[Federal Register Volume 76, Number 69 (Monday, April 11, 2011)]
[Proposed Rules]
[Pages 19914-19926]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-8558]
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1224
[CPSC Docket No. CPSC-2011-0019]
Safety Standard for Portable Bed Rails: Notice of Proposed
Rulemaking
AGENCY: Consumer Product Safety Commission.
ACTION: Notice of proposed rulemaking.
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SUMMARY: Section 104(b) of the Consumer Product Safety Improvement Act
of 2008 (``CPSIA'') requires the U.S. Consumer Product Safety
Commission (``CPSC,'' ``Commission,'' or ``we'') to promulgate consumer
product safety standards for durable infant or toddler products. These
standards are to be ``substantially the same as'' applicable voluntary
standards or more stringent than the voluntary standard if the
Commission concludes that more stringent requirements would further
reduce the risk of injury associated with the product. The Commission
is proposing a more stringent safety
[[Page 19915]]
standard for portable bed rails that will further reduce the risk of
injury associated with these products.\1\
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\1\ The Commission voted 5-0 to approve publication of this
notice of proposed rulemaking. Commissioner Nancy Nord filed a
statement concerning this action which may be viewed on the
Commission's Web site at http://www.cpsc.gov/pr/statements.html or
obtained from the Commission's Office of the Secretary.
DATES: Written comments must be received by June 27, 2011. Interested
persons are requested to submit comments regarding information
collection by May 11, 2011, to the Office of Information and Regulatory
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Affairs, OMB (see ADDRESSES).
ADDRESSES: Comments, identified by Docket No. CPSC-2011-0019, may be
submitted by any of the following methods:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
To ensure timely processing of comments, the Commission is no
longer accepting comments submitted by electronic mail (e-mail) except
through http://www.regulations.gov.
Written Submissions
Submit written submissions in the following way:
Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions), preferably in five copies, to: Office of the Secretary,
U.S. Consumer Product Safety Commission, Room 502, 4330 East West
Highway, Bethesda, MD 20814; telephone (301) 504-7923.
Instructions: All submissions received must include the agency name
and docket number for this rulemaking. All comments received may be
posted without change, including any personal identifiers, contact
information, or other personal information provided, to http://www.regulations.gov. Do not submit confidential business information,
trade secret information, or other sensitive or protected information
electronically. Such information should be submitted in writing.
Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov.
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 e-mailed to [email protected].
FOR FURTHER INFORMATION CONTACT: Rohit Khanna, Project Manager, Office
of Hazard Identification and Reduction, U.S. Consumer Product Safety
Commission, 4330 East West Highway, Bethesda, MD 20814; telephone (301)
504-7546; [email protected].
SUPPLEMENTARY INFORMATION:
A. Background and Statutory Authority
1. The Consumer Product Safety Improvement Act
The Consumer Product Safety Improvement Act of 2008, Public Law
110-314 (``CPSIA'') was enacted on August 14, 2008. Section 104(b) of
the CPSIA requires the Commission to promulgate consumer product safety
standards for durable infant or toddler products. These standards are
to be ``substantially the same as'' applicable voluntary standards or
more stringent than the voluntary standard if the Commission concludes
that more stringent requirements would further reduce the risk of
injury associated with the product. This document proposes a safety
standard for portable bed rails. The proposed standard is substantially
the same as the voluntary standard developed by ASTM International
(formerly known as the American Society for Testing and Materials),
ASTM F 2085-10a, ``Standard Consumer Safety Specification for Portable
Bed Rails,'' but we are proposing some modifications to strengthen the
standard because these more stringent requirements would further reduce
the risk of injury associated with portable bed rails.
2. Previous Commission Rulemaking Activity Concerning Portable Bed
Rails
In the Federal Register of October 3, 2000 (65 FR 58968), we
published an advance notice of proposed rulemaking (``ANPR'') inviting
written comments concerning the risks of injury associated with
portable bed rails, regulatory alternatives discussed in the ANPR,
other possible ways to address the risks of injury associated with
portable bed rails, and the economic impacts of the regulatory
alternatives. The ANPR was intended to initiate a rulemaking proceeding
that could result in a rule banning portable bed rails that present an
unreasonable risk of injury, and we issued the ANPR under our authority
in the Federal Hazardous Substances Act (``FHSA''). Elsewhere in this
issue of the Federal Register, the Commission has issued a notice that
the Commission has terminated the rulemaking proceeding that it began
under the FHSA because it has been superseded by the rulemaking
required under section 104(b) of the CPSIA.
In May 2001, the ASTM published a standard, ASTM F 2085, ``Standard
Consumer Safety Specification for Portable Bed Rails.'' In October
2001, CPSC staff prepared a draft proposed standard, which included
performance requirements to address entrapment hazards on portable bed
rails. The Commission voted to direct CPSC staff to prepare a notice of
proposed rulemaking (``NPR'') based on its recommended standard.
Thereafter, the ASTM Portable Bed Rail Subcommittee agreed to ballot a
revision to ASTM F 2085 that was substantially the same as CPSC staff's
recommended standard. Accordingly, we did not issue an NPR at that
time. ASTM approved and published the revised standard in June 2003. In
2008, ASTM published another revision to the standard that included a
structural integrity test to address fall incidents involving hinge
lock mechanism failures. From 2009 to 2010, ASTM made and published
minor revisions to the standard. The current edition of the standard is
ASTM F 2085-10a, ``Standard Consumer Safety Specification for Portable
Bed Rails.'' The standard in this proposed rule would be more stringent
in some respects than the voluntary standard ASTM F 2085-10a. The
proposed modifications, if finalized, will further reduce the risk of
death and injury associated with portable bed rails.
B. The Product
ASTM F 2085-10a defines a ``portable bed rail'' as a ``portable
railing installed on the side of an adult bed and/or on the mattress
surface which is intended to keep a child from falling out of bed.''
The scope of the ASTM standard also states that a portable bed rail
``is as a device intended to be installed on an adult bed to prevent
children from falling out of bed.'' Portable bed rails are intended for
children (typically from 2 to 5 years of age) who can get in and out of
an adult bed unassisted. They include bed rails that only have a
vertical plane that presses against the side of the mattress but does
not extend over it (referred to as ``adjacent type bed rails''), as
well as bed rails that extend over the sleeping surface of the mattress
(called ``mattress-top bed rails'').
A review of market information shows that there are products that
differ from traditional, rigid portable bed rails in that they are
constructed of nonrigid materials, such as foam or inflatable
materials. Although these foam and inflatable products do not use the
term ``bed rails'' in their packaging or
[[Page 19916]]
labeling, we believe that the products meet the definition of a
portable bed rail and should be included in the scope of the voluntary
standard. However, most performance requirements of ASTM F 2085-10a do
not apply to these products because the standard was developed to
address the hazards from portable bed rails constructed from rigid
(wood/metal) materials. Accordingly, the proposed rule would revise
ASTM F 2085-10a to include foam and inflatable products, but would
require that only certain relevant provisions of the standard apply to
such items.
Both portable bed rails made for a specific manufacturer's adult-
size beds and ``universal'' bed rails that can attach to any adult-size
bed are included in the scope of ASTM F 2085-10a. However, guard rails
that are used with crib mattresses on toddler beds are not covered
under the voluntary standard. They are addressed under the Consumer
Safety Standard for Toddler Beds (April 28, 2010, 75 FR 22291). Other
products that are not covered by ASTM F 2085-10a include: side rails
that connect the headboard to the footboard and may or may not have any
barrier purposes; conversion rails intended to convert a crib to a
full-size bed; and adult-size beds where the rail is permanently
attached to the bed (i.e., bunk beds).
