Rule2023-17350
Ban of Inclined Sleepers for Infants
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 16, 2023
Effective
September 15, 2023
Issuing agencies
Consumer Product Safety Commission
Abstract
The Consumer Product Safety Commission is issuing this final rule to codify in its regulations the ban of inclined sleepers for infants pursuant to the Safe Sleep for Babies Act of 2021, which requires that inclined sleepers for infants, regardless of the date of manufacture, shall be considered a banned hazardous product under the Consumer Product Safety Act.
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 157 (Wednesday, August 16, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 157 (Wednesday, August 16, 2023)]
[Rules and Regulations]
[Pages 55554-55559]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-17350]
=======================================================================
-----------------------------------------------------------------------
CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1310
[CPSC Docket No. 2022-0025]
Ban of Inclined Sleepers for Infants
AGENCY: Consumer Product Safety Commission.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Consumer Product Safety Commission is issuing this final
rule to codify in its regulations the ban of inclined sleepers for
infants pursuant to the Safe Sleep for Babies Act of 2021, which
requires that inclined sleepers for infants, regardless of the date of
manufacture, shall be considered a banned hazardous product under the
Consumer Product Safety Act.
DATES: This rule is effective on September 15, 2023.
FOR FURTHER INFORMATION CONTACT: Will Cusey, Small Business Ombudsman,
U.S. Consumer Product Safety Commission, 4330 East West Highway,
Bethesda, MD 20814; telephone (301) 504-7945 or (888) 531-9070; email:
<a href="/cdn-cgi/l/email-protection#17647578577467647439707861"><span class="__cf_email__" data-cfemail="a3d0c1cce3c0d3d0c08dc4ccd5">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Pursuant to section 2 of the Safe Sleep for
Babies Act of 2021 (SSBA), 15 U.S.C. 2057d, the Consumer Product Safety
Commission (Commission or CPSC) is issuing this final rule to reflect,
in the Code of Federal Regulations, the statutory ban of inclined
sleepers for infants that took effect by operation of law on November
12, 2022.
I. Background and Statutory Authority
On May 3, 2022, Congress passed the Safe Sleep for Babies Act of
2021, H.R. 3182, Public Law 117-126, which the President signed on May
16, 2022. Section 2(a) of the SSBA requires that, not later than 180
days after enactment of that law, ``inclined sleepers for infants,
regardless of the date of manufacture, shall be considered a banned
hazardous product under section 8 of the Consumer Product Safety Act
(15 U.S.C. 2057).'' 15 U.S.C. 2057d(a). The SSBA defines inclined
sleepers for infants as ``product[s] with an inclined sleep surface
greater than ten degrees that [are] intended, marketed, or designed to
provide sleeping accommodations for an infant up to 1 year old.'' 15
U.S.C. 2057d(b). The SSBA went into effect as a ban enforced by the
Commission on November 12, 2022, which was the 180th day after its
enactment, making it unlawful for any person to sell, offer for sale,
manufacture for sale, distribute in
[[Page 55555]]
commerce, or import inclined sleepers for infants as of that date. See
15 U.S.C. 2068(a)(1).
On July 26, 2022, CPSC published a notice of proposed rulemaking
(NPR) stating the Commission's intention to codify in its regulations
the language in the SSBA requiring that inclined sleepers for infants
be considered a banned hazardous product under section 8 of the
Consumer Product Safety Act (CPSA). 87 FR 44309. CPSC requested and
received comments from the public on the proposed rule. Specifically,
CPSC requested comments regarding the effective date, interpretation of
the SSBA language, and whether testing and certification to the ban
should be required for sleep products for infants up to 1 year old.
CPSC received a total of 67 comments from medical professionals,
academic researchers, safety advocates, a children's products design
facility, and a trade association for children's products. Those
comments are summarized below in Section III.
