[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
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Total....................................................... 310 22 332
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Source: CPSRMS (2003-2021).
Table 2 details the distribution of these APBR-related incidents by
gender. Approximately 70 percent of all incident victims and incident
fatalities were female.
Table 2--Distribution of Reported APBR-Related Incidents by Gender
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Gender Fatalities Nonfatalities Total
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Male............................................................ 88 7 95
Female.......................................................... 221 8 229
Unknown/Unspecified............................................. 1 7 8
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Total....................................................... 310 22 332
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Source: CPSRMS (2003-2021).
Approximately 50 percent of all APBR-related incidents and
fatalities occurred at home. Other commonly reported locations included
nursing homes, assisted living facilities, and residential
institutions, 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
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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
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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.
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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