints—is intended to
prevent incidents where unused
restraints have entrapped and strangled
children.
• Side height requirement—is
intended to prevent falls.
• Segmented mattress flatness—is
intended to address suffocation hazards
associated with ‘‘V’’ shapes that can be
created by the segmented mattress folds.
The voluntary standard also includes:
(1) Torque and tension tests to prevent
components from being removed; (2)
requirements for several bassinet/cradle
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features to prevent entrapment and cuts
(minimum and maximum opening size,
small parts, hazardous sharp edges or
points, and edges that can scissor, shear,
or pinch); (3) requirements for the
permanency and adhesion of labels; (4)
requirements for instructional literature;
and (5) corner post extension
requirements intended to prevent
pacifier cords, ribbons, necklaces, or
clothing that a child may be wearing
from catching on a projection.
V. The SNPR and ASTM F2194–13
The SNPR proposed to incorporate by
reference ASTM F2194–12, with four
modifications/additions to the voluntary
standard:
(1) Scope and Terminology: The
SNPR proposed excluding inclined
products from the scope of the standard,
by revising the scope and including a
detailed note with examples of what
products were and were not included in
the scope of the standard. The SNPR
also proposed two existing definitions
be revised for clarity.
(2) Segmented Mattress Flatness Test:
The SNPR proposed a new test
requirement and associated test
procedure to address suffocation
incidents in segmented mattresses. As
discussed in the preamble to the SNPR,
the mattress flatness requirement is
primarily aimed at incidents involving
bassinet/play yard combination
products that tend to use segmented
mattresses, where seams could pose a
suffocation and positional asphyxiation
hazard. Under the Commission’s pass/
fail criteria proposed in the SNPR, a
bassinet attachment with a segmented
mattress would fail if any tested seam
creates an angle greater than 10 degrees.
(3) Removable Bed Stability
Requirement: The SNPR proposed a
new test requirement and associated test
procedure to address fatal and nonfatal
incidents associated with bassinets that
have removable bassinet beds. In the
proposed requirement, a removable
bassinet bed that was not properly
attached or assembled to its base would
be required to meet one of the following
requirements:
a. 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
b. The lock/latch shall automatically
engage under the weight of the bassinet
bed (without any other force or action);
or
c. The stand/base shall not be capable
of supporting the bassinet bed within 20
degrees of horizontal; or
d. The bassinet shall contain a visual
indicator mechanism that shall be
visible on both sides of the product to
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indicate whether the bassinet is
properly attached to the base; or
e. The bassinet shall not tip over and
shall retain the CAMI newborn dummy
when subjected to the stability test
outlined in the standard.
(4) Stability Test Procedure: The
SNPR proposed a revised test procedure
for stability. The revision specifies the
use of a newborn CAMI dummy, rather
than the six month CAMI dummy that
is referenced in the ASTM standard.
The SNPR’s provisions concerning the
scope and terminology and the
proposed segmented mattress flatness
test requirement were balloted by ASTM
in 2012, and the provisions are now
included in the latest revision of the
voluntary standard, ASTM F2194.
Although the mattress flatness test
procedure in ASTM F2194–13 is
identical to what is proposed in the
SNPR, the pass/fail criterion is different.
As stated previously, under the
Commission’s pass/fail criteria, as
proposed in the SNPR, a bassinet
attachment with a segmented mattress
will fail if any tested seam creates an
angle greater than 10 degrees. ASTM
F2194–13 allows measured angles
between 10 degrees and 14 degrees to
pass, as long as the mean of three
measurements on that seam is less than
10 degrees.
The removable bed stability
requirement proposed in the SNPR is
not in the current ASTM standard, but
a similar version is expected to be
balloted by ASTM for inclusion in the
next revision. Similarly, the change in
the stability test procedure proposed in
the SNPR is not in ASTM F2194–13, but
it is expected to be balloted by ASTM
for inclusion in its next revision.
VI. Response to Comments
There were 27 comments received on
the SNPR, including: one from Health
Canada; one from a group of consumer’s
groups (Kids In Danger, Consumers
Union, American Academy of
Pediatrics, Consumer Federation of
America, Public Citizen, and U.S. PIRG);
one from the Juvenile Products
Manufacturers Association (JPMA); and
two from bassinet manufacturers. The
remaining 22 comments were from
consumers, law students, or unaffiliated
sources. The comments raised several
issues, which resulted in two changes to
the final rule. Several commenters made
general statements supporting the
overall purpose of the proposed rule.
All of the comments can be viewed at:
www.regulations.gov, by searching
under the docket number of the
rulemaking, CPSC–2010–0028.
Following is a summary of and
responses to the comments.
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Scope
Comment: Two commenters provided
almost identical comments and
suggestions for changes to the scope.
The commenters asserted that the scope
was unclear about what products are
included in the scope and under what
conditions. For instance, one comment
stated that it was not clear from the
SNPR how products with an inclined
seat back surface (reclined seat back),
such as infant seats, infant bouncer
seats, and infant rockers that do not
provide an ‘‘inclined sleep surface’’
would be treated under the standard.
Response: The scope that was
proposed in the SNPR has subsequently
been adopted by ASTM and is the scope
in the current version of the ASTM
standard, ASTM F2194–13. The
comments received reflect continued
ambiguity regarding some aspects of the
scope. Therefore, the Commission is
providing additional clarity in the final
rule.
Inclined products fall under a variety
of different ASTM standards, depending
on the product’s function. For instance,
ASTM standards include a handheld
carrier standard, an infant bouncer
standard, and a new rocker standard
that is currently under development.
None of those products is intended for
sleep. An inclined product intended for
sleeping would fall under the inclined
sleep product standard currently under
development by ASTM. The
Commission’s intent is that the scope of
the bassinet standard exclude all
inclined products when the incline is
more than 10 degrees from horizontal.
However, the Commission intends
that any product that has both a flat (10
degrees or less) sleep surface and an
inclined surface greater than 10 degrees
from horizontal shall fall under the
scope of the bassinet standard when
configured in the flat mode, and will fall
under the scope of the appropriate
inclined product standard(s) while in
the inclined mode. In this manner, all
uses of the product are addressed by
safety standards. This type of product is
considered a multimode product, or a
combination product, i.e., the product
can convert from one use mode to
another.
During the recent ASTM F15 juvenile
products subcommittee meetings held
in April 2013, scope clarity was raised
in various product subcommittees
where multimode products are
commonly considered. Most of those
product subcommittees proposed to
modify the scope section of the
appropriate standard to clarify that
these combination products shall fall
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under the scope of all relevant standards
when in the corresponding use mode.
This intent to include multimode
products under multiple standards is
well established in ASTM standards,
including the bassinet standard. One
example of a multimode product is a
carriage basket that is removable from a
stroller base. The scope section of
ASTM F2194–13 clearly states that
products used in conjunction with a
stroller are not covered by the standard.
Yet, the current scope section also
states: ‘‘Carriage baskets/bassinets that
are removable from the stroller base are
covered under the scope of this standard
when the carriage basket/bassinet meets
the definition of a bassinet/cradle found
in 3.1.1.’’ Clearly, the intent of the
ASTM standard is to see that this
multimode product falls within the
scope of the stroller standard when
attached to the stroller frame and falls
within the scope of the bassinet
standard when attached to a separate
frame/stand.
Thus, to remove any ambiguity
regarding multimode products, the
Commission’s standard modifies the
note that accompanies the scope
provision of ASTM F2194–13 to clarify
that a multimode product with a
bassinet-use mode must meet the
bassinet standard when in the bassinetuse mode.
Comment: One commenter suggested
that the scope of the standard needs
more specific age restrictions.
Response: The scope of a standard is
intended to define broadly an entire
product category. Within that category,
manufacturers have the freedom to
tailor their product to a specific market
niche, which might be more specialized
than other products in the same
category. Providing too many specific
restrictions within the scope of a
standard makes the standard weaker by
excluding many products that ought to
be included. In general, ASTM
standards are defined by their respective
industries, using terms that produce a
standard that is as useful as possible to
that industry. The Commission agrees
with the bassinet industry on the
existing age recommendations in the
ASTM standard.
Removable Bassinet Bed Requirements
Comment: One group of commenters
suggested that the Commission
eliminate the two ‘‘passive’’ pass
conditions (20 degrees and passing
stability) of the removable bassinet bed
stability requirement in favor of the
other pass criteria, which the group of
commenters said they believe makes the
user actively aware that the bassinet is
not attached properly.
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Response: The SNPR proposed several
options to meet the removable bassinet
bed requirements. This approach is less
restrictive than prescribing one pass
criterion, and the approach allows for
more innovation in product designs. By
permitting five different options to meet
this requirement, manufacturers have a
variety of design choices available.
Comment: Some commenters said
they believe that allowing the bassinet
to ‘‘fail’’ (by falling to the ground or to
a 20 or more degree angle) encourages
manufacturers to make products that are
less stable to ensure that their bassinets
pass this requirement. Another
commenter stated that it was foreseeable
that some caregivers may attempt to
attach the bassinet bed to its stand while
the child is in the product and that this
might expose children to unnecessary
hazards.
Response: Two of the five options to
pass the removable bed requirement are
closely related to one another. These
two options are: (1) The sleep surface
shall be at least 20 degrees off from a
horizontal plane; and (2) the bassinet
bed falls from the stand and contacts the
floor. These two requirements were
added after consultations with
stakeholders (ASTM task group
members). Several stakeholders stated
that if a bassinet stand was designed to
support the bassinet bed only if it were
locked properly, then the bassinet stand
should be able to pass the requirement.
For instance, in the case of a stand that
looks like a saw horse, or ‘‘A’’ frame that
has a lock/latch connection at the top of
the ‘‘A’’ on the frame and on the
underside of the bassinet bed, the
caregiver would have to line up both
halves of the lock/latch to attach the bed
to the stand. It would be unreasonable
to believe that caregivers would place
the bassinet bed on an ‘‘A’’ frame stand
without engaging the lock/latch because
the design of the stand would cause the
bassinet bed to fall to the ground if the
lock was not engaged.
Rather than specifying a design
requirement, the task group converted
the requirement to a performance
requirement, by simulating what would
happen if the unreasonable act
occurred. In other words, this option
requires the bassinet bed to fall to the
ground if the lock is not properly
engaged.
Once that requirement was vetted by
the task group, another stakeholder
raised the possibility that the bassinet
bed, in the act of falling, might get
caught on the stand before hitting the
ground. The stakeholder asserted that
simply because the bassinet bed did not
hit the ground should not constitute a
failure. Thus, the 20-degree tilt option
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was added to address the possibility
that the bassinet bed, in the process of
falling, might get caught on the stand
and to complement the fall-to-theground option.
A bassinet that relies on either of
these two options to pass the
requirement would be considered to
provide immediate positive feedback.
Caregivers who attempt to place the
bassinet bed on this type of stand
without locking it in place will realize
instantly that they did not engage the
lock because the bassinet bed will not
assume a stable position that allows the
caregivers to release their grasp. The
immediate feedback of instability will
minimize the possible hazards, making
falling unlikely. The Commission
believes that the steep angle needed to
pass is unlikely to allow consumers to
let children fall. The instability of such
a unit is immediately obvious to the
user, precluding a delayed response.
Consumers are likely to check the
stability of the product before removing
their hands from it. Even in the case of
a caregiver who attempts to place an
occupied bassinet bed on a stand using
this option, the caregiver will be present
and potentially will be able to prevent
or arrest the fall of the bassinet bed. The
Commission considers the possibility of
a fall hazard in this scenario to be
highly unlikely; and on the rare chance
that a fall occurs, the fall in these
circumstances would be considered less
significant than an unattended fall to
the floor.
Comment: One commenter stated that
the option—‘‘The lock/latch shall
automatically engage under the weight
of the bed (without any other force/
action)’’—should be a requirement for
all bassinets.
Response: The Commission is
providing manufacturers with options to
meet the removable bassinet bed
requirements. This approach is less
restrictive than prescribing one
requirement and allows for more
innovation in product designs.
Comment: One commenter stated that
adding the removable bassinet bed
stability requirement is premature. The
commenter expressed the belief that the
requirement should be removed from
the regulation and that ASTM should be
allowed to continue working on the
issue.
Response: The Commission is aware
of two deaths associated with this
hazard scenario. (One of these deaths
occurred in Canada; thus, it was not
included in incident data counts
reported in the SNPR briefing package.)
Therefore, the Commission does not
believe that this requirement is
premature. The Commission believes
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that stakeholders have had plenty of
time to test, review, discuss, and refine
the proposed requirements before and
after the SNPR was published. In fact,
the language recommended for the final
rule is essentially the same as what
ASTM expects to ballot soon as a new
requirement to address the same hazard.
Comment: A commenter stated that
color-only visual indicators should not
be allowed as an option to pass the
removable bassinet bed requirement
because people who are color-blind
would not be able to distinguish
between locked and unlocked.
Response: The requirement for visual
indicators allows manufacturers to
design a visual indicator that can be
recognized by a person with a color
vision deficiency. In addition, there are
many other options to pass the
requirement, and individuals who are
color-blind can choose to purchase a
product that does not use color
indicators.
Comment: Some commenters
expressed a belief that allowing
removable bassinet beds to pass the
stability test by tilting to a 20-degree
angle was hazardous because consumers
might think that a 20-degree angle is
still usable, perhaps as an inclined
sleeper.
Response: The Commission believes
that an angle of 20° or more is
acceptable to demonstrate that the
bassinet is not useable. A steeper angle
would also be acceptable, but the
Commission is not convinced this is
needed. Twenty degrees is twice the
maximum allowable tilt for bassinets,
which are intended to have a flat
sleeping surface. In deciding on the 20°
angle, the ASTM task group noted an
incident (101101HCC3107) where a
consumer clearly saw that something
was wrong with his bassinet when he
saw it tilted and deemed it to be
unusable. From the photos, the tilt was
estimated to be approximately 17°.
Mattress Flatness
Comment: Some commenters
suggested that the mattress flatness
requirements should be limited to 8°
from the horizontal rather than 10°.
Response: Although the Commission
would be amenable to using this more
conservative margin of safety, i.e., a
tolerance of 16° of motion rather than
20°, the industry has maintained that a
larger tolerance is necessary, due to the
inherent variability of manufacturing
products with fabric and foam. The
industry claims that tighter tolerances
on a segmented mattress made with the
materials that are commonly used in
these products would make it
impossible to manufacture such
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mattresses. The Commission believes
that the 10° limit is adequate to protect
the expected user population.
Comment: A commenter suggested
that the threshold limit for flatness
should be 14° to preserve test-retest
reliability.
Response: ASTM F2194–13 now
includes the mattress flatness test
requirement and procedure, as written
in the SNPR, with the exception of the
angle requirement. ASTM’s requirement
allows the use of an average for
measurements over 10° and under 14°,
while the SNPR proposed a maximum
allowable measurement of 10°. Based on
testing performed by an ASTM task
group that was established to assess the
reliability and repeatability of the
mattress flatness test, the reliability of
the test is adequate when the test is
performed on products designed to pass
the test. The commenter did not provide
any new or different information to the
Commission to support the suggestion
for using the averaging method; thus,
the Commission continues to support
the 10° flatness criterion as proposed in
the SNPR.
Comment: Some commenters
questioned the use of a cylinder as a
surrogate for a human occupant, and
another commenter suggested that an
automated human model would be more
appropriate.
Response: An automated human
model is not readily available. It is
customary in the juvenile product
industry to use easily manufactured
shapes made from common materials.
This testing strategy enhances the
repeatability of the test. An ASTM task
group conducted a repeatability and
reproducibility study to compare
various surrogates for use in the
mattress flatness test. The cylinder was
the best choice, based on the study
results.
Comment: Some commenters
suggested using the dummy in the test
for mattress flatness so that infant
position would be a factor.
Response: The test cylinder is a
repeatable method that identifies
hazardous products to the satisfaction of
industry and the Commission.
Unfortunately, the CAMI dummy is too
stiff to be useful for simulating
suffocation positions and would not be
suitable to serve that purpose.
Comment: Some commenters wanted
more explanation of how the cylinder
sufficiently simulates an infant rolling
into a mattress crease, as demonstrated
in the mattress flatness test.
Response: The Commission has
examined bassinets that pass the test
and bassinets that fail. When visual
comparisons and measurements of
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angles are made to compare the
movements of the mattresses during a
test using an anthropomorphic dummy
versus tests using a cylinder, few
discernible differences are evident. The
shape of the test weight does not seem
to be as important as the mass of the test
weight in identifying hazardous
products.
Comment: Two commenters offered
opinions about the mattress flatness
testing and designs of bassinet
accessories that use support rods
underneath the mattress. One of the two
comments suggested that the mattress
flatness test be performed with and
without the bars in place. Moreover, the
commenter suggested that if the bars are
required to be in place to pass the
flatness test, then they should be
attached permanently. Similarly, the
other comment suggested that the frame
supporting the floor (mattress) should
come preassembled to eliminate the
possibility that the consumer can
misassemble the product.
Response: The Commission agrees
with these comments. In January 2013,
ASTM balloted a revised mattress
flatness test, requiring that any
segmented mattress that has consumerassembled mattress support rods, be
tested with and without the mattress
support rods. This requirement resulted
from the Commission’s play yard
misassembly NPR that was published in
August 2012. The ballot item passed
and is now part of ASTM F2194–13.
The final rule incorporates by reference
ASTM F2194–13; thus, the test will
include the suggestion from the
commenters.
Comment: A commenter stated that
that the mattress flatness test could not
be performed on bassinets that were less
than 15 inches wide because of the
width of the cylinder and the block used
in that test method. Furthermore, the
commenter noted that such a small,
narrow occupant-retention space would
not present the same hazards involved
in incidents with wider play yard
bassinet accessories.
Response: The Commission agrees
that bassinets with occupant-retention
spaces that are narrower than the test
apparatus are unlikely to be used with
an infant placed orthogonally between
walls that are so narrow. In the case
where an infant is placed in a narrow
bassinet correctly and then moves or
shifts 90°, the narrowness of the
bassinet would likely not permit the
infant to lie in a fully prone position,
face down in an orthogonal seam. Thus,
an exemption from the flatness test for
mattress pad seams that run
orthogonally between the sides of a
bassinet with a width of 15 inches or
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less seems reasonable. Therefore, the
Commission is modifying the standard
to exempt from the mattress flatness test
bassinets that are narrower than 15
inches.
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Effective Date
Comment: We received several
comments on the effective date
proposed in the SNPR. One commenter,
representing several advocacy groups,
supported the six-month effective date
proposed in the SNPR. A second
commenter agreed, expressing concerns
that if the date were extended and a
death occurred, ‘‘consumers might view
the death as the result of the CPSC
putting the interests of for-profit entities
. . . ahead of the safety of infants who
use their products.’’
In contrast, several other commenters,
including one manufacturer,
recommended longer effective dates to
reduce the impact of the rule,
particularly for small businesses that
have ‘‘fewer resources and connections
within the industry’’ and that ‘‘may
have to significantly alter their means of
production.’’ Suggested effective dates
ranged from 9 to 15.5 months, with
commenters recommending that the
CPSC focus on relief for firms that
would be disproportionately impacted
by the rule. Commenters suggested
longer effective dates for firms newly
covered by the expanded scope, and
firms whose products would be subject
to the removable bassinet bed
requirement.
A manufacturer commenting on the
effective date stated that a longer
effective date is needed for firms that
will need to redesign their products to
meet the removable bassinet bed
requirement. This firm stated that an
effective date of at least 15.5 months is
needed to reflect accurately the
challenges of redesigning the product.
Response: The Commission
recognizes that some manufacturers will
be required to redesign, test new
prototype products, and then retool
their production process to meet the
new removable bassinet bed provision.
Based on a comment from one
manufacturer who stated it would need
a minimum of 15.5 months to redesign
its product, the Commission considers
18 months to be a reasonable time
period to accommodate other
manufacturers that might also need to
redesign their products. Therefore, the
Commission is implementing a sixmonth effective date for the final rule,
with the specific exception of extending
the effective date for the removable
bassinet bed test requirement to 18
months.
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Stability Testing—CAMI Dummy
Comment: Some commenters
suggested using an infant and a
newborn dummy in the stability test
methods, while others said they believe
the incident data do not support the
need to change from an infant dummy
to a newborn dummy because this
change neglects the evidence that larger
infants also use bassinets and cradles.
Response: The use of both dummies is
unnecessary because the worst case
scenario for stability is the smaller size
dummy. The larger size dummy makes
the product more stable. Therefore, if a
product passes with a newborn, the
product will also pass with an infant.
Performing the test with two different
dummies would be redundant and
would only add to the cost of testing.
The Commission is requiring use of
the newborn CAMI to make the test
more stringent. Even if a majority of the
incidents were not directly attributable
to product stability, the instability of the
product, in many incidents, was to
blame, including two fatal incidents
(one of which was reported from
Canada).
Incident Data Analysis
Comment: Some commenters asserted
that a causal relationship could not be
established for fatalities that the
Commission attributed to design
defects. They also stated that the
information used by the Commission to
analyze fall incidents was
circumstantial. Other commenters
suggested that additional information
should be collected to determine the
extent to which product design was at
fault, to evaluate the cause of falls, and
to ‘‘improve and expand on the
regulations and guidelines set forth in
the proposed rule.’’
Response: The Commission gathered
as much information as possible on
every cited product-related fatality
through an in-depth, on-site field
investigation. Although the Commission
agrees with the commenters that
additional information-gathering on all
nonfatal injuries could be useful, given
resource limitations, the Commission
cannot follow up on every injury report
with an in-depth investigation. Many of
the nonfatal injuries were based on
emergency department-treated cases
from NEISS hospitals, and
confidentiality requirements often
prevent any additional contact with
patients. In addition, even with cases
that are followed, completion of the
investigation is not guaranteed because
of a lack of consumer cooperation or the
inability to establish contact with the
consumer.
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Short of a controlled experimental
setting, causal links are difficult to
establish from observational data based
on un-witnessed incidents. However,
the combined judgment of subject
matter experts at CPSC, corroborated by
investigating state/county/local officials,
supports the conclusions.
Comment: One set of commenters
expressed the belief that the data
presented in the SNPR is skewed and
purposely misleading. There were
specifics outlined in the comment,
which are addressed in the response.
Response: The Commission disagrees
strongly with the commenters’ assertion
regarding the way the data are
presented. For fatalities, the
commenters contend that almost all of
the incidents were due to caregiver
negligence, even the ones that the
Commission considered to be product
related.
The commenters first argued that the
Commission needed to gather more
information on the fatalities deemed by
the Commission to be product related.
CPSC staff gathered as much
information as possible on every cited
product-related fatality through an indepth, on-site field investigation.
Because these incidents were not
witnessed, the judgments of subject
matter experts at CPSC and state/
county/local investigating officials were
combined to arrive at the conclusions
about the manner of the deaths.
