Safety Standard for Infant Inclined Sleep Products, 16963-16975 [2017-06875]

Agencies

• Consumer Product Safety Commission

[Federal Register Volume 82, Number 66 (Friday, April 7, 2017)]
[Proposed Rules]
[Pages 16963-16975]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-06875]


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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Parts 1112, 1130, and 1236

[CPSC Docket No. 2017-0020]


Safety Standard for Infant Inclined Sleep Products

AGENCY: Consumer Product Safety Commission.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Danny Keysar Child Product Safety Notification Act, 
section 104 of the Consumer Product Safety Improvement Act of 2008 
(CPSIA), requires the United States Consumer Product Safety Commission 
(Commission or CPSC) to promulgate consumer product safety standards 
for durable infant or toddler products. These standards are to be 
``substantially the same as'' 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. The Commission is proposing a safety 
standard for infant inclined sleep products (inclined sleep products) 
in response to the direction under section 104(b) of the CPSIA. In 
addition, the Commission is proposing an amendment to include inclined 
sleep products in the list of notice of requirements (NORs) issued by 
the Commission. The Commission is also proposing to explicitly identify 
infant inclined sleep products as a durable infant or toddler product 
subject to CPSC's consumer registration requirements.

DATES: Submit comments by June 21, 2017.

ADDRESSES: Comments related to the Paperwork Reduction Act aspects of 
the marking, labeling, and instructional literature requirements of the 
proposed mandatory standard for inclined 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 oira_submission@omb.eop.gov.
    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. The Commission does not accept 
comments submitted by electronic mail (email), except through 
www.regulations.gov. The Commission encourages you to submit electronic 
comments by using the Federal eRulemaking Portal, as described above.
    Written Submissions: Submit written submissions by mail/hand 
delivery/courier to: Office of the Secretary, Consumer Product 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 confidential business information, 
trade secret information, or other sensitive or protected information 
that you do not want to be available to the public. If furnished at 
all, such information should be submitted 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: 
ckish@cpsc.gov.

[[Page 16964]]


SUPPLEMENTARY INFORMATION: 

I. Background and Statutory Authority

    The CPSIA was enacted on August 14, 2008. Section 104(b) of the 
CPSIA, part of the Danny Keysar Child Product Safety Notification Act, 
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.
    Section 104(f)(1) of the CPSIA defines the term ``durable infant or 
toddler product'' as ``a durable product intended for use, or that may 
be reasonably expected to be used, by children under the age of 5 
years.'' The definition lists examples of several categories of durable 
infant or toddler products, including bassinets and cradles. Staff 
initially considered inclined sleep products to fall within the scope 
of the bassinet/cradle standard, but as work progressed on that 
standard, it became evident that one rule could not effectively address 
all products. Accordingly, the Commission directed staff to separate 
inclined sleep products into a separate rulemaking effort. Thus, the 
inclined sleep products safety standard is an outgrowth of the 
bassinet/cradle safety standard, addressing products with an incline 
greater than 10 degrees from horizontal. ASTM simultaneously began work 
on developing a voluntary standard for inclined sleep products. ASTM 
published the resulting infant inclined sleep products standard in May 
2015, and most recently revised the standard in January of 2017.
    This proposed rule would establish a standard for inclined sleep 
products as a type of durable infant or toddler product under section 
104 of the CPSIA. Because the inclined sleep product standard is an 
outgrowth of the bassinet/cradle standard, a category that the 
statutory definition of ``durable infant or toddler product'' 
explicitly lists, inclined sleep products could be considered a type of 
bassinet. Section 104(f). Thus, to avoid possible confusion about 
inclined sleep products being a durable infant or toddler product, the 
Commission proposes to amend the definition of ``durable infant or 
toddler product'' in the consumer registration rule to explicitly 
include ``infant inclined sleep products.''
    Pursuant to section 104(b)(1)(A) of the CPSIA, the Commission 
consulted with manufacturers, retailers, trade organizations, 
laboratories, consumer advocacy groups, consultants, and members of the 
public in the development of this notice of proposed rulemaking (NPR), 
largely through the ASTM process.
    Based on a briefing package prepared by CPSC staff, the NPR would 
incorporate by reference the most recent voluntary standard developed 
by ASTM International, ASTM F3118-17, Standard Consumer Safety 
Specification for Inclined Sleep Products, with a modification to the 
standard's definition of ``accessory.'' [https://www.cpsc.gov/s3fs-public/Proposed%20Rule%20-%20Safety%20Standard%20for%20Infant%20Inclined%20Sleep%20Products%20-%20March%2022%2C%202017.pdf] If finalized, the ASTM standard, as 
modified, would be a mandatory safety rule under the Consumer Product 
Safety Act (CPSA).
    The testing and certification requirements of section 14(a) of the 
CPSA apply to the standards promulgated under section 104 of the CPSIA. 
Section 14(a)(3) of the CPSA requires the Commission to publish an NOR 
for the accreditation of third party conformity assessment bodies (test 
laboratories) to assess conformity with a children's product safety 
rule to which a children's product is subject. The proposed rule for 
inclined sleep products, if issued as a final rule, would be a 
children's product safety rule that requires the issuance of an NOR. To 
meet the requirement that the Commission issue an NOR for the inclined 
sleep products standard, this NPR also proposes to amend 16 CFR part 
1112 to include 16 CFR part 1236, the CFR section where the inclined 
sleep products standard will be codified, if the standard becomes 
final.

II. Product Description

A. Infant Inclined Sleep Products, Generally

    There are many different styles of infant inclined sleep products 
available for infants and newborns. These can be categorized as:
    [ssquf] Hammocks (typically constructed of fabric and suspended 
from one or two points, either above or on either side; constructed of 
various materials; generally conform to the shape of the child when 
placed in the product; can either be supported by a frame or other 
structure, such as a ceiling);
    [ssquf] Newborn or infant frame type (intended to be placed on the 
floor; self-supporting; typically use a metal frame with a rigid or 
semi-rigid sleeping surface; base may be stationary or allow side to 
side rocking; may be intended for use by either newborns or infants, or 
both, depending on the size);
    [ssquf] Compact (freestanding with the bottom of the seat a maximum 
of 6 inches above the floor; generally constructed of foam with a fixed 
seat back angle between 10[deg] and 30[deg]; intended to be used on the 
floor); and
    [ssquf] Newborn or infant inclined sleep product accessories 
(intended to provide sleeping accommodations and are attached to or 
supported in some way by another product; a rigid frame product that 
has either a stationary or fixed base and in some cases may be removed 
and used independently; products intended for newborn use have a seat 
back less than 17 inches).
    Products intended for use with newborns are generally similar in 
design to products intended for infants, except that products intended 
for use with newborns have a seat back length of 17 inches or less.

