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The unique features of the side stick
must therefore be demonstrated through
flight and simulator tests to have
suitable handling and control
characteristics when considering the
following:
1. The handling-qualities tasks and
requirements of the Airbus Model
A321neo XLR airplane special
conditions, and other 14 CFR part 25
requirements for stability, control, and
maneuverability, including the effects of
turbulence.
2. General ergonomics: Armrest
comfort and support, local freedom of
movement, displacement angle
suitability, and axis harmony.
3. Inadvertent input in turbulence.
4. Inadvertent pitch-roll crosstalk.
The FAA Handling Qualities Rating
Method (HQRM) of Appendix E of the
Flight Test Guide for Certification of
Transport Category Airplanes, AC 25–
7D, may be, but is not required to be,
used to show compliance.
These special conditions contain the
additional safety standards that the
Administrator considers necessary to
establish a level of safety equivalent to
that established by the existing
airworthiness standards.
Applicability
As discussed above, these special
conditions apply to Airbus Model
A321neo XLR airplanes. Should Airbus
apply later for a change to the type
certificate to include another model
incorporating the same novel or unusual
design feature, the special conditions
would apply to that model as well.
Conclusion
This action affects only certain novel
or unusual design features on one model
series of airplanes. It is not a rule of
general applicability.
List of Subjects in 14 CFR Part 25

The authority citation for these
special conditions is as follows:

The Special Conditions

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BILLING CODE 4910–13–P

CONSUMER PRODUCT SAFETY
COMMISSION
16 CFR Part 1270
[CPSC Docket No. CPSC–2013–0022]

Safety Standard for Adult Portable Bed
Rails

The U.S. Consumer Product
Safety Commission (Commission or
CPSC) has determined that there is an
unreasonable risk of injury and death
associated with entrapment and other
hazards from adult portable bed rails
(APBRs). CPSC has identified 284 fatal
incidents related to entrapment by
APBRs between January 2003 and
December 2021. To address the risk, the
Commission is promulgating a rule
under the Consumer Product Safety Act
(CPSA) to require that APBRs meet the
requirements of the existing voluntary
standard for APBRs, with modifications.
CPSC estimates that the final rule will

SUMMARY:

Authority: 49 U.S.C. 106(f), 106(g), 40113,
44701, 44702, 44704.

Accordingly, pursuant to the
authority delegated to me by the
Administrator, the following special
conditions are issued as part of the type
certification basis for Airbus Model
A321neo XLR airplanes.
(a) Pilot Strength. In lieu of the
‘‘strength of pilots’’ limits of § 25.143(d)
for pitch and roll, and in lieu of the
specific pitch force requirements of

Jkt 259001

[FR Doc. 2023–15466 Filed 7–20–23; 8:45 am]

Consumer Product Safety
Commission.
ACTION: Final rule.

Authority Citation

18:12 Jul 20, 2023

Issued in Kansas City, Missouri, on July 17,
2023.
Patrick R. Mullen,
Manager, Technical Policy Branch, Policy and
Standards Division, Aircraft Certification
Service.

AGENCY:

Aircraft, Aviation safety, Reporting
and recordkeeping requirements.

VerDate Sep<11>2014

§§ 25.145(b) and 25.175(d), the
following applies:
The applicant must show that the
temporary and maximum prolonged
force levels for the side-stick controllers
are suitable for all expected operating
conditions and configurations, whether
normal or non-normal.
(b) Controller Coupling. The
electronic side-stick controller coupling
design must provide for corrective and/
or overriding control inputs by either
pilot with no unsafe characteristics.
Annunciation of controller status must
be provided and must not be confusing
to the flightcrew.
(c) Pilot Control. The applicant must
show by flight tests that the use of sidestick controllers does not produce
unsuitable pilot-in-the-loop control
characteristics when considering
precision path control tasks and
turbulence. In addition, pitch and roll
control-force sensitivity and
displacement sensitivity must be
compatible, so that normal inputs on
one control axis will not cause
significant unintentional inputs on the
other.

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provide up to $298 million per year in
societal benefits, while the costs
associated with the rule’s requirements
are expected to be approximately $2
million per year.
The rule is effective on August
21, 2023. The incorporation by reference
of the publication listed in this rule is
approved by the Director of the Federal
Register as of August 21, 2023.

DATES:

Will
Cusey, Small Business Ombudsman,
U.S. Consumer Product Safety
Commission, 4330 East West Highway,
Bethesda, MD 20814; telephone (301)
504–7945 or (888) 531–9070; email:
[email protected].

FOR FURTHER INFORMATION CONTACT:

SUPPLEMENTARY INFORMATION:

I. Background and Statutory Authority
In 2013, the CPSC received two
requests to initiate rulemaking
proceedings under the Consumer
Product Safety Act (CPSA) to address an
unreasonable risk of injury associated
with APBRs. Gloria Black, the National
Consumer Voice for Quality Long-Term
Care, Consumer Federation of America,
and 60 other organizations submitted
one request; Public Citizen Health
Research Group submitted the other
request. Collectively, the petitioners
stated that many of the deaths and
injuries involving APBRs result from
asphyxiation caused by entrapment
within openings of the APBR rail or
between the rail and the mattress or bed
frame. The petitioners requested that the
CPSC initiate rulemaking proceedings
under section 8 of the CPSA to ban all
APBRs. Alternatively, petitioners
requested that the Commission initiate a
rulemaking under section 9 of the CPSA
to promulgate mandatory standards,
including warning labels, to reduce the
unreasonable risk of asphyxiation and
entrapment posed by APBRs. Petitioners
also requested action under section
27(e) of the CPSA to require
manufacturers of APBRs to provide
performance and technical data
regarding the safety of their products.
The CPSC docketed the petition
requests as a single petition: Petition CP
13–1, Petition Requesting a Ban or
Standard on APBRs under the CPSA. On
June 4, 2013, the Commission published
a notice in the Federal Register seeking
public comment on the petition. 78 FR
33393. Also in 2013, ASTM
International (ASTM) formed the ASTM
F15.70 subcommittee to begin
developing a voluntary standard for
APBRs.
On April 23, 2014, staff sent a briefing
package on APBRs to the Commission

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(Staff’s 2014 briefing package).1 In that
briefing package, staff recommended the
Commission defer a decision on the
petition until a voluntary standard for
APBRs was developed and evaluated by
staff. On April 29, 2014, the
Commission voted to defer the petition
pending ASTM’s further work on a
voluntary standard.
On April 28, 2015, the Commission
voted again to defer a decision on the
petition to allow the ASTM voluntary
standard development process
additional time to continue. Throughout
this period, staff participated in the
ASTM F15.70 subcommittee to develop
the voluntary standard for APBRs. In
August 2017, ASTM published the
voluntary standard, ASTM F3186–17,
Standard Specification for Adult
Portable Bed Rails and Related
Products.
On July 15, 2020, staff provided the
Commission its review of ASTM F3186–
17 (Staff’s 2020 briefing package).2 Staff
indicated that ASTM F3186–17 would
adequately address the hazards
identified in the known incident reports
if there were certain modifications to
the labeling, warning statements, and
instructional literature requirements
and to physical test requirements.
However, when staff assessed
compliance to the voluntary standard,
staff found no market compliance with
the voluntary standard.
In June 2020, CPSC’s Office of
Compliance sent a letter to 19 known
APBR manufacturers, urging industry
members to stop manufacturing,
distributing, and selling APBRs that do
not comply with ASTM F3186–17. Staff
also continued to engage actively at the
ASTM F15.70 subcommittee meetings.
Staff presented and explained its testing
results to the subcommittee members,
provided the subcommittee with
Compliance’s letter to industry,
supplied updated incident data for the
subcommittee’s review, and participated
as technical experts on all subcommittee
task groups.
On March 9, 2022, staff sent to the
Commission another briefing package
regarding ASTM F3186–17 (Staff’s 2022
briefing package).3 That briefing
package updated the Staff’s 2020
briefing package with incident data that
1 Available at: https://www.cpsc.gov/s3fs-public/
pdfs/foia_PetitionCP131RequestforBanorStandard
forAdultPortableBedRail.pdf.
2 Available at: https://www.cpsc.gov/s3fs-public/
Update%20on%20Peititon%20CP%2013-1%20%20Requesting%20a%20Ban%20or
%20Mandatory%20Standard%20on%20Adult
%20Portable%20Bed%20Rails.pdf?kiDixW
5Z7x9xcOqjxSeS3QpvspdfQMBY.
3 Available at: https://www.cpsc.gov/s3fs-public/
Petition-Requesting-a-Ban-or-Standard-on-AdultPortable-Bed-Rails-Petition-CP-13-1.pdf.

VerDate Sep<11>2014

18:12 Jul 20, 2023

Jkt 259001

included all known APBR safety
incidents from January 2003 through
September 2021. In addition, Staff’s
2022 briefing package discussed the
results of the two rounds of testing staff
had conducted on APBRs, and the
continuing lack of compliance with
ASTM’s voluntary standard. Staff
recommended that the Commission
grant the petition and direct staff to
prepare a notice of proposed rulemaking
(NPR) to address the entrapment
hazards associated with APBRs. On
March 16, 2022, the Commission voted
to grant Petition CP 13–1 and directed
staff to proceed with a draft NPR.
On September 21, 2022, staff sent the
Commission an NPR briefing package
for APBRs.4 On October 13, 2022, the
Commission voted to publish the NPR
for APBRs in the Federal Register. On
November 9, 2022, the Commission
published its NPR in the Federal
Register, determining preliminarily that
there is an unreasonable risk of injury
and death associated with entrapment
hazards from APBRs. To address those
risks, the Commission proposed a rule
under the CPSA that would require
APBRs to meet the requirements of the
ASTM F3186–17 voluntary standard,
with modifications. 87 FR 67586. The
Commission received seven written
comments regarding the NPR. Although
the Commission offered an opportunity
for interested parties to present oral
comments on the NPR, the Commission
did not receive any requests to provide
oral comments.
In this final rule, the Commission
determines that APBRs pose an
unreasonable risk of injuries and deaths
associated with entrapment hazards.5
To address this risk, the Commission
adopts ASTM F3186–17, with
modifications, to improve the safety of
APBRs. The information discussed in
this preamble is derived primarily from
CPSC staff’s briefing package for the
NPR and briefing package for the final
rule (staff’s final rule briefing package).6
4 Available at: https://www.cpsc.gov/s3fs-public/
ProposedRuleSafetyStandard
forAdultPortableBedRails.pdf?VersionId=
Ypa89Iczh13C40Tq7EJRSMDZoatChf1.
5 On July 5, 2023, the Commission voted 4–0 to
approve this document. Chair Hoehn-Saric and
Commissioner Trumka issued statements in
connection with their votes available at: https://
www.cpsc.gov/About-CPSC/Chairman/AlexanderHoehn-Saric/Statement/Statement-of-ChairAlexander-Hoehn-Saric-on-Issuance-of-a-FinalSafety-Standard-for-Adult-Portable-Bed-Rails and
https://www.cpsc.gov/About-CPSC/Commissioner/
Richard-Trumka/Statement/CPSC-Finalizes-RockSolid-New-Safety-Rule-for-Adult-Bedrails-SavingLives-and-300M-a-Year-in-Costs-to-Americans.
6 Available at: https://www.cpsc.gov/s3fs-public/
Final-Rule-Safety-Standard-for-Adult-Portable-BedRails.pdf?VersionId=CUfr4q0N1VaGv2o8jnGyQzii
Wcg8qfu3.

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46959

This final rule is authorized by the
CPSA, 15 U.S.C. 2051–2084. Section
7(a) of the CPSA authorizes the
Commission to promulgate a mandatory
consumer product safety standard that
sets forth performance or labeling
requirements for a consumer product if
such requirements are reasonably
necessary to prevent or reduce an
unreasonable risk of injury. 15 U.S.C.
2056(a). Section 9 of the CPSA specifies
the procedure that the Commission
must follow to issue a consumer
product safety standard under section 7
of the CPSA. In accordance with section
9, the Commission is issuing this final
rule for APBRs.
According to section 9(f)(1) of the
CPSA, before promulgating a consumer
product safety rule the Commission
must consider, and make appropriate
findings to be included in the rule, on
the following issues:
• The degree and nature of the risk of
injury that the rule is designed to
eliminate or reduce;
• The approximate number of
consumer products subject to the rule;
• The need of the public for the
products subject to the rule and the
probable effect the rule will have on
utility, cost, or availability of such
products; and
• Any means to achieve the objective
of the rule while minimizing adverse
effects on competition, manufacturing,
and commercial practices.
15 U.S.C. 2058(f)(1).
Under section 9(f)(3) of the CPSA, to
issue a final rule, the Commission must
find that the rule is ‘‘reasonably
necessary to eliminate or reduce an
unreasonable risk of injury associated
with such product’’ and that issuing the
rule is in the public interest. Id.
2058(f)(3)(A) and (B). Additionally, if a
voluntary standard addressing the risk
of injury has been adopted and
implemented, the Commission must
find that:
• The voluntary standard is not likely
to eliminate or adequately reduce the
risk of injury, or
• Substantial compliance with the
voluntary standard is unlikely.
Id. 2058(f)(3)(D). The Commission also
must find that expected benefits of the
rule bear a reasonable relationship to its
costs and that the rule imposes the least
burdensome requirements that would
adequately reduce the risk of injury. Id.
2058(f)(3)(E) and (F).
II. The Subject Products
Several types of bed rails under CPSC
jurisdiction are available to consumers.7
7 Information on adult bed rails regulated by the
U.S. Food and Drug Administration (FDA) is

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Federal Register / Vol. 88, No. 139 / Friday, July 21, 2023 / Rules and Regulations

ASTM F3186–17 (section 1.2) describes
‘‘portable bed rails and related
products’’ as products installed by
consumers and ‘‘not designed as part of
the bed by the bed manufacturer.’’

Generally, APBRs within CPSC’s
jurisdiction include products that are
installed or used alongside a bed by
consumers and are intended to reduce
the risk of falling from the bed, assist

the consumer in repositioning in the
bed, or assist the consumer in
transitioning into or out of the bed.
Figure 1 below shows four common
types of APBRs.

Because of the similarity in design
and means of attachment to the side of
the bed, products intended for both
types of uses can present the same
potential entrapment hazards, as
discussed in section III of this preamble.
In September and October 2021, CPSC
staff conducted an online search that
identified 12 firms supplying 65 distinct
APBR models. Retail prices for the
identified APBR models ranged from
$38 to $275. Based on an interview with
one APBR manufacturer’s representative
and market information from the
identified APBR models, CPSC staff
estimates that in 2021, the mean retail
price was $50 per APBR; total market
revenues were approximately $9
million; and the number of APBRs sold
that year was approximately 180,000
units. See Tab C of the staff’s briefing
package for the final rule for additional
details.

III. Risk of Injury

incidents were identified from death
certificates, medical examiner reports,
or coroner reports. Death certificate data
often have lag time of approximately
two to three years from the initial date
of reporting. As the APBR data in
CPSRMS are heavily reliant on death
certificates, data collection is ongoing
and incident data for 2020 and 2021
should be considered incomplete and
likely to increase.
The remaining incidents were
extracted from various sources
including newspaper clippings,
consumer reports, and manufacturer
and retailer reports to CPSC. These
documents contain limited information
on incident scenarios. The age range of
victims in the 305 fatal incidents for
which age was reported was 14 to 103
years. More than 75 percent of the
incident victims were age 70 or older,
and almost 80 percent of the reported
fatalities involved victims 70 or older.

available at: www.fda.gov/medical-devices/bed-railsafety/safety-concerns-about-bed-rails. FDA
regulations do not reference ‘‘bed rails’’ or ‘‘bed
handles;’’ rather, they refer to ‘‘movable and
latchable side rails.’’ See 21 CFR 880.5100,
880.5110, 880.5120. Bed rails that are an accessory

or appurtenance to regulated hospital beds are
considered by the FDA to have a medical purpose
and to be devices subject to FDA jurisdiction.
APBRs intended for use with a non-FDA regulated
bed and that are not otherwise a medical device fall
under the CPSC’s jurisdiction regardless of the

VerDate Sep<11>2014

18:12 Jul 20, 2023

Jkt 259001

In the NPR proceeding, CPSC staff
summarized the data on deaths and
injuries involving APBRs. See Tab A:
Division of Hazard Analysis: Directorate
for Epidemiology (EPHA) of the staff
NPR briefing package. In particular, staff
reviewed Consumer Product Safety Risk
Management System (CPSRMS) injury
cases and National Electronic Injury
Surveillance System (NEISS) injury
cases that occurred in the period from
January 1, 2003, through December 31,
2021. The Commission received no
comments on that analysis. The final
regulatory analysis is substantively the
same as the preliminary analysis.
A. CPSRMS Reports
Staff identified a total of 332 incident
reports for the period January 2003 to
December 2021. Of these, 310 were
reports of fatalities, and 22 were reports
of nonfatal incidents. Most of the

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bed’s location (e.g., long-term care facility, hospice,
or residence). ASTM F3186–17 (section 1.3) covers
both APBRs that meet the definition of a medical
device and APBRs that are not medical devices.

