Safety Standard for Play Yards, 50328-50335 [2013-19964]
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Federal Register / Vol. 78, No. 160 / Monday, August 19, 2013 / Rules and Regulations
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[FR Doc. 2013–19465 Filed 8–16–13; 8:45 am]
BILLING CODE 4910–13–P
CONSUMER PRODUCT SAFETY
COMMISSION
16 CFR Part 1221
[CPSC Docket No. CPSC–2011–0064]
RIN 3041–AC92
Safety Standard for Play Yards
Consumer Product Safety
Commission.
ACTION: Final rule.
AGENCY:
The United States Consumer
Product Safety Commission
(Commission or CPSC or we) is issuing
a final rule, amending the play yard
mandatory standard. Currently, the
CPSC play yard standard incorporates
by reference ASTM F406–12a, Standard
Consumer Safety Specification for NonFull-Size Baby Cribs/Play Yards. In this
final rule, the Commission is amending
the play yard standard to incorporate by
reference the most recent version of
ASTM’s play yard standard, ASTM
F406–13. Through this amendment, the
Commission is addressing hazards
associated with misassembly of play
yard bassinet accessories.
DATES: This rule will become effective
on February 19, 2014 and will apply to
all play yards manufactured or imported
on or after that date. The incorporation
by reference of the publication listed in
this rule is approved by the Director of
the Federal Register as of February 19,
2014.
FOR FURTHER INFORMATION CONTACT:
Justin Jirgl, Compliance Officer, Office
of Compliance and Field Investigations,
U.S. Consumer Product Safety
Commission, 4330 East West Highway,
Bethesda, MD 20814; email: jjirgl@
cpsc.gov.
SUPPLEMENTARY INFORMATION:
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SUMMARY:
A. Background
On August 29, 2012, the Commission
published a final rule establishing a
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CPSC safety standard for play yards. 77
FR 52220. On the same date, the
Commission published a notice of
proposed rulemaking (NPR), seeking
comments on the addition of a
requirement to the play yard mandatory
standard to address the hazards
associated with play yard bassinet
accessories that can be assembled
without key structural elements. 77 FR
52272. The NPR was prompted by the
death of an infant in a play yard
bassinet accessory, in which the end
support rods, which attached two of the
bassinet accessory’s four sides to the
play yard rails, were omitted during
assembly. The other two sides were
attached with plastic clips. After the
infant was left to sleep, one of the
plastic clips that attached the bassinet
accessory to the play yard detached.
Because the support rods were not in
place to secure the bassinet accessory,
the bassinet sleep surface tilted, and the
infant slid into the corner of the tilted
bassinet accessory and suffocated.
In the August 2012 NPR, we proposed
a provision that would require that all
‘‘key structural elements’’ be
permanently attached to the bassinet
accessory or pass the ‘‘catastrophic
failure test,’’ which is described in more
detail in section D of this preamble. In
the August 2012 NPR, the term ‘‘key
structural elements’’ included all
structures that attach the bassinet
accessory to the play yard, as well as all
structures that reinforce the bassinet
accessory mattress by keeping it flat and
stable, such as the mattress support
rods.
Since publication of the August 2012
NPR, the ASTM play yard subcommittee
carefully assessed the incident that
prompted this requirement. The
subcommittee worked closely with the
ASTM bassinet/cradle subcommittee
and chose to address the hazards
associated with bassinet accessory
misassembly in two different ASTM
standards: (1) The play yard standard,
ASTM F406–13, now addresses safety
issues related to bassinet accessory
attachment components (i.e., structures
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that attach the bassinet accessory to the
play yard); and (2) the bassinet
standard, ASTM F2194–13, Standard
Consumer Safety Specification for
Bassinets and Cradles, addresses safety
issues related to mattress support rods
(and all other structures that ensure that
the bassinet accessory mattress is flat
and stable) through the segmented
mattress flatness test contained in the
bassinet standard. That approach is now
part of the current ASTM standard for
play yards, ASTM F406–13, and for
bassinets, ASTM F2194–13. Likewise,
the Commission is following this
approach in the CPSC standard for play
yards and in the CPSC standard for
bassinets and cradles. The Commission
believes that this approach addresses
the hazards known to CPSC staff
associated with play yard bassinet
misassembly.
B. The Product
ASTM F406–13 defines a ‘‘play yard’’
as a ‘‘framed enclosure that includes a
floor and has mesh or fabric sided
panels primarily intended to provide a
play or sleeping environment for
children. It may fold for storage or
travel.’’ Play yards are intended for
children who are less than 35 inches tall
and who cannot climb out of the
product. Some play yards include
accessory items that attach to the
product, such as mobiles, toy bars,
canopies, bassinets, and changing
tables. The accessory item usually
attaches to the side rails or corner
brackets of the play yard.
A ‘‘bassinet/cradle accessory’’ is
defined in ASTM F406–13 as ‘‘an
elevated sleep surface that attaches to a
play yard designed to convert the
product into a bassinet/cradle intended
to have a horizontal sleep surface while
in a rest (non-rocking) position.’’ Play
yard bassinet accessories commonly
consist of a textile shell that provides an
elevated sleep surface within the play
yard. The floor of the bassinet accessory
is typically the same dimensions as the
play yard floor. Usually, the segmented
mattress pad that is used on the floor of
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the play yard is inserted into the
bassinet shell. The floor of the bassinet
accessory is typically reinforced with
mattress support rods to ensure a flat,
stable sleep surface. The top edges of
the sides of the bassinet accessory can
be secured to the play yard top rails
with any number of devices, but most
often is done through plastic clips sewn
onto the sides of the shell. Metal rods
may also be used to secure the bassinet
to the play yard. These metal rods are
usually inserted into a sleeve on the top
edge of the shell’s side wall and clipped
into a play yard’s corner brackets.
C. History of the Play Yard Mandatory
Standard
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In the Federal Register of September
20, 2011 (76 FR 58167), the Commission
published an NPR to establish a safety
standard for play yards. The NPR
proposed incorporating by reference
ASTM F406–11. It is important to note
that ASTM F406 is the safety standard
for both non-full-size cribs and play
yards. The NPR for play yards indicated
which sections of the ASTM standard
would apply to play yards and excluded
from CPSC’s play yard standard the
provisions of ASTM F406 that apply to
non-full-size cribs. After publication of
the 2011 NPR, CPSC staff became aware
of an incident, mentioned in section A
of this preamble and described in more
detail in section D of this preamble,
where an infant died while sleeping in
a play yard bassinet accessory that had
been assembled without end supports.
The Commission received a comment to
the 2011 NPR requesting that we
address play yard bassinet accessory
misassembly.
On August 29, 2012, the Commission
published a final rule to establish a
safety standard for play yards that
incorporated by reference ASTM F406–
12a. 77 FR 52220. The final rule did not
address the hazards associated with the
use of play yard bassinet accessories
that can be assembled missing key
structural elements. On the same date,
the Commission published an NPR
proposing an addition to the play yard
mandatory standard to address the
hazards associated with the use of play
yard bassinet accessories that can be
assembled missing key structural
elements and asking for comments on
the proposal. 77 FR 52272.
D. The Play Yard Bassinet Accessory
Misassembly Provision
1. Summary of the Hazard and the
Infant Fatality
Many play yards are sold with
accessories that attach to the product,
such as mobiles, toy bars, canopies,
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bassinets, and changing tables. Play
yard bassinet accessories are unique
among play yard accessories because
they are intended to be used as a
sleeping environment, and infants are
meant to be left unsupervised in them
for extended periods of time. Serious
injuries or fatalities can result if a play
yard bassinet accessory has been
assembled without support structures.
Those structures are intended to attach
the bassinet accessory to the side of the
play yard, as well as support the
bassinet accessory mattress in order to
keep the sleep surface flat and level. A
tilt in the sleeping surface of the
bassinet can result in an infant getting
into a position where he or she is unable
to breathe and is at risk of suffocation.
In August 2011, the CPSC received a
report of an infant fatality that occurred
in the bassinet accessory of a play yard.
The child died when the sleeping
surface of the bassinet tilted, causing the
child to slip into the corner of the
bassinet accessory, where she
suffocated. A review of the In-Depth
Investigation Report (IDI), as well as
CPSC staff testing on an exemplar model
of the bassinet accessory and play yard
involved in the fatality, led CPSC staff
to conclude that the incident was
caused by the omission of metal support
rods that were used to secure two of the
bassinet accessory’s ends to the side of
the play yard. The bassinet accessory
also had sewn-on plastic clips that
attached the product to the side rails of
the play yard. Sometime after the child
was placed in the bassinet accessory,
one of the plastic clips detached. If the
metal support rods had been used in the
assembly of the play yard, the
detachment of the plastic clip would not
have been enough to cause the tilt in the
sleeping surface that led to the fatality.
However, the plastic clips caused the
consumer to assume erroneously that
the product was safe when key
structural elements, the end support
rods that secured the bassinet
accessory’s ends to the play yard end
rails, were missing. The omission of the
metal support rods caused the fatal tilt
of the bassinet accessory sleep surface
and resulted in the infant’s death.
As in this case, a consumer initially
may not see that supporting rods are
missing. If the misassembled accessory
supports an infant without a
catastrophic and obvious change to the
sleep surface, a consumer may continue
to use the accessory and inadvertently
place a child in danger. If the bassinet’s
sleep surface tilts while the child is
unsupervised, the caregiver may not
discover the condition for hours,
placing the child in a potentially fatal
situation.
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2. The Bassinet Misassembly
Requirement Contained in the August
2012 NPR
The requirement the Commission
proposed in the August 2012 NPR was
designed to address the hazards that can
occur when play yard bassinet
accessories are misassembled by
omitting key structural elements during
assembly. The NPR proposed two
compliance options. First, the bassinet
accessory would meet the requirement if
all of the key structural elements were
attached permanently to the bassinet
accessory. This would prevent any
support rods, tubes, bars, and hooks
from being omitted inadvertently when
the consumer assembles the bassinet
accessory. Manufacturers who choose to
affix all key structural elements to their
bassinets permanently would not need
to conduct further testing on their
product to meet the requirement.
The second method for compliance
proposed in the NPR involved a test
method that CPSC refers to as the
‘‘catastrophic failure test.’’ If a
manufacturer chooses not to attach
support rods, tubes, bars, or hooks
permanently to the bassinet, the
bassinet would have to be tested by
removing each key structural element
and numbering each from 1 through n.
Subsequently, all of the key structural
elements would be put back into place.
Key structural element number 1 would
then be removed from the bassinet. To
pass the test when an anthropomorphic
infant dummy is placed in the center of
the sleep surface, the product must: (1)
Collapse completely, or (2) tilt more
than 30°. The angle of 30° represents a
safety factor of three times the 10°
maximum safe sleep surface angle of
incline. CPSC Human Factors staff
concluded that an angle of 30° would be
sufficiently obvious to a consumer to
discourage the consumer from
continuing to use the bassinet. The test
would continue until each key
structural element has been tested
individually (thus, key structural
element number 1 would be inserted
back into the product, key structural
element number 2 would be removed,
and the test would be repeated.)
