29672 Federal Register / Vol. 83, No. 123 / Tuesday, June 26, 2018 / Rules and Regulations 

From To MEA 

BARBY, HI FIX .............................................................................. *RABAT, HI FIX ........................................................................... **10000 

*10000—MCA RABAT, HI FIX, W BND 

**2700—MOCA 

§ 95.6422 HAWAII VOR Federal Airway V22 is Amended to Read in Part 

PLUMB, HI FIX ............................................................................. MAUI, HI VORTAC ...................................................................... 6300 

MAUI, HI VORTAC ....................................................................... *BARBY, HI FIX ........................................................................... 8400 

*12000—MCA BARBY, HI FIX, SE BND 

From To MEA MAA 

§ 95.7001 Jet Routes 

§ 95.7225 Jet Route J225 is Amended to Read in Part 

CEDAR LAKE, NJ VOR/DME ........................................... KENNEDY, NY VOR/DME ............................................... 18000 45000 

§ 95.7536 Jet Route J536 is Amended to Read in Part 

SISTERS ISLAND, AK VORTAC ..................................... U.S. CANADIAN BORDER .............................................. #21000 45000 

#MEA is ESTABLISHED WITH A GAP IN NAVIGATION SIGNAL COVERAGE. 

Airway segment Changeover points 

From To Distance From 

§ 95.8003 VOR Federal Airway Changeover Point V291 is Amended to Add Changeover Point 

FLAGSTAFF, AZ VOR/DME ........................................ PEACH SPRINGS, AZ VOR/DME ............................. 39 FLAGSTAFF

V325 is Amended to Add Changeover Point 

ATHENS, GA VOR/DME .............................................. COLUMBIA, SC VORTAC .......................................... 24 ATHENS 

V417 is Amended to Add Changeover Point 

ATHENS, GA VOR/DME .............................................. COLLIERS, SC VORTAC ........................................... 24 ATHENS 

[FR Doc. 2018–13611 Filed 6–25–18; 8:45 am] 

BILLING CODE 4910–13–P 

CONSUMER PRODUCT SAFETY 

COMMISSION 

16 CFR Parts 1112 and 1235 

[Docket No. CPSC–2016–0023] 

Safety Standard for Baby Changing 

Products 

AGENCY: Consumer Product Safety 

Commission. 

ACTION: Final rule. 

SUMMARY: The Consumer Product Safety 

Improvement Act of 2008 (CPSIA) 

requires the United States Consumer 

Product Safety Commission (CPSC) to 

adopt consumer product safety 

standards for durable infant or toddler 

products. To comply with the CPSIA, 

the Commission is issuing a safety 

standard for baby changing products. 

This rule incorporates by reference 

ASTM F2388–18, Standard Consumer 

Safety Specification for Baby Changing 

Products for Domestic Use (ASTM 

F2388–18). In addition, this rule 

amends the regulations regarding third 

party conformity assessment bodies to 

include the safety standard for baby 

changing products in the list of Notices 

of Requirements (NORs). 

DATES: The rule will become effective 

on June 26, 2019. The incorporation by 

reference of the publication listed in 

this rule is approved by the Director of 

the Federal Register as of June 26, 2019. 

FOR FURTHER INFORMATION CONTACT: 

Keysha Walker, Office of Compliance 

and Field Operations, U.S. Consumer 

Product Safety Commission; 4330 EastWest Highway, Bethesda, MD 20814; 

telephone: (301) 504–6820; email: 

KWalker@cpsc.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background and Statutory Authority 

Congress enacted the CPSIA (Pub. L. 

110–314, 122 Stat. 3016), including the 

Danny Keysar Child Product Safety 

Notification Act, on August 14, 2008. 

Section 104(b) of the CPSIA requires the 

Commission to: (1) Examine and assess 

the effectiveness of voluntary consumer 

product safety standards for durable 

infant or toddler products, in 

consultation with representatives of 

consumer groups, juvenile product 

manufacturers, and independent child 

product engineers and experts; and (2) 

promulgate consumer product safety 

standards for durable infant or toddler 

products. Any standard the Commission 

adopts under this mandate must be 

substantially the same as the applicable 

voluntary standard, or more stringent 

than the voluntary standard if the 

Commission determines that more 

stringent requirements would further 

reduce the risk of injury associated with 

the product. Section 104(f)(1) of the 

CPSIA defines the term ‘‘durable infant 

or toddler product’’ as ‘‘a durable 

product intended for use, or that may be 

reasonably expected to be used, by 

children under the age of 5 years,’’ and 

the Commission identified baby 

changing tables as a durable infant or 

toddler product in the product 

registration card rule codified in 16 CFR 

1130.2(a)(14). 

On September 29, 2016, the 

Commission issued a notice of proposed 

rulemaking (NPR), proposing to 

incorporate by reference the thencurrent voluntary standard for baby 

changing products, ASTM F2388–16, 

with more stringent requirements for 


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1ASTM F2388–18 defines a ‘‘changing pad’’ as: 

‘‘a flat or contoured pad specifically designed for 

the purpose of changing the diaper of a child with 

a body weight of up to 30 lb (13.6 kg) on an elevated 

surface. The child is placed on the pad during the 

process of changing.’’ 2Under SBA size standards, a baby changing 

product manufacturer is ‘‘small’’ if it has 500 or 

fewer employees, and an importer is ‘‘small’’ if it 

has 100 or fewer employees. 

3The NPR indicated that CPSC had received 182 

reports of baby changing product-related incidents 

that occurred between January 1, 2005 and 

December 31, 2015, of which 5 were fatal, 30 

reported injuries, 113 did not result in injuries, and 

34 did not provide sufficient information to 

determine whether an injury occurred. Since the 

NPR, CPSC staff identified one additional fatality 

that occurred in 2010, and CPSC received an 

additional five reports of incidents that occurred 

Continued 

structural integrity, restraint system 

integrity, and warnings on labels and in 

instructional literature. 81 FR 66881. 

After the Commission issued the NPR, 

ASTM revised the voluntary standard 

several times, as discussed in section V 

of this preamble, and published the 

current version of the standard, ASTM 

F2388–18, in March 2018. 

In this final rule, the Commission is 

incorporating by reference ASTM 

F2388–18, with no modifications, as the 

mandatory safety standard for baby 

changing products. As section 

104(b)(1)(A) of the CPSIA requires, 

CPSC staff consulted with 

manufacturers, retailers, trade 

organizations, laboratories, consumer 

advocacy groups, consultants, and the 

public to develop this standard, largely 

through the ASTM standarddevelopment process. In addition, this 

final rule amends the list of NORs in 16 

CFR part 1112 to include the standard 

for baby changing products. This rule is 

based on information CPSC staff 

provided in its briefing package, ‘‘Draft 

Final Rule for Baby Changing Products 

for Domestic Use under the Danny 

Keysar Child Product Safety 

Notification Act,’’ which is available on 

CPSC’s website at: https://cpsc.gov/s3fspublic/Final%20Rule%20-%20Safety

%20Standard%20for 

%20Baby%20Changing%20Products 

%20-%20June%2013%

202018.pdf?ZbvMCsfyQfL

FivqHRbFWKclOordsuVeC. 

II. Product Description 

ASTM F2388–18 defines a ‘‘changing 

product’’ as ‘‘one of the following: 

changing table, changing table 

accessory, add-on changing unit, 

contoured changing pad.’’ The standard 

defines each of those terms, as follows: 

• A changing table is ‘‘an elevated, 

freestanding structure generally 

designed to support and retain a child 

with a body weight of up to 30 lb (13.6 

kg) in a horizontal position for the 

purpose of allowing a caregiver to 

change the child’s diaper. Changing 

tables may convert from or to other 

items of furniture, such as, but not 

limited to, a dresser, desk, hutch, 

bookshelf, or play yard, may have pullout or drop-down changing surfaces, 

and may provide storage for diapers and 

diaper products’’; 

• a changing table accessory is ‘‘an 

accessory that attaches to a crib or play 

yard designed to convert the product 

into a changing table typically having a 

rigid frame with soft fabric or mesh 

sides or bottom surface, or both’’; 

• an add-on changing unit is ‘‘a rigid 

addition to or separate product used in 

conjunction with an item of furniture 

that provides barriers to prevent the 

infant from rolling off the product when 

a diaper is being changed’’; and 

• a contoured changing pad is ‘‘a 

changing pad designed for use on an 

elevated surface which incorporates 

barriers to prevent a child from rolling 

off the changing surface.’’ 1

Changing tables used in public facilities, 

such as public restrooms, are covered by 

ASTM F2285, Standard Consumer 

Safety Performance Specification for 

Diaper Changing Tables for Commercial 

Use, and are not subject to ASTM 

F2388–18 or this final rule. 

