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Proposed Rule2024-07706

Safety Standard for Bassinets and Cradles

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Published

April 16, 2024

Issuing agencies

Consumer Product Safety Commission

Abstract

In 2013, the United States Consumer Product Safety Commission (Commission or CPSC) published a safety standard for bassinets and cradles (bassinets/cradles). By statute, after promulgating a mandatory rule, the Commission must periodically review and revise rules for durable infant or toddler products to ensure that they provide the highest level of safety for such products that is feasible. Accordingly, this proposed rule (NPR) would revise the existing rule for bassinets/cradles to ensure that it addresses identified hazards and that these sleep products for young infants provide the highest level of safety feasible.

Full Text

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<title>Federal Register, Volume 89 Issue 74 (Tuesday, April 16, 2024)</title>
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[Federal Register Volume 89, Number 74 (Tuesday, April 16, 2024)]
[Proposed Rules]
[Pages 27246-27285]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-07706]

[[Page 27245]]

Vol. 89

Tuesday,

No. 74

April 16, 2024

Part III

Consumer Product Safety Commission

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16 CFR Parts 1112 and 1218

Safety Standard for Bassinets and Cradles; Proposed Rule

Federal Register / Vol. 89 , No. 74 / Tuesday, April 16, 2024 /
Proposed Rules

[[Page 27246]]

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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Parts 1112 and 1218

[CPSC Docket No. CPSC-2010-0028]

Safety Standard for Bassinets and Cradles

AGENCY: Consumer Product Safety Commission.

ACTION: Notice of proposed rulemaking.

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SUMMARY: In 2013, the United States Consumer Product Safety Commission
(Commission or CPSC) published a safety standard for bassinets and
cradles (bassinets/cradles). By statute, after promulgating a mandatory
rule, the Commission must periodically review and revise rules for
durable infant or toddler products to ensure that they provide the
highest level of safety for such products that is feasible.
Accordingly, this proposed rule (NPR) would revise the existing rule
for bassinets/cradles to ensure that it addresses identified hazards
and that these sleep products for young infants provide the highest
level of safety feasible.

DATES: Submit comments by June 17, 2024.

ADDRESSES: Comments related to the Paperwork Reduction Act aspects of
the marking, labeling, and instructional literature requirements of the
NPR should be directed to the Office of Information and Regulatory
Affairs, the Office of Management and Budget, Attn: CPSC Desk Officer,
FAX: 202-395-6974, or emailed to: <a href="/cdn-cgi/l/email-protection#056a6c77645a767067686c76766c6a6b456a68672b606a752b626a73">[email&#160;protected]</a>.
Submit all other comments, identified by Docket No. CPSC-2010-0028,
by any of the following methods:
Electronic Submissions: Submit electronic comments to the Federal
eRulemaking Portal at: <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow the
instructions for submitting comments. CPSC typically does not accept
comments submitted by email, except through <a href="http://www.regulations.gov">www.regulations.gov</a>. CPSC
encourages you to submit electronic comments by using the Federal
eRulemaking Portal, as described above.
Mail/Hand Delivery/Courier/Confidential Written Submissions: Submit
comments by mail, hand delivery, or courier to: Office of the
Secretary, Consumer Product Safety Commission, 4330 East-West Highway,
Bethesda, MD 20814; (301) 504-7479. If you wish to submit confidential
business information, trade secret information, or other sensitive or
protected information that you do not want to be available to the
public, you may submit such comments by mail, hand delivery, or
courier, or you may email them to: <a href="/cdn-cgi/l/email-protection#1477646777397b6754776467773a737b62">[email&#160;protected]</a>.
Instructions: All submissions must include the agency name and
docket number. CPSC may post all comments without change, including any
personal identifiers, contact information, or other personal
information provided, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Do not submit
through this website: Confidential business information, trade secret
information, or other sensitive or protected information that you do
not want to be available to the public. If you wish to submit such
information, please submit it according to the instructions for mail/
hand delivery/courier/confidential written submissions.
Docket: For access to the docket to read background documents or
comments received, go to: <a href="https://www.regulations.gov">https://www.regulations.gov</a>, and insert the
docket number, CPSC-2010-0028, into the ``Search'' box, and follow the
prompts.

FOR FURTHER INFORMATION CONTACT: Celestine T. Kish, Project Manager,
Division of Human Factors, Directorate for Engineering Sciences,
Consumer Product Safety Commission, 5 Research Place, Rockville, MD
20850; 301-987-2547; <a href="/cdn-cgi/l/email-protection#e380888a908ba380939080cd848c95">[email&#160;protected]</a>.

SUPPLEMENTARY INFORMATION:

I. Background and Statutory Authority

Section 104(b) of the Consumer Product Safety Improvement Act of
2008 (CPSIA), 15 U.S.C. 2056a(b), requires the Commission to promulgate
standards for durable infant or toddler products that are
``substantially the same as'' any applicable voluntary standards, or
more stringent than the voluntary standards, if the Commission
determines that more stringent requirements would further reduce the
risk of injury associated with the product. 15 U.S.C. 2056a(b)(1)(B).
Pursuant to section 104(b)(1) of the CPSIA, the Commission promulgated
the current mandatory standard for bassinets and cradles (bassinets/
cradles) in October 2013, Safety Standard for Bassinets and Cradles,
codified at 16 CFR part 1218 (part 1218). 78 FR 63019 (Oct. 23, 2013).
The current bassinet/cradle rule found in part 1218 incorporates by
reference the 2013 version of the bassinets/cradles voluntary standard,
ASTM F2194-13, Standard Consumer Safety Specification for Bassinets and
Cradles (ASTM F2194-13), with modifications to make the standard more
stringent, to further reduce the risk of injury associated with
bassinets/cradles.\1\ Part 1218 modifies ASTM F2194-13 by: clarifying
the scope of rule, exempting from the flatness requirement bassinets
with seams less than 15 inches long, requiring a more stringent
stability test, and requiring a smaller CAMI dummy \2\ for testing.
After issuing the mandatory standard in 2013, ASTM International (ASTM)
published several revisions to ASTM F2194, including ASTM F2194-2013a,
-2016, and -2016[egr]\1\. ASTM did not notify CPSC of these revisions,
so the mandatory rule has not been updated since 2013. However, ASTM
F2194-2016[egr]\1\ is substantially the same as the existing mandatory
rule for bassinets/cradles codified in part 1218. 86 FR 33022, 33034-35
(June 3, 2021).
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\1\ Bassinets/cradles are durable infant or toddler products
that, since 2013, require product registration cards and
certificates based on testing by a CPSC-accepted third party
laboratory. Section 104(f)(2)(L) of the CPSIA specifically
identifies bassinets/cradles as durable infant or toddler products.
The NPR proposes to add testing and labeling requirements that will
not change the existing requirements for product registration cards
and third party testing and certification. Additionally, although
ASTM F2194-22[egr]\1\ is copyrighted, by permission of ASTM the
voluntary standard can be viewed as a read-only document during the
comment period at: <a href="http://www.astm.org/cpsc.htm">http://www.astm.org/cpsc.htm</a>.
\2\ Designated ASTM testing device. CAMI (Civil Aeromedical
Institute) dummies are based on child anthropometric data and come
in multiple sizes. The CPSC mandatory safety standard for bassinets
and cradles specifies the newborn size CAMI.
\3\ After challenge, the United States Court of Appeals for the
District of Columbia Circuit held that CPSC did not exceed its
authority in promulgating the ISP Rule. Finnbin, LLC v. CPSC, 45
F.4th 127 (D.C. Cir. Aug. 2, 2022).
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In June 2021, also pursuant to section 104 of the CPSIA, the
Commission promulgated a Safety Standard for Infant Sleep Products (ISP
Rule), codified at 16 CFR part 1236. 86 FR 33022 (June 23, 2021). The
ISP Rule applies to products that are marketed or intended to provide a
sleeping accommodation for infants up to five months of age that do not
already meet the requirements of one of the following CPSC sleep
standards: full-size cribs, non-full-size cribs, play yards, bedside
sleepers, or bassinets/cradles. The ISP Rule requires that such infant
sleep products, at a minimum, have a head-to-toe sleep surface angle of
10 degrees or less from horizontal, and meet the mandatory rule for
bassinets/cradles, including the definition of a bassinet/cradle, which
means that products must have a stand. Because of the ISP Rule, the
bassinets/cradles rule provides a safe sleep baseline for infant sleep
products.\3\ The intent of the ISP Rule was to ensure that infants are
placed to sleep on a firm, flat sleep surface and that caregivers are
discouraged from

[[Page 27247]]

placing infant sleep products, including those bassinets that were
lightweight and low to the ground, on unsafe surfaces, such as beds,
couches, tables, and countertops.
In 2022, ASTM approved and published another revised voluntary
standard for bassinets/cradles--ASTM F2194-22[egr]\1\--and notified
CPSC of the revision on July 18, 2022. Revised ASTM F2194-22[egr]\1\
added a new product category--compact bassinets/cradles--and new
requirements for these products, including stability requirements and
marking and labeling requirements. Among its other provisions, ASTM
F2194-22[egr]\1\ eliminated stands for compact bassinets/cradles, but
also included new requirements for battery compartments, warnings, and
instructional literature. CPSC issued a notice of availability (NOA)
requesting comment on the revised ASTM standard. 87 FR 45303 (July 28,
2022).
Pursuant to the procedure outlined for revised voluntary standards
in section 104(b)(4) of the CPSIA, 15 U.S.C. 2056a(b)(4), CPSC had 90
days from receiving notice of ASTM's 2022 revision to either allow the
revised ASTM F2194 to become the new mandatory standard for bassinets/
cradles, or to notify ASTM that the Commission determined that the
revised ASTM standard did not improve the safety of bassinets/cradles
and that CPSC was retaining the existing mandatory standard. On
September 14, 2022, CPSC staff provided to the Commission a Staff
Briefing Package: ASTM's Notice of a Revised Voluntary Standard for
Bassinets and Cradles (2022 Bassinet Rejection Staff Briefing Package)
which reviewed the comments from the NOA and assessed ASTM F2194-
2[egr]\1\. Staff recommended that the Commission reject ASTM F2194-
22[egr]\1\.\4\
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\4\ Available at: <a href="https://www.cpsc.gov/s3fs-public/ASTMs-Notice-of-a-Revised-Voluntary-Standard-for-Bassinets-and-Cradles.pdf?VersionId=x73F5OmeW4AJujWJEq8.kBZ28aTFLb2x">https://www.cpsc.gov/s3fs-public/ASTMs-Notice-of-a-Revised-Voluntary-Standard-for-Bassinets-and-Cradles.pdf?VersionId=x73F5OmeW4AJujWJEq8.kBZ28aTFLb2x</a>.
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In the 2022 Bassinet Rejection Staff Briefing Package, staff
advised that the requirements for compact bassinets/cradles in ASTM
F2194-22[egr]\1\ were less stringent than the requirements for
traditional bassinets/cradles in the existing bassinets/cradles rule
(part 1218), in part because ASTM F2194-22[egr]\1\ did not require that
compact bassinets/cradles have a stand. Moreover, because the ISP Rule,
part 1236, makes the bassinet rule, part 1218, the baseline for safe
sleep requirements, amending part 1218 to allow compact bassinets that
are low to the ground, as specified in ASTM F2194-22[egr]\1\, would
also allow infant sleep products that were less stable and could be
placed on unsafe surfaces, such as elevated and soft surfaces. Staff
explained in the 2022 Bassinet Rejection Staff Briefing Package that
consumers are likely to place smaller, lighter, and more portable
compact bassinets in unsafe locations, such as elevated and soft
surfaces (tables, counters, couches, and beds), and that CPSC's data
demonstrate that infants have suffered serious head injuries and death
when using these products in unsafe locations.\5\ Additionally, staff
advised that ASTM F2194-22[egr]\1\ added a new stability test that
applies only to compact bassinets/cradles, and that this new stability
test is less stringent than the stability test for regular-sized
bassinets/cradles. Staff advised that infant sleep products without a
stand present a risk of injury from falls that may lead to suffocation,
head injuries, and/or death.
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\5\ Tab A of the 2022 Bassinet Rejection Staff Briefing Package
discusses consumer behavior with portable, compact products.
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On September 23, 2022, the Commission voted 5-0 to determine that
ASTM F2194-22[egr]\1\ did not improve the safety of bassinets and
cradles or infant sleep products.\6\ Staff notified ASTM of the
Commission's rejection of ASTM F2194-22[egr]\1\ by letter on October 6,
2022.\7\ Subsequent to the Commission's rejection of ASTM F2194-
22[egr]\1\, staff continued to work with the ASTM F15.18 Bassinets and
Cradles Subcommittee and the ASTM F15.18 Bassinet Elevated Surface and
Data Task Group to revise the performance requirements for bassinets/
cradles to set acceptable baseline safe sleep requirements for
bassinets/cradles and for infant sleep products.
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\6\ See Record of Commission Action at: <a href="https://www.cpsc.gov/s3fs-public/RCA-ASTMs-Notice-of-a-Revised-Voluntary-Standards-for-Bassinets-and-Cradles.pdf?VersionId=cfj.qZe5KlTS2AY3G69UwltalltP4LRk">https://www.cpsc.gov/s3fs-public/RCA-ASTMs-Notice-of-a-Revised-Voluntary-Standards-for-Bassinets-and-Cradles.pdf?VersionId=cfj.qZe5KlTS2AY3G69UwltalltP4LRk</a>.
\7\ October 6, 2022 letter to K. Morgan, available at: <a href="https://www.cpsc.gov/s3fs-public/Bassinet_Rule_Update_letter_to_ASTM_2022-10-06%2010-7-2022.pdf?VersionId=PpvmrIEhQT.z3P57h8lhtc1UTvQITpSR">https://www.cpsc.gov/s3fs-public/Bassinet_Rule_Update_letter_to_ASTM_2022-10-06%2010-7-2022.pdf?VersionId=PpvmrIEhQT.z3P57h8lhtc1UTvQITpSR</a>.
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The Commission is now proposing to revise the existing rule for
bassinets/cradles to address the hazards identified in this NPR and
ensure that the mandatory bassinet/cradle regulation in part 1218
provides the highest level of safety feasible.\8\ The Commission is
authorized to issue this NPR pursuant section 104(b)(2) of the CPSIA,
15 U.S.C. 2056a(b)(2), which requires that after the Commission issues
mandatory safety standards for durable infant or toddler products, the
Commission shall periodically review and revise the standards to ensure
that such standards provide the highest level of safety for such
products that is feasible. Building on staff's continued work with ASTM
on safe sleep requirements, the Commission is issuing this NPR to adopt
ASTM F2194-22[egr]\1\ with modifications. The proposed modifications
remove the compact bassinet category and address five hazard patterns
associated with young infants placed in or on:
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\8\ On March 20, 2024, the Commission voted (4-0) to publish
this NPR, available at: <a href="https://www.cpsc.gov/s3fs-public/Commission-Meeting-Minutes-NPR-Safety-Standard-for-Bassinets-and-Cradles.pdf?VersionId=GwpmKZ4S9sRrEiBmDFaEWn1fBre6eZ2r">https://www.cpsc.gov/s3fs-public/Commission-Meeting-Minutes-NPR-Safety-Standard-for-Bassinets-and-Cradles.pdf?VersionId=GwpmKZ4S9sRrEiBmDFaEWn1fBre6eZ2r</a>.
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<bullet> Non-level bassinets/cradles (suffocation hazard);
<bullet> Bassinets/cradles on elevated and soft surfaces such as
beds, couches, tables, and countertops (falls, suffocation, skull
fractures, and asphyxia hazards);
<bullet> Mattresses that are non-flat, too thick, too soft, ill-
fitting, or unattached to the bassinet/cradle (suffocation hazard);
<bullet> Bassinets/cradles with design issues, such as low to the
ground or unstable, or with loose sidewalls and/or non-mesh sidewalls
(containment, tipping, gap entrapment, and suffocation hazards); and
<bullet> Products with electrical problems such as smoke, shock,
and battery leakage (shock and burn).
The Commission is also proposing to align the rule's warnings with
ASTM F2194-22[egr]\1\ but not to include warnings related solely to
compact bassinets. The NPR proposes to require warnings on all
bassinets within the scope of the rule.
Staff provided a February 28, 2024, Memorandum, Staff's Draft
Proposed Rule to Revise the Safety Standard for Bassinets and Cradles
in support of the NPR, which is available at: <a href="https://www.cpsc.gov/s3fs-public/Briefing-Package-Draft-Notice-of-Proposed-Rulemaking-Safety-Standard-for-Bassinets-and-Cradles.pdf?VersionId=l37iJVSjn32WnUTBDV27L6c37uJC4Iis">https://www.cpsc.gov/s3fs-public/Briefing-Package-Draft-Notice-of-Proposed-Rulemaking-Safety-Standard-for-Bassinets-and-Cradles.pdf?VersionId=l37iJVSjn32WnUTBDV27L6c37uJC4Iis</a>. This NPR
contains an overview of staff's assessment and analysis, and the
Commission's basis for issuing this NPR, which is also based on the
2022 Bassinet Rejection Staff Briefing Package. Based on the
information and analysis in this NPR and the above staff packages, the
Commission preliminarily determines that the proposed requirements are
more stringent than the requirements in ASTM F2194-22[egr]\1\, would
further reduce the risk of injury associated with products within the
scope of the NPR, and would provide the highest level of safety that is
feasible for such products. The Commission specifically seeks

[[Page 27248]]

comment on the feasibility of each proposed requirement, including
technical feasibility.

II. The Product

A. Definition of Bassinet/Cradle

The existing mandatory standard defines a ``bassinet/cradle'' based
on the incorporated section 3.1.1 of ASTM F2194-13, as a ``small bed
designed primarily to provide sleeping accommodations for infants,
supported by free standing legs, a stationary frame/stand, a wheeled
base, a rocking base, or which can swing relative to a stationary
base.'' The definition also requires that while a bassinet/cradle is in
a resting, non-rocking, or swinging position, ``a bassinet/cradle is
intended to have a sleep surface less than or equal to 10[deg] from
horizontal.''
ASTM F2194-22[egr]\1\ introduced a new ``compact bassinet'' product
category, defined as ``a bassinet/cradle having a distance of less than
6.0 inches (152.4 mm) between the lowest point of the underside of the
sleep surface support and the product support surface (floor).'' In the
2022 Bassinet Rejection Staff Briefing Package, staff assessed the
compact bassinet category and advised the Commission that including
compact bassinets/cradles within the scope of the voluntary standard,
which contain product characteristics that the Commission specifically
stated in the ISP Rule were not safe for infant sleep, and allowing a
less-stringent stability test for these products, contradicts the
Commission's safe sleep goals in part 1218 and in the ISP Rule.
The Commission now proposes to amend part 1218 to incorporate ASTM
F2194-22[egr]\1\ by reference, but with modifications that exclude from
the mandatory rule ``compact bassinets'' and associated requirements.
As described in section V of this preamble, the modifications in the
NPR further clarify the products within the scope of the rule and seek
to enhance the safety requirements in part 1218, and thus also the
minimum safe sleep requirements in the ISP Rule.