The proposed requirement was meant
to ensure that the omission of a key
structural element would be so visually
obvious that the consumer would not
use the product and place the child in
danger inadvertently. To pass this test,
the item must fail catastrophically when
each key structural element is omitted.
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3. The Bassinet Misassembly
Requirement Contained in ASTM F406–
13 and Incorporated in the Final Rule
The work on the play yard bassinet
accessory misassembly requirement
began after we received a comment on
the issue in response to the September
2011 play yard NPR. CPSC staff worked
with the ASTM play yard subcommittee
for more than a year to develop the
language to address this hazard. The
ASTM play yard subcommittee is made
up of key stakeholders, including
manufacturers, retailers, third party test
laboratories, independent consultants,
consumer advocates, representatives
from Health Canada, and CPSC staff.
The result of this effort is the language
now contained in ASTM F406–13,
which this rule incorporates by
reference. The requirement addressing
play yard bassinet accessory
misassembly is essentially the same as
the requirement proposed in the August
2012 NPR, with two important
differences that were suggested in
comments that the Commission received
in response to the August 2012 NPR.
The first difference involves
addressing the bassinet accessory
structural supporting elements in two
different standards: Play yards and
bassinets/cradles. In the August 2012
NPR, the term ‘‘key structural
elements,’’ included all rods, tubes,
bars, and hooks that supported the
bassinet accessory or that were used in
assembling the bassinet accessory. Not
only did the term include structures that
attach the bassinet to the play yard, but
the term also encompassed the mattress
support rods and other structures that
support the bassinet accessory mattress
in order to keep the sleep surface flat
and stable. The ASTM play yard
subcommittee, working closely with the
ASTM bassinet/cradle subcommittee,
determined that any issues dealing with
misassembly of the mattress support
rods should be addressed in the bassinet
standard. Thus, both ASTM
subcommittees agreed that: (1) The play
yard standard, ASTM F406–13, will
address safety issues related to bassinet
accessory attachment components (i.e.,
structures that attach the bassinet
accessory to the play yard); and (2) the
bassinet standard, ASTM F2194–13,
will address mattress support rods (and
all other structures that keep the
bassinet accessory mattress flat and
stable) through the segmented mattress
flatness test contained in the bassinet
standard.
The second substantive difference is
also the result of a comment received in
response to the August 2012 NPR. As
proposed in the August 2012 NPR, the
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catastrophic failure test is conducted
with a 7.5-pound newborn CAMI
dummy. ASTM F406–13 requires that
the test be conducted with a four-pound
test mass. This weight represents the
mass of the smallest newborn known to
staff that would be released from a
hospital, and thus, the smallest
expected play yard bassinet accessory
occupant. Using a smaller test mass
makes the play yard bassinet
misassembly provision in ASTM F406–
13 more stringent than the requirement
the Commission proposed in the August
2012 NPR.
The final rule incorporates by
reference ASTM F 406–13. By
referencing this newer version of the
ASTM play yard standard, the CPSC
standard addresses the hazards known
to CPSC staff posed by misassembly of
play yard bassinet accessories in
substantially the same manner as the
Commission proposed in the 2012 NPR.
The final rule continues to exclude from
the CPSC’s play yard standard the
provisions in ASTM F 406 that apply to
non-full-size cribs. The Commission has
a separate standard for non-full-size
cribs. See 16 CFR part 1220.
E. Response to Comments on the
Proposed Rule
The preamble to the NPR invited
comments concerning all aspects of the
proposed rule. We received 13
comments. Many of the comments
contained more than one issue. Thus,
we organized our responses by issue,
rather than respond to each commenter
individually. All of the comments can
be viewed on www.regulations.gov, by
searching under the docket number for
this rulemaking, CPSC–2011–0064.
1. Generally Unsupportive
(Comment 1)—Two commenters
indicate that they generally do not
support the requirement. Both
commenters feel that the regulation is
unnecessary because the hazard was
caused by misassembly of the product.
(Response 1) —The Danny Keysar
Child Product Safety Notification Act,
section 104 of the Consumer Product
Safety Improvement Act of 2008
(CPSIA) requires that we promulgate
mandatory regulations for durable infant
and toddler products, including play
yards, that are substantially the same as
an existing voluntary standard, or more
stringent than the voluntary standard if
the Commission determines that more
stringent standards would reduce the
risk of injury associated with the
product. In this case, we believe that the
proposed final rule incorporating by
reference ASTM F406–13 is appropriate
to reduce the risk of injury associated
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with play yards. Therefore, the issuance
of this final rule fulfills a statutory
mandate given to the CPSC by Congress.
In addition, we disagree with the
assertion that hazards caused by
misassembly should not be addressed
through mandatory regulations. The
CPSC is often faced with hazards that
result from the reasonably foreseeable
use of consumer products. Preventing
the possibility of misassembly is
especially critical when the product in
question has been designed to provide
a safe sleep environment for an infant,
and when the result of misassembly
could be severe, such as an infant
fatality. The CPSC must assess whether
there are solutions that would minimize
the possibility of misassembly. One
solution could be to improve assembly
instructions or warning labels. Another
solution, and the one that has been
chosen here, is to require that products
that must be assembled by consumers be
designed in such a way that they are
very difficult to misassemble.
(Comment 2)—One commenter
expresses a number of concerns about
the new requirement. Specifically, the
commenter feels that the requirement:
(1) Does not address completely the
hazards that caused the infant fatality;
(2) was created too quickly and the
process rushed; (3) is design restrictive;
and (4) will fail safe products.
(Response 2)—The bassinet accessory
misassembly performance requirement
and test method were fine-tuned for
more than a year from January 2012
through April 2013. The circumstances
involving the infant fatality were
analyzed in detail and significant
changes were made to the requirement
to ensure that it addressed the hazard in
the least burdensome manner. Notably,
the scope of the play yard bassinet
accessory misassembly requirement was
reduced by focusing only on accessory
attachment components and not all key
structural elements. This reduction in
scope was a direct result of careful
analysis of the circumstances that
resulted in the infant fatality.
The requirement was created and
approved through consultation with
members of the ASTM play yard
subcommittee, which includes many
play yard importers and manufacturers,
as well as other stakeholders, such as
retailers, testing laboratories,
independent consultants,
representatives from consumer
advocacy groups, and representatives
from Health Canada.
To provide manufacturers with
options, and to avoid creating a design
restrictive standard, two methods of
compliance were provided. A
manufacturer can permanently attach all
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beyond the effective date. However,
ongoing compliance activities would
continue to be used to remove unsafe
play yards from the market.
2. Generally Supportive
(Comment 3)—Several commenters
support the new requirement. One
commenter notes: ‘‘(o)ur organizations
strongly support these specific
requirements and test methods as well
as the general principle that
misassembly is a design safety issue and
should be adequately addressed in
product safety standards.’’ Another
commenter indicates: ‘‘(w)hile I strongly
support and would prefer to see all key
structural elements permanently
attached to the bassinet accessory, the
catastrophic failure test provides an
option for manufacturers to come into
compliance and appears to address the
hazards associated with play yard
bassinet accessories.’’ Another
commenter expresses ‘‘overall support’’
for the requirement and notes: ‘‘(o)ne
infant death is too many, and the CPSC
has acted quickly to develop a new
safety standard for bassinet
accessories.’’
(Response 3)—We agree with the
commenters.
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accessory attachment components or
design a product that passes the
catastrophic failure test. Finally, if the
standard is found to be too severe and
is failing safe products, it can be
updated as more data is received by the
CPSC.
(Comment 5)—Four commenters
discuss the overlap between the
mattress flatness requirement contained
in ASTM F2194–13, Standard
Consumer Safety Specification for
Bassinets and Cradles, and the proposed
play yard bassinet accessory
misassembly requirements. The
commenters state that the play yard
bassinet accessory misassembly
requirements, as published in the
August 2012 NPR, contain requirements
that are more appropriately addressed in
the bassinet segmented mattress flatness
requirement contained in the bassinet
voluntary standard.
(Response 5)—The CPSC agrees with
these comments. As discussed above,
the play yard bassinet accessory
misassembly requirement contained in
ASTM F406–13 now only applies to
accessory attachment components (i.e.,
those structures that attach the bassinet
accessory to the play yard).
Misassembly issues related to mattress
support rods are now addressed in
ASTM F2194–13, the standard for
bassinets and cradles. ASTM F2194–13
requires that if the mattress support rods
are not permanently attached, the
bassinet must be tested pursuant to the
mattress flatness test contained in
ASTM F2194–13, and the product must
pass the mattress flatness test both with
and without the mattress support rods
in place. The CPSC is finalizing a rule
for bassinets/cradles that incorporates
by reference ASTM F2194–13.
3. Effective Date
(Comment 4)—We received four
comments addressing the appropriate
effective date for this regulation. One
individual indicates her agreement with
the proposed six-month effective date.
Other commenters recommend a shorter
effective date. Some commenters
suggest that a 90-day effective date
would be more appropriate because
safer products would be available
sooner, and manufacturers have had
adequate notice that the play yard
bassinet accessory misassembly
requirement will soon be mandatory.
Some commenters note that only
products manufactured after the
effective date are impacted by the
regulation. Thus, products made before
the effective date (products that may not
be in compliance with the bassinet
accessory misassembly requirement
contained in ASTM F406–13) can
continue to be sold.
(Response 4)—The CPSC has
generally recommended a six-month
effective date for rules issued under
section 104 of the CPSIA and we find no
compelling reason to deviate from this
practice for this rule. We share concerns
about noncompliant products, those
manufactured or imported before the
effective date, being available for years
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4. Coordination Between the Play Yard
and Bassinet Standard
5. Clarity of ‘‘Key Structural Element’’
Definition
(Comment 6)—One commenter asks
that the definition of ‘‘key structural
element’’ be clarified. Specifically, the
commenter asks if the following are key
structural elements: (1) clips that are
sewn to the play yard bassinet accessory
shell; and (2) metal bars that provide
support for the bassinet mattress.
(Response 6)—The definition of ‘‘key
structural element’’ presented in the
August 2012 NPR has been modified.
The final rule incorporates by reference
ASTM F406–13. The language
published in ASTM F406–13 now limits
the scope of the play yard bassinet
misassembly requirement by defining
‘‘accessory attachment components’’ as
‘‘the components that provide the
means of attachment for a bassinet/
cradle accessory to a play yard.’’
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Thus, clips sewn to the play yard
bassinet accessory shell that attach the
bassinet accessory to the play yard are
accessory attachment components.
Metal bars that provide support to the
bassinet accessory mattress, and that do
not attach the bassinet accessory to the
play yard, are not accessory attachment
components; therefore, they are not
subject to the play yard bassinet
accessory misassembly requirement
contained in ASTM F406–13.
6. Catastrophic Failure Test Is
Confusing or Is Arbitrary and
Capricious
(Comment 7)—One commenter
indicates that it would be easier, and
cause less confusion, if the play yard
bassinet accessory misassembly
provision simply required that all key
structural elements be permanently
attached to the bassinet accessory
instead of giving manufacturers the
option of complying with the
catastrophic failure test. Another
commenter indicates that the permanent
affixture test should be the only method
of complying with the requirement and
asserts that the catastrophic failure test
is not the least burdensome requirement
and violates the Administrative
Procedure Act because it is arbitrary and
capricious.
