Safety Standard for Baby Changing Products, 66881-66898 [2016-22557]

Agencies

• Consumer Product Safety Commission

[Federal Register Volume 81, Number 189 (Thursday, September 29, 2016)]
[Proposed Rules]
[Pages 66881-66898]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22557]


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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: Notice of proposed rulemaking.

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SUMMARY: The Danny Keysar Child Product Safety Notification Act, 
section 104(b) 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 must be 
substantially the same as applicable voluntary standards or more 
stringent than the voluntary standard if the Commission determines that 
more stringent requirements would further reduce the risk of injury 
associated with a product. Pursuant to the direction under section 
104(b) of the CPSIA, the Commission is

[[Page 66882]]

proposing a safety standard for baby changing products. The proposed 
rule would incorporate by reference ASTM F2388-16, Standard Consumer 
Safety Specification for Baby Changing Tables for Domestic Use (ASTM 
F2388-16) into our regulations and impose more stringent requirements 
for structural integrity, restraint system integrity, and warnings on 
labels and in instructional literature. In addition, the Commission 
proposes to amend our regulations include the proposed safety standard 
for baby changing products in the list of notice of requirements (NORs) 
issued by the Commission.

DATES: Submit comments by December 13, 2016.

ADDRESSES: Comments related to the Paperwork Reduction Act aspects of 
the labeling and instructional literature requirements of the proposed 
mandatory standard for baby changing 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-2016-0023, 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 comments 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 by mail/hand delivery/
courier.
    Docket: For access to the docket to read background documents or 
comments received, go to: https://www.regulations.gov, insert docket 
number CPSC-2016-0023 into the ``Search'' box, and follow the prompts.

FOR FURTHER INFORMATION CONTACT: Mark Kumagai, Project Manager, 
Directorate for Engineering Sciences, U.S. Consumer Product Safety 
Commission, 5 Research Place, Rockville, MD 20850; telephone: 301-987-
2234; email: MKumagai@cpsc.gov.

SUPPLEMENTARY INFORMATION:

I. Background and Statutory Authority

    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. Any standard the Commission adopts under this directive must 
be substantially the same as the applicable voluntary standard or more 
stringent, if the Commission determines that more stringent 
requirements would further reduce the risk of injury associated with 
the product.
    A ``durable infant or toddler product,'' as defined in section 
104(f)(1) of the CPSIA, is ``a durable product intended for use, or 
that may be reasonably expected to be used, by children under the age 
of 5 years.'' Section 104(f)(2) lists examples of ``durable infant or 
toddler products,'' such as cribs, high chairs, and strollers. Although 
this list of example products does not include baby changing products, 
baby changing products satisfy the statutory definition, as they are 
intended for use by children under the age of 5 years and are durable 
products made of sturdy material that last for several years; they are 
similar to the example products listed in the CPSIA; and the Commission 
has identified changing tables as ``durable infant or toddler 
products'' in the product registration rule that the Commission issued 
under section 104(d) of the CPSIA. 16 CFR 1130.2(a)(14).
    Pursuant to section 104(b)(1)(A) of the CPSIA, the Commission 
consulted with representatives of manufacturers, consumer groups, 
consultants, retailers, and industry trade groups in reviewing and 
assessing the effectiveness of the existing voluntary standard for baby 
changing products, ASTM F2388-16, largely through ASTM International's 
(ASTM; formerly the American Society for Testing and Materials) 
standard-development process. The standard the Commission proposes in 
this notice of proposed rulemaking (NPR) is based on ASTM F2388-16 with 
more stringent requirements for structural integrity, restraint system 
integrity, and warnings on labels and in instructional literature.
    The testing and certification requirements of section 14(a) of the 
Consumer Product Safety Act (CPSA; 15 U.S.C. 2051-2089) 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 (i.e., test 
laboratories) to assess whether a children's product conforms to 
applicable children's product safety rules. If adopted, the proposed 
rule for baby changing products would be a children's product safety 
rule that requires the issuance of an NOR. For this reason, this NPR 
also proposes to amend 16 CFR part 1112 to include a reference to 
proposed 16 CFR part 1235, the section in which the standard for baby 
changing products would be codified.

II. The Product

A. Definition

    ASTM F2388-16 applies to baby changing tables and other changing 
products. The standard defines ``changing tables'' as ``elevated, 
freestanding structures'' designed ``to support and retain a child'' 
with a body weight up to 30 pounds (13.6 kilograms) for the purpose of 
a diaper change. Changing tables may convert to other furniture pieces, 
such as dressers or play yards, and they may have storage or other 
pull-out or drop-down features. ASTM F2388-16 also applies to other 
changing products, such as contoured changing pads and add-on changing 
units that are sold separately for use on furniture products other than 
changing tables. Contoured changing pads have barriers designed to keep 
children up to 30 pounds on the pad for diaper changes on elevated 
surfaces. Add-on changing units are used with pieces of furniture to 
provide changing surfaces and/or barriers to keep children on the 
products during diaper changes.
    The majority of changing tables and add-on changing units are made 
of wood; contoured changing pads are generally made of a combination of 
synthetic-covered foam. Changing tables come in various designs, some 
of which

[[Page 66883]]

include drawers, cabinets, or retractable stairs.
    Throughout this NPR, the Commission uses the term ``baby changing 
products'' to refer to changing tables and other changing products, 
such as contoured changing pads and add-on changing units that are sold 
separately for use on furniture products other than changing tables.

B. Market Description

    Commission staff identified 85 firms, including manufacturers, 
importers, and wholesalers, that supply baby changing products to the 
U.S. market. Seventy-one of these firms are domestic, consisting of 57 
manufacturers, 12 importers, one wholesaler, and one retailer; 14 are 
foreign, consisting of 12 manufacturers, one importer, and one 
retailer. Of the domestic firms, 59 are small businesses, as discussed 
is Section XI. Regulatory Flexibility Act, below, and 12 are large. 
Eighty-one of the firms market their products to consumers, while seven 
also market them for commercial daycare use. Fifty-six of the firms 
offer multiple baby changing products.
    Stand-alone changing tables intended for home use range widely in 
price, from approximately $35 to $1,400. Other baby changing products 
also vary greatly in price. Contoured changing pads range from about $7 
to $100; add-on changing units, such as changing trays, range from 
approximately $12 to $1,050; and other baby products, such as cribs, 
play yards, dressers, and bath tubs, with attachable or built-in baby 
changing products, range from approximately $100 to $4,500.

III. Incident Data

    The Commission receives data regarding product-related injuries 
from several sources. One such source is the National Electronic Injury 
Surveillance System (NEISS), from which CPSC can estimate the number of 
injuries associated with specific consumer products that are treated in 
U.S. hospital emergency departments (EDs) nationwide, based on a 
probability sample. 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 (collectively 
referred to as Consumer Product Safety Risk Management System data 
(CPSRMS)).
    Commission staff reviewed the NEISS and CPSRMS databases for 
incidents involving baby changing products involving children younger 
than 3 years old because that age corresponds with the 30-pound weight 
limit in the definition of ``changing tables.'' See Centers for Disease 
Control and Prevention, National Center for Health Statistics, Data 
Table of Infant Weight-for-Age Charts, https://www.cdc.gov/growthcharts/html_charts/wtageinf.htm (last visited Aug. 5, 2016) (indicating 30 
pounds is the 50th percentile weight of boys at 31 months old and girls 
at 34 months old). Staff considered CPSRMS data from January 1, 2005 
through December 31, 2015, and NEISS data from January 1, 2005 through 
December 31, 2014 (NEISS data was not yet updated for 2015 at the time 
of analysis).
    Through CPSRMS sources, the Commission has received 182 reports of 
incidents related to baby changing products that occurred between 2005 
and 2015. These reports include five fatalities, 30 injuries or adverse 
health problems, 113 incidents that did not result in injuries, and 34 
incidents for which the Commission did not receive sufficient 
information to determine whether an injury occurred.
    EDs participating in NEISS reported 1,305 injuries and no deaths 
related to baby changing products between 2005 and 2014. Extrapolating 
from this probability sample, there were approximately 31,780 injuries 
and no fatalities related to baby changing products treated in EDs 
between 2005 and 2014. In analyzing the number of injuries that 
occurred each year between 2005 and 2014, Commission staff found that 
there was a statistically significant increasing trend in injuries over 
this period. The NEISS data also indicates that the incidence of 
injuries was the same for males and females and that 75 percent of the 
injured children were under 1 year old.

A. Fatalities

    The Commission received reports of five fatalities associated with 
baby changing products between 2005 and 2015. The five reported deaths 
all involved caregivers using baby changing products as sleep products, 
which is not their intended use. All of the victims in these incidents 
were younger than 1 year old.
    Four of the incidents involved play yards with changing table 
attachments. In one of these cases, a strap hanging from a changing 
table accessory in a play yard strangled a child sleeping in the play 
yard beneath. In the remaining four deaths, children asphyxiated while 
sleeping on a baby changing product; three of the products were the 
changing table attachments on play yards, and one was a portable 
changing pad placed in a crib as a sleep positioner.
    In three of the reports regarding these fatalities, the caregivers 
and investigators appeared to be mistaken about the intended use of the 
product, referring to the changing table product as a ``crib'' and 
``bassinet.''

B. Nonfatal Injuries

    Of the 182 CPSRMS incidents related to baby changing products that 
occurred between 2005 and 2015, 30 reportedly resulted in injuries or 
adverse health problems. The most frequently cited injuries were cuts, 
lacerations, scratches, and bruises; however, there were several more 
serious injuries reported as well. Three reports indicated that the 
victim visited the hospital; in one incident involving a leg injury, 
the victim was treated and released, and in two incidents involving a 
skull fracture and leg fracture, respectively, the victims were 
admitted to hospitals.
    For injuries estimated through NEISS, 94 percent were treated and 
released, while 5 percent were admitted to the hospital. The most 
commonly injured body parts were the head (71 percent) and face (13 
percent). The most common types of injuries were injuries to internal 
organs (50 percent), contusions or abrasions (27 percent), and 
fractures (9 percent). Of those injuries affecting internal organs, 99 
percent were head injuries; of those injuries resulting in contusions 
or abrasions, 83 percent affected the victim's head or face.

C. Hazard Pattern Identification

    CPSC staff reviewed NEISS and CPSRMS data to identify hazard 
patterns associated with baby changing products. Both sets of data 
revealed several common hazard patterns, but because CPSRMS data 
sources generally provide greater detail about incidents, staff was 
able to identify more distinct hazard patterns using that data. Five 
hazard patterns emerged from staff's review: (1) Issues with structural 
integrity, (2) design hazards, (3) problems with restraint systems, (4) 
miscellaneous problems, and (5) undetermined hazards. Table 1 provides 
the frequency of each hazard pattern and category.

