[Federal Register Volume 77, Number 40 (Wednesday, February 29, 2012)]
[Rules and Regulations]
[Pages 12182-12197]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-4451]


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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1224

[CPSC Docket No. CPSC-2011-0019]


Safety Standard for Portable Bed Rails: Final Rule

AGENCY: Consumer Product Safety Commission.

ACTION: Final rule.

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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. In this rule, 
the Commission is issuing a safety standard for portable bed rails in 
response to the CPSIA.\1\
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    \1\ The Commission voted 4-0 to approve publication of this 
final rule.

DATES: The rule will become effective August 29, 2012 and apply to 
product manufactured or imported on or after that date. The 
incorporation by reference of the publication listed in this rule is 
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approved by the Director of the Federal Register as of August 29, 2012.

FOR FURTHER INFORMATION CONTACT: Rohit Khanna, Project Manager, Office 
of Hazard Identification and Reduction, U.S. Consumer Product Safety 
Commission, 5 Research Place, Rockville, MD 20850; telephone (301) 987-
2508 ; rkhanna@cpsc.gov.

SUPPLEMENTARY INFORMATION: 

A. Background: Section 104(b) of 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. The term ``durable infant or 
toddler product'' is defined in section 104(f) of the CPSIA as a 
durable product intended for use, or that may be reasonably expected to 
be used, by children under the age of 5 years. Portable bed rails (also 
referred to as ``bed rail'' or ``bedrail'') are one of the products 
identified by the Commission under section 104(f) of the CPSIA as 
durable infant or toddler products. On December 29, 2009, the 
Commission issued requirements for consumer registration of durable 
infant or toddler products and a bed rail was identified as a durable 
infant or toddler products that needed to comply with the registration 
card requirements. 76 FR 68668.
    In the Federal Register of April 11, 2011 (76 FR 19914), we 
published a proposed rule that would incorporate by reference ASTM 
F2085-10a, ``Standard Consumer Safety Specification for Portable Bed 
Rails'' but with several modifications that strengthen the standard. In 
response to the proposed rule and based on comments to the proposed 
rule, the ASTM Subcommittee on Portable Bed Rails, in collaboration 
with CPSC staff, developed a newer edition of the standard, ASTM F2085-
12, ``Standard Consumer Safety Specification for Portable Bed Rails,'' 
which incorporates many of the proposed modifications in the proposed 
rule, with a few clarifications and modifications that strengthen the 
standard. ASTM F2085-12 contains more stringent requirements than its 
predecessor, ASTM F2085-10a, and would further reduce the risk of 
injury associated with portable bed rails. In this document, we are 
issuing a safety standard for portable bed rails, which incorporates by 
reference, the new voluntary safety standard developed by ASTM 
International (formerly known as the American Society for Testing and 
Materials), ASTM F2085-12, ``Standard Consumer Safety Specification for 
Portable Bed Rails.'' We summarize the proposed rule and discuss the 
final rule (including differences between the proposal and the final 
rule) in section F of this preamble. The information discussed in this 
preamble comes from CPSC staff's briefing package for the portable bed 
rails final rule, which is

[[Page 12183]]

available on the CPSC's Web site at http://www.cpsc.gov/library/foia/foia12/brief/briefing.html.

B. The Product

    ASTM F2085-12, and its predecessor ASTM F2085-10a, define 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 ASTM F2085-12, and its 
predecessor, ASTM F2085-10a, 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'').
    As discussed in the preamble to the proposed rule, a review of 
market information showed that there are products that differ from 
traditional, rigid portable bed rails in that they are constructed of 
nonrigid (also referred to as ``non-rigid'') materials, such as foam or 
inflatable materials. (76 FR 19915 through 19916). Although these foam 
and inflatable products do not use the term ``bed rails'' in their 
packaging or labeling, we stated that such products meet the definition 
of a portable bed rail and should be included in the scope of the 
standard. However, most of the performance requirements in the ASTM 
standard, which pertain to traditional, rigid portable bed rails, did 
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 revised ASTM F2085-12 standard 
now covers foam and inflatable products but would require that only 
certain relevant provisions of the standard apply to such bed rails.
    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 F2085-12 and its predecessor, 
ASTM F2085-10a. However, as we stated in the preamble to the proposed 
rule (76 FR 19916), guard rails that are used with crib mattresses on 
toddler beds are not covered under this voluntary standard. They are 
addressed under the Consumer Safety Specification for Toddler Beds. 
Other products that are not covered 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). ASTM F2085-12 now makes it clear that such 
products are not covered under the standard.
    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 final rule.

C. Incident Data

    The preamble to the proposed rule (76 FR 19916 through 19917) 
summarized the data for incidents from January 1, 2000 through March 
31, 2010, related to portable bed rails. For that period, 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. Of the 13 fatalities, 
there were two deaths that resulted from portable bed rail 
displacement, when the portable bed rail partially pushed away from 
beneath the mattress and allowed the child to fall into the opening and 
get trapped. There were three cases of portable bed rail misassembly. 
In three additional fatal incidents, not enough information was 
available to determine the contributing factor(s) that led to the 
hazardous entrapment scenario. The beds used in the eight cases 
mentioned previously were adult-size beds. More information concerning 
these incidents is provided in the preamble to the proposed rule (76 FR 
19916 through 19917).
    On the remaining five fatalities (out of 13), after publication of 
the proposed rule, we received additional information, through in-depth 
follow-up investigations on 4 deaths out of the 5 remaining fatalities 
that were listed as having insufficient information at the time of 
publication of the proposed rule. One of the 4 fatalities included 
among the incident data in the portable bed rail proposed rule is now 
known to have occurred from partial displacement of the bed rail, which 
led to the entrapment of the decedent. A second fatality listed 
previously as lacking sufficient information, still remains in that 
status. The third fatality is now known not to involve any portable bed 
rail; what was originally reported as a bed rail has now been confirmed 
to be a crib rail. Finally, it seems unlikely that the fourth fatality 
was associated with a portable bed rail. The decedent, co-sleeping with 
a sibling and a parent, suffocated. The role, if any, of a portable bed 
rail, now seems questionable. A fifth fatality could not be 
investigated because the victim's name was not released.
    While preparing a final rule, CPSC staff also conducted a new 
search of the CPSC's epidemiological databases and found that there 
were 23 new portable bed rail-related incidents reported between April 
1, 2010 and November 9, 2011. These incidents are reported to have 
occurred between 2009 and 2011. Four of the 23 incidents were fatal, 
and 19 were nonfatal incidents, 8 of which reported an injury. Among 
the 23 newly reported incidents that specified age (18 out of 23), 
three reported a child younger than 15 months old. The majority of the 
incidents (15 out of 18) reported the child's age to be between 15 
months and 4 years.
    Among the newly reported incidents, there were 4 fatalities. One 
resulted from a misinstalled bed rail, where the decedent was strangled 
by the straps of the reinforced anchor system. The second fatality 
occurred when the infant slipped through the torn section of the mesh 
and got caught when the bed rail flipped down and caught him at the 
neck. The remaining 2 fatalities lacked any information on the product 
or scenario-specific details.
    Among the newly reported incidents, there were 19 nonfatal 
incidents resulting in 8 injuries. The 8 injuries sustained were mostly 
bumps and bruises; one case reported a laceration that was severe 
enough to require multiple stitches, and another reported a fractured 
collar-bone. None of the injuries required hospitalization. The hazard 
patterns identified among the 23 incident reports were similar to the 
hazard patterns identified in the data included in the proposed rule, 
including hinge-lock failure (8 incidents including 4 injuries and 1 
fatality). The fatality was attributable, in part, to the hinge-lock 
failure of the bed rail and, in part, to the torn mesh panel). Other 
hazard patterns showed displacement of the bed rail (7 incidents, 
including 3 injuries, where the bed rail pushed out from underneath the 
mattress and created an opening between the mattress

[[Page 12184]]

and the rail); sharp surface (3 incidents, including 1 injury, due to 
sharp surfaces on the bed rail); misinstallation (1 strangulation 
fatality on the straps of the reinforced anchor system of the bed rail 
was reported to have been due to the improper misinstallation of the 
bed rail); and miscellaneous issues that included 4 incidents and 2 
fatalities with insufficient information on the product or scenario and 
2 non-fatal incidents (1 reporting hazards from broken screws and the 
other reporting design issues with the bed rail).

