[Federal Register Volume 65, Number 192 (Tuesday, October 3, 2000)]
[Proposed Rules]
[Pages 58968-58970]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-25279]
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Chapter II
Portable Bed Rails; Advance Notice of Proposed Rulemaking;
Request for Comments and Information
AGENCY: Consumer Product Safety Commission.
ACTION: Advance notice of proposed rulemaking.
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SUMMARY: The Commission has reason to believe that certain portable bed
rails may present an unreasonable risk of injury. A portable bed rail
is a device intended to be installed on an adult bed to prevent a child
from falling out of the bed. At least some bed rails are constructed in
a manner that children can become entrapped between the portable bed
rail and the bed. This entrapment can result in serious injury or
death.
This advance notice of proposed rulemaking (ANPR) initiates a
rulemaking proceeding that could result in a rule banning portable bed
rails that present an unreasonable risk of injury. This proceeding is
commenced under the Federal Hazardous Substances Act.
The Commission solicits written comments concerning the risks of
injury associated with portable bed rails, the regulatory alternatives
discussed in this notice, other possible ways to address these risks,
and the economic impacts of the various regulatory alternatives. The
Commission also invites interested persons to submit an existing
standard, or a statement of intent to modify or develop a voluntary
standard, to address the risk of injury described in this notice.
DATES: Written comments and submissions in response to this notice must
be received by December 4, 2000.
ADDRESSES: Comments should be mailed, preferably in five copies, to the
Office of the Secretary, Consumer Product Safety Commission,
Washington, D.C. 20207-0001, or delivered to the Office of the
Secretary, Consumer Product Safety Commission, Room 502, 4330 East-West
Highway, Bethesda, Maryland; telephone (301) 504-0800. Comments also
may be filed by telefacsimile to (301)504-0127 or by email to [email protected]. Comments should be captioned ``ANPR for Portable Bed
Rails.''
FOR FURTHER INFORMATION CONTACT: Patricia L. Hackett, Directorate for
Engineering Sciences, Consumer Product Safety Commission, Washington,
D.C. 20207; telephone (301) 504-0494, ext. 1309.
SUPPLEMENTARY INFORMATION:
A. The Product
A portable bed rail (PBR) is a device intended to be installed on
an adult bed to prevent a child from falling out of the bed. PBRs are
intended for use by children who can get in and out of bed unassisted.
(Manufacturers generally recommend them for use with children from two
to five years old.) However, many of the reported incidents of
injuries/death involved children younger than two years.
A typical PBR generally includes a vertical rail about fifteen
inches in height and four feet in length with two or more horizontal
arms at right angles to the plane of the rail that are intended to be
slipped between the mattress support or box springs and the mattress.
The PBR is held under the mattress by a variety of slip-resistant
knobs, pads or other means intended to provide frictional resistance.
However, this ANPR extends to any other designs that may present an
entrapment hazard to young children.
The Commission has information which indicates that PBRs with the
following characteristics have resulted in injuries and deaths from
entrapment between the PBR and the mattress:
1. A vertical rail or rails intended to prevent a child from
falling out of an adult bed.
2. Two or more horizontal arms, slats, or other surfaces at right
angles to the
[[Page 58969]]
vertical plane of the rail that are intended to be slipped between the
mattress support and the mattress.
3. Frictional resistance between the horizontal arms, slats or
other surfaces of the PBR and the underside of the mattress provided by
slip-resistant knobs, pads, or otherwise as the intended means to
prevent outward movement of the PBR.
B. The Risk of Death or Injury
1. Description of Typical Incident
When a PBR is not installed snugly against the mattress or when the
rods/bars that go under the mattress slip outward, a child can be
entrapped in the resulting space between the PBR and the mattress or
between the rods/bars themselves. The result can be an injury or death
by asphyxia or strangulation.
2. Death/Injury Data
The Commission has learned of fourteen instances in which a PBR was
associated with the death of a child. The cause of death in these
incidents was asphyxia or strangulation. In ten of these incidents,
death resulted from entrapment between the PBR and mattress. In one
case the child slipped between the rails of the PBR and in another the
child was found hanging from a protrusion on a PBR. Lastly, two
children were found entrapped in the space between the portable bed
rail and the headboard/bedpost of the bed. Eleven of the fourteen
fatalities associated with PBRs were children under two years of age.
In addition to the fatalities, the Commission is aware of 40 non-
fatal incidents. Nine of these resulted in injuries. The age range for
the non-fatal incidents is from 4 months to 5 years old.