[[Page 66884]]



  Table 1--Hazard Patterns for CPSRMS Incidents Involving Baby Changing
         Products Between January 1, 2005 and December 31, 2015
------------------------------------------------------------------------
                                                                 Total
                       Hazard pattern                          incidents
------------------------------------------------------------------------
Structural Integrity........................................         119
Design......................................................          38
Restraint System............................................          14
Miscellaneous...............................................           8
Undetermined................................................           3
------------------------------------------------------------------------

    Structural integrity issues include collapsing or unstable 
products, hardware issues, and assembly problems. This hazard pattern 
accounted for approximately 65 percent of CPSRMS incident reports (119 
of 182 incidents). Fifty-five percent of the reported incidents in this 
hazard pattern involved collapsing baby changing products or parts 
(with 50 percent of those reports attributable to three particular 
models). The next most common type of structural integrity issue was 
unstable baby changing products.
    Product design issues included limb entrapments, in parts such as 
slats, rails, and doors, chipping finishes, unstable steps, pinching, 
children hitting their heads on metal parts, and a strangulation hazard 
from a restraint strap in a play yard changing table accessory. 
Approximately 21 percent of incidents reported through CPSRMS (38 of 
182) fell into this hazard pattern. The majority of these incidents 
involved accessory components that are common to other furniture, as 
well as changing tables, and are not generally accessible to children 
when occupying a changing table as intended.
    About 8 percent of incidents (14 of 182) related to restraint 
systems, which include loose, broken, or detached straps, cracked or 
faulty buckles, pinching, choking on small parts, and the absence of a 
restraint system.
    Approximately 4 percent of CPSRMS incidents (8 of 182) involved 
miscellaneous issues, including chemical odors and the use of changing 
tables for unintended purposes, such as sleeping. All of the deaths 
associated with baby changing products involved children sleeping on 
the products.
    Two percent of the incident reports (3 of 182) did not provide 
sufficient information for Commission staff to identify a hazard 
pattern.
    The most frequently reported event associated with an injury in 
both NEISS and CPSRMS data involved children falling off, or through, 
baby changing products. Within NEISS data, 94 percent of injuries 
involved falls, while 64 percent of non-fatal CPSRMS incidents involved 
children falling from baby changing products. These incidents were 
prevalent in the structural integrity and restraint system hazard 
patterns. Eight of the CPSRMS fall incidents were the result of the 
baby changing product or supporting structure collapsing. Ten of the 14 
restraint system incidents resulted in actual or potential falls, and 
one resulted in injury.
    Some of the fall incidents resulted in injuries of varying 
severity. Within the NEISS incidents, several of the fall injuries 
resulted in a serious head injury, such as a concussion or fractured 
skull. Ten CPSRMS incidents involving falls also resulted in injuries. 
One of these 10 incidents resulted in a fractured skull, one a 
fractured leg, seven involved minor injuries, such as bruises, 
scratches, and lacerations that did not require medical attention and 
one did not indicate the severity of injury. Additionally, in several 
cases, caregivers reported catching a falling child, potentially 
preventing injuries.

D. Product Recalls

    Since January 1, 2005, two firms have recalled baby changing 
products. In 2006, one firm recalled approximately 130 baby changing 
products, due to a fall hazard. The products included cloth sections 
secured by zippers to support occupants. The firm found that if the 
zipper was misaligned, the cloth section supporting an occupant could 
detach. In 2007, a second firm recalled approximately 425,000 baby 
changing products. The product was an infant play yard with a raised 
changing table accessory that had a restraint strap that formed a loop 
beneath the changing table, posing a strangulation hazard to a child in 
the play yard. This recalled product was associated with one child's 
death.

IV. International Standards for Changing Tables

    CPSC is aware of two international standards that apply to baby 
changing products:
     ASTM F2388-16, and
     British/European Standard BS EN 12221: 2008, Child use and 
care articles--Changing units for domestic use, Part 1: Safety 
requirements, Part 2: Test methods (European standard).
    CPSC staff reviewed the provisions in these standards and believes 
that ASTM F2388-16 best addresses the hazard patterns indicated in the 
incident data, and in most areas, ASTM F2388-16 includes more stringent 
requirements than the European standard. For example, although both 
standards require barrier durability testing, ASTM F2388-16 requires 
pre-conditioning or aging of contoured changing pads before testing. In 
contrast, the European standard does not require precondition or aging, 
which makes ASTM F2388-16 the more stringent standard.
    There are some areas in which the European standard includes more 
stringent requirements than ASTM F2388-16. For example, the European 
standard limits the dimensions of cords and loops, while ASTM F2388-16 
does not. However, the incident data does not indicate that cords or 
loops present a safety hazard, apart from the one strangulation death 
involving a loop in a play yard, but the play yard standard has since 
been updated to address that hazard. In reviewing this and other 
provisions in which the European standard is more stringent than ASTM 
F2388-16, Commission staff found that the incident data does not 
indicate that the more stringent requirement is necessary to reduce the 
risk of injury, and further determined that the requirements in ASTM 
F2388-16 are sufficient.
    Some requirements in the two standards differ in ways that make it 
difficult to compare their relative stringency. Nevertheless, for these 
requirements, Commission staff believes that ASTM F2388-16 arguably is 
more stringent, the incident data does not demonstrate that the 
European standard is necessary, or the additional requirements proposed 
in this NPR are the most effective method of addressing the risk. For 
example, the stability tests in ASTM F2388-16 and the European standard 
differ in ways that make them difficult to compare, but the incident 
data indicates that tip-over incidents are not an issue, which suggests 
that ASTM F2388-16, to which many manufacturers conform, is adequate. 
Likewise, the load tests in ASTM F2388-16 and the European standard 
differ, but staff believes that the ASTM test reflects actual load 
conditions better. Moreover, this NPR proposes additional, more 
stringent requirements for this test that are not in either standard.
    Based on these comparisons, CPSC believes that ASTM F2388-16, in 
general, is more stringent than the European standard and is better 
tailored to address the hazard patterns evident in the incident data.

V. ASTM F2388-16

A. History of ASTM F2388-16

    ASTM first approved and published a standard for baby changing 
products in July 2004, as ASTM F2388-04,

[[Page 66885]]

Standard Consumer Safety Specification for Baby Changing Tables for 
Domestic Use. ASTM has revised the voluntary standard several times 
since then, adding and modifying requirements. Some of the more 
substantial revisions, to date, include:
     Expanding the scope of the standard to include changing 
table products, such as contoured changing pads and add-on changing 
units;
     requiring preconditioning before conducting barrier 
testing on contoured changing pads;
     marking packaging with the maximum occupant weight; and
     requiring toy accessories to comply with applicable safety 
requirements.
    ASTM approved the current version of the standard, ASTM F2388-16, 
on July 1, 2016.

B. Description of ASTM F2388-16

    CPSC staff, together with stakeholders on the ASTM subcommittee 
task group for baby changing products, developed modified and new 
requirements for ASTM F2388-16 to address the hazards associated with 
these products. ASTM F2388-16 includes the following key provisions: 
Scope, terminology, calibration and standardization, general 
requirements, performance requirements, test methods, marking and 
labeling, and instructional literature. The following provides an 
overview of these provisions. To view the complete standard, see the 
instructions in Section IX. Incorporation by Reference.

1. Scope

    This section states the scope and intent of the standard.

2. Terminology

    This section provides definitions of terms specific to the 
standard.

3. Calibration and Standardization

    This section provides general instructions for conducting tests.

4. General Requirements

    This section includes general requirements addressing various 
safety issues, such as sharp edges and points, small parts, lead in 
paint, wood parts, openings, changing table attachments to play yards 
and non-full-size cribs, and toy accessories.

5. Performance Requirements and Test Methods

    These sections contain performance requirements and associated test 
methods for baby changing products. The following summarizes key 
requirements in these sections.
    a. Protective Components: These requirements provide for testing 
protective components, such as caps and plugs.
    b. Structural Integrity: A changing table must not break or fail 
any other requirements after applying a specified weight for a set time 
period. The purpose of this requirement is to test whether changing 
tables can withstand the loads they will bear. Contoured changing pads 
and add-on changing units that are sold separately are not subject to 
this requirement.
    c. Stability: A changing table must not tip over when pushed 
downward by a specified force on the edge most likely to cause the 
product to tip over. The purpose of this requirement is to test the 
changing table's resistance to tipping over if there is weight on the 
edge of the product. Contoured changing pads and add-on changing units 
that are sold separately are not subject to this requirement.
    d. Barriers: Baby changing products must include barriers that are 
integral to the product. These barriers must be on all sides of flat 
changing surfaces and two sides of contoured surfaces. Barriers must 
not break or fail any other requirements or allow a test object to fall 
when holding a rolling test weight at an incline. Contoured changing 
pads must withstand this test after preconditioning or aging. The 
purpose of this requirement is to prevent children from rolling off of 
baby changing products or being injured by damaged barriers.
    e. Retention of Contoured Changing Pads and Add-on Changing Units: 
Contoured changing pads and add-on changing units must not move more 
than a specified distance during the barrier testing described above. 
The purpose of this requirement is to prevent children from falling 
when they move on baby changing products. Changing table accessories 
for non-full-size cribs and play yards are not subject to this 
requirement because they are subject to a similar requirement in 
another standard.
    f. Entrapment in Enclosed Openings: Any completely-bounded openings 
that are accessible to children in or near the base of a changing table 
must meet specified dimension limits for gaps and openings. The purpose 
of this requirement is to prevent children's heads from becoming 
entrapped in openings.
    g. Entrapment by Shelves: Any shelf that is not enclosed in doors 
and that is within a specified distance from the floor must not permit 
a probe, designed to simulate a child's head, to pass through. The 
purpose of this requirement is to prevent children from becoming 
entrapped in shelves on baby changing products.

6. Permanency of Labels and Warnings

    This section specifies testing and criteria for determining the 
permanency of labels.

7. Marking and Labeling

    This section contains various requirements related to warnings, 
package markings, and labels including content, format, and placement 
requirements.

8. Instructional Literature

    This section requires instructions to accompany baby changing 
products, be easy to read and understand, and include specific content.

C. Ongoing Revisions of ASTM F2388-16

    ASTM, with the participation of CPSC staff, has continued to review 
the effectiveness of ASTM F2388-16 in light of incidents and hazard 
patterns. As a result, ASTM has developed additional requirements that 
are currently under review. ASTM participants have voted on some of 
these changes and submitted comments, and the committee reviewing ASTM 
F2388-16 is working to resolve these comments. The requirements that 
the Commission proposes in this NPR that are more stringent than the 
requirements in ASTM F2388-16 are the same as, or similar to, the 
requirements ASTM is currently reviewing. ASTM has authorized the 
Commission to print requirements that are the same as, or similar to, 
those ASTM drafted and is currently reviewing.
    Additionally, an ASTM group, referred to as the ASTM Ad Hoc Wording 
Task Group, with CPSC staff's input, has reviewed warning requirements, 
in general, to develop one set of requirements that would be useful for 
various standards. The ASTM Ad Hoc Wording Task Group developed 
recommendations for product warnings, particularly focusing on form, to 
provide effective and uniform warning requirements that can be adapted 
for various products. The goal of this effort was to have one 
consistent set of requirements from which ASTM committees could draw 
and adjust, as necessary, when developing or revising individual 
product standards. The result of the group's work is a set of 
recommendations, rather than a formalized standard. The ASTM Ad Hoc 
Wording Task Group requested ASTM participants' input on these 
recommendations in early 2016, received feedback, and has since 
finalized its warning recommendations.