B. Scope of Products Within the NPR

The NPR would apply to: (1) bassinets and cradles; (2) combination
products in bassinet or cradle mode, including play yards, bedside
sleepers, strollers, and cradle swings that have a bassinet or cradle
mode; (3) play yard and stroller bassinet accessories, when used
separately from the play yard or stroller; (4) small bassinets,
sometimes marketed as ``travel bassinets'' or ``floor bassinets,''
including both items with rigid frames and with soft sides; (5) Moses
baskets, sold with or without a stand; (6) travel bassinets, outdoor
bassinets, and ``play pens'' that do not meet the side height
requirements of the mandatory play yard standard and are marketed for
sleep; and (7) after-market bassinet mattresses.\9\
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\9\ Several related products are out of scope of this NPR. A few
products marketed as ``bassinets'' have relatively high side rails,
rigid sides, and a distance between the top rail and the sleep
surface of at least 22 inches. Some of these products are marketed
as compliant with the mandatory safety standard for non-full-size
cribs and play yards. These products may be within the scope of the
mandatory standard for non-full-size cribs and play yards specified
in 16 CFR part 1220, rather than this rule, but the performance
requirements of the two standards are very similar. Moreover,
hospital bassinets are medical devices regulated by the Food and
Drug Administration (FDA) and are not within the scope of this rule.
See 21 CFR 880.5145 ``Medical bassinet.'' Finally, thin mattress
protectors and covers, such as waterproof mattress covers, that
cannot be used as a standalone mattress, are not within the scope of
this proposed rule.
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Commonly, bassinets have multiple-use modes and therefore fall
within the scope of multiple CPSC regulations, particularly the
standard for hand-held infant carriers in 16 CFR part 1225, and/or the
standard for infant sleep products in 16 CFR part 1236. Combination
products must meet the bassinet standard when in the bassinet mode. All
multi-mode products, as sold, including stroller bassinets, play yard
bassinets, and Moses baskets, would need to meet the requirements of a
revised rule, regardless of whether the product is sold with or without
a stand. This means that stroller and play yard bassinets marketed for
use without the stand, or that can be foreseeably used without the
stand, would need to meet the requirements of a final rule.
Part 1218 requires bassinets to be sold with a mattress and
includes requirements for these mattresses and original equipment
manufacturer (OEM) replacements that are equivalent in dimensions and
specifications to the mattress provided with the original product. This
NPR proposes also to include after-market bassinet mattresses within
the scope of the rule. After-market bassinet mattresses are sold
separately from the bassinet and are typically small oval or
rectangular mattresses marketed to fit a bassinet, including products
marketed to fit a bassinet accessory product to a play yard or
stroller. OEM replacement mattresses are, and have always been,
included in part 1218 and are not considered after-market mattresses.
The NPR also includes products marketed as ``mattress toppers'' as a
type of after-market bassinet mattress.

C. Market Description

As discussed in section VIII of this preamble, staff estimates the
annual sales of new bassinets/cradles, including items with a bassinet
mode or attachment, to be approximately 3.1 million units per year in
the United States. Staff estimates the annual U.S. sales of used
bassinets/cradles to be 500,000 units per year, and the annual sales of
new after-market bassinet mattresses to be 680,000 units per year.
Prices for traditional bassinets range from under $50 to more than
$1,500, with most products in the $50 to $125 range. Prices for cradles
range from $100 to more than $1,000, with most products in the $100 to
$200 range. Solid hardwood cradles are available for more than $1,000.
Combination bedside sleeper/bassinets typically sell for $75 to more
than $600, with most products in the $125 to $200 range. Bassinet
attachments to play yards are usually not priced or sold separately.
Some stroller bassinet attachments are sold separately, with most such
products in the $100 to $200 range. Play yard and stroller bassinet
attachments are designed to attach to a specific model or set of models
from one manufacturer, and/or to a stand sold separately by that
manufacturer. The stands typically sell for $125 to $175. Prices for
after-market bassinet mattresses range from $20 to $180, with most
products in the $30 to $40 range.
Bassinets do not have a single, best-selling size, price range, or
set of features. The wide range of prices and features reflect that
parents and other caregivers buy bassinets for different purposes,
including but not limited to as primary sleep space or for occasional
use, and as a permanent piece of nursery furniture or an easily
portable sleep space. With approximately 3.1 million new bassinets sold
per year, including items such as bedside sleepers, play yards, and
strollers with a bassinet mode, at an average price of approximately
$100 per unit, the total U.S. bassinet market is approximately $310
million dollars in sales per year. This total does not include the
market for used items. At an estimated used price of $40, based on
observed prices of used bassinets on Ebay and Mercari as a percentage
of original retail prices, the used market represents approximately $20
million dollars in sales per year. Staff estimates annual unit sales of
new after-market bassinet mattresses to be 680,000 units, with a market
of $23.8 million per year.

[[Page 27249]]

Many manufacturers and importers, as well as foreign direct
shippers, supply bassinets and cradles to the U.S. market. In March
2023, CPSC staff identified more than 120 suppliers, including
suppliers that sell play yards or strollers with bassinet attachments.
The Juvenile Product Manufacturers Association (JPMA) currently has 22
member companies that are certified for bassinets/cradles. Bassinets
and cradles are available from online general retail sites, online baby
product sites, and brick and mortar general retail stores, including
``big box'' stores. Additionally, hundreds of suppliers, including
importers and U.S. based hand crafters, supply after-market bassinet
mattresses, which are sold almost exclusively online.

III. Incident Data and Hazard Patterns

Staff searched two CPSC-maintained databases to identify incidents
and hazard patterns addressed in this NPR that are associated with
bassinets and cradles: the Consumer Product Safety Risk Management
System (CPSRMS) 10 11 and the National Electronic Injury
Surveillance System (NEISS).\12\ From these sources, for this NPR staff
identified seven fatalities and 13 injuries related to bassinets/
cradles from January 1, 2017, through December 31, 2022. CPSC staff is
also aware of 182 non-injury incidents from January 1, 2021, through
December 31, 2022. Staff identified the following hazard patterns from
this data.
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\10\ CPSRMS includes data primarily from three groups of
sources: incident reports, death certificates, and in-depth follow-
up investigation reports. A large portion of CPSRMS consists of
incident reports from consumer complaints, media reports, medical
examiner or coroner reports, retailer or manufacturer reports
(incident reports received from a retailer or manufacturer involving
a product they sell or make), safety advocacy groups, law firms, and
Federal, State, or local authorities, among others. It also contains
death certificates that CPSC purchases from all 50 states, based on
selected external cause of death codes (ICD-10). The third major
component of CPSRMS is the collection of in-depth follow-up
investigation reports. Based on the incident reports, death
certificates, or National Electronic Injury Surveillance System
(NEISS) injury reports, CPSC Field staff conduct in-depth
investigations (on-site, telephone, or online) of incidents, deaths,
and injuries, which are then stored in CPSRMS.
\11\ Staff searched all data coded under product code 1537
(Bassinets or Cradles). In addition, staff extracted data coded
under 1513 (Playpens and Play Yards), 1529 (Portable Cribs), 1542
(Baby Mattresses or Pads), 1505/1522 (Baby Carriages/Strollers),
1519/1548 (Car Seats/Baby Carriers), 1502 (Baby Changing Tables),
1558 (Baby Bouncer Seats), and 1553 (Portable Baby Swings). Staff
further screened data searched from this wide range of products
using keywords to identify the potentially in-scope bassinet
accessories or multi-mode products that may have been used as a
bassinet at the time of the incident. Staff extracted data on
January 13, 2023, and restricted age to 12 months and younger. Upon
careful joint review with CPSC's Directorates for Engineering
Sciences, Health Sciences, and Economics, staff considered many
cases out-of-scope for the purposes of this NPR. For example, staff
excluded from this analysis cases with Sudden Unexpected Infant
Death (SUID) or other pre-existing medical conditions as official
cause of death and no additional circumstantial information
available.
\12\ NEISS is the source of the injury estimates; it is a
statistically valid injury surveillance system. NEISS injury data
are gathered from EDs of about 100 hospitals, with 24-hour EDs and
at least six beds, selected as a probability sample of all U.S.
hospitals. The surveillance data gathered from the sample hospitals
enable staff to make timely national estimates of the number of
injuries associated with specific consumer products.
---------------------------------------------------------------------------

A. Products Not Sitting Level

Two deaths, three non-emergency department (ED)-treated injury, and
95 of the 182 non-injury product-related incident reports describe a
bassinet or cradle not sitting level. The narratives describe the
products as non-level, leaning forward or to one side, and having legs
or sides with uneven heights. A bassinet not sitting level creates a
hazardous situation where an infant is more likely to roll into a
compromising position as described below, whether the infant is
developmentally capable of rolling or not, thereby posing a risk of
asphyxia/suffocation. The fatal incidents involve infants rolling to
the side, often into the mesh/siding of the bassinet:
<bullet> In CPSC In-Depth Investigation (IDI) \13\ 200211HCC3248, a
2-month-old male was found unresponsive in his bassinet after moving
into a compromising position where his nose was positioned adjacent to
a crease on the right side of the bassinet. The bassinet was not level,
and the edge of an adult bed was protruding into the mesh right
sidewall of the bassinet.
---------------------------------------------------------------------------

\13\ IDIs are CPSC-generated investigation summaries of events
surrounding product-related injuries or incidents. Based on victim/
witness interviews, the reports provide details about incident
sequence, human behavior, and product involvement.
---------------------------------------------------------------------------

<bullet> In IDI 190610CCC3431, a 1-month-old male was found
unresponsive in his bassinet after a non-level sleep surface allowed
the victim to roll into a compromising position in the presence of
excess bedding.
According to the American Academy of Pediatrics (AAP), infants
should be placed to sleep in a supine position (on their back) on a
firm, flat, level surface without soft bedding in the sleep
setting.14 15 Positional asphyxia is a type of asphyxia
associated with abnormal body position, where the position of the
subject compromises adequate breathing.16 17 18 Infants
under 12 months of age are considered at risk of positional asphyxia,
but infants 2 to 6 months of age, premature infants, and infants who
are born as a set of multiples are particularly vulnerable and at
highest risk because they may be developmentally capable of moving
around in the sleep environment and moving into a vulnerable situation
but do not yet have the physical capability to extricate themselves
from a hazardous situation.19 20 21 22 23 24
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\14\ Moon RY, Carlin RF, Hand I. The Task Force on Sudden Infant
Death Syndrome and the Committee on Fetus and Newborn; Evidence Base
for 2022 Updated Recommendations for a Safe Infant Sleeping
Environment to Reduce the Risk of Sleep-Related Infant Deaths.
Pediatrics July 2022; 150 (1): e2022057991. 10.1542/peds.2022-
057991.
\15\ Task Force on Infant Positioning and SIDS. Positioning and
infant death syndrome (SIDS): update Arch Pediatr Adolesc Med.
1996;150:834-837.
\16\ Chmieliauskas S, Mundinas E, Fomin D, Andriuskeviciute G,
Laima S, Jurolaic E, Stasiuniene J, Jasulaitis A. Sudden deaths from
positional asphyxia: A case report. Medicine (Baltimore). 2018
Jun;97(24):e11041. doi: 10.1097/MD.0000000000011041. PMID: 29901602;
PMCID: PMC6023692.
\17\ Gordon I, Shapiro HA. Deaths usually initiated by hypoxia
or anoxic anoxia. In: Gordon I, Shapiro HA, editors. Forensic
medicine: 2nd ed. Edinburgh, UK: Churchill Livingstone, 1982; 95-
129.
\18\ Gordon I. The medicolegal aspects of rapid deaths initiated
by hypoxia and anoxia. Leg Med Annu. 1975:29-47. PMID: 768671.
\19\ Dwyer T, Ponsonby A-L, Blizzard L, Newman NM, Cochane JA.
The contribution of changes in prevalence of prone sleeping position
to the decline in sudden infant death syndrome in Tasmania. JAMA.
1995;273:783-789.
\20\ Byard RW, Beal S and Bourne AJ. Potentially dangerous
sleeping environment and accidental asphyxia in infancy and early
childhood. Arch Dis Child 1994; 71: 497-500.
\21\ Fleming PJ, Blair PS, Bacon C, et al. Environment of
infants during sleep and risk of the sudden infant death syndrome:
results of 1993-5 case-control study for confidential inquiry into
stillbirths and deaths in infancy. BMJ. 1996;313:191-195.
\22\ Hauck FR, Herman SM, Donovan M, et al. ``Sleep Environment
and the Risk of Sudden Infant Death Syndrome in an Urban Population:
The Chicago Infant Mortality Study.'' Pediatrics 2003; (111): 1207-
1214.
\23\ Ponsonby AL, Dwyer T, Gibbons LE, Cochrane JA, Wang Y-G.
Factors potentiating the risk of sudden infant death syndrome
associated with prone position. N Engl J Med. 1993;329:377-382.
\24\ Smialek, JE, Smialek, PZ and Spitz, WU. Accidental bed
deaths in infants due to unsafe sleeping situations. Clinical
Pediatrics 1977; 15 (11):1031-1035.
---------------------------------------------------------------------------

An infant can suffocate/asphyxiate against anything that partially
or fully obstructs the nose and mouth and prevents breathing.\25\ Once
an infant's airflow is compromised, decreased levels of oxygen in the
blood can further impair the infant's ability to respond to the
situation. If an infant cannot respond, a feedback loop of decreased
heart and respiration rate develops that can eventually lead to
cessation of

[[Page 27250]]

breathing and may become fatal if
uninterrupted.26 27 28 29 30 The prognosis for hypoxic
(experiencing a state of low levels of oxygen in body tissues) victims
due to smothering depends primarily on the extent of oxygen
deprivation, the duration of unconsciousness, and the speed at which
cardiopulmonary resuscitation (CPR) is attempted relative to the timing
of cardiac arrest. Rapid reversal of the hypoxic state is essential to
prevent or limit the development of pulmonary and cerebral edema that
can lead to serious injury or death. Thus, victims who are oxygen
deprived for short durations or quickly receive cardiopulmonary
resuscitation to reestablish air flow have the most favorable clinical
outcomes.
---------------------------------------------------------------------------

\25\ Wanna-Nakamura S. White Paper--Unsafe Sleep Settings:
Hazards associated with the infant sleep environment and unsafe
practices used by caregivers: a CPSC staff perspective. Bethesda,
MD: Office of Hazard Identification and Reduction, U.S. Consumer
Product Safety Commission, 2010.
\26\ Rosen CL et al., Two siblings and recurrent
cardiorespiratory arrest; Munchausen syndrome by proxy or child
abuse Paediatrics 1983; 71:715-720.
\27\ Medalia AA, Merriam AE, Ehrenreich JH. The
neuropsychological sequelae of attempted hanging. J Neurol Neurosurg
Psychiatry. 1991; 54:546-8.
\28\ Jongewaard WR, Cogbill TH, Landercasper J. Neurologic
consequences of traumatic asphyxia. J Trauma. 1992 Jan;32(1):28-31.
doi: 10.1097/00005373-199201000-00006. PMID: 1732570.
\29\ Polson CJ. Hanging In: Polson CJ and Gee DJ (eds.)
Essentials of forensic medicine Oxford England, 1973 371-404.
\30\ Spitz WU. Asphyxia. In: Spitz WU, Spitz DJ, editors. Spitz
and Fisher's medico-legal investigation of death: guidelines for the
application of pathology to crime investigation, 4th edn.
---------------------------------------------------------------------------

Because the brain is the organ in the body most sensitive to oxygen
deprivation, a period of oxygen deprivation of as short as three
minutes can lead to a wide range of serious injuries. The severity of
oxygen deprivation ultimately governs the infant's chance for survival
and the degree of neurological damage. The extent of injury is directly
related to the duration and magnitude of hypoxia. Inadequate supply of
oxygen to the brain can lead to loss of consciousness, cardiac arrest,
and death. Victims who are rescued from oxygen deprivation of less than
four minutes can still suffer a wide range of serious injuries and
lasting neurological issues, including delays to reach milestones,
paralysis, sensory disturbances, seizures, cognitive and memory
deficits, and neuropsychological problems.31 32 33 Patients
who survive cardiac arrest can remain in a coma for various periods and
some may remain in a persistent vegetative state. Patients who survive
prolonged anoxic episodes require a multidisciplinary rehabilitation
that may include speech therapy, physical therapy, and/or prolonged
specialized care inside or outside of the home, with the level of care
dependent on the severity of the injury.
---------------------------------------------------------------------------

\31\ Dzikien[edot] R, Luko[scaron]evi[ccaron]ius S,
Laurynaitien[edot] J, Marmien[edot] V, Nedzelskien[edot] I,
Tamelien[edot] R, Rimdeikien[edot] I, Kudrevi[ccaron]ien[edot] A.
Long-Term Outcomes of Perinatal Hypoxia and Asphyxia at an Early
School Age. Medicina (Kaunas). 2021 Sep 18;57(9):988. doi: 10.3390/
medicina57090988. PMID: 34577911; PMCID: PMC8466311.
\32\ Jongewaard WR, Cogbill TH, Landercasper J. Neurologic
consequences of traumatic asphyxia. J Trauma. 1992 Jan;32(1):28-31.
doi: 10.1097/00005373-199201000-00006. PMID: 1732570.
\33\ van Handel, M., Swaab, H., de Vries, L.S. et al. Long-term
cognitive and behavioral consequences of neonatal encephalopathy
following perinatal asphyxia: a review. Eur J Pediatr 166, 645-654
(2007). <a href="https://doi.org/10.1007/s00431-007-0437-8">https://doi.org/10.1007/s00431-007-0437-8</a>.
---------------------------------------------------------------------------

B. Bassinet Mattresses and Mattress Supports

Mattresses that are not flat (e.g., bent, warped, sagging, with
bumps, bulges, or dips) or not well-fitting, or mattress boards that
are bent, warped, pop out of place, or provide little or no support, or
that have bars (that support the mattress boards) that are broken or
not staying in place, can lead to an uneven sleep surface, putting the
infant at risk of asphyxia/suffocation. Staff illustratively identified
two deaths, one ED visit, one non-ED injury, and 75 of the 182 non-
injury product-related incidents that demonstrate this hazard. These
non-injury incidents could have resulted in asphyxiation/suffocation if
someone had not intervened to rescue the occupant. One death associated
with a bassinet mattress involved a depression in the middle of the
mattress, while the other death involved poor fit of the mattress,
which allowed enough space for the infant to get wedged between the
mattress and the sidewall of the bassinet.
<bullet> In IDI 220804HCC1109, a 3-month-old male was found
unresponsive in a concave depression in the center of a bassinet.
<bullet> In IDI 210824HCC1792, a 3-month-old female was found prone
wedged in a gap between the bassinet mattress and bassinet frame under
a pillow.
Any object that obstructs an infant's airway, including an overly
soft mattress, can lead to serious injury or death. This category
includes a bassinet that was subject to a CPSC safety recall because
the mattress support was disengaging, posing fall and entrapment
hazards.\34\
---------------------------------------------------------------------------

\34\ DaVinci Recalls Bassinets Due to Fall and Entrapment
Hazards (Recall Alert) [bond] <a href="http://CPSC.gov">CPSC.gov</a>.
---------------------------------------------------------------------------

C. Structural Integrity/Quality

Products with insufficient structural robustness (including
components of the bassinet/cradle that reportedly break or crack;
hardware coming loose; and stitching coming undone) can also increase
the potential for infants to get into a compromising position,
increasing the risk of asphyxiation/suffocation. Staff identified one
reported hospitalization (laceration injury), one reported ED visit
(broken metal piece injured infant), and seven of the 182 non-injury
product-related incidents that demonstrate this hazard pattern.

D. Product Design

Product design can lead to safety concerns, including products
being unstable (increasing risk of rolling into a compromising position
and suffocating), products sitting too low to the ground (allowing
easier access by older siblings and creating suffocation hazards), and
products having non-mesh sidewalls that create a suffocation hazard.
Staff identified two deaths, one non-ED injury, and three of the 182
non-injury product-related incident reports that demonstrate this
hazard. One product reportedly was unstable, while another reported
that the non-mesh sidewall was a suffocation hazard. The two deaths
involved play yard accessories that were reportedly very low to the
ground, allowing access by older siblings.
<bullet> In IDI 210929HCC1229, a 1-month-old female was found
unresponsive in a bassinet placed on the floor with her 2-year-old
sibling partially resting on top of her.
<bullet> In IDI 200713HCC2638, a 5-month-old female was found
unresponsive in a bassinet placed on the floor with her 15-month-old
sibling asleep on top of the victim.

E. Electrical Problems

Some bassinets contain battery-operated or plug-in powered features
including sounds, lights, vibrations, and motorized rocking movements.
Electrical problems with bassinets can result in smoke, shock, or
battery leakage. Staff identified one hospitalization, one non-ED-
treated injury, and two of the 182 non-injury product-related incident
reports demonstrating this hazard pattern.