Most changing tables and add-on 

changing units are constructed of wood; 

contoured changing pads often consist 

of synthetic-covered foam with 

contoured edges; and changing table 

accessories that attach to a play yard or 

crib generally are constructed of plastic 

or wood with a foam pad. Changing 

tables come in various designs, some of 

which include drawers, cabinets, or 

retractable stairs to assist children 

getting onto them. 

III. Market Description 

CPSC staff has identified 102 

domestic firms that currently supply 

baby changing products to the U.S. 

market. Eighty-four of the firms (61 

manufacturers and 23 importers or 

wholesalers) are small, according to the 

U.S. Small Business Administration’s 

(SBA) standards,2 and the remaining 18 

firms are large. In addition, staff 

identified 17 foreign firms that supply 

baby changing products to the U.S. 

market, and one additional firm for 

which staff lacked sufficient 

information to determine a location or 

supply source. Staff also identified 

numerous baby changing products that 

are manufactured outside the United 

States and bought domestically through 

online sales. 

At the time CPSC staff assessed the 

baby changing products market, staff 

identified 22 of the 61 small domestic 

manufacturers, and 10 of the 23 small 

domestic importers and wholesalers, as 

compliant with the ASTM standard for 

baby changing products (based on firms’ 

assertions of compliance, certifications 

from the Juvenile Products 

Manufacturers Association, or 

participation in the development of the 

ASTM changing products standard). 

IV. Incident Data 

A. Summary 

CPSC receives data regarding productrelated injuries from several sources. 

One source is the National Electronic 

Injury Surveillance System (NEISS), 

from which CPSC can estimate, based 

on a probability sample, the number of 

injuries that are associated with specific 

consumer products that are treated in 

U.S. hospital emergency departments 

(U.S. EDs) nationwide. Other sources 

include reports from consumers and 

others through the Consumer Product 

Safety Risk Management System (which 

also includes some NEISS data) and 

reports from retailers and manufacturers 

through CPSC’s Retailer Reporting 

System—CPSC refers to these sources 

collectively as Consumer Product Safety 

Risk Management System data 

(CPSRMS). 

For this rulemaking, CPSC staff 

reviewed the NEISS and CPSRMS 

databases for incidents involving baby 

changing products and children younger 

than 3 years old because that age 

corresponds with the 30-pound weight 

limit in the ASTM standard. See Centers 

for Disease Control and Prevention, the 

National Center for Health Statistics, 

Data Table of Infant Weight-for-Age 

Charts, http://www.cdc.gov/ 

growthcharts/html_charts/wtageinf.htm 

(last visited Apr. 9, 2018). 

The preamble to the NPR summarized 

reports of incidents involving baby 

changing products that occurred 

between January 1, 2005 and December 

31, 2015, which CPSC received through 

CPSRMS sources. For the final rule, 

CPSC staff has updated this information 

to reflect one reported changing product 

incident that occurred between January 

1, 2005 and December 31, 2015, but was 

not included in the NPR, as well as new 

incidents that occurred between January 

1, 2016 and November 30, 2017. In total, 

CPSC has received 188 reports of 

incidents involving baby changing 

products that occurred between January 

1, 2005 and November 30, 2017. These 

incidents involved 7 fatalities, 31 

injuries or adverse health problems, 116 

incidents that did not result in injuries, 

and 34 incidents for which CPSC did 

not receive sufficient information to 

determine whether an injury occurred.3


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between January 1, 2016 and November 30, 2017, 

of which one was fatal, one reported injuries, and 

three did not result in injuries. 

The preamble to the NPR also 

summarized NEISS estimates for baby 

changing product incidents that 

occurred between January 1, 2005 and 

December 31, 2014. After the 

Commission issued the NPR, complete 

injury data became available for 2015 

and 2016, and CPSC staff has updated 

this information for the final rule. 

Including this new data and 

extrapolating from the probability 

sample, CPSC staff estimates that there 

were 39,010 baby changing productrelated injuries to children under 3 

years old that were treated in U.S. EDs 

between January 1, 2005 and December 

31, 2016. There was a statistically 

significant increasing linear trend for 

injuries associated with baby changing 

products over this period. Seventy-six 

percent of the estimated injuries 

involved children between 0 and 11 

months old, and 94 percent of the 

estimated injuries involved children 

under 2 years old. 

B. Fatalities 

CPSC is aware of seven fatal incidents 

to children under 3 years old that 

occurred between January 1, 2005 and 

November 30, 2017, involving baby 

changing products. One death involved 

a 10-month-old male who was strangled 

by a strap hanging from a changing table 

accessory in a play yard while the child 

was in the play yard beneath. Another 

death involved a 3-month old female 

who rolled over and compressed her 

neck on the changing table ledge, 

resulting in suffocation. The remaining 

five reported deaths involved children 

sleeping on baby changing products, 

which is not their intended use. All of 

the victims in these incidents were 

younger than 1 year old. 

One of these incidents involved a 4- 

month-old male who was sleeping on a 

changing pad in a crib and died from 

positional asphyxia when his head hung 

over the raised side of the changing pad. 

Another incident involved a 3-day-old 

female, who died while sleeping on the 

changing portion of a play yard; her 

death was determined to be the result of 

mechanical asphyxia from being 

swaddled too tightly in a sleep sack. 

The remaining three sleep-related 

deaths involved babies (ages 6 weeks, 2 

months, and 2 months) sleeping in the 

changing accessory portion of a play 

yard. 

C. Nonfatal Injuries 

The injuries and treatments reported 

through NEISS for 2015 and 2016 were 

consistent with those for 2005 through 

2014, described in the NPR. In 94 

percent of cases between 2005 and 2016, 

the patient was treated in the U.S. ED 

and released; in 5 percent of cases, the 

child was hospitalized. The most 

commonly injured body parts were the 

head (71 percent for 2005–2014; 73 

percent for 2015–2016) and face (13 

percent for 2005–2014; 12 percent for 

2015–2016). The most common types of 

injuries were injuries to internal organs 

(50 percent for 2005–2014; 53 percent 

for 2015–2016), contusions and 

abrasions (27 percent for 2005–2014; 29 

percent for 2015–2016), and fractures (9 

percent for 2005–2014; 8 percent for 

2015–2016). 

D. Hazard Patterns 

The hazards reported in the new 

incidents are consistent with the hazard 

patterns staff identified in the incidents 

presented in the NPR. The fatal 

incidents are discussed above, and 

primarily involved suffocation or 

asphyxia when babies were sleeping on 

baby changing products. 

As reported in the NPR, structural 

integrity issues were the primary hazard 

associated with nonfatal incidents. 

Incident reports CPSC received after the 

NPR, for incidents that occurred 

between January 1, 2016 and November 

30, 2017, also involved structural 

integrity issues. Three of the four 

nonfatal incidents that occurred 

between January 1, 2016 and November 

30, 2017, were related to structural 

integrity. These incidents involved: A 

wooden shelf on the bottom of the 

changing table that fell because the 

small pins were too weak to keep the 

shelf in place; drawers falling out of a 

changing table; and bolts falling out. 

The fourth incident involved an 11- 

month-old male who fell off of a 

changing table when his caregiver was 

distracted. 

V. ASTM F2388–18 

In this final rule, the Commission 

incorporates by reference ASTM F2388– 

18. The Commission is incorporating by 

reference ASTM F2388–18 because it 

includes provisions that are the same as, 

or consistent with, the requirements 

proposed in the NPR, and CPSC staff 

believes that the standard addresses the 

hazards associated with baby changing 

products. 

A. History of ASTM F2388 

ASTM F2388, Standard Consumer 

Safety Specification for Baby Changing 

Products for Domestic Use, is the 

voluntary standard that addresses the 

hazard patterns associated with the use 

of baby changing products (in domestic 

settings). ASTM first approved and 

published the standard in 2004, as 

ASTM F2388–04, Standard Consumer 

Safety Specification for Baby Changing 

Tables for Domestic Use. ASTM has 

revised the standard several times since 

then. In the NPR, the Commission 

proposed to incorporate by reference 

ASTM F2388–16, with modifications. 

After the Commission issued the NPR, 

ASTM revised ASTM F2388 three times. 

CPSC staff worked with representatives 

of manufacturers, consumer groups, 

retailers, and other industry members 

and groups on the ASTM subcommittee 

for baby changing products to develop 

requirements to address the hazards 

associated with baby changing products, 

including issues raised in the NPR. 

CPSC staff also participated in the 

ASTM Ad Hoc Committee on 

Standardized Wording for Juvenile 

Product Standards (Ad Hoc TG) to 

finalize recommendations for warning 

labels, entitled, ‘‘Recommended 

Language Approved by Ad Hoc Task 

Group, Revision C’’ (November 10, 

2017), to provide consistent and 

effective warnings for juvenile product 

standards. The most recent version of 

the standard, ASTM F2388–18, reflects 

the work of these groups. ASTM 

approved ASTM F2388–18 on February 

15, 2018, and published it in March 

2018. 

