[Federal Register Volume 87, Number 216 (Wednesday, November 9, 2022)]
[Proposed Rules]
[Pages 67586-67611]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-22692]


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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: Notice of proposed rulemaking; notice of opportunity for oral 
presentation of comments.

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SUMMARY: The U.S. Consumer Product Safety Commission (Commission or 
CPSC) has determined preliminarily that there is an unreasonable risk 
of injury and death associated with entrapment hazards from adult 
portable bed rails (APBRs). To address these risks, the Commission 
proposes a rule under the Consumer Product Safety Act (CPSA) to require 
that APBRs meet the requirements of the applicable voluntary standard 
on APBRs, with modifications. The Commission is providing an 
opportunity for interested parties to present written and oral comments 
on this notice of proposed rulemaking (NPR). Like written comments, any 
oral comments will be part of the rulemaking record.

DATES: 
    Deadline for Written Comments: Written comments must be received by 
January 9, 2023.
    Deadline for Request to Present Oral Comments: Any person 
interested in making an oral presentation must send an electronic mail 
(email) indicating this intent to the Office of the Secretary at [email protected] by December 9, 2022.

ADDRESSES: 
    Written Comments: Comments related to the Paperwork Reduction Act 
aspects of the instructional literature and marking requirements of the 
proposed rule should be directed to the Office of Information and 
Regulatory Affairs, OMB, Attn: CPSC Desk Officer, FAX: 202-395-6974, or 
emailed to [email protected]. In addition, written comments 
that are sent to OMB also should be submitted electronically at: 
www.regulations.gov, under Docket No. CPSC-2013-0022.
    Other comments, identified by Docket No. CPSC-2013-0022, may be 
submitted by any of the following methods:
    Electronic Submissions: Submit electronic comments to the Federal 
eRulemaking Portal at: www.regulations.gov. Follow the instructions for 
submitting comments. CPSC typically does not accept comments submitted 
by email, except as described below. CPSC encourages you to submit 
electronic comments by using the Federal eRulemaking Portal, as 
described above.
    Mail/Hand Delivery/Courier Written Submissions: Submit comments by 
mail/hand delivery/courier to: Office of the Secretary, Consumer 
Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814; 
telephone: (301) 504-7479. If you wish to submit confidential business 
information, trade secret information, or other sensitive or protected 
information that you do not want to be available to the public, you may 
submit such comments by mail, hand delivery, or courier, or you may 
email them to: [email protected].
    Instructions: All submissions must include the agency name and 
docket number. CPSC may post all comments without change, including any 
personal identifiers, contact information, or other personal 
information provided, to: www.regulations.gov. Do not submit through 
this website: confidential business information, trade secret 
information, or other sensitive or protected information that you do 
not want to be available to the public. If you wish to submit such 
information, please submit it according to the instructions for mail/
hand delivery/courier written submissions.
    Docket for NPR: For access to the docket to read background 
documents or comments received, go to: www.regulations.gov, insert the 
docket number CPSC-2013-0022 into the ``Search'' box, and follow the 
prompts.

FOR FURTHER INFORMATION CONTACT: Vineed Dayal, Directorate for 
Engineering Sciences, Office of Hazard Identification and Reduction, 
Consumer Product Safety Commission, National Product Testing and 
Evaluation Center, 5 Research Place, Rockville, MD 20850; telephone: 
301-987-2292; [email protected].

SUPPLEMENTARY INFORMATION:

I. Background and Statutory Authority

    In 2013, the CPSC received two requests to initiate proceedings 
under the CPSA to address an unreasonable risk of injury associated 
with APBRs. Gloria Black, the National Consumer

[[Page 67587]]

Voice for Quality Long-Term Care, Consumer Federation of America, and 
60 other organizations made one request; Public Citizen Health Research 
Group made 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 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 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 concerning 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 delivered a briefing package to the Commission (Staff's 2014 
briefing package).\1\ In that briefing package, staff responded to the 
comments received on the petition and recommended that the Commission 
defer a decision on the petition to allow the voluntary standards 
process to continue until the APBR standard had been developed and 
evaluated by staff. On April 29, 2014, the Commission voted to defer 
the petition to allow progress to continue on the 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 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 a briefing package 
on its review of ASTM F3186-17 (Staff's 2020 briefing package).\2\ 
Staff's review indicated that ASTM F3186-17, with certain modifications 
to the labeling, warning statements, and instructional literature, 
would adequately address the hazards identified in the known incident 
reports. However, when staff assessed compliance to the voluntary 
standard, as discussed in section IV.B. of this preamble, staff found 
no market compliance with the voluntary standard. To increase market 
awareness of and compliance with the voluntary standard, in June 2020, 
CPSC's Office of Compliance sent a letter to 19 known APBR 
manufacturers, urging industry members to stop manufacturing, 
distributing, and selling APBRs that do not comply with ASTM F3186-17. 
Staff also continued to engage actively with 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 for all its members to review and 
disseminate, supplied updated incident data for the subcommittee's 
review, and participated as technical experts at all subcommittee task 
groups.
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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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    On March 9, 2022, staff provided to the Commission another briefing 
package on ASTM F3186-17 (Staff's 2022 briefing package).\3\ Staff's 
2022 briefing package updated the Staff's 2020 briefing package with 
incident data that included all known APBR incidents from January 2003 
through September 2021. In addition, staff discussed the results of the 
two rounds of testing it had conducted on APBRs, and whether there was 
any change in the levels of compliance in the APBR market. Staff 
recommended that the Commission grant the petition and direct staff to 
prepare a briefing package and initiate rulemaking through a notice of 
proposed rulemaking (NPR) to address the entrapment hazards associated 
with APBRs.
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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 March 16, 2022, the Commission voted to grant Petition CP 13-1 
and directed staff to proceed with this NPR. In this proposed rule, the 
Commission preliminarily determines that APBRs pose an unreasonable 
risk of injuries and deaths associated with entrapment hazards.\4\ As 
discussed in section V. of this preamble, the Commission preliminarily 
determines that the voluntary standard is not likely to eliminate or 
adequately reduce the unreasonable risk of injury associated with 
entrapments on APBRs. Accordingly, the Commission is proposing to adopt 
the voluntary standard with specified modifications necessary to 
improve safety and adequately reduce the unreasonable risk of injury 
associated with entrapment on APBRs. The information discussed in this 
preamble is derived primarily from CPSC staff's briefing package for 
the NPR (Staff's NPR briefing package).\5\
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    \4\ The Commission voted 4-0 to approve this document.
    \5\ Available at: https://www.cpsc.gov/s3fs-public/ProposedRuleSafetyStandardforAdultPortableBedRails.pdf?VersionId=Ypa89Iczh13C40Tq7EJRSMDZoatChf1.
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    This proposed rulemaking 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 commencing this rulemaking 
by issuing an NPR.
    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
     The means to achieve the objective of the rule while 
minimizing adverse effects on competition, manufacturing, and 
commercial practices.

Id. 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)&(B). Additionally, if a

[[Page 67588]]

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)&(F).

II. Product Description

    There are several types of bed rails available to consumers under 
CPSC jurisdiction.\6\ 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 of 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 types of bed rails.
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    \6\ Information on adult bed rails regulated by the U.S. Food 
and Drug Administration (FDA) jurisdiction 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, FDA regulations refer to ``movable and latchable 
side rails.'' See 21 CFR 880.5100, 880.5110, 880.5120. The FDA 
regulates adjustable hospital beds used for medical purposes. 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. APBR intended for use with a 
non-FDA regulated bed and that are not considered by the FDA to have 
a medical purpose fall under the CPSC's jurisdiction. These types of 
bed rails are within the CPSC's jurisdiction regardless of the bed's 
location (i.e., long-term care facility, hospice, or residence). 
ASTM F3186-17 (section 1.3) covers both APBRs that meet the 
definition of a medical device under FDA's jurisdiction, and APBRs 
that are not medical devices, and fall under CPSC's jurisdiction 
pursuant to the CPSA.
[GRAPHIC] [TIFF OMITTED] TP09NO22.000

    Although similar in design, these products may have different 
functions. Some are meant to keep the occupant from rolling out of bed, 
and others are intended to assist an occupant in getting in and out of 
bed or repositioning on the bed surface. Some of these products can 
serve both functions. Because of the similarity in design and means of 
attachment to the side of the bed, products intended for both types of 
uses can have 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, staff estimates 
that in 2021, the mean retail price is $50 per APBR; total market 
revenues are approximately $9 million; and the number of APBRs sold 
that year was approximately 180,000 units.

III. Risk of Injury

    CPSC staff summarized the data on deaths and injuries involving 
APBRs (Tab A: Division of Hazard Analysis: Directorate for Epidemiology 
(EPHA)). 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.

A. CPSRMS

    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

[[Page 67589]]

incidents were identified from death certificates, medical examiner 
reports, or coroner reports. Death certificate data often have lag time 
of around two to three years from date of reporting. As the APBR data 
in CPSRMS are heavily reliant on death certificates, data collection is 
ongoing and incident data for 2020, 2021, and 2022 should all 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 ages 70 or older. 
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
                                                                 -----------------------------------------------
    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
                                                                 -----------------------------------------------
    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, for example.\7\ Table 3 below shows the frequency of each 
location reported.
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    \7\ All of these reported incidents occurred with APBRs that 
fall under 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.

[[Page 67590]]



                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...............................................              10               0              10
Cancer..........................................................               7               0               7
Cerebral palsy..................................................               6               0               6
Multiple sclerosis..............................................               5               0               5
Other *.........................................................              20               0              20
Unknown/Not Reported............................................             123              21             144
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Source: CPSRMS (2003-2021).
* Other significant conditions included tracheotomy and G-tube, severe burn, post-surgery, fracture, seizure,
  Lesch-Nyhan syndrome, amyotrophic lateral sclerosis, multiple drug ingestion, renal disease, agitation,
  diabetes, sepsis, leukemia, severe disabilities, advanced age, and general weakness.
+ Table 4 sums to more than 332 due to multiple conditions reported.

B. NEISS

    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 appeared to 
be a statistically significant increasing trend in injuries during this 
period. Staff's review showed that in the vast majority of NEISS cases, 
there was insufficient information available in the case narrative to 
determine whether the bed rail product involved was specifically an 
adult portable bed rail, or just a regular adult 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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    \8\ According to the NEISS publication criteria, an estimate 
must be 1,200 or greater, the sample size must be 20 or greater, and 
the coefficient of variation must be 33 percent or smaller. All 
yearly estimates meet these criteria, and thus, are reportable.
    \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 here: 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 \8\     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: NEISS (2003-2021). Estimates rounded to nearest 100; rows may not add to total due to rounding.

