28 April 2010
Also, Safety Standards for Toddler Beds:
http://cryptome.org/0001/cpsc042810-2.htm
[Federal Register: April 28, 2010 (Volume 75, Number 81)]
[Proposed Rules]
[Page 22303-22317]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28ap10-22]
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1218
[CPSC Docket No. CPSC-2010-0028]
Safety Standard for Bassinets and Cradles: Notice of Proposed
Rulemaking
AGENCY: Consumer Product Safety Commission.
ACTION: Notice of proposed rulemaking.
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SUMMARY: Section 104(b) of the Consumer Product Safety Improvement Act
of 2008 (``CPSIA'') requires the United States Consumer Product Safety
Commission (``CPSC'' or ``Commission'') to promulgate consumer product
safety standards for durable infant or toddler products. These
standards are to be ``substantially the same as'' applicable voluntary
standards or more stringent than the voluntary standard if the
Commission concludes that more stringent requirements would further
reduce the risk of injury associated with the product. The Commission
is proposing a more stringent safety standard for bassinets and cradles
that will further reduce the risk of injury associated with these
products.
DATES: Written comments must be received by July 12, 2010.
ADDRESSES: Comments relating to the instructional literature and
marking required by the proposed rule relating to the Paperwork
Reduction Act should be directed to the Office of Information and
Regulatory Affairs, OMB, Attn: CPSC Desk Officer, FAX: 202-395-6974, or
e-mailed to oira_submission@omb.eop.gov.
Other comments, identified by Docket No. CPSC-2010---------, may be
submitted by any of the following methods:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov. Follow the
instructions for submitting comments. To ensure timely processing of
comments, the Commission is no longer accepting comments submitted by
electronic mail (e-mail) except through http://www.regulations.gov.
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 502, 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 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
electronically. 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.
FOR FURTHER INFORMATION CONTACT: Han Lim, Project Manager, Directorate
for Engineering Sciences, Consumer Product Safety Commission, 4330
East-West Highway, Bethesda, MD 20814; telephone (301) 504-7538;
hlim@cpsc.gov.
SUPPLEMENTARY INFORMATION:
A. Background and Statutory Authority
The Consumer Product Safety Improvement Act of 2008, Public Law
110-314 (``CPSIA'') was enacted on August 14, 2008. Section 104(b) of
the CPSIA requires the Commission 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 document the Commission
proposes a safety standard for bassinets and cradles. The proposed
standard is more stringent in some respects than the voluntary standard
developed by ASTM International (formerly the American Society for
Testing and Materials), ASTM F 2194-07a [egr]\1\, ``Standard Consumer
Safety Specification for Bassinets and Cradles.'' The proposed
modifications, if finalized, will further reduce the risk of injury
associated with bassinets and cradles.
B. The Product
A bassinet or cradle is a small bed for infants supported by free-
standing legs, a wheeled base, a rocking base, or that can swing
relative to a stationary base. A bassinet or cradle is not intended to
be used with children who are beyond the age of approximately 5 months.
Bassinet and cradle attachments for non-full-size cribs or play yards
are considered a part of this product category, as are bedside sleeper
bassinets that can be converted to a four-sided bassinet not attached
to a bed.
Full-size cribs and infant swings are not included under the
definition of bassinet or cradle. Products used in conjunction with
infant swings or strollers or Moses baskets (hand-carrying baskets) are
not included under the definition of bassinet or cradle. However, a
Moses basket or a similar product used with infant swings or strollers
that can attach to a separate base which can convert it to a bassinet
[[Page 22304]]
or cradle is considered a bassinet or cradle.
While the current ASTM F 2194-07a [egr]\1\ standard does not
explicitly state that infant hammocks are within the scope of the
standard, the Juvenile Products Manufacturers Association, (JPMA),
historically has certified infant hammocks under the bassinet/cradle
standard. Two firms have hammocks certified by JPMA to the ASTM F
2194--07a [egr]\1\ standard.
By nature of their design, most hammocks do not have a rigid sleep
surface. The Commission believes that many of the current designs it
has been studying result in uneven suspension of the product, which can
cause the hammock to tip to one side, trapping the baby in a face down
position and increasing the risk of positional asphyxia or suffocation.
Because of this hazard pattern, CPSC recently recalled an infant
hammock. Since the sleeping environment of most hammocks differs from
that of bassinets and cradles, the Commission believes a separate
standard for hammocks may be necessary. Most hammocks have mattresses
that are flexible and conform to the body contours of the infant,
whereas bassinets and cradles have flat mattresses with solid or fabric
sides. In a November 17, 2009 CPSC/ASTM teleconference, ASTM agreed to
form a subcommittee to develop requirements for a new hammock standard.
Until a separate standard for hammocks is developed, the Commission
believes it is prudent to include hammocks under the proposed rule for
bassinets and cradles as an interim measure because the proposed rule
addresses the hazard pattern which causes the infant to roll/press up
against the side or corner of the product, posing a risk of positional
asphyxia or suffocation. The Commission is aware that, by their nature,
most infant hammocks will likely be unable to meet the proposed
performance criteria of a 5[deg] rest angle, 5[deg] flatness angle, and
a 20[deg] maximum rock/swing angle in this proposed standard, and will
thus be effectively banned. The Commission seeks comment on whether
such action is necessary given the risk of positional asphyxia the rule
attempts to address. The Commission may remove hammocks from the scope
of a bassinets/cradles standard in the future, should ASTM develop an
effective voluntary standard for hammocks. The Commission seeks
information regarding proposals for an infant hammock standard.
Applying American Baby Group survey data from 2005 to the most
recent U.S. birth data from the Centers for Disease Control and
Prevention (CDC) yields annual estimates of about 1.4 million
bassinets, 333,000 cradles, 596,000 portable play yards with bassinet
attachments, and 749,000 full-size play yards with bassinet
attachments. (The data collected for the Baby Products Tracking Study
does not represent an unbiased statistical sample.) This yields a total
of approximately 3.1 million units sold per year.
C. ASTM Voluntary Standard
ASTM first approved and published the voluntary standard for
bassinets and cradles in 2002 as ASTM F 2194, Standard Consumer Safety
Specification for Bassinets and Cradles. ASTM has revised the standard
a number of times since 2002, with the current version, ASTM F 2194-07a
[egr]\1\, published in November 2007. ASTM F 2194-07 [egr]\1\ contains
requirements to address the following:
Lead in paint;
Hazardous sharp edges or points;
Small parts;
Wood parts;
Scissoring, shearing, pinching;
Unintentional folding;
Openings;
Labeling;
Fasteners;
Corner posts;
Toy accessories;
Bassinet/cradle attachments to play yards/non-full sized
cribs;
Spacing of rigid sided bassinet/cradle components;
Openings for mesh/fabric-sided bassinet/cradle;
Static load;
Stability;
Sleeping pad properties; and
Protective components.
JPMA operates a certification program to certify bassinets and
cradles to the voluntary standard. To obtain JPMA certification,
manufacturers submit their products to an independent test laboratory
for conformance testing to the most current voluntary standard.
Currently, bassinets or cradles supplied by eight small manufacturers
and four small importers are JPMA certified to ASTM F 2194-07a
[egr]\1\.
D. Incident Data
1. Categories of Incidents
The CPSC Directorate for Epidemiology reports that there have been
209 incidents related to bassinets and cradles since 2006, of which
there were 61 fatalities, 38 non-fatal injuries, and 110 non-injury
incidents. The incidents were grouped into five categories: (a)
Product-related issues, in which sufficient information was available
to describe the product failure modes or defects; (b) non-product-
related issues; (c) unknown issues (incidents that lacked specificity),
(d) recalled product-related issues; and (e) miscellaneous other
issues.
a. Product-Related Issues. Eighty-seven of the 209 incidents, or
approximately 42%, involved hardware failures or design issues related
to the product. The reported problems are listed below, beginning with
the most frequently reported problems:
Inadequate structural integrity, which included unstable
bassinets or cradles, loose hardware, collapse of the product, loose
wheels, etc.;
Locking or tilting issues with the bassinets or cradles,
which cause the infant to roll or press up against the side or corner
of the product, posing a suffocation hazard;
Problems with mattress flatness, such as mattresses that
would not remain horizontal because of metal rods or other structures
designed to be positioned underneath the mattress, lack of rigid
mattress support, and failure of straps or hooks designed to hold
bassinets inside play yards. One death was associated with a mattress
flatness issue; and
Problems with battery-powered bassinet mobiles which had
components that overheated, smoked, or sparked.
b. Non-Product-Related Issues. Sixty of the 209 incident reports,
or 29%, were of deaths or injuries that could not be attributed to a
product defect or failure. Fifty-seven of the 60 incidents were deaths
where a determination of causation or association was complicated by
the inappropriate use of pillows, blankets, or mattresses.
c. Unknown Issues. Twenty-six of the incidents, or 12%, had little
or no information. Twenty-five of these reported a fall of the infant
out of the bassinet or cradle.
d. Recalled Product-Related Issues. There were 19 reports (9%) that
involved recalled products. Among them were seven entrapments (three
deaths, two non-fatal injuries, and two non-injury incidents) between
the metal rods of the bassinet. The remaining 12 reports were
complaints or inquiries from consumers regarding a recalled product.
e. Miscellaneous Other Issues. The remaining 17 incident reports
involved a host of miscellaneous problems, including a tear in the
bassinet fabric, odors, and product assembly or quality issues.