II. Overview of the Final Rule Banning Inclined Sleepers for Infants
The Commission issues this final rule \1\ to codify the ban of
inclined sleepers for infants pursuant to the SSBA as proposed, with a
clarification in the purpose and scope section of the ban to make clear
that the rule prohibits not only the sale of inclined sleepers for
infants but also the offer for sale, manufacture for sale, distribution
in commerce, or importation into the United States, of these products.
The final rule codifies the definition of ``inclined sleeper for
infants'' as a product with an inclined sleep surface greater than ten
degrees that is intended, marketed, or designed to provide sleeping
accommodations for an infant up to 1 year old. The final rule also
affirms that, regardless of the date of manufacture, inclined sleepers
for infants are banned hazardous products as of November 12, 2022. The
final rule is further discussed in the Staff Briefing Package: Ban of
Inclined Sleepers for Infants Under the Safe Sleep for Babies Act.\2\
---------------------------------------------------------------------------
\1\ The Commission voted 4-0 to publish this final rule. Chair
Hoehn-Saric and Commissioners Feldman and Trumka issued statements
in connection with their votes.
\2\ Staff Briefing Package: Ban of Inclined Sleepers for Infants
Under the Safe Sleep for Babies Act, available at <a href="https://www.cpsc.gov/s3fs-public/Draft-Final-Rule-Ban-of-Inclined-Sleepers-for-Infants.pdf?VersionId=t7I_9B_J3r1aXJ2Epbm0PabWOWg2k2T7">https://www.cpsc.gov/s3fs-public/Draft-Final-Rule-Ban-of-Inclined-Sleepers-for-Infants.pdf?VersionId=t7I_9B_J3r1aXJ2Epbm0PabWOWg2k2T7</a>.
_____________________________________-
III. Response to Comments
Of the 67 comments received by CPSC in response to the NPR, 55 were
from medical professionals including doctors, pediatricians, nurses,
academic researchers, and infant safety advocates who provided
substantially similar comments expressing general support for the
proposed rule. The comments are viewable online at <a href="http://www.regulations.gov">www.regulations.gov</a>
under docket number CPSC-2022-0025.\3\
---------------------------------------------------------------------------
\3\ The Commission also received comments beyond the scope of
this final rule. Those comments are summarized in the Staff Briefing
Package and available at <a href="http://www.regulations.gov">www.regulations.gov</a>. Many of the commenters
provided context for the SSBA, sharing data on the extent of Sudden
Infant Death Syndrome (SIDS) in the U.S. over various time periods.
The American Academy of Pediatrics (AAP), for example, provided data
that shows SIDS deaths since 2000 in the U.S. have not declined,
despite extensive outreach and education campaigns on safe sleep
practices for babies. Several commenters referred to an AAP report
on SIDS/SUID (Sudden Unexpected Infant Death) that estimated 3,500
infant deaths per year. March of Dimes noted that ``Rates of preterm
birth are increasing . . . [with] disparities in birth outcomes
between women and infants of color and their White peers. An
estimated 700 women [die] from complications related to pregnancy
each year and more than 22,000 babies die before their first
birthday each year.''
---------------------------------------------------------------------------
A. Effective Date
Comment A.1: The majority of commenters supported setting an
effective date as soon as possible, but not later than the statutory
effective date of November 12, 2022. No commenters advocated for a
later date.
Response A.1: The SSBA's statutory ban of inclined sleepers for
infants went into effect on November 12, 2022, and CPSC has been
enforcing it since that time. Accordingly, the final rule will have an
effective date 30 days after publication, which is the minimum period
provided in the Administrative Procedure Act (APA). 5 U.S.C. 553(d).
This effective date for the rule does not change the fact that inclined
sleepers for infants have been banned pursuant to the SSBA as of
November 12, 2022.
B. Interpretation
Congress enacted the SSBA after the Commission had implemented its
Safety Standard for Infant Sleep Products (ISP Rule; 16 CFR part 1236).