F. Falls From Elevated Heights

In the 2022 Bassinet Rejection Staff Briefing Package, staff of
CPSC's Division of Human Factors, Directorate for Engineering Sciences
(HF staff), examined the revisions made to ASTM F2194--22[egr]\1\ and
expressed concern regarding the inclusion of ``compact bassinets/
cradles'' and products with a ``compact bassinet/cradle mode'' within
the scope of the voluntary standard. Specifically, HF staff concluded
that products covered by the definition of a ``compact bassinets/
cradle'' are significantly more likely to be placed onto a soft and/or
elevated surface, such

[[Page 27251]]

as a table, sofa, countertop, or bed, and that the less stringent
stability requirements for compact products make them more prone to
tipping over.
In the same briefing package, staff identified one fatality and
three injuries related to infants falling out of compact bassinets,
where the product was placed on an elevated or soft surface, such as an
adult bed, countertop, and couch. Of these three incidents, one
incident (IDI 200940506) involved placement on a countertop, one (IDI
201234191) involved placement on a couch, and one (IDI 210246657)
involved placement on a chair. The incidents involving placement on a
countertop and couch resulted in head injuries. Staff is also aware of
several additional incidents in which bassinets were placed on soft/
elevated surfaces resulting in one fatal incident (IDI 2101050001),
when a bassinet was placed on top of an adult bed, leaning against a
nearby wall. Staff is also aware of an incident (IDI 211207687) in
which an infant climbed out of a bassinet placed on an adult bed and
fell off the bed. Further, customer reviews of various compact
bassinets indicate use in/on mattresses, sofas, tables, and
countertops.

G. National Estimates From NEISS

Based on NEISS data, staff estimates 3,500 injuries (sample
size=160, coefficient of variation=0.23) related to bassinets and
cradles were treated in U.S. hospital emergency departments over a
five-year period from 2017 through 2021. Of the 160 sample cases, four
incidents were fatal. About 59 percent of the injuries involved infants
5 months of age or younger and about 89 percent involved infants 8
months or younger. Forty-one percent of the injured infants were male,
while 59 percent were female. The most commonly occurring ED-treated
injuries related to bassinets and cradles were falls and interaction
with other children.
<bullet> Falls (52 percent): the majority of reports did not
specify the manner or cause of the fall. An additional 5 percent
indicated that the infant had been dropped, and another 2 percent
indicated that the infant had climbed out of the bassinet/cradle and
fallen.
<bullet> Interaction with other children (24 percent): many of the
reports involved siblings or other young children pulling/tipping the
bassinet over, tripping on the bassinet and tipping it over, attempting
to pull/lift an infant out of the bassinet, or climbing into the
bassinet to be with the infant. These incidents are usually associated
with infants falling out of the product. A few scenarios described
infants sustaining contusions/lacerations from older children striking/
biting them.
Sixty-nine percent of reported injuries were to the infant's head,
while 9 percent were to the infant's face. Seven percent of reported
injuries did not state the injury location. Injury types include
internal organs (58 percent) and fractures (10 percent), among others.
Regarding patient disposition, 82 percent were treated and released, 14
percent were admitted to the hospital or transferred to another
hospital, and 2 percent died from their injuries.

H. Availability of Incident Data

Upon publication of this NPR in the Federal Register, CPSC will
make available for review and comment the CPSRMS and NEISS incident
reports relied upon and discussed in this NPR, to the extent allowed by
applicable law, along with the associated IDIs. The data will be made
available by submitting a request at: <a href="https://forms.office.com/g/Pvn3yPePPf">https://forms.office.com/g/Pvn3yPePPf</a>. You will then receive a website link to access the data at
the email address you provided.

I. Bassinet/Cradle Recalls

From June 2012 through March 2023, the Office of Compliance and
Field Operations conducted 10 recalls of bassinets, cradles, and
related products as described in Table 1, including recalls of
bassinets, cradles, and multi-modal products where the recall involved
the bassinet mode. This summary includes recalls of Infant Sleep
Products with flat sleep surfaces that must, pursuant to the ISP Rule,
comply with 16 CFR part 1218, Safety Standard for Bassinets and
Cradles, because such products are not subject to another mandatory
safety standard for a sleep product. Not included in this recall
summary are recalls of inclined infant sleep products and multi-modal
products where the recall did not involve the bassinet mode, or after-
market bassinet mattresses. The recalls involved products with risks of
suffocation, entrapment, fall, and choking hazards and involved one
reported death, two reported injuries, and 132 reported other
incidents. Recalls affected approximately 396,500 units.

Table 1--Summary of Bassinet and Cradle Recalls
----------------------------------------------------------------------------------------------------------------
Approximate Number of
number of incidents
Press release date Firm Hazard recalled units/ (injuries & Press
product type deaths) reported release No.
\35\ \35\
----------------------------------------------------------------------------------------------------------------
October 23, 2012.......... Dorel Juvenile Suffocation..... 97,000 Bassinet. 17 incidents (2 \36\ 13-017
Group. injuries, 0
deaths).
November 16, 2012......... KidCo, Inc....... Suffocation and 220,000 Baby 6 incidents (0 \37\ 13-043
Entrapment. tent. injuries, 1
death).
January 15, 2013.......... Bugaboo Americas. Fall and choking 46,300 Carriage/ 58 incidents (0 \38\ 13-092
stroller with injuries, 0
removable deaths).
carrycot
bassinet.
March 27, 2013............ Bugaboo Americas. Fall............ 9,200 Carriage/ 16 incidents (0 \39\ 13-153
stroller with injuries, 0
removable deaths).
carrycot
bassinet.
November 13, 2013......... Dream on Me Inc.. Fall............ 700 Cradle...... 2 incidents (0 \40\ 14-019
injuries, 0
deaths).
March 3, 2015............. Dream on Me Inc.. Fall............ 13,000 Bassinet. 1 incident (0 \41\ 15-088
injuries, 0
deaths).
September 2, 2015......... Sleeping Partners Fall............ 5,500 baskets 0 incidents (0 \42\ 15-230
International and 800 stands injuries, 0
Inc. Hand-held deaths).
infant carrier
and Bassinet.
January 18, 2018.......... Multipro Limited. Fall and 1,000 Cradle.... 0 incidents (0 \43\ 18-716
Entrapment. injuries, 0
deaths).
December 5, 2019.......... Bexco Fall............ 3,000 Bassinet.. 19 incidents (0 \44\ 20-711
Enterprises, D/B/ injuries, 0
A DaVinci. deaths).
July 9, 2020.............. Bexco Fall and 3,000 Bassinet.. 13 incidents (0 \45\ 20-762
Enterprises, D/B/ Entrapment. injuries, 0
A DaVinci. deaths).
-------------------------------------------------------------------------------------

[[Page 27252]]

Total................. ................. ................ \46\ 396,500.... 132 incidents (2 10
injuries, 1
death).
----------------------------------------------------------------------------------------------------------------
\35\ When the recall press release delineates the approximate number of recalled units, number of incidents, or
number of injuries by country, this summary only includes the reported United States values.
\36\ <a href="https://www.cpsc.gov/Recalls/2013/Dorel-Juvenile-Group-Recalls-Eddie-Bauer-Rocking-Wood-Bassinets-Due-to-Infant-Suffocation-Hazard">https://www.cpsc.gov/Recalls/2013/Dorel-Juvenile-Group-Recalls-Eddie-Bauer-Rocking-Wood-Bassinets-Due-to-Infant-Suffocation-Hazard</a>.
\37\ <a href="https://www.cpsc.gov/Recalls/2013/Suffocation-Entrapment-Risks-Prompt-Recall-of-PeaPod-Travel-Tents-by-KidCo">https://www.cpsc.gov/Recalls/2013/Suffocation-Entrapment-Risks-Prompt-Recall-of-PeaPod-Travel-Tents-by-KidCo</a> KidCo.
\38\ <a href="https://www.cpsc.gov/Recalls/2013/bugaboo-recalls-strollers-due-to-fall-and-choking-hazards">https://www.cpsc.gov/Recalls/2013/bugaboo-recalls-strollers-due-to-fall-and-choking-hazards</a>.
\39\ <a href="https://www.cpsc.gov/Recalls/2013/Bugaboo-Recalls-Cameleon3-Strollers">https://www.cpsc.gov/Recalls/2013/Bugaboo-Recalls-Cameleon3-Strollers</a>.
\40\ <a href="https://www.cpsc.gov/Recalls/2014/Dream-On-Me-Recalls-Cradle-Gliders">https://www.cpsc.gov/Recalls/2014/Dream-On-Me-Recalls-Cradle-Gliders</a>.
\41\ <a href="https://www.cpsc.gov/Recalls/2015/Dream-on-Me-Recalls-2-in-1-Bassinet-to-Cradle">https://www.cpsc.gov/Recalls/2015/Dream-on-Me-Recalls-2-in-1-Bassinet-to-Cradle</a>.
\42\ <a href="https://www.cpsc.gov/Recalls/2015/Tadpoles-Baby-and-Kids-Recalls-Moses-Basket-and-Stand">https://www.cpsc.gov/Recalls/2015/Tadpoles-Baby-and-Kids-Recalls-Moses-Basket-and-Stand</a>.
\43\ <a href="https://www.cpsc.gov/Recalls/2018/Bassinets-Recalled-Due-to-Violation-of-Bassinet-Cradle-Standard-Made-By-Multipro-Recall-Alert">https://www.cpsc.gov/Recalls/2018/Bassinets-Recalled-Due-to-Violation-of-Bassinet-Cradle-Standard-Made-By-Multipro-Recall-Alert</a>.
\44\ <a href="https://www.cpsc.gov/Recalls/2020/DaVinci-Recalls-Bassinets-Due-to-Fall-Hazard-Recall-Alert">https://www.cpsc.gov/Recalls/2020/DaVinci-Recalls-Bassinets-Due-to-Fall-Hazard-Recall-Alert</a>.
\45\ <a href="https://www.cpsc.gov/Recalls/2020/DaVinci-Recalls-Bassinets-Due-to-Fall-and-Entrapment-Hazards-Recall-Alert">https://www.cpsc.gov/Recalls/2020/DaVinci-Recalls-Bassinets-Due-to-Fall-and-Entrapment-Hazards-Recall-Alert</a> Alert.
\46\ The Bexco Enterprises D/B/A DaVinci December 5, 2019 and July 9, 2020 recalls involve different hazards
with the same products, and so the approximate number of recalled units are not counted twice in the total.

IV. Voluntary Standard Development

A. Description and Assessment of ASTM F2194-22 [egr]\1\

ASTM F2194-22[egr]\1\ is the voluntary standard for bassinets/
cradles, which includes the general requirements present in most
durable infant or toddler product standards, such as restrictions
related to lead in paint, small parts, hazardous sharp edges and
points, wood parts, scissoring, shearing, or pinching, as well as
performance and labeling requirements specific to bassinets/cradles,
such as performance tests for static load and segmented mattresses.
Compared to previous versions of the F2194 standard, ASTM F2194-
22[egr]\1\ contains revisions to the scope, terminology, performance
requirements, test methods, marking and labeling requirements, and
instructional literature requirements for bassinets/cradles. Many of
these changes relate to the introduction of compact bassinets/cradles.
Tabs A and C of the 2022 Bassinet Rejection Staff Briefing Package
provide staff's full description of ASTM F2194-22[egr]\1\ and detailed
human factors and engineering assessments of the revised voluntary
standard.
Based on staff's recommendation in the 2022 Bassinet Rejection
Staff Briefing Package that elements of the revised standard decreased
safety, the Commission voted to reject ASTM F2194-22[egr]\1\ and retain
the existing mandatory standard in part 1218. The primary reason the
Commission stated for rejecting ASTM F2194-22[egr]\1\ involved the
addition of compact bassinets/cradles with legs shorter than six
inches,\47\ because caregivers are likely to place smaller and more
portable compact bassinets in unsafe locations, such as elevated and
soft surfaces (tables, counters, couches, and beds). CPSC's data
demonstrate that infants have suffered serious head injuries and death
when using small, portable products in unsafe locations. Moreover, ASTM
F2194-22[egr]\1\ added a new stability test that applied only to
compact bassinets/cradles that is less stringent than the stability
test for regular bassinets/cradles. The Commission determined that,
taken together, these additions decrease the safety of bassinets/
cradles, as well as other infant sleep products subject to the bassinet
standard.
---------------------------------------------------------------------------

\47\ RCA-ASTMs-Notice-of-a-Revised-Voluntary-Standards-for-
Bassinets-and-Cradles.pdf (cpsc.gov).
---------------------------------------------------------------------------

B. Voluntary Standards Development Since September 2022

The ASTM subcommittee formed the F15.18 Bassinets Elevated Surface
and Data Task Group (Task Group) to work with CPSC staff to develop
performance requirements to address the hazards of consumers placing
bassinets/cradles on elevated and/or soft surfaces. The Task Group met
three times between November 2022 and February 2023 48 49 50
to develop a proposal that all bassinets/cradles must meet either one
of the following requirements:
---------------------------------------------------------------------------

\48\ Meeting Log for November 16, 2022 task group: <a href="https://www.cpsc.gov/s3fs-public/ASTM-F15-18-Data-and-Compact-Bassinet-TG.pdf?VersionId=iMqK1Fy3s2xLSxuhFAbBVY5FJxIQNAgo">https://www.cpsc.gov/s3fs-public/ASTM-F15-18-Data-and-Compact-Bassinet-TG.pdf?VersionId=iMqK1Fy3s2xLSxuhFAbBVY5FJxIQNAgo</a>.
\49\ Meeting Log for December 14, 2022 task group: <a href="https://www.cpsc.gov/s3fs-public/F15-18-Bassinets-Elevated-Surface-and-Data-Task-Group-Meeting.pdf?VersionId=4sDOc.36I7O1.pSw8OLJM7bYmGzTOoTZ">https://www.cpsc.gov/s3fs-public/F15-18-Bassinets-Elevated-Surface-and-Data-Task-Group-Meeting.pdf?VersionId=4sDOc.36I7O1.pSw8OLJM7bYmGzTOoTZ</a>.
\50\ Meeting Log for February 28, 2023 task group: <a href="https://www.cpsc.gov/s3fs-public/ASTM-F15-18-Bassinet-Elevated-Hazard-Task-Group-Meeting-Log.pdf?VersionId=xi2Cs5BZSnJWSbBEnBr7jF2gaqoflYbT">https://www.cpsc.gov/s3fs-public/ASTM-F15-18-Bassinet-Elevated-Hazard-Task-Group-Meeting-Log.pdf?VersionId=xi2Cs5BZSnJWSbBEnBr7jF2gaqoflYbT</a>.
---------------------------------------------------------------------------

1. The bassinet/cradle only fully supports infants and functions
when the top rail is 16 inches or greater above the external floor with
a minimum internal side height of 7.5 inches. Examples of ways to meet
this requirement include:
(a) Bassinet collapses/fails when removed from the stand, so that
it cannot be used when removed from the stand.
(b) Bassinet does not have a removable stand.
2. The smallest lateral dimension shall be equal to or greater than
24 inches, with a minimum internal side height of 7.5 inches.
CPSC staff assessed these proposed requirements developed by the
ASTM task group, as follows:
Minimum 16-inch external side height requirement: CPSC staff
assesses that a 16-inch external product side height is likely to be
too low to the ground and to require the caregiver to squat or bend
significantly to attend to the infant (Figure 1, first two images on
the top left). For a variety of reasons, including to improve their
posture while interacting with the baby, caregivers may choose to move
the bassinet onto an elevated surface as shown in Figure 1, such as a
countertop, dining table, coffee table, sofa, chair, or adult bed,
despite this putting the infant at risk.
Figure 1 demonstrates a 16-inch-tall bassinet positioned on
elevated surfaces. Even a 50th percentile female (height 64 inches
\51\) would have to bend over considerably to access the child on the
ground and thus staff assesses that caregivers are likely to use the
bassinet in combination with a raised surface. Because of this
likelihood, staff assesses that the minimum height of 16 inches may not
be sufficient to discourage caregivers from using the bassinet on
elevated surfaces.
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\51\ PeopleSize Pro v 2.02, US Female 18-64.

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[GRAPHIC] [TIFF OMITTED] TP16AP24.026

Minimum 24-inch lateral dimension requirement: CPSC staff and the
ASTM Bassinets Subcommittee also discussed a 24-inch lateral dimension
as a means of deterring use of bassinets on soft and/or elevated
surfaces. This dimension represents the upper end of typical sofa seat
depth range (i.e., distance from a typical couch seat bight to
edge).\52\ Based on discussions with the ASTM Bassinets Subcommittee,
CPSC staff assesses that ``wide footprint'' bassinets/cradles are
likely to somewhat visually discourage caregivers from placing
bassinets/cradles on soft/elevated surfaces. Specifically, the ``wide
footprint'' requirement (i.e., all lateral dimensions greater than 24
inches) could reduce consumers' ability and likelihood to place
products onto soft and/or elevated surfaces to a limited degree, as
those products will be less portable and will either no longer fit onto
soft/elevated surfaces or will take up enough space that caregivers may
not wish to place the product onto said surfaces.
---------------------------------------------------------------------------

\52\ The typical sofa seat depth is 21 inches to 24 inches.
https://blog.roomstogo.com/what-do-i-need-to-know-about-couch-depth/
#:~:text=Outside%20depth%20ranges%20from%2031,sit%20with%20an%20uprig
ht%20posture.
---------------------------------------------------------------------------

Figure 2 shows three bassinets of varying lateral dimensions on a
sofa with a seat depth of approximately 20.25 inches. Staff assesses
that the two bassinets with a lateral dimension greater than or equal
to 24 inches (bottom two photos) are less likely to be placed on a
narrow sofa because they hang partially off of the edge of the sofa,
whereas the bassinet with a smaller lateral dimension (top photo) is
more likely to be placed on a sofa, as it fits entirely on the sofa.
However, sofas with a larger seat depth, such as ``deep-seated'' sofa
depths which can extend to 36 inches, can accommodate placement of a
wide bassinet.\53\
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\53\ <a href="https://www.thesofareview.com/guides/the-best-deep-seated-sofas">https://www.thesofareview.com/guides/the-best-deep-seated-sofas</a> and https://blog.roomstogo.com/what-do-i-need-to-know-about-
couch-depth/
#:~:text=Outside%20depth%20ranges%20from%2031,sit%20with%20an%20uprig
ht%20posture.

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[[Page 27254]]

[GRAPHIC] [TIFF OMITTED] TP16AP24.027

Staff also analyzed the ability to place a wide footprint bassinet
on traditional mattress sizes. Staff assesses that a full size
mattress, a queen size mattress, and a king size mattress can
accommodate a single adult caregiver and a 24-inch-wide bassinet. For
two-caregiver households, a 24-inch footprint would take up too much
space to allow for two adult occupants in a full size bed. For queen
size beds, the bassinet would take up a significant amount of space but
would still allow for two adult occupants. For king size beds, two
parents can comfortably fit a 24-inch bassinet on the bed. Overall,
staff assesses that a bassinet with a 24-inch-wide footprint is still
likely to be used on full, queen, and king size adult beds with one or
two caregivers (Figure 3). For this reason, staff assesses that the 24-
inch footprint does not adequately address the hazard of bassinets
being used on adult beds. Additionally, based on typical countertop,
dining table, and coffee table dimensions, staff assesses that the 24-
inch footprint alone does not deter consumers from placing bassinets on
these elevated surfaces, because a bassinet with a 24-inch-wide
footprint will likely fit onto many of these surfaces, and consumers
would easily be able to reach into the product to place/retrieve the
infant.\54\
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\54\ Standard countertop depth is 25.5 inches. Dining tables are
generally 36'' wide at minimum. Coffee tables often exceed 24'' in
length and width.

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[[Page 27255]]

[GRAPHIC] [TIFF OMITTED] TP16AP24.028

V. NPR Description and Explanation
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\55\ The 50th percentile adult male (18-64) height is 69.64
inches and shoulder breadth is 19 inches (PeopleSize, Pro v 2.02)
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A. ASTM Approaches Not Requiring Modification

The Commission preliminarily determines that three particular
aspects of the current part 1218 rule, which are not proposed for
revision in ASTM F2194-22[egr]\1\, remain adequate to address
associated hazards and do not require modification: locking/latching
mechanism (section 5.6 of ASTM F2194-22[egr]\1\, product finish-related
requirements (sections 5.2 and 5.4 of ASTM F2194-22[egr]\1\), and the
static load requirement to address mattress support issues (section 7.3
of ASTM F2194-22[egr]\1\).
ASTM developed locking/latching requirements for bassinets/cradles
to address incidents associated with collapse of the product. After
reviewing the reported incidents potentially implicating these
requirements, none of which included evidence of injury, staff advises
that the existing requirements address the hazard of the product
collapsing or folding. Therefore, the Commission preliminarily
concludes that the existing performance requirements address the hazard
and do not require modification.
Currently, no provisions in part 1218 address rough product
surfaces. Incidents regarding product finish, such as rough mesh
surfaces and labels with sharp edges (addressed in Sections 5.2 and 5.4
of ASTM F2194--22[egr]\1\) were not widespread in the incident data;
all but one infant in this type of reported incident received only non-
medical treatment. The Commission will continue to monitor these
incidents and, in particular, invites comment on how to address the
rough mesh surface hazard.
Finally, the static load requirement in the existing part 1218,
requiring the product to support up to three times the heaviest
intended infant, adequately verifies that the bassinet/cradle sleep
area is designed to hold and not break or create a hazardous condition
when subject to the weight of a child. The NPR does not modify this
test and proposes to apply it to all bassinets within the scope of the
standard.

