[Federal Register Volume 77, Number 168 (Wednesday, August 29, 2012)]
[Proposed Rules]
[Pages 52272-52277]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-21169]
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1221
[CPSC Docket No. CPSC-2011-0064]
Safety Standard for Play Yards
AGENCY: Consumer Product Safety Commission.
ACTION: Notice of proposed rulemaking.
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SUMMARY: The United States Consumer Product Safety Commission
(Commission, CPSC, us, or we) is proposing to amend the play yard
mandatory standard. This proposed rule would address the hazards
associated with the use of play yard bassinet accessories that can be
assembled with missing key structural elements. The amendment is being
proposed pursuant to section 104(b) of the Consumer Product Safety
Improvement Act of 2008 (CPSIA), also known as the ``Danny Keysar Child
Product Safety Notification Act'' which requires us to promulgate
consumer product safety standards for durable infant or toddler
products.
DATES: Submit comments by November 13, 2012.
ADDRESSES: You may submit comments, identified by CPSC Docket No. CPSC-
2011-0064 by any of the following methods:
Electronic Submissions: Submit electronic comments to the Federal
eRulemaking Portal at: http://www.regulations.gov. Follow the
instructions for submitting comments. To ensure timely processing of
comments, the Commission is no longer directly accepting comments
submitted by electronic mail (email), except through
www.regulations.gov. The Commission encourages you to submit electronic
comments by using the Federal eRulemaking Portal, as described above.
Written Submissions: Submit written submissions in the following
way: Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions), preferably in five copies, to: Office of the Secretary,
Consumer Product Safety Commission, Room 820, 4330 East West Highway,
Bethesda, MD 20814; telephone (301) 504-7923.
Instructions: All submissions received must include the agency name
and docket number for this proposed rulemaking. All comments received
may be posted without change, including any personal identifiers,
contact information, or other personal information provided, to http://www.regulations.gov. Do not submit confidential business information,
trade secret information, or other sensitive or protected information
that you do not want to be available to the public. If furnished at
all, such information should be submitted in writing.
Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov, and insert the
docket number, CPSC-2011-0064, into the ``Search'' box and follow the
prompts.
FOR FURTHER INFORMATION CONTACT: Gregory K. Rea, Project Manager,
Directorate for Laboratory Sciences, Consumer Product Safety
Commission, 5 Research Place, Rockville, MD 20850; email:
[email protected].
SUPPLEMENTARY INFORMATION:
A. Background
In the Federal Register of September 20, 2011 (76 FR 58167), we
published a notice of proposed rulemaking (NPR) to establish a safety
standard for play yards pursuant to section 104(b) of the CPSIA, also
known as the ``Danny Keysar Child Product Safety Notification Act.'' On
June 6, 2012, a draft final rule on play yards was submitted to the
Commission for their consideration. The draft final rule incorporated
by reference ASTM F406-12a, ``Standard Consumer Safety Specification
for Non-Full-Size Baby Cribs/Play Yards.'' The draft final rule
included one additional requirement not present in ASTM F406-12a. That
requirement would have addressed the hazards associated with the use of
play yard bassinet accessories that can be assembled with missing key
structural elements. We refer to this provision in this document as the
``bassinet misassembly requirement.'' The bassinet misassembly
requirement was created after we received a comment in response to the
play yard NPR.
On June 27, 2012, the Commission voted unanimously to approve
publication in the Federal Register of the draft final rule to
establish a safety standard for play yards. Today, elsewhere in the
Federal Register, we are publishing the final rule, which reflects
several changes directed by the Commission in its vote. Specifically,
the Commission voted to remove the bassinet misassembly requirement
from the draft play yard final rule submitted by staff. In light of
that, the Commission also voted to provide a 6-month effective date for
the safety standard for play yards, instead of 12 months as stated in
the draft final rule because the recommendation for a 12 month
effective date was based on the inclusion of the bassinet misassembly
requirement. In addition, the Commission directed staff to draft and
publish an NPR seeking comment regarding an amendment to the play yard
mandatory standard to include the bassinet misassembly requirement,
which is the subject of this notice. The Commission's Order, as well as
Chairman Inez M. Tenenbaum's statement on the final rule to establish a
safety standards for play yards, can be viewed at: http://www.cpsc.gov/library/foia/ballot/ballot12/ballot12.html.
