Safety Standard for Infant Sleep Products, 60949-60963 [2019-23724]

Agencies

• Consumer Product Safety Commission

[Federal Register Volume 84, Number 218 (Tuesday, November 12, 2019)]
[Proposed Rules]
[Pages 60949-60963]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23724]


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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Parts 1112, 1130, and 1236

[CPSC Docket No. 2017-0020]


Safety Standard for Infant Sleep Products

AGENCY: Consumer Product Safety Commission.

ACTION: Supplemental notice of proposed rulemaking.

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SUMMARY: In the Federal Register of April 7, 2017, the Consumer Product 
Safety Commission (CPSC) published a notice of proposed rulemaking 
(2017 NPR) pursuant to the Danny Keysar Child Product Safety 
Notification Act, section 104 of the Consumer Product Safety 
Improvement Act of 2008 (CPSIA), to promulgate a consumer product 
safety standard for infant inclined sleep products (inclined sleep 
products). The 2017 NPR allowed an incline between 10 and 30 degrees 
for the seat back angle of an inclined sleep product. The 2017 NPR 
proposed to adopt a voluntary standard for inclined sleep products 
developed by ASTM International, with a modification to the standard's 
definition of ``accessory.'' Based on subsequent information and 
events, the Commission is now issuing a supplemental proposed rule 
(Supplemental NPR), proposing to adopt the current ASTM standard for 
inclined sleep products, with modifications that would make the 
mandatory standard more stringent than the voluntary standard. The 
proposed changes include limiting the seat back angle for sleep to 10 
degrees or less. CPSC's proposed standard would cover products intended 
for infant sleep that are not already addressed by another standard. 
Additionally, the Commission proposes to include the mandatory standard 
for infant sleep products in the Commission's list of notices of 
requirements (NORs). The Commission also proposes to amend the consumer 
registration rule to identify explicitly infant sleep products as a 
durable infant or toddler product subject to CPSC's consumer 
registration requirements.

DATES: Submit comments by January 27, 2020.

ADDRESSES: Comments related to the Paperwork Reduction Act aspects of 
the marking, labeling, and instructional literature requirements of the 
proposed mandatory standard for infant sleep products should be 
directed to the Office of Information and Regulatory Affairs, the 
Office of Management and Budget, Attn: CPSC Desk Officer, FAX: 202-395-
6974, or emailed to [email protected].
    Other comments, identified by Docket No. CPSC-2017-0020, may be 
submitted electronically or in writing:
    Electronic Submissions: Submit electronic comments to the Federal 
eRulemaking Portal at: https://www.regulations.gov. Follow the 
instructions for submitting comments. CPSC does not accept comments 
submitted by electronic mail (email), except through 
www.regulations.gov. CPSC encourages you to submit electronic comments 
by using the Federal eRulemaking Portal, as described above.
    Written Submissions: Submit written submissions in the following 
way: Mail/Hand delivery/Courier (for paper, disk, or CD-ROM 
submissions) to: Division of the Secretariat, Consumer Product

[[Page 60950]]

Safety Commission, Room 820, 4330 East West Highway, Bethesda, MD 
20814; telephone (301) 504-7923.
    Instructions: All submissions received must include the agency name 
and docket number for this proposed rulemaking. All comments received 
may be posted without change, including any personal identifiers, 
contact information, or other personal information provided, to: https://www.regulations.gov. Do not submit electronically any confidential 
business information, trade secret information, or other sensitive or 
protected information that you do not want to be available to the 
public. If you wish to provide such information, please submit it in 
writing.
    Docket: For access to the docket to read background documents or 
comments received, go to: https://www.regulations.gov, and insert the 
docket number, CPSC-2017-0020, into the ``Search'' box, and follow the 
prompts.

FOR FURTHER INFORMATION CONTACT: Celestine T. Kish, Project Manager, 
Directorate for Engineering, U.S. Consumer Product Safety Commission, 5 
Research Place, Rockville, MD 20850; telephone: (301) 987-2547; email: 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background and Statutory Authority

A. Statutory Authority

    Section 104(b) of the CPSIA, 15 U.S.C. 2056a(b), requires the 
Commission to: (1) Examine and assess the effectiveness of voluntary 
consumer product safety standards for durable infant or toddler 
products, in consultation with representatives of consumer groups, 
juvenile product manufacturers, and independent child product engineers 
and experts; and (2) promulgate consumer product safety standards for 
durable infant or toddler products. Standards issued under section 104 
are to be ``substantially the same as'' the applicable voluntary 
standards, or more stringent than the voluntary standard if the 
Commission concludes that more stringent requirements would further 
reduce the risk of injury associated with the product. 15 U.S.C. 
2056a(b)(1)(B).
    Section 104 of the CPSIA requires the Commission to consult with 
representatives of consumer groups, juvenile product manufacturers, and 
independent child product engineers and experts to examine and assess 
the effectiveness of the relevant voluntary standards. CPSC staff 
regularly participates in the juvenile products subcommittee meetings 
of ASTM International (ASTM). ASTM subcommittees consist of members who 
represent producers, users, consumers, government, and academia.\1\ The 
consultation process for the inclined sleep products rulemaking 
commenced in 2011, and CPSC staff has been actively participating in 
the development of the new standard since that time.
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    \1\ ASTM International website: www.astm.org, About ASTM 
International.
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    A ``durable infant or toddler product'' is a ``durable product 
intended for use, or that may be reasonably expected to be used, by 
children under the age of 5 years.'' Id. 2056a(f)(1). The CPSIA 
includes a non-exhaustive list of categories of products that are 
durable infant or toddler products, such as cribs, toddler beds, and 
bassinets and cradles. Id. 2056a(f)(2). As discussed in section I.B of 
this preamble, in the 2017 NPR CPSC proposed to categorize infant 
inclined sleep products as a ``durable infant or toddler product'' 
under section 104 of the CPSIA, as a subset of the bassinet and cradle 
category. In this Supplemental NPR, CPSC proposes to identify ``infant 
sleep products'' as a category of durable infant or toddler products 
under section 104(f) of the CPSIA. CPSC proposes to define ``infant 
sleep products'' as products that provide sleeping accommodations for 
infants and are not currently covered by bassinets/cradles, cribs 
(full-size and non-full size), play yards, and bedside sleepers, as a 
durable infant or toddler product under section 104(f) of the CPSIA. 
Section 104(d) of the CPSIA requires durable infant or toddler products 
to establish product registration programs and comply with CPSC's 
implementing rule, 16 CFR part 1130. Under section 14 of the CPSA, 
children's products (such as durable infant or toddler products) must 
comply with testing and certification requirements that are implemented 
through 16 CFR parts 1107 and 1109.

B. 2017 NPR

    When staff began work on the bassinet and cradle standard, staff 
considered infant inclined sleep products to fall within the scope of 
the bassinet/cradle standard. However, because the bassinet/cradle 
standard did not address products on the market that had a sleep 
incline greater than 10 degrees, the Commission directed staff to 
initiate a separate rulemaking effort for infant inclined sleep 
products. Accordingly, the infant inclined sleep products safety 
standard was an outgrowth of the bassinet/cradle safety standard, 
intended to address products with an incline greater than 10 degrees 
from horizontal.
    In 2011, at the time CPSC separated infant inclined sleep products 
from the bassinet/cradle standard, ASTM simultaneously began work on 
developing a voluntary standard for infant inclined sleep products. 
ASTM published the resulting infant inclined sleep products standard in 
May 2015, and updated the standard twice in 2016 and twice in 2017. 
ASTM's latest standard for this product category is designated, ASTM 
F3118-17a, Standard Consumer Safety Specification for Infant Inclined 
Sleep Products (ASTM F3118-17a).
    Pursuant to the procedure described in section 104 of the CPSIA, 
the 2017 NPR proposed a mandatory standard for infant inclined sleep 
products, incorporating by reference the then-current voluntary 
standard, ASTM F3118-17, with a modification to the standard's 
definition of ``accessory.'' 82 FR 16964 (April 7, 2017). At the time 
of the 2017 NPR for infant inclined sleep products, which included 
hammocks, the Commission was aware of 14 fatal incidents related to 
infant inclined sleep products, which were reported to have occurred 
between January 1, 2005 and September 30, 2016. Staff determined that 8 
of the 14 infant deaths involved freestanding, framed inclined sleep 
products, and that 3 infant deaths involved an unrestrained infant who 
was found to have rolled over into a facedown position. Staff found 
that in two additional deaths, the infant reportedly rolled over into a 
facedown position, but the reports did not include any information 
about use of a restraint. CPSC staff had little information about the 
cause or manner of the three remaining infant deaths. Id. at 16965-66. 
Staff's incident data analysis in the 2017 NPR considered that these 14 
fatalities and other reported incidents could be addressed by the 
requirements in the voluntary standard, ASTM F3118-17. Id. at 16967-68.
    The 2017 NPR indicated that ASTM F3118-17 addressed the primary 
hazard patterns CPSC identified in the 657 incidents (including 14 
deaths), except for the definition of ``accessory.'' Specifically, the 
2017 NPR proposed that CPSC's standard would not include the term 
``rigid frame'' in the definition of ``accessory inclined sleep 
product'' in section 3.1.1 of ASTM F3118-17, broadening the definition 
to encompass a new product that did not have a rigid frame. Id. at 
16968-69, and 16975. The Commission concluded that these more stringent 
requirements were necessary to further reduce the risk of injury 
associated with infant inclined sleep products relating to the use of 
an

[[Page 60951]]

inclined sleep product accessory. Id. at 16967.
    As the 2017 NPR explained, durable infant or toddler products are 
children's products that must be certified as complying with all 
applicable CPSC-enforced requirements. 15 U.S.C. 2063(a); 82 FR at 
16969. Certification must be based on testing conducted by a CPSC-
accepted third party conformity assessment body (test laboratory). 15 
U.S.C. 20163(a)(2). CPSC must publish a NOR for the accreditation of 
test laboratories to assess a product's conformity with a children's 
product safety rule, such as the proposed rule on infant inclined sleep 
products. Accordingly, the 2017 NPR proposed that if issued as a final 
rule, the new Standard Consumer Safety Specification for Infant 
Inclined Sleep Products, to be codified at 16 CFR part 1236, would be 
added to the list of NORs for children's product safety rules in 16 CFR 
part 1112, so that test laboratories applying for CPSC-acceptance could 
seek accreditation to test inclined infant sleep products. 82 FR at 
16969.
    Finally, the 2017 NPR proposed to amend 16 CFR part 1130, the 
Commission's requirements for consumer registration for durable infant 
or toddler products. Id. at 16969-70. The Commission proposed to amend 
the definition of ``durable infant or toddler product'' to clarify that 
infant inclined sleep products fall within the term, and are subject to 
the product registration card requirements in part 1130. Id.
    On June 12, 2019, CPSC staff submitted a briefing package and a 
draft Federal Register notice to the Commission recommending that the 
Commission terminate the 2017 NPR. Staff recommended terminating the 
2017 NPR because, by that time, CPSC had received reports of 42 
additional fatalities since issuing the 2017 NPR, which were associated 
with rocker-like inclined sleep products, and because the Commission 
had issued additional safety alerts and recalls involving infant 
inclined sleep products. On October 16, 2019, staff provided the 
Commission with a briefing package recommending that the Commission 
instead issue this Supplemental NPR.\2\
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    \2\ The October 16, 2019, Staff Briefing Package: Draft 
Supplemental Notice of Proposed Rulemaking for Infant Sleep Products 
under the Danny Keysar Child Product Safety Notification Act (Staff 
Supplemental Briefing Package) is available at: https://www.cpsc.gov/s3fs-public/SupplementalNoticeofProposedRulemakingforInfantSleepProducts_10_16_2019.pdf?TPVAJZEQcz9x9sKeEGltm4LskkonxUWv.
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C. 2019 Supplemental NPR--Overview

    In this Supplemental NPR, the Commission proposes to issue a 
standard for infant sleep products, i.e., products that (1) Provide 
sleeping accommodations for infants and (2) are not currently covered 
by bassinets/cradles, cribs (full-size and non-full size), play yards, 
and bedside sleepers. The Supplemental NPR proposes to incorporate by 
reference ASTM F 3118-17a with modifications to require that: (1) The 
seat back angle intended for sleep must be equal to or less than 
10[deg] and (2) the infant sleep product must meet the requirements for 
a bassinet/cradle in the standard at 16 CFR part 1218. The Commission 
also proposes to amend the consumer registration rule to identify 
``infant sleep products'' as a category of durable infant or toddler 
products under section 104(f) of the CPSIA. Additionally, the 
Commission proposes to amend its regulation at 16 CFR part 1112 to add 
infant sleep products to the list of products that require third party 
testing.