(Response 7)—The catastrophic
failure test can appear confusing and
counterintuitive because, in order to
pass the test, the product must fail
catastrophically when one piece is
missing. However, this test was
thoroughly vetted during the ASTM
process. The ASTM subcommittee
stakeholders felt that the test is a sound
alternative to permanently attaching all
accessory attachment components. In
fact, initially, CPSC staff suggested that
the only method of compliance should
be to require that all key structural
elements be permanently attached. The
catastrophic failure option was added at
the request of manufacturers’
representatives. However, once the
requirement goes into effect, both ASTM
and the CPSC will monitor any issues
that arise in using the catastrophic
failure test to meet the requirement and
will address them as necessary.
Additionally, the catastrophic failure
test is an alternative to the permanent
affixture test. Although the CPSC does
not feel that the permanent affixture test
is design restrictive, providing as many
alternatives for compliance as possible
is important, so that products with
drastically different designs are able to
meet the requirement.
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9. Redundant Product Safety Features
7. Catastrophic Failure Test and the
Test Mass Size, Use, and Location
(Comment 8)—One commenter
questions the use of the newborn CAMI
dummy (weighing 7.5 pounds), as
proposed in the August 2012 NPR. The
commenter ultimately questions the use
of a test mass at all, hypothesizing that
the requirement could be more severe if
no test mass were used. Another
commenter recommends that the CPSC
consider a lighter test mass so that a
greater proportion of the newborn
population will be covered by the play
yard bassinet accessory misassembly
requirement.
(Response 8)—We agree that the mass
of the newborn CAMI dummy is too
large. CPSC staff developed a new fourpound test mass and presented the fourpound test mass proposal to the ASTM
play yard subcommittee for review and
consideration. The play yard bassinet
accessory misassembly requirement,
contained in section 5.19 of ASTM
F406–13, contains a rationale that states
that the four-pound mass represents the
weight of the smallest newborn who
would be using the bassinet accessory
because infants smaller than four
pounds are unlikely to be released from
a hospital. Using the smallest reasonable
mass makes the play yard bassinet
accessory misassembly requirement
more stringent than the proposal in the
August 2012 NPR. Eliminating the test
mass entirely, as one commenter
suggests, is unnecessarily restrictive.
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8. Catastrophic Failure Test and the
Basis for the 30° Mattress Angle
Requirement
(Comment 9)—Several commenters
object to the 30° tilt requirement in the
catastrophic failure test. Many
commenters feel that the requirement is
not adequately supported by scientific
data.
(Response 9)—The angle of 30°
represents a safety factor of three times
the 10° maximum safe sleep surface
angle of incline. CPSC Human Factors
staff concluded that an angle of 30°
would be sufficiently visually obvious
to a consumer, such that the consumer
would be discouraged from continuing
to use the bassinet. Staff then
recommended that the ASTM play yard
subcommittee review and critique the
30° angle. ASTM stakeholders agreed
with CPSC staff that 30° was reasonable
and would be considered by caregivers
to be obviously hazardous. CPSC staff,
as well as ASTM members, can
reconsider the tilt angle requirement
should evidence be presented indicating
that the angle is too small or large.
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(Comment 10)—One commenter states
that the play yard bassinet accessory
misassembly requirement, as contained
in the August 2012 NPR, may result in
manufacturers eliminating ‘‘redundant
safety features that are already a
component of the product.’’ The
commenter mentions mattress support
rods as an example of a structure that
is not necessary to comply with the
voluntary standard but does improve
product safety, by helping to create a
‘‘flatter and more stable sleeping
position.’’ The commenter concludes
that the added cost of being required to
permanently affix redundant structures
would lead to the elimination of the
structures to avoid this cost, resulting in
compliant but less safe products being
sold.
(Response 10)—Like many members
of the ASTM play yard subcommittee,
this commenter is concerned that
regulating mattress support rods in the
play yard rule through the bassinet
accessory misassembly requirement is
inappropriate. Members of the play yard
and bassinet subcommittees resolved
this issue by agreeing to regulate
bassinet accessory attachment
components in the play yard standard,
and by agreeing to regulate bassinet
accessory mattress support rods in the
bassinet/cradle standard. As a result, the
play yard bassinet accessory
misassembly requirement in F406–13
now only applies to accessory
attachment components. Misassembly
issues related to mattress support rods
are now addressed in ASTM F2194–13,
the voluntary standard for bassinets and
cradles. ASTM F2194–13 requires that
bassinets with removable mattress
support rods be tested both with and
without the mattress support rods. The
bassinet must pass the segmented
mattress flatness test contained in
ASTM F2194–13 with and without the
mattress support rods. In this way, all
misassembly issues known to CPSC staff
related to play yard bassinet accessories
are addressed in either the play yard or
the bassinet standard.
10. Other Options for Compliance
(Comment 11)—One commenter asks
that a third option for compliance be
considered in addition to the two
already proposed in the August 2012
NPR. The commenter suggests that a
product be considered to be in
compliance if the product continues to
meet the standard’s requirements after
all of the key structural elements are
removed.
(Response 11)—This approach has
been adopted in the bassinet standard
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contained in ASTM F2194–13. ASTM
F2194–13 requires that removable
mattress support rods be tested pursuant
to the segmented mattress flatness tests
contained in ASTM F2194–13 without
the rods in place. If the product passes
the mattress flatness test, even without
the mattress support rods in place, the
product meets the requirements.
We do not agree, however, that this
commenter’s proposal should be an
option for accessory attachment
components meant to attach the bassinet
accessory to the play yard rails. In the
fatal incident, one of the accessory
attachment components, the end
support rods, was omitted and only the
plastic clips were used. The fatality
resulted when the caregiver assumed
that the product was safe because no
visually obvious cues suggested that the
product was unsafe. Therefore, for
accessory attachment components, we
believe that the standard should require
that the accessory attachment
components be either permanently
attached or pass the catastrophic failure
test by obviously failing when an
accessory attachment component is
missing.
11. Cost of Play Yard Bassinet Accessory
Misassembly Requirement
(Comment 12)—One commenter
indicates that cost of ‘‘re-engineering’’
and ‘‘retooling’’ would be significant.
The commenter also mentions that the
requirement would necessitate a change
to the packaging. The commenter
believes that the issue merits additional
research.
(Response 12)—Although the new
requirement might impose additional
costs on manufacturers and importers,
staff consulted and worked closely with
members of the industry to devise an
acceptable solution that would address
the safety hazard but not impose
unnecessary costs.
12. Ability To Launder
(Comment 13)—One commenter
indicates that permanently affixing key
structural elements to the product may
interfere with the ability to launder the
product. The commenter is specifically
concerned about the metal rods that
support a bassinet accessory shell or
liner. If the metal rods were required to
be affixed permanently to the liner, the
bassinet accessory shell would be
difficult to clean.
(Response 13)—Although the CPSC’s
primary concern is that play yards and
bassinet accessories are safe, the CPSC
does consider practical issues, such as
the ability to launder, in connection
with new standards and requirements.
The commenter’s specific concern
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regarding the ability to launder a
bassinet accessory shell that is
supported by metal support rods is no
longer an issue addressable by the play
yard bassinet accessory misassembly
requirement because ASTM F406 no
longer applies to mattress support rods.
Instead, ASTM F406–13 focuses only on
accessory attachment components that
attach the bassinet accessory to the play
yard.
The bassinet standard applies to
mattress support rods. However, the
bassinet standard does not require the
metal rods to be attached permanently
to the liner. If the product passes the
segmented mattress flatness test
contained in the bassinet standard with
the mattress support rods removed, the
mattress support rods do not need to be
permanently attached.
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13. Concern That Patent-Only
Technology May Be Required
(Comment 14)—One commenter
indicates that there is a patent
application pending detailing 10
different methods to ‘‘stiffen a play yard
mattress pad before it is used in a play
yard bassinet accessory.’’ The
commenter acknowledges that ‘‘there
may not be any products on the market
today that would be impacted by this
patent application’’ but that the CPSC
should ‘‘evaluate this issue and avoid
design restrictions that limit
marketplace competition.’’
(Response 14)—The concern
regarding the means of stiffening a
mattress pad is no longer an issue for
the play yard rule because the play yard
bassinet accessory misassembly
requirement no longer applies to
mattress support rods or any other
methods that might be used to stiffen a
mattress pad. Instead, the play yard rule
only focuses on accessory attachment
components that attach the bassinet
accessory to the play yard.
Likewise, the bassinet rule, which
does address mattress flatness, does not
require that a specific design be used to
pass the standard. As a result, the
bassinet mattress flatness test can be
met in a variety of ways without
necessarily implicating patented
technology.
14. International Harmonization/Impact
on Trade
(Comment 15)—One commenter
expresses concerns that the requirement
could impact trade agreements and
emphasizes the importance of
international standard harmonization.
(Response 15)—When drafting the
NPR for the play yard mandatory
standard, published in September 2011,
CPSC staff reviewed, compared, and
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considered a variety of play yard
standards, including the Canadian
standard, the European standard, and
the Australian/New Zealand standard.
These international standards vary in a
variety of respects. Thus, even if we
adopt all or part of an international
standard, we still would not achieve
complete international harmonization.
We are aware of the utility of having
harmonized standards in a global
marketplace, and we continue to strive
to achieve this harmonization whenever
practicable. Notably, no other standard
addresses the risks associated with play
yard bassinet accessory misassembly.
However, we will continue to monitor
the effects that our standards have on
international standards.
15. Deference to ASTM Standard
(Comment 16)—One commenter
requests that staff defer to the ASTM
standard.
(Response 16)—Under section 104 of
the CPSIA, the Commission must
establish a mandatory standard for play
yards and cannot defer to a voluntary
standard. However, the CPSC is
incorporating the current ASTM
standard, ASTM F406–13, by reference.
F. 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). We are providing a sixmonth effective date, as proposed in the
NPR. The CPSC has generally
recommended a six-month effective date
for rules issued under section 104 of the
CPSIA and we find no reason to deviate
from this practice for this rule.
G. Regulatory Flexibility Act
1. Introduction
The Regulatory Flexibility Act (RFA),
5 U.S.C. 601–605, requires that final
rules be reviewed for their potential
economic impact on small entities,
including small businesses. Section 604
of the RFA requires that we prepare a
final regulatory flexibility analysis when
promulgating final rules, unless the
head of the agency certifies that the rule
will not have a significant economic
impact on a substantial number of small
entities. As explained in this section, we
certify that the rule will not have a
significant impact on a substantial
number of small entities.
2. The Market
There are 26 firms known to be
supplying play yards to the U.S. market.
However, not all 26 firms supply
bassinet accessories with the play yard.
Of the 26 firms, 11 do not supply
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50333
bassinet accessories. The remaining 15
firms supply at least one model of a play
yard that is accompanied by a bassinet
accessory: 13 are domestic
manufacturers or importers; one is a
foreign manufacturer; and one is a
foreign importer who imports from a
foreign country and distributes the
products from outside the United States.
Under U.S. Small Business
Administration Guidelines, eight of the
15 firms are small firms (five domestic
manufacturers and three domestic
importers).