B. Mechanical and Electrical Hazards Addressed in the NPR

Based on incident data (described in section III of this preamble)
and staff's engineering and human factors assessments, the NPR proposes
revisions and additions to some of the performance and labeling
requirements in ASTM F2194-22[egr]\1\ that would better address known
hazards and provide the highest level of safety feasible for bassinets/
cradles.
1. Requirements To Discourage Product Use on Unsafe Surfaces
To reduce the likelihood of consumers placing bassinets/cradles
onto elevated and/or soft surfaces, the NPR proposes both of the
following performance requirements and test methods.
a. The bassinet/cradle only fully supports infants and functions
when the lowest portion of the top side/rail is 27 inches or greater
above the product support surface (i.e., floor) with a minimum internal
side height of 7.5 inches. Examples that would meet this requirement
include:
(1) Products with a removeable stand that collapses or fails when
removed.
(2) Products that do not have a removeable stand.
b. The occupant support surface (i.e., mattress) shall be at least
15 inches from the product support surface (i.e., floor).
As shown in Figure 4, with these modifications caregivers can
comfortably reach and attend to the infant in a 27-inch-tall bassinet
located on the floor and will not need to elevate the bassinet. In
fact, elevating a 27-inch-tall bassinet into a hazardous position makes
it more difficult and inconvenient to reach the baby. Figure 4
demonstrates a 50th percentile female in relation to a bassinet with
the proposed requirements on various elevated surfaces. These elevated
surfaces are unlikely to be utilized due to caregivers' difficulty to
reach the baby compared to their reach when the bassinet is located on
the floor (Figure 4, first two images on the top left).

[[Page 27256]]

[GRAPHIC] [TIFF OMITTED] TP16AP24.029

While caregivers can easily reach into a 27-inch-tall bassinet when
it is on the floor, they may have difficulty reaching their infant if
the mattress is positioned too low to the ground (Figure 5); therefore,
the combination of the two proposed dimensions would improve the safety
of the bassinet by discouraging its use on elevated surfaces while
making it more comfortable and convenient to use on the floor.
[GRAPHIC] [TIFF OMITTED] TP16AP24.030

In the 2022 Bassinet Rejection Staff Briefing Package, staff
expressed concern about ASTM's removal from the voluntary standard of
the requirement for a bassinet to have a stand or base and the
Commission rejected the revised standard that included ``compact
bassinets.'' The requirements proposed in this NPR address CPSC's
concerns regarding bedsharing and unsafe placement by requiring
specific occupant sleep surface and side rail height requirements,
while still subjecting products to the same stability requirements as
bassinets with a traditional stand.
CPSC staff reviewed a variety of products (see Figure 6 for two
examples) and determined that some products available to consumers
already meet the 27-inch top rail height and 15-inch mattress height
requirement. Therefore, implementation of this NPR requirement is
feasible.

[[Page 27257]]

[GRAPHIC] [TIFF OMITTED] TP16AP24.031

Regarding hazards associated with other children attempting to
climb into the bassinet, staff advises that given children's propensity
for climbing (see Staff Briefing Package for Clothing Storage Units
\56\), a 27-inch side height is unlikely to dissuade children from
attempting to climb into the product. However, setting a minimum side
height taller than 27 inches would likely result in products being
significantly less stable in the event of a child climbing them, and
would not prevent children from climbing.57 58 59 60 61
Incidents demonstrate toddlers' ability to climb on raised surfaces
including cribs, showing that increasing the bassinet exterior side
height to more than 27 inches would not effectively address sibling's
access to the product.
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\56\ <a href="https://www.cpsc.gov/s3fs-public/Final-Rule-Safety-Standrd-for-Clothing-Storage-Units.pdf?VersionId=X2prG3G0cqqngUwZh3rk01mkmFB40Gjf">https://www.cpsc.gov/s3fs-public/Final-Rule-Safety-Standrd-for-Clothing-Storage-Units.pdf?VersionId=X2prG3G0cqqngUwZh3rk01mkmFB40Gjf</a>.
\57\ The incident data reported in section III of this preamble
contains two climbing-associated deaths: an older sibling (15 months
and two years old) climbed into the bassinet and laid on top of the
infant inside, suffocating them. Older 1-year-olds are known to be
capable of climbing on and off furniture without assistance.\57\
Gross motor play and the use of climbers are dominant, starting at
about 1\1/2\ years of age.\58\ Two-year-old children especially
enjoy climbing, and can climb steps, short ladders, and jungle
gyms.59 60 Moreover, incident data reported to CPSC
include numerous cases involving children climbing on furniture as
well as cribs. For example, in an incident reported through NEISS
(IDI 210108288), a two-year-old male climbed up on a nightstand and
was climbing into baby crib. In another NEISS incident (IDI
200740286), a 22-month-old female climbed into her brother's crib.
In another NEISS incident (IDI 200130999), the two-year-old girl
climbed into a portable play yard or crib and bit her 15-month-old
sister. In a fatal incident (IDI X19C0292A), a one-year-old male was
put down for a nap in a room with his toddler brother. The toddler
climbed into the crib with him with a pillow and a blanket.
\58\ Therrell, J.A., Brown, P., Sutterby, J.A., Thornton, C.D.,
(2002). Age Determination Guidelines: Relating Children's Ages to
Toy Characteristics and Play Behavior. T. P. Smith (Ed.), Bethesda,
MD: U.S. Consumer Product Safety Commission.
\59\ Frost, J.L., Wortham, S., & Reifel, S. (2001). Play and
Child Development. Upper Saddle River, NJ: Prentice-Hall.
\60\ Therrell, Brown, Sutterby, & Thornton, 2002.
\61\ Hughes, F.P. (1991). Children, Play, and Development.
Boston: Allyn & Bacon.
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Caregivers depend on infant sleep products to be safe places in
which to leave an infant for sleep; accordingly, these products must be
safe for infant sleep as sold. While these modifications, as written,
would not necessarily require bassinets/cradles to have a stand, they
would ensure that bassinets and cradles, including small portable
products, are raised off the ground to discourage caregivers from
placing them on elevated and soft surfaces such as beds and couches.
The proposed requirements would thus work toward achieving the highest
level of safety feasible for sleeping infants left to sleep unattended
while in the product.
2. Requirements for Sidewall Rigidity
The current mandatory rule in part 1218 does not have a sidewall
rigidity requirement. Many bassinets/cradles on the market have
sidewalls constructed of fabric, foam, fiberfill, mesh, or cardboard,
which can deflect downward, inward, and/or outward when subjected to a
load. CPSC is concerned that bassinets with non-rigid sidewalls may
permanently deform or collapse and not contain the infant if an
external force is applied to the sidewall, such as when a sibling pulls
on the sidewall of an occupied bassinet.
CPSC engineering staff considered whether the existing bassinet
stability test, which simulates a 2-year-old pulling on the bassinet
sidewall, could also be used to test adequate sidewall rigidity to
contain an infant. To test this concept, staff conducted the stability
test in ASTM F2194-13 on three non-rigid sided bassinets as shown in
Figures 7-9.\62\ Staff applied a 23-pound downward force and a five-
pound outward force on the bassinets as specified in the stability
test. The cardboard box bassinets bowed outward 3-5 inches (Figure 7b,
8b) during stability testing. The soft sided compact bassinet was not
able to support the 23-pound load and collapsed more than 8 inches
outward (Figure 9b). These tests demonstrate that bassinets with non-
rigid sidewalls may permanently deform or collapse and not contain the
infant if an external force is applied to the sidewall of an occupied
bassinet, for instance by a sibling pulling on it.
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\62\ The laser line used to determine deflection is enhanced for
visibility.

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[[Page 27258]]

[GRAPHIC] [TIFF OMITTED] TP16AP24.032

[[Page 27259]]

Staff next conducted this same stability test on rigid-sided
bassinets, which did not deflect or deform during testing. Staff
advises that 0.5 inch of deflection in any direction during the
stability test allows for reasonable movement of rigid sidewalls to
account for minor movements in fasteners in the construction of the
product. Based on this testing, the NPR proposes two requirements.
First, unlike ASTM F2194-22[egr]\1\, the NPR proposes to subject all
bassinets/cradles to the stability requirement.\63\ Second, the NPR
proposes that during this stability test, sidewall deflection can also
be measured, requiring that the sidewall shall not deflect in any
direction more than 0.5 inches. These proposed modifications ensure
bassinet/cradle stability and containment of the infant.
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\63\ As explained in section I of this preamble, the ASTM F2194-
22[egr]\1\ that the Commission has rejected created a new category
of ``compact bassinets'' and subjected this category to a new, less
stringent, stability test.
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3. Requirements for Mattresses and Mattress Supports
a. Requirements for Sleep Surface Deflection/Firmness
The NPR proposes mattress firmness requirements consistent with the
mandatory crib mattress requirements in 16 CFR part 1241 to address
incidents of infant's face/head conforming to the sleep surface. The
mandatory crib mattress rule requires a firmness test intended to
prevent the hazard of positional asphyxia involving infants suffocating
when face down in a soft mattress that can conform to an infant's face.
The firmness test involves placing a test fixture, as shown below in
Figure 10, level on the sleep surface of the mattress. The mattress
must be sufficiently firm and flat to support the weight of the test
fixture (approximately 11.5 lb.) so that the feeler arm does not make
any contact with the surface of the mattress.
[GRAPHIC] [TIFF OMITTED] TP16AP24.033

Staff tested two samples using the mattress firmness test fixture.
Figure 11 shows the mattress firmness test fixture feeler arm touching
the surface of the mattress, indicating that the mattress is too soft
and fails the draft firmness requirement. Test results showed that some
products failed the firmness test (feeler arm contacting the surface of
the mattress) because the mattress was too soft (Figure 11).
[GRAPHIC] [TIFF OMITTED] TP16AP24.034

[[Page 27260]]

Accordingly, to verify that the bassinet sleep surface (mattress
and/or support) is not too soft and does not form a concavity that can
pose a positional asphyxia hazard to infants, the NPR proposes to
include in part 1218 the same mattress firmness test as is found in the
crib mattress rule.
b. Requirements for Structural Integrity of Bassinet Mattresses and
Mattress Supports
Part 1218 currently specifies a static load requirement for the
sleep enclosure of the product. Section 6.3 of ASTM F2194-13, Static
Load, specifies that the product shall support the static load without
causing any hazardous conditions as identified within Section 5
(General Requirements). The static load test (Section 7.3) consists of
placing a 54-pound load or three times the manufacturer's recommended
weight (whichever is greater) within 5 seconds on an aluminum block and
maintain for 60 seconds. For play yard bassinets, the test is conducted
in all four corners of the product.
The static load test verifies that the bassinet/cradle sleep area
is designed to hold and not break or create a hazardous condition upon
the weight of a child by requiring the product to support up to three
times the heaviest intended occupant (95th percentile 5-month-old male
(19.8 lb.)). Although staff advises that the static load requirement is
adequate to address some of the mattress and/or support issues, the
mattress firmness test (discussed in section V.B of this preamble) is
an added verification of the flatness of the sleep surface (mattress
and/or support), to further address these mattress/supports issues.
c. Requirements for After-Market Mattresses for Bassinets/Cradles
The crib mattress rule (part 1241) includes performance
requirements for after-market mattresses but does not specifically
identify bassinet/cradle mattresses as being included in the
regulation. Instead, part 1218 establishes requirements for mattresses
sold with bassinets/cradles (generally known as OEM mattresses.) CPSC
is aware, however, of incidents that have arisen from consumer use of
ill-fitting after-market mattresses. Based on the prominent
availability and use of after-market bassinet/cradle mattresses, and
the use of bassinets/cradles for infant sleep, the NPR proposes
performance requirements for after-market bassinet mattresses to ensure
the same level of safety as OEM bassinet/cradles mattresses and after-
market mattresses for other infant sleep products.
Crib mattresses and bassinet/cradle mattresses, including after-
market bassinet/cradle mattresses, share common hazard patterns
associated with poorly fitting and overly soft mattresses. The
mandatory crib mattress rule in part 1241 addresses similar hazards
found in after-market play yard mattresses and non-full-size crib
mattresses. Part 1241 requires such mattresses to meet the same
performance requirements as the OEM mattress sold with the product,
when tested with the product for which the after-market mattress is
intended. In particular, these mattresses must have a minimum level of
firmness (section V.B.3 of this preamble). Part 1241 already requires
after-market mattresses intended for use in the bassinet attachment of
a play yard to meet the provisions in the existing bassinet rule, part
1218, when tested with each bassinet/cradle brand and model in which
the mattress is intended to be used. 16 CFR 1241.2(b)(5)(iv).
Additionally, the crib mattress rule requires that after-market
mattresses must be at least the same size as the OEM mattress or larger
and must lay flat, must include a floor support structure that is at
least as thick as the OEM mattress, and must include equivalent storage
accommodations (such as a pouch for the product instruction manual). 16
CFR 1241.2(b)(4).
To reduce the risk of injury caused by poorly fitting and overly
soft mattresses associated with after-market mattresses for bassinets/
cradles, the NPR proposes to adopt the after-market requirements from
the crib mattress rule into the bassinet/cradle mandatory standard.
4. Requirements for Bassinet Sleep Surface Angles
Minimum safe sleep requirements for young infants, particularly
those 5 months old and younger, require that infants be placed to sleep
on their backs on a firm, flat, sleep surface. As described in section
III of the preamble, this avoids the hazard created by bassinets that
are non-level--for example leaning forward or to one side, or with legs
or sides with uneven heights--which could cause the infants to roll to
the side, often into the mesh/siding of the bassinet/cradle before the
infant is developmentally capable of rolling.
a. Requirement for Head-To-Toe Incline Angle
The definition of bassinet in part 1218 (based on ASTM F2194-13)
states that ``[w]hile in a rest (non-rocking or swinging) position, a
bassinet/cradle is intended to have a sleep surface less than or equal
to 10[deg] from horizontal.'' 16 CFR 1218.2(b)(1)(i) citing section 1.3
of ASTM F2194-13. The angle limitation in the definition is intended to
ensure that the bassinet provides a safe, flat sleep surface. However,
neither ASTM F2194--13 nor the revised ASTM F2194-22[egr]\1\ contain a
test to measure the sleep surface incline to ensure that the sleep
surface does not exceed 10 degrees from horizontal. The Commission's
ISP Rule in part 1236 contains a test to measure the head-to-toe sleep
surface angle. This test consists of placing a Hinged Weight Gauge-
Infant (17.5 lb.) on the product and measuring the lengthwise incline
angle along the upper torso/head area. This 10-degree head-to-toe safe
sleep angle is supported in a report by Erin M. Mannen, Ph.D., the
Biomechanical Analysis of Inclined Sleep Products--Final Report
September 18, 2019.\64\ Dr. Mannen's testing showed that angles greater
than 20 degrees present a hazard that infants may move into a
compromising position in the product from which they cannot self-
rescue. Based on the results of Dr. Mannen's biomechanical study,
``fewer differences in muscle activity or lying posture were revealed
at a 10-degree mattress incline compared to the zero-incline surface.
Ten degrees is likely a safe incline for sleep on a crib mattress type
of surface.'' The NPR proposes to remove the head-to-toe sleep surface
angle statement from the definition of a bassinet, and instead to add a
performance and test requirement for the 10-degree head-to-toe sleep
surface angle limit, using the same incline test from the ISP Rule.
This is an improvement to safety because it will ensure consistent and
repeatable testing across test labs for all bassinets/cradles.
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\64\ The 10 degree incline angle requirement in the Infant Sleep
Product Final Rule, available at: <a href="https://www.cpsc.gov/s3fs-public/Final-Rule-Safety-Standard-for-Infant-Sleep-Products.pdf">https://www.cpsc.gov/s3fs-public/Final-Rule-Safety-Standard-for-Infant-Sleep-Products.pdf</a>, is based
on findings in the 2019, Biomechanical Analysis of Inclined Sleep
Products--Final Report 09.18.2019 by Erin M Mannen Ph.D., available
at: <a href="https://www.cpsc.gov/s3fs-public/Dr-Mannen-Study-FINAL-Report-09-18-2019_Redacted.corrected_0.pdf?g.Jao0IN_zU.TjiX4FeSUM3SPc3Zt_25">https://www.cpsc.gov/s3fs-public/Dr-Mannen-Study-FINAL-Report-09-18-2019_Redacted.corrected_0.pdf?g.Jao0IN_zU.TjiX4FeSUM3SPc3Zt_25</a>.
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b. Side-to-Side Tilt Angle
Part 1218 specifies a side-to-side tilt angle of no more than 7
degrees for rocking bassinets/cradles when they are at rest (section
6.9.2 of ASTM F2194-13), but does not specify side-to-side tilt
requirements for bassinets/cradles without a rocking function. On
December 7, 2021, CPSC staff sent a letter \65\ to the ASTM
subcommittee

[[Page 27261]]

chair for bassinets/cradles regarding four fatal incidents (occurring
from 2019 through 2021) involving bassinets with a cantilever design in
which infants reportedly rolled into the side of the bassinet, or into
a prone position. The cantilever design supports the bassinet by a leg/
frame on one side of the product so that the suspended side without a
support can be positioned over an adult bed. In the December 7, 2021
letter, CPSC staff stated concern with the then-current ASTM F2194-
16[egr]\1\ allowance of a side-to-side 7-degree maximum tilt angle,
because minimum safe sleep guidance requires infants be placed to sleep
on a firm, flat surface.\66\
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\65\ Staff letter to Mr. Lewis, chair of ASTM F15.18 on
Bassinets and Cradles, dated December 7, 2021. <a href="https://www.cpsc.gov/s3fs-public/BassinetwcantileverltrAttachedSpreadsheet-120821.pdf?VersionId=fyFz2">https://www.cpsc.gov/s3fs-public/BassinetwcantileverltrAttachedSpreadsheet-120821.pdf?VersionId=fyFz2</a> Ac9HFDyp0yWa83WphujK.KJHEVS.
\66\ After staff's further review of bassinet-related data, the
tilt hazard pattern is evidenced in the 2 deaths, 3 injuries, and 95
non-injury incidents summarized in section III of this preamble.
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However, on February 14, 2023, ASTM proposed side-to-side tilt
requirements in the voluntary standard for non-rocking bassinets/
cradles stating that the bassinet sleep surface shall not exceed a
side-to-side tilt angle of 7 degrees. This angle limit is based on the
existing rocking bassinet/cradle rest angle requirement in section
6.9.2 of ASTM F2194-13. The test consists of two parts: simulating a
five-month-old infant located against each side of the sleep surface,
and then simulating a low weight newborn infant located against each
side and the center of the sleep surface. The current side-to-side tilt
angle for at rest rocking bassinets/cradles cannot exceed 7 degrees in
either test. Based on this, ASTM's proposed modified test requirements
for non-rocking bassinets/cradles provides the following:
(i) Five-month-old infant.--The Hinged Weight Gauge-Infant (17.4
lb.) is placed parallel to and contacting one of the lateral sidewalls
of the bassinet/cradle, equidistant between both head and toe ends of
the sleep surface. The side-to-side angle is measured on top of the
Hinged Weight Gauge-Infant. The angle measurement is taken three times
and then averaged. The test then is repeated on the other side of the
sleep surface.
(ii) Newborn infant.--A 6 by 4 by 0.5-inch nominal thickness steel
block weighing 3.3 lb. is placed parallel to and contacting one of the
lateral sidewalls of the bassinet/cradle, equidistant between both head
and toe ends of the sleep surface. The side-to-side angle is measured
on top of the steel block. The angle measurement is taken three times
and then averaged. The test then is repeated on the other side and in
the geometrical center of the sleep surface.
CPSC staff has assessed ASTM's proposal. Based on incident data,
cantilevered designed bassinets that have 7 degree or less side-to-side
tilt angle \67\ can still facilitate infants rolling before they are
developmentally capable of rolling and present the potential for a
suffocation hazard. CPSC staff conducted testing on 10 products with
cantilevered designs (see Table 2 below), using the NPR proposed test.
Four products, A, B, D, H, were associated with incidents that involved
the infant rolling over into a compromising position. Fortunately, the
caregiver was able to intervene in these cases before suffocation
ensued. However, in one case, Product B, involved a fatality incident
(IDI 200211HCC3248). Product H had the largest tilt angle (7.1 degrees)
and product D had the smallest tilt angle (1.2 degrees) of models
associated with incidents.
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\67\ CPSC proposes that bassinets/cradles have two different
tilt angle requirements for head-to-toe and side-to-side, based on
how the suffocation hazard manifests. The hazard associated with a
head-to-toe tilt greater than 10 degrees occurs when an infant
unexpectedly rolls (either side-to-side or into a chin-to-chest
position) and the infant cannot self-rescue when on an incline and
can suffocate. However, when a bassinet/cradle has a side-to-side
tilt, even if the tilt is less than 7 degrees, incident data and
sample analysis suggest that this tilt can facilitate rolling before
an infant is developmentally capable of rolling and cannot self-
rescue. A suffocation hazard presents when the infant's nose and
mouth become occluded in the side or mattress.