II. Product Description

A. Scope of Products Within the Supplemental NPR

    The scope of products covered by the 2017 NPR tracked the scope of 
ASTM F3118-17, covering ``a free standing product with an inclined 
sleep surface primarily intended and marketed to provide sleeping 
accommodations for an infant up to 5 months old or when the infant 
begins to roll over or pull up on sides, whichever comes first.'' The 
Supplemental NPR proposes to incorporate ASTM F3118-17a with 
substantial modifications, including revisions in the scope of the 
standard, section 1.3, to remove the term ``inclined,'' and to include 
any infant sleep product not currently covered by another mandatory 
rule for infant sleep products: Bassinets/cradles, cribs (full-size and 
non-full-size), play yards, and bedside sleepers. Accordingly, the 
scope of the Supplemental NPR includes all of the products in the 2017 
NPR, plus additional infant sleep products not covered by any other 
infant sleep product standard. The following types of infant sleep 
products fall within the scope of the Supplemental NPR:
     Frame-Type Inclined Sleep Products--Frame-type inclined 
sleep products are elevated, intended to be placed on the floor, and 
are self-supporting. Typically, this design uses a metal frame covered 
by a fabric insert that contains the occupant. Some frame-type products 
have a rigid plastic insert under the sleeping surface, and/or extra 
padding with head positioning cushions. The base may be stationary or 
allow side-to-side/head-to-toe rocking. This type of product could have 
a fixed incline or be adjustable. Frame-type products can be intended 
for use by newborns or infants, or both, depending on the size of the 
product.
     Hammocks--Hammocks are typically constructed of fabric and 
suspended from one or two points, either above or on either side. 
Hammock products are constructed of various materials and generally 
conform to the shape of the child when placed in the product. However, 
some hammock designs use a mat, mattress, or other type of pad to 
provide a semi-rigid sleeping surface that maintains the product's 
form. Hammocks are intended to be suspended and can be supported by a 
frame or other structure, such as a ceiling.
     Compact Inclined Sleep Products--Compact inclined sleep 
products are freestanding, with the bottom of the seat a maximum of 6 
inches (152 mm) above the floor. These products tend to be constructed 
of foam and are intended to be used on the floor.
     Accessory Inclined Sleep Products--An accessory inclined 
sleep product is intended to provide sleeping accommodations for 
infants or newborns and are attached to, or supported in some way, by 
another product. These products can be fixed or adjustable. An inclined 
sleep accessory is typically a rigid-frame product that has a 
stationary or fixed base and, in some cases, inclined sleep product 
accessories may be removed and used independently.

B. Market Description

    The Supplemental NPR proposes to cover any infant product 
``primarily intended and marketed \3\ to provide sleeping 
accommodations'' that is designed for infants five months old or 
younger and that is not covered by another standard.\4\ In general, the 
Supplemental NPR does not propose to cover products with adjustable 
seat back positions that are covered by other mandatory or voluntary 
standards in inclined position(s), such as bouncers, rockers, hand-held 
carriers, or infant swings, unless they have a seat back angle that is 
specifically marketed for sleep for children 5 months or younger.

[[Page 60952]]

To date, CPSC staff has found one bouncer on the market with an 
inclined position marketed for sleep for children in this age range.
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    \3\ This would include marketing information (such as on 
websites or in ad campaigns), product and retail package labeling, 
as well as supplier statements about the product.
    \4\ These include: Safety Standard for Full-Size Baby Cribs (16 
CFR 1219); Safety Standard for Non-Full-Size Baby Cribs and Ply 
Yards (16 CFR 1220 and 1221); Safety Standard for Bedside Sleepers 
(16 CFR 1222); and Safety Standard for Bassinets and Cradles (16 CFR 
1218).
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    Inclined infant sleep products sell on the U.S. market for 
approximately $65 for a frame-style inclined sleeper, $110 for a 
compact sleeper, $165 for an infant hammock,\5\ and $236 for a play 
yard with an inclined sleeper accessory.\6\ A hammock-style crib 
accessory that would be covered by the Supplemental NPR (but does not 
currently fall under the voluntary inclined sleeper standard or another 
sleep standard) sells for approximately $50.
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    \5\ The average price for an infant hammock supplied by a home-
based manufacturer is approximately $200.
    \6\ Staff averaged prices across all models found for a 
particular type. Staff ignored as unknown shipping costs for a few 
hammock models delivered from overseas suppliers, which means that 
the average cost for an infant hammock may be a low estimate, 
depending upon how many hammocks are entering the U.S. via these 
overseas suppliers.
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    Several product categories would not fall under the scope of the 
Supplemental NPR: (1) Sleep positioners; (2) sleep wedges, many of 
which are marketed as medical devices, putting them under the 
jurisdiction of the Food and Drug Administration; and (3) miniature 
infant hammocks marketed exclusively for use as photographic props 
(i.e., photos of newborn babies).

III. Incident Data and Hazard Patterns

    At the time of the 2017 NPR, the Commission was aware of 14 fatal 
incidents related to infant inclined sleep products, which were 
reported to have occurred between January 1, 2005 and September 30, 
2016. Eight of the 14 deaths involved rocker-like inclined sleep 
products; in three cases, the unstrapped decedent was found to have 
rolled over into a facedown position. Two additional cases also 
reported a rollover into a facedown position, but the reports did not 
include any information about use of a restraint. CPSC had little 
information about the cause or manner of the three remaining deaths. 
The NPR recognized that reporting was ongoing and the number of 
reported fatalities could change. This Supplemental NPR updates fatal 
and nonfatal incident reports associated with the use of an infant 
inclined sleep product.
    CPSC is aware of 451 incidents (59 fatal and 392 nonfatal) related 
to infant inclined sleep products that occurred from January 1, 2005 
through June 30, 2019 and reported between October 1, 2016 and June 30, 
2019. This count includes incidents reported after the reporting end 
date stated in the 2017 NPR. Forty-three percent of the incident 
reports (196 out of 451) are based solely on information from 
manufacturers/retailers. Various sources, such as hotlines, internet 
reports, newspaper clippings, medical examiners, and other state/local 
authorities provided the remaining incident reports to CPSC. Reporting 
is ongoing, and therefore, the number of reported fatalities, nonfatal 
injuries, and non-injury incidents may change in the future. Tab A of 
the Staff Supplemental Briefing Package describes the incident data and 
the hazard patterns associated infant inclined sleep products.

A. Fatalities

    Since the 2017 NPR, through June 30, 2019, CPSC received reports of 
59 deaths. One fatality involved a foam-based infant reclined sleeper; 
two fatalities occurred in napper attachments of play yards; and the 
remaining fatalities occurred in freestanding framed inclined sleep 
products. CPSC staff reviewed and categorized incident reports 
associated with the fatalities:
     Twenty-eight of the 59 reports contain unclear, 
conflicting, and/or inconsistent information. For example, in this 
category medical examiners often conclude the cause of death to be 
Sudden Infant Death Syndrome (SIDS) or Sudden Unexpected Infant Death 
(SUID) along with a co-contributing condition such as unsafe sleep 
environment (e.g., soft bedding, inclined sleep surface) or other pre-
existing medical condition. Considering all factors in each report 
confounds staff's ability to determine the pre-dominant factor causing 
a fatality. Occasionally, wording on the documents cite ``several 
possibilities'' and the cause of death is coded as Undetermined. Lack 
of clarity in these reports make it difficult for CPSC staff to 
consistently classify the 28 deaths.
     Eighteen reports describe infants placed in the product 
supine but who ended up in a compromised position in the product, 
resulting in suffocations or positional asphyxiations. In 11 of the 18 
cases, no restraints were used; another six infants were placed in a 
supine position, but the use of restraints is unknown; and in one case, 
the infant was left restrained and supine, but found supine, slumped in 
a chin-to-chest position. One additional unrestrained infant fell out 
of the product and became wedged in a confined space.
     Eight reports provide very little information on the 
incidents. Lack of any information on the circumstances leading up to 
the death does not allow staff to classify these deaths.
     Four reports describe infant placement issues; three of 
the four decedents were reportedly placed prone on soft bedding in the 
product; and another decedent suffocated when a young sibling climbed 
into the sleep product on top of her.
    CPSC does not know the age for 10 deceased infants. Staff concludes 
that for the remaining deaths, 39 infants were 5 months or less in age, 
while six infants were between 6- and 8-months of age. One decedent was 
9-months old.

B. Nonfatal Incidents

    Reports indicate that 96 of the 451 inclined sleep product-related 
nonfatal incidents involved an injury to the infant during product use. 
The severity of the injury types among the 96 reported injuries are as 
follows:
    [ssquf] Seven infants required hospital admission. Six of the seven 
infants suffered episodes of respiratory distress due to rolling over 
in the product; mold in the product; or undetermined reasons. One of 
the seven infants had to be hospitalized for scoliosis (curvature) of 
the back attributed to product use.
    [ssquf] Sixteen infants were treated and released from emergency 
departments (EDs). Eleven of these infants were treated for head 
injuries and contusions/bruises resulting from falls; three infants 
were treated for unexplained respiratory distress. Mold growth on the 
product was associated with respiratory distress in one additional 
infant and seizure symptoms in another.
    [ssquf] Seventy-three infants received some professional medical 
care, first-aid treatment, or the level of care received was not 
reported. Among them, 32 infants suffered from plagiocephaly (flat head 
syndrome), torticollis (twisted neck syndrome), or both conditions, 
associated with the use of the inclined sleep product; 27 infants 
suffered mostly respiratory and some skin problems associated with mold 
on the product; infants sustained the remaining injuries due to a fall 
from the product or a minor electric shock, or their injuries are 
unspecified.
    The remaining 296 incident reports indicate that no injury occurred 
to the infant or provided no information about an injury. However, many 
of the descriptions indicate the potential for a serious injury, or 
even death, similar to those reported in the incident data.

