Federal Register, Volume 77 Issue 168 (Wednesday, August 29, 2012)

[Federal Register Volume 77, Number 168 (Wednesday, August 29, 2012)]
[Rules and Regulations]
[Pages 52220-52228]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-21168]

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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: Section 104(b) of the Consumer Product Safety Improvement Act
of 2008 (CPSIA), also known as the ``Danny Keysar Child Product Safety
Notification Act,'' requires the United States Consumer Product Safety
Commission (Commission, CPSC, us, or we) to promulgate consumer product
safety standards for durable infant or toddler products. These
standards are to be ``substantially the same as'' applicable voluntary
standards or more stringent than the voluntary standard if the
Commission concludes that more stringent requirements would further
reduce the risk of injury associated with the product. In this rule, we
are issuing a safety standard for play yards in response to the
CPSIA.\1\
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\1\ The Commission voted 4-0 to approve publication of this
rule. Chairman Inez M. Tenenbaum filed a statement concerning this
action which may be viewed on the Commission's Web site at http://www.cpsc.gov/library/foia/ballot/ballot12/playyards.pdf or obtained
from the Commission's Office of the Secretary.

DATES: This rule is effective on February 28, 2013 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 28,
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2013.

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: Section 104(b) of the Consumer Product Safety
Improvement Act

The Consumer Product Safety Improvement Act of 2008 (CPSIA, Pub. L.
110-314) was enacted on August 14, 2008. Section 104(b) of the CPSIA
requires the Commission to promulgate consumer product safety standards
for durable infant and toddler products. These standards are to be
``substantially the same as'' applicable voluntary standards or more
stringent than the voluntary standard if the Commission concludes that
more stringent requirements would further reduce the risk of injury
associated with the product. The term ``durable infant or toddler
product'' is defined in section 104(f)(1) of the CPSIA as a durable
product intended for use, or that may be reasonably expected to be
used, by children under the age of 5 years. Play yards are one of the
products specifically identified in section 104(f)(2)(F) as a durable
infant or toddler product.
In the Federal Register of September 20, 2011 (76 FR 58167), we
published a notice of proposed rulemaking (NPR) for play yards,
incorporating by reference ASTM F406-11, ``Standard Consumer Safety
Specification for Non-Full-Size Baby Cribs/Play Yards,'' with three
clarifications. ASTM F406 is the safety standard for both non-full-size
cribs and play yards. In the proposed rule for play yards, we indicated
which sections of the ASTM standard apply to play yards, and we
excluded the provisions of ASTM F406 that apply to non-full-size cribs.
The ASTM subcommittee on play yards developed a newer edition of
this standard, ASTM F406-12a, which includes the three clarifications
we proposed in the NPR. ASTM F406-12a also contains two clarifications
that were suggested in comments we received from the public in response
to the NPR. Those two clarifications: (1) Added a preload to the
mattress vertical displacement test; and (2) exempted from the top rail
configuration requirement play yards with upward-folding top rails.
In this document, we are issuing a safety standard for play yards,
which incorporates by reference ASTM F406-12a and provides a 6-month
(from the date of publication) effective date for the mandatory play
yard standard.

B. The Product

ASTM F406-12a 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, who cannot climb out of the product. Some play
yards include accessory items that attach to the product, including
mobiles, toy bars, canopies, bassinets, and changing tables.

C. Incident Data

The preamble to the NPR (76 FR 58168) summarized the data for
incidents related to play yards reported to us from early November 2007
through early April 2011. The final rule is based on the data provided
in the NPR, as well as updated data on incidents related to play yards
reported to us from April 2011 through December 31, 2011.
From April 10, 2011, through December 31, 2011, we received
information on 41 play yard-related incidents. Fifteen of the 41
incidents were fatal. Of the remaining 26 incidents, eight resulted in
injuries to the child.

[[Page 52221]]

Eleven of the 15 fatal incidents are attributable to an unsafe
sleep environment, such as the presence of soft bedding. For one
fatality, very little information was supplied to us and, we were
unable to determine the cause of the death. Three of the 15 fatalities
were play yard related. One child died when the bassinet accessory
being used as a sleep environment was assembled without key structural
elements, which resulted in a dangerous tilt of the sleep surface. The
child slid into the corner of the bassinet and suffocated. In another
incident, a child was attempting to climb out of a play yard and, while
holding onto a separate bassinet nearby, the canopy of the bassinet
fell forward and caught him on the back of the neck, suffocating him. A
third child suffocated when he got his head stuck in a torn opening
between the floor and the mesh side of the play yard.
The recent incidents have hazard patterns similar to those reported
in the NPR, and include:
Eleven incidents, all resulting in fatalities, were the
result of unsafe sleep environments and unsafe sleep practices.
Ten incidents were caused by broken or detached component
parts, such as loose wheels and loose hardware, which resulted in the
instability or collapse of the product. There were three injuries
reported in this category.
Five incidents were related to the mesh or fabric sides of
the play yard, such as stitching that unraveled, tears in the fabric,
and mesh holes that were too large. There were two injuries and one
fatality reported in this category.
Four incidents were caused by hazardous accessories, such
as broken or detached components from a mobile or a tent accessory.
There was one injury reported in this category.
Three incidents were related to the mattress pad or floor
of the play yard, including reports that the fasteners designed to keep
the floor board in place failed. There were no injuries reported in
this category.
Three incidents were due to the side rail of the play yard
collapsing. There were no injuries in this category.
Two incidents were the result of the child being able to
climb out of the play yard. There was one injury and one fatality
reported in this category.
One incident, which resulted in a fatality, can be
attributed to assembly issues in the bassinet accessory of a play yard.
In this incident, the bassinet was missing key structural elements
meant to support the accessory. The sleep surface of the bassinet
tilted, and the child slid into the corner and suffocated.
One incident was the result of a child nearly choking on a
sticker that was a component of the play yard.
For one reported fatality associated with a play yard,
there was insufficient information to determine the cause.