[[Page 66886]]

However, as the group continues to review issues, it may revise and 
update these recommendations. The labeling and instructional literature 
requirements that the Commission proposes in this NPR that differ from 
those in ASTM F2388-16 are drawn from the ASTM Ad Hoc Wording Task 
Group's recommendations. ASTM authorized the Commission to publish 
content from these recommendations in this NPR.
    Because of the ongoing review and revision of ASTM F2388-16 and the 
ASTM Ad Hoc Wording Task Group's recommendations, the Commission may, 
after reviewing comments, finalize the rule as proposed in this NPR or 
incorporate by reference a revised ASTM standard if that standard 
adopts changes consistent with the requirements that the Commission 
proposes in this NPR.

VI. Assessment of ASTM F2388-16

    CPSC staff evaluated ASTM F2388-16 in light of the fatalities, 
injuries, and non-injury incidents associated with baby changing 
products that occurred between January 1, 2005 and December 31, 2015 to 
determine whether the voluntary standard addresses the risk of injury 
associated with baby changing products or whether a more stringent 
standard would further reduce the hazards. CPSC believes that ASTM 
F2388-16 effectively addresses the hazards indicated in the incident 
data, with the exception of three areas--structural integrity, 
restraint system integrity, and warnings on labels and in instructional 
literature. CPSC proposes more stringent requirements for these areas 
to further reduce the risk of injury associated with baby changing 
products.
    This section provides CPSC's assessments of how ASTM F2388-16 
addresses the hazard patterns shown in the incident data.

A. Structural Integrity

    There were 119 CPSRMS incidents involving the structural integrity 
of baby changing products. The most common incidents in this category 
involved unstable changing tables and collapses, with the majority of 
incidents (55 of 119) involving changing table surfaces cracking or 
collapsing. More than half of these reports involved three particular 
changing table models. Falls resulting from these instability issues or 
collapses made up the majority of injuries reported through NEISS and 
80 percent of the injuries reported through CPSRMS.
    Although most of the reported collapses resulted in minor injuries, 
such as scrapes and bruises, falls have the potential for serious 
injuries, such as severe head injuries, which can have long-term 
effects. As mentioned, some fall injuries have resulted in serious head 
injuries, such as concussions and fractured skulls, or other fractured 
bones. Serious head injuries, such as concussions and skull fractures, 
can cause extensive brain damage and affect development.
    The next most common problem in this category was unstable baby 
changing products, half of which involved cantilevered changing 
accessories for play yards tilting under the weight of an occupant. No 
injuries were reported for these incidents.
    ASTM F2388-16 has two provisions intended to address the structural 
integrity of changing tables--a stability test and a structural 
integrity test. The stability test requires a product to remain upright 
when testers apply a load that is greater than the maximum recommended 
weight limit for product occupants to the edge most likely to tip over. 
The structural integrity test requires baby changing products to 
withstand a specified load for a set amount of time, without damage.
    In addition, ASTM F2388-16 requires baby changing products to have 
warning labels with specific content about fall hazards, and requires 
instructions on secure use of contoured changing pads and add-on 
changing units. ASTM F2388-16 also includes form and placement 
requirements for warnings and similar content requirements for 
instructional literature to make the warnings and instructions visible 
and understandable.
    The stability and structural integrity tests have been in ASTM 
F2388, in a similar form, since ASTM first published the standard in 
2004. However, despite these requirements, the incident data still 
reveals a high occurrence of structural integrity issues. Likewise, 
fall incidents continue, despite the warnings required in ASTM F2388-
16. Therefore, CPSC believes that more stringent requirements would 
further reduce the risk of injury from collapses and falls. Section 
VII. Description of Proposed Changes to ASTM Standard, discusses CPSC's 
proposed requirements regarding threaded fasteners, secondary support 
straps, and warnings that address this hazard.

B. Design

    There were 38 CPSRMS incidents involving design hazards. These 
issues included children becoming entrapped in gaps between vertical 
slats and beneath horizontal rails; children pinching their fingers in 
drawers or doors; and problems with finishes, such as chipped surface 
coatings. There was also one fatality associated with this hazard 
pattern, in which a changing accessory restraint strap in a play yard 
strangled a child.
    Several general requirements in ASTM F2388-16 address this hazard 
pattern, including provisions on sharp points and edges, small parts, 
surface coatings, wood parts, and openings. ASTM F2388-16 also includes 
specific performance requirements for protective components and to 
prevent entrapments in enclosed openings and shelves. Additionally, 
ASTM has since revised its play yard standard to address the changing 
accessory restraint strap hazard.
    Most of the incidents in this category involved accessory 
components that are common in many other types of furniture and are not 
accessible to children when they are in the changing table as intended. 
All of the pinching incidents involved children who were not on the 
baby changing product and involved the same hazard that is present on 
numerous other furniture items. Commission staff also found that the 
gaps in changing tables that have entrapped children's limbs are 
similar in size and shape to spaces between crib slats. When the 
Commission reviewed the same entrapment hazard for cribs, it found that 
reducing opening sizes may not prevent entrapments, but instead, may 
result in younger children being entrapped or pinched, making it 
difficult to develop a requirement that would prevent all entrapments.
    Consequently, the Commission believes that ASTM F2388-16 adequately 
addresses this hazard pattern and more stringent requirements would not 
further reduce the risk of injury.

C. Restraint Systems

    There were 14 CPSRMS incidents involving restraint systems, 
including broken straps, detached straps, loose or broken buckles, and 
concerns that products did not have restraint systems. Ten of these 14 
incidents resulted in actual or potential falls, and one resulted in an 
injury. One of these reports, and several other fall incident reports, 
indicated that the caregiver was near the child at the time of the 
fall, indicating that incidents can occur even when a caregiver is 
nearby.
    ASTM F2388-16 does not include any requirements regarding restraint 
systems. It does not require restraint systems in baby changing 
products, but also does not prohibit them; nor does the standard 
include any performance requirements for restraint systems that are 
included with products. There are

[[Page 66887]]

several factors that support not requiring restraint systems. First, 
barrier requirements in ASTM F2388-16 address the hazard of children 
rolling off of baby changing products, serving the same safety purpose 
as a restraint system. Second, it is difficult to design a restraint 
system that adequately restrains a child and also allows enough 
mobility for a caregiver to change the child's diaper. The most 
effective restraint systems are 3-point and 5-point restraints, which 
would limit a caregiver's ability to change a child's diaper. And 
third, restraints may give caregivers a sense of safety that diminishes 
their attentiveness.
    CPSC believes that ASTM F2388-16 requirements, particularly 
regarding barriers, adequately address the risks that restraint systems 
are designed to mitigate. Accordingly, it is not necessary to require 
restraint systems on baby changing products. Therefore, the Commission 
is not proposing a more stringent requirement to mandate the presence 
of restraint systems on baby changing products. However, the incident 
data suggests that when a restraint system is present, caregivers 
expect it to be effective. If caregivers expect restraints to be 
effective, they are likely to rely on them, necessitating that the 
restraints function effectively when included on a product.
    Because there are numerous incidents involving restraint systems 
breaking during normal use, the Commission considers the existing 
absence of restraint system requirements to be inadequate. As such, 
when restraints are provided, the Commission believes that more 
stringent requirements regarding restraint system integrity would 
further reduce the risk of injury. Section VII. Description of Proposed 
Changes to ASTM Standard, discusses CPSC's proposed requirements 
regarding restraint systems.

D. Miscellaneous

    There were eight CPSRMS incidents involving miscellaneous issues 
with baby changing products. These reports included complaints of 
chemical odors and caregivers using baby changing products as sleep 
products. Each of the five reported deaths related to baby changing 
products involved children sleeping on the products. In three of these 
deaths, caregivers placed the child in the changing accessory of a play 
yard to sleep. In all three cases, the investigatory reports suggest 
that consumers may view baby changing products as suitable for sleep 
because parents and law enforcement personnel, in reporting these 
incidents, mistakenly referred to the play yard changing accessories as 
``cribs'' or ``bassinets.''
    ASTM F2388-16 addresses the chemical content of baby changing 
products, requiring compliance with 16 CFR part 1303, which bans paint 
containing lead. Given this requirement, the low incidence of issues, 
and no injuries involving odors or chemicals, the Commission believes 
that ASTM F2388-16 adequately addresses this issue.
    With respect to caregivers using baby changing products as sleep 
products, ASTM F2388-16 does not include any requirements to address 
this safety issue. However, five deaths resulted from children sleeping 
on baby changing products, which is not their intended use. The 
Commission believes that more stringent requirements are necessary to 
reduce the risk of injury associated with this hazard. Section VII. 
Description of Proposed Changes to ASTM Standard, discusses CPSC's 
proposed requirements regarding warnings and instructional literature 
that would address this hazard.

E. Undetermined

    Three CPSRMS reports involving baby changing products did not 
provide sufficient information for CPSC to determine how the incidents 
occurred. Thus, the Commission cannot assess the effectiveness of ASTM 
F2388-16 in addressing these issues.

VII. Description of Proposed CPSC Standard for Baby Changing Products

    The proposed rule would create part 1235, titled, Safety Standard 
for Baby Changing Products. As explained, the Commission believes that 
ASTM F2388-16 effectively addresses the safety hazards associated with 
baby changing products, with the exception of structural integrity, 
restraint system integrity, and warnings on labels and in instructional 
literature. For this reason, the Commission proposes to incorporate by 
reference ASTM F2388-16, with modified requirements for structural 
integrity, restraint system integrity, and warnings on labels and in 
instructional literature. This section discusses the proposed 
modifications.