B. Description of the Proposed Rule
1. Summary of the Hazard and the Infant Fatality
In August 2011, we received a report of an infant fatality 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 where she suffocated. A review of the In-Depth Investigation
Report (IDI) 110825CAA2853, as well as our tests on an exemplar model
of the bassinet accessory and play yard involved in the fatality, led
us to conclude that the incident was caused by the omission of key
structural elements.
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 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 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.
As seen in the IDI, it is possible that the omission of key
structural elements may not initially be visually evident to the
consumer. If the misassembled accessory supports an infant without a
catastrophic and obvious change to the sleep surface, a consumer may
continue to use the accessory and inadvertently place a child in
danger. If the bassinet's
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sleep surface tilts while the child is unsupervised, the condition may
not be discovered by the caregiver for hours, placing the child in a
potentially fatal situation.
Initially, the IDI completed for the fatality in August 2011
indicated that the tilt in the sleeping surface was caused by the
detachment of plastic clips attached to the bassinet shell that secured
the shell to the side rails of the play yard. Sometime after the child
was placed in the bassinet accessory, one of the plastic clips
detached. However, our testing indicates that detachment of one of the
plastic clips is not enough to cause the tilt in the sleeping surface
that led to the fatality. Indeed, the plastic clips caused the consumer
to erroneously assume that the product was safe, when key structural
elements, the supporting rods, were missing.
The requirement we are proposing here will address this hazard.
Manufacturers will be given two ways to comply. The first way to comply
prevents misassembly by requiring that all key structural elements be
attached permanently to the bassinet shell. The second method of
compliance is designed to alert consumers if a key structural element
is missing by requiring that the removal of even one key structural
element results in a catastrophic failure of the bassinet. The test for
this method of compliance is referred to as the ``catastrophic failure
test'' in this document.
2. The Bassinet Misassembly Requirement
Most bassinet accessories consist of a fabric shell that is
attached to the side rails of the play yard. The shell is supported by
rods, tubes, bars, or hooks. The segmented mattress pad that is used on
the floor of the typical play yard is inserted into the bassinet shell.
The requirement we are proposing offers two avenues for compliance.
First, the bassinet accessory would meet the requirement if all of the
key structural elements are attached permanently to the bassinet
accessory. Thus, manufacturers who attach the support rods, tubes,
bars, or hooks permanently into the bassinet shell would not need to
have their product tested to this requirement.
If a manufacturer chooses not to permanently attach key structural
elements to the bassinet, the bassinet would have to be tested by
removing each key structural element and numbering them from 1 through
n. Subsequently, all the key structural elements are put back into
place. Key structural element number 1 is then removed from the
bassinet. In order to pass the test, when an anthromorphic 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. Our 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. The test continues until each key structural
element has been tested individually (thus, key structural element
number 1 is inserted back into the product, key structural element
number 2 is removed, and the test is repeated.) We refer to this test
as the ``catastrophic failure test.''
The requirement is meant to ensure that the omission of a key
structural element is so visually obvious that the consumer will not
use the product and place the child in danger inadvertently. It should
be noted that in order to pass this test, the item must fail
catastrophically when each key structural element is omitted.
Most manufacturers will use rods, tubes, bars, or hooks to support
the bassinet shell. Thus, the mattress pad is not a key structural
element under this provision, unless the manufacturer chooses to
stiffen the mattress pad itself in order to provide structural support
to the bassinet. If the mattress pad provides the structural support
for the bassinet, it becomes a key structural element and must either
be attached permanently to the bassinet or designed in such a way that
omission of the mattress pad causes the bassinet to become obviously
unusable.
In addition to the performance requirement and test method, we are
also proposing to modify one definition, add one definition, and
include several graphics in the mandatory play yard standard in order
to ensure that this requirement is clear to play yard suppliers and
testing laboratories. We are modifying the definition of ``key
structural elements'' to include ``the components that provide the
supporting frame and/or means of attachment for a bassinet/cradle
accessory.'' We are also proposing to add a new term, ``bassinet/cradle
accessory,'' defined as ``a supported sleep surface that attaches to a
non-full-size crib or 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.''
