ÿþ<html> <head> <title>Safety Standard for Bunk Beds </title> </head> <body> <pre> [Federal Register: December 22, 1999 (Volume 64, Number 245)] [Rules and Regulations] [Page 71887-71915] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr22de99-25] [[Page 71887]] _______________________________________________________________________ Part III Consumer Product Safety Commission _______________________________________________________________________ 16 CFR Parts 1213, 1500, and 1513 Safety Standard for Bunk Beds; Final Rule [[Page 71888]] CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Parts 1213, 1500, and 1513 Safety Standard for Bunk Beds AGENCY: Consumer Product Safety Commission. ACTION: Final rules. ----------------------------------------------------------------------- SUMMARY: The Consumer Product Safety Commission (CPSC or Commission) has determined that unreasonable risks of injury and death are associated with bunk beds that are constructed so that <strong>children</strong> can become entrapped in the beds' structure or become wedged between the bed and a wall. This document issues the final rules mandating bunk bed performance requirements to reduce this hazard. The rules are issued under both the Federal Hazardous Substances Act (FHSA), for bunk beds intended for use by <strong>children</strong>, and the Consumer Product Safety Act (CPSA), for bunk beds not ``intended'' for (but often used by) <strong>children</strong>. DATES: These rules will become effective June 19, 2000 and will apply to all bunk beds manufactured in the United States, or imported, on or after that date. ADDRESSES: Documents relating to these rules can be obtained from the Office of the Secretary, Consumer Product Safety Commission, Washington, D.C. 20207-0001, or inspected at the Office of the Secretary, Consumer Product Safety Commission, Room 502, 4330 East-West Highway, Bethesda, Maryland; telephone (301) 504-0800. FOR FURTHER INFORMATION CONTACT: Pamela Major, Office of Compliance, Consumer Product Safety Commission, Washington, D.C. 20207; telephone (301) 504-0608, ext. 1373; email pmajor@cpsc.gov. SUPPLEMENTARY INFORMATION: A. Background In this document, the Commission issues rules mandating requirements to protect against the entrapment of <strong>children</strong> in bunk beds. &lt;SUP&gt;1&lt;/SUP&gt; Without proper guardrails and safe dimensions for openings in the bed's structure, a bunk bed may allow a child to be entrapped, and thus strangle or suffocate. This can occur when the child becomes wedged between the bed and the wall, when the child slips his or her torso through an opening in the bed that is too small for its head to pass through (torso-first entrapment), or when the child places his or her head in an opening, then moves to a narrower area of the opening where the head cannot pull out, and then falls or loses his/her footing (head-first entrapment). --------------------------------------------------------------------------- \1\ The Commission voted 2-1 to issue this rule. Chairman Ann Brown and Commissioner Thomas H. Moore voted to issue the rule. Commissioner Mary Sheila Gall voted against. Statements of the Commissioners concerning this vote are available from the Office of the Secretary. --------------------------------------------------------------------------- There is a voluntary standard for bunk beds, ASTM F1427-96, that contains provisions to protect <strong>children</strong> from entrapment. The ASTM standard requires: &lt;bullet&gt; Guardrails on both sides of the upper bunk, except for up to 15 inches at each end of the bed. The upper edge of the guardrails shall be no less than 5 inches above the top surface of the mattress when a mattress of the maximum thickness specified by the bed manufacturer's instructions is on the bed. Guardrails shall be attached so that they cannot be removed without either intentionally releasing a fastening device or applying forces sequentially in different directions. &lt;bullet&gt; That openings in the structure surrounding the upper bunk be small enough to prevent passage of a tapered block having a base measuring 3.5 inches by 6.2 inches. &lt;bullet&gt; That openings in the end structures within 9 inches above the sleeping surface of the lower bunk mattress be either small enough to prevent passage of the 3.5 by 6.2 inch block or large enough to permit passage of a 9-inch diameter sphere (the space needed to withdraw a child's head). &lt;bullet&gt; Labels and instructions. Because of continued reports of deaths and other incidents associated with entrapment in bunk beds, and because of indications there might not be adequate compliance with the voluntary ASTM standard, the CPSC published an advance notice of proposed rulemaking (ANPR) to begin a rulemaking proceeding that could result in performance or other standards to address the risk of entrapment associated with bunk beds. &lt;SUP&gt;2&lt;/SUP&gt; 63 FR 3280 (January 22, 1998); 64 FR 3456 (January 22, 1999) (extension of time to issue proposed rule). After considering the comments received in response to the ANPR, the Commission voted 2-0-1 &lt;SUP&gt;3&lt;/SUP&gt; to publish a notice of proposed rulemaking (NPR) to propose a new 16 CFR Part 1213 under the Consumer Product Safety Act (CPSA) and a new 16 CFR Part 1513 under the Federal Hazardous Substances Act (FHSA). 64 FR 10245 (March 3, 1999); 64 FR 14158 (March 24, 1999) (notice of opportunity for presentation of oral comments). The entrapment provisions of these two rules are identical. As discussed below in Section E of this notice, the CPSA rule addresses hazards associated with adult bunk beds (those not specifically intended for use by <strong>children</strong>, although they are often used for that purpose), and the FHSA rule addresses hazards associated with bunk beds intended for use by <strong>children</strong>. --------------------------------------------------------------------------- \2\ The ANPR was approved by a 2-1 vote of the Commission. Chairman Ann Brown and Commissioner Thomas H. Moore voted to approve the ANPR; Commissioner Mary Sheila Gall voted not to publish the ANPR. \3\ Chairman Ann Brown and Commissioner Thomas H. Moore voted to publish the NPR; Commissioner Mary Sheila Gall abstained. --------------------------------------------------------------------------- After the original proposal, discussions at ASTM meetings indicated that requirements in addition to those originally proposed are needed to adequately address fatalities due to entrapment of <strong>children</strong>'s necks in the end structures of bunk beds. The Commission voted 2-1 to propose these additional requirements. 64 FR 37051 (July 9, 1999). B. Incident Data Deaths From January 1990 through August 9, 1999, CPSC received reports of 91 bunk-bed-related deaths of <strong>children</strong> under age 15 (see Table 1 below). Table 1.--Fatal Bunk Bed Incidents Reported to CPSC, by Year and Hazard Pattern [January 1990 to August 9, 1999] ------------------------------------------------------------------------ Year Total Entrap. Hanging Falls -------------------------------------------&lt;SUP&gt;1&lt;/SUP&gt;---------------------------- 1990.................................. 7 5 2 ...... 1991.................................. 15 10 2 3 1992.................................. 4 3 1 ...... 1993.................................. 19 10 7 2 1994.................................. 10 6 3 1 1995.................................. 12 5 5 2 1996.................................. 12 11 1 ...... 1997 &lt;SUP&gt;2&lt;/SUP&gt;................................ 8 6 2 ...... 