Additionally, the U.S. Food and Drug Administration (``FDA'') has
several regulations pertaining to hospital beds, including a regulation
for pediatric hospital beds (21 CFR 880.5140). The FDA regulations, in
general, identify a hospital bed as having (among other things) movable
and latchable side rails. If a pediatric hospital bed is subject to
regulation by the FDA as a medical device, then the bed rails on that
pediatric hospital bed are outside the scope of this proposed rule.
C. ASTM Voluntary Standard
The ASTM standard for portable bed rails was first published in May
2001 (ASTM F 2085-01). This was a minimum standard with requirements
for labeling but no performance requirements. The portable bed rails
that met the 2001 standard typically were designed with two arms at
right angles to the vertical portion of the rail. This type of portable
bed rail was installed on a bed by inserting the arms between the
mattress foundation and the mattress. These older style portable bed
rails relied on friction between the arms and the foundation/mattress
to stay in place. However, this type of design allowed the portable bed
rail to be moved outward away from the mattress unintentionally if a
force was applied in that direction. An outward force may result from
activity by a child in the bed while the child is asleep or awake. Once
the bed rail is moved outward, a gap could be created between the
vertical portion of the rail and the side of the mattress. The primary
hazard scenario would involve a child rolling into a gap between the
mattress and portable bed rail and becoming entrapped. Once entrapped,
the child could suffocate or strangle.
To address this hazard, the ASTM Subcommittee on Portable Bed Rails
revised the standard in June 2003 (ASTM F 2085-03). ASTM F 2085-03
addressed the entrapment hazard by including a new section, ``Openings
Created by a Displacement,'' with requirements to deal with
displacement of a portable bed rail. In 2008, ASTM published a revised
standard (ASTM F 2085-10) that included a structural integrity test to
address incidents involving hinge lock mechanism failures. From 2009 to
2010, ASTM made and published minor revisions to the standard. The
current edition of the standard is ASTM F 2085-10a.
To assess the adequacy of ASTM F 2085-10a, we tested a variety of
portable bed rails currently in the market. Several portable bed rails
were certified to ASTM F 2085-10a by the Juvenile Products
Manufacturers Association (``JPMA''). JPMA operates a program to
certify portable bed rails to the voluntary standard. To obtain JPMA
certification, manufacturers submit their products to an independent
test laboratory for conformance testing to the most current voluntary
standard. For portable bed rails that are assembled and installed in
accordance with the manufacturer's instructions, we believe that the
requirements to address structural integrity and prevent displacement
from the mattress are adequate. However, if a portable bed rail is
misassembled or misinstalled on the bed, it could present an entrapment
hazard. ASTM F 2085-10a does not address misassemby or misinstallation
of portable bed rails.
We also reviewed the British Standard Institution (``BSI'')
standard for bed rails, BS 7972:2001+A1:2009 Safety Requirements and
Test Methods for Children's Bedguards for Domestic Use. The BSI
standard primarily addresses entrapment and structural integrity, but
also includes some requirements for warning labels. The BSI standard
also contains a performance requirement that the bed rail remain
attached to the bed after rolling a 30 lb cylinder into the bed rail.
The test simulates a child rolling into the bed rail; the ASTM standard
does not have an equivalent requirement. We conducted limited testing
to compare this requirement with requirements in the ASTM standard that
address potential entrapment hazards. Based on staff's review, we find
that the ASTM standard is more stringent than the BSI standard because
the ASTM test methods provide more stress to the portable bed rail and
mattress interface when evaluating entrapment hazards.
D. Incident Data
1. Incident Reports
The CPSC Directorate for Epidemiology analyzed incident data
related to portable bed rails from January 1, 2000 through March 31,
2010. We received reports of a total of 132 incidents related to
portable bed rails. Among the 132 reported incidents, there were 13
fatalities, 40 nonfatal injuries, and 79 noninjury incidents. Of the 13
child fatalities reported involving portable bed rails, most children
(9 out of 13) were under 1 year old; two were between 1 and 2 years
old; and two children, both physically handicapped, were 6 years old.
While all 13 incidents reported some sort of entrapment of the child
between the portable bed rail and the mattress, no additional product-
or scenario-specific information was available for five reports. Among
the remaining eight incidents, two deaths resulted from portable bed
rail displacement, when the portable bed rail partially pushed away
from underneath the mattress and allowed the child to fall into the
opening and get trapped. There were three cases of portable bed rail
misassembly. In the first incident, the middle bar was absent, and the
child rolled into the mesh and got wedged between the mattress and the
rail. In the second incident, the middle bar was not inserted through
the mesh sleeve, and the child's head slipped between the bottom edge
of the mesh panel and the top edge of the mattress. In the third
incident, the bottom horizontal bar was not attached to the vertical
bar, resulting in a hazardous gap. In the remaining three fatality
incidents, not enough information was available to determine the
contributing factor(s) that led to the hazardous entrapment scenario.
The beds used in all eight cases were adult-size.
A total of 40 nonfatal incidents associated with the use of a
portable bed rail involved injury to a child. Eighty-three percent of
the injured children were 2 years old or older. The majority of the
injuries (28 out of 40, or 70 percent) were identified as fractures/
contusions resulting from a fall when the portable bed rail became
dislodged,
[[Page 19917]]
or lacerations/scratches on sharp or broken surfaces of the portable
bed rail. The remaining injuries resulted from the child getting caught
on a torn mesh panel of the rail; the child getting partially entrapped
in a portable bed rail that was partly pushed out; and the child nearly
choking on small parts (e.g., hardware or labels) that separated from
the portable bed rail. While no injuries were reported for the
remaining 79 incidents, the incident scenarios indicate that injuries
or fatalities potentially could have occurred.
2. Hazard Patterns
We considered the 132 incidents together to identify the hazard
patterns associated with portable bed rail-related incidents. The
hazard patterns can be grouped into the following categories:
Displacement of the portable bed rail--Sixty-nine of the
132 incidents (52 percent) involved the displacement of the portable
bed rail, where the portable bed rail pushed out from underneath the
mattress and created an opening between the mattress and the rail. In
cases where the opening was small, the child became entrapped in the
space. In cases where the opening was wide or the rail dislodged
completely, the child fell to the floor. There were two fatal
incidents, where the portable bed rail had pushed out partially and
entrapped the child. There were about 21 nonfatal injuries that
resulted from displacement of the rail. A small proportion of the 69
incident reports provided enough information to indicate that, for some
``double-rail'' configurations (i.e., a design that has two bed rails,
one on each side of the mattress), failure of the push-pin or buckle
lock mechanism (on the connecting bars/straps underneath the mattress)
usually was the main cause of the portable bed rail displacement.
Worn or poor quality fabric on mesh panel--Seventeen of
the 132 incidents (13 percent) involved a tear in the mesh, the
unraveling of the stitching around the mesh, or simply very loose
fabric on the mesh panel. Most nonfatal incident reports in this
category involved the child getting caught in the tear/hole (tooth,
limb, or even head); loose thread from the stitching getting tightly
wound around the child (finger or neck); and mesh coming completely
loose, allowing the child to slide through the panel and fall. Many
consumers in the incident reports expressed concern over the potential
of the tears/holes in the mesh to become larger and increase the risk
of strangulation.
