Ban of Inclined Sleepers for Infants, 55554-55559 [2023-17350]
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Federal Register / Vol. 88, No. 157 / Wednesday, August 16, 2023 / Rules and Regulations
described in Subtitle VII, Part A,
Subpart I, Section 40103. Under that
section, the FAA is charged with
prescribing regulations to assign the use
of the airspace necessary to ensure the
safety of aircraft and the efficient use of
airspace. This regulation is within the
scope of that authority as it modifies
Class E airspace to supports the safety
and management of IFR operations at
Alliance Municipal Airport.
History
The FAA published a notice of
proposed rulemaking for Docket No.
FAA–2023–0583 in the Federal Register
(88 FR 22385, April 13, 2023),
proposing to modify Class E airspace at
Alliance Municipal Airport, Alliance,
NE. Interested parties were invited to
participate in this rulemaking effort by
submitting written comments on the
proposal to the FAA. No comments
were received.
Incorporation by Reference
Class E5 airspace area is published in
paragraph 6005 of FAA Order JO
7400.11, Airspace Designations and
Reporting Points, which is incorporated
by reference in 14 CFR 71.1 on an
annual basis. This document amends
the current version of that order, FAA
Order JO 7400.11G, dated August 19,
2022 and effective September 15, 2022.
FAA Order JO 7400.11G is publicly
available as listed in the ADDRESSES
section of this document. These
amendments will be published in the
next update to FAA Order JO 7400.11.
FAA Order JO 7400.11G lists Class A,
B, C, D, and E airspace areas, air traffic
service routes, and reporting points.
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The Rule
This action amends 14 CFR part 71 by
modifying Class E airspace beginning at
700 feet above the surface at Alliance
Municipal Airport, NE. Class E airspace
beginning at 700 feet above the surface
is expanded to a 7.6-mile radius to fully
contain arriving IFR aircraft operating
below 1,500 feet above the surface.
Regulatory Notices and Analyses
The FAA has determined that this
regulation only involves an established
body of technical regulations for which
frequent and routine amendments are
necessary to keep them operationally
current. It, therefore: (1) is not a
‘‘significant regulatory action’’ under
Executive Order 12866; (2) is not a
‘‘significant rule’’ under DOT
Regulatory Policies and Procedures (44
FR 11034; February 26, 1979); and (3)
does not warrant preparation of a
regulatory evaluation as the anticipated
impact is so minimal. Since this is a
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routine matter that only affects air traffic
procedures and air navigation, it is
certified that this rule, when
promulgated, does not have a significant
economic impact on a substantial
number of small entities under the
criteria of the Regulatory Flexibility Act.
CONSUMER PRODUCT SAFETY
COMMISSION
Environmental Review
AGENCY:
The FAA has determined that this
action qualifies for categorical exclusion
under the National Environmental
Policy Act in accordance with FAA
Order 1050.1F, ‘‘Environmental
Impacts: Policies and Procedures,’’
paragraph 5–6.5.a. This airspace action
is not expected to cause any potentially
significant environmental impacts, and
no extraordinary circumstances exist
that warrant preparation of an
environmental assessment.
Lists of Subjects in 14 CFR Part 71
Airspace, Incorporation by reference,
Navigation (air).
The Amendment
In consideration of the foregoing, the
Federal Aviation Administration
amends 14 CFR part 71 as follows:
PART 71—DESIGNATION OF CLASS A,
B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND
REPORTING POINTS
1. The authority citation for 14 CFR
part 71 continues to read as follows:
■
Authority: 49 U.S.C. 106(f), 106(g), 40103,
40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR,
1959–1963 Comp., p. 389.
§ 71.1
[Amended]
Paragraph 6005 Class E Airspace Areas
Extending Upward From 700 Feet or More
Above.
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ACE NE E5 Alliance, NE [Amended]
Alliance Municipal Airport, NE
(Lat. 42°03′12″ N, long. 102°48′14″ W)
That airspace extending upward from 700
feet above the surface within a 7.6-mile
radius of the airport.
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Issued in Des Moines, Washington, on
August 3, 2023.
B.G. Chew,
Group Manager, Operations Support Group,
Western Service Center.
[FR Doc. 2023–17511 Filed 8–15–23; 8:45 am]
BILLING CODE 4910–13–P
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[CPSC Docket No. 2022–0025]
Ban of Inclined Sleepers for Infants
Consumer Product Safety
Commission.
ACTION: Final rule.
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:
sbo@cpsc.gov.
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.