B. ASTM F2388–18: Comparison With 

the NPR and Assessment of 

Requirements 

In the NPR, the Commission proposed 

to incorporate by reference ASTM 

F2388–16, which addressed many of the 

hazard patterns associated with baby 

changing products, with modifications 

to four areas of the standard. 

Specifically, the Commission proposed 

more stringent requirements than those 

in ASTM F2388–16 for structural 

integrity, restraint systems, warnings on 

labels, and instructional literature. 

The requirements in ASTM F2388–18 

are largely the same as those the 

Commission proposed in the NPR. 

ASTM F2388–18 includes the same 

scope, definitions, general requirements 

(e.g., small parts; openings), 

performance requirements, and test 

methods that the Commission proposed 

incorporating by reference from ASTM 

F2388–16. In addition, ASTM F2388–18 

includes modifications to reflect the 

more stringent requirements the 

Commission proposed in the NPR, to 

address comments filed in response to 

the NPR, and to provide additional 

detail and clarity. The following 

discussion compares the areas in which 

the NPR and ASTM F2388–18 differ, 

describes the more stringent 


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requirements in the NPR and ASTM 

F2388–18, and provides CPSC staff’s 

assessment of the ASTM F2388–18 

provisions. 

1. Definitions 

ASTM F2388–18 includes six 

definitions that were not in ASTM 

F2388–16, two of which are consistent 

with definitions the Commission 

proposed in the NPR. In the NPR, the 

Commission proposed to define ‘‘key 

structural elements’’ and ‘‘non-rigid 

add-on changing unit accessory.’’ ASTM 

F2388–18 includes these definitions, 

but uses the term ‘‘changing table 

accessory’’ instead of ‘‘non-rigid add-on 

changing unit accessory.’’ In addition, 

ASTM F2388–18 defines the terms 

‘‘changing product,’’ ‘‘protective 

component,’’ ‘‘secondary support 

component,’’ and ‘‘threaded fastener.’’ 

As explained below, the Commission 

concludes that these definitions are 

appropriate and provide additional 

clarity. 

ASTM F2388–18 defines ‘‘changing 

product’’ to clarify that this general 

term, used in the title of the standard 

and throughout the standard, 

encompasses changing tables, changing 

table accessories, add-on changing 

units, and contoured changing pads. 

Although the Commission did not 

propose to define this term in the NPR, 

the NPR did use ‘‘changing products’’ as 

the general term encompassing all 

products subject to the standard and the 

proposed rule, which included each of 

the products listed in the ASTM F2388– 

18 definition. Accordingly, this 

definition is appropriate and provides 

clarity about the products that are 

subject to the standard. 

ASTM F2388–16 (and the NPR, 

through proposed incorporation by 

reference) used the term ‘‘protective 

component,’’ although that version of 

the standard did not define it. ASTM 

F2388–16 described protective 

components as ‘‘caps, sleeves, or plugs 

used for protection from sharp edges, 

points or entrapment of fingers and 

toes.’’ The definition in ASTM F2388– 

18 is nearly identical to this description, 

stating ‘‘any component used for 

protection from sharp edges, points or 

entrapment of fingers or toes.’’ 

Consequently, this definition is accurate 

and adds clarity to the standard. 

Although the Commission did not 

propose to define ‘‘secondary support 

component’’ in the NPR, the NPR did 

propose requirements regarding 

secondary support straps, and the 

preamble to the NPR described the 

feature as ‘‘a metal band that runs under 

the center of the changing surface to 

provide additional support’’ that is 

installed by consumers when 

assembling a baby changing product. 81 

FR at 66888. ASTM F2388–18 defines a 

‘‘secondary support component’’ as ‘‘a 

strap, bar, rod, or other component that 

is consumer installed and provides 

added support, to the changing surface 

of the changing table.’’ Because these 

descriptions are consistent, this 

definition is appropriate, and it 

provides added clarity to include an 

explicit definition in the standard. 

Similarly, the Commission did not 

propose to define ‘‘threaded fastener’’ in 

the NPR, but the NPR did describe 

threaded fasteners as products, such as 

wood or sheet metal screws, metal 

inserts, and machine screws, which 

allow consumers to assemble and 

disassemble products. 81 FR at 66887. 

ASTM F2388–18 defines a ‘‘threaded 

fastener’’ as ‘‘a discrete piece of 

hardware that has internal or external 

screw threads which is used for the 

assembly of multiple parts and 

facilitates disassembly.’’ This definition 

is consistent with the NPR description, 

indicating that the definition is 

accurate, and including it in the 

standard provides clarity. 

2. Scissoring, Shearing, and Pinching 

ASTM F2388–18 requires baby 

changing products to be designed to 

prevent injuries from scissoring, 

shearing, or pinching, and includes a 

method of assessing compliance with 

this requirement (which consists of 

admitting a probe of particular 

dimensions). ASTM F2388–16 did not 

include requirements regarding 

scissoring, shearing, and pinching, and 

the Commission did not propose 

additional requirements to address these 

hazards in the NPR. However, these 

requirements are appropriate in light of 

other durable infant and toddler product 

standards. The scissoring, shearing, and 

pinching provisions in ASTM F2388–18 

are identical to those in other ASTM 

durable infant and toddler product 

standards (e.g., high chairs, infant 

walkers, full-size baby cribs, play yards) 

that have the potential for these injuries. 

Accordingly, these requirements are 

appropriate to address a hazard 

common across products. 

3. Self-Folding Steps 

ASTM F2388–18 includes two 

distinct methods of assessing the single 

action release mechanism on selffolding steps, depending on the type of 

action necessary to release the 

mechanism. In ASTM F2388–16, the 

test for assessing self-folding steps on a 

baby changing product applied to all 

products with self-folding steps that had 

a ‘‘single action release mechanism.’’ 

The test involved applying a force of 10 

lbf (45 N) to the locking or latching 

mechanism. The NPR proposed to 

incorporate this requirement by 

reference, without modification. ASTM 

F2388–18 retains this test for 

mechanisms that require a ‘‘pull or push 

action,’’ and adds a duration for 

applying the force. Specifying a test 

duration is helpful to provide clarity 

about the test procedure. 

ASTM F2388–18 also includes a 

different test for self-folding steps with 

a release mechanism that requires a 

‘‘twist or turn action’’ to release, which 

was not in ASTM F2388–16 and was not 

proposed in the NPR. For steps with this 

mechanism, testers must apply a torque 

of 4 lb-in. (0.5 N-m) to the mechanism. 

This separate test is appropriate to 

better reflect and assess the different 

types of release mechanisms on selffolding steps. 

4. Structural Integrity Requirements 

In the NPR, the Commission proposed 

more stringent requirements in two 

areas to address structural integrity 

issues—threaded fasteners and 

secondary support straps. First, the 

Commission proposed requirements for 

threaded fasteners, to provide secure 

connections between fasteners and key 

structural elements of changing tables 

and products. Specifically, the 

Commission proposed to: 

• Prohibit the use of threaded 

fasteners, such as wood screws or sheet 

metal fasteners, directly into wood 

components that are key structural 

elements assembled by consumers; 

• 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 proposed these limits 

for key structural elements, such as 

primary changing surface supports and 

side, end, base, and leg assemblies to 

address the stability of components that 

support the weight of occupants. 

ASTM F2388–18 includes the same 

requirements regarding threaded 

fasteners as the Commission proposed 

in the NPR, as well as two additions. As 

one minor addition, ASTM F2388–18 

includes additional detail about the 

features that are ‘‘non-key structural 

elements,’’ and therefore, not subject to 

the threaded fastener requirements. 

Specifically, where the NPR listed 

drawers, secondary supports, storage 

components, and accessory items, 

ASTM F2388–18 lists these as well as 


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other examples, such as fasteners that 

attach contoured pads and add-on 

changing units to supporting furniture 

(section 5.8.1.1). This additional detail 

is consistent with the requirements 

proposed in the NPR, which will 

improve the structural integrity of baby 

changing products. ASTM F2388–18 

also specifies that the prohibition of 

threaded fasteners on key structural 

elements assembled by consumers does 

not apply to products that are also 

clothing storage units, because those 

products fall under the scope of ASTM 

F2057, Safety Specification for Clothing 

Storage Units. This added exemption is 

acceptable because incident data 

indicate that the products that were 

involved in structural integrity 

incidents associated with fasteners were 

traditional stand-alone changing 

products, and not clothing storage units, 

such as dressers. 

Second, the Commission proposed to 

adopt the structural integrity testing 

required in ASTM F2388–16, but 

modified the test to specify that 

consumer-installed secondary support 

straps must not be installed for the test. 