    The vast majority (88 percent) of 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. This 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

    Staff from CPSC's Directorate for Health Sciences (HS) and from the 
Human Factors Division of the Directorate for Engineering Sciences 
(ESHF) (Tabs B and C of Staff's NPR briefing package) reviewed the 
incident

[[Page 67591]]

data to assess the affected population and the hazard modes associated 
with incidents involving APBRs. Staff found that 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 286 incidents 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. This category includes 284 fatalities and 
two nonfatal injuries from entrapment or wedging between the bed rail 
and mattress.
     Falls: There were 25 incidents 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. This category includes 23 deaths, one 
nonfatal knee fracture and one non-injury incident.
     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\ 
confirmed that APBRs product types, like those shown in Figure 1, were 
involved in these entrapment incidents. The victim was 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) patient 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 causes 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. Sustained external pressure on the neck 
can lead to ``asphyxia,'' defined in medical literature as the failure 
of cells to thrive in the absence of oxygen. 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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    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. The vast majority of nonfatal incident reports (all reports 
except one) did not list any 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;\11\ 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 represent the victims in 
most APBR-related fatalities, are especially vulnerable to such 
declines. Also, consumers commonly purchase and use APBRs because they 
require help when getting in or out of bed. Therefore, many APBR users 
would likely be less capable of escaping an entrapment scenario than 
the general population.
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    \11\ A rare genetic disease characterized by neurological and 
behavioral abnormalities and occurs almost exclusively in males.
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    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 fatality. Staff found that most falls 
associated with APBRs involve the victim falling against or striking 
the APBR, but these incident reports usually have limited details. 
Therefore, the APBRs might have played an incidental role in some of 
these cases. 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.
    Based on staff's review of ASTM F3186-17, the Commission has 
preliminarily determined that the voluntary standard is not likely to 
eliminate or adequately reduce the unreasonable risk of injury 
associated with entrapments on APBRs. In addition, based on several 
rounds of testing of APBRs, conducted by staff as discussed below, the 
Commission has preliminarily determined that substantial compliance 
with the voluntary standard is also unlikely. Accordingly, in this 
rule, the Commission proposes to incorporate by reference ASTM F3186-
17, with modifications, to address the entrapment hazards associated 
with APBRs. CPSC staff's assessment of the provisions of ASTM F3186-17 
are summarized below.

[[Page 67592]]

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 preliminarily determines that these definitions are 
appropriate for evaluating 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 a bed that articulates (i.e., is adjustable) must 
meet the performance requirements when the bed is in the flat and 
articulated positions.
    General requirements mandating smooth edges on exposed parts 
improve safety by preventing potential lacerations or skin injuries 
from APBRs. In addition, testing APBR products on articulating beds 
allows assessment of openings that could potentially lead to entrapment 
when 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
    Staff identified 284 fatal incidents related to rail entrapment. 
This hazard pattern is the most prevalent among the incidents, 
accounting for more than 90 percent of all fatal incidents. 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 call for the product to be tested without 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 (6.2), entrapment (6.3), or openings (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. However, the Commission seeks comment on whether this 
sufficiently reduces the risk, or if other measures, are needed.
b. Falls
    Falls were the second most common hazard pattern in the incident 
data, accounting for 25 incidents (8 percent). Staff found that most 
falls associated with APBRs involve the victim falling against or 
striking the APBR, but these incident reports usually have limited 
details. Therefore, the APBRs might have played an incidental role in 
some of these cases. If the fall was triggered by the APBR becoming 
dislodged, or 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. For example, section 6.2 
of ASTM F3186-17 includes a ``structural integrity'' requirement that 
calls for the installed APBR to extend at least 4 inches above the top 
of the thickest recommended mattress. This minimum height requirement 
for APBRs may address some fall incidents by limiting the ability of 
consumers to climb over these products. 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. In accordance with the entrapment test methods 
specified in section 8 of the standard, 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.\12\ The FDA's guidance is based on recommendations from the 
Hospital Bed Safety Workgroup (HBSW), which was formed in 1999 to 
address reports of patient entrapment. ASTM F3186-17 specifies the FDA 
probe to test entrapment zones. The probe design is based on the 
anthropometric dimensions of key body

[[Page 67593]]

parts, including the head, neck, and chest of at-risk adults.
---------------------------------------------------------------------------

    \12\ 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 zones require 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.
[GRAPHIC] [TIFF OMITTED] TP09NO22.001

    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.

  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.........  Zones 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 that rail entrapments predominantly occur in 
Zones 1 through 4 is also 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 proposed modifications, as discussed in section V. of 
this preamble.

[[Page 67594]]

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. The space between the APBR 
and headboard or footboard is considered Zone 6 under the 2006 FDA 
guidance document. ASTM F3186-17 requires the consumer to correctly 
install the APBR 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 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.
    For the reasons discussed in section V. of this preamble, the 
Commission preliminarily determines that the voluntary standard is not 
likely to eliminate or adequately reduce the unreasonable risk of 
injury associated with entrapments on APBRs. Accordingly, the 
Commission is proposing to adopt the voluntary standard with specified 
modifications necessary to improve safety and adequately reduce the 
unreasonable risk of injury associated with entrapment on 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, 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 APBR Market Compliance Testing
    From 2018 through 2019, CPSC's Directorate for Laboratory Sciences, 
Division of Mechanical Engineering staff tested 35 randomly selected 
APBR models for compliance with ASTM F3186-17, which became effective 
in August 2017. APBRs were purchased in 2018. Staff tested the products 
to determine if they conformed to the general requirements and the 
performance requirements of the standard. Staff also tested conformance 
with the labeling, warning, and instructional literature requirements. 
Staff found that none of the 35 sampled products conformed to the 
voluntary standard. Staff assessment showed that market compliance with 
the standard was low when staff purchased the samples in 2018, after 
the standard had become effective. However, due to the lack of 
compliant labeling, staff could not confirm all the manufacture dates 
for the products to compare them to the standard's effective date. As 
shown in Table 8 below, compliance varied by section of the standard. 
Overall, 33 APBR models did not meet the entrapment performance 
requirements, and none of the 35 models met the labeling, warnings, or 
instructional literature requirements.

                   Table 8--ASTM F3186-17, 2018 APBR Market Compliance Testing Result Summary
----------------------------------------------------------------------------------------------------------------
 
----------------------------------------------------------------------------------------------------------------
Section                                      Title........................          Number of       Failure rate
                                                                               failed samples                (%)
                                                                           -------------------------------------
                                             .............................      (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
----------------------------------------------------------------------------------------------------------------


[[Page 67595]]

    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.
    Staff's testing also revealed high failure rates in several other 
sections, 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,\13\ 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.
---------------------------------------------------------------------------

    \13\ The proposed 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 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 APBRs; 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 APBR Market Compliance Testing
    In 2021, CPSC 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 was sufficient for manufacturers to increase their 
overall level of compliance to the standard. A representative total of 
17 APBR products were selected and procured for testing: these included 
all 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 as available in the 
2018 analysis, and were included to account for any undisclosed changes 
to the 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 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 testing of a sample was 
stopped after it failed 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 changes in the market over this time.

                   Table 9--ASTM F3186-17, 2021 APBR Market Compliance Testing Result Summary
----------------------------------------------------------------------------------------------------------------
                                                                            Number of  failed      Number of
                  Section                                Title                   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 Literature:
    11.....................................  Instructional Literature.....                 17                 17
----------------------------------------------------------------------------------------------------------------

4. Section 15 Compliance Actions 2021-2022
    CPSC has issued five public notices regarding 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.\14\ Bed Handles, Inc., 
manufactured approximately 193,000 units of the bed rails, and CPSC is 
aware of four entrapment deaths associated with them.
---------------------------------------------------------------------------

    \14\ 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

[[Page 67596]]

entrapment hazard and risk of death by asphyxia posed by their 
products:
     Drive DeVilbiss Healthcare (496,100 units, 2 deaths); \15\
---------------------------------------------------------------------------

    \15\ 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); and \16\
---------------------------------------------------------------------------

    \16\ 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).\17\
---------------------------------------------------------------------------

    \17\ 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 model have occurred.\18\ Neither firm 
agreed to conduct a recall. Approximately 285,000 units were 
manufactured.
---------------------------------------------------------------------------

    \18\ 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.
---------------------------------------------------------------------------

5. APBR Market Compliance Testing Summary
    As discussed in section V. of this preamble, the Commission 
preliminarily determines that, without additional modifications, the 
voluntary standard is insufficient to eliminate or adequately reduce 
the unreasonable risk of injury of entrapments on APBRs. Moreover, 
based on staff's test results showing that there is no market 
compliance with the voluntary standard, the Commission preliminarily 
determines that substantial compliance to a voluntary adult portable 
bed rail safety standard is unlikely. Accordingly, the Commission 
proposes to incorporate by reference, ASTM F3186-17 with modifications, 
to require APBR manufacturers to comply with the mandatory standard and 
thereby improve safety.

V. Proposed Requirements

    The Commission preliminarily determines that ASTM F3186-17, with 
modifications to improve safety, would likely address all known product 
hazard modes associated with APBRs, and particularly entrapment. These 
modifications are as follows:
     Provide additional definitions for product ``assembly'' 
and ``installation'' to ensure their consistent and differentiated use 
throughout the document;
     Include recommendations for manufacturers to take into 
account the range of mattress thicknesses to ensure safe use of the 
product by the consumer and provide testers with additional guidance 
for selecting the mattress thickness during the test setup;
     Address inconsistencies with stated dimensions to ensure 
consistent dimensional tolerances;
     Provide additional clarity for Zone 1 and 2 test setup and 
methods;
     Provide additional guidance for identifying potential Zone 
2 openings;
     Update the requirements for Zone 3 testing for 
consistency; and
     Make grammatical and editorial corrections.\19\
---------------------------------------------------------------------------

    \19\ Tab F of Staff's NPR briefing package provides a redline 
version in sequential order as the sections appear in ASTM F3186-17.
---------------------------------------------------------------------------

A. Description of Proposed Sec.  1270.1--Scope, Application, and 
Effective Date

    Proposed Sec.  1270.1 provides that new part 1270 establishes a 
consumer product safety standard for APBRs manufactured after 30 days 
after publication of the final rule in the Federal Register.