A. Structural Integrity

    Based on the incident data, CPSC believes that a more stringent 
standard for structural integrity than what is in ASTM F2388-16 would 
further reduce the risk of injury from collapses and falls from baby 
changing products. To identify requirements that would address these 
hazards, Commission staff reviewed incident data, evaluated design 
features common in baby changing products involved in incidents, and 
tested various baby changing products. Based on this information, 
Commission staff, together with ASTM, developed two provisions 
regarding threaded fasteners and secondary support straps to improve 
the structural integrity of baby changing products. Additionally, CPSC 
staff developed requirements for warnings in labels and instructional 
literature to address these issues.
1. Threaded Fasteners
    Commission staff noted that many of the baby changing products 
involved in collapse incidents required consumers to assemble the 
products using self-tapping threaded fasteners, such as wood or sheet 
metal screws. Threaded fasteners can be difficult to install properly, 
and installing them incorrectly or attempting to install them multiple 
times can make the assembled product unstable. Multiple attempts to 
install threaded fasteners can strip the fastener; an over-tightened 
threaded fastener may crack the part it is attached to; and an under-
tightened threaded fastener can create an insecure connection between 
parts. These issues are particularly likely with durable products, such 
as baby changing products, which a consumer may disassemble and 
reassemble for use with multiple children. Several ASTM standards for 
durable children's products have recognized the potential for consumers 
to install threaded fasteners improperly, resulting in unstable 
products, and certain standards prohibit them in key structural 
elements that consumers assemble.
    For these reasons, the Commission proposes additional requirements 
that would provide for secure connections between fasteners and key 
structural elements of changing tables and products. Specifically, the 
Commission proposes to:
     Prohibit the use of threaded fasteners on key structural 
elements assembled by consumers;
     require a means of preventing manufacturer-installed metal 
threaded fasteners used in key structural elements from loosening (such 
as with lock washers); and
     require a means of preventing manufacturer-installed metal 
inserts in key structural elements from loosening (such as by gluing).
    The Commission proposes 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. CPSC believes that these more stringent

[[Page 66888]]

standards would further reduce the risk of injury associated with baby 
changing products collapsing.
2. Secondary Support Straps
    Commission staff examined many of the baby changing products 
involved in reported incidents through photographs, by collecting some 
of the products, and by purchasing changing tables from consumers to 
examine their post-use condition. Through these examinations, staff 
observed that several consumers had not installed secondary support 
straps at all, or had installed them improperly. A secondary support 
strap is a metal band that runs under the center of the changing 
surface to provide additional support. Secondary support straps are 
generally one of the last components that consumers install when 
assembling baby changing products. If a consumer does not install the 
strap, or installs the strap incorrectly, the product does not have the 
added support this feature provides to enhance the product's structural 
integrity.
    To accurately test the structural integrity of baby changing 
products, the Commission believes that structural integrity testing 
should reflect the least structurally sound condition the product may 
be in when consumers use it. Given that consumers often do not install 
secondary support straps or install them incorrectly, products should 
be tested without consumer-installed secondary support straps attached. 
Therefore, the Commission proposes to adopt the structural integrity 
testing required in ASTM F2388-16, but modify the test to specify that 
consumer-installed secondary support straps not be installed for the 
test. CPSC believes that this more stringent standard would further 
reduce the risk of injury associated with baby changing product 
collapses.

B. Restraint Systems

    ASTM F2388-16 does not require or prohibit restraint systems on 
baby changing products and does not contain any performance 
requirements for restraint systems that are included with these 
products. As discussed, although the Commission does not believe it is 
necessary to require restraint systems for baby changing products, the 
Commission does believe that a performance standard that requires 
restraint systems to be effective and durable when they are included 
with a baby changing product would further reduce the risk of injury 
from falls.
    To develop requirements for restraint systems that would address 
the hazard pattern evident in the incident data, CPSC staff conducted 
lab testing of products and worked with an ASTM task group to review 
the incident data and ASTM standards addressing restraint systems in 
other durable children's products. As a result of this effort, the 
group developed a performance test for restraint systems that 
identifies baby changing products that were involved in restraint 
system failures. This test requires 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 must not break or 
separate from baby changing products more than 1 inch from their 
initial adjustment positions. CPSC believes that this more stringent 
standard would further reduce the risk of injury associated with 
restraint systems, by ensuring that those included with baby changing 
products function effectively.

C. Warnings in Labels and Instructional Literature

    As discussed, the most commonly-reported incidents involving baby 
changing products were falls, and the most common cause of fatalities 
was children sleeping on baby changing products. ASTM F2388-16 requires 
warnings about falls on labels and in instructional literature, but the 
standard does not require any warnings about the suffocation hazard 
when children sleep on baby changing products. Considering the 
frequency and severity of reported incidents and deaths, CPSC believes 
that more stringent requirements would further reduce these risks of 
injury and death.
    To develop appropriate warning requirements, Commission staff 
examined incident data and research on effective warnings, and worked 
with the ASTM Ad Hoc Wording Task Group. To further reduce the risk of 
injury associated with falls and children sleeping on baby changing 
products, the Commission proposes additional content and form 
provisions for on-product warning labels and parallel requirements for 
instructional literature. Tab E of CPSC staff's briefing package for 
this proposed rule includes additional details about these proposed 
requirements and the rationale for adding them. The briefing package is 
available at: https://www.cpsc.gov/Newsroom/FOIA/Commission-Briefing-Packages/.
1. Content
    Section 9 of ASTM F2388-16 requires baby changing products to be 
labeled with a warning that states: ``FALL HAZARD--To prevent death or 
serious injury, always keep child within arm's reach.'' Additionally, 
removable pads that are intended to be attached to a support surface 
must warn users: ``Always secure this pad to the support surface by 
[insert instructions on securing the changing pad]. See instructions.'' 
And for contoured changing pads and add-on changing units sold 
separately, warnings must specify products they attach to or specify 
that the support surface should be ``level, stable, and structurally 
sound,'' along with the minimum support surface dimensions. Section 10 
of ASTM F2388-16 requires the same warnings to appear in instructional 
literature for baby changing products.
    ASTM F2388-16 does not include warning requirements regarding 
children sleeping on baby changing products.
    To develop proposed warning language, Commission staff reviewed 
information developed through research on the content of warnings, 
assessed other standards, and reviewed the ASTM Ad Hoc Wording Task 
Group recommendations. Literature and guidelines about warnings 
consistently recommend that warnings include:
     A description of the hazard;
     information about the consequences of exposure to the 
hazard; and
     instructions about appropriate hazard-avoidance behaviors.

Studies indicate that when a person receives information about a 
hazard, its consequences, and mitigating actions, that information 
motivates appropriate behavior.
    The Commission believes that the warning statements in ASTM F2388-
16 lack important details regarding fall and suffocation hazards, their 
consequences, and appropriate avoidance behaviors. Moreover, the 
Commission believes that the warning statements in the standard provide 
only a vague description of the types of injuries that may occur from 
falls and the statements do not refer to suffocation at all. The 
Commission believes that strengthening the requirements in ASTM F2388-
16 would further reduce the risk of injury associated with falls and 
suffocation. Additionally, the Commission believes that these proposed 
changes would improve readability and consistency across standards. 
CPSC developed the following proposed language to describe the specific 
hazards, consequent injuries and dangers, and precise actions that can 
help reduce the likelihood of falls and suffocation. CPSC proposes to 
require the following warning label to appear on baby changing 
products:

[[Page 66889]]

    Fall hazard. Children have suffered serious injuries after falling 
from changing [tables/pads/areas]. Falls can happen quickly.
     STAY in arm's reach.

Manufacturers will select one of the terms in brackets, or a similar 
term, that most-appropriately describes the particular product. 
Similarly, CPSC proposes to require the following warning label to 
appear on contoured changing pads that attach to a support surface and 
changing products that attach to play yards:

    Fall hazard. Children have suffered serious injuries after falling 
from changing [tables/pads/areas]. Falls can happen quickly.
     STAY in arm's reach.
     ALWAYS secure this pad to the support surface by 
[manufacturer's instructions for securing the changing product].
    Suffocation hazard. Babies have suffocated while sleeping on 
changing pads. Changing pad is not designed for safe sleeping.
     NEVER allow baby to sleep on changing pad.

Manufacturers will select one of the terms in brackets, or a similar 
term, that most-appropriately describes the particular product. The 
Commission proposes to require the same modifications to the content of 
the warnings in instructional literature.
    Additionally, the Commission proposes minor changes to the language 
in section 9 of ASTM F2388-16, as detailed in the proposed regulatory 
text, to make the warnings clearer, and thereby, more effective and 
consistent with similar standards.
2. Form
    Research indicates that the form of a warning can affect the extent 
to which consumers notice and read the warning and can communicate the 
seriousness of a hazard, which can affect compliance with the warning. 
ASTM F2388-16 does not include any form requirements for on-product 
warnings, apart from text size, and does not include any form 
requirements for warnings in instructional literature.
    As discussed, Commission staff worked closely with the ASTM Ad Hoc 
Wording Task Group to develop recommendations for product warnings, 
particularly focused on form, to provide effective and uniform warning 
requirements. The requirements for warnings on labeling and in 
instructional literature that the Commission is proposing in this NPR 
are drawn from the ASTM Ad Hoc Wording Task Group's recommendations.
    The ASTM Ad Hoc Wording Task Group's recommendations are largely 
consistent with ANSI Z535.4, Product Safety Signs and Labels (ANSI 
Z535.4; available at: https://www.ansi.org/), which provides guidance on 
warning label designs, specifically addressing the design, application, 
use, and placement of on-product warning labels. ANSI Z535.4 is the 
primary U.S. voluntary consensus standard for product safety signs and 
labels and CPSC's Division of Human Factors staff uses the standard 
regularly. ANSI Z535.4 includes requirements about signal words; sign 
and label format, arrangement, and placement; word messages; colors; 
borders; letter styles and sizes; and the durability of labels.
    CPSC considered research on effective forms for warnings, including 
the requirements in ANSI Z535.4, in developing the proposed form 
requirements. Commission staff and the ASTM Ad Hoc Wording Task Group 
modified these requirements to account for the unique nature of durable 
nursery products, the wide range of such products, industry concerns, 
and insights from CPSC's past rulemakings on durable nursery products. 
The resulting recommendations and the requirements the Commission 
proposes in this NPR are designed to increase consumer attention to 
warnings, improve comprehension, and increase behaviors that would 
minimize hazards. These proposed requirements include:
     Warnings must conform to the 2011 edition of ANSI Z535.4, 
which is incorporated by reference into the regulations with certain 
exceptions;
     warnings must be easy to read and understand, and be in 
English;
     warnings must be permanent;
     additional markings or labels must not contradict the 
required warning information or be confusing or misleading; and
     the specific typefaces, size, alignment, layout, and text 
formats to use to facilitate readability.
    The Commission believes that these requirements would further 
reduce the risk of injury associated with falls and suffocation, by 
making the warnings regarding these risks more effective. The 
Commission proposes the same design requirements for on-product 
warnings and warnings in instructional literature, except that 
instructional literature need not meet the color requirements in ANSI 
Z535.4.
    Additionally, CPSC proposes 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: https://www.ansi.org/), for optional additional guidance 
about the design of product safety messages in instructional 
literature. CPSC does not propose to require compliance with ANSI 
Z535.6, but the standard may offer regulated entities additional useful 
information for developing effective warnings in instructional 
literature. Although the Commission believes compliance with this 
standard is advisable, product instructions vary greatly, depending on 
the product, purpose, content, length, and other factors. Thus, the 
Commission believes it is appropriate to reference ANSI Z535.6, but not 
mandate compliance with it.
3. Placement
    ASTM F2388-16 requires warning labels to be ``conspicuous,'' that 
is, visible to a caretaker standing in a place normally associated with 
changing a diaper. The Commission believes that this requirement is 
adequate because it provides caregivers the opportunity to see a 
warning during routine use of the product and just before they would 
leave a child unattended, sleeping, or out of their reach on the baby 
changing product. This requirement is also consistent with ANSI Z535.4.

