[Federal Register Volume 83, Number 123 (Tuesday, June 26, 2018)]
[Rules and Regulations]
[Pages 29672-29682]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-13556]


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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Parts 1112 and 1235

[Docket No. CPSC-2016-0023]


Safety Standard for Baby Changing Products

AGENCY: Consumer Product Safety Commission.

ACTION: Final rule.

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SUMMARY: The Consumer Product Safety Improvement Act of 2008 (CPSIA) 
requires the United States Consumer Product Safety Commission (CPSC) to 
adopt consumer product safety standards for durable infant or toddler 
products. To comply with the CPSIA, the Commission is issuing a safety 
standard for baby changing products. This rule incorporates by 
reference ASTM F2388-18, Standard Consumer Safety Specification for 
Baby Changing Products for Domestic Use (ASTM F2388-18). In addition, 
this rule amends the regulations regarding third party conformity 
assessment bodies to include the safety standard for baby changing 
products in the list of Notices of Requirements (NORs).

DATES: The rule will become effective on June 26, 2019. The 
incorporation by reference of the publication listed in this rule is 
approved by the Director of the Federal Register as of June 26, 2019.

FOR FURTHER INFORMATION CONTACT: Keysha Walker, Office of Compliance 
and Field Operations, U.S. Consumer Product Safety Commission; 4330 
East-West Highway, Bethesda, MD 20814; telephone: (301) 504-6820; 
email: <a href="/cdn-cgi/l/email-protection#4b001c2a27202e390b283b3828652c243d"><span class="__cf_email__" data-cfemail="5d160a3c3136382f1d3e2d2e3e733a322b">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: 

I. Background and Statutory Authority

    Congress enacted the CPSIA (Pub. L. 110-314, 122 Stat. 3016), 
including the Danny Keysar Child Product Safety Notification Act, on 
August 14, 2008. Section 104(b) of the CPSIA 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. Any standard the Commission adopts under this mandate 
must be substantially the same as the applicable voluntary standard, or 
more stringent than the voluntary standard if the Commission determines 
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,'' and the Commission 
identified baby changing tables as a durable infant or toddler product 
in the product registration card rule codified in 16 CFR 1130.2(a)(14).
    On September 29, 2016, the Commission issued a notice of proposed 
rulemaking (NPR), proposing to incorporate by reference the then-
current voluntary standard for baby changing products, ASTM F2388-16, 
with more stringent requirements for

[[Page 29673]]

structural integrity, restraint system integrity, and warnings on 
labels and in instructional literature. 81 FR 66881. After the 
Commission issued the NPR, ASTM revised the voluntary standard several 
times, as discussed in section V of this preamble, and published the 
current version of the standard, ASTM F2388-18, in March 2018.
    In this final rule, the Commission is incorporating by reference 
ASTM F2388-18, with no modifications, as the mandatory safety standard 
for baby changing products. As section 104(b)(1)(A) of the CPSIA 
requires, CPSC staff consulted with manufacturers, retailers, trade 
organizations, laboratories, consumer advocacy groups, consultants, and 
the public to develop this standard, largely through the ASTM standard-
development process. In addition, this final rule amends the list of 
NORs in 16 CFR part 1112 to include the standard for baby changing 
products. This rule is based on information CPSC staff provided in its 
briefing package, ``Draft Final Rule for Baby Changing Products for 
Domestic Use under the Danny Keysar Child Product Safety Notification 
Act,'' which is available on CPSC's website at: https://cpsc.gov/s3fs-public/Final%20Rule%20-%20Safety%20Standard%20for 
%20Baby%20Changing%20Products %20-
%20June%2013%202018.pdf?ZbvMCsfyQfLFivqHRbFWKclOordsuVeC.

II. Product Description

    ASTM F2388-18 defines a ``changing product'' as ``one of the 
following: changing table, changing table accessory, add-on changing 
unit, contoured changing pad.'' The standard defines each of those 
terms, as follows:
    <bullet> A changing table is ``an elevated, freestanding structure 
generally designed to support and retain a child with a body weight of 
up to 30 lb (13.6 kg) in a horizontal position for the purpose of 
allowing a caregiver to change the child's diaper. Changing tables may 
convert from or to other items of furniture, such as, but not limited 
to, a dresser, desk, hutch, bookshelf, or play yard, may have pull-out 
or drop-down changing surfaces, and may provide storage for diapers and 
diaper products'';
    <bullet> a changing table accessory is ``an accessory that attaches 
to a crib or play yard designed to convert the product into a changing 
table typically having a rigid frame with soft fabric or mesh sides or 
bottom surface, or both'';
    <bullet> an add-on changing unit is ``a rigid addition to or 
separate product used in conjunction with an item of furniture that 
provides barriers to prevent the infant from rolling off the product 
when a diaper is being changed''; and
    <bullet> a contoured changing pad is ``a changing pad designed for 
use on an elevated surface which incorporates barriers to prevent a 
child from rolling off the changing surface.'' \1\
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    \1\ ASTM F2388-18 defines a ``changing pad'' as: ``a flat or 
contoured pad specifically designed for the purpose of changing the 
diaper of a child with a body weight of up to 30 lb (13.6 kg) on an 
elevated surface. The child is placed on the pad during the process 
of changing.''

Changing tables used in public facilities, such as public restrooms, 
are covered by ASTM F2285, Standard Consumer Safety Performance 
Specification for Diaper Changing Tables for Commercial Use, and are 
not subject to ASTM F2388-18 or this final rule.
    Most changing tables and add-on changing units are constructed of 
wood; contoured changing pads often consist of synthetic-covered foam 
with contoured edges; and changing table accessories that attach to a 
play yard or crib generally are constructed of plastic or wood with a 
foam pad. Changing tables come in various designs, some of which 
include drawers, cabinets, or retractable stairs to assist children 
getting onto them.

III. Market Description

    CPSC staff has identified 102 domestic firms that currently supply 
baby changing products to the U.S. market. Eighty-four of the firms (61 
manufacturers and 23 importers or wholesalers) are small, according to 
the U.S. Small Business Administration's (SBA) standards,\2\ and the 
remaining 18 firms are large. In addition, staff identified 17 foreign 
firms that supply baby changing products to the U.S. market, and one 
additional firm for which staff lacked sufficient information to 
determine a location or supply source. Staff also identified numerous 
baby changing products that are manufactured outside the United States 
and bought domestically through online sales.
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    \2\ Under SBA size standards, a baby changing product 
manufacturer is ``small'' if it has 500 or fewer employees, and an 
importer is ``small'' if it has 100 or fewer employees.
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    At the time CPSC staff assessed the baby changing products market, 
staff identified 22 of the 61 small domestic manufacturers, and 10 of 
the 23 small domestic importers and wholesalers, as compliant with the 
ASTM standard for baby changing products (based on firms' assertions of 
compliance, certifications from the Juvenile Products Manufacturers 
Association, or participation in the development of the ASTM changing 
products standard).