This would reflect the less-structurally 

sound condition the product may be in 

when consumers use it without 

installing the secondary support strap or 

install the strap incorrectly. 

ASTM F2388–18 includes the same 

provisions proposed in the NPR. The 

only minor difference is that where the 

NPR used the term ‘‘secondary support 

straps or bars,’’ ASTM F2388–18 uses 

‘‘secondary support components.’’ The 

meaning of these terms is the same, and 

these requirements are appropriate to 

provide greater product stability. 

5. Restraint System Requirements 

ASTM F2388–16, the NPR, and ASTM 

F2388–18 do not require baby changing 

products to include restraint systems. 

However, to ensure that restraints 

function effectively if provided, in the 

NPR, the Commission proposed to 

require testing of restraint systems. The 

proposed test required any restraint 

provided with a baby changing product 

to be secured on a CAMI dummy and 

pulled in four directions anticipated 

during normal use with a 30 pound 

force. To pass this performance 

standard, straps and buckles were 

required not to break or separate from 

baby changing products more than 1 

inch from their initial adjustment 

positions. 

ASTM F2388–18 includes the same 

restraint system testing requirements as 

those proposed in the NPR. 

Accordingly, these requirements are 

appropriate to reduce the hazards 

associated with ineffective restraints. 

6. Warning Label Requirements 

In the NPR, the Commission proposed 

more stringent warning label content 

and format requirements than those in 

ASTM F2388–16. With respect to 

content, the NPR proposed to require 

on-product warning labels specifically 

addressing fall hazards, proper 

securement of attachable changing 

products, and the suffocation hazard if 

babies sleep on a changing product. 

With respect to form, the NPR proposed 

to include form requirements for 

warnings, to increase the likelihood that 

consumers would notice, read, and 

follow the warnings. The requirements 

for warning format proposed in the NPR 

were drawn from the Ad Hoc TG 

recommendations, which were under 

development at the time. 

ASTM F2388–18 includes labeling 

requirements that are the same as those 

proposed in the NPR. ASTM F2388–18 

includes some minimal modifications 

that do not notably alter the 

requirements. For example, ASTM 

F2388–16 and the NPR specified that 

changing accessories sold with non-fullsize cribs and play yards were exempt 

from the requirement to mark 

manufacturer and manufacturing date 

information on the product and retail 

package because they were subject to 

another ASTM standard with similar 

requirements. ASTM F2388–18 extends 

this exemption to accessories sold with 

full-size cribs, as well. This does not 

reduce the stringency of the requirement 

because full-size cribs are also subject to 

another ASTM standard that addresses 

this information. As another example, 

ASTM F2388–18 includes more 

example figures of warnings than the 

NPR provided, which clarify the 

meaning of some requirements and 

provide examples of additional 

combinations of warning statements. 

Additionally, ASTM F2388–18 includes 

a note, explaining what ‘‘address’’ 

means in the requirement that product 

warnings ‘‘address’’ specified 

information. The NPR also required 

warnings to ‘‘address’’ specific 

information, but did not explicitly 

define that term. This explanatory note 

is useful and including it aligns with the 

Ad Hoc TG recommendations. 

7. Instructional Literature Requirements 

In the NPR, the Commission proposed 

more stringent requirements for 

instructional literature, including format 

requirements consistent with those for 

on-product warnings, a requirement that 

instructions be in English (at a 

minimum), and that additional labels 

must not contradict the meaning of 

required information. Additionally, the 

Commission proposed to include a note 

in the regulatory text, referencing ANSI 

Z535.6, Product Safety Information in 

Product Manuals, Instructions, and 

Other Collateral Materials (ANSI 

Z535.6; available at: http://

www.ansi.org/), for optional additional 

guidance about the design of product 

safety messages in instructional 

literature. 

The instructional literature 

requirements in ASTM F2388–18 are 

consistent with those in the NPR, with 

minor adjustments to align with the Ad 

Hoc TG recommendations. For example, 

where the NPR required warnings in 

instructions to align with the onproduct warning format requirements 

generally, ASTM F2388–18 includes an 

equivalent requirement, but exempts 

warnings in instructions from 

distinctiveness and color requirements. 

These requirements are appropriate 

because they are consistent with the 

NPR and the Ad Hoc TG 

recommendations. 

VI. Comments Filed in Response to the 

NPR 

CPSC received nine comments in 

response to the NPR. The comments are 

available in the docket for this 

rulemaking, CPSC–2016–0023, at: 

www.regulations.gov. A summary of the 

comments, grouped by topic, and CPSC 

staff’s responses are below. 

A. Postpone Rulemaking 

Summary of Comment: Comments 

recommended that the Commission 

delay issuing a final rule or issue a 

supplemental NPR because ASTM’s 

then-upcoming 2017 revisions to the 

standard likely would address the 

concerns raised in the NPR. 

Response: ASTM has updated its 

standard several times since the NPR, 

and approved ASTM F2388–18 on 

February 15, 2018. ASTM F2388–18, 

which the Commission is incorporating 

by reference without modification, 

addresses the issues raised in the NPR. 

As discussed in section V of this notice, 

the requirements in ASTM F2388–18 

align with the requirements in the NPR, 

making a supplemental NPR 

unnecessary. 

B. Wood Screws 

Summary of Comment: Comments 

requested that the Commission only 

apply the wood screw restriction to 

‘‘open frame’’ products, or exclude from 

the wood screw restrictions furniture, 

such as dressers, that include barriers or 

a changing pad. Commenters stated that 

incident data does not indicate that 

these types of products are involved in 

incidents. Commenters stated that 


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furniture is often sold unassembled and 

consumers use wood screws to assemble 

it, making it difficult for such products 

to comply with the wood screw 

restriction. Commenters noted that the 

ASTM subcommittee considered 

excluding these types of furniture from 

the wood screw restriction. One 

commenter recommended removing the 

wood screw restriction and, instead, 

relying on the structural performance 

tests in the standard. 

Response: Consistent with these 

comments, ASTM F2388–18 excludes 

changing tables that are also clothing 

storage units (such as dressers) from the 

wood screw restriction. This exclusion 

is reasonable because incident data 

indicate that fastener failures occur in 

open-frame changing tables, rather than 

changing tables that are also clothing 

storage units. In addition, changing 

tables that are also clothing storage units 

are subject to requirements in ASTM 

F2057, Safety Specification for Clothing 

Storage Units. For all other changing 

tables, ASTM F2388–18 prohibits the 

use of wood screws on key structural 

elements, consistent with requirements 

in other ASTM durable infant or toddler 

product standards, such as cribs and 

high chairs. This requirement is good 

engineering practice and addresses 

incidents in which a changing product 

collapsed due to wood screws coming 

out or missing from the product. 

C. Metal Inserts 

Summary of Comment: Comments 

opposed the proposal to require glue or 

other locking means for metal inserts. 

Commenters stated that glue inside the 

insert can result in assembly difficulties 

for consumers, is design restrictive, and 

unnecessary. In addition, one 

commenter requested definitions of 

‘‘key structural elements’’ and 

‘‘threaded fasteners’’ to clarify which 

products and features would be subject 

to the requirement. 

Response: This requirement is similar 

to requirements in other ASTM durable 

infant or toddler product standards 

(such as cribs and high chairs), is good 

engineering practice, and addresses 

structural integrity issues identified in 

incident data. CPSC staff does not 

consider the wording ‘‘. . . shall be 

glued or include other means to impede 

loosening or detaching’’ to be design 

restrictive because it provides 

manufacturers with flexibility to meet 

the requirements by any means (glue is 

just an example of how the requirement 

can be met). In addition, to provide 

clarity about the features subject to this 

requirement, ASTM F2388–18 includes 

definitions for ‘‘key structural elements’’ 

and ‘‘threaded fasteners.’’ 

D. Restraints 

Summary of Comment: A comment 

requested that the Commission require 

baby changing products to include 

restraint straps, rather than allow them 

to be optional. The commenter stated 

that barriers are not sufficient to prevent 

children from rolling off of products and 

that there are restraint designs that 

would not interfere with changing a 

diaper. 

Response: Restraints may give 

caregivers a sense of safety, diminishing 

their attentiveness, and increasing 

potential hazards. For example, if 

caregivers believe that restraint straps 

provide safety, they may leave a child 

unattended on a changing table, and an 

unattended child in a restraint 

consisting of a single waist strap is 

exposed to a potential strangulation 

hazard. As such, the Commission does 

not believe it is appropriate to require 

restraints at this time. Moreover, 

incident data indicate that restraint 

failures involve restraints detaching 

from the product, or straps or buckles 

breaking. The final rule addresses these 

demonstrated hazards by requiring that 

if restraints are provided, they must be 

tested to ensure they are effective. 

E. Warnings 

Summary of Comment: A comment 

suggested that the Commission require 

pictograms in warnings to convey the 

hazards associated with baby changing 

products. 