1998 &lt;SUP&gt;2&lt;/SUP&gt;................................ 3 1 1 1 1999 &lt;SUP&gt;2&lt;/SUP&gt;................................ 1 ....... 1 ...... --------------------------------- Total............................... 91 57 25 9 ------------------------------------------------------------------------ Source: CPSC data files, January 1990-August 9, 1999. &lt;SUP&gt;1&lt;/SUP&gt; These deaths are neither a complete count of all that occurred during this time period nor a sample of known probability of selection. However, they provide a minimum number of deaths occurring during this time period and illustrate the circumstances involved in some bunk-bed- related fatalities. &lt;SUP&gt;2&lt;/SUP&gt; The Death Certificate files for 1997 through August 9, 1999, are not complete. Of the 91 fatalities, 57 resulted from entrapment. An additional 25 <strong>children</strong> died when they inadvertently were hung from the bed by such items as belts, ropes, clothing, and bedding, and 9 <strong>children</strong> died in falls from bunk beds. As shown in Table 2, over 96% (55 of 57) of those who died in entrapment incidents were age 3 and younger, and [[Page 71889]] all but one were younger than 5. In contrast, about 76% (19 of 24) of those who died in hanging incidents were age 6 and older. Fall deaths were split among <strong>children</strong> 4 years of age and younger and <strong>children</strong> 9 and older. Table 2.--Fatal Bunk Bed Incidents Reported to CPSC, by Victim Age and Hazard Pattern [January 1990-August 9, 1999] ------------------------------------------------------------------------ Age (years) Total Entrap. Hanging Falls ------------------------------------------------------------------------ &lt;1.................................... 18 16 1 1 1..................................... 20 19 1 ...... 2..................................... 16 13 2 1 3..................................... 8 7 ....... 1 4..................................... 4 1 1 2 5..................................... 1 ....... 1 ...... 6..................................... 3 ....... 3 ...... 7..................................... 3 1 \1\ 2 ...... 8..................................... 2 ....... 2 ...... 9..................................... 3 ....... 2 1 10+................................... 13 ....... 10 3 --------------------------------- Total............................... 91 57 25 9 ------------------------------------------------------------------------ Source: CPSC data files, January 1990-August 9, 1999. \1\ Child was blind and confined to upper bunk by removal of the ladder. Using statistical methodology (capture-recapture), about 10 bunk- bed-related entrapment deaths are estimated to have occurred in the United States each year since 1990. Injuries From hospital emergency room data reported through the National Electronic Injury Surveillance System (NEISS), the Commission estimates that about 34,300 bunk-bed-related injuries to <strong>children</strong> under the age of 15 were treated in U.S. hospital emergency rooms during 1998. Forty- one percent of the victims were younger than 5 years. A review of the descriptive comments received for each injury revealed that falls from the bed were involved in a majority of the incidents. There were a few reports of limb entrapment incidents, and one incident involved a 2- year-old male who was found hanging from a bunk bed with a sheet wrapped around his neck; he was admitted to the hospital with a head injury. Entrapment Incidents The Commission reviewed entrapment-related incidents, which accounted for the majority of deaths, in further detail to obtain additional information about the circumstances involved. Both fatal and ``near-miss'' incidents were included. The ``near-miss'' incidents, usually reported through consumer complaints, were those in which a child became entrapped in the bed, often requiring rescue by the parent or caregiver. In these cases, there were generally no injuries or injuries were minor (contusions/abrasions). However, the Commission examined ``near-miss'' incidents because they have the potential for death or serious injury. There were 122 entrapment incidents from January 1990 through August 9, 1999, of which 57 were fatalities and 65 were ``near- misses.'' Table 3 illustrates the location in the bunk bed where the child was entrapped. Table 3.--Location in Bunk Bed of Fatal and ``Near-Miss'' Entrapment Incidents ------------------------------------------------------------------------ Type of incident ------------------------ Location of entrapment Near- Total Fatal Miss ------------------------------------------------------------------------ Top Bunk....................................... 77 39 38 Guardrail.................................. 51 27 24 Bed/Wall................................... 11 9 2 End structure.............................. 12 1 11 Add-on rail................................ 1 1 0 Other...................................... 1 0 1 Unknown.................................... 1 1 0 Bottom Bunk.................................... 27 12 15 Guardrail.................................. 1 0 1 Bed/Wall................................... 6 6 0 End structure.............................. 14 3 11 Add-on rail................................ 2 2 0 Other...................................... 4 1 3 Ladder......................................... 7 2 5 Unknown Bunk................................... 11 4 7 Guardrail.................................. 2 0 2 Bed/Wall................................... 1 1 0 End structure.............................. 4 0 4 ``Safety rails''........................... 1 1 0 Other...................................... 1 0 1 Unknown.................................... 2 2 0 ------------------------ Total.................................. 122 57 65 ------------------------------------------------------------------------ Source: CPSC data files, January 1990--August 9, 1999. Based on a review of the 57 bunk bed entrapment deaths, the Commission concludes that 39 deaths could have been prevented if the beds had conformed to the current ASTM standard and that 42 could have been prevented by the Commission's bunk bed rules. Of the three incidents that occurred in bunk beds conforming to the ASTM standard, two involved entrapment in the upper bunk. In these separate incidents, an 18-month-old infant and a child who was almost 5 years old slipped through the space between the end of the guardrail and the end structure of the bed and became wedged between the bed and a wall. In the third incident, a 22-month-old child became entrapped by the head in an opening. The opening was between the underside of the upper bunk foundation [[Page 71890]] support and a curved structural member in the bunk bed end structure. C. The Rule's Requirements The final rule defines a bunk bed as any bed in which the underside of any foundation is over 30 inches from the floor. Any bunk bed shall provide at least two upper bunk guardrails, at least one on each side of the bed. One guardrail shall be continuous between each of the bed's end structures. The other guardrail may terminate before reaching the bed's end structures, providing there is no more than 15 inches (380 mm) between either end of the guardrail and the nearest bed end structure. For bunk beds designed to have a ladder attached to one side of the bed, the continuous guardrail shall be on the other side of the bed. Guardrails shall be attached so that they cannot be removed without either intentionally releasing a fastening device or applying forces sequentially in different directions. There has been some question