43470 Federal Register / Vol. 82, No. 179 / Monday, September 18, 2017 / Rules and Regulations 

proposals covered by this policy the 

department or agency head may take 

into account, in addition to all other 

eligibility requirements and program 

criteria, factors such as whether the 

applicant has been subject to a 

termination or suspension under 

paragraph (a) of this section and 

whether the applicant or the person or 

persons who would direct or has/have 

directed the scientific and technical 

aspects of an activity has/have, in the 

judgment of the department or agency 

head, materially failed to discharge 

responsibility for the protection of the 

rights and welfare of human subjects 

(whether or not the research was subject 

to federal regulation). 

§ 1028.124 Conditions 

With respect to any research project 

or any class of research projects the 

department or agency head of either the 

conducting or the supporting Federal 

department or agency may impose 

additional conditions prior to or at the 

time of approval when in the judgment 

of the department or agency head 

additional conditions are necessary for 

the protection of human subjects. 

Alberta E. Mills, 

Acting Secretary, Consumer Product Safety 

Commission. 

[FR Doc. 2017–19737 Filed 9–15–17; 8:45 am] 

BILLING CODE 6355–01–P 

CONSUMER PRODUCT SAFETY 

COMMISSION 

16 CFR Parts 1112 and 1229 

[Docket No. CPSC–2015–0028] 

Safety Standard for Infant Bouncer 

Seats 

AGENCY: Consumer Product Safety 

Commission. 

ACTION: Final rule. 

SUMMARY: The Danny Keysar Child 

Product Safety Notification Act, section 

104 of the Consumer Product Safety 

Improvement Act of 2008 (CPSIA), 

requires the United States Consumer 

Product Safety Commission 

(Commission or CPSC) to promulgate 

consumer product safety standards for 

durable infant or toddler products. 

These standards are to be ‘‘substantially 

the same as’’ applicable voluntary 

standards or more stringent than the 

voluntary standard, if the Commission 

determines that more stringent 

requirements would further reduce the 

risk of injury associated with the 

product. The Commission is issuing this 

final rule establishing a safety standard 

for infant bouncer seats (bouncer seats) 

in response to the direction of section 

104(b) of the CPSIA. Additionally, the 

Commission is finalizing an amendment 

to its regulations regarding third party 

conformity assessment bodies to include 

safety standard for bouncer seats in the 

list of notice of requirements (NORs) 

issued by the Commission. 

DATES: This rule will become effective 

March 19, 2018. The incorporation by 

reference of the publication listed in 

this rule is approved by the Director of 

the Federal Register as of March 19, 

2018. 

FOR FURTHER INFORMATION CONTACT: 

Keysha Walker, Compliance Officer, 

U.S. Consumer Product Safety 

Commission, 4330 East West Highway, 

Bethesda, MD 20814; telephone: 301– 

504–6820; email: kwalker@cpsc.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background and Statutory Authority 

The CPSIA was enacted 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 and toddler 

products. Standards issued under 

section 104 are to be ‘‘substantially the 

same as’’ the applicable voluntary 

standards or more stringent than the 

voluntary standard, if the Commission 

determines that more stringent 

requirements would further reduce the 

risk of injury associated with the 

product. 

The term ‘‘durable infant or toddler 

product’’ is defined in section 104(f)(1) 

of the CPSIA 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 statute specifies twelve categories of 

products that are included in the 

definition, including walkers, carriers 

and various types of children’s chairs. 

When issuing a regulation governing 

product registration under section 104, 

the Commission determined that an 

‘‘infant bouncer’’ falls within the 

definition of a ‘‘durable infant or toddler 

product.’’ 74 FR 68668 (Dec. 29, 2009); 

16 CFR 1130.2(a)(15). 

On October 19, 2015, the Commission 

issued a notice of proposed rulemaking 

(NPR) for infant bouncer seats. 80 FR 

63168. The NPR proposed to 

incorporate by reference the 2015 

version of the voluntary standard, 

ASTM F2167 Standard Consumer 

Safety Specification for Infant Bouncer 

Seats (ASTM F2167), as a mandatory 

consumer product safety rule with 

several modifications to the content, 

format, and placement of warning labels 

and instructions, to strengthen the 

standard. 

In this document, the Commission is 

issuing a mandatory consumer product 

safety standard for bouncer seats. As 

required by section 104(b)(1)(A), the 

Commission consulted with 

manufacturers, retailers, trade 

organizations, laboratories, consumer 

advocacy groups, consultants, and the 

public to develop this rule, largely 

through the ASTM process. Based on 

revisions to the voluntary standard 

since the NPR published, the final rule 

incorporates by reference the most 

recent voluntary standard for infant 

bouncer seats, developed by ASTM 

International, ASTM F2167–17, with 

two modifications related to warning 

label content and placement. These 

modifications strengthen the standard 

by requiring a more stringent warning to 

caregivers to use the restraints, even if 

an infant falls asleep in the bouncer, 

and requires the fall hazard warning to 

be placed on the upper seat back of the 

bouncer seat, to ensure that caregivers 

read and heed the warning. The 

Commission’s more stringent 

requirements are intended to further 

reduce the risk of injury to infants that 

fall from, and with, bouncer seats, 

especially bouncer seats that are placed 

on an elevated surface. 

Additionally, the final rule amends 

the list of NORs issued by the 

Commission in 16 CFR part 1112 to 

include the standard for infant bouncer 

seats. Under section 14 of the CPSA, the 

Commission promulgated 16 CFR part 

1112 to establish requirements for 

accreditation of third party conformity 

assessment bodies (or testing 

laboratories) to test for conformity with 

a children’s product safety rule. 

Amending part 1112 adds an NOR for 

the infant bouncer seat standard to the 

list of children’s product safety rules. 

II. Product Description 

A. Definition of ‘‘Bouncer Seats’’ 

Section 1.2 of ASTM F2167–17 

defines an ‘‘infant bouncer seat’’ as: ‘‘a 

freestanding product intended to 

support an occupant in a reclined 

position to facilitate bouncing by the 

occupant, with the aid of a caregiver or 

by other means.’’ Additionally, section 

1.2 states that infant bouncer seats are 

intended for ‘‘infants who have not 

developed the ability to sit up 

unassisted (approximately 0 to 6 months 

of age).’’ 


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1Staff categorized each firm using information 

from Dun & Bradstreet and ReferenceUSAGov, as 

well as firm Web sites. 

2 JPMA typically allows six months for products 

in their certification program to shift to a new 

standard once it is published. Therefore, firms are 

likely already complying with ASTM F2167–16, 

which was published in May 2016. Firms are not 

expected to comply with the recently published 

ASTM F2167–17 until December 2017. 

Bouncer seats vary widely in style 

and complexity, but typically, bouncer 

seats consist of a cloth cover stretched 

over a wire or tubular frame. Wire frame 

bouncers have two designs. The forward 

bend design is constructed with the 

seating area supported from the front 

side of the product. The second wire 

frame design is a rear bend design. In 

the rear bend design, the seat is 

supported from the rear side of the 

product. Other bouncer designs are also 

currently available, including, but not 

limited to, products with individual 

wire legs, solid bases, and spring 

designs. These infant bouncer designs 

use different methods to support the 

seat and are intended for ‘‘bouncing,’’ as 

defined in ASTM F2167. 

All bouncer seats support the child in 

an inclined position, and some brands 

have adjustable seat backs. Various 

bouncer seat models include a 

‘‘soothing unit’’ that vibrates or bounces 

the chair, and may play music or other 

sounds. Most bouncer seats also feature 

an accessory bar with attached toys that 

are, or at some point will be, within the 

child’s reach. Most of the bouncer seat 

models examined by Commission staff 

provide a 3-point restraint system, 

consisting of wide cloth crotch 

restraints and short adjustable waist 

straps with plastic buckles. Only two 

models of bouncer seats reviewed by 

CPSC for the NPR employed upper body 

restraints. Many bouncer seat brands 

also include an ‘‘infant insert,’’ intended 

for use to support smaller babies. Tabs 

C and D, Staff Briefing Package: Infant 

Bouncer Seats Notice of Proposed 

Rulemaking, dated September 30, 2015 

(Staff NPR Briefing Package), available 

at: http://www.cpsc.gov/Global/

Newsroom/FOIA/CommissionBriefing

Packages/2015/ProposedRuleSafety

StandardforInfantBouncerSeat

September302.pdf. 

B. Market Description 

For the final rule, staff identified 23 

firms supplying infant bouncer seats to 

the U.S. market, with several firms 

moving into or out of the market since 

the NPR was published. The 23 

identified firms primarily specialize in 

the manufacture and/or distribution of 

children’s products, including durable 

nursery products. Eight of the 23 known 

firms are domestic manufacturers and 8 

are domestic importers. The remaining 

seven firms are foreign (four 

manufacturers, two importers, and one 

retailer).1 Tab C, Staff Briefing Package: 

Final Rule for Infant Bouncer Seats, 

dated August 23, 2017 (Staff Final Rule 

Briefing Package), available at: https://

www.cpsc.gov/s3fs-public/Final-RuleSafety-Standard-for-Infant-BouncerSeats-August-23–2017.pdf?

ctmyMqMkYWQ1t3QN9

DUXCDKnJQ5rKCX6. 