IV. Incident Data

A. Summary

    CPSC receives data regarding product-related injuries from several 
sources. One source is the National Electronic Injury Surveillance 
System (NEISS), from which CPSC can estimate, based on a probability 
sample, the number of injuries that are associated with specific 
consumer products that are treated in U.S. hospital emergency 
departments (U.S. EDs) nationwide. Other sources include reports from 
consumers and others through the Consumer Product Safety Risk 
Management System (which also includes some NEISS data) and reports 
from retailers and manufacturers through CPSC's Retailer Reporting 
System--CPSC refers to these sources collectively as Consumer Product 
Safety Risk Management System data (CPSRMS).
    For this rulemaking, CPSC staff reviewed the NEISS and CPSRMS 
databases for incidents involving baby changing products and children 
younger than 3 years old because that age corresponds with the 30-pound 
weight limit in the ASTM standard. See Centers for Disease Control and 
Prevention, the National Center for Health Statistics, Data Table of 
Infant Weight-for-Age Charts, http://www.cdc.gov/growthcharts/html_charts/wtageinf.htm (last visited Apr. 9, 2018).
    The preamble to the NPR summarized reports of incidents involving 
baby changing products that occurred between January 1, 2005 and 
December 31, 2015, which CPSC received through CPSRMS sources. For the 
final rule, CPSC staff has updated this information to reflect one 
reported changing product incident that occurred between January 1, 
2005 and December 31, 2015, but was not included in the NPR, as well as 
new incidents that occurred between January 1, 2016 and November 30, 
2017. In total, CPSC has received 188 reports of incidents involving 
baby changing products that occurred between January 1, 2005 and 
November 30, 2017. These incidents involved 7 fatalities, 31 injuries 
or adverse health problems, 116 incidents that did not result in 
injuries, and 34 incidents for which CPSC did not receive sufficient 
information to determine whether an injury occurred.\3\
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    \3\ The NPR indicated that CPSC had received 182 reports of baby 
changing product-related incidents that occurred between January 1, 
2005 and December 31, 2015, of which 5 were fatal, 30 reported 
injuries, 113 did not result in injuries, and 34 did not provide 
sufficient information to determine whether an injury occurred. 
Since the NPR, CPSC staff identified one additional fatality that 
occurred in 2010, and CPSC received an additional five reports of 
incidents that occurred between January 1, 2016 and November 30, 
2017, of which one was fatal, one reported injuries, and three did 
not result in injuries.

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[[Page 29674]]

    The preamble to the NPR also summarized NEISS estimates for baby 
changing product incidents that occurred between January 1, 2005 and 
December 31, 2014. After the Commission issued the NPR, complete injury 
data became available for 2015 and 2016, and CPSC staff has updated 
this information for the final rule. Including this new data and 
extrapolating from the probability sample, CPSC staff estimates that 
there were 39,010 baby changing product-related injuries to children 
under 3 years old that were treated in U.S. EDs between January 1, 2005 
and December 31, 2016. There was a statistically significant increasing 
linear trend for injuries associated with baby changing products over 
this period. Seventy-six percent of the estimated injuries involved 
children between 0 and 11 months old, and 94 percent of the estimated 
injuries involved children under 2 years old.

B. Fatalities

    CPSC is aware of seven fatal incidents to children under 3 years 
old that occurred between January 1, 2005 and November 30, 2017, 
involving baby changing products. One death involved a 10-month-old 
male who was strangled by a strap hanging from a changing table 
accessory in a play yard while the child was in the play yard beneath. 
Another death involved a 3-month old female who rolled over and 
compressed her neck on the changing table ledge, resulting in 
suffocation. The remaining five reported deaths involved children 
sleeping on baby changing products, which is not their intended use. 
All of the victims in these incidents were younger than 1 year old.
    One of these incidents involved a 4-month-old male who was sleeping 
on a changing pad in a crib and died from positional asphyxia when his 
head hung over the raised side of the changing pad. Another incident 
involved a 3-day-old female, who died while sleeping on the changing 
portion of a play yard; her death was determined to be the result of 
mechanical asphyxia from being swaddled too tightly in a sleep sack. 
The remaining three sleep-related deaths involved babies (ages 6 weeks, 
2 months, and 2 months) sleeping in the changing accessory portion of a 
play yard.

C. Nonfatal Injuries

    The injuries and treatments reported through NEISS for 2015 and 
2016 were consistent with those for 2005 through 2014, described in the 
NPR. In 94 percent of cases between 2005 and 2016, the patient was 
treated in the U.S. ED and released; in 5 percent of cases, the child 
was hospitalized. The most commonly injured body parts were the head 
(71 percent for 2005-2014; 73 percent for 2015-2016) and face (13 
percent for 2005-2014; 12 percent for 2015-2016). The most common types 
of injuries were injuries to internal organs (50 percent for 2005-2014; 
53 percent for 2015-2016), contusions and abrasions (27 percent for 
2005-2014; 29 percent for 2015-2016), and fractures (9 percent for 
2005-2014; 8 percent for 2015-2016).

D. Hazard Patterns

    The hazards reported in the new incidents are consistent with the 
hazard patterns staff identified in the incidents presented in the NPR. 
The fatal incidents are discussed above, and primarily involved 
suffocation or asphyxia when babies were sleeping on baby changing 
products.
    As reported in the NPR, structural integrity issues were the 
primary hazard associated with nonfatal incidents. Incident reports 
CPSC received after the NPR, for incidents that occurred between 
January 1, 2016 and November 30, 2017, also involved structural 
integrity issues. Three of the four nonfatal incidents that occurred 
between January 1, 2016 and November 30, 2017, were related to 
structural integrity. These incidents involved: A wooden shelf on the 
bottom of the changing table that fell because the small pins were too 
weak to keep the shelf in place; drawers falling out of a changing 
table; and bolts falling out. The fourth incident involved an 11-month-
old male who fell off of a changing table when his caregiver was 
distracted.

V. ASTM F2388-18

    In this final rule, the Commission incorporates by reference ASTM 
F2388-18. The Commission is incorporating by reference ASTM F2388-18 
because it includes provisions that are the same as, or consistent 
with, the requirements proposed in the NPR, and CPSC staff believes 
that the standard addresses the hazards associated with baby changing 
products.

A. History of ASTM F2388

    ASTM F2388, Standard Consumer Safety Specification for Baby 
Changing Products for Domestic Use, is the voluntary standard that 
addresses the hazard patterns associated with the use of baby changing 
products (in domestic settings). ASTM first approved and published the 
standard in 2004, as ASTM F2388-04, Standard Consumer Safety 
Specification for Baby Changing Tables for Domestic Use. ASTM has 
revised the standard several times since then. In the NPR, the 
Commission proposed to incorporate by reference ASTM F2388-16, with 
modifications.
    After the Commission issued the NPR, ASTM revised ASTM F2388 three 
times. CPSC staff worked with representatives of manufacturers, 
consumer groups, retailers, and other industry members and groups on 
the ASTM subcommittee for baby changing products to develop 
requirements to address the hazards associated with baby changing 
products, including issues raised in the NPR. CPSC staff also 
participated in the ASTM Ad Hoc Committee on Standardized Wording for 
Juvenile Product Standards (Ad Hoc TG) to finalize recommendations for 
warning labels, entitled, ``Recommended Language Approved by Ad Hoc 
Task Group, Revision C'' (November 10, 2017), to provide consistent and 
effective warnings for juvenile product standards. The most recent 
version of the standard, ASTM F2388-18, reflects the work of these 
groups. ASTM approved ASTM F2388-18 on February 15, 2018, and published 
it in March 2018.