D. Miscellaneous Additional Requirements

    The Commission also proposes several additional minor changes that 
would further reduce the risk of injury associated with baby changing 
products and provide greater clarity or detail regarding requirements 
in ASTM F2388-16. These include:
     Adding definitions for ``key structural elements'' and 
``non-rigid add-on changing unit accessory'';
     adding a provision to prohibit components attached by 
screws from separating more than 0.04 in. (1 mm) after structural 
integrity testing; and
     requiring a marking including both the address and 
telephone number of the manufacturer, distributor, or seller, rather 
than one or the other.
    The proposed definitions would add clarity to the standard and are 
relevant to the additional requirements. ``Key structural elements'' 
are central to the proposed requirements regarding threaded fasteners, 
and specific requirements for ``non-rigid add-on changing unit 
accessories'' are in the proposed labeling provisions. The separation 
limit would further reduce the risk of injury associated with 
structural integrity issues demonstrated in the incident data. 
Providing the address, as well as the telephone number for firms that 
supply baby changing products would provide the

[[Page 66890]]

Commission and consumers with more complete contact information, in 
case it is necessary to contact a supplier. This would expedite any 
safety measures necessary and thereby, reduce the risk of safety 
hazards.

VIII. Amend 16 CFR Part 1112 To Include NOR for Baby Changing Products 
Standard

    Section 14 of the CPSA establishes requirements for product testing 
and certification. Manufacturers of products that are subject to a 
consumer product safety rule under the CPSA or another rule the 
Commission enforces must certify, based on product testing, that their 
product complies with all such rules. 15 U.S.C. 2063(a)(1). 
Additionally, manufacturers of children's products that are subject to 
a children's product safety rule must have these products tested by a 
third party conformity assessment body that CPSC has accredited, and 
manufacturers must certify that their products comply with all 
applicable children's product safety rules. Id. at 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. Id. at 2063(a)(3). Because the proposed rule is a 
children's product safety rule, if the Commission issues 16 CFR part 
1235, Safety Standard for Baby Changing Products, as a final rule, the 
CPSC must also issue an NOR.
    The Commission published a final rule, codified at 16 CFR part 
1112, titled, Requirements Pertaining to Third Party Conformity 
Assessment Bodies, which established requirements for accreditation of 
third party conformity assessment bodies to test for conformity with 
children's product safety rules in accordance with the CPSA. 78 FR 
15836 (Mar. 12, 2013). Part 1112 also codifies all of the NORs that the 
Commission previously issued.
    NORs for new children's product safety rules, such as the baby 
changing products standard, require the Commission to amend part 1112. 
To accomplish this, as part of this NPR, the Commission proposes to 
amend part 1112 to add baby changing products to the list of children's 
product safety rules for which CPSC has issued an NOR.
    Test laboratories applying for acceptance as a CPSC-accepted third 
party conformity assessment body to test for compliance with the 
proposed standard for baby changing products would be required to meet 
the third party conformity assessment body accreditation 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 have 16 CFR part 1235, Safety Standard for Baby 
Changing 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. Incorporation by Reference

    Section 1235.1 of the proposed rule incorporates by reference ASTM 
F2388-16 and ANSI Z535.4. The Office of the Federal Register (OFR) has 
regulations concerning incorporation by reference. 1 CFR part 51. Under 
these regulations, in the preamble of the NPR, an agency must summarize 
the incorporated material and discuss the ways in which the material is 
reasonably available to interested parties or how the agency worked to 
make the materials reasonably available. 1 CFR 51.5(a). In accordance 
with the OFR's requirements, Section V. ASTM F2388-16 of this preamble 
summarizes the provisions of ASTM F2388-16 and Section VII. Description 
of Proposed Changes to ASTM Standard summarizes the provisions of ANSI 
Z535.4 that the Commission proposes to incorporate by reference.
    ASTM F2388-16 is copyrighted material. By permission of ASTM, 
interested parties may view the standard as a read-only document during 
the comment period of this NPR at: https://www.astm.org/cpsc.htm. 
Interested parties may also purchase a copy of ASTM F2388-16 from ASTM 
International, 100 Bar Harbor Drive, P.O. Box 0700, West Conshohocken, 
PA 19428; https://www.astm.org/cpsc.htm.
    ANSI Z535.4 is also copyrighted material. Interested parties may 
purchase a copy of ANSI Z535.4 from the American National Standards 
Institute (ANSI), 1899 L Street NW., 11th Floor, Washington, DC 20036, 
or through the ANSI Web site at: https://www.ansi.org.
    Interested parties may also inspect copies of the standard 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.

X. Effective Date

    The Administrative Procedure Act (5 U.S.C. 551-559) 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). To allow time for baby 
changing products to come into compliance with the standard, the 
Commission proposes that the standard become effective 6 months after 
publication of the final rule in the Federal Register. Without evidence 
to the contrary, CPSC generally considers 6 months to be sufficient 
time for suppliers to come into compliance with a new standard, and 6 
months is typical for other CPSIA section 104 rules. Six months is also 
the period that the Juvenile Products Manufacturers Association (JPMA) 
typically allows for products in its certification program to 
transition to a new standard after publication.
    The Commission also proposes that the amendment to part 1112 become 
effective 6 months after publication of the final rule.
    The Commission requests comments on the proposed effective date.

XI. Regulatory Flexibility Act

A. Introduction

    The Regulatory Flexibility Act (RFA; 5 U.S.C. 601-612) requires 
agencies to consider the impact of proposed rules on small entities, 
including small businesses. Section 603 of the RFA requires the 
Commission to prepare an initial regulatory flexibility analysis (IRFA) 
and make it available to the public for comment when the NPR is 
published. 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 
discuss:
     The reasons the agency is considering the action;
     the objectives of and legal basis for the proposed rule;
     the small entities that would be subject to the proposed 
rule and an estimate of the number of small entities that would be 
impacted;
     the reporting, recordkeeping, and other requirements of 
the proposed rule, including the classes of small entities subject to 
it and the skills necessary to prepare the reports or records; and
     the relevant federal rules that may duplicate, overlap, or 
conflict with the proposed rule.
    5 U.S.C. 603.
    This section summarizes the IRFA for this proposed rule. The 
complete IRFA is available in Tab F of staff's briefing package for 
this proposed rule, available at: https://www.cpsc.gov/Newsroom/FOIA/Commission-Briefing-Packages/. To summarize, the Commission cannot rule 
out a significant economic impact for 40 of the 59 (68 percent) small 
entities that supply baby changing products in the U.S. market.

[[Page 66891]]

B. Market Description

    CPSC identified 85 firms that supply baby changing products to the 
U.S. market. Seventy-one of these firms are domestic (57 manufacturers, 
12 importers, one wholesaler, and one retailer), and 14 are foreign (12 
manufacturers, one importer, and one retailer). Eighty-one of these 
firms market their products to consumers, while seven also market their 
products for commercial daycare use. Fifty-six offer multiple types of 
baby changing products.

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

    Section 104 of the CPSIA requires the CPSC to promulgate mandatory 
standards for durable infant or toddler products that are substantially 
the same as a 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. As 
discussed in Section I. Background and Statutory Authority, baby 
changing products are durable infant or toddler products.

D. Description of the Proposed Rule

    CPSC proposes to adopt ASTM F2388-16 with modifications to the 
structural integrity requirements, restraint system requirements, and 
provisions on warnings on labels and instructional literature. Section 
V. ASTM F2388-16 of this preamble discusses key provisions of ASTM 
F2388-16 and Section VII. Description of Proposed Changes to ASTM 
Standard discusses the proposed requirements that are more stringent 
than ASTM F2388-16. To help evaluate the economic impact of the 
proposed rule, Commission staff contacted nine industry members who 
would be impacted by the rule, and three responded.

E. Other Relevant Federal Rules

    CPSC has not identified any federal or state rules that would 
duplicate, overlap or conflict with the proposed rule.

F. Impact of the Proposed Rule on Small Businesses

    Under U.S. Small Business Administration (SBA) guidelines, a baby 
changing product manufacturer is a small business if it has 500 or 
fewer employees; importers and wholesalers are small businesses if they 
have 100 or fewer employees. CPSC analyzed domestic firms because SBA 
guidelines and definitions apply to U.S. entities. CPSC identified 85 
firms that currently market baby changing products in the United 
States; 71 are domestic firms. Fifty-nine of these firms (49 
manufacturers, 9 importers, and 1 wholesaler) are small businesses, 
based on the SBA guidelines and available information about the firms.
    To determine the extent to which the proposed rule would impact 
small businesses, the Commission identified firms that comply with ASTM 
F2388-16 by considering the following factors: JPMA certification, the 
firm's claims of compliance, active participation in ASTM standards 
development, and CPSC compliance testing. Table 2 lists the number of 
firms by location, size, type, and compliance:

      Table 2--Firms That Market Baby Changing Products in the U.S.
------------------------------------------------------------------------
                       Category                         Number of firms
------------------------------------------------------------------------
Domestic.............................................                 71
    Small............................................                 59
        Manufacturers................................                 49
            Compliant with ASTM F2388................                 22
            Not Compliant with ASTM F2388............                 27
        Importers and Wholesalers....................                 10
            Compliant with ASTM F2388................                  4
            Not Compliant with ASTM F2388............                  6
    Large............................................                 12
Foreign..............................................                 14
Total................................................                 85
------------------------------------------------------------------------

    Looking first at the proposed requirements that would prohibit the 
use of consumer-installed threaded fasteners in key structural 
elements, the Commission believes that the overall economic impact of 
this requirement would be small. CPSC testing indicates that most baby 
changing products on the market already follow this restriction and 
non-compliant firms could make inexpensive changes to meet this 
requirement.
    With respect to structural integrity testing without consumer-
installed secondary support straps, it is possible that some firms 
would incur costs to comply with this requirement. CPSC testing 
indicates that some products do not pass structural integrity testing 
without their consumer-installed secondary support straps; however, 
these products are not currently on the market. The cost of complying 
would vary, depending on the modifications that a firm adopts.
    Next, the Commission proposes to adopt a structural integrity test 
for restraints when they are included with a product. The Commission 
found that approximately 21 percent of baby changing products on the 
U.S. market include restraints. Through limited testing, staff found 
that some of these products do not meet the proposed requirement. To 
comply with the proposed requirement, firms have several low-cost 
options to reinforce restraints.
    Finally, the Commission is proposing additional requirements for 
warnings on labels and in instructional literature. All firms would 
have to modify the wording and format of their warnings to meet these 
requirements; however, the costs of such changes are generally small, 
particularly compared to overall firm revenues.
1. Small Manufacturers With Compliant Baby Changing Products
    Of the 49 small manufacturers, 22 produce baby changing products 
that comply with ASTM F2388-16, making the economic impact of adopting 
ASTM F2388-16 small. Additionally, the proposed requirements for 
threaded fasteners, restraints, and warnings likely would also create 
only small costs for these manufacturers. Compliant manufacturers are 
unlikely to use consumer-installed threaded fasteners in key structural 
components because other children's product standards