B. Description of Proposed Sec.  1270.2--Requirements for Adult 
Portable Bed Rails

    Proposed Sec.  1270.2 sets forth the requirements for APBRs that 
are required in addition to those required by ASTM F3186-17. Section 
1270.2(a) would require each APBR to comply with all applicable 
provisions of ASTM F3186-17 with the following changes as set forth in 
Sec.  1270(b):
1. Propose New Clarifying Definitions on ``Assembly'', ``Installation'' 
and ``Component''(Sections 3.18, 3.1.9, 3.1.10)
    The Commission proposes to add the following new definitions to 
ASTM F3186-17.
     Section 3.1.8: Initial Assembly, the first assembly of the 
product components after purchase, and prior to installing on the bed.
     Section 3.1.9: Initial Installation, the first 
installation of the product onto a bed or mattress.
     Section 3.1.10: Installation Component, component(s) of 
the bed rail that is/are specifically designed to attach the bed rail 
to the bed and typically located under the mattress when in the 
manufacturer's recommended use position.
    These proposed definitions are intended to differentiate between 
``assembly'' and ``installation'' so manufacturers can ensure products 
meet the requirements of sections 6.1.3 and 9.2.7, as discussed below. 
Although ``installation component'' is used throughout the voluntary 
standard, it was not explained. The new proposed definition helps 
clarify the location of warnings from section 9.2.7.
2. Propose Clarifications to Sections 6.1.3 and 9.2.7
    The Commission proposes to revise sections 6.1.3 and 9.2.7 with the 
definitions provided in proposed sections 3.1.8, 3.1.9 and 3.1.10 as 
follows:
     Section 6.1.3: Revise ``Permanently attached retention 
system components shall not be able to be removed without the use of a 
tool after initial installation'' by changing ``initial installation'' 
to ``initial assembly.''
    Staff's review shows that making the retention system permanent 
during product assembly ensures that retention system integrity is 
maintained, even if the product is reinstalled after initial assembly. 
Retention systems are a critical component for reducing known product 
hazards. Removable retention systems are known to lead to entrapment 
hazards. The additional definitions make clear that retention system 
should remain attached to the product and should not be compromised 
after initial assembly and between uninstallation, and reinstallation 
of the product.
     Section 9.2.7: Revise ``At least one conspicuous component 
of the product must be labeled with the following entrapment warning'' 
by changing ``conspicuous component'' to ``installation component.''

[[Page 67597]]

[GRAPHIC] [TIFF OMITTED] TP09NO22.002

    Staff's review demonstrates that this warning is intended to draw 
attention to the installation component and to encourage its use. The 
installation component is commonly located under the mattress during 
use, and therefore, the warning would not be ``conspicuous'' when in 
the manufacturer's recommended use position. Requiring the warning to 
be on a ``conspicuous component'' most likely would not permit the 
warning to be placed on an installation component. The proposed 
language would instead draw attention to the installation component. 
Furthermore, the warning required by section 9.2.6, which also 
discusses entrapment hazards and keeping the product tight against the 
mattress, is required to be placed on an installation component rather 
than on a conspicuous component.
3. Propose Clarifications to Sections 6.5.1 and 6.5.2
    The Commission proposes to clarify the following sections of ASTM 
F3186-17:
     Sec.  6.5.1: Revise ``Any structural components and 
retention system components of a product covered by this specification 
that require consumer assembly shall not be able to be misassembled 
when evaluated to 6.5.2'' to ``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 6.5.2.''
    This revision clarifies that disassembly with the use of a tool is 
not considered as ``misassembly'' under section 6.5.
    Section 6.5.2: Revise ``Determining Misassembled Product: A product 
covered by this specification shall be considered misasssembled if it 
appears to be functional under any condition and it does not meet the 
requirements of 6.1-6.4.''
    This editorial change corrects the misspelling of ``misasssembled'' 
to ``misassembled.''
4. Propose New Sections to Address Mattress Variability (Section 
6.2.1.1, Section 7.1.3)
    Staff's review shows that mattress thickness is a known variable 
that may cause some APBR product designs to have hazardous entrapment 
zones. Accordingly, to improve the safety of APBRs, the ASTM F3186-17 
requirements should provide additional guidance on what thickness of 
mattress to use for testing APBR products. The following proposed new 
sections address this issue:
     Section 6.2.1.1: If the manufacturer does not recommend a 
specific applicable range of mattress heights or thicknesses, the test 
personnel shall choose a mattress that provides the most severe 
condition per test requirement. If the product has adjustable settings, 
and the manufacturer does not recommend orienting or adjusting features 
on the product in a specific manner, the testers shall adjust the 
product to the most severe condition per test requirement.
    Defining a range of recommended mattress thicknesses provides 
consumers with necessary information for safe use of the product. If no 
mattress thickness is recommended, consumers may incorrectly assume 
safe use with any mattress thickness. Similarly, products may come with 
many types of adjustable settings. If appropriate setting 
recommendations are not provided, consumers may incorrectly assume all 
settings are safe. This requirement does not supersede misassembly 
requirements in section 6.5 but is proposed to be applied in addition 
to those requirements.
     Section 7.1.3: Mattress thickness ranges used for testing 
may be up to 1.5 in (38 mm) larger or smaller than the range specified 
by the manufacturer. If the manufacturer does not recommend a 
particular range of mattress heights, the testers shall choose a 
mattress that provides the most severe condition per test requirement. 
NOTE *: Proposed Mattress Type Clarification: 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.
    Because mattress types are constantly changing, the proposed 
language in sections 6.2.1.1 and 7.1.3 informs manufacturers and 
testers to be aware of the types and variability of mattresses 
consumers may be using with these products and test accordingly. 
Consumers cannot be expected to be able to consistently measure 
mattress thickness, nor to purchase a new mattress for proper 
compatibility with a bed rail. Additionally, consumers are likely to 
follow nominal thickness descriptors of their mattresses which may vary 
from actual specifications. This additional range proposed for testing 
in new proposed section 7.1.3 may be up to 1.5 in (38 mm) larger or 
smaller than the range specified by the manufacturer, will increase 
safety by accounting for foreseeable reasonable differences between 
nominal and actual mattress thicknesses.
5. Propose Revisions to Entrapment Test Probe (Section 7.2) To Update 
References
     Section 7.2: Entrapment Test Probe--This section is 
revised to update references. Currently, ASTM F3186-17 provides that: 
The test probe shall be as described in the FDA Guidance Document, 
``Hospital Bed System Dimensional and Assessment Guidance to Reduce 
Entrapment,'' which can be found at: http://www.fda.gov/MedicalDeviceRegulationandGuidance/GuidanceDocuments/ucm072662. The 
test probe can be independently manufactured or it can be purchased 
from NST Sales & Customer Service Office, 5154 Enterprise Blvd., 
Toledo, Ohio 43612, 800-678-7072, www.nst-usa.com. video illustrating 
use of the test probe is available at the NST website (free 
registration required).
    To update outdated references, this section is proposed to be 
changed to state that the FDA guidance may 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 Development 
Corporation, 5154 Enterprise Blvd., Toledo, OH 43612,

[[Page 67598]]

800-551-7096, https://bionix.com. Videos illustrating use of the test 
probe are available at www.youtube.com/c/BionixLLC/search.''
6. Propose Revisions to Performance Requirements for Zone 3 Entrapment 
(Sections 6.3.3, 8.4.5.4, and 6.4.1)
    The Commission is proposing revisions to test for Zone 3 entrapment 
hazards
     Section 6.3.3: Zone 3--Revise ``The highest point on the 
cylinder of the test probe (see 7.2) shall not pass completely below 
the horizontal uncompressed plane of the mattress when tested according 
to 8.4.5.'' Add at the end of the sentence ``. . .when tested in 
accordance with section 8.4.5, the horizontal centerline on the face of 
the 4.7 in (120 mm) end of the test probe (see 7.2) shall be above the 
highest point of the uncompressed mattress.''
     Section 8.4.5.4: Revise ``Turn the cone until the 
centerline on the face of the 4.7 in (119.38 mm) end is horizontal and 
let the cone sink into the space by its own weight. (1) If the line on 
the face of the 4.7 in (120 mm) end of the cone is above the surface of 
the mattress highest point of the uncompressed mattress, as shown in 
Figure 4a, the space passes the test. (2) If the line on the face of 
the 4.7 in (120 mm) end of the cone is at or below the surface of the 
mattress, the space fails the test.'' Instead of the ``below the 
surface of the mattress'' insert ``below the highest point of the 
uncompressed mattress, as shown in Figure 4b.''
     Section 8.4.5.4. Add the following proposed figures 
(Figure 4a and Figure 4b) for reference for Zone 3 test:
[GRAPHIC] [TIFF OMITTED] TP09NO22.003

    CPSC staff's review showed that the Zone 3 entrapment performance 
requirement in section 6.3.3 is redundant due to the failure criteria 
described in the associated test method, section 8.4.5.4. To ensure 
consistency, proposed revisions to these sections more accurately 
describe the test method for the highest level of safety and are also 
more consistent with the FDA guidance document referenced in the 
standard. In addition, the Figures 4a and 4b are proposed to assist 
testers in visualizing the test criteria.
     Section 6.4.1 Revise the measurements in ``Holes or slots 
that extend entirely through a wall section of any rigid material less 
than \1/4\ in (6.35 mm) thick and admit a \5/8\ in (15.9 mm) diameter 
rod shall also admit a 1 in (25.4 mm) diameter rod. Holes or slots that 
are between 8 mm and 25 mm and have a wall thickness less than \1/4\ in 
(6.35 mm) but are limited in depth to \1/4\ in (6.35 mm) maximum by 
another rigid surface shall be permissible (see Fig. 2)'' to the 
following: ``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 Fig. 2).''
    Staff's review showed that the measurement references in 6.4.1 were 
not accurate or consistent throughout the section, or the referenced 
Figure 2. The proposed change to this section fixes those issues and 
harmonizes the requirements with other established ASTM standards that 
have similar requirements such as ASTM F2085 (Children's Portable Bed 
Rails), codified under 16 CFR part 1224.
7. Revise Entrapment Testing Probe Pull Force Application for 
Entrapment Zones 1 and 2
    To make the current language and test method in ASTM F816-17 
section 8.4.4 for Zone 2 entrapment testing (Between the Product 
Support(s) and the Bed Mattress, When Applicable, Under the Product) 
clearer and more repeatable, the proposed rule contains the following 
changes under section 8.4.4.
     Section 8.4. NOTE 1: Revise ``The tests described in this 
section are identical to those described in the referenced FDA Guidance 
Document and in the NSA video'' to ``The tests described in this 
section are similar to those described in the referenced FDA Guidance 
Document.''
    Although the FDA guidance document is the source of the entrapment 
test methodologies, there are several differences in the proposed 
standard and the FDA guidance document. In addition, the NSA video is 
not available.
     Section 8.4.3.4: Revise ``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 tool perpendicular to the plane of the opening in both directions. 
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 and pass through any of the openings, this 
space fails the test'' to ``If the test probe does not pull through 
freely attach the force gauge and exert a 22.5 lbf (100 N) pulling 
force along the axis of the cone, perpendicular to the 2.4 in (60 mm) 
cylindrical end of the entrapment test tool. If the 4.7 in (120 mm) end 
of the cone does not enter any

