[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 [www.gpo.gov]
[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: 
[email protected].

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 https://www.cpsc.gov/s3fs-public/Draft-Final-Rule-Ban-of-Inclined-Sleepers-for-Infants.pdf?VersionId=t7I_9B_J3r1aXJ2Epbm0PabWOWg2k2T7.
_____________________________________-

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 www.regulations.gov 
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 www.regulations.gov. 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, https://www.cpsc.gov/Business--Manufacturing/Business-Education/Business-Guidance/Infant-Sleep-Products-Business-Guidance-and-Small-Entity-Compliance-Guide. 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:
     Older infants have greater arm strength and the ability to 
roll and change body positions, including from supine to prone;
     Older infants have increased head and neck muscle 
strength;
     Older infants generally have the ability to lift and hold 
up their heads;
     Older infants have more mature brain development, which 
enables regulation of autonomic nervous functions, including breathing;
     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
     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).'' www.aap.org/en/patient-care/safe-sleep/.
---------------------------------------------------------------------------

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