D. The ASTM Voluntary Standard

    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. We have consulted with these groups regarding the ASTM 
voluntary standard, ``Standard Consumer Safety Specification for 
Portable Bed Rails,'' throughout its development. In response to the 
proposed rule, and in comments to the proposed rule, the ASTM 
Subcommittee on Portable Bed Rails, in collaboration with the CPSC 
staff, developed a new ASTM standard on portable bed rails, ASTM F2085-
12, ``Standard Consumer Safety Specification for Portable Bed Rails,'' 
which incorporates many of the proposed modifications in the proposed 
rule, with a few clarifications and modifications that strengthen the 
standard. ASTM F2085-12 contains more stringent requirements than its 
predecessor, ASTM F2085-10a, and it would further reduce the risk of 
injury associated with portable bed rails.

E. Response to Comments on the Proposed Rule

    The preamble to the proposed rule invited comments concerning all 
aspects of the proposed rule. We received 16 comments. Eight commenters 
stated general support for the proposed rule. Eight commenters raised 
specific issues that are addressed by topic below.
    We describe and respond to the comments in section E of this 
document and also describe the final rule. To make it easier to 
identify the comments and our responses, the word ``Comment,'' in 
parentheses, will appear before the comment's description, and the word 
``Response,'' in parentheses, will appear before our response. We also 
have numbered each comment to help distinguish between different 
comments. The number assigned to each comment is purely for 
organizational purposes and does not signify the comment's value or 
importance, or the order in which it was received.

1. Proposed Misassembly and Misinstallation Requirements

    (Comment 1) One commenter questioned the need for a revised 
standard. Two commenters expressed concerns about the proposed 
requirements to address portable bed rail misassembly and 
misinstallation. The commenters stated that the proposed language is 
vague, arbitrary, and invites unacceptable variability in test 
conditions because there are too many possible misassembly options.
    (Response 1) We believe that requirements are necessary to address 
the entrapment hazards that may result from the misassembly and 
misinstallation of portable bed rails based on our incident data. 
However, we agree that the proposed requirements of the proposed rule 
could be clarified and improved. After publication of the proposed 
rule, the ASTM Portable Bed Rail Subcommittee working group developed 
alternate performance requirements to address the commenters' concerns 
about testing and limited the misassembly possibilities to 
configurations most likely to present entrapment hazards. These 
requirements have been added to ASTM F2085-12, ``Standard Consumer 
Safety Specification for Portable Bed Rails,'' which improves upon the 
proposed test requirements in the proposed rule. In order to improve 
the misassembly requirements, ASTM F208-12 requires captive hardware to 
ensure that fasteners remain attached to their respective components 
before normal assembly and after normal disassembly. The addition of 
Figure 1 depicts types of captive hardware, including bolts that are 
free floating and that can retract but are not completely removable, as 
well as a pin that is retractable but is not removable without tools. 
Installation components are required to be fully assembled, 
inseparable, and permanently attached to a component requiring consumer 
assembly.
    ASTM F2085-12 also addresses the issue regarding the potential for 
variability in misassembly test conditions. A significant difference 
between the proposed rule and ASTM F2085-12 is that there are no longer 
any test requirements or procedures to determine if a misassembled bed 
rail lacks sufficient vertical structure or provides sufficient visual 
cues that would notify a consumer that the bed rail is not assembled 
properly. Instead, the new standard focuses the testing on components 
that were identified in the incident data. The addition of figures and 
illustrations clarifies the pass and fail criteria of the requirements. 
Figure 5 in ASTM F2085-12 shows an example of a center horizontal 
structural component that is omitted; consequently, the bed rail's mesh 
fabric does not engage the center structural component. Figure 6 in 
ASTM F2085-12 shows additional examples of fail conditions, including a 
bed rail fabric with the bottom zipper misassembled,where the fabric 
cover can be zipped up without engaging the bottom horizontal bar. 
There also is an illustration of how the bottom bar can be omitted from 
insertion into the fabric sleeve or channel located at the base of the 
fabric component. Figure 7 in ASTM F2085-12 gives an example of a 
condition that is not to be tested; Figure 8 in ASTM F2085-12 gives an 
example of a tube that is inverted or interchanged; and Figure 9 shows 
an example of a test for unidirectional arm. Test personnel will 
conduct visual assessments of a bed rail after attempting to 
misassemble the bed rail. This will require some judgment to determine 
whether a bed rail can be misassembled using reasonable engineering 
judgment. We believe that the addition of such illustrations and 
figures will identify the misassembly combinations that actually would 
occur and that will prevent unnecessary testing of an unlimited variety 
of test configurations.

2. Foam and Inflatable (Nonrigid) Bed Rails

    (Comment 2) Several commenters requested that inflatable and foam 
bed rails be included in the scope. A few commenters stated that these 
types of bed rails should meet all of the requirements in the standard 
and/or have requirements to address a potential suffocation hazard.
    (Response 2) Nonrigid portable bed rails are included in the scope 
of ASTM F2085-12 and will need to meet the general requirements to 
address sharp edges or point, small parts, and permanency of labels, as 
well as requirements for a new warning label. However, the standard was 
developed for rigid portable bed rails, and many of the test 
requirements would not be applicable to these products. Although we are 
not imposing additional requirements at this time, we expect the ASTM 
Subcommittee on Portable Bed Rails to continue to monitor these types 
of nonrigid portable bed rails and pursue the development of additional 
requirements, as necessary.

[[Page 12185]]

3. Test Equipment: Mattress Platform and Sheeting Material

    (Comment 3) One commenter stated that the specifications for the 
Mattress Test Platform 2 and the bed sheeting requirements in ASTM 
F2085-10a--Section 7.1.2.1 (and 7.1.1.1 for sheeting) Mattress 
Construction are too restrictive and difficult to obtain.
    (Response 3) We agree that the Mattress Test Platform 2 and the bed 
sheeting specification in ASTM F2085-10a are unnecessarily restrictive. 
ASTM F2085-12 removes the Intention Load Deflection (``ILD'') test that 
is designed to test the firmness of a foam material and is relevant for 
Test Platform 1, which is a 4''-thick foam mattress. Test Platform 1 
was selected to use on a thin and not very firm mattress. Test Platform 
2 is an inner spring mattress, and thus, not solid foam. It was 
selected for use on a thick mattress (10-11''). However, there is no 
concern about the foam firmness of Test Platform 2 because the inner 
spring design gives the mattress rigidity. Therefore, there is no need 
to have an ILD requirement and test for Test Platform 2. In addition, 
there is no practical way to test the foam in an inner spring mattress 
to the ILD test. ASTM F2085-12 also allows greater flexibility for 
available bed sheet types for use in testing. The change in the sheet 
specifications was based on our finding that sheets that provide the 
weight-per-ounce were not practical. We believe that a 50/50 cotton-
poly sheet over the mattress is a basic requirement for the test and 
that the range in thread count would not otherwise affect the results. 
Accordingly, ASTM F2085-12 allows greater flexibility for available 
mattress and bed sheet types for use in testing.