[[Page 67599]]

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.''
    As explained by CPSC staff, the intent of this test is to determine 
if both the 2.4 in and 4.7 in portions of the test probe cone can enter 
or pass through any Zone 1 opening under the required force. This would 
mean that a body part can be entrapped, and a hazard is present. 
Furthermore, applying the force perpendicular to the opening may have 
multiple interpretations and may not always emulate the known hazard of 
head or limb entrapment. Applying the pull force perpendicular to the 
2.4 in cylindrical end of the cone better represents these known 
hazards when compared to a pull force applied perpendicular to the face 
of the rail.
     Section 8.4.4.3: Revise ``Insert the 2.4 in (60 mm) end of 
the cone perpendicular to the opening from the longitudinal centerline 
of the mattress'' to ``Insert the 2.4 in (60 mm) end of the cone into 
the opening.'' Slide 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.
    The intent of this requirement is to address entrapment hazards 
associated with bed rails and head entrapment in Zone 2 by ensuring 
that the test probe cannot pass through any openings in the entrapment 
zone. This criterion is based on the FDA guidance document, which 
includes a dimension of 120 mm (4.75 in), encompassing the 5th 
percentile female head breadth. This dimension is represented by the 
4.7 in portion of the test probe, and it should be applied in any 
orientation in which the head may be entrapped. The removed language 
may have led test personnel to unnecessarily restrict orientations to 
which the probe is applied.
     Section 8.4.4.4: Revise ``Using the force gauge, exert a 
22.5 lbf (100 N) pulling force to the 2.4 in (60 mm) cylindrical end of 
cone in both directions perpendicular to the rail'' to ``If the test 
probe does not pull through freely, use the force gauge to exert a 22.5 
lbf (100 N) pulling force along the axis of the cone, perpendicular to 
the 2.4 in (60 mm) cylindrical end of cone.''
    The intent of this test is to determine if both the 2.4 in and 4.7 
in portions of the test probe cone can enter or pass through the Zone 2 
opening under the required force. This would mean that a body part can 
be entrapped, and a hazard is present. Applying the pull force 
perpendicular to the 2.4 in cylindrical end of the cone represents 
these known hazards better when compared to a pull force applied 
perpendicular to the face of the rail, and also reduces ambiguity.
    In addition, to take in account bed rails that have significant 
overhang, the NPR proposes to add new section 8.4.4.5.
     Section 8.4.4.5: If a horizontal section of the rail 
greater than 4.7 in (120 mm) exists along the bottom of the rail, that 
section must also meet the Zone 2 requirements.
    Bed rails that have significant overhanging elements that would 
allow the passage of the head in a manner consistent with identified 
Zone 2 entrapment hazards were not considered during the development of 
the APBR testing procedure, but the overhang could potentially result 
in a similar entrapment. Thus, the requirements and test methods for 
these types of openings should be consistent with the Zone 2 
requirements as reflected in the proposed language.
8. Propose New Note To Clarify Retention Test
    Section 8.6.3 of ASTM F3186-17 currently requires that ``a 50 lbf 
force (222.5 N) force to be applied to the free end of the retention 
system in the horizontal direction,'' without adequately defining the 
term ``free end''. By adding a note to the end of section 8.6.3., to 
explain the location of the ``free end'' will clarify the test method 
for testers and make it more repeatable. Accordingly, the Commission 
proposes to add the following note:
     Section 8.6.3 NOTE ***: 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.
9. Propose Clarifications to Labels and Warning Requirements.
     Section 9.1.1.3: Revise ``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 either <2.4 in (60 mm) or >12.5 in (318 mm)'' to remove ``either 
<2.4 in (60 mm) or'' from the last sentence.
    This proposed change addresses an inconsistency between section 
9.1.1.3, which states that products may be installed <2.4 in or >12.5 
in away from head or footboards, and section 9.2.6, which states that 
products must be installed at least 12.5 in from headboards or 
footboards.
     Section 9.2.5: Revise the warning statement: Each 
product's retail package and instructions shall include the following 
warning statements:
[GRAPHIC] [TIFF OMITTED] TP09NO22.004

    This proposed change is a grammatical edit and brings the warning 
language into alignment with similar language used in section 9.2.6.
     Section 11.1.1.3: Revise ``In addition to contacting the 
manufacturer directly, consumers should report

[[Page 67600]]

problems to the CPSC at is website SaferProducts.gov or call 1-800-638-
2772, or to the FDA at 1-800-332-1088'' to change ``is'' to ``its.''
    This proposed change is a grammatical edit.

C. Description of Proposed Sec.  1270.3--Prohibited Stockpiling

    The CPSC is proposing an anti-stockpiling provision to prevent 
firms from manufacturing large quantities of non-compliant APBRs before 
the rule takes effect and seeks comment on this provision. This section 
would make it a prohibited act for manufacturers and importers to 
manufacture or import APBRs that do not comply with the requirements of 
this part in any 1-month period between the date of publication of the 
final rule and the effective date of the final rule 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. 
The proposed base period for APBRs would be the calendar month with the 
median manufacturing or import volume within the last 13 months 
immediately preceding the month of promulgation of a final rule.

D. Proposed Findings--Sec.  1270.4

    The findings required by section 9 of the CPSA are discussed 
throughout this preamble and set forth in Sec.  1270.4 of the proposed 
rule.

VI. Preliminary Regulatory Analysis

    Pursuant to section 9(c) of the Consumer Product Safety Act, 
publication of a proposed rule must include a preliminary regulatory 
analysis containing:
     A preliminary description of the potential benefits and 
potential costs of the proposed 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 discussion of why a relevant voluntary safety standard 
would not eliminate or adequately reduce the risk of injury addressed 
by the proposed rule.
     A description of any reasonable alternatives to the 
proposed rule, together with a summary description of their potential 
costs and benefits and why such alternatives should not be published as 
a proposed rule.

A. Preliminary Description of Potential Benefits and Costs of the Rule

    CPSC's preliminary assessment of the potential benefits and costs 
show that the annualized present value of the potential societal costs 
of the proposed rule is $298.11 million. If 92 percent of deaths caused 
by entrapment are addressed by the proposed rule, there are potential 
annual benefits of $266.99 million. CPSC also assessed lower efficacy 
rates of the proposed rule which showed the quantifiable benefits of 
the proposed rule in the range of $66.75 million (assuming a 25% 
efficacy rate) to $200.24 million per year (assuming a 75% efficacy 
rate). The costs associated with the proposed 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 proposed rule are 
estimated between $110.59 per APBR (25%) and $331.78 per APBR (75%), 
and the costs are estimated at $3.34 per APBR. All these amounts are in 
2021 dollars using a discount rate of 3 percent. Staff's analysis is 
based 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 whether these incidents would be prevented by the proposed 
rule.
1. Benefits of the Proposed Rule
    The potential benefits and costs of the proposed rule are discussed 
in Tab G of the Staff's NPR briefing package. 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. For the 
preliminary regulatory analysis, staff chose the period of 2010 through 
2019 to base its rates of fatalities per product because it was the 
most recent 10-year window where all or nearly all incidents have been 
reported. Staff 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 proposed rule. To 
forecast entrapment deaths into the future, staff used death rates per 
million APBRs in conjunction with its forecast of APBRs in use 
throughout the study period. Staff assumed deaths would stay the same 
as the average rates observed between 2010 to 2019: 31.9 deaths per 
million APBRs. Staff forecasted APBRs in use using the population 
breakdown by age of APBR users, adjusted for population demographics 
and the growth of home healthcare spending.
    To estimate the societal costs of entrapment deaths, staff applied 
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. This is a ``willingness to pay'' methodology that attempts to 
measure how much individuals are willing to pay for a small reduction 
in their own mortality risks, or how much additional compensation they 
would require to accept slightly higher mortality risks. For this 
analysis, staff applied estimates 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. Staff 
multiplied 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 proposed rule.
    CPSC staff assumes that the number of firms and APBR 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 between 2024 and 2053 as a result of an 
aging U.S. population. Assuming the rates 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 value of a 
statistical life (VSL) of $10.5 million (2021 dollars), the annualized 
present value of the potential costs of the proposed rule is $298.11 
million.
    Staff did not include injuries in its benefit-cost assessment 
because for many incidents involving injuries, there is not sufficient 
information to determine whether they would be prevented by the 
proposed rule. However, staff has quantified and monetized the injuries 
in a sensitivity analysis as a potential upper limit to assess the 
benefits of this proposed rule. The requirements of the proposed rule 
are expected to address 92 percent of deaths caused by entrapment. 
However, staff also assessed potential benefits under three scenarios 
derived from this baseline efficacy, estimating benefits at: 75 
percent, 50 percent, and 25 percent of their potential value.
    At these rates under varying conservative assumptions (i.e., likely 
to underestimate the benefits of the rule), CPSC staff estimates the 
annualized benefits of the proposed rule to be $200.24 million, $133.49 
million, and $66.75 million, respectively. As discussed below, staff 
estimates

[[Page 67601]]

annualized costs associated with the proposed requirements to prevent 
APBR hazards 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 shows the annualized net benefits 
under the scenarios.