[[Page 22305]]
2. Deaths and Injuries
All 61 fatalities reported to CPSC staff were asphyxiation deaths.
The majority of deaths (57 out of 61) were asphyxiations where the
incident report noted the presence of soft or extra bedding in the
bassinet, prone placement of the infant, or the infant getting wedged
between the side of the bassinet and mattress or bedding. Soft or extra
bedding and the prone placement of an infant are associated with infant
mortality from asphyxiation, independent of any design hazard. A few
were reported as asphyxiation deaths, with no further information
available. Only four of these deaths were determined to have resulted
from design flaws of the product. Three of the four deaths were due to
entrapment of the infant between the metal bars of a particular brand
of bassinet. Of those three deaths, two of the three infants were six
months old and should not have been using the bassinet or cradle
because by definition they are only for use up to five months. The
fourth death resulted from an infant suffocating in the corner of the
bassinet when he rolled into that position due to the unlevel mattress
pad.
Thirty-eight incidents reported an injury to an infant. Twenty-
three out of the 38 incidents, or 61%, were identified as falls out of
the bassinets. Serious injuries included a skull fracture resulting
from an infant falling out of the bassinet due to non-level mattress
issues, an arm fracture resulting from a fall due to problems with a
bassinet's rocking feature, and a second-degree burn resulting from the
bassinet's overheated mobile. The remaining injuries were mostly
limited to contusions and abrasions.
3. Hammock Incidents
The Commission is aware of three fatalities, six non-fatal
injuries, and five non-injury incidents related to infant hammocks that
were reported to have occurred since 2006. All three fatalities
reported to CPSC were asphyxiation deaths. One five-month old infant
was found rolled into a corner in a prone position with the bed in an
inclined position. A four-month old infant was found with her face flat
against the foam mattress. In the third case, the medical examiner
reporting the fatality expressed concern about the safety of the
hammock as a sleeping environment. However, the death of the six-month
old infant, who was found in a prone position, was officially ruled to
be asphyxiation due to respiratory infection.
All six non-fatal injuries were reported through the National
Electronic Injury Surveillance System (``NEISS''). Five of the injuries
were reported to have been falls out of hammocks, while the sixth
injury was sustained when a broken component of the hammock struck the
infant. Little or no circumstantial information is available on how the
falls occurred, except that three of the six infants were eight months
or older.
Two of the five non-injury reports involved infants (a seven-month
old and a 12-month old) in near-strangulation incidents where the
hammock flipped over with the infants dangling from restraints. The
remaining three reports involved near-suffocation incidents where the
infant rolled into a position from which it was unable to move or free
itself. All three infants were under five months of age.
E. Assessment of Voluntary Standard ASTM F 2194-07a [egr]1 and
Description of Proposed Changes and the Proposed Rule
1. Assessment of Voluntary Standard ASTM F 2194-07a [egr]1
Section 104(b) of the CPSIA requires the Commission to assess the
effectiveness of the voluntary standard in consultation with
representatives of consumer groups, juvenile product manufacturers, and
other experts. This consultation process began in October 2009 during
the ASTM International subcommittee meeting regarding the ASTM bassinet
and cradle voluntary standard. Consultations with members of this
subcommittee are still ongoing.
ASTM F 2194-07a [egr]1 contains several labeling and performance
criteria. The standard addresses many of the same hazards associated
with other durable nursery products and includes requirements for tip
stability, unintentional folding of the product, lead in paints, sharp
edges/sharp points, small parts, wood part splinters, scissoring/
shearing/pinching, openings/entrapments, warning labels, and toys
(which includes battery-powered mobiles). The Commission believes that
updates and modifications in certain areas also may address the hazards
described in the incident data, such as suffocation due to mattress
tilting, placing of inappropriate bedding materials (e.g., pillows,
additional blankets, etc.), and entrapment in the frame structure.
While overheating of battery-powered mobiles was identified in the
incidents, those incidents were isolated to one company.
2. Proposed Changes to the ASTM Standard's Requirements
Consistent with section 104(b) of the CPSIA, the Commission,
through this proposed rule, would establish a new 16 CFR part 1218,
``Safety Standard for Bassinets and Cradles.'' The new part would
incorporate by reference the requirements for bassinets and cradles in
ASTM F 2194-07a [egr]1 with certain changes to specific provisions and
additions to the standard, as discussed below. The proposed
modifications and additions to the standard will further reduce the
risk of injury associated with bassinets and cradles. Therefore, the
proposed rule would adopt ASTM F 2194-07a [egr]1 as the mandatory
safety standard for bassinets and cradles with the following additions
and modifications:
Specify in the scope that the standard is a performance
specification for bassinets and cradles and that the intended use is
for infants who are not able to push up on their hands and knees;
Add terminology that defines what constitutes a bassinet
or cradle;
Add a performance requirement and test procedure for
maximum allowable rocking angle, maximum allowable rest angle of the
sleep surface, and maximum allowable flatness angle;
Add a performance requirement and test procedure for
fabric-sided bassinets and cradles;
Add a performance requirement and test procedure for
locking mechanisms intended to prevent rocking or swinging cradles from
rocking or swinging the mattress bed;
Add updated warnings to address proper use of bedding
materials by providing more emphasis and prominence to the warnings;
and
Exclude strap restraints in bassinets and cradles.
Following is a more detailed discussion of these additions and
modifications. To best understand the proposed standard, it is helpful
to view the current ASTM F 2194-07a [egr]1 standard for bassinets and
cradles and the Commission's proposed modifications along with the
explanations provided in section E.2 of the preamble. The ASTM standard
is available for viewing for this purpose during the comment period
through this link: http://www.astm.org/cpsc.htm.
a. Scope (Proposed Sec. 1218.2(b)(1)(i))
Bassinets and cradles should only be used in the early stages of an
infant's development. Once an infant can push up by him/herself, a
number of hazards are created, most notably falling
[[Page 22306]]
hazards. Thus, the proposed rule would add objective criteria of an
infant capable of pushing up on hands and knees to the scope of the
standard to clarify which products would be considered bassinets or
cradles. The proposed rule also would clarify that the bassinet or
cradle should be used only for infants up to approximately five months
of age.
b. Newborn Infant CAMI Dummy (Proposed Sec. 1218.2(b)(2)(i))
Because the proposed standard would require testing with a 7 pound
Newborn CAMI Dummy in the Rock/Swing Angle test and the Bassinet/Cradle
Flatness Angle test, proposed Sec. 1218.2(b)(2) would provide this
reference and a photograph.
c. Definition of Bassinet/Cradle (Proposed Sec. 1218.2(b)(3)(i))
Proposed Sec. 1218.2(b)(3)(i) would improve the definition of
bassinet/cradle by identifying the products that are excluded from the
standard. The updated definition would clarify that full-size and non-
full size cribs are not covered. Also, because a bassinet or cradle is
defined as a product that must be supported by a base, hand-carrying
baskets would not be covered.
d. Bassinet/Cradle Accessory (Proposed Sec. 1218.2(b)(4)(i))
The proposal would update the definition of a bassinet/cradle
accessory to avoid confusion with accessories that can attach to
products that are not intended exclusively for sleep, such as
strollers.
e. Double Action Release Mechanism (Proposed Sec. 1218.2(b)(5)(i))
Section 5.6.3 of ASTM F 2194-07a-[egr]1 requires that products with
a ``double action release mechanism'' latching or locking device
require two distinct and separate actions for release of the mechanism.