B. Definition of ``Infant Inclined Sleep Product''

    An ``infant inclined sleep product,'' as defined by ASTM F3118-17, 
includes three key components:
    [ssquf] Age of intended product occupant: the product must be 
intended for infants up to five months old (3 months for certain 
smaller products). The product may additionally be intended for older 
children, possibly in a different configuration, provided that its 
intended use also includes children up to five months.
    [ssquf] Sleep: the product must be primarily intended and marketed 
to provide sleeping accommodations.
    [ssquf] Surface incline: the product must have at least one 
inclined sleep surface position that is greater than 10 degrees, but 
less than or equal to 30 degrees.
    In sum, the inclined sleep products standard covers ``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 ASTM standard also covers newborn inclined sleep products, 
compact inclined sleep products, and inclined sleep product 
accessories. According to the ASTM standard, a newborn inclined sleep 
product is a

[[Page 16965]]

``smaller product intended for newborns up to 3 months old or when 
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.'' A compact 
inclined sleep product is ``a free standing infant or newborn inclined 
sleep product having a distance of 6.0 in. or less between the 
underside of the lowest point on the seat bottom and the support 
surface (floor).'' The ASTM standard defines ``infant and newborn 
inclined sleep product accessories'' as products ``which are attached 
to, or supported by, another product with the same age or abilities, or 
both, as the free standing products.'' The ASTM standard currently 
limits inclined sleep product accessories to rigidly framed products, 
but the Commission proposes to modify the definition in ASTM F3118-17 
of ``infant and newborn inclined sleep product accessories'' to remove 
the phrase ``rigidly framed'' so that the standard will include 
recently-identified soft-sided products that attach to cribs and play 
yards.
    The scope section of ASTM F3118-17 further provides that if the 
inclined 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, in addition to 
those of ASTM F3118-17.
    CPSC and ASTM recognize that the scope section of the standard as 
currently written may contain some ambiguity about the meaning of 
``intended and marketed to provide sleeping accommodations.'' CPSC and 
ASTM staff continue to work to reduce this ambiguity to provide greater 
clarity for inclined sleep product suppliers to determine whether their 
products fall within the scope of the ASTM standard. One option would 
be for the standard to clarify ``intended . . . to provide sleeping 
accommodations.'' ASTM and CPSC recognize that infants sleep in many 
products, some of which are designed specifically for sleep, while 
others are designed for other purposes (i.e., infant swings). CPSC 
requests comments on the need to define ``intended or marketed to 
provide sleeping accommodations,'' along with potential definitions of 
that term, as well as whether and the extent to which clarification 
regarding which products constitute multi-use inclined sleep products 
is needed.

III. Incident Data

    The Commission is aware of a total of 657 incidents (14 fatal and 
643 nonfatal) related to infant inclined sleep products, reported to 
have occurred between January 1, 2005 and September 30, 2016. 
Information on 40 percent (261 out of 657) of the incidents was based 
solely on reports submitted to CPSC by manufacturers and retailers 
through CPSC's ``Retailer Reporting System.'' Various sources, such as 
hotlines, internet reports, newspaper clippings, medical examiners, and 
other state and local authorities provided the CPSC with the remaining 
incident reports. Because reporting is ongoing, the number of reported 
fatalities, nonfatal injuries, and non-injury incidents may change in 
the future.

A. Fatalities

    CPSC has reports of 14 fatalities associated with the use of an 
infant inclined sleep product, which occurred between January 1, 2005 
and September 30, 2016.
    [ssquf] Eight of the 14 deaths involved rocker-like inclined sleep 
products.
    [cir] In three cases, the unstrapped decedent was found to have 
rolled over into a face-down position.
    [cir] In two additional cases, the decedent reportedly rolled over 
into a face down position, but no information was available on the use 
of a restraint.
    [cir] For the remaining three cases, there was insufficient 
information about the cause or manner of the deaths.
    [ssquf] Four of the 14 deaths involved reclined infant seat-type 
products.
    [cir] In three cases, the products were placed inside cribs and the 
decedents (two with restraints, one without restraints) were found to 
have rolled over the edge of the products into the bedding in the 
cribs.
    [cir] In the remaining one case, restraints were not used and the 
decedent was found to have rolled over into a face-down position.
    [ssquf] Two of the 14 deaths involved infant hammocks.
    [cir] In one case, the decedent had rolled over on her stomach--
restraint-use not mentioned--and was found face down on a foam 
mattress.
    [cir] In the one remaining case, the decedent was trapped in the 
head down position, with face pressed against bedding material after 
product straps were not assembled correctly, allowing the product to 
tip out of position.

B. Nonfatalities

    CPSC has reports of 643 inclined sleep product-related nonfatal 
incidents that were reported to have occurred between January 1, 2005 
and September 30, 2016. Of the 643 incidents, 301 involved an injury to 
the infant during use of the product. The majority of the injured (256 
out of 301) were between 1 month and 8 months of age. Age was reported 
to be over 8 months for 16 of the injured infants, and was not reported 
for 29 of the injured infants.
    The severity of the injury types among the 301 reported injuries 
were as follows:
    [ssquf] 20 required hospital admissions (17 for respiratory 
problems suffered due to mold on the sleep product, 2 for treatment of 
a head injury due to a fall, and 1 for observation of an infant who had 
stopped breathing for unspecified reasons).
    [ssquf] 27 were treated and released from emergency departments. 
These infants were treated for respiratory problems, head injuries 
(such as a skull fracture or a closed-head injury), contusions/bruises, 
and, in one case, foreign objects (namely, metal shavings from the 
product) that entered the infant's eye.
    [ssquf] 151 required treatment for plagiocephaly (flat head 
syndrome), torticollis (twisted neck syndrome), or both conditions, 
associated with the use of the inclined sleep product.
    [ssquf] 90 were treated for mostly respiratory and some skin 
problems associated with mold on the product.
    [ssquf] Seven infants suffered minor bumps/bruises/lacerations due 
to falls or near-falls.
    [ssquf] Three suffered a combination of respiratory problems along 
with flat head syndrome or fall injuries.
    [ssquf] One eye-burn injury, one thermal burn due to electrical 
overheating, and one abnormal back curvature condition attributed to 
the use of an inclined sleep product.
    The remaining 342 incident reports stated that no injury had 
occurred or provided no information about any injury. However, many of 
the descriptions indicated the potential for a serious injury or even 
death.