Second, the commenters asserted that
of the three deaths that were due to
infants sliding out of the fabric-sided
opening, two were of the infants were
older than the recommended-user age.
Hence, the commenters further asserted,
these two deaths cannot be counted as
product-related because they were the
result of caregiver negligence. The
Commission disagrees with this
assertion because the third decedent,
who died in the same manner, was well
within the recommended age limit.
Therefore, the age of the other two
decedents, barely a month above the
recommended age limit, was deemed
not to be a factor in the entrapments.
Third, the commenters stated that the
non-product-related deaths appear to be
due to caregiver negligence and do not
justify CPSC’s increasing the economic
burden on manufacturers through added
regulations. This argument has no basis
because CPSC’s regulation does not
make any changes to the current
voluntary standard based on these nonproduct-related fatalities.
For the nonfatal injuries, the
commenters said they believe there is
no justification for placing a burden on
manufacturers by including one injury,
due to a moldy mattress, in the report.
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CPSC staff includes all in-scope
incidents in its hazard sketch, even if
the Commission is not proposing any
provisions to address the issue.
Therefore, the manner in which staff
reports the incident data does not
impose any burden on manufacturers.
In addition, the commenters argued
that six percent of the injuries from
bassinets that were damaged during
delivery were instances of blatant
negligence on the part of the owners.
First, to clarify, the Commission
reported that six percent of the
incidents, not injuries, involved
bassinets damaged during delivery.
Second, there were no injuries
associated with these incidents, and the
Commission did not propose any
provisions to address the issue.
Comment: Some commenters said that
the Commission needs to provide
justification for its statement that the
descriptions in the noninjury incident
reports indicated the potential for
serious injury. The commenters stated
that without any further explanation,
the statement seems ‘‘arbitrary.’’
Response: CPSC staff has reviewed a
number of incidents in which the
caregiver was reported to be nearby and
was able to rescue the infant from
danger. Similar scenarios, with the
infant unattended, have led to less
favorable outcomes. Thus, the potential
for serious consequences is not
conjecture, and the statement is
justified.
Size and Weight Limits
Comment: Some commenters
suggested that the weight of an infant
occupant should be considered in the
standard’s scope to safeguard infants
who exceed the recommended weight
and size.
Response: The maximum weight of an
occupant is already considered in the
static load requirements in ASTM
F2194–13, which the rule incorporates
by reference. The industry requires a
bassinet to be loaded to three times the
manufacturer’s recommended weight.
The side heights are also intended to
account for the largest infants who
might still use the bassinet.
tkelley on DSK3SPTVN1PROD with RULES
Bassinet Misuse
Comment: One commenter expressed
concern that the possibility of consumer
misuse of bassinets would negate any
effects of the new requirements.
Response: The Commission believes
that strengthening the standard is the
best way to improve product safety and
that if significant product misuse
becomes evident in injury reports, more
developments are possible.
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Comment: Another commenter
suggested that educational campaigns
about the proper and improper uses of
bassinets would be sufficient.
Response: The Commission believes
that educational campaigns play an
important role in injury prevention but
are best preceded by mechanical and
physical safety requirements designed
to make accidents as unlikely as
possible to occur.
Restraints
Comment: One commenter expressed
the belief that the lack of incidents with
harnesses could be due to other factors,
as much as to the lack of harnesses in
bassinets.
Response: Deaths and injuries in other
infant products have been attributed to
restraints/harness that were not used or
were used improperly. Therefore the
Commission is not making any changes
regarding the current prohibition of
restraints in bassinets.
Warnings
Comment: Some commenters
recommended the use of pictures or
visual aids to clarify the warning
messages.
Response: The Commission
acknowledges that well-designed
graphics can be useful in certain
circumstances. However, the design of
effective graphics can be difficult. Some
seemingly obvious graphics are poorly
understood and can give rise to
interpretations that are opposite the
intended meaning (so called ‘‘critical
confusions’’); therefore, a warning
pictogram should be developed with
empirical study and well tested on the
target audience. Although the
Commission may take action in the
future if it believes graphic symbols are
needed to reduce the risk of injury
associated with these products, the rule
permits, but does not mandate, such
supporting graphics.
With respect to the idea of creating a
pictogram to communicate the dangers
of soft bedding, the Commission agrees
that a well-developed and tested
pictogram could increase
comprehension and acknowledges that
such elements could be developed with
some empirical study; the Commission,
however, does not have the resources
for such a project at this time and could
not validate a warning graphic without
research. However, there are a number
of products for which such a soft
bedding pictogram could be useful, such
as bedside sleepers, bassinets, cribs,
play yards, inclined sleep products, and
others. Because of this, an ASTM crossproduct ad hoc working group may be
the best place to develop such a
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pictogram. This could foster crossproduct harmonization of such a
pictogram and would allow testing and
validation of the pictogram. CPSC staff
will gladly participate in any such
group, and should the need arise, staff
will consider future action once such a
graphic is developed.
Comment: A commenter suggested
adding statistics to the suffocation
warning.
Response: Crafting a warning requires
balancing the brevity of the message
with its attention-grabbing features and
informational content. Too much
information makes a long label that is
likely to be ignored by consumers. On
the other hand, too little information
leaves consumers unsure of the
message. CPSC staff’s opinion is that the
addition of statistical information on the
suffocation warning label will not
increase the effectiveness of the
warning.
Comment: A commenter suggested
that the warnings contain the maximum
recommended age of the bassinet
occupant, i.e., five months.
Response: The current warning
contains a developmental milestone,
rather than an age maximum.
Developmental milestones have the
advantage of allowing for individual
variability in use patterns. Some
children will gain strength and
coordination faster than others and will
need to be removed from the bassinet
sooner. Since children’s abilities are
more important than their age when
evaluating the applicability of the
warning, the age is not included in the
warning.
Comment: A commenter suggested
that the warnings should be displayed
in a prominent position.
Response: The ASTM standard, which
the rule incorporates by reference,
already contains a common definition
for ‘‘conspicuous’’ warnings in Section
3.3.3, with corresponding requirements
in Sections 8.3, 8.4, and 8.5.
Comment: A commenter suggested
strengthening the warning labels by
requiring mattress pads to have the
following statement: ‘‘This padding has
been tested to reduce the risk of
suffocation to a minimal level,’’ adding
that ‘‘additional padding increases this
risk substantially and has caused
fatalities.’’
Response: Although the standard does
contain a requirement for the mattress
pad to remain level, the standard does
not contain a test for reducing the risk
of suffocation created by the softness of
the padding, which seems to be the
assumption made by the commenter.
The standard already contains a
warning in Section 8.4.2, instructing
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against the use of additional bedding
materials. This required warning must
be visible to the consumer when the
product is in the manufacturer’s
recommended-use position. Thus, the
warning will not be covered by sheets,
which are allowed, and will be more
effective than on the mattress pad where
any messages will be covered.
Comment: Another commenter
suggested that consumers need to be
warned of the hazards associated with
segmented mattresses.
Response: Warnings are the last stage
at which attempts are made to remove
a hazard from a product. Changing the
product is more effective. The standard
contains performance requirements
designed to eliminate the hazards
associated with segmented mattresses,
so it is not necessary to include a
warning.
Comment: Several commenters
suggested that warnings should have
larger fonts, duplication on opposing
walls of the bassinet, duplication on the
packaging and on the product, more
detailed hazard descriptions, and more
information in supporting educational
materials and product advertisements.
Response: Although CPSC staff agrees
that any warning could be strengthened
with a size, color, or other graphical
features, the product’s final appearance
also needs to be considered because
exceptionally large or graphic warnings
may cause consumers to remove or
deface the warnings, thereby rendering
them ineffective for later users. The
current warning requirements match
industry standards for many juvenile
products.
tkelley on DSK3SPTVN1PROD with RULES
The Necessity for a Standard
Comment: Several commenters stated
that the proposed standard for bassinets
and cradles should not be adopted
because the number of injuries and
fatalities due to design defects was very
low.
Response: The Consumer Product
Safety Improvement Act (CPSIA)
requires the Commission to issue a
mandatory standard for bassinets and
cradles, regardless of the number of
incidents involving those products.
Given the the CPSIA directive, the
options are either to adopt the existing
voluntary standard, as is, or revise the
standard to make improvements. Even if
a majority of the incidents were not
directly attributable to defects in the
product design, many incidents were.
Congress mandated that CPSC adopt a
more stringent standard if the
Commission determined that a more
stringent standard ‘‘would further
reduce the risk of injury.’’ The
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Commission feels strongly that the final
rule would do so.
Mattress Thickness (Rigid Products and
Falls)
Comment: Some commenters
expressed concern that the standard
allows for rigid-sided bassinets with
thicker mattresses than soft-sided
bassinets. These commenters said they
feel that thicker mattresses may pose
more of a risk of babies falling out when
a baby rolls to one side and the product
tilts.
Response: There are two requirements
in the existing ASTM standard, which
the rule incorporates by reference,
which would prevent the scenario
described by the commenters. The first
is the side height requirement, which
states that the side height of the bassinet
be 7.5″ above the uncompressed surface
of the mattress. Thus, if a bassinet
maker supplies a thick mattress with the
rigid-sided bassinet, the side heights
must account for the thicker mattress
and still yield 7.5″ of side height above
the mattress surface. In addition, the
standard has a rock/swing angle
requirement that limits the maximum
angle a rocking bassinet can have, as
well as a maximum rest angle it can
have. The rest angle is measured using
a CAMI doll placed up against the side
of the bassinet. Thus, the standard uses
a worst-case placement scenario for the
occupant during the testing.
Health Canada Standard
Comment: A representative of Health
Canada corrected a statement in the
SNPR and the corresponding staff
briefing package, which states: ‘‘The
Canadian standard (SOR 86–962:2010)
includes requirements for cribs and
non-full-size cribs. This standard does
not distinguish between a bassinet and
non-full-size cribs.’’ The commenter
noted that this overview statement was
incorrect because on November 18,
2010, the amended Cribs, Cradles, and
Bassinets Regulations (SOR/2010–261)
came into effect, and now bassinets are
included in the scope.
Response: The Commission thanks
Health Canada staff for the correction
and the subsequent information
regarding how SOR 2010/261
distinguishes bassinets, cradles, and
cribs. As the Commission now
understands, Health Canada defines
these three products according to the
sleep surface area contained in the
product.
Play Yard Misassembly Requirement in
Docket CPSC–2011–0064
Comment: The commenter repeated
comments submitted for Docket CPSC–
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2011–0064, regarding the play yard
misassembly requirement that was
proposed in August 2012.
Response: The Commission has
addressed these comments in the final
rule briefing package for Play Yard
Misassembly Requirement, dated June
26, 2013.
International Standards
Comment: Commenters remarked that
more information regarding the
international standards that were
mentioned in the SNPR would be
helpful.
Response: The Commission provided
the names and designations of the
standards, plus a description of where
they differed substantially from the
ASTM standard. Due to copyright laws,
the Commission was not able to provide
full copies of the standards. All of the
standards are available for purchase
online by anyone who seeks more
information.
ASTM Copyright and Accessibility
Comment: Some commenters stated
that the ASTM standard for bassinets
and cradles should not be the basis of
a mandatory rule because, as a
copyrighted standard, the ASTM
standard is not easily accessible to the
public and creates an undue financial
burden on small manufacturers and the
general public.
Response: Section 104(b) of the CPSIA
requires the Commission to issue
standards for durable infant or toddler
products that are substantially the same
as applicable voluntary standards or are
more stringent if more stringent
standards would further reduce the risk
of injury. Incorporating a voluntary
standard, such as incorporating the
ASTM standard by reference, is a wellrecognized procedure for agencies. The
incorporation satisfies the requirement
of publication in the Federal Register.
See 5 U.S.C. 552(a)(1)(E) (‘‘matter
reasonably available to the class of
persons affected thereby is deemed
published in the Federal Register when
incorporated by reference therein with
the approval of the Director of the
Federal Register’’).
Falls From Bassinets/Side Height
Comment: Some commenters
suggested that the side height
requirements need to be higher because
consumers seem to be using bassinets
with children older than the
recommended ages. One commenter
expressed the belief that the standard
should match the Canadian side height
requirement.
Response: The ASTM subcommittee
discussed the side heights of bassinets
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for years. There was no side height
requirement until recently. Consumers
use the products longer than
manufacturers recommend. High side
heights could cause consumers to use
their bassinets even longer than they
have been using them because the older,
larger children who can push up on
their hands and sit unassisted will look
safer in a bassinet with tall sides. The
unintended consequence of taller sides
might be an increase in falls from
bassinets because older children are
stronger and more agile than newborns.
After much discussion, the ASTM
subcommittee agreed to a 7.5-inch side
height, based on the precedent set by
the Canadians, who measure from the
bottom of the bassinet rather than the
mattress top. This difference in
measurement landmarks makes it
appear that the ASTM standard permits
shorter sides; but in reality, the effective
side height of a bassinet in Canada is the
same as in the ASTM standard. This
side height requirement did not
necessitate drastic changes in the
bassinet designs on the market; so it
would be unlikely that instituting the
requirement would have any effect on
consumer behavior.
Comment: Several commenters
suggested that side height requirements
might not be effective against misuse.
One commenter expressed the belief
that the burden should be placed on
caregivers and that the standard needs
no modification to address falls.
Another suggested that warning labels
should be strengthened instead.
Response: The side height
requirement (7.5-inch minimum) is
already part of ASTM F2194–13, which
this rule incorporates by reference. The
rule does not add anything further
because the Commission believes that
the requirements should be effective
against misuse. The Commission
believes that, at a minimum, this
requirement will help protect infants
who have not exceeded the maximum
age requirement for bassinet use.
Additionally, the Commission supports
the current warnings in the ASTM
standard.
Existing Inventory
Comment: One commenter expressed
concern that the Commission did not
address the existing cradle and bassinet
inventory that would need ‘‘to be
discarded or recalled’’ when the
regulation becomes effective.
Response: The bassinet and cradle
standard is prospective. It will apply to
products manufactured or imported on
or after the effective date. Therefore,
existing inventory would not be
affected.
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Cost Benefit Analysis
Comment: Several commenters
expressed the belief that a cost-benefit
analysis should be performed, and they
stated that the proposed rule should not
be adopted because costs are likely to
exceed benefits.
Response: Section 104(b) of the
Consumer Product Safety Improvement
Act (CPSIA), part of the Danny Keysar
Child Product Safety Notification Act,
requires the CPSC to issue a standard at
least as stringent as the voluntary
standard, or more stringent if the
Commission determines that a more
stringent standard would further reduce
the risk of injury associated with such
products. Thus, the Commission must
issue a mandatory standard for bassinets
and cradles, regardless of the costs and
benefits of the rule.
Third Party Testing Cost
Comment: Two commenters
expressed concern about the
‘‘substantial additional costs’’ that will
result from a new requirement for third
party testing that will be added by the
bassinet/cradle standard.
Response: The testing costs referred to
by the commenters result from the third
party testing and certification
requirements imposed under sections
14(a)(2) and 14(d)(2) of the Consumer
Product Safety Act (CPSA), as amended
by the CPSIA. The costs associated with
testing will be substantially the same,
regardless of the form the final bassinet/
cradle standard takes.
Definition of a Small Business
Comment: One commenter questioned
defining ‘‘small manufacturers’’ as those
with fewer than 500 employees. The
commenter noted that business size can
vary widely within such a broadly
defined group. The commenter
expressed concern that the economic
impact could be disproportionately
significant for the very smallest firms.
Response: The U.S. Small Business
Administration (SBA) is the source of
the definition of ‘‘small manufacturers’’
of bassinets and cradles. Regardless of
the desirability of a finer gradation in
defining small businesses, the SBA
definition governs the small business
determination in the context of a
regulatory flexibility analysis.
Impact of Expanding the Scope
Comment: One commenter expressed
concern about the ‘‘adverse monetary
impact’’ that expanding the scope of the
standard to include Moses baskets
would have upon some suppliers. The
commenter felt that the alternative of
ceasing to supply stands for these newly
covered products requires further
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inquiry before ‘‘suggesting that this is a
viable alternative.’’ Other commenters
questioned methods firms might use to
mitigate their ‘‘upfront costs,’’ including
amortizing, ‘‘increased product sales,’’
and passing ‘‘the additional costs on to
consumers.’’
Response: When used with a stand,
Moses baskets meet the definition of a
‘‘bassinet’’ (or ‘‘cradle,’’ in the case of a
rocking stand), and therefore, they must
be tested as a bassinet. Given that most
suppliers of Moses baskets do not
include stands, supplying Moses baskets
without stands is one viable option that
firms are already practicing.
Similarly, the statement that ‘‘direct
impact may be mitigated if costs are
treated as new product expenses that
can be amortized’’ recognizes one of the
methods firms use routinely in the
development of new products to reduce
the immediate financial impact; rather
than incurring all of the development
costs up front, amortizing allows the
firm to spread the impact over time.
Finally, for most products, firms are
usually able to pass on some, but not all,
increases in production costs to
consumer. The portion of costs that are
passed on (i.e. not absorbed by the firm)
partially offset or mitigate the impact of
the rule.
Aiding Small Businesses
Comment: One commenter suggested
that the Commission ‘‘create a
framework with which to aid some of
the smaller manufacturers and
distributors with finding the resources,
information and connections they need
to comply with the new standards.’’
Response: CPSC’s Small Business
Ombudsman provides small businesses
with guidance to assist them in
complying with CPSC requirements.
Assistance is available to firms in
understanding and complying with
CPSC regulations (https://www.cpsc.gov/
en/Business—Manufacturing/SmallBusiness-Resources/).
Small Bedding Suppliers
Comment: One commenter asked that
the Commission put ‘‘less weight’’ on
small bedding suppliers in the
regulatory flexibility analysis. The
commenter expressed concern that:
‘‘[N]oncompliant bedding could
potentially negate the efficiency of . . .’’
safety measures such as strangulation
warnings ‘‘. . . or require manufacturers
to take additional steps to correct
noncompliant bedding.’’
Response: The standard does not
include any bedding requirements.
However, in investigating the bassinet/
cradle market, staff could not determine
the underlying source of bassinets for
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several suppliers of bassinets. The firms
for whom the bassinet source could not
be identified shared one major
characteristic: They were primarily
bedding suppliers who sold bassinets or
cradles with the appropriate bedding
covering the bassinet/cradle frame.
Because these firms supply bassinets/
cradles, they are affected by the rule and
impacts must be fully considered under
the Regulatory Flexibility Act.
Labeling Costs
Comment: One commenter objected to
the costs that will be associated with
changing the warning labels.
Response: The commenter
misunderstood the information
presented in the Paperwork Reduction
Act section of the SNPR. The
commenter interpreted the cost per
burden hour associated with labeling
($27.55) to be the increased cost per
unit, which is an incorrect conclusion.
VII. Assessment of Voluntary Standard
ASTM F2194–13 and Description of
Final Rule
Consistent with section 104(b) of the
CPSIA, this rule establishes new 16 CFR
part 1218, ‘‘Safety Standard for
Bassinets and Cradles.’’ The new part
incorporates by reference the
requirements for bassinets and cradles
in ASTM F2194–13, with certain
additions and changes to strengthen the
ASTM standard, to further reduce the
risk of injury. The following discussion
describes the final rule, the changes,
and the additions to the ASTM
requirements. (The description of the
amendment to 16 CFR part 1112 may be
found in Section XIII of this preamble.)
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A. Scope (§ 1218.1)
The final rule states that part 1218
establishes a consumer product safety
standard for bassinets and cradles
manufactured or imported on or after
the date that is six months after the date
of publication of a final rule in the
Federal Register, except that the
effective date for the removable bassinet
bed requirements would be 18 months
after the date of publication of a final
rule in the Federal Register.
B. Incorporation by Reference (§ 1218.2)
Section 1218.2(a) explains that,
except as provided in § 1218.2(b), each
bassinet and cradle must comply with
all applicable provisions of ASTM
F2194–13, ‘‘Standard Consumer Safety
Specification for Bassinets and
Cradles,’’ which is incorporated by
reference. Section 1218.2(a) also
provides information on how to obtain
a copy of the ASTM standard or to
inspect a copy of the standard at the
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CPSC. The Commission received no
comments on this provision in the
SNPR, but the Commission is changing
the language in the incorporation in the
final rule to refer to ASTM F2194–13,
the current version of the ASTM
standard.
C. Changes to Requirements of ASTM
F2194–13
1. Clarification of Scope.
(§ 1218.2(b)(1)(i)). The final rule
modifies the scope of ASTM F2194–13
to clarify that multimode combination
products must meet the bassinet/cradle
standard in any configuration where the
seat incline is 10 degrees or less from
horizontal. This modification resulted
from comments on the SNPR seeking
clarification on what products are
included in the scope, as more fully
discussed in Section VI.
2. Change to Stability Test Procedure.
(§ 1218.2(b)(2) and § 1218.2(b)(6)). In the
SNPR, the Commission proposed that
bassinet/cradle stability testing be
conducted with a CAMI newborn
dummy, rather than the CAMI infant
dummy. Because ASTM has yet to adopt
this modification (although it is
expected to be balloted in the near
future), the Commission is including it
in the final rule.
It is appropriate that the smaller
newborn CAMI dummy be used for
stability testing, because bassinets and
cradles are intended to be used by very
young children. The heavier (17.5pound) infant CAMI currently specified
for stability testing in ASTM F2194–13
could make these products more stable
when tested than they would actually be
in a real-world situation.
3. Removable Bassinet Bed.
(§ 1218.(b)(3), (5), and (7)). In the SNPR,
the Commission proposed adding a
requirement for removable bassinet beds
(along with test procedures and new
definitions). As stated in the preamble
of the SNPR (77 FR 64061), there have
been several incidents involving
bassinet beds that were designed to be
removed from their stand, four of which
have In-Depth Investigations. During the
incidents, the bed portion of the unit
was not locked completely or attached
properly to its stand. The bed portion of
the unit appeared to be stable, giving the
caregivers a false sense of security. For
various reasons, the bed portion fell or
tilted off of its stand. There have also
been nonfatal incidents involving
bassinet beds that tipped over or fell off
their base/stand when they were not
properly locked/latched to their base/
stand, or the latch failed to engage as
intended. In May 2012, 46,000 bassinets
that could appear to latch to the stand
when they actually had not latched
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were recalled. (https://www.cpsc.gov/
cpscpub/prerel/prhtml12/12173.html).
The SNPR proposed multiple options
for a bassinet with a removable bed
attachment to pass the proposed
requirement. These options include: (1)
Ensuring that the bed portion of the
bassinet is inherently stable when the
bassinet bed is placed on the stand
unlatched; (2) use of a false lock/latch
visual indicator mechanism; (3) use of a
stand that collapses if the bassinet bed
is not properly attached; and (4) the
presence of an obvious unsafe angle
(more than 20 degrees) or a bassinet bed
falls to the floor when it is not properly
attached to the stand.