B. ASTM F2388-18: Comparison With the NPR and Assessment of 
Requirements

    In the NPR, the Commission proposed to incorporate by reference 
ASTM F2388-16, which addressed many of the hazard patterns associated 
with baby changing products, with modifications to four areas of the 
standard. Specifically, the Commission proposed more stringent 
requirements than those in ASTM F2388-16 for structural integrity, 
restraint systems, warnings on labels, and instructional literature.
    The requirements in ASTM F2388-18 are largely the same as those the 
Commission proposed in the NPR. ASTM F2388-18 includes the same scope, 
definitions, general requirements (e.g., small parts; openings), 
performance requirements, and test methods that the Commission proposed 
incorporating by reference from ASTM F2388-16. In addition, ASTM F2388-
18 includes modifications to reflect the more stringent requirements 
the Commission proposed in the NPR, to address comments filed in 
response to the NPR, and to provide additional detail and clarity. The 
following discussion compares the areas in which the NPR and ASTM 
F2388-18 differ, describes the more stringent

[[Page 29675]]

requirements in the NPR and ASTM F2388-18, and provides CPSC staff's 
assessment of the ASTM F2388-18 provisions.
1. Definitions
    ASTM F2388-18 includes six definitions that were not in ASTM F2388-
16, two of which are consistent with definitions the Commission 
proposed in the NPR. In the NPR, the Commission proposed to define 
``key structural elements'' and ``non-rigid add-on changing unit 
accessory.'' ASTM F2388-18 includes these definitions, but uses the 
term ``changing table accessory'' instead of ``non-rigid add-on 
changing unit accessory.'' In addition, ASTM F2388-18 defines the terms 
``changing product,'' ``protective component,'' ``secondary support 
component,'' and ``threaded fastener.'' As explained below, the 
Commission concludes that these definitions are appropriate and provide 
additional clarity.
    ASTM F2388-18 defines ``changing product'' to clarify that this 
general term, used in the title of the standard and throughout the 
standard, encompasses changing tables, changing table accessories, add-
on changing units, and contoured changing pads. Although the Commission 
did not propose to define this term in the NPR, the NPR did use 
``changing products'' as the general term encompassing all products 
subject to the standard and the proposed rule, which included each of 
the products listed in the ASTM F2388-18 definition. Accordingly, this 
definition is appropriate and provides clarity about the products that 
are subject to the standard.
    ASTM F2388-16 (and the NPR, through proposed incorporation by 
reference) used the term ``protective component,'' although that 
version of the standard did not define it. ASTM F2388-16 described 
protective components as ``caps, sleeves, or plugs used for protection 
from sharp edges, points or entrapment of fingers and toes.'' The 
definition in ASTM F2388-18 is nearly identical to this description, 
stating ``any component used for protection from sharp edges, points or 
entrapment of fingers or toes.'' Consequently, this definition is 
accurate and adds clarity to the standard.
    Although the Commission did not propose to define ``secondary 
support component'' in the NPR, the NPR did propose requirements 
regarding secondary support straps, and the preamble to the NPR 
described the feature as ``a metal band that runs under the center of 
the changing surface to provide additional support'' that is installed 
by consumers when assembling a baby changing product. 81 FR at 66888. 
ASTM F2388-18 defines a ``secondary support component'' as ``a strap, 
bar, rod, or other component that is consumer installed and provides 
added support, to the changing surface of the changing table.'' Because 
these descriptions are consistent, this definition is appropriate, and 
it provides added clarity to include an explicit definition in the 
standard.
    Similarly, the Commission did not propose to define ``threaded 
fastener'' in the NPR, but the NPR did describe threaded fasteners as 
products, such as wood or sheet metal screws, metal inserts, and 
machine screws, which allow consumers to assemble and disassemble 
products. 81 FR at 66887. ASTM F2388-18 defines a ``threaded fastener'' 
as ``a discrete piece of hardware that has internal or external screw 
threads which is used for the assembly of multiple parts and 
facilitates disassembly.'' This definition is consistent with the NPR 
description, indicating that the definition is accurate, and including 
it in the standard provides clarity.
2. Scissoring, Shearing, and Pinching
    ASTM F2388-18 requires baby changing products to be designed to 
prevent injuries from scissoring, shearing, or pinching, and includes a 
method of assessing compliance with this requirement (which consists of 
admitting a probe of particular dimensions). ASTM F2388-16 did not 
include requirements regarding scissoring, shearing, and pinching, and 
the Commission did not propose additional requirements to address these 
hazards in the NPR. However, these requirements are appropriate in 
light of other durable infant and toddler product standards. The 
scissoring, shearing, and pinching provisions in ASTM F2388-18 are 
identical to those in other ASTM durable infant and toddler product 
standards (e.g., high chairs, infant walkers, full-size baby cribs, 
play yards) that have the potential for these injuries. Accordingly, 
these requirements are appropriate to address a hazard common across 
products.
3. Self-Folding Steps
    ASTM F2388-18 includes two distinct methods of assessing the single 
action release mechanism on self-folding steps, depending on the type 
of action necessary to release the mechanism. In ASTM F2388-16, the 
test for assessing self-folding steps on a baby changing product 
applied to all products with self-folding steps that had a ``single 
action release mechanism.'' The test involved applying a force of 10 
lbf (45 N) to the locking or latching mechanism. The NPR proposed to 
incorporate this requirement by reference, without modification. ASTM 
F2388-18 retains this test for mechanisms that require a ``pull or push 
action,'' and adds a duration for applying the force. Specifying a test 
duration is helpful to provide clarity about the test procedure.
    ASTM F2388-18 also includes a different test for self-folding steps 
with a release mechanism that requires a ``twist or turn action'' to 
release, which was not in ASTM F2388-16 and was not proposed in the 
NPR. For steps with this mechanism, testers must apply a torque of 4 
lb-in. (0.5 N-m) to the mechanism. This separate test is appropriate to 
better reflect and assess the different types of release mechanisms on 
self-folding steps.
4. Structural Integrity Requirements
    In the NPR, the Commission proposed more stringent requirements in 
two areas to address structural integrity issues--threaded fasteners 
and secondary support straps. First, the Commission proposed 
requirements for threaded fasteners, to provide secure connections 
between fasteners and key structural elements of changing tables and 
products. Specifically, the Commission proposed to:
    <bullet> Prohibit the use of threaded fasteners, such as wood 
screws or sheet metal fasteners, directly into wood components that are 
key structural elements assembled by consumers;
    <bullet> require a means of preventing manufacturer-installed metal 
threaded fasteners used in key structural elements from loosening (such 
as with lock washers); and
    <bullet> require a means of preventing manufacturer-installed metal 
inserts in key structural elements from loosening (such as by gluing).