4. Double-Sided Bed Rails

    (Comment 4) Several commenters recommended that portable bed rails 
be sold in sets of two (double-sided) only, to reduce entrapment 
between the wall and a piece of furniture.
    (Response 4) Double-sided bed rails currently, are available to 
consumers. However, we believe that the potential for entrapment 
between the bed and the wall is not related to, or limited by, the use 
of a single-sided bed rail, and there is no evidence to support the 
assertion that requiring double-sided bed rails will address this 
hazard. We believe that consumers should continue to be educated 
regarding a safe sleep environment for children, including being aware 
of and eliminating hazards that are caused by gaps between a mattress 
and a wall.

5. Bed Sheet Changing

    (Comment 5) One commenter stated that the proposed standard does 
not address issues such as daily changing of bed sheets or other 
routine use that can cause movement or stress on the components of a 
bed rail and lead to an unsafe product.
    (Response 5) A review of the incident data did not indicate that 
changing of bedding or other routine behavior contributed to fatal or 
nonfatal incidents due to additional stress on the component parts of a 
bed rail. The standard contains requirements that test the strength of 
the bed rail. We believe that these requirements are adequate to 
address potential stress-related failures.

6. Mattress Systems

    (Comment 6) One commenter stated that the rulemaking proceeding 
does not address the fact that portable bed rails can be used in 
various mattress systems.
    (Response 6) Our review of portable bed rail products showed that 
most portable bed rails are adjustable to fit various size mattresses. 
ASTM F2085-12 contains test requirements that evaluate the safety of 
portable bed rails on test platforms intended to represent the 
different types of adult beds available in the market.

7. Warning Language

    In general, all eight comments that addressed the warning 
requirements appear to support the general approach to improving the 
warning language that was in ASTM F2085-10a. However, some comments 
raised specific issues and suggested that additional revisions to these 
requirements would be helpful.
    (Comment 7) Several commenters requested more specificity in the 
warning language. One commenter stated that warning labels should 
include age limits because bed rails should not be used with children 
younger than 2 years old. Another commenter noted the importance of 
describing the hazard more concisely than the warning in the current 
voluntary standard. One commenter stated that the proposed rule 
suggested that the revision to the entrapment hazard warning for 
critical installation components misleads consumers because it provides 
a false sense of security for those with children who can get in and 
out of an adult bed without help.
    (Response 7) We agree that the primary bed rail warning label on 
the product and its retail packaging should include explicit age 
guidance and that the warning statements in the previous edition of the 
voluntary standard, ASTM F2085-10a, lacked this specificity. We believe 
that the new ASTM F2085-12 warning requirements address the public 
comments and are an improvement to the requirements in both the prior 
version of the voluntary standard and the proposed rule. The age at 
which children should not be using a bed rail has been made more 
explicit with the statement: ``NEVER use with children younger than 2 
years old''; and the statement immediately following: ``Use ONLY with 
older children who can get in and out of adult bed without help,'' 
clarifies that children must meet both criteria. Additional revisions 
to the language, such as ``Gaps in and around bed rails have entrapped 
young children and killed infants'' clarify the mechanism by which 
children are dying or becoming injured.
    The new warning requirements in ASTM F2085-12 also result in a more 
concise warning, which may increase the likelihood that consumers will 
take the time to read the warning and understand the information. For 
example, the proposed rule's warning requirements would result in a 
warning approximately 148 words long; whereas, the warning requirements 
in ASTM F2085-12 result in a much shorter warning of 102 words long. 
The revised warning language is now written at a slightly lower grade 
level than the proposed rule warning language, so that more people who 
read the warning may be more likely to understand it.
    We disagree that the entrapment hazard warning for critical 
installation components misleads consumers. The purpose of the 
entrapment hazard warning is to alert consumers to the importance of 
installing the bed rail correctly. The statement in question--
``Incorrect installation can allow the portable bed rail to move away 
from the mattress, which can lead to entrapment and death''--refers 
specifically to incorrect installation as the mechanism by which the 
bed rail can move away from the mattress. Nothing in the warning 
suggests that other mechanisms of entrapment exist that do not involve 
movement of the bed rail. Moreover, the bed rail itself includes a more 
comprehensive warning that discusses other sources of entrapment, such 
as the placement of the bed rail relative to the headboard or footboard 
of the adult bed, which clearly shows that other hazards and entrapment 
scenarios exist.
    (Comment 8) One commenter stated that the warning labels should 
describe the materials used when producing the bed rails.
    (Response 8) We disagree that the warning requirements should 
specify the materials used in the product.

[[Page 12186]]

Warnings are intended to be used only to identify a significant hazard. 
The commenter has not identified what materials present a hazard or 
what a warning requirement would address. The consequences of exposure 
to the hazard and appropriate avoidance behavior in response to the 
hazard also are key pieces of information that should be present in a 
warning, unless this information can be inferred readily. The commenter 
did not specify any of this information. Thus, including in a warning 
label a description of the materials used when the bed rail is produced 
is not appropriate at this time.
    (Comment 9) Another commenter stated that there should be a strict 
warning about modification of the bed rail and the bed rail components.
    (Response 9) We disagree that warning requirements should include 
provisions regarding modification of the bed rail and its components. 
We interpret this comment to indicate that the commenter seeks the 
addition of warning language to address the scenario of consumers 
intentionally altering the bed rail components. Our review of incident 
data does not support that consumers' intentional alteration of bed 
rail components leads to injury. Thus, mandating such warning language 
is not supported by the data.

8. Adult Bed Rails

    (Comment 10) Two commenters stated that the scope of the rule 
should guarantee more stringent safety standards for all portable bed 
rails, including adult bed rails. These commenters note that bed rails 
are used routinely in nursing facilities, hospitals, and private homes. 
According to the commenters' data, between 1985 and 2009, the FDA 
received reports of 803 incidents of patients caught, trapped, 
entangled, or strangled in hospital beds, including 408 deaths, 138 
non-fatal injuries, and 185 near-misses due to staff intervention. To 
address these types of incidents, the commenters requested that the 
Commission take action on adult bed rails, including mandating warning 
labels, enforcing reporting requirements, recalls, and civil penalties, 
and engaging in greater collaboration with the FDA.
    (Response 10) Section 104(b) of the Consumer Product Safety 
Improvement Act requires the Commission to promulgate consumer product 
safety standards for durable infant or toddler products. Accordingly, 
this rulemaking is limited to bed rails intended for use with children 
(typically from 2 to 5 years of age) to keep them from falling out of 
an adult bed. Comments pertaining to other bed rail products intended 
for use by older children or adults are outside the scope of this 
proceeding. With respect to bed rails intended for use by adults or 
older children, we are aware that some bed rails may be considered 
``devices'' under the Federal Food, Drug, and Cosmetic Act (``FDCA''); 
therefore, they are subject to regulation by the FDA. The 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. However, the commenters raised important 
issues regarding incidents with bed rails that were not intended to be 
either a part of, or an accessory to, a hospital bed or FDA-regulated 
pediatric bed. To the extent that there may be such bed rails that are 
not regarded as medical devices regulated by the FDA, but that are 
considered, instead, to be ``consumer products'' under the CPSA or 
otherwise subject to our jurisdiction, we will continue to review this 
issue and consider what actions are appropriate, if any.