Response: The commenter did not 

provide recommended pictograms for 

staff to evaluate. CPSC’s Division of 

Human Factors staff believes that a welldeveloped and tested pictogram can 

increase comprehension, but designing 

effective, understandable graphics can 

be difficult. Readers do not properly 

understand some seemingly obvious 

graphics, which can result in 

misinterpretations. 

F. Effective Date 

Summary of Comment: CPSC received 

comments about the proposed 6-month 

effective date. One comment, submitted 

by three consumer advocate groups, 

supported the 6-month effective date. 

Two commenters requested a longer 

effective date (one firm requested 1 year 

and the other at least 1 year). The latter 

two commenters expressed concern that 

six months would not provide adequate 

time for producers to modify their 

products, and one of the commenters 

noted that some manufacturers 

‘‘purchase their materials as a single 

order to cover an entire year,’’ which 

would be problematic if these firms 

need to change their products sooner 

than that. 

Response: The Commission generally 

considers 6 months an appropriate 

effective date for rules issued under 

section 104 of the CPSIA, but recognizes 

that longer effective dates minimize the 

impact on affected firms. As the final 

regulatory flexibility analysis for this 

rule explains, the final rule could have 

a significant economic impact on as 

much as 43 percent of the small firms 

that supply baby changing products to 

the U.S. market. Many of those firms 

may not be aware of the ASTM 

voluntary standard for changing 

products or this rulemaking. 

Accordingly, the Commission is 

providing a longer effective date for the 

final rule than proposed in the NPR. 

The rule will take effect 12 months after 

publication of this final rule. 

G. Miscellaneous 

Summary of Comment: A comment 

stated that a mandatory standard for 

baby changing products would not 

reduce the risk of fatalities because the 

fatalities reported to CPSC involved 

babies sleeping on products, which is 

not their intended use. 

Response: As the Division of Human 

Factors memorandum in the NPR 

briefing package explained, the fatal 

incidents involving baby changing 

products suggest that caregivers may 

mistake changing accessories for sleep 

surfaces. To address this issue and 

reduce the risk associated with babies 

sleeping on baby changing products, the 

NPR proposed and the final rule 

requires baby changing products to bear 

warnings specifically cautioning against 

allowing babies to sleep on the 

products. The Commission believes that 

this will reduce the risk of such 

foreseeable misuse and the resulting 

injuries and deaths. 

VII. Incorporation by Reference 

The Office of the Federal Register 

(OFR) has regulations regarding 

incorporation by reference. 1 CFR part 

51. These regulations require the 

preamble to a final rule to summarize 

the material and discuss the ways in 

which the material the agency 

incorporates by reference is reasonably 

available to interested persons, and how 

interested parties can obtain the 

material. 1 CFR 51.5(b). In accordance 

with the OFR regulations, this section 

summarizes ASTM F2388–18, and 

describes how interested parties may 

obtain a copy of the standard. 

ASTM F2388–18 contains 

requirements concerning: 

• Sharp points and edges; 

• small parts; 

• surface coatings; 

• wood parts; 


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• openings; 

• toys; 

• threaded fasteners; 

• protective components; 

• scissoring, shearing, and pinching; 

• structural integrity; 

• stability; 

• barriers; 

• retention of contoured changing pads 

and add-on changing units; 

• entrapment in shelves and in 

enclosed openings; 

• self-folding steps; 

• restraint systems; 

• warnings and labels; and 

• instructional literature. 

The standard also includes test methods 

to assess conformance with these 

requirements. Interested parties may 

obtain a copy of ASTM F2388–18 from 

ASTM, through its website (http://

www.astm.org), or by mail from ASTM 

International, 100 Bar Harbor Drive, 

P.O. Box 0700, West Conshohocken, PA 

19428. Alternatively, interested parties 

may inspect a copy of the standard at 

CPSC’s Office of the Secretary. 

VIII. Final Rule 

Section 1235.2(a) of the final rule 

requires baby changing products to 

comply with ASTM F2388–18 and 

incorporates the standard by reference. 

Section VII of this preamble describes 

the OFR requirements for incorporating 

material by reference. In accordance 

with those requirements, section VII 

summarizes ASTM F2388–18, explains 

how the standard is reasonably available 

to interested parties, and how interested 

parties may obtain a copy of the 

standard. 

The final rule also amends 16 CFR 

part 1112 to add a new § 1112.15(b)(45) 

that lists 16 CFR part 1235, Safety 

Standard for Baby Changing Products, 

as a children’s product safety rule for 

which the Commission has issued an 

NOR. Section XIV of this preamble 

provides additional information about 

certifications and NORs. 

IX. Effective Date 

The Administrative Procedure Act (5 

U.S.C. 551–559) generally requires that 

agencies set an effective date for a final 

rule that is at least 30 days after the 

Federal Register publishes the final 

rule. 5 U.S.C. 553(d). The NPR proposed 

that the final rule for baby changing 

products, and the amendment to part 

1112, would take effect 6 months after 

publication. CPSC received comments 

requesting an implementation date of 1 

year, asserting that additional time 

would be necessary for firms to modify 

products to meet the standard. CPSC 

believes that 1 year is sufficient for 

firms to modify their products to meet 

the new standard. Therefore, this rule 

will take effect 1 year after publication 

in the Federal Register, and will apply 

to products manufactured or imported 

on or after that date. 

X. Paperwork Reduction Act 

This rule contains information 

collection requirements that are subject 

to public comment and Office of 

Management and Budget (OMB) review 

under the Paperwork Reduction Act of 

1995 (PRA; 44 U.S.C. 3501–3521). 

Under the PRA, CPSC must estimate the 

‘‘burden’’ associated with each 

‘‘collection of information.’’ 44 U.S.C. 

3506(c). 

In this rule, section 9 of ASTM 

F2388–18 contains labeling 

requirements that meet the definition of 

‘‘collection of information’’ in the PRA. 

44 U.S.C. 3502(3). In addition, section 

10 of ASTM F2388–18 requires 

instructions to be provided with baby 

changing products; however, CPSC 

believes this requirement can be 

excluded from the PRA burden estimate. 

OMB allows agencies to exclude from 

the PRA burden estimate any ‘‘time, 

effort, and financial resources necessary 

to comply with a collection of 

information that would be incurred by 

persons in the normal course of their 

activities,’’ if the disclosure activities 

required to comply are ‘‘usual and 

customary.’’ 5 CFR 1320.3(b)(2). 

Because baby changing products 

generally require use and assembly 

instructions, and CPSC is not aware of 

baby changing products that generally 

require instructions but lack them, 

CPSC believes that providing 

instructions with baby changing 

products is ‘‘usual and customary.’’ For 

this reason, the burden estimate 

includes only the labeling requirements. 

The preamble to the NPR discussed 

the information collection burden of the 

proposed rule and requested comments 

on the accuracy of CPSC’s estimates. 81 

FR 66893 to 66894. CPSC did not 

receive any comments about the 

information collection burden of the 

proposed rule. However, the 

information collection burden has 

changed since the NPR because CPSC 

staff has identified 120 baby changing 

product suppliers (102 domestic firms, 

17 foreign firms, and 1 firm of unknown 

location), rather than the 85 firms 

identified in the NPR, that it estimates 

will be subject to the information 

collection burden. Accordingly, the 

estimated burden of this collection of 

information is as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN

16 CFR section Number of 

respondents 

Frequency 

of responses 

Total annual 

responses 

Hours per 

response 

Total burden 

hours 

1235.2 ........................................................................ 120 6 720 1 720 

The estimated reporting burden is 

based on CPSC staff’s expectation that 

all 120 baby changing product suppliers 

known to CPSC will need to modify 

their labels to comply with the final 

rule. CPSC staff estimates that it will 

take about 1 hour per model to make 

these modifications and, based on staff’s 

evaluation of product lines, that each 

supplier has an average of 6 models of 

baby changing products. Consequently, 

CPSC estimates that the burden 

associated with the labeling 

requirements is: 120 entities × 1 hour 

per model × 6 models per entity = 720 

hours. CPSC staff estimates that the 

hourly compensation for the time 

required to create and update labels is 

$34.21 (U.S. Bureau of Labor Statistics, 

‘‘Employer Costs for Employee 

Compensation,’’ Sept. 2017, Table 9, 

total compensation for all sales and 

office workers in goods-producing 

private industries: http://www.bls.gov/ 

ncs/). Therefore, the estimated annual 

cost associated with the labeling 

requirements is: $34.21 per hour × 720 

hours = $24,631.20. CPSC staff does not 

expect there to be operating, 

maintenance, or capital costs associated 

with this information collection. 

As the PRA requires, CPSC has 

submitted the information collection 

requirements of this final rule to OMB. 

