Safety Standard for Adult Portable Bed Rails, 46958-46983 [2023-15189]

Agencies

• Consumer Product Safety Commission

[Federal Register Volume 88, Number 139 (Friday, July 21, 2023)]
[Rules and Regulations]
[Pages 46958-46983]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-15189]


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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1270

[CPSC Docket No. CPSC-2013-0022]


Safety Standard for Adult Portable Bed Rails

AGENCY: Consumer Product Safety Commission.

ACTION: Final rule.

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SUMMARY: 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 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.

DATES: 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.

FOR FURTHER INFORMATION CONTACT: 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].

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

[[Page 46959]]

(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.
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    \1\ Available at: https://www.cpsc.gov/s3fs-public/pdfs/foia_PetitionCP131RequestforBanorStandardforAdultPortableBedRail.pdf.

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    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.
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    \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?kiDixW5Z7x9xcOqjxSeS3QpvspdfQMBY.
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    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 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.
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    \3\ Available at: https://www.cpsc.gov/s3fs-public/Petition-Requesting-a-Ban-or-Standard-on-Adult-Portable-Bed-Rails-Petition-CP-13-1.pdf.
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    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.
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    \4\ Available at: https://www.cpsc.gov/s3fs-public/ProposedRuleSafetyStandardforAdultPortableBedRails.pdf?VersionId=Ypa89Iczh13C40Tq7EJRSMDZoatChf1.
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    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\
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    \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/Alexander-Hoehn-Saric/Statement/Statement-of-Chair-Alexander-Hoehn-Saric-on-Issuance-of-a-Final-Safety-Standard-for-Adult-Portable-Bed-Rails and https://www.cpsc.gov/About-CPSC/Commissioner/Richard-Trumka/Statement/CPSC-Finalizes-Rock-Solid-New-Safety-Rule-for-Adult-Bedrails-Saving-Lives-and-300M-a-Year-in-Costs-to-Americans.
    \6\ Available at: https://www.cpsc.gov/s3fs-public/Final-Rule-Safety-Standard-for-Adult-Portable-Bed-Rails.pdf?VersionId=CUfr4q0N1VaGv2o8jnGyQziiWcg8qfu3.
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    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\

[[Page 46960]]

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.
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    \7\ Information on adult bed rails regulated by the U.S. Food 
and Drug Administration (FDA) is available at: www.fda.gov/medical-devices/bed-rail-safety/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 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.
[GRAPHIC] [TIFF OMITTED] TR21JY23.006

    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

    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 
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.

[[Page 46961]]

Table 1 below presents the distribution of these APBR incidents by age.

                         Table 1--Distribution of Reported APBR-Related Incidents by Age
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                        Age group (years)                           Fatalities     Nonfatalities       Total
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13-29...........................................................               7               0               7
30-59...........................................................              30               0              30
60-69...........................................................              22               0              22
70-79...........................................................              47               2              49
80-89...........................................................             124               2             126
90 or older.....................................................              75               1              76
Unknown/Unspecified.............................................               5              17              22
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    Total.......................................................             310              22             332
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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
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                             Gender                                 Fatalities     Nonfatalities       Total
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Male............................................................              88               7              95
Female..........................................................             221               8             229
Unknown/Unspecified.............................................               1               7               8
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    Total.......................................................             310              22             332
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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.
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    \8\ All of these reported incidents occurred with APBRs that 
were identified as being within the CPSC's jurisdiction.

                      Table 3--Distribution of Reported APBR-Related Incidents by Location
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                            Location                                Fatalities     Nonfatalities       Total
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Home............................................................             158               6             164
Nursing Home....................................................              50               0              50
Assisted Living Facility........................................              40               2              42
Residential Institution.........................................              14               0              14
Other *.........................................................              23               0              23
Unknown/Not Reported............................................              25              14              39
                                                                 -----------------------------------------------
    Total.......................................................             310              22             332
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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     Nonfatalities       Total
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Cardiovascular disease..........................................              87               0              87
Alzheimer's/Dementia/Mental.....................................              73               0              73
Mobility/Paralysis/Stroke.......................................              20               0              20
Parkinson's disease.............................................              17               1              18
Pulmonary disease...............................................              11               0              11

[[Page 46962]]

 
Cancer..........................................................               7               0               7
Cerebral palsy..................................................               6               0               6
Multiple sclerosis..............................................               5               0               5
Other *.........................................................              21               0              21
Unknown/Not Reported............................................             123              21             144
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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.
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    \9\ Obtained by dividing NEISS estimates by U.S. Census Bureau 
population estimate for the respective year (for ages 13+). Latest 
data can be found at: National Population by Characteristics: 2020-
2021 (census.gov), https://www.census.gov/data/tables/time-series/demo/popest/2020s-national-detail.html.