C. Hazard Pattern Identification

    The 2017 NPR identified nine hazard patterns among the 657 reported 
incidents. These hazard patterns included: Design issues, lack of

[[Page 60953]]

structural integrity, inadequate restraints, electrical issues, non-
product-related or unknown issues, difficulty with correct positioning, 
miscellaneous product-related issues, unspecified falls, and consumer 
comments. Although the distribution of the data in this Supplemental 
NPR update varied somewhat, CPSC finds that the broader hazard 
categories are very similar. Within the broader hazard category of 
design, the Supplemental NPR identifies one new hazard pattern, as 
described below.
    CPSC staff considered all 451 reported incidents (59 fatal and 392 
nonfatal) to identify hazard patterns associated with infant inclined 
sleep products. The infant inclined sleep products category includes a 
variety of products. Some products, like hammocks, are suspended in 
air, while other seat-like products are meant to be placed on a floor 
level (yet incident reports indicate these products often were not 
placed on floor level). Other products sit on top of larger nursery 
products as attachments. CPSC staff identified hazard patterns that are 
quite different depending on which product is involved and how the 
product is being used. In order of frequency of incident reports, CPSC 
staff grouped the hazard patterns into the following categories:
    1. Design of the infant inclined sleep product: One hundred and 
thirty-eight of the 451 reported incidents (31 percent) are in this 
category. Staff identified three major issues:
    a. Fifty-nine reported incidents (43 percent) involved infants who 
developed respiratory and/or skin ailments due to the growth of mold on 
the product;
    b. Forty-six reported incidents (33 percent) involved infants that 
rolled over--fully or partially--from their original supine position. 
Reports describe infants as young as 1- or 2-months of age as having 
rolled over; parents/caregivers, who witnessed and reported some of the 
nonfatal incidents, were able to rescue distressed infants quickly. 
Eighteen infants died due to suffocation or asphyxiation. Although a 
few of the infants were strapped into the product, a majority of the 
infants were either not restrained or the use of restraint is 
unreported.
    c. Thirty-three reported incidents (24 percent) involved infants 
that developed physical deformations from extended product use, such as 
plagiocephaly (flat head syndrome), scoliosis (curvature) of the back, 
and/or torticollis (twisted neck syndrome).
    The design category includes 19 deaths, 5 hospitalizations, and 4 
emergency department (ED) visits. All but two of the deaths resulted 
from infants rolling over into a prone or semi-prone position, one 
decedent was found still supine and restrains, but slumped in a chin-
to-chest position. The other infant rolled out of the product and 
wedged into a confined space. Infants unrestrained in the product 
caused two ED-treated falls. An additional 62 non-hospitalized, non-ED 
injuries are reported in this category.
    2. Electrical issues: One hundred and twenty-seven of the 451 
incident reports (28 percent) report battery leakage, electric shock, 
and/or overheating/melting of components, such as the vibrating unit, 
battery cover, switch, plug, or motor. Reports include two injuries in 
this category due to electric shock.
    3. Consumer comments: Ninety of the 451 reports (20 percent) fall 
into this category. The reports consist of consumer comments/
observations of perceived safety hazards, complaints about unauthorized 
sale of infant inclined sleep products, or inquiries regarding safety 
recall on inclined sleep products. One complaint describes 
misinformation in the instruction material. None of these reports 
indicate that an incident actually occurred.
    4. Undetermined due to confounding information: Thirty-four of the 
451 reports (8 percent) provide unclear, conflicting, and/or 
inconsistent information. Among the 28 deaths reported in this 
category, for example, medical examiners often concluded the cause of 
death to be SIDS or SUID, along with a co-contributing condition such 
as an unsafe sleep environment (e.g., soft bedding, inclined sleep 
surface) or pre-existing medical condition. Staff is unable to 
determine the role of the product when documents describe multiple 
potentially contributing factors. Occasionally, the wording on the 
documents cite ``several possibilities,'' and the cause of death is 
coded as Undetermined. For the 6 nonfatal injuries, including the 2 
hospitalized and 2 ED-treated injuries, the report described 
respiratory distress due to temporary cessation of breathing; however, 
these reports contain no official diagnosis for these episodes.
    5. Lack of structural integrity: Twenty-eight of the 451 incidents 
(6 percent) report some sort of breakage of the product or its 
components. These reports include complaints of buckle/straps breaking, 
components such as hub, rail, or leg detaching/disengaging, hardware 
coming loose, and other unspecified components breaking. This category 
includes two ED-treated injuries, both due to falls.
    6. Other product-related issues: Thirteen of the 451 incidents (3 
percent) report other product-related issues, such as instability 
(product tipping over), inadequacy of restraint (infants falling out in 
spite of being restrained), or product assembly/installation 
difficulties. This category contains seven fall-related injuries, 
including two injuries that were treated and released from a hospital 
ED.
    7. Infant placement issues: Four of the 451 incidents reports (1 
percent) indicate that infant placement contributed to the incident. Of 
the four fatalities, reports describe three infants placed in a prone 
position on soft bedding; and another infant being crushed by a young 
sibling who climbed on top of her.
    8. Insufficient information: For 17 of the 451 incidents (4 
percent), reports contain insufficient information for staff to 
categorize them accurately. Staff has no information available on the 
circumstances of 8 deaths in this category. Reports for six injuries in 
this category describe unspecified falls treated in hospital EDs, with 
no information was on restraint usage.

D. Product Recalls and Safety Alerts

    From May 10, 2000 to August 20, 2019, CPSC conducted 13 consumer-
level recalls involving infant inclined sleep products. The recalls 
were conducted in response to hazards involving strangulation, 
suffocation, fall, structural stability, entrapment, exposure to mold, 
and death. Six recalls involved infant hammocks, six recalls involved 
infant inclined sleep products, and one recall involved an infant 
inclined sleep accessory included with a play yard. Tab G in the Staff 
Supplemental Briefing Package contains a detailed chart outlining 
recalls involving infant inclined sleep products.
    The six infant hammocks were recalled for hazards including: 
Strangulation, suffocation, fall, structural stability, and entrapment. 
Recalls affected approximately 25,400 units of infant hammocks.
    The six infant inclined sleep products and one infant inclined 
sleep accessory included with a play yard were recalled due to hazards 
including: entrapment, suffocation, fall, exposure to mold, and death 
after infants rolled from their back to their stomach or side while 
unrestrained in the products. Recalls affected approximately 6.4 
million units of infant inclined sleep products. One recall for 
exposure to mold affected 800,000 units, and two recalls for entrapment 
and suffocation affected 195,000 units.

[[Page 60954]]

    In 2019, two recalls occurred due to reports of infant deaths while 
using infant inclined sleep products, after the infants rolled from 
their back to their stomach or side while unrestrained, or under other 
circumstances. In response to the reported deaths in those products, 
CPSC conducted two additional recalls due to safety concerns with 
infant inclined sleep products, one with an infant inclined sleep 
product, and one with an infant inclined sleep accessory included with 
a play yard. Recalls involving infant inclined sleep products affected 
approximately 5.4 million units and the recall involving the infant 
inclined sleep accessory affected approximately 71,000 units.
    The Commission also has issued two safety alerts involving infant 
inclined sleep products. A May 31, 2018 safety alert \7\ advised of 
infant rollover deaths in inclined sleep products, and reminded 
caregivers to always use restraints and to stop using the product as 
soon as an infant can roll over. An April 5, 2019 safety alert \8\ 
advised consumers to stop use of the inclined sleep product when an 
infant reaches three months of age, or as soon as an infant exhibits 
rollover capabilities.
---------------------------------------------------------------------------

    \7\ https://www.cpsc.gov/content/cpsc-consumer-alert-caregivers-urged-to-use-restraints-with-inclined-sleep-products.
    \8\ https://www.cpsc.gov/Newsroom/News-Releases/2019/CPSC-ALERT-CPSC-and-Fisher-Price-Warn-Consumers-About-Fisher-Price-Rock-N-Play-Due-to-Reports-of-Death-When-Infants-Roll-Over-in-the-Product.
---------------------------------------------------------------------------

IV. Mannen Study

    During the development of this Supplemental NPR briefing package, 
staff received reports of 451 new incidents, 59 of which were deaths 
that occurred while in infant inclined sleep products. Accordingly, 
Commission staff contracted with Dr. Erin Mannen, Ph.D., a mechanical 
engineer with a biomechanics specialization, to conduct infant testing 
to evaluate the design of inclined sleep products. Tab B of the Staff 
Supplemental Briefing Package contains Dr. Mannen's study, 
Biomechanical Analysis of Inclined Sleep (Mannen Study).
    The Mannen Study examined how 10 infants move and use their muscles 
on flat, inclined surfaces, and in selected inclined sleep products, 
and whether such product designs directly impact safety or present a 
risk factor that could contribute to the suffocation of an infant. 
Testing compared infants' muscle movement and oxygen saturation on a 
flat crib mattress at 0[deg], 10[deg], and 20[deg] versus seven 
different inclined sleep products. Researchers recorded infant muscle 
activity using surface electromyography (EMG), and recorded oxygen 
saturation using a medical grade pulse oximeter. Researchers placed 
infants in a random order in each of the 10 testing conditions, in both 
the supine and prone positions, for at least 60 seconds (unless the 
oximeter data fell below 95%, in which case they were removed early to 
ensure safety).
    Following are key findings of the Mannen Study:
     Inclined surfaces and incline sleep products resulted in 
significantly higher muscle activity of the turn core muscle 
(abdominals), which may lead to quicker fatigue and suffocation if an 
infant finds themselves prone in an incline sleep product.
     Muscle synergies (i.e., how muscles work together) are 
significantly different in inclined sleep products. If an infant rolls 
from supine to prone in an inclined sleep product, it is likely the 
first time the baby has experienced the position and the demands the 
position requires of the muscles.
     Some inclined sleep products require greater neck and 
trunk adjustments during prone positioning, indicating that infants may 
struggle to adjust their posture to enable breathing and attempt to 
self-correct if a roll from supine to prone occurs.
     Prone lying in the incline sleep products puts infant at 
higher risk of suffocation as evidenced by oxygen saturation results.
     Some evidence was found that supports the idea that the 
inclined sleep products make the babies roll more easily from supine to 
prone. The flexed trunk and ease of head lifting during supine lying in 
an inclined sleep product may indicate that supine to prone rolling is 
achieved more easily.
     If babies roll from supine to prone in an inclined sleep 
product, then, due to the high musculoskeletal demands necessary to 
maintain safe posture to prevent suffocation, babies would fatigue 
faster than they would on a stable, flat surface.
     None of the inclined sleep products that were tested and 
evaluated as a part of this study are safe for infant sleep.
    Additionally, the Mannen Study concludes:
     20-Degree Incline Puts Infants at Risk for Muscle Fatigue 
and Suffocation: Based on the results of the biomechanical study, the 
20-degree incline resulted in significantly different muscle activity 
for the infants compared to the zero-degree incline surface. The 
increased demand on the abdominal muscles could lead to increased 
fatigue and suffocation if an infant is unable to reposition themselves 
after an accidental roll from supine to prone occurs.
     10-Degree Incline Does Not Significantly Impact Infant 
Motion or Muscle Activity: Based on the results of the biomechanical 
study, fewer differences in muscle activity or lying posture were 
revealed at a 10-degree mattress incline compared to the zero-degree 
incline surface. Ten degrees is a safe incline for sleep on a crib 
mattress surface.
     Inclines Between 10 and 20 Degrees Should Be More 
Thoroughly Studied: The experimental design of this study did not 
examine the angles between 10 and 20 degrees, so future work should 
focus on understanding which, if any, angles between 10 and 20 degrees 
may be safe for infant sleep.
    The Mannen Study further states: ``It is likely that in incidents 
where babies were found deceased in the prone position, that an 
accidental roll occurred, and after some amount of struggling, the baby 
was fatigued and could no longer move into a position to prevent 
suffocation.'' Dr. Mannen concludes that an incline of 20 degrees or 
more puts an infant at risk compared to a 0-10 degree incline. Although 
her study did not test infants on inclines between 10-20 degrees, and 
thus did not offer conclusions for these angles, CPSC staff advises 
that additional testing on inclines between 10-20 degrees is 
unnecessary, because staff concludes that a flat surface that does not 
exceed 10 degrees offers the safest sleep environment for infants. This 
conclusion comports with staff's recommendations to remove the term 
``inclined'' from the proposed mandatory standard, and to require that 
all sleep products not otherwise specified as cribs (full-size or non-
full-size), play yards, or bedside sleepers meet the requirements in 16 
CFR 1218 Safety Standard for Bassinets and Cradles, which, among other 
requirements, mandates that the seat back surface angle intended for 
sleep be 10 degrees or less.