Staff expects that the infant bouncer 

seats of 14 of these firms already comply 

with ASTM F2167 because the firms 

either: (1) Have their bouncers certified 

by the Juvenile Products Manufacturers 

Association (JPMA) (five firms); (2) 

claim compliance with the voluntary 

standard (eight firms); or (3) have been 

tested to the ASTM standard by CPSC 

staff (one firm).2

III. Incident Data 

For the NPR, CPSC’s Directorate for 

Epidemiology, Division of Hazard 

Analysis, described 277 reported 

incidents involving bouncer seats, 

including 11 fatalities and 51 injuries, 

occurring between January 1, 2006 and 

February 2, 2015. The incidents 

described in the NPR were based on 

reports involving victims 12 months old 

and younger in the Injury or Potential 

Injury Incident (IPII), In-Depth 

Investigation (INDP), and Death 

Certificates (DTHS) databases 

(collectively referred to as Consumer 

Product Safety Risk Management 

System data, or CPSRMS data). A 

detailed discussion of the incidents and 

hazard patterns developed for the NPR 

can be found in Tab A of the Staff NPR 

Briefing Package. 

A. CPSRMS Data 

For the final rule, CPSC staff reviewed 

bouncer seat incident reports in 

CPSRMS from February 2, 2015 through 

July 6, 2016. CPSC staff found 70 

incident reports in addition to those 

discussed in the NPR, including one 

fatality and three injuries. The fatality 

involved a 4-month-old female who 

died after suffering a fractured skull 

injury when the infant bouncer she was 

seated in fell from a table. Two of the 

reported injuries were head contusions. 

A 5-month-old male sustained a head 

contusion when a bouncer seat bent 

backward to the floor. A 6-month-old 

male sustained a head contusion when 

a bouncer cover came off of the wire 

frame and the infant flipped forward, 

striking his head on the battery 

compartment. In another reported 

incident, the victim suffered minor leg 

burns from a hot metal bar under a 

bouncer cover. Tab A, Staff Final Rule 

Briefing Package. 

Staff did not identify any hazards in 

the updated incident data that were not 

included in the hazard patterns 

described in the NPR (product design, 

structural integrity, toy bar-related, 

stability, chemical/electric hazards, 

restraints, hazardous environment), 

which specifically identified product 

design and structural integrity as the top 

two product-related hazards (in terms of 

frequency of occurrence). Staff found 

that product design and structural 

integrity continue to be the top two 

product-related hazards (in terms of 

frequency) for the updated CPSRMS 

data. Of the 70 new incident reports 

involving bouncer seats, 51 incident 

reports described issues with product 

design, and 13 incident reports 

described issues with structural 

integrity. Staff determined that almost 

all of the issues with product design 

were related to lopsided or low-riding 

bouncer frames. Data for the final rule 

can be found in Tab A of the Staff Final 

Rule Briefing Package. 

B. NEISS Data 

For the NPR, CPSC staff found 672 

bouncer-related incidents, including 

two fatalities, reported in the National 

Electronic Injury Surveillance System 

(NEISS) records retrieved for bouncer 

incidents from January 1, 2006 to 

December 31, 2013, involving children 

12 months old and younger. Staff found 

that 385 cases, or an estimated 9,200 

injuries, occurred in hazardous 

environments (counters, tables, and 

other elevated surfaces). 

Staff updated information on bouncerrelated incidents from the NEISS 

records for the final rule. From January 

1, 2014 through December 31, 2015, 

staff found 202 additional NEISS 

records describing infant bouncer 

incidents. Staff’s inspection of the 

updated NEISS data revealed that 100 

cases, or an estimated 2,800 injuries, 

took place in hazardous environments. 

The remaining 102 cases, or an 

estimated 2,800 injuries, took place on 

the floor or an unknown location. Staff 

found no additional fatalities in the 

NEISS data during this time frame. Staff 

estimates that 4,700 (85%) bouncer 

injuries involved the head and face. 

ESTIMATED NEISS BOUNCER

INJURIES, 2006–2015 

[age 0–1] 

Year Cases Estimated 

injuries 

2006 .................. 67 1,400 


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3CPSC link to recalled product: http://

www.cpsc.gov/en/Recalls/2007/Infant-BouncerSeats-Recalled-Due-to-Frame-Failure/. 

4CPSC link to recalled product: http://

www.cpsc.gov/en/Recalls/2009/BabySwede-LLCRecalls-Bouncer-Chairs-Due-to-Laceration-Hazard/. 

5Prior to the NPR publishing in October 2015, 

ASTM F2167 was revised several times as part of 

the rulemaking consultation process. In February 

2014 (ASTM F2167–14) the standard was revised to 

improve the sideward and rearward stability tests. 

Additionally in 2014, ASTM F2167–14a included 

changes to the stability test to make the ASTM 

standard more strict, to address tip-over incidents, 

and to add requirements and test procedures to 

address incidents involving battery leakage, 

corrosion, and overheating. 

6The Ad Hoc Task Group was formed by ASTM 

and consists of members of the various voluntary 

standards groups whose standards are affected by 

the durable nursery product rules. The purpose of 

the Ad Hoc Task Group is to harmonize the 

wording and warning label format of durable infant 

and toddler products. Ad Hoc Task Group 

recommendations for warning statements were 

originally published as a reference document titled, 

‘‘Ad Hoc Wording—May 4, 2016,’’ as part of the F15 

Committee Documents, and subsequently, the 

recommendations were revised and published in 

October 2016, with the title, ‘‘Ad Hoc Approved 

Wording, Revision A—October 17, 2016’’ (Ad Hoc 

Approved Wording). 

ESTIMATED NEISS BOUNCER

INJURIES, 2006–2015—Continued 

[age 0–1] 

Year Cases Estimated 

injuries 

2007 .................. 66 1,700 

2008 .................. 74 1,600 

2009 .................. 86 2,200 

2010 .................. 94 2,300 

2011 .................. 121 3,400 

2012 .................. 90 2,500 

2013 .................. 74 2,100 

2014 .................. 98 2,900 

2015 .................. 104 2,700 

2006–2015 877 22,800 

Based on the annual estimates provided 

in the table, staff found a statistically 

significant upward trend (p-value of 

0.006) in the estimated emergency 

department-treated injuries involving 

bouncers for victims under 1-year-old 

from 2006 to 2015. 

IV. Product Recalls 

The NPR described two recalls of 

infant bouncer seats since January 2006, 

involving two different firms, one recall 

in April 2007 3 (involving breakage of a 

tubular steel frame) and another recall 

in July 2009 4 (involving small, sharp 

metal objects that could protrude 

through the bouncer fabric). No injuries 

were associated with either product at 

the time of the recall. See Tab E, Staff 

NPR Briefing Package. For the final rule, 

staff reports that no additional recalls 

involving bouncer seats have occurred. 

V. Overview and Assessment of ASTM 

F2167 

A. Overview 

The voluntary standard for infant 

bouncer seats, ASTM F2167, Standard 

Consumer Safety Specification for 

Infant Bouncer Seats, is intended to 

minimize the risk of injury or death to 

infants in bouncer seats associated with 

falls from elevated surfaces, product 

disassembly or collapse, stability, and 

suffocation. ASTM F2167 was first 

approved in December 2001, and the 

standard published in January 2002. 

Since then, ASTM has revised the 

standard 11 times. Tab C of the Staff 

NPR Briefing Package includes a 

description of these revisions through 

2015.5

More recently, in May 2016, ASTM 

revised the standard to add specific 

developmental guidance for caregivers 

about when to stop using the bouncer, 

and ASTM removed a general 

requirement for banned toys or other 

articles because those requirements do 

not apply to infant bouncer seats. As 

discussed below, the standard was 

subsequently revised in June of 2017 to 

incorporate changes recommended by 

ASTM’s Ad Hoc Task Group 6

concerning warning label formatting 

requirements, and to add a requirement 

that limits the maximum weight of an 

occupant in an infant bouncer seat. The 

June 2017 version of the voluntary 

standard also removed a requirement for 

manufacturers of bouncer seats to 

change the model number whenever the 

product underwent a significant 

structural or design modification. We 

agree with ASTM that although 

changing the model number represents 

a best practice, most ASTM standards 

do not include the statement, and such 

practice does not impact the safety of 

the product. 

B. Assessment of the Voluntary 

Standard 

For the NPR, CPSC staff examined the 

relationship between the performance 

requirements in ASTM F2167–15 and 

each of the hazard patterns staff 

identified in the incident data for 

bouncer seats. Tab C, Staff NPR Briefing 

Package. Based on staff’s assessment, 

the Commission issued the NPR 

proposing to incorporate ASTM F2167– 

15 with the following modifications to 

warnings content, placement, and 

format: 

• Revised content of the warnings, 

markings, and instructions: 

—Modify text in the warnings stating to 

use the restraints ‘‘even if baby is 

sleeping’’; 

—change the text in the warnings to 

read, ‘‘stop using when baby starts 

trying to sit up’’; and 

—change the developmental guidance 

in the instructions, if stated, to read: 

‘‘from birth (or ‘‘0’’) until baby starts 

trying to sit up.’’ 