9. Shipment Costs and Product Size

    (Comment 11) One commenter stated that shipping costs are a 
significant portion of the product's total cost and increasing the box 
size to contain a preassembled product could potentially increase the 
cost to ship the product by 50 percent. This commenter also stated that 
the proposed rule may result in adverse retail response to stocking 
bulkier packages on shelves or in inventory, or retailers dropping 
products, or refusing to accept a price increase, thus, placing the 
cost burden on manufacturers.
    (Response 11) Not all products would need to be preassembled or put 
in larger boxes. Retooled and redesigned components may allow 
manufacturers to use existing boxes. To the extent that a manufacturer 
decides to preassemble parts, or the portable bed rail, we agree that 
preassembling portable bed rails may require larger boxes and that 
shipping larger boxes is likely to increase shipping costs. It is 
possible that the increased shipping costs could be significant for 
some small firms. We also agree that if larger boxes for bed rails were 
required, they would need additional storage and shelving space. As a 
result, some retailers might choose to decrease the number or type of 
bed rail models they offer to the public, which, in turn, could result 
in decrease in product demand for some manufacturers.

F. Summary of ASTM F2085-12, ``Standard Consumer Safety Specification 
for Portable Bed Rails''

    When the Commission issued its proposed rule in April 2011, the 
Commission proposed incorporating by reference ASTM F2085-10a, Standard 
Consumer Safety Specification for Portable Bed Rails, with certain 
modifications, under a new 16 CFR part 1224, Safety Specification for 
Portable Bed Rails. The requirements for portable bed rails in ASTM 
F2085-12 incorporate many of the proposed changes in the proposed rule, 
with additional clarifications and improvements. Accordingly, 16 CFR 
part 1224 will incorporate by reference, without modification, ASTM 
F2085-12, which includes more stringent requirements that would further 
reduce the risk of injury associated with portable bed rails.

1. Scope

    ASTM F2085-10a provided that under section 1, Scope, 1.1: ``This 
consumer safety specification establishes requirements for the 
performance of portable bed rails. It also contains requirements for 
labeling and instructional literature.''
    The proposed rule would not make any change to section 1.1. However 
the preamble to the proposed rule made clear that the standard did not 
cover guardrails that fall under the scope of the ``Consumer Safety 
Specification for Toddler Beds'', ASTM F1821; or side rails that 
connect the headboard to the footboard; conversion rails that convert a 
crib to a full-size bed; and adult-size beds, on which the rail is 
permanently attached to the bed. 76 FR 19916. Accordingly, to make the 
scope of portable bed rails explicit so that it does not include such 
products, ASTM F2085-12 now provides under section 1.1: ``This consumer 
safety specification establishes requirements for the performance of 
portable bed rails. It also contains requirements for labeling and 
instructional literature. This consumer safety specification does not 
cover guardrails that fall under the scope of the Consumer Safety 
Specification for Toddler Beds, F1821 or guardrails that are designed 
for a specific model of bed and which attaches at the headboard or 
footboard.''
    The proposed rule also would revise section 1.4 of ASTM F2085-10a 
to state: ``In addition to complying with section 1.4 of ASTM F2085-
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.

[[Page 12187]]

Enclosed Openings, and the warning requirement of section 9.3.1.'' This 
section is addressed below in section 3, ``Terminology,'' and section 
5, ``General Requirement.''

2. Referenced Documents

    Consistent with the clarification in scope under section 1 
(Scope)--that the new standard does not cover toddler beds--ASTM F2085-
12 includes in section 2, (Referenced Documents) ASTM F1821, ``Consumer 
Safety Specification for Toddler Beds.'' In addition, ASTM F2085-12 
includes Reference Document ASTM F1487, ``Consumer Safety Performance 
Specification for Playground Equipment for Public Use'' to specify the 
protusion gauge for entanglement used in the performance requirements.

3. Terminology

    The proposed rule would revise the terminology in section 3 of ASTM 
F2085-10a, by creating the following new terms:
     3.1.10 foam bed rail, n--portable bed rail constructed 
primarily of nonrigid materials such as fabric or foam.
     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.
     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.
     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.
     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.
    In ASTM F2085-12 the following terminology and figures have been 
included in section 3:
     3.1.4 captive hardware, n--fasteners that remain attached 
to their respective components before normal assembly and after normal 
disassembly (see Fig. 1).
[GRAPHIC] [TIFF OMITTED] TR29FE12.004

     3.1.6 consumer adjustment, n--those activities defined by 
the instructions to be taken by the consumer in order to properly fit 
and secure the bedrail to the mattress.
     3.1.6.1 Discussion--Examples include sliding telescoping 
poles for proper fit, or initial adjustment for use, tightening of 
anchoring straps and positioning or changing of attachment components 
or locking pins.
     3.1.7 consumer assembly, v--the fitting together of 
components of the bedrail according to manufacturer instructions.
     3.1.8 installation component, n--component of the bed rail 
that is specifically designed to attach the bed rail to the bed and 
typically located under the mattress when in the manufacturer's 
recommended use position.
     3.1.10 misassembled bed rail, n--a bed rail that has been 
assembled incorrectly but appears to function as a bedrail.
     3.1.12 non-rigid bed rail, n--portable bed rail 
constructed of non-rigid materials, including but not limited to fabric 
or foam, or that requires air be inflated into the product to achieve 
structure.
    The new standard, ASTM F2085-12, contains some, but not all, of the 
proposed terminology. Proposed sections 3.1.10, foam bed rail, and 
3.1.11, inflatable bed rail, are terms that are now incorporated as 
non-rigid bed rail under new section 3.1.12 in ASTM F2085-12. ASTM 
F2085-12 does not add proposed section 3.1.12, critical assembly 
component, because all of the bed rail components are critical to 
safety. Proposed section 3.1.13, critical installation component, has 
been modified to make clear the purpose of the installation component 
under new section 3.1.8 in ASTM F2085-12. Proposed section 3.1.14, 
misassembled/functional portable bed rail, also has been modified to 
make clear under new section 3.1.10 in ASTM F2085-12 what is meant by 
misassembled bed rail. ASTM F2085-12 also adds additional terms for 
captive hardware under new section 3.1.4, consumer assembly under new 
section 3.1.7, consumer adjustment under new section 3.1.6, and new 
section 3.1.6.1 Discussion. These new sections create terminology to 
help testing laboratories differentiate between components that require 
consumer adjustment, such as straps and telescoping rods, and 
components that are fitted or fastened together for the bed rails' 
structure, and components that do not require consumer adjustment.
    The basis for the new terminology is explained further under 
section 5 (General Requirements), section 6 (Performance Requirements), 
section 7 (Test Equipment), section 8 (Test Methods), section 9 
(Marking and Labeling), and section 11 (Instructional Literature).

4. Calibration and Standardization

    The proposed rule would not make any changes to section 4 of ASTM 
F2085-10a (Calibration and Standardization). This section is unchanged 
in ASTM F2085-12.

5. General Requirements

    The proposed rule would add a section 1.4.1 stating, ``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.''
    New section 5.5 of ASTM F2085-12 provides that ``Non-rigid bed 
rails need only meet the general requirements of Section 5, the 
performance requirement of 6.3, and the warning requirements of 9.3.'' 
This section provides that both foam and inflatable bed rails are 
covered under the term ``non-rigid'' but are not limited to foam and 
inflatable products that are also used as bed rails.
    In addition, the proposed rule would add the following sections to 
ASTM F2085-10a:
     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.
     5.6.1 Critical installation components must be permanently 
affixed to a structural component(s) of the portable bed rail.
     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.
    ASTM F2085-12 provides similar, but modified, language under new 
section 5.7 and section 5.8.
     5.7 Installation components that are required to meet the 
performance requirements of 6.4, 6.5, and 6.6 shall be fully assembled, 
inseparable, and permanently attached to a component requiring consumer 
assembly (this excludes any consumer adjustment).