Table 2--Bassinet Tilt Testing Results
------------------------------------------------------------------------
Max side-to-
Height setting (note side tilt
Product ID 1) angle
[degrees]
------------------------------------------------------------------------
A (Note 2)........................ Lowest (mattress 5.6
upper position).
Highest (mattress 6.3
upper position).
Lowest (mattress 6.1
lower position).
Highest (mattress 5.7
lower position).
B................................. Lowest.............. 3.3
Highest............. 1.8
C................................. Lowest.............. 3.9
Highest............. 4.4
D................................. Lowest.............. 1.8
Highest............. 1.2
E................................. Lowest.............. 2.2
Highest............. 2.5
F................................. Lowest.............. 3.9
Highest............. 3.5
G................................. Lowest.............. 2.7
Highest............. 2.7
H................................. Lowest.............. 6.0
Highest............. 7.1
I................................. Lowest.............. 1.4
Highest............. 1.0
J................................. Lowest.............. 2.5
Highest............. 3.0
------------------------------------------------------------------------
Notes:
(1) All products had several height settings. Staff tested each sample
on the highest and lowest height setting.
(2) Product A has several height settings as well as two mattress
positioning settings. Staff tested on the highest and lowest height
setting for each of the two mattress positioning settings.

[[Page 27262]]

Based on review of incidents and testing, staff determined that the
current ASTM side-to-side tilt restriction of 7 degrees does not
adequately address the rolling and suffocation hazard. Staff testing
showed that cantilevered bassinets with tilt angles of 1.2-7.1 degrees
were associated with rollover incidents. Accordingly, to address the
potential for infants to roll into unsafe sleep positions and to
provide the highest level of safety that is feasible, the NPR proposes
to add the side-to-side tilt angle test requirements from ASTM's
February 14, 2023, proposal, with two modifications: (1) decrease the
allowed tilt angle to 0 <plus-minus>1 degree, which means a maximum
angle not to exceed one degree from horizontal, and (2) apply this
requirement to both rocking bassinets at rest and non-rocking
bassinets. The NPR also proposes that for bassinets with adjustable
heights, the side-to-side tilt test be performed on both the highest
and lowest height settings. The Commission requests comment on a side-
to-side tilt angle limit (including the proposed 0-degree angle) and an
appropriate manufacturing tolerance (including the proposed 1-degree
maximum variation) that is as consistently close to flat as is
feasible.
5. Requirements for Electrical Systems
Section III of the preamble describes hazards associated with
electrical systems, including smoke, shock, and battery leakage. While
part 1218 does not address electrical hazards, other Commission rules
for durable infant or toddler products, such as the infant swings rule,
16 CFR part 1223, incorporating ASTM F2088-22, Standard Consumer Safety
Specification for Infant and Cradle Swings, include adequate
requirements to address electrical hazards, such as the conditions that
can lead to battery leakage. To address bassinet/cradle incidents
associated with defective electrical systems, the NPR proposes to
include the battery compartment requirements from part 1223 in part
1218.
6. Requirements for Multi-Use Products
Regarding multi-use products, section 5.14 of ASTM F2194-22[egr]\1\
states that if ``converted into another product for which a consumer
safety specification exits, the product shall comply with the
applicable requirements of that standard when in that use mode.''
Because the Commission's mandatory standard and ASTM's ``consumer
safety specifications'' can diverge and are not always the same, the
NPR proposes that multi-use products comply with the applicable
mandatory CPSC consumer product safety standard when in each use mode,
rather than the applicable voluntary standard. This modification
clarifies CPSC's expectation and creates certainty for test labs.

C. Revised Requirements for Marking, Warning, Labeling, and
Instructional Literature

Tab A of Staff's 2022 Bassinet Rejection Staff Briefing Package
provides a detailed description of the marking and warning requirements
in ASTM F2194-22[egr]\1\ and an analysis of whether the revised
labeling requirements improve the safety of bassinets and cradles.
Modifications in ASTM F2194-22 [egr]\1\ include additional language or
changes addressing battery-related hazards, product warnings, compact
bassinets and compact bassinets made of cardboard, and the warning
language currently incorporated by reference in part 1218.
After considering literature, incident data, and consumer feedback,
the Commission preliminarily finds that the marking, warning, labeling,
and instructional literature requirements specified in ASTM F2194-22
[egr]\1\ are largely adequate but require several modifications to
provide the highest level of safety feasible.
Battery Compartment Warnings--ASTM revised section 8 of ASTM F2194-
22[egr]\1\ to include specific marking requirements for battery-
operated products (Section 8.4-Battery-Operated Product Marking). The
ASTM standard now requires that, for battery-operated products, the
product's battery compartment, battery compartment door/cover, or area
immediately adjacent to the battery compartment must be marked or
labeled permanently and legibly to show the correct battery polarity,
size, and voltage. ASTM F2194-22[egr]\1\ exempts products using one or
more non-replaceable batteries, except when they are accessible with
the use of a coin, screwdriver, or other common household tool, in
which case they must be marked or labeled permanently and legibly with
a statement that the batteries are not replaceable. If marking or
labeling the product is not practicable, then this statement shall be
included in the instructions. The bassinet subcommittee adopted these
marking/labeling requirements from ASTM's Ad Hoc Language Task Group
\68\ and the requirements are consistent with other juvenile product
standards.
---------------------------------------------------------------------------

\68\ ASTM Ad Hoc Language Task Group (Ad Hoc TG) consists of
members of various durable nursery product voluntary standards
committees, including CPSC staff. The Ad Hoc TG's purpose is to
harmonize the wording of common sections (e.g., introduction, scope,
protective components) and warning label requirements across durable
infant and toddler product voluntary standards.
---------------------------------------------------------------------------

Staff advises that these requirements are adequate and necessary to
address hazards associated with battery-operated products that are not
currently addressed in part 1218. Accordingly, the NPR proposes to
incorporate Section 8.4 of ASTM F2194--22[egr]\1\ without modification.
Alignment with Ad Hoc Warnings--Section 8 of ASTM F2194-[egr]22\1\
also contains multiple revisions intended to align with current
recommendations from ASTM's Ad Hoc Language Task Group. ASTM F2194-
22[egr]\1\ now specifies that warnings shall be in English at minimum,
states that any additional markings or labels shall not contradict or
confuse the required information or mislead the consumer, and sets
formatting requirements for warnings (e.g., font size, text alignment,
safety alert symbol, bullet points for cautionary statements).
Per Ad Hoc Recommendations, the standard uses ANSI Z535.4-2011,
Product Safety Signs and Labels, as a reference for its warning
formatting requirements. ANSI Z535.4 is the primary United States
voluntary consensus standard for product safety signs and labels. For
example, CPSC staff consistently uses this standard when developing or
assessing the adequacy of warning labels. Literature on the design and
evaluation of on-product warnings frequently cites ANSI Z535.4 as the
minimum set of requirements governing products sold in the United
States containing such labels, and human factors experts generally
consider the ANSI Z535 series of requirements the benchmark and state
of the art standards against which warning labels should be evaluated
for adequacy. The NPR proposes to adopt all warnings that align with
ANSI Z535.4 formatting requirements.
Suffocation Hazard Warnings--Section 8 of ASTM F2194-22[egr]\1\
also contains multiple revisions to the warning statements incorporated
in part 1218, specifically to the language for suffocation hazards.
ASTM F2194-22[egr]\1\ specifies that the statement ``Failure to follow
these warnings and the instructions could result in death or serious
injury'' shall be the first warning to appear in a message panel,
followed immediately by a suffocation hazard warning addressing the
following:

[[Page 27263]]

[GRAPHIC] [TIFF OMITTED] TP16AP24.035

ASTM F2194-22[egr]\1\ also requires that warnings address the
following statement:

Always place baby on back to sleep to reduce the risk of SIDS
and suffocation.

ASTM F2194-22[egr]\1\ requires compact bassinets to address the
following:

Product can roll over on soft surfaces and suffocate child.
NEVER place product on beds, sofas or other soft surfaces.

The Commission rejected the inclusion of compact bassinets into the
mandatory standard for bassinets and cradles in 2022. However, staff
advises that this warning language addresses hazards associated with
all bassinets/cradles and recommends that this language be required for
all products within the scope of the standard. Accordingly, the NPR
proposes to require this warning for all bassinets/cradles within the
scope of the rule.
Fall Hazard Warnings--ASTM F2194-22[egr]\1\ does not change the
existing warning language related to fall hazards. However, in the
voluntary standard, fall hazard statements are now required to appear
after the suffocation hazard warning statements. Additionally, the
warning language, ``FALL HAZARD,'' required for products where the
bassinet bed is removeable from the base/stand without the use of tools
and contains a lock/latch mechanism that secures the bassinet bed to
the base/stand, is no longer required, as the message is instead
required to be located in the fall hazard section of the warning,
making the inclusion of a second ``FALL HAZARD'' statement redundant.
However, ASTM F2194-22[egr]\1\ requires that compact products address
the following statements in the ``FALL HAZARD'' section:

(1) Always use product on the floor. Never use on an unintended
elevated surface.
(2) Do not carry baby in the [manufacturer to insert type of
product]. [Exception: A product that is intended to carry a baby is
exempt from this requirement].
(3) Compact bassinet/cradles constructed of cardboard shall also
address: Do not reuse [manufacturer to insert type of product] for
second child.

Like the suffocation warnings for compact bassinets, staff advises
that these fall hazard warnings will address fall hazards that are
associated with all bassinets/cradles, not just compact bassinets.
Accordingly, the NPR proposes that these fall hazard warnings be
required for all products within the scope of the standard with two
modifications. Specifically, the NPR proposes that the phrase ``an
unintended elevated surface'' in warnings statement (1) be changed to
``any elevated surface,'' as any elevated surface presents a potential
fall hazard. Additionally, for warning statement (3), the NPR proposes
that the reference to ``compact'' bassinets be removed consistent with
the Commission's rejection of this product category.
The fall hazard warning language in ASTM F2194-22[egr]\1\; also
contains requirements for products where the bassinet bed uses a lock/
latch mechanism to secure the bassinet bed to the base/stand, so that
the bassinet bed is removable without the use of tools. ASTM F2194-
22[egr]\1\; requires the following warning language for these products:

Always check that the bassinet is securely locked on the base/
stand by pulling upwards on the bassinet bed.

Lastly, ASTM added three example warnings to the standard: one for
bassinet/cradle products, one for compact bassinet/cradles, and one for
compact bassinet/cradles made of cardboard. Shown below is an example
warning that complies with part 1218 (Figure 12), as well as the
example warnings shown in ASTM F2194-22[egr]\1\ (Figures 13-14). While
the warnings shown in Figure 14 are intended for compact products, and
the NPR proposes to remove references to ``compact'' bassinets from the
mandatory standard, the text included in the warnings meets proposed
NPR requirements and does not make a specific reference to ``compact''
bassinets, other than the title of the figures. The warnings in Figure
14 contain a statement warning against use on ``unintended'' elevated
surfaces. Fall hazards, however, can occur with non-compact products
and on any elevated surface. Additionally, the warning in Figure 13,
which is intended for ``standard' bassinets/cradles, does not contain
language warning consumers against using the product on soft or hard
elevated surfaces or carrying infants in the product. Therefore, this
NPR proposes that the warning shown in Figure 13 (Fig. 29 in ASTM
F2194-22[egr]\1\) be removed, and that the warnings shown in Figure 14
(Fig. 30-31 in ASTM F2194-22[egr]\1\;) be renumbered and renamed to
remove the reference to ``compact'' products and revised so that the
statement warning against use on ``an unintended elevated surface''
instead warns against use on ``any elevated surface.''

[[Page 27264]]

[GRAPHIC] [TIFF OMITTED] TP16AP24.036

[[Page 27265]]

[GRAPHIC] [TIFF OMITTED] TP16AP24.037

After-Market Bassinet/Cradle Mattresses Warnings--Included in this
final rule are warning requirements for after-market mattresses. As
discussed above in section V.B.3.c of this preamble, the safety
standard for crib mattresses (part 1241) includes performance
requirements for after-market mattresses but does not specifically
identify bassinet/cradle mattresses as being included in the
regulation. However, given the existence of after-market bassinet/
cradle mattresses, as well as the similar manners of sleep use between
bassinets/cradles, cribs, and play yards, staff advises that similar
warning requirements for after-market bassinet/cradle mattresses are
appropriate and necessary. Accordingly, the NPR proposes that the
warning shown in Figure 15, which is identical to the warning used in
part 1241 for after-market mattresses, be required for after-market
bassinet/cradle mattresses.
---------------------------------------------------------------------------

\69\ All figures with ``*'' denotation are reprinted, with
permission, from ASTM F2194-22[egr]\1\ Standard Consumer Safety
Specification for Bassinets and Cradles, copyright ASTM
International, 100 Barr Harbor Drive, West Conshohocken, PA 19428. A
copy of the complete standard may be obtained from ASTM
International, <a href="http://www.astm.org">www.astm.org</a>.
---------------------------------------------------------------------------

Additionally, the NPR proposes that the statement ``Use ONLY
mattress provided by manufacturer,'' appearing in the warnings for
bassinets/cradles in part 1218 and in ASTM F2194-22[egr]\1\, be
replaced with the statement ``USE ONLY one mattress at a time.'' This
revision communicates to consumers to only use a single mattress in the
bassinet/cradle; when combined with other warning statements, the
revision signals that the use of after-market bassinet/cradle
mattresses is acceptable when the mattress has the appropriate fit for
the bassinet/cradle; and will ensure that the warnings on bassinets/
cradles are consistent with the warnings on after-market mattresses.
This also addresses the potential hazard presented by after-market
mattresses marketed as ``mattress toppers.''

[[Page 27266]]

[GRAPHIC] [TIFF OMITTED] TP16AP24.038

Instructional Literature Warnings--The instructional literature
requirements in ASTM F2194-22[egr]\1\ contain multiple revisions. Many
revisions are intended to ensure consistency with on-product markings
and warnings and current recommendations from ASTM's Ad Hoc Language
Task Group. ASTM F2194-22[egr]\1\ now specifies that instructions shall
be in English at minimum, state that any additional instructions shall
not contradict or confuse the required information or mislead the
consumer, and sets formatting requirements for warnings (e.g., font
size, text alignment, safety alert symbol, bullet points for cautionary
statements). Per the Ad Hoc Language Task Group's recommendations, the
ASTM F2194-22[egr]\1\ standard uses ANSI Z535.4-2011 as reference for
its warning formatting requirements.
Additionally, ASTM F2194-22[egr]\1\ requires that instructions for
battery-operated products address the following:
[GRAPHIC] [TIFF OMITTED] TP16AP24.039

ASTM F2194-22[egr]\1\ provides that instructions for products that
use more than one battery in any one circuit shall also address the
following under the same CAUTION header:
<bullet> Always replace the entire set of batteries at one time.
<bullet> Never mix old and new batteries, or batteries of different
brands or types.
Additionally, ASTM F2194-22[egr]\1\ states that instructions are
now required to address the following statements:

Do not use if any part of the (manufacturer to insert type of
product) is broken, torn, or missing.

Additionally, ASTM F2194-22[egr]\1\ requires that the instructions
for products constructed of cardboard must now address the following
statements:

Use only on a flat, dry floor.
Do not place the (manufacturer to insert type of product) near a
space heater, open fire or other source of strong heat.

Lastly, ASTM F2194-22[egr]\1\ contains two example instructional
literature warnings, one for bassinet/cradle products, and one for
battery-powered bassinets. Figure 16 provides these two example
warnings:

[[Page 27267]]

[GRAPHIC] [TIFF OMITTED] TP16AP24.040

The Commission preliminarily determines that the instructional
literature requirements in ASTM F2194-22[egr]\1\ are adequate and
proposes to adopt these warnings provisions into the mandatory
standard.

VI. Incorporation by Reference

The Commission proposes incorporating ASTM F2194-22[egr]\1\ by
reference into the mandatory standard for bassinets/cradles codified in
part 1218, with modifications to reduce the risk of injury associated
with these products and to ensure the standard provides the highest
level of safety that is feasible. The Office of the Federal Register
(OFR) has regulations concerning incorporation by reference. 1 CFR part
51. For a proposed rule, agencies must discuss in the preamble of the
NPR ways that the materials that the agency proposes to incorporate by
reference are reasonably available to interested persons, and how
interested parties can obtain the materials. Additionally, the preamble
to the rule must summarize the material. 1 CFR 51.5(b).
In accordance with the OFR's requirements, section IV.A of this
preamble summarizes the provisions of ASTM F2194-22[egr]\1\ that the
Commission proposes to incorporate by reference. ASTM F2194-22[egr]\1\
is copyrighted. By permission of ASTM, the standard can be viewed as a
read-only document during the comment period on this NPR, at <a href="http://www.astm.org/cpsc.htm">http://www.astm.org/cpsc.htm</a>. To download or print the standard, interested
persons may purchase a copy of ASTM F2194-22[egr]\1\ from ASTM through
its website (<a href="http://www.astm.org">http://www.astm.org</a>), or by mail from ASTM International,
100 Bar Harbor Drive, P.O. Box 0700, West Conshohocken, PA 19428.
Alternatively, interested parties may inspect a copy of the standard at
CPSC's Office of the Secretary by contacting Alberta E. Mills,
Secretary, U.S. Consumer Product Safety Commission, 4330 East-West
Highway, Bethesda, MD 20814; telephone: 301-504-7479; email: <a href="/cdn-cgi/l/email-protection#98fbe8ebfbb5f7ebd8fbe8ebfbb6fff7ee">[email&#160;protected]</a>.

VII. 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). The Commission proposes a 180-day
effective date for this rule. The rule would apply to all bassinets/
cradles and after-market bassinet mattresses manufactured after the
effective date. 15 U.S.C. 2058(g)(1). This amount of time is typical
for durable infant or toddler rules promulgated under section 104 of
the CPSIA.\70\ Six months is also the period that the JPMA typically
allows for products in their certification program to shift to a new
standard once a new standard is published. Therefore, juvenile product
manufacturers are accustomed to adjusting to new standards within this
timeframe.
---------------------------------------------------------------------------

\70\ See, e.g., Safety Standard for Infant Swings, 77 FR 66713
(Nov. 7, 2012); Safety Standard for Crib Mattresses, 87 FR 8640
(Feb. 15, 2022).
---------------------------------------------------------------------------

Moreover, although the NPR proposes to add requirements, the test
methods and test equipment are not unique, in that other CPSC rules
also use the same methods and equipment. For example, 41 third party
laboratories are CPSC-accepted to test to part 1218. Eleven of 12
laboratories accepted to test to the crib mattress rule are also
accredited for testing to the bassinet standard. Accordingly, the CPSC
expects that these laboratories are competent to conduct the required
testing and can have their International Organization for
Standardization (ISO) accreditation and CPSC-acceptance updated in the
normal course. The Commission invites comments, particularly from small
businesses, regarding the proposed additional testing and the amount of
time needed to come into compliance with a final rule.