The ISP Rule became effective on June 23, 2022, and applies to products
``marketed or intended to provide a sleeping accommodation for an
infant up to 5 months of age'' that are not subject to another CPSC
sleep standard.\4\ The ISP Rule requires that the seat back or sleep
surface angle for these products be 10 degrees or less from horizontal
when measured as specified in part 1236. 86 FR 33022, 33060-61 (June
23, 2021). The SSBA, by its terms, applies to ``inclined sleepers for
infants,'' defined as ``a product with an inclined sleep surface
greater than ten degrees that is intended, marketed, or designed to
provide sleeping accommodations for an infant up to 1 year old.'' 15
U.S.C. 2057d(b). Because the SSBA and the ISP Rule overlap but are not
identical, the Commission sought comment on the following questions in
particular:
---------------------------------------------------------------------------
\4\ The other sleep standards currently are 16 CFR part 1218
(bassinets and cradles); 16 CFR part 1219 (full-size cribs); 16 CFR
part 1220 (non-full-size cribs); 16 CFR part 1221 (play yards); and
16 CFR part 1222 (bedside sleepers).
---------------------------------------------------------------------------
1. How should the Commission interpret and implement the phrase
``sleeping accommodations'' for purposes of the SSBA ban?
Comment B.1: Several commenters (children's product design facility
Iron Mountains, the Juvenile Products Manufacturers Association (JPMA),
and consumer advocacy groups Kids in Danger (KID) and Consumer
Federation of America (CFA)) stated that CPSC should use the ISP Rule's
definition of ``sleeping accommodations'' to interpret the same
language in the SSBA.
Commenters including KID, AAP, U.S. Public Interest Research Group
(PIRG), Consumer Reports, CFA, March of Dimes, and Public Citizen,
stated that ``sleeping accommodations'' should apply to products
marketed for any kind of sleep, including napping or resting. KID
stated that words such as ``rest'' or ``nap,'' or statements such as
``not for overnight, unattended or extended sleep,'' should not exclude
a product from being considered a sleep product. PIRG suggested that
while many infants can and do fall asleep anywhere, regardless of
comfort, noise level or darkness, CPSC should define ``sleeping
accommodations'' as products in which parents or caregivers believe an
infant can sleep and stay unattended because of the way the product is
designed, intended, or marketed. Consumer Reports stated that the term
should apply broadly to include products remarketed as soothers or
loungers.
The March of Dimes stated that CPSC should consider ``sleeping
accommodations'' to be any product that is designed, intended,
marketed, or commonly used by consumers for the purpose of putting a
child to sleep, particularly if the sleep is unattended by an adult.
KID stated that the definition should include not just self-
contained products, but also inclined sleep positioners, accessory
products, and wedges that are used in the sleep environment.
Response B.1: The SSBA does not define ``sleeping accommodations.''
In the preamble to the ISP Rule, the Commission explained that sleeping
accommodations are ``products that are
[[Page 55556]]
marketed or intended for both extended, unattended sleep, and also
napping, snoozing, and other types of sleep in which a parent may or
may not be present, awake, and attentive.'' 86 FR 33047. The Commission
agrees with commenters that ``sleeping accommodations'' should refer to
products in which infants are placed for the purpose of napping or
overnight sleep regardless of whether the sleep is ``attended or
supervised,'' and that utilizing the same interpretation of sleeping
accommodations in these overlapping rules will reduce confusion for the
public and industry. Therefore, the Commission interprets the phrase
``sleeping accommodations'' in the SSBA consistent with the term as
used in the ISP Rule. See 86 FR 33025-26.
2. What, if any, effect should inclusion of the term ``designed'' in
the SSBA have on the Commission's interpretation and implementation of
the SSBA as compared to the ISP Rule?
Comment B.2: Comments from pediatricians and other medical
professionals, as well as from AAP, stated that CPSC should be alert to
changes to product marketing or categorization that could be cited as
justification for the continued sale of dangerous products.