• Restricted the fall hazard label on 

the front surface of the bouncer to be 

adjacent to the area where the child’s 

head would rest, and modified the 

visibility test to reflect this requirement. 

• Specified a standard format 

(including black text on a white 

background, table design, bullet points, 

and black border) for the warnings on 

the product and in the instructions. 

The most recent version of the 

voluntary standard for bouncer seats, 

ASTM F2167–17, was approved on June 

1, 2017, and published in June 2017. 

ASTM F2167–17 includes modified and 

new performance and labeling 

requirements developed by ASTM in 

conjunction with stakeholders and 

CPSC staff on the ASTM subcommittee 

task group, to address the hazards 

associated with bouncer seats. ASTM 

F2167–17 addresses several of the 

hazards identified by the Commission in 

the NPR. Accordingly, after reviewing 

and considering comments received in 

response to the NPR, as well as the work 

of the Ad Hoc Task Group, the 

Commission incorporates by reference 

ASTM F2167–17, with two 

modifications that were identified in the 

NPR related to warning content and 

warning placement, as the mandatory 

safety standard for infant bouncer seats. 

Below we assess ASTM F2167–17 and 

explain how it differs from what the 

Commission proposed. 

1. Content of the Warnings, Markings, 

and Instructions 

The NPR proposed to incorporate by 

reference ASTM F2167–15, with 

modifications to warning, marking, and 

instruction requirements. ASTM F2167– 

15 advised caregivers: ‘‘Always use 

restraints. Adjust to fit snugly.’’ Based 

on the incident data that relate deaths 

to suffocation among unrestrained 

infants while they slept, and relate 

serious head injuries to unrestrained 

infants due to falls from bouncer seats 

that are placed on elevated surfaces and 

falls from bouncer seats that are being 

carried by caregivers, the Commission 

stated in the NPR that the voluntary 

standard was inadequate to address the 

risk of injury to infants from falls out of 

bouncer seats, or the risk of suffocation 

among unrestrained infants who are 

sleeping. In the NPR, the Commission 

proposed warning language stating: 

‘‘Adjust to fit snugly, even if baby is 


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7For example, see the American Academy of 

Pediatrics Web site, http://

www.healthychildren.org/English/ages-stages/baby/ 

sleep/Pages/default.aspx. 

8 During the April 2017 ASTM meetings, several 

Ad Hoc Task Group members requested the removal 

of this sentence from the Ad Hoc recommendations 

because no subcommittee had adopted the 

sentence. In the discussions, some manufacturers 

stated that these products are not appropriate for 

sleep, stating that the language ‘‘even if baby falls 

asleep,’’ may mislead caregivers. The Ad Hoc Group 

balloted the removal of the sentence in June 2017; 

however, the ballot received multiple negative votes 

and did not pass. 

sleeping.’’ Tab D, Staff NPR Briefing 

Package. 

The newest version of the voluntary 

standard, ASTM F2167–17, still does 

not require a warning statement that 

caregivers should use the restraints, 

even if an infant is asleep. We disagree 

with this approach. We note that some 

NPR commenters were concerned by the 

addition of language to the product 

warnings regarding sleep because such 

language may suggest that bouncer seats 

are intended to be used for long-term, 

unattended, sleep. However, CPSC staff 

advises that young infants, such as those 

who are intended to use bouncer seats, 

spend more time asleep than awake.7

Infants spending more than brief 

periods in a bouncer seat will fall asleep 

on occasion (and caregivers will place 

infants to sleep in bouncer seats under 

some circumstances), just as infants will 

fall asleep in strollers, swings, and carseat carriers. It may be counterintuitive, 

and therefore unlikely to occur to 

consumers, that products made for 

infants’ use, especially those that have 

features intended to sooth and comfort 

infants, would be unsafe places for 

infants to sleep. In fact, despite claims 

that bouncer seats are not intended for 

children to sleep in, CPSC staff found 

that some manufacturers’ marketing 

suggests that bouncers are intended for 

sleep as well as play. Moreover, 

incident data and Health Sciences’ 

assessment demonstrate that the 

severity of injury from a fall from a 

bouncer seat increases for a child who 

is unrestrained. Accordingly, in the 

final rule, the Commission requires that 

the fall hazard warning state that 

caregivers should use the restraints, 

even if baby falls asleep. 

Based on staff’s recommendation and 

the work of the Ad Hoc Task Group, the 

final rule uses the phrase ‘‘falls asleep’’ 

instead of the phrase ‘‘is sleeping’’ that 

the Commission had proposed in the 

NPR. This change aligns with wording 

approved by the Ad Hoc Task Group, 

which is ‘‘Never leave child unattended, 

even if child falls asleep.’’ The Ad Hoc 

Task Group intends for this warning to 

be used on products for infants who are 

likely to fall asleep in the product, but 

which are not intended for periods of 

unattended sleep (i.e. bouncers, swings, 

infant rockers, and handheld carriers).8

The Commission notes that the final 

rule does not preclude manufacturers 

from including an additional statement 

indicating that bouncers are not 

intended for long term sleep. 

Accordingly, the required fall and 

suffocation warning label text regarding 

use of restraints for the final rule is: 

• Always use restraints and adjust to 

fit snugly, even if baby falls asleep. 

ASTM F2167–17 includes the other 

modifications the Commission had 

proposed for warning statement 

requirements. Specifically, sections 

8.5.2.1 and 9.2.1 Fig. 11 of ASTM 

F2167–17 requires text in the warnings 

to state: ‘‘stop using when baby starts 

trying to sit up.’’ ASTM F2167–17 

requires additional text in the 

suffocation hazard warning label to 

limit the maximum weight for an 

occupant in an infant bouncer seat. The 

rationale for ASTM’s change is based on 

surveillance of the marketplace, which 

demonstrated that some manufacturers 

have weight limits that do not correlate 

to the developmental milestones 

contemplated in the current warnings. 

Section 8.5.2.1 of ASTM F2167–17 

requires text in the warnings to instruct 

caregivers to: ‘‘STOP using bouncer 

when baby starts trying to sit up or has 

reached [insert manufacturer’s 

recommended maximum weight, not to 

exceed 20 lb], whichever comes first.’’ 

2. Warning Label Placement and 

Visibility Test 

The NPR proposed a modification to 

ASTM F2167–15’s requirement for label 

placement. ASTM F2167–15 required 

that the fall hazard label be placed on 

the front surface of the bouncer seat 

back so that it is visible when a 

newborn CAMI dummy is placed in the 

bouncer seat. In the NPR, the 

Commission assessed this provision of 

the voluntary standard and found that it 

did not adequately address the risk of 

injury to infants falling from bouncer 

seats placed on elevated surfaces, a 

foreseeable misuse of infant bouncer 

seats. Tab D, Staff NPR Briefing Package. 

To strengthen the standard and further 

reduce the risk of injury, the NPR 

proposed that the fall hazard warning 

label be on the front surface of the 

bouncer seat, adjacent to where the 

child’s head would rest, and the NPR 

also modified the visibility test. ASTM 

F2167–17 retains the fall hazard 

warning placement and corresponding 

visibility test from ASTM F2167–15. 

Thus, the current voluntary standard 

still does not address the Commission’s 

concern about the visibility of the fall 

hazard warning. 

NPR Commenters expressed concern 

that some products were designed with 

insufficient space in the area adjacent to 

the child’s head to accommodate the 

necessary warning labels. Commenters 

were also concerned about the 

repeatability of the visibility test 

proposed in the NPR. We note, however, 

that staff’s research on the seat back 

space, including models with narrow 

seat backs, did not corroborate the 

commenters’ concerns. Nevertheless, to 

enhance test repeatability and to 

address the comments regarding 

insufficient seat back space for warning 

labels, the final rule allows a larger area 

for warning label placement than 

proposed in the NPR and clarifies the 

corresponding visibility test. 

The visibility test in the final rule is 

based on ASTM F2167–17. Using the 

CAMI dummy, as shown in Figure 1 

below, the allowable area for warning 

label placement starts from a dotted line 

that crosses the junctions of underarm 

and both sides of the torso of the CAMI 

dummy. 


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This observable line expands the seat 

back space allowed for warning labels 

and clarifies the precision of the 

visibility test, both of which address 

commenter concerns. 

3. Warning Label Format 

The NPR proposed modifications to 

the requirements in ASTM F2167–15 

regarding the format of warning labels 

noting that ASTM F2167–15 did not 

provide for a consistent warning label 

format across infant bouncer seats. Staff 

evaluated the warnings format in the 

voluntary standard and recommended 

that the Commission establish minimum 

requirements for presenting the hazard 

information that are consistent with best 

practices to attract and maintain 

attention, as well as aid reading and 

comprehension. Tab D, Staff NPR 

Briefing Package. Accordingly, the NPR 

proposed to specify a standard format 

(including black text on a white 

background, table design, bullet points, 

and black border) for the warnings on 

bouncer seats and in the instructions. 