We are proposing to include four new graphics that will assist
stakeholders in understanding the new requirement. The first is a
figure of the ``CAMI Newborn Dummy'' that will be used in the bassinet
misassembly test method. In other ASTM standards, the reference to a
CAMI Dummy is included at the beginning of the standard in a section
titled, ``Referenced Documents.'' Consistent with ASTM custom, we are
adding the CAMI Newborn Dummy to this section, accompanied by a
footnote to indicate that the figure we are using is copied from a
drawing provided by the U.S. Department of Transportation.
We are also proposing to include three other graphics to
illustrate: (1) examples of bassinet/cradle key structural elements;
(2) the infant CAMI dummy positioned for the bassinet/cradle accessory
sleep surface test; and (3) the bassinet/cradle accessory sleep surface
test angle measurement.
3. Consultation With the ASTM Play Yard Subcommittee
The requirement we are proposing was created with the assistance of
key stakeholders, such as manufacturers, third party test laboratories,
consumer advocates, and CPSC staff. In early 2012, we approached the
ASTM Play Yard subcommittee and asked that the infant fatality reported
to us in August 2011 be reviewed, and, if possible, a requirement be
developed to address injuries and fatalities that can result from play
yard bassinet accessories that are assembled incorrectly. The
subcommittee formed a task group, which met six times from January
through April 2012, and was comprised of major stakeholders, including
manufacturers, third party test laboratories, consumer advocates, and
CPSC staff.
The result of the task group's efforts is the language proposed
here and is intended to address the specific hazard that resulted in
the death of the infant. The requirement and test method apply only to
bassinet accessories, and only address hazards associated with
assembling the bassinet without key structural elements.
C. Effective Date of Final Rule
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). To allow time for play yard manufacturers
to come into compliance, we recommend that this proposed amendment to
the play yard standard become effective 6 months after the publication
of the final rule in the Federal Register. We invite comment on how
long it will take play yard manufacturers to come into compliance.
[[Page 52274]]
D. Regulatory Flexibility Act
1. Introduction
The Regulatory Flexibility Act (``RFA''), 5 U.S.C. 601-612,
requires agencies to consider the impact of proposed rules on small
entities, including small businesses. Section 603 of the RFA requires
us to prepare an initial regulatory flexibility analysis and make it
available to the public for comment when the NPR is published. The
initial regulatory flexibility analysis must describe the impact of the
proposed rule on small entities. In addition, it must identify any
significant alternatives to the proposed rule that would accomplish the
stated objectives of the rule and, at the same time, reduce the
economic impact on small businesses. Specifically, the initial
regulatory flexibility analysis must contain:
A description of, and where feasible, an estimate of the
number of small entities to which the proposed rule will apply;
A description of the reasons why action by the agency is
being considered;
A succinct statement of the objectives of, and legal basis
for, the proposed rule;
A description of the projected reporting, recordkeeping,
and other compliance requirements of the proposed rule, including an
estimate of the classes of small entities subject to the requirements,
and the type of professional skills necessary for the preparation of
reports or records; and
Identification, to the extent possible, of all relevant
federal rules that may duplicate, overlap, or conflict with the
proposed rule.
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.
3. Impact of the Standard on Small Businesses
Not every play yard manufacturer makes a bassinet accessory for
their product. However, the majority of known small play yard
manufacturers have a least one model that includes a bassinet
accessory. For these firms, in order to meet this proposed requirement,
they will have to: (1) Modify their existing designs in order to attach
key structural elements to the bassinet accessory permanently, or (2)
design the accessory such that it is obviously unusable when any one
key structural element is left out.
It is likely that most suppliers will choose to comply with this
requirement by attaching key structural elements to the bassinet
accessory permanently. We know of one manufacturer who produces a play
yard with a bassinet accessory that is already compliant with this
requirement. Several of the firms impacted by this new requirement were
involved in the ASTM language development process and have indicated
that they are moving toward attaching key structural elements to play
yard bassinet accessories permanently. The cost to manufacturers who
elect to meet the requirement in this way is expected to be minimal,
primarily involving additional stitching, rivets, or other methods of
attachment.