C. Hazard Pattern Identification

    CPSC staff considered all 657 reported incidents to identify hazard 
patterns associated with inclined sleep products. ASTM F3118-17 covers 
a variety of products. Some, like hammocks, are suspended in air, while 
other seat-like products are meant to be placed on a level floor 
(although incident reports indicate they often were not). Yet others 
sit as attachments on larger nursery products.
    Because inclined sleep products include a variety of product types, 
staff identified different hazard patterns depending on which product 
was involved and how it was used. CPSC staff identified the following 
hazard patterns associated with inclined sleep products:
    1. Design Problems (75%): 492 incidents fell within this category. 
Staff

[[Page 16966]]

identified two major design issues: (1) Infants reportedly developed 
respiratory and/or skin ailments due to the growth of mold on the 
product; and (2) infants reportedly developed physical deformations 
such as plagiocephaly (flat head syndrome) and/or torticollis (twisted 
neck syndrome) from extended use of the product. Although this category 
does not include any deaths, this category includes 17 hospitalizations 
and 13 emergency department (ED) visits, all for treating respiratory 
problems associated with the use of the inclined sleep product. This 
category also includes an additional 244 non-hospitalized, non-ED 
injuries.
    2. Compromised Structural integrity (5%): 36 incident reports noted 
some level of failure of the product or its components. These failures 
included buckles or straps breaking, pads/seats/liners tearing, 
hardware coming loose, and metal stands/bars and other unspecified 
components breaking. No injuries or fatalities were reported in this 
category.
    3. Inadequate restraints (5%): 35 incidents reportedly occurred 
when the restraint failed to adequately confine the infant in position. 
These incidents include two deaths when an infant, although restrained, 
rolled over, out of position, and ended up with face buried in nearby 
soft bedding. Three of the nine injuries in this category were treated 
in emergency departments and resulted from a strapped-in infant falling 
out of the product entirely.
    4. Electrical issues (3%): 22 incidents involved overheating or 
melting of components such as the vibrating unit, battery cover, 
switch, or motor. One incident resulted in a thermal burn.
    5. Non-product-related/unknown issues (3%): In 18 incidents either 
the manner in which the product was used led to an incident or not 
enough information was available to determine how the incident 
occurred. This category includes 10 fatalities and four injuries. User 
error contributed to six asphyxiation fatalities in this category; all 
decedents were left unstrapped and later found in a prone position. Two 
additional fatalities occurred when an infant rolled out of position 
while in the product; it was unknown if a restraint was used. The 
incident reports did not indicate clearly the circumstances that led to 
the remaining two fatalities. Of the four injuries, staff attributed 
two to user error; staff has very little information about the 
circumstances leading to the remaining two injury incidents.
    6. Infant positioning during use (2%): In 13 reported incidents the 
infant moved into a compromised position. Most of the incidents 
involved hammock-like products, which shifted into a non-level rest 
position as the infant moved. Two infants ended up trapped in a corner 
with face in the fabric/bedding of the product. In two other reports, 
consumers complained of difficulty in preventing the infant from 
getting into a head-to-chin position.
    7. Miscellaneous product-related issues (1%): Nine incident reports 
noted a variety of product-related issues. These included: Complaints 
of poor finish (metal shavings, sharp edges, a threaded needle left in 
the product), instability (product, suspended mid-air, flipping over, 
or product, sitting on floor, tipping over), incomplete packaging 
(missing parts and instructions), and noxious odor. In addition, one 
incident reported both restraint inadequacy and mold growth, indicating 
a design problem. Two injuries were reported in this category, 
including one treated and released from a hospital emergency 
department.
    8. Unspecified falls (1%): In nine incidents, an infant fell from 
the inclined sleep product, but very little information was available 
on the circumstances surrounding the falls. All of the incidents were 
reported through hospital emergency departments and were reports of 
head injuries (skull fracture or closed-head injury) or face contusion. 
One infant was hospitalized while others were treated and released.
    9. Consumer comments (4%): 23 incidents fall in this category. The 
reports consisted of consumer comments/observations of perceived safety 
hazards or complaints about unauthorized sale of infant inclined sleep 
products. None of these reports indicated that any incident actually 
occurred.

D. Product Recalls

    Compliance staff reviewed recalls of infant inclined sleep products 
from May 10, 2000 to March 1, 2016. During that time, there were nine 
consumer-level recalls involving infant inclined sleep products. The 
recalls were conducted to resolve issues involving mold, structural 
stability, entrapment, suffocation, falls, and strangulation. Three 
recalls involved inclined sleep products and six recalls involved 
infant hammocks (which are within the scope of F3118-17).
    One recall for mold affected 800,000 units of infant inclined sleep 
products. Two recalls for entrapment and suffocation affected 195,000 
units of inclined sleep products. The six additional recalls were the 
result of potential suffocation, strangulation, structural stability, 
entrapment, and fall hazards. Those recalls collectively affected 
25,368 hammock units.

IV. International Standards for Inclined Sleep Products

    Other standards include infant inclined sleep products within their 
scope, but these standards are intended primarily to address hazards 
associated with products having flat sleeping surfaces, such as 
bassinets and cradles. These 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 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. 
Upon review, CPSC staff determined that the Canadian regulation 
provides similar performance requirements, but does not provide the 
comprehensive product assessment of the specific hazards identified in 
CPSC incident data that the ASTM standard does.
    [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. Based on evaluation, CPSC staff believes the 
ASTM standard is more inclusive because it includes all hammock styles 
and provides a more comprehensive assessment of potential hazards 
associated with inclined sleep products.
    [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. It is unclear if 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. There are also other 
general provisions such as those for included toys. AS/NZS 4385

[[Page 16967]]

has some similar performance requirements, but is not as comprehensive 
as ASTM F3118 in assessing the potential hazards associated with 
inclined sleep products.

V. 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, CPSC staff 
requested that ASTM 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 F3118-17, was approved on January 1, 2017, and published 
in March of 2017. This is the third revision to the standard since it 
was first published in May 2015.