[[Page 66892]]

prohibit them. About 10 of these firms produce at least one baby 
changing product with restraints, but if their products are not 
compliant, then the firm can remove the restraints or make other low-
cost adjustments. Similarly, the cost to comply with the proposed 
requirements for warnings is also likely to be low because the 
additional requirements would merely modify the text and format of the 
ASTM F2388-16 warnings.
    In contrast, the proposed additional requirement regarding user-
installed secondary support straps may result in significant costs. 
Five of the compliant manufacturers may use consumer-installed 
secondary support straps. If these products do not pass the structural 
integrity test without these supports, the cost of modifying the 
products could range from minimal to great, depending on the product 
type and the changes employed. Therefore, staff cannot rule out a 
significant economic impact for the five manufacturers of compliant 
products that may employ user-installed secondary support straps.
2. Small Manufacturers With Non-Compliant Baby Changing Products
    Twenty-seven of the 49 small manufacturers produce baby changing 
products that do not comply with ASTM F2388-16. These firms may incur 
costs to conform to ASTM F2388-16 and the additional proposed 
requirements. The Commission does not have sufficient information to 
determine the extent and cost of these changes. Therefore, the 
Commission cannot rule out a significant economic impact on these 
firms.
3. Third Party Testing Costs for Small Manufacturers
    Under section 14 of the CPSA, if CPSC adopts the proposed 
requirements, all manufacturers would be subject to the third party 
testing and certification requirements under 16 CFR part 1107. Third 
party testing would include any physical and mechanical test 
requirements, and the cost of obtaining testing would be in addition to 
the costs of meeting the baby changing products standard.
    Almost half of small baby changing product manufacturers (22 out of 
49) already test their products for compliance with ASTM F2388, 
although not necessarily through a third party laboratory. For these 
manufacturers, the cost of the proposed rule, with respect to third 
party testing, would be limited to the difference between the cost of 
their current testing regimes and the cost of third party tests, which 
is likely to be low.
    Of the remaining 27 firms that do not currently test their products 
for compliance with ASTM F2388-16, third party testing could result in 
a significant economic impact for five firms. Testing costs may exceed 
1 percent of gross revenue for these firms if five or fewer samples are 
tested (assuming high-end, U.S.-based testing costs of $1,200 per model 
sample). CPSC could not obtain revenue information for all of the 
small, non-compliant manufacturers. Therefore, CPSC could not evaluate 
the economic impact for six firms.
4. Small Importers and Wholesalers With Compliant Baby Changing 
Products
    CPSC 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. The four small importers that comply 
with ASTM F2388-16 would require modifications to meet the proposed 
additional requirements. However, as discussed, the costs of complying 
with the additional threaded fastener, restraints, and warning 
requirements are likely to be low.
    The proposed requirement regarding user-installed secondary support 
straps, however, could be more costly and possibly require firms to 
retrofit or redesign their products. Two of the four importers may 
require modifications to pass structural integrity testing under this 
requirement. Both firms could eliminate changing products from their 
product lines without a significant adverse impact, but likely could 
not use an alternate supplier.
5. Small Importers and Wholesalers With Non-Compliant Baby Changing 
Products
    There is insufficient information to rule out a significant impact 
for any of the five importers and one wholesaler of non-compliant baby 
changing products. Whether there would be a significant economic impact 
would depend on the extent of the changes required for these firms to 
come into compliance and the response of their suppliers, who may pass 
on the increased costs to the importers and wholesalers.
    Four of the six importers and wholesalers with non-compliant 
products do not appear to have direct ties to their suppliers and may 
select alternative suppliers. Three of these firms supply numerous 
products. Thus, they could stop supplying baby changing products. 
However, one firm only supplies baby changing products, so there would 
be a significant economic impact if that firm left the market.
    The remaining two firms are tied to their foreign suppliers, so 
they are not likely to choose alternative suppliers. However, these 
foreign suppliers may comply with the proposed requirements to continue 
to market their products in the United States. Alternatively, these 
firms may stop selling baby changing products altogether because they 
represent only a small portion of their product lines. Without sales 
revenues, CPSC could not determine whether exiting the baby changing 
products market would generate significant economic impacts.
6. Third Party Testing Costs for Small Importers and Wholesalers
    Importers and wholesalers would be subject to costs similar to 
manufacturers' costs if their foreign suppliers do not obtain third 
party testing. Four importers already test their products to verify 
compliance with the ASTM standard. As such, their costs would be 
limited to the incremental costs of third party testing over their 
current testing regimes.
    There may be significant costs for two or three firms that do not 
comply with the ASTM standard. For two firms, the cost of testing as 
few as two units per model could exceed 1 percent of their gross 
revenues. For a third firm, testing costs may exceed 1 percent of its 
gross revenue, depending on how many units per model the firm tests. 
CPSC was unable to obtain revenue data for one small, non-compliant 
wholesaler, so could not examine the size of the impact on that firm.
7. Summary of Impacts
    The Commission identified 59 small firms that market baby changing 
products in the United States, of which 49 are domestic manufacturers 
and 10 are domestic importers or wholesalers. Of the 49 small 
manufacturers, 17 are unlikely to experience significant economic 
impacts if the Commission adopts the proposed rule. However, CPSC 
cannot rule out a significant economic impact for the remaining 32 
manufacturers. For two of the small importers and wholesalers, it is 
likely that the proposed rule would not have a significant economic 
impact. However, it is possible that the proposed rule would have a 
significant economic impact on the remaining eight small importers and 
wholesalers. Therefore, to summarize, CPSC cannot rule out a 
significant economic impact for 40 of the 59 small firms (68 percent) 
operating in the U.S. baby changing products market.

[[Page 66893]]

8. Impacts of Test Laboratory Accreditation Requirements on Small 
Laboratories
    In accordance with section 14 of the CPSA, all children's products 
that are subject to a children's product safety rule must be tested by 
a third party conformity assessment body that has been accredited by 
CPSC. These third party conformity assessment bodies test products for 
compliance with applicable children's product safety rules. Testing 
laboratories that want to conduct this testing must meet the NOR for 
third party conformity testing. CPSC has codified NORs in 16 CFR part 
1112. CPSC proposes to amend 16 CFR part 1112 to establish an NOR for 
testing laboratories to test for compliance with the proposed baby 
changing products standard. This section assesses the impact of this 
proposed amendment on small laboratories.
    CPSC conducted a Final Regulatory Flexibility Analysis (FRFA) when 
it adopted part 1112. 78 FR 15836 (Mar. 12, 2013). The FRFA concluded 
that the accreditation requirements would not have a significant 
adverse impact on a substantial number of small laboratories because no 
requirements were imposed on laboratories that did not intend to 
provide third party testing services. The only laboratories that were 
expected to provide such services were laboratories that anticipated 
receiving sufficient revenue from the mandated testing to justify 
accepting the requirements as a business decision.
    For the same reasons, including the NOR for baby changing products 
in part 1112 would not have a significant adverse impact on small 
laboratories. Moreover, CPSC expects that only a small number of 
laboratories would request accreditation to test baby changing 
products, based on the number of laboratories that have applied for 
CPSC accreditation to test other juvenile products. Most laboratories 
would already have accreditation to test for conformance to other 
juvenile product standards; accordingly, the only cost would be to add 
the baby changing products standard to their accreditation. Test 
laboratories have indicated that this cost is extremely low when they 
are already accredited for other CPSIA section 104 rules. Therefore, 
the Commission certifies that the NOR for the baby changing products 
standard will not have a significant impact on a substantial number of 
small entities.

G. Alternatives

    At least three alternatives are available to minimize the economic 
impact on small entities supplying baby changing products, while also 
complying with the direction of section 104 of the CPSIA.
    First, the Commission could adopt ASTM F2388-16, with no 
modifications. Section 104 of the CPSIA directs the Commission to 
promulgate a standard that is either substantially the same as the 
voluntary standard or more stringent if the Commission determines that 
would further reduce the risk of injury associated with the product. 
Therefore, adopting ASTM F2388-16 with no modifications is the least 
stringent rule CPSC could adopt. This alternative would reduce the 
economic impact on all of the small businesses supplying baby changing 
products to the U.S. market. Although choosing this alternative would 
not reduce the testing costs associated with the rule, this alternative 
would eliminate the economic impact of the additional proposed 
requirements. This option would eliminate the cost of complying with 
the additional requirements for the 22 small domestic manufacturers and 
four small importers and wholesalers with baby changing products that 
conform to ASTM F2388-16. However, adopting ASTM F2388-16 with no 
modifications would not further reduce the risks associated with falls 
and suffocations.
    Second, the Commission could adopt ASTM F2388-16 with the proposed 
modifications, except for the requirement regarding secondary support 
straps. This additional requirement is likely to have the largest 
economic impact, and removing it would reduce the impact on 11 small 
suppliers (9 small manufactures and 2 small importers). However, 
without this requirement, the standard may not reduce the risk of 
injuries associated with falls as effectively.
    Third, the Commission could set a later effective date for the 
final rule. A later effective date would reduce the economic impact on 
firms in two ways. First, firms would be less likely to experience a 
lapse in production or imports if they are unable to modify their 
products and secure third party testing within the required timeframe. 
Second, firms could spread costs over a longer period, thereby reducing 
annual costs and the present value of total costs. CPSC requests 
comments on the 6-month effective date.

H. Requested Information

    The Commission would find comments on the following issues 
particularly helpful:
     The changes, costs, and time needed to conform to ASTM 
F2388-16;
     how affected firms would modify their products, the 
associated costs, and the time needed to meet each of the proposed 
requirements regarding:
    [cir] Threaded fasteners;
    [cir] consumer-installed secondary support straps;
    [cir] restraint system integrity; and
    [cir] labels and instructional literature;
     whether a particular effective date, or time of year would 
reduce the costs associated with the proposed requirements;
     whether the costs of complying with the proposed ban of 
consumer-installed threaded fasteners on key structural elements would 
be ``economically significant'' (i.e., amount to an impact greater than 
1 percent of revenue or similar economic benchmarks);
     the types of baby changing products that include user-
installed secondary support straps and their prevalence in the U.S. 
market;
     the extent to which firms would remove restraints 
entirely, rather than conform to the proposed requirement, and the 
associated costs;
     testing costs and incremental costs of third party testing 
(i.e., how much moving from a voluntary to a mandatory third party 
testing regime would add to testing costs in total and on a per-test 
basis); and
     the number of products that must be tested to provide a 
``high degree of assurance'' with respect to third party testing.