D. Response to Comments on the Proposed Rule

The preamble to the NPR invited comments concerning all aspects of
the proposed rule. We received comments from 23 individuals or
organizations. Many of the comments contained more than one issue.
Thus, we organized our responses by issue, rather than responding to
each individual commenter. Each comment and response is numbered below
to help distinguish between different comments. The number assigned to
each comment is purely for organizational purposes and does not signify
the comment's value or importance, or the order in which it was
received. 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 of Regulations

(Comment 1)--One commenter does not support government regulation
of this, or any, consumer product and asserts that the free market will
``weed out those manufacturers of unsafe products.''
(Response 1)--The CPSIA requires that we promulgate mandatory
regulations for durable infant or toddler products, including play
yards. This final rule fulfills a statutory obligation given to us by
Congress. Accordingly, issuance of a play yard mandatory standard is
consistent with the statutory requirements of the CPSIA.

2. The Definition of ``Play Yard''

(Comment 2)--One commenter notes a possible loophole in the ASTM
F406 definition of ``play yard'' because materials other than mesh or
fabric could be used to form the walls. According to the commenter,
this would allow a manufacturer to circumvent the mandatory play yard
rule.
(Response 2)--Play yards with sides made of materials that are not
flexible would be considered rigid-sided products. These products would
be classified as full-size- or non-full-size cribs, subject to more
severe requirements under 16 CFR part 1219 (full-size cribs) or 16 CFR
part 1220 (non-full-size cribs). It would be less burdensome to produce
a mesh- or fabric-sided product. Accordingly, we do not believe that a
play yard manufacturer would attempt to evade the play yard standard
requirements by making a rigid-sided product.

3. ASTM Voluntary Standard as the Basis for the Mandatory Standard

(Comment 3)--Three commenters note that the ASTM standard might not
be the best basis for the mandatory play yard rule. Each commenter
asserts that because we do not have data to indicate whether the
fatalities and injuries were caused by play yards not in compliance
with the current ASTM standard, we cannot be sure that incorporating by
reference the ASTM standard will result in safer play yards.
(Response 3)--The CPSIA requires that we base our mandatory
standard for play yards on a voluntary standard. We chose the ASTM
standard because it is the most widely used play yard standard in the
United States. The ASTM committees that produce the durable infant and
toddler product standards represent a cross-section of stakeholders,
including manufacturers, retailers, testing laboratories, independent
consultants, representatives from consumer advocacy groups,
representatives from Health Canada, as well as CPSC staff. The creation
of an ASTM standard involves analyzing CPSC incident data in detail,
assessing other standards (including international standards), and
testing products. The ASTM standard upon which we are basing the
mandatory regulation addresses the known hazards of play yards and it
is the most stringent standard available. Therefore, we believe that it
is an appropriate standard upon which to base the play yard mandatory
rule.

4. Injury Rates

(Comment 4)--One commenter indicates that ``the extremely low
incidence of injury puts into question the need for regulation at all,
outside of the CPSIA mandate, as there probably is no heinous market
failure.''
(Response 4)--The standard is based on careful analysis of
incidents, injuries, and fatalities associated with play yards. Injury
rates, when available, are an important part of that analysis. In this
case, however, even if we agreed with the commenter that the injury
rate is too low, that does not negate the requirement for the issuance
of a play yard mandatory standard, which fulfills a statutory
obligation given to us by Congress. However, we disagree with the
commenter and believe that the incidents, injuries, and fatalities
justify

[[Page 52222]]

the issuance of a play yard mandatory standard.

5. American Baby Group Data

(Comment 5)--One commenter says that the ``record demonstrates that
the Commission relies solely upon information provided by a 2005 survey
by American Baby Group for all market data,'' and that ``affected
parties may challenge the rule by claiming that the Commission's
actions are based on old, inaccurate data.''
(Response 5)--The commenter is incorrect in assuming that the 2005
American Baby Group survey (2006 Baby Products Tracking Study) was the
sole source of market information we considered in the rulemaking
process. The Baby Products Tracking Study was used to provide an
estimate of the magnitude of the play yard market. The initial
regulatory flexibility analysis recognized the limitations of this
data, both for its age and potentially biased sampling methods.
However, we also used market research--conducted independently--to
perform the regulatory flexibility analysis. This research provided
information on the number of firms supplying play yards to the U.S.
market, their type, their size, and their location. We also researched,
independently, the number of products supplied by each firm, each
firm's compliance with the voluntary standard, as well as details about
accessories sold with each play yard. It is this information, along
with input from our staff and play yard manufacturers, which led to the
conclusions of the initial regulatory flexibility analysis.

6. Small Business Impact

(Comment 6)--One commenter expresses concerns about how effectively
the CPSC complied with the requirements of the Regulatory Flexibility
Act (RFA). The commenter asserts that the proposed rule will have a
significant impact on all small firms.
(Response 6)--The economic impact of the mandatory play yard
standard proposed in the NPR would not be significant for play yard
suppliers who already are in compliance with the ASTM play yard
standard. Many play yard manufacturers and importers have a history of
making adjustments to their play yards to remain in compliance with the
ASTM standard, and they likely would continue to comply in the absence
of a mandatory standard. Firms with a history of voluntary compliance
would have few, if any, costs associated with the proposed rule,
regardless of their size.
The initial regulatory flexibility analysis recognized that the
impact on firms that supply noncompliant play yards to the U.S. market
potentially could be significant. However, because the CPSIA requires
that we promulgate a mandatory standard that is substantially the same
as, or more stringent than, the voluntary standard, the CPSC is limited
in how it can minimize the economic impact on small firms that are not
in compliance with the standard.