The incidents that resulted in death are as follows:
a. March 6, 1990--A 7-month old male suffocated when his body
slipped feet first through horizontal bars in a PBR and he was pinned
head first into the mattress of a single size bed.
b. August 2, 1991--A 3-month old male died of asphyxia when his
head became entrapped between the bottom of a PBR and the mattress
resulting in his hanging. One of the L-shaped rods had pulled out from
under the mattress of the full size bed.
c. October 31, 1991--A 15-month old female died of mechanical
asphyxia when her neck and upper body were pinned between a PBR and the
mattress. The PBR was installed on the lower bunk of a bunk bed.
d. November 10, 1991--A 14-month old male died of ligature
strangulation. He was found hanging by his shirt collar which caught on
a metal clip with a small metal tab on the exterior of a PBR installed
on a single size bed.
e. June 23, 1993--A 2-year old female died of positional asphyxia.
The child, who had brain deformities, was found with her face inside a
2-3 inch gap between the mattress and the attached side rail of her
toddler bed. The PBR was designed with a tubular extension to fit under
the mattress to hold it in place. The PBR was secured below the
mattress to the bottom slats of the bed with string.
f. October 14, 1994--A 7-month old male died of restrictive
asphyxia when his neck became entrapped in a 2-3 inch gap between the
end of a retractable bed rail and the bed post of a small twin bed.
g. December 8, 1995--A 2.5-year old female suffering from cerebral
palsy died of positional asphyxia. She was found lying on her stomach
between the mattress of her ``youth size'' bed and a PBR. The left side
of her face was against the mattress and a plastic sheet that covered
the mattress was covering much of the child's face.
h. March 7, 1996--A 5-month old male died of asphyxia when he
became entrapped between a PBR and the mattress on an adult bed. The
child was found face down with his face toward the mattress.
i. January 15, 1997--A 19-month old male died of pneumonia due to a
cervical injury sustained by hanging when he became entrapped between a
PBR and the upper bunk mattress on the wall side of a bunk bed. The
victim was found hanging/suspended with the back of his head on the
guard rail and his mouth pressed into the mattress.
j. March 18, 1998--A 4-year old mentally retarded male died of
asphyxia due to hanging when he became entrapped between a wooden PBR
with vertical slats and the mattress of a toddler bed. The victim's
head/neck area was caught at the bottom of the bed rail with his head
against the mattress and his torso and feet under the bed.
k. August 17, 1998--A 7-month old male died of asphyxia when his
head became entrapped between the headboard of a toddler bed and a
youth PBR.
l. November 7, 1998--A 5-month old female died of asphyxiation when
she became entrapped between the mattress of a king size bed and a PBR.
She was found with her chin on the mattress. The medical examiner in
this case believed the child's neck was resting on the PBR causing
strangulation.
m. April 29, 1999--A 4-month old female died of positional asphyxia
on a toddler bed when she apparently rolled between the mattress and
the bed rail.
n. May 21, 2000--A 6-month old female died of positional asphyxia
on an adult bed. She was found on her side wedged between the mattress
and the bed rail.
C. Relevant Statutory Provisions
This proceeding is conducted pursuant to the Federal Hazardous
Substances Act (FHSA), 15 U.S.C. 1261 et seq. Section 2(f)(1)(D) of the
FHSA defines ``hazardous substance'' to include any toy or other
article intended for use by children that the Commission determines, by
regulation, presents an electrical, mechanical, or thermal hazard. 15
U.S.C. 1261(f)(1)(D). An article may present a mechanical hazard if its
design or manufacture presents an unreasonable risk of personal injury
or illness during normal use or when subjected to reasonably
foreseeable damage or abuse. Among other things, a mechanical hazard
could include a risk of injury or illness ``(3) from points or other
protrusions, surfaces, edges, openings, or closures, * * * or (9)
because of any other aspect of the article's design or manufacture.''
15 U.S.C. 1261(s).
Under section 2(q)(1)(A) of the FHSA, a toy, or other article
intended for use by children, which is or contains a hazardous
substance accessible by a child is a ``banned hazardous substance.'' 15
U.S.C. 1261(q)(1)(A).
Sections 3(f) through 3(i) of the FHSA, 15 U.S.C. 1262(f)-(i),
govern a proceeding to promulgate a regulation determining that a toy
or other children's article presents an electrical, mechanical, or
thermal hazard. As provided in section 3(f), this proceeding is
commenced by issuance of this ANPR. After considering any comments
submitted in response to this ANPR, the Commission will decide whether
to issue a proposed rule and a preliminary regulatory analysis in
accordance with section 3(h) of the FHSA. If a proposed rule is issued,
the Commission would then consider the comments received in response to
the proposed rule in deciding whether to issue a final rule and a final
regulatory analysis. 15 U.S.C. 1262(i).
D. Regulatory Alternatives
One or more of the following alternatives could be used to reduce
the identified risks associated with PBRs.
1. Mandatory rule. The Commission could issue a rule declaring
certain PBRs to be banned hazardous substances. This rule could define
the banned products in terms of physical or performance
characteristics, or both.
[[Page 58970]]
2. Labeling rule. The Commission could issue a rule banning PBRs
that did not contain specified warnings and instructions.
3. Voluntary standard. If the industry developed, adopted, and
substantially conformed to an adequate voluntary standard, the
Commission could defer to the voluntary standard in lieu of issuing a
mandatory rule.