Since the issuance of the SNPR,
ASTM has made several clarifying
changes to the removable bassinet bed
requirement, definitions, and test
procedures, and ASTM is expected to
send these changes out for ballot in the
near future. Most of the differences are
editorial changes to provide clarity to
the test requirement and the test
procedure. The significant, noneditorial
differences between the requirement
proposed in the SNPR and what ASTM
is expected to ballot are as follows:
• The next ASTM ballot is expected
to exclude play yard bassinets, as
defined in the standard, from the
removable bassinet bed definition.
Thus, play yard bassinets would not be
subject to the removable bassinet bed
stability requirement.
• The next ASTM ballot is expected
to expand on one of the pass criteria for
the removable bed stability requirement,
to allow bassinet stands that cannot
remain in their proper use position
unless the bassinet bed is properly
attached.
The Commission agrees with these
revisions and is adding the revised
removable bassinet bed requirement as
part of the final bassinet/cradle rule.
4. Mattress Flatness.
(§ 1218.2(b)(4)(i)). A segmented mattress
flatness requirement and associated test
procedures were proposed by the
Commission as part of the SNPR. ASTM
adopted the requirement with modified,
less stringent pass/fail criteria. The final
rule modifies the pass/fail criteria in
ASTM F2194–13 to mirror the SNPR
proposal.
As stated in Section V, the mattress
flatness requirement is primarily aimed
at incidents involving bassinet/play
yard combination products that tend to
use segmented mattresses, where seams
could pose a suffocation and positional
asphyxiation hazard. Under the
Commission’s pass/fail criteria, a
bassinet attachment with a segmented
mattress will fail if any tested seam
creates an angle greater than 10 degrees.
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ASTM F2194–13 allows measured
angles between 10 degrees and 14
degrees to pass, as long as the mean of
three measurements on that seam is less
than 10 degrees. As discussed in the
preamble to the SNPR, the 14-degree
angle was based on an extrapolation of
angles formed by dimensions of average
infant faces. 77 FR 64060–64061. The
Commission is uncomfortable using the
average infant facial dimension as the
basis for this requirement. Therefore,
instead of using the average infant
anthropometrics as a basis for the pass/
fail criteria, the Commission continues
to support using the smallest users’
anthropometrics to set the test
requirement of 10 degrees maximum for
each measurement taken.
5. Exemption from Mattress Flatness
Requirement. (§ 1218.2(b)(4)(i)). The
final rule exempts from the mattress
flatness requirement bassinets that are
less than 15 inches across. These
products do not pose the hazard the
requirement is intended to address, and
they are also not wide enough to test
using the required procedures and
equipment.
VIII. Effective Date
The Administrative Procedure Act
(APA) generally requires that the
effective date of a rule be at least 30
days after publication of the final rule.
5 U.S.C. 553(d). The Commission is
setting an effective date for the standard
six months after publication for
products manufactured or imported on
or after that date, with the exception of
the removable bassinet bed test
requirement and procedure.
The Commission recognizes that some
manufacturers will be required to
redesign, test new prototype products,
and then retool their production process
in order to meet the new removable
bassinet bed provision. Based on a
comment from a manufacturer who
asked for a minimum of 15.5 months to
redesign its product, the Commission
considers 18 months to be a reasonable
time period to take into account other
manufacturers who might also need to
redesign their product. Therefore, the
Commission is setting an 18-month
effective date for the removable bassinet
bed test requirement.
IX. Regulatory Flexibility Act
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A. Introduction
The Regulatory Flexibility Act (RFA)
requires that agencies review rules for
their potential economic impact on
small entities, including small
businesses. 5 U.S.C. 604. Section 604 of
the RFA requires that agencies prepare
a final regulatory flexibility analysis
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when they promulgate a final rule,
unless the head of the agency certifies
that the rule will not have a significant
economic impact on a substantial
number of small entities. The final
regulatory flexibility analysis must
describe the impact of the rule on small
entities and identify any alternatives
that may reduce the impact.
Specifically, the final regulatory
flexibility analysis must contain:
• A succinct statement of the
objectives of, and legal basis for, the
rule;
• a summary of the significant issues
raised by public comments in response
to the initial regulatory flexibility
analysis, a summary of the assessment
of the agency of such issues, and a
statement of any changes made in the
proposed rule as a result of such
comments;
• a description of, and, where
feasible, an estimate of, the number of
small entities to which the rule will
apply;
• a description of the projected
reporting, recordkeeping, and other
compliance requirements of the rule,
including an estimate of the classes of
small entities subject to the
requirements and the type of
professional skills necessary for the
preparation of reports or records; and
• a description of the steps the agency
has taken to reduce the significant
economic impact on small entities,
consistent with the stated objectives of
applicable statutes, including a
statement of the factual, policy, and
legal reasons for selecting the alternative
adopted in the rule, and why each one
of the other significant alternatives to
the rule considered by the agency,
which affect the impact on small
entities, was rejected.
B. The Market for Bassinets/Cradles
Bassinets and cradles are typically
produced and/or marketed by juvenile
product manufacturers and distributors,
or by furniture manufacturers and
distributors, some of which have
separate divisions for juvenile products.
CPSC staff believes that there are
currently at least 62 suppliers of
bassinets and/or cradles to the U.S.
market; 26 are domestic manufacturers;
19 are domestic importers; three are
domestic retailers; and two are domestic
firms with unknown supply sources.
Twelve foreign firms currently supply
the U.S. market: 10 manufacturers, one
firm with an unknown supply source,
and one importer that imports from
foreign companies and distributes from
outside of the United States. Eight
additional firms specialize in children’s
bedding, some of which is sold with
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bassinets or cradles; the supply sources
for these eight firms could not be
identified.
Bassinets and cradles from 11 of the
62 firms have been certified as
compliant by the Juvenile Products
Manufacturers Association (JPMA), the
major U.S. trade association that
represents juvenile product
manufacturers and importers. Firms
supplying bassinets or cradles would be
certified to the ASTM voluntary
standard F2194–12a, while firms
supplying play yards with bassinet/
cradle attachments would also have to
meet F406–12a. (JPMA typically allows
six months for products in their
certification program to shift to a new
standard once it is published. ASTM
F2194–12a was published in September
2012, and therefore, the standard would
have become effective in March 2013.
The more recent standard, ASTM
F2194–12b, was published in December
2012, and therefore, that standard was
not yet effective when research for this
rule was conducted.) Twenty-four
additional firms claim compliance with
the relevant ASTM standard for at least
some of their bassinets and cradles.
Whether the bassinets or cradles
supplied by the eight bedding suppliers
comply with ASTM F2194 is not
known.
According to a 2005 survey conducted
by the American Baby Group (2006
Baby Products Tracking Study), 64
percent of new mothers own bassinets;
18 percent own cradles; and 39 percent
own play yards with bassinet
attachments. Approximately 50 percent
of bassinets, 56 percent of cradles, and
18 percent of play yards were handed
down or purchased secondhand. Thus,
approximately 50 percent of bassinets,
44 percent of cradles, and 82 percent of
play yards were acquired new. These
statistics suggest annual sales of a total
of approximately three million units
sold per year, consisting of about 1.3
million bassinets (.5 × .64 × 4 million
births per year), 317,000 cradles (.44 ×
.18 × 4 million), and 1.3 million play
yards with bassinet attachments (.82 ×
.39 × 4 million). (U.S. Department of
Health and Human Services, Centers for
Disease Control and Prevention (CDC),
National Center for Health Statistics,
National Vital Statistics System, ‘‘Births:
Final Data for 2010,’’ National Vital
Statistics Reports Volume 61, Number 1
(August 28, 2012): Table I. Number of
births in 2010 is rounded from
3,999,386.)
National injury estimates were not
reported by the Directorate for
Epidemiology in the supplemental NPR
or in the current FR briefing package
because the data failed to meet NEISS
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publication criteria. However,
emergency department injury estimates
over the approximately five years
covered by the supplemental NPR and
the current FR briefing package, from
2008 through 2012, averaged less than
250 annually. Based on data from the
2006 Baby Products Tracking Study,
approximately 4.8 million bassinets and
cradles were owned by new mothers.
Therefore, the injury rate may be on the
order of about 0.5 emergency
department-treated injuries per 10,000
bassinets/cradles available for use in the
households of new mothers ((250
injuries ÷ 4.84 million products in
households of new mothers) × 10,000).
C. Reason for Agency Action and Legal
Basis for the Rule
The Danny Keysar Child Product
Safety Notification Act requires the
CPSC to promulgate a mandatory
standard for bassinets/cradles that is
substantially the same as, or more
stringent than, the voluntary standard.
The Commission is adopting ASTM
F2194–13 with five modifications or
additions that reflect: (1) Changes
proposed in the SNPR that are not part
of F2194–13; (2) responses to public
comments; and/or (3) additional work
undertaken by ASTM, but not yet
adopted. The changes will address a
variety of known hazard patterns,
including suffocation and positional
asphyxia.
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D. Requirements of the Final Rule
As stated in Section VII, the
Commission is incorporating the
voluntary standard for bassinets/cradles,
ASTM F2194–13, by reference, with five
changes.
The Commission is implementing two
modifications to ASTM F2194–13 in
response to SNPR comments; neither is
expected to have a negative impact on
firms. The first is a modification to the
scope that would clarify that multimode
or combination products must meet the
bassinet/cradle standard in any
configuration where the seat incline is
10 degrees or less from horizontal.
Because the clarifying modifications do
not change the scope of the standard,
the modifications have no additional
impact. The second is an exemption
from the mattress flatness requirement
for bassinets that are less than 15 inches
across. Because of the characteristics of
the narrower bassinets, these products
are not subject to the hazard that the
requirement is intended to address.
Additionally, these narrower bassinets
are not wide enough to test using the
required procedures and equipment.
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The Commission is implementing
three additional changes to ASTM
F2194–13, each of
1. Stability Testing
As stated in Section V of this
preamble, in the SNPR, the Commission
proposed that bassinet/cradle stability
testing be conducted with a CAMI
newborn dummy, rather than the CAMI
infant dummy. Because ASTM has yet
to adopt this modification (although the
modification is expected to be balloted
in the near future), the Commission is
including the modification in the final
rule. Based on limited testing, many
bassinets/cradles appear to be able to
pass this modified test procedure
without modification. However, a few
products may potentially require
modifications to meet the revised
stability test procedure. Staff believes
that the modified test procedure is
likely to affect only a few
manufacturers, and likely will not
require product redesign. Affected firms
would most likely increase the stability
of their product by widening the
structure, making the bassinet bed
deeper, or making the base heavier. The
cost of meeting the modified
requirement could be more significant if
a change to the hard tools used to
manufacture the bassinet is necessary.
During the production process, a hard
tool, which is a mold of the desired
bassinet component shape, is injected
with plastic or another material using a
molding machine.
2. Mattress Flatness
A segmented mattress flatness
requirement and associated test
procedures were proposed by the
Commission as part of the SNPR. ASTM
adopted the requirement with modified
(and less stringent) pass/fail criteria.
The Commission is modifying the pass/
fail criteria in ASTM F2194–13 to
mirror the SNPR proposal.
The mattress flatness requirement is
primarily aimed at incidents involving
bassinet/play yard combination
products that tend to use segmented
mattresses, where seams could pose a
suffocation and positional asphyxiation
hazard. Under the Commission’s pass/
fail criteria, a bassinet attachment with
a segmented mattress will fail if any
tested seam creates an angle greater than
10 degrees. ASTM F2194–13 allows
measured angles between 10 degrees
and 14 degrees to pass, as long as the
mean of three measurements on that
seam is less than 10 degrees.
Based on staff’s testing, the play yard
bassinet attachments of many suppliers
(both compliant and non-compliant)
appear to pass the requirement without
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any modifications. Bassinet attachments
that would require some modification
would need to increase the mattress
support in their bassinets. Additional
mattress support could be
accomplished, for example, by
retrofitting play yard bassinets to use
longer rods or a better-fitting mattress
shell. The cost of such a retrofit is
unknown and would likely vary from
product to product; however, a retrofit
generally is less expensive than a
product redesign.
3. Removable Bassinet Bed
As stated in Section V of this
preamble, in the SNPR, the Commission
proposed adding a requirement for
removable bassinet beds (along with test
procedures and new definitions). Since
then, an ASTM task group has made
several clarifying changes to the
requirement, definitions, and test
procedures and is expected to
recommend them for ballot. The
Commission is adopting the revised
removable bassinet bed requirement as
part of the final bassinet/cradle rule.
There are several firms supplying
bassinets with removable bassinet beds
to the U.S. market. The majority will
require no modifications to meet the
requirement. However, at least three
firms are expected to need changes to
one or more of their bassinets. Firms
could meet the removable bassinet
requirement in a number of ways,
including redesigning the product
entirely. However, many firms are likely
to opt for less expensive alternatives,
such as more sensitive locks that
activate with little pressure (i.e., with
just the weight of the bassinet), where
possible.
The costs and time involved in a
redesign could be significant; one
manufacturer stated in SNPR comments
that the manufacturer would require
15.5 months to redesign its product to
meet the removable bassinet bed
requirement. Therefore, the Commission
is setting an 18-month effective date for
this requirement, while maintaining a
six-month effective date for the
remainder of the final rule.
E. Other Federal or State Rules
A final rule implementing sections
14(a)(2) and 14(i)(2) of the Consumer
Product Safety Act (CPSA), as amended
by the CPSIA, Testing and Labeling
Pertaining to Product Certification, 16
CFR part 1107, became effective on
February 13, 2013 (the 1107 rule).
Section 14(a)(2) of the CPSA requires
every manufacturer of a children’s
product that is subject to a product
safety rule to certify, based on third
party testing, that the product complies
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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 bassinets and cradles will be
subject to a mandatory children’s
product safety rule, these products also
will be subject to the third party testing
requirements of section 14(a)(2) of the
CPSA and the 1107 rule when the
bassinet/cradle mandatory standard and
the notice of requirements become
effective.
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F. Impact on Small Businesses
At least 62 firms are currently known
to be marketing bassinets and/or cradles
in the United States. Under U.S. Small
Business Administration (SBA)
guidelines, a manufacturer of bassinets/
cradles is small if the business has 500
or fewer employees; importers and
wholesalers are considered small if they
have 100 or fewer employees. Based on
these guidelines, about 39 of the 62 total
firms are small firms—21 domestic
manufacturers, 16 domestic importers,
and two firms with unknown supply
sources. An additional eight small firms
supplying bassinets/cradles along with
their bedding; these may or may not
originate from one of the 62 firms
already accounted for. Other unknown
small bassinet/cradle suppliers also may
operate in the U.S. market.
Small Manufacturers
The expected impact of the final
standard on small manufacturers will
differ based on whether their bassinets/
cradles are already compliant with
F2194–12a. (Play yards with bassinet
attachments must comply with the
effective play yard standard (F406),
which includes a requirement that the
attachment meet the bassinet/cradle
standard.) In general, firms whose
bassinets and cradles meet the
requirements of F2194–12a are likely to
continue to comply with the voluntary
standard as new versions are published.
Many of these firms are active in the
ASTM standard development process,
and compliance with the voluntary
standard is part of an established
business practice. Firms supplying
bassinets and cradles that comply with
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ASTM F2194–12a are likely also to
comply with F2194–13 before the final
bassinet/cradle rule becomes effective.
The majority of the changes to the
voluntary standard (ASTM F2194–13)
are the same as at the SNPR level; only
the expanded scope proposed in the
SNPR has been completely incorporated
into the voluntary standard. Therefore,
the expected impact of the final rule
remains substantially the same as the
impact presented in the initial
regulatory flexibility analysis for the
SNPR.
For manufacturers whose products are
likely to meet the requirements of
ASTM F2194–13 (14 of 21 firms), the
direct impact could be significant for
one or more firms if they must redesign
their bassinets to meet the final rule.
Although the products of all firms
would be subject to the stability testing
requirements, in most cases,
modifications are unlikely to be
required and the costs are not expected
to be significant. The products of five
firms could be affected by the mattress
flatness requirement (i.e., they produce
play yards with bassinet attachments),
and at least three (and possibly five) of
the known firms may be affected by the
removable bassinet bed requirement.
For the most part, the bassinets/cradles
and bassinet cradle attachments
supplied by these firms will be able to
meet the changes to ASTM F2194–13
without modification. In cases where
modifications are necessary, firms
would most likely opt to retrofit their
products, rather than undertake an
expensive redesign. However, some
products may require redesign,
particularly to meet the new removable
bassinet bed requirement, and therefore,
costs could be significant in some cases.
The Commission is adopting an 18month effective date for the removable
bassinet bed portion of the final rule to
reduce the impact on affected firms.
Meeting ASTM F2194–13’s
requirements could necessitate product
redesign for at least some bassinets/
cradles not believed to be compliant
with F2194–12a (7 of 21 firms). These
firms could require redesign regardless
of the modifications. A redesign would
be minor if most of the changes involve
adding straps and fasteners or using
different mesh or fabric, but could be
more significant if changes to the frame
are required, including changes to side
height. One manufacturer estimated that
a complete play yard redesign,
including engineering time, prototype
development, tooling, and other
incidental costs, would cost
approximately $500,000. The
Commission believes that a bassinet
redesign would tend to be comparable.
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Consequently, the final rule could
potentially have a significant direct
impact on small manufacturers whose
products do not conform to F2194–12a.
Any direct financial impact may be
mitigated if a firm chooses to treat costs
as new product expenses that can be
amortized over time rather than a large,
one time expense.
Some firms whose bassinets/cradles
are neither certified as compliant, nor
claim compliance with F2194–12a, in
fact, may be compliant with the
standard. The Commission has
identified many such cases with other
products. To the extent that some of
these firms may supply compliant
bassinets/cradles and have developed a
pattern of compliance with the
voluntary standard, the direct impact of
the final rule will be less significant
than described above. If two small firms
with unknown supply sources, none of
whose products appear to comply with
F2194–12a, are manufacturers, these
firms also may need to redesign their
products to meet the final rule.
In addition to the direct impact of the
final rule described above, the rule will
have some indirect impacts. Once the
new requirements become effective, all
manufacturers will be subject to the
additional costs associated with the
third party testing and certification
requirements under the testing rule,
Testing and Labeling Pertaining to
Product Certification (16 CFR part
1107). Third party testing will pertain to
any physical and mechanical test
requirements specified in the bassinet/
cradle final rule; lead and phthalates
testing is already required. Impacts of
third party testing are not due directly
to the bassinet/cradle rule’s
requirements, but are due to the testing
rule’s requirements. Consequently,
impacts from the testing rule are
indirect impacts from the bassinet/
cradle final rule, and such indirect
impacts could be significant.
One manufacturer estimated that
testing to the ASTM voluntary standard
runs around $1,000 per model sample,
although the manufacturer noted that
the costs could be lower for some
models where the primary difference is
fabric rather than structure.
On average, each small domestic play
yard manufacturer supplies seven
different models of bassinets/cradles
and play yards with bassinet/cradle
accessories to the U.S. market annually.
Therefore, if third party testing were
conducted every year on a single sample
for each model, third party testing costs
for each manufacturer would be about
$7,000 annually. Based on a review of
firm revenues, the impact of third party
testing to ASTM F2194–13 is unlikely to
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be significant if only one bassinet/cradle
sample per model is required. However,
if more than one sample would be
needed to meet the testing requirements,
third party testing costs could have a
significant impact on a few of the small
manufacturers.
Small Importers
As with manufacturers of compliant
bassinets/cradles, the seven small
importers of bassinets/cradles currently
in compliance with F2194–12a could
experience significant direct impacts as
a result of the final rule if product
redesign is necessary. In the absence of
regulation, these importing firms would
likely continue to comply with the
voluntary standard as it evolves, as well
as the final mandatory standard. Any
increase in production costs
experienced by their suppliers may be
passed on to the importers.
Importers of bassinets/cradles would
need to find an alternate source if their
existing supplier does not come into
compliance with the requirements of the
final rule, which may be the case with
the nine importers of bassinets/cradles
not believed to be in compliance with
F2194–12a. Some could respond to the
rule by discontinuing the import of their
noncomplying bassinets/cradles,
possibly discontinuing the product line
altogether. The impact of such a
decision could be mitigated by replacing
the noncompliant bassinet/cradle with a
compliant bassinets/cradle, or by
deciding to import an alternative
product.
As is the case with manufacturers, all
importers will be subject to third party
testing and certification requirements,
and consequently, will experience costs
similar to those for manufacturers if
their supplying foreign firm(s) does not
perform third party testing. The
resulting costs could have a significant
impact on a few small importers that
must perform the testing themselves if
more than one sample per model were
required.
Other Possible Suppliers
Eight known small firms specialize in
the supply of bedding, including
bedding for bassinets and cradles, and
the eight firms sell bassinet and cradle
bedding with a bassinet or cradle.
Although these firms do not
manufacture the bassinets or cradles
themselves, whether they purchase the
bassinets or cradles domestically or
from overseas is not known. These firms
may source the bassinets and cradles
sold with bedding in full or in part from
one of the 62 firms discussed above. If
the eight firms do not source from one
of the 62 firms, then the eight firms
represent additional suppliers to the
U.S. market.
The eight firms with unknown supply
sources would be affected in a manner
similar to importers; they would need to
find an alternate source if their existing
supplier does not come into compliance
with the requirements of the final rule.
Unlike most importers, however, the
firms would not have the option of
replacing a noncompliant bassinet/
cradle with another product. Although
the firms could opt to sell the bedding
without the associated bassinet/cradle,
such an approach would represent a
change from their historical method of
sale and might adversely impact their
business strategy.
As with manufacturers and importers,
these eight firms will also be subject to
third party testing and certification
requirements, and will experience costs
similar to those for manufacturers if
their supplying firm(s) does not perform
third party testing. The resulting costs
could have a significant impact on some
of these small bassinet or cradle
suppliers that must perform the testing
themselves.
G. Alternatives
Under the Danny Keysar Child
Product Safety Notification Act of the
CPSIA, one alternative that would
reduce the impact on small entities is to
make the voluntary standard mandatory
with no modifications. Doing so would
reduce the potential impact on firms
whose bassinets/cradles comply with
the voluntary standard. However,
because of the severity of the incidents
associated with removable bassinet
beds, instability, and mattress tilt, the
Commission is not pursuing this
alternative.
The Commission is imposing a sixmonth effective date for the final rule
with an 18-month effective date,
supported by SNPR comments
submitted by one manufacturer, for the
removable bassinet bed requirement.
Setting a later effective date for either
part will allow suppliers additional time
to modify and/or develop compliant
bassinets/cradles and spread the
associated costs over a longer period of
time.
X. Environmental Considerations
The Commission’s regulations address
whether the Commission is required to
prepare an environmental assessment or
an environmental impact statement.
