Federal Register: October 3, 2000 (Volume 65, Number 192)
DOCID: FR Doc 00-25279
CONSUMER PRODUCT SAFETY COMMISSION
Consumer Product Safety Commission
CFR Citation: 16 CFR Chapter II
NOTICE: PROPOSED RULES
ACTION: Federal Hazardous Substances Act:
DOCUMENT ACTION: Advance notice of proposed rulemaking.
Portable Bed Rails; Advance Notice of Proposed Rulemaking; Request for Comments and Information
DATES: Written comments and submissions in response to this notice must be received by December 4, 2000.
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.
Portable bed rails; safety standards,
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 slipresistant 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
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
slipresistant 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 nonfatal incidents is from 4 months to 5 years old.
The incidents that resulted in death are as follows:
a. March 6, 1990A 7month 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, 1991A 3month 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 Lshaped rods had pulled out from under the mattress of the full size bed.
c. October 31, 1991A 15month 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, 1991A 14month 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, 1993A 2year old female died of positional asphyxia. The child, who had brain deformities, was found with her face inside a 23 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, 1994A 7month old male died of restrictive asphyxia when his neck became entrapped in a 23 inch gap between the end of a retractable bed rail and the bed post of a small twin bed.
g. December 8, 1995A 2.5year 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, 1996A 5month 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, 1997A 19month 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, 1998A 4year 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, 1998A 7month old male died of asphyxia when his head became entrapped between the headboard of a toddler bed and a youth PBR.
l. November 7, 1998A 5month 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, 1999A 4month old female died of positional asphyxia on a toddler bed when she apparently rolled between the mattress and the bed rail.
n. May 21, 2000A 6month 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.
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 entrapmentrelated 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).
CPSC staff has identified eleven firms that marketed PBRs in the United States during the period 19801998. 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 PBRattributable deaths is approximately $6.7 million annually. This estimate does not account for the costs associated with nonfatal PBRrelated 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
202070001, or delivered to the Office of the Secretary, Consumer
Product Safety Commission, Room 502, 4330 EastWest Highway, Bethesda,
Maryland 20814; telephone (301) 5040800. Comments also may be filed by
telefacsimile to (301) 5040127 or by email to firstname.lastname@example.org.
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. 0025279 Filed 10200; 8:45 am] BILLING CODE 635501P
FOR FURTHER INFORMATION CONTACT
Patricia L. Hackett, Directorate for Engineering Sciences, Consumer Product Safety Commission, Washington, D.C. 20207; telephone (301) 5040494, ext. 1309.