V. International Standards for Inclined Sleep Products

    The 2017 NPR described international standards that include infant 
inclined sleep products within their scope, noting that these standards 
are intended primarily to address hazards associated with products 
having flat sleeping surfaces, such as bassinets and cradles. These 
standards include:
    [ssquf] The Cribs, Cradles, and Bassinets regulation included in 
the Canada Consumer Product Safety Act: The Canadian regulation has 
similar requirements to ASTM F3118, such as

[[Page 60955]]

warnings, labels, and general performance requirements (e.g. lead 
content, small parts, openings). The Canadian regulation has additional 
requirements for slat strength, mesh material, structural integrity, 
and mattress supports. CPSC staff determined that the Canadian 
regulation provides similar performance requirements as ASTM F3118, but 
contains a more stringent requirement limiting the sleep seat back 
angle to 7[deg] or less. However, the Canadian regulation allows a 
product to be marketed as a ``napper,'' which the Supplemental NPR 
proposes not to allow.
    [ssquf] The European standard (SS-EN 1130: Furniture, Cribs, and 
Cradles Safety Requirements): EN 1130 covers only inclined sleep 
products with a body and frame. The European standard would not include 
hammocks or similar products that are suspended from ceilings or other 
structures. EN 1130 includes requirements for construction and 
materials similar to the general ASTM F3118 requirements. Additional 
requirements include labeling, use instructions, packaging, and 
stability. EN 1130 is intended primarily to address hazards associated 
with bassinets and cradles and not the unique hazards associated with 
inclined sleep products. CPSC staff believes the ASTM standard is more 
inclusive because it includes all hammock styles. Additionally, EN 1130 
does not address the hazards identified in the Mannen Study.
    [ssquf] The Australian standard (AS/NZS 4385 Infants' rocking 
cradles--Safety requirements): AS/NZS 4385 is intended for rocking 
cradles that swing, rock, or tilt, but specifically excludes hammocks 
that do not have this feature. Staff is unclear whether tilt means 
incline, thereby including in the Australian standard inclined sleep 
products as defined in ASTM F3118. AS/NZS 4385 contains requirements 
for construction, toxicology, and flammability, as well as general 
provisions, such as those for included toys. AS/NZS 4385 has some 
similar performance requirements as ASTM F3118, but is not as 
comprehensive. Additionally, the AS/NZS 4385 does not address the 
hazards identified in the Mannen Study.

VI. Voluntary Standard--ASTM F3118

A. History of ASTM F3118

    Section 104(b)(1)(A) of the CPSIA requires the Commission to 
consult representatives of ``consumer groups, juvenile product 
manufacturers, and independent child product engineers and experts'' to 
``examine and assess the effectiveness of any voluntary consumer 
product safety standards for durable infant or toddler products.'' As a 
result of incidents arising from inclined sleep products, the 
Commission directed CPSC staff to work with ASTM to develop voluntary 
requirements to address the hazard patterns related to the use of 
inclined sleep products. ASTM first approved ASTM F3118 on April 1, 
2015, and published it in May 2015. Through the ASTM process, CPSC 
staff consulted with manufacturers, retailers, trade organizations, 
laboratories, consumer advocacy groups, consultants, and members of the 
public. The current standard, ASTM F3118-17a, was approved on September 
1, 2017, and published in October of 2017. This is the fourth revision 
to the standard since it was first published in May 2015. ASTM F3118-
17a is intended to address the following hazards: (1) Falls, (2) 
positional asphyxiation, and (3) obstruction of nose and mouth by 
bedding.

B. Description of the Current Voluntary Standard--ASTM F3118-17a

    The 2017 NPR described the key provisions of ASTM F3118-17, 
including: scope, terminology, general requirements, performance 
requirements, test methods, marking and labeling, and instructional 
literature. 82 FR at 16967. The Supplemental NPR proposes to 
incorporate by reference the most recent version of the voluntary 
standard, ASTM F3118-17a, which is substantially the same as ASTM 
F3118-17, except that the accessory definition was updated to match the 
modification recommended in the 2017 NPR. Like the previous version, 
ASTM F3118-17a describes the scope of the voluntary standard, defines 
terms for various types of inclined sleep products, and sets out 
requirements for performance (such as for structural integrity and 
stability) and for warnings and instructions. As discussed elsewhere in 
this preamble, CPSC's proposed standard would make substantial 
modifications to ASTM F3118-17a.

VII. Assessment of the Voluntary Standard ASTM F3118-17a

    In the 2017 NPR, CPSC proposed that incorporating by reference ASTM 
F3118-17, with a modification to the definition of ``accessory,'' would 
address the primary hazard patterns identified in the incident data. 82 
FR at 16967-68. However, since the 2017 NPR, CPSC has become aware of 
additional fatalities and contracted the Mannen Study. The Mannen Study 
and more recent incident data indicate that ASTM F3118-17a is not 
adequate to address the risk of injury associated with infant inclined 
sleep products because the standard allows for products with a seat 
back angle greater than 10 degrees. The Commission finds that more 
stringent requirements than those found in ASTM F3118-17a are necessary 
in a mandatory rule to further reduce the risk of injury associated 
with infant inclined sleep products.
    Following is an explanation of how the Supplemental NPR would 
address the product-related hazard patterns identified in section III.C 
of this preamble, discussing the proposed more stringent requirements 
where appropriate.

A. Design Problems

1. Suffocation Hazard
    The Mannen Study results reveal that a 20[deg] incline results in 
significantly different muscle activity for the infants compared to a 
0[deg] incline surface. The increased demand on infant abdominal 
muscles could lead to increased fatigue and suffocation if an infant is 
unable to reposition themselves after a roll from supine to prone 
occurs. At a 10[deg] incline, fewer differences in muscle activity or 
lying posture were revealed compared to the 0[deg] incline surface. 
According to Dr. Mannen's report, ``ten degrees is likely a safe 
incline for sleep on a crib mattress surface.'' Accordingly, the 
Commission proposes modifications to the introduction, scope, 
definitions, and performance requirements in ASTM F3118-17a, as 
described in section VIII of this preamble, to address the potential 
hazards of an infant sleeping on an inclined surface. Although her 
study did not test infants on inclines between 10[deg]-20[deg], and 
thus did not offer conclusions for these angles, CPSC staff advises 
that additional testing on inclines between 10[deg]-20[deg] is 
unnecessary, concluding that a flat surface that does not exceed 
10[deg] offers the safest sleep environment for infants and would 
further reduce the risk of injury associated with inclined sleep 
products.
2. Additional Design Issues
    CPSC staff identified two additional design issues: (1) Infant 
respiratory and/or skin ailments due to mold growth on the product, and 
(2) infant physical deformations such as plagiocephaly (flat head 
syndrome) and/or torticollis (twisted neck syndrome) from extended 
product use. In the reported cases of mold that resulted in respiratory 
problems for infants using the product, all cases were related to one 
particular

[[Page 60956]]

manufacturer's inclined sleep product. CPSC conducted a recall of that 
product in 2013. Infants who use an inclined sleep product that is 
known to develop visible mold can be at risk of developing health 
effects such as allergies, asthma, mycosis, and effects of mycotoxins. 
However, because the mold growth was restricted to one manufacturer's 
product and that product was recalled, the Commission is not proposing 
any modifications to address potential hazards associated with mold.
    Plagiocephaly, cranial deformity or asymmetry (commonly known as 
flat head) is a condition that may exist at birth due to mechanical 
constraint of fetal head movement in the womb, birth-related injuries 
during assisted delivery, or as a result of increased likelihood of 
skull deformity as a consequence of premature birth. Muscular 
torticollis (twisted neck) is a known risk factor associated with 
plagiocephaly caused by constraint of head and neck movement. Although 
incident data indicate that consumers believe use of an inclined sleep 
product is the cause for their child's plagiocephaly/torticollis, no 
evidence supports this belief. Increase in the number of children with 
plagiocephaly may actually be attributed to the American Academy of 
Pediatrics' (AAP) recommendation to place infants to sleep on their 
backs to decrease the risk of sudden infant death syndrome (SIDS). 
Because the development of plagiocephaly and torticollis is not 
exclusively attributable to the use of infant inclined sleep products, 
the conditions are not addressable with performance standards. The 
Commission is not proposing any modifications to the voluntary standard 
to address these issues. Tab E of the Staff Supplemental Briefing 
Package provides the Directorate for Health Science's analysis of 
plagiocephaly and torticollis related to infant sleep products.

B. Electrical Issues

    Staff determined that 127 of the 451 new incidents are related to 
electrical issues. The electrical-related issues included battery 
leakage, electric shock, and overheating of components. Some inclined 
sleep products have accessories that provide music, rocking motion, or 
vibration, which are either battery- or a/c-powered; however, F3118-17a 
does not include any performance requirements for electrical 
components. Other juvenile products that have similar features include 
performance requirements that could apply for infant sleep products. 
CPSC staff has raised this issue and is working with the ASTM Ad Hoc 
task group to develop performance requirements to address electrical 
hazards across juvenile products. Performance requirements would apply 
to other children's product standards, such as bouncers, swings, and 
bassinets. Because these requirements are currently under development, 
the Commission is not proposing electrical requirements in this 
Supplemental NPR, and instead expects staff to continue working with 
applicable ASTM subcommittees to develop electrical requirements for 
all applicable durable infant or toddler products with electrical 
components.