44 U.S.C. 3507(d). OMB has assigned 

control number 3041–0175 to this 

information collection. 

XI. Regulatory Flexibility Act 

A. Introduction 

The Regulatory Flexibility Act (RFA; 

5 U.S.C. 601–612) requires agencies to 

consider the potential economic impact 


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of a proposed and final rule on small 

entities, including small businesses. 

Section 604 of the RFA requires 

agencies to prepare and publish a final 

regulatory flexibility analysis (FRFA) 

when they issue a final rule, unless the 

head of the agency certifies that the rule 

will not have a significant economic 

impact on a substantial number of small 

entities. The FRFA must discuss: 

• The need for and objectives of the 

rule; 

• significant issues raised in public 

comments about the initial regulatory 

flexibility analysis (IRFA), a response to 

comments from the Chief Counsel for 

Advocacy of the SBA, the agency’s 

assessment of the comments, and any 

changes made to the rule as a result of 

the comments; 

• the description and estimated 

number of small entities that will be 

subject to the rule; 

• the reporting, recordkeeping, and 

other compliance requirements of the 

rule, as well as the small entities that 

would be subject to those requirements, 

and the types of skills necessary to 

prepare the reports or records; 

• steps the agency took to minimize 

the significant economic impact on 

small entities; and 

• the factual, policy, and legal 

reasons the agency selected the 

alternative in the final rule, and why it 

rejected other significant alternatives. 

5 U.S.C. 604. 

Based on an assessment by CPSC’s 

Directorate for Economic Analysis staff, 

CPSC cannot certify that this rule will 

not have a significant economic impact 

on a substantial number of small 

entities. As a result, staff has prepared 

a FRFA. This section summarizes the 

FRFA for this final rule. The complete 

FRFA is available as part of CPSC staff’s 

briefing package at: https://cpsc.gov/ 

s3fs-public/Final%20Rule%20- 

%20Safety%20Standard

%20for%20Baby%20Changing

%20Products%20-%20June%2013

%202018.pdf?ZbvMCsfyQf

LFivqHRbFWKclOordsuVeC. 

B. Comments Relevant to the FRFA 

CPSC did not receive any comments 

specifically addressing the IRFA that 

accompanied the proposed rule or from 

the Chief Counsel for Advocacy of SBA. 

However, CPSC received comments 

about the effective date of the final rule, 

which are relevant to the FRFA insofar 

as they address the costs associated with 

the rule. These comments are discussed 

in section VI.F. of this preamble. After 

considering these comments, and the 

potential economic impact of the rule 

on small firms, the Commission is 

extending the effective date for the final 

rule to 1 year, rather than the proposed 

6 months. CPSC believes that this longer 

effective date will reduce the economic 

impact of the rule on firms, some of 

which may not be aware of the ASTM 

standard or this rulemaking, by 

reducing the potential for a lapse in 

production or imports while bringing 

products into compliance with the rule, 

and spreading the costs of compliance 

over a longer period. 

C. Description of Small Entities Subject 

to the Rule 

CPSC staff identified 120 firms that 

supply baby changing products to the 

U.S. market, consisting of 102 domestic 

firms, 17 foreign firms, and 1 firm for 

which staff could not determine the 

location. Of the 102 domestic firms, 84 

are small entities, according to SBA’s 

standards, and 18 are large. Of the 84 

small domestic entities, 61 are 

manufacturers, and 23 are importers or 

wholesalers. It is possible that there are 

additional baby changing product 

suppliers in the U.S. market that staff 

has not identified. 

D. Description of the Final Rule 

Sections V and VII of this preamble 

describe the requirements in the final 

rule, which incorporates by reference 

ASTM F2388–18. In addition, the final 

rule amends the regulations regarding 

third party conformity assessment 

bodies to include the safety standard for 

baby changing products in the list of 

NORs. 

E. Impact on Small Businesses 

For the FRFA, staff limited its 

analysis to the 84 small domestic firms 

staff identified as supplying baby 

changing products to the U.S. market 

because SBA guidelines and definitions 

apply to domestic entities. In assessing 

whether a rule will have a significant 

economic impact on small entities, staff 

generally considers impacts 

‘‘significant’’ if they exceed 1 percent of 

a firm’s revenue. This section provides 

details about staff’s assessment of the 

economic impact of the final rule on 

small domestic entities. To summarize, 

staff believes that it is unlikely that the 

final rule will have a significant 

economic impact on 22 of the 61 small 

manufacturers and 10 of the 23 small 

importers and wholesalers, all of which 

already comply with a version of the 

ASTM standard. Of the remaining firms, 

which do not already comply with the 

voluntary standard, staff does not expect 

the final rule to have a significant 

economic impact on 13 of the 39 small 

manufacturers and 3 of the 13 small 

importers and wholesalers because most 

of these firms supply products that staff 

does not expect will require changes to 

conform to the rule. Staff could not rule 

out a significant economic impact on 

the remaining 26 small manufacturers 

and 10 small importers and wholesalers. 

1. Small Manufacturers 

At the time staff prepared the FRFA, 

22 of the 61 small manufacturers 

reported that their baby changing 

products complied with the thencurrent ASTM standard. Staff believes 

that firms that report complying with 

the voluntary standard will continue to 

comply with the standard as it evolves, 

as part of an established business 

practice. Staff does not expect the final 

rule to have a significant economic 

impact on any of these 22 firms because 

ASTM F2388–18 was published well 

before the effective date of this rule. 

Staff expects third party testing costs to 

be minimal because these firms already 

test their products for compliance with 

the voluntary standard. 

The remaining 39 small 

manufacturers produce baby changing 

products that do not comply with the 

voluntary standard. Seven of these firms 

manufacture only wooden changing 

trays that are sold separately from 

furniture, which are subject to few 

requirements other than side height, 

labeling, and instructions. Staff does not 

expect changes to warnings, 

instructions, or side heights to create 

significant costs. An additional 12 firms 

manufacture only contoured changing 

pads, which are also subject to minimal 

requirements, primarily including 

barrier and retention requirements, 

labels, and instructions. Staff believes 

that firms will not have to modify most 

of these changing pads to meet these 

requirements, but it is possible that a 

few firms would need to modify their 

products to meet the barrier and 

retention requirements. These 

modifications could be costly because 

firms would need new molds for foam 

products. For purposes of the FRFA, 

staff assumed that two firms would need 

to modify their contoured changing 

pads to comply with the final rule. 

The remaining 20 firms manufacture 

a variety of changing products. Firms 

staff interviewed before the Commission 

issued the NPR indicated that the cost 

of completely redesigning a product 

could range from $25,000 to $200,000, 

depending on the type of changing 

product. It is likely that the final rule 

will have a significant impact on nine 

of these firms (and possibly one more) 

based on their revenue levels; it is 

unlikely the rule will have a significant 

economic impact on three of these 

firms, based on their revenues; and staff 


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could not determine the revenues of the 

remaining seven firms. 

Staff believes that third party testing 

costs are not likely to have a significant 

economic impact on 21 of the 39 small 

domestic noncompliant manufacturers, 

but could exceed 1 percent of revenues 

for the remaining 18 firms, with varying 

degrees of likelihood. Staff also believes 

that third party testing costs could result 

in significant economic impacts for 7 of 

the 20 small domestic noncompliant 

manufacturers that are not likely to 

experience significant economic 

impacts from the requirements in ASTM 

F2388–18. 

2. Small Importers and Wholesalers 

At the time staff prepared the FRFA, 

10 of the 23 small importers and 

wholesalers reported that their baby 

changing products complied with the 

then-current ASTM standard. Staff 

considered the economic impact to 

importers and wholesalers together 

because both rely on outside firms to 

supply the products they distribute to 

the U.S. market. Like small, compliant 

manufacturers, staff expects that these 

importers and wholesalers will comply 

with ASTM F2388–18 before the 

effective date of the final rule. 

Therefore, staff does not expect the final 

rule to have a significant economic 

impact on any of these firms. Likewise, 

staff expects third party testing costs to 

be minimal because costs would be 

limited to the difference between the 

cost of current testing regimes and third 

party testing costs. 

The remaining 13 small importers and 

wholesalers supply baby changing 

products that do not comply with the 

voluntary standard. The economic 

impact of the rule on these importers 

and wholesalers depends on the extent 

of the changes needed for their products 

to comply with the rule and the 

response of their suppliers. Staff 

generally cannot determine this 

information for importers and 

wholesalers that do not comply with the 

voluntary standard. 

Nevertheless, staff anticipates that the 

rule could have a significant economic 

impact on some of these firms. Staff 

estimates that the rule will not have a 

significant economic impact on one 

importer that supplies only wooden 

changing trays. The rule also may not 

have a significant economic impact on 

two importers and one wholesaler that 

provide only contoured changing pads. 