VIII. Regulatory Flexibility Act (RFA)

The RFA requires that agencies review a proposed rule for the
rule's potential economic impact on small entities, including small
businesses. Section 603 of the RFA generally requires that agencies
prepare an initial regulatory flexibility analysis (IRFA)

[[Page 27268]]

and make the analysis available to the public for comment when the
agency publishes an NPR. 5 U.S.C. 603. The IRFA must describe the
impact of the proposed rule on small entities and identify significant
alternatives that accomplish the statutory objectives and minimize any
significant economic impact of the proposed rule on small entities.
This proposed rule would have a significant economic impact on a
substantial number of small U.S. entities, primarily from redesign
costs in the first year that the final rule would be effective. A
significant impact would occur for small companies whose products do
not meet the proposed revised requirements, particularly suppliers of
small bassinets and bassinet accessory products for strollers and play
yards, as well as suppliers of cantilever style bassinets and after-
market bassinet mattresses. Third party testing costs should not be a
new significant cost for most small firms, given that bassinet
suppliers should already be testing to the current mandatory standard
in part 1218. However, for after-market bassinet mattress suppliers,
the third party testing costs to comply with the final rule would be
new, although these firms already incur costs for testing to establish
compliance with other relevant CPSC regulations, including those for
lead and phthalate content.

A. Reason for Agency Action, NPR Objectives, Product Description, and
Market Description

Section I of this preamble explains why CPSC proposes to update the
mandatory rule for bassinets/cradles and provides a statement of the
objectives of, and legal basis for, the proposed rule. Section II of
this preamble describes the types of products within the scope of the
NPR, the market for bassinets/cradles, and the use of bassinets/cradles
in the U.S. The requirements in the NPR are more stringent than the
ASTM voluntary standard for bassinets/cradles, as described in sections
IV and V of this preamble. The NPR addresses known hazards, discussed
in section III of this preamble, that the current rule does not
adequately address, as well as products on the market that were not
common when the current rule was promulgated, such as products that
resemble short play yards with canopies marketed for outdoor infant
sleep.
The scope of this proposed rule also includes after-market bassinet
mattresses, which are not in scope of the current regulation in part
1218 or the crib mattress regulation in 16 CFR part 1241. Accordingly,
the registration card already required for bassinets/cradles under
section 14 of the CPSA (15 U.S.C. 2056a(d)) will now be required for
after-market mattresses as well. Registration cards are exempt from PRA
or RFA analysis, per section 104(d)(1) of the CPSIA. 15 U.S.C.
2056a(d)(1).

B. Small Entities to Which the NPR Would Apply

Section II of this preamble describes the products within the scope
of the rule and an overview of the markets for bassinets/cradles and
for after-market bassinet mattresses. This section XIII.B of the
preamble provides additional detail on the market for products within
the scope of the rule.
Annual Units Sold: CPSC estimates the annual U.S. sales of new
bassinets, including items with a bassinet mode or attachment, to be--
rounded for the purposes of further analysis--3.1 million units per
year. CPSC made this estimate using Centers for Disease Control (CDC)
data on the number of newborns,\71\ State Department data on adoptions
from foreign countries,\72\ and a survey by Statista \73\ in 2017 on
the estimated ownership of bassinets, play yards, and strollers, also
taking into account the market for used items.
---------------------------------------------------------------------------

\71\ <a href="https://www.cdc.gov/nchs/nvss/births.htm">https://www.cdc.gov/nchs/nvss/births.htm</a>.
\72\ <a href="https://travel.state.gov/content/travel/en/Intercountry-Adoption/adopt_ref/AnnualReports.html">https://travel.state.gov/content/travel/en/Intercountry-Adoption/adopt_ref/AnnualReports.html</a>.
\73\ <a href="https://www.statista.com/forecasts/987681/ownership-of-baby-furniture-in-the-us">https://www.statista.com/forecasts/987681/ownership-of-baby-furniture-in-the-us</a>. This data from 2017 is consistent with the
Durable Nursery Products Exposure Survey that a contractor conducted
for CPSC in 2013, which found that about 30% of families with
children under age 6 owned a bassinet, cradle, or infant hammock.
---------------------------------------------------------------------------

Specifically, CPSC estimates the total sales of new bassinets in
the U.S. as the total of the sales of traditional bassinets and
cradles, plus play yard bassinets, plus stroller bassinets, plus
bedside sleepers with a bassinet mode, which is 3,080,942, rounded for
the purposes of analysis to 3.1 million (see Table 3). While this may
seem high (corresponding to roughly 80 percent of the number of
newborns in the U.S. each year), it is consistent with the prevalence
of multi-mode products with a bassinet mode or attachment.
---------------------------------------------------------------------------

\74\ The number of newborns is from CDC data on births and State
Department data on adoptions from other countries; the data on
product ownership is from the Statista survey.
\75\ <a href="https://www.statista.com/study/49911/baby-products-in-the-us/?locale=en">https://www.statista.com/study/49911/baby-products-in-the-us/?locale=en</a>. A survey by Statista in 2017 of parents with children
under the age of 4.
\76\ <a href="https://www.statista.com/forecasts/987072/ownership-of-a-rocking-crib-amongst-parents-in-the-us">https://www.statista.com/forecasts/987072/ownership-of-a-rocking-crib-amongst-parents-in-the-us</a>.
\77\ A Statista report from the same survey group in 2017 found
that 14 percent of parents bought a ``rocking crib'' second hand.
CPSC assumes that the secondary market is similar for bassinets. If
14 percent of bassinet or cradle owners are used, then 86 percent
are bought new.
\78\ Based on internet search in January 2023, seven of the top
20 best-selling play yards came with a bassinet attachment. Thus,
approximately 35 percent.
\79\ The Statista survey also found that 17 percent of parents
reported that their stroller had a ``removable carrycot'' feature
(``bassinet'' feature was not a survey item).
\80\ Based on a popular online general retail site in March
2023, fourteen of the top 20 best-selling beside sleepers came with
a bassinet mode. Thus, approximately 70 percent.
---------------------------------------------------------------------------

CPSC estimates the annual sales of used bassinets and products with
bassinet mode to be 500,000 units per year, rounded for the purpose of
analysis. Table 3 below displays the calculations, providing the
sources in footnotes, for CPSC's estimation of sales for new and used
bassinets and cradles.

Table 3--Estimated Sales for New and Used Bassinets/Cradles
--------------------------------------------------------------------------------------------------------------------------------------------------------
Families/ . . . and bought Percentage of
Number of caregivers who own it new or received these items that Estimated annual Estimated annual
Product \74\ newborns this item \75\ it new as a gift include a bassinet unit new sales in unit used sales in
(percent) \76\ \77\ (percent) scope of this rule scope of this rule
(a) (b) (c) (d) (e) = (f) =
(a) x (b) x (c) x (a) x (b) x (1-c)
(d) x (d)
Bassinet/cradle........................ 3,666,077 38 86 percent 100 1,198,074 195,035
Play yard.............................. 66 \78\ 35 728,303 118,561
Stroller............................... 96 \79\ 17 514,541 83,763
Bedside sleeper/bassinet............... 29 \80\ 70 640,024 104,190
----------------------------------------------------------------------------------------------------------------
Total.............................. ........... .................. .................. .................. 3,080,942 501,549
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 27269]]

Some families might have more than one newborn, some parents with a
newborn might have separate residences, and non-parent caregivers also
buy these items, so sales could be higher. However, because the
expected product life and warranty for these items is typically several
years, while the recommended use per infant is only five months,
parents may use the same bassinet for subsequent children or obtain a
used one through gift or purchase.
CPSC estimates the size of the used market for all bassinet
products, including products with bassinet attachments, at 501,549
units, rounded to 500,000 for the purposes of the cost analysis. CPSC
assumes that at least a majority of consumers in the secondary market
would choose to dispose of the used mattress and purchase a new after-
market mattress. For this analysis, CPSC conservatively assumes that 75
percent of parents purchasing a used bassinet will buy a new after-
market mattress. CPSC also assumes that roughly 10 percent of parents
who buy a bassinet or product with bassinet attachment new will also
purchase a new after-market mattress for use by a subsequent sibling,
or for the same infant due to heavy soiling. Therefore, CPSC estimates
the total annual market for after-market mattresses at 75 percent of
the used sales (75% x 501,549 = 376,162) plus 10 percent of new sales
(10% x 3,080,942 = 308,094), for a total of 684,256 units, rounded to
680,00 for the purpose of the cost analysis.
The availability of hundreds of after-market bassinet mattresses
online confirms that there is substantial demand for after-market
mattresses, as well as a substantial volume of sales. The top seller by
volume on Amazon currently sells more than 1,800 after-market bassinet
mattresses per month. The Commission requests comments from the public
on the estimated annual sales volume, including any information that
would validate a different estimate on the rate of after-market
mattress sales (number of units sold per year).
While other possible outlets for bassinet and after-market bassinet
mattress sales exist that are not included in this estimate
(specifically, sales to hotels, daycares, and hospitals), they are
likely to be minimal. Hotels generally provide a sleep space that can
accommodate larger children, typically cribs or play yards without a
bassinet. Similarly, daycare centers typically purchase cribs and play
yards rather than traditional bassinets; and major daycare and
hospitality child furniture suppliers do not sell bassinets or cradles,
although daycares may use consumer grade play yards with bassinet
attachments. Hospital ownership of bassinets is small, reported as only
55,085 units in 2019,\81\ and hospital bassinets are medical devices
regulated by the Food and Drug Administration (FDA), and thus out of
scope of this NPR.
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\81\ <a href="https://www.statista.com/statistics/824751/total-hospital-bassinet-numbers-in-the-us/">https://www.statista.com/statistics/824751/total-hospital-bassinet-numbers-in-the-us/</a>.
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Prices and Features: Prices for traditional bassinets range from
under $50 to more than $1,500, with most products in the $50 to $125
range. The least expensive products tend to be under 30 inches high and
come with legs rather than a stand or base. The more expensive products
tend to be larger and come with features that include canopies,
motorized sounds or vibrations, attached toy bars, and pouches or
shelves for storing diapers and bottles. Prices for cradles range from
$100 to more than $1,000, with most products in the $100 to $200 range.
Solid hardwood cradles are available for more than $1,000. Some
products advertised as ``rocking bassinets'' are physically identical
to cradles, with a curved rocker base. Combination bedside sleeper/
bassinets typically sell from $75 to more than $600, with most products
in the $125 to $200 range. Attachments to play yards are usually not
priced or sold separately. Some stroller bassinet attachments are sold
separately, with most such products in the $100 to $200 range. Play
yard and stroller bassinet attachments are designed to attach to a
specific model or set of models from one manufacturer, and/or to a
stand sold separately by that manufacturer. The stands typically sell
for $125 to $175.
The wide range of prices and features reflect that parents and
other caregivers buy bassinets for different purposes. Some people buy
a large bassinet with a non-folding stand as a primary sleep space for
the nursery, while others buy small portable items for travel, napping,
or occasional care by a non-parent. No one best-selling size, price
range, or set of features exists for bassinets. For example, the ten
best-selling bassinets on Amazon in February 2023 ranged in price from
$42 to $200 and included two small traditional bassinets that fold for
transport, five bassinet/bedside sleeper combination products, two
large cantilever bassinets, and an ``infant lounger'' with a rigid
frame. Prices and features on <a href="http://Walmart.com">Walmart.com</a> had a similar variety, with
prices of the ten best-selling bassinets ranging from $50 to $150. The
best-selling products there included small portable bassinets,
traditional bassinets on a stand that do not fold for transport, a
combination bassinet/play yard, and several combination bassinet/
bedside sleepers.
With approximately 3.1 million new bassinets sold per year,
including items with a bassinet mode, at an average price of
approximately $100 per unit, CPSC estimates the total U.S. bassinet
market is approximately $310 million in sales per year. This total does
not include the market for used items. Based on this IRFA's estimate of
approximately 500,000 used units per year (see previous section), and
an estimated used price of $40 based on observed prices of used
bassinets on Ebay and Mercari as a percentage of original retail
prices, the used market would represent approximately $20 million
dollars in sales per year.
Prices for after-market bassinet mattresses range from $20 to $180,
with most products in the $30 to $40 range, which is also the price
range for replacement mattresses from the original bassinet supplier.
The high end of the price range for after-market mattresses are hand-
crafted items with a specialty fill and/or cover, such as natural
rubber or organic fiber. Most after-market mattresses are sold online
by small importers and foreign direct shippers. Several hundred U.S.-
based crafters sell after-market mattresses that appear to have been
hand-cut from upholstery foam. With a typical price of $35 and annual
sales of 680,000 units per year, the after-market bassinet mattress
market is approximately $23.8 million per year.
Bassinet and Bassinet Mattress Suppliers: Many manufacturers and
importers, as well as foreign direct shippers, supply bassinets and
cradles. CPSC identified more than 120 suppliers in March of 2023,
including suppliers that sell play yards or strollers with bassinet
attachments. Most companies that supply bassinets also supply a variety
of other infant and children's products; bassinets are typically not
their only or main product line. JPMA currently has 22 member companies
that are certified for bassinet/cradles,\82\ including companies that
manufacture or import stroller bassinets and play yard bassinet
attachments, although one of the 22 does not appear to currently have
any products on the U.S. market.
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\82\ JPMA runs a certification program for members, which
includes third party testing to current ASTM and CPSC standards. See
<a href="https://www.jpma.org/page/certification">https://www.jpma.org/page/certification</a>.
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Bassinets and cradles are available from online general retail
sites, online baby product sites, and brick and mortar general retail
stores, including ``big box''

[[Page 27270]]

stores. Two brick and mortar specialty chain stores for infants and
children sell bassinets. Multiple online furniture stores associated
with religious communities sell traditional solid hardwood cradles made
in the U.S. A few woodworkers from foreign countries sell carved wooden
cradles on a prominent online site for hand-crafted items.
Hundreds of suppliers, including importers and U.S.-based hand
crafters, supply after-market bassinet mattresses. These products are
sold almost exclusively online, although a few are available to pick up
in local big box stores after ordering online. While replacement
mattresses from the original supplier are also sold primarily online, a
few are similarly available for pick up in a big box or children's
specialty store after ordering online.
Small Entities to Which the Proposed Rule Would Apply: Currently,
over 120 firms supply more than 250 models of bassinets to the U.S.
market. Large U.S. business and foreign businesses of all sizes
constitute the majority of the suppliers of the available models. Most
of the U.S.-based manufacturers and importers are small companies based
on Small Business Administration (SBA) size standards. Of the
identified 50 U.S-based suppliers to the U.S. market, 43 are small
importers or small manufacturers, five are large U.S. manufacturers,
and two are large U.S. importers. The rest of the market is foreign
direct shippers \83\ and foreign manufacturers. Eight foreign
manufacturers have U.S. distribution/warehouse operations that would
meet the SBA size standard for a small importer if considered
separately.\84\
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\83\ CPSC uses this term to refer to sellers who ship directly
to the consumer from an address in a foreign country.
\84\ The SBA regulations in 13 CFR 121.105 specify that a U.S.
small business for the purposes of SBA program eligibility is ``a
business entity organized for profit, with a place of business
located in the United States, and which operates primarily within
the United States or which makes a significant contribution to the
U.S. economy through payment of taxes or use of American products,
materials or labor.'' Consistent with this definition, CPSC
considered a company to be a U.S. manufacturer if they have a
headquarters and design products in the U.S., and market products
with their own brand name, although production may take place
overseas. Similarly, we considered a U.S. company affiliated with a
foreign company, such as a licensed distributor, to be a U.S.
importer if they ship from a U.S. address, because shipping from a
U.S. address would require ``use of American products, materials or
labor.''
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The total number of suppliers estimated here is approximate because
online third party sellers (primarily small importers and foreign
direct shippers) sell a wide variety of products, and can enter and
exit the market quickly. In addition, as noted, multiple online
furniture stores associated with religious communities sell wooden
bassinets and cradles manufactured in the U.S.; CPSC was unable to
estimate how many individual small manufacturers each of these
furniture distributors might represent. The SBA size standards for
small entities are based on the number of employees or the annual
revenue of the firm, and there is a specific size standard for each 6-
digit North American Industry Classification Series (NAICS)
category.\85\ The U.S. Census Bureau conducts an annual survey of small
businesses in the U.S. and counts how many large and small businesses
are in each NAICS category.\86\
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\85\ The North American Industry Classification System (NAICS)
is the standard used by Federal statistical agencies in classifying
business establishments for the purpose of collecting, analyzing,
and publishing statistical data related to the U.S. business
economy. For more information, see <a href="https://www.census.gov/naics/">https://www.census.gov/naics/</a>.
Some programs use 6-digit NAICS codes, which provide more specific
information than programs that use more general 3- or 4-digit NAICS
codes.
\86\ <a href="https://www.census.gov/programs-surveys/susb/data/tables.html">https://www.census.gov/programs-surveys/susb/data/tables.html</a>.
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A NAICS category specifically for bassinet manufacturing or
importing does not exist. Companies that manufacture bassinets may be
categorized as furniture, textile product, toy and game, or apparel
manufacturers. Importers are generally considered a type of merchant
wholesaler, as are furniture wholesale distributors. Other NAICS
categories may apply to companies that manufacture or import bassinets,
but for whom bassinets are not their main product line. As seen in the
table below of applicable NAICS categories, the SBA small entity
threshold for manufacturers is generally 500 to 1000 employees, while
it is generally 100 to 150 employees for importers and wholesalers.
Companies that manufacture or import bassinets would fit into the
NAICS categories shown in Table 4. As shown in Table 4, the majority of
the U.S. businesses in the applicable categories for manufacturing and
importing bassinets are small businesses, and there are thousands of
such small businesses.

Table 4--NAICS Categories for Manufacturers and Importers of Bassinets/Cradles
----------------------------------------------------------------------------------------------------------------
SBA size
standard Number of Number of Percentage of
NAICS series No. NAICS series description for small businesses small businesses that
business in series businesses are small (%)
(employees) in series
----------------------------------------------------------------------------------------------------------------
314999.................. All Other Miscellaneous 500 2,415 2,396 99
Textile Product Mills.
315240.................. Women's, Girls', and Infants' 750 888 888 100
Cut and Sew Apparel
Manufacturing.
337122.................. Non-upholstered Wood 750 1,992 1,982 99
Household Furniture
Manufacturing.
337124.................. Metal Household Furniture 750 258 252 98
Manufacturing.
337125.................. Household Furniture (except 750 151 151 100
Wood and Metal)
Manufacturing.
337910.................. Mattress Manufacturing....... 1,000 324 315 97
339930.................. Doll, Toy, and Game 500 507 503 99
Manufacturing.
423220.................. Home Furnishing Merchant 100 5,784 5,511 95
Wholesalers.
423920.................. Toy and Hobby Goods and 150 1904 1859 98
Supplies Merchant
Wholesalers.
424330.................. Women's, Children's, and 100 6,669 6,458 97
Infants' Clothing and
Accessories Merchant
Wholesalers.
---------------------------------------------------------------------------------------
Total............... ............................. ........... 20,892 20,315 97
----------------------------------------------------------------------------------------------------------------

The applicable NAICS category for after-market mattress
manufacturers is 337910 ``Mattress manufacturing,'' for which the SBA
size standard for a small business is 1,000 employees. For after-market
mattress importers, the applicable NAICS category is 423210 ``Furniture
Merchant Wholesalers,'' for which the SBA size standard for a small
business is 100 employees. In the 2019 Census data, 324 businesses
manufactured mattresses and 4,824 businesses were furniture merchant
wholesalers. More than 95 percent of

[[Page 27271]]

these suppliers were small businesses using the SBA size standards.
The proposed rule would not impose any requirements or direct
impacts on retailers of any size, unless they themselves manufacture or
import bassinets or after-market mattresses, because the rule would not
prevent the sale of products manufactured or imported before the
effective date. Indirect impacts could occur if the rule were to reduce
consumer demand for bassinets or after-market mattresses, but it is
unlikely that impact would be significant (more than one percent of
annual revenue) for any retailer.