These regulations recognize that certain
CPSC actions normally have ‘‘little or no
potential for affecting the human
environment.’’ One such action is
establishing rules or safety standards for
products. 16 CFR 1021.5(c)(1). This rule
falls within the categorical exclusion.
XI. Paperwork Reduction Act
This rule contains information
collection requirements that are subject
to public comment and review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3521). The
preamble to the proposed rule (77 FR at
64055 through 64076) discussed the
information collection burden of the
proposed rule and specifically requested
comments on the accuracy of our
estimates. Briefly, sections 8 and 9 of
ASTM F2194–13 contain requirements
for marking, labeling, and instructional
literature. These requirements fall
within the definition of ‘‘collection of
information,’’ as defined in 44 U.S.C.
3502(3).
OMB has assigned control number
3041–0157 to this information
collection. The Commission did not
receive any comments regarding the
information collection burden of this
proposal. However, the final rule makes
modifications regarding the information
collection burden because the number
of estimated suppliers subject to the
information collection burden is now
estimated to be 62 firms, rather than the
55 firms initially estimated in the
proposed rule.
Accordingly, the estimated burden of
this collection of information is
modified as follows:
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TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
16 CFR Section
Number of
respondents
Frequency of
responses
Total annual
responses
Hours per
response
Total burden
hours
1218 .....................................................................................
62
5
310
1
310
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There are 62 known entities
supplying bassinets to the U.S. market.
All 62 firms are assumed to use labels
already on both their products and their
packaging, but they might need to make
some modifications to their existing
labels. The estimated time required to
make these modifications is about one
hour per model. Each entity supplies an
average of five different models of
bassinets; therefore, the estimated
burden associated with labels is 1 hour
per model × 55 entities × 5 models per
entity = 310 hours. We estimate that the
hourly compensation for the time
required to create and update labels is
$27.55 (U.S. Bureau of Labor Statistics,
‘‘Employer Costs for Employee
Compensation,’’ March 2012, Table 9,
total compensation for all sales and
office workers in goods-producing
private industries: https://www.bls.gov/
ncs/). Therefore, the estimated annual
cost to industry associated with the
labeling requirement is $8,540.50
($27.55 per hour × 310 hours =
$8,540.50).
In compliance with the Paperwork
Reduction Act of 1995 (44 U.S.C.
3507(d)), we have submitted the
information collection requirements of
this final rule to the OMB, and OMB has
assigned control number 3041–0157 to
the information collection.
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XII. 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.
XIII. 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
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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 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
safety standard for bassinets and cradles
is a children’s product safety rule that
requires the Commission to issue an
NOR.
The Commission recently published a
final rule, Requirements Pertaining to
Third Party Conformity Assessment
Bodies, 78 FR 15836 (March 12, 2013),
which is codified at 16 CFR part 1112
(referred to here as Part 1112). This rule
became effective June 10, 2013. Part
1112 establishes requirements for
accreditation of third party conformity
assessment bodies (or laboratories) to
test for conformance with a children’s
product safety rule in accordance with
Section14(a)(2) of the CPSA. Part 1112
also codifies a list of all of the NORs
that the CPSC had published at the time
part 1112 was issued. All NORs issued
after the Commission published part
1112, such as the bassinet and cradle
standard, require an amendment to part
1112. Accordingly, this rule amends
part 1112 to include the bassinet and
cradle standard in the list with the other
children’s product safety rules for
which the CPSC has issued NORs.
Laboratories applying for acceptance
as a CPSC-accepted third party
conformity assessment body to test to
the new standard for bassinets and
cradles are required to meet the third
party conformity assessment body
accreditation requirements in part 1112.
When a laboratory meets the
requirements as a CPSC-accepted third
party conformity assessment body, it
can apply to the CPSC to have 16 CFR
part 1218, ‘‘Safety Standard for
Bassinets and Cradles,’’ included in its
scope of accreditation of CPSC safety
rules listed for the laboratory on the
CPSC Web site at: www.cpsc.gov/
labsearch.
In connection with the part 1112
rulemaking, CPSC staff conducted an
analysis of the potential impacts on
small entities of the rule establishing
accreditation requirements, 78 FR
15836, 15855–58 (March 12, 2013), as
required by the Regulatory Flexibility
Act and prepared a Final Regulatory
Flexibility Analysis (FRFA). Briefly, the
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FRFA concluded that the requirements
would not have a significant adverse
impact on a substantial number of small
laboratories because no requirements
are imposed on laboratories that do not
intend to provide third party testing
services under section 14(a)(2) of the
CPSA. The only laboratories that are
expected to provide such services are
those that anticipate receiving sufficient
revenue from providing the mandated
testing to justify accepting the
requirements as a business decision.
Laboratories that do not expect to
receive sufficient revenue from these
services to justify accepting these
requirements would not likely pursue
accreditation for this purpose. Similarly,
amending the part 1112 rule to include
the NOR for the bassinet and cradle
standard would not have a significant
adverse impact on small laboratories.
Most of these laboratories will have
already been accredited to test for
conformance to other juvenile product
standards and the only costs to them
would be the cost of adding the bassinet
and cradle standard to their scope of
accreditation. As a consequence, the
Commission certifies that the notice
requirements for the bassinet and cradle
standard will not have a significant
impact on a substantial number of small
entities.
To ease the transition to new third
party testing requirements for bassinets
and cradles subject to the standard and
to avoid a ‘‘bottlenecking’’ of products
at laboratories at or near the effective
date of required third party testing for
bassinets and cradles, the Commission,
will, under certain circumstances,
accept certifications based on testing
that occurred before the effective date
for third party testing.
The Commission will accept
retrospective testing for 16 CFR part
1218, safety standard for bassinets and
cradles, if the following conditions are
met:
• The children’s product was tested
by a third party conformity assessment
body accredited to ISO/IEC
17025:2005(E) by a signatory to the
ILAC–MRA at the time of the test. The
scope of the third party conformity body
accreditation must include testing in
accordance with 16 CFR part 1218. For
firewalled third party conformity
assessment bodies, the firewalled third
party conformity assessment body must
be one that the Commission, by order,
has accredited on or before the time that
the children’s product was tested, even
if the order did not include the tests
contained in the safety standard for
bassinets and cradles at the time of
initial Commission acceptance. For
governmental third party conformity
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assessment bodies, accreditation of the
body must be accepted by the
Commission, even if the scope of
accreditation did not include the tests
contained in the safety standard for
bassinets and cradles at the time of
initial CPSC acceptance.
• The test results show compliance
with 16 CFR part 1218.
• The bassinet or cradle was tested,
with the exception of the removable
bassinet bed attachment requirements,
on or after the date of publication in the
Federal Register of the final rule for 16
CFR part 1218 and before April 23,
2014. For bassinets or cradles that are
subject to the removable bassinet bed
attachment requirements, testing to the
removable bassinet bed attachment
requirements was conducted on or after
the date of publication in the Federal
Register of the final rule for 16 CFR part
1218 and before April 23, 2015.
• The laboratory’s accreditation
remains in effect through April 23,
2014.
List of Subjects
16 CFR Part 1112
Administrative practice and
procedure, Audit, Consumer protection,
Reporting and recordkeeping
requirements, Third party conformity
assessment body.
16 CFR Part 1218
Consumer protection, Imports,
Incorporation by reference, Infants and
children, Labeling, Law enforcement,
and Toys.
For the reasons discussed in the
preamble, the Commission amends 16
CFR chapter II as follows:
PART 1112—REQUIREMENTS
PERTAINING TO THIRD PARTY
CONFORMITY ASSESSMENT BODIES
1. The authority citation for part 1112
continues to read as follows:
■
Authority: 15 U.S.C. 2063; Pub. L. 110–
314, section 3, 122 Stat. 3016, 3017 (2008).
2. Amend § 1112.15 by adding
paragraph (b)(33) to read as follows:
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■
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§ 1112.15 When can a third party
conformity assessment body apply for
CPSC acceptance for a particular CPSC rule
or test method?
*
*
*
*
*
(b) * * *
(33) 16 CFR part 1218, Safety
Standard for Bassinets and Cradles.
■ 3. Add a new part 1218 to read as
follows:
PART 1218—SAFETY STANDARD FOR
BASSINETS AND CRADLES
Sec.
1218.1 Scope.
1218.2 Requirements for bassinets and
cradles.
Authority: Sec. 104, Pub. L. 110–314, 122
Stat. 3016 (August 14, 2008); Pub. L. 112–28,
125 Stat. 273 (August 12, 2011).
§ 1218.1
Scope.
This part establishes a consumer
product safety standard for bassinets
and cradles manufactured or imported
on or after April 23, 2014, except for the
removable bassinet bed attachment
requirements at § 1218.2(b)(3)(i) through
(iv), (b)(5), and (b)(7), which are
effective April 23, 2015.
§ 1218.2 Requirements for bassinets and
cradles.
(a) Except as provided in paragraph
(b) of this section, each bassinet and
cradle must comply with all applicable
provisions of ASTM F2194–13,
Standard Consumer Safety Specification
for Bassinets and Cradles, approved on
April 1, 2013. The Director of the
Federal Register approves this
incorporation by reference in
accordance with 5 U.S.C. 552(a) and 1
CFR part 51. You may obtain a copy
from ASTM International, 100 Bar
Harbor Drive, P.O. Box 0700, West
Conshohocken, PA 19428; https://
www.astm.org/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,
PO 00000
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or go to: https://www.archives.gov/
federal_register/code_of_federal
regulations/ibr_locations.html.
(b) Comply with ASTM F2194–13
standard with the following additions or
exclusions:
(1) Instead of complying with Note 1
of section 1.3.1 of ASTM F2194–13,
comply with the following:
(i) Note 1—Cradle swings with an
incline less than or equal to 10° from
horizontal while in the rest (nonrocking) position are covered under the
scope of this standard. A sleep product
that only has inclined sleeping surfaces
(intended to be greater than 10° from
horizontal while in the rest (nonrocking) position) does not fall under
the scope of this standard. If a product
can be converted to a bassinet/cradle
use mode and meets the definition of a
bassinet/cradle found in 3.1.1 while in
that mode, the product shall be
included in the scope of this standard,
when it is in the bassinet/cradle use
mode. For example, strollers that have
a carriage/bassinet feature are covered
by the stroller/carriage standard when
in the stroller use mode. Carriage
baskets/bassinets that are removable
from the stroller base are covered under
the scope of this standard when the
carriage basket/bassinet meets the
definition of a bassinet/cradle found in
3.1.1. In addition, bassinet/cradle
attachments to cribs or play yards, as
defined in 3.1.2 or 3.1.12, are included
in the scope of the standard when in the
bassinet/cradle use mode.
(ii) [Reserved]
(2) Add ‘‘CAMI Newborn Dummy (see
Figure 1A). Drawing numbers 126–0000
through 126–0015 (sheets 1 through 3),
126–0017 through 126–0027, a parts list
entitled ‘‘Parts List for CAMI Newborn
Dummy,’’ and a construction manual
entitled ‘‘Construction of the Newborn
Infant Dummy’’ (July 1992). Copies of
the materials may be inspected at
NHTSA’s Docket Section, 400 Seventh
Street SW., Room 5109, Washington,
DC, or at the Office of the Federal
Register, 800 North Capital Street NW.,
Suite 700, Washington, DC.’’ to ‘‘2.3
Other References’’ and use the following
figure:
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(3) In addition to complying with
section 3.1.17 of ASTM F2194–13,
comply with the following:
(i) 3.1.18. bassinet bed, n—the
sleeping area of the bassinet/cradle,
containing the sleep surface and side
walls.
(ii) 3.1.19. removable bassinet bed,
n—A bassinet bed that is designed to
separate from the base/stand without
the use of tools. Play yard bassinets, as
defined in 3.1.13, are excluded from this
definition.
(iii) 3.1.20. false lock/latch visual
indicator, n—a warning system, using
contrasting colors, lights, or other
similar means designed to visually alert
caregivers when a removable bassinet
bed is not properly locked onto its base/
stand.
(iv) 3.1.21. intended use orientation,
n—The bassinet bed orientation (i.e., the
position where the head and foot ends
of the bassinet bed are located), with
respect to the base/stand, as
recommended by the manufacturer for
intended use.
(4) Instead of complying with section
6.7 of ASTM F2194–13, comply with
the following:
(i) 6.7. Bassinets with Segmented
Mattresses: Flatness Test—If the
bassinet or bassinet accessory has a
folding or segmented mattress, or both,
any angle when measured in 7.8 less
than or equal to 10° is an immediate
pass. Any angle when measured in 7.8
greater than 10° is an immediate failure.
Segmented bassinet mattresses that have
seams (located between segments or
where the mattress folds) that are less
than 15 inches in length are excluded
from this requirement.
(ii) [Reserved]
(5) In addition to complying with
section 6.9.2 of ASTM F2194–13,
comply with the following:
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(i) 6.10. Removable Bassinet Bed
Attachment—Any product containing a
removable bassinet bed with a latching
or locking device intended to secure the
bassinet bed to the base/stand, shall
comply with at least one of the
following 6.10.1, 6.10.2, 6.10.3, 6.10.4 or
6.10.5 when tested in accordance with
7.12.
(ii) 6.10.1. The base/stand shall not
support the bassinet bed (i.e., the
bassinet bed falls from the stand and
contacts the floor or the base/stand
collapses when the bassinet bed is not
locked on the base/stand).
(iii) 6.10.2. The lock/latch shall
automatically engage under the weight
of the bassinet bed (without any other
force or action) in all lateral positions
(Figure 24).
(iv) 6.10.3. The sleep surface of the
bassinet bed shall be at an angle of at
least 20° from a horizontal plane when
the bassinet bed is in an unlocked
position.
(v) 6.10.4. The bassinet/cradle shall
provide a false latch/lock visual
indicator(s). At a minimum, an indicator
shall be visible to a person standing
near both of the two longest sides of the
product.
(vi) 6.10.5. The bassinet bed shall not
tip over and shall retain the CAMI
newborn dummy when tested in
accordance with 7.12.5.3.
(6) Instead of complying with section
7.4.4 of ASTM F2194–13, comply with
the following:
(i) 7.4.4. Place the CAMI Newborn
Dummy, Mark II, on the sleeping pad in
the center of the product face up with
the arms and legs straightened.
(A) Rationale. The newborn CAMI
dummy represents a 50th percentile
newborn infant, which is a more
appropriate user of a bassinet than the
CAMI infant dummy, which represents
a 50th percentile 6-month-old infant.
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(B) [Reserved]
(ii) [Reserved]
(7) In addition to complying with
section 7.11.4 of ASTM F2194–13,
comply with the following:
(i) 7.12. Removable Bassinet Bed
Attachment Tests
(ii) 7.12.1. Assemble the bassinet/
cradle base/stand only, in accordance
with manufacturer’s instructions in one
of the manufacturer’s recommended use
positions. If the base/stand does not
remain in the use position when the
bassinet bed is not locked onto it, the
product meets the requirements of
6.10.1.
(iii) 7.12.2. Place the base/stand and
the inclinometer on a flat level
horizontal surface (0 ± ¥0.5°) to
establish a test plane. Zero the
inclinometer.
(iv) 7.12.3. Remove the mattress pad
from the bassinet bed.
Note to paragraph (b)(7)(iv): For mattresses
that are integral with the mattress support, do
not remove the mattress and perform all
angle measurements for 7.12 on a 6 by 6 by
3⁄8-in. nominal aluminum block placed on
the center of the mattress.
(v) 7.12.4. Place the bassinet bed on
the base/stand in the intended use
orientation without engaging any latch
or lock mechanism between the base/
stand and the bassinet bed. If the bed
automatically engages to the base/stand
do not disengage the lock/latch. If the
bassinet bed can rest on the base/stand
in its intended use orientation in one or
more lateral unlocked position (Figure
24), the unit shall be evaluated in the
lateral position most likely to fail the
requirements specified in 6.10.
(vi) Figure 24: Bassinet Bed Resting
on Stand, Showing Possible Alternate
Lateral Positions.
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(vii) 7.12.4.1. If the base/stand
supports the bassinet bed in any
unlocked position, place the
inclinometer on the mattress support at
the approximate center of the mattress
support. Care should be taken to avoid
seams, snap fasteners, or other items
that may affect the measurement
reading. Record the angle measurement.
(viii) 7.12.4.2. If the base/stand
supports the bassinet bed and the angle
of the mattress support surface
measured in 7.12.4.1 is less than 20
degrees from a horizontal plane,
evaluate whether the bassinet has a false
latch/lock visual indicator per 6.10.4.
(ix) 7.12.4.3. If the base/stand
supports the bassinet bed, and the angle
of the mattress support surface
measured in 7.12.4.1 is less than 20
degrees from a horizontal plane, and the
bassinet does not contain a false latch/
lock visual indicator, test the unit in
accordance with sections 7.4.2 through
7.4.7.
(x) 7.12.5. Repeat 7.12.2 through
7.12.4 for all of the manufacturer’s base/
stand recommended positions and use
modes.
(xi) 7.12.6. Repeat 7.12.4 through
7.12.5 with the bassinet bed rotated 180
degrees from the manufacturers
recommended use orientation, if the
base/stand supports the bassinet bed in
this orientation.
(A) Rationale. (1) This test
requirement addresses fatal and nonfatal
incidents involving bassinet beds that
tipped over or fell off their base/stand
when they were not properly locked/
latched to their base/stand or the latch
failed to engage as intended. Products
that appear to be in an intended use
position when the lock or latch is not
properly engaged can create a false
VerDate Mar<15>2010
16:30 Oct 22, 2013
Jkt 232001
sense of security by appearing to be
stable. Unsecured or misaligned lock/
latch systems are a hidden hazard
because they are not easily seen by
consumers due to being located beneath
the bassinet or covered by decorative
skirts. In addition, consumers will avoid
activating lock/latch mechanisms for
numerous reasons if a bassinet bed
appears stable when placed on a stand/
base. Because of these foreseeable use
conditions, this requirement has been
added to ensure that bassinets with a
removable bassinet bed feature will be
inherently stable or it is obvious that
they are not properly secured.
(2) 6.10 allows bassinet bed designs
that:
(i) Cannot be supported by the base/
stand in an unlocked configuration,
(ii) Automatically lock and cannot be
placed in an unlocked position on the
base/stand,
(iii) Are clearly and obviously
unstable when the lock/latch is
misaligned or unused,
(iv) Provide a visual warning to
consumers when the product is not
properly locked onto the base/stand, or
(v) Have lock/latch mechanisms that
are not necessary to provide needed
stability.
(B) [Reserved]
Dated: September 30, 2013.
Todd A. Stevenson,
Secretary, Consumer Product Safety
Commission.
[FR Doc. 2013–24203 Filed 10–22–13; 8:45 am]
BILLING CODE 6355–01–P
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DEPARTMENT OF ENERGY
Federal Energy Regulatory
Commission
18 CFR Part 40
[Docket Nos. RM12–1–000 and RM13–9–
000; Order No. 786]
Transmission Planning Reliability
Standards
Federal Energy Regulatory
Commission, Energy.
ACTION: Final rule.
AGENCY:
Under section 215 of the
Federal Power Act, the Federal Energy
Regulatory Commission approves
Transmission Planning (TPL) Reliability
Standard TPL–001–4, submitted by the
North American Electric Reliability
Corporation, the Commission-certified
Electric Reliability Organization.
Reliability Standard TPL–001–4
introduces significant revisions and
improvements by requiring annual
assessments addressing near-term and
long-term planning horizons for steady
state, short circuit and stability
conditions. Reliability Standard TPL–
001–4 also includes a provision that
allows a transmission planner to plan
for non-consequential load loss
following a single contingency by
providing a blend of specific
quantitative and qualitative parameters
for the permissible use of planned nonconsequential load loss to address bulk
electric system performance issues,
including firm limitations on the
maximum amount of load that an entity
may plan to shed, safeguards to ensure
against inconsistent results and arbitrary
determinations that allow for the
planned non-consequential load loss,
SUMMARY:
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63036
Agencies
[Federal Register Volume 78, Number 205 (Wednesday, October 23, 2013)]
[Rules and Regulations]
[Pages 63019-63036]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-24203]
[[Page 63019]]
=======================================================================
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Parts 1112 and 1218
[Docket No. CPSC-2010-0028]
Safety Standard for Bassinets and Cradles
AGENCY: Consumer Product Safety Commission.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Danny Keysar Child Product Safety Notification Act,
Section 104 of the Consumer Product Safety Improvement Act of 2008
(CPSIA), requires the United States Consumer Product Safety Commission
(Commission or CPSC) to promulgate consumer product safety standards
for durable infant or toddler products. These standards are to be
``substantially the same as'' applicable voluntary standards or more
stringent than the voluntary standard if the Commission concludes that
more stringent requirements would further reduce the risk of injury
associated with the product. The Commission is issuing a safety
standard for bassinets and cradles in response to the direction under
Section 104(b) of the CPSIA.
DATES: The rule will become effective on April 23, 2014, with the
exception of Sec. 1218.2(b)(3)(i) through (iv), (b)(5), and (b)(7),
which will become effective on April 23, 2015. The incorporation by
reference of the publication listed in this rule is approved by the
Director of the Federal Register as of April 23, 2014.
FOR FURTHER INFORMATION CONTACT: William Dewgard, Directorate for
Compliance, Consumer Product Safety Commission, telephone: 301-504-
7599; email: WDewgard@cpsc.gov.
SUPPLEMENTARY INFORMATION:
I. 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 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.'' Bassinets and cradles are specifically identified in
section 104(f)(2)(L) of the CPSIA as a durable infant or toddler
product.
On April 28 2010, the Commission issued a notice of proposed
rulemaking (NPR) for bassinets and cradles. 75 FR 22303. The NPR
proposed to incorporate by reference the voluntary standard, ASTM
F2194-07a [egr]1, Standard Consumer Safety Specification for Bassinets
and Cradles, with certain changes to provisions in the voluntary
standard to strengthen the ASTM standard.
The Commission published a supplemental notice of proposed
rulemaking (SNPR) on October 18, 2012. 77 FR 64055. The SNPR proposed
to incorporate the voluntary standard, ASTM F2194-12, with: (1)
Modifications to sections pertaining to scope and terminology and the
stability test procedure, and (2) the addition of new provisions for a
segmented mattress flatness test and a removable bed stability
requirement.
In this document, the Commission is issuing a safety standard for
bassinets and cradles. 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 standard, largely through the ASTM
process. The rule incorporates the voluntary standard, ASTM F2194-13,
Standard Consumer Safety Specification for Bassinets and Cradles (ASTM
F2194-13), by reference, with the following modifications and
additions: a clarification to the scope of the bassinet/cradle
standard; a change to the pass/fail criterion for the mattress flatness
test; an exemption from the mattress flatness requirement for bassinets
that are less than 15 inches across; the addition of a removable bed
stability requirement; and a change to the stability test procedure
requiring the use of a newborn CAMI dummy rather than an infant CAMI
dummy.