7. International Standards

(Comment 7)--We received two comments regarding international play
yard standards. One commenter expresses the concern that our play yard
mandatory standard could impact trade agreements and emphasizes the
importance of standards harmonization as a way to avoid this. Another
commenter states that international harmonization should be a priority.
(Response 7)--When drafting the NPR for play yards, we reviewed,
compared, and considered a variety of play yard standards, including
the Canadian standard, the European standard, and the Australian/New
Zealand standard. There are differences among all of the international
standards. Thus, even if we adopt part, or all, of one of the standards
listed here, we still would not have complete international
harmonization. We are aware of the utility of having harmonized
standards in a global marketplace, and we will continue to strive to
achieve this harmonization, whenever possible.

8. Adequacy of Testing

(Comment 8)--One commenter states that the proposed test methods
for play yards, which do not include any cyclic tests (tests that
involve hundreds or thousands of testing cycles in order to evaluate a
product's durability), are insufficient because play yards are set up
and taken down more often than cribs.
(Response 8)--Cyclic testing is time-consuming and expensive. For
play yards, we have found that using very heavy loads applied for one
testing cycle (instead of cyclic testing that would require relatively
lighter loads and testing cycles that are repeated hundreds or
thousands of times) can simulate a lifetime of use. The tests found in
the play yard standard were developed over time, and they have been
found to be reliable indicators of when a play yard could present a
hazard.

9. Quality Control

(Comment 9)--One commenter states that the CPSC should establish a
mandatory set of production and manufacturing inspection standards for
the industry.
(Response 9)--The CPSC's role is to monitor the results of the
manufacturing process, not participate in the process itself. We
monitor the manufacturing process in several ways. First, we are able
to act preventatively by issuing mandatory standards and requiring
children's products be third party tested by an accredited laboratory.
Second, we have the ability to act if the manufacturing process fails
and a product is sold that does not meet a mandatory standard or is
defective and presents a substantial risk of injury to the public.

10. Effective Date

(Comment 10)--Several commenters weigh in on the appropriate
effective date for the proposed rule. One commenter, representing
numerous juvenile product manufacturers, supports the proposed 6-month
effective date. One manufacturer says: ``from an industrial point of
view, 6 months of fulfilling a new legislation is very short'' and,
therefore, suggests a 12-month effective date. Two other commenters
also feel that the effective date should be longer. One suggests that
it is ``doubtful that a six month grace period would provide sufficient
protection for the small businesses that the RFA intends to protect,''
while the other says that an effective date ``6 months after
publication of the final rule'' is ``seemingly arbitrary'' and that
other alternatives ``may encourage more compliance.''
One commenter, representing several consumer advocacy groups,
recommends: ``an effective date of 90 days after publication in the
Federal Register.'' Their rationale is twofold. First, ``the changes to
the voluntary standard proposed by CPSC are minor,'' the commenter
opines. Second, the commenter adds: ``it affects only product
manufactured after that date, not sold by that date,'' and
``manufacturers and retailers have large inventories of children's
products and will be able to sell noncompliant product for years after
the effective date. The sooner new products meet the standard, the
better for the infants and toddlers who will be using them.''
(Response 10)--We consider 6 months sufficient time for suppliers
to come into compliance with the proposed rule. Although a longer
effective date would allow small entities to spread their costs

[[Page 52223]]

out over a longer period of time, 6 months is common in the industry.
For example, 6 months is the amount of time the Juvenile Products
Manufacturers Association allows for products in their certification
program to shift to a new standard. On the other hand, a shorter
effective date could put a substantial burden on firms, particularly
those whose play yards currently do not meet the requirements of the
voluntary ASTM standard.
We share concerns about noncompliant products being available for
years beyond the effective date. However, the number and severity of
play yard incidents does not seem to warrant a shorter effective date
than that used for other durable infant products, particularly given
that ongoing compliance activities would continue to be used to pull
unsafe play yards from the market.

11. Bassinet and Cradle Accessory Misassembly

(Comment 11)--One commenter states that incidents arise from
products that appear to be set up correctly but are actually
misassembled. The commenter recommends that we add language to the
mandatory play yard standard to address this hazard, by requiring
products with consumer-assembled components be designed to prevent
misassembly. If that is not possible, the commenter suggests that clear
visual indicators be included to alert consumers that the accessory has
not been assembled correctly.
(Response 11)--Many play yards are sold with accessories that
attach to the product, such as bassinets, changing tables, and mobiles.
Bassinet accessories are unique among play yard accessories because
bassinet accessories 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 key structural
elements, such as rods, tubes, bars, and hooks, which 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.
It is possible that the omission of key structural elements
initially may not be visually evident to the consumer. If the
misassembled accessory supports an infant without a catastrophic and
obvious change to the sleep surface, then a consumer may continue to
use the accessory and place a child in danger inadvertently.
We considered adding a provision to the play yard final rule to
address the hazards associated with play yard bassinet accessories that
can be assembled while missing key structural elements. However, we
have chosen, instead, to publish an NPR in today's issue of the Federal
Register, in which we propose a requirement and a test method to
address bassinet accessory misassembly in play yards.