                                     Table 10--Net Benefits of Proposed 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
----------------------------------------------------------------------------------------------------------------

    Table 11 compares the benefits and costs on a per-unit basis, to 
add a marginal value perspective.\20\ These metrics again show the 
proposed rule's benefits well exceed costs at each scenario.
---------------------------------------------------------------------------

    \20\ Average undiscounted benefits are calculated by summing the 
benefits from the proposed rule over the 2024-2053 study period and 
dividing by the number of APBRs produced during the same period. 
Average undiscounted costs are similarly calculated. Present Values 
are calculated by determining the benefits and costs of the proposed 
rule in the year in which they were incurred and discounting those 
values by 3 percent for each future year. The present values are 
summed over the 30-year study period and divided by the number of 
APBRs produced during this same period.
---------------------------------------------------------------------------



                         Table 11--Shows the Per-APBR Net Benefits of the Proposed 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
----------------------------------------------------------------------------------------------------------------

2. Costs of the Proposed Rule
    Staff's regulatory assessment of the costs of the proposed rule 
assumed that 100 percent of manufacturers will fully redesign their 
APBR models to comply with ASTM F3186-17, with 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 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.\21\
---------------------------------------------------------------------------

    \21\ Discounting future estimates to the present allows staff 
not only to consider the time value of money, but also the 
opportunity cost of the investment, which is, the value of the best 
alternative use of funds.
---------------------------------------------------------------------------

    The cost of implementing an APBR fix to address entrapment hazards 
includes the costs manufacturers incur to redesign existing models and 
produce new designs to comply with ASTM F3186-17, as well as any 
additional cost of producing the APBR that is associated with its 
redesign. Manufacturers incur design costs that include redesigning 
existing APBR models, and designing APBR models in the future, to 
comply with the ASTM F3186 as modified. Manufacturers would likely 
incur expenditures in design labor, design production, design 
validation, and compliance testing. 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, staff 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 proposed rule. For this analysis, staff estimated 
deadweight loss for each year the proposed rule is expected to have an 
impact on marginal cost and market price. Table 12 summarizes the cost 
of the proposed rule:

                Table 12--Total Cost of the Proposed 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

[[Page 67602]]

 
Deadweight Loss.........................            2.07            1.23
                                         -------------------------------
    Total Costs.........................           65.24           39.46
------------------------------------------------------------------------

3. Sensitivity Analysis
    A major source of uncertainty is the omission of nonfatal 
entrapment injuries in the benefits assessment. This may result in a 
significant under-estimation of the benefits of the proposed rule. In 
its sensitivity analysis, staff included the benefits of averting all 
nonfatal injuries reported in NEISS, despite the uncertainty of whether 
these incidents would be in-scope of this proposed rule. These 
estimates serve as the theoretical upper bound of benefits from the 
proposed rule.
    Staff used NEISS incidents and the Injury Cost Model (ICM) to 
extrapolate and generate national estimates for injuries from 
entrapment treated in EDs and other settings. The ICM calculated that 
there were 125,121 nonfatal injuries from entrapment in the United 
States from 2010 to 2019. Of this total, 79,563 were treated in an 
outpatient setting (e.g., doctor's office, or clinic), 39,149 resulted 
in ED treatment, and 6,409 resulted in hospital admissions. Over 30 
years, staff estimates the societal costs from injuries associated with 
entrapments, annualized and discounted at 3 percent, to be $195.52 
million for doctor's office/clinic, $179.49 million for ED, and $289.64 
million for hospital admissions.
    To forecast injuries from entrapment into the future, staff used 
injury rates per million APBRs in conjunction its forecast of APBRs in 
use throughout the study period. Staff assumed injuries would stay the 
same as the average rates observed between 2010 to 2019: 1,293.6 
hospital admissions per million APBRs in use; 7,902.2 ED admissions per 
million APBRs in use; and 16,059.7 doctor/clinic visits per million 
APBRs in use. Staff forecasted APBRs in use based on the population 
breakdown by age of APBR users, adjusted for population demographics 
and the growth of home healthcare spending. Staff estimated the 
societal costs of nonfatal injuries using the ICM. The ICM estimates 
that the costs (in 2021 dollars) associated with nonfatal entrapment 
injuries using the quality adjusted life years are: $15,270 for 
injuries treated at the doctor's office/clinic; $28,849 for injuries 
treated in the ED; and $280,832 for injuries that result in hospital 
admission.
    Table 13 below displays metrics for the benefits and costs of the 
proposed rule. The table displays net benefits (difference between 
benefits and costs) and the benefit-cost ratio (benefits divided by 
costs) to assess the cost-benefit relationship. The table displays 
these metrics using annualized benefits for the three scenarios: 75 
percent, 50 percent, and 25 percent. These metrics show the proposed 
rule's benefits well exceed costs in each scenario.
    Table 13 displays metrics for benefits, with nonfatal injuries 
included, and costs of the proposed rule.

                                     Table 13--Net Benefits of Proposed Rule
----------------------------------------------------------------------------------------------------------------
                                                                  Portion of benefits achieved over the baseline
                                                                         efficacy rate of redesigned APBRs
         Annualized net benefits  ($M, discounted at 3%)         -----------------------------------------------
                                                                        75%             50%             25%
----------------------------------------------------------------------------------------------------------------
Benefits........................................................         $698.73         $465.82         $232.91
Costs...........................................................            2.01            2.01            2.01
Net Benefits (Benefits-Costs)...................................          696.72          463.81          230.90
B/C Ratio.......................................................          347.04          231.36          115.68
----------------------------------------------------------------------------------------------------------------

    Table 14 compares the benefits, with nonfatal injuries included, to 
costs on a per-unit basis.

                                Table 14--Per-APBR Net Benefits of Proposed Rule
----------------------------------------------------------------------------------------------------------------
                                                                  Portion of benefits achieved over the baseline
                                                                         efficacy rate of redesigned APBRs
          Per-unit net benefits  ($, discounted at 3%)           -----------------------------------------------
                                                                        75%             50%             25%
----------------------------------------------------------------------------------------------------------------
Benefits........................................................       $1,157.74         $771.83         $385.91
Costs...........................................................            3.34            3.34            3.34
Net Benefits (Benefits-Costs)...................................        1,154.41          768.49          382.58
B/C Ratio.......................................................          347.04          231.36          115.68
----------------------------------------------------------------------------------------------------------------

B. Voluntary Standard

    Based on staff's evaluation of ASTM F3186-17, the Commission 
preliminarily determines that the voluntary standard is not likely to 
eliminate or adequately reduce the unreasonable risk of injury 
associated with entrapments on APBRs. Further, as discussed in section 
II of this preamble, and Tabs C and D of the staff NPR briefing 
package, staff collected sample populations of APBR models and tested 
them, first in 2018 through 2019, and then again in 2021. In each 
instance, all

[[Page 67603]]

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 thought that their products already conformed; two indicated some 
modifications were required to bring their products into compliance; 
and two expressed uncertainty 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 show that there 
is no substantial industry compliance with the voluntary standard at 
this time. Furthermore, substantial future industry compliance appears 
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 standard.

C. Alternatives to the Proposed Rule

    The Commission considered six alternatives to the proposed rule: 
(1) take no regulatory action; (2) conduct a recall of APBRs instead of 
promulgating a final rule; (3) conduct an educational campaign; (4) ban 
APBRs from the market entirely; (5) require enhanced safety warnings 
for APBRs; and (6) a later effective date. The Commission preliminarily 
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 to fail to address the entrapment hazards 
associated with APBRs, and consumers would remain at risk. The 
estimated $298.11 million average annualized societal costs would 
continue to be incurred by consumers in the form of deaths and 
injuries. For this reason, 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 to recall APBRs in use that present a 
substantial product hazard. With this alternative, manufacturers would 
continue to not comply with the voluntary standard and would not incur 
any costs to modify or test APBRs to comply with the proposed rule. 
However, recalls only apply to an individual manufacturers and sellers 
of APBRs, and do not extend to similar products that fall within the 
scope of ASTM 3186-17 and present the same hazards. In addition, 
recalls occur only after consumers have purchased and used such 
products and may have been killed or injured due to exposure to the 
hazard. Finally, recalls cannot directly prevent unsafe products from 
entering the market. Therefore, 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. For these reasons, 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 news releases or use other information 
and marketing techniques to warn consumers about entrapment hazards 
associated with APBRs, instead of issuing a mandatory rule. Information 
and marketing campaigns, in conjunction with CPSC recall actions, may 
reduce the number of injuries and societal costs associated with APBR 
entrapment hazards. However, education campaigns and recalls are not 
likely to adequately reduce the risk of injury from the entrapment 
hazard. As noted above, CPSC has issued recall announcements for APBRs 
in the past, and these have not adequately addressed the entrapment 
hazard. Furthermore, recalls and associated education campaigns occur 
only after consumers have been exposed to the hazard and potentially 
suffered injury or death due as the result. Therefore, the Commission 
does not find this alternative would adequately address the 
unreasonable risk of injury associated with APBRs.
4. Total Ban of APBRs From the Market
    The Commission could ban APBRs sold as consumer products. However, 
in considering this alternative, the Commission must weigh both 
quantifiable and unquantifiable factors of the utility of APBR use to 
consumers. APBRs provide benefits to users, including mobility, ease of 
access to beds, and the potential for at-home care. Considering both 
the quantifiable and unquantifiable costs and benefits, the net benefit 
of this alternative is likely less than that of the proposed rule. 
However, the Commission seeks comments on whether the proposed adoption 
of the modified ASTM standard sufficiently addresses the hazard and 
whether a ban is warranted, and if so, what the impact of a ban would 
be on consumers (e.g., lost consumer utility from not having the 
product).
5. Enhanced Safety Warnings on APBRs
    The Commission could require enhanced safety warnings on APBRs. 
Warning labels on APBRs have not produced the desired results of 
reducing entrapment injuries and deaths. 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. Accordingly, the Commission preliminarily 
finds that warnings alone would not adequately address the unreasonable 
risk of injury associated with APBRs. Although warnings and 
instructions have limited effectiveness, the labeling, warning, and 
instructional literature requirements of ASTM F3186-17 do beneficially 
address the risk of injuries and deaths associated with APBRs and CPSC 
proposes that they be adopted with modifications set forth in the 
proposed rule.
6. Later Effective Date
    The Commission could issue the new rule with an introduction time 
greater than the 30 days recommended in this proposed rule. APBRs that 
present an unreasonable risk of death or injury from entrapment would 
continue to enter the marketplace during that time. Delaying the 
benefits of the rule likely results in higher social costs, in exchange 
for limited benefits to producers, who would still be required to 
revise their APBR products. Furthermore, manufacturers of APBRs have 
long had notice of the requirements of ASTM F3186-17 and, as staff 
investigation confirms, are familiar with the core requirements of the 
proposed rule. For this reason, staff does not recommend this 
alternative.