The voluntary standard does not define ``double action release
mechanism.'' The Commission has observed various multi-use products
that can convert from a rocking bassinet to a stationary one. During
this conversion, there are dual-action locking mechanisms that require
rotating pop-out casters and then engaging a ``tab''-lock to prevent
the casters from rolling. Despite appearances, such dual-action locking
mechanisms are not double action release mechanisms. To avoid confusion
in what constitutes a double action release mechanism and to ensure
that the locking mechanism works as intended in resisting collapse and/
or movement, the Commission is proposing to adopt the same definition
as used in the voluntary ASTM high chair standard F 404-08.
Specifically, the proposed rule would define a double action release
mechanism as a ``mechanism requiring either two consecutive actions,
the first of which must be maintained while the second is carried out
or two separate and independent single action locking mechanisms that
must be activated simultaneously to fully release.''
f. Removable Cover (Proposed Sec. 1218.2(b)(5)(ii))
Because the term removable cover is referenced in the test
procedure for evaluating possible scenarios of entrapment hazards from
bounded areas of fabric and rigid sides of a bassinet or cradle in
proposed Sec. 1218.2(b)(11)(iii), the proposed rule would add a
definition of ``removable cover'' to the standard.
g. Maximum Deflection Angle and Rest Angle (Proposed Sec.
1218.2(b)(5)(iii), 1218.2(b)(5)(iv), 1218.2(b)(10), and 1218.2(b)(11))
When a bassinet or cradle is not in a swinging or rocking mode, it
needs to be level to facilitate a safe sleeping environment for
infants. There was one death and several close calls associated with
non-level bassinets/cradles. According to an in-depth investigation
(IDI) report, a two month old male died in a bassinet portion of a play
yard. The infant rolled, causing his face to be placed in the corner of
the bassinet. One side was approximately five inches higher than the
other. The metal poles upon which the bassinet was seated were too
short to keep the sleep surface level. In one non-fatal incident, a
mother found her two-week old male infant with his face against the
mattress, covering his nose and mouth after he had slid down the side
of the mattress. The product involved was a play yard-swinging bassinet
combination. The IDI report states that the locking mechanism to
prevent the swinging motion disengaged when the mother placed her son
in the product. The infant was not injured, and the mother returned the
product to the store. In another non-fatal incident, a mother found her
five-month-old daughter in a bassinet-play yard combination asleep up
against the back side of the bassinet portion. The infant was not
injured when the strap holding the bassinet insert to the side of her
play yard ripped, causing the bassinet to tip sideways. The photographs
from the IDI report showed the bassinet sleep surface at a substantial
angle when the strap failure occurred. The infant could have been
trapped between the bassinet and side of the play yard.
To ensure a level sleeping environment for infants, the proposal
would establish a performance requirement and test method for the
maximum allowable rock/swing angle and maximum allowable rest angle of
the bassinet/cradle. CPSC staff worked with ASTM to develop these
performance requirements and test procedures to reduce potential
suffocations and entrapments. The 20[ordm] maximum rock/swing angle
recommendation is based on the Canadian regulation for cribs and
cradles (SOR 86-962, available in its entirety at http://
www.canlii.org/en/ca/laws/regu/sor-86-962/latest/sor-86-962.html), as
well as on observations and measurements made by the Commission on
recent model bassinets and cradles. The Canadian crib and cradle
regulation is a widely accepted standard. The Commission believes the
20[deg] limit included in the Canadian regulation allows sufficient
rocking/swinging motion while maintaining safety. The 5[deg]
recommendation for the mattress rest angle is based on conclusions from
the Australian study, ``The Danger of Freely Rocking Cradles,'' by S.M.
Beal et al., Journal of Pediatric Child Health (1995) and the
performance requirements from AS/NZS 4385:1996 the Australian/New
Zealand standard for infant's rocking cradles. The conclusions from the
Australian study suggest that a maximum 5[deg] rest angle from rocking
cradles could minimize the risk of an infant rolling and getting
trapped in a corner or other entrapment/asphyxiation scenario. The
Commission seeks comment on the Australian study and any other
literature that may be relevant to the recommendation on the mattress
rest angle.
The test method for the maximum allowable rock/swing angle and rest
angle performance requirements, the ``Rock/Swing Angle test,'' is found
in proposed Sec. 1218.2(b)(11)(i). The test method is based on the
procedure developed by the Task Group of the ASTM subcommittee for
bassinets and cradles, with specific changes proposed by the
Commission. CPSC test data have shown that some products have better
angle measurement results (i.e., a less steep angle) with the Newborn
CAMI Dummy, and others get better results with the CAMI Dummy, Mark II.
Thus, the proposal would require that the testing be done with the
Newborn Infant CAMI Dummy, in addition to the CAMI Dummy, Mark II. Test
data also showed that the placement of the dummy in the sleep surface
can affect the results. For
[[Page 22307]]
example, placing the dummy next to the wall in a rocking cradle may
produce an angle that is more severe compared to placing the dummy in
the center. Therefore, the proposed procedures would describe how the
dummy should be placed in the sleep surface. The proposed rule would
also provide specific angle measurement procedures. Finally, because
some products can swing along the head-to-toe axis, the proposed rule
would require such products to be tested in that direction as well.
h. Flatness Angle (Proposed Sec. 1218.2(b)(5)(v), 1218.2(b)(10)(ii),
and 1218.2(b)(11)(ii)
Incidents involving bassinet/play yard combinations suggest that a
sloped surface or a mattress with multiple seams (mattresses that
double as a play yard cover) may have the potential for an asphyxia
suffocation hazard, as an infant's head may become entrapped between
the sloped mattress and bassinet wall surface. Proposed Sec.
1218.2(b)(10)(ii) would require that the angle of the bassinet or
cradle sleeping support surface not be greater than 5[deg] when tested
in accordance with the test procedures in proposed Sec.
1218.2(b)(11)(ii). This is to ensure that the mattress does not deform
and create a depression, sloped surface, or an appreciable gap between
a bassinet wall surface and the mattress.
Proposed Sec. 1218.2(b)(11)(ii) includes testing with the CAMI
Infant Dummy, Mark II and the Newborn CAMI Dummy. The test is intended
to ensure that the sleep surface of the bassinet or cradle is flat and
will not tilt when either CAMI dummy is placed in a corner or edge of
the sleeping surface. A dynamic test, which is a force applied over a
relatively short period of time, is needed because it will simulate
children turning themselves over in the mattress bed area, particularly
in a bassinet/play yard combination product with multiple segmented
seams.
i. Testing equipment (Proposed Sec. 1218.2(b)(6))
In the standardization and calibration section, proposed Sec.
1218.2(b)(6) would specify the type of angle instrument and its
measurement resolution to minimize angle measurement variability. Also,
proposed Sec. 1218.2(b)(6) would specify the tolerance and calibration
interval for the force gauge required on several performance tests to
minimize force measurement variability.
j. Restraints (Proposed Sec. 1218.2(b)(7)(i))
Infants lying on a flat surface do not need restraints and the use
of restraints could contribute to a possible strangulation hazard.
Therefore, proposed Sec. 1218.2(b)(7)(i) would add language to the
standard to clarify that bassinets should not include any restraint
system that requires action on the part of the caregiver to secure the
restraint.
k. Spacing of Rigid and Fabric-Sided Bassinet/Cradle Components
(Proposed Sec. 1218.2(b)(8), 1218.2(b)(10)(iii) and
1218.2(b)(11)(iii))
Seven incidents (among them three deaths) involved recalled
products where infants were trapped between structural members of the
bassinet. Bassinets and cradles with fabric sides can present similar
entrapment hazards from bounded areas of fabric and rigid sides of a
bassinet or cradle. ASTM F 2194--07a [egr]\1\ contains performance
requirements and test methods for the spacing of rigid sided bassinet
and cradle components, intended to minimize torso and/or head
entrapments. Because similar hazards are presented by fabric-sided
bassinets and cradles, the proposed rule would include performance
requirements and test methods for fabric-sided bassinets and cradles as
well. For some types of bassinets or cradles with fabric removable
covers, it is foreseeable that a parent or caregiver will place fabric
back loosely onto a bassinet or cradle after washing and forget to
fasten the snaps, zippers, or other fasteners. If the fabric should
slip and separate from the structural members of the bassinet/cradle
wall, an infant's torso may become entrapped between two structural
members of a bassinet/cradle. Also, it is possible that an infant can
suffocate if he or she is trapped in a bounded area between structural
members and fabric. Thus, the proposed rule would require testing in
this configuration, i.e., where the fabric cover is placed loosely on
the bassinet or cradle but is unfastened, as well.
