[Federal Register Volume 66, Number 45 (Wednesday, March 7, 2001)]
[Rules and Regulations]
[Pages 13645-13652]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-5478]
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1500
Dive Sticks; Final Rule
AGENCY: Consumer Product Safety Commission.
ACTION: Final rule.
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SUMMARY: The Commission is issuing a rule to ban certain dive sticks
under the authority of the Federal Hazardous Substances Act.\1\ Dive
sticks are used for underwater activities, such as retrieval games and
swimming instruction. They are typically made of rigid plastic and
stand upright at the bottom of a swimming pool. Due to these
characteristics, if a child jumps onto a dive stick in shallow water he
or she may suffer severe injuries.
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\1\ Commissioner Mary Gall filed a separate statement which is
available from the Office of the Secretary, Room 502, 4330 East-West
Highway, Bethesda, Maryland.
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DATES: The rule will become effective on April 6, 2001.
FOR FURTHER INFORMATION CONTACT: Renae Rauchschwalbe, Office of
Compliance, Consumer Product Safety Commission, Washington, DC 20207;
telephone (301) 504-0608, ext. 1362.
SUPPLEMENTARY INFORMATION:
A. Background
As of November 2000, the Commission is aware of nine confirmed
impalement incidents involving dive sticks that were submerged and
standing vertically. These incidents resulted in injuries to the
perineal region of young children. The products were cylindrical
batons, approximately 7\7/8\ to 8\5/8\ inches long and \7/8\ to one
inch in diameter. They were all constructed of rigid plastic.
In early 1999, when the Commission staff first learned of incidents
involving dive sticks, the staff worked with product manufacturers to
recall hazardous dive sticks. On June 24, 1999, the Commission
announced that it had reached agreements with 15 manufacturers and
importers to voluntarily recall their dive sticks. The recalls have
removed most dive sticks from the market.[1,9] \2\ However, because the
hazard posed by dive sticks appeared to be inherent to the product and
not related to any specific model or manufacturer, the Commission began
a proceeding to ban all dive sticks with hazardous characteristics.
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\2\ Numbers in brackets refer to documents listed at the end of
this notice.
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On July 16, 1999, the Commission issued an advance notice of
proposed rulemaking (``ANPR'') announcing the Commission's intent to
issue a rule addressing the risk of injury presented by dive sticks. 64
FR 38387 (1999). One alternative discussed in the ANPR was a rule
declaring certain dive sticks to be banned hazardous substances.
On July 19, 2000, the Commission published a notice of proposed
rulemaking (``NPR'') proposing to ban hazardous dive sticks. 65 FR
44703 (2000). The proposed rule stated that it would ban dive sticks
that (1) are rigid; (2) submerge to the bottom of a pool of water; and
(3) stand upright in water. The Commission proposed a performance test
to determine the rigidity of a dive stick. Dive sticks that come to
rest underwater at an angle greater than 45 degrees from vertical would
be exempt under the proposed rule as would dive sticks that maintain a
compressive force of less than 5-lbf under a prescribed performance
test. The Commission has determined to
[[Page 13646]]
issue the proposed rule as a final standard without change.
The Commission received one comment on the proposed rule. That
comment came from a student at Florida International University. He
asked whether it would be safer to discontinue the sale of all dive
sticks, both soft and rigid. Based on available medical literature, the
Commission concludes that only rigid dive sticks pose the threat of
impalement injuries to children. The Commission is not aware of any
impalement incidents, reported to CPSC or in the medical literature,
involving any flexible objects. Thus, the Commission believes that the
rule, including the exemption for non-rigid dive sticks, will
adequately protect the public.[11]
B. Statutory Authority
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).
Section 3(f) through 3(i) of the FHSA, 15 U.S.C. 1262(f)-(i),
governs a proceeding to promulgate a regulation determining that a toy
or other children's article presents an electrical, mechanical, or
thermal hazard. As required by section 3(f), this proceeding began with
an ANPR. 64 FR 38387 (1999). After considering the one comment
submitted in response to the ANPR, the Commission issued a proposed
rule and a preliminary regulatory analysis in accordance with section
3(h) of the FHSA. 65 FR 44703 (2000). The Commission then considered
the comment received in response to the proposed rule and determined to
issue a final rule and a final regulatory analysis. 15 U.S.C.
1262(i)(1).
Before the Commission can issue a final rule it must find (1) if an
applicable voluntary standard has been adopted and implemented, that
compliance with the voluntary standard is not likely to adequately
reduce the risk of injury, or compliance with the voluntary standard is
not likely to be substantial; (2) that benefits expected from the
regulation bear a reasonable relationship to its costs; and (3) that
the regulation imposes the least burdensome alternative that would
adequately reduce the risk of injury. Id. 1261(i)(2).