The Commission proposed these limits for key structural elements, such 
as primary changing surface supports and side, end, base, and leg 
assemblies to address the stability of components that support the 
weight of occupants.
    ASTM F2388-18 includes the same requirements regarding threaded 
fasteners as the Commission proposed in the NPR, as well as two 
additions. As one minor addition, ASTM F2388-18 includes additional 
detail about the features that are ``non-key structural elements,'' and 
therefore, not subject to the threaded fastener requirements. 
Specifically, where the NPR listed drawers, secondary supports, storage 
components, and accessory items, ASTM F2388-18 lists these as well as

[[Page 29676]]

other examples, such as fasteners that attach contoured pads and add-on 
changing units to supporting furniture (section 5.8.1.1). This 
additional detail is consistent with the requirements proposed in the 
NPR, which will improve the structural integrity of baby changing 
products. ASTM F2388-18 also specifies that the prohibition of threaded 
fasteners on key structural elements assembled by consumers does not 
apply to products that are also clothing storage units, because those 
products fall under the scope of ASTM F2057, Safety Specification for 
Clothing Storage Units. This added exemption is acceptable because 
incident data indicate that the products that were involved in 
structural integrity incidents associated with fasteners were 
traditional stand-alone changing products, and not clothing storage 
units, such as dressers.
    Second, the Commission proposed to adopt the structural integrity 
testing required in ASTM F2388-16, but modified the test to specify 
that consumer-installed secondary support straps must not be installed 
for the test. This would reflect the less-structurally sound condition 
the product may be in when consumers use it without installing the 
secondary support strap or install the strap incorrectly.
    ASTM F2388-18 includes the same provisions proposed in the NPR. The 
only minor difference is that where the NPR used the term ``secondary 
support straps or bars,'' ASTM F2388-18 uses ``secondary support 
components.'' The meaning of these terms is the same, and these 
requirements are appropriate to provide greater product stability.
5. Restraint System Requirements
    ASTM F2388-16, the NPR, and ASTM F2388-18 do not require baby 
changing products to include restraint systems. However, to ensure that 
restraints function effectively if provided, in the NPR, the Commission 
proposed to require testing of restraint systems. The proposed test 
required any restraint provided with a baby changing product to be 
secured on a CAMI dummy and pulled in four directions anticipated 
during normal use with a 30 pound force. To pass this performance 
standard, straps and buckles were required not to break or separate 
from baby changing products more than 1 inch from their initial 
adjustment positions.
    ASTM F2388-18 includes the same restraint system testing 
requirements as those proposed in the NPR. Accordingly, these 
requirements are appropriate to reduce the hazards associated with 
ineffective restraints.
6. Warning Label Requirements
    In the NPR, the Commission proposed more stringent warning label 
content and format requirements than those in ASTM F2388-16. With 
respect to content, the NPR proposed to require on-product warning 
labels specifically addressing fall hazards, proper securement of 
attachable changing products, and the suffocation hazard if babies 
sleep on a changing product. With respect to form, the NPR proposed to 
include form requirements for warnings, to increase the likelihood that 
consumers would notice, read, and follow the warnings. The requirements 
for warning format proposed in the NPR were drawn from the Ad Hoc TG 
recommendations, which were under development at the time.
    ASTM F2388-18 includes labeling requirements that are the same as 
those proposed in the NPR. ASTM F2388-18 includes some minimal 
modifications that do not notably alter the requirements. For example, 
ASTM F2388-16 and the NPR specified that changing accessories sold with 
non-full-size cribs and play yards were exempt from the requirement to 
mark manufacturer and manufacturing date information on the product and 
retail package because they were subject to another ASTM standard with 
similar requirements. ASTM F2388-18 extends this exemption to 
accessories sold with full-size cribs, as well. This does not reduce 
the stringency of the requirement because full-size cribs are also 
subject to another ASTM standard that addresses this information. As 
another example, ASTM F2388-18 includes more example figures of 
warnings than the NPR provided, which clarify the meaning of some 
requirements and provide examples of additional combinations of warning 
statements. Additionally, ASTM F2388-18 includes a note, explaining 
what ``address'' means in the requirement that product warnings 
``address'' specified information. The NPR also required warnings to 
``address'' specific information, but did not explicitly define that 
term. This explanatory note is useful and including it aligns with the 
Ad Hoc TG recommendations.
7. Instructional Literature Requirements
    In the NPR, the Commission proposed more stringent requirements for 
instructional literature, including format requirements consistent with 
those for on-product warnings, a requirement that instructions be in 
English (at a minimum), and that additional labels must not contradict 
the meaning of required information. Additionally, the Commission 
proposed to include a note in the regulatory text, referencing ANSI 
Z535.6, Product Safety Information in Product Manuals, Instructions, 
and Other Collateral Materials (ANSI Z535.6; available at: http://www.ansi.org/), for optional additional guidance about the design of 
product safety messages in instructional literature.
    The instructional literature requirements in ASTM F2388-18 are 
consistent with those in the NPR, with minor adjustments to align with 
the Ad Hoc TG recommendations. For example, where the NPR required 
warnings in instructions to align with the on-product warning format 
requirements generally, ASTM F2388-18 includes an equivalent 
requirement, but exempts warnings in instructions from distinctiveness 
and color requirements. These requirements are appropriate because they 
are consistent with the NPR and the Ad Hoc TG recommendations.

VI. Comments Filed in Response to the NPR

    CPSC received nine comments in response to the NPR. The comments 
are available in the docket for this rulemaking, CPSC-2016-0023, at: 
www.regulations.gov. A summary of the comments, grouped by topic, and 
CPSC staff's responses are below.

A. Postpone Rulemaking

    Summary of Comment: Comments recommended that the Commission delay 
issuing a final rule or issue a supplemental NPR because ASTM's then-
upcoming 2017 revisions to the standard likely would address the 
concerns raised in the NPR.
    Response: ASTM has updated its standard several times since the 
NPR, and approved ASTM F2388-18 on February 15, 2018. ASTM F2388-18, 
which the Commission is incorporating by reference without 
modification, addresses the issues raised in the NPR. As discussed in 
section V of this notice, the requirements in ASTM F2388-18 align with 
the requirements in the NPR, making a supplemental NPR unnecessary.

B. Wood Screws

    Summary of Comment: Comments requested that the Commission only 
apply the wood screw restriction to ``open frame'' products, or exclude 
from the wood screw restrictions furniture, such as dressers, that 
include barriers or a changing pad. Commenters stated that incident 
data does not indicate that these types of products are involved in 
incidents. Commenters stated that

[[Page 29677]]

furniture is often sold unassembled and consumers use wood screws to 
assemble it, making it difficult for such products to comply with the 
wood screw restriction. Commenters noted that the ASTM subcommittee 
considered excluding these types of furniture from the wood screw 
restriction. One commenter recommended removing the wood screw 
restriction and, instead, relying on the structural performance tests 
in the standard.
    Response: Consistent with these comments, ASTM F2388-18 excludes 
changing tables that are also clothing storage units (such as dressers) 
from the wood screw restriction. This exclusion is reasonable because 
incident data indicate that fastener failures occur in open-frame 
changing tables, rather than changing tables that are also clothing 
storage units. In addition, changing tables that are also clothing 
storage units are subject to requirements in ASTM F2057, Safety 
Specification for Clothing Storage Units. For all other changing 
tables, ASTM F2388-18 prohibits the use of wood screws on key 
structural elements, consistent with requirements in other ASTM durable 
infant or toddler product standards, such as cribs and high chairs. 
This requirement is good engineering practice and addresses incidents 
in which a changing product collapsed due to wood screws coming out or 
missing from the product.