about how to interpret the requirement that the guardrail shall be ``continuous'' between the end structures. The Commission will tolerate a gap between the guardrail and end structure of up to 0.22 inches (so as to not cause a finger entrapment hazard for a child). Moreover, the guardrail need not necessarily be fastened to the end structure (as by bolting or welding). The upper edge of the guardrails shall be no less than 5 inches (130 mm) above the top surface of the mattress when a mattress of the maximum thickness specified by the bed manufacturer's instructions is on the bed. The Commission does not intend for this requirement to prohibit designs where the wall-side guardrail terminates in a quarter- circle bend and attaches to the side rail of the upper bunk foundation. With no mattress on the bed, there shall be no openings in the structure between the lower edge of the uppermost member of the guardrail and the underside of the upper bunk's foundation that would permit passage of the wedge block (representing a child's torso) shown in Figure 1 of Parts 1213 and 1513. The upper edge of the upper bunk end structures shall be at least 5 inches (130 mm) above the top surface of the mattress for at least 50 percent of the distance between the two posts at the head and foot of the upper bunk when a mattress and foundation of the maximum thickness specified by the manufacturer's instructions is on the bed. With no mattress on the bed, there shall be no openings in the end structures above the foundation of the upper bunk that will permit the free passage of the wedge block shown in Figure 1 of Parts 1213 and 1513. There shall be no openings in the end structures between the underside of the foundation of the upper bunk and upper side of the foundation of the lower bunk that will permit the free passage of the wedge block shown in Figure 1, unless the openings are also large enough to permit the free passage of a 9-inch (230-mm) diameter rigid sphere (representing a child's head). In order to protect against head-first entrapment in a bed's end structure, the Commission's staff developed a test procedure using the template shown in Figure 2 of Parts 1213 and 1513. This template and procedure are similar to those that were developed to address neck entrapment hazards in playground equipment structures and that are specified in ASTM F 1487-98, ``Standard Specification for Playground Equipment for Public Use.'' The ASTM standard for bunk beds does not contain a comparable provision. Any portion of an opening in the bed's end structure below the foundation of the upper bunk that is required to be probed by the wedge-block probe shown in Figure 1 of Parts 1213 and 1513, and that will allow free passage of a 9-inch diameter sphere, must satisfy the new neck entrapment provisions in the rules. The template of Figure 2 embodies the following principles. First, a child will not be able to insert his or her neck sideways into an opening of less than 1.88 inches. (This dimension represents the neck breadth of 2.5 inches for a 5th percentile 2-year-old child, minus an allowance of 0.62 inches for tissue compression.) Second, there is a minimal likelihood of entrapment when the boundaries of an opening converge on the neck at an included angle of greater than 75 deg.. See CPSC memorandum from Shelley Waters Deppa to John Preston, ``Voluntary Standards for Gates and Enclosures,'' January 15, 1985. This angle was chosen because it is slightly larger than the angles involved in neck entrapment accidents with baby gates and expandable enclosures. In addition, in some boundary configurations, a child who slips while his/her head is in the opening will be removed from the opening by the force of gravity. In the final rule, an opening that indicates a neck entrapment potential when tested with the template of Figure 2 is nevertheless allowed if its lower boundary slopes downward at 45 deg. or more for the whole distance from the narrowest part of the opening the neck can reach to the part of the opening that will freely pass a 9-inch diameter sphere. The template is used to protect against head-first entrapment as follows. First, all portions of the boundary of the opening are probed with the ``A'' section of the test template of Figure 2. The template is inserted into the opening, with the plane of the template in the plane of the opening and with the ``top'' of the template perpendicular to the centerline of the portion of the boundary being probed. (It may be necessary to detach the ``B'' section of the template to fit the ``A'' section into the opening.) The ``A'' section of the template is then moved along the centerline of the portion of the boundary being probed until it is stopped by contact with the boundaries of the opening (see Figure 3 of Parts 1213 and 1513). If there is simultaneous contact between the boundary of the opening and both sides of the ``A'' section of the template, the boundary is converging on a potential neck entrapment point at an angle of less than 75 deg., and further investigation is required. (Contact at an upper corner of the template, as shown in Figure 2, is not considered to be contact with a ``side.'') To check further for the potential for neck entrapment, place the neck portion of the ``B'' section of the template into the opening, with the template's plane perpendicular to both the plane of the opening and the centerline of the opening (see Figure 4 of Parts 1213 and 1513). If the neck portion can completely enter the opening (pass 0.75 inch or more beyond the points where contact with the sides of the ``A'' section of the template occurred), the opening may present a neck entrapment hazard. Such an opening is not allowed unless the lower boundary of the opening slopes downward at 45'' or more for the whole distance from the narrowest part of the opening the neck can reach to the larger (greater than 9-inch) part of the opening. There shall be a permanent label or marking on each bed stating the name and address (city, state, and zip code) of the manufacturer, distributor, or retailer; the model number; and the month and year of manufacture. The following warning label shall be permanently attached to the inside of an upper bunk bed end structure in a location that cannot be covered by the bedding, but that may be covered by the placement of a pillow. BILLING CODE 6355-01-P [[Page 71891]] [GRAPHIC] [TIFF OMITTED] TR22DE99.000 BILLING CODE 6355-01-C Instructions shall accompany each bunk bed set, and shall include the following information. (a) Size of mattress and foundation. The length and width of the intended mattress and foundation shall be clearly stated, either numerically or in conventional terms such as twin size, twin extra- long, etc. In addition, the maximum thickness of the mattress and foundation required for compliance with Sec. 1213.3(a)(5) and (b)(1) shall be stated. (b) Safety warnings. The instructions shall provide the following safety warnings: (1) Do not allow <strong>children</strong> under 6 years of age to use the upper bunk. (2) Use guardrails on both sides of the upper bunk. (3) Prohibit horseplay on or under beds. (4) Prohibit more than one person on upper bunk. (5) Use ladder for entering or leaving upper bunk. D. The ASTM Standard The entrapment requirements in the final rules being issued are identical to those in the ASTM standard, with the following exceptions. 1. Definition of <strong>bunkbed</strong>: In the ASTM standard, a bunk bed is defined as a bed in which the underside of the foundation is over 35 inches from the floor, rather than the 30 inches in the final rule. Neither of these definitions requires that there be two separate sleeping surfaces. 