12. Play Yards With Upward Folding Side Rails

(Comment 12)--One commenter, a play yard manufacturer, states that
play yards with side rails that fold upward should be excluded from the
top rail configuration requirement. The commenter notes that most play
yards form a dangerous V-shape if the side rail latch mechanisms are
not locked properly. The commenter states that his firm's play yards
are designed differently than the ``typical'' play yard, in that the
top rail folds upward, which forms a non-dangerous upside down V-shape.
If a child were to put their weight on the top rail by leaning on it,
their weight would actually lock the top side rail further, rather than
unlock it. The commenter requests that the play yard standard exempt
play yards that fold upward from the top rail configuration requirement
because they will not expose a child to a dangerous V-shape.
(Response 12)--We agree with the commenter. The top rail
configuration requirements, found in section 7.10 of ASTM F406-12a, are
intended to address entrapment hazards associated with side rails
folding and creating a V-shape. If a child's neck is caught in the V-
shape, the child could suffocate. The exemption for play yards with
upward folding side rails has already been added to ASTM F406-12a. By
incorporating by reference ASTM F406-12a, we support the inclusion of
this clarification in the play yard mandatory standard.

13. Unsafe Sleep Environment

(Comment 13)--Five commenters raise concerns about the addition of
soft bedding, such as blankets, pillows, and quilted covers, which can
create an unsafe sleep environment for an infant. Some commenters
suggest methods to educate the public about this issue, including:
Publishing a safety guide, providing public outreach through
traditional and social media, and offering information on the Web site:
www.saferproducts.gov, in addition to: www.cpsc.gov.
(Response 13)--We agree that this is an extremely serious issue,
and we are dedicated to public outreach and education campaigns that
could prevent infant fatalities caused by unsafe sleep environments and
practices. Safety guides, blogs, and videos addressing safe sleep are
already available on the agency's Web site at: www.cpsc.gov.
Additionally, we use traditional media channels, as well as popular
social media outlets, such as Twitter, YouTube and Flickr, to
disseminate information to the public about unsafe sleep environments
and practices.
(Comment 14)--One commenter recommends that graphics or pictograms
depicting the dangers of unsafe sleep environments be added to the
existing warnings in the play yard standard in order to enhance their
effectiveness.
(Response 14)--We believe that graphics depicted on warnings are
useful and potentially can enhance the effectiveness of warnings.
However, the development of an effective pictogram warning takes
considerable testing to ensure that the graphic is not confusing or
counterintuitive or does not lessen the effectiveness of current
warnings. We continue to evaluate warnings on play yards and other
children's products and will revise such warnings, as necessary.

14. Clearance Around Play Yards

(Comment 15)--One commenter is concerned about outside objects,
such as window blind cords and computer cords, which can fall into the
play yard and potentially strangle a child. The commenter feels that
requiring a minimum clearance of 24 inches around a play yard would
prevent children from reaching out and pulling window blind cords or
other hazardous objects into the play yard.
(Response 15)--For children who are too young to climb out of the
play yard, a minimum clearance of about 3 feet usually would suffice.
However, once a child can climb out of the play yard, this minimum
clearance has limited utility. For this reason, we feel that the
existing required warning on play yards, advising parents to stop using
the product once the child can climb out, is the most effective way to
prevent these incidents. The ASTM standard also includes warnings that
address the hazards of strings, cords, and window blind cords that may
fall into the play yard.

15. Play Yard Covers

(Comment 16)--One commenter is concerned about fatalities that have
occurred when caregivers place improvised covers on the play yard in an
attempt to keep children in the product. In some instances, children
were killed when attempting to climb

[[Page 52224]]

out of the play yard because they became trapped between the cover and
the play yard side rail. The commenter feels that perhaps, there is a
``market failure in providing adequate, and adequately priced,
covers.'' The commenter also suggests that play yard covers could be
subject to mandatory regulations.
(Response 16)--Before a child can stand and reach a cover, the
cover likely presents little risk. Once the child can reach it, the
cover itself becomes a hazard. We are aware of two fatal incidents
associated with covers and tents that can be affixed on top of play
yards and cribs. In one incident, a child was able to tear the tent
fabric and strangle in the loose strands. In the other incident, the
child was able to deform the tent poles and become trapped beneath the
mattress and the inverted poles. Because of these incidents, we
recommend that consumers avoid using tents and covers on play yards and
cribs. We believe that the following existing warning in section
9.4.2.6 of ASTM F406-12a is sufficient to address this hazard: ``Child
can become entrapped and die when improvised netting or covers are
placed on top of product. Never add such items to confine child in
product.''

16. Risks Associated With Children Climbing Out of a Play Yard

(Comment 17)--One commenter feels that the CPSC has ``unnecessarily
disregarded the idea to make the play yard walls higher'' as a way to
prevent children from climbing out of the product.
(Response 17)--A designer of a play yard faces limited options for
preventing children from climbing out of the product. The play yard is
essentially a lidless box. Play yards that prevent climbing out would
require either higher sides or lids to be effective. Both designs could
introduce other problems that potentially are of more concern than the
problem of climbing out of the play yard. For instance, making the
sides higher increases the difficulty caregivers have placing their
children, especially the youngest ones, into the play yard. This could
increase the use of alternative sleeping arrangements, such as allowing
children to sleep in adult beds, which can have serious hazards
associated with them. Introducing a lid or some other kind of cover to
a play yard creates more movable parts and the potential for mechanical
failures that could lead to entrapment, entanglement, or strangulation.
We have been unable to identify a performance requirement for
inclusion in the play yard standard that would effectively reduce
incidents of children climbing out of play yards without simultaneously
introducing other potential hazards. The current ASTM standard contains
a warning advising parents to stop using the product once a child can
climb out of the play yard. We feel that this is the most effective way
to prevent injuries associated with children being able to climb out of
play yards.