Since the NPR published in 2015, 

ASTM’s Ad Hoc Task Group issued 

recommendations regarding warnings 

intended to apply across juvenile 

products. These recommendations, 

based on ANSI Z535.4, American 

National Standard for Product Safety 

Signs and Labels, have been 

incorporated into ASTM F2167–17. The 

Commission notes that Human Factors 

staff regularly cites ANSI Z535.4 as a 

baseline in developing warning 

materials, including those proposed in 

the bouncer seat NPR. The approved Ad 

Hoc Task Group recommendations are 

very similar to the ANSI Z535.4, with 

modifications to make the 

recommendations more stringent. The 

recommendations provide noticeable 

and consistent warning labels on infant 

bouncer seats and across juvenile 

products. Accordingly, for the final rule, 

the Commission incorporates by 

reference ASTM F2167–17, without any 

modifications to the formatting 

provisions. 

VI. Response to Comments 

CPSC received six comments in 

response to the NPR, including a joint 

letter submitted by four consumer 

advocacy groups. Three commenters 

supported the changes proposed in the 

NPR, and the remaining commenters 

expressed concern over the 

Commission’s proposed modifications. 

We summarize and respond to the 

commenters below. 

A. Warning Label Location 

Comment 1: One commenter stated 

that the proposed requirement for the 

fall hazard warning label to be adjacent 

to an infant’s head would necessitate a 

wider seat back to accommodate a 

warning label in multiple languages, 

which is desirable for international 

sales. According to the same 

commenter, the ASTM F15.21 

Subcommittee had already evaluated 

this location and concluded that other 

locations above and below the infant’s 

head were considered to be just as 

visible as the locations adjacent to an 

infant’s head. A second commenter 

stated that the proposed fall hazard 

label visibility test procedure is not 

specific and can be misinterpreted by 

test labs. This commenter suggested 

using the test protocol in the current 

ASTM standard that uses the CAMI 

newborn dummy. 

Response 1: Based on the incident 

data and research, the final rule requires 

that the fall hazard warning label be 

placed near the child’s face. This 

location allows caregivers to notice the 

label while making eye contact with the 

infant, and potentially creates mental 

images of the consequence (‘‘skull 

fracture’’) of not complying with the 

instructions because the warning label 

would be placed next to the body part 

at risk. Tab D, Staff NPR Briefing 

Package. 

Commenters claim that the area on 

the infant bouncer adjacent to an 

infant’s head could be severely limited 

in some cases due to the design of the 

seat back and allowance needed for 

stitching tolerances. CPSC staff’s 

research did not corroborate this claim. 

Tab D, Staff NPR Briefing Package. 

Accordingly, the NPR, 80 FR at 63179– 

80, invited commenters to provide 

information on costs and design changes 

that would be required if the label were 

required to be next to an infant’s head. 

Staff reports that during the ASTM Ad 

Hoc Task Group meetings held in 

January and February 2016, 

manufacturers provided several 

examples of juvenile products, 

including infant bouncer seats, to 

demonstrate difficulties associated with 

warning label placement in proposed 


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9The recommended wording is as follows: 

‘‘Products likely to be used for infants who are 

sleeping (i.e., bouncers, swings, infant rockers, 

handheld carriers) that are not intended for periods 

of unattended sleep, would benefit from this 

warning about unattended use. Never leave child 

unattended, even if child falls asleep.’’ 

locations. However, NPR commenters 

provided neither cost estimates, nor 

specific comments, other than stating 

that the location would require a wider 

seat back and would limit representing 

multiple languages. 

To resolve concerns about the amount 

of space for warning label placement 

and address the Commission’s concern 

about an effective warning label, the 

final rule states the test procedure 

language in ASTM F2167–17, but 

clarifies the allowable area for the fall 

hazard warning label. The fall hazard 

warning label must be visible when 

placed above an imaginary horizontal 

line that crosses through the junctions 

of underarm and side of the torso 

(armpits) on both left and right of the 

CAMI, and not obscured by any part of 

the dummy. A warning label located at 

or around the infant’s shoulders can 

address the visibility and caregiver 

motivational concerns expressed in the 

Human Factors staff memorandum for 

the NPR (Tab D), and also provide 

additional surface area to accommodate 

the recommended warning label. 

B. Warning Label Format 

Comment 2: Two commenters 

recommended against the proposed 

formatting requirements. Commenters 

specifically highlighted the following 

proposed warning formatting 

requirements: 

• A heavy black border around the 

label, 

• Delineating message panels with 

solid lines, 

• Black text on white message panel, 

• Bullet points preceding 

precautionary statements, 

• Choosing a background color for the 

signal word panel based on a best 

contrast against the product material, 

and 

• Using non-condensed style font. 

Commenters stated that, in general, 

ASTM standards provide flexibility to 

manufacturers to pick colors and 

formatting features that are most 

appropriate for the product. One 

commenter recommended delaying the 

publication of the final rule for any and 

all warnings requirements until the 

warnings format and content revisions 

proposed in the NPR can be reviewed by 

ASTM Ad Hoc Task Group, balloted 

through the ASTM process, and then 

implemented into F2167. The same 

commenter also indicated that the 

formatting requirements in the bouncer 

NPR and several other NPRs are 

inconsistent with each other. 

Response 2: Human Factors staff at 

CPSC employs the ANSI Z535.4, 

American National Standard for 

Product Safety Signs and Labels as a 

baseline to develop warning materials. 

Since the NPR was published, the 

ASTM Ad Hoc Task Group met and 

made recommendations for warning 

label formatting across juvenile 

products. The ASTM Ad Hoc Task 

Group’s recommendations are based on 

ANSI Z535.4 and are more stringent 

than the ANSI Z535 series. ASTM 2167– 

17 now incorporates recommendations 

made by the Ad Hoc Task Group. 

Accordingly, the final rule incorporates 

by reference ASTM 2167–17 without 

any modifications to warning label 

format. 

C. Warning Label Content 

Comment 3: Two commenters 

recommended against the proposed 

addition of ‘‘even if baby is sleeping’’ to 

the end of the precautionary statement: 

‘‘Always use restraints. Adjust to fit 

snugly.’’ One commenter believes that 

this statement implies that sleeping in a 

bouncer is acceptable and may 

encourage caregivers to use the product 

for extended periods of sleep. The 

second commenter believes that this 

statement contradicts the warning to 

never leave children unattended. 

Response 3: Incident data associated 

with bouncer seats demonstrate that 

unrestrained infants suffer serious head 

injuries from falls and get into 

compromised positions that may result 

in suffocation. Tab A, Staff NPR Briefing 

Package; Tab A, Staff Final Rule Briefing 

Package. Young infants will sleep in 

bouncers as they spend more time 

asleep than awake. Tab D, Staff NPR 

Briefing Package. Some bouncers in the 

market include references to calming 

and soothing features of a bouncer, as 

well as appropriateness for short 

periods of sleep in a bouncer, such as 

‘‘Your child can also sleep for short 

periods of time in the bouncer if he or 

she is content doing so.’’ Based on 

incident data, the final rule requires that 

the warning statement reference sleep to 

reflect this foreseeable product use 

scenario and to address the risk of 

injury from falls. 

In October 2016, the ASTM Ad Hoc 

Task Group approved a recommended 

warning to address products likely to be 

used for short-term sleep.9 The 

Commission agrees with the Ad Hoc 

Task Group’s language and has modified 

the warning in the final rule to use the 

phrase ‘‘even if child falls asleep’’ to 

align with the Ad Hoc Task Group’s 

language. Manufacturers who produce 

bouncers in which infants should not be 

allowed to sleep may add language to 

their warnings statements alerting 

caregivers to this issue. 

Comment 4: One commenter 

recommended that the ASTM 

subcommittee reach a consensus on the 

need for the additional proposed 

language: ‘‘Stop using bouncer when 

baby starts trying to sit up.’’ 

Response 4: At the January 12, 2016 

ASTM meeting, the F15.18 

subcommittee on Infant Bouncer Seats 

reviewed and agreed with the 

Commission’s proposed language on 

developmental guidance. ASTM 

balloted and approved the proposed 

language, and such language has been 

included in ASTM F2167 since the 2016 

version of the standard. 

D. Other Warning Label Issues 

Comment 5: Two commenters 

recommended that the warning label be 

attached on the product using 

embroidery or stamping to increase its 

permanency. 

Response 5: The ASTM standard does 

not require a certain type of attachment 

for labels but requires the labels to be 

tested per section 7.8 to determine the 

labels’ permanency. A similar 

permanency test procedure is used in 

other ASTM standards. No data were 

provided by the commenter, and the 

Commission has no information 

suggesting that these requirements are 

ineffective. Accordingly, the 

Commission incorporates by reference 

ASTM F2167–17, without any 

modification to section 7.8. 

Comment 6: Three commenters 

recommended using pictures to clarify 

warning messages. 

Response 6: The Commission 

acknowledges that well-designed 

graphics can be useful to increase the 

noticeability of the warnings as they 

help capture a user’s attention. 

Pictograms are also helpful for users 

with limited or no English literacy. 