C. Metal Inserts

    Summary of Comment: Comments opposed the proposal to require glue 
or other locking means for metal inserts. Commenters stated that glue 
inside the insert can result in assembly difficulties for consumers, is 
design restrictive, and unnecessary. In addition, one commenter 
requested definitions of ``key structural elements'' and ``threaded 
fasteners'' to clarify which products and features would be subject to 
the requirement.
    Response: This requirement is similar to requirements in other ASTM 
durable infant or toddler product standards (such as cribs and high 
chairs), is good engineering practice, and addresses structural 
integrity issues identified in incident data. CPSC staff does not 
consider the wording ``. . . shall be glued or include other means to 
impede loosening or detaching'' to be design restrictive because it 
provides manufacturers with flexibility to meet the requirements by any 
means (glue is just an example of how the requirement can be met). In 
addition, to provide clarity about the features subject to this 
requirement, ASTM F2388-18 includes definitions for ``key structural 
elements'' and ``threaded fasteners.''

D. Restraints

    Summary of Comment: A comment requested that the Commission require 
baby changing products to include restraint straps, rather than allow 
them to be optional. The commenter stated that barriers are not 
sufficient to prevent children from rolling off of products and that 
there are restraint designs that would not interfere with changing a 
diaper.
    Response: Restraints may give caregivers a sense of safety, 
diminishing their attentiveness, and increasing potential hazards. For 
example, if caregivers believe that restraint straps provide safety, 
they may leave a child unattended on a changing table, and an 
unattended child in a restraint consisting of a single waist strap is 
exposed to a potential strangulation hazard. As such, the Commission 
does not believe it is appropriate to require restraints at this time. 
Moreover, incident data indicate that restraint failures involve 
restraints detaching from the product, or straps or buckles breaking. 
The final rule addresses these demonstrated hazards by requiring that 
if restraints are provided, they must be tested to ensure they are 
effective.

E. Warnings

    Summary of Comment: A comment suggested that the Commission require 
pictograms in warnings to convey the hazards associated with baby 
changing products.
    Response: The commenter did not provide recommended pictograms for 
staff to evaluate. CPSC's Division of Human Factors staff believes that 
a well-developed and tested pictogram can increase comprehension, but 
designing effective, understandable graphics can be difficult. Readers 
do not properly understand some seemingly obvious graphics, which can 
result in misinterpretations.

F. Effective Date

    Summary of Comment: CPSC received comments about the proposed 6-
month effective date. One comment, submitted by three consumer advocate 
groups, supported the 6-month effective date. Two commenters requested 
a longer effective date (one firm requested 1 year and the other at 
least 1 year). The latter two commenters expressed concern that six 
months would not provide adequate time for producers to modify their 
products, and one of the commenters noted that some manufacturers 
``purchase their materials as a single order to cover an entire year,'' 
which would be problematic if these firms need to change their products 
sooner than that.
    Response: The Commission generally considers 6 months an 
appropriate effective date for rules issued under section 104 of the 
CPSIA, but recognizes that longer effective dates minimize the impact 
on affected firms. As the final regulatory flexibility analysis for 
this rule explains, the final rule could have a significant economic 
impact on as much as 43 percent of the small firms that supply baby 
changing products to the U.S. market. Many of those firms may not be 
aware of the ASTM voluntary standard for changing products or this 
rulemaking. Accordingly, the Commission is providing a longer effective 
date for the final rule than proposed in the NPR. The rule will take 
effect 12 months after publication of this final rule.

G. Miscellaneous

    Summary of Comment: A comment stated that a mandatory standard for 
baby changing products would not reduce the risk of fatalities because 
the fatalities reported to CPSC involved babies sleeping on products, 
which is not their intended use.
    Response: As the Division of Human Factors memorandum in the NPR 
briefing package explained, the fatal incidents involving baby changing 
products suggest that caregivers may mistake changing accessories for 
sleep surfaces. To address this issue and reduce the risk associated 
with babies sleeping on baby changing products, the NPR proposed and 
the final rule requires baby changing products to bear warnings 
specifically cautioning against allowing babies to sleep on the 
products. The Commission believes that this will reduce the risk of 
such foreseeable misuse and the resulting injuries and deaths.

VII. Incorporation by Reference

    The Office of the Federal Register (OFR) has regulations regarding 
incorporation by reference. 1 CFR part 51. These regulations require 
the preamble to a final rule to summarize the material and discuss the 
ways in which the material the agency incorporates by reference is 
reasonably available to interested persons, and how interested parties 
can obtain the material. 1 CFR 51.5(b). In accordance with the OFR 
regulations, this section summarizes ASTM F2388-18, and describes how 
interested parties may obtain a copy of the standard.
    ASTM F2388-18 contains requirements concerning:

<bullet> Sharp points and edges;
<bullet> small parts;
<bullet> surface coatings;
<bullet> wood parts;

[[Page 29678]]

<bullet> openings;
<bullet> toys;
<bullet> threaded fasteners;
<bullet> protective components;
<bullet> scissoring, shearing, and pinching;
<bullet> structural integrity;
<bullet> stability;
<bullet> barriers;
<bullet> retention of contoured changing pads and add-on changing 
units;
<bullet> entrapment in shelves and in enclosed openings;
<bullet> self-folding steps;
<bullet> restraint systems;
<bullet> warnings and labels; and
<bullet> instructional literature.

The standard also includes test methods to assess conformance with 
these requirements. Interested parties may obtain a copy of ASTM F2388-
18 from ASTM, through its website (http://www.astm.org), or by mail 
from ASTM International, 100 Bar Harbor Drive, P.O. Box 0700, West 
Conshohocken, PA 19428. Alternatively, interested parties may inspect a 
copy of the standard at CPSC's Office of the Secretary.

VIII. Final Rule

    Section 1235.2(a) of the final rule requires baby changing products 
to comply with ASTM F2388-18 and incorporates the standard by 
reference. Section VII of this preamble describes the OFR requirements 
for incorporating material by reference. In accordance with those 
requirements, section VII summarizes ASTM F2388-18, explains how the 
standard is reasonably available to interested parties, and how 
interested parties may obtain a copy of the standard.
    The final rule also amends 16 CFR part 1112 to add a new Sec.  
1112.15(b)(45) that lists 16 CFR part 1235, Safety Standard for Baby 
Changing Products, as a children's product safety rule for which the 
Commission has issued an NOR. Section XIV of this preamble provides 
additional information about certifications and NORs.