17. Standing/Choking Deaths

(Comment 18)--In the NPR, we reported that two toddlers were killed
in separate incidents while standing up in a play yard. It is believed
that they leaned forward against the side rail (perhaps to reach an
object that the child had thrown outside the play yard), lost
consciousness, or suffocated when the pressure from the side rail
compressed their airway. One commenter asks that we continue to
investigate these deaths and address this hazard.
(Response 18)--We are very concerned about these deaths. At this
time, we are unable to explain how these children died; and thus, we
are unable to comment on whether there are changes that could be made
to play yard designs that would prevent fatalities like this from
occurring. We have reached out to medical professionals and are
continuing to collect information that might assist us in understanding
the deaths and determining whether there is an engineering solution
that could prevent them.

18. Hazards Related to Accessories

(Comment 19)--One commenter notes that the accessories that come
with play yards can be dangerous. Specifically, the commenter feels
that changing table attachments should come with restraints.
(Response 19)--There are strong arguments against changing table
attachments having restraints, including the concern that the presence
of restraints will give the consumer a false sense of security about
the accessory. Restraints might lead to the caregiver walking away
while the infant is left on the table. More troubling is the concern
that parents mistakenly will use changing tables as a sleep
environment, which is not the intended use of the product and can be
very dangerous. Thus, we cannot recommend that changing tables have
restraints.
(Comment 20)--One commenter requests that play yard accessories,
such as changing tables and bassinets, be banned completely. Failing
this, the commenter asks that these products be required to lock in
place so that they cannot be manipulated by infants and toddlers. The
commenter's 13-month-old daughter died when her head became trapped
between a non-locking changing table attachment and side rail of a play
yard.
(Response 20)--The current ASTM standard includes a requirement to
address this hazard. It can be found in section 5.15 of ASTM F406-12a,
titled, Entrapment in Accessories. The requirement was added in 2005.
The standard requires that accessories not separate from a play yard
when an infant-size head probe is pushed against the attachment from
inside the play yard with 25 pounds of force. The pushing direction is
varied to evaluate the security of the attachment to the play yard
better. We feel that this test is adequate to address the hazard the
commenter mentions, and we are not recommending any further action.
(Comment 21)--One commenter states that the cyclic testing required
for rigid-sided products, contained in section 8.5 of ASTM F406-12a,
should be required for mesh-sided products, such as play yards. The
commenter states that a cyclic test would better assess the integrity
of play yard accessory attachment points used to secure bassinets and
changing tables to the side rails of play yards. The commenter
recommends that the cyclic testing in section 8.5 of the ASTM standard
be repeated with and without the attachments installed. The commenter
states that it appears that many incidents reported to the CPSC occur
when the accessory became unattached at one or more attachment points
and that additional durability testing will ensure that the attachment
points will hold through a lifetime of use.
(Response 21)--The purpose of the cyclic testing requirement, found
in section 8.5, is to evaluate the attachment security of threaded
fasteners, such as screws, used in rigid-sided products, specifically
full- and non-full-size cribs. Of the accessories mentioned by the
commenter, bassinet play yard accessories are of the greatest concern
because they are intended to be used while an infant is sleeping
unsupervised. The majority of play yard bassinet accessories are
structureless, fabric shells that attach to the top rails of play
yards. Because they have no structure of their own they will be
substantially unaffected by this kind of cyclic testing. The attachment
components in play yards typically consist of plastic clips, hook-and-
loop (Velcro) straps, or snaps sewn into soft material around the inner
perimeter of

[[Page 52225]]

the play yard. These attachment means are substantially different than
the threaded fasteners this test is intended to evaluate. Thus, we feel
that cyclic testing would not adequately test the durability of
attachment points in play yard accessories.
We identified five incidents where the attachment points of a play
yard bassinet accessory failed. None of the incidents resulted in an
injury to the child. Three incidents were caused by weak fabric or poor
stitching. These hazards are addressed in the ASTM standard for play
yards at sections 7.7 and 7.8, which address the durability of fabric
and the strength of seams. The other two incidents were caused by
separated hook-and-loop (Velcro) closures. On one, the closure failed
to secure during the consumer's first use of the product and permitted
the sleep surface to tilt slightly. The consumer noticed the problem
immediately. We have evaluated the incident and determined that it can
be attributed, most likely, to poor quality control in the
manufacturing process. In the other incident, the hook-and-loop
closure, used as a back-up means of attachment, wore out over time. The
concern is that if the primary attachment were to fail, the worn hook-
and-loop closure might permit the sleep surface to tilt. However, in
this case, because the hook-and-loop closure was a secondary means of
attachment, the product did not cause an injury or incident.
We share the commenter's concern about the robustness of bassinet
and cradle attachments, but we do not agree that requiring cyclic
testing for the attachment points will address those concerns. At this
point, we cannot recommend a performance requirement and test method
that would reduce the risk of injury associated with this hazard.
Incoming data will be monitored to ensure that any emerging trends are
identified.

19. Mattress Vertical Displacement Test Repeatability

(Comment 22)--One commenter feels that the consistency of the
mattress vertical displacement test could be improved by adding a
provision that accounts for slack in the mattress.
(Response 22)--The change the commenter suggests will improve
testing consistency for vertical mattress displacement by ensuring that
free movement of fabric is taken up before establishing the initial
clamp position reference point. It has already been approved by ASTM
members and was published in ASTM F406-12. It is also contained in
F406-12a. By incorporating by reference ASTM F406-12a, we support the
inclusion of this clarification in the play yard mandatory standard.