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

    ASTM F3118-17 includes the following key provisions: Scope, 
terminology, general requirements, performance requirements, test 
methods, marking and labeling, and instructional literature.
    Scope. This section states the scope of the standard, detailing 
what constitutes an infant inclined sleep product. As stated in section 
II.A. of this preamble, the Scope section describes an inclined sleep 
product as ``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.'' This section also states 
that the standard covers newborn inclined sleep products, compact 
inclined sleep products, and inclined sleep products accessories. This 
section further explains that if the inclined 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, in addition to those of ASTM F3118-17.
    Terminology. This section provides definitions of terms specific to 
this standard.
    General Requirements. This section addresses numerous hazards with 
several general requirements, most of which are also found in the other 
ASTM juvenile product standards. The general requirements included in 
this section are:
    [ssquf] Lead in paint;
    [ssquf] Sharp edges or points;
    [ssquf] Small parts;
    [ssquf] Wood parts;
    [ssquf] Scissoring, shearing, and pinching;
    [ssquf] Openings;
    [ssquf] Exposed coil springs;
    [ssquf] Protective components;
    [ssquf] Labeling; and
    [ssquf] Toys.
    Performance Requirements and Test Methods. These sections contain 
performance requirements specific to inclined sleep products (discussed 
here) and the test methods that must be used to assess conformity with 
such requirements.
    [ssquf] Stability: This requirement is intended to prevent inclined 
sleep products from tipping over while in use.
    [ssquf] Unintentional folding: This requirement is intended to 
prevent unintentional folding of the product while it is in use, 
regardless of type of lock/latch the product uses (if any).
    [ssquf] Restraint systems: This requirement is intended to ensure 
the integrity and effectiveness of restraint systems, which (when 
present) must include both a waist and crotch restraint, but not 
shoulder straps. Additionally, the inclined sleep product's restraint 
system must be designed so that the crotch restraint has to be used 
whenever the restraint system is used. The restraint system must be 
attached to the product in one of the manufacturer's recommended use 
positions at the time of shipment.
    [ssquf] Side height: This requirement is intended to prevent falls, 
in conjunction with head, foot, and side containment requirements.
    [ssquf] Head, foot, and side containment: This requirement is 
intended to prevent falls, in conjunction with side height 
requirements.
    [ssquf] Side to side surface containment: This requirement is 
intended to ensure a seat back shape that prevents children from 
rotating into a sideways position.
    [ssquf] Seat back length: This requirement is intended to prevent 
older children from being placed in inclined sleep products intended 
for younger users by restricting the head containment area available on 
the seat back.
    [ssquf] Structural integrity: This requirement is intended to 
ensure that the inclined sleep product remains cohesive after both 
dynamic and static load testing. It is also intended to ensure that the 
product can support the intended user's weight when a safety margin is 
factored in.
    Marking and Labeling. This section contains various requirements 
relating to warnings, labeling, and required markings for inclined 
sleep products. This section prescribes various substance, format, and 
prominence requirements for such information.
    Instructional Literature. This section requires that instructions 
be provided with inclined sleep products and be easy to read and 
understand. Additionally, the section contains requirements relating to 
instructional literature contents and format.

VI. Assessment of the Voluntary Standard ASTM F3118-17

    CPSC staff identified 657 incidents (including 14 deaths) related 
to the use of inclined sleep products. CPSC staff examined the incident 
data, identified hazard patterns in the data, and worked with ASTM to 
develop the performance requirements in ASTM F3118. The incident data 
and identified hazard patterns served as the basis for the development 
of ASTM F3118-15 and F3118-17 by ASTM with CPSC staff support 
throughout the process.
    CPSC believes that the current voluntary standard, ASTM F3118-17, 
addresses the primary hazard patterns identified in the incident data, 
with one modification to the standard's definition of ``accessory.'' 
CPSC concludes that more stringent requirements relating to the 
standard's definition of ``accessory'' would further reduce the risk of 
injury associated with inclined sleep products.
    The following section discusses how each of the identified product-
related issues or hazard patterns listed in section III.C. of this 
preamble is addressed by the current voluntary standard, ASTM F3118-17, 
and discusses the proposed more stringent requirement where 
appropriate:

A. Design Problems

    Incident reports indicate that 75 percent of reported incidents 
were associated with the design of the inclined sleep product. Staff 
identified two major design issues: 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

[[Page 16968]]

related to one particular 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, there 
is no evidence to support this belief. The 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.

B. Inadequate Restraints

    ASTM F3118-17 does not require the inclusion of any type of 
restraint system. However, for products that do include restraints, the 
ASTM standard includes performance requirements to address restraint 
operation and function. Two deaths occurred in an inclined sleep 
product that was recalled during the development of the ASTM voluntary 
standard. The ASTM standards subcommittee developed the restraint 
requirements and containment requirements to address these deaths and 
injuries. The Commission believes that these restraint performance 
requirements adequately address this hazard pattern, and notes that 
these are similar requirements used in other juvenile product safety 
standards.

C. Compromised Structural Integrity

    The incidents included in this category consisted of complaints 
related to buckles/straps breaking, pads/seats/liners tearing, hardware 
coming loose, and metal stands/bars and other unspecified components 
breaking. The static and dynamic load tests included in F3118-17 
address structural integrity in a similar manner to other ASTM juvenile 
product standards. Following evaluation of these tests, the Commission 
believes that these requirements adequately address this hazard 
pattern.

D. Infant Positioning During Use

    Most infant position incidents involved hammock-like products, 
which shifted into a non-level rest position as the infants moved, 
resulting in the infants becoming trapped in a corner with their face 
in the fabric/bedding of the product. Two fatalities occurred in this 
manner. Hazardous positioning involves multiple factors, such as the 
fabric or material used on the product's side, inclusion of a mat or 
mattress, and the infant's ability to reposition in the product. As the 
factors involved in these incidents are complex and not easily 
addressable, ASTM F3118-17 does not include specific performance 
requirements to directly address this scenario at this time. The 
voluntary standard addresses instability with a performance test; 
however, the intent of that test is to address incidents such as 
siblings pulling on the side and tipping the inclined sleep product. 
CPSC will continue to monitor incident data and could consider changes 
to the standard in the future if needed.

E. Non-Product-Related/Unknown

    There were ten fatalities and four injuries in this category. User 
error contributed to six of the asphyxiation fatalities. All decedents 
were left unstrapped and later found in a prone position. ASTM F3118-17 
has requirements for restraints (where the product includes restraints) 
and side containment to prevent infants from moving out of position. In 
addition, CPSC staff has worked with the ASTM subcommittee on the 
warnings and instructions to provide consumers with adequate 
information to use the product correctly.

F. Miscellaneous Product-Related Issues

    CPSC considers incidents in this category (involving such hazards 
as stray objects, incomplete packaging, missing parts, and noxious 
odors) to present manufacturing quality control issues, not safety-
related issues. Therefore, these incidents are not addressable by this 
standard. Requirements relating to other miscellaneous product-related 
issues, such as prevention of rough finishes, sharp edges, and points 
are included in the general requirements of ASTM F3118-17. The 
voluntary standard also includes performance requirements for the 
stability of infant, newborn, and compact inclined sleep products. CPSC 
evaluated these requirements and concludes that they are adequate to 
address this hazard pattern.