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Federal Register / Vol. 88, No. 139 / Friday, July 21, 2023 / Rules and Regulations
Table 1 below presents the distribution
of these APBR incidents by age.

TABLE 1—DISTRIBUTION OF REPORTED APBR-RELATED INCIDENTS BY AGE
Age group
(years)

Fatalities

Nonfatalities

Total

13–29 ...........................................................................................................................................
30–59 ...........................................................................................................................................
60–69 ...........................................................................................................................................
70–79 ...........................................................................................................................................
80–89 ...........................................................................................................................................
90 or older ...................................................................................................................................
Unknown/Unspecified ..................................................................................................................

7
30
22
47
124
75
5

0
0
0
2
2
1
17

7
30
22
49
126
76
22

Total ......................................................................................................................................

310

22

332

Source: CPSRMS (2003–2021).

Table 2 details the distribution of
these APBR-related incidents by gender.
Approximately 70 percent of all

incident victims and incident fatalities
were female.

TABLE 2—DISTRIBUTION OF REPORTED APBR-RELATED INCIDENTS BY GENDER
Gender

Fatalities

Nonfatalities

Total

Male .............................................................................................................................................
Female .........................................................................................................................................
Unknown/Unspecified ..................................................................................................................

88
221
1

7
8
7

95
229
8

Total ......................................................................................................................................

310

22

332

Source: CPSRMS (2003–2021).

Approximately 50 percent of all
APBR-related incidents and fatalities
occurred at home. Other commonly

reported locations included nursing
homes, assisted living facilities, and
residential institutions.8 Table 3 below

shows the frequency of each location
reported.

TABLE 3—DISTRIBUTION OF REPORTED APBR-RELATED INCIDENTS BY LOCATION
Location

Fatalities

Nonfatalities

Total

Home ...........................................................................................................................................
Nursing Home ..............................................................................................................................
Assisted Living Facility ................................................................................................................
Residential Institution ...................................................................................................................
Other * ..........................................................................................................................................
Unknown/Not Reported ...............................................................................................................

158
50
40
14
23
25

6
0
2
0
0
14

164
50
42
14
23
39

Total ......................................................................................................................................

310

22

332

Source: CPSRMS (2003–2021).
* Includes care home/center, foster home, group home, retirement center, adult family home and hospice.

The majority of reports, 58 percent,
indicated that the victim suffered from
at least one underlying medical

condition. Almost 34 percent were
reported to have more than one medical
condition. Table 4 below summarizes

the most common underlying medical
conditions reported.

TABLE 4—DISTRIBUTION OF REPORTED APBR-RELATED INCIDENTS BY MEDICAL CONDITION

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Condition

Fatalities

Cardiovascular disease ...............................................................................................................
Alzheimer’s/Dementia/Mental ......................................................................................................
Mobility/Paralysis/Stroke ..............................................................................................................
Parkinson’s disease .....................................................................................................................
Pulmonary disease ......................................................................................................................

Nonfatalities
87
73
20
17
11

8 All of these reported incidents occurred with
APBRs that were identified as being within the
CPSC’s jurisdiction.

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Total
0
0
0
1
0

87
73
20
18
11

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Federal Register / Vol. 88, No. 139 / Friday, July 21, 2023 / Rules and Regulations
TABLE 4—DISTRIBUTION OF REPORTED APBR-RELATED INCIDENTS BY MEDICAL CONDITION—Continued
Condition

Fatalities

Cancer .........................................................................................................................................
Cerebral palsy ..............................................................................................................................
Multiple sclerosis .........................................................................................................................
Other * ..........................................................................................................................................
Unknown/Not Reported ...............................................................................................................

7
6
5
21
123

Nonfatalities

Total

0
0
0
0
21

7
6
5
21
144

Source: Staff briefing memorandum in the staff package for the final rule.

B. NEISS Reports
Between January 2003 and December
2021, there were an estimated 79,500
injuries related to adult bed rails treated
in hospital emergency departments
(EDs) across the United States. There
was a statistically significant increasing
trend in injuries during this period. In

the vast majority of NEISS cases, there
was insufficient information available in
the case narrative for CPSC staff to
determine whether the bed rail product
involved was specifically an adult
portable bed rail, or another type of bed
rail; only one case narrative specifies
the product involved as an adult
portable bed rail. Hence, the estimates

presented in Table 5, which provides an
overview of the estimated number of
adult bed rail-related injuries per year,
may be an overestimate. An estimated
injury rate per 100,000 population has
also been calculated, based on estimates
of population ages 13 and older
provided by the U.S. Census Bureau.

TABLE 5—NEISS ESTIMATES FOR INJURIES RELATED TO ADULT BED RAILS, JANUARY 2003–DECEMBER 2021
Year
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021

Estimate

Sample size

Injury Rate 9

.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................

4,500
3,400
3,900
3,400
4,300
4,200
3,600
4,000
3,700
3,100
4,700
4,400
4,600
3,700
4,900
4,300
4,500
5,100
5,100

98
82
94
72
98
102
98
100
95
81
127
108
112
91
128
104
112
113
131

1.88
1.39
1.61
1.38
1.73
1.67
1.42
1.56
1.44
1.20
1.79
1.66
1.73
1.36
1.81
1.55
1.63
1.82
1.83

Total ......................................................................................................................................

79,500

1,946

........................

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Source: Staff briefing memorandum in staff package for the final rule.

The vast majority (88 percent) of the
ED patients were treated and released or
examined and released without
treatment, while approximately 11
percent were hospitalized or held for
observation. There was only one NEISS
case that involved a death; the
remaining 1,945 involving nonfatal
injuries. The one NEISS case involving
a death is separate from any of the
CPSRMS incidents, and it was unclear
what specific type of product was
involved.
C. Hazard Patterns
As explained in Tabs B and C of
staff’s NPR briefing package, the vast
9 Obtained by dividing NEISS estimates by U.S.
Census Bureau population estimate for the
respective year (for ages 13+). Latest data can be

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majority of incident victims in CPSRMS
were members of vulnerable
populations.
• More than 75 percent of the victims
were age 70 or older.
• More than 80 percent of the
reported fatalities involved victims ages
70 or older.
• Fifty-eight percent of victims
suffered from at least one underlying
medical condition.
• Almost 34 percent of victims were
reported to have more than one medical
condition.
Staff grouped the hazard types into
four categories based on the bed rail’s
role in the incident. The categories are

listed in order of highest to lowest
frequency.
• Rail Entrapment: There were 284
fatalities and two not-fatal injuries
related to rail entrapment. This category
includes incidents in which the victim
was caught, stuck, wedged, or trapped
between the mattress/bed and the bed
rail, between bed rail bars, between a
commode and rail, between the floor
and rail, between the night table and
rail, or between a dresser and rail. Based
on the narratives, the most frequently
injured body parts were the neck and
head.
• Falls: There were 23 deaths, one
nonfatal knee fracture, and one non-

found at: National Population by Characteristics:
2020–2021 (census.gov), https://www.census.gov/

data/tables/time-series/demo/popest/2020snational-detail.html.

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Federal Register / Vol. 88, No. 139 / Friday, July 21, 2023 / Rules and Regulations
injury incident related to falls. This
category includes incidents in which
the victim fell off the bed, fell and hit
the bed rail, or hit and fell near the bed
rail, and fell after climbing over the bed
rail.
• Structural Integrity: There were 11
incidents related to structural
component problems (weld of bed rail
broke and bed rail not sturdy). This
category includes one laceration, one
head bump, one bruise, two unspecified
injuries, and six non-injury incidents.
• Miscellaneous: There were 10
incidents with miscellaneous problems
(hanging on the bed rail after garment
got caught, hand, arm, or leg laceration,
pinched radial nerve against the bed
rail, complaint about a misleading label,
complaint about a bed rail that was
noncompliant with the ASTM standard,
and a claim against a bed rail
manufacturer about an unspecified
issue). This category includes three
deaths, three lacerations, one pinched
nerve, one unspecified injury, and two
non-injury incidents.
Rail entrapment, the most common
hazard pattern among all reported
incidents, accounted for more than 90
percent (284 of 310) of the fatal
incidents. A review of the In-Depth
Investigations (IDIs) 10 showed that the
victims were typically found with their
torso between the product and the
mattress frame, with their neck resting
on the lower bar. Three other hazard
patterns were also reported: (1) chin
resting on the bar; (2) slumped
backwards, partially suspended with the
thorax lodged and compressed in the
gap between the rail and mattress; and
(3) slumped through the bar opening.
The medical examiners in these cases
listed the cause of death as ‘‘positional
asphyxia,’’ with an additional list of
‘‘underlying factors’’ or ‘‘contributory
causes.’’ Staff’s analysis of the data
revealed that the head and neck were
the body parts most frequently
entrapped, with positional asphyxia
(neck against rail) identified as the most
common cause of death. Neck
compression, with or without airway
blockage, can result in death, even when
the body remains partially supported,
because blood vessels taking blood to
and from the brain and the carotid
sinuses are located in soft tissues of the
neck and are relatively unprotected.
The vast majority of nonfatal incident
reports (all reports except one) did not
list any underlying medical condition.
Of the 310 fatal incidents,
10 IDIs contain summaries of reports of
investigations into events surrounding productrelated injuries or incidents based on victim/
witness interviews.

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approximately 34 percent reported the
victim to have multiple medical
conditions, and approximately 58
percent of incidents reported at least
one underlying medical condition.
Preexisting chronic medical conditions
or disorders included Alzheimer’s
disease, dementia, and other mental
limitations; Parkinson’s disease;
cerebral palsy; multiple sclerosis; LeschNyhan syndrome; amyotrophic lateral
sclerosis; cancer; cardiovascular disease;
and pulmonary disease. Other
conditions included victims with stroke,
paralysis, seizures, heavy sedation, and
drug ingestion. These factors can limit
mobility or mental acuity and contribute
to the risk of death by entrapment,
because individuals with these
conditions are particularly vulnerable
and often cannot respond to the danger
and free themselves. As discussed in
Tab B of the staff’s NPR briefing
package, adult aging issues can
contribute to entrapments, including
age-related declines in muscular
strength, muscular power, motor control
and coordination, and balance.
Consumers 70 years and older, who are
the victims in most APBR-related
fatalities, are especially vulnerable to
such age-related declines.
CPSC staff identified falls as the
second most common hazard pattern
associated with APBRs, accounting for
25 incidents (8 percent), 23 of which
resulted in a fatality. Staff found that
most falls associated with APBRs
involve the victim falling against or
striking the APBR. A minority of fallrelated incidents, according to staff’s
review, involved the victim deliberately
climbing over the APBR.
IV. ASTM F3186–17
To issue a final rule under section
9(f)(3) of the CPSA if a voluntary
standard addressing the risk of injury
has been adopted and implemented, the
Commission must find that:
• The voluntary standard is not likely
to eliminate or adequately reduce the
risk of injury, or
• Substantial compliance with the
voluntary standard is unlikely.
Staff’s review of ASTM F3186–17
shows that the voluntary standard, with
modifications, is likely to eliminate or
adequately reduce the entrapment
hazards associated with ABPRs. The
Commission determines, however, that
the voluntary standard is not likely to
eliminate or adequately reduce the risk
of entrapments on ABPRs without
modifications. In addition, based on
testing of ABPRs conducted by CPSC
staff as discussed below, the
Commission determines that substantial
compliance with the voluntary standard

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46963

is unlikely. Accordingly, in the final
rule the Commission incorporates by
reference ASTM F3186–17, with
modifications, to address the
entrapment hazards associated with
APBRs.
A. Assessment of ASTM F3186–17
Performance Requirements
1. Terminology
ASTM F3186–17 establishes
performance requirements for APBRs,
including requirements for resistance to
entrapment, marking and labeling, and
instructional literature. Section 3.1.1 of
ASTM F3186–17 defines ‘‘adult portable
bed rail’’ as:
[A]n adjacent type bed rail, grab bar,
assistive bar, transfer aid, cane, or rail
(henceforth identified as the product or
products) intended by the manufacturer to be
installed on, against, or adjacent to an adult
bed. The product may vary in lengths (for
example, full, half, or partial rails, grab bar
or handle or transfer post or pole) and is
intended by the manufacturer to aid the bed
occupant in moving on the bed surface, in
entering or exiting the bed, to minimize the
possibility of falling out of bed, or for other
similar purposes. This includes similar
products that are likely to be used for these
purposes even if this is not explicitly stated
by the manufacturer. However, the standard
does not address all products that might be
so used, for example, a chair.

ASTM F3186–17 (section 3.1.2) defines
‘‘adjacent type bed rail’’ as:
[A] portable bed rail or related product in
which the guard portion (portion that an
adult would contact when rolling toward the
mattress edge) is essentially a vertical plane
or pole that is positioned against the side of
the mattress.

The Commission determines that
these definitions are appropriate for
addressing hazards associated with
APBRs that: (1) are installed or used
along the side of a bed and intended to
reduce the risk of falling from the bed;
(2) assist the consumer in repositioning
in the bed; or (3) assist the consumer in
transitioning into or out of the bed.
2. General Requirements
Section 5 of ASTM F3186–17 sets out
general requirements. Section 5.1
requires that there will be no hazardous
sharp points or edges. Section 5.2 states
that any exposed parts shall be smooth
and free from rough edges. Section 5.3
requires that products covered by the
standard that are installed on an
adjustable bed that articulates must
meet the performance requirements
when the bed is in either the flat or
articulated position. General
requirements mandating smooth edges
on exposed parts improve safety by
preventing potential lacerations or skin

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injuries from APBRs. In addition, testing
APBR products on articulating beds
allows assessment of openings that
could potentially lead to entrapment
after the bed is adjusted from the flat
position to the articulated position.
3. Performance Requirements
In addition to the general
requirements, several performance
requirements in ASTM F3186–17 are
intended to address the risk of injury
associated with APBRs. These include
requirements for assembly, structural
integrity, retention system performance,
and fall and entrapment prevention.

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a. Misassembly and Misinstallation
Effectively addressing the entrapment
hazard associated with APBRs depends
upon, among other things, consumers
assembling and installing the product
properly. ASTM F3186–17 includes
performance requirements intended to
improve the likelihood that the APBR
will be assembled and installed
properly. For example:
• Section 6.1 sets forth a requirement
for products to include a retention
system, which maintains the installed
product in position without requiring
readjustment of the components. This
retention system must be permanently
attached to the APBR once it has been
assembled and must not be removable
without the use of a tool.
• Section 6.2 includes structural
integrity requirements that require the
product to withstand testing without
deforming or changing dimensions.
• Section 6.5 requires that structural
components and retention system
components must not be capable of
being misassembled, which the standard
defines as the APBR being assembled in

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a way that appears functional but would
not meet the retention system (section
6.1), structural integrity (section 6.2),
entrapment (section 6.3), or openings
(section 6.4) requirements.
The requirement that retention
systems be permanently attached to the
APBR once it has been assembled, and
removable only with a tool, reduces the
likelihood that consumers will misplace
the retention system and increases the
likelihood that consumers, including
secondary users, will continue to use
the retention system. The requirement
that structural and retention system
components not be misassembled
reduces the risk of injury or death that
could arise from the consumer omitting
key parts of the APBR (e.g., a center rail)
during assembly, in ways that could
result in entrapment or other hazards.
b. Falls
Falls were the second most common
hazard pattern in the incident data,
accounting for 25 incidents (8 percent).
If the fall was triggered by the APBR
becoming dislodged, or if its position
shifted, then these incidents potentially
may be addressed by the voluntary
standard’s structural integrity testing
and the requirement of a permanently
attached retention system to maintain
the installed product in position.
However, some fall-related incidents
involved the victim deliberately
climbing over the APBR and this
requirement may not prevent such
consumers from falling over the bed rail.
c. Entrapment Testing
Staff identified entrapment as the
most prevalent hazard pattern among
the incidents. Section 6.3 of ASTM
F3186–17 requires products to be tested

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to assess the potential for entrapment in
four different zones. These zones
represent four of the seven sectors
identified by the FDA in its 2006
guidance document, Hospital Bed
System Dimensional and Assessment
Guidance to Reduce Entrapment (FDA,
2006), as potential areas of entrapment
in hospital bed systems.11 APBRs
present a similar entrapment hazard in
these four zones. ASTM F3186–17
specifies the FDA probe to test
entrapment zones.
Section 8.4 defines the four
entrapment zones tested under ASTM
F3186–17, which are: (1) within the
product; (2) between rail support(s) and
the bed mattress, when applicable,
under the product; (3) between the
product and the mattress; and (4)
between the underside of the end of the
product and the mattress. Entrapment
testing to ASTM F3186–17 is performed
using the anthropometric ‘‘entrapment
test probe,’’ which is the cone and
cylinder tool described in the 2006 FDA
guidance document (section 7.2). In
addition, some entrapment testing
requires using a force gauge to test the
force applied on the test probe (section
7.3). Table 6 below, describes the four
entrapment zones, with illustrations
from the 2006 FDA guidance document
of sample entrapments within each of
these zones.
11 The FDA guidance document is available at:
https://www.fda.gov/regulatory-information/searchfda-guidance-documents/hospital-bed-systemdimensional-and-assessment-guidance-reduceentrapment. (FDA, 2016) Three of the zones
identified in the FDA guidance (Zone 5, Zone 6,
and Zone 7) are not applicable to APBRs, or could
not be tested for entrapment, and therefore, they are
excluded from ASTM F3186–17.