Sharp surface--Fourteen of the 132 incidents (11 percent)
involved lacerations or scratches, or the potential thereof, on sharp
surfaces of the portable bed rail. Some of the portable bed rails
reportedly involved in these incidents had sharp surfaces to begin
with, while in other incidents, sharp surfaces were created when parts
of the portable bed rail broke away. Occasionally, depending upon the
part that broke, the broken components created a potential fall hazard.
Hinge lock disengagement--Eleven of the 132 incidents (8
percent) involved the hinge lock mechanism failing to remain locked to
keep the side panel in an upright position. This allowed the child to
fall out. Three out of the 11 incidents involving hinge lock mechanism
failures resulted in injuries.
Misassembly--Seven of the 132 incidents (5 percent)
involved either misassembly or misinstallation of the portable bed
rail. Misassembly resulted in three fatalities. In the first case, the
middle bar was absent; in the second case, the middle bar was not
inserted through the mesh sleeve; and in the third case, the bottom
horizontal bar was not attached to the vertical bar. Examples of
nonfatal incidents related to misinstallation included the use of a
portable bed rail on a toddler bed, as well as the use of a portable
bed rail with an extra thick mattress, which prevented the portable bed
rail from attaching securely.
Miscellaneous Other or Unknown Issues--Fourteen of the 132
incidents (11 percent) involved other problems not listed above. Six
reports--including five fatalities--did not provide any product- or
scenario-specific information. Three additional fatality reports
provided insufficient information to draw any conclusions about why the
portable bed rail was not flush with the mattress. The remaining five
nonfatal incidents involved the potential for choking on small parts,
such as loose hardware or labels; instability issues resulting from
loose hardware; and inadequate design issues, such as extra-wide
openings in nonmesh side panels or insufficient rail height.
E. Assessment of Voluntary Standard ASTM F 2085-10a and Description of
Proposed Changes and the Proposed Rule
1. Assessment of Voluntary Standard ASTM F 2085-10a
Section 104(b) of the CPSIA requires the Commission to assess the
effectiveness of the voluntary standard in consultation with
representatives of consumer groups, juvenile product manufacturers, and
other experts. CPSC staff has consulted with these groups regarding the
ASTM voluntary standard, Consumer Safety Specification for Portable Bed
Rails, throughout its development. Consultation with members of this
subcommittee is ongoing. ASTM F 2085-10a contains several labeling and
performance criteria. The standard addresses many of the same hazards
associated with other durable nursery products, and includes
requirements for lead in paints, sharp edges/sharp points, small parts,
wood part splinters, structural integrity, openings, protrusions, and
warning labels. For the eight fatal incidents associated with portable
bed rails for which investigations by CPSC staff were completed, we
identified two major contributing factors: (1) Improper installation,
and (2) misassembly. It is also notable that 11 of the 13 deaths
involved children under 2 years old. Portable bed rails, which are
meant to be installed on an adult bed, are not intended for this age
group. Placing a railing on the side of an adult bed does not make the
adult bed safe for infants (i.e. convert an adult bed into a crib).
Despite the current warning label cautioning against the use of this
product with children under 2 years old, parents of infants continue to
use this product with their infants.
Most portable bed rails currently in the market are difficult for
consumers to assemble correctly, due to the number of components and
the complexity of the fastening hardware. There were three fatal
incidents involving misassembled portable bed rails and, based on our
testing of sample portable bed rails, consumers are likely to have
difficulty assembling and installing portable bed rails correctly. The
proposed rule would contain new performance requirements and associated
test methods to address misassembly of portable bed rails.
These proposed performance requirements should reduce the
likelihood of portable bed rail misassembly. The proposed misassembly
performance requirements would prevent portable bed rail entrapment
fatalities that result from assembly of a product without critical
assembly components (i.e., any component of the portable bed rail that
requires consumer assembly to meet the performance requirements);
incorrectly installing the portable bed rail's fabric cover/mesh (if
present); or inverting/interchanging parts of the portable bed rail.
The addition in the standard of misassembly performance requirements
will result in portable bed rail designs that will render the portable
bed rail no longer functional if it is not assembled according to the
manufacturer-intended
[[Page 19918]]
final assembly, or make it obvious to the consumer that the product is
misassembled. While current portable bed rail designs do not meet the
proposed misassembly requirements, we are aware of the technical
feasibility of this requirement because we have developed and
demonstrated to ASTM, two prototypes using common portable bed rails
designs (adjacent style and mattress top) that meet the proposed
requirements.
The proposed rule also would contain a new performance requirement
and associated warning label for portable bed rail critical
installation components to address issues related to misinstallation of
portable bed rails. Although we are not aware of any deaths associated
with portable bed rail misinstallation, we are aware of entrapment
hazards caused by misinstallation. Furthermore, review and testing of
market samples indicate that some consumers may have difficulty
installing portable bed rails, which could lead to potentially
hazardous conditions. Installation of a portable bed rail onto a bed
can require complex or physically demanding adjustments to the portable
bed rail, particularly when reaching between the mattress and mattress
foundation. A portable bed rail that has been installed improperly
could move away from the mattress and form a hazardous gap. Portable
bed rail installation components, such as anchor plate and strap
combinations, can be misplaced, or not used at all. The proposed
performance requirement for critical installation components would
increase the likelihood that such components are attached permanently
to a structural component of the portable bed rail. In addition, a
proposed new warning label for critical installation components would
reinforce the importance of using the installation components when
installing portable bed rails onto the bed and reduce the likelihood of
misinstallation.
2. Proposed Changes to the ASTM Standard's Requirements
Consistent with section 104(b) of the CPSIA, the Commission,
through this proposed rule, would establish a new 16 CFR part 1224,
Safety Standard for Portable Bed Rails. The new part 1224 would
incorporate by reference the requirements for portable bed rails in
ASTM F 2085-10a with certain changes to specific provisions and
additions to the standard. The proposed modifications and additions to
the standard would reduce further the risk of injury associated with
portable bed rails.
Part 1224 would consist of two sections: Sec. 1224.1, Scope,
application, and effective date, and Sec. 1224.2, Requirements for
portable bed rails.
To understand the proposed rule, it is helpful to view the current
ASTM F 2085-10a standard for portable bed rails and our proposed
modifications, along with the explanations provided in part E.2 of this
preamble. The ASTM standard is available for viewing for this purpose
during the comment period through this link: http://www.astm.org/cpsc.htm. For example, the proposed rule would create several new
sections in ASTM F 2085-10a. To distinguish between the requirements
that would be published in the Code of Federal Regulations, we describe
those requirements as proposed Sec. 1224.1 or proposed Sec. 1224.2,
and describe the new sections that the proposed rule would create in
ASTM F 2085-10a as a ``new section.''
a. Scope, Application, and Effective Date (Proposed Sec. 1224.1)
Proposed Sec. 1224.1 would explain that part 1224 establishes a
consumer product safety standard for portable bed rails manufactured or
imported on or after a specific date. The date would be the effective
date of a final rule, which is normally six months after date of
publication of a final rule in the Federal Register.
b. Requirements for Portable Bed Rails (Proposed Sec. 1224.2)
(i). Incorporation by Reference (Proposed Sec. 1224.2(a)).
Proposed Sec. 1224.2(a) would state that each portable bed rail,
as defined in ASTM F 2085-10a, must comply with all applicable
provisions of ASTM F 2085-10a, except as provided in proposed Sec.