C. The Product
Dive sticks are generally used in swimming pools for underwater
retrieval activities, such as retrieval games and swimming instruction.
They are made of rigid plastic. They are typically cylindrical in
shape, ten inches or less in length with a diameter one inch or less,
but some have novelty shapes such as shark silhouettes. They are or can
be weighted so that when dropped into water they sink and stand upright
on the bottom.
Before the June 1999 recall, retail prices usually ranged from $4
to $7 per set or about $1 per individual stick. Retail prices were
almost always less than $10, even when sold with other products such as
disks, rings, and snorkels. An estimated 4 to 5 million dive sticks
were sold in both 1997 and 1998. Altogether, about 20 million dive
sticks have been sold since 1990. Sales of dive sticks increased
substantially during the 1990's. About 1 million households may have
owned dive sticks during any given year.[8,12]
Before the June 1999 recalls, the CPSC staff identified at least 15
firms that manufactured or imported dive sticks into the United States.
Most of the importers obtained their products from China, Hong Kong, or
Taiwan. Because the product is inexpensive and simple to manufacture,
it is relatively easy for firms to enter or leave the dive stick
market. Therefore, firms that have not supplied dive sticks in the
past, and were not part of the June 1999 recalls, could begin or renew
producing or supplying dive sticks.[8,12]
D. The Risk of Injury
1. Description of Injury. Impalement injuries have occurred when a
child accidently sat, fell or jumped buttocks-first into shallow water
and landed on a dive stick. As discussed in the NPR, serious rectal or
vaginal injuries can result. The severity of injuries depends on the
degree of penetration by the object. The injuries could range from
laceration of the rectum and sphincter, to puncture wounds and tears of
the colon. Less serious injuries such as facial and eye injuries are
also possible when a child attempts to retrieve a dive stick under the
water.[2,10]
2. Impalement Injury Data. As of November 2000, the Commission is
aware of nine confirmed impalement injuries involving submerged
vertically-standing dive sticks. All the victims were children ranging
in age from three to nine years old.[10]
Four females (ages 7 to 9) sustained injuries when the dive stick
penetrated the vagina. Two males (ages 3 and 7) and two females (ages 5
and 6) suffered injuries when the dive stick penetrated the rectum. In
the remaining incident, a female received external lacerations around
the rectum after landing on a dive stick. Medical attention was sought
after each incident, and six of the injuries required surgery to
address multiple internal and external injuries.These nine incidents
involved vertical-standing dive sticks. The products were cylindrical
batons, approximately 7\7/8\ to 8\5/8\ inches long and \7/8\ to one
inch in diameter.[2,10]
Eight of the impalement injuries occurred in shallow depths of
water. Of these, five occurred in small wading pools with water levels
between 12 and 24 inches. Of the remaining three incidents, one
occurred on the top step of a spa, one occurred in a pool measuring
three feet in height with approximately 27 inches of water, and the
final incident occurred in a bathtub with approximately 6 inches of
water. The ninth incident reportedly took place in a pool; however,
neither the type of pool nor the water depth is known.[2,10] \3\
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\3\ A tenth unconfirmed incident was reported to CPSC, but many
details of the incident remain unclear.
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The July 1999 ANPR provided summaries of impalement incidents
reported at that time. The NPR published in July 2000 provided
summaries of the three impalement injuries reported between publication
of the ANPR and the NPR. One additional incident was not included in
either the ANPR or the NPR. That incident involved a three-year-old boy
who jumped or slid into a shallow pool and landed on an upright dive
stick which penetrated his rectum. He suffered a 1\1/2\ inch puncture
wound and tear in his bowels. Doctors performed a temporary colostomy
and will have to reattach his intestines to his bowels once the
puncture wound heals. The dive stick came in a package with a retrofit
so that
[[Page 13647]]
the dive stick would not stand upright in the water. This retrofit was
not attached to the product at the time of the incident.[10]
3. Non-Impalement Injury Data. In addition to genital and rectal
injuries, the Commission received reports of four injuries to other
body parts that occurred when the victim submerged onto the vertical-
standing dive stick. As discussed in the NPR, the injuries occurred
when the children attempted to retrieve the dive sticks from the bottom
of the pool. The Commission has also received reports of 11 incidents
of victims struck by a thrown dive stick. Five of these incidents were
reported since the June 2000 briefing package. Seven females and four
males were involved in the incidents. The victims ranged in age from 4
years old to 40 years old. One of the recent incidents involved a foam
dive stick as opposed to the recalled dive sticks made of hard plastic.