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Staff’s review of the rail entrapment
incidents, test requirements, and test
methods showed that most of the
reported entrapment fatalities involved
one of the four zones listed above.
Specifically, staff could determine the

entrapment location of 214 of the 284
fatal incidents, and all but six of these
cases occurred in one of the four zones
of entrapment tested in ASTM F3186–
17, as shown in Table 7 below. Based
on this analysis, it is likely that most of

the 70 incidents for which there was
insufficient information to identify the
location of the entrapment also involved
one of these four zones. See staff’s
briefing packages for the NPR and the
final rule.

Number of
fatalities

Rail entrapment location

Entrapment testing location

Between APBR and mattress .....................................................
Within APBR itself ......................................................................
Against outside of APBR ............................................................
Between APBR and headboard .................................................
Unknown location .......................................................................

Zone 2, 3, or 4 ............................................................................
Zone 1 ........................................................................................
None ...........................................................................................
None (Zone 6) ............................................................................
Unknown .....................................................................................

200
8
5
1
70

Total .....................................................................................

.....................................................................................................

284

Staff’s evaluation found that APBR
entrapments predominantly occur in
Zones 1 through 4, and this is consistent
with the FDA’s finding that these four
zones accounted for about 80 percent of
hospital bed rail entrapment events
reported to the FDA. FDA’s
recommended dimensional limits for
these zones and the anthropometric test
probe serve as the basis for the
entrapment requirements of ASTM
F3186–17. CPSC’s review indicates that
the performance requirements in the
standard, which are based on identified
entrapment patterns and related
anthropometric data, would effectively
address the entrapment hazard patterns
related to APBRs with modifications,

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discussed below, to eliminate or
adequately reduce the unreasonable risk
of injury of entrapments.
d. Labeling, Warning, and Instructional
Literature Requirements
Section 9.1 of ASTM F3186–17
specifies that the labeling on the APBR
and its retail packaging must be marked
with the type and size of beds and
mattresses, including the mattress
thickness range for which the APBR is
intended. In addition, the labeling and
retail packaging on the APBR must state
the appropriate distance between an
installed APBR and the headboard or
footboard of the bed. ASTM F3186–17
requires labeling on the product and its

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retail packaging to indicate how to
correctly install the ABPR at the
specified distance from the headboard
or footboard to prevent entrapment.
This hazard is addressed by requiring
labeling on the APBR to state the
appropriate distance between an
installed APBR and the headboard or
footboard of the bed. Section 9.1 also
specifies that all on-product labels must
be permanent.
Section 9.2 establishes requirements
for warning statements that must appear
on the APBR and its retail packaging,
instructions, and digital or print
advertising. The warning statements
must be easy to understand, and any
other labels or written instructions

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TABLE 7—RAIL ENTRAPMENT INCIDENT LOCATIONS RELATIVE TO ASTM F3186–17 ENTRAPMENT ZONES

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provided along with the required
statements cannot contradict or confuse
the meaning of the required warnings or
otherwise be misleading.
Section 11 specifies requirements for
instructional literature that must
accompany APBRs. The instructions
provided must be easy to read and
understand; include assembly,
installation, maintenance, cleaning,
operation, and adjustment instructions
and warnings, where applicable;
include drawings or diagrams to provide
a better understanding of set up and
operation of the product; include
drawings that depict all the entrapment
zones; and include all warning
statements specified in section 9.2,
including warnings about product
damage or misalignment.
Although requirements for labeling,
warning, and instructional requirements
are less effective at reducing hazards
than product designs that directly
address known hazards, these
requirements in the standard improve

safety by addressing risks that may not
be eliminated through design.
Although many provisions of ASTM
F3186–17 do improve safety, for the
reasons discussed in section V. of the
preamble of the NPR, the Commission
determines that, without additional
modifications, the voluntary standard is
insufficient to eliminate or adequately
reduce the unreasonable risk of injury of
entrapments from APBRs.
B. Assessment of Compliance to ASTM
F3186–17
Staff conducted two rounds of market
compliance testing to ASTM F3186–17:
the first round in 2018 and 2019, the
second round in 2021. In both rounds,
no APBRs met all requirements of
ASTM F3186–17. All products failed at
least one critical mechanical
requirement, such as retention strap
performance, structural integrity, and
entrapment. As described in Tabs C and
D of the staff’s NPR briefing package and
the staff’s final rule briefing package, an
APBR that fails any one mechanical

performance requirement could result in
a fatal entrapment. Furthermore, all
products failed the labeling, warning,
and instructional requirements. This
section discusses market compliance
with ASTM F3186–17.
1. 2018–2019 Market Compliance
Testing
From 2018 through 2019, staff of
CPSC’s Directorate for Laboratory
Sciences, Division of Mechanical
Engineering, tested 35 randomly
selected APBR models for compliance
with ASTM F3186–17. That voluntary
standard became effective in August
2017. APBRs were purchased in 2018.
Staff found that none of the 35 sampled
products conformed to the voluntary
standard. As shown in Table 8 below,
compliance varied depending on the
relevant section of the voluntary
standard. Overall, 33 APBR models did
not meet the entrapment performance
requirements, and none of the 35
models met the labeling, warnings, or
instructional literature requirements.

TABLE 8—ASTM F3186–17, 2018 APBR MARKET COMPLIANCE TESTING RESULT SUMMARY
Section

Number of
failed
samples

Title

Failure rate
(percent)

(Of 35 Total Samples Tested)

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General Requirements:
5.1 ...........................................................................................
5.2 ...........................................................................................
5.3 ...........................................................................................
Performance Requirements:
6.1 ...........................................................................................
6.2 ...........................................................................................
6.3 ...........................................................................................
6.4 ...........................................................................................
6.5 ...........................................................................................
Labels and Warnings Requirements:
9.1 ...........................................................................................
9.2 ...........................................................................................
Instructional Literature:
11 ............................................................................................

Of the 35 APBR models staff tested,
33 failed at least one of the entrapment
requirements for the four different zones
in and around the APBR. In other
words, 94 percent of samples had at
least one major zone where a body part
could be entrapped. Furthermore, many
samples failed the entrapment
requirements in multiple zones: 14
failed the Zone 1 entrapment
requirement; 27 failed Zone 2; 11 failed
Zone 3; and 6 failed Zone 4.
Testing conducted by staff also
revealed high failure rates for several
other sections of the ASTM standard,
including the retention system
requirements (28 of 35 samples), and

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Hazardous Points/Edges ............................
Jagged Surfaces .........................................
Articulated Beds ..........................................

0
0
0

0
0
0

Retention Systems ......................................
Structural Integrity .......................................
Entrapment ..................................................
Openings .....................................................
Misassembled Products ..............................

28
15
33
0
8

80
43
94
0
23

Labeling .......................................................
Warning Statements ...................................

35
35

100
100

Instructional Literature ................................

35

100

structural integrity requirements (15 of
35 samples). These types of failures
indicate that the product may not stay
rigidly in place after installation and
will not adequately support the
consumer during normal use conditions,
such as leaning against the product. Not
meeting these requirements thus
significantly increases the likelihood of
entrapment and fall hazards.
Retention system failures occurred
when components were not
permanently attached to the product,
the retention strap permanently
deflected or detached during the free

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end pull test,12 or the retention system
did not restrain the product during
entrapment testing. Structural integrity
failures occurred when the APBR did
not extend at least 4 inches over the top
of the thickest recommended mattress,
or when fasteners loosened or detached
during testing, causing the product to
change dimensions.
All 35 models failed the labeling,
warning, and instructional literature
requirements. None of the 35 models
12 The ASTM standard does not define ‘‘freeend.’’ The final rule defines ‘‘free-end’’ as the
location on the retention system that is designed to
produce a counter force; it may be a single distinct
point or a location on a loop.

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fully met the following requirements:
section 9.1 for retail packaging and
product labels; section 9.2, which
specifies that warning statements must
appear on the product, its retail
package, and its instructions; and
section 11’s requirement to include
instructional literature with required
warning statements. None of the
samples adequately instructed
consumers how to safely install the
APBR; nor did the samples adequately
inform consumers of the known hazards
related to APBRs. Detailed testing
results are provided in Appendix A of
the staff’s NPR briefing package.
2. 2021 Market Compliance Testing
In 2021, staff conducted a second
round of product testing to ASTM
F3186–17 to determine if the additional
time and outreach efforts by staff since
2018 were sufficient for manufacturers

to increase their overall level of
compliance to the standard. A
representative total of 17 APBR
products were procured for testing:
these included all of the eight APBR
models that staff identified as new to
the market since the 2018 analysis, and
nine additional, randomly selected
models from the remaining models
available in the market. The nine
randomly selected models were
products previously identified in the
2018 analysis as available for purchase
at that time and were again included in
2021 to account for any changes to those
models that may have improved their
compliance to the voluntary standard.
The 2021 testing, like the 2018
analysis, was designed to assess overall
compliance to the voluntary standard,
with a focus on certain sections of
ASTM F3186–17 including Retention

46967

Systems, Structural Integrity,
Entrapment, Openings, Misassembled
Products, Warning Statements, and
Instructional Literature. All 17 samples
failed at least one of these performance
requirements. Detailed testing results
are provided in Appendix B of the
staff’s NPR briefing package. Because
performance testing of a sample was
stopped after failing to meet at least one
performance requirement, the data
collected may not account for all the
potential nonconformities for each
product.
Additionally, none of the 17 models
met the labeling, warnings, and
instructional literature requirements. As
shown in Table 9 below, the failure
modes of this analysis are similar to
those in the 2018 analysis, indicating
little-to-no significant change in the
market over this time.

TABLE 9—ASTM F3186–17, 2021 APBR MARKET COMPLIANCE TESTING RESULT SUMMARY
Title

Number of
failed
samples

Hazardous Points/Edges ............................
Jagged Surfaces .........................................
Articulated Beds ..........................................

0
0
........................

17
17
0

Retention Systems ......................................
Structural Integrity .......................................
Entrapment ..................................................
Openings .....................................................
Misassembled Products ..............................

13
7
14
........................
1

17
7
16
0
1

Labeling .......................................................
Warning Statements ...................................

17
17

17
17

Instructional Literature ................................

17

17

Section
General Requirements:
5.1 ...........................................................................................
5.2 ...........................................................................................
5.3 ...........................................................................................
Performance Requirements:
6.1 ...........................................................................................
6.2 ...........................................................................................
6.3 ...........................................................................................
6.4 ...........................................................................................
6.5 ...........................................................................................
Labels and Warnings Requirements:
9.1 ...........................................................................................
9.2 ...........................................................................................
Instructional Literatue:
11 ............................................................................................

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3. CPSA Section 15 Compliance Actions
2021–2022
CPSC has issued five public warnings
regarding specific APBRs that did not
comply with ASTM F3186–17. In April
2021, CPSC warned consumers to stop
using three models of APBRs
manufactured by Bed Handles, Inc.,
because the products pose an
entrapment hazard.13 Bed Handles, Inc.,
manufactured approximately 193,000
units of the bed rails, and CPSC is aware
of four entrapment deaths associated
with the product.
In December 2021, CPSC announced
voluntary recalls of APBRs
manufactured by three firms, due to the
13 Press Release (PR) #21–122, https://
www.cpsc.gov/Newsroom/News-Releases/2021/
CPSC-Warns-Consumers-to-Stop-Use-of-ThreeModels-of-Adult-Portable-Bed-Rails-Manufacturedby-Bed-Handles-Inc-Due-to-Entrapment-AsphyxiaHazard.

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entrapment hazard and risk of death by
asphyxia posed by their products:
• Drive DeVilbiss Healthcare (496,100
units, 2 deaths); 14
• Compass Health Brands (104,900
units, 3 deaths); 15 and
• Essential Medical Supply, Inc.
(272,000 units, 1 death).16
In June 2022, CPSC warned
consumers to stop using 10 models of
APBRs manufactured and sold by
Mobility Transfer Systems, Inc. from
1992 to 2021, and by Metal Tubing
14 PR #22–025, https://www.cpsc.gov/Recalls/
2022/Drive-DeVilbiss-Healthcare-Recalls-AdultPortable-Bed-Rails-After-Two-Deaths-Entrapmentand-Asphyxiation-Hazards.
15 PR #22–040, https://www.cpsc.gov/Recalls/
2022/Compass-Health-Brands-Recalls-Carex-AdultPortable-Bed-Rails-After-Three-Deaths-Entrapmentand-Asphyxiation-Hazards.
16 PR #22–039, https://www.cpsc.gov/Recalls/
2022/Essential-Medical-Supply-Recalls-AdultPortable-Bed-Rails-Due-to-Entrapment-andAsphyxia-Hazard-One-Death-Reported.

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Number of
samples
tested

USA, Inc. in 2021 and 2022. Three
entrapment deaths involving one of
these models have occurred.17 Neither
of the two manufacturers agreed to
conduct a recall. Approximately
285,000 units were manufactured.
4. Market Compliance Testing Summary
The Commission determines that,
without additional modifications as
discussed in the NPR and below, the
voluntary standard is insufficient to
eliminate or adequately reduce the
unreasonable risk of injury of
entrapments presented by APBRs.
Moreover, based on staff’s test results
showing that there is no market
compliance with the voluntary
17 PR #22–148, https://www.cpsc.gov/Newsroom/
News-Releases/2022/CPSC-Urges-Consumers-toImmediately-Stop-Use-of-Mobility-TransferSystems-Adult-Portable-Bed-Rails-Due-toEntrapment-and-Asphyxia-Hazard-Three-DeathsReported.

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standard, the Commission determines
that substantial compliance to a
voluntary adult portable bed rail safety
standard is unlikely. Accordingly, the
Commission rule incorporates by
reference, ASTM F3186–17 with
modifications, to require ABPR
manufacturers to comply with the
fundamental requirements of the
mandatory standard and thereby
improve safety.
V. Response to Comments
CPSC received seven written
comments during the NPR comment
period. The comments are available on:
www.regulations.gov, by searching
under docket number CPSC–2013–0022.
For more details about the comments
CPSC received on the NPR, see the final
rule staff briefing package. This section
describes key issues raised in the
comments and CPSC’s responses to
them.

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A. Banning APBRs
Comments: Four commenters
addressed the issue of banning APBRs.
Public Citizen urged the CPSC to
withdraw its proposed rule and instead
promulgate a rule under section 8 of the
CPSA, declaring all currently marketed
adult bed rails to be banned hazardous
products. National Center for Health
Research (NCHR), National Consumer
Voice for Quality Long-Term Care
(Consumer Voice), and California
Advocates for Nursing Home Reform
(CANHR) commented that they do not
support a ban at this time. However,
they stated that they would support a
ban on APBRs if the final rule is
adopted and proves to be ineffective in
preventing deaths and injuries resulting
from APBR entrapment.
Response: At this time there is not
sufficient evidence to support a ban on
APBRs under section 8 of the CPSA.
Under section 8 of the CPSA, to issue
a ban, the Commission must find:
• a consumer product is being, or will
be, distributed in commerce and such
consumer product presents an
unreasonable risk of injury; and
• no feasible consumer product safety
standard under this Act would
adequately protect the public from the
unreasonable risk of injury associated
with such product.
15 U.S.C. 2057. The Commission finds
the final rule, promulgated under
section 9, will adequately address the
unreasonable risk of fatal and non-fatal
injuries related to APBR entrapment.
However, after the final rule is effective,
staff will monitor data they become
available, assessing the efficacy of the
final rule.