The test method for this performance requirement is found in
proposed Sec. 1218.2(b)(11)(iii). Proposed Sec. 1218.2(b)(11)(iii)
would require that fabric-sided bassinets or cradles comply with the
crib spacing requirements in 16 CFR Part 1509.4 when subjected to the
20 pound (lb) probe test. The fabric must not fully release and form a
completely bounded opening which would allow complete passage of the
torso test probe. The bassinets and cradles must comply both when the
fabric cover is fastened and when it is unfastened. The Commission
believes it is reasonable to use the crib spacing requirements in 16
CFR Part 1509.4, given that infants of similar ages are utilizing
bassinets or cradles and cribs. While the ASTM committee initially
proposed a 35 lb force for the probe test, the Commission believes that
20 lbs appears to be consistent with the crib standard (16 CFR Part
1509.6) and is more realistic for infants in the age range of less than
five months. ASTM subcommittee for bassinets and cradles, with CPSC
staff's input, developed the proposed test procedures.
k. Stability (Proposed Sec. 1218.2(b)(9)(i))
Because at least three of the 87 product-related incidents involved
a locking mechanism failure or malfunction, proposed rule Sec.
1218.2(b)(9)(i) would include test scenarios where the bassinet or
cradle is tested with the locking mechanism(s) engaged if it is
equipped with a locking mechanism to prevent swinging or rocking. This
requirement would ensure the stability of the product in modes where
the locks are engaged to prevent swinging or rocking.
l. Marking and Labeling Section (Proposed Sec. Sec. 1218.2(b)(12)
Through (b)(14))
Because many deaths and non-fatal incidents involve suffocation due
to caregivers and parents using bedding materials (such as pillows and
blankets) that are not specified by the manufacturer, and because these
incidents cannot be addressed by the design of the bassinet or cradle,
it is imperative to improve the warning labels regarding padding and
soft bedding in the standard. Consequently, proposed Sec. Sec.
1218.2(b)(12) through (14) would require certain warning statements or
labeling information regarding a suffocation hazard.
F. Request for Comments
This proposed rule begins a rulemaking proceeding under section
104(b) of the CPSIA to issue a consumer product safety standard for
bassinets and cradles. 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.
G. 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). To allow time for bassinets and
cradles to come into compliance, the Commission intends that the
standard would become effective six months after publication of a final
rule. The Commission seeks
[[Page 22308]]
comment on how long it would take manufacturers of bassinets and
cradles to come into compliance with the rule.
H. Regulatory Flexibility Act
The Regulatory Flexibility Act (``RFA'') generally requires that
agencies review proposed rules for their potential economic impact on
small entities, including small businesses. 5 U.S.C. 603.
1. The Market
Bassinets and cradles are typically produced and/or marketed by
juvenile product manufacturers and distributors. There are currently at
least 48 known manufacturers or importers supplying bassinets and/or
cradles to the United States market. (These counts also include firms
solely producing hammocks for infants as well. However, under the
standard proposed by the Commission, most hammock products will no
longer be able to conform. ASTM has started working on a new standard
to cover these products.) Nine firms (19 percent) are domestic
importers, 28 firms (58 percent) are domestic manufacturers, and 10
firms (21 percent) are foreign manufacturers. There is an additional
domestic firm whose status as a manufacturer or importer could not be
determined. Thirteen firms, including the firm whose means of supply
could not be determined, supply infant hammocks to the United States
market. (There is an additional hammock on the United States market
whose supplier could not be determined, as well as a small cottage
industry in knitted and crocheted infant hammocks.) The product lines
for seven of these firms rely primarily or entirely on infant hammocks
and related merchandise. (These determinations were made using
information from Dun & Bradstreet and ReferenceUSAGov, as well as firm
Web sites. Manufacturers include traditional manufacturers, as well as
firms that send out their designs to be manufactured, and firms that
import as well but are primarily manufacturers.)
Under Small Business Administration (SBA) guidelines, a
manufacturer of bassinets or cradles 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, 22 of the domestic manufacturers
and five of the domestic importers known to be supplying the United
States market are small. The sizes of the four remaining domestic
importers and two additional domestic manufacturers are unknown, but
they are likely to be small as well, as is the firm whose supply source
could not be determined. All of the firms supplying infant hammocks to
the United States market are believed to be small. Two of these small
firms are domestic manufacturers, four are domestic importers, six are
foreign firms, and one is an unknown domestic firm. There are probably
additional unknown small manufacturers and importers operating in the
United States market.
JPMA, the major United States trade association that represents
juvenile product manufacturers and importers, operates a voluntary
certification program for several juvenile products. Products
voluntarily submitted by manufacturers are tested against the
appropriate ASTM standard and only passing products are allowed to
display JPMA's Certification Seal. (See http://www.jpma.org/pdfs/
certfacts08.pdf for more information.) Approximately 33 percent of
firms supply bassinets/cradles to the United States market that have
been JPMA certified as compliant with the current ASTM voluntary
standard (16 firms). Two of these firms supply more than one relevant
product category, where one category of products is JPMA certified and
another is not. (For example, one firm has JPMA certified bassinets,
but its play yards are not JPMA certified.) Additionally, one firm
claims compliance although its products have not been certified by
JPMA, and one firm has recently had its product removed from JPMA's
list of certified products. Of the small domestic businesses (this
includes firms suspected of being small as well those known to be
small), 38 percent of manufacturers (nine of 24 firms) and 44 percent
of importers (four of nine firms) have products that are ASTM
compliant. This includes the small manufacturer that claims compliance
with the ASTM standard, but is not part of the JPMA Certification
Program, as well as the firms with only some product categories JPMA
certified. (It should be noted that non-JPMA certified products will
not necessarily fail to comply with the ASTM standard. Although there
is currently no testing to support such an assumption for bassinets and
cradles, testing of other products has revealed a pattern of non-
correlation.)
2. Compliance Requirements of the Proposed Rule
Several of the recommended modifications and new requirements to
the standard would be little to no burden on manufacturers or
importers. The developmental limit modification (limiting the product
use to when a child is able to push up on hands or knees), as well as
the changes to suffocation warnings, would only require changes to
instructional literature and packaging. The clarifications to what is
included and excluded from the definition of the product would
effectively eliminate some products from the scope of the proposed
standard. This would exclude some firms from compliance requirements
entirely, while reducing the number of products for others. As
discussed herein, however, the inclusion of infant hammocks will have a
substantial effect on many of these suppliers. The possible need to
eliminate product restraints would only affect a few firms and the
impact would be minimal. (It is possible that the lack of restraints
could reduce product desirability from the consumer's perspective.
However, this effect would be felt equally across all firms and is not
expected to cause a significant reduction in demand for these products
as a whole. The Commission believes that restraints are unnecessary for
infants who are lying on a flat surface and could pose a strangulation
hazard.)
Double action release mechanisms are typically used with multi-use
products to convert a rocking bassinet to a stationary one. The
expansion of locking and latching mechanism tests to cover double
action release mechanisms, as well as the addition of stability testing
with these locks engaged, are intended to resist collapsing or
movement. There have been several cases where locking mechanisms have
failed which caused the infant to roll and press up against the side or
corner of the product, posing a suffocation hazard. (See Memorandum
from Risana Chowdhury, EPI, Directorate for Epidemiology, dated
February 3, 2010, Subject: Bassinets, Cradles, and Infant Hammocks-
Related Deaths, Injuries and Potential Injuries; 2006-Present. It
should be noted that it is unclear how many of these lock failures were
double action release mechanisms.) This modification is not expected to
pose a substantial burden on firms. However, it is possible that a few
firms might have to make product modifications to comply. This would
most likely take the form of improved locking/latching mechanisms.
Expanding spacing requirements to openings in soft-sided products
could have a substantial effect on a small number of firms. Where
products cannot pass the new requirements, substantial modifications
and product redevelopment are likely. However, the Commission believes
that the severity of the incidents involving these types of products
and the recalls that resulted strongly support adding this requirement
to the proposed standard.
[[Page 22309]]
There are currently no maximum requirements for rocking or rest
angles on products intended to rock or swing. Tilting issues have
resulted in suffocation hazards similar to those of locking mechanism
failures. It is believed that adding maximum angle requirements to the
proposed standard could reduce future incidents, while affecting only a
small number of firms. The fact that these requirements are already a
part of non-United States safety standards indicates that compliance
has not proven difficult. However, it is possible that a few firms
might require product modifications to achieve compliance with these
new requirements.