G. Electrical Issues

    Since CPSC staff began monitoring the incident reports for inclined 
sleep products, incidents involving electrical issues have risen from 1 
percent to 3 percent of the total reported incidents. One thermal burn 
injury was reported in this category. CPSC staff recently shared this 
new data with the ASTM subcommittee and suggested that electrical 
requirements similar to those in other juvenile products be added to 
F3118. The Commission requests comments regarding inclusion of 
electrical requirements to prevent further additional incidents, such 
as overheating, melting battery compartments, and thermal burns.

H. Unspecified Falls

    There were eight reports of falls from the product with little 
detail on the incidents that led to the injury. Without details, it is 
unclear how the incident occurred or if it would be addressed by any 
performance standard. However, ASTM F3118-17 includes stability and 
containment requirements, as described in earlier sections, which 
address known hazard patterns that could result in falls.

I. Consumer Comments

    This category contained 23 reports from consumers about perceived 
product hazards that did not result in incidents. CPSC staff reviewed 
the reports and determined that the information did not describe a 
hazardous situation or a situation not already addressed in the ASTM 
standard.

VII. Proposed Standard for Infant Inclined Sleep Products

    As discussed in the previous section, most of the requirements of 
ASTM F3118-17 are sufficient to reduce the risk of injury posed by 
inclined sleep products. However, CPSC concludes that the accessory 
definition should be modified by removing ``rigid frame'' from the 
definition to further reduce the risk of injury associated with product 
use. ASTM F3118-17 defines

[[Page 16969]]

``accessory inclined sleep product'' as ``a rigid framed inclined sleep 
product that is intended to provide sleeping accommodations for infants 
or newborns and attaches to or is supported by another product.'' 
During 2016 ASTM subcommittee meetings, CPSC staff became aware of a 
new product that ASTM subcommittee members agreed should be classified 
as an accessory inclined sleep product, except for the fact that the 
product did not have a ``rigid frame.'' The subcommittee members agreed 
that ``rigid frame'' should be removed from the accessory definition. 
CPSC agrees with this approach and therefore proposes to incorporate by 
reference ASTM F3118-17 with a modification that would remove the 
phrase ``rigid frame'' from the definition of ``accessory inclined 
sleep product.''

VIII. Proposed Amendment to 16 CFR Part 1112 To Include NOR for Infant 
Inclined 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 Inclined 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 Inclined Sleep Products, included in the laboratory's scope of 
accreditation of CPSC safety rules listed for the laboratory on the 
CPSC Web site at: www.cpsc.gov/labsearch.

IX. 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:
    (f) Definition Of Durable Infant or Toddler Product. As used in 
this section, the term ``durable infant or toddler product''--
    (1) means a durable product intended for use, or that may be 
reasonably expected to be used, by children under the age of 5 years; 
and
    (2) includes--
    (A) full-size cribs and nonfull-size cribs;
    (B) toddler beds;
    (C) high chairs; booster chairs, and hook-on-chairs;
    (D) bath seats;
    (E) gates and other enclosures for confining a child;
    (F) play yards;
    (G) stationary activity centers;
    (H) infant carriers;
    (I) strollers;
    (J) walkers;
    (K) swings; and
    (L) bassinets and cradles.

Public Law 110-314, section 104(f).
    The infant inclined sleep products safety standard is an outgrowth 
of the bassinet safety standard. When considering the bassinet 
standard, the Commission stated that a separate standard targeted 
specifically to inclined sleep products would more effectively address 
the hazards associated with those products. 77 FR 64055, 64059 (Oct. 
18, 2012). Therefore, CPSC staff began working with ASTM to develop a 
voluntary standard that would cover the wide array of products on the 
market that provide infants and toddlers with inclined sleeping 
environments. Inclined sleep products, like bassinets, are thus durable 
products within the meaning of section 104 of the CPSIA.
    Because the inclined sleep product standard is an outgrowth of the 
bassinet standard, inclined 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 inclined 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

[[Page 16970]]

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 document, the Commission proposes to amend the definition 
of ``durable infant or toddler product'' in the consumer registration 
rule to clarify that inclined sleep products fall within the term 
``durable infant or toddler product'' as used in the product 
registration card rule and section 104 of the CPSIA.

X. Incorporation by Reference

    The Commission proposes to incorporate by reference ASTM F3118-17, 
with one modification to the standard, discussed above. 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 V.B. of this 
preamble summarizes the provisions of ASTM F3118-17 that the Commission 
proposes to incorporate by reference. ASTM F3118-17 is copyrighted. By 
permission of ASTM, the standard can 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.

XI. 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 F3118-17 is a 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 F3118-17, with one modification. To allow 
time for infant inclined sleep product manufacturers to bring their 
products into compliance after a final rule is issued, the Commission 
is proposing an effective date of 12 months after publication of the 
final rule in the Federal Register for products manufactured or 
imported on or after that date. The Commission believes that most firms 
should be able to comply with the 12-month timeframe, but asks for 
comments on the proposed 12-month effective date. We also propose a 12-
month effective date for the amendments to parts 1112 and 1130.

XII. 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. Staff could not rule 
out a significant economic impact for six of the 10 known small 
suppliers of inclined sleep products to the U.S. market. Accordingly, 
staff prepared an IRFA and poses several questions for public comment 
to help staff assess the rule's potential impact on small businesses.
    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
    In addition, 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.

B. Market Description

    The Commission has identified 25 firms supplying inclined sleep 
products to the U.S. market. Sixteen of these firms produce infant 
hammocks. The majority of the 25 known firms (including 12 
manufacturers and five importers) are domestic. The remaining eight 
firms (seven manufacturers and one retailer) are foreign.

C. Reason for Agency Action and Legal Basis for Proposed Rule

    As discussed in section I. of this preamble, section 104 of the 
CPSIA requires the CPSC to promulgate consumer product safety standards 
for durable infant or toddler products that are substantially the same 
as, or more stringent than, the relevant voluntary standard. As 
explained in section IX of this preamble, ASTM's standard for infant 
inclined sleep products developed out of CPSC's efforts on bassinets. 
CPSC and ASTM determined that a separate standard was necessary for 
these products.