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B. Comments on Alternatives to Using
APBRs and on Qualitative or
Quantitative Value of APBRs
Comment: Gloria Black, NCHR,
Consumer Voice, Public Citizen, and
CANHR identified several alternatives
to using APBRs, such as: bed trapezes,
adjustable beds, non-slip mattress pads,
bed exit alarms, body pillows, and
medical attendees.18 Gloria Black
specifically identified ‘‘no cost options’’
including lowering the bed or placing
the mattress on the floor to prevent falls,
placing cushioning on the floor to
prevent serious injury, and placing a
sturdy nightstand or table next to the
bed to assist individuals in getting in
and out of bed. Additionally, CANHR
stated that APBRs are ‘‘used primarily
as physical restraints for the
convenience of others, and almost
always unnecessary and in nursing
homes’’ and per ‘‘the Nursing Home
Reform Law of 1987’s prohibition of
physical restraints for the convenience
of staff, safe alternatives to prevent
injury from falls have been practiced for
decades in compliant facilities.’’
Two comments addressed the
qualitative or quantitative value of
APBRs. Sarina Martin expressed a
general concern that a ban on APBRs
will increase the risk of falls in longterm care facilities. Consumer Voice was
unaware of any qualitative or
quantitative evidence concerning the
utility that APBRs have for consumers
relative to products that might be used
as substitutes in the event APBRs are
banned. However, Consumer Voice
noted some consumers have expressed
fears that a ban could limit their ability
to leave their beds, lead to a decline in
mobility and functioning and therefore
increase their dependency, and result in
decreased quality of life due to greater
isolation.
Response: A ban on APBRs could
leave consumers without a product that
provides them with mobility and
independence. APBR products help
consumers by aiding them in safely
staying in a bed and providing them
with a safe grip for getting in/out of a
bed and repositioning while in bed.
Such products are particularly useful for
consumers who live in a personal
residence, rather than in a hospital or
care facility, as supervision or assistance
may be less readily available in a home
environment. However, considering the
number of fatal and non-fatal injuries
18 A bed trapeze is a product that consumers can
use to get in and out of bed or change position
while in bed. It typically consists of a horizontal bar
suspended from a metal frame. Bed trapezes are
typically larger than adjacent-type bed rails and are
therefore less portable.

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from APBRs, the Commission considers
the requirements for APBRs in the final
rule to be necessary to address the risks.
Consumers may choose to use
alternatives to APBRs, but while these
alternatives have been available to
consumers, many injuries and deaths
continue to occur. These alternatives
alone have not adequately reduced the
unreasonable risk of injury and death
presented by APBRs, and thus the final
rule is needed to address the identified
hazards.
C. The Effect of the Proposed Rule on
Long Term Care Facilities
Comment: Sarina Marlin expressed a
general concern regarding the effect of
the proposed rule on long-term care
facilities. Ms. Marlin asserted that data
from staff’s NPR package indicates that
a disproportionate number of recorded
fatalities associated with APBRs occur
in home settings when compared to
Long Term Care Facilities.
Response: The fatality location ratios
quoted by Ms. Marlin are drawn from
the preamble of the NPR, in which staff
identified 158, 50, 40, and 14 fatalities
associated with APBR entrapment in
homes, nursing homes, assisted living
facilities, and residential institutions,
respectively. Without knowing the level
of exposure in these different treatment
settings, one cannot infer that there are
fewer fatalities per APBR in professional
settings than in the home, or that APBRs
in professional settings do not pose
significant risk to the public, without
knowing the number of APBRs in use in
each setting. CPSC staff did not, and
does not, possess this information nor
data from which estimates of the
number of APBRs in use in each setting
may be drawn. No such information was
submitted by the commenter. However,
given that APBRs are marketed
primarily to individual consumers, staff
assesses that APBRs are more likely to
be found in homes than in professional
settings.19
The Commission disagrees with the
commenter’s assertion that an undue
impact will occur to long term care
facilities. In the NPR’s Preliminary
Regulatory Analysis, CPSC staff
considered the effect of the proposed
rule on APBR price, the dead weight
loss (the lost consumer and producer
surplus resulting from price-induced
decrease in APBR sales) associated with
the price change, cost, and net benefits.
Staff estimated the proposed rule would
increase manufacturer costs in the first
year by approximately $5.40 per APBR,
19 Professional care facilities may use a variety of
products, including APBRs and hospital bed rails,
depending on the needs of the patient.

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D. Hole Size Requirements
Comment: Louis A. Ferreira, of Stoel
Rives, LLP, representing Stander, Inc.
(Stander), a seller of APBRs, suggests
that the NPR’s proposal to regulate the
sizes of holes or slots that extend
entirely through a wall section on an
APBR is not reasonably necessary to
prevent or reduce an unreasonable risk

of injury. Stander disagreed with the
Commission’s proposal to make the
opening requirements consistent with
standards for other products such as
Children’s Portable Bed Rails and
instead suggests that the final rule
should only correct consistency errors
concerning dimensions in section 6.4 of
the voluntary standard. Stander claimed
that ‘‘the size of the holes do[es] not
increase the risk of a fall of entrapment’’
and that ‘‘[t]here is not even evidence in
the record that would support a
conclusion that finger entrapment in the
holes of an adult bed rail have ever
caused an injury.’’
Response: As reported in Tab A of the
staff briefing package for the NPR, about
7,400 of the estimated 79,500 adult bed
rail-related injuries treated in
emergency departments from 2003 to

2021 were hand or finger injuries. Of
these, about 3,400 were identified as
injuries to fingers, most of which
involved crushing or laceration.21
Section 6.4 of ASTM F3186–17
addresses the risk of finger entrapment
and laceration in small holes or
openings. Changes to this section are
necessary to correct errors and
inconsistent measurement references.
Specifically, in stating the dimensions
of the rods used to conduct testing, the
standard inaccurately refers to 13 mm as
the equivalent to 5⁄8 in. (whereas 5⁄8 in.
is approximately 16 mm). Also, while
the standard allows different
dimensions for holes or slots that do not
exceed 1⁄4 in. in depth, it refers to a
drawing depicting a hole up to ‘‘.375
(9.53 mm) deep,’’ or 3⁄8 in., shown below
in Figure 2.

Further, the proposed changes in the
NPR are necessary to adequately address
the risk of injury because the hole

dimensions referenced by the
commenter are not effective in
protecting vulnerable adult populations.

Vulnerable adults are often smaller and
more frail than other populations of
adults and are more likely to use APBR

20 Genworth Financial, Inc., estimates the
national median annual cost for a private room in
assisted care facilities and nursing homes in the

United States in 2021 at $54,000 and $108,405.
Median Cost of Nursing Home, Assisted Living, &
Home Care | Genworth.

21 NEISS data can be searched by the public
through the CPSC NEISS On-Line Query System—
https://www.cpsc.gov/cgibin/neissquery/home.aspx.

of which $4.00 is expected to be passed
on to APBR consumers (including
commercial enterprises) in the form of
higher prices. A $4.00 increase in APBR
price represents less than 0.01 percent
of the annual cost of a private room in
an assisted living facility, and
approximately half that already tiny
percentage for a private room in a
nursing home, which staff does not
consider an undue burden for these
facilities.20

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Federal Register / Vol. 88, No. 139 / Friday, July 21, 2023 / Rules and Regulations

Comment: Luis A. Ferreira,
representing Stander, suggested that
staff’s proposed entrapment test
modifications are ambiguous and
inadequate. Stander expresses concern
‘‘that the ASTM Standard with the
proposed modifications could be
misinterpreted, and a product fail the
test, not because of any unreasonable
risk posed by the bed rail, but simply
because a mattress is selected for testing
that is so soft that the probe can be
pulled beneath the bottom rail of the

APBR.’’ Stander suggests making
changes to the proposed entrapment test
requirements of the NPR.
Response: ASTM F3186–17 does not
have a specific definition for
‘‘entrapment zone.’’ Based on the
commenter’s interpretation of the
entrapment test methods, the voluntary
standard may not adequately describe
what an entrapment zone is and why it
is tested.
Each entrapment zone test addresses
specific hazard patterns that are
identified in both the FDA guidance
document as well as staff’s findings
from the incident data. The hazard
patterns associated with each
entrapment zone are described below.
• Zone 1 testing addresses head-first
entry into fully bounded openings
within the structure of the rail.
• Zone 2 testing addresses head-first
entry under the rail into any opening
between the mattress compressed by the
weight of a consumer’s head and a
section of the bedrail longer than 4.7 in.
• Zone 3 testing addresses entry of
the head into a gap between the inside
surface along the length of the rail and
the mattress compressed by the weight
of a consumer’s head.

• Zone 4 addresses neck-first
entrapment between the rail and
mattress compressed by the weight of a
consumer’s head and neck at the ends
of the rail.
We disagree with Stander’s
interpretations that entrapment zone
hazards only exist where there are
visible openings. According to the CPSC
staff’s analysis of the incident data, the
area ‘‘between the rail and mattress’’ is
the most common location for
entrapment. The hazards related to each
zone are present regardless of the
locations of the supports but are
dependent on the design of the rail in
relation to the anthropometric
dimensions of the user.
For example, per Zone 2, the known
hazard is head-first entry under the rail
in any section longer than the
anthropometric head dimension of the
entrapment test probe, which is 4.7
inches. Therefore, in Figure 3 below,
both the left and right areas should meet
Zone 2 requirements, in addition to the
other applicable tests, to ensure the
product adequately addresses the
known hazard.

Safety testing should represent known
hazard modes, including the
displacement caused by consumers
moving or pushing into the mattress or
product, which may create an opening
that was not previously visible. During
entrapment zone testing, the positioning

and application of the force via a force
gauge must be realistic and
representative of all reasonably
foreseeable scenarios of consumer
behavior. In many cases, applying the
force to the probe by attaching a force
gauge below the bottom of the rail is the

most accurate representation of the
worst case of this foreseeable hazard
scenario. Additionally, in contrast to the
current voluntary standard, entrapment
hazards are not present only in the
‘‘largest opening’’ of a product.
Entrapment hazards may exist in several

22 It is also foreseeable that children may interact
with APBRs, such as when visiting grandparents.

The NPR’s proposed modifications to the voluntary

standard would protect children without creating
any new hazards for adults.

products. The proposed changes in the
NPR align the rule with other
established children’s product
regulations that prevent hazards to a
range of finger sizes that covers both
children and adult users
simultaneously.22
The Commission therefore concludes
the language proposed in the NPR is
necessary to address the range of
foreseeable consumer exposures to
potentially hazardous holes in APBRs.
Therefore, no change will be made to
the final rule based on this comment.

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E. Proposed Entrapment Test
Modifications

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areas depending on the product
configuration and installation.
To ensure entrapment hazards are
adequately addressed, products must be
assessed in all areas that may constitute
an entrapment zone. Therefore, in
response to this comment, the
Commission has revised the language in
the final rule as follows:
• Adding a global definition for
‘‘entrapment zone’’ to the draft rule,
which will clarify what areas must be
tested.
• Removing language from the test
methodology that may have led test
personnel to unnecessarily restrict
locations and orientations of the
placement of the entrapment test probe
for testing.
• Improving instructions for test
personnel to apply forces in a manner
that is more representative of the
entrapment hazards.
F. Removing Mattress Thickness
Selection for Testers
Comment: Louis A. Ferreira,
representing Stander, suggests that the
proposed addition of section 7.1.3 of the
NPR’s proposed rule to the voluntary
standard’s requirements is not
reasonably necessary to prevent or
reduce an unreasonable risk of injury.
Staff’s proposal for this additional
section would allow testers to select for
testing a mattress that is up to 1.5 in. (38
mm) thicker or thinner than the range
specified by the manufacturer. Standard
asserts that ‘‘there is no evidence in the
record that a consumer has ever suffered
an injury because they used an adult
bed rail on the wrong size mattress.’’
Response: Mattress thickness has a
direct bearing on the entrapment
hazard. ASTM F3186–17 defines Zones
2, 3, and 4 in relation to the product and
the mattress. A mattress that is too thin
can result in larger entrapment zones,
posing a greater risk of entrapment. On
the other hand, an APBR used with a
mattress that is too thick can lead to an
APBR failing to meet the standard’s
structural integrity performance
requirement, found in section 6.2,
which states that the top of the bed rail
must extend 4 inches above the
mattress.
Staff has found that most APBR
models can be installed and adjusted
regardless of mattress thickness, and the
hazard created by using an APBR on an
incompatible mattress will not be
apparent to the typical consumer.
Therefore, it is preferable to design out
hazards rather than rely on consumers
to follow warnings and instructions.
Indeed, it is foreseeable that some
consumers will use APBRs with
mattresses that are not within the

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manufacturer’s recommended thickness
range. During APBR testing, staff found
that a mattress’s true thickness typically
differs from the thickness advertised by
the mattress manufacturer. Consumers
are unlikely to measure their mattress
prior to purchasing an APBR, or they
may not measure it accurately.
Additionally, consumers may not have
information about the mattress
thickness when they purchase APBRs
for use by another person, or for use on
a hotel or guest bed. Finally, consumers
who transfer existing APBRs to a new
mattress may not take any action to
ensure that the APBR is appropriate for
the new mattress’s thickness.
The mattress thickness variability
requirements in the final rule
anticipates these and similar foreseeable
scenarios. The requirement covers a
limited range of mattresses beyond what
is advertised to account for the known
hazards outside of the ‘‘compatible’’
range.
G. Language Modifications for Mattress
Thickness Selection
Comment: Consumer Voice notes that
language in the proposed modifications
to the voluntary standard could
potentially allow manufacturers to
avoid providing consumers a
recommended mattress thickness range
for their products. Consumer Voice
requested removing this language from
the final rule.
Response: The Commission agrees
with Consumer Voice. Section 9.1.1.3 of
the voluntary standard requires
manufacturers to list a recommended
thickness range. The final rule will
remove ‘‘If the manufacturer does not
recommend’’ and other related language
from the proposed additions to sections
6.2.1 and 7.1 of the voluntary standard
to avoid manufacturers potentially not
providing consumers a recommended
mattress thickness range for their
products.
H. Banning Retention Straps
Comment: Consumer Voice requested
staff ban the use of straps as a means of
attaching the product to a bed.
Consumer Voice asserts that the use of
straps to attach an APBR to a bed greatly
increases the risk of improper assembly
and the likelihood of harm, and that
straps can stretch and become loose
over time.
Response: Banning retention straps
would unnecessarily restrict APBR
designs. The proposed modifications to
the requirements of the standard, such
as the requirement for a warning on an
‘‘installation component,’’ will
adequately address known hazards
associated with APBRs and increase the

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likelihood of consumers installing the
retention strap. CPSC staff has not
identified any strangulation or other
hazards specifically associated with
retention straps, and therefore there is
not sufficient evidence to support
banning retention straps.
I. Modifying the Proposed Definition of
‘‘Conspicuous’’
Comment: Consumer Voice expressed
concerns that the proposed definition of
‘‘conspicuous,’’ adopted from section
3.1.3 of the voluntary standard, is too
narrow. Consumer Voice suggests
modifying the proposed definition in
the voluntary standard to increase the
requirements for visibility of warning
labels on the product. Specifically,
Consumer Voice recommends that the
definition be revised so that
‘‘conspicuous’’ labels/components be
visible to both the consumer and a
person standing near the unit from at
least two different positions.
Response: The definition of
‘‘conspicuous’’ in section 3.1.3 requires
certain labels to be visible from one
position rather than 2 positions, as
proposed by the commenter. The
commenter’s recommended alternative
definition does not provide sufficient
guidance regarding the two positions in
which warning labels would be required
to be visible, and it could foreseeably be
interpreted such that two viewing
positions are only marginally different.
Therefore, the commenter’s proposed
definition of ‘‘conspicuous’’ does not
represent a substantive improvement to
safety.
J. Adding ‘‘Conspicuous’’ to Warning
Labeling Requirements
Comment: Consumer Voice
recommended that the term
‘‘conspicuous’’ should not be deleted
from the warning label placement
requirements in section 9.2.7, as
proposed in § 1270.2(b)(18)(i) of the
NPR. Consumer Voice claimed the
removal of the word would weaken the
requirement and make the product less
safe.
Response: The warning in section
9.2.7 of ASTM F3186 is directly related
to product installation. As discussed in
the NPR briefing package, the warning
should draw attention to the installation
component and encourage its use during
installation (16 CFR part 1224, the
children’s bed rail standard, has this
same warning requiring it to be on an
‘‘installation’’ component). Therefore, it
is unnecessary for the warning on the
product to be conspicuous in the
manufacturer’s recommended use
position. Additionally, ASTM F3186–17
requires separate warnings that address