2. Guardrails: The final rule provides that one guardrail (the wall side) shall be continuous between the bed's end structures. The other guardrail may terminate before reaching the bed's end structures, providing there is no more than 15 inches between either end of the guardrail and the nearest bed end structure. The current ASTM standard permits both guardrails to end 15 inches from the nearest bed end structure. Compared to the final rule, this permits two areas where a child could become entrapped between the bed and the wall. 3. Bunk end structures: (a) The final rule provides that there shall be no openings in the end structures between the underside of the foundation of the upper bunk and the upper side of the foundation of the lower bunk that will permit the free passage of the wedge block shown in Figure 1 (representing a child's torso) unless the openings are also large enough to permit the free passage of a 9-inch diameter sphere (to ensure the head can also pass through). In the ASTM standard, these passage requirements apply only to that portion of the end structure that is between the level of the lower bunk foundation support system and 9.0 inches (230 mm) above the sleeping surface of the maximum thickness mattress and foundation combined as recommended by the manufacturer. During 1999, there were three meetings of the ASTM subcommittee at which changes to the ASTM standard were voted upon or discussed. The following discussion describes how these potential changes relate to how close the voluntary standard might have ultimately resembled the final rules if they were not now being issued by the Commission. The ASTM subcommittee approved a motion to define a bunk bed as a bed in which the underside of the foundation is over 30 inches from the floor, as in the mandatory rule. After discussing the meaning of the term ``continuous guardrail,'' the subcommittee approved a revision that would require one guardrail on the upper bunk to terminate no greater than 1.5 inches from the end structures, as opposed to the proposed requirement that the guardrail be continuous between the end structures. As noted above, the 1.5 inch space approved by the subcommittee would not comply with the final rule's requirement that the wall-side guardrail be continuous between the end structures. The revision approved by the ASTM subcommittee also clarified that the 15-inch space between the ends of the other upper bunk guardrail must be measured 5 inches above the sleeping surface of the maximum thickness mattress specified. This clarification agrees with the final rule. In addition, the subcommittee approved a change to the instructions that must accompany a bunk bed to inform consumers that a bunk bed placed adjacent to a wall must have the continuous guardrail on the wall-side of the bed. This requirement agrees with the final rule. The ASTM subcommittee voted to expand the current entrapment requirements to include the entire end structure between the level of the upper and lower bunk foundation support systems, as provided in the final rule. Further, it did not oppose adding a neck entrapment requirement to the ASTM standard. However, the members present questioned the need for a 75 deg. angle on the test probe, when a 55 deg. angle on a similar probe in the ASTM public playground equipment standard appeared to have been effective in addressing neck entrapment incidents in openings. A working group was established to draft a recommendation [[Page 71892]] for the subcommittee on whether the probe to be used in the ASTM bunk bed standard should have a 75 deg. angle as in the proposed rule or a 55 deg. angle as in the playground equipment standard. A motion was approved to accept the recommendation of the working group and to forward it, together with the other previously approved revisions, to ASTM for a ballot by the full subcommittee. At the request of ASTM, CPSC staff searched CPSC playground incident data and verified that no neck entrapments were reported in structures conforming to the requirements in the voluntary playground standards. A September 9, 1999 letter from the ASTM working group was submitted as a comment on the July 9, 1999 NPR. The letter stated that the working group had recommended to the ASTM subcommittee that the neck entrapment requirement to be added to the ASTM standard for bunk beds will specify the probe in the ASTM public playground equipment standard, which uses a 55 deg. angle. After the ASTM working group's decision to use the 55 deg. playground equipment probe, manufacturers discussed limiting the revision of the requirements for lower bunk end structures in the ASTM standard to metal bunk beds only. Their rationale for such a limitation is that there have been no known neck entrapment incidents in wooden bunk beds and that it is not likely that a wooden bunk bed would be manufactured with openings of a shape that would present neck entrapment. At the present time, the Commission does not know whether the lower bed end structure requirements in the ASTM standard will apply only to metal beds. The revisions to the voluntary standard that were approved during the meetings of the ASTM bunk bed subcommittee have not been sent for balloting by the entire subcommittee. The Commission does not know when the ballot will be mailed or what new requirements will be approved. E. Statutory Authorities for This Proceeding The FHSA authorizes the regulation of unreasonable risks of injury associated with articles intended for use by <strong>children</strong> that present mechanical (or electrical or thermal) hazards. FHSA Sec. 2(f)(D), 15 U.S.C. 1261(f)(D). The hazards associated with bunk beds that are described above are mechanical. See FHSA Sec. 2(s), 15 U.S.C. 1261(s). The CPSA authorizes the regulation of unreasonable risks of injury associated with ``consumer products,'' which include bunk beds''whether intended for the use of <strong>children</strong> or adults. CPSA Sec. 3(a)(1), 15 U.S.C. Sec. 2052(a)(1). Thus, bunk beds intended for the use of adults can be regulated only under the CPSA, while bunk beds intended for the use of <strong>children</strong> potentially could be regulated under either the FHSA or the CPSA. The Commission considers a bunk bed to be intended for use by <strong>children</strong> if it has smaller than twin-size mattresses or incorporates styling or other features especially intended for use by <strong>children</strong>. The available data do not indicate whether the known deaths and injuries are occurring on beds intended for use by <strong>children</strong>. Nevertheless, any regulation for bunk beds should include beds intended for <strong>children</strong>, since there is no reason why such beds, to the extent they exist, do not present the same risks to <strong>children</strong> as do adults' bunk beds. Section 30(d) of the CPSA, however, provides that a risk associated with a consumer product that can be reduced to a sufficient extent by action under the FHSA can be regulated under the CPSA only if the Commission, by rule, finds that it is in the public interest to do so. 15 U.S.C. 2079(d). Because the risks of bunk beds can be addressed with the two-pronged approach (i.e., by both statutes), there appears to be no strong reason why it would be in the public interest to regulate bunk beds only under the CPSA. Accordingly, the requirements were proposed, and are issued, as two separate rules, one under the CPSA for ``adult'' bunk beds and the other under the FHSA for beds intended for use