Multiple commenters, including KID, March of Dimes, CFA, Consumer
Reports, and AAP, stated that by including the term ``designed'' in the
statutory text, Congress sought to comprehensively ban all inclined
sleep products and prohibit rebranding or reclassification of products
to evade regulatory attention. These commenters stated that use of the
word ``designed'' signals Congress's intent to ban products that
caregivers would reasonably see as suitable for sleep, regardless of
how they are marketed.
One doctor (Hauck) advocated removing inclined products from the
market, regardless of whether they are marketed for sleeping or awake
infants, stating that ``manufacturers will attempt to market these
items for infants who are not shown to be sleeping . . . [but] infants
placed in these products will fall asleep and then be at risk for dying
in them.'' The AAP stated although caregivers may believe inclined
sleep products aid with gastroesophageal reflux, research shows that
placing infants on their backs on inclined surfaces is ineffective in
reducing gastroesophageal reflux and may result in the infant sliding
into a position that could compromise breathing.
PIRG and Public Citizen asserted that the addition of the word
``designed'' will allow CPSC to review the design as well as the
marketing of inclined sleep products. These commenters stated that
focusing on the manufacturer's stated intent or consumer-facing
marketing would enable manufacturers to argue that a product is not
meant for sleep, when common sense dictates otherwise based on the
design. These commenters urged the Commission to consider a product's
design, in addition to the company's stated intention or marketing.
Several commenters stated that if the product is not designed for any
other purpose, then a logical conclusion is that the product is
designed for sleep.
A children's product design facility (Iron Mountains) stated that
caregivers need products that restrain supervised, awake infants so
that they can complete daily tasks and that swings, rockers, and
bouncers are intended for such situations, and are the only alternative
to the sofa or other unsafe surfaces. JPMA asserted that ``infant
rockers, swings, and bouncers are not designed to provide children with
a place to sleep'' and that any decision to include in the scope of the
ban products that are not designed for sleep would misinterpret
Congressional intent. JPMA further stated that if Congress had intended
to include rockers, swings, and bouncers in the SSBA, it would have
explicitly done so.
Response B.2: The Commission agrees that to give effect to the word
``designed'' within the definition of ``inclined sleeper for infants''
in the SSBA, the Commission should interpret that word as supplementing
the accompanying words ``intended'' and ``marketed.'' In the ISP Rule,
the Commission identified characteristics to be considered in
evaluating whether a product is intended for sleep, including product
packaging, marketing materials, instructions, product design, and
pictures of consumer usage. See, e.g., 86 FR 33048, <a href="https://www.cpsc.gov/Business--Manufacturing/Business-Education/Business-Guidance/Infant-Sleep-Products-Business-Guidance-and-Small-Entity-Compliance-Guide">https://www.cpsc.gov/Business--Manufacturing/Business-Education/Business-Guidance/Infant-Sleep-Products-Business-Guidance-and-Small-Entity-Compliance-Guide</a>. To assess product design, the Commission will
consider a number of factors, including those set forth in Response B.3
below.
In the absence of otherwise conclusive evidence regarding design,
previous marketing for sleep, while not dispositive, will be persuasive
evidence that an inclined product was designed to provide sleeping
accommodations. Similarly, if an inclined product's design is
materially the same as another product that is an inclined sleeper for
infants, that would be persuasive, though not dispositive, evidence
that the product is designed to provide sleeping accommodations.
Products that are designed to provide sleeping accommodations but also
for one or more other purpose(s) likewise are covered by the language
of the statutory ban, despite having the other, non-sleep use(s).
3. In the SSBA, what product characteristics, if any, demonstrate that
a product is ``designed'' for sleep?
