[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