by <strong>children</strong>. F. Statutory Findings Relating to the Voluntary Standard The Commission may not issue a standard under either the CPSA or the FHSA if an industry has adopted and implemented a voluntary standard to address the risk, unless the Commission finds that ``(i) compliance with such voluntary * * * standard is not likely to result in the elimination or adequate reduction of such risk of injury; or (ii) it is unlikely that there will be substantial compliance with such voluntary * * * standard.'' See 9(f)(3)(D) of the CPSA, 15 U.S.C. 2058(f)(3)(D), and 3(i)2) of the FHSA, 15 U.S.C. 1262(i)(2). The percentage of currently produced bunk beds that conform to the ASTM standard could be as high as 90% or more. This raises the questions of whether the ASTM standard is substantively adequate and, if so, whether it will command ``substantial compliance.'' The rule goes beyond the provisions of the ASTM voluntary standard. First, it eliminates the voluntary standard's option to have an opening of up to 15 inches at each end of the wall-side guardrail. Second, the voluntary standard protects against entrapment only within the 9-inch space immediately above the upper surface of the lower bunk's mattress. The mandatory standard extends this area of protection upward to the level of the underside of the upper bunk foundation. Third, the mandatory standard contains protection against neck entrapment that the voluntary standard lacks. Finally, the mandatory rule applies to bunk beds having a foundation over 30 inches from the floor, rather than the 35 inches in the ASTM standard. These provisions, which are in the rule but not in the voluntary standard, address fatalities and, as noted below, have benefits that bear a reasonable relationship to their costs. Therefore, the Commission finds that compliance with the voluntary standard is unlikely to eliminate or adequately reduce the risk of entrapment injury or death. For this reason, the voluntary standard does not bar issuance of a rule. Even if the voluntary and mandatory standards were identical, however, there is the issue of whether there will be substantial compliance with the voluntary standard. Neither the CPSA nor the FHSA define ``substantial compliance.'' The March 3, 1999 Notice of Proposed Rulemaking summarized an interpretation of ``substantial compliance'' that the Office of General Counsel provided to the Commission. 64 Fed. Reg. 10245, 10248-49 (March 3, 1999). The Commission specifically invited public comment on that interpretation from ``all persons who would be affected by such an interpretation.'' Id. at 10249. The Commission received more than 20 comments on the interpretation. Having now considered all the evidence that the staff has presented, the comments from the public, and the legal advice from the Office of General Counsel, the Commission concludes that there is not ``substantial compliance'' with the ASTM voluntary standard for bunk beds within the meaning of the Consumer Product Safety Act and the Federal Hazardous Substances Act. See, e.g., 15 U.S.C. 2058(f)(3)(D)(ii); 15 U.S.C. 1262(i)(2)(A)(ii). However, the Commission does not adopt a general interpretation of ``substantial compliance'' focusing on whether the level of compliance with a voluntary standard could be improved under a mandatory standard. Rather, the grounds for the Commission's decision [[Page 71893]] focus on the specific facts of this rulemaking and are stated below. The legislative history regarding the meaning of ``substantial compliance'' indicates that the Commission should consider whether compliance is sufficient to eliminate or adequately reduce the risk of injury in a timely fashion and that, generally, compliance should be measured in terms of the number of complying products, rather than the number of manufacturers who are in compliance. E.g., Senate Report No. 97-102, p. 14 (May 15, 1981); House Report No. 97-158, p. 11 (June 19, 1981); H. Conf. Rep. No. 97-208, 97th Cong., 1st Sess. 871, reprinted in 1981 U.S. Code Cong. &amp; Admin. News 1010, 1233. Given this Congressional guidance, the Commission believes it appropriate to examine the number of conforming products as the starting point for analysis. However, the Commission does not believe that there is any single percentage of conforming products that can be used in all cases to define ``substantial compliance.'' Instead, the percentage must be viewed in the context of the hazard the product presents. Thus, the Commission must examine what constitutes substantial compliance with a voluntary standard in light of its obligation to safeguard the American consumer. There are certain factors the agency considers before it initiates regulatory action, such as the severity of the potential injury, whether there is a vulnerable population at risk, and the risk of injury. See 16 CFR 1009.8. These and other factors also appropriately inform the Commission's decision regarding whether a certain level of conformance with a voluntary standard is substantial. In the light of these factors, industry's compliance rate with the voluntary standard for bunk beds is not substantial. In this case, the Commission deals with the most severe risk-- death--to one of the most vulnerable segments of our population-- infants and young <strong>children</strong>. While the risk of death is not high, it exists whenever a young child is in a residence with a nonconforming bunk bed. Additionally, some products, such as hairdryers without shock protection devices, require some intervening action (dropping the hair dryer into water) to create the hazard. By contrast, deaths in bunk beds occur during the intended use of the product--a child rolling over in bed or climbing in or out of it--without any intervening action. The Commission must also consider that bunk beds have a very long product life, frequently being passed on to several families before being discarded. Thus, a number of <strong>children</strong> may be exposed to a bed during its useful life. Every noncomplying bed that poses an entrapment hazard presents the potential risk of death to any young child in the house. It is a risk that is hard for a parent to protect against, as <strong>children</strong> find their way onto these beds even if they are not put to sleep in them. Bunk beds are products that can be made relatively easily by very small companies, or even by a single individual. The Office of Compliance believes smaller entities will always present a compliance problem, because new manufacturers can enter the marketplace relatively easily and need little expertise to make a wooden bunk bed. The evidence seems to support the view that there will always be an irreducible number of new, smaller bunk bed manufacturers who will not follow the voluntary standard. What constitutes substantial compliance is also a function of what point in time the issue is examined. In 1989, the Commission denied a petition for a mandatory bunk bed rule. At that time, industry was predicting that by April of 1989, 90% of all beds being manufactured would comply with the voluntary guidelines. But that was in the context of years of steadily increasing conformance and the hope that conformance would continue to grow and that deaths and near-misses would begin to decline. But the conformance level never grew beyond the projection for 1989 and deaths and near-misses have not dropped. Even with the existing compliance rate, the Commission is contemplating the prospect of perhaps 50,000 nonconforming beds a year (or more) entering the marketplace, with many beds remaining in use for perhaps 20 