          Table 5--NEISS Estimates for Injuries Related to Adult Bed Rails, January 2003-December 2021
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                                                                                                    Injury Rate
                              Year                                   Estimate       Sample size         \9\
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2003............................................................           4,500              98            1.88
2004............................................................           3,400              82            1.39
2005............................................................           3,900              94            1.61
2006............................................................           3,400              72            1.38
2007............................................................           4,300              98            1.73
2008............................................................           4,200             102            1.67
2009............................................................           3,600              98            1.42
2010............................................................           4,000             100            1.56
2011............................................................           3,700              95            1.44
2012............................................................           3,100              81            1.20
2013............................................................           4,700             127            1.79
2014............................................................           4,400             108            1.66
2015............................................................           4,600             112            1.73
2016............................................................           3,700              91            1.36
2017............................................................           4,900             128            1.81
2018............................................................           4,300             104            1.55
2019............................................................           4,500             112            1.63
2020............................................................           5,100             113            1.82
2021............................................................           5,100             131            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 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-

[[Page 46963]]

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.
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    \10\ IDIs contain summaries of reports of investigations into 
events surrounding product-related injuries or incidents based on 
victim/witness interviews.
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    The vast majority of nonfatal incident reports (all reports except 
one) did not list any underlying medical condition. Of the 310 fatal 
incidents, 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; Lesch-Nyhan 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 fall-related 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 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

[[Page 46964]]

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.
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 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 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.
---------------------------------------------------------------------------

    \11\ The FDA guidance document is available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/hospital-bed-system-dimensional-and-assessment-guidance-reduce-entrapment. (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.
---------------------------------------------------------------------------

    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.

[[Page 46965]]

[GRAPHIC] [TIFF OMITTED] TR21JY23.007

    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.

  Table 7--Rail Entrapment Incident Locations Relative to ASTM F3186-17
                            Entrapment Zones
------------------------------------------------------------------------
                                     Entrapment testing      Number of
     Rail entrapment location             location          fatalities
------------------------------------------------------------------------
Between APBR and mattress.........  Zone 2, 3, or 4.....             200
Within APBR itself................  Zone 1..............               8
Against outside of APBR...........  None................               5
Between APBR and headboard........  None (Zone 6).......               1
Unknown location..................  Unknown.............              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, 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 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

[[Page 46966]]

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
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of     Failure rate
                    Section                                   Title               failed samples     (percent)
----------------------------------------------------------------------------------------------------------------
                                          (Of 35 Total Samples Tested)
----------------------------------------------------------------------------------------------------------------
General Requirements:
    5.1.......................................  Hazardous Points/Edges..........               0               0
    5.2.......................................  Jagged Surfaces.................               0               0
    5.3.......................................  Articulated Beds................               0               0
Performance Requirements:
    6.1.......................................  Retention Systems...............              28              80
    6.2.......................................  Structural Integrity............              15              43
    6.3.......................................  Entrapment......................              33              94
    6.4.......................................  Openings........................               0               0
    6.5.......................................  Misassembled Products...........               8              23
Labels and Warnings Requirements:
    9.1.......................................  Labeling........................              35             100
    9.2.......................................  Warning Statements..............              35             100
Instructional Literature:
    11........................................  Instructional Literature........              35             100
----------------------------------------------------------------------------------------------------------------

    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 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 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.
---------------------------------------------------------------------------

    \12\ The ASTM standard does not define ``free-end.'' 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.
---------------------------------------------------------------------------

    All 35 models failed the labeling, warning, and instructional 
literature requirements. None of the 35 models

[[Page 46967]]