VII. Initial Regulatory Flexibility Analysis

    Whenever an agency publishes an NPR, section 603 of the Regulatory 
Flexibility Act (RFA), 5 U.S.C. 601-612, requires agencies to prepare 
an initial regulatory flexibility analysis (IRFA), unless the head of 
the agency certifies that the rule will not have a significant

[[Page 67604]]

economic impact on a substantial number of small entities. The IRFA, or 
a summary of it, must be published in the Federal Register with the 
proposed rule. Under section 603(b) of the RFA, each IRFA must address:
    (1) a description of why action by the agency is being considered;
    (2) a succinct statement of the objectives of, and legal basis for, 
the proposed rule;
    (3) a description and, where feasible, an estimate of the number of 
small entities to which the proposed rule will apply;
    (4) a description of the projected reporting, recordkeeping, and 
other compliance requirements of the proposed 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
    (5) an identification, to the extent practicable, of all relevant 
Federal rules which may duplicate, overlap, or conflict with the 
proposed rule.
    The IRFA must also describe any significant alternatives to the 
proposed rule that would accomplish the stated objectives and that 
minimize any significant economic impact on small entities. Staff's 
initial regulatory flexibility analysis is provided in Tab H of Staff's 
NPR briefing package.

A. Reason for Agency Action

    The purpose of the proposed rule is to reduce deaths and injuries 
resulting from entrapment on APBRs. CPSC staff identified 310 fatal 
injuries associated with APBR hazards in years 2003 through 2021. 
Although staff's assessment with ASTM F3186-17 shows that, with 
modifications, it would adequately reduce the unreasonable risk of 
injury associated with APBRs, there is no compliance with the voluntary 
standard. Accordingly, the Commission preliminarily finds that a 
mandatory rule is reasonably necessary to reduce the unreasonable risk 
of injury of entrapment hazards from APBRs.

B. Objectives and Legal Basis for the Rule

    The Commission proposes this rule to reduce the risk of death and 
injury associated with APBRs. The proposed rule is promulgated under 
the authority in sections 7 and 9 of the CPSA.

C. Small Entities to Which the Rule Will Apply

    The proposed rule would apply to all manufacturers and importers of 
APBRs. Staff identified seven U.S. APBR manufacturers that meet the SBA 
criteria for small businesses. Importers of APBRs could be wholesale or 
retail distributers. Staff identified one U.S. APBR firm in these 
categories that could be considered a small business.

D. Compliance, Reporting, and Record-Keeping Requirements of Proposed 
Rule

    The proposed rule would establish a performance requirement for 
APBRs and test procedures that suppliers would have to meet to sell 
APBRs in the United States. Specifically, the NPR would require APBRs 
sold in the United States to comply with the ASTM F3186-17 standard, 
with the proposed 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 proposed 
rule, as well as costs related to testing and issuing a General 
Certificate of Conformity (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 proposed rule. According to section 14 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. Federal Rules That May Duplicate, Overlap, or Conflict With the 
Proposed Rule

    CPSC has not identified any other Federal rules that duplicate, 
overlap, or conflict with the proposed rule.

F. Potential Impact on Small Entities

    Generally, CPSC considers an impact to be potentially significant 
if it exceeds 1 percent of firm's gross revenue. Staff identified seven 
APBR manufacturers that meet SBA size standards for small businesses. 
Staff applied both the per-model and per-unit costs to each 
manufacturer's number of models and estimated unit sales in 2021. Staff 
found that the initial cost to comply with the proposed rule exceeds 
one percent of reported annual revenue for three of the seven 
manufacturers identified as small businesses. For these three APBR 
manufacturers, the economic impact of the proposed rule is expected to 
be significant. As discussed in Tab G of Staff's NPR Briefing Package, 
to achieve compliance with the proposed rule's performance 
requirements, APBR suppliers would incur costs from redesigning, 
retooling, and testing. 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 $10.01 per unit produced in the first 
year, of which $7.74 is expected to be passed on to the consumer.
    Staff identified one possible importer of APBRs from foreign 
suppliers that would be considered small businesses based on SBA size 
standards. Small importers would be adversely impacted by the proposed 
rule if its foreign supplier withdrew from the U.S. market, rather than 
incur the cost of compliance. Small importers would also be adversely 
impacted if foreign manufacturers failed to provide a GCC and the 
importers had to perform their own testing for compliance. If sales of 
APBRs are a substantial source of the importer's business, and the 
importer cannot find an alternative supplier of APBRs, the economic 
impact on these firms may be significant. However, staff estimates the 
U.S. APBR market will grow at annual rate of approximately 2.01 percent 
over the next 20 years. It is unlikely that foreign manufacturers would 
exit a market growing at this rate. APBR importers also import other 
medical equipment, devices, and supplies. For these firms, any decline 
in APBR sales and revenue may be partially or fully offset by 
increasing sales and revenues of these other products. Small importers 
would be responsible for issuing a GCC certifying that their APBRs 
comply with the rule's requirements. However, importers may issue GCCs 
based upon certifications provided by or testing performed by their 
suppliers. Based on an estimated $4,532 per model for testing, the 
impact on small importers whose suppliers provide GCCs is unlikely to 
be significant.

VIII. Incorporation by Reference

    The Commission proposes to incorporate 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, 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 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 proposes to incorporate by reference into 16 CFR part 1270. 
The standard

[[Page 67605]]

itself is reasonably available to interested parties. Until the end of 
the comment period, 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.

IX. 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 proposed 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).

X. Preemption

    Executive Order (E.O.) 12988, Civil Justice Reform (Feb. 5, 1996), 
directs agencies to specify the preemptive effect of a rule in the 
regulation. 61 FR 4729 (Feb. 7, 1996). The proposed regulation for 
APBRs is issued under authority of the CPSA. 15 U.S.C. 2051-2089. 
Section 26 of the CPSA provides that ``whenever a consumer product 
safety standard under this Act is in effect and 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.'' Id. 2075(a). 
Thus, the proposed rule for APBRs, if finalized, would preempt non-
identical state or local requirements for APBRs 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).

XI. Paperwork Reduction Act

    This proposed 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. 3501-3520. We describe the provisions in this section 
of the document with an estimate of the annual reporting burden. Our 
estimate includes the time for reviewing instructions, searching 
existing data sources, gathering and maintaining the data needed, and 
completing and reviewing each collection of information.
    CPSC particularly invites comments on: (1) whether the collection 
of information is necessary for the proper performance of the CPSC's 
functions, including whether the information will have practical 
utility; (2) the accuracy of the CPSC's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; (4) ways to 
reduce the burden of the collection of information on respondents, 
including the use of automated collection techniques, when appropriate, 
and other forms of information technology; and (5) estimated burden 
hours associated with label modification, including any alternative 
estimates.

Title: Safety Standard for Adult Portable Bed Rails

    Description: The proposed rule would require each APBR to comply 
with ASTM F3186-17, Standard Specification for Adult Portable Bed Rails 
and Related Products, with modifications. Sections 9, 10, and 11 of 
ASTM F3186-17 contain requirements for labels, warnings and 
instructional literature.
    Description of Respondents: Persons who manufacture or import adult 
portable bed rails.
    Staff estimates the burden of this collection of information as 
follows in Table 15:

                                                       Table 15--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             Number of     Frequency of    Total annual      Hours per     Total burden
                       Burden type                          respondents      responses       responses       response          hours        Annual cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
Labeling................................................              12               6              72               8             576         $20.304
Instructional Literature................................              12               6              72              24           1,728          60,912
                                                         -----------------------------------------------------------------------------------------------
    Total Burden........................................  ..............  ..............  ..............  ..............           2,304          81,216
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Our estimate is based on the following. There are 12 known entities 
supplying APBRs to the U.S. market. On average, each entity supplies 
six APBR models to the market. All 12 entities are assumed to already 
use labels on both their products and packaging. However, none of the 
APBR models tested comply with ASTM F3186-17 labeling and informational 
requirements. CPSC therefore expects all entities will need to make 
modifications to their existing labels. The estimated time required to 
make these modifications is about eight hours per model. Each entity 
supplies an average of six different APBR models. Therefore, the 
estimated burden associated with labels is 576 hours (12 entities x 6 
models per entity x 8 hours per model = 576 hours). We estimate the 
hourly compensation for the time required to create and update labels 
is $35.25 (U.S. Bureau of Labor Statistics, ``Employer Costs for 
Employee Compensation,'' March 2022, total compensation for all sales 
and office workers in goods-producing private industries: www.bls.gov/ncs/.) Therefore, the estimated annual cost to industry associated with 
the labeling requirements is $20,304 ($35.25 per hour x 576 hours). 
There are no

[[Page 67606]]

operating, maintenance, or capital costs associated with the 
collection.
    The proposed rule would also require instructions to be supplied 
with the product. Under the OMB's regulations (5 CFR 1320.3(b)(2)), the 
time, effort, and financial resources necessary to comply with a 
collection of information that would be incurred by persons in the 
``normal course of their activities'' are excluded from a burden 
estimate, where an agency demonstrates that the disclosure activities 
required to comply are ``usual and customary.'' APBRs require 
installation on an existing bed, which implies instructions for proper 
use, fit, and position on a bed, as well as cleaning are necessary. 
While many APBR entities already provide some instructional material, 
CPSC expects all will need to make some modifications to existing 
material. The estimated time to modify the instructional material is 24 
hours per model. Each entity supplies an average of six different APBR 
models. Therefore, the estimated burden associated with instructional 
literature is 1,728 hours (12 entities x 6 models per entity x 24 hours 
per model). We estimate the hourly compensation for the time required 
to create and update instructional material is $35.25 (U.S. Bureau of 
Labor Statistics, ``Employer Costs for Employee Compensation,'' March 
2022), total compensation for all sales and office workers in goods-
producing private industries: www.bls.gov/ncs/). Therefore, the 
estimated annual cost to industry associated with the instructional 
material requirements is $60,912 ($35.25 per hour x 1,728 hours). There 
are no operating, maintenance, or capital costs associated with the 
collection.
    Based on this analysis, the proposed standard for APBRs would 
impose a burden to industry of 2,304 hours, at an estimated cost of 
$81,216 annually ($20,304 + $60.912). Existing APBR entities would 
incur these costs in the first year following the proposed rule's 
effective date. In subsequent years, costs could be less, depending on 
the number of new APBR models introduced by existing entities and/or by 
entities entering the APBR market. As required under the PRA (44 U.S.C. 
3507(d)), CPSC has submitted the information collection requirements of 
this proposed rule to the OMB for review. Interested persons are 
requested to submit comments regarding information collection by 
December 9, 2022, to the Office of Information and Regulatory Affairs, 
OMB as described under the ADDRESSES section of this document.