20. Impact on Play Yard

(Comment 23)--One commenter states that small children have
``wobbly legs and can fall down'' and sustain an injury because the
play yard is not secured firmly to the floor, or it might be placed on
an unlevel floor. The commenter suggests securing play yards to the
surface of hard floors with suction cups.
(Response 23)--Our incident data suggest that most children who are
injured by falling in a play yard simply lose their balance. Thus, we
disagree that children fall in play yards because the products are not
secured firmly to the floor. However, even if that were the case, we
disagree that suction cups will provide an improved attachment to hard
surfaces. The length of time for which the suction effect can be
maintained depends significantly on the porosity, flatness, and
cleanliness of the floor surface. Furthermore, play yards typically are
set up and taken down multiple times and are used on a multitude of
indoor surfaces, including carpet, hardwood, and tile, as well as
outdoor surfaces, such as grass or dirt. A consumer would not only have
to inspect the suction cups for cleanliness and physical deformation
before each use, but also remember to remove and install the suction
cups, as needed, depending upon the floor surface. Therefore, we feel
that requiring suction cups is not an adequate means of preventing
injuries to children who fall in play yards.

21. Warnings Statements

(Comment 24)--One commenter notes that the ASTM standard does not
require multilingual warnings, and they ask us to consider requiring
them. The commenter argues that the use of multilingual warnings
reasonably could be expected to reduce play yard injuries by educating
caregivers who do not speak or read English.
(Response 24)--We are not opposed to the use of multilingual
labels. Many manufacturers already use multilingual warnings, although
currently, they are not required. We feel that play yard manufacturers
are in the best position to determine who uses their product and decide
when to create labels and instructional materials in other languages.
(Comment 25)--One commenter feels that the warning label on play
yards requiring adult supervision while the child uses the product is
unreasonable because you cannot reasonably expect a parent to supervise
a child who is sleeping in a play yard.
(Response 25)--The warning label that this commenter refers to can
be found in section 9.4.2.11 of ASTM F406-12a, and it advises
caregivers: ``(a)lways provide the supervision necessary for the
continued safety of your child. When used for playing, never leave
child unattended.'' This warning is intended to address the use of play
yards as a play environment, not as a sleep environment. We agree with
the commenter that a caregiver is not expected to continuously
supervise a child who is sleeping in a play yard. This warning is
intended for caregivers who are using the product as a play
environment.

22. Package and Product Marking To Indicate Compliance With the
Mandatory Rule

(Comment 26)--One commenter recommends that products be marked
clearly to enable a consumer to determine if the product was
manufactured after the play yard mandatory standard became effective.
This would enable consumers to discern easily which products comply
with the mandatory rule, and which were manufactured before the
standard became effective.
(Response 26)--A date code is already required to be on the
product, under section 9.1.1.2 of ASTM F406-12a. In addition, future
changes to the standard may come into effect. Because it is not
practicable to delineate every change to the standard through a new
mark on the product, we decline to take action.

E. Summary of ASTM F406-12a and Description of the Final Rule

For the play yard final rule, we are incorporating by reference
ASTM F406-12a. The final rule excludes sections of ASTM F406-12a that
apply to non-full-size cribs exclusively. In this section, we: (1)
summarize the requirements of ASTM F406-12a; and (2) describe the final
rule, listing the excluded provisions of ASTM F406-12a that only apply
to non-full-size cribs.

1. Summary of ASTM F406-12a

In the NPR (76 FR 58169 through 58170), we described, in detail,
the key provisions of ASTM F406-11 that apply to play yards. ASTM F406-
12a differs from ASTM F406-11 in the following ways:
It includes the three changes to the play yard standard we
proposed in the NPR, specifically two clarifications to the testing
method used to measure the strength of the play yard floor, and one
change to the Top Rail to Corner Post

[[Page 52226]]

Attachment Test that would allow testers to choose the shape and area
of the clamping surface, within a specified range. We reviewed the
language that ASTM adopted and, while not exactly the same as the
wording we proposed in the NPR, we believe it provides better clarity
than what we proposed. By incorporating by reference ASTM F406-12a, we
support the inclusion of these clarifications in the play yard
mandatory standard.
On its own initiative, the ASTM committee clarified the
Top Rail to Corner Post Attachment Test, as well as the accompanying
explanatory graphics. By incorporating by reference ASTM F406-12a, we
support the inclusion of these clarifications in the play yard
mandatory standard.
A preload was added to the Mattress Vertical Displacement
Test in order to improve testing consistency by ensuring that free
movement of fabric is taken up before establishing the initial clamp
position reference point. We also received a comment to the NPR
suggesting this change. By incorporating by reference ASTM F406-12a, we
support the inclusion of this clarification in the play yard mandatory
standard.
An exemption was included in the Top Rail Configuration
requirement to exclude play yards with side rails that fold upward. The
side rails of most play yards move downward vertically. If the side
rail latch mechanisms are not locked properly, they can form a
dangerous V-shape. If the child's neck is caught in the V-shape, the
child could suffocate. Play yards with side rails that fold upward,
however, do not create this risk. We also received a comment to the NPR
suggesting this change. By incorporating by reference of ASTM F406-12a,
we support the inclusion of this clarification in the play yard
mandatory standard.

2. Description of the Final Rule

The final play yard rule incorporates by reference ASTM F406-12a,
with several exclusions for provisions that apply to non-full-size
cribs only. In the Federal Register of December 28, 2010 (75 FR 81766),
we issued a final rule on safety standards for non-full-size cribs.
Thus, the final rule excludes provisions of ASTM F406-12a that apply to
non-full-size cribs, including the following:
Section 5.17 of ASTM F406-12a, containing the requirements
for mattresses in rigid-sided products;
Section 5.19 of ASTM F406-12a, containing a provision to
prevent misassembly in non-full-size cribs;
Section 5.20 of ASTM F406-12a, containing record keeping
requirements for non-full-size cribs;
The entirety of section 6 of ASTM F406-12a, containing the
performance requirements for rigid-sided products;
Sections 8.1 through 8.10.5 of ASTM F406-12a, containing
the test methods for rigid-sided products;
A portion of section 9.4.2.10 of ASTM F406-12a, containing
warning label requirements for nonrectangular cribs; and
Section 10.1.1.1 of ASTM F406-12a, containing
instructional literature requirements for non-full-size cribs.