C. Structural Integrity and Other Product Related Issues

    Structural integrity and other product related issues identified in 
this Supplemental NPR are similar to issues previously found in 
bassinet/cradle incidents. Accordingly, performance and testing 
requirements in the bassinet/cradle standard will likely address these 
incidents for infant sleep products.

D. Infant Placement Issues

    Infants placed prone on soft bedding in inclined sleep products are 
at great risk for suffocation because of the incline and the soft 
bedding. Although requiring infant sleep products to comply with the 
bassinet/cradle standard will reduce the incline angle, and will 
provide warnings about not using soft bedding, parents may still place 
infants prone in the product. Staff will continue to work with ASTM and 
other organizations with information and education campaigns to prevent 
infants' deaths due to unsafe sleep practices.

VIII. Proposed Standard for Infant Sleep Products

    This Supplemental NPR proposes to establish a children's product 
safety standard for infant sleep products as a type of durable infant 
or toddler product under section 104 of the CPSIA. The Mannen Study 
findings and incident reports indicate that neither ASTM F3118-17, nor 
ASTM F3118-17a, are adequate to address the risk of injury associated 
with infant inclined sleep products, because these voluntary standards 
allow for infant inclined sleep products with a seat back angle greater 
than 10 degrees. More stringent requirements are necessary in the 
mandatory standard to further reduce the risk of injury associated with 
infant inclined sleep products. Accordingly, the Supplemental NPR 
proposes to incorporate by reference ASTM F3118-17a as the mandatory 
standard for infant sleep products, with the following modifications:
    a. Modify the introduction and scope of the standard to state the 
purpose of the standard is to address all infant sleep products not 
already covered by traditional sleep product standards.
    b. Modify the definitions of accessory, compact, infant inclined 
sleep products, and newborn inclined sleep products to remove the term 
``inclined.''
    c. Modify seat back angle so the maximum allowable seat back angle 
must be equal to or less than 10[deg] in all positions recommended for 
sleep.
    d. Add new requirement--infant sleep products must meet 16 CFR 1218 
Safety Standard for Bassinets and Cradles.
    e. Remove all the performance requirements except for the above new 
or modified requirements.
    f. Remove all test methods except for maximum seat back angle.
    The Supplemental NPR proposes that infant sleep products meet 16 
CFR 1218 Safety Standard for Bassinets and Cradles because this 
standard is an established standard for products that provide sleep 
accommodations for infants, and the standard addresses the hazard 
associated with inclined sleep by limiting the seat back angle to 10 
degrees or less. Additionally, the name of CPSC's standard would not 
include the term ``inclined,'' and would be codified as 16 CFR part 
1236, Safety Standard for Infant Sleep Products. A redline of these 
proposed changes is included at Tab C of the Staff Supplemental 
Briefing Package.
    The Supplemental NPR proposes that infant sleep products meet the 
warning requirements in the bassinet and cradle standard, instead of 
those stated in ASTM F3118-17a. For this proposed modification, the 
Supplemental NPR relies on focus groups with parents and grandparents 
of infants less than 1 year of age. Participants provided information 
on caregivers' perceptions and reactions to safety messaging, 
indicating that participants were aware of warning labels on infant 
sleep products. Additionally, participants reported that the label 
shown during the focus group looked similar and contained comparable 
information to labels that they find on products they own. Some 
participants reported that they tend to gloss over warning labels, as 
they believe the language to be the same on every label. Some 
participants reported that they thought the main message on a warning 
label was to be careful and keep an eye on their infant. In contrast, a 
few participants believed that manufacturers use warning labels to 
protect themselves from liability or litigation. Participants'

[[Page 60957]]

recommendations to improve warning labels included making the labels 
more concise and making the labels ``stand out.'' CPSC staff is working 
with a contractor to develop new safe sleep warnings and messaging, 
potentially across all sleep products. In the future, staff could 
recommend changes in warnings based on this work.

IX. Proposed Amendment to 16 CFR Part 1112 To Include NOR for Infant 
Sleep Products

    The CPSA establishes certain requirements for product certification 
and testing. Products subject to a consumer product safety rule under 
the CPSA, or to a similar rule, ban, standard or regulation under any 
other act enforced by the Commission, must be certified as complying 
with all applicable CPSC-enforced requirements. 15 U.S.C. 2063(a). 
Certification of children's products subject to a children's product 
safety rule must be based on testing conducted by a CPSC-accepted third 
party conformity assessment body. Id. 2063(a)(2). The Commission must 
publish an NOR for the accreditation of third party conformity 
assessment bodies to assess conformity with a children's product safety 
rule to which a children's product is subject. Id. 2063(a)(3). Thus, 
the proposed rule for 16 CFR part 1236, Standard Consumer Safety 
Specification for Infant Sleep Products, if issued as a final rule, 
would be a children's product safety rule that requires the issuance of 
an NOR.
    The Commission published a final rule, Requirements Pertaining to 
Third Party Conformity Assessment Bodies, 78 FR 15836 (March 12, 2013), 
codified at 16 CFR part 1112 (``part 1112'') and effective on June 10, 
2013, which establishes requirements for accreditation of third party 
conformity assessment bodies to test for conformity with a children's 
product safety rule in accordance with section 14(a)(2) of the CPSA. 
Part 1112 also codifies all of the NORs issued previously by the 
Commission.
    All new NORs for new children's product safety rules, such as the 
inclined sleep products standard, require an amendment to part 1112. To 
meet the requirement that the Commission issue an NOR for the inclined 
sleep products standard, as part of this NPR, the Commission proposes 
to amend the existing rule that codifies the list of all NORs issued by 
the Commission to add inclined sleep products to the list of children's 
product safety rules for which the CPSC has issued an NOR.
    Test laboratories applying for acceptance as a CPSC-accepted third 
party conformity assessment body to test to the new standard for 
inclined sleep products would be required to meet the third party 
conformity assessment body accreditation requirements in part 1112. 
When a laboratory meets the requirements as a CPSC-accepted third party 
conformity assessment body, the laboratory can apply to the CPSC to 
have 16 CFR part 1236, Standard Consumer Safety Specification for 
Infant Sleep Products, included in the laboratory's scope of 
accreditation of CPSC safety rules listed for the laboratory on the 
CPSC website at: www.cpsc.gov/labsearch.

X. Proposed Amendment to Definitions in Consumer Registration Rule

    The statutory definition of ``durable infant or toddler product'' 
in section 104(f) applies to all of section 104 of the CPSIA. In 
addition to requiring the Commission to issue safety standards for 
durable infant or toddler products, section 104 of the CPSIA also 
directed the Commission to issue a rule requiring that manufacturers of 
durable infant or toddler products establish a program for consumer 
registration of those products. Public Law 110-314, section 104(d).
    Section 104(f) of the CPSIA defines the term ``durable infant or 
toddler product'' and lists examples of such products, including 
several types of infant sleep products, such as cribs and bassinets and 
cradles. Section 104(f)(2)(A) & (L). As discussed previously, the 
infant sleep products safety standard is an outgrowth of the bassinet 
safety standard. The Supplemental NPR proposes that any infant sleep 
product that is not already subject to a mandatory consumer product 
safety rule for infant sleep, be subject to proposed part 1236, which 
would limit the seat back incline angle to 10 degrees or less. Like 
bassinets, such sleep products are durable products within the meaning 
of section 104 of the CPSIA.
    Because this infant sleep product standard is an outgrowth of the 
bassinet standard, infant sleep products may be considered a sub-
category of bassinets. To provide greater clarity that inclined sleep 
products are durable infant or toddler products, the Commission 
proposes to amend the Commission's consumer registration rule to 
explicitly include infant sleep products.
    In 2009, the Commission issued a rule implementing the consumer 
registration requirement. 16 CFR part 1130. As the CPSIA directs, the 
consumer registration rule requires each manufacturer of a durable 
infant or toddler product to: provide a postage-paid consumer 
registration form with each product; keep records of consumers who 
register their products with the manufacturer; and permanently place 
the manufacturer's name and certain other identifying information on 
the product. When the Commission issued the consumer registration rule, 
the Commission identified six additional products as ``durable infant 
or toddler products'':
    [ssquf] Children's folding chairs
    [ssquf] changing tables;
    [ssquf] infant bouncers;
    [ssquf] infant bathtubs;
    [ssquf] bed rails; and
    [ssquf] infant slings.
    16 CFR 1130.2. The Commission stated that the specified statutory 
categories were not exclusive, but that the Commission should 
explicitly identify the product categories that are covered. The 
preamble to the 2009 final consumer registration rule states: ``Because 
the statute has a broad definition of a durable infant or toddler 
product but also includes 12 specific product categories, additional 
items can and should be included in the definition, but should also be 
specifically listed in the rule.'' 74 FR 68668, 68669 (Dec. 29, 2009).
    In this Supplemental NPR, the Commission proposes to amend the 
definition of ``durable infant or toddler product'' in the consumer 
registration rule to clarify that infant sleep products fall within the 
term ``durable infant or toddler product'' as a subset of bassinets and 
cradles, and must comply with the product registration card rule and 
section 104 of the CPSIA.

XI. Incorporation by Reference

    The Commission proposes to incorporate by reference ASTM F3118-17a, 
with substantial modifications to further reduce the risk of injury. 
The Office of the Federal Register (OFR) has regulations concerning 
incorporation by reference. 1 CFR part 51. For a proposed rule, 
agencies must discuss in the preamble of the NPR ways that the 
materials the agency proposes to incorporate by reference are 
reasonably available to interested persons or how the agency worked to 
make the materials reasonably available. In addition, the preamble of 
the proposed rule must summarize the material. 1 CFR 51.5(a).
    In accordance with the OFR's requirements, section VIII of this 
preamble summarizes the provisions of ASTM F3118-17a that the 
Commission proposes to incorporate by reference. ASTM F3118-17a is 
copyrighted. By permission of ASTM, the standard can

[[Page 60958]]

be viewed as a read-only document during the comment period on this 
NPR, at: https://www.astm.org/cpsc.htm. Interested persons may also 
purchase a copy of ASTM F3118-17 from ASTM International, 100 Bar 
Harbor Drive, P.O. Box 0700, West Conshohocken, PA 19428; https://www.astm.org/cpsc.htm. One may also inspect a copy at CPSC's Office of 
the Secretary, U.S. Consumer Product Safety Commission, Room 820, 4330 
East West Highway, Bethesda, MD 20814, telephone 301-504-7923.