XII. Certification

    Section 14(a) of the CPSA requires that products subject to a 
consumer product safety rule under the CPSA, or to a similar rule, ban, 
standard or regulation under any other act enforced by the Commission, 
must be certified as complying with all applicable CPSC-enforced 
requirements. 15 U.S.C. 2063(a). A final rule on APBRs would subject 
them to this requirement.

XIII. 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.
    If finalized, the Commission proposes an effective date of 30 days 
after publication of the final rule. 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 ASTM F3186-17 and 
should be ready and able to comply with the requirements included in 
the proposed rule. Therefore, the Commission preliminarily finds a 30-
day effective date following publication of the rule in the Federal 
Register appropriate to address the risks of APBRs expeditiously. The 
rule would apply to all APBRs manufactured after the effective date. 
However, the Commission requests comments on the proposed effective 
date. The CPSC is proposing an anti-stockpiling provision to prevent 
firms from manufacturing large quantities of non-compliant APBRs before 
the rule takes effect and seeks comment on this provision.

XIV. Request for Comments

    We invite all interested persons to submit comments on any aspect 
of the proposed rule. Specifically, the Commission seeks comments on 
the following:
     Information regarding any analysis and/or tests done on 
APBRs in relation to the risks of injury or death they present;
     Information regarding any potential costs or benefits of 
the proposed rule that were not included the foregoing preliminary 
regulatory analysis;
     Information regarding the number of small businesses 
impacted by the proposed rule and the magnitude of the impacts of the 
proposed rule;
     The testing procedures and methods of the proposed rule 
and whether they sufficiently reduce the risk associated with APBRs, or 
whether other measures are necessary and information demonstrating how 
these measures address the identified risks;
     Potential alternatives to APBRs if they are banned, and 
the impact that a ban on APBRs would have on consumers (e.g., lost 
consumer utility from not having the product);
     Any qualitative or quantitative evidence concerning the 
utility that APBRs have for consumers relative to alternative products 
that might be used as substitutes in the event APBRs are banned; and
     The appropriateness of the 30-day effective date, and a 
quantification of how a 30-day effective date would affect the benefits 
and costs of the proposed rule.

XV. Notice of Opportunity for Oral Presentation

    Section 9 of the CPSA requires the Commission to provide interested 
parties ``an opportunity for oral presentation of data, views, or 
arguments.'' 15 U.S.C. 2058(d)(2). The Commission must keep a 
transcript of such oral presentations. Id. Any person interested in 
making an oral presentation must contact the Commission, as described 
under the DATES and ADDRESSES section of this document.

XVI. Promulgation of a Final Rule

    Section 9(d)(1) of the CPSA requires the Commission to promulgate a 
final consumer product safety rule within 60 days of publishing a 
proposed rule. 15 U.S.C. 2058(d)(1). Otherwise, the Commission must 
withdraw the proposed rule if it determines that the rule is not 
reasonably necessary to eliminate or reduce an unreasonable risk of 
injury associated with the product or is not in the public interest. 
Id. However, the Commission can extend the 60-day period, for good 
cause shown, if it publishes the reasons for doing so in the Federal 
Register. Id.
    The Commission finds that there is good cause to extend the 60-day 
period for this rulemaking. Under both the APA and the CPSA, the 
Commission must provide an opportunity for interested parties to submit 
written comments on a proposed rule. 5 U.S.C. 553; 15 U.S.C. 
2058(d)(2). The

[[Page 67607]]

Commission is providing 60 days for interested parties to submit 
written comments. A shorter comment period may limit the quality and 
utility of information CPSC receives in comments, particularly for 
areas where it seeks data and other detailed information that may take 
time for commenters to compile. Additionally, the CPSA requires the 
Commission to provide interested parties with an opportunity to make 
oral presentations of data, views, or arguments. 15 U.S.C. 2058. This 
requires time for the Commission to arrange a public meeting for this 
purpose and provide notice to interested parties in advance of that 
meeting, if any interested party requests the opportunity to present 
such comments. After receiving written and oral comments, CPSC staff 
must have time to review and evaluate those comments.
    These factors make it impractical for the Commission to issue a 
final rule within 60 days of this proposed rule. Moreover, issuing a 
final rule within 60 days of the NPR may limit commenters' ability to 
provide useful input on the rule, and CPSC's ability to evaluate and 
take that information into consideration in developing a final rule. 
Accordingly, the Commission finds that there is good cause to extend 
the 60-day period for promulgating the final rule after publication of 
the proposed rule.

List of Subjects in 16 CFR Part 1270

    Administrative practice and procedure, Consumer protection, 
Incorporation by reference, Adult portable bed rails.

0
For the reasons discussed in this preamble, the Commission proposes to 
amend 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.
1270.4 Findings.

    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 1270 establishes a consumer product safety standard for 
adult portable bed rails manufactured after [DATE 30 DAYS AFTER DATE OF 
PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER].


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. 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. You may inspect 
a copy from the Office of the Secretary, U.S. Consumer Product Safety 
Commission, 4330 East West Highway, Bethesda, MD 20814, telephone (301) 
504-7479, email [email protected], or at the National Archives and 
Records Administration (NARA). 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.
    (b) Comply with the ASTM F3186-17 standard with the following 
changes:
    (1) In addition to complying with section 3.1.7 of ASTM F3186-17, 
each adult portable bed rail must comply with the following:
    (i) 3.1.8 Initial assembly. The first assembly of the product 
components after purchase, and prior to installing on the bed.
    (ii) 3.1.9 Initial installation. The first installation of the 
product onto a bed or mattress.
    (iii) 3.1.10 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) Under section 6.1.3, 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) Under section 6.2.1.1, if the manufacturer does not recommend a 
specific applicable range of mattress heights or thicknesses, the test 
personnel shall choose a mattress that provides the most severe 
condition per test requirement. If the product has adjustable settings, 
and the manufacturer does not recommend orienting or adjusting features 
on the product in a specific manner, the testers shall adjust the 
product to the most severe condition per test requirement.
    (ii) [Reserved]
    (4) Instead of complying with section 6.3.3 of ASTM F3186-17, 
comply with the following:
    (i) 6.3.3. Zone 3. When tested in accordance with section 8.4.5, 
the horizontal centerline on the face of the 4.7 in (120 mm) end of the 
test probe (see 7.2) shall be above the highest point of the 
uncompressed mattress.
    (ii) [Reserved]
    (5) Instead of complying with section 6.4.1 of ASTM F3186-17, 
comply with the following:
    (i) Under section 6.4.1, 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) Under section 6.5.1, 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 6.5.2.
    (ii) [Reserved]
    (7) Instead of complying with section 6.5.2 of ASTM F3186-17, 
comply with the following:
    (i) 6.5.2 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 6.1-6.4.
    (ii) [Reserved]
    (8) In addition to complying with section 7.1 of ASTM F3186-17, 
comply with the following:
    (i) Under section 7.1.3, mattress thickness ranges used for testing 
may be up to 1.5 in (38 mm) larger or smaller than the range specified 
by the manufacturer. If the manufacturer does not recommend a 
particular range of mattress heights, the testers shall choose

[[Page 67608]]

a mattress that provides the most severe condition per test 
requirement.

    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) In addition to complying with section 7.2 of ASTM F3186-17, 
comply with the following:
    (i) 7.2. Entrapment test probe. The test probe shall be as 
described in the 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) Instead of complying with Note 1 in section 8.4 of ASTM F3186-
17, comply with the following:

    Note 1 to paragraph (b)(10)(i): The tests described in this 
section are similar to those described in the referenced FDA 
Guidance Document.

    (11) Instead of complying with section 8.4.3.4 of ASTM F3186-17, 
comply with the following:
    (i) Under section 8.4.3.4, if the test probe does not pull through, 
freely attach the force gauge and exert a 22.5 lbf (100 N) pulling 
force along the axis of the cone, perpendicular to the 2.4 in (60 mm) 
cylindrical end of the entrapment test tool. 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) Under section 8.4.4.3, insert the 2.4 in (60 mm) end of the 
cone perpendicular into the opening. Slide 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) Under section 8.4.4.4, if the test probe does not pull through 
freely use the force gauge to exert a 22.5 lbf (100 N) pulling force 
along the axis of the cone, perpendicular to the 2.4 in (60 mm) 
cylindrical end of cone.
    (ii) Under section 8.4.4.5, 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.
    (14) Instead of complying with section 8.4.5.4 of ASTM F3186-17, 
comply with the following:
    (i) Under section 8.4.5.4, 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 1 to paragraph (b)(14) of this section, 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 1 to paragraph (b)(14) of this section, the space fails the 
test.

Figure 1 to paragraph (b)(14) of this section: Zone 3 test: (a) Pass, 
(b) Fail
[GRAPHIC] [TIFF OMITTED] TP09NO22.005

    (ii) [Reserved]
    (15) In addition to complying with section 8.6.3 of ASTM F3186-17, 
define ``free end'' in a note as follows:

    Note 1 to Paragraph (b)(15)(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.

    (16) Instead of complying with section 9.1.1.3 of ASTM F3186-17, 
comply with the following:
    (i) Under section 9.1.1.3, 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

[[Page 67609]]

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]
    (17) Instead of complying with section 9.2.5 of ASTM F3186-17, 
comply with the following:
    (i) Under section 9.2.5, each product's retail package and 
instructions shall include the warning statements in Figure 2 to 
paragraph (b)(17)(i) of this section.

Figure 2 to paragraph (b)(17)(i): Warning Statements for Product Retail 
Package and Instructions
[GRAPHIC] [TIFF OMITTED] TP09NO22.006

    (ii) [Reserved]
    (18) Instead of complying with section 9.2.7 of ASTM F3186-17, 
comply with the following:
    (i) Under section 9.2.7, at least one installation component of the 
product must be labeled with the entrapment warning in Figure 3 to 
paragraph (b)(18)(i).