XII. Environmental Considerations

    The Commission's regulations outline the types of agency actions 
that require an environmental assessment (EA) or environmental impact 
statement (EIS). Rules that have ``little or no potential for affecting 
the human environment'' fall within a ``categorical exclusion'' under 
the National Environmental Policy Act (NEPA; 42 U.S.C. 4231-4370h) and 
the regulations implementing NEPA (40 CFR parts 1500-1508) and do not 
normally require an EA or EIS. As stated in 16 CFR 1021.5(c)(1), rules 
or safety standards that provide design or performance requirements for 
products fall within that categorical exclusion. Because this proposed 
rule would create design and performance requirements for baby changing 
products, the proposed rule falls within the categorical exclusion. 
Thus, no EA or EIS is required.

XIII. Paperwork Reduction Act

    This proposed rule contains information collection requirements 
that are subject to public comment and review by the Office of 
Management and

[[Page 66894]]

Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA; 44 U.S.C. 
3501-3521). Under 44 U.S.C. 3507(a)(1)(D), an agency must publish the 
following information:
     A title for the collection of information;
     a summary of the collection of information;
     a brief description of the need for the information and 
the proposed use of the information;
     a description of the likely respondents and proposed 
frequency of response to the collection of information;
     an estimate of the burden that shall result from the 
collection of information; and
     notice that comments may be submitted to OMB.

In accordance with this requirement, the Commission provides the 
following information:

    Title: Safety Standard for Baby Changing Products.
    Description: The proposed rule would require each baby changing 
product to comply with ASTM F2388-16, with additional requirements 
regarding structural integrity, restraint system integrity, and 
warnings in labels and instructional literature. Sections 9 and 10 of 
ASTM F2388-16 contain requirements for labels and instructional 
literature. These requirements fall within the definition of a 
``collection of information'' provided in the PRA at 44 U.S.C. 3502(3).
    Description of Respondents: Persons who manufacture or import baby 
changing products.
    Estimated Burden: CPSC estimates the burden of this collection of 
information as follows:

                                                       Table 3--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Number of       Frequency of     Total annual      Hours per      Total  burden
                           16 CFR section                              respondents       responses        responses         response          hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
1235.3.............................................................              85                6              510                1              510
--------------------------------------------------------------------------------------------------------------------------------------------------------

    CPSC's estimate is based on the following:
    Section 9.1.1 of ASTM F2388-16 requires that the name and place of 
business (mailing address) or the telephone number of the manufacturer, 
distributor, or seller appear on each baby changing product and its 
retail package. The additional requirements proposed in this NPR would 
require both the specified address information and the telephone 
number, instead of a choice between the two. Section 9.1.2 of ASTM 
F2388-16 requires a code mark or other product identification on each 
product and retail package that indicates the date (month and year) of 
manufacture.
    Eighty-five known entities supply baby changing products to the 
U.S. market and may need to modify their existing labels to comply with 
ASTM F2388-16. CPSC estimates 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 six models 
of baby changing products. Therefore, the estimated burden associated 
with labels is 1 hour per model x 85 entities x 6 models per entity = 
510 hours. CPSC estimates the hourly compensation for the time required 
to create and update labels is $33.02 (U.S. Bureau of Labor Statistics, 
``Employer Costs for Employee Compensation,'' Mar. 2016, Table 9, total 
compensation for all sales and office workers in goods-producing 
private industries: https://www.bls.gov/ncs/). Therefore, the estimated 
annual cost associated with the proposed labeling requirements is 
$16,840 ($33.02 per hour x 510 hours = $16,840). No operating, 
maintenance, or capital costs are associated with the collection.
    Section 10.1 of ASTM F2388-16 requires instructions to be supplied 
with baby changing products. Baby changing products generally require 
use and assembly instructions. As such, products sold without use and 
assembly instructions would not compete successfully with those that 
supply this information. Under OMB's regulations, the time, effort, and 
financial resources necessary to comply with a collection of 
information incurred by parties in the ``normal course of their 
activities'' are excluded from a burden estimate when an agency 
demonstrates that the disclosure activities required are ``usual and 
customary.'' 5 CFR 1320.3(b)(2). CPSC is unaware of baby changing 
products that generally require use or assembly instructions but lack 
such instructions. Therefore, CPSC estimates that no burden hours are 
associated with section 10.1 of ASTM F2388-16 because any burden 
associated with supplying instructions with baby changing products 
would be ``usual and customary,'' and thus, excluded from ``burden'' 
estimates under OMB's regulations.
    Based on this analysis, the proposed standard for baby changing 
products would impose a burden to industry of 510 hours at a cost of 
$16,840 annually.
    CPSC has submitted the information collection requirements of this 
rule to OMB for review in accordance with PRA requirements. 44 U.S.C. 
3507(d). CPSC requests that interested parties submit comments 
regarding information collection to the Office of Information and 
Regulatory Affairs, OMB (see the ADDRESSES section at the beginning of 
this NPR).
    Pursuant to 44 U.S.C. 3506(c)(2)(A), the Commission invites 
comments on:
     Whether the proposed collection of information is 
necessary for the proper performance of CPSC's functions, including 
whether the information will have practical utility;
     the accuracy of CPSC's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used;
     ways to enhance the quality, utility, and clarity of the 
information the Commission proposes to collect;
     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
     the estimated burden hours associated with modifying 
labels and instructional literature, including any alternative 
estimates.

XIV. 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). States or political 
subdivisions of states may, however, apply to the Commission for an 
exemption, allowing them to establish or continue such a requirement if 
the state requirement provides a significantly high degree of 
protection from the risk of injury and

[[Page 66895]]

does not unduly burden interstate commerce. Id. at 2075(c).
    One of the functions of the CPSIA was to amend the CPSA, adding 
several provisions to CPSA, including CPSIA section 104 in 15 U.S.C. 
2056a. As such, consumer product safety standards that the Commission 
creates under CPSIA section 104 are covered by the preemption provision 
in the CPSA. Consequently, the rule proposed in this NPR would be a 
federal consumer product safety standard, and the preemption provision 
in section 26 of the CPSA would apply.

XV. Request for Comments

    This NPR begins a rulemaking proceeding under section 104(b) of the 
CPSIA to issue a consumer product safety standard for baby changing 
products and to amend part 1112 to add baby changing products to the 
list of children's product safety rules for which CPSC has issued an 
NOR. We invite all interested persons to submit comments on any aspect 
of the proposed mandatory safety standard for baby changing products 
and on the proposed amendment to part 1112. Specifically, the 
Commission requests comments on the following:
     The requirements in ASTM F2388-16, including their 
effectiveness in addressing the risks of injury associated with baby 
changing products and the costs of complying with these requirements;
     the additional requirements proposed for structural 
integrity, specifically regarding threaded fasteners and secondary 
support straps, including their effectiveness in addressing the risk of 
injury associated with collapses and falls and the costs of complying 
with these requirements;
     the additional requirement proposed for restraint systems, 
including its effectiveness in addressing the risk of injury associated 
with restraints and falls and the costs of complying with this 
requirement;
     the additional requirements proposed for labels and 
instructional literature, including their effectiveness at addressing 
the hazards associated with falls and suffocation and the costs of 
complying with these requirements;
     the costs to small businesses associated with the 
requirements proposed in this NPR, including the costs to comply with 
the proposed additional requirements for structural integrity, 
restraint system integrity, and warnings on labels and in instructional 
literature;
     alternatives to the proposed requirements that would 
reduce impacts on small businesses;
     the proposed effective date and whether an extended 
effective date would further mitigate the impact on small businesses 
and to what extent; and
     any additional information relevant to the issues 
discussed in this NPR and the proposed requirements.
    During the comment period, ASTM F2388-16 and ANSI Z535.4 are 
available for review. Please see Section IX. Incorporation by Reference 
for instructions on viewing them.
    Please submit comments in accordance with the instructions in the 
ADDRESSES section at the beginning of this NPR.

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, 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; Public Law 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 Incorporation by reference.
1235.2 Scope.
1235.3 Requirements for baby changing products.

    Authority:  Sec. 104, Pub. L. 110-314, 122 Stat. 3016.


Sec.  1235.1  Incorporation by reference.

    Certain material is incorporated by reference into this part with 
the approval of the Director of the Federal Register under 5 U.S.C. 
552(a) and 1 CFR part 51. All approved material is available for 
inspection at the U.S. Consumer Product Safety Commission, Office of 
the Secretary, 4330 East West Highway, Room 820, Bethesda, MD 20814, 
telephone 301-504-7923, and is available from the sources listed below. 
It is also available for inspection 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.
    (a) American National Standards Institute, Inc., 1899 L Street, 
NW., 11th Floor, Washington, DC 20036; telephone 202-293-8020; https://www.ansi.org.
    (1) ANSI Z535.4-2011, Product Safety Signs and Labels, 2011 (ANSI 
Z535.4-2011), IBR approved for Sec.  1235.3.
    (2) [Reserved]
    (b) ASTM International, 100 Bar Harbor Drive, P.O. Box 0700, West 
Conshohocken, PA 19428; telephone 877-909-2786; https://www.astm.org/cpsc.htm.
    (1) ASTM F2388-16, Standard Consumer Safety Specification for Baby 
Changing Tables for Domestic Use, 2016 (ASTM F2388-16), IBR approved 
for Sec.  1235.3.
    (2) [Reserved]


Sec.  1235.2  Scope.

    This part establishes a consumer product safety standard for baby 
changing products, including changing tables and other changing 
products, such as contoured changing pads and add-on changing units 
sold separately for use on furniture products other than changing 
tables.


Sec.  1235.3  Requirements for baby changing products.