1224.2(b). Proposed Sec. 1224.2(a) also would incorporate ASTM F 2085-
10a by reference, and inform interested parties how they can obtain a
copy of the standard or inspect the standard at the CPSC or at the
National Archives and Records Administration.
(ii). Foam and Inflatable Products (Proposed Sec. 1224.2(b)(1)).
Proposed Sec. 1224.2(b)(1) would revise the scope section in ASTM
F 2085-10a to include foam and inflatable products. A ``foam bed rail''
is defined as a portable bed rail constructed primarily of nonrigid
materials, such as fabric or foam. An ``inflatable bed rail'' is
defined as a portable bed rail constructed primarily of nonrigid
material that requires air to be inflated into the product to achieve
structure. Our review of market information indicates that there are
products that differ from traditional, rigid portable bed rails in that
they are constructed of foam or inflatable rubber materials and meet
the definition of a portable bed rail under ASTM F 2085-10a. However,
most performance requirements of ASTM F 2085-10a do not apply to these
products because the standard was developed to address the hazards from
portable bed rails that consist of rigid (wood/metal) materials.
Accordingly, the proposed rule would state that the foam and inflatable
portable bed rails must meet only the General Requirements of section
5; the performance requirement of subsection 6.3, Enclosed Openings;
and the warning statements of subsection 9.3.1 of ASTM F 2085-10a
because those requirements can be applied to foam and inflatable
portable bed rail products.
(iii). Terminology (Proposed Sec. 1224.2(b)(2)).
Proposed 1224.2(b)(2) would revise the terminology in section 3 of
ASTM F 2085-10a by creating new terms to be numbered as new sections
3.1.10 through 3.1.14 of ASTM F 2085-10a. The new terms would be as
follows:
Foam bed rail is a portable bed rail constructed primarily of
nonrigid materials, such as fabric or foam;
Inflatable bed rail is a portable bed rail constructed primarily of
nonrigid material that requires air to be inflated into the product to
achieve structure;
Critical assembly component is any component of the portable bed
rail that requires consumer assembly in order to meet the performance
requirements of sections 6.1, Structural Integrity, 6.3 Enclosed
Openings; 6.4, Openings Created by Portable Bed Rail Displacement of
Adjacent Style Portable Bed Rails; 6.5, Openings Created by
Displacement of Mattress-Top Portable Bed Rails; and 6.6, Openings
Created by Displacement of Portable Bed Rails Intended for Use on
Specific Manufacturers' Beds of ASTM F 2085-10a;
Critical installation component is any component of the portable
bed rail that is used to attach the portable bed rail onto the bed; and
Misassembled/functional portable bed rail is a portable bed rail
that has been assembled incorrectly but appears to function as a
portable bed rail. Misassembly/functionality is determined by meeting
one of the criteria listed in proposed section 6.9, Determining
Misassembled/Functional Portable Bed Rail, of ASTM F 2085-10a.
The proposed rule would create these new terms because the
Commission is proposing new requirements for foam and inflatable
products. In addition, the
[[Page 19919]]
Commission is proposing new requirements to address misassembly and
misinstallation of portable bed rails. Accordingly, the addition of the
new terms will help testing laboratories understand the new performance
requirements and associated test methods to reduce entrapment hazards
associated with portable bed rails.
(iv). General Requirements (Proposed Sec. 1224.2(b)(3)).
Proposed section 1224.2(b)(3) would create a new section 5.6 of
ASTM F 2085-10a, Critical Installation Components. This new section of
ASTM F 2085-10a (new section 5.6.1) would provide that critical
installation components that are also critical assembly components and
meet the definition of a misassembled/functional portable bed rail must
be permanently affixed to a structural component(s) of the portable bed
rail. If a critical installation component(s) is also a critical
assembly component and may result in a misassembled/functional portable
bed rail, a new section 5.6.2 of ASTM F 2085-10a would require that a
portable bed rail not remain upright or that the vertical height must
decrease by 6 inches at any point along the top rail when tested to the
method for determining the acceptability of the vertical structure of a
misassembled/functional portable bed rail. (The requirement regarding a
portable bed rail not remaining upright or meeting certain vertical
height requirements would be at a new section 6.10.1 of ASTM F 2085-
10a, which we discuss later in section v of this document.) The
addition of critical installation components would reduce the
likelihood of portable bed rail misassembly in that a misassembled bed
rail would no longer be functional without the critical installation
components.
(v). Determining Misassembled/Functional Portable Bed Rail
(Proposed Sec. 1224.2(b)(4)(i) and (ii)).
Proposed Sec. 1224.2(b)(4)(i) would create a new section 6.9 of
ASTM F 2085-10a, Determining Misassmbled/Functional Portable Bed Rail.
It would consider a portable bed rail to be a misassembled/functional
portable bed rail if:
The portable bed rail can be assembled without any
critical assembly component (new section 6.9.1 of ASTM F 2085-10a);
The portable bed rail can be assembled without the
supplied fasteners, such as screws, nuts, or bolts that are not captive
to a critical assembly component like the frame (new section 6.9.2 of
ASTM F 2085-10a);
The portable bed rail's fabric cover or mesh can be placed
over the rigid frame structure without engaging critical parts of the
frame as intended in final assembly (new section 6.9.3 of ASTM F 2085-
10a), or
The portable bed rail can be assembled by improper
placement of any critical component, such as an inverted or an
interchanged part, without permanent deformation or breakage (new
section 6.9.4 of ASTM F 2085-10a).
To determine the acceptability of a misassembled/functional
portable bed rail, proposed section 1224.2(b)(4)(ii) would set forth
the requirements for a new section 6.10, Determining Acceptability of
Misassmbled/Functional Portable Bed Rail, of ASTM F 2085-10a. The new
section would provide that misassembled/functional portable bed rails
must meet sections 6.10.1, 6.10.2, 6.10.3, or 6.10.4 of ASTM F 2085-
10a. Under the proposed rule, a new section 6.10.1 of ASTM F 2085-10a
would provide that the portable bed rail must not remain upright or the
vertical height must decrease by 6 inches at any point along the top
rail when tested to new section 8.7 (Test Method for Determining
Acceptability of Vertical Structure of a Misassembled/Functional
Portable Bed Rail) of ASTM F 2085-10a. This section would provide
criteria to determine whether a misassembled portable bed rail lacks
sufficient vertical structure.
A new section 6.10.2 of ASTM F 2085-10a would provide that the
fabric cover or mesh attached to the bed rail must have a permanent sag
that is a minimum of 3 inches after tested in accordance with new
section 8.8 (Test Method for Determining Fabric Sag Acceptability of a
Misassembled/Functional Portable Bed Rail) of ASTM F 2085-10a. A new
section 6.10.3 of ASTM F 2085-10a would provide that a product will not
be considered acceptable if the fabric cover will not fit over the
frame without tearing. A new section 6.10.4 of ASTM F 2085-10a would
provide that mating parts must clearly show misassembly by two parts
overlapping and creating a minimum of a \1/2\ inch protrusion out of
the plane of the rail. These new sections would provide the criteria
for testing laboratories to determine the sufficiency of visual cues
for fabric mesh misassembly.
(vi). Test Equipment (Proposed Sec. 1224.2(b)(5)(i)).
Proposed section 1224.2(b)(5)(i) would state that a force gauge
must have a minimum range of 0 to 50 lb (222N) with a maximum tolerance
of 0.25 lb (1.11N), as set forth under a new section 7.6
of ASTM F 2085-10a. The addition of this section will help clarify the
manner in which the force will be applied under the proposed test
methods discussed in section (vii) below.