C. Compliance, Reporting, Paperwork, and Recordkeeping Requirements of
the Proposed Rule

The proposed rule would require suppliers (manufacturers and
importers) of bassinets to meet performance, warning label, and user
instruction requirements, and to conduct third party testing to
demonstrate compliance. This section discusses the reporting and
paperwork requirements; compliance costs are analyzed in detail in
section VIII.E of this preamble.
Suppliers must demonstrate that they have met the performance
requirements of the rule by providing a children's product certificate.
As specified in 16 CFR part 1109, suppliers who are not the original
manufacturer, such as importers, may rely on the testing or
certification suppliers provide, as long as the requirements in part
1109 are met. Manufacturers and importers are required to furnish
certificates to retailers and distributors (section 14(g)(3) of the
CPSA); retailers are not required to third party test the children's
products that they sell unless they are also the manufacturer or
importer. Suppliers must also provide product registration cards. The
recordkeeping and compliance documentation does not require specialized
expertise, nor does it include new requirements. CPSC's public website
provides instructions and examples for how to develop the children's
product certificates and product registration cards.\87\
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\87\ See, for example: <a href="https://www.cpsc.gov/Testing-Certification/Childrens-Product-Certificate-CPC">https://www.cpsc.gov/Testing-Certification/Childrens-Product-Certificate-CPC</a> and <a href="https://www.cpsc.gov/Business--Manufacturing/Business-Education/Durable-Infant-or-Toddler-Products/FAQs-Durable-Infant-or-Toddler-Product-Consumer-Registration">https://www.cpsc.gov/Business--Manufacturing/Business-Education/Durable-Infant-or-Toddler-Products/FAQs-Durable-Infant-or-Toddler-Product-Consumer-Registration</a>.
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The proposed reporting and recordkeeping requirements are the same
as those in the current mandatory bassinet standard. The proposed rule
does not require additional packaging or instructions beyond what the
current standard requires. While the proposed rule revises the warning
label to match the current ASTM standard, with modifications, the cost
to implement the requirement should be the same as under the existing
part 1218 requirement. All children's products under OMB Control Number
3041-0159 require Certificates of Conformance. However, CPSC is seeking
a new OMB control number for bassinets/cradles and after-market
bassinet mattresses. When the Children's Product Testing and
Certification OMB Control Number 3041-0159 is next updated, the
Information Collection burden estimates for the products within the
scope of this rule will be updated to reflect current estimates of the
number of suppliers and to add the requirement for warning labels on
after-market bassinet mattresses. Registration cards are exempt from
PRA burden analysis under section 104(d)(1) of the CPSIA.

D. Federal and State Rules That May Overlap With This NPR

CPSC has not identified any other Federal rules that duplicate,
overlap, or conflict with the proposed rule. Some products marketed as
``bassinets'' may be within the scope of CPSC's mandatory standards for
infant sleep products, hand-held infant carriers, or non-full-size
cribs. The FDA regulates medical bassinets, so those products are not
within scope of this rule and thus there is no overlap with FDA
regulations. Combination products, such as bedside sleepers with a
bassinet mode, must meet the requirements of both standards. Also, the
rules for after-market bassinet mattresses and crib mattresses do not
overlap, as after-market bassinet mattresses are not within scope of
the Safety Standard for Crib Mattresses, codified at 16 CFR part 1241.
If finalized, the proposed rule will impact infant sleep product
suppliers that are compliant with the current ISP Rule but do not meet
the requirements of this NPR because the ISP Rule references part 1218.
Therefore, all infant sleep products within the scope of the ISP Rule
must comply with the updated bassinet performance requirements.

E. Potential Impact on Small Entities

Some products currently on the market would likely meet the
proposed requirements without physical modifications, particularly
larger traditional bassinets and cradles, many combination bedside
sleeper/bassinets, and mesh attachments to play yards that meet the
current standard. However, small bassinets, floor bassinets, in-bed
sleepers, Moses baskets, and stroller and play yard bassinets that are
shorter than 27 inches at the top side/rail, or do not have a sleep
surface 15 inches above the floor, would need to be modified to meet
the standard or taken off the market. Bassinets and cradles that are
not flat may not meet the new, more stringent requirement for resting
angle. Products with soft mattresses or other types of non-rigid floors
may not meet the new mattress firmness requirement. Products with soft
sides may not meet the new side rigidity requirement. Some multi-mode
products with adjustable heights have settings lower than 15 inches,
which will require modification to achieve compliance. After-market
mattresses that are thicker than the required maximum thickness, do not
meet the firmness requirements, or have a larger than allowable gap
between the mattress and the side of the intended product would require
modification. All after-market mattresses will require warning labels
and registration cards.
Based on staff's review of products currently on the market, the
majority of the bassinet products that appear to be too short to meet
the proposed height requirements are sold by foreign companies,
including foreign direct shippers. However, at least 19 small U.S.
manufacturers and nine small U.S. importers may be significantly
impacted by this proposed rule because they would have to modify or
discontinue some or all of their products. This represents slightly
more than half of the 43 small U.S. firms identified as bassinet
manufacturers or importers. CPSC considers a cost impact of greater
than or equal to one percent of annual revenue to be a ``significant''
economic impact, consistent with other Federal Government agencies.
1. Products That Would Require Modification, Cost of Modifying Product
Products on the market that would need to be redesigned to meet the
new standard, particularly the side/rail height requirement, include:
<bullet> Small rigid-framed conventional bassinets, sometimes
marketed as portable, travel, or compact bassinets, with a top side/
rail height of less than 27 inches, and short feet or legs.\88\
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\88\ Small bassinets under 27 inches high with short feet or
legs may be compliant with the current bassinet standard, and the
ISP standard, in part because they have feet or legs. But they will
not meet the requirements of this NPR if they are under 27 inches
high at the side/rail or have less than 15 inches of ``ground
clearance'' between the sleep surface and the floor.
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<bullet> Small soft-sided bassinets, sometimes marketed as in-bed
sleepers or compact bassinets, with a top rail

[[Page 27272]]

height of less than 27 inches, and short feet or legs.
<bullet> Bassinets of any size or type that do not meet the
requirements for sidewall structural integrity or mattress firmness.
<bullet> Rocking bassinets or cradles, cantilever products, and any
other bassinet that does not meet the new, more stringent requirement
for resting angle.
<bullet> Moses baskets sold without a stand.
<bullet> Travel and outdoor bassinets, sometimes marketed as ``play
pens,'' that are shorter than 27 inches high at the top side/rail and
have very short or no legs.
<bullet> Combination bedside sleeper/bassinets with adjustable
heights where at least some of the height settings have the sleep
surface less than 15 inches from the floor.
<bullet> Play yard and stroller attachments that are sold
separately, and are below 27 inches in height at the top side/rail and
have short or no legs.
<bullet> Play yard and stroller attachments sold with the play yard
or stroller that are below 27 inches in height, have short or no legs,
and can be used as a bassinet separately from the play yard or
stroller.
<bullet> After-market mattresses that are marketed for use with
unspecified brands/models of bassinet, cradle, or bassinet accessory,
because it would not be possible to verify that such mattress meets the
gap requirement.
<bullet> After-market mattresses that do not meet the thickness,
firmness, or gap requirements in the rule.
Bassinets and Cradles: Some manufacturers would need to redesign
their bassinet products, at a cost of approximately $80,000 per model
(calculation explained in the next paragraph) or remove the products
from the market. The cost of modifying the product to meet the standard
could be significant for small entities whose products do not meet the
performance requirements in the NPR.
Based on level of effort, CPSC estimates a one-time redesign at 400
hours of professional staff time per model, including in-house testing
of the prototypes.\89\ Using Bureau of Labor Statistics (BLS) Employer
Costs of Employee Compensation,\90\ the estimated cost per supplier for
labor, at a current cost for professional labor of $62.65 per hour, is
$25,060 (which can be rounded to $25,000 for the purpose of this cost
estimate). Given that many bassinets have metal or molded plastic
parts, new molds or metal templates may be required. These materials
costs for prototyping are estimated to be up to $10,000, with up to
$100,000 for new molds or templates for the eventual final design if
those are required. Therefore, CPSC estimates the total cost of
redesign is approximately $35,000 to $125,000 per model, with a
midpoint estimate of $80,000.
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\89\ This reflects an estimate of 10 weeks of professional
engineering, design, and testing staff time per model. While a
redesign of one product could take less effort, this estimate
reflects that an iterative process with multiple attempts to meet
the NPR requirements may be required. This estimate also reflects
time to design the molds or templates to scale up for commercial
production.
\90\ <a href="https://www.bls.gov/news.release/archives/ecec_03172023.pdf">https://www.bls.gov/news.release/archives/ecec_03172023.pdf</a>. These costs reflect the employers' cost for
salaries, wages, and benefits for civilian workers in December 2022.
---------------------------------------------------------------------------

In many cases, the redesign cost would not be significant. For
example, redesigning mesh sides or making a mattress firmer would not
require significant expenses or new templates or molds. Also, changing
a resting side angle tilt from 7 degrees to 1 degree may be a minor
redesign for models without motorized movements. Making a short rigid
bassinet that otherwise meets all the stability and structural
requirements a few inches taller may also not require a significant
redesign. Modifying a bedside sleeper/bassinet combination product to
remove the lowest height settings below 15 inches would not require a
significant redesign. Some companies may offer a wide selection of
fabric coverings and attachments such as canopies and toy bars on
structurally similar models where the cost of redesign per model could
be less for structurally similar models from the same supplier. In some
cases, the redesign of a stroller bassinet or Moses basket to achieve
compliance could involve requiring it to be sold only with the stroller
or stand, which might require redesigning the packaging. Many bassinet
designs are physically similar, so it is possible that smaller
manufacturers will be able to learn from innovative redesign solutions
by other manufacturers. Redesigning a mattress to be a compliant
thickness and shape to fit a specific bassinet product should not
require iterative prototyping or changes in production inputs. If a
thick mattress is redesigned in a way that uses less material, the cost
of production might be less in the long term. In most cases,
redesigning an after-market mattress will also require redesigning the
marketing and packaging to specify which bassinet product it fits with
the required maximum ``gap.''
Many manufacturers have outsourced production to Asia, but design
their products in North America, thus reflecting U.S. labor and
materials costs for prototype designs. Manufacturers with a range of
physically similar products may be able to reduce the design cost per
model. However, smaller manufacturers would be less likely to be able
to benefit from such economies of scale. For example, a large
manufacturer may have several dozen play yard models with bassinet
inserts or attachments, while a smaller manufacturer may have only one
or two such models. While importers would not directly pay for the cost
of redesign, the cost of redesign by others would almost certainly be
reflected in the wholesale price. Small importers are less likely than
large importers to have the market power to negotiate wholesale prices.
CPSC considers one percent of revenue to be a ``significant''
economic impact, consistent with other federal government agencies.
Eighty thousand dollars would be one percent of revenue for a firm with
$8 million in revenue, which would represent sales of about 80,000
units at a retail price of $100. Given that there are more than 250
models in this market, with annual sales for the whole industry
estimated at 3.1 million units per year, the average number of sales
per model is estimated at less than 12,500 units. Thus, the cost could
be significant for small U.S. firms with limited sales volume whose
products are not compliant with the new requirements. However, no small
firms appear to have bassinets as their only product, so the cost of
bassinet redesign could be less significant when the revenues from
other products are considered. CPSC estimates that 19 small U.S.
manufacturers and nine U.S. importers supplying about 70 different
models may need to redesign some or all of their products or remove
them from the market. CPSC also estimates that the cost could be
significant for some of those small firms, depending on their revenue
from other products and on how much redesign is required.
With an estimated 70 bassinet models from 28 small U.S. businesses
that need to be redesigned, at $80,000 per model, the total cost for
all small U.S. entities is estimated at about $5.6 million for redesign
only in the first year after that the proposed rule would be published.
While cosmetic redesigns each year are typical in this industry, the
structural redesigns required by this proposed rule would not have
occurred in the status quo. Therefore, they should properly be
considered a cost of the rule, and not routine costs. The ongoing cost
of compliance after the first year that the final rule is in effect is
expected to be minimal for materials and labor, as the redesigned
products would likely use the same types of materials and production
methods as current products. There may be additional,

[[Page 27273]]

indirect costs as a result of this proposed rule, such as redesigning
packaging to accommodate different physical designs, or increased
shipping costs for larger products. As noted earlier, there may be
additional costs for suppliers of infant sleep products that are
compliant with the current ISP rule but will require modification to
comply with the final rule that will follow this NPR. CPSC analysis
indicates that there will likely not be a substantial number of
impacted small ISP suppliers, as many short, small products in scope of
the ISP regulation (that are not bassinets) have been recalled or
voluntarily removed from the market since the ISP rule was published.
In addition to these estimates of the cost to small businesses, the
estimated total cost to the bassinet industry for compliance with the
proposed rule in the first year is approximately $10.25 million. This
estimate is based on $80,000 in redesign costs per model, times 125
models (about half the existing models), which is $10 million, plus
another $1000 per model for testing, times 250 models, which is
$250,000. This amount is the incremental cost for bassinets/cradles to
comply with the proposed rule, above the cost of complying with the
current rule. Therefore, this estimate does not include packaging,
shipping, labeling, or marketing costs, because those would be costs
suppliers would already be incurring to comply with the existing part
1218.
After-Market Bassinet Mattresses: The majority of after-market
bassinet mattress on the market appear to be not compliant with this
rule because the mattress is thicker than specified in this NPR, and/or
the mattress is not marketed to be used with a specific product for
which the fit has been verified. No after-market mattresses currently
on the market have the required warning label. There are hundreds of
suppliers, many of which appear to be small U.S.-based importers and
handcrafters. The cost of modifying an after-market mattress design is
expected to take 200 hours of time at an estimated hourly rate of
$62.65 according to BLS Employer Costs of Compensation for professional
labor, which equates to approximately $12,500 per model. For crafters,
the redesign may be as simple as purchasing different filling and
cutting to the appropriate size, and adding a warning label, in which
case the cost of redesign could be less than $12,500. If a thick
mattress is redesigned in a way that uses less material, the cost of
production might decrease in the long term.
For after-market mattresses suppliers, $12,500 would be one percent
of revenue for a firm with $1.25 million in revenue, which would
represent sales of about 41,667 units. Given that there are hundreds of
models in this market, with annual sales for the whole industry
estimated at 680,000 units per year, the average number of sales per
model is far less than 41,667 units. Thus, the cost for a one-time
redesign could be significant for small U.S. manufacturing firms,
particularly hand crafters, with limited sales of after-market
mattresses. However, if crafters can make their product compliant by
simply using thinner foam, their cost of redesign might be less than
$12,500. Small mattress manufacturers would likely not have bassinet
mattresses as their only product, so the cost of redesign could be less
than one percent of their total revenue from all products combined. For
importers, foreign manufacturers will likely spread the redesign cost
across a large number of units so that the impact on importers is not
significant. In addition, most importers do not have bassinet
mattresses as their only product.
For after-market mattress suppliers, the cost to U.S.-based
importers could be minimal, if their foreign suppliers spread the cost
of redesign across many units. For example, if a foreign manufacturer
redesigns a model at a cost of $12,500, and sells 10,000 units to U.S.
importers, the cost per model of the redesign is $1.25. It would not be
a significant cost for the importer if their supplier raises the price
by just over one dollar on an item that retails for $35. It is also
likely that importer would be able to raise the retail price by $1.25
without reducing demand for the product. Similarly, if crafters can
source a thinner foam material easily, their cost of redesign may be
minimal. As noted earlier, the cost of a warning label is expected to
be less than $1 per unit. Assuming that 50 small manufacturers have to
redesign their product at a cost of $12,500, the total cost to U.S.
small manufacturers for redesign would be about $625,000 in the first
year that the rule is effective. This cost may not be significant for
some small manufacturers, particularly if they manufacture and/or
import other products, which is common, and therefore they can cover at
least some of the cost of redesign with revenue from other products.
In addition to these estimates of the cost to small businesses, the
estimated total cost to the after-market bassinet mattress industry for
compliance with the proposed rule in the first year is approximately
$4.05 million, comprised of $12,500 per model in redesign costs, times
300 models (nearly all the existing models), which is $3.75 million,
plus another $1000 per model for testing, times 300 models, which is
$300,000. This amount is the total cost for after-market to comply with
the proposed rule, above the cost of complying with any other
applicable CPSC regulations such as those for lead and phthalate
content.
2. Products That May Be Removed From the Market, Cost of Discontinuing
Products
The cost estimate in the previous sections assumes that all non-
compliant products supplied by small U.S. entities would be redesigned.
A similarly significant impact could occur for small firms if products
are instead removed from the market, causing small companies to lose
sales revenue from those products. For in-bed sleepers, the performance
requirements are intended to discourage use on an elevated or soft
surface, and it is likely that all in-bed sleepers would be removed
from the market rather than redesigned. Two small U.S. manufacturers
and two U.S. importers (included in the count above of 28 impacted U.S.
small businesses) currently sell such products that are less than 27
inches tall, as well as more than a dozen foreign direct shippers.
Stroller bassinets could be redesigned to meet the requirements of
the standard, because some soft-sided stroller bassinets already
collapse/fold so they cannot be used off the stroller as a bassinet.
Some are already sold only with the stroller, so that the stroller
itself provides the compliant side/rail height, or so they could be re-
packaged to be sold only with the stroller. However, some non-compliant
rigid stroller bassinets may be removed from the market rather than
redesigned to be 27 inches tall, sold only with the stroller, or
designed to collapse/fold when not on the stroller. Three small U.S.
manufacturers and five small importers currently sell such products, as
well as more than a dozen foreign direct shippers and foreign companies
with U.S. distributors.
Outdoor bassinets or ``play pens'' that are too short to meet the
play yard mandatory standard and have short legs or no legs could be
redesigned to meet the requirements of either this standard or the play
yard standard. However, they may be removed from the market instead, as
redesigning them to meet either standard would involve making them 10
to 16 inches taller. Two small U.S. manufacturers currently sell such
product, as well as multiple large and foreign companies.

[[Page 27274]]

Compliant after-market mattresses will serve the same consumer need
as non-compliant mattresses. Therefore, it is unlikely that they will
be removed from the market rather than redesigned, except for a few
handcrafter firms for which the redesign cost could be significant.
Even a very small manufacturer with limited sales may be able to raise
the retail price to partially cover the one-time cost of redesign.
However, after-market mattresses suppliers will no longer be able to
market their products for use with a generic bassinet because of the
gap requirement (which requires a close fit between the bassinet and
mattress). The demand for mattresses of a specific bassinet product may
be lower than the demand for mattresses for generic/universal fit,
therefore the rule could contribute to an overall decrease in demand
for after-market mattresses and result in some firms exiting the
market.
3. Third Party Testing Costs
This NPR would require manufacturers and importers of bassinets to
comply with its performance requirements and demonstrate that
compliance through third party testing. As specified in 16 CFR part
1109, entities that are not manufacturers of children's products, such
as importers, may rely on the certificate of compliance provided by
others. Manufacturers and importers of after-market bassinet mattresses
would also be required to demonstrate compliance through third party
testing.
While this proposed rule would require all manufacturers and
importers of bassinets to arrange and pay for third party testing, this
should not be a new cost for any supplier because they are already
required to conduct third party testing on their products to comply
with the current version of the CPSC mandatory safety standard as
specified in part 1218. In addition, 22 of the suppliers are members of
the JPMA certification testing program, which provides discounted third
party testing to CPSC and ASTM standards. JPMA currently has 22 member
companies that are certified specifically for bassinet/cradles,
including companies that manufacture or import stroller bassinets and
play yard bassinet attachments. JPMA's program requires annual testing,
as well as more frequent testing when the product design has been
updated or the underlying standard has been revised.
Third party testing will be a new requirement for suppliers of
after-market mattresses. Based on testing costs for other consumer
products, testing could be $500 to $1000 per model, for the relatively
simple tests to confirm thickness and fit. Given that mattresses may
already require testing for compliance with other CPSC requirements for
lead and phthalates content, the incremental cost of testing to this
rule may be less as part of a bundled testing price.
The NPR would require new tests for sidewall integrity, mattress
firmness, side-to-side tilt, and sleep surface incline for bassinets,
and would require the use of new equipment during testing, including a
metal plate to measure side tilt and a tool to test mattress firmness.
The NPR proposes an effective date 180 days after publication of the
final rule, giving suppliers limited time to test to the new standard.
Annual testing costs for bassinets may rise by $100 to $200 per model,
to pay for one to two hours of additional laboratory personnel time to
test and document the testing results per model. Given the 180-day
proposed effective date of the rule, it is possible that companies
would be able to replace their annual testing for the current standard
with the testing required for this standard without having to conduct
an extra testing cycle.