3. Impact of the Standard on Small
Businesses
Currently, all but one of the 15 firms
supplying play yards to the U.S. market
that are accompanied by bassinet
accessories have their accessory
attachment components permanently
attached to the bassinet accessory. The
remaining firm has started developing a
design that permanently attaches all of
the accessory attachment components to
the bassinet accessory. Therefore, the
CPSC believes that this requirement is
not likely to have a significant impact
on a substantial number of small
entities.
H. Paperwork Reduction Act (PRA), 44
U.S.C. 3501–3521
ASTM F406–12a, which is
incorporated by reference into the play
yard standard codified at 16 CFR Part
1221, requires labels and instructions to
be supplied with the product. The PRA
requirements for the play yard standard
codified at 16 CFR Part 1221 have been
submitted to the Office of Management
and Budget (OMB), and OMB has
assigned control number 3041–0152 to
the information collection. We estimate
that there are no additional burden
hours associated with incorporating by
reference ASTM F406–13.
I. Environmental Considerations
The Commission’s regulations address
whether we are required to prepare an
environmental assessment or an
environmental impact statement. Our
rules generally have ‘‘little or no
potential for affecting the human
environment,’’ and therefore, our rules
are generally exempt from any
requirement to prepare an
environmental assessment or impact
statement. 16 CFR 1021.5(c)(1). This
rule falls within the categorical
exclusion.
J. Preemption
Section 26(a) of the Consumer
Product Safety Act (CPSA), 15 U.S.C.
2075(a), provides that where a consumer
product safety standard is in effect and
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applies to a product, no state or political
subdivision of a state may establish or
continue in effect a requirement dealing
with the same risk of injury, unless the
state’s requirement is identical to the
federal standard. Section 26(c) of the
CPSA also provides that states or
political subdivisions of states may
apply to the Commission for an
exemption from this preemption under
certain circumstances. Section 104(b) of
the CPSIA refers to the rules to be
issued under that section as ‘‘consumer
product safety rules,’’ thus implying
that the preemptive effect of section
26(a) of the CPSA would apply.
Therefore, a rule issued under section
104 of the CPSIA will invoke the
preemptive effect of section 26(a) of the
CPSA when the rule becomes effective.
other children’s product safety rules for
which the CPSC has issued NORs.
K. Certification and Notice of
Requirements (NOR)
Testing to Functionally Equivalent
Provisions of ASTM F406–12a and
ASTM 406–13
For purposes of testing, the provisions
of revised ASTM F406–13 are
equivalent or functionally equivalent to
ASTM F406–12a, with one significant
exception discussed below. (By
‘‘functionally equivalent,’’ we mean that
the standards organization made certain
changes in the revised standard
compared to the earlier standard, but
the changes are not substantial and do
not affect the associated conformance
testing.)
Consequently, the Commission is
continuing to recognize acceptance of
accreditation of laboratories currently
accredited under ASTM F406–12a for
the provisions in ASTM F406–13 that
are equivalent or functionally
equivalent to their corresponding
provisions in ASTM F406–12a. The
laboratories should test play yards for
compliance with ASTM F406–13, and
based on such testing, manufacturers
should issue certificates under section
14(a)(2) of the CPSA. Laboratories that
are accredited to test to provisions of
ASTM F406–12a that are equivalent or
functionally equivalent for children’s
product certification purposes do not
need to become accredited to ASTM
F406–13 before the next time their
accreditation body reassesses that
laboratory and recognizes that the scope
of the laboratory’s accreditation
includes ASTM F406–13. In the course
of applying to the CPSC for acceptance
of their accreditation, the laboratory
must submit CPSC Form 223 with the
applicable accompanying documents to
continue to have their accreditation to
16 CFR Part 1221 (incorporating by
reference ASTM F406–13) accepted. We
will revise our listing for the laboratory
when the laboratory becomes accredited
to 16 CFR Part 1221 (incorporating by
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1. Background
Section 14(a) of the CPSA requires
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 CPSCenforced 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 (or
laboratory). Section 14(a)(3) of the CPSA
requires the Commission to publish a
notice of requirements (NOR) for
laboratories to assess conformity with a
children’s product safety rule to which
a children’s product is subject. The rule
for 16 CFR Part 1221, ‘‘Safety Standard
for Play Yards,’’ 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), and
became effective on June 10, 2013. Part
1112 establishes requirements for
accreditation for third party conformity
assessment bodies to test for
conformance with a children’s product
safety rule in accordance with section
14(a)(2) of the CPSA. The final rule also
codifies a list of all the NORs that the
CPSC had published, to date, at the time
part 1112 was issued. The Commission
published an NOR for the play yard rule
in the final rule for part 1112. The play
yard standard is listed along with all the
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Jkt 229001
2. Play Yards
Testing laboratories applying to be a
CPSC-accepted third party conformity
assessment body to test to the standard
for play yards are required to meet the
accreditation requirements in part 1112.
When a laboratory meets the
requirements as a CPSC-accepted third
party conformity assessment body, the
laboratory can apply to the CPSC to
have 16 CFR Part 1221, ‘‘Safety
Standard for Play Yards,’’ included in
the laboratory’s scope of accreditation.
All of the CPSC safety rules included in
a laboratory’s scope of accreditation are
listed on the CPSC Web site at:
www.cpsc.gov/labsearch.
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reference ASTM F406–13) and the CPSC
accepts the laboratory’s application for
accreditation.
Testing to the New Bassinet
Misassembly Provisions
ASTM F406–13 added one new
testing requirement that is not present
in ASTM F406–12a. Section 8.31 of
ASTM F406–13 adds a new test to
evaluate conformity with a new
substantive requirement found in
section 5.19 regarding missing accessory
attachment components for play yard
bassinet/cradle accessories. Neither of
these provisions existed in ASTM F406–
12a. Third party testing for section 8.31,
as required by the new performance
requirement contained in section 5.19,
is required only for play yards with
bassinet/cradle accessories and applies
to products manufactured or imported
after this final rule becomes effective.
If a laboratory wishes to test play
yards for compliance with the play yard
bassinet accessory misassembly
requirement, the laboratory will need to
become accredited under ASTM F406–
13 first. This may mean that the
laboratory will need to become
accredited to ASTM F406–13 before the
regularly scheduled reassessment by
their accreditation body.
New Applicants
New third party conformity
assessment body applicants that apply
for CPSC acceptance on or after
February 19, 2014, must be accredited to
16 CFR Part 1221 (incorporating by
reference ASTM F406–13), when
applying for CPSC acceptance of their
accreditation to test play yards
3. Retrospective Testing
Some laboratories may want to start
testing play yards to assess conformity
with the play yard bassinet accessory
misassembly requirement before the
Commission is able to accept their
accreditation to 16 CFR Part 1221
(incorporating by reference ASTM
F406–13.) Laboratories may begin
testing for conformance with the play
yard bassinet accessory misassembly
requirement before the CPSC accepts
their accreditation, and their test results
will be valid retrospectively, if the
following conditions are met:
• At the time of testing, the product
was tested by a laboratory that was ISO/
IEC 17025:2005(E) accredited by an
ILAC–MRA member at the time of the
test. At the time of testing, the scope of
the third party conformity body
accreditation, as reported by the
accreditation body, must include testing
in accordance with ASTM F406–13 or
16 CFR Part 1221 (incorporating by
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reference ASTM F406–13). In addition,
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 ASTM
F406–13 or 16 CFR Part 1221
(incorporating by reference ASTM
F406–13) at the time of initial
Commission acceptance. For
governmental third party conformity
assessment bodies, accreditation of the
body must be accepted by the
Commission on or before the time that
the children’s product was tested, even
if the scope of accreditation did not
include ASTM F406–13 or 16 CFR Part
1221 (incorporating by reference ASTM
F406–13) at the time of initial CPSC
acceptance.
• The test results show compliance
with ASTM F406–13 or 16 CFR Part
1221 (incorporating by reference ASTM
F406–13).
• The play yard was tested on or after
May 1, 2013, the date that ASTM
approved ASTM F406–13, and before
February 19, 2014.
• The laboratory’s accreditation
remains in effect through February 19,
2014.
List of Subjects in 16 CFR Part 1221
Consumer Protection, Imports,
Incorporation by reference, Infants and
children, Labeling, Law enforcement,
Safety and toys.
Therefore, the Commission amends
Title 16 of the Code of Federal
Regulations as follows:
PART 1221—SAFETY STANDARD FOR
PLAY YARDS
Register approves this incorporation by
reference in accordance with 5 U.S.C.
552(a) and 1 CFR Part 51. You may
obtain a copy from ASTM International,
100 Bar Harbor Drive, P.O. Box 0700,
West Conshohocken, PA 19428; https://
www.astm.org. You may inspect a copy
at the Office of the Secretary, U.S.
Consumer Product Safety Commission,
Room 820, 4330 East West Highway,
Bethesda, MD 20814, telephone 301–
504–7923, or at the National Archives
and Records Administration (NARA).
For information on the availability of
this material at NARA, call 202–741–
6030, or go to: https://www.archives.gov/
federal_register/code_of_federal
regulations/ibr_locations.html.
(b) Comply with the ASTM F406–13
standard with the following exclusions:
(1) Do not comply with section 5.17
of ASTM F406–13.
(2) Do not comply with section 5.20
of ASTM F406–13.
(3) Do not comply with section 6,
Performance Requirements for RigidSided Products, of ASTM F406–13, in
its entirety.
(4) Do not comply with sections 8.1
through 8.10.5 of ASTM F406–13.
(5) Instead of complying with section
9.4.2.10 of ASTM F406–13, comply only
with the following:
(i) 9.4.2.10 For products that have a
separate mattress that is not
permanently fixed in place: Use ONLY
mattress/pad provided by manufacturer.
(ii) [Reserved]
(6) Do not comply with section
10.1.1.1 of ASTM F406–13.
Dated: August 13, 2013.
Todd A. Stevenson,
Secretary, Consumer Product Safety
Commission
[FR Doc. 2013–19964 Filed 8–16–13; 8:45 am]
BILLING CODE 6355–01–P
■
2. Revise § 1221.1 to read as follows:
§ 1221.1
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■
§ 1221.2
Requirements for play yards.
(a) Except as provided in paragraph
(b) of this section, each play yard must
comply with all applicable provisions of
ASTM F406–13, Standard Consumer
Safety Specification for Non-Full-Size
Baby Cribs/Play Yards, approved on
May 1, 2013. The Director of the Federal
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DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 168
[Docket No. USCG–2012–0975]
RIN 1625–AB96
Double Hull Tanker Escorts on the
Waters of Prince William Sound,
Alaska
DEPARTMENT OF THE TREASURY
Fiscal Service
SUMMARY:
Sale and Issue of Marketable BookEntry Treasury Bills, Notes, and Bonds
3. Revise § 1221.2 to read as follows:
BILLING CODE 1505–01–D
Coast Guard, DHS.
Interim rule with request for
comments.
[Docket No. Fiscal-BPD–2013–0001]
This part establishes a consumer
product safety standard for play yards
manufactured or imported on or after
February 19, 2014.
[FR Doc. C1–2013–18178 Filed 8–16–13; 8:45 am]
ACTION:
31 CFR Part 356
Scope.
2. On the same page, in the second
column, in the sixth line from the
bottom, ‘‘a1’’ should read ‘‘ai’’.