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 6-month effective date, as proposed in the NPR.
This will give suppliers sufficient time to come into compliance with
the mandatory standard.

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. The final regulatory flexibility analysis
must describe the impact of the rule on small entities and identify any
alternatives that may reduce the impact. Specifically, the final
regulatory flexibility analysis must contain:
1. A succinct statement of the need for, and objectives of, the
rule;
2. A summary of the significant issues raised by the public
comments in response to the initial regulatory flexibility analysis, a
summary of the assessment of the agency of such issues, and a statement
of any changes made in the proposed rule as a result of such comments;
3. A description of, and an estimate of, the number of small
entities to which the rule will apply, or an explanation of why no such
estimate is available;
4. A description of the projected reporting, recordkeeping, and
other compliance requirements of the rule, including an estimate of the
classes of small entities that will be subject to the requirement, and
the type of professional skills necessary for preparation of the report
or record; and
5. A description of the steps that the agency has taken to minimize
the significant economic impact on small entities, consistent with the
stated objectives of applicable statutes, including a statement of the
factual, policy, and legal reasons for selecting the alternative
adopted in the final rule, and why each one of the other significant
alternatives to the rule considered by the agency that affect the
impact on small entities was rejected.

2. The Market

There are 21 domestic firms known to be producing or selling play
yards in the United States. Ten are domestic manufacturers, and 11 are
domestic importers. Under the U.S. Small Business Administration (SBA)
guidelines, a manufacturer of play yards is small if it has 500 or
fewer employees, and an importer is considered small if it has 100 or
fewer employees. Based on these guidelines, nine domestic manufacturers
and 10 domestic importers known to supply play yards to the U.S. market
are small businesses. The remaining domestic entities are one large
manufacturer and one large importer. There are also three foreign firms
supplying play yards to the U.S. market. There may be additional
unknown small manufacturers and importers operating in the U.S. market.
The Juvenile Products Manufacturers Association (JPMA) runs a
voluntary certification program for juvenile products. Certification
under the JPMA program is based on the most recent ASTM voluntary play
yard standard, typically with a 6-month delay. Six of the nine small
manufacturers produce play yards that are certified as compliant with
the ASTM voluntary play yard standard by the JPMA. Of the importers,
three import play yards that have been certified as compliant with the
ASTM voluntary standard. One additional importer claims compliance with
the ASTM standard but is not JPMA certified.

3. Impact of the Standard on Small Businesses

a. Costs of Complying With the Voluntary Standard
The extent to which each firm will be impacted by the play yard
mandatory standard depends upon whether the firm's play yards currently
comply with the ASTM voluntary standard. Small firms whose play yards
already comply with the voluntary standard will not incur any new
costs. Many of these firms are active in the ASTM standard development
process, and compliance with the voluntary standard is part of an
established business practice. Thus, it is

[[Page 52227]]

likely that most of the firms that already comply with the ASTM
standard would continue to do so, even in the absence of a mandatory
regulation.
b. Small Domestic Manufacturers
Six of the small manufacturers produce play yards known to comply
with the voluntary standard. Small firms whose play yards already
comply with the voluntary standard will not incur any new costs. For
the three manufacturing firms whose play yards may not be compliant
with the voluntary standard, the costs could be more significant.
Meeting the existing voluntary standard could require manufacturers to
redesign their product. The impact on manufacturers who produce
noncompliant play yards may be mitigated if the costs are treated as
new product expenses and amortized over time.
This scenario also assumes that the three firms whose play yards
are not JPMA certified do not meet the voluntary standard. In fact, we
have identified many instances in which a juvenile product not
certified by the JPMA complies with the ASTM voluntary standard. To the
extent that these firms already may supply play yards that meet the
ASTM voluntary standard, the costs incurred would be lower.
c. Small Domestic Importers
Four of the 10 small importers produce play yards known to comply
with the voluntary standard. Three are certified by the JPMA, and one
additional firm claims compliance with the ASTM standard. Small firms
whose play yards already comply with the voluntary standard will not
incur any new costs.
The costs to the six importers whose play yards may not be
compliant with the voluntary standard could be more significant.
Importers of play yards would need to find an alternate source if their
existing supplier does not come into compliance with the standard.
Purchasing compliant, higher quality play yards could increase the cost
of the product.
This will not be an option for two of the noncompliant play yard
importers because they specialize in the importation of play yards from
a specific foreign company. Thus, finding an alternative supply source
is probably not an option for them. These firms could respond to the
rule by discontinuing the import of play yards. The impact of this
decision could be mitigated by replacing play yards with a different
infant or toddler product. Deciding to import an alternative infant or
toddler product would be a reasonable and realistic way to offset any
lost revenue.
As with manufacturers, to the extent that some of the firms
believed to supply noncompliant play yards actually may supply play
yards that meet the ASTM voluntary standard, the costs incurred would
be lower.

4. Alternatives

An alternative that could minimize the economic impact on small
business is providing an effective date longer than 6 months. However,
the JPMA, which represents many play yard manufacturers, felt that a 6-
month effective date was adequate to allow suppliers to come into
compliance with the mandatory standard. We agree. Therefore, we have
chosen a 6-month effective date for the play yard mandatory standard.