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 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
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of       Number of
                    Section                                   Title               failed samples  samples tested
----------------------------------------------------------------------------------------------------------------
General Requirements:
    5.1.......................................  Hazardous Points/Edges..........               0              17
    5.2.......................................  Jagged Surfaces.................               0              17
    5.3.......................................  Articulated Beds................  ..............               0
Performance Requirements:
    6.1.......................................  Retention Systems...............              13              17
    6.2.......................................  Structural Integrity............               7               7
    6.3.......................................  Entrapment......................              14              16
    6.4.......................................  Openings........................  ..............               0
    6.5.......................................  Misassembled Products...........               1               1
Labels and Warnings Requirements:
    9.1.......................................  Labeling........................              17              17
    9.2.......................................  Warning Statements..............              17              17
Instructional Literatue:
    11........................................  Instructional Literature........              17              17
----------------------------------------------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \13\ Press Release (PR) #21-122, https://www.cpsc.gov/Newsroom/News-Releases/2021/CPSC-Warns-Consumers-to-Stop-Use-of-Three-Models-of-Adult-Portable-Bed-Rails-Manufactured-by-Bed-Handles-Inc-Due-to-Entrapment-Asphyxia-Hazard.
---------------------------------------------------------------------------

    In December 2021, CPSC announced voluntary recalls of APBRs 
manufactured by three firms, due to the entrapment hazard and risk of 
death by asphyxia posed by their products:
     Drive DeVilbiss Healthcare (496,100 units, 2 deaths); \14\
---------------------------------------------------------------------------

    \14\ PR #22-025, https://www.cpsc.gov/Recalls/2022/Drive-DeVilbiss-Healthcare-Recalls-Adult-Portable-Bed-Rails-After-Two-Deaths-Entrapment-and-Asphyxiation-Hazards.
---------------------------------------------------------------------------

     Compass Health Brands (104,900 units, 3 deaths); \15\ and
---------------------------------------------------------------------------

    \15\ PR #22-040, https://www.cpsc.gov/Recalls/2022/Compass-Health-Brands-Recalls-Carex-Adult-Portable-Bed-Rails-After-Three-Deaths-Entrapment-and-Asphyxiation-Hazards.
---------------------------------------------------------------------------

     Essential Medical Supply, Inc. (272,000 units, 1 
death).\16\
---------------------------------------------------------------------------

    \16\ PR #22-039, https://www.cpsc.gov/Recalls/2022/Essential-Medical-Supply-Recalls-Adult-Portable-Bed-Rails-Due-to-Entrapment-and-Asphyxia-Hazard-One-Death-Reported.
---------------------------------------------------------------------------

    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 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.
---------------------------------------------------------------------------

    \17\ PR #22-148, https://www.cpsc.gov/Newsroom/News-Releases/2022/CPSC-Urges-Consumers-to-Immediately-Stop-Use-of-Mobility-Transfer-Systems-Adult-Portable-Bed-Rails-Due-to-Entrapment-and-Asphyxia-Hazard-Three-Deaths-Reported.
---------------------------------------------------------------------------

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

[[Page 46968]]

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.

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.

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.''
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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 long-term 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 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\
---------------------------------------------------------------------------

    \19\ Professional care facilities may use a variety of products, 
including APBRs and hospital bed rails, depending on the needs of 
the patient.
---------------------------------------------------------------------------

    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,

[[Page 46969]]

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\
---------------------------------------------------------------------------

    \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 [bond] 
Genworth.
---------------------------------------------------------------------------

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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
[GRAPHIC] [TIFF OMITTED] TR21JY23.008

    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

[[Page 46970]]

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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.

E. Proposed Entrapment Test Modifications

    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.
[GRAPHIC] [TIFF OMITTED] TR21JY23.009

    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

[[Page 46971]]

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 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 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 Sec.  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

[[Page 46972]]

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

    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.
    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.

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 30-day 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

[[Page 46973]]

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.