II. The Product
ASTM F2194-13 defines ``bassinet/cradle'' as a ``small bed designed
primarily to provide sleeping accommodations for infants, supported by
free standing legs, a stationary frame/stand, a wheeled base, a rocking
base, or which can swing relative to a stationary base.'' While in a
rest position, a bassinet/cradle is intended to have a sleep surface
less than or equal to 10[deg] from horizontal. The bassinet/cradle is
not intended to be used beyond the age of approximately five months or
when a child is able to push up on his hands and knees. Bassinet and
cradle attachments for non-full-size cribs or play yards are considered
part of the bassinet/cradle category, as are bedside sleepers that can
be converted to four-sided bassinets not attached to a bed.
Cribs, Moses baskets, and products used in conjunction with an
inclined infant swing or stroller, and products that are intended to
provide only an inclined sleep surface of greater than 10 degrees
horizontal, are not included under the category of ``bassinets/
cradles.'' (A Moses basket is a portable cradle for a newborn or
infant, often made of straw or wicker, that can be used with a variety
of rocking and stationary stands. As with other bassinets and cradles,
Moses baskets are not intended for use after a child can push up on its
hands and knees.) However, Moses baskets and carriage accessories that
can be converted to a bassinet or cradle by attachment to a separate
base/stand would be considered bassinets/cradles when used with the
base/stand. Similarly, products that could be used at an incline of 10
degrees or less from horizontal, as well as more than 10 degrees from
horizontal, would be considered bassinets/cradles when in the flatter
configuration(s).
III. Incident Data
The preamble to the SNPR summarized incident data involving
bassinets and cradles reported to the Commission as of January 18,
2012. 77 FR 64055 (October 18, 2012). CPSC's Directorate for
Epidemiology, Division of Hazard Analysis has updated this information
to include bassinet- and cradle-related incident data reported to the
Commission from January 18, 2012 through March 31, 2013. A search of
the CPSC epidemiological databases showed that there were 71 new
incidents related to bassinets and cradles reported during this time
frame. Thirty-eight of the 71 were fatal, and 33 were nonfatal. Sixteen
of the nonfatal incidents involved injuries. Almost all of the new
incidents reportedly occurred between 2010 and 2012. Reporting is
ongoing, however, so the incident totals are subject to change.
[[Page 63020]]
A. Fatalities
The majority of the deaths (32 out of 38) were asphyxiations due to
the presence of soft or extra bedding in the bassinet, prone placement
of the infant, and/or the infant getting wedged between the side of the
bassinet and additional bedding. All but four of the 38 decedents were
five months or less in age, the ASTM-recommended age range for bassinet
use; three of the decedents were six months old and another was an
eight-month-old.
Two of the 38 deaths were associated with design aspects of the
product. One of these was a suffocation death in a corner of the
bassinet whose rocking feature contributed to its non-level resting
position; the other fatality occurred when the bassinet was knocked
over by an older sibling.
There were three fatalities with insufficient information and one
fatality with confounding information preventing CPSC from determining
the hazard scenario.
B. Nonfatal Incidents
A total of 33 bassinet-related nonfatal incidents were reported
from January 18, 2012 through March 31, 2013. Of these, 16 reports
indicated an injury to an infant using the bassinet or cradle at the
time of the incident. The majority of these injuries (11 out of 16, or
69 percent) were due to falls out of the bassinets. All 11 fall
injuries were reported through NEISS, with little or no circumstantial
information on how the fall occurred. However, the reports do indicate
that 55 percent of the injured infants who fell out of bassinets were
older than the ASTM-recommended maximum age limit of five months. All
of the falls resulted in head injuries. Among the remaining five
nonfatal injuries, mostly head injuries, no hospitalizations were
reported. All but six of the injured were five months or less in age.
The remaining 17 incident reports indicated that no injury had
occurred or provided no information about any injury. However, many of
the descriptions indicated the potential for a serious injury or even
death.
C. Hazard Pattern Identification
The hazard patterns identified in the 71 new incident reports were
similar to the hazard patterns that were identified in the incidents
considered for the SNPR and are grouped in the following categories (in
descending order of frequency of incidents):
1. Non-product-related issues: Thirty-four of the 71 reports (48
percent) concerned incidents that involved no product defect or
failure. This category consisted of 32 fatalities that were associated
with the use of soft/extra bedding, prone positioning, and/or the
infant getting wedged between the side of the bassinet and additional
bedding. In addition, there were two nonfatal injury incidents that did
not involve any product-related issues.
2. Product-related issues: The hazard scenarios in 25 of the 71
reported incidents (35 percent) were attributed to a failure/defect or
a potential design flaw in the product. This category includes one
fatality and 13 injuries. Listed below are the reported problems,
beginning with the most frequently reported concerns:
Reports of infants falling or climbing out of bassinets/
cradles accounted for a total of 13 incidents, all of which were
received from emergency departments around the United States. Eleven of
the incidents reported a nonfatal injury; the remaining two infants
were reported to be uninjured.
Lack of structural integrity, which includes issues such
as instability, loose hardware, and product collapse, among others, was
reported in nine incidents--one with a fatality and two with nonfatal
injuries.
Problems with accessories (such as the stand or sheets),
which were sold with the bassinets, were reported in two incidents.
However, no injuries were reported.
One other product-related problem, involving the battery
compartment of an older product, was reported in one non-injury
incident.
3. Recalled product-related issues: There were six reports (eight
percent) that were associated with three different recalled product-
related issues. (Two of the recalls were published since the incident
data for the SNPR briefing package was presented; at the time, these
issues were classified under the ``structural integrity'' and
``rocking'' categories.) Although there were no injuries, there was a
fatality included among the six incident reports. In the fatal
incident, it is reported that the tilting of the bassinet caused the
decedent to roll and press up against the side and suffocate.
4. Miscellaneous other issues: The remaining six incident reports
(eight percent) were related to other unspecified issues. The reports
described the incidents with insufficient specificity or provided
confounding information, preventing CPSC staff from identifying the
hazard scenario. There were four fatalities, one nonfatal injury, and
one non-injury incident reported in this category.
IV. Overview of ASTM F2194
ASTM F2194, Standard Consumer Safety Specification for Bassinets
and Cradles, establishes safety performance requirements, test methods,
and labeling requirements to minimize the identified hazard patterns
associated with the use of bassinets/cradles. ASTM first published a
consumer product safety standard for bassinets and cradles in 2002. The
standard was revised several times over the next 11 years. The current
version of the standard is ASTM F2194-13. The more significant
requirements of ASTM F2194 include:
Scope--describes the types of products intended to be
covered under the standard.
Spacing of rigid side components--is intended to prevent
child entrapment between both uniformly and non-uniformly spaced
components, such as slats.
Openings for mesh/fabric--is intended to prevent the
entrapment of children's fingers and toes, as well as button
ensnarement.
Static load test--is intended to ensure structural
integrity even when a child three times the recommended (or 95th
percentile) weight uses the product.
Stability requirements--is intended to ensure that the
product does not tip over when pulled on by a two-year-old male.
Sleeping pad thickness and dimensions--is intended to
minimize gaps and the possibility of suffocation due to excessive
padding.
Tests of locking and latching mechanisms--is intended to
prevent unintentional folding while in use.
Suffocation warning label--is intended to help prevent
soft bedding incidents.
Fabric-sided openings test--is intended to prevent
entrapments.
Rock/swing angle requirement--is intended to address
suffocation hazards that can occur when latch/lock problems and
excessive rocking or swinging angles press children into the side of
the bassinet/cradle.
Occupant restraints--is intended to prevent incidents
where unused restraints have entrapped and strangled children.
Side height requirement--is intended to prevent falls.
Segmented mattress flatness--is intended to address
suffocation hazards associated with ``V'' shapes that can be created by
the segmented mattress folds.
The voluntary standard also includes: (1) Torque and tension tests
to prevent components from being removed; (2) requirements for several
bassinet/cradle
[[Page 63021]]
features to prevent entrapment and cuts (minimum and maximum opening
size, small parts, hazardous sharp edges or points, and edges that can
scissor, shear, or pinch); (3) requirements for the permanency and
adhesion of labels; (4) requirements for instructional literature; and
(5) corner post extension requirements intended to prevent pacifier
cords, ribbons, necklaces, or clothing that a child may be wearing from
catching on a projection.
V. The SNPR and ASTM F2194-13
The SNPR proposed to incorporate by reference ASTM F2194-12, with
four modifications/additions to the voluntary standard:
(1) Scope and Terminology: The SNPR proposed excluding inclined
products from the scope of the standard, by revising the scope and
including a detailed note with examples of what products were and were
not included in the scope of the standard. The SNPR also proposed two
existing definitions be revised for clarity.
(2) Segmented Mattress Flatness Test: The SNPR proposed a new test
requirement and associated test procedure to address suffocation
incidents in segmented mattresses. As discussed in the preamble to the
SNPR, the mattress flatness requirement is primarily aimed at incidents
involving bassinet/play yard combination products that tend to use
segmented mattresses, where seams could pose a suffocation and
positional asphyxiation hazard. Under the Commission's pass/fail
criteria proposed in the SNPR, a bassinet attachment with a segmented
mattress would fail if any tested seam creates an angle greater than 10
degrees.
(3) Removable Bed Stability Requirement: The SNPR proposed a new
test requirement and associated test procedure to address fatal and
nonfatal incidents associated with bassinets that have removable
bassinet beds. In the proposed requirement, a removable bassinet bed
that was not properly attached or assembled to its base would be
required to meet one of the following requirements:
a. 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
b. The lock/latch shall automatically engage under the weight of
the bassinet bed (without any other force or action); or
c. The stand/base shall not be capable of supporting the bassinet
bed within 20 degrees of horizontal; or
d. The bassinet shall contain a visual indicator mechanism that
shall be visible on both sides of the product to indicate whether the
bassinet is properly attached to the base; or
e. The bassinet shall not tip over and shall retain the CAMI
newborn dummy when subjected to the stability test outlined in the
standard.
(4) Stability Test Procedure: The SNPR proposed a revised test
procedure for stability. The revision specifies the use of a newborn
CAMI dummy, rather than the six month CAMI dummy that is referenced in
the ASTM standard.
The SNPR's provisions concerning the scope and terminology and the
proposed segmented mattress flatness test requirement were balloted by
ASTM in 2012, and the provisions are now included in the latest
revision of the voluntary standard, ASTM F2194. Although the mattress
flatness test procedure in ASTM F2194-13 is identical to what is
proposed in the SNPR, the pass/fail criterion is different. As stated
previously, under the Commission's pass/fail criteria, as proposed in
the SNPR, a bassinet attachment with a segmented mattress will fail if
any tested seam creates an angle greater than 10 degrees. ASTM F2194-13
allows measured angles between 10 degrees and 14 degrees to pass, as
long as the mean of three measurements on that seam is less than 10
degrees.
The removable bed stability requirement proposed in the SNPR is not
in the current ASTM standard, but a similar version is expected to be
balloted by ASTM for inclusion in the next revision. Similarly, the
change in the stability test procedure proposed in the SNPR is not in
ASTM F2194-13, but it is expected to be balloted by ASTM for inclusion
in its next revision.
VI. Response to Comments
There were 27 comments received on the SNPR, including: one from
Health Canada; one from a group of consumer's groups (Kids In Danger,
Consumers Union, American Academy of Pediatrics, Consumer Federation of
America, Public Citizen, and U.S. PIRG); one from the Juvenile Products
Manufacturers Association (JPMA); and two from bassinet manufacturers.
The remaining 22 comments were from consumers, law students, or
unaffiliated sources. The comments raised several issues, which
resulted in two changes to the final rule. Several commenters made
general statements supporting the overall purpose of the proposed rule.
All of the comments can be viewed at: www.regulations.gov, by searching
under the docket number of the rulemaking, CPSC-2010-0028. Following is
a summary of and responses to the comments.
Scope
Comment: Two commenters provided almost identical comments and
suggestions for changes to the scope. The commenters asserted that the
scope was unclear about what products are included in the scope and
under what conditions. For instance, one comment stated that it was not
clear from the SNPR how products with an inclined seat back surface
(reclined seat back), such as infant seats, infant bouncer seats, and
infant rockers that do not provide an ``inclined sleep surface'' would
be treated under the standard.
Response: The scope that was proposed in the SNPR has subsequently
been adopted by ASTM and is the scope in the current version of the
ASTM standard, ASTM F2194-13. The comments received reflect continued
ambiguity regarding some aspects of the scope. Therefore, the
Commission is providing additional clarity in the final rule.
Inclined products fall under a variety of different ASTM standards,
depending on the product's function. For instance, ASTM standards
include a handheld carrier standard, an infant bouncer standard, and a
new rocker standard that is currently under development. None of those
products is intended for sleep. An inclined product intended for
sleeping would fall under the inclined sleep product standard currently
under development by ASTM. The Commission's intent is that the scope of
the bassinet standard exclude all inclined products when the incline is
more than 10 degrees from horizontal.
However, the Commission intends that any product that has both a
flat (10 degrees or less) sleep surface and an inclined surface greater
than 10 degrees from horizontal shall fall under the scope of the
bassinet standard when configured in the flat mode, and will fall under
the scope of the appropriate inclined product standard(s) while in the
inclined mode. In this manner, all uses of the product are addressed by
safety standards. This type of product is considered a multimode
product, or a combination product, i.e., the product can convert from
one use mode to another.
During the recent ASTM F15 juvenile products subcommittee meetings
held in April 2013, scope clarity was raised in various product
subcommittees where multimode products are commonly considered. Most of
those product subcommittees proposed to modify the scope section of the
appropriate standard to clarify that these combination products shall
fall
[[Page 63022]]
under the scope of all relevant standards when in the corresponding use
mode.
This intent to include multimode products under multiple standards
is well established in ASTM standards, including the bassinet standard.
One example of a multimode product is a carriage basket that is
removable from a stroller base. The scope section of ASTM F2194-13
clearly states that products used in conjunction with a stroller are
not covered by the standard. Yet, the current scope section also
states: ``Carriage baskets/bassinets that are removable from the
stroller base are covered under the scope of this standard when the
carriage basket/bassinet meets the definition of a bassinet/cradle
found in 3.1.1.'' Clearly, the intent of the ASTM standard is to see
that this multimode product falls within the scope of the stroller
standard when attached to the stroller frame and falls within the scope
of the bassinet standard when attached to a separate frame/stand.
Thus, to remove any ambiguity regarding multimode products, the
Commission's standard modifies the note that accompanies the scope
provision of ASTM F2194-13 to clarify that a multimode product with a
bassinet-use mode must meet the bassinet standard when in the bassinet-
use mode.
Comment: One commenter suggested that the scope of the standard
needs more specific age restrictions.
Response: The scope of a standard is intended to define broadly an
entire product category. Within that category, manufacturers have the
freedom to tailor their product to a specific market niche, which might
be more specialized than other products in the same category. Providing
too many specific restrictions within the scope of a standard makes the
standard weaker by excluding many products that ought to be included.
In general, ASTM standards are defined by their respective industries,
using terms that produce a standard that is as useful as possible to
that industry. The Commission agrees with the bassinet industry on the
existing age recommendations in the ASTM standard.
Removable Bassinet Bed Requirements
Comment: One group of commenters suggested that the Commission
eliminate the two ``passive'' pass conditions (20 degrees and passing
stability) of the removable bassinet bed stability requirement in favor
of the other pass criteria, which the group of commenters said they
believe makes the user actively aware that the bassinet is not attached
properly.
Response: The SNPR proposed several options to meet the removable
bassinet bed requirements. This approach is less restrictive than
prescribing one pass criterion, and the approach allows for more
innovation in product designs. By permitting five different options to
meet this requirement, manufacturers have a variety of design choices
available.
Comment: Some commenters said they believe that allowing the
bassinet to ``fail'' (by falling to the ground or to a 20 or more
degree angle) encourages manufacturers to make products that are less
stable to ensure that their bassinets pass this requirement. Another
commenter stated that it was foreseeable that some caregivers may
attempt to attach the bassinet bed to its stand while the child is in
the product and that this might expose children to unnecessary hazards.
Response: Two of the five options to pass the removable bed
requirement are closely related to one another. These two options are:
(1) The sleep surface shall be at least 20 degrees off from a
horizontal plane; and (2) the bassinet bed falls from the stand and
contacts the floor. These two requirements were added after
consultations with stakeholders (ASTM task group members). Several
stakeholders stated that if a bassinet stand was designed to support
the bassinet bed only if it were locked properly, then the bassinet
stand should be able to pass the requirement. For instance, in the case
of a stand that looks like a saw horse, or ``A'' frame that has a lock/
latch connection at the top of the ``A'' on the frame and on the
underside of the bassinet bed, the caregiver would have to line up both
halves of the lock/latch to attach the bed to the stand. It would be
unreasonable to believe that caregivers would place the bassinet bed on
an ``A'' frame stand without engaging the lock/latch because the design
of the stand would cause the bassinet bed to fall to the ground if the
lock was not engaged.
Rather than specifying a design requirement, the task group
converted the requirement to a performance requirement, by simulating
what would happen if the unreasonable act occurred. In other words,
this option requires the bassinet bed to fall to the ground if the lock
is not properly engaged.
Once that requirement was vetted by the task group, another
stakeholder raised the possibility that the bassinet bed, in the act of
falling, might get caught on the stand before hitting the ground. The
stakeholder asserted that simply because the bassinet bed did not hit
the ground should not constitute a failure. Thus, the 20-degree tilt
option was added to address the possibility that the bassinet bed, in
the process of falling, might get caught on the stand and to complement
the fall-to-the-ground option.
A bassinet that relies on either of these two options to pass the
requirement would be considered to provide immediate positive feedback.
Caregivers who attempt to place the bassinet bed on this type of stand
without locking it in place will realize instantly that they did not
engage the lock because the bassinet bed will not assume a stable
position that allows the caregivers to release their grasp. The
immediate feedback of instability will minimize the possible hazards,
making falling unlikely. The Commission believes that the steep angle
needed to pass is unlikely to allow consumers to let children fall. The
instability of such a unit is immediately obvious to the user,
precluding a delayed response. Consumers are likely to check the
stability of the product before removing their hands from it. Even in
the case of a caregiver who attempts to place an occupied bassinet bed
on a stand using this option, the caregiver will be present and
potentially will be able to prevent or arrest the fall of the bassinet
bed. The Commission considers the possibility of a fall hazard in this
scenario to be highly unlikely; and on the rare chance that a fall
occurs, the fall in these circumstances would be considered less
significant than an unattended fall to the floor.
Comment: One commenter stated that the option--``The lock/latch
shall automatically engage under the weight of the bed (without any
other force/action)''--should be a requirement for all bassinets.
Response: The Commission is providing manufacturers with options to
meet the removable bassinet bed requirements. This approach is less
restrictive than prescribing one requirement and allows for more
innovation in product designs.
Comment: One commenter stated that adding the removable bassinet
bed stability requirement is premature. The commenter expressed the
belief that the requirement should be removed from the regulation and
that ASTM should be allowed to continue working on the issue.
Response: The Commission is aware of two deaths associated with
this hazard scenario. (One of these deaths occurred in Canada; thus, it
was not included in incident data counts reported in the SNPR briefing
package.) Therefore, the Commission does not believe that this
requirement is premature. The Commission believes
[[Page 63023]]
that stakeholders have had plenty of time to test, review, discuss, and
refine the proposed requirements before and after the SNPR was
published. In fact, the language recommended for the final rule is
essentially the same as what ASTM expects to ballot soon as a new
requirement to address the same hazard.
Comment: A commenter stated that color-only visual indicators
should not be allowed as an option to pass the removable bassinet bed
requirement because people who are color-blind would not be able to
distinguish between locked and unlocked.
Response: The requirement for visual indicators allows
manufacturers to design a visual indicator that can be recognized by a
person with a color vision deficiency. In addition, there are many
other options to pass the requirement, and individuals who are color-
blind can choose to purchase a product that does not use color
indicators.
Comment: Some commenters expressed a belief that allowing removable
bassinet beds to pass the stability test by tilting to a 20-degree
angle was hazardous because consumers might think that a 20-degree
angle is still usable, perhaps as an inclined sleeper.
Response: The Commission believes that an angle of 20[deg] or more
is acceptable to demonstrate that the bassinet is not useable. A
steeper angle would also be acceptable, but the Commission is not
convinced this is needed. Twenty degrees is twice the maximum allowable
tilt for bassinets, which are intended to have a flat sleeping surface.
In deciding on the 20[deg] angle, the ASTM task group noted an incident
(101101HCC3107) where a consumer clearly saw that something was wrong
with his bassinet when he saw it tilted and deemed it to be unusable.
From the photos, the tilt was estimated to be approximately 17[deg].
Mattress Flatness
Comment: Some commenters suggested that the mattress flatness
requirements should be limited to 8[deg] from the horizontal rather
than 10[deg].
Response: Although the Commission would be amenable to using this
more conservative margin of safety, i.e., a tolerance of 16[deg] of
motion rather than 20[deg], the industry has maintained that a larger
tolerance is necessary, due to the inherent variability of
manufacturing products with fabric and foam. The industry claims that
tighter tolerances on a segmented mattress made with the materials that
are commonly used in these products would make it impossible to
manufacture such mattresses. The Commission believes that the 10[deg]
limit is adequate to protect the expected user population.
Comment: A commenter suggested that the threshold limit for
flatness should be 14[deg] to preserve test-retest reliability.
Response: ASTM F2194-13 now includes the mattress flatness test
requirement and procedure, as written in the SNPR, with the exception
of the angle requirement. ASTM's requirement allows the use of an
average for measurements over 10[deg] and under 14[deg], while the SNPR
proposed a maximum allowable measurement of 10[deg]. Based on testing
performed by an ASTM task group that was established to assess the
reliability and repeatability of the mattress flatness test, the
reliability of the test is adequate when the test is performed on
products designed to pass the test. The commenter did not provide any
new or different information to the Commission to support the
suggestion for using the averaging method; thus, the Commission
continues to support the 10[deg] flatness criterion as proposed in the
SNPR.
Comment: Some commenters questioned the use of a cylinder as a
surrogate for a human occupant, and another commenter suggested that an
automated human model would be more appropriate.
Response: An automated human model is not readily available. It is
customary in the juvenile product industry to use easily manufactured
shapes made from common materials. This testing strategy enhances the
repeatability of the test. An ASTM task group conducted a repeatability
and reproducibility study to compare various surrogates for use in the
mattress flatness test. The cylinder was the best choice, based on the
study results.
Comment: Some commenters suggested using the dummy in the test for
mattress flatness so that infant position would be a factor.
Response: The test cylinder is a repeatable method that identifies
hazardous products to the satisfaction of industry and the Commission.
