Safety Standard for Portable Bed Rails: Notice of Proposed Rulemaking, 19914-19926 [2011-8558]

Agencies

• Consumer Product Safety Commission

[Federal Register Volume 76, Number 69 (Monday, April 11, 2011)]
[Proposed Rules]
[Pages 19914-19926]
From the Federal Register Online via the Government Printing 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 https://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: https://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 https://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 https://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 https://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 oira_submission@omb.eop.gov.

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; rkhanna@cpsc.gov.

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: https://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 effect