Appendix to Part 1513 - Findings Under the Federal Hazardous Substances Act
16:2.0.1.3.104.0.2.7.54 :
Appendix to Part 1513 - Findings Under the Federal Hazardous
Substances Act
The Federal Hazardous Substances Act (FHSA) requires that the
Commission, in order to issue part 1513, make the following
findings and include them in the rule. 15 U.S.C. 1261(s), 1262(i).
Because of this, the facts and determinations in these findings
apply as of the date the rule was issued, December 22, 1999.
A. Bunk beds present a mechanical hazard. Section 2(s) of
the FHSA states that an “article may be determined to present a
mechanical hazard if, in normal use or when subjected to reasonably
foreseeable damage or abuse, its design or manufacture presents an
unreasonable risk of personal injury or illness * * * (3 from * * *
surfaces, edges, openings, or closures * * * , or (9) because of
any other aspect of the articles design or manufacture.” 15 U.S.C.
1261(s).
2. For a recent 9.6-year period, the CPSC received reports of 57
deaths of children under age 15 who died when they were trapped
between the upper bunk of a bunk bed and the wall or when they were
trapped in openings in the bed's structure. Over 96% of those who
died in entrapment incidents were age 3 or younger. On average,
averting these deaths is expected to produce a benefit to society
with a present value of about $175 to $350 for each bed that
otherwise would not have complied with one or more of the rule's
requirements.
3. This increased safety will be achieved in three main ways.
First, all bunk beds will be required to have a guardrail on both
sides of the bed. If the bed is placed against a wall, the
guardrail on that side is expected to prevent a child from being
entrapped between the bed and the wall. The guardrail on the wall
side of the bed must extend continuously from one end to the other.
Second, the end structures of the bed must be constructed so that,
if an opening in the end structure is large enough so a child can
slip his or her body through it, it must be large enough that the
child's head also can pass through. Third, this area must also be
constructed so that a child cannot insert his or her head into an
opening and move to another part of the opening where the head
cannot be pulled out and the neck can become entrapped.
4. For the reasons discussed in paragraph C of this appendix,
the benefits of the changes to bunk beds caused by this rule will
have a reasonable relationship to the changes' costs. The rule
addresses a risk of death, and applies primarily to a vulnerable
population, children under age 3. The life-saving features required
by the rule are cost-effective and can be implemented without
adversely affecting the performance and availability of the
product. The effective date provides enough time so that production
of bunk beds that do not already comply with the standard can
easily be changed so that the beds comply. Accordingly, the
Commission finds that there is an unreasonable risk of entrapment
injury associated with bunk beds that do not comply with part
1513.
B. Where a voluntary standard has been adopted and
implemented by the affected industry, that compliance with such
voluntary standard is not likely to result in the elimination or
adequate reduction of the risk of injury, or it is unlikely that
there will be substantial compliance with such voluntary
standard.
1. Adequacy of the voluntary standard. In this instance,
there is a voluntary standard addressing the risk of entrapment in
bunk beds. However, the rule goes beyond the provisions of the
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, it requires more of the lower bunk end
structures to have entrapment protection. 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. Both of
these provisions, which are in the rule but not in the voluntary
standard, address fatalities and, as noted in this paragraph
(a)(18), have benefits that bear a reasonable relationship to their
costs.
Therefore, the Commission finds that compliance with the
voluntary standard is not likely to result in the elimination or
adequate reduction of the risk of entrapment injury or death.
2. Substantial compliance. i. The FHSA does not 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
FR 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.
ii. 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 focus on the
specific facts of this rulemaking and are stated below.
iii. 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. & Admin. News 1010, 1233.
iv. 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.
v. 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.
vi. 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 children. While the risk of death is not high,
it exists whenever a young child is in a residence with a
nonconforming bunk bed.
vii. 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.
viii. 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 children 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 children find their way onto
these beds even if they are not put to sleep in them.
ix. 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.
x. 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.
xi. 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.
xii. 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 children 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.
xiii. 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 children and which have
no special attraction for children; - 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.
xiv. 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.
xv. 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.
C. The benefits expected from the rule bear a reasonable
relationship to its costs.
1. Bunk beds that do not comply with ASTM's requirements for
guardrails. The cost of providing a second guardrail for bunk
beds that do not have one is expected to be from $15-40 per
otherwise noncomplying bed. If, as expected, the standard prevents
virtually all of the deaths it addresses, the present value of the
benefits of this modification are estimated to be from $175-350 per
otherwise noncomplying bed. Thus, the benefit of this provision is
about 4-23 times its cost.
2. Bunk beds that comply with ASTM's requirements for
guardrails. The voluntary standard allows up to a 15-inch gap
in the coverage of the guardrail on the wall side of the upper
bunk. Additional entrapment deaths are addressed by requiring that
the wall-side guardrail be continuous from one end of the bed to
the other. The estimated present value of the benefits of this
requirement will be $2.40 to $3.50 per otherwise noncomplying bed.
The Commission estimates that the materials cost to extend one
guardrail an additional 30 inches (760 mm) will be less than the
present value of the benefits of making the change. Further, the
costs of any design changes can be amortized over the number of
bunk beds produced after the design change is made. Thus, any
design costs are nominal.
3. Lower bunk end structures. The Commission is aware of
a death, involving entrapment in the end structures of the lower
bunk, occurring in a scenario not currently addressed by the
voluntary standard. This death is addressed by extending the upper
limit of the voluntary standard's lower bunk end structures
entrapment provisions from 9 inches above the lower bunk's sleeping
surface to the bottom of the upper bunk and by also including a
test for neck entrapment in this area. The Commission expects the
costs of this requirement to be design-related only, and small.
Indeed, for some bunk beds, material costs may decrease since less
material may be required to comply with these requirements than are
currently being used. Again, the design costs for these
modifications to the end structures can be amortized over the
subsequent production run of the bed.
4. Effect on market. The small additional costs from any
wall-side guardrail and end-structure modifications are not
expected to affect the market for bunk beds, either alone or added
to the costs of compliance to ASTM's provisions.
5. Conclusion. The Commission has no reason to conclude
that any of the standard's requirements have costs that exceed the
requirement's expected benefits. Further, the total effect of the
rule is that the benefits of the rule will exceed its costs by
about 4-23 times. Accordingly, the Commission concludes that the
benefits expected from the rule will bear a reasonable relationship
to its costs.
D. The rule imposes the least burdensome requirement that
prevents or adequately reduces the risk of injury for which the
rule is being promulgated. 1. The Commission considered relying
on the voluntary standard, either alone or combined with a
third-party certification program. However, the Commission
concludes that a mandatory program will be more effective in
reducing these deaths, each of which is caused by an unreasonable
risk of entrapment. Accordingly, these alternatives would not
prevent or adequately reduce the risk of injury for which the rule
is being promulgated.
2. The Commission also considered a suggestion that bunk beds
that conformed to the voluntary standard be so labeled. Consumers
could then compare conforming and nonconforming beds at the point
of purchase and make their purchase decisions with this safety
information in mind. This, however, would not necessarily reduce
injuries, because consumers likely would not know there is a
voluntary standard and thus would not see any risk in purchasing a
bed that was not labeled as conforming to the standard.