D. Impact of Proposed 16 CFR Part 1236 on Small Businesses

    CPSC staff is aware of approximately 25 firms currently marketing 
inclined sleep products in the United States, 17 of which are domestic. 
Under U.S. Small Business Administration (SBA) guidelines, a 
manufacturer of inclined sleep products is considered small if it has 
500 or fewer employees; and importers and wholesalers are considered 
small if they have 100 or fewer employees. Staff limited its analysis 
to domestic firms because SBA guidelines and definitions pertain to 
U.S.-based entities. Based on these guidelines, 14 of the 17 domestic 
firms are small--10 manufacturers and four importers. Additional 
unknown small domestic inclined product suppliers may be operating in 
the U.S. market.
1. Small Manufacturers
i. Small Manufacturers With Compliant Inclined Sleep Products
    Of the ten small manufacturers, three produce inclined sleep 
products that are likely to comply with ASTM F3118-17 which is in 
effect for testing purposes

[[Page 16971]]

under the Juvenile Product Manufactures Association (JPMA) 
certification program. Although only one large firm is currently listed 
on the JPMA Web site as having certified inclined sleep products, we 
expect the products of these three small manufacturers to comply 
because the firms were involved in the standard's development. In 
general, staff expects that small manufacturers whose inclined sleep 
products comply with the current voluntary standard will remain 
compliant with the voluntary standard as it evolves, because they 
follow and, in this case, actively participate in the standard 
development process. Therefore, compliance with the voluntary standard 
is part of an established business practice. ASTM F3118-17 is the 
version of the voluntary standard upon which the staff-recommended 
mandatory standard is based; therefore, we expect these firms are 
already in compliance.
    In light of the expectation that these firms will already be 
complying with ASTM F3118-17 by the time it becomes effective, and that 
none would be impacted by the proposed change to the definition of an 
``accessory inclined sleep product,'' the economic impact of the 
proposed rule should be small for the three small domestic 
manufacturers supplying compliant inclined sleep products to the U.S. 
market.
ii. Small Manufacturers With Noncompliant Inclined Sleep Products
    Seven small manufacturers (two of which would only be included due 
to the proposed change to the definition of an ``accessory inclined 
sleep product'') produce inclined sleep products that do not comply 
with the voluntary standard. CPSC cannot rule out a significant 
economic impact for six small manufacturers, but was able to rule out a 
significant impact for one small manufacturer (one of the manufacturers 
that the standard covers only as a result of CPSC's proposed 
modification). These firms may not be aware of the ASTM voluntary 
standard or may believe that their product falls outside the scope of 
the standard. All six firms are likely to require modifications, some 
of which may be significant, to meet the base requirements of the 
voluntary standard. Four of these firms (two of which would be covered 
by the standard as a result of the proposed modification to the 
standard) may not currently have warning labels or instruction manuals 
for their products, and therefore may be required to make modifications 
to comply with the ASTM standard.
    The extent and cost of the changes that these firms would be 
required to make to comply with the standard cannot be determined and, 
therefore, staff cannot rule out a significant economic impact. 
Additionally, the four firms that do not currently have warning labels 
or instruction manuals for their products appear to very small, 
supplying very few products in very low quantities. The cost of 
developing warning labels and instruction manuals is, therefore, more 
likely to have a significant economic impact on these firms, as their 
resources may be more limited.
    Additionally, staff believes that as many as five of the seven 
firms with noncompliant inclined sleep products may not be aware of the 
inclined sleep products voluntary standard, which could increase the 
time period required for firms to come into compliance. The Commission 
proposes a longer than usual effective date of 12 months to give firms 
time to familiarize themselves with the scope of the new standard and 
develop new/modified products if needed.
    The Commission requests information on the changes that may be 
required to meet the voluntary standard ASTM F3118-17, in particular 
whether redesign or retrofitting would be necessary, as well as the 
associated costs and time frame for the changes.
Third Party Testing Costs for Small Manufacturers
    Under section 14 of the CPSA, when new inclined sleep product 
requirements become effective, all manufacturers will be subject to the 
third party testing and certification requirements under the 1107 rule. 
Third party testing will include any physical and mechanical test 
requirements specified in the final inclined sleep products rule. 
Manufacturers and importers should already be conducting required lead 
testing for inclined sleep products. Third party testing costs are in 
addition to the direct costs of meeting the inclined sleep product 
standard.
    Three of the small inclined sleep product manufacturers are already 
testing their products to verify compliance with the ASTM standard, 
though not necessarily by a third party. For these manufacturers, the 
impact to testing costs would be limited to the difference between the 
cost of third party tests and the cost of current testing regimes. 
Staff contacted manufacturers of inclined sleep products. They estimate 
that third party testing inclined sleep products to the ASTM voluntary 
standard would cost about $300 to $1,000 per model sample. For the 
three small manufacturers that are already testing, the incremental 
costs are unlikely to be economically significant, and informal 
discussions with several firms actively participating in the ASTM 
voluntary standard development process suggest such.
    For the seven small manufacturers that are not currently testing 
their products to verify compliance with the ASTM standard, the impact 
of third party testing, by itself, could result in significant costs 
for one firm. Staff made this determination based on an examination of 
firm revenues from recent Dun & Bradstreet or ReferenceUSAGov reports. 
Although staff does not know how many samples will be needed to meet 
the ``high degree of assurance'' criterion required in the 1107 rule, 
testing costs could exceed one percent of gross revenue with as few as 
four samples tested for this firm (assuming high-end testing costs of 
$1,000 per model sample). Revenue information was not available for the 
four small manufacturers and, therefore, no impact evaluation could be 
made. All four firms are very small, however, so staff cannot rule out 
a significant impact.
    The Commission welcomes comments regarding overall testing costs 
and incremental costs due to third party testing (i.e., how much does 
moving from a voluntary to a mandatory third party testing regime add 
to testing costs, in total and on a per test basis). In addition, the 
Commission welcomes comments regarding the number of inclined sleep 
product units that typically need to be tested to provide a ``high 
degree of assurance.''
2. Small Importers
    Four small importers supply inclined sleep products to the U.S. 
market (two of which are multi-use products that the clarified scope is 
meant to address); none of their products comply with the ASTM 
voluntary standard. Staff has insufficient information to rule out a 
significant impact for these firms, particularly given the lack of 
sales revenue data. Whether there is a significant economic impact will 
depend upon the extent of the changes required to come into compliance 
and the response of their supplying firms. Manufacturers may pass onto 
importers any increase in production costs that manufacturers incur as 
a result of changes made to meet the mandatory standard. These costs 
would include those associated with coming into compliance with the 
voluntary standard, as well as those associated with the proposed 
modification to the voluntary standard.