(vii). Test Method for Determining Acceptability of Vertical
Structure of a Misassembled/Functional Portable Bed Rail. (Proposed
Sec. Sec. 1224.2(b)(6)(i) and (ii)).
Proposed Sec. Sec. 1224.2(b)(6)(i) and (ii) would require new test
methods to address misassembly of portable bed rails. These proposed
requirements would include a test method for determining the
acceptability of the vertical structure of a misassembled/functional
portable bed rail under a new section 8.7 of ASTM F 2085-10a, as well
as a test method for determining fabric sag acceptability of a
misassembled/functional portable bed rail under a new section 8.8 of
ASTM F 2085-10a. These tests would provide a method for testing
laboratories to determine if a misassembled portable bed rail lacks
sufficient vertical structure and also determine the sufficiency of
visual cues for portable bed misassembly.
Under a new section 8.7 of ASTM F 2085-10a, the proposed test
method for determining acceptability of vertical structure of a
misassembled/functional bed would require, if possible, an attempt to
assemble the portable bed rail in a misassembled configuration(s), as
described in new section 6.9 of ASTM F 2085-10a. The proposed test
method also would include:
Firmly securing the misassembled portable bed rail on a
table top or other stationary flat surface using clamps (new section
8.7.2 of ASTM F 2085-10a). The clamps should be located 4 to 6 inches
from the intersection of the portable bed rail legs to the vertical
plane.
Gradually applying a force of 10 lbs, using a \1/2\ inch
disc to the uppermost horizontal component of the rail in a downward
direction at a location along the horizontal component most likely to
vertically deform the portable bed rail; and applying the force over a
period of 5 seconds, and holding the force for 10 seconds and releasing
(new section 8.7.3 of ASTM F 2085-10a); and
Repeating the steps in new sections 8.7.1 through 8.7.3
for all misassembly configurations (new section 8.7.4 of ASTM F 2085-
10a).
The proposed test method for determining fabric sag acceptability
of a misassembled/functional portable bed rail (new section 8.8 of ASTM
F 2085-10a) would require, if possible, an attempt to assemble the
portable bed rail
[[Page 19920]]
in a misassembled configuration(s), as described in new section 6.9 of
ASTM F 2085-10a, and depicted in new Figure 8. The proposed test method
would include:
Gradually applying a force of 1 lb using a \1/2\ inch disc
on the fabric/mesh in any direction or location along the fabric/mesh
that is most likely to cause it to come off of the frame; applying the
force over a period of 5 seconds; and holding for an additional 10
seconds and releasing (new section 8.8.2 of ASTM F 2085-10a); and
Repeating these steps for all misassembly configurations
discovered in new section 6.9 of ASTM F 2085-10a (new section 8.8.3 of
ASTM F 2085-10a).
(viii). Marking and Labeling. (Proposed Sec. 1224.2(b)(7), (8), and
(9).
Proposed section 1224.2(b)(7) would add a warning symbol
[GRAPHIC] [TIFF OMITTED] TP11AP11.007
and the word ``WARNING'' prior to ``Suffocation and Strangulation
Hazard'' under section 9.3.1.1 of ASTM F 2085-10a. This proposed
addition would give the warning more emphasis.
Proposed section 1224.2(b)(8) would replace the existing marking
under section 9.3.1.3 of ASTM F 2085-10a, which states: ``Infants who
cannot get in and out of an adult bed without help can be trapped
between a mattress and a wall and suffocate. NEVER place infants in
adult beds with or without a portable bed rail.'' The proposed warning
would state instead: ``Children who cannot get in and out of an adult
bed without help can be trapped between a mattress and a wall and
suffocate. NEVER place children younger than 2 years old in adult beds
with or without a portable bed rail.'' Despite the current warning
label cautioning against the use of this product with children under 2
years old, parents of infants continue to use this product with their
infants. Accordingly, the revised language would emphasize the hazard
presented to children younger than 2 years old when placed in adult
beds.
Proposed section 1224.2(b)(9) would require critical installation
components to be labeled with the entrapment hazard warning for
portable bed rail use to warn of issues related to misinstallation of
portable bed rails under a new section 9.4 of ASTM F 2085-10a. A new
section 9.4 of ASTM F 2085-10a would require the entrapment hazard
warning to be in contrasting colors, permanent, conspicuous, and sans
serif-style font. The proposed warning would require in the entrapment
hazard warning statement the safety alert symbol
[GRAPHIC] [TIFF OMITTED] TP11AP11.008
and the words ``WARNING--ENTRAPMENT HAZARD'' to be not less than 0.20
in. (5 mm) high. The remainder of the text would consist of characters
whose upper case must be at least 0.10 in. (2.5 mm) high. The warning
would state: ``NEVER use portable bed rail without installing this part
onto bed. Incorrect installation can allow the portable bed rail to
move away from mattress, which can lead to entrapment and death.''
Components such as a locking clamp on a mattress-top portable bed rail
or an anchor plate/strap are critical installation components. If these
components are not installed properly, the portable bed rail will not
be secure and may move away from the mattress and can result in an
entrapment hazard. The warning requirement would emphasize the
importance of proper installation of key components.
(ix). Instructional Literature (Proposed Sec. 1224.2(b)(10)). This
proposed section would revise the language in section 11.1 of ASTM F
2085-10a to add the word ``installation'' among the topics in
instructional literature. This proposed section would read:
``Instructions must be provided with the portable bed rail and must be
easy to read and understand. Assembly, installation, maintenance,
cleaning, operating, and adjustment instructions and warnings, where
applicable, must be included.'' This requirement would add clear
instructional literature for installation components to provide
consumers easy to understand information for securing portable bed
rails on beds.
F. Request for Comments
This proposed rule begins a rulemaking proceeding under section
104(b) of the CPSIA to issue a consumer product safety standard for
portable bed rails. We invite all interested persons to submit comments
on any aspect of the proposed rule. Comments should be submitted in
accordance with the instructions in the ADDRESSES section at the
beginning of this notice.
G. Effective Date
The Administrative Procedure Act (``APA'') generally requires that
the effective date of a rule be at least 30 days after publication of
the final rule. 5 U.S.C. 553(d). To allow time for manufacturers of
portable bed rails to bring their products into compliance with the new
requirements, the Commission intends that the standard would become
effective six months after publication of a final rule. The Commission
seeks comment on how long it would take manufacturers of portable bed
rails to come into compliance with the rule.
H. Regulatory Flexibility Act
1. Introduction
The Regulatory Flexibility Act (``RFA''), 5 U.S.C. 601-612,
requires agencies to consider the impact of proposed rules on small
entities, including small businesses. Section 603 of the RFA requires
that we prepare an initial regulatory flexibility analysis and make it
available to the public for comment when the general notice of proposed
rulemaking is published. The initial regulatory flexibility analysis
must describe the impact of the proposed rule on small entities and
identify any alternatives that may reduce the impact. Specifically, the
initial regulatory flexibility analysis must contain:
1. A description of and, where feasible, an estimate of the number
of small entities to which the proposed rule will apply;
2. A description of the reasons why action by the agency is being
considered;
3. A succinct statement of the objectives of, and legal basis for,
the proposed rule;
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 subject to the requirements
and the type of professional skills necessary for the preparation of
reports or records; and
5. An identification, to the extent possible, of all relevant
federal rules that may duplicate, overlap, or conflict with the
proposed rule.