[[Page 12188]]

     5.8 For products requiring consumer assembly, supplied 
hardware used for assembly of the bed rail such as screws, nuts or 
bolts shall be captive hardware to their respective components.
    The proposed rule's critical installation components would prevent 
components (such as anchor plates and straps) that are used to attach 
the bed rail to the bed from being discarded or lost. All installation 
component(s) would be attached permanently to a structural component(s) 
of the bed rail. ASTM F2085-12 combines 5.6, 5.6.1, and 5.6.2 of the 
proposed rule into new section 5.7 and section 5.8. Like the proposed 
rule, these sections in ASTM F2085-12 require all installation 
components to be permanently attached to a structural component(s) that 
is required to make up the bed rail. This prevents installation 
components from being discarded or lost. The wording in ASTM F2085-12 
clarifies the difference between installation components will require 
consumer adjustment and those components are part of consumer assembly. 
Test personnel will be able to identify components subject to the 
misinstallation requirement and it addresses the concern raised by 
commenters about the ambiguity of test requirements for installation 
components that are adjustable.

6. Performance Requirements

    The proposed rule would add the following sections to ASTM F2085-
10a:
     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.
     6.9.1 The portable bed rail can be assembled without any 
critical assembly component.
     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.
     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.
     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.
     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.
     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.
     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.
     6.10.3 The fabric cover will not fit over the frame 
without tearing.
     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. Under ASTM F2085-12, the following new 
sections and figures have been added:
     6.9 Bed rail components requiring consumer assembly shall 
not be able to be misassembled when evaluated to 6.9.1.
     6.9.1 Determining Misassembled Bed Rail--A bed rail shall 
be considered a misassembled bed rail if it appears to be a functional 
bed rail under any one of the conditions listed in 6.9.1.1, 6.9.1.2, or 
6.9.1.3 and it does not meet the requirements of 6.4, 6.5, or 6.6.
     6.9.1.1 The bed rail's fabric cover or mesh can be placed 
over the rigid frame structure without engaging all structural 
components of the frame as intended in final assembly (Fig. 5 and Fig. 
6). When the bed rail is evaluated, zippers and other means of 
attachment should be fully fastened. If possible to fasten the means of 
attachments without engaging said structural components, evaluation for 
misassembly should account for that (see Fig. 6).
     Note 1--Any means of attachment, including, but not 
limited to, zippers, hooks and loops, and snaps, should be fully 
fastened. Fig. 7 represents a passing condition.
     6.9.1.2 The bed rail can be consumer assembled with any 
horizontal structural components improperly positioned such as being 
inverted or interchanged, without permanent deformation or breakage of 
the component or bed rail. This excludes consumer adjustment or 
universal components that are designed to be interchangeable (Fig. 8). 
For example:
    (1) Horizontal structural components shall be interchanged 
(Components 1, 2, 3).
    (2) Horizontal structural components shall be inverted (AB:BA); 
(CD:DC); (EF:FE).
     6.9.1.3 Bed rails where the position of the arms are 
intended to be unidirectional are able to be assembled when the arms 
are rotated 180 degrees above the vertical axis (Fig. 9).

[[Page 12189]]

[GRAPHIC] [TIFF OMITTED] TR29FE12.005

    The proposed rule contained performance requirements that did not 
exist in ASTM F2085-10a and were intended to address the risk of 
entrapment hazards associated with consumer misassembly of portable bed 
rails. The proposed rule contained test methods and performance 
criteria to determine if a misassembled bed rail provided sufficient 
visual cues for a consumer to identify that the bed rail was 
misassembled. If the misassembled bed rail did not stay upright, or the 
top rail collapsed after testing, the misassembly was considered to 
have a sufficient visual cue for the consumer to recognize that the 
product was not assembled correctly. This condition would be considered 
a passing result because the bed rail only could be misassembled in a 
way that was obvious to the consumer. Bed rails that are preassembled 
or designed to reduce the potential for consumer misassembly,

[[Page 12190]]

without deforming or breaking parts, also would meet these 
requirements. CPSC staff developed two prototype bed rails to 
demonstrate that products could be redesigned to meet the proposed 
requirement.
    ASTM F2085-12 provides a means for determining misassembled 
portable bed rails that is similar to the proposed rule, but targets 
specific misassembled portable bed rail scenarios, such as missing 
horizontal components, fastening the fabric mesh without engaging a 
horizontal bar, and assembling parts to the wrong components or 
inverted components.
    ASTM F2085-12 addresses misassembly by identifying criteria similar 
to the proposed rule, but it contains additional figures and 
illustrations showing examples of passing and failing bed rails that 
have been misassembled. ASTM F2085-12 section 5.8 is equivalent to 
section 6.9.2 of the proposed rule, and it requires that nuts and bolts 
be attached to the bed rail structure to prevent the consumer from 
discarding or misplacing the fasteners. ASTM F2085-12 section 6.9.1.1 
is equivalent to sections 6.9.3 and 6.9.4 of the proposed rule. These 
requirements identify a misassembled bed rail as a bed rail that can be 
assembled without a part or without the fabric engaging the entire 
frame as intended by the manufacturer. These requirements directly 
address the fatal incidents where the horizontal bar was not used or 
where the fabric was not installed properly over the bottom horizontal 
bar. ASTM F2085-12 sections 6.9.1.2 and 6.9.1.3 are equivalent to 
section 6.9.4 of the proposed rule and require that bed rail components 
not be interchanged or inverted. This prevents the consumer from 
assembling a component in a backward or upside-down position.
    The primary difference between ASTM F2085-12 and the proposed rule 
is that ASTM F2085-12 does not have a physical test that establishes 
pass and fail criteria to determine whether a misassembled bed rail 
appears to be functional as proposed in section 6.10.1 of the proposed 
rule. Determination of whether a misassembled bed rail appears to be 
functional (failing the standard) or appears not to be functional 
(passing the standard) is up to the judgment of the testing laboratory. 
The figures that show examples of passing and failing bed rails will 
provide guidance to testing laboratories in making the determination. 
The new requirements reduce the potential for numerous test 
configurations, eliminate the testing of zippered products for sag 
variability, reduce the possibility of misassembly of adjustable 
components for installation, and improve repeatability of testing 
between labs.