Unfortunately, the CAMI dummy is too stiff to be useful for simulating
suffocation positions and would not be suitable to serve that purpose.
Comment: Some commenters wanted more explanation of how the
cylinder sufficiently simulates an infant rolling into a mattress
crease, as demonstrated in the mattress flatness test.
Response: The Commission has examined bassinets that pass the test
and bassinets that fail. When visual comparisons and measurements of
angles are made to compare the movements of the mattresses during a
test using an anthropomorphic dummy versus tests using a cylinder, few
discernible differences are evident. The shape of the test weight does
not seem to be as important as the mass of the test weight in
identifying hazardous products.
Comment: Two commenters offered opinions about the mattress
flatness testing and designs of bassinet accessories that use support
rods underneath the mattress. One of the two comments suggested that
the mattress flatness test be performed with and without the bars in
place. Moreover, the commenter suggested that if the bars are required
to be in place to pass the flatness test, then they should be attached
permanently. Similarly, the other comment suggested that the frame
supporting the floor (mattress) should come preassembled to eliminate
the possibility that the consumer can misassemble the product.
Response: The Commission agrees with these comments. In January
2013, ASTM balloted a revised mattress flatness test, requiring that
any segmented mattress that has consumer-assembled mattress support
rods, be tested with and without the mattress support rods. This
requirement resulted from the Commission's play yard misassembly NPR
that was published in August 2012. The ballot item passed and is now
part of ASTM F2194-13. The final rule incorporates by reference ASTM
F2194-13; thus, the test will include the suggestion from the
commenters.
Comment: A commenter stated that that the mattress flatness test
could not be performed on bassinets that were less than 15 inches wide
because of the width of the cylinder and the block used in that test
method. Furthermore, the commenter noted that such a small, narrow
occupant-retention space would not present the same hazards involved in
incidents with wider play yard bassinet accessories.
Response: The Commission agrees that bassinets with occupant-
retention spaces that are narrower than the test apparatus are unlikely
to be used with an infant placed orthogonally between walls that are so
narrow. In the case where an infant is placed in a narrow bassinet
correctly and then moves or shifts 90[deg], the narrowness of the
bassinet would likely not permit the infant to lie in a fully prone
position, face down in an orthogonal seam. Thus, an exemption from the
flatness test for mattress pad seams that run orthogonally between the
sides of a bassinet with a width of 15 inches or
[[Page 63024]]
less seems reasonable. Therefore, the Commission is modifying the
standard to exempt from the mattress flatness test bassinets that are
narrower than 15 inches.
Effective Date
Comment: We received several comments on the effective date
proposed in the SNPR. One commenter, representing several advocacy
groups, supported the six-month effective date proposed in the SNPR. A
second commenter agreed, expressing concerns that if the date were
extended and a death occurred, ``consumers might view the death as the
result of the CPSC putting the interests of for-profit entities . . .
ahead of the safety of infants who use their products.''
In contrast, several other commenters, including one manufacturer,
recommended longer effective dates to reduce the impact of the rule,
particularly for small businesses that have ``fewer resources and
connections within the industry'' and that ``may have to significantly
alter their means of production.'' Suggested effective dates ranged
from 9 to 15.5 months, with commenters recommending that the CPSC focus
on relief for firms that would be disproportionately impacted by the
rule. Commenters suggested longer effective dates for firms newly
covered by the expanded scope, and firms whose products would be
subject to the removable bassinet bed requirement.
A manufacturer commenting on the effective date stated that a
longer effective date is needed for firms that will need to redesign
their products to meet the removable bassinet bed requirement. This
firm stated that an effective date of at least 15.5 months is needed to
reflect accurately the challenges of redesigning the product.
Response: The Commission recognizes that some manufacturers will be
required to redesign, test new prototype products, and then retool
their production process to meet the new removable bassinet bed
provision. Based on a comment from one manufacturer who stated it would
need a minimum of 15.5 months to redesign its product, the Commission
considers 18 months to be a reasonable time period to accommodate other
manufacturers that might also need to redesign their products.
Therefore, the Commission is implementing a six-month effective date
for the final rule, with the specific exception of extending the
effective date for the removable bassinet bed test requirement to 18
months.
Stability Testing--CAMI Dummy
Comment: Some commenters suggested using an infant and a newborn
dummy in the stability test methods, while others said they believe the
incident data do not support the need to change from an infant dummy to
a newborn dummy because this change neglects the evidence that larger
infants also use bassinets and cradles.
Response: The use of both dummies is unnecessary because the worst
case scenario for stability is the smaller size dummy. The larger size
dummy makes the product more stable. Therefore, if a product passes
with a newborn, the product will also pass with an infant. Performing
the test with two different dummies would be redundant and would only
add to the cost of testing.
The Commission is requiring use of the newborn CAMI to make the
test more stringent. Even if a majority of the incidents were not
directly attributable to product stability, the instability of the
product, in many incidents, was to blame, including two fatal incidents
(one of which was reported from Canada).
Incident Data Analysis
Comment: Some commenters asserted that a causal relationship could
not be established for fatalities that the Commission attributed to
design defects. They also stated that the information used by the
Commission to analyze fall incidents was circumstantial. Other
commenters suggested that additional information should be collected to
determine the extent to which product design was at fault, to evaluate
the cause of falls, and to ``improve and expand on the regulations and
guidelines set forth in the proposed rule.''
Response: The Commission gathered as much information as possible
on every cited product-related fatality through an in-depth, on-site
field investigation. Although the Commission agrees with the commenters
that additional information-gathering on all nonfatal injuries could be
useful, given resource limitations, the Commission cannot follow up on
every injury report with an in-depth investigation. Many of the
nonfatal injuries were based on emergency department-treated cases from
NEISS hospitals, and confidentiality requirements often prevent any
additional contact with patients. In addition, even with cases that are
followed, completion of the investigation is not guaranteed because of
a lack of consumer cooperation or the inability to establish contact
with the consumer.
Short of a controlled experimental setting, causal links are
difficult to establish from observational data based on un-witnessed
incidents. However, the combined judgment of subject matter experts at
CPSC, corroborated by investigating state/county/local officials,
supports the conclusions.
Comment: One set of commenters expressed the belief that the data
presented in the SNPR is skewed and purposely misleading. There were
specifics outlined in the comment, which are addressed in the response.
Response: The Commission disagrees strongly with the commenters'
assertion regarding the way the data are presented. For fatalities, the
commenters contend that almost all of the incidents were due to
caregiver negligence, even the ones that the Commission considered to
be product related.
The commenters first argued that the Commission needed to gather
more information on the fatalities deemed by the Commission to be
product related. CPSC staff gathered as much information as possible on
every cited product-related fatality through an in-depth, on-site field
investigation. Because these incidents were not witnessed, the
judgments of subject matter experts at CPSC and state/county/local
investigating officials were combined to arrive at the conclusions
about the manner of the deaths.
Second, the commenters asserted that of the three deaths that were
due to infants sliding out of the fabric-sided opening, two were of the
infants were older than the recommended-user age. Hence, the commenters
further asserted, these two deaths cannot be counted as product-related
because they were the result of caregiver negligence. The Commission
disagrees with this assertion because the third decedent, who died in
the same manner, was well within the recommended age limit. Therefore,
the age of the other two decedents, barely a month above the
recommended age limit, was deemed not to be a factor in the
entrapments.
Third, the commenters stated that the non-product-related deaths
appear to be due to caregiver negligence and do not justify CPSC's
increasing the economic burden on manufacturers through added
regulations. This argument has no basis because CPSC's regulation does
not make any changes to the current voluntary standard based on these
non-product-related fatalities.
For the nonfatal injuries, the commenters said they believe there
is no justification for placing a burden on manufacturers by including
one injury, due to a moldy mattress, in the report.
[[Page 63025]]
CPSC staff includes all in-scope incidents in its hazard sketch, even
if the Commission is not proposing any provisions to address the issue.
Therefore, the manner in which staff reports the incident data does not
impose any burden on manufacturers.
In addition, the commenters argued that six percent of the injuries
from bassinets that were damaged during delivery were instances of
blatant negligence on the part of the owners. First, to clarify, the
Commission reported that six percent of the incidents, not injuries,
involved bassinets damaged during delivery. Second, there were no
injuries associated with these incidents, and the Commission did not
propose any provisions to address the issue.
Comment: Some commenters said that the Commission needs to provide
justification for its statement that the descriptions in the noninjury
incident reports indicated the potential for serious injury. The
commenters stated that without any further explanation, the statement
seems ``arbitrary.''
Response: CPSC staff has reviewed a number of incidents in which
the caregiver was reported to be nearby and was able to rescue the
infant from danger. Similar scenarios, with the infant unattended, have
led to less favorable outcomes. Thus, the potential for serious
consequences is not conjecture, and the statement is justified.
Size and Weight Limits
Comment: Some commenters suggested that the weight of an infant
occupant should be considered in the standard's scope to safeguard
infants who exceed the recommended weight and size.
Response: The maximum weight of an occupant is already considered
in the static load requirements in ASTM F2194-13, which the rule
incorporates by reference. The industry requires a bassinet to be
loaded to three times the manufacturer's recommended weight. The side
heights are also intended to account for the largest infants who might
still use the bassinet.
Bassinet Misuse
Comment: One commenter expressed concern that the possibility of
consumer misuse of bassinets would negate any effects of the new
requirements.
Response: The Commission believes that strengthening the standard
is the best way to improve product safety and that if significant
product misuse becomes evident in injury reports, more developments are
possible.
Comment: Another commenter suggested that educational campaigns
about the proper and improper uses of bassinets would be sufficient.
Response: The Commission believes that educational campaigns play
an important role in injury prevention but are best preceded by
mechanical and physical safety requirements designed to make accidents
as unlikely as possible to occur.
Restraints
Comment: One commenter expressed the belief that the lack of
incidents with harnesses could be due to other factors, as much as to
the lack of harnesses in bassinets.
Response: Deaths and injuries in other infant products have been
attributed to restraints/harness that were not used or were used
improperly. Therefore the Commission is not making any changes
regarding the current prohibition of restraints in bassinets.
Warnings
Comment: Some commenters recommended the use of pictures or visual
aids to clarify the warning messages.
Response: The Commission acknowledges that well-designed graphics
can be useful in certain circumstances. However, the design of
effective graphics can be difficult. Some seemingly obvious graphics
are poorly understood and can give rise to interpretations that are
opposite the intended meaning (so called ``critical confusions'');
therefore, a warning pictogram should be developed with empirical study
and well tested on the target audience. Although the Commission may
take action in the future if it believes graphic symbols are needed to
reduce the risk of injury associated with these products, the rule
permits, but does not mandate, such supporting graphics.
With respect to the idea of creating a pictogram to communicate the
dangers of soft bedding, the Commission agrees that a well-developed
and tested pictogram could increase comprehension and acknowledges that
such elements could be developed with some empirical study; the
Commission, however, does not have the resources for such a project at
this time and could not validate a warning graphic without research.
However, there are a number of products for which such a soft bedding
pictogram could be useful, such as bedside sleepers, bassinets, cribs,
play yards, inclined sleep products, and others. Because of this, an
ASTM cross-product ad hoc working group may be the best place to
develop such a pictogram. This could foster cross-product harmonization
of such a pictogram and would allow testing and validation of the
pictogram. CPSC staff will gladly participate in any such group, and
should the need arise, staff will consider future action once such a
graphic is developed.
Comment: A commenter suggested adding statistics to the suffocation
warning.
Response: Crafting a warning requires balancing the brevity of the
message with its attention-grabbing features and informational content.
Too much information makes a long label that is likely to be ignored by
consumers. On the other hand, too little information leaves consumers
unsure of the message. CPSC staff's opinion is that the addition of
statistical information on the suffocation warning label will not
increase the effectiveness of the warning.
Comment: A commenter suggested that the warnings contain the
maximum recommended age of the bassinet occupant, i.e., five months.
Response: The current warning contains a developmental milestone,
rather than an age maximum. Developmental milestones have the advantage
of allowing for individual variability in use patterns. Some children
will gain strength and coordination faster than others and will need to
be removed from the bassinet sooner. Since children's abilities are
more important than their age when evaluating the applicability of the
warning, the age is not included in the warning.
Comment: A commenter suggested that the warnings should be
displayed in a prominent position.
Response: The ASTM standard, which the rule incorporates by
reference, already contains a common definition for ``conspicuous''
warnings in Section 3.3.3, with corresponding requirements in Sections
8.3, 8.4, and 8.5.
Comment: A commenter suggested strengthening the warning labels by
requiring mattress pads to have the following statement: ``This padding
has been tested to reduce the risk of suffocation to a minimal level,''
adding that ``additional padding increases this risk substantially and
has caused fatalities.''
Response: Although the standard does contain a requirement for the
mattress pad to remain level, the standard does not contain a test for
reducing the risk of suffocation created by the softness of the
padding, which seems to be the assumption made by the commenter. The
standard already contains a warning in Section 8.4.2, instructing
[[Page 63026]]
against the use of additional bedding materials. This required warning
must be visible to the consumer when the product is in the
manufacturer's recommended-use position. Thus, the warning will not be
covered by sheets, which are allowed, and will be more effective than
on the mattress pad where any messages will be covered.
Comment: Another commenter suggested that consumers need to be
warned of the hazards associated with segmented mattresses.
Response: Warnings are the last stage at which attempts are made to
remove a hazard from a product. Changing the product is more effective.
The standard contains performance requirements designed to eliminate
the hazards associated with segmented mattresses, so it is not
necessary to include a warning.
Comment: Several commenters suggested that warnings should have
larger fonts, duplication on opposing walls of the bassinet,
duplication on the packaging and on the product, more detailed hazard
descriptions, and more information in supporting educational materials
and product advertisements.
Response: Although CPSC staff agrees that any warning could be
strengthened with a size, color, or other graphical features, the
product's final appearance also needs to be considered because
exceptionally large or graphic warnings may cause consumers to remove
or deface the warnings, thereby rendering them ineffective for later
users. The current warning requirements match industry standards for
many juvenile products.
The Necessity for a Standard
Comment: Several commenters stated that the proposed standard for
bassinets and cradles should not be adopted because the number of
injuries and fatalities due to design defects was very low.
Response: The Consumer Product Safety Improvement Act (CPSIA)
requires the Commission to issue a mandatory standard for bassinets and
cradles, regardless of the number of incidents involving those
products. Given the the CPSIA directive, the options are either to
adopt the existing voluntary standard, as is, or revise the standard to
make improvements. Even if a majority of the incidents were not
directly attributable to defects in the product design, many incidents
were. Congress mandated that CPSC adopt a more stringent standard if
the Commission determined that a more stringent standard ``would
further reduce the risk of injury.'' The Commission feels strongly that
the final rule would do so.
Mattress Thickness (Rigid Products and Falls)
Comment: Some commenters expressed concern that the standard allows
for rigid-sided bassinets with thicker mattresses than soft-sided
bassinets. These commenters said they feel that thicker mattresses may
pose more of a risk of babies falling out when a baby rolls to one side
and the product tilts.
Response: There are two requirements in the existing ASTM standard,
which the rule incorporates by reference, which would prevent the
scenario described by the commenters. The first is the side height
requirement, which states that the side height of the bassinet be 7.5''
above the uncompressed surface of the mattress. Thus, if a bassinet
maker supplies a thick mattress with the rigid-sided bassinet, the side
heights must account for the thicker mattress and still yield 7.5'' of
side height above the mattress surface. In addition, the standard has a
rock/swing angle requirement that limits the maximum angle a rocking
bassinet can have, as well as a maximum rest angle it can have. The
rest angle is measured using a CAMI doll placed up against the side of
the bassinet. Thus, the standard uses a worst-case placement scenario
for the occupant during the testing.
Health Canada Standard
Comment: A representative of Health Canada corrected a statement in
the SNPR and the corresponding staff briefing package, which states:
``The Canadian standard (SOR 86-962:2010) includes requirements for
cribs and non-full-size cribs. This standard does not distinguish
between a bassinet and non-full-size cribs.'' The commenter noted that
this overview statement was incorrect because on November 18, 2010, the
amended Cribs, Cradles, and Bassinets Regulations (SOR/2010-261) came
into effect, and now bassinets are included in the scope.
Response: The Commission thanks Health Canada staff for the
correction and the subsequent information regarding how SOR 2010/261
distinguishes bassinets, cradles, and cribs. As the Commission now
understands, Health Canada defines these three products according to
the sleep surface area contained in the product.
Play Yard Misassembly Requirement in Docket CPSC-2011-0064
Comment: The commenter repeated comments submitted for Docket CPSC-
2011-0064, regarding the play yard misassembly requirement that was
proposed in August 2012.
Response: The Commission has addressed these comments in the final
rule briefing package for Play Yard Misassembly Requirement, dated June
26, 2013.
International Standards
Comment: Commenters remarked that more information regarding the
international standards that were mentioned in the SNPR would be
helpful.
Response: The Commission provided the names and designations of the
standards, plus a description of where they differed substantially from
the ASTM standard. Due to copyright laws, the Commission was not able
to provide full copies of the standards. All of the standards are
available for purchase online by anyone who seeks more information.
ASTM Copyright and Accessibility
Comment: Some commenters stated that the ASTM standard for
bassinets and cradles should not be the basis of a mandatory rule
because, as a copyrighted standard, the ASTM standard is not easily
accessible to the public and creates an undue financial burden on small
manufacturers and the general public.
Response: Section 104(b) of the CPSIA requires the Commission to
issue standards for durable infant or toddler products that are
substantially the same as applicable voluntary standards or are more
stringent if more stringent standards would further reduce the risk of
injury. Incorporating a voluntary standard, such as incorporating the
ASTM standard by reference, is a well-recognized procedure for
agencies. The incorporation satisfies the requirement of publication in
the Federal Register. See 5 U.S.C. 552(a)(1)(E) (``matter reasonably
available to the class of persons affected thereby is deemed published
in the Federal Register when incorporated by reference therein with the
approval of the Director of the Federal Register'').
Falls From Bassinets/Side Height
Comment: Some commenters suggested that the side height
requirements need to be higher because consumers seem to be using
bassinets with children older than the recommended ages. One commenter
expressed the belief that the standard should match the Canadian side
height requirement.
Response: The ASTM subcommittee discussed the side heights of
bassinets
[[Page 63027]]
for years. There was no side height requirement until recently.
Consumers use the products longer than manufacturers recommend. High
side heights could cause consumers to use their bassinets even longer
than they have been using them because the older, larger children who
can push up on their hands and sit unassisted will look safer in a
bassinet with tall sides. The unintended consequence of taller sides
might be an increase in falls from bassinets because older children are
stronger and more agile than newborns. After much discussion, the ASTM
subcommittee agreed to a 7.5-inch side height, based on the precedent
set by the Canadians, who measure from the bottom of the bassinet
rather than the mattress top. This difference in measurement landmarks
makes it appear that the ASTM standard permits shorter sides; but in
reality, the effective side height of a bassinet in Canada is the same
as in the ASTM standard. This side height requirement did not
necessitate drastic changes in the bassinet designs on the market; so
it would be unlikely that instituting the requirement would have any
effect on consumer behavior.
Comment: Several commenters suggested that side height requirements
might not be effective against misuse. One commenter expressed the
belief that the burden should be placed on caregivers and that the
standard needs no modification to address falls. Another suggested that
warning labels should be strengthened instead.
Response: The side height requirement (7.5-inch minimum) is already
part of ASTM F2194-13, which this rule incorporates by reference. The
rule does not add anything further because the Commission believes that
the requirements should be effective against misuse. The Commission
believes that, at a minimum, this requirement will help protect infants
who have not exceeded the maximum age requirement for bassinet use.
Additionally, the Commission supports the current warnings in the ASTM
standard.
Existing Inventory
Comment: One commenter expressed concern that the Commission did
not address the existing cradle and bassinet inventory that would need
``to be discarded or recalled'' when the regulation becomes effective.
Response: The bassinet and cradle standard is prospective. It will
apply to products manufactured or imported on or after the effective
date. Therefore, existing inventory would not be affected.
Cost Benefit Analysis
Comment: Several commenters expressed the belief that a cost-
benefit analysis should be performed, and they stated that the proposed
rule should not be adopted because costs are likely to exceed benefits.
Response: Section 104(b) of the Consumer Product Safety Improvement
Act (CPSIA), part of the Danny Keysar Child Product Safety Notification
Act, requires the CPSC to issue a standard at least as stringent as the
voluntary standard, or more stringent if the Commission determines that
a more stringent standard would further reduce the risk of injury
associated with such products. Thus, the Commission must issue a
mandatory standard for bassinets and cradles, regardless of the costs
and benefits of the rule.
Third Party Testing Cost
Comment: Two commenters expressed concern about the ``substantial
additional costs'' that will result from a new requirement for third
party testing that will be added by the bassinet/cradle standard.
Response: The testing costs referred to by the commenters result
from the third party testing and certification requirements imposed
under sections 14(a)(2) and 14(d)(2) of the Consumer Product Safety Act
(CPSA), as amended by the CPSIA. The costs associated with testing will
be substantially the same, regardless of the form the final bassinet/
cradle standard takes.
Definition of a Small Business
Comment: One commenter questioned defining ``small manufacturers''
as those with fewer than 500 employees. The commenter noted that
business size can vary widely within such a broadly defined group. The
commenter expressed concern that the economic impact could be
disproportionately significant for the very smallest firms.
Response: The U.S. Small Business Administration (SBA) is the
source of the definition of ``small manufacturers'' of bassinets and
cradles. Regardless of the desirability of a finer gradation in
defining small businesses, the SBA definition governs the small
business determination in the context of a regulatory flexibility
analysis.
Impact of Expanding the Scope
Comment: One commenter expressed concern about the ``adverse
monetary impact'' that expanding the scope of the standard to include
Moses baskets would have upon some suppliers. The commenter felt that
the alternative of ceasing to supply stands for these newly covered
products requires further inquiry before ``suggesting that this is a
viable alternative.'' Other commenters questioned methods firms might
use to mitigate their ``upfront costs,'' including amortizing,
``increased product sales,'' and passing ``the additional costs on to
consumers.''
Response: When used with a stand, Moses baskets meet the definition
of a ``bassinet'' (or ``cradle,'' in the case of a rocking stand), and
therefore, they must be tested as a bassinet. Given that most suppliers
of Moses baskets do not include stands, supplying Moses baskets without
stands is one viable option that firms are already practicing.
Similarly, the statement that ``direct impact may be mitigated if
costs are treated as new product expenses that can be amortized''
recognizes one of the methods firms use routinely in the development of
new products to reduce the immediate financial impact; rather than
incurring all of the development costs up front, amortizing allows the
firm to spread the impact over time. Finally, for most products, firms
are usually able to pass on some, but not all, increases in production
costs to consumer. The portion of costs that are passed on (i.e. not
absorbed by the firm) partially offset or mitigate the impact of the
rule.