IX. Effective Date

    The Administrative Procedure Act (5 U.S.C. 551-559) generally 
requires that agencies set an effective date for a final rule that is 
at least 30 days after the Federal Register publishes the final rule. 5 
U.S.C. 553(d). The NPR proposed that the final rule for baby changing 
products, and the amendment to part 1112, would take effect 6 months 
after publication. CPSC received comments requesting an implementation 
date of 1 year, asserting that additional time would be necessary for 
firms to modify products to meet the standard. CPSC believes that 1 
year is sufficient for firms to modify their products to meet the new 
standard. Therefore, this rule will take effect 1 year after 
publication in the Federal Register, and will apply to products 
manufactured or imported on or after that date.

X. Paperwork Reduction Act

    This rule contains information collection requirements that are 
subject to public comment and Office of Management and Budget (OMB) 
review under the Paperwork Reduction Act of 1995 (PRA; 44 U.S.C. 3501-
3521). Under the PRA, CPSC must estimate the ``burden'' associated with 
each ``collection of information.'' 44 U.S.C. 3506(c).
    In this rule, section 9 of ASTM F2388-18 contains labeling 
requirements that meet the definition of ``collection of information'' 
in the PRA. 44 U.S.C. 3502(3). In addition, section 10 of ASTM F2388-18 
requires instructions to be provided with baby changing products; 
however, CPSC believes this requirement can be excluded from the PRA 
burden estimate. OMB allows agencies to exclude from the PRA burden 
estimate any ``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,'' if the disclosure 
activities required to comply are ``usual and customary.'' 5 CFR 
1320.3(b)(2). Because baby changing products generally require use and 
assembly instructions, and CPSC is not aware of baby changing products 
that generally require instructions but lack them, CPSC believes that 
providing instructions with baby changing products is ``usual and 
customary.'' For this reason, the burden estimate includes only the 
labeling requirements.
    The preamble to the NPR discussed the information collection burden 
of the proposed rule and requested comments on the accuracy of CPSC's 
estimates. 81 FR 66893 to 66894. CPSC did not receive any comments 
about the information collection burden of the proposed rule. However, 
the information collection burden has changed since the NPR because 
CPSC staff has identified 120 baby changing product suppliers (102 
domestic firms, 17 foreign firms, and 1 firm of unknown location), 
rather than the 85 firms identified in the NPR, that it estimates will 
be subject to the information collection burden. Accordingly, the 
estimated burden of this collection of information is 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
1235.2.............................................................    120                      6               720                 1               720
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The estimated reporting burden is based on CPSC staff's expectation 
that all 120 baby changing product suppliers known to CPSC will need to 
modify their labels to comply with the final rule. CPSC staff estimates 
that it will take about 1 hour per model to make these modifications 
and, based on staff's evaluation of product lines, that each supplier 
has an average of 6 models of baby changing products. Consequently, 
CPSC estimates that the burden associated with the labeling 
requirements is: 120 entities x 1 hour per model x 6 models per entity 
= 720 hours. CPSC staff estimates that the hourly compensation for the 
time required to create and update labels is $34.21 (U.S. Bureau of 
Labor Statistics, ``Employer Costs for Employee Compensation,'' Sept. 
2017, Table 9, total compensation for all sales and office workers in 
goods-producing private industries: http://www.bls.gov/ncs/). 
Therefore, the estimated annual cost associated with the labeling 
requirements is: $34.21 per hour x 720 hours = $24,631.20. CPSC staff 
does not expect there to be operating, maintenance, or capital costs 
associated with this information collection.
    As the PRA requires, CPSC has submitted the information collection 
requirements of this final rule to OMB. 44 U.S.C. 3507(d). OMB has 
assigned control number 3041-0175 to this information collection.

XI. Regulatory Flexibility Act

A. Introduction

    The Regulatory Flexibility Act (RFA; 5 U.S.C. 601-612) requires 
agencies to consider the potential economic impact

[[Page 29679]]

of a proposed and final rule on small entities, including small 
businesses. Section 604 of the RFA requires agencies to prepare and 
publish a final regulatory flexibility analysis (FRFA) when they issue 
a final rule, unless the head of the agency certifies that the rule 
will not have a significant economic impact on a substantial number of 
small entities. The FRFA must discuss:
    <bullet> The need for and objectives of the rule;
    <bullet> significant issues raised in public comments about the 
initial regulatory flexibility analysis (IRFA), a response to comments 
from the Chief Counsel for Advocacy of the SBA, the agency's assessment 
of the comments, and any changes made to the rule as a result of the 
comments;
    <bullet> the description and estimated number of small entities 
that will be subject to the rule;
    <bullet> the reporting, recordkeeping, and other compliance 
requirements of the rule, as well as the small entities that would be 
subject to those requirements, and the types of skills necessary to 
prepare the reports or records;
    <bullet> steps the agency took to minimize the significant economic 
impact on small entities; and
    <bullet> the factual, policy, and legal reasons the agency selected 
the alternative in the final rule, and why it rejected other 
significant alternatives.

5 U.S.C. 604.
    Based on an assessment by CPSC's Directorate for Economic Analysis 
staff, CPSC cannot certify that this rule will not have a significant 
economic impact on a substantial number of small entities. As a result, 
staff has prepared a FRFA. This section summarizes the FRFA for this 
final rule. The complete FRFA is available as part of CPSC staff's 
briefing package at: https://cpsc.gov/s3fs-public/Final%20Rule%20-%20Safety%20Standard%20for%20Baby%20Changing%20Products%20-
%20June%2013%202018.pdf?ZbvMCsfyQfLFivqHRbFWKclOordsuVeC.

B. Comments Relevant to the FRFA

    CPSC did not receive any comments specifically addressing the IRFA 
that accompanied the proposed rule or from the Chief Counsel for 
Advocacy of SBA. However, CPSC received comments about the effective 
date of the final rule, which are relevant to the FRFA insofar as they 
address the costs associated with the rule. These comments are 
discussed in section VI.F. of this preamble. After considering these 
comments, and the potential economic impact of the rule on small firms, 
the Commission is extending the effective date for the final rule to 1 
year, rather than the proposed 6 months. CPSC believes that this longer 
effective date will reduce the economic impact of the rule on firms, 
some of which may not be aware of the ASTM standard or this rulemaking, 
by reducing the potential for a lapse in production or imports while 
bringing products into compliance with the rule, and spreading the 
costs of compliance over a longer period.

C. Description of Small Entities Subject to the Rule

    CPSC staff identified 120 firms that supply baby changing products 
to the U.S. market, consisting of 102 domestic firms, 17 foreign firms, 
and 1 firm for which staff could not determine the location. Of the 102 
domestic firms, 84 are small entities, according to SBA's standards, 
and 18 are large. Of the 84 small domestic entities, 61 are 
manufacturers, and 23 are importers or wholesalers. It is possible that 
there are additional baby changing product suppliers in the U.S. market 
that staff has not identified.

D. Description of the Final Rule

    Sections V and VII of this preamble describe the requirements in 
the final rule, which incorporates by reference ASTM F2388-18. In 
addition, the final rule amends the regulations regarding third party 
conformity assessment bodies to include the safety standard for baby 
changing products in the list of NORs.