XII. Effective Date

    The Administrative Procedure Act (APA) generally requires that the 
effective date of a rule be at least 30 days after publication of the 
final rule. 5 U.S.C. 553(d). ASTM F3118-17a is a relatively new 
voluntary standard that covers a variety of products whose 
manufacturers may not be aware that their product must comply. The 
Commission is proposing to incorporate by reference ASTM F3118-17a, 
with substantial modifications to further reduce the risk of injury 
associated with infant inclined sleep products. To allow time for 
infant sleep product manufacturers to bring their products into 
compliance after a final rule is issued, the Commission proposes a 12-
month effective date after publication of a final rule, for products 
manufactured or imported on or after that date. Because of the number 
of proposed modifications to ASTM F3118-17a, compliance with the 
mandatory standard may require time beyond the typical 6-month 
effective date for a section 104 rule. The Commission expects that most 
firms should be able to comply within the 12-month timeframe. 
Alternatively, given the hazards involved with infant inclined sleep 
products, the Commission could issue a final rule with a shorter 
effective date so that safer products would be available sooner. The 
Commission requests comments on whether either a longer or shorter 
effective date would be appropriate.

XIII. Regulatory Flexibility Act

A. Introduction

    The Regulatory Flexibility Act (RFA) requires that agencies review 
a proposed rule for the rule's potential economic impact on small 
entities, including small businesses. Section 603 of the RFA generally 
requires that agencies prepare an initial regulatory flexibility 
analysis (IRFA) and make the analysis available to the public for 
comment when the agency publishes an NPR. 5 U.S.C. 603. Section 605 of 
the RFA provides that an IRFA is not required if the agency certifies 
that the rule will not, if promulgated, have a significant economic 
impact on a substantial number of small entities. The IRFA must 
describe the impact of the proposed rule on small entities and identify 
significant alternatives that accomplish the statutory objectives and 
minimize any significant economic impact of the proposed rule on small 
entities. Specifically, the IRFA must contain:
    [ssquf] A description of the reasons why action by the agency is 
being considered;
    [ssquf] a succinct statement of the objectives of, and legal basis 
for, the proposed rule;
    [ssquf] a description of, and where feasible, an estimate of the 
number of small entities to which the proposed rule will apply;
    [ssquf] a description of the projected reporting, recordkeeping, 
and other compliance requirements of the proposed rule, including an 
estimate of the classes of small entities subject to the requirements 
and the type of professional skills necessary for the preparation of 
reports or records; and
    [ssquf] identification, to the extent possible, of all relevant 
federal rules that may duplicate, overlap, or conflict with the 
proposed rule; and
    Additionally, the IRFA must describe any significant alternatives 
to the proposed rule that accomplish the stated objectives of 
applicable statutes and minimize any significant economic impact of the 
proposed rule on small entities.
    CPSC staff prepared an IRFA for this rulemaking which appears at 
Tab F of the Staff Supplemental Briefing Package. We provide a summary 
of the IRFA below.

B. Reasons for Agency Action and Legal Basis for Supplemental NPR

    As explained elsewhere in this preamble, section 104 of the CPSIA 
authorizes the Commission to issue standards for durable infant or 
toddler products and requires that such products comply with product 
registration requirements. The Commission is issuing this Supplemental 
NPR in response to reports of deaths involving inclined sleep products.

C. Supplemental NPR Requirements

    The Supplemental NPR would incorporate by reference the voluntary 
standard for inclined sleep products (ASTM F3118-17a) with substantial 
modifications described in section VIII of this preamble. Products 
subject to the proposed standard would need to have a sleep surface 
angle no greater than 10[deg] and would need to meet the requirements 
of the CPSC standard for bassinets and cradles. If the Commission 
issues a final rule, the proposed rule would become a mandatory 
standard, and firms with a sleep product that is subject to the rule 
would need to evaluate their product, determine what changes would be 
required to meet the standard, and modify the product so that it 
complies with the standard or cease supplying the product to the U.S. 
market. The manufacture or importation of noncompliant products would 
be prohibited after the effective date of the standard. Additionally, 
manufacturers and importers must certify that their products comply 
with applicable children's products safety standards, and this 
certification must be based on testing by a third party. 16 CFR part 
1107.

D. Small Entities Supplying Infant Sleep Products and the Supplemental 
NPR's Impact on Small Businesses

    Since the Commission issued the 2017 NPR, the U.S. inclined sleep 
product market has changed substantially. Manufacturers and importers 
have largely stopped producing for sale most frame-style inclined sleep 
products from the market, including some that were not subject to 
recalls, although one or two types of products remain.\9\ Additionally, 
a significant decline in the infant hammock market has occurred, both 
among larger-scale suppliers and home-based manufacturers.
---------------------------------------------------------------------------

    \9\ Some units may still be available for sale even for products 
that are no longer being produced (this does not include recalled 
models).
---------------------------------------------------------------------------

    As part of the current market evaluation, staff identified 18 firms 
still supplying sleep products to the U.S. market with sleep surface 
angles greater than 10 degrees, but less than or equal to 30 degrees. 
Staff identified an additional firm supplying a sleep product with an 
incline of 10 degrees or less that is not being tested for compliance 
with either the bassinet standard or another sleep product standard 
(and thus, likely would be subject to the Supplemental NPR). Of these 
19 total firms, six appear to be very small, home-based manufacturers 
of infant hammocks (two operating domestically and four overseas).\10\ 
The RFA covers only domestic suppliers. Seven of the 19 firms are not 
as small as the home-based infant hammock

[[Page 60959]]

manufacturers, but would meet the definition of ``small'' domestic 
entities based on U.S. Small Business Administration (SBA) guidelines 
for their North American Industry Classification System (NAICS) codes. 
These seven firms typically have only one inclined sleep model in their 
product lines.
---------------------------------------------------------------------------

    \10\ These suppliers were identified online, and staff believes 
that there may be additional home-based manufacturers supplying 
infant hammocks on a very small scale (possibly including some 
without an on-line presence).
---------------------------------------------------------------------------

    In summary, CPSC staff is aware of nine small domestic firms 
currently marketing products that would be impacted by the Supplemental 
NPR in the United States (two home-based domestic hammock 
manufacturers, four small domestic manufacturers of inclined sleep 
products, and three small importers of inclined sleep products). Staff 
cannot definitively determine the impact of the Supplemental NPR 
because the impact would depend on several unknown factors including:
     How firms respond to the rule (e.g., they would redesign, 
remarket, or drop products subject to the Supplemental NPR);
     The costs associated with redesigning, remarketing, or 
replacing an inclined sleep product;
     The change, if any, on demand for that product.
    Staff estimates that third party testing costs could be $30 to $100 
per sample for the maximum incline test alone, and testing to the 
bassinet standard could add costs up to another $1,000. Reliance on 
third party tests obtained by suppliers as allowed by the component 
part testing rule (16 CFR part 1109) could reduce testing costs to some 
extent. Staff found that third party costs are likely to be significant 
for the two very small home-based manufacturers of infant hammocks if 
they choose to redesign; and costs could be significant for an 
additional two small manufacturers, if they chose to redesign their 
products and testing as few as four units per model were required to 
provide a ``high degree of assurance.''

E. Alternatives

    At least two alternatives are available that could minimize the 
economic impact on small entities while also meeting the statutory 
objectives: \11\ (1) Eliminate the requirement that products must meet 
the bassinet standard if they do not already fall into another sleep 
product standard; or (2) allow a later effective date. However, under 
the first alternative, the cost of redesign would still likely be 
significant. Moreover, the Supplemental NPR is intended to ensure that 
all products providing sleep accommodations for infants meet a base set 
of safety requirements. This alternative would not accomplish this 
goal.
---------------------------------------------------------------------------

    \11\ Staff considered whether adopting the voluntary inclined 
sleeper standard with no modifications might also be an alternative, 
but ruled it out because it would not address the injuries and 
deaths that led to the recent inclined sleeper recalls.
---------------------------------------------------------------------------

    Second, the Commission could also reduce the Supplemental NPR's 
impact on small businesses by setting a later effective date than the 
proposed 12 months. A later effective date would reduce the economic 
impact on firms redesigning their existing products in two ways. Firms 
would be less likely to experience a lapse in production/importation, 
which could result if they are unable to bring their products into 
compliance and certify compliance based on third party tests within the 
required timeframe. Also, firms could spread the costs of developing 
compliant products over a longer time period, thereby reducing their 
annual costs, as well as the present value of their total costs (i.e., 
they could time their spending to better accommodate their individual 
circumstances). The Commission requests comments on the 12-months 
effective date, which was set to help reduce the impact on affected 
firms, as well as feedback on how firms would likely respond to the 
Supplemental NPR.

F. Small Business Impacts of the Accreditation Requirements for Testing 
Laboratories

    In accordance with section 14 of the CPSA, all children's products 
that are subject to a children's product safety rule must be tested by 
a CPSC-accepted third party conformity assessment body (i.e., testing 
laboratory) for compliance with applicable children's product safety 
rules. Testing laboratories that want to conduct this testing must meet 
the NOR pertaining to third party conformity testing. NORs have been 
codified for existing rules at 16 CFR part 1112. Consequently, the 
Commission proposes to amend 16 CFR part 1112 to establish the NOR for 
those testing laboratories that want to test for compliance with the 
infant sleep products final rule (in essence, test for maximum seat 
back angle). This section assesses the impact of the amendment on small 
laboratories.
    A final regulatory flexibility analysis (FRFA) was conducted as 
part of the promulgation of the original 1112 rule (78 FR 15836, 15855-
58), as required by the RFA. Briefly, the FRFA concluded that the 
accreditation requirements would not have a significant adverse impact 
on a substantial number of small laboratories because no requirements 
were imposed on laboratories that did not intend to provide third party 
testing services. The only laboratories that were expected to provide 
such services were those that anticipated receiving sufficient revenue 
from the mandated testing to justify accepting the requirements as a 
business decision.
    Based on similar reasoning, amending the rule to include the NOR 
for the infant sleep product standard will not have a significant 
adverse impact on small laboratories. Moreover, based upon the number 
of laboratories in the United States that have applied for CPSC 
acceptance of the accreditation to test for conformance to other 
juvenile product standards, we expect that only a few laboratories will 
seek CPSC acceptance of their accreditation to test for conformance 
with the infant sleep product standard. Most of these laboratories will 
have already been accredited to test for conformance to other juvenile 
product standards, and the only costs to them would be the cost of 
adding the infant sleep product standard to their scope of 
accreditation, a cost that test laboratories have indicated is 
extremely low when they are already accredited for other section 104 
rules. Consequently, the Commission certifies that the NOR for the 
infant sleep product standard will not have a significant impact on a 
substantial number of small entities.