    (a) Except as provided in paragraphs (b) through (m) of this 
section, each baby changing product must comply with all applicable 
provisions of ASTM F2388-16 (incorporated by reference, see Sec.  
1235.1)
    (b) Comply with ASTM F2388-16 with the additions or exclusions 
listed in paragraphs (c) through (m) of this section:
    (c) In addition to the definitions in section 3.1 of ASTM F2388-16, 
the following definitions apply to this section:
    (1) 3.1.14 key structural elements, n--side assemblies, end 
assemblies, base assemblies, leg assemblies, primary

[[Page 66896]]

changing surface supports, or other components designed to support the 
weight of the occupant, or a combination thereof.
    (2) 3.1.15 non-rigid add-on changing unit accessory, n--a supported 
changing unit 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 and/or bottom surface.
    (d) In addition to complying with sections 5.1 through 5.7 of ASTM 
F2388-16, comply with the following:
    (1) 5.8 Threaded Fasteners (Wood Screws and Sheet Metal Screws)--
    (i) 5.8.1 No changing table shall require consumer assembly of key 
structural elements using wood screws or sheet metal fasteners directly 
into wood components. This shall not apply to non-key structural 
elements such as drawers, secondary support straps, other storage 
components, or accessory items.
    (ii) 5.8.2 Metal inserts, with external wood screw threads for 
screwing into a wood component and providing internal machine threads 
to accommodate a machine screw, that are used to secure key structural 
elements shall be glued or include other means to impede loosening or 
detaching.
    (iii) 5.8.3 Metal threaded fasteners, such as sheet metal screws 
and machine screws, secured into metal components and used to attach 
key structural elements shall have lock washers, self-locking nuts, or 
other means to impede loosening or detachment during the testing 
required by this specification, as described in section 6.2 of ASTM 
F2388-16.
    (2) [Reserved]
    (e) Instead of complying with section 6.2 of ASTM F2388-16, comply 
with the following:
    (1) 6.2 Structural Integrity--When tested in accordance with 7.2, 
there shall be no breakage of the unit, nor shall it fail to conform to 
any other requirements in this specification before and after all 
testing. Components attached by screws shall not have separated by more 
than 0.04 in. (1 mm) upon completion of testing.

    Note 1: Contoured changing pads and add-on changing units that 
are sold separately are exempt from this requirement.

    (2) [Reserved]
    (f) In addition to complying with section 6.8 of ASTM F2388-16, 
comply with the following:
    (1) 6.9 Restraint System--

    Note 2: A restraint system may be provided to restrict upward or 
lateral movement of the occupant's torso. Inclusion of a restraint 
system is not mandatory.

    (i) 6.9.1 If a restraint system is installed on the product or 
available as an option, it shall meet the following:
    (A) 6.9.1.1 A restraint system and its closing means (for example, 
buckle) shall not break or separate when tested in accordance with 7.8.
    (B) 6.9.1.2 The anchorages shall not separate from the unit when 
tested in accordance with 7.8.
    (C) 6.9.1.3 Restraints shall be capable of adjustment with a 
positive, self-locking mechanism that is capable, when locked, of 
withstanding the forces of tests in 7.8 without allowing restraint 
movement or slippage of more than 1 in. (25.4 mm).
    (ii) [Reserved]
    (2) [Reserved]
    (g) Instead of complying with section 7.2 of ASTM F2388-16, comply 
with the following:
    (1) 7.2 Structural Integrity--Assemble the unit in accordance with 
the manufacturer's assembly instructions. If the product design employs 
secondary support bars or straps beneath the changing surface that are 
not factory preassembled in their intended use position, this test is 
to be conducted without the support bars/straps installed. Place the 
unit on the test floor, center a 6 by 6 in. (150 by 150 mm) wood block 
on the changing surface and gradually apply a 100 lb (45.4 kg) weight 
onto the wood block within a period of 5 s. Maintain the weight for an 
additional period of 60 s.
    (2) [Reserved]
    (h) Instead of complying with section 7.4 of ASTM F2388-16, comply 
with the following:
    (1) 7.4 Barrier Structural Integrity and Retention Tests:
    (i) 7.4.1 Test Equipment and Test Set Up
    (A) 7.4.1.3 Test Set Up--Assemble the unit in accordance with the 
manufacturer's assembly instructions. If the product design employs 
secondary support bars or straps beneath the changing surface that are 
not factory preassembled in their intended use position, this test is 
to be conducted without the support bars/straps installed.
    (B) [Reserved]
    (ii) [Reserved]
    (2) [Reserved]
    (i) In addition to complying with section 7.7 of ASTM F2388-16, 
comply with the following:
    (1) 7.8 Restraint System--
    (i) 7.8.1 Secure the unit in its recommended use position so that 
it cannot move in the direction of the force being applied.
    (ii) 7.8.2 Secure a CAMI Infant Dummy, Mark II on the changing 
surface in accordance with the manufacturer's instructions.
    (iii) 7.8.3 Adjust the restraint, using the webbing tension pull 
device shown in Figure 1, below, so that a force of 2 lbf (9 N) applied 
to the restraint will provide a \1/4\ in. (6 mm) space between the 
restraint and the CAMI Dummy.
    (iv) 7.8.4 Using the webbing tension pull device shown in Figure 1, 
below, perform the following tests without readjusting the restraint 
system.
    (A) 7.8.4.1 Within 5 s, gradually apply a pull force of 30 lbf (200 
N) on the restraint strap and maintain for an additional 10 s. Release 
the restraint strap. Repeat this test for a total of four pulls in the 
following directions: Horizontally away from the table in the direction 
an occupant could roll, in a direction that is 45 degrees from the 
horizontal changing surface towards the head of the changing pad, in a 
direction that is 45 degrees from the horizontal changing surface 
towards the foot of the changing pad, and vertically straight up away 
from the changing pad.

[[Page 66897]]

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    (B) [Reserved]
    (2) [Reserved]
    (j) Instead of complying with sections 9.1.1 and 9.1.2 of ASTM 
F2388-16, comply with the following:
    (1) 9.1.1 The name, place of business (mailing address, including 
city, state, and zip code), and telephone number of the manufacturer, 
distributor, or seller.
    (2) 9.1.2 A code mark or other means that identifies the date 
(month and year as a minimum) of manufacture.

    Note 3: Add-on changing units, non-rigid add-on changing unit 
accessories, or contoured changing pads sold with non-full size 
cribs and play yards are exempt from the labeling requirements of 
9.1.1 and 9.1.2, as labeling requirements for these accessories are 
included in Consumer Safety Specification F406.

    (k) Instead of complying with section 9.3 of ASTM F2388-16, comply 
with the following:
    (1) 9.3 The marking and labeling on the product shall be permanent.
    (2) [Reserved]
    (l) In addition to complying with section 9.3, as revised in 
paragraph (k) of this section, comply with the following:
    (1) 9.4 Warning Design for Product
    (i) 9.4.1 The warning shall be easy to read and understand and be 
in the English language at a minimum.
    (ii) 9.4.2 Any marking or labeling provided in addition to those 
required by this section shall not contradict or confuse the meaning of 
the required information, or be otherwise misleading to the consumer.
    (iii) 9.4.3 The warnings shall be conspicuous and permanent.
    (iv) 9.4.4 The warnings shall conform to sections 6.1-6.4, 7.2-
7.6.3, and 8.1 of ANSI Z535.4-2011 (incorporated by reference, see 
Sec.  1235.1), with the changes indicated in paragraph (l)(1)(iv)(A), 
(B), and (C) of this section
    (A) 9.4.4.1 In sections 6.2.2, 7.3, 7.5, and 8.1.2, replace 
``should'' with ``shall.''
    (B) 9.4.4.2 In section 7.6.3, replace ``should (when feasible)'' 
with ``shall.''
    (C) 9.4.4.3 Strike the word ``safety'' when used immediately before 
a color (e.g., replace ``safety white'' with ``white'').
    (v) 9.4.5 The safety alert symbol and the signal word ``WARNING'' 
shall not be less than 0.2 in. (5 mm) high. The remainder of the text 
shall be in characters whose upper case shall be at least 0.1 in. (2.5 
mm), except where otherwise specified.

    Note 4: For improved warning readability, the warning designer 
should avoid the use of typefaces with large height-to-width ratios, 
which are commonly identified as ``condensed,'' ``compressed,'' 
``narrow,'' or similar.

    (vi) 9.4.6 Message Panel Text Layout
    (A) 9.4.6.1 The text shall be left aligned, ragged right for all 
but one-line text messages, which can be left aligned or centered.

    Note 5: Left aligned means that the text is aligned along the 
left margin, and, in the case of multiple columns of text, along the 
left side of each individual column.

    (B) 9.4.6.2 The text in each column should be arranged in list or 
outline format, with precautionary (hazard avoidance) statements 
preceded by bullet points. Multiple precautionary statements shall be 
separated by bullet points if paragraph formatting is used.
    (vii) 9.4.7 An example warning in the format described in this 
section is shown in Figure 2, below.

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    (2) 9.5 Warning Statements--Each product shall have warnings 
statements to address the following, at a minimum:
    (i) 9.5.1 The following warning statements shall be placed on all 
changing tables, including add-on changing units and contoured changing 
pads that are sold separately:
    Fall Hazard. Children have suffered serious injuries after falling 
from changing [tables/pads/areas]. Falls can happen quickly.
     STAY in arm's reach.

    Note 6: The words in brackets provide wording options. The 
manufacturer should select the most appropriate term for the product 
and may substitute another term that is consistent with the 
product's marketing and instructions.

    (ii) 9.5.2 Removable pads that are included with changing tables, 
contoured pads, non-rigid add-on changing unit accessories, and add-on 
changing units sold separately that are intended to be physically 
attached to the support surface shall have a warning on the pad or 
changing unit, and its retail packaging, to address the following:
     ALWAYS secure this [unit/pad] to the support [surface/
frame] by (manufacturer's instructions for securing the changing unit). 
See instructions.

    Note 7: The words in the brackets provide wording options. The 
manufacturer should select the most appropriate term for the product 
and may substitute another term that is consistent with the 
product's marketing and instructions.

    (iii) 9.5.3 Non-rigid add-on changing unit accessories, changing 
pads, and contoured changing pads, whether sold with the changing table 
or sold separately, shall include the following additional warning 
statements:
    Suffocation Hazard. Babies have suffocated while sleeping [in/on] 
changing [tables/pads/areas]. Changing [table/pad/area] is not designed 
for safe sleeping.
     NEVER allow baby to sleep [in/on] changing [table/pad/
area].

    Note 8: The words in brackets provide wording options. The 
manufacturer should select the most appropriate term for the product 
and may substitute another term that is consistent with the 
product's marketing and instructions.

    (iv) 9.5.4 Contoured changing pads, non-rigid add-on changing unit 
accessories, and add-on changing units sold separately shall include 
additional warnings addressing either: (a) The specific products to 
attach the contoured changing pad or add-on unit to; or (b) That the 
surface used should be level, stable, and structurally sound with 
minimum surface dimensions of ``X'' by ``Y.''
    (m) Instead of complying with section 10.1.1 of ASTM F2388-16, 
comply with the following:
    (1) 10.1.1 The instructions shall contain the warnings as specified 
in 9.5 and address the statements in 10.1.1.1 through 10.1.1.8. These 
required warning statements shall meet the requirements described in 
9.4, except for the color requirements provided in ANSI Z535.4-2011, 
(e.g., the background of the signal word panel need not be a specific 
color).

    Note 9:  For additional guidance on the design of warnings for 
instructional literature, please refer to the most-recent edition of 
ANSI Z535.6, Product Safety Information in Product Manuals, 
Instructions, and Other Collateral Materials, American National 
Standards Institute, Inc., available at https://www.ansi.org/.

    (2) [Reserved]

    Dated: September 14, 2016
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2016-22557 Filed 9-28-16; 8:45 am]
 BILLING CODE 6355-01-P