Comment B.3: Commenters from consumer safety advocacy groups, such
as AAP, KID, PIRG, Consumer Reports, Public Citizen, and CFA, suggested
product features they consider indicative of a product ``designed'' for
sleep, including: padded sides; excess padding or pillow-like items;
soothing sounds, lights, or vibrations; a nest-like appearance; muted
color schemes, nighttime themes; illustrations of sleeping animals or
closed eyes; warning labels that fail to warn against infant sleep
generally and warn only against specific types of sleep, such as
``prolonged,'' ``unattended,'' or ``overnight'' sleep; and no features
for another primary purpose, such as feeding or transportation of the
child. The March of Dimes identified the following factors that it
views as indicators a product is designed for sleep: a focus on
comforting an infant to a point it could easily fall asleep in the
product; nothing designed to stimulate an infant or prevent a child
from sleeping; an absence of non-sleep related purposes, such as
feeding or transportation; emphasis on the ability to leave a child
unattended, where it may fall asleep.
Several commenters, including AAP, PIRG, Consumer Reports, and CFA,
also stated that a product is designed for sleep if the purpose is to
position an infant at an angle with the intent of leaving the infant in
the product unattended during routine sleep, or if the product is
intended to relax an infant in a way that it is reasonably expected the
infant will fall asleep and be left unattended. PIRG gave examples of
products with other primary purposes that involve supervised use,
including high chairs, which are designed for feeding; car seats, which
are designed for travel in a motor vehicle; and strollers, which are
designed to contain a child being pushed on a walk.
JPMA stated that a ``product designed for sleep would be
constructed with features that are specifically intended to accommodate
an unattended sleeping infant.'' Iron Mountains stated that sleep
products generally have ``flat, horizontal occupant surfaces with no
contour, shaping, or restraint'' and are generally
[[Page 55557]]
larger than ``awake time'' products. Iron Mountains further stated that
a product is designed, intended, and marketed for sleep if it is
visually very similar to a play yard, bassinet, crib, or bedside
sleeper, and features include some of or all of the following: vertical
side-walls, high side-walls indicating containment, typically a
distinct angle between the occupant surface and the side walls,
generally large size, flat and horizontal sleep surface with little or
no contouring, and lack of a restraint.
Response B.3: The Commission agrees with commenters' identification
of characteristics that could be relevant to distinguishing whether
products are designed for infant sleep for purposes of the SSBA,
including, but not limited to: padded sides; excess padding or pillow-
like items; soothing sounds, motions, lights, or vibrations; nighttime
themes; and labels that warn only against specific types of sleep and
not sleep generally.
4. How should the Commission interpret and implement the terms
``marketed'' and ``intended'' as a sleeping accommodation in the SSBA?
Should these terms be interpreted and implemented the same as in the
ISP Rule? Why or why not?
Comment B.4: JPMA, AAP, PIRG, Consumer Reports, CFA, and KID stated
that the terms ``marketed'' and ``intended'' should be interpreted and
implemented under the SSBA consistent with how they are discussed in
the preamble to the ISP Rule. AAP added that evaluation of marketing
and intent should include assessment of marketing and promotional
materials, audience targeting (including algorithms), the firm's public
and private communications about a product, and the firm's foreseeable
awareness about a product (including images, consumer comments, and
discussion on social media and product review pages regarding the use
of the product for routine sleep). KID added that while the terms
``marketed'' and ``intended'' overlap, together they ``paint a line
between infant products that have other purposes such as play,
interaction, transport or feeding and those products [for which] . . .
sleep is clearly an intended purpose.''
Response B.4: In the preamble of the ISP Rule, the Commission
stated that ``if a product's packaging, marketing materials, inserts,
or instructions indicate that the product is for sleep, or includes
pictures of sleeping infants, then CPSC will consider the product to be
marketed for sleep.'' 86 FR 33063. The Commission also stated that
staff will consider a ``[m]anufacturer's intent, which can be evaluated
through stated warning messages, marketing photos, product instructions
and other factors.'' Id. at 33051. Consistent with the comments
received in response to the NPR for this final rule, and to promote
ease of administration and clarity for regulated parties, the
Commission adopts for administration of the SSBA and this final rule
the same interpretation of ``marketed'' and ``intended'' as exists for
the ISP Rule. Therefore, for example, if a manufacturer or importer
markets a product as a space for infant sleep, the product will fall
within the scope of the SSBA and this final rule and must meet the
requirement to have a sleep surface angle of not greater than ten
degrees.