Aiding Small Businesses
Comment: One commenter suggested that the Commission ``create a
framework with which to aid some of the smaller manufacturers and
distributors with finding the resources, information and connections
they need to comply with the new standards.''
Response: CPSC's Small Business Ombudsman provides small businesses
with guidance to assist them in complying with CPSC requirements.
Assistance is available to firms in understanding and complying with
CPSC regulations (https://www.cpsc.gov/en/Business--Manufacturing/Small-
Business-Resources/).
Small Bedding Suppliers
Comment: One commenter asked that the Commission put ``less
weight'' on small bedding suppliers in the regulatory flexibility
analysis. The commenter expressed concern that: ``[N]oncompliant
bedding could potentially negate the efficiency of . . .'' safety
measures such as strangulation warnings ``. . . or require
manufacturers to take additional steps to correct noncompliant
bedding.''
Response: The standard does not include any bedding requirements.
However, in investigating the bassinet/cradle market, staff could not
determine the underlying source of bassinets for
[[Page 63028]]
several suppliers of bassinets. The firms for whom the bassinet source
could not be identified shared one major characteristic: They were
primarily bedding suppliers who sold bassinets or cradles with the
appropriate bedding covering the bassinet/cradle frame. Because these
firms supply bassinets/cradles, they are affected by the rule and
impacts must be fully considered under the Regulatory Flexibility Act.
Labeling Costs
Comment: One commenter objected to the costs that will be
associated with changing the warning labels.
Response: The commenter misunderstood the information presented in
the Paperwork Reduction Act section of the SNPR. The commenter
interpreted the cost per burden hour associated with labeling ($27.55)
to be the increased cost per unit, which is an incorrect conclusion.
VII. Assessment of Voluntary Standard ASTM F2194-13 and Description of
Final Rule
Consistent with section 104(b) of the CPSIA, this rule establishes
new 16 CFR part 1218, ``Safety Standard for Bassinets and Cradles.''
The new part incorporates by reference the requirements for bassinets
and cradles in ASTM F2194-13, with certain additions and changes to
strengthen the ASTM standard, to further reduce the risk of injury. The
following discussion describes the final rule, the changes, and the
additions to the ASTM requirements. (The description of the amendment
to 16 CFR part 1112 may be found in Section XIII of this preamble.)
A. Scope (Sec. 1218.1)
The final rule states that part 1218 establishes a consumer product
safety standard for bassinets and cradles manufactured or imported on
or after the date that is six months after the date of publication of a
final rule in the Federal Register, except that the effective date for
the removable bassinet bed requirements would be 18 months after the
date of publication of a final rule in the Federal Register.
B. Incorporation by Reference (Sec. 1218.2)
Section 1218.2(a) explains that, except as provided in Sec.
1218.2(b), each bassinet and cradle must comply with all applicable
provisions of ASTM F2194-13, ``Standard Consumer Safety Specification
for Bassinets and Cradles,'' which is incorporated by reference.
Section 1218.2(a) also provides information on how to obtain a copy of
the ASTM standard or to inspect a copy of the standard at the CPSC. The
Commission received no comments on this provision in the SNPR, but the
Commission is changing the language in the incorporation in the final
rule to refer to ASTM F2194-13, the current version of the ASTM
standard.
C. Changes to Requirements of ASTM F2194-13
1. Clarification of Scope. (Sec. 1218.2(b)(1)(i)). The final rule
modifies the scope of ASTM F2194-13 to clarify that multimode
combination products must meet the bassinet/cradle standard in any
configuration where the seat incline is 10 degrees or less from
horizontal. This modification resulted from comments on the SNPR
seeking clarification on what products are included in the scope, as
more fully discussed in Section VI.
2. Change to Stability Test Procedure. (Sec. 1218.2(b)(2) and
Sec. 1218.2(b)(6)). In the SNPR, the Commission proposed that
bassinet/cradle stability testing be conducted with a CAMI newborn
dummy, rather than the CAMI infant dummy. Because ASTM has yet to adopt
this modification (although it is expected to be balloted in the near
future), the Commission is including it in the final rule.
It is appropriate that the smaller newborn CAMI dummy be used for
stability testing, because bassinets and cradles are intended to be
used by very young children. The heavier (17.5-pound) infant CAMI
currently specified for stability testing in ASTM F2194-13 could make
these products more stable when tested than they would actually be in a
real-world situation.
3. Removable Bassinet Bed. (Sec. 1218.(b)(3), (5), and (7)). In
the SNPR, the Commission proposed adding a requirement for removable
bassinet beds (along with test procedures and new definitions). As
stated in the preamble of the SNPR (77 FR 64061), there have been
several incidents involving bassinet beds that were designed to be
removed from their stand, four of which have In-Depth Investigations.
During the incidents, the bed portion of the unit was not locked
completely or attached properly to its stand. The bed portion of the
unit appeared to be stable, giving the caregivers a false sense of
security. For various reasons, the bed portion fell or tilted off of
its stand. There have also been nonfatal incidents involving bassinet
beds that tipped over or fell off their base/stand when they were not
properly locked/latched to their base/stand, or the latch failed to
engage as intended. In May 2012, 46,000 bassinets that could appear to
latch to the stand when they actually had not latched were recalled.
(https://www.cpsc.gov/cpscpub/prerel/prhtml12/12173.html).
The SNPR proposed multiple options for a bassinet with a removable
bed attachment to pass the proposed requirement. These options include:
(1) Ensuring that the bed portion of the bassinet is inherently stable
when the bassinet bed is placed on the stand unlatched; (2) use of a
false lock/latch visual indicator mechanism; (3) use of a stand that
collapses if the bassinet bed is not properly attached; and (4) the
presence of an obvious unsafe angle (more than 20 degrees) or a
bassinet bed falls to the floor when it is not properly attached to the
stand.
Since the issuance of the SNPR, ASTM has made several clarifying
changes to the removable bassinet bed requirement, definitions, and
test procedures, and ASTM is expected to send these changes out for
ballot in the near future. Most of the differences are editorial
changes to provide clarity to the test requirement and the test
procedure. The significant, noneditorial differences between the
requirement proposed in the SNPR and what ASTM is expected to ballot
are as follows:
The next ASTM ballot is expected to exclude play yard
bassinets, as defined in the standard, from the removable bassinet bed
definition. Thus, play yard bassinets would not be subject to the
removable bassinet bed stability requirement.
The next ASTM ballot is expected to expand on one of the
pass criteria for the removable bed stability requirement, to allow
bassinet stands that cannot remain in their proper use position unless
the bassinet bed is properly attached.
The Commission agrees with these revisions and is adding the
revised removable bassinet bed requirement as part of the final
bassinet/cradle rule.
4. Mattress Flatness. (Sec. 1218.2(b)(4)(i)). A segmented mattress
flatness requirement and associated test procedures were proposed by
the Commission as part of the SNPR. ASTM adopted the requirement with
modified, less stringent pass/fail criteria. The final rule modifies
the pass/fail criteria in ASTM F2194-13 to mirror the SNPR proposal.
As stated in Section V, the mattress flatness requirement is
primarily aimed at incidents involving bassinet/play yard combination
products that tend to use segmented mattresses, where seams could pose
a suffocation and positional asphyxiation hazard. Under the
Commission's pass/fail criteria, a bassinet attachment with a segmented
mattress will fail if any tested seam creates an angle greater than 10
degrees.
[[Page 63029]]
ASTM F2194-13 allows measured angles between 10 degrees and 14 degrees
to pass, as long as the mean of three measurements on that seam is less
than 10 degrees. As discussed in the preamble to the SNPR, the 14-
degree angle was based on an extrapolation of angles formed by
dimensions of average infant faces. 77 FR 64060-64061. The Commission
is uncomfortable using the average infant facial dimension as the basis
for this requirement. Therefore, instead of using the average infant
anthropometrics as a basis for the pass/fail criteria, the Commission
continues to support using the smallest users' anthropometrics to set
the test requirement of 10 degrees maximum for each measurement taken.
5. Exemption from Mattress Flatness Requirement. (Sec.
1218.2(b)(4)(i)). The final rule exempts from the mattress flatness
requirement bassinets that are less than 15 inches across. These
products do not pose the hazard the requirement is intended to address,
and they are also not wide enough to test using the required procedures
and equipment.
VIII. Effective Date
The Administrative Procedure Act (APA) generally requires that the
effective date of a rule be at least 30 days after publication of the
final rule. 5 U.S.C. 553(d). The Commission is setting an effective
date for the standard six months after publication for products
manufactured or imported on or after that date, with the exception of
the removable bassinet bed test requirement and procedure.
The Commission recognizes that some manufacturers will be required
to redesign, test new prototype products, and then retool their
production process in order to meet the new removable bassinet bed
provision. Based on a comment from a manufacturer who asked for a
minimum of 15.5 months to redesign its product, the Commission
considers 18 months to be a reasonable time period to take into account
other manufacturers who might also need to redesign their product.
Therefore, the Commission is setting an 18-month effective date for the
removable bassinet bed test requirement.
IX. Regulatory Flexibility Act
A. Introduction
The Regulatory Flexibility Act (RFA) requires that agencies review
rules for their potential economic impact on small entities, including
small businesses. 5 U.S.C. 604. Section 604 of the RFA requires that
agencies prepare a final regulatory flexibility analysis when they
promulgate a final rule, unless the head of the agency certifies that
the rule will not have a significant economic impact on a substantial
number of small entities. The final regulatory flexibility analysis
must describe the impact of the rule on small entities and identify any
alternatives that may reduce the impact. Specifically, the final
regulatory flexibility analysis must contain:
A succinct statement of the objectives of, and legal basis
for, the rule;
a summary of the significant issues raised by public
comments in response to the initial regulatory flexibility analysis, a
summary of the assessment of the agency of such issues, and a statement
of any changes made in the proposed rule as a result of such comments;
a description of, and, where feasible, an estimate of, the
number of small entities to which the rule will apply;
a description of the projected reporting, recordkeeping,
and other compliance requirements of the rule, including an estimate of
the classes of small entities subject to the requirements and the type
of professional skills necessary for the preparation of reports or
records; and
a description of the steps the agency has taken to reduce
the significant economic impact on small entities, consistent with the
stated objectives of applicable statutes, including a statement of the
factual, policy, and legal reasons for selecting the alternative
adopted in the rule, and why each one of the other significant
alternatives to the rule considered by the agency, which affect the
impact on small entities, was rejected.
B. The Market for Bassinets/Cradles
Bassinets and cradles are typically produced and/or marketed by
juvenile product manufacturers and distributors, or by furniture
manufacturers and distributors, some of which have separate divisions
for juvenile products. CPSC staff believes that there are currently at
least 62 suppliers of bassinets and/or cradles to the U.S. market; 26
are domestic manufacturers; 19 are domestic importers; three are
domestic retailers; and two are domestic firms with unknown supply
sources. Twelve foreign firms currently supply the U.S. market: 10
manufacturers, one firm with an unknown supply source, and one importer
that imports from foreign companies and distributes from outside of the
United States. Eight additional firms specialize in children's bedding,
some of which is sold with bassinets or cradles; the supply sources for
these eight firms could not be identified.
Bassinets and cradles from 11 of the 62 firms have been certified
as compliant by the Juvenile Products Manufacturers Association (JPMA),
the major U.S. trade association that represents juvenile product
manufacturers and importers. Firms supplying bassinets or cradles would
be certified to the ASTM voluntary standard F2194-12a, while firms
supplying play yards with bassinet/cradle attachments would also have
to meet F406-12a. (JPMA typically allows six months for products in
their certification program to shift to a new standard once it is
published. ASTM F2194-12a was published in September 2012, and
therefore, the standard would have become effective in March 2013. The
more recent standard, ASTM F2194-12b, was published in December 2012,
and therefore, that standard was not yet effective when research for
this rule was conducted.) Twenty-four additional firms claim compliance
with the relevant ASTM standard for at least some of their bassinets
and cradles. Whether the bassinets or cradles supplied by the eight
bedding suppliers comply with ASTM F2194 is not known.
According to a 2005 survey conducted by the American Baby Group
(2006 Baby Products Tracking Study), 64 percent of new mothers own
bassinets; 18 percent own cradles; and 39 percent own play yards with
bassinet attachments. Approximately 50 percent of bassinets, 56 percent
of cradles, and 18 percent of play yards were handed down or purchased
secondhand. Thus, approximately 50 percent of bassinets, 44 percent of
cradles, and 82 percent of play yards were acquired new. These
statistics suggest annual sales of a total of approximately three
million units sold per year, consisting of about 1.3 million bassinets
(.5 x .64 x 4 million births per year), 317,000 cradles (.44 x .18 x 4
million), and 1.3 million play yards with bassinet attachments (.82 x
.39 x 4 million). (U.S. Department of Health and Human Services,
Centers for Disease Control and Prevention (CDC), National Center for
Health Statistics, National Vital Statistics System, ``Births: Final
Data for 2010,'' National Vital Statistics Reports Volume 61, Number 1
(August 28, 2012): Table I. Number of births in 2010 is rounded from
3,999,386.)
National injury estimates were not reported by the Directorate for
Epidemiology in the supplemental NPR or in the current FR briefing
package because the data failed to meet NEISS
[[Page 63030]]
publication criteria. However, emergency department injury estimates
over the approximately five years covered by the supplemental NPR and
the current FR briefing package, from 2008 through 2012, averaged less
than 250 annually. Based on data from the 2006 Baby Products Tracking
Study, approximately 4.8 million bassinets and cradles were owned by
new mothers. Therefore, the injury rate may be on the order of about
0.5 emergency department-treated injuries per 10,000 bassinets/cradles
available for use in the households of new mothers ((250 injuries /
4.84 million products in households of new mothers) x 10,000).
C. Reason for Agency Action and Legal Basis for the Rule
The Danny Keysar Child Product Safety Notification Act requires the
CPSC to promulgate a mandatory standard for bassinets/cradles that is
substantially the same as, or more stringent than, the voluntary
standard. The Commission is adopting ASTM F2194-13 with five
modifications or additions that reflect: (1) Changes proposed in the
SNPR that are not part of F2194-13; (2) responses to public comments;
and/or (3) additional work undertaken by ASTM, but not yet adopted. The
changes will address a variety of known hazard patterns, including
suffocation and positional asphyxia.
D. Requirements of the Final Rule
As stated in Section VII, the Commission is incorporating the
voluntary standard for bassinets/cradles, ASTM F2194-13, by reference,
with five changes.
The Commission is implementing two modifications to ASTM F2194-13
in response to SNPR comments; neither is expected to have a negative
impact on firms. The first is a modification to the scope that would
clarify that multimode or combination products must meet the bassinet/
cradle standard in any configuration where the seat incline is 10
degrees or less from horizontal. Because the clarifying modifications
do not change the scope of the standard, the modifications have no
additional impact. The second is an exemption from the mattress
flatness requirement for bassinets that are less than 15 inches across.
Because of the characteristics of the narrower bassinets, these
products are not subject to the hazard that the requirement is intended
to address. Additionally, these narrower bassinets are not wide enough
to test using the required procedures and equipment.
The Commission is implementing three additional changes to ASTM
F2194-13, each of
1. Stability Testing
As stated in Section V of this preamble, in the SNPR, the
Commission proposed that bassinet/cradle stability testing be conducted
with a CAMI newborn dummy, rather than the CAMI infant dummy. Because
ASTM has yet to adopt this modification (although the modification is
expected to be balloted in the near future), the Commission is
including the modification in the final rule. Based on limited testing,
many bassinets/cradles appear to be able to pass this modified test
procedure without modification. However, a few products may potentially
require modifications to meet the revised stability test procedure.
Staff believes that the modified test procedure is likely to affect
only a few manufacturers, and likely will not require product redesign.
Affected firms would most likely increase the stability of their
product by widening the structure, making the bassinet bed deeper, or
making the base heavier. The cost of meeting the modified requirement
could be more significant if a change to the hard tools used to
manufacture the bassinet is necessary. During the production process, a
hard tool, which is a mold of the desired bassinet component shape, is
injected with plastic or another material using a molding machine.
2. Mattress Flatness
A segmented mattress flatness requirement and associated test
procedures were proposed by the Commission as part of the SNPR. ASTM
adopted the requirement with modified (and less stringent) pass/fail
criteria. The Commission is modifying the pass/fail criteria in ASTM
F2194-13 to mirror the SNPR proposal.
The mattress flatness requirement is primarily aimed at incidents
involving bassinet/play yard combination products that tend to use
segmented mattresses, where seams could pose a suffocation and
positional asphyxiation hazard. Under the Commission's pass/fail
criteria, a bassinet attachment with a segmented mattress will fail if
any tested seam creates an angle greater than 10 degrees. ASTM F2194-13
allows measured angles between 10 degrees and 14 degrees to pass, as
long as the mean of three measurements on that seam is less than 10
degrees.
Based on staff's testing, the play yard bassinet attachments of
many suppliers (both compliant and non-compliant) appear to pass the
requirement without any modifications. Bassinet attachments that would
require some modification would need to increase the mattress support
in their bassinets. Additional mattress support could be accomplished,
for example, by retrofitting play yard bassinets to use longer rods or
a better-fitting mattress shell. The cost of such a retrofit is unknown
and would likely vary from product to product; however, a retrofit
generally is less expensive than a product redesign.
3. Removable Bassinet Bed
As stated in Section V of this preamble, in the SNPR, the
Commission proposed adding a requirement for removable bassinet beds
(along with test procedures and new definitions). Since then, an ASTM
task group has made several clarifying changes to the requirement,
definitions, and test procedures and is expected to recommend them for
ballot. The Commission is adopting the revised removable bassinet bed
requirement as part of the final bassinet/cradle rule.
There are several firms supplying bassinets with removable bassinet
beds to the U.S. market. The majority will require no modifications to
meet the requirement. However, at least three firms are expected to
need changes to one or more of their bassinets. Firms could meet the
removable bassinet requirement in a number of ways, including
redesigning the product entirely. However, many firms are likely to opt
for less expensive alternatives, such as more sensitive locks that
activate with little pressure (i.e., with just the weight of the
bassinet), where possible.
The costs and time involved in a redesign could be significant; one
manufacturer stated in SNPR comments that the manufacturer would
require 15.5 months to redesign its product to meet the removable
bassinet bed requirement. Therefore, the Commission is setting an 18-
month effective date for this requirement, while maintaining a six-
month effective date for the remainder of the final rule.
E. Other Federal or State Rules
A final rule implementing sections 14(a)(2) and 14(i)(2) of the
Consumer Product Safety Act (CPSA), as amended by the CPSIA, Testing
and Labeling Pertaining to Product Certification, 16 CFR part 1107,
became effective on February 13, 2013 (the 1107 rule). Section 14(a)(2)
of the CPSA requires every manufacturer of a children's product that is
subject to a product safety rule to certify, based on third party
testing, that the product complies
[[Page 63031]]
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 bassinets and cradles will be subject to a mandatory
children's product safety rule, these products also will be subject to
the third party testing requirements of section 14(a)(2) of the CPSA
and the 1107 rule when the bassinet/cradle mandatory standard and the
notice of requirements become effective.
F. Impact on Small Businesses
At least 62 firms are currently known to be marketing bassinets
and/or cradles in the United States. Under U.S. Small Business
Administration (SBA) guidelines, a manufacturer of bassinets/cradles is
small if the business has 500 or fewer employees; importers and
wholesalers are considered small if they have 100 or fewer employees.
Based on these guidelines, about 39 of the 62 total firms are small
firms--21 domestic manufacturers, 16 domestic importers, and two firms
with unknown supply sources. An additional eight small firms supplying
bassinets/cradles along with their bedding; these may or may not
originate from one of the 62 firms already accounted for. Other unknown
small bassinet/cradle suppliers also may operate in the U.S. market.
Small Manufacturers
The expected impact of the final standard on small manufacturers
will differ based on whether their bassinets/cradles are already
compliant with F2194-12a. (Play yards with bassinet attachments must
comply with the effective play yard standard (F406), which includes a
requirement that the attachment meet the bassinet/cradle standard.) In
general, firms whose bassinets and cradles meet the requirements of
F2194-12a are likely to continue to comply with the voluntary standard
as new versions are published. Many of these firms are active in the
ASTM standard development process, and compliance with the voluntary
standard is part of an established business practice. Firms supplying
bassinets and cradles that comply with ASTM F2194-12a are likely also
to comply with F2194-13 before the final bassinet/cradle rule becomes
effective.
The majority of the changes to the voluntary standard (ASTM F2194-
13) are the same as at the SNPR level; only the expanded scope proposed
in the SNPR has been completely incorporated into the voluntary
standard. Therefore, the expected impact of the final rule remains
substantially the same as the impact presented in the initial
regulatory flexibility analysis for the SNPR.
For manufacturers whose products are likely to meet the
requirements of ASTM F2194-13 (14 of 21 firms), the direct impact could
be significant for one or more firms if they must redesign their
bassinets to meet the final rule. Although the products of all firms
would be subject to the stability testing requirements, in most cases,
modifications are unlikely to be required and the costs are not
expected to be significant. The products of five firms could be
affected by the mattress flatness requirement (i.e., they produce play
yards with bassinet attachments), and at least three (and possibly
five) of the known firms may be affected by the removable bassinet bed
requirement. For the most part, the bassinets/cradles and bassinet
cradle attachments supplied by these firms will be able to meet the
changes to ASTM F2194-13 without modification. In cases where
modifications are necessary, firms would most likely opt to retrofit
their products, rather than undertake an expensive redesign. However,
some products may require redesign, particularly to meet the new
removable bassinet bed requirement, and therefore, costs could be
significant in some cases. The Commission is adopting an 18-month
effective date for the removable bassinet bed portion of the final rule
to reduce the impact on affected firms.
Meeting ASTM F2194-13's requirements could necessitate product
redesign for at least some bassinets/cradles not believed to be
compliant with F2194-12a (7 of 21 firms). These firms could require
redesign regardless of the modifications. A redesign would be minor if
most of the changes involve adding straps and fasteners or using
different mesh or fabric, but could be more significant if changes to
the frame are required, including changes to side height. One
manufacturer estimated that a complete play yard redesign, including
engineering time, prototype development, tooling, and other incidental
costs, would cost approximately $500,000. The Commission believes that
a bassinet redesign would tend to be comparable. Consequently, the
final rule could potentially have a significant direct impact on small
manufacturers whose products do not conform to F2194-12a. Any direct
financial impact may be mitigated if a firm chooses to treat costs as
new product expenses that can be amortized over time rather than a
large, one time expense.