The maximum sleep surface angle requirement and test is primarily
aimed at incidents involving bassinet/play yard combination products.
These incidents suggest that products with sloped surfaces or
mattresses with multiple seams could pose a suffocation hazard. (See
Memorandum from Han Lim, ESME, Directorate for Engineering Sciences,
dated February 16, 2010, Subject: Engineering Assessment of ASTM F
2194-07 a [egr]1, Standard Consumer Safety Specification for Bassinets
and Cradles; see also Memorandum from Risana Chowdhury, EPI,
Directorate for Epidemiology, dated February 3, 2010, Subject:
Bassinets, Cradles and Infant Hammocks-Related Deaths, Injuries and
Potential Injuries; 2006-Present.) There are numerous such combination
products on the market, but only a few known suppliers; therefore, this
requirement could require product modifications (and possibly product
redesign) by a few firms.
The rock/rest angles and sleep surface angles are likely to
disproportionately affect most of the thirteen infant hammock
suppliers. Infant hammocks typically hang from a standing base and rock
naturally. Most have sleep surfaces that curve, molding to an infant's
body.
However, two infant hammock suppliers have flat sleep surfaces.
These two firms are not expected to require further modifications to
comply with the recommended sleep surface angle requirement, and it is
likely that they will be able to meet the rock/rest angle requirements
inexpensively, with known fixes running no more than $5 per unit. For
example, they could add a clipping mechanism that has been recently
developed to limit the swing angle for hammocks involved in product
recalls. Alternatively, they may be able to change the number and
placement of the ties from which the hammock hangs.
For the remaining eleven firms supplying infant hammocks, even
though it would be possible to inexpensively modify their products to
meet both the rock/rest angle and sleep surface angle requirements,
such modifications would change their products too extensively to
remain in the market. A niche market exists among parents with colicky
babies for hammocks that curve around babies' bodies and rock
naturally. The suppliers, both manufacturers and importers, are
unlikely to make even inexpensive modifications to meet the
requirements as proposed. Any known fix would eliminate their niche
market, thereby eliminating demand for their products, and may drive
them out of business.
3. Impact of the Proposal on Small Business
There are approximately 48 firms currently known to be marketing
bassinets, cradles, and/or infant hammocks in the United States. Four
are large domestic manufacturers and ten are foreign manufacturers or
importers. The impact on the remaining 34 small firms--24 small
domestic manufacturers and 9 small domestic importers (one of these
firms produces only hammocks, while another produces both hammocks and
bassinets)--is the focus of the remainder of this analysis. Of these
small firms, two domestic manufacturers and four domestic importers (as
well as the unknown domestic firm) supply infant hammocks.
Small Manufacturers (Other than Infant Hammock Manufacturers). The
impact of the proposed standard (if finalized) on small manufacturers
will differ based on whether they are currently compliant with the
voluntary ASTM standard. For the 15 firms that are not complaint with
the current voluntary standard, the proposed standard could have
substantial impact because their products would most likely have to be
redesigned. Product development costs include product design,
development and marketing staff time, product testing, and focus group
expenses. These costs can be high, but they can be treated as new
product expenses and amortized over time, as can other one-time costs
such as the retooling of manufacturing equipment. There also may be
increased costs of production, particularly if modifications to
structural integrity are required, which could include additional raw
materials. This could potentially increase shipping costs as well. The
actual cost of such an effort is unknown, but could be substantial for
some firms, particularly those that rely primarily or entirely on
bassinets/cradles and related products, such as bedding.
The impact on most of the nine firms that comply with the current
voluntary standard is expected to be less substantial. The majority of
modifications recommended by the Commission are expected to have only
minor effects on small manufacturers. There are, however, three
recommended changes (rocking/rest angles, sleep surface angle, and
spacing requirements for soft-sided products) that could require
product modifications. While these requirements may affect only a few
firms, they may require product redevelopment, which has the potential
to impose unknown but substantial, costs. The Commission seeks comment
on the cost associated with these product modifications.
Even though the proposed standard could potentially affect a few
small firms significantly, the costs associated with compliance could
be gradually recouped over the sales of numerous units. Bassinets and
cradles are unique products designed to provide a sleeping environment
for very young children that is smaller and more like the womb.
Therefore, other sleeping products are unlikely to be suitable
substitutes for these products, allowing firms to pass at least some
costs on to consumers and to still compete effectively. (There is also
the possibility, however, that some consumers may instead use
unsuitable sleeping environments, such as bouncers, as substitutes.)
The scenario just described assumes that only those firms that are
JPMA-certified or claim ASTM compliance will meet the voluntary
standard's requirements. This is not necessarily the case. CPSC has
identified many cases where products not certified by JPMA do comply
with the relevant ASTM standard; however, there is insufficient
evidence of this for bassinets/cradles to quantify this impact.
Additionally, the effect of the new and modified requirements may be
less substantial than just outlined to the extent that some products
may already comply with non-United States standards with some more
rigorous requirements. For example, a product that complies with the
Australian standard would pass the proposed rock angle requirement.
However, there is insufficient information to quantify this effect.
Small Importers (Other than Infant Hammock Importers). Four of the
nine small importers are compliant with the current voluntary standard.
Two of these compliant importers supply infant hammocks exclusively. Of
the remaining five non-compliant importers, two supply infant hammocks
[[Page 22310]]
exclusively. Therefore, if their existing supplier does not come into
compliance with the proposed standard, these firms will need to find an
alternate source of bassinets and cradles. Manufacturers are likely to
pass at least some costs onto importers, making the bassinets/cradles
more expensive. (These products would also be expected to be higher
quality given the additional safety requirements.) However, importers
can follow suit, passing some costs on to consumers. Even if importers
responded to the rule by discontinuing the import of their non-
complying bassinets and cradles, either replacing them with a complying
product or another juvenile product, deciding to import an alternative
product would be a reasonable and realistic way to offset any lost
revenue given that most import a variety of products. To the extent
that some firms may comply with the current voluntary standard or one
or more of the new/modified requirements in the proposed standard, the
impact of the proposed rule would be lower.
Small Hammock Manufacturers and Importers. The impact of the
proposed standard on small hammock manufacturers and importers depends
primarily on two factors: (1) Whether their hammocks have a flat sleep
surface; and (2) whether their product line consists (primarily or
entirely) of infant hammocks and related products. If a supplier's
hammocks already have a flat sleep surface (as is the case with one
known small domestic manufacturer), it is likely that it will modify
its existing infant hammocks. This modification can be made
inexpensively based upon a recent product recall fix that minimized the
rock/rest angle of these types of products. (The known fixes are
unlikely to cost more than $5 per unit.) However, the remaining small
infant hammock suppliers, both manufacturers and importers, are
unlikely to make even inexpensive modifications to meet the proposed
requirements. Doing so would eliminate their niche market for
naturally-rocking, flexible-sleep-surface products intended to calm
colicky babies. Among the six small domestic firms supplying this niche
market, four small importers and one unknown firm rely entirely (or
almost entirely) upon infant hammocks and related products. Therefore,
the proposed rule, if finalized, may be likely to put these firms out
of business. The remaining small domestic manufacturer, however, does
supply other products, and the likely elimination of infant hammocks
from its product line is not expected to drive it out of business,
although it is likely to have a substantial effect on its sales
revenue. The Commission seeks comment on the effect of the proposed
modifications to the standard on small hammock manufacturers and
importers.
3. Alternatives. Under section 104 of the CPSIA, the primary
alternative that would reduce the impact on small entities is to make
the voluntary standard mandatory with no additions or modifications.
Adopting the current voluntary standard without any changes could
potentially reduce the costs for nine of the 24 small manufacturers and
four of the nine small importers who already comply with the voluntary
standard. However, the actual reduction in impact for these firms is
likely to be smaller, since many would likely not require substantial
changes even under the proposed standard. For the six small domestic
firms supplying infant hammocks to the United States market, making the
current voluntary standard mandatory with no modifications would
substantially reduce the impact. It would be likely to prevent five
firms from going out of business, while the sixth might be spared a
substantial decrease in sales revenue. It also should be noted that
eliminating the market for potentially hazardous infant hammocks
intended to lull colicky babies may have the unintended consequence of
leading caregivers to use similar products intended for older children
instead, thereby creating a potentially new hazard.