SUMMARY:
I. Background and Statutory Authority
2. The incorporation by reference in
14 CFR 71.1 of FAA Order JO 7400.11G,
Airspace Designations and Reporting
Points, dated August 19, 2022, and
effective September 15, 2022, is
amended as follows:
■
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16 CFR Part 1310
Sfmt 4700
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
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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
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III. Response to Comments
Of the 67 comments received by CPSC
in response to the NPR, 55 were from
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/DraftFinal-Rule-Ban-of-Inclined-Sleepers-forInfants.pdf?VersionId=t7I_9B_J3r1aXJ2Epbm0Pab
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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
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
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.’’
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).
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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:
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
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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
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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/BusinessEducation/Business-Guidance/InfantSleep-Products-Business-Guidance-andSmall-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
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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
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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 pillowlike 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,
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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
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• 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.
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.
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/.
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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
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16:04 Aug 15, 2023
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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
PO 00000
Frm 00008
Fmt 4700
Sfmt 4700
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
E:\FR\FM\16AUR1.SGM
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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.
For the reasons stated in the preamble,
the Commission adds part 1310 to title
16 of the Code of Federal Regulations as
follows:
§ 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).
§ 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]
Sec.
1310.1
1310.2
1310.3
1310.4
New Animal Drugs; Approval of New
Animal Drug Applications; Withdrawal
of Approval of New Animal Drug
Applications, Change of Sponsor,
Change of Sponsor Address
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).
§ 1310.2
Food and Drug Administration
[Docket No. FDA–2023–N–0002]
Authority: 15 U.S.C. 2057d.
§ 1310.1
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
21 CFR Parts 500, 510, 516, 520, 522,
524, 526, 529, 556 and 558
Purpose and Scope.
Definition.
Banned Hazardous Product.
Effective Date.
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.
AGENCY:
of summaries of the basis of approval
and of environmental review
documents, where applicable. The
animal drug regulations are also being
amended to improve their accuracy and
readability.
DATES: This rule is effective August 16,
2023.
FOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary
Medicine (HFV–6), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–5689,
george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Approvals
BILLING CODE 6355–01–P
■
PART 1310—BAN OF INCLINED
SLEEPERS FOR INFANTS
55559
Food and Drug Administration,
HHS.
Final rule; technical
amendments.
ACTION:
The Food and Drug
Administration (FDA or we) is
amending the animal drug regulations to
reflect application-related actions for
new animal drug applications (NADAs),
abbreviated new animal drug
applications (ANADAs), and
conditionally approved new animal
drug applications (cNADAs) during
April, May, and June 2023. FDA is
informing the public of the availability
SUMMARY:
FDA is amending the animal drug
regulations to reflect approval actions
for NADAs, ANADAs, and cNADAs
during April, May, and June 2023, as
listed in table 1. In addition, FDA is
informing the public of the availability,
where applicable, of documentation of
environmental review required under
the National Environmental Policy Act
(NEPA) and, for actions requiring
review of safety or effectiveness data,
summaries of the basis of approval (FOI
Summaries) under the Freedom of
Information Act (FOIA). These public
documents may be seen in the office of
the Dockets Management Staff (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852, between 9 a.m. and 4 p.m.,
Monday through Friday, 240–402–7500.
Persons with access to the internet may
obtain these documents at the CVM
FOIA Electronic Reading Room: https://
www.fda.gov/about-fda/centerveterinary-medicine/cvm-foiaelectronic-reading-room. Marketing
exclusivity and patent information may
be accessed in FDA’s publication,
Approved Animal Drug Products Online
(Green Book) at: https://www.fda.gov/
animal-veterinary/products/approvedanimal-drug-products-green-book.
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS, ANADAS, AND CNADAS APPROVED DURING APRIL, MAY, AND JUNE
2023 REQUIRING EVIDENCE OF SAFETY AND/OR EFFECTIVENESS
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Approval date
File No.
Sponsor
Product name
April 5, 2023 ...............
200–612
Bimeda Animal Health Ltd.,
1B The Herbert Building,
The Park, Carrickmines,
Dublin 18, Ireland.
BIMASONE (flumethasone)
Injectable Solution.
April 10, 2023 .............
038–439
Phibro Animal Health Corp.,
GlenPointe Centre East, 3d
Floor, 300 Frank W. Burr
Blvd., Suite 21, Teaneck,
NJ 07666.
TERRAMYCIN for Fish (oxytetracycline) Type A Medicated Article.
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16:04 Aug 15, 2023
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Sfmt 4700
Effect of the action
Public
documents
Original approval for the treatment of various inflammatory conditions in horses,
dogs, and cats as a generic
copy of NADA 030–414.
Supplemental approval for the
control of mortality due to
columnaris disease in catfish and freshwater-reared
salmonids.
FOI Summary
522.960c
FOI Summary
558.450
E:\FR\FM\16AUR1.SGM
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21 CFR
section
Agencies
[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.
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\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