Some firms whose bassinets/cradles are neither certified as
compliant, nor claim compliance with F2194-12a, in fact, may be
compliant with the standard. The Commission has identified many such
cases with other products. To the extent that some of these firms may
supply compliant bassinets/cradles and have developed a pattern of
compliance with the voluntary standard, the direct impact of the final
rule will be less significant than described above. If two small firms
with unknown supply sources, none of whose products appear to comply
with F2194-12a, are manufacturers, these firms also may need to
redesign their products to meet the final rule.
In addition to the direct impact of the final rule described above,
the rule will have some indirect impacts. Once the new requirements
become effective, all manufacturers will be subject to the additional
costs associated with the third party testing and certification
requirements under the testing rule, Testing and Labeling Pertaining to
Product Certification (16 CFR part 1107). Third party testing will
pertain to any physical and mechanical test requirements specified in
the bassinet/cradle final rule; lead and phthalates testing is already
required. Impacts of third party testing are not due directly to the
bassinet/cradle rule's requirements, but are due to the testing rule's
requirements. Consequently, impacts from the testing rule are indirect
impacts from the bassinet/cradle final rule, and such indirect impacts
could be significant.
One manufacturer estimated that testing to the ASTM voluntary
standard runs around $1,000 per model sample, although the manufacturer
noted that the costs could be lower for some models where the primary
difference is fabric rather than structure.
On average, each small domestic play yard manufacturer supplies
seven different models of bassinets/cradles and play yards with
bassinet/cradle accessories to the U.S. market annually. Therefore, if
third party testing were conducted every year on a single sample for
each model, third party testing costs for each manufacturer would be
about $7,000 annually. Based on a review of firm revenues, the impact
of third party testing to ASTM F2194-13 is unlikely to
[[Page 63032]]
be significant if only one bassinet/cradle sample per model is
required. However, if more than one sample would be needed to meet the
testing requirements, third party testing costs could have a
significant impact on a few of the small manufacturers.
Small Importers
As with manufacturers of compliant bassinets/cradles, the seven
small importers of bassinets/cradles currently in compliance with
F2194-12a could experience significant direct impacts as a result of
the final rule if product redesign is necessary. In the absence of
regulation, these importing firms would likely continue to comply with
the voluntary standard as it evolves, as well as the final mandatory
standard. Any increase in production costs experienced by their
suppliers may be passed on to the importers.
Importers of bassinets/cradles would need to find an alternate
source if their existing supplier does not come into compliance with
the requirements of the final rule, which may be the case with the nine
importers of bassinets/cradles not believed to be in compliance with
F2194-12a. Some could respond to the rule by discontinuing the import
of their noncomplying bassinets/cradles, possibly discontinuing the
product line altogether. The impact of such a decision could be
mitigated by replacing the noncompliant bassinet/cradle with a
compliant bassinets/cradle, or by deciding to import an alternative
product.
As is the case with manufacturers, all importers will be subject to
third party testing and certification requirements, and consequently,
will experience costs similar to those for manufacturers if their
supplying foreign firm(s) does not perform third party testing. The
resulting costs could have a significant impact on a few small
importers that must perform the testing themselves if more than one
sample per model were required.
Other Possible Suppliers
Eight known small firms specialize in the supply of bedding,
including bedding for bassinets and cradles, and the eight firms sell
bassinet and cradle bedding with a bassinet or cradle. Although these
firms do not manufacture the bassinets or cradles themselves, whether
they purchase the bassinets or cradles domestically or from overseas is
not known. These firms may source the bassinets and cradles sold with
bedding in full or in part from one of the 62 firms discussed above. If
the eight firms do not source from one of the 62 firms, then the eight
firms represent additional suppliers to the U.S. market.
The eight firms with unknown supply sources would be affected in a
manner similar to importers; they would need to find an alternate
source if their existing supplier does not come into compliance with
the requirements of the final rule. Unlike most importers, however, the
firms would not have the option of replacing a noncompliant bassinet/
cradle with another product. Although the firms could opt to sell the
bedding without the associated bassinet/cradle, such an approach would
represent a change from their historical method of sale and might
adversely impact their business strategy.
As with manufacturers and importers, these eight firms will also be
subject to third party testing and certification requirements, and will
experience costs similar to those for manufacturers if their supplying
firm(s) does not perform third party testing. The resulting costs could
have a significant impact on some of these small bassinet or cradle
suppliers that must perform the testing themselves.
G. Alternatives
Under the Danny Keysar Child Product Safety Notification Act of the
CPSIA, one alternative that would reduce the impact on small entities
is to make the voluntary standard mandatory with no modifications.
Doing so would reduce the potential impact on firms whose bassinets/
cradles comply with the voluntary standard. However, because of the
severity of the incidents associated with removable bassinet beds,
instability, and mattress tilt, the Commission is not pursuing this
alternative.
The Commission is imposing a six-month effective date for the final
rule with an 18-month effective date, supported by SNPR comments
submitted by one manufacturer, for the removable bassinet bed
requirement. Setting a later effective date for either part will allow
suppliers additional time to modify and/or develop compliant bassinets/
cradles and spread the associated costs over a longer period of time.
X. Environmental Considerations
The Commission's regulations address whether the Commission is
required to prepare an environmental assessment or an environmental
impact statement. These regulations recognize that certain CPSC actions
normally have ``little or no potential for affecting the human
environment.'' One such action is establishing rules or safety
standards for products. 16 CFR 1021.5(c)(1). This rule falls within the
categorical exclusion.
XI. Paperwork Reduction Act
This rule contains information collection requirements that are
subject to public comment and review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3521). The preamble to the proposed rule (77 FR at 64055 through 64076)
discussed the information collection burden of the proposed rule and
specifically requested comments on the accuracy of our estimates.
Briefly, sections 8 and 9 of ASTM F2194-13 contain requirements for
marking, labeling, and instructional literature. These requirements
fall within the definition of ``collection of information,'' as defined
in 44 U.S.C. 3502(3).
OMB has assigned control number 3041-0157 to this information
collection. The Commission did not receive any comments regarding the
information collection burden of this proposal. However, the final rule
makes modifications regarding the information collection burden because
the number of estimated suppliers subject to the information collection
burden is now estimated to be 62 firms, rather than the 55 firms
initially estimated in the proposed rule.
Accordingly, the estimated burden of this collection of information
is modified as follows:
Table 1--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Frequency of Total annual Hours per Total burden
16 CFR Section respondents responses responses response hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
1218............................................................... 62 5 310 1 310
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 63033]]
There are 62 known entities supplying bassinets to the U.S. market.
All 62 firms are assumed to use labels already on both their products
and their packaging, but they might need to make some modifications to
their existing labels. The estimated time required to make these
modifications is about one hour per model. Each entity supplies an
average of five different models of bassinets; therefore, the estimated
burden associated with labels is 1 hour per model x 55 entities x 5
models per entity = 310 hours. We estimate that the hourly compensation
for the time required to create and update labels is $27.55 (U.S.
Bureau of Labor Statistics, ``Employer Costs for Employee
Compensation,'' March 2012, Table 9, total compensation for all sales
and office workers in goods-producing private industries: https://www.bls.gov/ncs/). Therefore, the estimated annual cost to industry
associated with the labeling requirement is $8,540.50 ($27.55 per hour
x 310 hours = $8,540.50).
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3507(d)), we have submitted the information collection requirements of
this final rule to the OMB, and OMB has assigned control number 3041-
0157 to the information collection.
XII. 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.
XIII. 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 safety standard for
bassinets and cradles is a children's product safety rule that requires
the Commission to issue an NOR.
The Commission recently published a final rule, Requirements
Pertaining to Third Party Conformity Assessment Bodies, 78 FR 15836
(March 12, 2013), which is codified at 16 CFR part 1112 (referred to
here as Part 1112). This rule became effective June 10, 2013. Part 1112
establishes requirements for accreditation of third party conformity
assessment bodies (or laboratories) to test for conformance with a
children's product safety rule in accordance with Section14(a)(2) of
the CPSA. Part 1112 also codifies a list of all of the NORs that the
CPSC had published at the time part 1112 was issued. All NORs issued
after the Commission published part 1112, such as the bassinet and
cradle standard, require an amendment to part 1112. Accordingly, this
rule amends part 1112 to include the bassinet and cradle standard in
the list with the other children's product safety rules for which the
CPSC has issued NORs.
Laboratories applying for acceptance as a CPSC-accepted third party
conformity assessment body to test to the new standard for bassinets
and cradles are required to meet the third party conformity assessment
body accreditation requirements in part 1112. When a laboratory meets
the requirements as a CPSC-accepted third party conformity assessment
body, it can apply to the CPSC to have 16 CFR part 1218, ``Safety
Standard for Bassinets and Cradles,'' included in its scope of
accreditation of CPSC safety rules listed for the laboratory on the
CPSC Web site at: www.cpsc.gov/labsearch.
In connection with the part 1112 rulemaking, CPSC staff conducted
an analysis of the potential impacts on small entities of the rule
establishing accreditation requirements, 78 FR 15836, 15855-58 (March
12, 2013), as required by the Regulatory Flexibility Act and prepared a
Final Regulatory Flexibility Analysis (FRFA). Briefly, the FRFA
concluded that the requirements would not have a significant adverse
impact on a substantial number of small laboratories because no
requirements are imposed on laboratories that do not intend to provide
third party testing services under section 14(a)(2) of the CPSA. The
only laboratories that are expected to provide such services are those
that anticipate receiving sufficient revenue from providing the
mandated testing to justify accepting the requirements as a business
decision. Laboratories that do not expect to receive sufficient revenue
from these services to justify accepting these requirements would not
likely pursue accreditation for this purpose. Similarly, amending the
part 1112 rule to include the NOR for the bassinet and cradle standard
would not have a significant adverse impact on small laboratories. Most
of these laboratories will have already been accredited to test for
conformance to other juvenile product standards and the only costs to
them would be the cost of adding the bassinet and cradle standard to
their scope of accreditation. As a consequence, the Commission
certifies that the notice requirements for the bassinet and cradle
standard will not have a significant impact on a substantial number of
small entities.
To ease the transition to new third party testing requirements for
bassinets and cradles subject to the standard and to avoid a
``bottlenecking'' of products at laboratories at or near the effective
date of required third party testing for bassinets and cradles, the
Commission, will, under certain circumstances, accept certifications
based on testing that occurred before the effective date for third
party testing.
The Commission will accept retrospective testing for 16 CFR part
1218, safety standard for bassinets and cradles, if the following
conditions are met:
The children's product was tested by a third party
conformity assessment body accredited to ISO/IEC 17025:2005(E) by a
signatory to the ILAC-MRA at the time of the test. The scope of the
third party conformity body accreditation must include testing in
accordance with 16 CFR part 1218. For firewalled third party conformity
assessment bodies, the firewalled third party conformity assessment
body must be one that the Commission, by order, has accredited on or
before the time that the children's product was tested, even if the
order did not include the tests contained in the safety standard for
bassinets and cradles at the time of initial Commission acceptance. For
governmental third party conformity
[[Page 63034]]
assessment bodies, accreditation of the body must be accepted by the
Commission, even if the scope of accreditation did not include the
tests contained in the safety standard for bassinets and cradles at the
time of initial CPSC acceptance.
The test results show compliance with 16 CFR part 1218.
The bassinet or cradle was tested, with the exception of
the removable bassinet bed attachment requirements, on or after the
date of publication in the Federal Register of the final rule for 16
CFR part 1218 and before April 23, 2014. For bassinets or cradles that
are subject to the removable bassinet bed attachment requirements,
testing to the removable bassinet bed attachment requirements was
conducted on or after the date of publication in the Federal Register
of the final rule for 16 CFR part 1218 and before April 23, 2015.
The laboratory's accreditation remains in effect through
April 23, 2014.
List of Subjects
16 CFR Part 1112
Administrative practice and procedure, Audit, Consumer protection,
Reporting and recordkeeping requirements, Third party conformity
assessment body.
16 CFR Part 1218
Consumer protection, Imports, Incorporation by reference, Infants
and children, Labeling, Law enforcement, and Toys.
For the reasons discussed in the preamble, the Commission amends 16
CFR chapter II as follows:
PART 1112--REQUIREMENTS PERTAINING TO THIRD PARTY CONFORMITY
ASSESSMENT BODIES
0
1. The authority citation for part 1112 continues to read as follows:
Authority: 15 U.S.C. 2063; Pub. L. 110-314, section 3, 122
Stat. 3016, 3017 (2008).
0
2. Amend Sec. 1112.15 by adding paragraph (b)(33) to read as follows:
Sec. 1112.15 When can a third party conformity assessment body apply
for CPSC acceptance for a particular CPSC rule or test method?
* * * * *
(b) * * *
(33) 16 CFR part 1218, Safety Standard for Bassinets and Cradles.
0
3. Add a new part 1218 to read as follows:
PART 1218--SAFETY STANDARD FOR BASSINETS AND CRADLES
Sec.
1218.1 Scope.
1218.2 Requirements for bassinets and cradles.
Authority: Sec. 104, Pub. L. 110-314, 122 Stat. 3016 (August
14, 2008); Pub. L. 112-28, 125 Stat. 273 (August 12, 2011).
Sec. 1218.1 Scope.
This part establishes a consumer product safety standard for
bassinets and cradles manufactured or imported on or after April 23,
2014, except for the removable bassinet bed attachment requirements at
Sec. 1218.2(b)(3)(i) through (iv), (b)(5), and (b)(7), which are
effective April 23, 2015.
Sec. 1218.2 Requirements for bassinets and cradles.
(a) Except as provided in paragraph (b) of this section, each
bassinet and cradle must comply with all applicable provisions of ASTM
F2194-13, Standard Consumer Safety Specification for Bassinets and
Cradles, approved on April 1, 2013. The Director of the Federal
Register approves this incorporation by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy from ASTM
International, 100 Bar Harbor Drive, P.O. Box 0700, West Conshohocken,
PA 19428; https://www.astm.org/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_federal regulations/ibr_locations.html.
(b) Comply with ASTM F2194-13 standard with the following additions
or exclusions:
(1) Instead of complying with Note 1 of section 1.3.1 of ASTM
F2194-13, comply with the following:
(i) Note 1--Cradle swings with an incline less than or equal to
10[deg] from horizontal while in the rest (non-rocking) position are
covered under the scope of this standard. A sleep product that only has
inclined sleeping surfaces (intended to be greater than 10[deg] from
horizontal while in the rest (non-rocking) position) does not fall
under the scope of this standard. If a product can be converted to a
bassinet/cradle use mode and meets the definition of a bassinet/cradle
found in 3.1.1 while in that mode, the product shall be included in the
scope of this standard, when it is in the bassinet/cradle use mode. For
example, strollers that have a carriage/bassinet feature are covered by
the stroller/carriage standard when in the stroller use mode. Carriage
baskets/bassinets that are removable from the stroller base are covered
under the scope of this standard when the carriage basket/bassinet
meets the definition of a bassinet/cradle found in 3.1.1. In addition,
bassinet/cradle attachments to cribs or play yards, as defined in 3.1.2
or 3.1.12, are included in the scope of the standard when in the
bassinet/cradle use mode.
(ii) [Reserved]
(2) Add ``CAMI Newborn Dummy (see Figure 1A). Drawing numbers 126-
0000 through 126-0015 (sheets 1 through 3), 126-0017 through 126-0027,
a parts list entitled ``Parts List for CAMI Newborn Dummy,'' and a
construction manual entitled ``Construction of the Newborn Infant
Dummy'' (July 1992). Copies of the materials may be inspected at
NHTSA's Docket Section, 400 Seventh Street SW., Room 5109, Washington,
DC, or at the Office of the Federal Register, 800 North Capital Street
NW., Suite 700, Washington, DC.'' to ``2.3 Other References'' and use
the following figure:
[[Page 63035]]
[GRAPHIC] [TIFF OMITTED] TR23OC13.000
(3) In addition to complying with section 3.1.17 of ASTM F2194-13,
comply with the following:
(i) 3.1.18. bassinet bed, n--the sleeping area of the bassinet/
cradle, containing the sleep surface and side walls.
(ii) 3.1.19. removable bassinet bed, n--A bassinet bed that is
designed to separate from the base/stand without the use of tools. Play
yard bassinets, as defined in 3.1.13, are excluded from this
definition.
(iii) 3.1.20. false lock/latch visual indicator, n--a warning
system, using contrasting colors, lights, or other similar means
designed to visually alert caregivers when a removable bassinet bed is
not properly locked onto its base/stand.
(iv) 3.1.21. intended use orientation, n--The bassinet bed
orientation (i.e., the position where the head and foot ends of the
bassinet bed are located), with respect to the base/stand, as
recommended by the manufacturer for intended use.
(4) Instead of complying with section 6.7 of ASTM F2194-13, comply
with the following:
(i) 6.7. Bassinets with Segmented Mattresses: Flatness Test--If the
bassinet or bassinet accessory has a folding or segmented mattress, or
both, any angle when measured in 7.8 less than or equal to 10[deg] is
an immediate pass. Any angle when measured in 7.8 greater than 10[deg]
is an immediate failure. Segmented bassinet mattresses that have seams
(located between segments or where the mattress folds) that are less
than 15 inches in length are excluded from this requirement.
(ii) [Reserved]
(5) In addition to complying with section 6.9.2 of ASTM F2194-13,
comply with the following:
(i) 6.10. Removable Bassinet Bed Attachment--Any product containing
a removable bassinet bed with a latching or locking device intended to
secure the bassinet bed to the base/stand, shall comply with at least
one of the following 6.10.1, 6.10.2, 6.10.3, 6.10.4 or 6.10.5 when
tested in accordance with 7.12.
(ii) 6.10.1. The base/stand shall not support the bassinet bed
(i.e., the bassinet bed falls from the stand and contacts the floor or
the base/stand collapses when the bassinet bed is not locked on the
base/stand).
(iii) 6.10.2. The lock/latch shall automatically engage under the
weight of the bassinet bed (without any other force or action) in all
lateral positions (Figure 24).
(iv) 6.10.3. The sleep surface of the bassinet bed shall be at an
angle of at least 20[deg] from a horizontal plane when the bassinet bed
is in an unlocked position.
(v) 6.10.4. The bassinet/cradle shall provide a false latch/lock
visual indicator(s). At a minimum, an indicator shall be visible to a
person standing near both of the two longest sides of the product.
(vi) 6.10.5. The bassinet bed shall not tip over and shall retain
the CAMI newborn dummy when tested in accordance with 7.12.5.3.
(6) Instead of complying with section 7.4.4 of ASTM F2194-13,
comply with the following:
(i) 7.4.4. Place the CAMI Newborn Dummy, Mark II, on the sleeping
pad in the center of the product face up with the arms and legs
straightened.
(A) Rationale. The newborn CAMI dummy represents a 50th percentile
newborn infant, which is a more appropriate user of a bassinet than the
CAMI infant dummy, which represents a 50th percentile 6-month-old
infant.
(B) [Reserved]
(ii) [Reserved]
(7) In addition to complying with section 7.11.4 of ASTM F2194-13,
comply with the following:
(i) 7.12. Removable Bassinet Bed Attachment Tests
(ii) 7.12.1. Assemble the bassinet/cradle base/stand only, in
accordance with manufacturer's instructions in one of the
manufacturer's recommended use positions. If the base/stand does not
remain in the use position when the bassinet bed is not locked onto it,
the product meets the requirements of 6.10.1.
(iii) 7.12.2. Place the base/stand and the inclinometer on a flat
level horizontal surface (0 -0.5[deg]) to establish a test
plane. Zero the inclinometer.
(iv) 7.12.3. Remove the mattress pad from the bassinet bed.
Note to paragraph (b)(7)(iv): For mattresses that are integral
with the mattress support, do not remove the mattress and perform
all angle measurements for 7.12 on a 6 by 6 by \3/8\-in. nominal
aluminum block placed on the center of the mattress.
(v) 7.12.4. Place the bassinet bed on the base/stand in the
intended use orientation without engaging any latch or lock mechanism
between the base/stand and the bassinet bed. If the bed automatically
engages to the base/stand do not disengage the lock/latch. If the
bassinet bed can rest on the base/stand in its intended use orientation
in one or more lateral unlocked position (Figure 24), the unit shall be
evaluated in the lateral position most likely to fail the requirements
specified in 6.10.
(vi) Figure 24: Bassinet Bed Resting on Stand, Showing Possible
Alternate Lateral Positions.
[[Page 63036]]
[GRAPHIC] [TIFF OMITTED] TR23OC13.001
(vii) 7.12.4.1. If the base/stand supports the bassinet bed in any
unlocked position, place the inclinometer on the mattress support at
the approximate center of the mattress support. Care should be taken to
avoid seams, snap fasteners, or other items that may affect the
measurement reading. Record the angle measurement.
(viii) 7.12.4.2. If the base/stand supports the bassinet bed and
the angle of the mattress support surface measured in 7.12.4.1 is less
than 20 degrees from a horizontal plane, evaluate whether the bassinet
has a false latch/lock visual indicator per 6.10.4.
(ix) 7.12.4.3. If the base/stand supports the bassinet bed, and the
angle of the mattress support surface measured in 7.12.4.1 is less than
20 degrees from a horizontal plane, and the bassinet does not contain a
false latch/lock visual indicator, test the unit in accordance with
sections 7.4.2 through 7.4.7.
(x) 7.12.5. Repeat 7.12.2 through 7.12.4 for all of the
manufacturer's base/stand recommended positions and use modes.
(xi) 7.12.6. Repeat 7.12.4 through 7.12.5 with the bassinet bed
rotated 180 degrees from the manufacturers recommended use orientation,
if the base/stand supports the bassinet bed in this orientation.
(A) Rationale. (1) This test requirement addresses fatal and
nonfatal incidents involving bassinet beds that tipped over or fell off
their base/stand when they were not properly locked/latched to their
base/stand or the latch failed to engage as intended. Products that
appear to be in an intended use position when the lock or latch is not
properly engaged can create a false sense of security by appearing to
be stable. Unsecured or misaligned lock/latch systems are a hidden
hazard because they are not easily seen by consumers due to being
located beneath the bassinet or covered by decorative skirts. In
addition, consumers will avoid activating lock/latch mechanisms for
numerous reasons if a bassinet bed appears stable when placed on a
stand/base. Because of these foreseeable use conditions, this
requirement has been added to ensure that bassinets with a removable
bassinet bed feature will be inherently stable or it is obvious that
they are not properly secured.
(2) 6.10 allows bassinet bed designs that:
(i) Cannot be supported by the base/stand in an unlocked
configuration,
(ii) Automatically lock and cannot be placed in an unlocked
position on the base/stand,
(iii) Are clearly and obviously unstable when the lock/latch is
misaligned or unused,
(iv) Provide a visual warning to consumers when the product is not
properly locked onto the base/stand, or
(v) Have lock/latch mechanisms that are not necessary to provide
needed stability.
(B) [Reserved]
Dated: September 30, 2013.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2013-24203 Filed 10-22-13; 8:45 am]
BILLING CODE 6355-01-P