Safety Standard for Bassinets and Cradles: Notice of Proposed Rulemaking, 22303-22317 [2010-7667]

Agencies

• Consumer Product Safety Commission

[Federal Register Volume 75, Number 81 (Wednesday, April 28, 2010)]
[Proposed Rules]
[Pages 22303-22317]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-7667]


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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: https://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 https://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 https://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 https://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: https://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 https://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 https://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,