E. Impact on Small Businesses

    For the FRFA, staff limited its analysis to the 84 small domestic 
firms staff identified as supplying baby changing products to the U.S. 
market because SBA guidelines and definitions apply to domestic 
entities. In assessing whether a rule will have a significant economic 
impact on small entities, staff generally considers impacts 
``significant'' if they exceed 1 percent of a firm's revenue. This 
section provides details about staff's assessment of the economic 
impact of the final rule on small domestic entities. To summarize, 
staff believes that it is unlikely that the final rule will have a 
significant economic impact on 22 of the 61 small manufacturers and 10 
of the 23 small importers and wholesalers, all of which already comply 
with a version of the ASTM standard. Of the remaining firms, which do 
not already comply with the voluntary standard, staff does not expect 
the final rule to have a significant economic impact on 13 of the 39 
small manufacturers and 3 of the 13 small importers and wholesalers 
because most of these firms supply products that staff does not expect 
will require changes to conform to the rule. Staff could not rule out a 
significant economic impact on the remaining 26 small manufacturers and 
10 small importers and wholesalers.
1. Small Manufacturers
    At the time staff prepared the FRFA, 22 of the 61 small 
manufacturers reported that their baby changing products complied with 
the then-current ASTM standard. Staff believes that firms that report 
complying with the voluntary standard will continue to comply with the 
standard as it evolves, as part of an established business practice. 
Staff does not expect the final rule to have a significant economic 
impact on any of these 22 firms because ASTM F2388-18 was published 
well before the effective date of this rule. Staff expects third party 
testing costs to be minimal because these firms already test their 
products for compliance with the voluntary standard.
    The remaining 39 small manufacturers produce baby changing products 
that do not comply with the voluntary standard. Seven of these firms 
manufacture only wooden changing trays that are sold separately from 
furniture, which are subject to few requirements other than side 
height, labeling, and instructions. Staff does not expect changes to 
warnings, instructions, or side heights to create significant costs. An 
additional 12 firms manufacture only contoured changing pads, which are 
also subject to minimal requirements, primarily including barrier and 
retention requirements, labels, and instructions. Staff believes that 
firms will not have to modify most of these changing pads to meet these 
requirements, but it is possible that a few firms would need to modify 
their products to meet the barrier and retention requirements. These 
modifications could be costly because firms would need new molds for 
foam products. For purposes of the FRFA, staff assumed that two firms 
would need to modify their contoured changing pads to comply with the 
final rule.
    The remaining 20 firms manufacture a variety of changing products. 
Firms staff interviewed before the Commission issued the NPR indicated 
that the cost of completely redesigning a product could range from 
$25,000 to $200,000, depending on the type of changing product. It is 
likely that the final rule will have a significant impact on nine of 
these firms (and possibly one more) based on their revenue levels; it 
is unlikely the rule will have a significant economic impact on three 
of these firms, based on their revenues; and staff

[[Page 29680]]

could not determine the revenues of the remaining seven firms.
    Staff believes that third party testing costs are not likely to 
have a significant economic impact on 21 of the 39 small domestic 
noncompliant manufacturers, but could exceed 1 percent of revenues for 
the remaining 18 firms, with varying degrees of likelihood. Staff also 
believes that third party testing costs could result in significant 
economic impacts for 7 of the 20 small domestic noncompliant 
manufacturers that are not likely to experience significant economic 
impacts from the requirements in ASTM F2388-18.
2. Small Importers and Wholesalers
    At the time staff prepared the FRFA, 10 of the 23 small importers 
and wholesalers reported that their baby changing products complied 
with the then-current ASTM standard. Staff considered the economic 
impact to importers and wholesalers together because both rely on 
outside firms to supply the products they distribute to the U.S. 
market. Like small, compliant manufacturers, staff expects that these 
importers and wholesalers will comply with ASTM F2388-18 before the 
effective date of the final rule. Therefore, staff does not expect the 
final rule to have a significant economic impact on any of these firms. 
Likewise, staff expects third party testing costs to be minimal because 
costs would be limited to the difference between the cost of current 
testing regimes and third party testing costs.
    The remaining 13 small importers and wholesalers supply baby 
changing products that do not comply with the voluntary standard. The 
economic impact of the rule on these importers and wholesalers depends 
on the extent of the changes needed for their products to comply with 
the rule and the response of their suppliers. Staff generally cannot 
determine this information for importers and wholesalers that do not 
comply with the voluntary standard.
    Nevertheless, staff anticipates that the rule could have a 
significant economic impact on some of these firms. Staff estimates 
that the rule will not have a significant economic impact on one 
importer that supplies only wooden changing trays. The rule also may 
not have a significant economic impact on two importers and one 
wholesaler that provide only contoured changing pads. However, one of 
these firms may need to redesign its product, which would have a 
significant economic impact on the firm. Each of these firms has wide 
enough product lines that it could stop supplying changing products, 
although the impact of that on revenue is unclear.
    Of the remaining six importers and three wholesalers, four firms 
have low enough revenues that they are likely to experience a 
significant economic impact, regardless of how their suppliers respond, 
as their suppliers are not likely to absorb any of the costs and 
finding alternative suppliers can be costly. Three of these firms may 
be able to stop supplying changing products, but it is not clear what 
impact this would have on their revenues. Staff does not have revenue 
information for the remaining five firms. As a result, staff cannot 
rule out the possibility that the rule will have a significant economic 
impact on these five firms. However, one of these firms appears to be 
tied to its suppliers, who may absorb some of the costs, and another 
firm has a wide enough product line that it could stop supplying 
changing products.
    Staff believes that third party testing could result in significant 
costs for three of the firms that import noncompliant baby changing 
products. For two of these firms, testing costs could exceed 1 percent 
of gross revenue if the firm tests only one unit per model. A third 
firm would need to test about three units per model before testing 
costs would exceed 1 percent of its gross revenue. Staff did not have 
access to revenue data for seven of the small noncompliant importers 
and wholesalers to determine the potential economic impact of the rule.
3. Accreditation Requirements for Testing Laboratories
    Section 14 of the Consumer Product Safety Act (CPSA; 15 U.S.C. 
2051-2089) requires all children's products that are subject to a 
children's product safety rule to be tested by a third party conformity 
assessment body (i.e., testing laboratory) that has been accredited by 
CPSC. Testing laboratories that want to conduct this testing must meet 
the NOR for third party conformity testing. The final rule amends 16 
CFR part 1112 to establish an NOR for testing laboratories to test for 
compliance with the baby changing product rule.
    In the IRFA for this rule, staff anticipated that the accreditation 
requirements would not have a significant economic impact on a 
substantial number of small laboratories because: (1) The rule imposed 
requirements only on laboratories that intended to provide third party 
testing services; (2) laboratories would assume the costs only if they 
anticipated receiving sufficient revenue from the testing to justify 
accepting the requirements as a business decision; and (3) most 
laboratories would already have accreditation to test for conformance 
to other juvenile product standards, thereby limiting the costs to 
adding the baby changing product standard to their scope of 
accreditation. CPSC has not received any information to date that 
contradicts this assessment. Therefore, staff believes that the NOR for 
the baby changing product standard will not have a significant economic 
impact on a substantial number of small entities.