7. Test Equipment

    The proposed rule did not suggest any changes to the test platforms 
in ASTM F2085-10a. However, we received comments to the proposed rule 
that the specifications for the Mattress Test Platform and the bed 
sheeting requirements in ASTM F2085-10a under Section 7.1.1.1 and 
7.1.1.2 are too restrictive. In response to the comments, ASTM F2085-12 
modifies the language to make it easier to test the mattresses and 
sheeting.
    ASTM F2085-10a provided under section 7. Test Equipment, 7.1.1 Test 
Platform 1, 7.1.1.1 Mattress Construction:
     The mattress shall be of standard twin size, 38 by 74.5 
in. 6 0.5 in. (0.97 by 1.89 m + 13 mm). The mattress shall be made from 
open cell polyurethane foam padding and be 4 to 5 in. (102 to 127 mm) 
thick with a density of 1 lb/ft3 +0.2, -0 (16 kg/m3 +3.2, -0). The 
mattress shall weigh between 6.0 and 9.5 lb (2.7 to 4.3 kg). There 
shall be no surface texture features (for example, quilting) on the 
test mattress. The mattress shall be covered with a standard twin sized 
fitted sheet. The sheet shall be white, 50/50 cotton/polyester blend. 
It shall have 180 threads per square inch and fabric weight of 
approximately 3.5 oz/yd2 (161 g/m2). The sheet shall be laundered once 
before use in an automatic home washer, using hot water setting and 
longest normal cycle with the manufacturer's recommended quantity of a 
commercial detergent, and dried in an automatic home tumble dryer.
    ASTM F2085-12 provides under new section 7:
     7. Test Equipment, 7.1.1 Test Platform 1, 7.1.1.1 Mattress 
Construction--The mattress shall be of standard twin size, 38 by 74.5 
in.  0.5 in. (0.97 by 1.89 m  13 mm). The 
mattress shall be made from open cell polyurethane foam padding and be 
4 to 5 in. (102 to 127 mm) thick with a density of 1 lb/ft3 +0.2, -0 
(16 kg/m3 +3.2, -0). The mattress shall weigh between 6.0 and 9.5 lb 
(2.7 to 4.3 kg). There shall be no surface texture features (for 
example, quilting) on the test mattress. The mattress shall be covered 
with a standard twin sized fitted sheet. The sheet shall be white, 50/
50 cotton/polyester blend. It shall have 100 to 300 threads per square 
inch.
    ASTM F2085-10a provided under section 7. Test Equipment, 7.1.2 Test 
Platform 2, 7.1.2.1 Mattress Construction:
     The mattress shall be of standard twin size, 38 in. by 
74.5 in.  0.5 in. (0.97 m by 1.89m  13 mm). The 
mattress shall be of an innerspring design and be between 10.0 in. 
(0.25 m) and 11.0 in. (0.28 m) thick. The mattress shall weigh 50 
 10 lb (22.7  4.5 kg). The mattress shall be 
covered with a standard twin sized cotton fitted sheet. The sheet shall 
be white, 50/50 cotton/polyester blend. It shall have 180 threads per 
square inch and fabric weight of approximately 3.5 oz/yd2 (161 g/m2). 
The sheet shall be laundered once before use in an automatic home 
washer using hot water setting and longest normal cycle with the 
manufacturer's recommended quantity of a commercial detergent, and 
dried in an automatic home tumble dryer.
    ASTM F2085-12 provides that under new section 7.1.2. Test Platform 
2:
     7.1.2.1 Mattress Construction--The mattress shall be of 
standard twin size, 38 in. by 74.5 in.  0.5 in. (0.97 m by 
1.89m  13 mm). The mattress shall be of an innerspring 
design and be between 10.0 in. (0.25 m) and 11.0 in. (0.28 m) thick. 
The mattress shall weigh 50  10 lb (22.7  4.5 
kg). The mattress shall be covered with a standard twin sized cotton 
fitted sheet. The sheet shall be white, 50/50 cotton/polyester blend. 
It shall have 100 to 300 threads per square inch.
    ASTM F2085-12 also deletes section 7.1.2.2 of ASTM F2085-10a, which 
provides:
     7.1.2.2 Mattress Performance--The foam shall have an 
Indentation Load Deflection (ILD) of between 28 and 33 when tested in 
accordance with Test Methods D3574, Method B1.
    In response to comments to the proposed rule that asserted that the 
specifications for the mattress platform and sheeting material were 
unduly restrictive (Comment 3 and Response 3), ASTM F2085-12 removed 
the Intention Load Deflection (``ILD'') test that is designed to test 
the firmness of a foam material because it was not appropriate for a 
rigid mattress under Test Platform 2. In addition, we agreed that 
purchasing sheets that provide the weight per ounce is not practical 
and that the range in thread count would not otherwise affect the 
results. Accordingly, we believe that the new requirements are an 
improvement over the existing standard.
    The proposed rule would add the following section to ASTM F2085-10a 
on the force gauge:
     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) 
to clarify the manner

[[Page 12191]]

in which the force will be applied under the proposed test method to 
determine acceptability of vertical structure of a misassembled/
functional portable bed rail.
    ASTM F2085-12 does not have a test to determine acceptability of 
the vertical structure of a misassembled/functional portable bed rail. 
Accordingly, under the new section, reference to the vertical structure 
of a misassembled/functional portable bed rail is omitted. However, 
because the force gauge is used for other tests in the standard, 
section 7.6 of ASTM F2085-12 states:
     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).

8. Test Methods

    The proposed rule would add the following sections to ASTM F-2085-
10a:
     8.7 Test Method for Determining Acceptability of Vertical 
Structure of a Misassembled/Functional Portable Bed Rail:
     8.7.1 If possible, attempt to assemble the bed rail in a 
misassembled configuration(s), as defined in 6.9 Determining 
Misassembled/Functional Portable Bed Rail:
     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).
     8.7.3 Gradually apply 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 that 
would most likely vertically deform the bed rail (see figure 8). Apply 
the force over a period of 5 seconds; hold the force for 10 seconds, 
and release.
     8.7.4 Repeat 8.7.1 through 8.7.3 for all misassembly 
configurations discovered in 6.9.
     8.8 Test Method for Determining Fabric Sag Acceptability 
of a Misassembled/Functional Portable Bed Rail:
     8.8.1 If possible, attempt to assemble the bed rail in a 
misassembled configuration(s), as defined in 6.9 Determining 
Misassembled/Functional Portable Bed Rail.
     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.
     8.8.3 Repeat 8.8.1 through 8.8.2 for all misassembly 
configurations discovered in 6.9.
[GRAPHIC] [TIFF OMITTED] TR29FE12.006

    Section 6 in ASTM F2085-12 establishes requirements for determining 
misassembled portable bed rails, by targeting specific misassembled 
portable bed rail scenarios, such as missing horizontal components, 
fastening the fabric mesh without engaging a horizontal bar, and 
assembling parts to the wrong components or inverted components. ASTM 
F2085-12 does not have a test to determine acceptability of the 
vertical structure of a misassembled/functional portable bed rail. The 
testing laboratories are in the best position to determine whether a 
misassembled bed rail appears to be functional (failing the standard) 
or appears not to be functional (passing the standard). Accordingly, we 
believe that the new requirements under sections 5 (General 
Requirements) and 6 (Performance Requirements) are an improvement over 
the proposed rule's test requirements; accordingly, our proposed 
requirements in section 8 are not necessary.