years or longer. Under these circumstances, a 10% rate of noncompliance is too high. It is now clear that the bunk bed voluntary standard has not achieved an adequate reduction of the unreasonable risk of death to infants and <strong>children</strong> in a timely fashion, and it is unlikely to do so. Accordingly, the Commission finds that substantial compliance with the voluntary standard for bunk beds is unlikely. Products that present some or all of the following factors might not be held to as strict a substantial compliance analysis. Those which: --Rarely or never cause death; --Cause only less severe injuries; --Do not cause deaths or injuries principally to a vulnerable segment of the population; --Are not intended for <strong>children</strong> and which have no special attraction for <strong>children</strong>; --Have a relatively short life span; --Are made by a few stable manufacturers or which can only be made by specialized manufacturers needing a significant manufacturing investment to produce the product; --Are covered by a voluntary standard which continues to capture an increasing amount of noncomplying products; or --Require some additional intervening action to be hazardous. And, in analyzing some other product, there could be other factors that would have to be taken into consideration in determining what level of compliance is adequate to protect the public. The tolerance for nonconformance levels has to bear some relationship to the magnitude and manageability of the hazard addressed. The Commission emphasizes that its decision is not based on the argument that a mandatory rule provides more powerful enforcement tools. If this were sufficient rationale, mandatory rules could always displace voluntary standards, and this clearly was not Congress's intent. But, with a mandatory standard, the necessity of complying with a mandatory federal regulation will be understandable to small manufacturers. State and local governments will have no doubt about their ability to help us in our efforts to locate these manufacturers. G. Response to Comments The Commission received 21 written comments in response to the NPR published in the Federal Register on March 3, 1999. In addition, six people gave oral testimony in a public hearing held on May 6, 1999. Also, five comments were received in response to the revised entrapment requirements published in the July 9, 1999, Federal Register. The Commission's responses to these comments are given below: 1. Comments on the March 3, 1999, NPR a. Favoring a mandatory rule: Seven commenters responding in writing to the March 3, 1999, NPR, and three persons at the May 6, 1999, public hearing, favored a mandatory rule addressing entrapment in bunk beds. Their reasons were varied and included: &lt;bullet&gt; Reports of deaths show there is an unreasonable risk; &lt;bullet&gt; A mandatory standard will improve compliance; &lt;bullet&gt; The benefits show a reasonable relationship to costs; [[Page 71894]] &lt;bullet&gt; A mandatory rule permits the Commission to seek penalties from violators; &lt;bullet&gt; There is increased awareness of mandatory standards; and &lt;bullet&gt; A mandatory standard removes the cost advantage of producing nonconforming beds. b. Reference the ASTM standard: Two comments on the NPR neither opposed nor favored a mandatory rule. The President of ASTM and the chairman of the ASTM F15.30 subcommittee for bunk beds requested that, if the Commission elects to proceed with a mandatory standard, it should reference the ASTM F1427 voluntary standard. At the present time, there are some significant differences in the entrapment requirements in the ASTM standard and those in the mandatory rule. Although the ASTM subcommittee for bunk beds has agreed to make certain revisions to the voluntary standard, these revisions would not make the entrapment requirements in the ASTM standard identical to those in the rule (see additional discussion below in the response to comments on the July 9, 1999 NPR). Further, the Commission does not know that these revisions will be approved by the formal ASTM ballot process. Therefore, the mandatory rule does not reference the ASTM standard, but instead contains specific requirements addressing entrapment. c. Substantial compliance: As noted, where there is a voluntary standard in place, both the CPSA and the FHSA prohibit the Commission from issuing a mandatory standard unless the Commission finds either that the voluntary standard is not likely to eliminate or adequately reduce the risk or that it is unlikely that there will be ``substantial compliance'' with the voluntary standard. For the reasons stated in Section F of this notice, the Commission has found both that the voluntary standard will not adequately reduce the risk of injury from bunk beds and that it is unlikely that there will be substantial compliance with the voluntary standard. Therefore, the voluntary standard is not a bar to issuance of a rule. d. OMB Circular No. A-119: One commenter noted that OMB Circular No. A-119 directs agencies to use voluntary standards in lieu of government-unique standards except where they are inconsistent with law or otherwise impractical. However, Circular No. A-119 states that it should not ``be construed to commit any agency to the use of a voluntary standard which * * * is, in its opinion, inadequate * * * or is otherwise inappropriate.'' The Commission determines that, in this case, reliance on the voluntary standard is ``inappropriate'' for the reasons stated in Section H of this notice. Thus, Circular No. A-119 does not prevent issuance of a final rule. e. Entrapment incidents: A bunk bed manufacturer claimed that the extra cost and major design changes required to comply with the proposed rule's provisions for a continuous guardrail do not reduce or eliminate the potential hazards. The manufacturer also claimed that there were no incidents of entrapment between a bunk bed and a wall prior to the inception of the 1996 ASTM standard. However, CPSC is aware of 9 fatalities resulting from entrapment between a top bunk and a wall from 1990 through August 9, 1999. Two of these fatalities occurred in beds conforming to the ASTM standard's requirement for a wall-side guardrail that permits gaps up to 15 inches in width between each end of the guardrail and the bed's end structures. One of these deaths occurred in 1994 and the other in 1996. In both, the victims slipped through the unprotected area between the end of the guardrail and bed end structure. The requirement in the rule for a continuous wall-side guardrail will prevent future incidents of this type. f. Hazards in other types of beds: It was noted by one commenter that other types of beds, such as small single beds and trundle beds, could have the same entrapment hazards as bunk beds if they are used by preschool age <strong>children</strong>. The commenter, therefore, suggested that any bed intended for preschool age <strong>children</strong>, and adult beds (since it is predictable that young <strong>children</strong> will be placed in these beds), should be subject to a mandatory standard. The Commission did not extend the scope of the standard to cover beds other than bunk beds, because this would involve different considerations of risk, cost, and benefits, and is outside the scope of the present proceeding. This commenter also recommended that both adult and <strong>children</strong>'s bunk beds should be covered by a single standard, and that the standard should be issued under the CPSA. As explained in the proposal and in Section E of this notice, the CPSA provides that a