3. On the same page, in the same
column, in the third line from the
bottom, ‘‘T1’’ should read ‘‘Ti’’.
4. On the same page, in the third
column, in the seventh line above Table
3, ‘‘0.004278267 + 0.00472818’’ should
read ‘‘0.004278267 + 0.004472818’’.
5. On page 46438, in the first column,
in the third line, ‘‘Ti-1’’ should read ‘‘Ti
¥ Ti-1’’.
6. On the same page, in the same
column, in the ninth line, ‘‘Ai = 61 ×
0.000625077 = 0.038129697’’ should
read ‘‘A1 = 61 × 0.000625077 =
0.038129697’’.
7. One the same page, in the second
column, in the fourth line, ‘‘Bi = 1 + (r
+ m) × (Ti ¥ 1)/360’’, should read ‘‘Bi
= 1 + (r + m) × (Ti ¥ Ti-1)/360’’.
8. On page 46441, in Table 6, in the
second column, in the first line, ‘‘TO ¥
T-1 = 31’’ should read ‘‘T0 ¥ T¥1 = 31’’.
9. On the same page, in the second
column, the tenth line above Table 4,
‘‘Ti-1 and T1’’ should read ‘‘Ti-1 and Ti’’.
AGENCY:
1. The authority citation for part 1221
continues to read as follows:
■
Authority: The Consumer Product Safety
Improvement Act of 2008, Pub. L. 110–314,
section 104, 122 Stat. 3016 (August 14, 2008).
50335
Correction
In rule document 2013–18178
appearing on pages 46426–46445 in the
issue of July 31, 2013, make the
following corrections:
Appendix B to Part 356 [Corrected]
1. On page 46437, in the first column,
in the third line from the bottom, ‘‘a1 =
100 × max(r + s, 0)/360’’ should read ‘‘ai
= 100 × max(r + s, 0)/360’’.
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The Coast Guard is amending
the escort requirements for certain
tankers operating on the waters of
Prince William Sound, Alaska (PWS).
This interim rule is necessary to
implement section 711 of the Coast
Guard Authorization Act of 2010 (Act),
which mandates two tug escorts for
double hull tankers over 5,000 gross
tons transporting oil in bulk in PWS.
The Act directed the Coast Guard to
promulgate interim regulations as soon
and practicable to ensure that tug escort
requirements apply to certain double
hull tankers.
DATES: This interim rule is effective
September 18, 2013. Comments and
related material must either be
submitted to our online docket via http:
E:\FR\FM\19AUR1.SGM
19AUR1
Agencies
[Federal Register Volume 78, Number 160 (Monday, August 19, 2013)]
[Rules and Regulations]
[Pages 50328-50335]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-19964]
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1221
[CPSC Docket No. CPSC-2011-0064]
RIN 3041-AC92
Safety Standard for Play Yards
AGENCY: Consumer Product Safety Commission.
ACTION: Final rule.
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SUMMARY: The United States Consumer Product Safety Commission
(Commission or CPSC or we) is issuing a final rule, amending the play
yard mandatory standard. Currently, the CPSC play yard standard
incorporates by reference ASTM F406-12a, Standard Consumer Safety
Specification for Non-Full-Size Baby Cribs/Play Yards. In this final
rule, the Commission is amending the play yard standard to incorporate
by reference the most recent version of ASTM's play yard standard, ASTM
F406-13. Through this amendment, the Commission is addressing hazards
associated with misassembly of play yard bassinet accessories.
DATES: This rule will become effective on February 19, 2014 and will
apply to all play yards manufactured or imported on or after that date.
The incorporation by reference of the publication listed in this rule
is approved by the Director of the Federal Register as of February 19,
2014.
FOR FURTHER INFORMATION CONTACT: Justin Jirgl, Compliance Officer,
Office of Compliance and Field Investigations, U.S. Consumer Product
Safety Commission, 4330 East West Highway, Bethesda, MD 20814; email:
jjirgl@cpsc.gov.
SUPPLEMENTARY INFORMATION:
A. Background
On August 29, 2012, the Commission published a final rule
establishing a CPSC safety standard for play yards. 77 FR 52220. On the
same date, the Commission published a notice of proposed rulemaking
(NPR), seeking comments on the addition of a requirement to the play
yard mandatory standard to address the hazards associated with play
yard bassinet accessories that can be assembled without key structural
elements. 77 FR 52272. The NPR was prompted by the death of an infant
in a play yard bassinet accessory, in which the end support rods, which
attached two of the bassinet accessory's four sides to the play yard
rails, were omitted during assembly. The other two sides were attached
with plastic clips. After the infant was left to sleep, one of the
plastic clips that attached the bassinet accessory to the play yard
detached. Because the support rods were not in place to secure the
bassinet accessory, the bassinet sleep surface tilted, and the infant
slid into the corner of the tilted bassinet accessory and suffocated.
In the August 2012 NPR, we proposed a provision that would require
that all ``key structural elements'' be permanently attached to the
bassinet accessory or pass the ``catastrophic failure test,'' which is
described in more detail in section D of this preamble. In the August
2012 NPR, the term ``key structural elements'' included all structures
that attach the bassinet accessory to the play yard, as well as all
structures that reinforce the bassinet accessory mattress by keeping it
flat and stable, such as the mattress support rods.
Since publication of the August 2012 NPR, the ASTM play yard
subcommittee carefully assessed the incident that prompted this
requirement. The subcommittee worked closely with the ASTM bassinet/
cradle subcommittee and chose to address the hazards associated with
bassinet accessory misassembly in two different ASTM standards: (1) The
play yard standard, ASTM F406-13, now addresses safety issues related
to bassinet accessory attachment components (i.e., structures that
attach the bassinet accessory to the play yard); and (2) the bassinet
standard, ASTM F2194-13, Standard Consumer Safety Specification for
Bassinets and Cradles, addresses safety issues related to mattress
support rods (and all other structures that ensure that the bassinet
accessory mattress is flat and stable) through the segmented mattress
flatness test contained in the bassinet standard. That approach is now
part of the current ASTM standard for play yards, ASTM F406-13, and for
bassinets, ASTM F2194-13. Likewise, the Commission is following this
approach in the CPSC standard for play yards and in the CPSC standard
for bassinets and cradles. The Commission believes that this approach
addresses the hazards known to CPSC staff associated with play yard
bassinet misassembly.
B. The Product
ASTM F406-13 defines a ``play yard'' as a ``framed enclosure that
includes a floor and has mesh or fabric sided panels primarily intended
to provide a play or sleeping environment for children. It may fold for
storage or travel.'' Play yards are intended for children who are less
than 35 inches tall and who cannot climb out of the product. Some play
yards include accessory items that attach to the product, such as
mobiles, toy bars, canopies, bassinets, and changing tables. The
accessory item usually attaches to the side rails or corner brackets of
the play yard.
A ``bassinet/cradle accessory'' is defined in ASTM F406-13 as ``an
elevated sleep surface that attaches to a play yard designed to convert
the product into a bassinet/cradle intended to have a horizontal sleep
surface while in a rest (non-rocking) position.'' Play yard bassinet
accessories commonly consist of a textile shell that provides an
elevated sleep surface within the play yard. The floor of the bassinet
accessory is typically the same dimensions as the play yard floor.
Usually, the segmented mattress pad that is used on the floor of
[[Page 50329]]
the play yard is inserted into the bassinet shell. The floor of the
bassinet accessory is typically reinforced with mattress support rods
to ensure a flat, stable sleep surface. The top edges of the sides of
the bassinet accessory can be secured to the play yard top rails with
any number of devices, but most often is done through plastic clips
sewn onto the sides of the shell. Metal rods may also be used to secure
the bassinet to the play yard. These metal rods are usually inserted
into a sleeve on the top edge of the shell's side wall and clipped into
a play yard's corner brackets.
C. History of the Play Yard Mandatory Standard
In the Federal Register of September 20, 2011 (76 FR 58167), the
Commission published an NPR to establish a safety standard for play
yards. The NPR proposed incorporating by reference ASTM F406-11. It is
important to note that ASTM F406 is the safety standard for both non-
full-size cribs and play yards. The NPR for play yards indicated which
sections of the ASTM standard would apply to play yards and excluded
from CPSC's play yard standard the provisions of ASTM F406 that apply
to non-full-size cribs. After publication of the 2011 NPR, CPSC staff
became aware of an incident, mentioned in section A of this preamble
and described in more detail in section D of this preamble, where an
infant died while sleeping in a play yard bassinet accessory that had
been assembled without end supports. The Commission received a comment
to the 2011 NPR requesting that we address play yard bassinet accessory
misassembly.
On August 29, 2012, the Commission published a final rule to
establish a safety standard for play yards that incorporated by
reference ASTM F406-12a. 77 FR 52220. The final rule did not address
the hazards associated with the use of play yard bassinet accessories
that can be assembled missing key structural elements. On the same
date, the Commission published an NPR proposing an addition to the play
yard mandatory standard to address the hazards associated with the use
of play yard bassinet accessories that can be assembled missing key
structural elements and asking for comments on the proposal. 77 FR
52272.
D. The Play Yard Bassinet Accessory Misassembly Provision
1. Summary of the Hazard and the Infant Fatality
Many play yards are sold with accessories that attach to the
product, such as mobiles, toy bars, canopies, bassinets, and changing
tables. Play yard bassinet accessories are unique among play yard
accessories because they are intended to be used as a sleeping
environment, and infants are meant to be left unsupervised in them for
extended periods of time. Serious injuries or fatalities can result if
a play yard bassinet accessory has been assembled without support
structures. Those structures are intended to attach the bassinet
accessory to the side of the play yard, as well as support the bassinet
accessory mattress in order to keep the sleep surface flat and level. A
tilt in the sleeping surface of the bassinet can result in an infant
getting into a position where he or she is unable to breathe and is at
risk of suffocation.
In August 2011, the CPSC received a report of an infant fatality
that occurred in the bassinet accessory of a play yard. The child died
when the sleeping surface of the bassinet tilted, causing the child to
slip into the corner of the bassinet accessory, where she suffocated. A
review of the In-Depth Investigation Report (IDI), as well as CPSC
staff testing on an exemplar model of the bassinet accessory and play
yard involved in the fatality, led CPSC staff to conclude that the
incident was caused by the omission of metal support rods that were
used to secure two of the bassinet accessory's ends to the side of the
play yard. The bassinet accessory also had sewn-on plastic clips that
attached the product to the side rails of the play yard. Sometime after
the child was placed in the bassinet accessory, one of the plastic
clips detached. If the metal support rods had been used in the assembly
of the play yard, the detachment of the plastic clip would not have
been enough to cause the tilt in the sleeping surface that led to the
fatality. However, the plastic clips caused the consumer to assume
erroneously that the product was safe when key structural elements, the
end support rods that secured the bassinet accessory's ends to the play
yard end rails, were missing. The omission of the metal support rods
caused the fatal tilt of the bassinet accessory sleep surface and
resulted in the infant's death.
As in this case, a consumer initially may not see that supporting
rods are missing. If the misassembled accessory supports an infant
without a catastrophic and obvious change to the sleep surface, a
consumer may continue to use the accessory and inadvertently place a
child in danger. If the bassinet's sleep surface tilts while the child
is unsupervised, the caregiver may not discover the condition for
hours, placing the child in a potentially fatal situation.