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entrapment hazards and securing the
APBR to the bed that are required to be
placed on a conspicuous component of
the product and/or packaging/
instructions. Therefore, the warning in
section 9.2.7 should be on an
installation component but is not
required to be conspicuous for the
reasons discussed above.
K. Making Compliance Testing Records
Publicly Available
Comment: Consumer Voice requested
an additional requirement that
manufacturers provide consumers with
records of compliance testing upon
request.
Response: Manufacturers and
importers of APBRs will be required to
issue a General Certificate of Conformity
(GCC) under section 14 of the CPSA and
16 CFR part 1110 for the APBR
mandatory standard. A GCC requires
manufacturers or importers to certify
that their general use products comply
with all applicable consumer product
safety rules (or similar rules, bans,
standards, or regulations) under any law
enforced by the Commission for that
product. A GCC must accompany the
applicable product or shipment of
products covered by the certificate. A
manufacturer or importer must furnish
the GCC to distributors or retailers.
Based on the available information there
is not significant evidence indicating
that the commenter’s proposed
requirement that manufacturers also
provide records of compliance testing
directly to consumers will substantially
decrease the known hazards related to
APBRs given the existing GCC
framework.
L. Reorganizing Labeling Requirements

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Comment: Consumer Voice argued
that the labeling and warning
requirements for retail packaging,
instructions, and the product labels set
out in the proposed rule are confusing
and contradictory. Consumer Voice
specifically suggested reorganizing the
labeling requirements.
Response: We do not agree with
Consumer Voice’s proposed change to
the proposed rule. The current
requirement in ASTM F3186–17, which
is included in the final rule, clearly
states the required location for each
warning.
M. Adding Labeling Requirements for
Intended Use
Comment: Consumer Voice suggested
adding labeling requirements to include
information about the intended use of
APBRs and for whom the products are
designed.

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Response: APBR manufacturers
should specify how their product(s)
function in their instructions and on
their product packaging. However,
staff’s familiarity with existing ABPRs’
marketing, packaging, labeling, and
appearance leads staff to assess that
consumers are likely to understand that
the products are designed for elderly
users and/or adult users with
disabilities/inhibited movement, so the
Commission finds that additional
recommended labeling is unnecessary.
N. Adding Email Address to Contact
Information Requirements
Comment: Consumer Voice argues
that email is an increasingly used form
of communication, and including an
email will make contacting
manufacturers more accessible for
consumers. Consumer Voice requests
that the final rule should require
manufacturers to include their email
address in addition to the other contact
information currently required.
Response: The required contact
information already in the standard is
adequate for consumers to contact the
manufacturer. We do not have any
evidence indicating that requiring an
email address will decrease known
hazards related to APBR products.
O. Adding Language to Warning
Statements
Comment: Consumer Voice suggests
adding to the language throughout the
final rule’s warning statements,
specifically by including a discussion of
the risk of ‘‘serious injury or death from
entrapment.’’
Response: Each warning clearly states
that improper use and/or installation
can lead to entrapment and death.
Therefore, no change to the final rule is
necessary based on this comment.
P. Adding Drawings in Instructional
Literature Requirements
Comment: Consumer Voice
recommends requiring manufacturers to
include drawings in the instructions
that depict potential examples of
entrapment to allow consumers to better
understand the potential hazards of
APBRs.
Response: Section 11.1 of the APBR
voluntary standard, ASTM F3186–17
includes a similar requirement and is
incorporated by reference in the final
rule. Manufacturers are required to
include drawings of all entrapment
zones (Zones 1–4). The FDA drawings
are provided as a reference in Appendix
X1.1 but manufacturers are free to use
their own illustrations should they
choose to do so.

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Q. Stockpiling
Comment: Consumer Voice and
CANHR, submitted comments in favor
of the stockpiling provision proposed in
the NPR. No comments objecting to the
proposed stockpiling provision were
submitted. Therefore, the prohibition on
stockpiling will be finalized as
proposed.
R. Effective Date
Comments: Three commenters
submitted comments regarding the
effective date. Consumer Voice and
CANHR were in favor of the 30-day
effective date. Louis A. Ferreira,
representing Stander, urged that the rule
should not prohibit Stander from selling
existing stock of APBRs that are
compliant with the ASTM F3186–17
standard.
Consumer Voice considered the 30day effective date to be appropriate and
fair, and stated that ‘‘manufacturers
should not need more than 30 days.’’
They also commented that the ASTM
standards went into effect in 2017 and
that ‘‘[f]ive years is more than enough
time to understand the standards and
take the steps necessary to comply.’’
CANHR ‘‘support[ed] the staff’s
recommendation not to issue the new
rule with an introduction time more
than 30 days’’ while also noting that the
ASTM voluntary standard has been
available to manufacturers and other
interested parties since 2017.
Stander states, ‘‘Stander has made a
significant investment to produce
product consistent with the existing
ASTM Standard’’ and ‘‘it would require
a least a year to sell its existing stock
that is compliant with the existing
ASTM Standard but not the modified
ASTM Standard.’’ Stander further states
that ‘‘[a]s the CPSC has found that the
compliance with the existing ASTM
Standard is sufficient to eliminate the
‘unreasonable’ risks posed by APBRs,
CPSC should expressly allow
manufacturers a reasonable period of
time to sell existing stock that complies
with the current ASTM Standard.’’
Stander ‘‘believes that a reasonable
period to sell its ASTM Standard
compliant stock would be one year.’’
Response: No commenter contends
that a 30-day period is insufficient for
manufacturers to come into compliance
with the final rule. However, Stander
expressed concerns regarding selling
their existing stock of APBRs. The final
rule does not prohibit Stander from
selling its existing stock that was
manufactured before publication of the
final rule in the Federal Register.
Finally, for clarity, we disagree with
Stander’s claim that ‘‘the CPSC has

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Federal Register / Vol. 88, No. 139 / Friday, July 21, 2023 / Rules and Regulations
found the compliance with the existing
ASTM Standard is sufficient to
eliminate the ‘unreasonable’ risks posed
by APBRs.’’ In the NPR, the Commission
preliminarily determined that the
combined requirements of the voluntary
standard—with the proposed
modifications that were deemed
necessary—would adequately reduce
unreasonable risk and injury associated
with APBR entrapment. 87 FR 67586.
The Commission did not find the
voluntary standard by itself sufficient to
address the unreasonable risk posed by
APBRs. That approach is unchanged for
the final rule.
VI. Description of the Final Rule
The Commission determines that
ASTM F3186–17, with modifications to
improve safety, will address all known
product hazard modes associated with
APBRs, particularly entrapment. The
provisions of the final rule are described
below.

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A. Section 1270.1—Scope, Application,
and Effective Date
Section 1270.1 provides that new part
1270 establishes a consumer product
safety standard for APBRs manufactured
after the effective date of the final rule.
This section is being finalized as
proposed.
B. Section 1270.2—Requirements for
Adult Portable Bed Rails
Section 1270.2 of the final rule sets
forth the requirements for APBRs.
Section 1270.2(a) requires each APBR to
comply with all applicable provisions of
ASTM F3186–17. Section 1270.2(a) is
being finalized as proposed.
Section 1270.2(b) provides the
requirements for APBRs in addition to
those based on ASTM F3186–17. Most
of the requirements of § 1270.2(b) are
being finalized as proposed in the NPR.
Detailed descriptions and justifications
for the proposed requirements can be
found in the preamble of the NPR and
the staff briefing package for the NPR.
Several provisions of proposed
§ 1270.2(b) have been revised in the
final rule in response to comments. For
additional information regarding the
comments that resulted in changes to
the final rule and a detailed summary of
the comments and responses see section
V. of this preamble and the staff briefing
package for the final rule. Below is a
description of the changes made from
the proposed rule to the final rule. In
addition to the changes described below
to the final rule, non-substantive
conforming, editorial edits, and changes
to numbering and cross references were
made in the final rule for consistency
and accuracy.

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1. Section 1270.2(b)(1)
A comment from APBR seller Stander
indicated that the proposed rule is
ambiguous regarding the testing of
entrapment zones. ASTM F3186–17
does not define the term ‘‘entrapment
zone.’’ The preamble of the NPR
referenced both the FDA guidance
document and incident data to explain
how the entrapment zones will be
identified, and the different ways
entrapment can occur within the
entrapment zones. However, adding a
global definition for ‘‘entrapment zone’’
to the final rule will clarify what areas
must be tested. Therefore,
§ 1270.2(b)(1)(i) of the final rule
includes a new definition for
‘‘entrapment zone,’’ which is defined as
‘‘An area, gap, or opening that can
potentially capture or restrain a person’s
body part. Hazardous openings may not
always be visible prior to testing.’’ The
three original definitions in proposed
§ 1270.2(b)(1) have been renumbered
from proposed § 1270.2(b)(1)(i) through
(iii) to § 1270.2(b)(1)(ii) through (iv) in
the final rule to account for the addition
of the new definition of entrapment
zone in § 1270.2(b)(1)(i) of the final rule.
2. Section 1270.2(b)(3)
Based on Stander’s comment that
recommended revisions to the proposed
language for mattress thickness
selection, the Commission is removing
from § 1270.2(b)(3)(i) of the final rule
language that could be interpreted as
exempting manufacturers from
including a range of compatible mattress
thicknesses, which is contradictory to
the intent of the standard.
3. Section 1270.2(b)(8)
A comment from Consumer Voice was
submitted indicating that the original
proposed language seems to create an
alternative requirement for
manufacturers that do not provide a
recommended thickness range, as
required by section 9.1.1.3 of the
voluntary standard. Based on the
comment, § 1270.2(b)(8)(i) of the final
rule adds an additional range that will
increase safety by accounting for
foreseeable differences between nominal
and actual mattress thicknesses, as well
as consumer mattress selection that
deviates from manufacturer
recommendations.
4. Section 1270.2(b)(9)
Proposed § 1270.2(b)(9) contained the
introductory instruction of ‘‘In addition
to complying with section 7.2 of ASTM
F3186–17’’, when it should have read
‘‘Instead of complying with section 7.2
of ASTM F3186–17’’. The final rule has
been revised to correct this error.

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5. Section 1270.2(b)(11) and (13)
Based on a comment from Stander,
the language in proposed
§ 1270.2(b)(11)(i) and (b)(13)(i) has been
revised in the final rule to remove
restrictions on how the probe and force
should be applied, and thereby better
represent the known hazard patterns
and ensure consistent interpretations of
the test methods. Applying the force
perpendicular to the 2.4-inch end of the
probe may not always emulate the
potential hazard of head or limb
entrapment. Therefore, the language in
§ 1270.2(b)(11)(i) and (b)(13)(i) of the
final rule has been revised to ‘‘in the
direction most likely to lead to failure
of the requirement’’ to make it clearer
and more easily understood by safety
testing personnel.
6. Section 1270.2(b)(12)
Also based on a comment from
Stander, § 1270.2(b)(12)(i) has been
revised in the final rule to remove
restrictions on how the probe and force
should be applied to better represent the
known hazard patterns. The language in
§ 1270.2(b)(12)(i) of the final rule has
been revised to read ‘‘at the angle most
likely to allow it to pass through’’ to
make it clearer and more easily
understood by safety testing personnel.
7. Section 1270.2(b)(14) (previously
proposed § 1270.2(b)(13)(ii))
The requirements of proposed
§ 1270.2(b)(13)(ii) in the NPR have been
renumbered as revised § 1270.2(b)(14) in
the final rule. Therefore, proposed
§ 1270.2(b)(14) through (19) have been
renumbered as § 1270.2(b)(15) through
(20) in the final rule. Revised
§ 1270.2(b)(14) has been modified from
the proposed rule because proposed
§ 1270.2(b)(13) introductory text
incorrectly stated that the language
‘‘Instead of complying with [the
applicable ASTM provision]’’ applied to
both § 1270.2(b)(13)(i) and (ii). The
introductory instructional text for
proposed § 1270.2(b)(13)(ii) should have
read ‘‘In addition to complying with
[the applicable ASTM provision]’’.
Therefore, in the final rule,
§ 1270.2(b)(14) has been revised to
provide the correct introductory text.
Additionally, § 1270.2(b)(14)(i) in the
final rule has been revised from
proposed § 1270.2(b)(13)(ii). Stander
raised concerns about the location of
Zone 2 on bed rails with multiple
supports. Zone 2 testing is meant to
address head-first entry under the rail
into any opening between the mattress
compressed by the weight of a
consumer’s head and a section of the
bedrail. Bed rails that have overhanging

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elements longer than 4.7 inches can
allow the passage of the head in a
manner consistent with identified Zone
2 entrapment hazards regardless of the
number or location of vertical support
rails. 4.7 inches is the diameter of the
test probe and encompasses the 5th
percentile female head breadth.
Therefore, revised § 1270.2(b)(14)(i)
clarifies which areas should be included
in Zone 2 testing along with adding a
new figure 1 illustration that visually
depicts the clarifying language.
C. Section 1270.3—Prohibited
Stockpiling
In the NPR, the Commission proposed
an anti-stockpiling provision to prevent
firms from manufacturing large
quantities of non-compliant APBRs
before the rule takes effect. This section
makes it a prohibited act, for the period
of time between the date of Federal
Register publication of the final rule
and the effective date of the final rule,
for manufacturers and importers to
manufacture or import APBRs at a rate
that is greater than 105 percent of the
rate at which they manufactured or
imported APBRs during the base period
of sales for the manufacturer or
importer. The prohibited stockpiling
provision is being finalized as proposed.
D. Findings in Appendix A to the Part
The findings required by section 9 of
the CPSA are discussed throughout the
preamble of this rule and set forth in
appendix A to part 1270. While the
findings have updated for the final rule,
they are substantively the same as the
proposed findings in the NPR.

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VII. Final Regulatory Analysis
Pursuant to section 9(f)(2) of the
Consumer Product Safety Act,
publication of a final rule must include
a final regulatory analysis containing:
• A description of the potential
benefits and potential costs of the rule,
including any benefits or costs that
cannot be quantified in monetary terms,
and an identification of those likely to
receive the benefits and bear the costs.
• A description of any alternatives to
the final rule which were considered by
the Commission, together with a
summary description of their potential
benefits and costs and a brief
explanation of the reasons why these
alternatives were not chosen.
• A summary of any significant issues
raised by the comments submitted
during the public comment period in
response to the preliminary regulatory
analysis, and a summary of the
assessment by the Commission of such
issues.