risk that can be adequately regulated under the FHSA can be regulated under the CPSA only if the Commission determines, by rule, that regulating the risk under the CPSA is in the public interest. Bunk beds intended for use by <strong>children</strong>, but not other bunk beds, could adequately be regulated under the FHSA, and the Commission did not find reasons why it would be in the public interest to regulate the risk from <strong>children</strong>'s bunk beds under the CPSA. Accordingly, the Commission proposed to regulate bunk beds intended for use by <strong>children</strong> under the FHSA and to regulate other (adult) bunk beds under the CPSA. Although this does not comply with the commenter's recommendation that both categories of bunk beds be regulated under the CPSA, it does comply with the recommendation that the standard's requirements apply to both adults' and <strong>children</strong>'s beds. g. Bunk beds for institutional use: Two comments addressed the issue of whether the rule should apply to bunk beds sold for institutional use, such as school or college dormitories, prisons, and military facilities. One comment, from a trade association representing a number of major producers of bunk beds, states that to include institutional beds in the scope of the rule would be a departure from past CPSC practice. The association asserts that the regulation of public accommodations has traditionally been accomplished through state and municipal building codes. The other comment, from a manufacturer of college dormitory furniture, strongly objects to a regulation that is unsupported by any data to show that there is a high risk for adults or college students. Institutional bunk beds are generally not provided with guardrails, and the manufacturer claims that to add such rails, and comply with other provisions in the proposed rule, would add $225 to the cost of each of his beds and be of no benefit to an adult user. Although the Commission cannot confirm the commenter's cost estimate, it agrees that the cost of compliance with the rule would be substantially higher for institutional bunk beds than for residential beds, in part because institutional beds typically do not have any guardrails (since they are intended for teenagers or adults). Furthermore, of the two known fatalities of <strong>children</strong> that occurred in beds that were originally sold for institutional use, one was an entrapment between the lower bunk mattress and a wall, a scenario not addressed by the rule. The other incident was an entrapment in a gap between the end structure and a mattress that was too short to fit properly on the lower bunk. This incident would be addressed by a label and the instructions for proper mattress size if institutional beds were included in the scope of the rule. According to information supplied by industry, there are about 200,000 bunk beds sold for the institutional market each year for use by colleges and [[Page 71895]] boarding schools, the military, mental health facilities, and correctional facilities. The expected useful life of these institutional products is estimated by industry at 7 to 10 years. Therefore, there may be about 1.7 million institutional beds in use. Manufacturers projected that the cost of compliance for institutional bunk beds would be considerably higher than that of residential bunk beds, due to the addition of two guard rails (rather than one for residential) and the heavier-duty materials used in institutional bunk beds. For comparison purposes, if the only significant cost was the addition of two guardrails (equivalent to rails used in residential beds), the cost of compliance for institutional bunk beds would be twice that of residential units, or $30 to $80 per bed. Given that one death would have been addressed during the last 9.5 years, and that an average of about 1.7 million institutional bunk beds may have been in use during those years, the risk addressed by inclusion of institutional beds in the mandatory standard would be about 0.06 deaths per million beds in use per year ((1 death/9.5 years)/1.7 million beds). Assuming a societal cost of $5 million per death, the annual societal value of averting this risk is about $0.30 per bed per year. If we assume a useful life of 10 years, and a discount rate of 3%, the estimated present value of averting this risk would be about $2.55 per bed over its entire useful life. Thus, based on available information, the benefits of the rule, if applied to institutional bunk beds, would likely be substantially less than the costs. Because of this, and because the likelihood that consumers will purchase institutional beds in the future is not known, the Commission decided not to include institutional bunk beds within the scope of the rule. For the purposes of this rule, facilities intended for use by <strong>children</strong> under age 6 are not considered to be institutions. h. Effective date: The Commission proposed an effective date of 180 days (6 months) after the final rule is published. A trade association representing a number of major bunk bed producers commented that there should be an 18-month lead time before the rule becomes effective; the association reiterated this in its comments on the July 9, 1999, NPR. A time line showing the tasks needed to comply with the proposed rule was included in the association's comments. The trade association stated that between 5 and 10 months of time were needed to allow manufacturers, distributors, and retailers to sell their inventories. An allowance of lead time to deplete inventory is not necessary, because the rule will apply only to bunk beds manufactured or imported after the rule's effective date. Deletion of the time allotted for inventory depletion from the trade association's time line would result in an effective date of 8 to 13 months after publication. The CPSA provides that an effective date shall not exceed 180 days unless the Commission finds that a longer period is in the public interest. Although the schedule provided by the association might be reasonable for a high-volume manufacturer with numerous models affected by the rule, the Commission considers the schedule to be unnecessarily long for the minor changes imposed by the rule on the small manufacturers likely to be affected. Thus, the Commission cannot conclude it is in the public interest to extend the effective date past the proposed 180-day period. The Commission concludes that the 180-day period between publication of the final rule and its effective date is reasonable and adequate to allow manufacturers time to make any necessary product changes. 