Figure 3 to paragraph (b)(18)(i): Entrapment Warning
[GRAPHIC] [TIFF OMITTED] TP09NO22.007

    (ii) [Reserved]
    (19) Instead of complying with section 11.1.1.3 of ASTM F3186-17, 
comply with the following:
    (i) Under section 11.1.1.3, in addition to contacting the 
manufacturer directly, consumers should report problems to the CPSC at 
its website SaferProducts.gov or call 1-800-638-2772, or to the FDA at 
1-800-332-1088.
    (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 in any 1-month period between 
[DATE OF PUBLICATION OF FINAL RULE] and [EFFECTIVE DATE OF FINAL RULE] 
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 the month of promulgation of the final 
rule.


Sec.  1270.4  Findings.

    (a) General. The Consumer Product Safety Act (CPSA) requires the 
Commission to make certain findings when issuing a consumer product 
safety standard. 15 U.S.C. 2058(f). This section discusses preliminary 
support for those findings.
    (b) Degree and Nature of the Risk of Injury. Between January 2003 
and December 2021, the Consumer Product Safety Risk Management System 
(CPSRMS) injury cases showed there were 332 incident reports concerning 
adult portable bed rails (APBR). Of these, 310 were reports of 
fatalities, and 22 were nonfatal. Rail entrapment is the most prevalent 
hazard pattern among the incidents, accounting for more than 90 percent 
of all fatal incidents. There were 284 fatal incidents related to rail 
entrapment. Falls were the second most common hazard pattern in the 
incident data, accounting for 25 incidents (8 percent). There were 23 
fatalities from falls. Most of the incidents were identified from death 
certificates, medical examiner reports, or coroner reports. Because 
death certificate data often have a lag time of around two to three 
years from the date of reporting to CPSC, data collection is ongoing 
and incidents for 2020, 2021, and 2022 are likely to increase.
    (c) 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.
    (d) 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. The market 
for APBRs is expected to grow at an average rate of 2.01 percent 
between 2024 and 2053 as a result of an aging U.S. population seeking 
to avoid institutional medical care. Without a mandatory standard, 
assuming the rates of incidents, per million APBRs, stay constant, this 
growth in the industry would lead to an average of 32 entrapment deaths 
per year.
    (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, as well as the cost 
of producing the redesigned APBR. Manufacturers would

[[Page 67610]]

likely incur expenditures in design labor, design production, design 
validation, and compliance testing. Manufacturers would also be 
required to upgrade all new APBR designs. CPSC estimates these costs to 
be $42,239 per model in the first year. Once existing models have been 
redesigned with a working solution, however, new models can adapt at a 
minimal cost. Manufacturers can transfer some, or all, of the increased 
production cost to consumers through price increases. 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. 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 would now probably be excluded from the market because the 
increased market price exceeds their personal price threshold for 
purchasing an APBR.
    (e) Any Means to Achieve the Objective of the Proposed Rule, While 
Minimizing Adverse Effects on Competition and Manufacturing. (1) The 
proposed requirement of the rule achieves the objective of reducing 
entrapment hazards on APBRs while minimizing the effect on competition 
and manufacturing. Because the proposed rule is based on an existing 
voluntary standard, and because of CPSC's outreach efforts, APBR 
manufacturers are generally aware of the requirements. The proposed 
rule would apply to all manufacturers and importers of APBRs. 
Manufacturers can transfer some, or all, of the increased production 
cost to consumers through price increases.
    (2) The Commission considered alternatives to the proposed rule to 
minimize impacts on competition and manufacturing including:
    (i) Take no regulatory action;
    (ii) Conduct a recall of APBRs instead of promulgating a final 
rule;
    (iii) Conduct an educational campaign;
    (iv) Require enhanced safety warnings; and
    (v) Longer effective date.
    (3) However, the Commission determines preliminarily that none of 
these alternatives would adequately reduce the risk of deaths and 
injuries associated with APBR entrapment that the proposed rule 
addresses.
    (f) Unreasonable Risk. Incident data show 284 fatal incidents 
related to rail entrapment. This hazard pattern is the most prevalent 
among the APBR incidents, accounting for more than 90 percent of all 
fatal incidents. There were also 23 fatalities related to falls. 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 APBRs is forecast to grow. The 
proposed mandatory standard would establish performance requirements to 
address the risk of entrapments associated with APBRs. Given the fatal 
and serious injuries associated with entrapments on APBRs, the 
Commission preliminarily finds that this rule is necessary to address 
the unreasonable risk of injury associated with APBR entrapments.
    (g) Public Interest. The proposed rule is intended to address an 
unreasonable risk of entrapments associated with APBRs. Adherence to 
the requirements of the proposed rule would reduce deaths and injuries 
from APBR entrapment incidents; thus, the rule is in the public 
interest.
    (h) Voluntary Standards. Under section 9(f)(3)(D) of the CPSA, 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 preliminarily determines that the voluntary 
standard is not likely to eliminate or adequately reduce the 
unreasonable risk of injury associated with entrapments on APBRs. 
Accordingly, the Commission is proposing to adopt the voluntary 
standard with specified modifications necessary to improve safety and 
adequately reduce the unreasonable risk of injury associated with 
entrapment on 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. 
These zones were identified by the FDA in its 2006 guidance document, 
Hospital Bed System Dimensional and Assessment Guidance to Reduce 
Entrapment (FDA, 2006) and used in the voluntary standard, as potential 
areas of entrapment for APBRs. The FDA's guidance is based on 
recommendations from the Hospital Bed Safety Workgroup (HBSW), which 
was formed in 1999 to address reports of patient entrapment. The 
voluntary standard specifies the FDA probe to test entrapment zones. 
The probe design is based on the anthropometric dimensions of key body 
parts, including the head, neck, and chest of at-risk adults. The four 
entrapment zones required to be tested are:
    (i) Within the product;
    (ii) Between rail support(s) and the bed mattress, when applicable, 
under the product;
    (iii) Between the product and the mattress; and
    (iv) Between the underside of the end of the product and the 
mattress.
    (2) 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. 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.
    (3) The Commission preliminarily determines that modifications to 
the voluntary standard are needed to improve safety. Such modifications 
include: provide additional definitions for product assembly and 
installation to ensure their consistent and differentiated use 
throughout the standard; add recommendations for manufacturers to take 
into account the range of mattress thicknesses to ensure safe use of 
the product by the consumer and provide testers with additional 
guidance for selecting the mattress thickness during the test setup; 
address inconsistencies with stated dimensions to ensure consistent 
dimensional tolerances; provide additional clarity for Zone 1 and 2 
test setup and methods; provide additional guidance for identifying 
potential Zone 2 openings; update the requirements for Zone 3 testing 
consistency; and correct grammatical errors.
    (4) The Commission preliminarily 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 of market 
compliance testing, 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 and 
all products failed the labeling, warning, and instructional 
requirements.
    (i) Reasonable Relationship of Benefits to Costs. (1) The benefits 
expected from the proposed rule bear a reasonable relationship to its 
cost. The proposed rule is intended to reduce the entrapment hazards 
associated with

[[Page 67611]]

APBRs, and thereby reduce the societal costs of the resulting injuries 
and deaths. CPSC assumes that the number of firms and APBR 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 between 2024 and 2053 as a result of an 
aging U.S. population. Assuming the rates 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 value of a 
statistical life (VSL) of $10.5 million (2021 dollars), the annualized 
present value of the potential societal costs of the proposed rule 
therefore is $298.11 million.
    (2) The requirements of the proposed rule, with modifications, are 
expected to address 92 percent of deaths caused by entrapment and 
produce estimated benefits of $266.99 million. Benefits were assessed 
under three more conservative scenarios derived from this baseline 
efficacy, estimating benefits at: 75 percent, 50 percent, and 25 
percent of their potential value. Even under the most conservative 
assumption that only one quarter, or 25 percent of the potential 
benefits are achieved, the net benefits greatly exceed the costs of the 
rule. The annualized benefits of the proposed rule are estimated as 
follows: at 75 percent--$200.24 million, 50 percent-$133.49 million, 
and 25 percent-$66.75 million, respectively. The estimated annualized 
costs associated with the proposed requirements to prevent APBR hazards 
is $2.01 million. This results in net quantifiable net benefits of 
$198.23 million, $131.48 million, and $64.74 million on an annualized 
basis. On a per product basis, the benefits of the proposed rule are 
estimated between $331.78 per APBR (75%), $221.19 (50%), and $110.59 
per APBR (25%), and the costs are $3.34 per APBR. All these amounts are 
in 2021 dollars using a discount rate of 3 percent.
    (3) Injuries from entrapment and other hazards on APBRs are not 
included in the benefit-cost assessment because for many incidents 
involving injuries, there is not sufficient information to determine 
whether they would fall under the scope of this proposed rule. However, 
the injuries are quantified in a sensitivity analysis as a potential 
upper limit to assess the benefits of this proposed rule. The 
sensitivity analysis used NEISS incidents and the Injury Cost Model 
(ICM) to extrapolate and generate national estimates for injuries from 
entrapment treated in an ED or other settings. The ICM calculated that 
the aggregate number of nonfatal injuries in the United States from 
entrapment from 2010 to 2019 was 125,121. Staff estimated that from the 
total of these injuries, 79,563 were treated in an outpatient setting 
(e.g., doctor's office or clinic), 39,149 resulted in ED treatment, and 
6,409 resulted in hospital admissions.
    (j) Least-Burdensome Requirement that Would Adequately Reduce the 
Risk of Injury. The Commission considered six alternatives to the 
proposed rule including:
    (i) Take no regulatory action;
    (ii) Conduct a recall of APBRs instead of promulgating a final 
rule;
    (iii) Conduct an educational campaign;
    (iv) Ban APBRs from the market entirely;
    (v) Require enhanced safety warnings; and
    (vi) Longer effective date.
    (4) Although most of these alternatives may be a less burdensome 
alternative to the proposed rule, the Commission determines 
preliminarily that none of the less burdensome alternatives would 
adequately reduce the risk of deaths and injuries associated with APBRs 
that is addressed in the proposed rule.

Alberta E. Mills,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2022-22692 Filed 11-8-22; 8:45 am]
BILLING CODE 6355-01-P