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A. Final Description of Potential
Benefits and Costs of the Rule
Since the publication of the NPR in
the Federal Register on November 9,
2022, the Commission has not identified
any material changes in the APBR
market, or in the data used in the
preliminary analysis of benefits and
costs. Though some of the comments on
the NPR described possible economic
impacts of the rule, none of the
comments specifically addressed or
otherwise suggested changes to the
preliminary regulatory analysis.
Therefore, the final regulatory analysis
for the final rule discussed below is
substantively unchanged from the
analysis described in the preamble of
the NPR and in Tab G of the staff NPR
briefing package, as explained in Tab C
of the final rule briefing package.
CPSC’s assessment of the final rule’s
potential benefits and costs is that the
quantifiable benefits of the rule are in
the range of $66.75 million per year
(assuming a 25% efficacy rate for the
rule’s requirements) to $200.24 million
per year (assuming a 75% efficacy rate).
The costs associated with the rule’s
requirements to prevent the hazards
associated with APBRs are expected to
be $2.01 million per year. On a per
product basis, the benefits of the final
rule are estimated to be between
$110.59 per APBR (25% efficacy) and
$331.78 per APBR (75% efficacy), and
the costs are estimated at $3.34 per
APBR. All these amounts are in 2021
dollars using a discount rate of 3
percent. The Commission’s analysis is
based on incident reports for
entrapments, only. Although APBRs
may have been involved in other deaths
or injuries, such as falls, those incidents
are not considered in the benefit-cost
analysis because there are limited
details involving such incidents, and it
is unclear what percentage, if any, of fall
incidents would be prevented by the
final rule.
1. Benefits of the Final Rule
The expected benefits and costs of the
final rule are discussed below. The most
common hazard pattern among all
reported incidents is rail entrapment,
accounting for more than 90 percent
(284 of 310) of the fatal incidents. CPSC
uses the period 2010 through 2019 for
its rates of fatalities because, at the time
of the NPR, it was the most recent 10year window where all or nearly all
incidents have been reported. The NPR
identified 158 deaths from entrapment
that occurred from 2010 through 2019.
This number accounts for 92 percent of
observed death incidents; the remaining
8 percent were caused by underlying

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incidents that may or may not be
prevented by the final rule. To forecast
entrapment deaths into the future, CPSC
used death rates per million APBRs in
conjunction with its forecast of APBRs
in use throughout the study period. The
NPR assumed deaths would stay the
same as the average rates observed
between 2010 to 2019: 31.9 deaths per
million APBRs.
To estimate the societal costs of
entrapment deaths, CPSC applies the
value of statistical life (VSL). VSL is an
estimate used in benefit-cost analysis to
place a value on reductions in the
likelihood of premature deaths. The
VSL does not place a value on
individual lives, but rather, it represents
an extrapolated estimate, based on the
rate at which individuals trade money
for small changes in mortality risk.
CPSC specifically applies the estimate
of the VSL developed by the U.S.
Environmental Protection Agency
(EPA). The EPA estimate of the VSL,
when adjusted for inflation, is $10.5
million in 2021 dollars. CPSC multiplies
the VSL by the number of forecasted
deaths throughout the study period to
calculate societal costs of deaths from
entrapment in the absence of the final
rule.
We further assume that the number of
firms and ABPR models in use will tend
to be stable in future years around the
values in 2022: 12 firms and 65 models.
The market for APBRs is expected to
grow at an average rate of 2.01 percent
per between 2024 and 2053 as a result
of an aging U.S. population. Assuming
the rate of incidents per million APBRs
stays constant, an industry of this size
would result in an average of 32 deaths
from entrapment per year. At a VSL of
$10.5 million (2021 dollars), the
annualized present value of the
potential benefits of the final rule is
$298.11 million.
The Commission has not included
non-fatal injuries in the foregoing
benefit-cost assessment because for
many incidents involving such injuries,
there is not sufficient information to
determine whether they would be
prevented by the final rule. However,
non-fatal injuries have been quantified
and monetized in a sensitivity analysis
as a potential upper limit to assess the
benefits of this final rule. Further, the
requirements of the final rule are
expected to address the 92 percent of
deaths caused by entrapment. However,
because we do not assume the final rule
will eliminate all deaths caused by
entrapment, we assessed potential
benefits for the final rule under three
scenarios, estimating benefits at 75
percent, 50 percent, and 25 percent of
the 92 percent baseline efficacy.

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million, $131.48 million, and $64.74
million on an annualized basis under
these various scenarios that assume
reduced benefits. Table 10 summarizes
the projected benefits of the final rule.

respectively. As discussed below,
annualized costs associated with the
final requirements to prevent APBR
hazards are estimated to be
approximately $2 million. This results
in net quantifiable benefits of $198.23

At these rates under varying
conservative assumptions (i.e., likely to
underestimate the benefits of the rule),
CPSC estimates the annualized benefits
of the final rule to be $200.24 million,
$133.49 million, and $66.75 million,

46975

TABLE 10—BENEFITS OF THE FINAL RULE
Effective rates
Benefits discounted at 3%
75%
Total Benefits (2024–2053 in $B) ................................................................................................
Annualized Benefits (in $M) ........................................................................................................
Per-Unit Benefits (in $) ................................................................................................................

2. Costs of the Final Rule
The Commission’s regulatory
assessment of the costs of the final rule
assumes that 100 percent of
manufacturers will fully redesign their
APBR models to comply with ASTM
F3186–17, with the final rule’s
modifications. Like the benefits
estimation, the time span of the cost
analysis covers a 30-year period that
starts in 2024, which is the expected
year of implementation of the final rule.
This cost analysis presents all cost
estimates in 2021 dollars. This cost
analysis also discounts costs in the
future and uses a 3 percent discount rate
to estimate their present value.
The cost of implementing APBR
requirements to address entrapment

hazards includes the costs
manufacturers incur to redesign existing
models and produce new designs to
comply with the final rule, as well as
any additional cost of producing the
APBR that is associated with its
redesign. Manufacturers would likely
incur expenditures in design labor,
design production, design validation,
and compliance testing. CPSC staff’s
review indicates that once existing
models have been redesigned with a
working solution, new models can adapt
the solution at a minimal cost.
Manufacturers can transfer some, or
all, of the increased production cost to
consumers through price increases. In
the first year, the Commission expects
producer manufacturing costs to

$3.92
200.24
331.78

50%
$2.62
133.49
221.19

25%
$1.31
66.75
110.59

increase by $5.40 per APBR, of which
$4.00 per APBR is expected to be passed
on to the consumer in the form of higher
prices. At the margins, some producers
may exit the market because their
increased marginal costs now exceed
the increase in market price. Likewise,
a fraction of consumers would now
probably be excluded from the market
because the increased market price
exceeds their personal price threshold
for purchasing an APBR. Deadweight
loss is the measure of the losses faced
by marginal producers and consumers
who are forced out of the market due to
the new requirements of the final rule.
Table 11 summarizes the projected costs
of the final rule:

TABLE 11—TOTAL COST OF THE FINAL RULE
Total cost
($M)

Costs of proposed rule
Cost of Redesigning Existing Models ......................................................................................................................
Cost of Production of Redesigned APBRs ..............................................................................................................
Deadweight Loss .....................................................................................................................................................

3. Net Benefits of the Final Rule
Table 12 displays net benefits
(difference between benefits and costs)
and the benefit-cost ratio (benefits

divided by costs) to assess the costbenefit relationship of the final rule.
The table displays these metrics using
annualized benefits for the three

$2.75
60.43
2.07

Present value
($M)
$2.59
35.65
1.23

scenarios: 75 percent, 50 percent, and
25 percent efficacy rates. These metrics
show the draft final rule’s benefits well
exceed costs in each scenario.

TABLE 12—ANNUALIZED NET BENEFITS OF FINAL RULE
Portion of benefits achieved over the baseline
efficacy rate of redesigned APBRs

Annualized net benefits
($M, discounted at 3%)

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75%
Benefits ........................................................................................................................................
Costs ............................................................................................................................................
Net Benefits (Benefits¥Costs) ....................................................................................................
B/C Ratio .....................................................................................................................................

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$200.24
$2.01
$198.23
99.45

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50%
$133.49
$2.01
$131.48
66.30

25%
$66.75
$2.01
$64.73
33.15

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Table 13 compares the benefits and
costs on a per-unit basis, to add a

marginal value perspective. These
metrics again show the final rule’s

benefits well exceed costs in each
scenario.

TABLE 13—PER-APBR NET BENEFITS OF THE FINAL RULE
Portion of benefits achieved over the baseline
efficacy rate of redesigned APBRs

Per unit net benefits
($, discounted at 3%)

75%
Benefits ........................................................................................................................................
Costs ............................................................................................................................................
Net Benefits (Benefits¥Costs) ....................................................................................................
B/C Ratio .....................................................................................................................................

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B. Voluntary Standard
Based on staff’s evaluation of ASTM
F3186–17, the Commission determines
that ASTM F3186–17, with appropriate
modifications, will address the
entrapment hazard presented by APBRs.
As discussed in the preamble of the
NPR, and Tabs C and D of both the
staff’s NPR briefing package and the
staff’s final rule briefing package, CPSC
staff collected sample populations of
APBR models and tested them, first in
2018 through 2019, and then again in
2021. In each instance, all APBRs
examined by staff failed to comply with
one or more substantive requirements of
ASTM F3186–17.
CPSC staff also conducted informal
interviews with five firms in January
and February 2018, to determine if the
firms were familiar with the ASTM
standard, if they believed their products
conformed to the standard, and if they
believed other suppliers would conform
to the standard. Four firms indicated
they were familiar with the standard;
one stated that their products already
conformed; two indicated some
modifications were required to bring
their products into compliance; and two
expressed uncertainty as to whether
they would put warning labels required
by the voluntary standard on their
product. One firm expressed concern
that if they applied the required
warnings to their product and
competitors did not, then consumers
would believe their products were more
hazardous than competing APBRs
without warning labels, causing the firm
to lose market share.
Accordingly, CPSC testing and
informal interviews showed that for the
period 2018–2021 there was not
substantial industry compliance with
the voluntary standard. Furthermore,
substantial future industry compliance
is unlikely because firms have had
several years to comply with the
voluntary standard and, despite
repeated outreach and testing, no
APBRs are known to comply with all

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the requirements in the voluntary
standard.
C. Alternatives to the Final Rule
The Commission considered six
alternatives to the final rule adopted
here: (1) take no regulatory action; (2)
continue to conduct recalls of APBRs
instead of promulgating a rule; (3)
conduct an educational campaign
instead of promulgating a rule; (4) ban
APBRs from the market; (5) require
enhanced safety warnings without other
requirements; and (6) implement the
rule with a later effective date. The
Commission finds that none of these
alternatives would adequately address
the hazards associated with APBRs.
1. No Regulatory Action
If the Commission opted to take no
regulatory action, the industry
foreseeably would continue in its
current state, and consumers would
remain at risk of entrapment and
strangulation from APBRs. Rates of
injuries and deaths would likely
increase with the use of APBRs over
time, and the estimated $298.11 million
average annualized societal costs would
continue to be incurred by consumers in
the form of deaths and injuries.
Therefore, the Commission does not
find this alternative would address the
unreasonable risk of injury associated
with APBRs.
2. Conduct Recalls Instead of
Promulgating a Final Rule
The Commission could seek voluntary
or mandatory recalls of APBRs that
present a substantial product hazard.
With this alternative, manufacturers
could continue producing noncompliant
products without incurring any
additional costs to modify or test APBRs
for compliance with the final rule.
Furthermore, recalls only apply to an
individual manufacturer and product,
but do not extend to similar hazardous
products. Recalls also occur only after
consumers have purchased and used
such products with possible resulting
deaths or injuries due to exposure to the

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$331.78
$3.34
$328.45
99.45

50%
$221.19
$3.34
$217.85
66.30

25%
$110.59
$3.34
$107.26
33.15

hazard. Additionally, recalls can only
address products that are already on the
market but do not directly prevent
unsafe products from entering the
market. Recalls have removed several
APBR models from the U.S market since
2021. However, despite these efforts,
APBR sales volume remains at, or near,
the 2020 pre-recall level and noncompliant APBRs remain widely
available for purchase, which is to be
expected given the APBR market’s low
barriers to entry. Therefore, a significant
portion of the estimated $298.11 million
average annualized societal costs would
likely continue to be incurred by
consumers in the form of deaths and
injuries. Further, even if recalls had
reduced the size of the APBR market or
the share of the market comprised of
non-compliant APBRs, staff assesses the
rule’s benefits still would exceed the
rule’s costs. The final rule provides
significant benefits that far exceed costs
even if the draft final rule is only 75%,
50%, or 25% effective. Therefore, the
Commission does not find this
alternative would address the
unreasonable risk of injury associated
with APBRs.
3. Conduct Education Campaigns
The Commission could issue press
releases or use marketing techniques to
warn consumers about the entrapment
and strangulation hazards associated
with APBRs, instead of issuing a
mandatory rule. Information and
marketing campaigns may reduce the
number of injuries and societal costs
associated with APBR entrapment and
strangulation hazards. However,
marketing campaigns have historically
been less effective than designing the
hazard out of the product or guarding
the consumer from the hazard in the
first instance. Information and
marketing campaigns warning
customers of APBR entrapment and
strangulation hazards are not likely to
be as effective in reducing the risk of
injury as the final rule. Therefore, the
Commission does not find this
alternative would adequately address

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the unreasonable risk of injury
associated with APBRs.

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4. Ban APBRs From the Market
The Commission could ban APBRs
under CPSA section 8. Staff weighed
quantifiable and unquantifiable factors
concerning the utility of APBR use in
making a recommendation regarding
this alternative. The use of APBRs
provides many unquantifiable benefits
to users, including mobility, ease of
access to beds, protection against falls,
and the potential for at-home care. If the
Commission promulgated a rule
banning APBRs, the benefits from
reduced deaths and injuries would be
similar to this final rule, or potentially
even greater. However, the value of
individual users’ lost utility could
outweigh the incremental benefits of
this approach. Considering both the
quantifiable and unquantifiable costs
and benefits, staff assessed that the net
benefits of this alternative are likely less
than those of the final rule. In addition,
under CPSA section 8, the Commission
may only declare a product to be a
banned hazardous product if no feasible
consumer product safety standard
would adequately protect the public
from the unreasonable risk of injury
associated with APBRs. 15 U.S.C. 2057.
The Commission finds that this final
rule would adequately protect the
public from this risk. Therefore, the
Commission does not adopt the
alternative of a ban on APBRs.
5. Enhanced Safety Warnings on APBRs
The Commission could require
enhanced safety warnings on APBRs.
Yet the warning labels currently on
APBRs have not produced the desired
results of reducing entrapment and
strangulation injuries and deaths. In
general, safety warnings that rely on
consumers to alter their behavior to
avoid the hazard are less effective than
designing the hazard out of the product
or guarding the consumer from the
hazard in the first instance. Due to the
likely continued use of APBRs at similar
rates and patterns of use despite
warnings, much of the estimated
$298.11 million average annualized
societal costs would continue to be
incurred by consumers in the form of
deaths and injuries. Therefore, the
Commission does not find this
alternative would adequately address
the unreasonable risk of injury
associated with APBRs.
6. Later Effective Date
The Commission could issue the rule
with an effective date later than the
proposed 30 days, allowing APBR firms
additional time to meet the

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requirements of the final rule. However,
the APBR industry likely will be able to
comply quickly with the final rule
because the modifications needed do
not require extensive product redesign,
and because manufacturers have long
had notice of the requirements of ASTM
F3186–17. Delaying implementation of
the rule would allow the sale of noncompliant products for a longer period
of time, which would likely result in
higher social costs, in the form of fatal
and non-fatal APBR entrapment injuries
from products not subject to the
requirements of the final rule, in
exchange for a limited reduction in the
cost of compliance to suppliers. In
addition, no commenters stated any
opposition to the 30-day effective date.
Therefore, the Commission does not
find this alternative would adequately
address the unreasonable risk of injury
associated with APBRs.
VIII. Final Regulatory Flexibility
Analysis
When an agency is required to
publish a notice of proposed
rulemaking, the Regulatory Flexibility
Act (5 U.S.C. 601–612) generally
requires that the agency prepare an
initial regulatory flexibility analysis
(IRFA) for the NPR and a final
regulatory flexibility analysis (FRFA) for
the final rule. 5 U.S.C. 603, 604. These
analyses must describe the impact that
the rule would have on small businesses
and other entities. The FRFA must
contain:
(1) a statement of the need for and
objectives of the rule;
(2) significant issues raised by
commenters on the IRFA, the agency’s
assessment of those issues, and changes
made to the result as a result of the
comments;
(3) a response to any comments filed
by the Chief Counsel for Advocacy of
the U.S. Small Business Administration
(Advocacy), and changes made as a
result of those comments;
(4) a description and estimate of the
number of small entities to which the
rule will apply;
(5) a description of the projected
reporting, recordkeeping, and other
compliance requirements of the rule,
including an estimate of the classes of
small entities which will be subject to
the requirement and the type of
professional skills necessary for
preparation of the report or record; and
(6) steps the agency has taken to
minimize the significant economic
impact on small entities, consistent with
the objective of the applicable statute,
including the factual, policy, and legal
reasons for selecting the alternative in