5. What is the significance of the age distinction between the ISP Rule
and the SSBA's ban? How might this difference bear on implementation of
the SSBA as compared to the ISP Rule, including with respect to
developmental differences between a newborn to 5 month old as
identified in the ISP Rule, versus a newborn to 1 year old as
identified in the SSBA?
Comment B.5: JPMA stated that while most sleep products within the
scope of the SSBA already fall within the scope of the ISP Rule because
they are marketed for children 5 months or younger, the broader age
range in the SSBA could prevent ``bad actors'' from re-marketing such
products for infants 6 months to a year in an attempt to evade the ISP
Rule.
AAP and Consumer Reports commented that important differences exist
in the hazards for younger versus older infants, because there are
significant developmental differences between infants who are newborn
to 5 months old and those between 5 months and 1 year of age. AAP
identified the following differences between older and younger infants:
<bullet> Older infants have greater arm strength and the ability to
roll and change body positions, including from supine to prone;
<bullet> Older infants have increased head and neck muscle
strength;
<bullet> Older infants generally have the ability to lift and hold
up their heads;
<bullet> Older infants have more mature brain development, which
enables regulation of autonomic nervous functions, including breathing;
<bullet> Older infants in the 9-to-12-month range tend to face more
danger from strangulation from straps, restraints, and other loose
hazards on sleep products; and
<bullet> Younger infants are at greater risk of positional asphyxia
and the other biomechanical hazards.
Public Citizen recommended that the Commission address the
differences in hazard patterns by age group and make sure products for
children up to 1 year of age are included in the scope of the final
rule. KID stated that the risk to infants over 5 months is important
and noted they had recommended expanding the age range in response to
the NPR for the ISP Rule. KID emphasized that the SSBA will prevent new
inclined sleep products marketed for 6 months and older from entering
the marketplace, deter remarketing of existing products, and provide
CPSC with the authority to remove all inclined sleepers marketed for
children up to 1 year from the marketplace.
CFA stated that the SSBA, by including infants up to 1 year,
broadens CPSC's authority to include inclined sleep products for
infants over 5 months. CFA also noted that the expanded age range
prevents suppliers from remarketing infant products to an older age
group to evade the ISP Rule, when those products are not suitable for
an older child.
Response B.5: As commenters note, AAP's safe sleep guidance states
that infants less than 1 year old should sleep on a firm, flat,
surface, such as a crib, bassinet, play yard, or bedside sleeper.\5\
Consistent with that guidance, the SSBA and this final rule prohibit
inclined sleeping accommodations with an incline of greater than 10
degrees for all children from birth up to 1 year of age.
---------------------------------------------------------------------------
\5\ ``Place infants on their backs for sleep in their own sleep
space with no other people. Use a crib, bassinet, or portable play
yard with a firm, flat mattress and a fitted sheet. Avoid sleep on a
couch or armchair or in a seating device, like a swing or car safety
seat (except while riding in the car).'' <a href="http://www.aap.org/en/patient-care/safe-sleep/">www.aap.org/en/patient-care/safe-sleep/</a>.
---------------------------------------------------------------------------
6. How, if at all, should the SSBA's ban of inclined sleepers for
infants affect the ISP Rule or the Commission's application of it?
Comment B.6: Commenters largely expressed support for the continued
implementation and enforcement of the ISP Rule, without change. AAP and
Consumer Reports stated that the SSBA should build upon the successful
foundation of the ISP Rule to offer clarity on the importance of
banning all inclined infant sleep products, such as by including more
extensive examination of products to ensure that if a product is not
intended for another purpose (such as travel or eating) and can be used
for routine sleep, it does not have an incline greater than 10 degrees.