At least one manufacturer anticipates meeting the requirement by
designing the accessory such that it is obviously unusable when key
structural elements are left out. This approach is likely to be more
costly than permanently attaching key structural elements because,
currently, no design has been identified by manufacturers that would
succeed in failing visibly when each key structural element is removed
individually.
The impact on small importers will be similar. If an importer's
existing supplier is not willing to comply with the bassinet
misassembly provision, the importer would need to find an alternate
source. If that is not possible, these firms could respond to the rule
by discontinuing the importation 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.
4. Alternatives
Setting an effective date longer than 6 months could reduce the
impact. This would allow small manufacturers additional time to make
necessary changes to their product, and it would allow small importers
more time to find alternative sources. It would also allow entities to
spread costs over a longer period of time.
5. Conclusion of the Initial Regulatory Flexibility Analysis
It is possible that the proposed amendment, if finalized, could
have a significant impact on some small businesses. For manufacturers,
the extent of these costs could entail expensive product redesign.
Importers may need to find alternative sources of play yards or replace
play yards with another infant or toddler product.
We invite comments describing:
The possible impact of this rule on small manufacturers
and importers; and
Significant alternatives to the proposed rule that would
accomplish the stated objectives of the proposed rule, and at the same
time, reduce the economic impact on small businesses.
E. 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 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 this proposed amendment.
F. 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, they 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.
G. 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
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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.
H. Testing and Certification
Pursuant to section 14(a)(2) of the CPSA, play yards must be
certified by the manufacturer to the mandatory standard based on
testing conducted by a CPSC-accepted third party conformity assessment
body. The third party testing and certification requirement for this
proposed amendment to the play yard standard will not be in effect
until the proposal is final and effective, and we issue a final notice
of requirements (NOR). The NOR establishes requirements for how third
party conformity assessment bodies can become accepted by us to test
play yards. Play yard manufacturers will be required to certify
products to the play yard standard, including this proposed amendment
if it is finalized, based on third party testing once we have accepted
the accreditation of such laboratories.
I. Request for Comments
We invite all interested persons to submit comments on any aspect
of the proposed rule. Comments should be submitted in accordance with
the instructions in the ADDRESSES section at the beginning of this
notice.
Specifically, we invite comments on the following:
Whether this proposed requirement and test method will
address the hazards associated with play yard bassinet accessories that
can be assembled with missing key structural elements, and if not, what
alternative requirements and test methods would address this hazard;
Whether the second avenue of compliance, referred to as
the ``catastrophic failure test'' is necessary, or if manufacturers
should be required to attach all key structural elements permanently;
Whether the CAMI Newborn Dummy, weighing 7.5 pounds, is
appropriate to use for the catastrophic failure test, and if it is not,
what should be used;
Whether the language of the proposed requirements and test
methods should be changed in order to improve repeatability and
clarity, and if so, what those changes should be;
Whether 6 months is an appropriate effective date for this
provision; and
Descriptions of the possible impact of this proposed
requirement on small manufacturers and importers, as well as
alternatives to the proposed rule that would accomplish the stated
objectives of the proposed rule, and at the same time, reduce the
economic impact on small businesses.
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 proposes to amend 16 CFR part 1221 as
follows:
PART 1221--SAFETY STANDARD FOR PLAY YARDS
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).
2. Add Sec. 1221.3 to read as follows:
Sec. 1221.3 Play yard bassinet accessory misassembly provision.
(a) In addition to complying with section 2.4 of ASTM F406-12a,
comply with the following, along with the accompanying footnote:
(1) 2.5 Other References: CAMI Newborn Dummy (Department of
Transportation, Federal Aviation Administration, Drawing No. SA-1001).
(See Fig. A1.38.)
(2) [Reserved]
(b) Instead of complying with section 3.1.9 of ASTM F406-12a,
comply with the following:
(1) 3.1.9 key structural elements, n--side assemblies, end
assemblies, mattress supports, or stabilizing bars that create the
occupant retention area, or the components that provide the supporting
frame and/or means of attachment for a bassinet/cradle accessory. (See
Fig. A1.39.)