However, one of these firms may need 

to redesign its product, which would 

have a significant economic impact on 

the firm. Each of these firms has wide 

enough product lines that it could stop 

supplying changing products, although 

the impact of that on revenue is unclear. 

Of the remaining six importers and 

three wholesalers, four firms have low 

enough revenues that they are likely to 

experience a significant economic 

impact, regardless of how their 

suppliers respond, as their suppliers are 

not likely to absorb any of the costs and 

finding alternative suppliers can be 

costly. Three of these firms may be able 

to stop supplying changing products, 

but it is not clear what impact this 

would have on their revenues. Staff 

does not have revenue information for 

the remaining five firms. As a result, 

staff cannot rule out the possibility that 

the rule will have a significant 

economic impact on these five firms. 

However, one of these firms appears to 

be tied to its suppliers, who may absorb 

some of the costs, and another firm has 

a wide enough product line that it could 

stop supplying changing products. 

Staff believes that third party testing 

could result in significant costs for three 

of the firms that import noncompliant 

baby changing products. For two of 

these firms, testing costs could exceed 1 

percent of gross revenue if the firm tests 

only one unit per model. A third firm 

would need to test about three units per 

model before testing costs would exceed 

1 percent of its gross revenue. Staff did 

not have access to revenue data for 

seven of the small noncompliant 

importers and wholesalers to determine 

the potential economic impact of the 

rule. 

3. Accreditation Requirements for 

Testing Laboratories 

Section 14 of the Consumer Product 

Safety Act (CPSA; 15 U.S.C. 2051–2089) 

requires all children’s products that are 

subject to a children’s product safety 

rule to be tested by a third party 

conformity assessment body (i.e., testing 

laboratory) that has been accredited by 

CPSC. Testing laboratories that want to 

conduct this testing must meet the NOR 

for third party conformity testing. The 

final rule amends 16 CFR part 1112 to 

establish an NOR for testing laboratories 

to test for compliance with the baby 

changing product rule. 

In the IRFA for this rule, staff 

anticipated that the accreditation 

requirements would not have a 

significant economic impact on a 

substantial number of small laboratories 

because: (1) The rule imposed 

requirements only on laboratories that 

intended to provide third party testing 

services; (2) laboratories would assume 

the costs only if they anticipated 

receiving sufficient revenue from the 

testing to justify accepting the 

requirements as a business decision; 

and (3) most laboratories would already 

have accreditation to test for 

conformance to other juvenile product 

standards, thereby limiting the costs to 

adding the baby changing product 

standard to their scope of accreditation. 

CPSC has not received any information 

to date that contradicts this assessment. 

Therefore, staff believes that the NOR 

for the baby changing product standard 

will not have a significant economic 

impact on a substantial number of small 

entities. 

F. Alternatives and Steps To Minimize 

Economic Impacts 

In response to comments, the 

Commission is providing a 1 year 

effective date, rather than the proposed 

6 months. This should reduce the 

economic impact of the rule for small 

entities. Setting a later effective date 

reduces the likelihood of a lapse in 

production or imports if firms cannot 

comply with the standard or obtain 

third party testing within the time 

provided. In addition, a later effective 

date spreads the costs of compliance 

over a longer period, reducing annual 

costs and the present value of total 

costs. 

XII. Environmental Considerations 

CPSC’s regulations list categories of 

agency actions that ‘‘normally have little 

or no potential for affecting the human 

environment.’’ 16 CFR 1021.5(c). Such 

actions qualify as ‘‘categorical 

exclusions’’ under the National 

Environmental Policy Act (42 U.S.C. 

4321–4370m–12), which do not require 

an environmental assessment or 

environmental impact statement. One 

categorical exclusion listed in CPSC’s 

regulations is for rules or safety 

standards that ‘‘provide design or 

performance requirements for 

products.’’ 16 CFR 1021.5(c)(1). Because 

the final rule for baby changing 

products creates design or performance 

requirements, the rule falls within the 

categorical exclusion. 

XIII. Preemption 

Under section 26(a) of the CPSA, no 

state or political subdivision of a state 

may establish or continue in effect a 

requirement dealing with the same risk 

of injury as a federal consumer product 

safety standard under the CPSA unless 

the state requirement is identical to the 

federal standard. 15 U.S.C. 2075(a). 

However, states or political subdivisions 

of states may apply to CPSC for an 

exemption, allowing them to establish 

or continue such a requirement if the 

state requirement ‘‘provides a 

significantly higher degree of protection 

from [the] risk of injury’’ and ‘‘does not 


sradovich on DSK3GMQ082PROD with RULES
Federal Register / Vol. 83, No. 123 / Tuesday, June 26, 2018 / Rules and Regulations 29681 

unduly burden interstate commerce.’’ 

Id. 2075(c). 

Section 104 of the CPSIA requires the 

Commission to issue consumer product 

safety standards for durable infant or 

toddler products. As such, consumer 

product safety standards that the 

Commission creates under CPSIA 

section 104 are covered by the 

preemption provision in the CPSA. As 

a result, the preemption provision in 

section 26 of the CPSA applies to the 

mandatory safety standard for baby 

changing products. 

XIV. Testing, Certification, and 

Notification of Requirements 

Section 14(a) of the CPSA requires the 

manufacturer or private labeler of a 

children’s product that is subject to a 

children’s product safety rule to certify 

that, based on a third party conformity 

assessment body’s testing, the product 

complies with the applicable children’s 

product safety rule. 15 U.S.C. 

2063(a)(2)(A), 2063(a)(2)(B). Section 

14(a) also requires the Commission to 

publish an NOR for a third party 

conformity assessment body (i.e., testing 

laboratory) to obtain accreditation to 

assess conformity with a children’s 

product safety rule. 15 U.S.C. 

2063(a)(3)(A). Because this safety 

standard for baby changing products is 

a children’s product safety rule, it 

requires the Commission to issue an 

NOR. 

On March 12, 2013, the Commission 

published a final rule in the Federal 

Register, entitled Requirements 

Pertaining to Third Party Conformity 

Assessment Bodies, establishing 16 CFR 

part 1112, which sets out the general 

requirements and criteria concerning 

testing laboratories. 78 FR 15836. Part 

1112 includes procedures for CPSC to 

accept a testing laboratory’s 

accreditation and lists the children’s 

product safety rules for which the 

Commission has published NORs. When 

the Commission issues a new NOR, it 

must amend part 1112 to include that 

NOR. Accordingly, the Commission is 

amending part 1112 to include the baby 

changing products standard. 

Testing laboratories that apply for 

CPSC acceptance to test baby changing 

products for compliance with the new 

baby changing product rule would have 

to meet the requirements in part 1112. 

When a laboratory meets the 

requirements of a CPSC-accepted third 

party conformity assessment body, the 

laboratory can apply to CPSC to include 

16 CFR part 1235, Safety Standard for 

Baby Changing Products, in the 

laboratory’s scope of accreditation of 

CPSC safety rules listed on the CPSC 

website at: www.cpsc.gov/labsearch. 

As the RFA requires, CPSC staff 

conducted a FRFA for the rulemaking in 

which the Commission adopted part 

1112. 78 FR 15836, 15855 (Mar. 12, 

2013). To summarize, the FRFA 

concluded that the accreditation 

requirements would not have a 

significant economic impact on a 

substantial number of small laboratories 

because no requirements were imposed 

on laboratories that did not intend to 

provide third party testing services. The 

only laboratories CPSC expected to 

provide such services were those that 

anticipated receiving sufficient revenue 

from the mandated testing to justify 

accepting the requirements as a business 

decision. 

By the same reasoning, adding an 

NOR for the baby changing product 

standard to part 1112 will not have a 

significant economic impact on small 

test laboratories. A relatively small 

number of laboratories in the United 

States have applied for accreditation to 

test for conformance to existing juvenile 

product standards. Accordingly, CPSC 

expects that only a few laboratories will 

seek accreditation to test for compliance 

with the baby changing product 

standard. Of those that seek 

accreditation, CPSC expects that most 

will have already been accredited to test 

for conformance to other juvenile 

product standards. The only costs to 

those laboratories will be the cost of 

adding the baby changing product 

standard to their scopes of accreditation. 

For these reasons, CPSC certifies that 

amending 16 CFR part 1112 to include 

an NOR for the baby changing products 

standard will not have a significant 

economic impact on a substantial 

number of small entities. 

XV. Consumer Registration of Durable 

Infant or Toddler Products 

As section 104(d) of the CPSIA 

requires, regulations in 16 CFR part 

1130 require manufacturers of durable 

infant or toddler products to provide 

registration forms with each product, 

maintain the contact information 

consumers submit on these forms, and 

mark manufacturer and model 

information on products. Section 

1130.2(a)(14) lists ‘‘changing tables’’ as 

one of the products subject to the 

registration card requirements. 