2. The Bassinet Misassembly Requirement Contained in the August 2012
NPR
The requirement the Commission proposed in the August 2012 NPR was
designed to address the hazards that can occur when play yard bassinet
accessories are misassembled by omitting key structural elements during
assembly. The NPR proposed two compliance options. First, the bassinet
accessory would meet the requirement if all of the key structural
elements were attached permanently to the bassinet accessory. This
would prevent any support rods, tubes, bars, and hooks from being
omitted inadvertently when the consumer assembles the bassinet
accessory. Manufacturers who choose to affix all key structural
elements to their bassinets permanently would not need to conduct
further testing on their product to meet the requirement.
The second method for compliance proposed in the NPR involved a
test method that CPSC refers to as the ``catastrophic failure test.''
If a manufacturer chooses not to attach support rods, tubes, bars, or
hooks permanently to the bassinet, the bassinet would have to be tested
by removing each key structural element and numbering each from 1
through n. Subsequently, all of the key structural elements would be
put back into place. Key structural element number 1 would then be
removed from the bassinet. To pass the test when an anthropomorphic
infant dummy is placed in the center of the sleep surface, the product
must: (1) Collapse completely, or (2) tilt more than 30[deg]. The angle
of 30[deg] represents a safety factor of three times the 10[deg]
maximum safe sleep surface angle of incline. CPSC Human Factors staff
concluded that an angle of 30[deg] would be sufficiently obvious to a
consumer to discourage the consumer from continuing to use the
bassinet. The test would continue until each key structural element has
been tested individually (thus, key structural element number 1 would
be inserted back into the product, key structural element number 2
would be removed, and the test would be repeated.)
The proposed requirement was meant to ensure that the omission of a
key structural element would be so visually obvious that the consumer
would not use the product and place the child in danger inadvertently.
To pass this test, the item must fail catastrophically when each key
structural element is omitted.
[[Page 50330]]
3. The Bassinet Misassembly Requirement Contained in ASTM F406-13 and
Incorporated in the Final Rule
The work on the play yard bassinet accessory misassembly
requirement began after we received a comment on the issue in response
to the September 2011 play yard NPR. CPSC staff worked with the ASTM
play yard subcommittee for more than a year to develop the language to
address this hazard. The ASTM play yard subcommittee is made up of key
stakeholders, including manufacturers, retailers, third party test
laboratories, independent consultants, consumer advocates,
representatives from Health Canada, and CPSC staff.
The result of this effort is the language now contained in ASTM
F406-13, which this rule incorporates by reference. The requirement
addressing play yard bassinet accessory misassembly is essentially the
same as the requirement proposed in the August 2012 NPR, with two
important differences that were suggested in comments that the
Commission received in response to the August 2012 NPR.
The first difference involves addressing the bassinet accessory
structural supporting elements in two different standards: Play yards
and bassinets/cradles. In the August 2012 NPR, the term ``key
structural elements,'' included all rods, tubes, bars, and hooks that
supported the bassinet accessory or that were used in assembling the
bassinet accessory. Not only did the term include structures that
attach the bassinet to the play yard, but the term also encompassed the
mattress support rods and other structures that support the bassinet
accessory mattress in order to keep the sleep surface flat and stable.
The ASTM play yard subcommittee, working closely with the ASTM
bassinet/cradle subcommittee, determined that any issues dealing with
misassembly of the mattress support rods should be addressed in the
bassinet standard. Thus, both ASTM subcommittees agreed that: (1) The
play yard standard, ASTM F406-13, will address safety issues related to
bassinet accessory attachment components (i.e., structures that attach
the bassinet accessory to the play yard); and (2) the bassinet
standard, ASTM F2194-13, will address mattress support rods (and all
other structures that keep the bassinet accessory mattress flat and
stable) through the segmented mattress flatness test contained in the
bassinet standard.
The second substantive difference is also the result of a comment
received in response to the August 2012 NPR. As proposed in the August
2012 NPR, the catastrophic failure test is conducted with a 7.5-pound
newborn CAMI dummy. ASTM F406-13 requires that the test be conducted
with a four-pound test mass. This weight represents the mass of the
smallest newborn known to staff that would be released from a hospital,
and thus, the smallest expected play yard bassinet accessory occupant.
Using a smaller test mass makes the play yard bassinet misassembly
provision in ASTM F406-13 more stringent than the requirement the
Commission proposed in the August 2012 NPR.
The final rule incorporates by reference ASTM F 406-13. By
referencing this newer version of the ASTM play yard standard, the CPSC
standard addresses the hazards known to CPSC staff posed by misassembly
of play yard bassinet accessories in substantially the same manner as
the Commission proposed in the 2012 NPR. The final rule continues to
exclude from the CPSC's play yard standard the provisions in ASTM F 406
that apply to non-full-size cribs. The Commission has a separate
standard for non-full-size cribs. See 16 CFR part 1220.
E. Response to Comments on the Proposed Rule
The preamble to the NPR invited comments concerning all aspects of
the proposed rule. We received 13 comments. Many of the comments
contained more than one issue. Thus, we organized our responses by
issue, rather than respond to each commenter individually. All of the
comments can be viewed on www.regulations.gov, by searching under the
docket number for this rulemaking, CPSC-2011-0064.
1. Generally Unsupportive
(Comment 1)--Two commenters indicate that they generally do not
support the requirement. Both commenters feel that the regulation is
unnecessary because the hazard was caused by misassembly of the
product.
(Response 1) --The Danny Keysar Child Product Safety Notification
Act, section 104 of the Consumer Product Safety Improvement Act of 2008
(CPSIA) requires that we promulgate mandatory regulations for durable
infant and toddler products, including play yards, that are
substantially the same as an existing voluntary standard, or more
stringent than the voluntary standard if the Commission determines that
more stringent standards would reduce the risk of injury associated
with the product. In this case, we believe that the proposed final rule
incorporating by reference ASTM F406-13 is appropriate to reduce the
risk of injury associated with play yards. Therefore, the issuance of
this final rule fulfills a statutory mandate given to the CPSC by
Congress.
In addition, we disagree with the assertion that hazards caused by
misassembly should not be addressed through mandatory regulations. The
CPSC is often faced with hazards that result from the reasonably
foreseeable use of consumer products. Preventing the possibility of
misassembly is especially critical when the product in question has
been designed to provide a safe sleep environment for an infant, and
when the result of misassembly could be severe, such as an infant
fatality. The CPSC must assess whether there are solutions that would
minimize the possibility of misassembly. One solution could be to
improve assembly instructions or warning labels. Another solution, and
the one that has been chosen here, is to require that products that
must be assembled by consumers be designed in such a way that they are
very difficult to misassemble.
(Comment 2)--One commenter expresses a number of concerns about the
new requirement. Specifically, the commenter feels that the
requirement: (1) Does not address completely the hazards that caused
the infant fatality; (2) was created too quickly and the process
rushed; (3) is design restrictive; and (4) will fail safe products.
(Response 2)--The bassinet accessory misassembly performance
requirement and test method were fine-tuned for more than a year from
January 2012 through April 2013. The circumstances involving the infant
fatality were analyzed in detail and significant changes were made to
the requirement to ensure that it addressed the hazard in the least
burdensome manner. Notably, the scope of the play yard bassinet
accessory misassembly requirement was reduced by focusing only on
accessory attachment components and not all key structural elements.
This reduction in scope was a direct result of careful analysis of the
circumstances that resulted in the infant fatality.
The requirement was created and approved through consultation with
members of the ASTM play yard subcommittee, which includes many play
yard importers and manufacturers, as well as other stakeholders, such
as retailers, testing laboratories, independent consultants,
representatives from consumer advocacy groups, and representatives from
Health Canada.
To provide manufacturers with options, and to avoid creating a
design restrictive standard, two methods of compliance were provided. A
manufacturer can permanently attach all
[[Page 50331]]
accessory attachment components or design a product that passes the
catastrophic failure test. Finally, if the standard is found to be too
severe and is failing safe products, it can be updated as more data is
received by the CPSC.
2. Generally Supportive
(Comment 3)--Several commenters support the new requirement. One
commenter notes: ``(o)ur organizations strongly support these specific
requirements and test methods as well as the general principle that
misassembly is a design safety issue and should be adequately addressed
in product safety standards.'' Another commenter indicates: ``(w)hile I
strongly support and would prefer to see all key structural elements
permanently attached to the bassinet accessory, the catastrophic
failure test provides an option for manufacturers to come into
compliance and appears to address the hazards associated with play yard
bassinet accessories.'' Another commenter expresses ``overall support''
for the requirement and notes: ``(o)ne infant death is too many, and
the CPSC has acted quickly to develop a new safety standard for
bassinet accessories.''
(Response 3)--We agree with the commenters.
3. Effective Date
(Comment 4)--We received four comments addressing the appropriate
effective date for this regulation. One individual indicates her
agreement with the proposed six-month effective date. Other commenters
recommend a shorter effective date. Some commenters suggest that a 90-
day effective date would be more appropriate because safer products
would be available sooner, and manufacturers have had adequate notice
that the play yard bassinet accessory misassembly requirement will soon
be mandatory. Some commenters note that only products manufactured
after the effective date are impacted by the regulation. Thus, products
made before the effective date (products that may not be in compliance
with the bassinet accessory misassembly requirement contained in ASTM
F406-13) can continue to be sold.
(Response 4)--The CPSC has generally recommended a six-month
effective date for rules issued under section 104 of the CPSIA and we
find no compelling reason to deviate from this practice for this rule.
We share concerns about noncompliant products, those manufactured or
imported before the effective date, being available for years beyond
the effective date. However, ongoing compliance activities would
continue to be used to remove unsafe play yards from the market.
4. Coordination Between the Play Yard and Bassinet Standard
(Comment 5)--Four commenters discuss the overlap between the
mattress flatness requirement contained in ASTM F2194-13, Standard
Consumer Safety Specification for Bassinets and Cradles, and the
proposed play yard bassinet accessory misassembly requirements. The
commenters state that the play yard bassinet accessory misassembly
requirements, as published in the August 2012 NPR, contain requirements
that are more appropriately addressed in the bassinet segmented
mattress flatness requirement contained in the bassinet voluntary
standard.
(Response 5)--The CPSC agrees with these comments. As discussed
above, the play yard bassinet accessory misassembly requirement
contained in ASTM F406-13 now only applies to accessory attachment
components (i.e., those structures that attach the bassinet accessory
to the play yard). Misassembly issues related to mattress support rods
are now addressed in ASTM F2194-13, the standard for bassinets and
cradles. ASTM F2194-13 requires that if the mattress support rods are
not permanently attached, the bassinet must be tested pursuant to the
mattress flatness test contained in ASTM F2194-13, and the product must
pass the mattress flatness test both with and without the mattress
support rods in place. The CPSC is finalizing a rule for bassinets/
cradles that incorporates by reference ASTM F2194-13.