4. Conclusion of Initial Regulatory Flexibility Analysis
It is possible that the proposed standard, if finalized, could have
a significant impact on a few small firms. Most firms supplying
bassinets and/or cradles to the United States market are not JPMA-
certified as compliant with ASTM's voluntary standard and may therefore
require at least some product modifications to achieve compliance. (To
the extent that some of the products not certified by JPMA may still
comply, the impact will be reduced.) For these firms, as well as a few
of those who are JPMA-certified, additional changes to meet the more
significant recommended requirements of the proposed standard may be
required as well. The extent of these costs is unknown, but since
product redevelopment would likely be necessary, it is possible that
the costs could be large for some of the firms. However, at least some
of these costs are expected to be passed on to consumers without a
reduction in the firms' ability to compete due to the unique features
associated with these products. The Commission seeks comment on what
these costs may be, whether they may be passed on to the consumer, and
how these costs will impact small businesses.
The small firms likely to be most significantly impacted by the
staff-recommended rule, however, are those supplying infant hammocks
intended for colicky babies. The majority of these firms have focused
their entire product line on these goods and the required modifications
would eliminate demand for their products, and may drive them out of
business.
I. Environmental Considerations
The Commission's regulations provide a categorical exemption for
the Commission's rules from any requirement to prepare an environmental
assessment or an environmental impact statement as they ``have little
or no potential for affecting the human environment.'' 16 CFR
1021.5(c)(2). This proposed rule falls within the categorical
exemption.
J. Paperwork Reduction Act
This proposed rule contains information collection requirements
that are subject to public comment and review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520). We describe the provisions in this section of
the document with an estimate of the annual reporting burden. Our
estimate includes the time for reviewing instructions, searching
existing data sources, gathering and maintaining the data needed, and
completing and reviewing each collection of information.
We particularly invite comments on: (1) Whether the collection of
information is necessary for the proper performance of the CPSC's
functions, including whether the information will have practical
utility; (2) the accuracy of the CPSC's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Title: Safety Standard for Bassinets and Cradles.
Description: The proposed rule would require each bassinet and
cradle to comply with ASTM F 2194-07a [epsiv]1, ``Standard Consumer
Safety Specification for Bassinets and Cradles.'' Sections 8 and 9 of
ASTM F 2194-07a[epsiv]1
[[Page 22311]]
contain requirements for marking and instructional literature.
Description of Respondents: Persons who manufacture bassinets and
cradles.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Frequency of Total annual Hours per Total burden
16 CFR section respondents responses responses response hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
1218.2(a).......................................................... 30 7 30 0.5 105
--------------------------------------------------------------------------------------------------------------------------------------------------------
There are no capital costs or operating and maintenance costs
associated with this collection of information.
Our estimates are based on the following:
Proposed Sec. 1218.2(a) would require each bassinet and cradle to
comply with ASTM F 2194-07a [epsiv]1. Sections 8 and 9 of ASTM F 2194-
07a [epsiv]1 contain requirements for marking and instructional
literature that are disclosure requirements, thus falling within the
definition of ``collections of information'' at 5 CFR 1320.3(c).
Section 8.1.1 of ASTM F 2194-07a[epsiv]1 requires that the name and
either the place of business (city, State, and mailing address,
including zip code) or telephone number, or both of the manufacturer,
distributor, or seller be clearly and legibly marked on each product
and its retail package. Section 8.1.2 of ASTM F 2194-07a [epsiv]1
requires that a code mark or other means that identifies the date
(month and year as a minimum) of manufacture'' be clearly and legibly
marked on ``each product and its retail package. In both cases, the
information must be placed on both the product and the retail package.
There are 48 known firms supplying bassinets and/or cradles to the
United States market. Eighteen of the 48 firms are known to already
produce labels that comply with sections 8.1.1 and 8.1.2 of the
standard, so there would be no additional burden on these firms. The
remaining 30 firms are assumed to already use labels on both their
products and their packaging, but would need to make some modifications
to their existing labels. The estimated time required to make these
modification is about 30 minutes per model. Each of these firms
supplies an average of 7 different models of bassinets/cradles,
therefore, the estimated burden hours associated with labels is 30
minutes x 30 firms x 7 models per firm = 6,300 minutes or 105 annual
hours.
The Commission estimates that hourly compensation for the time
required to create and update labels is $27.78 (Bureau of Labor
Statistics, September 2009, all workers, goods-producing industries,
Sales and office, Table 9). Therefore, the estimated annual cost
associated with the Commission recommended labeling requirements is
approximately $2,917 ($27.78 per hour x 105 hours = $2,916.90, which we
have rounded up to $2,917).
Section 9.1 of ASTM F 2194-07a [epsiv]1 requires instructions to be
supplied with the product. Bassinets and cradles are products that
generally require some installation and maintenance, and products sold
without such information would not be able to successfully compete with
products supplying this information. Under OMB's regulations (5 CFR
1320.3(b)(2)), the time, effort, and financial resources necessary to
comply with a collection of information that would be incurred by
persons in the ``normal course of their activities'' are excluded from
a burden estimate where an agency demonstrates that the disclosure
activities needed to comply are ``usual and customary.'' Therefore,
because the CPSC is unaware of bassinets and cradles that: (a)
Generally require some installation, but (b) lack any instructions to
the user about such installation, we tentatively estimate that there
are no burden hours associated with the instruction requirement in
section 9.1 of ASTM F 2194-07a [epsiv]1 because any burden associated
with supplying instructions with a bassinet or cradle would be ``usual
and customary'' and not within the definition of ``burden'' under OMB's
regulations.
Based on this analysis, the requirements of the Commission-
recommended bassinet and cradle rule would impose a burden to industry
of 105 hours at a cost of $2,917 annually.
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3507(d)), we have submitted the information collection requirements of
this rule to OMB for review. Interested persons are requested to fax
comments regarding information collection by May 28, 2010, to the
Office of Information and Regulatory Affairs, OMB (see ADDRESSES).
K. Preemption
Section 26(a) of the CPSA, 15 U.S.C. 2075(a), provides that where a
``consumer product safety standard under [the CPSA]'' is in effect and
applies to a product, no State or political subdivision of a State may
either establish or continue in effect a requirement dealing with the
same risk of injury unless the State requirement is identical to the
Federal standard. (Section 26(c) of the CPSA also provides that States
or political subdivisions of States may apply to the Commission for an
exemption from this preemption under certain circumstances.) Section
104(b) of the CPSIA refers to the rules to be issued under that section
as ``consumer product safety rules,'' thus implying that the preemptive
effect of section 26(a) of the CPSA would apply. Furthermore, in
Natural Resources Defense Council v. CPSC, 597 F. Supp. 2d 370 (S.D. NY
2009), the court held that ``[d]esignating the phthalate prohibitions
[in section 108 of the CPSIA] as consumer product safety standards
brings them within a well established statutory preemption scheme [of
section 26(a) of the CPSA].'' Therefore, a rule issued under section
104 of the CPSIA will invoke the preemptive effect of section 26(a) of
the CPSA when it becomes effective.
L. Certification
Section 14(a) of the Consumer Product Safety Act (``CPSA'') imposes
the requirement that products subject to a consumer product safety rule
under the CPSA, or to a similar rule, ban, standard, or regulation
under any other act enforced by the Commission, be certified as
complying with all applicable CPSC-enforced requirements. 15 U.S.C.
2063(a). Such certification must be based on a test of each product or
on a reasonable testing program or, for children's products, on tests
on a sufficient number of samples by a third-party conformity
assessment body accredited by the Commission to test according to the
applicable requirements. As discussed in Section K, section
104(b)(1)(B) of the CPSIA refers to standards issued under that
section, such as the rule for bassinets and cradles being proposed in
this notice, as ``consumer product safety standards.'' Furthermore, the
designation as consumer product safety standards subjects such
standards to certain sections of the CPSA, such as
[[Page 22312]]
section 26(a), regarding preemption. By the same reasoning, such
standards would also be subject to section 14 of the CPSA. Therefore,
any such standard would be considered to be a consumer product safety
rule to which products subject to the rule must be certified.
In addition, the CPSIA is another act enforced by the Commission,
and the standards issued under section 104(b)(1)(B) of the CPSIA are
similar to consumer product safety rules. For this reason also,
bassinets and cradles will need to be tested and certified as complying
with the safety standard when it becomes effective. Because bassinets
and cradles are children's products, they must be tested by a third-
party conformity assessment body accredited by the Commission. In the
future, the Commission will issue a notice of requirements to explain
how laboratories can become accredited as a third-party conformity
assessment body to test to the new safety standard. (Bassinets and
cradles also must comply with all other applicable CPSC requirements,
such as the lead content and phthalate content requirements in sections
101 and 108 of the CPSIA, and the tracking label requirement in section
14(a)(5) of the CPSA, and the consumer registration form requirements
in section 104 of the CPSIA.)