[[Page 55558]]
Response B.6: Although the ISP Rule and the SSBA differ somewhat,
commenters did not identify any conflict between them. Therefore, the
Commission finds no reason to propose changes to the ISP Rule.
7. To the extent inclined sleepers remain on the market that are not
banned by this rule, and that are not regulated under the ISP Rule,
should CPSC require testing and certification to this ban, to
demonstrate that a product is not within the scope of the ban?
Comment B.7: Commenters differed as to whether testing and
certification under the SSBA are needed and what such testing would
achieve. JPMA opposed testing and certification to demonstrate that
inclined sleep products are not banned products pursuant to the SSBA.
JPMA further stated that a product with an incline of less than 10
degrees would not meet the definition of an ``inclined sleeper for
infants'' in the SSBA.
Consumer groups supported SSBA testing and certification. AAP
stated that CPSC should use its authority to require testing and
certification to ensure that noncompliant products are not sold. KID
and Consumer Reports supported testing and certification to demonstrate
which products are out of scope of the ban and thus allowed for sale,
stating that testing and certification could demonstrate that an
inclined sleep product either for older children or with an incline
under 10 degrees is not within the scope of the ban. Consumer Reports
stated that testing and certification would help to eliminate potential
loopholes and avoid muddling the longstanding ``bare is best''
messaging for safe infant sleep. CFA also supported testing, urging the
CPSC to use all of its authority, including enforcement, testing, and
certification, to protect infant sleep environments.
Response B.7: The NPR noted that when a ban does not remove all
products in a product category from the market, CPSC may require
testing and certification to demonstrate that a product is not within
the scope of the ban. Few bans completely remove all products in a
specific category from the market, instead removing a subset of
products with hazardous characteristics, while allowing sale of other
products in the category subject to regulation. The Commission has
previously stated that manufacturers of products in a category where a
subset of the products are subject to a ban must issue certificates. 28
FR 28079, 28082 (May 13, 2013). Moreover, section 14(a)(1) of the CPSA
requires that products subject to a rule, ban, standard, or regulation,
be tested and certified as compliant. 15 U.S.C. 2063(a)(1).
Congress did not prohibit all inclined sleepers for infants in the
SSBA--only those intended, marketed, or designed for infants from birth
to 1 year that have an incline greater than ten degrees. Therefore,
products may remain in the marketplace that could be subject to
regulation. Though the Commission is not implementing a testing and
certification program at this time, it may consider testing,
certification, and registration requirements in the future, based on
additional information collected by the agency.
IV. Changes Included in the Final Rule
The final rule contains three changes from the NPR: the effective
date and two minor technical or clarifying revisions.
A. Effective Date
The 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
NPR proposed an effective date of November 12, 2022, which was the date
that the SSBA took effect. Because that date has passed, and because
commenters supported CPSC implementing the rule expeditiously, the
Commission is finalizing this rule with a 30-day effective date, the
minimum permitted under the APA, and has revised 16 CFR 1310.4
accordingly. Section 1310.4 was further revised to clarify that the ban
of inclined sleepers for infants was effective as of November 12, 2022,
pursuant to the SSBA, but that the final rule is effective as of
September 15, 2023. The promulgation of this final rule does not change
the fact that inclined sleepers have been banned pursuant to the SSBA
since November 12, 2022.
B. Technical and Clarifying Revisions
For the final rule, the Commission has updated the language
proposed in the NPR by replacing the public law citation for the SSBA
(Pub. L. 117-126) with the newer U.S. Code citation (15 U.S.C. 2057d).
The Commission also revised proposed 16 CFR 1310.1, Purpose and
scope, to more fully describe the substantive effect of Congress's
classification of inclined sleepers for infants as banned hazardous
products. Section 1310.1 of the final rule makes clear that the rule
prohibits not only the sale of inclined sleepers for infants but also,
in accordance with section 19(a)(1) of the CPSA, the offer for sale,
manufacture for sale, distribution in commerce, or importation into the
United States, of these products. 15 U.S.C. 2068(a)(1).