5. Clarity of ``Key Structural Element'' Definition
(Comment 6)--One commenter asks that the definition of ``key
structural element'' be clarified. Specifically, the commenter asks if
the following are key structural elements: (1) clips that are sewn to
the play yard bassinet accessory shell; and (2) metal bars that provide
support for the bassinet mattress.
(Response 6)--The definition of ``key structural element''
presented in the August 2012 NPR has been modified. The final rule
incorporates by reference ASTM F406-13. The language published in ASTM
F406-13 now limits the scope of the play yard bassinet misassembly
requirement by defining ``accessory attachment components'' as ``the
components that provide the means of attachment for a bassinet/cradle
accessory to a play yard.''
Thus, clips sewn to the play yard bassinet accessory shell that
attach the bassinet accessory to the play yard are accessory attachment
components. Metal bars that provide support to the bassinet accessory
mattress, and that do not attach the bassinet accessory to the play
yard, are not accessory attachment components; therefore, they are not
subject to the play yard bassinet accessory misassembly requirement
contained in ASTM F406-13.
6. Catastrophic Failure Test Is Confusing or Is Arbitrary and
Capricious
(Comment 7)--One commenter indicates that it would be easier, and
cause less confusion, if the play yard bassinet accessory misassembly
provision simply required that all key structural elements be
permanently attached to the bassinet accessory instead of giving
manufacturers the option of complying with the catastrophic failure
test. Another commenter indicates that the permanent affixture test
should be the only method of complying with the requirement and asserts
that the catastrophic failure test is not the least burdensome
requirement and violates the Administrative Procedure Act because it is
arbitrary and capricious.
(Response 7)--The catastrophic failure test can appear confusing
and counterintuitive because, in order to pass the test, the product
must fail catastrophically when one piece is missing. However, this
test was thoroughly vetted during the ASTM process. The ASTM
subcommittee stakeholders felt that the test is a sound alternative to
permanently attaching all accessory attachment components. In fact,
initially, CPSC staff suggested that the only method of compliance
should be to require that all key structural elements be permanently
attached. The catastrophic failure option was added at the request of
manufacturers' representatives. However, once the requirement goes into
effect, both ASTM and the CPSC will monitor any issues that arise in
using the catastrophic failure test to meet the requirement and will
address them as necessary.
Additionally, the catastrophic failure test is an alternative to
the permanent affixture test. Although the CPSC does not feel that the
permanent affixture test is design restrictive, providing as many
alternatives for compliance as possible is important, so that products
with drastically different designs are able to meet the requirement.
[[Page 50332]]
7. Catastrophic Failure Test and the Test Mass Size, Use, and Location
(Comment 8)--One commenter questions the use of the newborn CAMI
dummy (weighing 7.5 pounds), as proposed in the August 2012 NPR. The
commenter ultimately questions the use of a test mass at all,
hypothesizing that the requirement could be more severe if no test mass
were used. Another commenter recommends that the CPSC consider a
lighter test mass so that a greater proportion of the newborn
population will be covered by the play yard bassinet accessory
misassembly requirement.
(Response 8)--We agree that the mass of the newborn CAMI dummy is
too large. CPSC staff developed a new four-pound test mass and
presented the four-pound test mass proposal to the ASTM play yard
subcommittee for review and consideration. The play yard bassinet
accessory misassembly requirement, contained in section 5.19 of ASTM
F406-13, contains a rationale that states that the four-pound mass
represents the weight of the smallest newborn who would be using the
bassinet accessory because infants smaller than four pounds are
unlikely to be released from a hospital. Using the smallest reasonable
mass makes the play yard bassinet accessory misassembly requirement
more stringent than the proposal in the August 2012 NPR. Eliminating
the test mass entirely, as one commenter suggests, is unnecessarily
restrictive.
8. Catastrophic Failure Test and the Basis for the 30[deg] Mattress
Angle Requirement
(Comment 9)--Several commenters object to the 30[deg] tilt
requirement in the catastrophic failure test. Many commenters feel that
the requirement is not adequately supported by scientific data.
(Response 9)--The angle of 30[deg] represents a safety factor of
three times the 10[deg] maximum safe sleep surface angle of incline.
CPSC Human Factors staff concluded that an angle of 30[deg] would be
sufficiently visually obvious to a consumer, such that the consumer
would be discouraged from continuing to use the bassinet. Staff then
recommended that the ASTM play yard subcommittee review and critique
the 30[deg] angle. ASTM stakeholders agreed with CPSC staff that
30[deg] was reasonable and would be considered by caregivers to be
obviously hazardous. CPSC staff, as well as ASTM members, can
reconsider the tilt angle requirement should evidence be presented
indicating that the angle is too small or large.
9. Redundant Product Safety Features
(Comment 10)--One commenter states that the play yard bassinet
accessory misassembly requirement, as contained in the August 2012 NPR,
may result in manufacturers eliminating ``redundant safety features
that are already a component of the product.'' The commenter mentions
mattress support rods as an example of a structure that is not
necessary to comply with the voluntary standard but does improve
product safety, by helping to create a ``flatter and more stable
sleeping position.'' The commenter concludes that the added cost of
being required to permanently affix redundant structures would lead to
the elimination of the structures to avoid this cost, resulting in
compliant but less safe products being sold.
(Response 10)--Like many members of the ASTM play yard
subcommittee, this commenter is concerned that regulating mattress
support rods in the play yard rule through the bassinet accessory
misassembly requirement is inappropriate. Members of the play yard and
bassinet subcommittees resolved this issue by agreeing to regulate
bassinet accessory attachment components in the play yard standard, and
by agreeing to regulate bassinet accessory mattress support rods in the
bassinet/cradle standard. As a result, the play yard bassinet accessory
misassembly requirement in F406-13 now only applies to accessory
attachment components. Misassembly issues related to mattress support
rods are now addressed in ASTM F2194-13, the voluntary standard for
bassinets and cradles. ASTM F2194-13 requires that bassinets with
removable mattress support rods be tested both with and without the
mattress support rods. The bassinet must pass the segmented mattress
flatness test contained in ASTM F2194-13 with and without the mattress
support rods. In this way, all misassembly issues known to CPSC staff
related to play yard bassinet accessories are addressed in either the
play yard or the bassinet standard.
10. Other Options for Compliance
(Comment 11)--One commenter asks that a third option for compliance
be considered in addition to the two already proposed in the August
2012 NPR. The commenter suggests that a product be considered to be in
compliance if the product continues to meet the standard's requirements
after all of the key structural elements are removed.
(Response 11)--This approach has been adopted in the bassinet
standard contained in ASTM F2194-13. ASTM F2194-13 requires that
removable mattress support rods be tested pursuant to the segmented
mattress flatness tests contained in ASTM F2194-13 without the rods in
place. If the product passes the mattress flatness test, even without
the mattress support rods in place, the product meets the requirements.
We do not agree, however, that this commenter's proposal should be
an option for accessory attachment components meant to attach the
bassinet accessory to the play yard rails. In the fatal incident, one
of the accessory attachment components, the end support rods, was
omitted and only the plastic clips were used. The fatality resulted
when the caregiver assumed that the product was safe because no
visually obvious cues suggested that the product was unsafe. Therefore,
for accessory attachment components, we believe that the standard
should require that the accessory attachment components be either
permanently attached or pass the catastrophic failure test by obviously
failing when an accessory attachment component is missing.
11. Cost of Play Yard Bassinet Accessory Misassembly Requirement
(Comment 12)--One commenter indicates that cost of ``re-
engineering'' and ``retooling'' would be significant. The commenter
also mentions that the requirement would necessitate a change to the
packaging. The commenter believes that the issue merits additional
research.
(Response 12)--Although the new requirement might impose additional
costs on manufacturers and importers, staff consulted and worked
closely with members of the industry to devise an acceptable solution
that would address the safety hazard but not impose unnecessary costs.
12. Ability To Launder
(Comment 13)--One commenter indicates that permanently affixing key
structural elements to the product may interfere with the ability to
launder the product. The commenter is specifically concerned about the
metal rods that support a bassinet accessory shell or liner. If the
metal rods were required to be affixed permanently to the liner, the
bassinet accessory shell would be difficult to clean.
(Response 13)--Although the CPSC's primary concern is that play
yards and bassinet accessories are safe, the CPSC does consider
practical issues, such as the ability to launder, in connection with
new standards and requirements. The commenter's specific concern
[[Page 50333]]
regarding the ability to launder a bassinet accessory shell that is
supported by metal support rods is no longer an issue addressable by
the play yard bassinet accessory misassembly requirement because ASTM
F406 no longer applies to mattress support rods. Instead, ASTM F406-13
focuses only on accessory attachment components that attach the
bassinet accessory to the play yard.
The bassinet standard applies to mattress support rods. However,
the bassinet standard does not require the metal rods to be attached
permanently to the liner. If the product passes the segmented mattress
flatness test contained in the bassinet standard with the mattress
support rods removed, the mattress support rods do not need to be
permanently attached.
13. Concern That Patent-Only Technology May Be Required
(Comment 14)--One commenter indicates that there is a patent
application pending detailing 10 different methods to ``stiffen a play
yard mattress pad before it is used in a play yard bassinet
accessory.'' The commenter acknowledges that ``there may not be any
products on the market today that would be impacted by this patent
application'' but that the CPSC should ``evaluate this issue and avoid
design restrictions that limit marketplace competition.''
(Response 14)--The concern regarding the means of stiffening a
mattress pad is no longer an issue for the play yard rule because the
play yard bassinet accessory misassembly requirement no longer applies
to mattress support rods or any other methods that might be used to
stiffen a mattress pad. Instead, the play yard rule only focuses on
accessory attachment components that attach the bassinet accessory to
the play yard.
Likewise, the bassinet rule, which does address mattress flatness,
does not require that a specific design be used to pass the standard.
As a result, the bassinet mattress flatness test can be met in a
variety of ways without necessarily implicating patented technology.
14. International Harmonization/Impact on Trade
(Comment 15)--One commenter expresses concerns that the requirement
could impact trade agreements and emphasizes the importance of
international standard harmonization.
(Response 15)--When drafting the NPR for the play yard mandatory
standard, published in September 2011, CPSC staff reviewed, compared,
and considered a variety of play yard standards, including the Canadian
standard, the European standard, and the Australian/New Zealand
standard. These international standards vary in a variety of respects.
Thus, even if we adopt all or part of an international standard, we
still would not achieve complete international harmonization. We are
aware of the utility of having harmonized standards in a global
marketplace, and we continue to strive to achieve this harmonization
whenever practicable. Notably, no other standard addresses the risks
associated with play yard bassinet accessory misassembly. However, we
will continue to monitor the effects that our standards have on
international standards.
15. Deference to ASTM Standard
(Comment 16)--One commenter requests that staff defer to the ASTM
standard.
(Response 16)--Under section 104 of the CPSIA, the Commission must
establish a mandatory standard for play yards and cannot defer to a
voluntary standard. However, the CPSC is incorporating the current ASTM
standard, ASTM F406-13, by reference.
F. 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). We are providing a six-month effective
date, as proposed in the NPR. The CPSC has generally recommended a six-
month effective date for rules issued under section 104 of the CPSIA
and we find no reason to deviate from this practice for this rule.