List of Subjects in 16 CFR 1218
Consumer protection, Imports, Incorporation by reference, Infants
and Children, Labeling, Law enforcement, and Toys.
Therefore, the Commission proposes to amend Title 16 of the Code of
Federal Regulations by adding a new part 1218 to read as follows:
PART 1218--SAFETY STANDARD FOR BASSINETS AND CRADLES
Sec.
1218.1 Scope, application and effective date.
1218.2 Requirements for bassinets and cradles.
Authority: The Consumer Product Safety Improvement Act of 2008,
Pub. L. 110-314, Sec. 104, 122 Stat. 3016 (August 14, 2008).
Sec. 1218.1 Scope, application and effective date.
This part establishes a consumer product safety standard for
bassinets and cradles manufactured or imported on or after (insert date
6 months after date of publication of a final rule in the Federal
Register).
Sec. 1218.2 Requirements for bassinets and cradles.
(a) Except as provided in paragraph (b) of this section, each
bassinet and cradle must comply with all applicable provisions of ASTM
F 2194-07a [egr]\1\, Standard Consumer Safety Specification for
Bassinets and Cradles, approved October 1, 2007. 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 502, 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 F 2194-07a[egr]\1\ standard with the
following additions or exclusions:
(1) Instead of complying with section 1.3 of ASTM F 2194-07a
[egr]\1\, comply with the following:
(i) 1.3 This consumer safety performance specification covers
products intended to provide sleeping accommodations only for infants
up to approximately 5 months of age or when the child begins to push up
on hands and knees, whichever comes first. Products used in conjunction
with an infant swing are not covered by this specification.
(ii) [Reserved]
(2) Following section 2.3 of ASTM F 2194-07a[egr]\1\, use the
following figure:
[GRAPHIC] [TIFF OMITTED] TP28AP10.007
(ii) [Reserved]
(3) Instead of complying with section 3.1.1 of ASTM F 2194-
07a[egr]\1\, comply with the following:
(i) 3.1.1 Bassinet/cradle, n--small bed designed exclusively to
provide sleeping accommodations for infants
[[Page 22313]]
supported by free standing legs, a wheeled base, a rocking base, or
which can swing relative to a stationary base. Products such as swings,
full and non-full size cribs, hand carrying baskets, and travel beds
are not included, unless the product is a bassinet/cradle attachment
per the definition in Section 3.1.2.
(ii) [Reserved]
(4) Instead of complying with section 3.1.2 of ASTM F 2194-07a
[egr]\1\, comply with the following:
(i) 3.1.2 bassinet/cradle accessory, n--accessory with a rigid
frame that attaches to non-full size crib, play yard, or other base
unit designed to convert the accessory into a bassinet/cradle.
(ii) [Reserved]
(5) In addition to section 3.1.11 of ASTM F 2194-07a [egr]\1\,
comply with the following:
(i) 3.1.12 Double action release mechanism, n--mechanism requiring
either two consecutive actions, the first of which must be maintained
while the second is carried out or two separate and independent single
action locking mechanisms that must be activated simultaneously to
fully release.
(ii) 3.1.13 removable cover, n--a fabric cover, containing snaps or
other fasteners such as zippers, Velcro, or buttons used to attach to a
bassinet/cradle frame that requires consumer action as a step for
removal or adjustment.
(iii) 3.1.14 Maximum deflection angle, n--the maximum rock/swing
angle measurement allowed by the product design in the manufacturer's
use position in the manner normally associated with rocking/swinging
and intended by the manufacturer when tested in accordance with 7.8.
(iv) 3.1.15 Rest angle, n--the resulting angle measurement of
bassinet/cradle sleeping surface or tilt angle of the bassinet/cradle
bed after the maximum deflection angle is applied and released and the
product has come to a complete rest when tested in accordance with 7.8.
(v) 3.1.16 Flatness angle, n--the resulting angle measurement of
the sleep support surface or tilt angle of the bassinet/cradle bed when
a compression force is applied to the chest of the CAMI dummy in
accordance with 7.9.
(6) In addition to section 4.5 of ASTM F 2194-07a [egr]\1\ comply
with the following:
(i) 4.6 Angle measurements shall be obtained using a digital
inclinometer capable of 0.1[deg] minimum resolution.
(ii) 4.7 Equipment--Force gauge with a range of 0 to 25 lbf (110N),
with a maximum tolerance of 0.25 lbf (1.11N) or a range of
0 to 50 lbf (222N) with a maximum tolerance of 0.25 lbf
(1.11N). A calibration interval shall be maintained for the force
gauges which will ensure that the accuracy does not drift beyond the
stated tolerances.
(7) In addition to section 5.12 of ASTM F 2194-07a [egr]\1\ comply
with the following:
(i) 5.13 Restraints-- The bassinet shall not include any restraints
system which requires action on the part of the caregiver to secure the
restraint.
(ii) [Reserved]
(8) Instead of complying with section 6.1 of ASTM F 2194-07a
[egr]\1\, comply with the following:
(i) 6.1 Spacing of Rigid and Fabric-Sided Bassinet/Cradle
Components or Bassinet/Cradle attachment Components--Spacing must
comply with 16 CFR Part 1509 Section 1509.4 when tested according to
7.1 and 7.10.
(ii) [Reserved]
(9) Instead of complying with section 6.4 of ASTM F 2194-07a
[egr]\1\, comply with the following:
(i) 6.4 Stability--A product in all manufacturers' recommended use
positions, including positions where the locks are engaged for
preventing rocking/swinging motion of the sleeping surface, shall not
tip over and shall retain the CAMI Infant Dummy, Mark II, when
subjected to the test described in 7.4.
(ii) [Reserved]
(10) In addition to section 6.6 of ASTM F 2194-07a [egr]\1\ comply
with the following:
(i) 6.7 Rock/Swing Angle--Bassinets or cradles that incorporate a
rocking/swinging feature shall meet the following:
(A) 6.7.1 Maximum deflection angle measurement on any reading shall
not exceed 20[deg] when tested in accordance with 7.8.
(B) 6.7.2 The arithmetic mean of the rest angle measurements shall
not exceed 5[deg] when tested in accordance with 7.8.
(ii) 6.8: Bassinet/Cradle Surface--The angle of the bassinet or
cradle sleeping support surface or the tilt angle of the bassinet/
cradle bed shall not be greater than 5[ordm] when tested in accordance
with 7.9.
(iii) 6.9 Fabric-Sided Enclosed Openings--For bassinets or cradles
with fabric sides, the fabric shall not release and form a completely
bounded opening that allows the complete passage of the torso probe
(Figure 3A) when tested in accordance with Section 7.10.
[GRAPHIC] [TIFF OMITTED] TP28AP10.008
[[Page 22314]]
(11) In addition to section 7.7 of ASTM F 2194-07a[egr]\1\ comply
with the following:
(i) 7.8 Rock/Swing Angle Test:
(A) 7.8.1 Side to Side Rock/Swing Test--for bassinets/cradles that
have a side-to-side rocking/swinging feature.
(B) 7.8.1.1 Assemble bassinet/cradle in accordance with
manufacturer's instructions and, if necessary, place the bassinet/
cradle in rocking/swinging mode.
(C) 7.8.1.2 Place the bassinet/cradle and the inclinometer on a
flat level horizontal plane (0[deg] 0.5[deg]) to establish
a reference plane. Zero the inclinometer.
(D) 7.8.1.3 Disengage any locking mechanisms designed to prevent
the unit from rocking/swinging, per the manufacturer's instructions.
(E) 7.8.1.4 Place the CAMI Infant Dummy, MARK II belly up, with
both arms contacting the torso, and the right arm touching the left
side wall in the bassinet cradle. See Figure 4A.
[GRAPHIC] [TIFF OMITTED] TP28AP10.009
(F) 7.8.1.5 Manually deflect and hold the bassinet/cradle to the
maximum side-to-side rock/swing angle allowed by the product design in
the manufacturer's use position in the manner normally associated with
rocking/swinging and intended by the manufacturer. Record the maximum
deflection angle.
(G) 7.8.1.6 Release the bassinet/cradle and allow it to come to
rest unassisted.