In addition, the initial regulatory flexibility analysis must
contain a description of any significant alternatives to the proposed
rule that would accomplish the stated objectives of the proposed rule
and at the same time reduce the economic impact on small entities.
2. The Market
Typically, portable bed rails are produced and/or marketed by
juvenile product manufacturers and distributors or by furniture
manufacturers and distributors. Currently, there are at least 14 known
manufacturers or importers supplying portable bed rails to the U.S.
market. Ten are domestic manufacturers (71 percent) and three are
domestic
[[Page 19921]]
importers (21 percent). The remaining firm has an unknown supply
source, and there is no publicly available information regarding its
size.
Under the U.S. Small Business Administration (``SBA'') guidelines,
a manufacturer of portable bed rails is small if it has 500 or fewer
employees, and an importer is considered small if it has 100 or fewer
employees. Based on these guidelines, nine of the domestic
manufacturers and all of the domestic importers known to be supplying
the U.S. market are small. There may be additional unknown small
manufacturers and importers operating in the U.S. market as well.
The Juvenile Product Manufacturers Association (``JPMA'') runs a
voluntary certification program for several juvenile products. Five
manufacturers supply portable bed rails to the U.S. market that are
compliant with the ASTM standard. Among them, four are JPMA-certified
as being compliant with the current ASTM voluntary standard, and one
claims compliance with the ASTM standard. Of the importers, one is
JPMA-certified, and one claims compliance. JPMA estimates that current
annual sales of portable bed rails are approximately 750,000 units, and
retail sales are approximately $20 million. This estimate is similar to
a 2003 sales estimate provided by JPMA. No information is available
about the average product life of portable bed rails; if, for example,
portable bed rail sales are assumed to have remained constant and
portable bed rails remain in use for three to five years, there might
be 2.25 million to 3.75 million portable bed rails in use. National
estimates of portable bed rail product injuries are not available
because National Electronic Injury Surveillance System (``NEISS'') data
does not allow for clear identification of portable bed rail incidents.
Therefore, the risk of injury associated with the number of products in
use cannot be calculated.
3. Impact of the Proposal on Small Business
Out of the 14 firms currently known to be producing or selling
portable bed rails in the United States, one is a large domestic
manufacturer, nine are small domestic manufacturers, and three are
small domestic importers; and there is insufficient information
regarding the size or supply source of the remaining firm. The impact
on the 12 small domestic firms could be significant. However, the
impact of the proposed standard on small manufacturers could differ,
based on whether their products are compliant with the voluntary ASTM F
2085-10a. Of the nine small domestic manufacturers, five produce
portable bed rails that are certified as compliant by JPMA or claim to
be in compliance with the voluntary standard. The four noncompliant
manufacturers may require substantial modifications to meet both the
ASTM standard and the proposed requirements. The costs associated with
these modifications could include product design, development and
marketing staff time, product testing, and focus group expenses. There
may be increased costs of production as well, particularly if
additional materials are required. The actual cost of such an effort is
unknown but could be significant for some firms. However, the impact of
these costs may be mitigated if they are treated as new product
expenses and amortized.
The impact of the proposed standard on the five compliant firms may
be less significant because they already comply with the voluntary
standard. However, even ASTM-compliant portable bed rails currently on
the market will require modifications to meet the proposed changes. Any
product redesign would entail costs similar to those outlined for non-
ASTM compliant firms. Some ASTM-compliant firms may opt to preassemble
the critical assembly components rather than redesign their product.
Preassembled products may require larger shipping boxes, and there may
be higher shipping costs associated with shipping larger boxes. To the
extent that retailers charge high stocking and inventory fees, firms
may face additional costs. Manufacturers may be able to offset these
fees if they are able to pass on some of the expense to consumers.
While preassembly may reduce product redesign costs, meeting a
requirement that critical installation components be affixed
permanently may also require some product redesign. There will be some
costs associated with redesign. In addition, all manufacturers will
need to modify existing warning labels. A new warning label poses a
small burden because it represents a minor modification. Costs
associated with the new warning label would be low because no new
materials are used. At least one small manufacturer's product line
consists entirely or primarily of nonrigid portable bed rails. This
firm may need to alter the warning label but otherwise is not likely to
be affected significantly by the proposed standard.
Of the three small domestic importers, two import portable bed
rails that are certified compliant by JPMA or claim to be in compliance
with the voluntary standard. All of these small importers would need to
find an alternate source of portable bed rails if their existing
supplier does not come into compliance with the new requirements of the
proposed standard. The cost to importers may increase, and, in turn,
they may pass on some of those increased costs to consumers. Some
importers may respond to the rule by discontinuing the import of their
portable bed rails. However, the impact of such a decision may be
lessened by replacing the noncompliant portable bed rail with a
complying product or another juvenile product. Deciding to import an
alternative product would be a reasonable and realistic way for most
importers to offset any lost revenue, given that most import a variety
of products. However, for small importers whose product lines rely
largely on portable bed rails, substituting another product may not be
realistic. The impact on these small importers likely would be more
significant.
4. Alternatives Regarding Impact on Small Business
If the current voluntary standard is adopted without any
modifications, the impact on small businesses potentially could be
reduced in terms of costs for manufacturers and importers because
redesign would not be required. Small manufacturers and importers who
are compliant with the voluntary standard would have a reduced burden.
However, firms that are not in compliance with the ASTM standard may
still need to make substantial product changes to meet ASTM F 2085-10a.
A second alternative to reduce the impact on small businesses would be
to set an effective date later than six months. This would allow
suppliers additional time to modify or develop compliant portable bed
rails and spread the associated costs over a longer period of time.
5. Conclusion of the Initial Regulatory Flexibility Analysis
It is possible that the proposed standard, if finalized, could have
a significant impact on some small firms. The extent of these costs is
unknown, but because product redevelopment would likely be necessary,
it is possible that the costs could be large for some firms.
Additionally, all manufacturers eventually will be subject to third
party testing and certification requirements, as discussed in section L
below. There will likely be some additional costs associated with third
party testing and certification.
However, at least some costs are expected to be passed on to
consumers without a reduction in the firms' ability to compete because
of the special
[[Page 19922]]
features associated with these products. We invite comment on what
these costs may be, whether they may be passed on to the consumer, and
how these costs will impact small businesses. We also seek information
on the effect on retailers (e.g., the impact of increased package size
on the number of units kept in stock).
I. Environmental Considerations
The Commission's environmental review regulation at 16 CFR part
1021 has established categories of actions that normally have little or
no potential to affect the human environment and therefore do not
require either an environmental assessment or an environmental impact
statement. The proposed rule is within the scope of the Commission's
regulation, at 16 CFR 1021.5(c)(1), which provides a categorical
exclusion for rules that provide design or performance requirements for
products. Thus, no environmental assessment or environmental impact
statement for this rule is required.
J. 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 (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.
We particularly invite 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 Portable Bed Rails.
Description: The proposed rule would require each portable bed rail
to comply with ASTM F 2085-10a, Standard Consumer Safety Specification
for Portable Bed Rails. Sections 9, 10, and 11 of ASTM F 2085-10a
contain requirements for marking and instructional literature.
Description of Respondents: Persons who manufacture or import
portable bed rails.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Frequency of Total annual Hours per Total burden
16 CFR section respondents responses responses response hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
1224.2(a).......................................................... 7 2 14 1 14
--------------------------------------------------------------------------------------------------------------------------------------------------------
There are no capital costs or operating and maintenance costs
associated with this collection of information.