5. Issues Raised by Public Comment

We received several comments from the public in response to the
initial regulatory flexibility analysis, including comments regarding
the use of market data, the impact on small businesses, and the
appropriate effective date. A summary of those comments and our
responses can be found in part D of this preamble, titled, ``Response
to Comments on the Proposed Rule.''

6. Conclusion of the Final Regulatory Flexibility Analysis

The impact of the final play yard rule on firms supplying non-ASTM-
compliant play yards could be significant. However, the requirements of
the final rule address known play yard hazard patterns and will help
reduce injuries and deaths. We are providing a 6-month effective date
as proposed in the NPR. This will give suppliers sufficient time to
come into compliance with the mandatory standard and spread the costs
over a longer period of time.

H. Environmental Considerations

The Commission's regulations address whether we are required to
prepare an environmental assessment or an environmental impact
statement. Our rules generally have ``little or no potential for
affecting the human environment,'' and therefore, are exempt from any
requirement to prepare an environmental assessment or impact statement.
16 CFR 1021.5(c)(1). This rule falls within the categorical exemption.

I. Paperwork Reduction Act

This rule contains information collection requirements that are
subject to public comment and review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995. The preamble to
the proposed rule (76 FR 58173 through 58174) discussed the information
collection burden of the proposed rule and specifically requested
comments on the accuracy of our estimates. Briefly, sections 9 and 10
of ASTM F406-12a contain requirements for marking, labeling, and
instructional literature. These requirements fall within the definition
of ``collection of information,'' as defined in 44 U.S.C. 3502(3).
OMB has assigned control number 3041-0152 to this information
collection. We did not receive any comments regarding the information
collection burden of this proposal. However, the final rule makes
modifications regarding the information collection burden because the
number of estimated suppliers subject to the information collection
burden is now estimated to be 24 firms rather than the nine firms
initially estimated in the proposed rule.
Accordingly, the estimated burden of this collection of information
is modified as follows:

Table 1--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Frequency of Total annual Hours per Total burden
16 CFR section respondents responses responses response hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
1221.2(a).......................................................... 24 3 72 1 72
--------------------------------------------------------------------------------------------------------------------------------------------------------

There are 24 known firms supplying play yards to the U.S. market.
All 24 firms are assumed to use labels already on both their products
and their packaging, but they might need to make some modifications to
their existing

[[Page 52228]]

labels. The estimated time required to make these modifications is
about 1 hour per model. Each entity supplies an average of three
different models of play yards; therefore, the estimated burden
associated with labels is 1 hour per model x 24 entities x 3 models per
entity = 72 hours. We estimate the hourly compensation for the time
required to create and update labels is $28.36 (U.S. Bureau of Labor
Statistics, ``Employer Costs for Employee Compensation,'' September
2011, Table 9, total compensation for all sales and office workers in
goods-producing private industries: http://www.bls.gov/ncs/).
Therefore, the estimated annual cost to industry associated with the
labeling requirements is $2,041.92 ($28.36 per hour x 72 hours =
$2,041.92). There are no operating, maintenance, or capital costs
associated with the collection.
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3507(d)), we have submitted the information collection requirements of
this final rule to the OMB.

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 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

Once in effect, the final rule on play yards will make it unlawful
for anyone to manufacture, distribute, or import a play yard into the
United States that is not in conformity with the standard. 15 U.S.C.
2068(1). Pursuant to section 14(a)(2) of the CPSA, play yards must be
certified by the manufacturer to the final standard based on testing
conducted by a CPSC-accepted third party conformity assessment body.
The third party testing and certification requirement for play yards
will not be in effect until we issue a final notice of requirements
(NOR). The final NOR establishes requirements for how third party
conformity assessment bodies can become accepted by us to test play
yards to the final rule. A proposed NOR for play yards was published in
the Federal Register on May 24, 2012, as part of an NPR titled,
``Requirements Pertaining to Third Party Conformity Assessment
Bodies.'' 77 FR 31086. When the final rule is effective and the NOR is
final, third party conformity assessment bodies can apply to us for
acceptance of their accreditation to test play yards. Play yard
manufacturers will be required to certify products to the final play
yard rule based on third party testing once we have accepted the
accreditation of such laboratories.

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 by adding part 1221 to read as follows:

PART 1221--SAFETY STANDARD FOR PLAY YARDS

Sec.
1221.1 Scope.
1221.2 Requirements for play yards.

Authority: The Consumer Product Safety Improvement Act of 2008,
Pub. L. 110-314, section 104, 122 Stat. 3016 (August 14, 2008).

Sec. 1221.1 Scope.

This part establishes a consumer product safety standard for play
yards manufactured or imported on or after February 28, 2013.

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 F406-12a,
Standard Consumer Safety Specification for Non-Full-Size Baby Cribs/
Play Yards, approved on May 1, 2012. The Director of the Federal
Register approves this incorporation by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy from ASTM
International, 100 Bar Harbor Drive, P.O. Box 0700, West Conshohocken,
PA 19428; http://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: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(b) Comply with the ASTM F406-12a standard with the following
exclusions:
(1) Do not comply with section 5.17 of ASTM F406-12a.
(2) Do not comply with section 5.19 of ASTM F406-12a.
(3) Do not comply with section 5.20 of ASTM F406-12a.
(4) Do not comply with section 6, Performance Requirements for
Rigid-Sided Products, of ASTM F406-12a, in its entirety.
(5) Do not comply with sections 8.1 through 8.10.5 of ASTM F406-
12a.
(6) Instead of complying with section 9.4.2.10 of ASTM F406-12a,
comply with only 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].
(7) Do not comply with section 10.1.1.1 of ASTM F406-12a.

Dated: August 23, 2012.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2012-21168 Filed 8-28-12; 8:45 am]
BILLING CODE 6355-01-P