[[Page 16972]]

    Two of the four known importers are tied directly to their foreign 
suppliers. Therefore, finding an alternative supply source would not be 
a viable alternative. However, the foreign suppliers to these firms may 
have an incentive to work with their U.S. distributors to maintain an 
American market presence. Discontinuing the sale of inclined sleep 
products would likely have a significant impact on one of these firms 
because their entire product line consists of inclined sleep products 
and accessory products. The remaining two small importers do not supply 
many other products, and as a result, discontinuing the sale of 
inclined sleep products could have a significant impact on those firms 
as well.
    As with manufacturers, importers will be subject to third party 
testing and certification requirements, and consequently, will be 
subject to costs similar to those for manufacturers if their supplying 
foreign firm(s) does not perform third party testing. The four known 
small importers do not currently test their products to verify 
compliance with the ASTM standard. Therefore, the full extent of third 
party testing costs would be due to these small importers having to 
comply with a mandatory standard (and not related to CPSC's proposed 
modification to the standard). Based on the revenue data available, it 
does not appear that third party testing will have a significant impact 
on one of the four small importers. However, there was no revenue data 
available for the remaining three small importers of inclined sleep 
products not believed to comply with the voluntary ASTM standard. 
Therefore, we had no basis for evaluating the size of the impact on 
that firm.
3. Summary
    In summary, based upon current information, we cannot rule out a 
significant economic impact for six of the ten firms operating in the 
U.S. market for inclined sleep products. The 12-month proposed 
effective date would help to spread costs over a longer time-frame.
4. Alternatives
    At least three alternatives are available to minimize the economic 
impact on small entities supplying inclined sleep products while also 
meeting the statutory objectives:
i. Adopt ASTM F3118-17 With No Modifications
    Section 104 of the CPSIA requires that the Commission promulgate a 
standard that is either substantially the same as the voluntary 
standard or more stringent if the Commission determines that more 
stringent standards would further reduce the risk of injury. Therefore, 
adopting ASTM F3118-17 with no modifications is the least stringent 
rule that could be promulgated for inclined sleep products. Although it 
would not reduce the testing costs triggered by the rule, this 
alternative would eliminate any economic impact on the two firms that 
would be subject to the rule as a result of the proposed modification 
to the definition of ``accessory inclined sleep product.'' However, 
adopting ASTM F3118-17 with no modifications would not address the risk 
of injuries and death in what are clearly inclined sleep product 
accessories except that they do not have rigid frames. Additionally, 
the impact on one of these firms would be limited to warning label and 
instructional literature changes.
ii. Allow a Later Effective Date
    The Commission could reduce the proposed rule's impact on small 
businesses by setting a later effective date. A later effective date 
would reduce the economic impact on firms 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 believes that the proposed 12-month 
effective date would allow firms that may not be aware of the ASTM 
voluntary standard or may believe that their product falls outside the 
scope of the standard time to make this determination and bring their 
products into compliance. However, an even later effective date would 
further reduce these costs.
iii. Time the Effective Date for Warning Labels and Instruction Manuals 
To Coincide With the Timing of Model Changes in the Durable Nursery 
Product Market
    The Commission could time the effective date for warning labels and 
instruction manuals to coincide with the timing of model changes in the 
durable nursery product market. This alternative may reduce the impact 
on all of the known small businesses supplying inclined sleep products 
to the U.S. market. In particular, this timing could reduce costs 
associated with inventory issues that may result from changes that 
companies may need to make to warning labels and instruction manuals 
that are keyed to model and SKU numbers. The Commission requests 
comments on the extent of cost savings that may result from timing the 
effective date of the rule to coincide with the timing of model changes 
within the industry.

E. Impact of Proposed 16 CFR Part 1112 Amendment on Small Businesses

    This proposed rule would also amend part 1112 to add inclined sleep 
products to the list of children's products for which the Commission 
has issued an NOR. As required by the RFA, staff conducted a Final 
Regulatory Flexibility Analysis (FRFA) when the Commission issued the 
part 1112 rule (78 FR 15836, 15855-58). The FRFA concluded that the 
accreditation requirements would not have a significant adverse impact 
on a substantial number of small testing laboratories because no 
requirements were imposed on test laboratories that did not intend to 
provide third party testing services. The only test 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 16 CFR part 1112 to include 
the NOR for the infant inclined sleep product standard will not have a 
significant adverse impact on small test laboratories. Moreover, based 
upon the number of test laboratories in the United States that have 
applied for CPSC acceptance of accreditation to test for conformance to 
other mandatory juvenile product standards, we expect that only a few 
test laboratories will seek CPSC acceptance of their accreditation to 
test for conformance with the infant inclined sleep product standard. 
Most of these test laboratories will have already been accredited to 
test for conformance to other mandatory juvenile product standards, and 
the only costs to them would be the cost of adding the infant inclined 
sleep product standard to their scope of accreditation. As a 
consequence, the Commission certifies that the proposed NOR amending 16 
CFR part 1112 to include the infant inclined sleep products standard 
will not have a significant impact on a substantial number of small 
entities.

F. Impact of Product Registration Rule, 16 CFR Part 1130, on Small 
Businesses

    As discussed above in Sections I and IX, the Commission proposes to 
amend

[[Page 16973]]

the definition of ``durable infant or toddler product'' in the consumer 
registration rule to reduce any uncertainty as to whether inclined 
sleep products are ``durable infant or toddler products.'' The product 
registration rule requires that firms provide consumers with a postage-
paid consumer registration card with each product, although firms may 
also maintain on-line registration pages as well. The information 
supplied on the cards (but not necessarily the cards themselves) must 
be maintained for a minimum of six years.
    Of the 14 small domestic firms identified by staff as supplying 
inclined sleep products to the U.S. market, it is likely that six will 
not be significantly impacted by the requirements of the product 
registration rule. Four of the six firms supply combination products, 
such as play yards with accessory inclined sleep products that are 
already covered under the product registration rule. All six firms have 
other products that are already subject to the product registration 
rule, as well as on-line product registration sites. Therefore, these 
firms likely already have the infrastructure to maintain the records 
and would, at most, require cards to be printed for, and shipped with, 
their inclined sleep products.
    To comply with the product registration rule, the remaining eight 
firms (most of which produce only infant hammocks on a very small 
scale) would need to develop a postage-paid product registration card 
for their inclined sleep products, include the card with their other 
packaged materials, and develop/maintain a system to store the 
information collected. Each model would require a unique registration 
card that clearly identifies the product (e.g., model name, model 
number, product identification number, or other identifier typically 
used by the firm). For many of the components that would make up the 
cost for firms that supply inclined sleep products to comply with 
product registration card requirements, cost would depend on the number 
of products an inclined sleep products supplier sells annually. Such 
cost components include card design, paper supplies, cutting and 
printing, postage, card attachment to product, and data entry, storage, 
and maintenance for returned cards. The Directorate for Economic 
Analysis's memorandum at Tab F of the staff's briefing package provides 
detailed information on the range of costs for individual elements of 
inclined sleep product suppliers complying with product registration 
card requirements. [https://www.cpsc.gov/s3fs-public/Proposed%20Rule%20-%20Safety%20Standard%20for%20Infant%20Inclined%20Sleep%20Products%20-%20March%2022%2C%202017.pdf] The prices for the 
inclined sleep products supplied by the eight firms likely to be 
impacted by the product registration rule range from $30 to $250. Firms 
selling inclined sleep products on the high end of that range may be 
able to easily absorb these costs if they sell a larger volume (for 
example, a $1.10 per product cost increase represents about 0.004% of a 
$250 inclined sleep product), while it may be more difficult for a 
company selling their inclined sleep products for $30 to absorb or pass 
on their cost increase even if they are a relatively high volume firm 
(a $1.10 per product cost increase represents about 0.037% of a $30 
inclined sleep product).