The foam dive stick was made of a foam cylinder with a weighted plastic
end. The plastic end of the dive stick is the part that contacted the
victim, resulting in a laceration to the scalp.[2,10]
E. The Ban
The Commission's rule will ban dive sticks with certain hazardous
characteristics. Although voluntary recalls have removed most, if not
all, of these products from the market for the present time, the
Commission is concerned that, without a rule banning them, they could
reappear on the market.
The rule will ban dive sticks that (1) are rigid, (2) submerge to
the bottom of a pool of water, and (3) stand upright in water. After
considering the reported impalement injuries, the Commission believes
that these are the essential characteristics that create the impalement
hazard. Dive sticks and similar articles that do not have these
characteristics, as well as dive rings and dive disks, are still
allowed.
All dive stick impalement incidents and other rectal or vaginal
impalement cases reported in the medical literature involved objects
that were rigid. The staff is not aware of any impalement injuries to
the perineum that involved a flexible object. In order to prevent
serious injuries, the dive stick should be of sufficient flexibility
that it would bend to a degree that prevents penetration when impact
occurs with the perineal area. The staff developed a test to
distinguish dive sticks that are sufficiently flexible so as to
effectively limit the potential for serious impalement injury.
The Commission believes that it is appropriate to base a rigidity
test on a fraction of the weight of a child who is first beginning to
walk. Although the youngest child involved in a reported impalement
incident was three years old, if a child can walk independently it is
possible that he or she might be playing in a shallow body of water and
fall onto a dive stick in the same manner that occurred in the
impalement incidents. Children begin to walk on their own at about
11\1/2\ months. Therefore, the test uses the weight of a 10 to 12
month-old child. The weight of a 5th percentile 10 to 12 month-old
child is 16.5 pounds (7.5 kg). The Commission believes that a failure
criterion of 5-lbf (approximately \1/3\ of the weight of a 10 to 12
month-old child) will provide a margin of safety to effectively limit
the potential for a serious impalement injury.
The performance test applies a gradual compression load to the top
of the dive stick for a period of 40 seconds. If the force reaches 5
lbf the dive stick is too rigid and fails the test. The Commission is
aware that some manufacturers are developing dive sticks that are
constructed of flexible material that would pass this test. The
Commission believes that such flexible articles would not pose an
impalement hazard.[5,7]
Commission staff tested samples of both rigid and flexible dive
sticks. The flexible dive sticks began deflecting almost immediately.
The maximum force remained under 5 lbf, which was achieved in under 10
seconds. When the compression load was applied for a total of 40
seconds, the dive stick bent significantly and the force readings
dropped further from the recorded maximum force. In contrast to the
flexible dive sticks, maximum force readings for rigid dive sticks
exceeded 25-lbf in less than 3 seconds, with no noticeable bending.[7]
All confirmed impalement injuries occurred with dive sticks that
had submerged to the bottom of a pool of water. It is unlikely that a
child falling onto a dive stick floating on the water would suffer
impalement. A floating dive stick is likely to move away before the
child's body strikes the bottom of the pool.[3,6]
The vertical orientation of a submerged dive stick is a key factor
in these impalement incidents. The Commission's Human Factors staff
examined the reported incidents and concluded that when force is
applied in line with the long axis of the dive sticks (as it is when a
child lands on it in a vertical position), the sticks do not move.
According to Human Factors, ``Because the stick is braced against the
floor, the impact causes a relatively rapid deceleration of the body
part which is struck, with the force of the impact concentrated on the
small area at the end of the stick.'' The Human Factors staff believes
that the potential for impalement injury declines as the angle of
impact moves away from the vertical. However, the orientation of a
child landing on a stick is variable, and impact at precisely the wrong
angle may reorient the stick perpendicular to the bottom surface. Thus,
slight deviations of the stick's position from vertical may not be
adequate to avoid impalement. If the angle of the stick is sufficiently
away from vertical, both impact in line with the axis and impact at an
angle to the axis would tend to move the stick and limit the
possibility of impalement. The Commission believes that a position at
least 45 degrees from vertical would provide a sufficient safety margin
to effectively limit the potential for impalement injuries.[3,6]
F. Alternatives
The Commission has considered other alternatives to reduce the risk
of impalement injury related to dive sticks. However, as discussed
below, the Commission does not believe that any of these would
adequately reduce the risk of injury.