(H) 7.8.1.7 Place the 6 in. x 6 in. wood block (ref. Section 7.3.2)
less than 1 in. from the dummy, where the horizontal center of the
block is in line with the centerline of the mattress bed perpendicular
to the head-to-toe axis of the dummy. See Figure 4A. If a block cannot
be placed in the prescribed location inside the mattress bed area due
to mattress size constraints, dummy position, or if the mattress is
substantially curved, then mount a 1 in. aluminum angle (ref. Section
7.4.2) on top of the rigid bassinet frame. See Figure 4B.
[[Page 22315]]
[GRAPHIC] [TIFF OMITTED] TP28AP10.010
(I) 7.8.1.8 Place the inclinometer on the top center of the 6 in. x
6 in. wood block or aluminum angle and record the resulting angle.
(J) 7.8.1.9 Repeat steps 7.8.1.2 to 7.8.1.8 four additional times.
Record each side-to-side maximum deflection angle and each resulting
side-to-side rest angle measurement. Calculate the arithmetic mean of
the five side-to-side rest angle measurements.
(K) 7.8.1.10 Repeat steps 7.8.1.2 to 7.8.1.9 except place the CAMI
infant Dummy, Mark II belly up, with both arms contacting the torso,
and the left arm touching the right side wall in the bassinet/cradle.
(L) 7.8.1.11 Repeat steps 7.8.1.2 to 7.8.1.10 using a CAMI Newborn
Dummy.
(M) 7.8.2 Front-to-Back Rock/Swing Test--for bassinets/cradles that
have a front-to-back (head-to-toe) rocking/swinging feature.
(N) 7.8.2.1 Assemble bassinet/cradle in accordance with
manufacturer's instructions and, if necessary, place the bassinet/
cradle in the front-to-back rocking/swinging mode.
(O) 7.8.2.2 Place the bassinet/cradle and the inclinometer on a
flat level horizontal plane (0[deg] 0.5[deg]) to establish
a test plane. Zero the inclinometer.
(P) 7.8.2.3 Disengage any locking mechanisms designed to prevent
the unit from rocking/swinging, per the manufacturer's instructions.
(Q) 7.8.2.4 Place the CAMI Infant Dummy, Mark II belly up, with
both arms contacting the torso, and the crown of the dummy's head
touching the inside wall at one end of the sleep surface and the
dummy's head-to-toe centerline is in line with the centerline
perpendicular to the short dimension of the sleep surface. See Figure
4C.
[[Page 22316]]
[GRAPHIC] [TIFF OMITTED] TP28AP10.011
(R) 7.8.2.5 Manually deflect and hold the bassinet/cradle to the
maximum rock/swing angle in the front-to-back direction allowed by the
product design in the manufacturer's use position in the manner
normally associated with rocking and intended by the manufacturer.
Record the maximum rock/swing angle.
(S) 7.8.2.6 Release the bassinet/cradle and allow it to come to
rest unassisted.
(T) 7.8.2.7 Place the 6 in. x 6 in. wood block (ref. Section 7.3.2)
where the horizontal centerline of the wood block is in line with the
horizontal centerline of the sleep surface. See Figure 4. If the wood
block cannot be placed in the prescribed location on the mattress bed
area due to mattress size constraints, dummy position, or if the
mattress is substantially curved, then mount a 1 in. aluminum angle
(ref. Section 7.4.2) spanning the top of the rigid bassinet frame in a
direction parallel to the long dimension of the bassinet.
(U) 7.8.2.8 Place the inclinometer on the top center of the 6 in. x
6 in. wood block or aluminum angle. Record the resulting rest angle.
(V) 7.8.2.9 Repeat steps 7.8.2.2 to 7.8.2.8 four additional times.
Record each front-to-back maximum deflection angle and each resulting
rest angle measurement. Calculate the arithmetic mean of the five rest
angle measurements.
(W) 7.8.2.10 Repeat 7.8.2.2 to 7.8.2.9 with the CAMI Dummy, Mark II
feet touching the inside at one end of the sleep surface and the
dummy's torso centerline in line with the centerline perpendicular to
the short dimension of the sleep surface.
(X) 7.8.2.11 Repeat 7.8.2.2 to 7.8.2.10 with the Newborn CAMI
Dummy.
(ii) 7.9 Bassinet/Cradle Flatness Angle Test
(A) 7.9.1 Disable the rocking/swinging feature if the product is
equipped with such a feature. Place the CAMI Infant Dummy, Mark II
belly up, on the sleep surface in the location most prone to creating a
depression, slope, or tilt (e.g., near a seam in the mattress, in a
corner, etc.).
(B) 7.9.2 Place the 6 in. x 6 in. wood block (ref. Section 7.3.2)
on the chest of the dummy and apply a 10.0 0.5 lb
compression force within 2 seconds with a force gauge. Discontinue
applying the force.
(C) 7.9.3 Place the 6 in. x 6 in. wood block (ref. Section 7.3.2)
less than 1 in. from the dummy, where the horizontal center of the
block is in line with the horizontal centerline of the dummy. If the
wood block cannot be placed inside the sleep surface of a rocking/
swinging product due to mattress size constraints, dummy position, or
if the mattress is substantially curved, then mount the 1 in. aluminum
angle (ref. Section 7.4.2) on top of the rigid bassinet frame.
(D) 7.9.4 Record the resulting flatness angle along the dummy's
head-to-toe axis and at 90[deg] from the head-to-toe axis.
(E) 7.9.5 Repeat steps 7.9.1 to 7.9.4 four additional times. Record
each angle measurement and calculate the arithmetic mean of the five
angle measurements in the head-to-toe direction and 90[deg] from the
head-to-toe axis.
(F) 7.9.6 If the dummy's height is equivalent to or less than the
width of the sleep surface then rotate the dummy 90[deg] and repeat
steps 7.9.1 to 7.9.5. See Figure 4D.
[[Page 22317]]
[GRAPHIC] [TIFF OMITTED] TP28AP10.012
(G) 7.9.7 Repeat 7.9.1 to 7.9.6 with the Newborn CAMI Dummy.
(iii) 7.10 Fabric Release Test Methods for Enclosed Openings.
(A) 7.10.1 Assemble and place the bassinet/cradle in the
manufacturers use position.
(B) 7.10.2 With the torso test probe attached to a force gauge,
place the small end of the probe against the fabric inside wall of the
product and any structural elements in any locations deemed most likely
to fail.
(C) 7.10.3 Apply a 20 lb force to the probe over a period of 5
seconds and hold for an additional 5 seconds.
(D) 7.10.4 Upon completion of 7.10.3, if an opening occurs in a
location, other than the location being tested, release the probe from
the original test location and repeat 7.10.3 at this additional
location without adjusting the fabric.
(E) 7.10.5 If the product has a removable cover, unfasten all
fasteners and/or snaps and repeat 7.10.2 to 7.10.4.
(F) 7.10.6 Repeat 7.10.1 to 7.10.5 in all manufacturers recommended
use positions. For multiple use products, the test shall be performed
in all possible use modes.
(12) Instead of complying with section 8.3.1 of ASTM F 2194-07a
[egr]\1\, comply with the following:
(i) 8.3.1 In the warning statements, the safety alert symbol
[GRAPHIC] [TIFF OMITTED] TP28AP10.013
and the word WARNING shall precede the warning statements at each
location where warnings are provided and shall not be less than 0.2 in.
(5 mm) high. The remainder of the text shall be in letters not less
than 0.1 in. (2.5 mm) high except as specified in 8.4.2.
(ii) [Reserved]
(13) Instead of complying with section 8.4.2.1 of ASTM F 2194-07a
[egr]\1\, comply with the following:
(i) Infants have suffocated in gaps between extra padding and side
of the bassinet/cradle and on soft bedding. Use only the pad provided
by manufacturer. NEVER add a pillow, comforter, or another mattress for
padding.
(ii) [Reserved]
(14) In addition to the changes to ASTM F 2194-07a[egr]\1\ in
paragraph (b)(13), comply with the following:
(i) 8.4.2.2 The words ``SUFFOCATION HAZARD'' shall be bold face
type not less than 0.2 in. (5 mm) high. The words ``Infants have
suffocated'' shall be in characters whose upper case is not less than
0.16 in. (4 mm) high. The remainder of the warning statement shall be
standard type style whose upper case shall be at least 0.1 in. (2.5 mm)
high.
(ii) [Reserved]
Dated: March 30, 2010.
Alberta Mills,
Acting Secretary, U.S. Consumer Product Safety Commission.
[FR Doc. 2010-7667 Filed 4-27-10; 8:45 am]
BILLING CODE 6355-01-P
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