9. Marking and Labeling

    The proposed rule would make the following revisions to section 9, 
Marking and Labeling of ASTM F085-10a:

[[Page 12192]]

[GRAPHIC] [TIFF OMITTED] TR29FE12.007

     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.
[GRAPHIC] [TIFF OMITTED] TR29FE12.008

     9.4.1. The warning must including [sic] the following, 
exactly as stated below:
[GRAPHIC] [TIFF OMITTED] TR29FE12.009

ASTM F2085-12 adopts some of the requirements in the proposed rule, but 
clarifies the warning label. The new provisions state:
     9.3.1 The warning statements shall include the following 
wording, exactly as stated below:

[[Page 12193]]

[GRAPHIC] [TIFF OMITTED] TR29FE12.010

     9.3.2 For manufacturers' specific bed rails, the warning 
statements shall also address the following:
    Use only on (manufacturer insert applicable bed and mattress/
platform information).
[GRAPHIC] [TIFF OMITTED] TR29FE12.011

     9.4.1 The following warning shall be addressed:
    [GRAPHIC] [TIFF OMITTED] TR29FE12.012
    

[[Page 12194]]


    Note 2--Addressed means that verbiage other than what is shown can 
be used as long as the intent is the same or information that is 
product-specific is presented.
    We believe that the new ASTM F2085-12 warning requirements address 
the comments received on the proposed rule and improve the requirements 
in the prior version of the voluntary standard and the proposed rule. 
The age at which children should not be using a portable bed rail has 
been made explicit with the statement: ``NEVER use with children 
younger than 2 years old.'' Also, the statement immediately following 
that: ``Use ONLY with older children who can get in and out of adult 
bed without help,'' clarifies that children must meet both criteria: 
They must be at least 2 years old, and they must be able to get in and 
out of an adult bed without help. Additional revisions to the language, 
such as the statement: ``Gaps in and around bed rails have entrapped 
young children and killed infants,'' clarifies for consumers the 
mechanism by which children are dying or becoming injured.
    The new warning requirements in ASTM F2085-12 also result in a 
considerably more concise warning, which may increase the likelihood 
that consumers will take the time to read the warning and encode the 
information. For example, the proposed rule's warning requirements 
would have resulted in a warning approximately 148 words long; whereas, 
the warning requirements in ASTM F2085-12 result in a warning that is 
102 words long. The revised warning language also is written at a 
slightly lower grade level than the proposed rule warning language, and 
people who read the warning may be more likely to understand it.

10. Permanency of Label and Warnings

    The proposed rule would not make any change to section 10 of ASTM 
F2085-10a ``Permanency of Label and Warnings.'' This section is 
unchanged in ASTM F2085-12.

11. Instructional Literature

    We proposed to revise section 11.1 of ASTM F2085-10a to state:
     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.
    ASTM F2085-12 incorporates this provision but adds clarifying 
language in section 11.1.1. ASTM F2085-10a provided that:
     11.1.1 The instructions shall contain the warning 
statements, required by 9.3.1 in the exact format, and shall address 
the statements in 9.3.2. In addition, instructions shall address the 
following: Discontinue use if damaged, broken or if parts are missing. 
ASTM 2085-12 section 11.1.1. now states:
     11.1.1 The instructions shall contain the warning 
statements, required by 9.3.1 in the exact format, and where 
applicable, shall address the statement in 9.3.2. In addition, 
instructions shall address the following:
     11.1.1.1 Discontinue use if damaged, broken, or if parts 
are missing.
    The revised requirement helps clarify that the instructions are 
appropriate for manufacturers' specific bed rails, including the 
manufacturer's applicable bed and mattress/platform information that 
was revised in section 7 (Test Equipment).

12. Keywords

    The proposed rule would not change section 12 of ASTM F2085-10a 
``Keywords.'' This section is unchanged in ASTM F2085-12.

13. Conforming Edits

    ASTM F2085-12 provides conforming edits, including renumbering the 
figures to incorporate the addition of figures in section 3 
(Terminology), and section 6 (Performance Requirements). ASTM F2085-12 
also provides additional rationale for the changes in its appendix. The 
appendix is nonmandatory information and may be viewed in the ASTM 
F2085-12 standard under ``Appendix (Nonmandatory Information); XI. 
Rationale.''

14. Additional Change to the Final Rule

    On our own initiative, we revised Sec.  1224.1, ``Scope, 
application, and effective date,'' by replacing ``This part 1224 
establishes * * *'' with ``This part establishes * * *.'' This is a 
non-substantive change intended to simplify the sentence structure in 
Sec.  1224.1.

G. Effective Date

    The Administrative Procedure Act (``APA'') generally requires that 
the effective date of a rule be a least 30 days after publication of 
the final rule. 5 U.S.C. 553(d). The preamble to the proposed rule 
indicated that the standard would become effective 6 months after 
publication of a final rule. We sought comment on how long it would 
take manufacturers of portable bed rails to come into compliance with 
the rule. One commenter stated that 6 months allowed for too much delay 
of administrative enforcement of the new requirements. One commenter 
stated that if a CPSC mandatory regulation differed from the ASTM 
standard, a minimum of 1 year is appropriate to allow adequate time for 
manufacturers to bring products into compliance with the new 
requirements. Because ASTM has published a new standard that was 
approved as of January 1, 2012, and because the final rule adopts the 
new standard as a CPSC mandatory regulation, we believe 6 months is an 
adequate length of time for manufacturers to comply with the new 
requirements. We believe that manufacturers would benefit from the 
additional 6 months after publication of a final rule to review the new 
requirements thoroughly and to ensure that new portable bed rails 
manufactured or imported after that date are in compliance with the new 
requirements, including the fabrication of new labels, as well as the 
retooling and redesign of products. Accordingly, the final rule 
provides that the rule will be effective 6 months after publication of 
the final rule in the Federal Register. A 6 month effective date should 
also enable the Commission to complete the required rulemaking with 
regard to the notice of requirements regarding the accreditation of 
laboratories to conduct the requisite third party testing to this new 
portable bed rails standard.

H. Regulatory Flexibility Act

1. Introduction

    The Regulatory Flexibility Act (``RFA''), 5 U.S.C. 601-612, 
requires that final rules be reviewed for their potential economic 
impact on small entities, including small businesses. Section 604 of 
the RFA requires that CPSC staff prepare a final regulatory flexibility 
analysis when the Commission promulgates a final rule. The final 
regulatory flexibility analysis must describe the impact of the rule on 
small entities and identify any alternatives that may reduce the 
impact. Specifically, the final regulatory flexibility analysis must 
contain:

    1. A succinct statement of the objectives of, and legal basis 
for, the rule;
    2. A summary of the significant issues raised by public comments 
in response to the initial regulatory flexibility analysis; a 
summary of the assessment of the agency of such issues; and a 
statement of any changes made in the proposed rule as a result of 
such comments;
    3. A description of, and where feasible, an estimate of, the 
number of small entities to which the rule will apply;
    4. A description of the projected reporting, recordkeeping, and 
other compliance requirements of the rule, including an estimate of 
the classes of small entities

[[Page 12195]]

subject to the requirements, and the type of professional skills 
necessary for the preparation of reports or records; and
    5. A description of the steps the agency has taken to reduce the 
significant economic impact on small entities, consistent with the 
stated objectives of applicable statutes, including a statement of 
the factual, policy, and legal reasons for selecting the alternative 
adopted in the rule, and why each one of the other significant 
alternatives to the rule considered by the agency, which affect the 
impact on small entities, was rejected.