However, ‘‘changing tables’’ is no longer 

used as the general term to encompass 

all baby changing products that are 

subject to ASTM F2388–18 and this 

final rule, and this term may create 

confusion since it is only one type of 

baby changing product. Because all of 

the baby changing products subject to 

this rule are ‘‘durable infant or toddler 

products,’’ section 104(d) of the CPSIA 

requires the registration card 

requirements to apply to all of these 

products. 

Accordingly, the Commission 

anticipates issuing a notice proposing to 

amend 16 CFR part 1130 to clarify that 

‘‘changing tables’’ include all changing 

products identified in ASTM F2388–18, 

which includes changing tables, 

contoured changing pads, changing 

table accessories, and add-on changing 

units. 

List of Subjects 

16 CFR Part 1112 

Administrative practice and 

procedure, Audit, Consumer protection, 

Reporting and recordkeeping 

requirements, Third-party conformity 

assessment body. 

16 CFR Part 1235 

Consumer protection, Imports, 

Incorporation by reference, Infants and 

children, Labeling, Law enforcement, 

Toys. 

For the reasons discussed in the 

preamble, the Commission amends 16 

CFR chapter II as follows: 

PART 1112—REQUIREMENTS 

PERTAINING TO THIRD PARTY 

CONFORMITY ASSESSMENT BODIES 

■ 1. The authority citation for part 1112 

continues to read as follows: 

Authority: Pub. L. 110–314, section 3, 122 

Stat. 3016, 3017 (2008); 15 U.S.C. 2063. 

■ 2. Amend § 1112.15 by adding 

paragraph (b)(45) to read as follows: 

§ 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. 

* * * * * 

■ 3. Add part 1235 to read as follows: 

PART 1235—SAFETY STANDARD FOR 

BABY CHANGING PRODUCTS 

Sec. 

1235.1 Scope. 

1235.2 Requirements for baby changing 

products. 

Authority: Sec. 104, Pub. L. 110–314, 122 

Stat. 3016 (August 14, 2008); Pub. L. 112–28, 

125 Stat. 273 (August 12, 2011). 

§ 1235.1 Scope. 

This part establishes a consumer 

product safety standard for baby 

changing products. 


sradovich on DSK3GMQ082PROD with RULES
29682 Federal Register / Vol. 83, No. 123 / Tuesday, June 26, 2018 / Rules and Regulations 

§ 1235.2 Requirements for baby changing 

products. 

Each baby changing product shall 

comply with all applicable provisions of 

ASTM F2388–18, Standard Consumer 

Safety Specification for Baby Changing 

Products for Domestic Use, approved on 

February 15, 2018. The Director of the 

Federal Register approves this 

incorporation by reference in 

accordance with 5 U.S.C. 552(a) and 1 

CFR part 51. You may obtain a copy 

from ASTM International, 100 Bar 

Harbor Drive, P.O. Box 0700, West 

Conshohocken, PA 19428; http://

www.astm.org. You may inspect a copy 

at the Office of the Secretary, U.S. 

Consumer Product Safety Commission, 

Room 820, 4330 East West Highway, 

Bethesda, MD 20814, telephone 301– 

504–7923, or at the National Archives 

and Records Administration (NARA). 

For information on the availability of 

this material at NARA, call 202–741– 

6030, or go to: https://

www.archives.gov/federal-register/cfr/ 

ibr-locations.html. 

Alberta E. Mills, 

Secretary, Consumer Product Safety 

Commission. 

[FR Doc. 2018–13556 Filed 6–25–18; 8:45 am] 

BILLING CODE 6355–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket Number USCG–2018–0499] 

RIN 1625–AA00 

Safety Zone; City of Erie Fourth of July 

Fireworks; Lake Erie, Erie, PA 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a temporary safety zone for 

navigable waters within a 280-foot 

radius of the launch site located at 

Dobbins Landing, Erie, PA. This safety 

zone is intended to restrict vessels from 

portions of Lake Erie during City of Erie 

Fourth of July fireworks display. This 

temporary safety zone is necessary to 

protect mariners and vessels from the 

navigational hazards associated with a 

fireworks display. Entry of vessels or 

persons into this zone is prohibited 

unless specifically authorized by the 

Captain of the Port Buffalo. 

DATES: This rule is effective from 9:45 

p.m. until 10:45 p.m. on July 3, 2018. 

ADDRESSES: To view documents 

mentioned in this preamble as being 

available in the docket, go to http://

www.regulations.gov, type USCG–2018– 

0499 in the ‘‘SEARCH’’ box and click 

‘‘SEARCH.’’ Click on Open Docket 

Folder on the line associated with this 

rule. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call or 

email LT Michael Collet, Chief 

Waterways Management Division, U.S. 

Coast Guard; telephone 716–843–9322, 

email D09-SMB-SECBuffalo-WWM@

uscg.mil. 

SUPPLEMENTARY INFORMATION: 

I. Table of Abbreviations 

CFR Code of Federal Regulations 

DHS Department of Homeland Security 

FR Federal Register 

NPRM Notice of proposed rulemaking 

§ Section 

U.S.C. United States Code 

II. Background Information and 

Regulatory History 

The Coast Guard is issuing this 

temporary rule without prior notice and 

opportunity to comment pursuant to 

authority under section 4(a) of the 

Administrative Procedure Act (APA) (5 

U.S.C. 553(b)). This provision 

authorizes an agency to issue a rule 

without prior notice and opportunity to 

comment when the agency for good 

cause finds that those procedures are 

‘‘impracticable, unnecessary, or contrary 

to the public interest.’’ Under 5 U.S.C. 

553(b)(B), the Coast Guard finds that 

good cause exists for not publishing a 

notice of proposed rulemaking (NPRM) 

with respect to this rule because the 

event sponsor did not submit notice to 

the Coast Guard with sufficient time 

remaining before the event to publish an 

NPRM. Delaying the effective date of 

this rule to wait for a comment period 

to run would be impracticable and 

contrary to the public interest by 

inhibiting the Coast Guard’s ability to 

protect spectators and vessels form the 

hazards associated with a fireworks 

display. 

Under 5 U.S.C. 553(d)(3), the Coast 

Guard finds that good cause exists for 

making this rule effective less than 30 

days after publication in the Federal 

Register because doing so would be 

impracticable and contrary to the public 

interest. Delaying the effective date 

would be contrary to the rule’s 

objectives of enhancing safety of life on 

the navigable waters and protection of 

persons and vessels in vicinity of the 

fireworks display. 

III. Legal Authority and Need for Rule 

The Coast Guard is issuing this rule 

under authority in 33 U.S.C. 1231. The 

Captain of the Port Buffalo (COTP) has 

determined that a fireworks display 

presents significant risks to the public 

safety and property. Such hazards 

include premature and accidental 

detonations, dangerous projectiles, and 

falling or burning debris. This rule is 

needed to protect personnel, vessels, 

and the marine environment in the 

navigable waters within the safety zone 

while the fireworks display takes place. 

IV. Discussion of the Rule 

This rule establishes a safety zone on 

July 3, 2018, from 9:45 p.m. until 10:45 

p.m. The safety zone will encompass all 

waters of Lake Erie, Erie, NY contained 

within 280-foot radius of: 42°08′17.13′′ 

N, 080°05′30.17′′ W. 

Entry into, transiting, or anchoring 

within the safety zone is prohibited 

unless authorized by the Captain of the 

Port Buffalo or his designated on-scene 

representative. The Captain of the Port 

or his designated on-scene 

representative may be contacted via 

VHF Channel 16. 

V. Regulatory Analyses 

We developed this rule after 

considering numerous statutes and 

Executive orders related to rulemaking. 

Below we summarize our analyses 

based on a number of these statutes and 

Executive orders, and we discuss First 

Amendment rights of protestors. 

A. Regulatory Planning and Review 

Executive Orders 12866 and 13563 

direct agencies to assess the costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits. 

Executive Order 13771 directs agencies 

to control regulatory costs through a 

budgeting process. This rule has not 

been designated a ‘‘significant 

regulatory action,’’ under Executive 

Order 12866. Accordingly, this rule has 

not been reviewed by the Office of 

Management and Budget (OMB), and 

pursuant to OMB guidance it is exempt 

from the requirements of Executive 

Order 13771. 

This regulatory action determination 

is based on the conclusion that this rule 

is not a significant regulatory action. We 

anticipate that it will have minimal 

impact on the economy, will not 

interfere with other agencies, will not 

adversely alter the budget of any grant 

or loan recipients, and will not raise any 

novel legal or policy issues. The safety 

zone created by this rule will be 

relatively small and enforced for a 

relatively short time. Also, the safety 

zone has been designed to allow vessels 

to transit around it. Thus, restrictions on 

vessel movement within that particular 


sradovich on DSK3GMQ082PROD with RULES