XIII. 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 proposed rule falls within the categorical exclusion.

XIV. 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;
    [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 Inclined Sleep Products.
    Description: The proposed rule would require each inclined sleep 
product to comply with ASTM F3118-17, Standard Consumer Safety 
Specification for Infant Inclined Sleep Products, with one 
modification. Sections 8 and 9 of ASTM F3118-17 contain requirements 
for marking, labeling, and instructional literature. These requirements 
fall within the definition of ``collection of information,'' as defined 
in 44 U.S.C. 3502(3).
    Description of Respondents: Persons who manufacture or import 
infant inclined 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
                           16 CFR section                              respondents       responses        responses         response          hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
1236...............................................................              25                2               50                1               50
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Our estimate is based on the following:
    Twenty-five known entities supply inclined sleep products to the 
U.S. market may need to make some modifications to their existing 
warning labels. We estimate that the time required to make these 
modifications is about 1 hour per model. Based on an evaluation of 
supplier product lines, each entity supplies an average of 2 models of 
inclined sleep products; therefore, the estimated burden associated 
with labels is 1 hour per model x 25 entities x 2 models per entity = 
50 hours. We estimate the hourly compensation for the time required to 
create and update labels is $33.30 (U.S. Bureau of Labor Statistics, 
``Employer Costs for Employee Compensation,'' September 2016, Table

[[Page 16974]]

9, total compensation for all sales and office workers in goods-
producing private industries: https://www.bls.gov/ncs/). Therefore, the 
estimated annual cost to industry associated with the labeling 
requirements is $1,665 ($33.30 per hour x 50 hours = $1,665). No 
operating, maintenance, or capital costs are associated with the 
collection.
    Section 9.1 of ASTM F3118-17 requires instructions to be supplied 
with the product. 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 
inclined sleep products that generally require use instructions but 
lack such instructions. However, it is possible that some firms selling 
homemade infant hammocks on a very small scale 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. It is uncertain how many homemade infant 
hammock suppliers are in operation at any point in time, but based on 
staff's review of the marketplace, 50 firms seems like a reasonable 
outside bound. 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 $82,550 (50 hours per model x 50 
entities x 1 models per entity = 2,500 hours x $33.02 per hour = 
$82,550). Not all firms would incur these costs every year, but new 
firms that enter the market would and this is a highly fluctuating 
market. Other firms are estimated to have no burden hours associated 
with section 9.1 of ASTM F3118-17 because any burden associated with 
supplying instructions with inclined sleep products would be ``usual 
and customary'' and not within the definition of ``burden'' under the 
OMB's regulations.
    Based on this analysis, staff estimates that the proposed standard 
for inclined sleep products would impose a burden to industry of 2,550 
hours at a cost of $84,915 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 May 8, 2017, 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; and
    [ssquf] the estimated burden hours associated with label 
modification, including any alternative estimates.

XV. 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.

XVI. Request for Comments

    This NPR begins a rulemaking proceeding under section 104(b) of the 
CPSIA to issue a consumer product safety standard for inclined sleep 
products, to amend part 1112 to add inclined 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 inclined sleep products as a 
durable infant or toddler product subject to CPSC consumer registration 
requirements. We invite all interested persons to submit comments on 
any aspect of this proposal. In addition to requests for specific 
comments elsewhere in this NPR, the Commission requests comments on the 
standard's scope language, the proposed effective date, and the costs 
of compliance with, and testing to, the proposed inclined sleep 
products safety standard. During the comment period, the ASTM F3118-17 
Standard Consumer Safety Specification for Infant Inclined Sleep 
Products, is available as a read-only document at: https://www.astm.org/cpsc.htm.
    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.

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

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 and/or test method?

* * * * *
    (b) * * *
    (46) 16 CFR part 1236, Safety Standard for Infant Inclined Sleep 
Products.
* * * * *
0
3. The authority citation for part 1130 continues to read as follows:


[[Page 16975]]


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

0
4. Amend Sec.  1130.2 by adding paragraph (a)(19) to read as follows:

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


Sec.  1130.2  Definitions.

* * * * *
    (a) * * *
    (19) Infant inclined sleep products.
* * * * *
0
5. Add part 1236 to read as follows:

PART 1236--SAFETY STANDARD FOR INFANT INCLINED SLEEP PRODUCTS

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

    Authority: Sec. 104, Pub. L. 110-314, 122 Stat. 3016 (August 14, 
2008); Sec. 3, Pub. L. 112-28, 125 Stat. 273 (August 12, 2011).


Sec.  1236.1  Scope.

    This part establishes a consumer product safety standard for infant 
inclined sleep products, including newborn inclined sleep products, 
compact inclined sleep products, and accessory inclined sleep products.


Sec.  1236.2  Requirements for infant inclined sleep products.

    (a) Except as provided in paragraph (b) of this section, each 
infant inclined sleep product must comply with all applicable 
provisions of ASTM F3118-17, Standard Consumer Safety Specification for 
Infant Inclined Sleep Products (approved on January 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, call 202-741-6030, or go to: https://www.archives.gov/federal_register/code_of_federalregulations/ibr_locations.html.
    (b) Instead of complying with section 3.1.1 of ASTM F3118-17, 
comply with the following:
    (1) 3.1.1 accessory inclined sleep product, n--an inclined sleep 
product that is intended to provide sleeping accommodations for infants 
or newborns and attaches to or is supported by another product.
    (2) [Reserved]

    Dated: April 3, 2017.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2017-06875 Filed 4-6-17; 8:45 am]
 BILLING CODE 6355-01-P