However, the design of effective 

graphics can be difficult. To avoid 

confusing consumers, a warning 

pictogram should be developed with an 

empirical study and well tested on the 

target audience. Although the 

Commission may take action in the 

future if it believes graphic symbols are 

needed to reduce the risk of injury 

associated with bouncer seats, the rule 

permits, but does not mandate, such 

supporting graphics. 

VII. Incorporation by Reference 

Section 1229.2(a) of the final rule 

provides that infant bouncer seats must 

comply with applicable sections of 


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ASTM F2167–17. The OFR has 

regulations concerning incorporation by 

reference. 1 CFR part 51. These 

regulations require that, for a final rule, 

agencies must discuss in the preamble 

to the rule the way in which materials 

that the agency incorporates by 

reference are reasonably available to 

interested persons, and how interested 

parties can obtain the materials. 

Additionally, the preamble to the rule 

must summarize the material. 1 CFR 

51.5(b). 

In accordance with the OFR’s 

requirements, the discussion in section 

VIII of this preamble summarizes the 

required provisions of ASTM F2167–17. 

Interested persons may purchase a copy 

of ASTM F2167–17 from ASTM, either 

through ASTM’s Web site, or by mail at 

the address provided in the rule. A copy 

of the standard may also be inspected at 

the CPSC’s Office of the Secretary, U.S. 

Consumer Product Safety Commission, 

as discussed above. Note that the 

Commission and ASTM arranged for 

commenters to have ‘‘read only’’ access 

to ASTM F2167–15 during the NPR’s 

comment period. 

VIII. Description of the Final Rule 

Section 1229.2(a) of the final rule for 

infant bouncer seats incorporates by 

reference ASTM F2167–17 with two 

modifications, as stated in § 1229.2(b), 

related to the content and placement of 

warnings. Section 1229.2(a) includes the 

following key provisions summarized 

below: scope, terminology, general 

requirements, performance 

requirements, test methods, marking 

and labeling, and instructional 

literature. As described below, 

§ 1229.2(b) includes modifications to 

test methods (§ 1229.2(b)(1)), marking 

and labeling (§ 1229.2(b)(2) and (3)), and 

instructional literature (§ 1229.2(b)(4)). 

Scope. Section 1 of ASTM F2167–17 

states the scope of the standard, 

detailing what constitutes an ‘‘infant 

bouncer seat.’’ As stated in section II.A 

of this preamble, the Scope section 

defines an ‘‘infant bouncer seat’’ as ‘‘a 

freestanding product intended to 

support an occupant in a reclined 

position to facilitate bouncing by the 

occupant, with the aid of a caregiver or 

by other means.’’ ASTM F2167–17 

states that infant bouncer seats are 

intended for ‘‘infants who have not 

developed the ability to sit up 

unassisted (approximately 0 to 6 months 

of age).’’ 

Terminology. Section 3 of ASTM 

F2167–17 provides definitions of terms 

specific to this standard. 

General Requirements. Section 5 of 

ASTM F2167–17 addresses numerous 

hazards with several general 

requirements, most of which are also 

found in the other ASTM juvenile 

product standards. Several requirements 

reference an existing CPSC standard. 

The following general requirements 

apply to bouncer seats. Where the 

ASTM standard relies on a CPSC 

mandatory standard, the mandatory 

standard is cited in parentheses next to 

the requirement: 

• Hazardous sharp points and edges 

(16 CFR 1500.48 and 1500.49); 

• Small parts (16 CFR part 1501); 

• Lead in paint (16 CFR part 1303); 

• Wood parts; 

• Latching and locking mechanisms; 

• Scissoring, shearing, and pinching; 

• Openings; 

• Exposed coil springs; 

• Protective components; 

• Permanency of labels and warnings; 

and 

• Toys (ASTM F963). 

Performance Requirements and Test 

Methods. Sections 6 and 7 of ASTM 

F2167–17 contain performance 

requirements specific to bouncer seats, 

as well as test methods that must be 

used to assess conformity with such 

requirements. Accordingly, the final 

rule includes performance requirements 

for the following: 

• Restraints; 

• Stability (forward, sideward, and 

rearward); 

• Slip Resistance 

• Structural Integrity; 

• Dynamic and Static Load; 

• Disassembly/Collapse; 

• Drop Test; 

• Toy Bar Attachment Integrity; and 

• Battery Compartment. 

Additionally, section 7 of ASTM 

F2167–17 includes test procedures to 

ensure the permanency of labels and 

warnings, and a fall hazard visibility 

test. The test procedure in § 1229.2(b)(1) 

of the final rule replaces the fall hazard 

visibility test in section 7.11.3.1 of 

ASTM F2167–17, as described in 

section V.B.2 of this preamble. 

Marking and Labeling. Section 8 of 

ASTM F2167–17 requires products to be 

marked or labeled with manufacturing 

information and relevant product 

warnings. Warning label requirements 

for bouncer seats in section 8.4.5 of 

ASTM F2167–17 require two groups of 

warning statements, a fall hazard 

warning and a suffocation warning. 

ASTM F2167–17 includes warning 

language and formatting requirements 

for both falls and suffocation warnings. 

Section 8.4.7.1 requires the fall hazard 

warning to be placed on the front 

surface of the infant bouncer seat back, 

so that it complies with the visibility 

requirement in section 7.11. 

Section 1229.2(b)(2) of the final rule 

replaces the content of the fall hazard 

warning in section 8.5.1.1 of ASTM 

F2167–17. Section 1229.3(b)(3) of the 

final rule replaces the content of the 

suffocation hazard warning in sections 

8.5.2.1 and 8.5.3 in ASTM F2167–17. 

Changes to warning content and the 

visibility test for the placement of the 

fall hazard warning are outlined in 

section V.B.1–2 of this preamble. 

Instructional Literature. Section 9 of 

ASTM F2167–17 requires that 

instructions be provided with bouncer 

seats and be easy to read and 

understand. Additionally, the section 

contains requirements relating to 

instructional literature contents, 

including warnings. 

Section 1229.2(b)(4) of the final rule 

replaces the content of sections 9.2.1 

and 9.2.2 of ASTM F2167–17. These 

sections contain example warning labels 

or references to example warning labels. 

The content of the example warning 

labels in § 1229.2(b)(4) reflects changes 

to the content of the fall hazard warning 

and suffocation hazard warning in 

§ 1229.2(b)(2) and (3) of the final rule. 

Changes to the instructional literature 

that relate to warnings content are 

outlined in section V.B.1–2 of this 

preamble. 

IX. Effective Date 

The Administrative Procedure Act 

(APA) generally requires that the 

effective date of a rule be at least 30 

days after publication of the final rule. 

5 U.S.C. 553(d). CPSC generally 

considers 6 months to be sufficient time 

for suppliers of durable infant and 

toddler products to come into 

compliance with a new standard under 

section 104 of the CPSIA. Six months is 

also the period that the Juvenile 

Products Manufacturers Association 

(JPMA) typically allows for products in 

the JPMA certification program to 

transition to a new standard once that 

standard is published. The Commission 

proposed a 6-month effective date in the 

NPR for infant bouncer seats and we 

received no comments on the proposed 

effective date. Accordingly, the final 

rule for bouncer seats, as well as the 

amendment to part 1112, has a 6-month 

effective date. 

X. Regulatory Flexibility Act 

A. Introduction 

The Regulatory Flexibility Act (RFA), 

5 U.S.C. 601–612, requires that agencies 

review a proposed rule and a final rule 

for the rule’s potential economic impact 

on small entities, including small 

businesses. Section 604 of the RFA 

generally requires that agencies prepare 

a final regulatory flexibility analysis 

(FRFA) when promulgating final rules, 


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10Staff categorized each firm using information 

from Dun & Bradstreet and ReferenceUSAGov, as 

well as firm Web sites. 

11 JPMA typically allows six months for products 

in their certification program to become compliant 

with a new voluntary standard once it is published. 

Therefore, firms are likely already complying with 

ASTM F2167–16, which was published in May 

2016. They are not expected to comply with the 

recently published ASTM F2167–17 until December 

2017. 

unless the head of the agency certifies 

that the rule will not have a significant 

economic impact on a substantial 

number of small entities. Staff prepared 

a FRFA that is available at Tab C of the 

Staff Final Rule Briefing Package. We 

provide a summary of the FRFA below. 

The final rule is unlikely to have a 

significant economic impact on the five 

domestic manufacturers of infant 

bouncer seats. Of the six small 

importers, a significant economic 

impact cannot be ruled out for four of 

the importers, either as a result of the 

final rule requirements or the resulting 

third party testing costs. Therefore, the 

Commission cannot rule out a 

significant economic impact for four of 

the 11 firms (36 percent) operating in 

the U.S. market for bouncers. 

B. The Product 

An infant bouncer seat is defined in 

ASTM F2167–17, Standard Consumer 

Safety Specification for Infant Bouncer 

Seats, as ‘‘a freestanding product 

intended to support an occupant in a 

reclined position to facilitate bouncing 

by the occupant, with the aid of a 

caregiver or by other means.’’ These 

products vary widely in price; they can 

be purchased for as little as $20, but can 

also easily cost more than $200. 