Our estimates are based on the following:
Proposed Sec. 1224.2(a) would require each portable bed rail to
comply with ASTM F 2085-10a. Sections 9 and 11 of ASTM F 2085-10a
contain requirements for marking, labeling, and instructional
literature that are disclosure requirements, thus falling within the
definition of ``collections of information'' at 5 CFR 1320.3(c).
Section 9.1.1 of ASTM F 2085-10a requires that the name and the
place of business (city, state, mailing address, including zip code, or
telephone number) of the manufacturer, importer, distributor, or seller
be clearly and legibly marked on each product and its retail package.
Section 9.1.2 of ASTM F 2085-10a requires a code mark or other means
that identifies the date (month and year as a minimum) of manufacture.
There are 14 known firms supplying portable bed rails to the U.S.
market. Seven of the 14 firms are known to produce labels that comply
with these sections of the standard, so there would be no additional
burden on these firms. The remaining seven firms are assumed to use
labels on their products and their packaging but would need to make
some modifications to their existing labels. The estimated time
required to make these modification is about 1 hour per model. Each
firm supplies an average of two different models of portable bed rails;
therefore, the estimated burden hours associated with labels is 1 hour
x 7 firms x 2 models per firm = 14 annual hours.
We estimate that the hourly compensation for the time required to
create and update labels is $28.00 (Bureau of Labor Statistics,
September 2010, all workers, goods-producing industries, sales, and
office, Table 9). Therefore, the estimated annual cost to industry
associated with the Commission-recommended labeling requirements is
$392 ($28.00 per hour x 14 hours = $392).
Section 11.1 of ASTM F 2085-10a requires instructions to be
supplied with the product. Portable bed rails are products that
generally require assembly, and products sold without such information
would not be able to compete successfully with products supplying this
information. 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.'' Therefore, because the
CPSC is unaware of portable bed rails that: (a) Generally require some
installation, but (b) lack any instructions to the user about such
installation, we estimate tentatively that there are no burden hours
associated with the instructions requirement in section 11.1 of ASTM F
2085-10a because any burden associated with supplying instructions with
portable bed rails would be ``usual and customary'' and not within the
definition of ``burden'' under the OMB's regulations. Based on this
analysis, the proposed standard for portable bed rails would impose a
burden to industry of 14 hours at a cost of $392 annually.
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3507(d)), we have submitted the information collection requirements of
this rule to the OMB for review. Interested persons are requested to
submit comments regarding information collection by May 11, 2011, to
the Office
[[Page 19923]]
of Information and Regulatory Affairs, OMB (see ADDRESSES).
K. Preemption
Section 26(a) of the CPSA, 15 U.S.C. 2075(a), provides that where a
``consumer product safety standard under [the CPSA]'' is in effect and
applies to a product, no state or political subdivision of a state may
either establish or continue in effect a requirement dealing with the
same risk of injury unless the state requirement is identical to the
Federal standard. Section 26(c) of the CPSA also provides that states
or political subdivisions of states may apply to the Commission for an
exemption from this preemption under certain circumstances. Section
104(b) of the CPSIA refers to the rules to be issued under that section
as ``consumer product safety rules,'' thus implying that the preemptive
effect of section 26(a) of the CPSA would apply. Therefore, a rule
issued under section 104 of the CPSIA will invoke the preemptive effect
of section 26(a) of the CPSA when it becomes effective.
L. Certification
Section 14(a) of the Consumer Product Safety Act (``CPSA'') imposes
the requirement 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, be certified as
complying with all applicable CPSC-enforced requirements. 15 U.S.C.
2063(a). Such certification must be based on a test of each product or
on a reasonable testing program or, for children's products, on tests
on a sufficient number of samples by a third party conformity
assessment body accredited by the Commission to test according to the
applicable requirements. As discussed in part K of this preamble,
section 104(b)(1)(B) of the CPSIA refers to standards issued under that
section, such as the rule for portable bed rails proposed in this
notice, as ``consumer product safety standards.'' Furthermore, the
designation as ``consumer product safety standards'' subjects such
standards to certain sections of the CPSA, such as section 26(a) of the
CPSA, regarding preemption. By the same reasoning, such standards also
would be subject to section 14 of the CPSA, regarding testing and
certification. Therefore, any such standard would be considered a
consumer product safety rule to which products subject to the rule must
be certified.
Because portable bed rails are children's products, certifications
of compliance must be based on testing conducted by a CPSC-approved
third party conformity assessment body. In the future, we will issue a
notice of requirements to explain how laboratories can become
accredited as third party conformity assessment bodies to test to the
new safety standard. We seek comment on the testing requirements of
this standard, particularly comment on whether any further specificity
is required for the testing procedures and equipment and comment on
whether the testing requirements are reliable, replicable, and
sufficiently specific to allow laboratories to set pass/fail criteria
for compliance determinations. We also seek comment on what a testing
program might entail for portable bed rails.
Portable bed rails also must comply with all other applicable CPSC
requirements, such as the lead content and phthalate content
requirements in sections 101 and 108 of the CPSIA; the tracking label
requirement in section 14(a)(5) of the CPSA; and the consumer
registration form requirements in section 104 of the CPSIA.
List of Subjects in 16 CFR Part 1224
Consumer protection, Imports, Incorporation by reference, Infants
and children, Labeling, and Law enforcement.
Therefore, the Commission proposes to amend Title 16 of the Code of
Federal Regulations by adding part 1224 to read as follows:
PART 1224--SAFETY STANDARD FOR PORTABLE BED RAILS
Sec.
1224.1 Scope, application, and effective date.
1224.2 Requirements for portable bed rails.
Authority: Sections 3 and 104 of Pub. L. 110-314, 122 Stat.
3016 (August 14, 2008).
Sec. 1224.1 Scope, application, and effective date.
This part 1224 establishes a consumer product safety standard for
portable bed rails manufactured or imported on or after [DATE 6 MONTHS
AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE FEDERAL REGISTER].
Sec. 1224.2 Requirements for portable bed rails.
(a) Except as provided in paragraph (b) of this section, each
portable bed rail as defined in ASTM F 2085-10a, Standard Consumer
Safety Specification for Portable Bed Rails, approved October 1, 2010,
must comply with all applicable provisions of ASTM F 2085-10a. The
Director of the Federal Register approves this incorporation by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may
obtain a copy of this ASTM standard from ASTM International, 100 Barr
Harbor Drive, P.O. Box C700, West Conshohocken, PA 19428-2959 USA,
phone: 610-832-9585; http://www.astm.org/. You may inspect copies at
the Office of the Secretary, U.S. Consumer Product Safety Commission,
Room 820, 4330 East West Highway, Bethesda, MD 20814, telephone 301-
504-7923, or at the National Archives and Records Administration
(NARA). For information on the availability of this material at NARA,
call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal regulations/ibr_locations.html.
(b) Comply with the ASTM F 2085-10a standard with the following
additions:
(1) In addition to complying with section 1.4 of ASTM F 2085-10a,
comply with the following:
(i) 1.4.1 Foam and inflatable bed rails need meet only the General
Requirements of section 5, the performance requirement of 6.3 Enclosed
Openings, and the warning requirement of section 9.3.1.