V. Preemption
Section 3(b)(2)(A) of Executive Order 12988, Civil Justice Reform
(Feb. 5, 1996), directs agencies to specify the preemptive effect of
any rule. 61 FR 4729 (Feb. 7, 1996). Because the SSBA states that
inclined sleepers for infants are banned hazardous products, any state
performance standards allowing the sale of inclined sleepers for
infants, as those products are defined in the SSBA and this rule, would
be inconsistent with Federal law and therefore preempted by this ban.
VI. Regulatory Flexibility Act
The Regulatory Flexibility Act, 5 U.S.C. 601-612, requires that
agencies review proposed and final rules for their potential economic
impact on small entities, including small businesses, and identify
alternatives that may reduce such impact, unless the agency certifies
that the rule will not, if promulgated, have a significant economic
impact on a substantial number of small entities. In the NPR, the
Commission certified that the rule will not have a significant economic
impact on substantial number of small entities and received no comment
on that issue. 87 FR 44309.
VII. Environmental Considerations
The Commission's regulations at 16 CFR part 1021 address whether
the agency must prepare an environmental assessment or an environmental
impact statement. Under those regulations, certain categories of CPSC
actions that have ``little or no potential for affecting the human
environment'' do not require an environmental assessment or an
environmental impact statement. 16 CFR 1021.5(c). This final rule
codifying section 2 of the SSBA falls within the categorical exclusion,
so no environmental assessment or environmental impact statement is
required.
VIII. Paperwork Reduction Act
This final rule contains no 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
(PRA; 44 U.S.C. 3501-3521).
IX. Congressional Review Act
The Congressional Review Act (CRA; 5 U.S.C. 801-808) states that,
before a rule can take effect, the agency issuing the rule must submit
the rule and certain related information to each House of Congress and
the Comptroller
[[Page 55559]]
General, 5 U.S.C. 801(a)(1), and indicate whether the rule is a ``major
rule'' as defined in 5 U.S.C. 804(2). The CRA further states that the
Office of Information and Regulatory Affairs (OIRA) determines whether
a rule qualifies as a ``major rule.'' OIRA has determined that this
rule is not a ``major rule'' under the CRA. To comply with the CRA, the
Commission will submit the required information to each House of
Congress and the Comptroller General.
List of Subjects in 16 CFR Part 1310
Administrative practice and procedure, Consumer protection, Infants
and children.
0
For the reasons stated in the preamble, the Commission adds part 1310
to title 16 of the Code of Federal Regulations as follows:
PART 1310--BAN OF INCLINED SLEEPERS FOR INFANTS
Sec.
1310.1 Purpose and Scope.
1310.2 Definition.
1310.3 Banned Hazardous Product.
1310.4 Effective Date.
Authority: 15 U.S.C. 2057d.
Sec. 1310.1 Purpose and Scope.
The purpose of this rule is to prohibit the sale, offer for sale,
manufacture for sale, distribution in commerce, or importation into the
United States, of any inclined sleepers for infants, as defined in part
1310.2 and as set forth in the Safe Sleep for Babies Act of 2021 (15.
U.S.C. 2057d).
Sec. 1310.2 Definition.
Inclined sleeper for infants means a product with an inclined sleep
surface greater than ten degrees that is intended, marketed, or
designed to provide sleeping accommodations for an infant up to 1 year
old.
Sec. 1310.3 Banned Hazardous Product.
Any inclined sleeper for infants, as defined in section 1310.2,
regardless of the date of manufacture, is a banned hazardous product
under section 8 of the Consumer Product Safety Act (15 U.S.C. 2057).
Sec. 1310.4 Effective Date.
By statute, the effective date of this ban is November 12, 2022.
The effective date of this rule is September 15, 2023.
Alberta E. Mills,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2023-17350 Filed 8-15-23; 8:45 am]
BILLING CODE 6355-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on August 16, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.