C. The Market for Infant Bouncer Seats 

For the FRFA, the Commission 

identified 23 firms supplying infant 

bouncer seats to the U.S. market, with 

several firms moving into or out of the 

market since the NPR. These firms 

primarily specialize in the manufacture 

and/or distribution of children’s 

products, including durable nursery 

products. Eight of the 23 known firms 

are domestic manufacturers and eight 

are domestic importers. The remaining 

seven firms are foreign (4 

manufacturers, 2 importers, and 1 

retailer).10 We expect that the infant 

bouncer seats of 14 of these firms 

already comply with ASTM F2167 

because the firms either: (1) Have their 

bouncers certified by JPMA (five firms); 

(2) claim compliance with the voluntary 

standard (eight firms); or (3) have been 

tested to the ASTM standard by CPSC 

staff (one firm).11

D. Impact on Small Businesses 

The Commission is aware of 

approximately 23 firms currently 

marketing infant bouncer seats in the 

United States, 16 of which are domestic. 

Under U.S. Small Business 

Administration (SBA) guidelines, a 

manufacturer of infant bouncer seats is 

categorized as small if it has 500 or 

fewer employees, and importers and 

wholesalers are considered small if they 

have 100 or fewer employees. We have 

limited our analysis to domestic firms 

because SBA guidelines and definitions 

pertain to U.S.-based entities. Based on 

these guidelines, the Commission 

determined that about 11 of the 23 firms 

are small—five domestic manufacturers 

and six domestic importers. Additional 

unknown small domestic infant bouncer 

seat suppliers may be operating in the 

U.S. market. 

1. Small Manufacturers 

The economic impact of the final rule 

for infant bouncer seats should be small 

for the five small domestic 

manufacturers. Each firm has an 

established history of compliance with 

the ASTM standard for infant bouncers 

and is therefore expected to be 

compliant with ASTM F2167–17, the 

version of the voluntary standard upon 

which the final rule is based, by the 

time the mandatory standard becomes 

final. 

None of these firms includes more 

than four languages in their warnings 

and redesign is not expected. Based 

upon staff’s inspection of their products, 

we expect products to have more than 

sufficient space for the required warning 

labels under the modified warning label 

for the final rule without the products 

seeming cluttered. 

Under section 14 of the CPSA, once 

the new infant bouncer seat 

requirements become effective, all 

manufacturers will be subject to the 

third party testing and certification 

requirements under the CPSA and the 

Testing and Labeling Pertaining to 

Product Certification rule (16 CFR part 

1107) (1107 rule). Third party testing 

will include any physical and 

mechanical test requirements specified 

in the final infant bouncer seats rule. 

Manufacturers and importers should 

already be conducting required lead 

testing for bouncer seats. 

Third party testing costs are in 

addition to the direct costs of meeting 

the infant bouncer seats standard. The 

Initial Regulatory Flexibility Analysis 

(IRFA) prepared for the NPR concluded 

that we could not rule out a significant 

economic impact, given that we do not 

know specifically how much the third 

party requirement adds to testing costs 

or precisely how many models are 

needed to meet the ‘‘high degree of 

assurance’’ standard but that it was 

unlikely to be economically significant 

for most small manufacturers (i.e., 

testing costs would be less than 1 

percent of gross revenue). Given that 

these firms are already testing to the 

voluntary standard and the Commission 

received no public comments about 

third party testing, the Commission 

believes that it is unlikely that third 

party testing would have a significant 

economic impact on any of the five 

small manufacturers. 

2. Small Importers 

a. Small Importers With Compliant 

Infant Bouncer Seats 

As noted in the IRFA, imported 

bouncers tend to be produced to meet 

the requirements for several trading 

partners simultaneously, including their 

different labeling requirements. 

Producers for international markets 

typically address labeling requirements 

for their various trading partners by 

simply providing a warning that covers 

all required safety issues in multiple 

languages. Specificity regarding warning 

label location impacts the practicability 

of replicating the warning label in 

multiple languages. This could mean 

that foreign producers will need to 

design a product for the U.S. market or 

reduce the number of languages used for 

warnings on U.S.-bound bouncer seats. 

The final rule provides additional 

space for warning label placement than 

that proposed in the NPR. With this 

additional space, reducing on-product 

warning languages should be a more 

viable alternative for firms than it was 

under the NPR proposal. Firms would 

not need to reduce the number of 

languages for their on-product warnings 

for the final rule as significantly as that 

required in the NPR. The additional 

space addresses the location 

requirement in the final rule, while 

ensuring that the appearance of 

bouncers remains comparable to firms’ 

competitor products (for which one to 

three languages is typical). 

Three small importers of infant 

bouncer seats are currently in 

compliance with the voluntary 

standard; these firms likely would 

continue compliance as new versions of 

the voluntary standard are published. 

One importer is unlikely to experience 

a significant economic impact, even if 

the importer opted to redesign its 

bouncers to accommodate more than 

eight warning label languages. The cost 

estimate to redesign an infant bouncer 

(based on information from several 


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firms) is between $200,000 and 

$300,000, which is less than 1 percent 

of this firm’s revenue. The remaining 

two small importers of compliant 

bouncer seats might experience 

significant economic costs, based on the 

same comparison (i.e., $200,000 to 

$300,000 could represent more than 1 

percent of their annual revenue). 

Although the Commission does not 

expect that these firms would require 

space for warning labels in more than 

eight languages, we cannot rule out a 

significant economic impact for one of 

these two firms, given an extremely low 

revenue level compared to estimated 

costs for redesign. The second firm 

appears to have the option of exiting the 

bouncer market without experiencing a 

significant impact. 

b. Small Importers With Noncompliant 

Infant Bouncer Seats 

Three firms import bouncers that do 

not comply with the voluntary standard. 

The bouncers for these firms will 

require changes to come into 

compliance with the voluntary standard 

as well as modifications to meet the 

warning label requirements in the final 

rule. In the absence of information on 

precisely what changes would be 

required to bring the bouncer seats 

supplied by all three firms into 

compliance with the final rule (as well 

as information on sales revenue for all 

three firms), the Commission cannot 

rule out a significant economic impact 

for any of these firms. 

The magnitude of the economic 

impact on the three firms with 

noncompliant infant bouncer seats will 

depend upon the cost of the changes 

required and the degree to which their 

supplying firms pass on any increases in 

production costs associated with 

changes to the product needed to meet 

the mandatory standard (a redesign is 

estimated to cost between $200,000 to 

$300,000). Two of the firms are directly 

tied to their foreign suppliers and 

therefore, finding an alternate supply 

source would not be a viable alternative. 

However, given this close relationship, 

it seems likely that their foreign 

suppliers would have an incentive to 

work with their U.S. subsidiaries to 

maintain an American market presence. 

One of those two firms likely would 

only avoid a significant economic 

impact if their supplier absorbed 100 

percent of the cost of a redesign. The 

third firm imports and wholesales a 

wide variety of children’s products. We 

do not know, however, how much of the 

firm’s revenue is due to bouncer sales 

and cannot determine what impact 

discontinuing bouncer sales might have 

on the third firm should the firm be 

unable to find a supplier of bouncers 

that comply with the standard. 

Based on the additional space 

provided in the final rule for placement 

of the fall hazard warning label, two of 

these firms should not require 

modifications to meet the requirement 

in the final rule (although they would 

have required modifications under the 

NPR). 

c. Third Party Testing Costs for Small 

Importers 

As with manufacturers, all importers 

will be subject to third-party testing and 

certification requirements, and 

consequently, will be subject to costs 

similar to those for manufacturers if 

their supplying foreign firm(s) does not 

perform third party testing. Half of the 

bouncer seat importers (3 of 6) are 

already testing their products to verify 

compliance with the ASTM standard, 

and any costs would be limited to the 

incremental costs associated with third 

party testing over the current testing 

regime. 

The Commission was able to obtain 

revenue data for one of the small 

importers with noncompliant bouncers. 

For that importer, third party testing 

costs, considered alone and apart from 

any additional performance 

requirements due to the final rule, 

would not exceed one percent of gross 

revenue unless around 12 units per 

model required testing to provide the 

‘‘high degree of assurance’’ required by 

16 CFR part 1107. The Commission has 

no basis for estimating the size of the 

impact for the remaining two importers 

of noncompliant bouncers. 

E. Summary of Impacts 

The Commission is aware of 11 small 

firms, five domestic manufacturers and 

six domestic importers, currently 

marketing infant bouncer seats in the 

United States. With regards to the five 

domestic manufacturers, the 

Commission considers it unlikely that 

testing costs would have a significant 

impact on any of these firms. Of the six 

small importers, a significant economic 

impact cannot be ruled out for four of 

the importers either as a result of the 

final rule requirements or the resulting 

third party testing costs. Therefore, the 

Commission cannot rule out a 

significant economic impact for four of 

the 11 firms (36 percent) operating in 

the U.S. market for bouncers. 

F. Alternatives 

One of the alternatives to reduce the 

impact on small entities discussed in 

the NPR was to adopt the voluntary 

standard with all of the modifications to 

the on-product warning labels, except 

for the location specificity (i.e., next to 

the child’s head). Based on comments 

received, the requirements regarding onproduct warning label placement have 

been modified in the final rule (i.e., up 

from the child’s armpits on either side). 