(2) [Reserved]
(c) In addition to complying with section 3.1.26 of ASTM F406-12a,
comply with the following:
(1) 3.1.27 bassinet/cradle accessory, n--a supported sleep surface
that attaches to a non-full-size crib or 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.
(2) [Reserved]
(d) Instead of complying with section 5.19 of ASTM F406-12a, comply
with the following:
(1) 5.19 Bassinet/Cradle Accessories Missing Key Structural
Elements:
(2) 5.19.1 Bassinet/cradle accessories that have all key structural
elements attached permanently to the bassinet/cradle accessory, or by
any permanent means, prohibiting their removal from the bassinet/cradle
accessory, are exempt from the following key structural element
requirements. For the purpose of this section, a mattress pad without
key structural elements attached permanently is not considered a key
structural element.
(3) 5.19.2 Bassinet/cradle accessories that require consumer
assembly of key structural element(s), and can be assembled and
attached to the product with any key structural element(s) missing,
shall meet either 5.19.2.1, or 5.19.2.2 when each key structural
element not attached permanently is removed. For the purpose of this
section, a mattress pad without key structural elements attached
permanently is not considered a key structural element.
(4) 5.19.2.1 The bassinet/cradle accessory shall collapse, such
that any part of the mattress pad contacts the bottom floor of the play
yard, or is not able to support the newborn CAMI dummy when tested to
8.31.
(5) 5.19.2.2 The bassinet/cradle accessory sleep surface shall tilt
by more than 30 degrees when tested to 8.31.
(6) 5.19.3 Rationale: The bassinet/cradle missing key structural
elements requirements were included to address IDI 110825CAA2853.
Bassinet or cradle accessory misassembly initially may not be visually
evident to the consumer. If the accessory with omitted component(s)
supports the 7 lbm. newborn CAMI dummy without a catastrophic and
obvious change to the sleep surface, a consumer might continue to use
the accessory and place a child in danger inadvertently.
(e) In addition to complying with 8.30 of ASTM F406-12a, comply
with the following:
(1) 8.31 Bassinet and Cradle Accessory Sleep Surface Collapse/Tilt.
(2) 8.31.1 Determine the number of removable (i.e., not attached
permanently to the accessory) key structural elements used in the
assembly of the bassinet/cradle accessory and number them 1 through n,
until all removable elements are numbered.
(3) 8.31.2 Assemble the bassinet/cradle accessory to the product
according to manufacturer's instructions.
[[Page 52276]]
(4) 8.31.3 Establish a horizontal reference plane by placing an
inclinometer on the floor of the testing area, and then zero the
inclinometer.
(5) 8.31.4 Remove key structural element 1 used in the
assembly of the bassinet/cradle accessory, and attempt to assemble the
accessory back onto the product.
(6) 8.31.4.1 If the accessory can be assembled onto the product
without element 1, proceed to 8.31.5.
(7) 8.31.4.2 If the accessory cannot be assembled onto the product
without element 1, the accessory shall be considered to meet
5.19.2. Proceed to 8.31.7.
(8) 8.31.5 Place a newborn CAMI dummy in the center of the sleep
surface, oriented parallel to the longest side of the bassinet/cradle
accessory. (See Fig. A1.40.) Determine visually whether the bassinet/
cradle accessory collapses or it no longer supports the newborn CAMI
within 2 seconds.
(9) 8.31.6 If collapse does not occur, measure the sleep surface's
angle of incline relative to the horizontal plane established in 8.31.3
at the location(s) most likely to meet the angle requirement in
5.19.2.2. Record this angle. (See Fig. A1.41.)
(10) 8.31.7 Replace the removed key structural element.
(11) 8.31.8 Repeat 8.31.4-8.31.7 removing and replacing each key
structural element (identified in 8.31.1) one at a time, starting with
2 through n and evaluating the resulting condition.
(f) In addition to Figure A1.37 of ASTM F406-12a, use the
following:
BILLING CODE 6355-01-P
[GRAPHIC] [TIFF OMITTED] TP29AU12.028
[[Page 52277]]
[GRAPHIC] [TIFF OMITTED] TP29AU12.029
BILLING CODE 6355-01-C
Dated: August 23, 2012.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2012-21169 Filed 8-28-12; 8:45 am]
BILLING CODE 6355-01-P