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 Sec.  
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 Sec.  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.
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, Sec.  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 
Sec.  1270.2(b)(1) have been renumbered from proposed Sec.  
1270.2(b)(1)(i) through (iii) to Sec.  1270.2(b)(1)(ii) through (iv) in 
the final rule to account for the addition of the new definition of 
entrapment zone in Sec.  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 Sec.  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, Sec.  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 Sec.  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.
5. Section 1270.2(b)(11) and (13)
    Based on a comment from Stander, the language in proposed Sec.  
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 Sec.  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, Sec.  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 Sec.  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 Sec.  1270.2(b)(13)(ii))
    The requirements of proposed Sec.  1270.2(b)(13)(ii) in the NPR 
have been renumbered as revised Sec.  1270.2(b)(14) in the final rule. 
Therefore, proposed Sec.  1270.2(b)(14) through (19) have been 
renumbered as Sec.  1270.2(b)(15) through (20) in the final rule. 
Revised Sec.  1270.2(b)(14) has been modified from the proposed rule 
because proposed Sec.  1270.2(b)(13) introductory text incorrectly 
stated that the language ``Instead of complying with [the applicable 
ASTM provision]'' applied to both Sec.  1270.2(b)(13)(i) and (ii). The 
introductory instructional text for proposed Sec.  1270.2(b)(13)(ii) 
should have read ``In addition to complying with [the applicable ASTM 
provision]''. Therefore, in the final rule, Sec.  1270.2(b)(14) has 
been revised to provide the correct introductory text.
    Additionally, Sec.  1270.2(b)(14)(i) in the final rule has been 
revised from proposed Sec.  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

[[Page 46974]]

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 Sec.  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.

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.

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 10-year 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 
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.

[[Page 46975]]

    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, 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 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.

                                      Table 10--Benefits of the Final Rule
----------------------------------------------------------------------------------------------------------------
                                                                                  Effective rates
                    Benefits discounted at 3%                    -----------------------------------------------
                                                                        75%             50%             25%
----------------------------------------------------------------------------------------------------------------
Total Benefits (2024-2053 in $B)................................           $3.92           $2.62           $1.31
Annualized Benefits (in $M).....................................          200.24          133.49           66.75
Per-Unit Benefits (in $)........................................          331.78          221.19          110.59
----------------------------------------------------------------------------------------------------------------

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 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     Present value
         Costs of proposed rule                ($M)            ($M)
------------------------------------------------------------------------
Cost of Redesigning Existing Models.....           $2.75           $2.59
Cost of Production of Redesigned APBRs..           60.43           35.65
Deadweight Loss.........................            2.07            1.23
------------------------------------------------------------------------

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 cost-benefit relationship of the final rule. The table displays 
these metrics using annualized benefits for the three 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%)         -----------------------------------------------
                                                                        75%             50%             25%
----------------------------------------------------------------------------------------------------------------
Benefits........................................................         $200.24         $133.49          $66.75
Costs...........................................................           $2.01           $2.01           $2.01
Net Benefits (Benefits-Costs)...................................         $198.23         $131.48          $64.73
B/C Ratio.......................................................           99.45           66.30           33.15
----------------------------------------------------------------------------------------------------------------


[[Page 46976]]

    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%             50%             25%
----------------------------------------------------------------------------------------------------------------
Benefits........................................................         $331.78         $221.19         $110.59
Costs...........................................................           $3.34           $3.34           $3.34
Net Benefits (Benefits-Costs)...................................         $328.45         $217.85         $107.26
B/C Ratio.......................................................           99.45           66.30           33.15
----------------------------------------------------------------------------------------------------------------

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 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 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 
non-compliant 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

[[Page 46977]]

the unreasonable risk of injury associated with APBRs.
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 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 
non-compliant 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 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

[[Page 46978]]

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.

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 East-West 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 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

[[Page 46979]]

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).

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. 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.


0
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.


Sec.  1270.1  Scope, application, and effective date.

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


Sec.  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 
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 [email protected], 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.

[[Page 46980]]

    (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 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/regulatory-information/search-fda-guidance-documents/hospital-bed-system-dimensional-and-assessment-guidance-reduce-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 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

[[Page 46981]]

[GRAPHIC] [TIFF OMITTED] TR21JY23.010

    (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.

Figure 2 to paragraph (b)(15)(i)--Zone 3 Test: (a) Pass, (b) Fail
[GRAPHIC] [TIFF OMITTED] TR21JY23.011

    (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).

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

[[Page 46982]]

[GRAPHIC] [TIFF OMITTED] TR21JY23.012

    (ii) [Reserved]
    (19) Instead of complying with section 9.2.7 of ASTM F3186-17, 
comply with the following:
    (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
[GRAPHIC] [TIFF OMITTED] TR21JY23.013

    (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]


Sec.  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.

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 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.

[[Page 46983]]

    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 
Sec.  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 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 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