This modification provides additional 

room and will reduce the economic 

impact of the warning label location 

specificity on small suppliers. The 

Commission could further reduce the 

economic impact on small entities by 

eliminating the location requirement for 

the fall hazard warning entirely. 

However, this would reduce the 

effectiveness of the fall hazard warning 

label. The location for the fall hazard 

warning ‘‘allows caregivers to notice the 

label while making eye contact with the 

infant, and potentially creates mental 

images of the consequence (‘‘skull 

fracture’’) of not complying with the 

instructions . . .’’ Tab D, Staff NPR 

Briefing Package; Tab B, Staff Final Rule 

Briefing Package. 

The Commission considered two 

additional alternatives discussed in the 

NPR that might minimize the economic 

impact on small entities: (1) Adopt 

ASTM F2167–17 with no modifications; 

and (2) allow a later effective date. 

Section 104 of the CPSIA requires that 

the Commission promulgate a standard 

that is either substantially the same as 

the voluntary standard or more 

stringent. Therefore, adopting ASTM 

F2167–17 with no modifications is the 

least stringent rule allowed by law. This 

alternative would reduce the impact on 

all of the known small businesses 

supplying infant bouncers to the U.S. 

market. If it were adopted, it should 

eliminate any economic impact related 

to warning label changes, but firms 

would continue to be affected by third 

party testing requirements. However, 

adopting ASTM F2167–17 without 

modification would not adequately 

address the fall hazard scenario 

identified in the incident data and 

would reduce the effectiveness of the 

fall hazard warning label. 

Finally, the Commission could reduce 

the final rule’s impact on small 

businesses by setting a later effective 

date. A later effective date would reduce 

the economic impact on firms in two 

ways. Firms would be less likely to 

experience a lapse in production/ 

importation, which could result if they 

are unable to comply and third party 

test within the required timeframe. 

Also, firms could spread costs over a 

longer time period, thereby reducing 

their annual costs, as well as the present 

value of their total costs. However, the 

Commission received no comments 

asserting that firms would not have 

sufficient time to comply with the 


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Federal Register / Vol. 82, No. 179 / Monday, September 18, 2017 / Rules and Regulations 43479 

proposed 6 month effective date. 

Accordingly, the Commission declines 

to extend the effective date of the final 

rule. 

G. Small Business Impacts of the 

Accreditation Requirements for Testing 

Laboratories 

In accordance with section 14 of the 

CPSA, all children’s products that are 

subject to a children’s product safety 

rule must be tested by a CPSC-accepted 

third party conformity assessment body 

(i.e., testing laboratory) for compliance 

with applicable children’s product 

safety rules. Testing laboratories that 

want to conduct this testing must meet 

the NOR pertaining to third party 

conformity testing. NORs have been 

codified for existing rules at 16 CFR part 

1112. Consequently, the Commission 

finalizes an amendment to 16 CFR part 

1112 that establishes an NOR for those 

testing laboratories that want to test for 

compliance with the bouncers final rule. 

This section assesses the impact of the 

amendment on small laboratories. 

A FRFA was conducted as part of the 

promulgation of the original 1112 rule 

(78 FR 15836, 15855–58) as required by 

the RFA. Briefly, the FRFA concluded 

that the accreditation requirements 

would not have a significant adverse 

impact on a substantial number of small 

laboratories because no requirements 

were imposed on laboratories that did 

not intend to provide third party testing 

services. The only laboratories that were 

expected to provide such services were 

those that anticipated receiving 

sufficient revenue from the mandated 

testing to justify accepting the 

requirements as a business decision. 

Based on similar reasoning, amending 

the rule to include the NOR for the 

bouncer standard will not have a 

significant adverse impact on small 

laboratories. Moreover, based upon the 

number of laboratories in the United 

States that have applied for CPSC 

acceptance of the accreditation to test 

for conformance to other juvenile 

product standards, we expect that only 

a few laboratories will seek CPSC 

acceptance of their accreditation to test 

for conformance with the infant bouncer 

seat standard. Most of these laboratories 

will have already been accredited to test 

for conformance to other juvenile 

product standards, and the only costs to 

them would be the cost of adding the 

bouncer standard to their scope of 

accreditation, a cost that test 

laboratories have indicated is extremely 

low when they are already accredited 

for other section 104 rules. As a 

consequence, the Commission certifies 

that the NOR for the infant bouncer seat 

standard will not have a significant 

impact on a substantial number of small 

entities. 

XI. Environmental Considerations 

The Commission’s regulations address 

whether the agency is required to 

prepare an environmental assessment or 

an environmental impact statement. 

Under these regulations, a rule that has 

‘‘little or no potential for affecting the 

human environment,’’ is categorically 

exempt from this requirement. 16 CFR 

1021.5(c)(1). The final rule for bouncer 

seats falls within the categorical 

exemption. 

XII. Paperwork Reduction Act 

The final rule for infant bouncer seats 

contains information collection 

requirements that are subject to public 

comment and review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The preamble to 

the proposed rule (80 FR at 63181–82) 

discussed the information collection 

burden of the proposed rule and 

specifically requested comments on the 

accuracy of our estimates. OMB has 

assigned control number 3041–0174 to 

this information collection. We did not 

receive any comment regarding the 

information collection burden of the 

proposal. However, the final rule makes 

modifications regarding the information 

collection burden because the number 

of estimated manufacturers subject to 

the information collection burden is 

now estimated at 23 manufacturers 

rather than the 22 manufacturers 

initially estimated in the proposed rule. 

Accordingly, the estimated burden of 

this collection of information is 

modified 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 

1229 ..................................................................................... 23 4 92 1 92 

Our estimate is based on the 

following: 

Section 8.1 of ASTM F2167–17 

requires that all infant bouncer seats 

and their retail packaging be 

permanently marked or labeled as 

follows: The manufacturer, distributor, 

or seller name, place of business (city, 

state, mailing address, including zip 

code), and telephone number; and a 

code mark or other means that identifies 

the date (month and year as a minimum) 

of manufacture. 

CPSC is aware of 23 firms that supply 

bouncer seats in the U.S. market. For 

PRA purposes, we assume that all 23 

firms use labels on their products and 

on their packaging already. All firms 

will need to make some modifications to 

their existing labels. We estimate that 

the time required to make these 

modifications is about 1 hour per 

model. Each of the 23 firms supplies an 

average of four different models of 

bouncer seats. Therefore, we estimate 

the burden hours associated with labels 

to be 92 hours annually (1 hour × 23 

firms × 4 models per firm = 92 hours 

annually). 

We estimate the hourly compensation 

for the time required to create and 

update labels is $33.58 (U.S. Bureau of 

Labor Statistics, ‘‘Employer Costs for 

Employee Compensation,’’ March 2017, 

Table 9, total compensation for all sales 

and office workers in goods-producing 

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

ncs/). Therefore, we estimate the annual 

cost to industry associated with the 

labeling requirements in the final rule to 

be approximately $3,089 ($33.58 per 

hour × 92 hours = $3,089.36). This 

collection of information does not 

require operating, maintenance, or 

capital costs. 

In compliance with the Paperwork 

Reduction Act of 1995 (44 U.S.C. 

3507(d)), we have submitted the 

information collection requirements of 

this final rule to the OMB. 

XIII. Preemption 

Section 26(a) of the CPSA, 15 U.S.C. 

2075(a), provides that when a consumer 

product safety standard is in effect and 

applies to a product, no state or political 

subdivision of a state may either 

establish or continue in effect a 

requirement dealing with the same risk 

of injury unless the state requirement is 

identical to the federal standard. Section 

26(c) of the CPSA also provides that 

states or political subdivisions of states 

may apply to the Commission for an 

exemption from this preemption under 


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43480 Federal Register / Vol. 82, No. 179 / Monday, September 18, 2017 / Rules and Regulations 

certain circumstances. Section 104(b) of 

the CPSIA refers to the rules to be 

issued under that section as ‘‘consumer 

product safety rules.’’ Therefore, the 

preemption provision of section 26(a) of 

the CPSA applies to this final rule 

issued under section 104. 

XIV. Amendment to 16 CFR Part 1112 

To Include NOR for Bouncer Seat 

Standard 

The CPSA establishes certain 

requirements for product certification 

and testing. Products subject to a 

consumer product safety rule under the 

CPSA, or to a similar rule, ban, standard 

or regulation under any other act 

enforced by the Commission, must be 

certified as complying with all 

applicable CPSC-enforced requirements. 

15 U.S.C. 2063(a). Certification of 

children’s products subject to a 

children’s product safety rule must be 

based on testing conducted by a CPSCaccepted third party conformity 

assessment body. Id. 2063(a)(2). The 

Commission must publish an NOR for 

the accreditation of third party 

conformity assessment bodies to assess 

conformity with a children’s product 

safety rule to which a children’s product 

is subject. Id. 2063(a)(3). The Safety 

Standard for Infant Bouncer Seats, to be 

codified at 16 CFR part 1229, is a 

children’s product safety rule that 

requires the issuance of an NOR. 