XIV. Environmental Considerations

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

XV. Paperwork Reduction Act

    This proposed rule contains information collection requirements 
that are subject to public comment and review by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501-3521). In this document, pursuant to 44 U.S.C. 
3507(a)(1)(D), we set forth:
    [ssquf] A title for the collection of information;
    [ssquf] a summary of the collection of information;
    [ssquf] a brief description of the need for the information and the 
proposed use of the information;

[[Page 60960]]

    [ssquf] a description of the likely respondents and proposed 
frequency of response to the collection of information;
    [ssquf] an estimate of the burden that shall result from the 
collection of information; and
    [ssquf] notice that comments may be submitted to the OMB.
    Title: Safety Standard for Infant Sleep Products.
    Description: The Supplemental NPR would incorporate by reference 
ASTM F3118-17a, Standard Consumer Safety Specification for Infant 
Inclined Sleep Products, but with modifications, including to sections 
8 and 9 which contain requirements for marking, labeling, and 
instructional literature. The Supplemental NPR would exclude from the 
rule infant sleep products covered by another mandatory standard for 
sleep products (Section 1.3). However, the Supplemental NPR would 
modify section 5.2 of ASTM F3118-17a to require that accessory, 
compact, infant sleep products, and newborn sleep products meet the 
requirements of the Safety Standard for Bassinets and Cradles (16 CFR 
1218), including the marking, labeling, and instructional requirements. 
These marking, labeling, and instructional requirements fall within the 
definition of ``collection of information,'' as defined in 44 U.S.C. 
3502(3).
    Description of Respondents: Persons who manufacture or import 
infant sleep products.
    Estimated Burden: We estimate the burden of this collection of 
information as follows:

                                                       Table 1--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Number of     Frequency of    Total annual      Hours per     Total burden
                Burden type                       Type of supplier          respondents      responses       responses       response          hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Labeling..................................  Home-based manufacturers....               6               1               6               7              42
                                            Other Suppliers.............              13               1              13               1              13
    Labeling Total........................  ............................  ..............  ..............  ..............  ..............              55
Instructional literature..................  Home-based manufacturers....               6               1              50             300             300
                                                                         -------------------------------------------------------------------------------
    Total Burden..........................  ............................  ..............  ..............  ..............  ..............             355
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Our estimate is based on the following:
    Two groups of quantifiable entities supply infant sleep products to 
the U.S. market that will likely need to make some modifications to 
their existing warning labels to meet the requirements for bassinet and 
cradle warnings. The first group consists of very small home-based 
manufacturers, which may not currently have warning labels on their 
infant sleep products. Similar rulemakings (such as that for sling 
carriers) assumed that it would take home-based manufacturers 
approximately 15 hours to develop a new label. Given that some home-
based manufacturers supply infant sleep products with warning labels 
already, we have estimated approximately 7 hours per response for this 
group of suppliers. Therefore, the total burden hours for very small 
home-based manufacturers is 7 hours per model x 6 entities x 1 models 
per entity = 42 hours.
    The second group of quantifiable entities supplying infant sleep 
products to the U.S. market that will need to make some modifications 
to their existing warning labels are non-home-based manufacturers and 
importers. These firms do not operate at the low production volume of 
the home-based firms. All of the firms in this second group have 
existing warning labels on their products, but not for bassinets and 
cradles and would therefore, have to make label modifications. Given 
that these firms are used to working with warning labels, we estimate 
that the time required to make any modifications now or in the future 
would be about 1 hour per model. Based on an evaluation of supplier 
product lines, each entity supplies an average of 1 model of infant 
sleeper; therefore, the estimated burden associated with labels for 
this second group is 1 hours per model x 13 entities x 1 models per 
entity = 13 hours.
    The total burden hours attributable to warning labels is the sum of 
the burden hours for both entity groups: Very small home-based 
manufacturers (42 burden hours) + non-home-based manufacturers and 
importers (13 burden hours) = 55 burden hours. We estimate the hourly 
compensation for the time required to create and update labels is 
$34.61 (U.S. Bureau of Labor Statistics, ``Employer Costs for Employee 
Compensation,'' March 2019, total compensation for all sales and office 
workers in goods-producing private industries, series id 
CMU201G000200000D: https://www.bls.gov/ncs/). Therefore, the estimated 
annual cost to industry associated with the labeling requirements is 
$1,904 ($34.61 per hour x 55 hours = $1,904). No operating, 
maintenance, or capital costs are associated with the collection.
    The Standard for Bassinets and Cradles (section 9) requires 
instructions to be supplied with the product. As already noted, the 
proposed Safety Standard for Infant Sleep Products requires accessory, 
compact, infant sleep products, and newborn sleep products to meet 
these requirements. Under the OMB's regulations (5 CFR 1320.3(b)(2)), 
the time, effort, and financial resources necessary to comply with a 
collection of information that would be incurred by persons in the 
``normal course of their activities'' are excluded from a burden 
estimate, where an agency demonstrates that the disclosure activities 
required to comply are ``usual and customary.''
    We are unaware of infant sleep products that generally require use 
instructions but lack such instructions. However, it is possible that 
the six home-based manufacturers of infant hammocks may not supply 
instruction manuals as part of their ``normal course of activities.'' 
Based on information collected for the infant slings rulemaking, staff 
tentatively estimates that each small entity supplying homemade infant 
hammocks might require 50 hours to develop an instruction manual to 
accompany their products. These firms typically supply only one infant 
hammock model. Therefore, the costs of designing an instruction manual 
for these firms could be as high as $10,383 (50 hours per model x 6 
entities x 1 models per entity = 300 hours x $34.61 per hour = 
$10,383). Not all firms would incur these costs every year, but new 
firms that enter the market would incur these costs, and this is a 
highly fluctuating market. Other firms are estimated to have no burden 
hours associated with section 9 of the Standard for Bassinets and 
Cradles because any burden associated with supplying instructions with 
infant sleep products would be ``usual and customary'' and not within

[[Page 60961]]

the definition of ``burden'' under the OMB's regulations.
    Based on this analysis, CPSC staff estimates that the Supplemental 
NPR for infant sleep products would impose a burden to industry of 355 
hours at a cost of $12,287 annually.
    In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 
3507(d)), we have submitted the information collection requirements of 
this rule to the OMB for review. Interested persons are requested to 
submit comments regarding information collection by December 12, 2019, 
to the Office of Information and Regulatory Affairs, OMB (see the 
ADDRESSES section at the beginning of this notice).
    Pursuant to 44 U.S.C. 3506(c)(2)(A), we invite comments on:
    [ssquf] Whether the collection of information is necessary for the 
proper performance of the CPSC's functions, including whether the 
information will have practical utility;
    [ssquf] the accuracy of the CPSC's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used;
    [ssquf] ways to enhance the quality, utility, and clarity of the 
information to be collected;
    [ssquf] ways to reduce the burden of the collection of information 
on respondents, including the use of automated collection techniques, 
when appropriate, and other forms of information technology;
    [ssquf] the estimated burden hours required for home-based 
manufacturers to modify warning labels;
    [ssquf] the estimated burden hours associated with label 
modification for non-home-based suppliers, including any alternative 
estimates;
    [ssquf] the estimated burden hours required for home-based 
manufacturers to modify (or, in some cases, create) instruction 
manuals.

XVI. Preemption

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

XVII. Request for Comments

    This Supplemental NPR proposes a rule under section 104(b) of the 
CPSIA to issue a consumer product safety standard for infant sleep 
products, to amend part 1112 to add infant sleep products to the list 
of children's product safety rules for which the CPSC has issued an 
NOR, and to amend part 1130 to identify infant sleep products as a 
durable infant or toddler product subject to CPSC consumer registration 
requirements. The Commission requests comments on the standard's scope 
language; the proposed effective date; the costs of compliance with, 
and testing to, the proposed Safety Standard for Infant Sleep Products; 
and any aspect of this proposal. During the comment period, the ASTM 
F3118-17a Standard Consumer Safety Specification for Infant Inclined 
Sleep Products, is available as a read-only document at: https://www.astm.org/cpsc.htm.
    The Commission requests comments on the following specific issues:
     Products likely to be impacted by the Supplemental NPR, 
including the product categories discussed in the preamble and any 
additional types of products that commenters believe may be impacted by 
the Supplemental NPR.
     How firms with inclined sleep surfaces will likely respond 
to the Supplemental NPR, including suppliers of products with inclines 
above 10 degrees and products with inclines less than or equal to 10 
degrees that do not already comply with the bassinet standard. We would 
also appreciate any information on the possible responses of consumers 
to changes in marketing. Additionally, any information on the 
approximate percentage of revenue attributable to these types of 
products would be valuable. The Commission also requests any 
information regarding the safety of sleep angles in excess of 10 
degrees but less than 20 degrees.
     The impact that promulgating the Supplemental NPR would 
have on the cost of testing and certifying products, particularly on 
small manufacturers and importers. Any information on the number of 
samples that must be tested would be especially helpful. The Commission 
also requests comments on the third party testing costs of the maximum 
incline test in the Supplemental NPR.
     The cost of redesign, the time required for redesign, the 
likely response of manufacturers to the Supplemental NPR's requirements 
(i.e., redesign, remarket, or drop), the possible change in demand due 
to remarketing or changing the sleep surface's degree of incline, the 
cost of (and time required for) remarketing, and (for firms supplying 
comments) the relative significance of inclined sleepers to their total 
revenue. The Commission also requests comments on testing costs, 
including the number of inclined sleeper units that typically need to 
be tested to provide a ``high degree of assurance'' of compliance.
     The age and developmental milestones referenced in the 
scope and definitions of the various infant inclined sleep products 
covered by ASTM F3118-17a. Because this Supplemental NPR proposes to 
address ``infant sleep products'' not already covered by traditional 
sleep products, the Commission is considering removing the upper age 
limit from the scope of the mandatory standard, to accommodate a broad 
scope of infant sleep products within the standard. The Commission's 
consideration is based on the fact that when staff knew the age of an 
infant, twenty percent of the fatalities and injuries involved infants 
6 months and older.
     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). Section XII of this preamble proposes a 12-month effective date 
after publication of a final rule, for products manufactured or 
imported on or after that date, stating that a longer effective date 
than the typical 6 months for a section 104 rule may be necessary 
because of the number of proposed modifications to ASTM F3118-17a. 
Given the hazards involved with infant inclined sleep products, the 
Commission could issue a final rule with a shorter effective date so 
that safer products would be available sooner. The Commission requests 
comments on whether either a longer or shorter effective date would be 
appropriate.
    Comments should be submitted in accordance with the instructions in 
the ADDRESSES section at the beginning of this notice.

List of Subjects

16 CFR Part 1112

    Administrative practice and procedure, Audit, Consumer protection, 
Reporting and recordkeeping requirements, Third party conformity 
assessment body.

[[Page 60962]]

16 CFR Part 1130

    Administrative practice and procedure, Business and industry, 
Consumer protection, Reporting and recordkeeping requirements.

16 CFR Part 1236

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

PART 1112--REQUIREMENTS PERTAINING TO THIRD PARTY CONFORMITY 
ASSESSMENT BODIES

0
1. The authority citation for part 1112 continues to read as follows:

    Authority: Pub. L. 110-314, section 3, 122 Stat. 3016, 3017 
(2008); 15 U.S.C. 2063.

0
2. Amend Sec.  1112.15 by adding paragraph (b)(46) to read as follows:


Sec.  1112.15   When can a third party conformity assessment body apply 
for CPSC acceptance for a particular CPSC rule or test method?

* * * * *
    (b) * * *
    (46) 16 CFR part 1236, Safety Standard for Infant Sleep Products.
* * * * *

PART 1130--REQUIREMENTS FOR CONSUMER REGISTRATION OF DURABLE INFANT 
OR TODDLER PRODUCTS

0
3. The authority citation for part 1130 continues to read as follows:

     Authority:  15 U.S.C. 2056a, 2065(b).