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the final rule and why other alternatives
were rejected.
The full regulatory flexibility analysis
provided in Tab D of staff’s final rule
briefing package is summarized below.
A. Need For and Objective of the Final
Rule
The purpose of the final rule is to
reduce deaths and injuries resulting
from entrapment, falls, and other APBR
hazards. CPSC identified 310 fatal
injuries and 1,946 nonfatal injuries
associated with APBR hazards in the
years 2003 through 2021. CPSC assesses
compliance with the voluntary
standard, ASTM F3186–17, with
modifications, would substantially
reduce fatal and nonfatal injuries
associated with APBR hazards.
Accordingly, the Commission finds that
a mandatory rule is reasonably
necessary to reduce the unreasonable
risk of injury of entrapments from
APBRs.
B. Significant Issues Raised by
Comments
Seven comments were submitted in
response to the NPR. Some of the
comments described possible economic
impacts of the rule, including economic
impacts on firms, the utility of the
product for consumers, costs associated
with the product hazards, and
alternative actions that the Commission
could take. However, none of the
comments specifically addressed, or
resulted in changes to, the initial
regulatory flexibility analysis. A
summary of the significant issues with
possible economic impacts and a
summary of staff’s assessment of such
issues is contained in section V of the
preamble and in the Appendix to Tab C
of the staff’s briefing package for the
final rule. The Chief Counsel for
Advocacy of the Small Business
Administration did not file a comment
on the NPR.
C. Small Entities to Which the Rule Will
Apply
The final rule will apply to all
manufacturers and importers of APBRs.
CPSC has identified seven U.S. APBR
manufacturers that meet the SBA
criteria for small businesses. Importers
of APBRs could be wholesale or retail
distributors. CPSC identified one U.S.
APBR firm in these categories that could
be considered a small business.
D. Compliance, Reporting, and
Recordkeeping Requirements of Final
Rule
The final rule establishes a
performance requirement for APBRs and
test procedures that suppliers would

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have to meet to sell APBRs in the
United States. Specifically, the final rule
requires APBRs sold in the United
States to comply with the ASTM F3186–
17 standard, with modifications. CPSC
expects most APBR manufacturers,
including those considered small by
SBA standards, would incur costs
associated with bringing their APBRs
into compliance with the final rule, as
well as costs related to testing and
issuing a GCC.
In accordance with section 14 of the
CPSA, manufacturers would have to
issue a GCC for each APBR model,
certifying that the model complies with
the final rule. According to section
14(a)(1) of the CPSA, GCCs must be
based on a test of each product, or a
reasonable testing program; and GCCs
must be provided to all distributors or
retailers of the product. The
manufacturer would have to comply
with 16 CFR part 1110 concerning the
content of the GCC, retention of the
associated records, and all other
applicable requirements.
E. Impact on Small Entities
Generally, CPSC considers an impact
to be potentially significant if it exceeds
1 percent of a firm’s gross revenue. The
initial cost to comply with the final rule
appears to exceed 1 percent of reported
annual revenue for 3 of the 7
manufacturers identified as small
businesses. For these 3 APBR
manufacturers, the economic impact of
the proposed rule is expected to be
significant. As discussed in Tab D of
staff’s final rule briefing package, to
achieve compliance with the final rule’s
performance requirements, APBR
suppliers would incur costs from
redesigning, retooling, and testing.
CPSC staff estimates this cost to be
$42,239 per model in the first year. Staff
estimates the additional production cost
for labor and material to be $5.40 per
unit produced in the first year, of which
$4.00 is expected to be passed on to the
consumer. CPSC has identified one
possible importer of APBRs from foreign
suppliers that would be considered
small businesses based on SBA size
standards. For this small importer, the
cost of certification testing is unlikely to
exceed 1 percent of annual revenue.
Additionally, the foreign manufacturers
are likely to provide a GCC certification
on which the small importer can rely.
Furthermore, given that the APBR
industry is expected to continue to
grow, CPSC does not anticipate foreign
manufacturers exiting the industry
because of the implementation of the
final rule. Therefore, the final rule will
not have a significant economic impact
on APBR importers.

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F. Other Significant Alternatives to the
Rule Considered
Section VII.C. of this preamble
provides a detailed discussion of six
alternatives to the final rule that were
considered and why those alternatives
were rejected. While the alternatives
could reduce the burden on small
entities, none of the alternatives are
consistent with achieving the rule’s
objective of improving consumer safety
by protecting consumers from
entrapment by APBRs.
IX. Incorporation by Reference
The Commission is incorporating by
reference ASTM F3186–17, Standard
Specification for Adult Portable Bed
Rails and Related Products. The Office
of the Federal Register (OFR) has
regulations regarding incorporation by
reference. 1 CFR part 51. Under these
regulations, agencies must discuss, in
the preamble to a final rule, ways in
which the material the agency
incorporates by reference is reasonably
available to interested parties, and how
interested parties can obtain the
material. In addition, the preamble to
the final rule must summarize the
material. 1 CFR 51.5(b).
In accordance with the OFR
regulations, section IV. of this preamble
summarizes the major provisions of
ASTM F3186–17 that the Commission
incorporates by reference into 16 CFR
part 1270. The standard itself is
reasonably available to interested
parties. Until the final rule takes effect,
a read-only copy of ASTM F3186–17 is
available for viewing, at no cost, on
ASTM’s website at: https://
www.astm.org/CPSC.htm. Once the rule
takes effect, a read-only copy of the
standard will be available for viewing,
at no cost, on the ASTM website at:
https://www.astm.org/
READINGLIBRARY/. Interested parties
can also schedule an appointment to
inspect a copy of the standard at CPSC’s
Office of the Secretary, U.S. Consumer
Product Safety Commission, 4330 EastWest Highway, Bethesda, MD 20814,
telephone: (301) 504–7479; email: [email protected]. Interested parties can
purchase a copy of ASTM F3186–17
from ASTM International, 100 Barr
Harbor Drive, P.O. Box C700, West
Conshohocken, PA 19428–2959 USA;
telephone: (610) 832–9585;
www.astm.org.
X. Paperwork Reduction Act
This rule contains information
collection requirements that are subject
to public comment and review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction

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Act of 1995 (PRA; 44 U.S.C. 3501–3521).
The preamble to the NPR discussed the
information collection burden of the
proposed rule and specifically requested
comments on the accuracy of CPSC’s
estimates. 87 FR 67586 (Nov. 9, 2022).
The NPR described the provisions of the
proposed rule and provided an estimate
of the annual reporting burden for the
rule under the PRA. See 87 FR 67605.
The estimated burden of this collection
of information is unchanged from the
NPR. CPSC did not receive any
comments regarding the information
collection burden in the NPR through
OMB. OMB has assigned control
number 3041–0192 to this information
collection.
XI. Effective Date
The Administrative Procedure Act
(APA) generally requires that the
effective date of a rule be at least 30
days after publication of a final rule. 5
U.S.C. 553(d). Section 9(g)(1) of the
CPSA states that a consumer product
safety rule shall specify the date such
rule is to take effect, and that the
effective date must be at least 30 days
after promulgation but cannot exceed
180 days from the date a rule is
promulgated, unless the Commission
finds, for good cause shown, that a later
effective date is in the public interest
and publishes its reasons for such
finding.
The Commission proposed in the NPR
an effective date of 30 days after
publication of the final rule in the
Federal Register. The Commission
received no negative comments on the
proposed effective date and has
determined the proposed 30-day
effective date is appropriate and will be
finalized as proposed. ASTM F3186–17
has been in existence since August
2017, and agency staff has conducted
outreach efforts to make firms aware of
the requirements of the standard.
Accordingly, manufacturers already are
familiar with the requirements of ASTM
F3186–17 and should be ready and able
to comply with the requirements
included in the final rule. The rule
applies to all APBRs manufactured after
the effective date.
XII. Certification
As discussed in section VIII.D. of this
preamble, in accordance with section 14
of the CPSA manufacturers would have
to issue a GCC for each APBR model,
certifying that the product complies
with the final rule.
XIII. Preemption
Executive Order 12988, Civil Justice
Reform (Feb. 5, 1996), directs agencies
to specify the preemptive effect of a

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rule. 61 FR 4729 (Feb. 7, 1996). The rule
for APBRs is issued under the authority
of the CPSA. 15 U.S.C. 2051–2089.
Section 26 of the CPSA provides that
when a consumer product safety
standard under the CPSA is in effect
that applies to a risk of injury associated
with a consumer product, ‘‘no State or
political subdivision of a State shall
have any authority either to establish or
to continue in effect any provision of a
safety standard or regulation which
prescribes any requirements as to the
performance, composition, contents,
design, finish, construction, packaging
or labeling of such product which are
designed to deal with the same risk of
injury associated with such consumer
product, unless such requirements are
identical to the requirements of the
Federal Standard.’’ 15 U.S.C. 2075(a).
Thus, the final rule for APBRs preempts
non-identical state or local requirements
for APBRs that are designed to protect
against the same risk of injury.
States or political subdivisions of a
state may apply for an exemption from
preemption regarding a consumer
product safety standard, and the
Commission may issue a rule granting
the exemption if it finds that the state
or local standard: (1) provides a
significantly higher degree of protection
from the risk of injury or illness than the
CPSA standard; and (2) does not unduly
burden interstate commerce. Id. 2075(c).

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XIV. Environmental Considerations
Generally, the Commission’s
regulations are considered to have little
or no potential for affecting the human
environment, and environmental
assessments and impact statements are
not usually required. See 16 CFR
1021.5(a). The final rule is not expected
to have an adverse impact on the
environment and is considered to fall
within the ‘‘categorical exclusion’’ for
the purposes of the National
Environmental Policy Act. 16 CFR
1021.5(c).
XIV. Congressional Review Act
The Congressional Review Act (CRA;
5 U.S.C. 801–808) states that before a
rule may take effect, the agency issuing
the rule must submit the rule, and
certain related information, to each
House of Congress and the Comptroller
General. 5 U.S.C. 801(a)(1). The CRA
submission must indicate whether the
rule is a ‘‘major rule.’’ The CRA states
that the Office of Information and
Regulatory Affairs determines whether a
rule qualifies as a ‘‘major rule.’’
Pursuant to the CRA, OMB’s Office of
Information and Regulatory Affairs has
determined that this rule qualifies as a
‘‘major rule,’’ as defined in 5 U.S.C.

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804(2). To comply with the CRA, CPSC
will submit the required information to
each House of Congress and the
Comptroller General and postpone
enforcement of the rule during the
congressional review period specified in
the CRA.
XV. Findings
As explained, the CPSA requires the
Commission to make certain findings
when issuing a consumer product safety
standard. 15 U.S.C. 2058(f)(1), (f)(3).
These findings are stated in appendix A
to part 1270 and are based on
information provided throughout this
preamble and the staff’s briefing
packages for the proposed and final
rules.
List of Subjects in 16 CFR Part 1270
Administrative practice and
procedure, Adult portable bed rails,
Consumer protection, Incorporation by
reference.
■ For the reasons discussed in the
preamble, the Commission amends title
16 of the Code of Federal Regulations by
adding part 1270 to read as follows:
PART 1270—SAFETY STANDARD FOR
ADULT PORTABLE BED RAILS
Sec.
1270.1 Scope, application, and effective
date.
1270.2 Requirements for adult portable bed
rails.
1270.3 Prohibited stockpiling.
Appendix A to Part 1270—Findings Under
the Consumer Product Safety Act
Authority: 15 U.S.C. 2056, 15 U.S.C 2058,
and 5 U.S.C. 553.
§ 1270.1
date.

Scope, application, and effective

This part establishes a consumer
product safety standard for adult
portable bed rails manufactured after
August 21, 2023.
§ 1270.2 Requirements for adult portable
bed rails.

(a) Except as provided in paragraph
(b) of this section, each adult portable
bed rail must comply with all applicable
provisions of ASTM F3186–17,
Standard Specification for Adult
Portable Bed Rails and Related
Products, approved on August 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. This incorporation by
reference (IBR) material is available for
inspection at the U.S. Consumer
Product Safety Commission and at the
National Archives and Records
Administration (NARA). Contact the
U.S. Consumer Product Safety

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46979

Commission at: Office of the Secretary,
U.S. Consumer Product Safety
Commission, 4330 East-West Highway,
Bethesda, MD 20814, telephone (301)
504–7479, email [email protected]. For
information on the availability of this
material at NARA, email fr.inspection@
nara.gov, or go to: www.archives.gov/
federal-register/cfr/ibr-locations.html. A
read-only copy of the standard is
available for viewing on the ASTM
website at https://www.astm.org/
READINGLIBRARY/. You may obtain a
copy from ASTM International, 100 Barr
Harbor Drive, P.O. Box C700, West
Conshohocken, PA 19428–2959;
telephone (610) 832–9585;
www.astm.org.
(b) Comply with the ASTM F3186–17
standard with the following changes:
(1) In addition to complying with the
definitions in section 3.1 of ASTM
F3186–17, comply with the following
definitions:
(i) Entrapment zone. An area, gap, or
opening that can potentially capture or
restrain a person’s body part. Hazardous
openings may not always be visible
prior to testing.
(ii) Initial assembly. The first
assembly of the product components
after purchase, and prior to installing on
the bed.
(iii) Initial installation. The first
installation of the product onto a bed or
mattress.
(iv) Installation component.
Component(s) of the bed rail that is/are
specifically designed to attach the bed
and typically located under the mattress
when in the manufacturer’s
recommended use position.
(2) Instead of complying with section
6.1.3 of ASTM F3186–17, comply with
the following:
(i) Permanently attached retention
system components shall not be able to
be removed without the use of a tool
after initial assembly.
(ii) [Reserved]
(3) In addition to complying with
section 6.2.1 of ASTM F3186–17,
comply with the following:
(i) The test personnel shall choose a
mattress and product setting
configuration that results in the most
severe condition per test requirement
(see paragraph (b)(8)(i) of this section).
(ii) [Reserved]
(4) Instead of complying with section
6.3.3 of ASTM F3186–17, comply with
the following:
(i) Zone 3. When tested in accordance
with section 8.4.5 of ASTM F3186–17,
the horizontal centerline on the face of
the 4.7 in (120 mm) end of the test probe
(see paragraph (b)(9)(i) of this section)
shall be above the highest point of the
uncompressed mattress.

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(ii) [Reserved]
(5) Instead of complying with section
6.4.1 of ASTM F3186–17, comply with
the following:
(i) Holes or slots that extend entirely
through a wall section of any rigid
material less than 0.375 in (9.53 mm)
thick and admit a 0.210 in (5.33 mm)
diameter rod shall also admit a 0.375 in
(9.53 mm) diameter rod. Holes or slots
that are between 0.210 in (5.33 mm) and
0.375 in (9.53 mm) and have a wall
thickness less than 0.375 in (9.53 mm)
but are limited in depth to 0.375 in (9.53
mm) maximum by another rigid surface
shall be permissible (see Opening
Example in Figure 2 of ASTM F3186–
17).
(ii) [Reserved]
(6) Instead of complying with section
6.5.1 of ASTM F3186–17, comply with
the following:
(i) Any structural components and
retention system components of a
product covered by this specification
that require consumer assembly or
adjustment, or components that may be
removed by the consumer without the
use of a tool, shall not be able to be
misassembled when evaluated to (see
paragraph (b)(7)(i) of this section).
(ii) [Reserved]
(7) Instead of complying with section
6.5.2 of ASTM F3186–17, comply with
the following:
(i) Determining misassembled
product. A product covered by this
specification shall be considered
misassembled if it appears to be
functional under any condition and it
does not meet the requirements of
sections 6.1 through 6.4 of ASTM
F3186–17.
(ii) [Reserved]
(8) In addition to complying with
section 7.1 of ASTM F3186–17, comply
with the following:
(i) Mattress thickness ranges used for
testing shall be up to 1.5 in. (38 mm)
larger or smaller than the range
specified by the manufacturer. Test
personnel shall choose a mattress and

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product setting configuration that
provide the most severe condition for
each test requirement in the standard.
Note 1 to paragraph (b)(8)(i): The
technology and consumer preferences for
bedding are highly variable and continuously
changing. Therefore, they cannot be
reasonably accounted for within this
standard. Test facilities and personnel should
consider current bedding trends and all types
of mattresses that may foreseeably be used
with the product when making a test mattress
selection.