The Commission published a final 

rule, Requirements Pertaining to ThirdParty Conformity Assessment Bodies, 78 

FR 15836 (March 12, 2013), which is 

codified at 16 CFR part 1112 (referred to 

here as part 1112). Part 1112 became 

effective on June 10, 2013 and 

establishes requirements for 

accreditation of third-party conformity 

assessment bodies (or laboratories) to 

test for conformance with a children’s 

product safety rule in accordance with 

section 14(a)(2) of the CPSA. Part 1112 

also codifies a list of all of the NORs 

that the CPSC had published at the time 

part 1112 was issued. All NORs issued 

after the Commission published part 

1112, such as the standard for bouncer 

seats, require the Commission to amend 

part 1112. Accordingly, the Commission 

is now amending part 1112 to include 

the standard for infant bouncer seats in 

the list of other children’s product 

safety rules for which the CPSC has 

issued NORs. 

Laboratories applying for acceptance 

as a CPSC-accepted third-party 

conformity assessment body to test to 

the new standard for infant bouncer 

seats would be required to meet the 

third-party conformity assessment body 

accreditation requirements in 16 CFR 

part 1112, Requirements Pertaining to 

Third-Party Conformity Assessment 

Bodies. When a laboratory meets the 

requirements as a CPSC-accepted thirdparty conformity assessment body, the 

laboratory can apply to the CPSC to 

have 16 CFR part 1229, Safety Standard 

for Infant Bouncer Seats, included in its 

scope of accreditation of CPSC safety 

rules listed for the laboratory on the 

CPSC Web site at: www.cpsc.gov/ 

labsearch. 

As required by the RFA, staff 

conducted a FRFA when the 

Commission issued the part 1112 rule 

(78 FR 15836, 15855–58). Briefly, the 

FRFA concluded that the accreditation 

requirements would not have a 

significant adverse impact on a 

substantial number of small test 

laboratories because no requirements 

were imposed on test laboratories that 

did not intend to provide third-party 

testing services. The only test 

laboratories that were expected to 

provide such services were those that 

anticipated receiving sufficient revenue 

from the mandated testing to justify 

accepting the requirements as a business 

decision. Moreover, a test laboratory 

would only choose to provide such 

services if it anticipated receiving 

revenues sufficient to cover the costs of 

the requirements. 

Based on similar reasoning, amending 

16 CFR part 1112 to include the NOR for 

the infant bouncer seats standard will 

not have a significant adverse impact on 

small test laboratories. Moreover, based 

upon the number of test laboratories in 

the United States that have applied for 

CPSC acceptance of accreditation to test 

for conformance to other mandatory 

juvenile product standards, we expect 

that only a few test laboratories will 

seek CPSC acceptance of their 

accreditation to test for conformance 

with the infant bouncer seats standard. 

Most of these test laboratories will have 

already been accredited to test for 

conformity to other mandatory juvenile 

product standards, and the only costs to 

them would be the cost of adding the 

infant bouncer seats standard to their 

scope of accreditation. For these 

reasons, the Commission certifies that 

the NOR amending 16 CFR part 1112 to 

include the infant bouncer seats 

standard will not have a significant 

impact on a substantial number of small 

entities. 

List of Subjects 

16 CFR Part 1112 

Administrative practice and 

procedure, Audit, Consumer protection, 

Incorporation by reference, Reporting 

and recordkeeping requirements, Third 

party conformity assessment body. 

16 CFR Part 1229 

Bouncer seats, Chairs, Consumer 

protection, Imports, Incorporation by 

reference, Infants and children, 

Labeling, Law enforcement, Seats, and 

Toys. 

For the reasons discussed in the 

preamble, the Commission amends title 

16 of the Code of Federal Regulations 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: 15 U.S.C. 2063; Pub. L. 110– 

314, section 3, 122 Stat. 3016, 3017 (2008). 

■ 2. Amend § 1112.15 by adding 

paragraph (b)(42) to read as follows: 

§ 1112.15 When can a third party 

conformity assessment body apply for 

CPSC acceptance for a particular CPSC rule 

and/or test method? 

* * * * * 

(b) * * * 

(42) 16 CFR part 1229, Safety 

Standard for Infant Bouncer Seats. 

* * * * * 

■ 3. Add part 1229 to read as follows: 

PART 1229—SAFETY STANDARD FOR 

INFANT BOUNCER SEATS 

Sec. 

1229.1 Scope. 

1229.2 Requirements for infant bouncer 

seats. 

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

Stat. 3016 (15 U.S.C. 2056a). 

§ 1229.1 Scope. 

This part establishes a consumer 

product safety standard for infant 

bouncer seats. 

§ 1229.2 Requirements for infant bouncer 

seats. 

(a) Except as provided in paragraph 

(b) of this section, each infant bouncer 

seat must comply with all applicable 

provisions of ASTM F2167–17, 

Standard Consumer Safety Specification 

for Infant Bouncer Seats, approved on 

June 1, 2017. The Director of the Federal 

Register approves this incorporation by 

reference in accordance with 5 U.S.C. 

552(a) and 1 CFR part 51. You may 

obtain a copy from ASTM International, 

100 Bar Harbor Drive, P.O. Box 0700, 

West Conshohocken, PA 19428; http:// 

www.astm.org/cpsc.htm. You may 

inspect a copy at the Office of the 

Secretary, U.S. Consumer Product 

Safety Commission, Room 820, 4330 

East West Highway, Bethesda, MD 

20814, telephone 301–504–7923, or at 


sradovich on DSKBBY8HB2PROD with RULES
Federal Register / Vol. 82, No. 179 / Monday, September 18, 2017 / Rules and Regulations 43481 

the National Archives and Records 

Administration (NARA). For 

information on the availability of this 

material at NARA, call 202–741–6030, 

or go to: www.archives.gov/federalregister/cfr/ibr-locations.html. 

(b) Comply with ASTM F2167–17 

with the following additions or 

exclusions: 

(1) Instead of complying with section 

7.11.3.1 of ASTM F2167–17, comply 

with the following: 

(i) 7.11.3.1 Visibility With CAMI 

Dummy Restrained in Seat—While 

standing in front of the product with the 

Newborn CAMI dummy installed, verify 

that the required warnings are visible 

and placed above an imaginary 

horizontal line that crosses through the 

junctions of under arm and side of the 

torso armpits on both left and right and 

not obscured by any part of the dummy 

(as shown in paragraph (b)(1)(ii), ‘‘Fig. 

10’’). 

(ii) Fig. 10: CAMI Dummy Restrained 

in Seat; Allowable area for warning 

label placement starts from the dotted 

line that crosses the junctions of 

underarm and both sides of the torso. 

(2) In section 8.5.1.1 of ASTM F2167– 

17, replace the warning statement 

‘‘ALWAYS use restraints. Adjust to fit 

snugly’’ with ‘‘ALWAYS use restraints 

and adjust to fit snugly, even if baby 

falls asleep.’’ 

(3) In section 8.5.2.1 of ASTM F2167– 

17, replace the warning statement 

‘‘ALWAYS use restraints. Adjust to fit 

snugly’’ with ‘‘ALWAYS use restraints 

and adjust to fit snugly, even if baby 

falls asleep.’’ 

(4) In section 8.5.3 of ASTM F2167– 

17, replace the reference to ‘‘Figs. 10 

and 11’’ with ‘‘Figs. 11 and 12.’’ 

(5) In section 9.2.1 of ASTM F2167– 

17: 

(i) Replace the reference to ‘‘Fig. 12’’ 

with ‘‘Fig. 13.’’ 

(ii) Replace Fig. 10 with paragraph 

(b)(5)(iii), ‘‘Fig. 11’’. 

(iii) Fig. 11: Fall Hazard Warning. 


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(iv) Replace Fig. 11 with paragraph 

(b)(5)(v), ‘‘Fig. 12’’. 

(v) Fig. 12: Suffocation Hazard 

Warning. 

(vi) Replace Fig. 12 with paragraph 

(b)(5)(vii), ‘‘Fig. 13’’. 

(vii) Fig. 13: Instruction Warning 

Statements. 

(6) In section 9.2.2 of ASTM F2167– 

17, replace the reference to ‘‘Fig. 12’’ 

with ‘‘Fig. 13.’’ 

Alberta E. Mills, 

Acting Secretary, Consumer Product Safety 

Commission. 

[FR Doc. 2017–19255 Filed 9–15–17; 8:45 am] 

BILLING CODE 6355–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 510, 520, 522, 524, and 

558 

[Docket No. FDA–2017–N–0002] 

New Animal Drugs; Approval of New 

Animal Drug Applications; Change of 

Sponsor’s Address 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; technical 

amendments. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

amending the animal drug regulations to 

reflect application-related actions for a 

new animal drug application (NADA) 

and abbreviated new animal drug 

applications (ANADAs) during March 

and April 2017. FDA is also informing 

the public of the availability of 

summaries of the basis of approval and 

of environmental review documents, 

where applicable. The animal drug 

regulations are also being amended to 

reflect a change of a sponsor’s address 

and to make technical amendments to 

improve the accuracy of the regulations. 

DATES: This rule is effective September 

18, 2017. 


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