F. Efforts To Minimize Impact, Alternatives Considered

The RFA specifies that the IRFA should describe alternatives to the
proposed rule which accomplish the rule's objective but minimize the
economic impact to small entities. Exempting small entities from this
rule or parts of this rule would not be consistent with the applicable
statutes, because this is a safety rule for durable infant or toddler
products. 15 U.S.C. 2063(d)(4)(C). The statute allows CPSC to provide
``small batch'' exemptions to testing requirements or alternative
requirements for small providers of certain products, but not durable
infant or toddler products. The proposed rule does not have design
requirements, so CPSC has already provided performance requirements
rather than a design standard. CPSC considered several alternatives to
this rule to minimize the impact on small entities, including:
<bullet> Not revising the mandatory standard;
<bullet> Incorporating the ASTM 2022[egr]\1\ standard by reference
without modifications; and
<bullet> A later effective date.
Not revising the mandatory standard: Part 1218 currently
incorporates the 2013 version of the ASTM standard by reference, with
some additional requirements. Section 104(b)(2) of the CPSIA requires
CPSC to ``periodically review and revise the standards set forth under
this subsection to ensure that such standards provide the highest level
of safety for such products that is feasible.'' Given CPSC's statutory
mandate, and continuing incidents associated with bassinets/cradles as
described in section III of this preamble, the Commission has decided
to prioritize the safety of infant sleep products ensuring that infant
sleep products provide a firm, flat, sleep surface and that caregivers
are discouraged from using bassinets/cradles on unsafe elevated and
soft surfaces.
The current bassinet standard only specifies that a product must
have legs, a base, or a stand, without specifying any specific height
for the bassinet, which has led to a proliferation of ``compact'' or
``floor'' bassinets that can foreseeably be misused on elevated and
soft surfaces. In addition, this means some in-bed sleepers and
``travel beds'' with very short legs and soft sides may be compliant
with the current bassinet standard and the ISP rule. If CPSC does not
revise the mandatory bassinet standard, suppliers could offer in-bed
sleepers with one inch tall ``feet'' and meet the standard with a
product shorter than 10 inches at the top rail. In addition, the
current regulation does not include after-market bassinet mattresses in
scope, nor are those products included in the scope of the crib
mattress regulation. Therefore, if CPSC did not revise the mandatory
standard, suppliers could continue to offer thick, soft after-market
mattresses marketed to fit an unspecified (generic) bassinet or cradle,
with an unknown gap between the mattress and the sidewall.
While not revising the mandatory standard would have no impact on
U.S. small businesses, it would not address the known hazards. Most of
the small bassinets and in-bed sleepers currently on the market are not
supplied by small U.S. businesses, but rather by foreign businesses and
particularly foreign direct shippers, so the impact of this rule on
small U.S. businesses is limited.
Incorporating the ASTM 2022[egr]1 standard by reference without
modifications, or waiting for ASTM to make additional modifications:
The Commission considered incorporating the ASTM 2022[egr]\1\ standard
by reference, and unanimously voted against doing so. The Commission
reached this decision after considering staff's analysis that the
requirements for ``compact bassinets'' in the 2022 version of the
standard are less stringent and less safe than the current standard.
Since the Commission's decision, ASTM has continued to meet to consider
additional revisions to the standard to address the Commission's

[[Page 27275]]

concerns. However, to date, ASTM has not issued a ballot to revise the
voluntary standard. CPSC is unsure whether such a ballot would include
revisions consistent with this NPR. Based on this uncertainty, the
Commission is choosing to move forward with rulemaking. While waiting
for ASTM would delay the impact on small businesses, it would not
necessarily reduce the impact, depending on the stringency of ASTM's
revisions.
A later effective date: The recommended effective date for the
final rule is 180 days after publication in the Federal Register. This
is consistent with other CPSIA section 104 rules, and with JPMA's
certification program, which generally allows manufacturers 180 days to
comply with a newly published standard. A longer effective date period
of one year after publication would reduce the burden on entities of
all sizes by allowing more time to redesign and test products. Several
hundred products from more than 100 companies would need to test to
this standard, and there are currently 41 test labs accredited to the
current bassinet standard. In addition, test labs will need to become
accredited to the new standard before any product can be tested to this
standard. Smaller companies are less likely to have the resources to
quickly redesign products than larger ones, and some of the small U.S.
companies that have products in scope of this proposed rule have
multiple products that do not appear to meet the new performance
requirements. However, given that many products already meet the
proposed requirements, many labs are already accepted to test the
existing bassinet standard and after-market mattresses, and providing a
longer effective date would allow the hazards of current bassinets/
cradles to continue for a longer period of time, the Commission
proposes a 180-day effective date for the final rule.

G. Impact on Testing Labs

In accordance with section 14 of the CPSA, all children's products
that are subject to a children's product safety rule must be tested for
compliance by a third-party conformity assessment body that has been
accredited by CPSC. Testing laboratories that conduct this testing must
meet the Notice of Requirements (NOR) for third party conformity
testing. CPSC has codified NORs in 16 CFR part 1112.
If finalized, the rule should not have an adverse impact on testing
laboratories. CPSC is not proposing to amend part 1112 because
bassinets/cradles are already part of that rule. Also, third party labs
will not require new testing equipment for the modifications described
in the NPR, other than a mattress firmness testing device and a metal
plate to measure resting side tilt. The instrument for measuring
mattress firmness is the same one specified in the regulation for crib
mattresses. No laboratory is required to provide testing services. The
only laboratories that would be expected to provide such services are
laboratories that anticipate receiving sufficient revenue from the
mandated testing to justify procuring the testing equipment and
obtaining accreditation. However, CPSC expects that most of the
existing 41 labs accredited to test bassinets would request updated
accreditation because they are already accredited and have met the NOR
for the current standard. Also, most laboratories are not small U.S.
businesses; more than 30 of those labs are in Asia or Europe.

IX. Environmental Consideration

The Commission's regulations address whether the agency is required
to prepare an environmental assessment or an environmental impact
statement. Under these regulations, certain categories of CPSC actions
normally have ``little or no potential for affecting the human
environment,'' and therefore do not require an environmental assessment
or an environmental impact statement. Safety standards providing
performance and labeling requirements for consumer products come under
this categorical exclusion. 16 CFR 1021.5(c)(1). The NPR falls within
the categorical exclusion.

X. Paperwork Reduction Act

This proposed rule for bassinets and cradles 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. 3501-3521). In this document, pursuant
to 44 U.S.C. 3507(a)(1)(D), we set forth a:
<bullet> Title for the collection of information;
<bullet> Summary of the collection of information;
<bullet> Brief description of the need for the information and the
proposed use of the information;
<bullet> Description of the likely respondents and proposed
frequency of response to the collection of information;
<bullet> Estimate of the burden that shall result from the
collection of information; and
<bullet> Notice that comments may be submitted to the OMB.
Title: Safety Standard for Bassinets and Cradles
Description: As described in section V.C of this preamble, the
proposed rule would update the existing labeling and instruction
requirements for bassinets and cradles, which has an OMB control number
(3041-0159). This NPR would also add after-market bassinet mattresses
to the scope of the rule and require new labeling. CPSC will seek a new
OMB control number for this update and then move the revised estimate
into control number 3041-0159 in the next PRA update for Children's
Products. The NPR proposes that bassinets and cradles meet the
requirements of ASTM F2194--22\e1\, Standard Consumer Safety
Specification for Bassinets and Cradles, with the proposed additional
requirements and modifications summarized in section V of this
preamble. Sections 8 and 9 of ASTM F2194--22\e1\ contain requirements
for marking, labeling, and instructional literature. These requirements
fall within the definition of ``collection of information,'' as defined
in 44 U.S.C. 3502(3).
Description of Respondents: Persons who manufacture or import
bassinets, cradles, and after-market mattresses for bassinets/cradles.
Over 120 firms supply more than 250 models of bassinets to the U.S.
market. Based on an evaluation of suppliers, most of the U.S.-based
manufacturers and importers are small companies, using SBA size
standards. In addition, hundreds of firms supply after-market bassinet
mattresses to the U.S. market, including many small importers and hand-
crafters in the U.S., as well as foreign direct shippers.
Estimated Burden: The estimated burden of this collection of
information is as follows:

[[Page 27276]]

Table 5--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Frequency of Total annual Hours per Total burden
Burden type respondents responses responses response hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Labeling and instructions.......................................... 220 2 440 2 880
--------------------------------------------------------------------------------------------------------------------------------------------------------

This estimate is based on the following: CPSC estimates there are
220 suppliers that would respond to this collection annually, and that
the majority of these entities would be considered small businesses.
CPSC assumes that on average each firm that reports annually would
respond twice, as product models for bassinets and cradles are brought
to market and new labeling and instruction materials are created, for a
total of 440 responses annually (220 respondents x 2 responses per
year). CPSC assumes that on average it will take one hour for each
respondent to create the required label and one hour for them to create
the required instructions, for an average response burden of two hours
per response. Therefore, the total burden hours for the collection is
estimated to be 880 hours annually (440 responses x 2 hours per
response = 880 total burden hours).
CPSC uses $37.87 \91\ from BLS as the hourly compensation for the
time required to create and update labeling and instructions.
Therefore, the estimated annual cost of the burden requirements is
$33,326 ($37.87 per hour x 880 hours = $33,325.60). No operating,
maintenance, or capital costs are associated with the collection. Based
on this analysis, the proposed revisions to the standard would impose a
burden to industry of 880 hours at a cost of $33,326 annually.
---------------------------------------------------------------------------

\91\ U.S. Bureau of Labor Statistics, ``Employer Costs for
Employee Compensation,'' September 2023, Table 4, total compensation
for all sales and office workers in goods-producing private
industries: <a href="https://www.bls.gov/news.release/archives/ecec_12152023.pdf">https://www.bls.gov/news.release/archives/ecec_12152023.pdf</a>.
---------------------------------------------------------------------------

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 the OMB for review. Interested persons are requested to
submit comments regarding information collection by June 17, 2024, to
the Office of Information and Regulatory Affairs, OMB (see the
ADDRESSES section at the beginning of this proposed rule).
Pursuant to 44 U.S.C. 3506(c)(2)(A), we invite comments on:
[ssquf] Whether the collection of information is necessary for the
proper performance of the CPSC's functions, including whether the
information will have practical utility;
[ssquf] 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;
[ssquf] Ways to enhance the quality, utility, and clarity of the
information to be collected;
[ssquf] Ways to reduce the burden of the collection of information
on respondents, including the use of automated collection techniques,
when appropriate, and other forms of information technology; and
[ssquf] The estimated burden hours associated with label
modification, including any alternative estimates.

XI. Preemption

Section 26(a) of the CPSA, 15 U.S.C. 2075(a), states that when a
consumer product safety standard is in effect and applies to a product,
no state or political subdivision of a state may either establish or
continue in effect a standard or regulation that prescribes
requirements for the performance, composition, contents, design,
finish, construction, packaging, or labeling of such product dealing
with the same risk of injury unless the state requirement is identical
to the Federal standard. Section 104(b) of the CPSIA refers to the
rules to be issued as ``consumer product safety rules.'' Therefore, the
preemption provision of section 26(a) of the CPSA would apply to a
revised rule for bassinets and cradles.

XII. Certification and Notice of Requirements

Section 14(a) of the 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, must be certified as complying with all applicable
CPSC-enforced requirements. 15 U.S.C. 2063(a). Section 14(a)(2) of the
CPSA requires that certification of children's products subject to a
children's product safety rule be based on testing conducted by a CPSC-
accepted third party conformity assessment body. Section 14(a)(3) of
the CPSA requires the Commission to publish an NOR for the
accreditation of third-party conformity assessment bodies (or
laboratories) to assess conformity with a children's product safety
rule to which a children's product is subject. The Commission already
issued an NOR for bassinets/cradles in 2013 when the existing rule was
promulgated.
Test laboratories applying for acceptance as a CPSC-accepted third
party conformity assessment body to test to the revised standard for
bassinets/cradles would be required to meet the third-party conformity
assessment body accreditation requirements in part 1112. Testing
laboratories should not be adversely impacted as a result of this rule.
Approximately 41 third party testing laboratories are CPSC-accepted to
test compliance with part 1218. Staff expects that these labs will
become accredited and CPSC-accepted to test to a revised bassinet
standard in the normal course of business. No new testing equipment is
required for the modifications described in the NPR, other than a
mattress firmness testing device, and a metal plate to measure resting
side tilt. The instrument for measuring mattress firmness is the same
as specified in the regulation for crib mattresses; 11 of 12
laboratories that are CPSC-accepted to conduct crib mattress testing
are also accredited to test requirements for bassinets/cradles. CPSC
expects that these laboratories will be able to test to a new rule in a
short time period. Furthermore, no laboratory is required to provide
testing services. The only laboratories that are expected to provide
such services are those that anticipate receiving sufficient revenue
from the mandated testing to justify procuring the testing equipment
and obtaining accreditation.

XIII. Request for Comments

[[Page 27277]]

This proposed rule is part of a rulemaking proceeding under section
104(b)(2) of the CPSIA to revise the consumer product safety standard
for bassinets and cradles to ensure that this standard provides the
highest level of safety that is feasible. The Commission requests
comments on the proposal to incorporate by reference ASTM F2194-
22[egr]\1\, with the modifications discussed in sections IV and V of
this preamble. The Commission also requests comments on the proposed
effective date, and any aspect of this proposal. During the comment
period, ASTM F2194-22[egr]\1\ is available as a read-only document at:
<a href="http://www.astm.org/cpsc.htm">http://www.astm.org/cpsc.htm</a>. Comments should be submitted in
accordance with the instructions in the ADDRESSES section at the
beginning of this document.
Specifically, CPSC requests comment on the following topics:

A. Proposed Side Height Requirements

1. Is the proposed requirement for a minimum 27-inch external side/
rail height feasible? Please provide any rationale, data, tests, and/or
scientific studies to support your comment.
2. Will the 27-inch proposed external side/rail height requirement
address the hazard of using the bassinet on an elevated surface such as
a bed or sofa? Is there a different height that can better address the
same hazard?
3. Does the 27-inch proposed external side/rail height requirement
cause a reduced utility, such as reduced portability, and would this
impact safety in a negative manner?
4. Will the 27-inch proposed external side/rail height requirement
impact bedside sleepers that are designed to fit lower to the ground
adult beds?
5. Should an exemption to the 27-inch proposed external side/rail
height requirement be included for bedside sleepers because they are
designed to be used next to the adult bed and not on top of the adult
bed?
6. Are there studies, surveys or anecdotal consumer feedback that
show the 16-inch external side/rail height set by ASTM F2194-22
[egr]\1\ will discourage use on elevated surfaces including an adult
bed?
7. Are there other potential requirements, such as leg designs, to
address the hazard of using the bassinet on an elevated surface?
8. Should a defined ``stand'' be required to discourage use on an
elevated surface?

B. Proposed Requirements For a Minimum 15-Inch Occupant Sleep Surface
Height

1. Will the proposed minimum 15-inch occupant sleep surface height
requirement address the hazard of using the bassinet on an elevated
surface such as a bed or sofa? If not, is there a more adequate
occupant sleep surface height and why?
2. Are there any other performance requirements needed for
bassinets that have a 27-inch external side/rail height and 15-inch
occupant sleep surface height?

C. Proposed Side Wall Rigidity Requirements

1. Are the proposed side wall rigidity requirements adequate to
address the risks of suffocation and falls from products?
2. Are there any other performance requirements CPSC should
consider to address the risks of suffocation and falls?

D. Proposed Mattress Firmness Requirements

1. Are the proposed mattress firmness requirements adequate to
address the risk of suffocation?
2. Are there any other performance requirements CPSC should
consider to address the risk of suffocation?

E. Firmness Requirements for Soft Sided Bassinets

1. Should CPSC propose side firmness requirements to address
infants rolling their face into the side of a bassinet?
2. If side firmness testing is necessary, what test method would
adequately evaluate side firmness?

F. Proposed Tilt and Incline Limitation Requirements

1. Is a 0-degree limitation on the side-to-side tilt of a bassinet,
with a maximum tilt angle limit not to exceed one degree (a tolerance
limit) for each direction independently (0 <plus-minus> 1[deg])
feasible? If not, what angle/tolerance is feasible, please provide
data.
2. Is the maximum 10-degree head to toe angle limitation adequate
to address chin to chest incidents and any other hazard patterns?
3. The proposed test method would require that the side-to-side
tilt test be conducted on all sides of the bassinet, if the unit is
circular, square, or has no obvious lateral sides. Would it improve
safety to require that bassinets wide enough to allow an infant to
sleep sideways be tested for side-to-side tilt in each position that a
baby could be placed? If so, what would be the appropriate width for
such a consideration?

G. Inclusion of After-Market Bassinet/Cradle Mattresses Within the
Scope of the NPR

1. Is the proposed warning label for after-market bassinet
mattresses appropriate?
2. Is the estimated annual sales volume in the IRFA (section VIII
of this preamble) accurate? If not, please provide any information that
would validate a different estimate on the rate of after-market
mattress sales (number of units sold per year).

H. Proposed Warning Label Requirements for Bassinets/Cradles

1. Are the proposed warnings adequate to address the hazards
associated with bassinets/cradles and after-market bassinet mattresses?
Should CPSC consider additional warnings?
2. Section 8.6.2.6 of ASTM F2194-22[egr]1 requires a
specific statement warning consumers not to carry infants in bassinets/
cradles constructed of cardboard; should all bassinets have this
statement except those that meet 16 CFR part 1225, Safety Standard for
Hand-Held Infant Carriers?

I. Initial Regulatory Flexibility Analysis and Other Topics

1. Significant impact. Is CPSC's estimated cost of redesign to
achieve compliance accurate? If not, please provide additional
information and support for your proposed correction. Also, do the
estimated costs represent more than one percent of annual revenue for
individual small U.S. manufacturers and importers?
2. Testing costs. Will third party testing costs for bassinets
increase as a result of the requirements in this NPR, and if so, by how
much?
3. Testing costs. Is CPSC's estimated third party testing costs for
after-market mattresses accurate? If not, please provide supporting
data, and the extent to which this cost will impact small businesses.
4. Effective date of 6 months. How much time is required to come
into compliance with a final rule (including product compliance and
third party testing)? Please provide supporting data with your comment,
particularly from small businesses.
5. Alternatives to reduce the impact on small businesses. Are there
any alternatives to the rule that could reduce the impact on small
businesses without reducing safety? Please provide supporting data with
your comment, particularly addressing small businesses.

[[Page 27278]]

J. Feasibility

1. Are the proposed requirements in this NPR feasible, both
technically and economically?
2. What would be the total cost to industry of implementing this
rule? Please be specific about labor and/or materials costs to redesign
products, and costs of third party testing.
3. Will complying with this rule increase the costs of production
or the retail price of bassinets? Why? By how much?
4. Will complying with this rule permanently increase the costs of
production or the retail price of after-market bassinet mattresses?
Why? By how much?

List of Subjects in 16 CFR Part 1218

Consumer protection, Imports, Incorporation by reference, Infants
and children, Labeling, Law enforcement, Toys.
For the reasons discussed in the preamble, the Commission proposes
to amend title 16 of the Code of Federal Regulations as follows:

PART 1218--SAFETY STANDARD FOR BASSINETS AND CRADLES

0
1. Revise the authority citation for part 1218 to read as follows:

Authority: 15 U.S.C. 2056a.
0
2. Revise Sec. 1218.2 to read as follows:

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
F2194-22[egr]\1\, Standard Consumer Safety Specification for Bassinets
and Cradles (approved on July 15, 2022). 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. This material is available for
inspection at the U.S. Consumer Product Safety Commission and at the
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