(ii) [Reserved]
(9) Instead of complying with section
7.2 of ASTM F3186–17, comply with
the following:
(i) Entrapment test probe. The test
probe used for the entrapment tests
shall be as described in the Food and
Drug Administration (FDA) Guidance
Document, ‘‘Hospital Bed System
Dimensional and Assessment Guidance
to Reduce Entrapment,’’ which can be
found at: www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/hospital-bed-systemdimensional-and-assessment-guidancereduce-entrapment. The test probe can
be independently manufactured per the
dimensional constraints in the guidance
document or purchased from Bionix,
5154 Enterprise Blvd., Toledo, OH
43612, 800–551–7096, www.bionix.com.
Videos illustrating use of the test probe
are available at: www.youtube.com/c/
BionixLLC/search.
(ii) [Reserved]
(10) Substitute the following text as
the content of Note 1 in section 8.4 of
ASTM F3186–17:
(i) The tests described in this section
are similar to those described in the
referenced FDA Guidance Document.
(ii) [Reserved]
(11) Instead of complying with section
8.4.3.4 of ASTM F3186–17, comply with
the following:
(i) If the test probe does not pull
through freely, attach the force gauge
and exert a 22.5 lbf (100 N) pulling force
to the 2.4 in (60 mm) cylindrical end of

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the entrapment test probe in the
direction most likely to lead to failure
of the requirement. If the 4.7 in (120
mm) end of the cone does not enter any
of the openings, this space passes the
test. If the 4.7 in (120 mm) end of the
test probe cone does enter any of the
openings, this space fails the test.
(ii) [Reserved]
(12) Instead of complying with section
8.4.4.3 of ASTM F3186–17, comply with
the following:
(i) Insert the 2.4 in (60 mm) end of the
cone into the opening at the angle most
likely to allow it to pass through. Insert
the cone into the opening until it is in
full contact with the product. The
mattress shall only be compressed by
the weight of the cone.
(ii) [Reserved]
(13) Instead of complying with section
8.4.4.4 of ASTM F3186–17, comply with
the following:
(i) If the test probe does not pull
through freely use the force gauge to
exert a 22.5 lbf (100 N) pulling force to
the 2.4 in (60 mm) cylindrical end of the
cone in the direction most likely to lead
to failure of the requirement.
(ii) [Reserved]
(14) In addition to complying with
section 8.4.4 of ASTM F3186–17,
comply with the following:
(i) If a horizontal section of the rail
greater than 4.7 in exists along the
bottom of the rail, that section must also
meet the Zone 2 requirements regardless
of the number or location of the
supports. Repeat testing described in
section 8.4.4.3 of ASTM F3186–17 (see
paragraph (b)(12)(i) of this section) and
section 8.4.4.4 of ASTM F3186–17 (see
paragraph (b)(13)(i) of this section) for
all applicable entrapment zones. Figure
1 to this paragraph (b)(14)(i) shows a
general example of areas subject to Zone
2 requirements.
Figure 1 to paragraph (b)(14)(i)—General
Example of Areas Subject to Zone 2
Requirements

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46981

(ii) [Reserved]
(15) Instead of complying with section
8.4.5.4 of ASTM F3186–17, comply with
the following:
(i) Turn the cone until the line on the
face of the 4.7 in (120 mm) end is
horizontal and let the cone sink into the
space by its own weight.

(A) If the line on the face of the 4.7
in (120 mm) end of the cone is above the
highest point of the uncompressed
mattress, as shown in Figure 2 to this
paragraph (b)(15)(i), the space passes the
test.
(B) If the line on the face of the 4.7
in (120 mm) end of the cone is at or

below the highest point of the
uncompressed mattress, as shown in
Figure 2 to this paragraph (b)(15)(i), the
space fails the test.

(ii) [Reserved]
(16) In addition to complying with
section 8.6.3 of ASTM F3186–17, use
the following definition:
(i) The ‘‘free end’’ is defined as the
location on the retention system that is
designed to produce a counter force; it
may be a single distinct point or a
location on a loop.
(ii) [Reserved]

(17) Instead of complying with section
9.1.1.3 of ASTM F3186–17, comply with
the following:
(i) That the product is to be used only
with the type and size of mattress and
bed, including the range of thickness of
mattresses, specified by the
manufacturer of the product. If beds
with head or footboards are allowed, the
distance between the head or footboard
and the placement of the product shall
be indicated to be >12.5 in (318 mm).

(ii) [Reserved]
(18) Instead of complying with section
9.2.5 of ASTM F3186–17, comply with
the following:
(i) Each product’s retail package and
instructions shall include the warning
statements in Figure 3 to this paragraph
(b)(18)(i).

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Figure 3 to paragraph (b)(18)(i)—
Warning Statements for Product
Retail Package and Instruction

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Figure 2 to paragraph (b)(15)(i)—Zone 3
Test: (a) Pass, (b) Fail

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46982

(i) At least one installation component
of the product must be labeled with the
entrapment warning in Figure 4 to this
paragraph (b)(19)(i).

Figure 4 to paragraph (b)(19)(i)—
Entrapment Warning

(ii) [Reserved]
(20) Instead of complying with section
11.1.1.3 of ASTM F3186–17, comply
with the following:
(i) In addition to contacting the
manufacturer directly, consumers can
report problems to the CPSC at its
website SaferProducts.gov or call 1–
800–638–2772.
(ii) [Reserved]

fatal incidents related to rail entrapment,
accounting for more than 90 percent of all
fatal incidents, and 2 nonfatal incidents.
Falls were the second most common hazard
pattern in the incident data, accounting for
25 incidents (8 percent of all incidents).
There were 23 fatalities from falls.
B. Number of Consumer Products Subject
to the Rule. An estimated 12 firms supply 65
distinct APBR models. In 2021, the number
of APBRs sold was approximately 180,000
units.
C. Need of the Public for the Products and
Probable Effect on Utility, Cost, and
Availability of the Product.
(1) APBRs are installed or used alongside
a bed by consumers to: reduce the risk of
falling from the bed; assist the consumer in
repositioning in the bed; or assist the
consumer in transitioning into or out of the
bed. Because the rule is a performance
standard that allows for the sale of compliant
of APBRs, it is not expected to have any
impact on the utility of the product.
(2) The cost of compliance to address
entrapment hazards includes the costs
manufacturers incur to redesign existing
models and produce new designs to comply
with the mandatory standard, the cost of
producing the redesigned APBR, dead weight
loss. To redesign existing and new models,
manufacturers would likely incur
expenditures in design labor, design
production, design validation, and
compliance testing. CPSC estimates these
costs to be $42,239 per model in the first
year. Manufacturers would also incur costs to
produce the redesigned APBRs, however,
these costs likely closely match existing
production costs and therefore incremental
cost is expected to be negligible. Dead weight
loss refers to the lost producer and consumer
surplus from reduced quantities of APBRs
sold and consumed due to rule-induced price
increases. Producer surplus represents the
foregone profit opportunities, meaning the
amount that price exceeds marginal cost for
those units no longer produced. Consumer
surplus represents the foregone utility from

consumption, meaning the amount that
willingness to pay exceeds price for units no
longer consumed. In the first year, producer
manufacturing costs are expected to increase
by $5.40 per APBR, of which $4.00 per APBR
is expected to be passed on to the consumer
in the form of higher prices. The resultant
decrease in the number of APBRs sold and
consumed is expected to generate a dead
weight loss of less than $70,000 per year
nationwide, so the rule is not expected to
have any significant impact on the
availability of APBRs.
D. Any Means to Achieve the Objective of
the Rule, While Minimizing Adverse Effects
on Competition and Manufacturing. (1) The
rule reduces entrapment and other hazards
on APBRs while minimizing the effect on
competition and manufacturing. Because the
rule is based on an existing voluntary
standard, and because of CPSC’s outreach
efforts, APBR manufacturers are generally
aware of the requirements. Manufacturers
can transfer some, or all, of the increased
production cost to consumers through price
increases. At the margins, some producers
may exit the market because their increased
marginal costs now exceed the increase in
market price. Likewise, a very small fraction
of consumers may be excluded from the
market if the increased market price exceeds
their personal price threshold for purchasing
an APBR.
(2) The Commission considered
alternatives to the rule to minimize impacts
on competition and manufacturing including:
take no regulatory action; continue to
conduct recalls of APBRs instead of
promulgating a rule; conduct an educational
campaign instead of promulgating a rule; ban
APBRs from the market; require enhanced
safety warnings without other requirements;
and implement the rule with a longer
effective date. The Commission determines
that none of these alternatives would
adequately reduce the risk of deaths and
injuries associated with APBR entrapment
and other hazards presented by APBRs.

§ 1270.3

Prohibited stockpiling.

(a) Prohibited acts. Manufacturers and
importers of adult portable bed rails
(APBRs) shall not manufacture or
import APBRs that do not comply with
the requirements of this part between
July 21, 2023, and August 21, 2023, at
a rate that is greater than 105 percent of
the rate at which they manufactured or
imported APBRs during the base period
for the manufacturer or importer.
(b) Base period. The base period for
APBRs is the calendar month with the
median manufacturing or import
volume within the last 13 months
immediately preceding July 21, 2023.

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Appendix A to Part 1270—Findings
Under the Consumer Product Safety Act
The Consumer Product Safety Act requires
that the Commission, in order to issue a
standard, make the following findings and
include them in the rule. 15 U.S.C. 2058(f)(3).
Because of this, the facts and determinations
in these findings apply as of the date the rule
was issued, July 21, 2023.
A. Degree and Nature of the Risk of Injury.
Between January 2003 and December 2021,
there were 332 incident reports concerning
adult portable bed rails (APBRs) in the
Consumer Product Safety Risk Management
System (CPSRMS). Of these, 310 were reports
of fatalities, and 22 were nonfatal. Rail
entrapment is the most prevalent hazard
pattern among the incidents. There were 284

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(ii) [Reserved]
(19) Instead of complying with section
9.2.7 of ASTM F3186–17, comply with
the following:

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Federal Register / Vol. 88, No. 139 / Friday, July 21, 2023 / Rules and Regulations
E. The rule (including its effective date) is
reasonably necessary to eliminate or reduce
an unreasonable risk of injury. Incident data
show 284 fatal incidents related to rail
entrapment between January 2003 and
December 2021. The incident data show that
these incidents continue to occur and are
likely to increase because APBR
manufacturers do not comply with the
voluntary standard and the market for ABPRs
is forecast to grow. The rule establishes
performance requirements to address the risk
of entrapments associated with ABPRs. Given
the fatal and serious injuries associated with
entrapments on APBRs, the Commission
finds that the rule and its effective date are
necessary to address the unreasonable risk of
injury associated with APBRs.
F. Public Interest. The rule addresses an
unreasonable risk of entrapments and other
hazards associated with APBRs. Adherence
to the requirements of the rule would reduce
deaths and injuries from APBR entrapment
incidents; thus, the rule is in the public
interest.
G. Voluntary Standards. If a voluntary
standard addressing the risk of injury has
been adopted and implemented, then the
Commission must find that the voluntary
standard is not likely to eliminate or
adequately reduce the risk of injury or
substantial compliance with the voluntary
standard is unlikely.
(1) The Commission determines that,
absent modification, the voluntary standard
is not likely to eliminate or adequately
reduce the risk of injury of entrapments on
ABPRs. The Commission also determines
that ASTM F3186–17, with the modifications
described in § 1270.2, is likely to adequately
reduce the risk of injury associated with
APBRs. Entrapment is the most prevalent
hazard pattern among the deaths and injuries
associated with APBRs. The entrapment test
methods specified in the voluntary standard
require products to be tested to assess the
potential for entrapment in four different
zones. The four entrapment zones required to
be tested each address specific types of
entrapment as follows: head-first entry into
fully bounded openings within the structure
of the bed rail; head-first entry under the rail
into any opening between the mattress and
the bed rail; entry of the head into a gap
between the inside surface along the length
of the bed rail and the compressed mattress;
and neck-first entrapment between the ends
of the bed rail and the compressed mattress.
Most of the reported entrapment fatalities
involved one of the four zones listed. In 214
out of 284 fatal incidents, the entrapment
location was identified and all but six of
these cases occurred in one of the four zones
of entrapment tested in ASTM F3186–17.
(2) The Commission determines that
modifications to the voluntary standard are
needed to improve safety. Such
modifications include: providing additional
definitions for product assembly and
installation to ensure their consistent and
differentiated use throughout the standard;
adding requirements for manufacturers to
take into account the range of mattress
thicknesses to ensure safe use of the product
and provide testers with additional guidance
for selecting the mattress thickness during

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the test setup; addressing inconsistencies
with stated dimensions to ensure consistent
dimensional tolerances; and providing
additional clarity for Zone 1 and 2 test setup
and methods, additional guidance for
identifying potential Zone 2 openings, and
updated requirements for Zone 3 testing
consistency.
(3) The Commission determines that
substantial compliance with the voluntary
standard is unlikely. CPSC conducted two
rounds of market compliance testing to
ASTM F3186–17: the first round in 2018 and
2019, the second round in 2021. In both
rounds, no APBRs met all requirements of
ASTM F3186–17. All products failed at least
one critical mechanical requirement, such as
retention strap performance, structural
integrity, and entrapment. All products failed
the labeling, warning, and instructional
requirements.
H. Reasonable Relationship of Benefits to
Costs. (1) The benefits expected from the rule
bear a reasonable relationship to its cost. The
rule reduces the entrapment hazard and other
hazards associated with APBRs, and thereby
reduces the societal costs of the resulting
injuries and deaths. The rule is expected to
address the 92 percent of deaths caused by
entrapment, resulting in potential societal
benefits of $298.11 million. Benefits
additionally were assessed under three
scenarios derived from this expected efficacy,
estimating benefits at: 75 percent, 50 percent,
and 25 percent of their potential value.
Under these three scenarios, the estimated
quantifiable annualized benefits of the rule
are approximately $200.24 million, $133.49
million, and $66.75 million, respectively.
The costs associated with the rule’s
requirements to prevent the hazards
associated with APBRs are expected to be
approximately $2.01 million per year. On a
per product basis, the estimated benefits of
the rule are approximately $331.78, $221.19,
and $110.59 per APBR when assessed at 75
percent, 50 percent, and 25 percent of their
potential value, respectively, and the costs
are approximately $3.34 per APBR. All these
amounts are in 2021 dollars using a discount
rate of 3 percent.
(2) The requirements of the rule, with
modifications, are expected to address 92
percent of deaths caused by entrapment.
Even under the most conservative
assumption that only 25 percent of the
potential benefits are achieved, every $1 in
costs for the market to adopt the rule equates
to approximately $33.15 in benefits to
society. The estimated annualized net
benefits of the rule are approximately
$198.23 million, $131.48 million, and $64.74
million, at when benefits are assessed at 75
percent, 50 percent, and 25 percent of their
potential value, respectively.
I. Least-Burdensome Requirement that
Would Adequately Reduce the Risk of Injury.
The Commission considered six alternatives
to the rule including: take no regulatory
action; continue to conduct recalls of APBRs
instead of promulgating a rule; conduct an
educational campaign without a rule; ban
APBRs from the market entirely; require
enhanced safety warnings without other
requirements; and implement the rule with a
longer effective date. Although most of these

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alternatives may be a less burdensome
alternative to the rule, the Commission
determines that none of the alternatives
would adequately reduce the risk of deaths
and injuries associated with APBRs that is
addressed by the rule while still preserving
the product’s utility to consumers.
Alberta E. Mills,
Secretary, Consumer Product Safety
Commission.
[FR Doc. 2023–15189 Filed 7–20–23; 8:45 am]
BILLING CODE 6355–01–P

DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1306
[Docket No. DEA–469]
RIN 1117–AB45

Partial Filling of Prescriptions for
Schedule II Controlled Substances
Drug Enforcement
Administration, Department of Justice.
ACTION: Final rule.
AGENCY:

On July 22, 2016, the
Comprehensive Addiction and Recovery
Act of 2016 became law. One provision
of the Comprehensive Addiction and
Recovery Act of 2016 amended the
Controlled Substances Act to allow for
the partial filling of prescriptions for
schedule II controlled substances under
certain conditions. The Drug
Enforcement Administration (DEA) is
amending its regulations to conform to
this statutory provision, as well as to
provide direction on gaps not addressed
by legislation. DEA will also be
amending its regulations to update a
cross-reference in a paragraph that will
be redesignated with this final rule.
DATES: This final rule is effective August
21, 2023.
FOR FURTHER INFORMATION CONTACT:
Scott A. Brinks, Regulatory Drafting and
Policy Support Section, Diversion
Control Division, Drug Enforcement
Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia
22152; Telephone: (571) 776–3882.
SUPPLEMENTARY INFORMATION:
SUMMARY:

I. Legal Authority
On July 22, 2016, the President signed
the Comprehensive Addiction and
Recovery Act (CARA) of 2016 into law
as Public Law 114–198. Section 702(a)
of the CARA amended 21 U.S.C. 829 of
the Controlled Substances Act (CSA) by
adding subsection (f) to allow a
pharmacist to partially fill a
prescription for a schedule II controlled
substance under certain conditions.

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