F. Alternatives and Steps To Minimize Economic Impacts

    In response to comments, the Commission is providing a 1 year 
effective date, rather than the proposed 6 months. This should reduce 
the economic impact of the rule for small entities. Setting a later 
effective date reduces the likelihood of a lapse in production or 
imports if firms cannot comply with the standard or obtain third party 
testing within the time provided. In addition, a later effective date 
spreads the costs of compliance over a longer period, reducing annual 
costs and the present value of total costs.

XII. Environmental Considerations

    CPSC's regulations list categories of agency actions that 
``normally have little or no potential for affecting the human 
environment.'' 16 CFR 1021.5(c). Such actions qualify as ``categorical 
exclusions'' under the National Environmental Policy Act (42 U.S.C. 
4321-4370m-12), which do not require an environmental assessment or 
environmental impact statement. One categorical exclusion listed in 
CPSC's regulations is for rules or safety standards that ``provide 
design or performance requirements for products.'' 16 CFR 1021.5(c)(1). 
Because the final rule for baby changing products creates design or 
performance requirements, the rule falls within the categorical 
exclusion.

XIII. Preemption

    Under section 26(a) of the CPSA, no state or political subdivision 
of a state may establish or continue in effect a requirement dealing 
with the same risk of injury as a federal consumer product safety 
standard under the CPSA unless the state requirement is identical to 
the federal standard. 15 U.S.C. 2075(a). However, states or political 
subdivisions of states may apply to CPSC for an exemption, allowing 
them to establish or continue such a requirement if the state 
requirement ``provides a significantly higher degree of protection from 
[the] risk of injury'' and ``does not

[[Page 29681]]

unduly burden interstate commerce.'' Id. 2075(c).
    Section 104 of the CPSIA requires the Commission to issue consumer 
product safety standards for durable infant or toddler products. As 
such, consumer product safety standards that the Commission creates 
under CPSIA section 104 are covered by the preemption provision in the 
CPSA. As a result, the preemption provision in section 26 of the CPSA 
applies to the mandatory safety standard for baby changing products.

XIV. Testing, Certification, and Notification of Requirements

    Section 14(a) of the CPSA requires the manufacturer or private 
labeler of a children's product that is subject to a children's product 
safety rule to certify that, based on a third party conformity 
assessment body's testing, the product complies with the applicable 
children's product safety rule. 15 U.S.C. 2063(a)(2)(A), 2063(a)(2)(B). 
Section 14(a) also requires the Commission to publish an NOR for a 
third party conformity assessment body (i.e., testing laboratory) to 
obtain accreditation to assess conformity with a children's product 
safety rule. 15 U.S.C. 2063(a)(3)(A). Because this safety standard for 
baby changing products is a children's product safety rule, it requires 
the Commission to issue an NOR.
    On March 12, 2013, the Commission published a final rule in the 
Federal Register, entitled Requirements Pertaining to Third Party 
Conformity Assessment Bodies, establishing 16 CFR part 1112, which sets 
out the general requirements and criteria concerning testing 
laboratories. 78 FR 15836. Part 1112 includes procedures for CPSC to 
accept a testing laboratory's accreditation and lists the children's 
product safety rules for which the Commission has published NORs. When 
the Commission issues a new NOR, it must amend part 1112 to include 
that NOR. Accordingly, the Commission is amending part 1112 to include 
the baby changing products standard.
    Testing laboratories that apply for CPSC acceptance to test baby 
changing products for compliance with the new baby changing product 
rule would have to meet the requirements in part 1112. When a 
laboratory meets the requirements of a CPSC-accepted third party 
conformity assessment body, the laboratory can apply to CPSC to include 
16 CFR part 1235, Safety Standard for Baby Changing Products, in the 
laboratory's scope of accreditation of CPSC safety rules listed on the 
CPSC website at: www.cpsc.gov/labsearch.
    As the RFA requires, CPSC staff conducted a FRFA for the rulemaking 
in which the Commission adopted part 1112. 78 FR 15836, 15855 (Mar. 12, 
2013). To summarize, the FRFA concluded that the accreditation 
requirements would not have a significant economic 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 CPSC 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.
    By the same reasoning, adding an NOR for the baby changing product 
standard to part 1112 will not have a significant economic impact on 
small test laboratories. A relatively small number of laboratories in 
the United States have applied for accreditation to test for 
conformance to existing juvenile product standards. Accordingly, CPSC 
expects that only a few laboratories will seek accreditation to test 
for compliance with the baby changing product standard. Of those that 
seek accreditation, CPSC expects that most will have already been 
accredited to test for conformance to other juvenile product standards. 
The only costs to those laboratories will be the cost of adding the 
baby changing product standard to their scopes of accreditation. For 
these reasons, CPSC certifies that amending 16 CFR part 1112 to include 
an NOR for the baby changing products standard will not have a 
significant economic impact on a substantial number of small entities.

XV. Consumer Registration of Durable Infant or Toddler Products

    As section 104(d) of the CPSIA requires, regulations in 16 CFR part 
1130 require manufacturers of durable infant or toddler products to 
provide registration forms with each product, maintain the contact 
information consumers submit on these forms, and mark manufacturer and 
model information on products. Section 1130.2(a)(14) lists ``changing 
tables'' as one of the products subject to the registration card 
requirements. However, ``changing tables'' is no longer used as the 
general term to encompass all baby changing products that are subject 
to ASTM F2388-18 and this final rule, and this term may create 
confusion since it is only one type of baby changing product. Because 
all of the baby changing products subject to this rule are ``durable 
infant or toddler products,'' section 104(d) of the CPSIA requires the 
registration card requirements to apply to all of these products.
    Accordingly, the Commission anticipates issuing a notice proposing 
to amend 16 CFR part 1130 to clarify that ``changing tables'' include 
all changing products identified in ASTM F2388-18, which includes 
changing tables, contoured changing pads, changing table accessories, 
and add-on changing units.

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 1235

    Consumer protection, Imports, Incorporation by reference, Infants 
and children, Labeling, Law enforcement, Toys.

    For the reasons discussed in the preamble, the Commission amends 16 
CFR chapter II 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)(45) 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) * * *
    (45) 16 CFR part 1235, Safety Standard for Baby Changing Products.
* * * * *

0
3. Add part 1235 to read as follows:

PART 1235--SAFETY STANDARD FOR BABY CHANGING PRODUCTS

Sec.
1235.1 Scope.
1235.2 Requirements for baby changing products.

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


Sec.  1235.1  Scope.

    This part establishes a consumer product safety standard for baby 
changing products.

[[Page 29682]]

Sec.  1235.2  Requirements for baby changing products.

    Each baby changing product shall comply with all applicable 
provisions of ASTM F2388-18, Standard Consumer Safety Specification for 
Baby Changing Products for Domestic Use, approved on February 15, 2018. 
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; http://www.astm.org. 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/cfr/ibr-locations.html.

Alberta E. Mills,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2018-13556 Filed 6-25-18; 8:45 am]
 BILLING CODE 6355-01-P


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