E. Existing Standards
The Commission is not aware of any promulgated state, voluntary,
foreign, international, or other standard dealing with the described
risk of injury or death. In February 1998, the CPSC staff requested
that ASTM develop a provisional standard for PBRs to address the hazard
of entrapment-related deaths. In May 1999, CPSC staff drafted proposed
performance requirements and submitted them to ASTM for consideration.
As of May 2000, the ASTM Portable Bed Rail Subcommittee had not
balloted a proposed performance standard for these products.
F. Economic Considerations
1. PBR Sales and Numbers Available for Use
Based on information gathered by the CPSC Office of Compliance,
eleven firms produced a total of approximately 7.7 million PBRs during
the period from January 1988 to July 14, 1998. Subsequent sales (1998
and 1999) were reportedly stable. Thus, based on available information,
approximately 733,000 units are sold per year. The retail cost of a PBR
is in the range of $15-$30.
No information is available on the average product life of a PBR.
CPSC staff estimate that for the period of first use an expected life
of two years would be appropriate. However, some units could see use
with subsequent children so four years is estimated as a reasonable
upper bound on the expected useful life of a PBR. Assuming an expected
useful life of four years and stable sales, there may be as many as
approximately 3 million PBRs in use at any one given time (733,000 PBRs
sold per year x 4 years).
2. Suppliers
CPSC staff has identified eleven firms that marketed PBRs in the
United States during the period 1980-1998. There may be other
manufacturers or importers that the staff has not identified.
3. Substitutes
Substitutes for PBRs include beds equipped with fixed side rails
that are designed for children in the two to five year old age range or
differently designed PBRs that do not pose an entrapment hazard.
4. Cost Effectiveness Considerations
The CPSC is aware of 14 deaths since 1990 that are directly
attributable to PBRs, for an average of 1.34 deaths per year over that
period. At a statistical value of life of $5 million, the aggregate
cost to society from PBR-attributable deaths is approximately $6.7
million annually. This estimate does not account for the costs
associated with non-fatal PBR-related injuries.
Using the death rate and annual sales estimates noted above, CPSC
staff calculate that the expected societal cost of those deaths over
the life of a PBR is approximately $9 per PBR. Thus, if product
improvements were 100% effective in preventing the predicted deaths, a
cost per bed rail for the improvements of $9 would be economically
justified. (The $9 per bed rail societal cost represents between 30%
and 60% of the retail price of a PBR.)
G. Solicitation of Information and Comments
This ANPR is the first step of a proceeding that could result in a
mandatory rule for PBRs to address the described risk of injury or
death. All interested persons are invited to submit to the Commission
their comments on any aspect of the alternatives discussed above. In
particular, CPSC solicits the following additional information:
1. The models and numbers of PBRs produced for sale in the U.S.
each year from 1990 to the present;
2. The names and addresses of manufacturers and distributors of
PBRs;
3. The expected useful life of PBRs;
4. Comparisons of the utility obtained from PBRs versus any
available substitute products;
5. The number of persons injured or killed by the hazards
associated with PBRs;
6. The circumstances under which these injuries and deaths occur,
including the ages of the victims;
7. An explanation of designs that could be adapted to PBRs to
reduce the described risk of injury;
8. Physical or performance characteristics of the product that
could or should not be used to define which products might be subject
to a rule;
9. The costs to manufacturers involved in either redesigning PBRs
to remove the risk or removing PBRs from the market;
10. Other information on the potential costs and benefits of
potential rules;
11. Steps that have been taken by industry or others to reduce the
risk of injury from the product;
12. The likelihood and nature of any significant economic impact of
a rule on small entities;
13. The costs and benefits of mandating a banning, labeling, or
instructions requirement.
Also, in accordance with section 3(f) of the FHSA, the Commission
solicits:
1. Written comments with respect to the risk of injury identified
by the Commission, the regulatory alternatives being considered, and
other possible alternatives for addressing the risk.
2. Any existing standard or portion of a standard which could be
issued as a proposed regulation.
3. A statement of intention to modify or develop a voluntary
standard to address the risk of injury discussed in this notice, along
with a description of a plan (including a schedule) to do so.
Comments should be mailed, preferably in five copies, to the Office
of the Secretary, Consumer Product Safety Commission, Washington, DC
20207-0001, or delivered to the Office of the Secretary, Consumer
Product Safety Commission, Room 502, 4330 East-West Highway, Bethesda,
Maryland 20814; telephone (301) 504-0800. Comments also may be filed by
telefacsimile to (301) 504-0127 or by email to [email protected].
Comments should be captioned ``ANPR for Portable Bed Rails.'' All
comments and submissions should be received no later than December 4,
2000.
Dated: September 27, 2000.
Todd A. Stevenson,
Deputy Secretary, Consumer Product Safety Commission.
[FR Doc. 00-25279 Filed 10-2-00; 8:45 am]
BILLING CODE 6355-01-P