1. Voluntary Recalls. Before beginning this proceeding the
Commission negotiated voluntary recalls with many companies that
manufactured or imported dive sticks, and many other firms voluntarily
removed their dive sticks from the market. One alternative to the
banning rule is for the Commission to continue pursuing recalls on a
case-by-case basis. However, it appears that the impalement hazard is
present in all dive sticks that have the hazardous characteristics the
staff has identified. The hazard is not limited to one particular model
or brand. Therefore, a rule banning all dive sticks with the identified
characteristics is more efficient. While the recalls have removed
hazardous dive sticks from the market for now, proceeding with future
recalls in the absence of a banning rule would allow hazardous dive
sticks to return to the market until the Commission had a chance to act
on the new dive sticks.[8,12]
2. Voluntary Standard. Currently, there is no applicable voluntary
standard, nor was one submitted in response to the ANPR or the NPR.
Moreover, because dive sticks are relatively inexpensive and easy to
manufacture, compliance with a voluntary standard may be low.[8,12]
[[Page 13648]]
3. Labeling. One alternative to a banning rule would be to require
cautionary labeling for dive sticks. Most dive sticks carry some
warnings regarding small parts (in reference to the end caps);
instructions to use only under the supervision of a competent swimmer,
and/or warning against diving in shallow water. In order for a label
warning of the impalement hazard to be fully effective, consumers must
notice, read, and understand it, then comply with it 100% of the time.
People are less likely to comply with a warning if the connection
between the product and the injury potential is not clear, if they
cannot imagine what the injury is, or if they do not fully understand
how to avoid the hazard. As the impalement hazard presented by dive
sticks is not apparent, the label would have to convey clearly that
severe rectal or genital injuries can result if children jump into the
water and land on the sticks. Further, a ``safe'' water depth would
have to be identified to give consumers adequate information on which
to base their purchasing decision.
A label that meets these criteria could have a significant impact
at the point of purchase, but would need to be reinforced with an on-
product warning. It would be difficult, however, to develop a label
that is highly noticeable and easy to read because of the small and
typically curved surface area of the dive stick. Moreover, a label may
not last the life of the product because it is used in water. In
contrast, the effectiveness of banning hazardous dive sticks is not in
question, because the impalement hazard would be minimized or
eliminated.[3, 8, 12]
4. Change in Scope. A final alternative considered was to modify
the scope of the rule so that it would apply only to pre-weighted dive
sticks. However, it is easy to add weight to certain unweighted dive
sticks by filling them with water, sand or similar materials so that
they too can stand vertically at the bottom of a pool. Because such
unweighted dive sticks can pose the same risk as pre-weighted ones, the
Commission is including them in the rule.
G. Final Regulatory Analysis
1. Introduction
The Commission has determined to ban dive sticks with certain
hazardous characteristics. Section 3(i) of the FHSA requires the
Commission to prepare a final regulatory analysis containing (1) a
description of the potential benefits and costs of the rule, including
any benefits or costs that cannot be quantified in monetary terms and
the identification of those likely to be affected; (2) a description of
alternatives considered by the Commission, a discussion of their costs
and benefits, and a brief explanation of why they were not chosen; and
(3) a discussion of any significant issues raised by comments on the
preliminary regulatory analysis published with the proposed rule. 15
U.S.C. 1261(i). The following discussion addresses these requirements.
2. Potential Benefits of a Rule Banning Certain Dive Sticks
When used in shallow water, rigid dive sticks that stand upright in
water can cause serious impalement injuries to the perineum. The CPSC
is aware of eight confirmed impalement injuries that occurred prior to
the 1999 recall. A ninth injury occurred in April 2000. However,
because the recall of dive sticks had an unknown impact on the number
of dive sticks in use, this analysis of the societal costs of dive
stick injuries is limited to the eight occurring from 1990 through
1999.\4\ All victims received medical attention after the injury and at
least five required surgery. In one case a temporary colostomy was
performed. The CPSC is aware of 17 non-impalement injuries associated
with dive sticks. Four of these incidents involved submerged dive
sticks and resulted in lacerations that required stitches or surgical
glue to close. Although the rule is not directly aimed at reducing
these injuries, some of these injuries may have been prevented by the
rule.
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\4\ An estimate of the number of dive sticks in use in needed to
estimate the pre-regulatory risk of injury that will be addressed by
the regulation.