G. Regulatory Flexibility Act
1. Introduction
The Regulatory Flexibility Act (RFA), 5 U.S.C. 601-605, requires
that final rules be reviewed for their potential economic impact on
small entities, including small businesses. Section 604 of the RFA
requires that we prepare a final regulatory flexibility analysis when
promulgating final rules, unless the head of the agency certifies that
the rule will not have a significant economic impact on a substantial
number of small entities. As explained in this section, we certify that
the rule will not have a significant impact on a substantial number of
small entities.
2. The Market
There are 26 firms known to be supplying play yards to the U.S.
market. However, not all 26 firms supply bassinet accessories with the
play yard. Of the 26 firms, 11 do not supply bassinet accessories. The
remaining 15 firms supply at least one model of a play yard that is
accompanied by a bassinet accessory: 13 are domestic manufacturers or
importers; one is a foreign manufacturer; and one is a foreign importer
who imports from a foreign country and distributes the products from
outside the United States. Under U.S. Small Business Administration
Guidelines, eight of the 15 firms are small firms (five domestic
manufacturers and three domestic importers).
3. Impact of the Standard on Small Businesses
Currently, all but one of the 15 firms supplying play yards to the
U.S. market that are accompanied by bassinet accessories have their
accessory attachment components permanently attached to the bassinet
accessory. The remaining firm has started developing a design that
permanently attaches all of the accessory attachment components to the
bassinet accessory. Therefore, the CPSC believes that this requirement
is not likely to have a significant impact on a substantial number of
small entities.
H. Paperwork Reduction Act (PRA), 44 U.S.C. 3501-3521
ASTM F406-12a, which is incorporated by reference into the play
yard standard codified at 16 CFR Part 1221, requires labels and
instructions to be supplied with the product. The PRA requirements for
the play yard standard codified at 16 CFR Part 1221 have been submitted
to the Office of Management and Budget (OMB), and OMB has assigned
control number 3041-0152 to the information collection. We estimate
that there are no additional burden hours associated with incorporating
by reference ASTM F406-13.
I. Environmental Considerations
The Commission's regulations address whether we are required to
prepare an environmental assessment or an environmental impact
statement. Our rules generally have ``little or no potential for
affecting the human environment,'' and therefore, our rules are
generally exempt from any requirement to prepare an environmental
assessment or impact statement. 16 CFR 1021.5(c)(1). This rule falls
within the categorical exclusion.
J. Preemption
Section 26(a) of the Consumer Product Safety Act (CPSA), 15 U.S.C.
2075(a), provides that where a consumer product safety standard is in
effect and
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applies to a product, no state or political subdivision of a state may
establish or continue in effect a requirement dealing with the same
risk of injury, unless the state's requirement is identical to the
federal standard. Section 26(c) of the CPSA also provides that states
or political subdivisions of states may apply to the Commission for an
exemption from this preemption under certain circumstances. Section
104(b) of the CPSIA refers to the rules to be issued under that section
as ``consumer product safety rules,'' thus implying that the preemptive
effect of section 26(a) of the CPSA would apply. Therefore, a rule
issued under section 104 of the CPSIA will invoke the preemptive effect
of section 26(a) of the CPSA when the rule becomes effective.
K. Certification and Notice of Requirements (NOR)
1. Background
Section 14(a) of the CPSA requires 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 (or laboratory). Section
14(a)(3) of the CPSA requires the Commission to publish a notice of
requirements (NOR) for laboratories to assess conformity with a
children's product safety rule to which a children's product is
subject. The rule for 16 CFR Part 1221, ``Safety Standard for Play
Yards,'' 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), and became effective on June 10, 2013. Part 1112
establishes requirements for accreditation for third party conformity
assessment bodies to test for conformance with a children's product
safety rule in accordance with section 14(a)(2) of the CPSA. The final
rule also codifies a list of all the NORs that the CPSC had published,
to date, at the time part 1112 was issued. The Commission published an
NOR for the play yard rule in the final rule for part 1112. The play
yard standard is listed along with all the other children's product
safety rules for which the CPSC has issued NORs.
2. Play Yards
Testing laboratories applying to be a CPSC-accepted third party
conformity assessment body to test to the standard for play yards are
required to meet the accreditation requirements in part 1112. When a
laboratory meets the requirements as a CPSC-accepted third party
conformity assessment body, the laboratory can apply to the CPSC to
have 16 CFR Part 1221, ``Safety Standard for Play Yards,'' included in
the laboratory's scope of accreditation. All of the CPSC safety rules
included in a laboratory's scope of accreditation are listed on the
CPSC Web site at: www.cpsc.gov/labsearch.
Testing to Functionally Equivalent Provisions of ASTM F406-12a and ASTM
406-13
For purposes of testing, the provisions of revised ASTM F406-13 are
equivalent or functionally equivalent to ASTM F406-12a, with one
significant exception discussed below. (By ``functionally equivalent,''
we mean that the standards organization made certain changes in the
revised standard compared to the earlier standard, but the changes are
not substantial and do not affect the associated conformance testing.)
Consequently, the Commission is continuing to recognize acceptance
of accreditation of laboratories currently accredited under ASTM F406-
12a for the provisions in ASTM F406-13 that are equivalent or
functionally equivalent to their corresponding provisions in ASTM F406-
12a. The laboratories should test play yards for compliance with ASTM
F406-13, and based on such testing, manufacturers should issue
certificates under section 14(a)(2) of the CPSA. Laboratories that are
accredited to test to provisions of ASTM F406-12a that are equivalent
or functionally equivalent for children's product certification
purposes do not need to become accredited to ASTM F406-13 before the
next time their accreditation body reassesses that laboratory and
recognizes that the scope of the laboratory's accreditation includes
ASTM F406-13. In the course of applying to the CPSC for acceptance of
their accreditation, the laboratory must submit CPSC Form 223 with the
applicable accompanying documents to continue to have their
accreditation to 16 CFR Part 1221 (incorporating by reference ASTM
F406-13) accepted. We will revise our listing for the laboratory when
the laboratory becomes accredited to 16 CFR Part 1221 (incorporating by
reference ASTM F406-13) and the CPSC accepts the laboratory's
application for accreditation.
Testing to the New Bassinet Misassembly Provisions
ASTM F406-13 added one new testing requirement that is not present
in ASTM F406-12a. Section 8.31 of ASTM F406-13 adds a new test to
evaluate conformity with a new substantive requirement found in section
5.19 regarding missing accessory attachment components for play yard
bassinet/cradle accessories. Neither of these provisions existed in
ASTM F406-12a. Third party testing for section 8.31, as required by the
new performance requirement contained in section 5.19, is required only
for play yards with bassinet/cradle accessories and applies to products
manufactured or imported after this final rule becomes effective.
If a laboratory wishes to test play yards for compliance with the
play yard bassinet accessory misassembly requirement, the laboratory
will need to become accredited under ASTM F406-13 first. This may mean
that the laboratory will need to become accredited to ASTM F406-13
before the regularly scheduled reassessment by their accreditation
body.
New Applicants
New third party conformity assessment body applicants that apply
for CPSC acceptance on or after February 19, 2014, must be accredited
to 16 CFR Part 1221 (incorporating by reference ASTM F406-13), when
applying for CPSC acceptance of their accreditation to test play yards
3. Retrospective Testing
Some laboratories may want to start testing play yards to assess
conformity with the play yard bassinet accessory misassembly
requirement before the Commission is able to accept their accreditation
to 16 CFR Part 1221 (incorporating by reference ASTM F406-13.)
Laboratories may begin testing for conformance with the play yard
bassinet accessory misassembly requirement before the CPSC accepts
their accreditation, and their test results will be valid
retrospectively, if the following conditions are met:
At the time of testing, the product was tested by a
laboratory that was ISO/IEC 17025:2005(E) accredited by an ILAC-MRA
member at the time of the test. At the time of testing, the scope of
the third party conformity body accreditation, as reported by the
accreditation body, must include testing in accordance with ASTM F406-
13 or 16 CFR Part 1221 (incorporating by
[[Page 50335]]
reference ASTM F406-13). In addition, 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 ASTM F406-13 or 16 CFR Part
1221 (incorporating by reference ASTM F406-13) at the time of initial
Commission acceptance. For governmental third party conformity
assessment bodies, accreditation of the body must be accepted by the
Commission on or before the time that the children's product was
tested, even if the scope of accreditation did not include ASTM F406-13
or 16 CFR Part 1221 (incorporating by reference ASTM F406-13) at the
time of initial CPSC acceptance.
The test results show compliance with ASTM F406-13 or 16
CFR Part 1221 (incorporating by reference ASTM F406-13).
The play yard was tested on or after May 1, 2013, the date
that ASTM approved ASTM F406-13, and before February 19, 2014.
The laboratory's accreditation remains in effect through
February 19, 2014.
List of Subjects in 16 CFR Part 1221
Consumer Protection, Imports, Incorporation by reference, Infants
and children, Labeling, Law enforcement, Safety and toys.
Therefore, the Commission amends Title 16 of the Code of Federal
Regulations as follows:
PART 1221--SAFETY STANDARD FOR PLAY YARDS
0
1. The authority citation for part 1221 continues to read as follows:
Authority: The Consumer Product Safety Improvement Act of 2008,
Pub. L. 110-314, section 104, 122 Stat. 3016 (August 14, 2008).
0
2. Revise Sec. 1221.1 to read as follows:
Sec. 1221.1 Scope.
This part establishes a consumer product safety standard for play
yards manufactured or imported on or after February 19, 2014.
0
3. Revise Sec. 1221.2 to read as follows:
Sec. 1221.2 Requirements for play yards.
(a) Except as provided in paragraph (b) of this section, each play
yard must comply with all applicable provisions of ASTM F406-13,
Standard Consumer Safety Specification for Non-Full-Size Baby Cribs/
Play Yards, approved on May 1, 2013. The Director of the Federal
Register approves this incorporation by reference in accordance with 5
U.S.C. 552(a) and 1 CFR Part 51. You may obtain a copy from ASTM
International, 100 Bar Harbor Drive, P.O. Box 0700, West Conshohocken,
PA 19428; https://www.astm.org. You may inspect a copy at the Office of
the Secretary, U.S. Consumer Product Safety Commission, Room 820, 4330
East West Highway, Bethesda, MD 20814, telephone 301-504-7923, or at
the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: https://www.archives.gov/federal_register/code_of_federal regulations/ibr_locations.html.
(b) Comply with the ASTM F406-13 standard with the following
exclusions:
(1) Do not comply with section 5.17 of ASTM F406-13.
(2) Do not comply with section 5.20 of ASTM F406-13.
(3) Do not comply with section 6, Performance Requirements for
Rigid-Sided Products, of ASTM F406-13, in its entirety.
(4) Do not comply with sections 8.1 through 8.10.5 of ASTM F406-13.
(5) Instead of complying with section 9.4.2.10 of ASTM F406-13,
comply only with the following:
(i) 9.4.2.10 For products that have a separate mattress that is not
permanently fixed in place: Use ONLY mattress/pad provided by
manufacturer.
(ii) [Reserved]
(6) Do not comply with section 10.1.1.1 of ASTM F406-13.
Dated: August 13, 2013.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission
[FR Doc. 2013-19964 Filed 8-16-13; 8:45 am]
BILLING CODE 6355-01-P