2. The Market

    Typically, portable bed rails are produced and/or marketed by 
juvenile product manufacturers and distributors or by furniture 
manufacturers and distributors. When the proposed rule was published, 
we were aware of 14 manufacturers or importers supplying bed rails to 
the U.S. market. We are now aware of at least 17 known manufacturers or 
importers supplying bed rails to the U.S. market. Thirteen are domestic 
manufacturers (76 percent), and three are domestic importers (17 
percent). The remaining firm has an unknown supply source, and there is 
no publically available information regarding its size.
    Under U.S. Small Business Administration (``SBA'') guidelines, a 
manufacturer of portable bed rails is small if it has 500 or fewer 
employees; an importer is considered small if it has 100 or fewer 
employees. Based on these guidelines, 12 of the domestic manufacturers 
and three of the domestic importers known to be supplying portable bed 
rails to 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 Products Manufacturers Association (``JPMA''), the 
major U.S. trade association that represents juvenile product 
manufacturers and importers, runs a voluntary Certification Program for 
several juvenile products. Five manufacturers supply bed rails to the 
U.S. market that are compliant with the ASTM standard F2085-10a (the 
previous voluntary standard). Among them, four are JPMA-certified as 
compliant with ASTM F2085-10a, and one firm claims compliance. Of the 
three importers, one firm is JPMA-certified as ASTM compliant with ASTM 
F2085-10a, and one firm claims to be in compliance. All seven firms, 
which are either JPMA-certified or claim compliance with ASTM F2085-
10a, are small. However, none of these firms meets the requirements of 
the current voluntary standard, ASTM F2085-12.
    JPMA estimates that current annual sales of portable bed rails are 
approximately 750,000 units, and retail sales are approximately $20 
million. No information is available about the average product life of 
bed rails; but if, for example, bed rail sales are assumed to have 
remained constant in recent years, and bed rails remain in use for 3 to 
5 years, then currently, there might be 2.25 million to 3.75 million 
bed rails in use. National estimates of bed rail product-related 
injuries are not available because the National Electronic Injury 
Surveillance System (``NEISS'') data do not allow for clear 
identification of youth bed rails. Therefore, the risk of injury 
associated with the number of products in use cannot be calculated.

3. Impact of the Standard on Small Business

    There are 17 firms currently known to be producing or selling 
portable bed rails in the United States. Of these firms, 12 are small 
domestic manufacturers, and three are small domestic importers. The 
remainder of this analysis focuses on these 15 small domestic firms.
Small Domestic Manufacturers
    The impact of the draft final rule on small manufacturers may 
differ, based on whether they compliant with the preceding ASTM 
standard, ASTM F2085-10a. Of the 12 domestic manufacturers, five 
produce portable bed rails that are certified as compliant by JPMA or 
claim to be in compliance with ASTM F2085-10a.
    The products of the firms that are not in compliance with ASTM 
F2085-10a may require substantial modifications to meet ASTM F2085-12. 
The costs associated with these modifications could include product 
redesign, development and marketing staff time, product testing, and 
focus group expenses. It is possible that some firms may change the 
type of materials used to make portable bed rails, resulting in some 
cost increase. Costs may also rise if additional materials are 
required, or the products need to be redesigned. The actual costs of 
product modifications are unknown, but they 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 on the firms that produce portable bed rails that are 
compliant with ASTM F2085-10a may be less significant. Firms already in 
compliance with ASTM F2085-10a may require fewer modifications in order 
to bring their product into compliance with the current voluntary 
standard. Some firms may opt to preassemble component(s) rather than 
redesign their product. If firms decide to preassemble products, then 
portable bed rails may require larger shipping boxes. Shipping larger 
boxes is likely to increase shipping costs, and increased shipping 
costs may be significant in some cases. Larger boxes will also require 
greater storage space and may cause some retailers to reduce portable 
bed rails from their shelves and inventories.
    All manufacturers will need to modify existing warning labels. 
Costs associated with the new warning label would be low because no new 
materials are used. However, eliminating the specified test methods in 
the proposed rule and reducing the number of testing configurations as 
well as reducing the number of warnings may result in a small reduction 
in costs. At least four small manufacturers' product lines consist 
primarily or entirely of nonrigid portable bed rails. These firms may 
need to alter the warning label and requirements for enclosed openings; 
but otherwise, these firms are not likely to be affected significantly 
by the voluntary standard.
    Additionally, once the final rule and the notice of requirements is 
in effect, all manufacturers will be subject to the additional costs 
associated with the third party testing and certification requirements.
Small Domestic Importers
    All three small domestic importers would need to find an alternate 
source of portable bed rails if their existing supplier does not come 
into compliance with the current voluntary 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 bed rails, substituting another product 
may not be realistic. The impact on these small importers likely would 
be more significant.
    As is the case with manufacturers, all importers will be subject to 
third party testing and certification requirements, and consequently, 
will experience additional costs.

[[Page 12196]]

4. Alternatives

    Section 104 of the CPSIA requires the Commission to adopt a 
mandatory standard substantially the same as, or more stringent than, 
the voluntary standard, if the Commission determines that more 
stringent standards would further reduce the risk of injury associated 
with such products. One alternative would be to set an effective date 
later than the staff-recommended 6 months. This would allow suppliers 
(and manufacturers) additional time to modify and/or develop compliant 
portable bed rails, thereby spreading the associated costs over a 
longer period of time.

I. Environmental Considerations

    The Commission's regulations provide a categorical exclusion for 
the Commission's rules from any requirement to prepare an environmental 
assessment or an environmental impact statement because they ``have 
little or no potential for affecting the human environment.'' 16 CFR 
1021.5(c)(2). This rule falls within the categorical exclusion, so no 
environmental assessment or environmental impact statement is required.

J. Paperwork Reduction Act

    This rule contains information collection requirements that are 
subject to public comment and review by the Office of Management and 
Budget (``OMB'') under the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501-3520). The preamble to the proposed rule (76 FR 19922 through 
19923) discussed the information collection burden of the proposed rule 
and specifically requested comments on the accuracy of our estimates. 
OMB has assigned control number 3041-0149 to this information 
collection. We did not receive any comment regarding the information 
collection burden of the proposal. However, the final rule makes 
modifications regarding the information collection burden because the 
number of estimated manufacturers subject to the information collection 
burden is now estimated at 17 manufacturers rather than the 14 
manufacturers initially estimated in the proposed rule.
    Accordingly, the estimated burden of this collection of information 
is modified 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)................................................                17                  2                 34                  1                 34
--------------------------------------------------------------------------------------------------------------------------------------------------------

There are no capital costs or operating and maintenance costs 
associated with this collection of information.
    There are 17 known firms that supply portable bed rails to the U.S. 
market. All 17 firms are assumed to use labels on their products and 
their packaging, but they would need to make some modifications to 
their existing labels. The estimated time required to make these 
modifications 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 17 firms x 2 models 
per firm = 34 annual hours. We estimate that the hourly compensation 
for the time required to create and update labels is $28.36 (Bureau of 
Labor Statistics, September 2011, 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 $964 ($28.36 per hour x 34 hours = $964.24, 
which we have rounded down to $964).
    In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 
3507(d)), we have submitted the information collection requirements of 
this final rule to the OMB.

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 this final rule for portable bed rails, as ``consumer 
product safety standards.'' Furthermore, the designation of ``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. We intend to 
issue a notice of requirements in the near future to explain how 
accredited laboratories can become recognized by CPSC as third party 
conformity assessments bodies to test to the new portable bed rails 
standard.
    Additionally, because portable bed rails covered by this final rule 
are ``children's products,'' they must comply with all other applicable 
CPSC requirements, such as the lead content and phthalates 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.

[[Page 12197]]

List of Subjects in 16 CFR Part 1224

    Consumer protection, Imports, Incorporation by reference, Infants 
and children, Labeling, and Law enforcement.

    For the reasons stated in the preamble, the Commission amends Title 
16 of the Code of Federal Regulations by adding a new part 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 establishes a consumer product safety standard for 
portable bed rails manufactured or imported on or afterAugust 29, 2012.


Sec.  1224.2  Requirements for portable bed rails.

    (a) Each portable bed rail as defined in ASTM F2085-12, Standard 
Consumer Safety Specification for Portable Bed Rails, approved January 
1, 2012, must comply with all applicable provisions of ASTM F2085-12. 
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) [Reserved]

    Dated: February 22, 2012.
Todd A. Stevenson,
Secretary, U.S. Consumer Product Safety Commission.
[FR Doc. 2012-4451 Filed 2-28-12; 8:45 am]
BILLING CODE 6355-01-P