0
4. Amend Sec.  1130.2 by revising paragraph (a)(12) to read as follows:


Sec.  1130.2  Definitions.

* * * * *
    (a) * * *
    (12) Bassinets and cradles, including bedside sleepers and infant 
sleep products;
* * * * *
0
5. Add part 1236 to read as follows:

PART 1236--SAFETY STANDARD FOR INFANT SLEEP PRODUCTS

Sec.
1236.1 Scope.
1236.2 Requirements for infant sleep products.

    Authority: Sec. 104, Pub. L. 110-314, 122 Stat. 3016 (15 U.S.C. 
2056a); Sec. 3, Pub. L. 112-28, 125 Stat. 273.


Sec.  1236.1  Scope.

    This part establishes a consumer product safety standard for infant 
sleep products, including: Frame-type, hammock, compact, and accessory. 
This consumer product safety standard covers all infant sleep products 
that are not covered by another consumer product safety standard, 
including:
    (a) 16 CFR part 1218 Safety Standard for Bassinets and Cradles;
    (b) 16 CFR part 1219 Safety Standard for Full-Size Baby Cribs;
    (c) 16 CFR part 1220 Safety Standard for Non-Full-Size Baby Cribs;
    (d) 16 CFR part 1221 Safety Standard for Play Yards; and
    (e) 16 CFR part 1222 Safety Standard for Bedside Sleepers.


Sec.  1236.2  Requirements for infant sleep products.

    (a) Except as provided in paragraph (b) of this section, each 
infant sleep product must comply with all applicable provisions of ASTM 
F3118-17a, Standard Consumer Safety Specification for Infant Inclined 
Sleep Products (approved on September 1, 2017). The Director of the 
Federal Register approves this incorporation by reference in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy from ASTM 
International, 100 Bar Harbor Drive, P.O. Box 0700, West Conshohocken, 
PA 19428; https://www.astm.org/cpsc.htm. You may inspect a copy at the 
Office of the Secretary, U.S. Consumer Product Safety Commission, Room 
820, 4330 East West Highway, Bethesda, MD 20814, telephone 301-504-
7923, or at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, email 
[email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.
    (b) Comply with ASTM F3118-17a with the following additions or 
exclusions:
    (1) Instead of complying with Introduction of ASTM F3118-17a, 
comply with the following:
    (i) Introduction. (A) This consumer safety specification addresses 
incidents associated with infant inclined sleep products identified by 
the U.S. Consumer Product Safety Commission (CPSC).
    (B) In response to incident data compiled by the CPSC, this 
consumer safety specification attempts to minimize the following: Fall 
hazards, positional asphyxiation, and obstruction of nose and mouth by 
bedding. The purpose of the standard is to address infant sleep 
products not already covered by traditional sleep product standards and 
to prevent deaths due to the use of Infant Sleep Products with a seat 
back angle greater than 10[deg] from the horizontal.
    (C) This consumer safety specification is written within the 
current state-of-the-art of infant sleep product technology and will be 
updated whenever substantive information becomes available that 
necessitates additional requirements or justifies the revision of 
existing requirements.
    (ii) [Reserved].
    (2) In section 1.1 of ASTM F3118-17a, replace the term ``infant 
inclined sleep products'' with ``infant sleep products.''
    (3) In section 1.2 of ASTM F3118-17a, replace the term ``infant 
inclined sleep products'' with ``infant sleep products.''
    (4) Instead of complying with section 1.3 of ASTM F3118-17a, comply 
with the following:
    (i) 1.3 This consumer safety performance specification covers 
products that are not covered by other ASTM standards such as:
    (A) ASTM F1169 Standard Consumer Safety Specification for Full-Size 
Baby Cribs;
    (B) ASTM F406 Standard Consumer Safety Specification for Non-Full-
Size Baby Cribs/Play Yards;
    (C) ASTM F2194 Standard Consumer Safety Specification for Bassinets 
and Cradles; and
    (D) ASTM F2906 Standard Consumer Safety Specification for Bedside 
Sleepers. This consumer safety performance specification covers free 
standing products with an infant sleep surface primarily intended and 
marketed to provide sleeping accommodations for an infant up to 5 
months old or when the infant begins to roll over or pull up on sides, 
whichever comes first. It also covers smaller products intended for 
newborns up to 3 months old or when a newborn begins to wiggle out of 
position or turn over in the product or weighs more than 15 lb (6.8 
kg), whichever comes first. It also covers infant and newborn sleep 
product accessories, which are attached to or supported by, another 
product with the same age or abilities, or both, as the free standing 
products. If the infant sleep product can be converted into a product 
for which another ASTM standard consumer safety specification exists, 
the product shall meet the applicable requirements of that standard.
    (ii) [Reserved].
    (5) In section 1.4 of ASTM F3118-17a, replace the term ``infant 
inclined sleep product'' with ``infant sleep product.''
    (6) Instead of complying with section 2 of ASTM F3118-17a, comply 
with the following:

[[Page 60963]]

    (i) 2. Referenced Documents.
    (ii) 2.1 ASTM Standards.\12\ (A) F406 Standard Consumer Safety 
Specification for Non-Full-Size Baby Cribs/Play Yards;
---------------------------------------------------------------------------

    \12\ For referenced ASTM standard, visit the ASTM website, 
www.astm.org, or contact ASTM Customer Service at [email protected]. 
For Annual Book of ASTM Standards volume information, refer to the 
standard's Document Summary page on the ASTM website.
---------------------------------------------------------------------------

    (B) F1169 Standard Consumer Safety Specification for Full-Size Baby 
Cribs;
    (C) F2194 Consumer Safety Specification for Bassinets and Cradles;
    (D) F2906 Standard Consumer Safety Specification for Bedside 
Sleepers.
    (iii) 2.2 Federal Standards.\13\
---------------------------------------------------------------------------

    \13\ Available from U.S. Government Printing Office 
Superintendent of Documents, 732 N. Capitol St. NW, Mail Stop: SDE, 
Washington, DC 20401, https://www.access.gpo.gov.
---------------------------------------------------------------------------

    (A) 16 CFR part 1218--Safety Standard for Bassinets and Cradles;
    (B) 16 CFR part 1219--Safety Standard for Full-Size Baby Cribs;
    (C) 16 CFR part 1220--Safety Standard for Non-Full-Size Baby Cribs;
    (D) 16 CFR part 1221--Safety Standard for Play Yards; and
    (E) 16 CFR part 1222--Safety Standard for Bedside Sleepers.
    (7) Do not comply with sections 2.3 and 2.4 of ASTM F3118-17a, 
including Figures 1 and 2.
    (8) In section 3.1.1 of ASTM F3118-17a, replace the following 
terms:
    (i) Replace the term ``accessory inclined sleep product'' with 
``accessory infant sleep product.''
    (ii) Replace the term ``inclined sleep product'' with ``infant 
sleep product.''
    (9) In section 3.1.2 of ASTM F3118-17a, replace the following 
terms:
    (i) Replace the term ``compact inclined sleep product'' with 
``compact infant sleep product.''
    (ii) Replace the term ``newborn inclined sleep product'' with 
``newborn infant sleep product.''
    (10) Do not comply with sections 3.1.3 through 3.1.6 of ASTM F3118-
17a.
    (11) Instead of complying with section 3.1.7 of ASTM F3118-17a, 
comply with the following:
    (i) 3.1.7 infant sleep product, n--a freestanding product, intended 
to provide a sleeping accommodation for an infant up to approximately 5 
months of age, that is generally supported by a stationary or rocker 
base and that is not subject to any of the following standards:
    (A) 16 CFR part 1218--Safety Standard for Bassinets and Cradles;
    (B) 16 CFR part 1219--Safety Standard for Full-Size Baby Cribs;
    (C) 16 CFR parts 1220 and 1221--Safety Standard for Non-Full-Size 
Baby Cribs and Play Yards; and
    (D) 16 CFR part 1222--Safety Standard for Bedside Sleepers.
    (ii) [Reserved].
    (12) Do not comply with sections 3.1.7.1 through 3.1.9 of ASTM 
F3118-17a.
    (13) Instead of complying with section 3.1.10 of ASTM F3118-17a, 
comply with the following:
    (i) 3.1.10 newborn sleep product, n--a free standing product, 
intended to provide sleeping accommodations for a newborn up to 
approximately 3 months of age, that is supported by a stationary or 
rocker base and whose seat back length, measured from the bight, is not 
greater than 17 in. (432 mm) and that is not subject to any of the 
following standards:
    (A) 16 CFR part 1218--Safety Standard for Bassinets and Cradles;
    (B) 16 CFR part 1219--Safety Standard for Full-Size Baby Cribs;
    (C) 16 CFR parts 1220 and 1221--Safety Standard for Non-Full-Size 
Baby Cribs and Play Yards; and
    (D) 16 CFR part 1222--Safety Standard for Bedside Sleepers.
    (ii) [Reserved].
    (14) Do not comply with sections 3.1.11 through 3.1.13 of ASTM 
F3118-17a.
    (15) Do not comply with section 5 of ASTM F3118-17a.
    (16) Do not comply with sections 6.1 through 6.8 of ASTM F3118-17a.
    (17) Instead of complying with section 6.9 of ASTM F3118-17a, 
comply with the following:
    (i) 6.9 Maximum Seat Back Angle.
    (ii) 6.9.1 Accessory, Compact, and Infant Sleep Product--The angle 
of the seat back surface intended for sleep along the occupant's head 
to toe axis relative to the horizontal shall not exceed 10[deg] when 
tested in accordance with 7.11.2.
    (iii) 6.9.2 Accessory, Compact, and Newborn Sleep Product--The 
angle of the seat back surface intended for sleep along the occupant's 
head to toe axis relative to the horizontal shall not exceed 10[deg] 
when tested in accordance with 7.11.3.
    (iv) 6.9.3 Accessory, Compact, Infant Sleep Products, and Newborn 
Sleep Products--shall meet requirements of 16 CFR part 1218 Safety 
Standard for Bassinets and Cradles.
    (18) Do not comply with sections 6.10 through 7.10 of ASTM F3118-
17a.
    (19) In section 7.11.2.1 of ASTM F3118-17a, replace ``Infant 
Inclined Sleep Product and Infant Inclined Sleep Product Accessory'' 
with ``Accessory, Compact, Infant Sleep Products, and Newborn Sleep 
Products.''
    (20) In section 7.11.2.1 of ASTM F3118-17a, replace ``If 
applicable, place the product in the manufacturer's recommended highest 
incline angle position.'' with ``If applicable, place the product in 
the manufacturer's recommended highest seat back angle position 
intended for sleep.''
    (21) In section 7.11.3 of ASTM F3118-17a, replace ``Newborn 
Inclined Sleep Product and Newborn Inclined Sleep Product Accessory'' 
with ``Accessory, Compact, Infant Sleep Products, and Newborn Sleep 
Products.''
    (22) Do not comply with sections 7.12 through 9, or the Appendix, 
of ASTM F3118-17a.

Alberta E. Mills,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2019-23724 Filed 11-8-19; 8:45 am]
BILLING CODE 6355-01-P