(ii) [Reserved]
(2) In addition to complying with section 3.1.9.1 of ASTM F 2085-
10a, comply with the following:
(i) 3.1.10 foam bed rail, n--portable bed rail constructed
primarily of nonrigid materials such as fabric or foam.
(ii) 3.1.11 inflatable bed rail, n--a portable bed rail constructed
primarily of nonrigid material that requires air be inflated into the
product to achieve structure.
(iii) 3.1.12 critical assembly component, n--any component of the
portable bed rail that requires consumer assembly in order to meet the
performance requirements of 6.1 Structural Integrity, 6.3 Enclosed
Openings, 6.4 Openings Created by Portable Bed Rail Displacement of
Adjacent Style Portable Bed Rails, 6.5 Openings Created by Displacement
of Mattress-Top Portable Bed Rails and 6.6 Openings Created by
Displacement of Portable Bed Rails Intended for Use on Specific
Manufacturers' Beds.
(iv) 3.1.13 critical installation component, n--any component of
the portable bed rail that is used to attach the portable bed rail onto
the bed.
(v) 3.1.14 misassembled/functional portable bed rail, n--a portable
bed rail that has been assembled incorrectly but appears to function as
a portable bed rail. Misassembly/functionality is determined by meeting
one of the criteria listed in 6.9.
[[Page 19924]]
(3) In addition to complying with section 5.5 of ASTM F F 2085-10a,
comply with the following:
(i) 5.6 Critical Installation Components that are also critical
assembly components and that meet the definition of a misassembled/
functional portable bed rail must meet 5.6.1 or 5.6.2.
(A) 5.6.1 Critical installation components must be permanently
affixed to a structural component(s) of the portable bed rail.
(B) 5.6.2 If a critical installation component(s) is also a
critical assembly component and may result in a misassembled/functional
portable bed rail, the portable bed rail must meet 6.10.1.
(4) In addition to complying with section 6.8 of ASTM F 2085-10a,
comply with the following:
(i) 6.9 Determining Misassembled/Functional Portable Bed Rail--a
portable bed rail must be considered a misassembled/functional portable
bed rail if it meets one of the criteria in 6.9.1, 6.9.2, 6.9.3, or
6.9.4.
(A) 6.9.1 The portable bed rail can be assembled without any
critical assembly component.
(B) 6.9.2 The portable bed rail can be assembled without the
supplied fasteners, such as screws, nuts, or bolts that are not captive
to a critical assembly component such as the frame.
(C) 6.9.3 The portable bed rail's fabric cover or mesh can be
placed over the rigid frame structure without engaging parts of the
frame as intended in final assembly.
(D) 6.9.4 The portable bed rail can be assembled by improper
placement of any critical assembly component, such as an inverted or an
interchanged part, without permanent deformation or breakage.
(ii) 6.10 Determining Acceptability of Misassembled/Functional
Portable Bed Rail--Misassembled/Functional Portable Bed Rails must meet
6.10.1, 6.10.2, 6.10.3 or 6.10.4.
(A) 6.10.1 The portable bed rail must not remain upright or the
vertical height must decrease by 6 inches at any point along the top
rail when tested to 8.7.
(B) 6.10.2 The fabric cover or mesh must have a permanent sag a
minimum of 3 inches after tested in accordance with 8.8.
(C) 6.10.3 The fabric cover will not fit over the frame without
tearing.
(D) 6.10.4 Mating parts must clearly show misassembly by two parts
overlapping and creating a minimum of a \1/2\-inch protrusion out of
the plane of the rail.
(5) In addition to complying with section 7.5 of ASTM F F 2085-10a,
comply with the following:
(i) 7.6 Force Gauge--gauge must have a minimum range of 0 to 50 lb
(222N) with a maximum tolerance of 0.25 lb (1.11N).
(ii) [Reserved]
(6) In addition to complying with section 8.6 of ASTM F 2085-10a,
comply with the following:
(i) 8.7 Test Method for Determining Acceptability of Vertical
Structure of a Misassembled/Functional Portable Bed Rail:
(A) 8.7.1 If possible, attempt to assemble the portable bed rail in
a misassembled configuration(s) as defined in 6.9 Determining
Misassembled/Functional Portable Red Rail:
(B) 8.7.2 Firmly secure the misassembled portable bed rail on a
table top or other stationary flat surface using clamps. The clamps
should be located 4 to 6 inches from the intersection of the portable
bed rail legs to the vertical plane (see figure 8).
(C) 8.7.3 Gradually apply a force of 10 lb using a \1/2\-inch disc
to the uppermost horizontal component of the rail in a downward
direction at a location along the horizontal component most likely to
vertically deform the portable bed rail (see figure 8). Apply the force
over a period of 5 seconds, hold the force for 10 seconds, and release.
(D) 8.7.4 Repeat 8.7.1 through 8.7.3 for all misassembly
configurations discovered in 6.9.
(ii) 8.8 Test Method for Determining Fabric Sag Acceptability of a
Misassembled/Functional Portable Bed Rail:
(A) 8.8.1 If possible, attempt to assemble the portable bed rail in
a misassembled configuration(s) as defined in 6.9 Determining
Misassembled/Functional Portable Bed Rail.
(B) 8.8.2 Gradually apply a force of 1 lb using a \1/2\-inch disc
on the fabric/mesh in any direction or location along the fabric/mesh
that is most likely to cause it to come off of the frame (see figure
8). Apply the force over a period of 5 seconds, hold for an additional
10 seconds, and release.
(C) 8.8.3 Repeat 8.8.1 through 8.8.2 for all misassembly
configurations discovered in 6.9.
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(7) Instead of complying with sections 9.3.1.1 of ASTM F 2085-10a,
comply with the following:
[GRAPHIC] [TIFF OMITTED] TP11AP11.010
(ii) [Reserved]
(8) Instead of complying with sections 9.3.1.3.of ASTM F 2085-10a,
comply with the following:
(i) 9.3.1.3 Children who cannot get in and out of an adult bed
without help can be trapped between a mattress and a wall and
suffocate. NEVER place children younger than 2 years old in adult beds
with or without a portable bed rail.
(ii) [Reserved]
(9) In addition to complying with section 9.3.2.5 of ASTM F 2085-
10a, comply with the following:
(i) 9.4 Critical installation components must be labeled with the
entrapment hazard warning in 9.4.1. The entrapment hazard warning must
be in contrasting colors, permanent, conspicuous, and sans serif-style
font. In the entrapment hazard warning statement the safety alert
symbol
[GRAPHIC] [TIFF OMITTED] TP11AP11.011
and the words ``WARNING--ENTRAPMENT HAZARD'' must not be less than 0.20
in. (5 mm) high. The remainder of the text must be characters whose
upper case must be at least 0.10 in. (2.5 mm) high.
(A) 9.4.1. The warning must including the following, exactly as
stated below:
[GRAPHIC] [TIFF OMITTED] TP11AP11.012
[[Page 19926]]
(B) [Reserved]
(ii) [Reserved]
(10) Instead of complying with section 11.1 of ASTM F 2085-10a,
comply with the following:
(i) 11.1 Instructions must be provided with the portable bed rail
and must be easy to read and understand. Assembly, installation,
maintenance, cleaning, operating, and adjustment instructions and
warnings, where applicable, must be included.
(ii) [Reserved]
Dated: April 6, 2011.
Todd A. Stevenson,
Secretary, U.S. Consumer Product Safety Commission.
[FR Doc. 2011-8558 Filed 4-8-11; 8:45 am]
BILLING CODE 6355-01-P