2. Comments on the July 9, 1999, NPR a. Support for the rule: One commenter, who had previously submitted a comment supporting the rule in the March 3, 1999, NPR, also supports the revised rule on the grounds that ``these requirements are necessary to address fatalities due to entrapment of <strong>children</strong>'s necks in end structures of bunk beds.'' The commenter also believes ``that the Commission should not defer to the ASTM voluntary standard because of widespread lack of compliance and because the current voluntary standard is inadequate.'' As previously stated, the Commission is not relying on the voluntary standard. b. Neck entrapment probe: Two comments from bunk bed manufacturers that are members of the ASTM F15.30 subcommittee addressed the angle incorporated into the probe in the revised proposed rule. One of the comments, submitted on behalf of the entire subcommittee, stated that the lower bunk end-structure requirements in the ASTM standard would be revised in accordance with the requirements in the proposed rule (Secs. 1213.3(b)(3) &amp; (4), 1213.4, 1513.3(b)(3) &amp; (4), and 1513.4)), except that the sides of the probe (see Figure 2) would have a 55 deg. angle relative to the centerline of the probe instead of the 75 deg. angle of the probe in the revised proposed rule. The comment from the other manufacturer, a member of the ASTM bunk bed subcommittee, also addressed the angle on the end-structure probe and stated that, while he could accept a probe with either angle, it was his opinion that the 55 deg. angle should be adopted. Both of these comments supported a 55 deg. angle based on its apparent success in preventing neck entrapment incidents in playground equipment. Another comment, from a trade association representing major manufacturers of bunk beds, reiterated the association's comment on the March 3, 1999 NPR that it was not opposed to a mandatory rule for bunk beds, and supported a provision to address neck entrapment in lower bunk end structures. It also takes no position on the appropriate probe for this purpose, but recommends ``a probe which eliminates or adequately reduces the risk of neck entrapment.'' In drafting the neck entrapment requirements, the CPSC staff initially considered using a probe identical to that in the ASTM F1487 standard for public playground equipment (with a 55 deg. angle). The rationale for the 55 deg. angle stems from a recommendation by a committee, convened in 1976 by the National Recreation and Park Association (NRPA), that developed requirements for a possible CPSC mandatory standard for playground equipment. The angle requirement was ``intended to eliminate dangerous angles that could form openings tending to entrap or strangle the user.'' The rationale for the committee's recommendation stated: ``[I]t is best engineering judgement at this point, and takes into consideration the fact that most angles present in current equipment are 60 deg. or greater.'' Based on this NRPA committee recommendation, the CPSC Handbook for Public Playground Safety, first published in 1981, also addresses neck entrapment in angles on public playground equipment by recommending that angles be greater than 55 deg.. The Commission decided that the angle on the neck entrapment probe in the bunk bed standard should be 75 deg., instead of 55 deg., for a number of reasons. First, in 1985, following a number of deaths resulting from neck entrapment in accordion-style baby gates and enclosures, the staff worked with industry to draft requirements for a voluntary standard for these products. The staff developed a probe that had an angle of 75 deg. at its base, because an 11-month-old child had become fatally entrapped in a diamond-shaped opening in a baby gate having a 71 deg. angle at its base. The probe was designed to protect <strong>children</strong> two years of age and younger. It was accepted by the ASTM gate and [[Page 71896]] enclosure subcommittee and eliminated V-shaped openings with angles less than 75 deg.. Second, the lack of injury data involving public playground equipment having angles greater than 55 deg. does not convince the Commission that a 55 deg. probe would adequately protect <strong>children</strong>. The potential for <strong>children</strong> to become entrapped in an angle between 55 deg. and 75 deg. depends on the type of equipment. The pieces of public playground equipment most likely to have angles between 55 and 75 deg. that could cause neck entrapment are dome climbers and handrails on ladders. Public playground equipment is generally intended for <strong>children</strong> from 2 through 12 years of age. Dome climbers are not appropriate for <strong>children</strong> under 5 years of age. <strong>Children</strong> 5 years of age and older who use dome climbers are more likely to be able to call out for assistance or pull themselves up and out if they become entrapped. As for ladder handrails, the angles that potentially could be an entrapment hazard are generally located at the bottom of the ladder below the neck level of even small <strong>children</strong>. Finally, <strong>children</strong> under 2 years of age are almost always supervised when playing in public playgrounds, and adult assistance would be readily available if needed. This is not the case with bunk beds, where <strong>children</strong> are left to sleep unattended. For the above reasons, the Commission concludes that a 75 deg. angle on the neck entrapment probe is necessary to adequately address the risk of entrapment in bunk bed end structures to protect <strong>children</strong> under 2 years of age. H. The Need for a Mandatory Standard As noted in Section F of this notice, a mandatory standard is needed to provide requirements that are not now in the voluntary standard. In deciding to issue this rule, the Commission also considered carefully the particular characteristics of the bunk bed industry. This industry is highly diverse and fragmented, with differing levels of sophistication relating to product safety. Firms can easily enter and leave the bunk bed manufacturing business. This fragmentation and diversity contributes to difficulties in achieving more complete compliance with the voluntary standard. Because it is difficult to identify all firms in the industry, it is difficult for voluntary standards organizations and trade associations to conduct outreach and education efforts regarding the voluntary standard. By contrast, in industries with a smaller number of firms (and particularly large firms), it is easier to find the firms and educate them about the existence and importance of voluntary standards. Mandatory standards--codified in the accessible Code of Federal Regulations--are easier to locate, and their significance is more obvious. These generalizations about the industry are supported by the staff's enforcement experience. The CPSC's Office of Compliance (EXC) is aware of 167 firms who currently either manufacture or import bunk beds. Between November 1994 and October 1997, CPSC staff participated in eight recalls of bunk beds that did not comply with the voluntary standard. The recalls involved 41 manufacturers and importers, and affected approximately 531,000 bunk beds. In early 1998, CPSC Compliance staff conducted limited retail surveillance of bunk beds for compliance with the voluntary standard. Twenty-three firms had at least one model of bunk bed that did not conform, and six of these firms were repeat violators. This surveillance resulted in five recalls, involving approximately 37,000 beds. Later in 1998, a consumer complaint and a report under Section 15 of the CPSA sparked investigations that resulted in recalls of 58,000 bunk beds and 5,400 bunk bed kits. To date, the total number of bunk beds and kits recalled since 1994 has risen to more than 630,000, involving 48 firms. Since 1994, at the completion of each round of surveillance and follow-up action, CPSC staff believed that the known bunk bed manufacturers complied with the voluntary standard. This is the case today. Yet, each time, the staff later discovered more manufacturers, and some of their beds had to be recalled because they presented a risk of entrapment. The Commission believes that, in the absence of a mandatory rule, this pattern would continue. Some manufacturers contacted by Compliance did not see an urgency to comply with a ``voluntary'' standard, and they did not recognize the hazards associated with noncompliance. Other manufacturers were not even aware of the standard. As a result, in the absence of a mandatory standard, entrapment hazards would continu