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The reduction in the societal costs of injuries represents the
societal benefits of a ban on certain dive sticks. Based on estimates
from the CPSC's Injury Cost Model, the costs of impalement injuries,
such as those from dive sticks, may range from about $9,000 for
injuries that do not require hospitalization to about $100,000 for
injuries that require hospitalization. These estimates are based on the
costs of injuries involving punctures or lacerations to the victims'
lower trunk or pubic region for children 5 to 9 years-of-age (the age
range of the known victims). These cost estimates include the cost of
medical treatment, pain and suffering, lost work time (including that
lost by parents and caregivers), and legal and liability costs.
If we assume that the only cases that required hospitalization were
the 5 incidents that required surgery, the total societal costs of the
known incidents are about $527,000 (5 cases x $100,000 and 3 cases
x $9,000) or an average of $52,700 a year since 1990. This is a low
estimate of the total societal cost because it is based only on the
cases known to CPSC. There may have been other injuries of which CPSC
is not aware.
A useful measure for analytical purposes is the annual average
injury cost per dive stick. This estimate is derived by dividing the
average annual societal costs of injuries by the average number of dive
sticks in use each year. As discussed earlier, the average number of
dive sticks in use each year from 1990 to 1999 ranged from about 3
million units (assuming a 1 year product life) to about 5.5 million
units (assuming a 4 year product life). Therefore, the annual societal
costs of dive stick injuries may range from about one cent per dive
stick in use ($52,700 5.5 million) to 2 cents per dive stick
in use ($52,700 3 million).
Since dive sticks may last from one to four years, the societal
costs of injuries per dive stick over the entire life of the dive stick
range from about 2 cents ($0.02 x 1 year) to about 4 cents ($.01 x
4 years). Since the benefit of a ban on certain dive sticks is the
reduction in the societal cost of the injuries, the benefits of a ban
that eliminates these injuries is about 2 to 4 cents per banned dive
stick removed from or prevented from entering the market.
The average total annual cost of dive stick injuries of $52,700 is
based on known injury cases from 1990 to 1999. However, as noted
earlier, dive stick sales increased from less than 1 million per year
to about 5 million. If rigid dive sticks that stand upright in water
had not been recalled and their annual sales had leveled off at about 5
million units annually (the sales volume in the late 1990s), the
product population model indicates that the number of dive sticks in
use would have reached 8 to 20 million units within the next few years.
Since we estimated that the societal cost of injuries per dive stick in
use was about 1 to 2 cents, this indicates that the annual cost of dive
stick impalement injuries would have reached approximately $160,000
($0.02 x 8 million) to $200,000 ($0.01 x 20 million) per year had
these dive sticks not been recalled.
The benefits of eliminating dive stick injuries most directly
affect households with children, since all victims have been 9 years
old or younger. However, since medical costs are generally pooled
through insurance, and some of the benefits include a reduction in lost
worktime of caregivers, the monetary benefits of the proposed rule
would be diffused through society as a whole.
[[Page 13649]]
3. Potential Costs of the Rule
Rigid dive sticks that stand upright were removed from the U.S.
market in 1999 when the Commission recalled dive sticks. Since then,
when the CPSC has become aware of a rigid dive stick that stands
upright being available in this country, the staff has taken action
under the authority of section 15 of the FHSA to remove the dive stick
from the market. The rule being issued now promulgates a ban on these
dive sticks and establishes a performance standard for dive sticks. The
performance standard establishes criteria for distinguishing dive
sticks that are unlikely to pose impalement risks (and so are not
banned) from dive sticks that may impose impalement risks (and
therefore, are banned).
Manufacturers that produced the banned dive sticks (or that
continue to produce these dive sticks for sale in other countries) will
incur some costs to modify their products to conform to the
requirements of the rule. The CPSC staff believes that the
modifications can be made with minimal impact on tooling and other
production processes. For example, some manufacturers may be able to
continue to use the same molds that they used for rigid dive sticks,
but with a softer or more flexible plastic. Other manufacturers may be
able to use the same material as before but adjust the center of
gravity of the dive sticks so that they do not stand upright in water.
Consequently, it seems reasonably likely that when the incremental cost
of the changes are spread over large production runs, the cost will be
no more than the benefits--2 to 4 cents per dive stick manufactured.\5\
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\5\ Manufacturers that enter the dive stick market after the
rule goes into effect may not incur any additional costs associated
with ``redesigning'' dive sticks because they would design their
products from the start to comply with the rule's requirements.
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The ban on rigid dive sticks that stand upright may reduce consumer
utility if consumers prefer the banned dive sticks to the substitute
products (i.e., dive sticks that do not stand upright, flexible dive
sticks, dive rings, dive disks, and so on). However, because these
substitute products serve essentially the same purposes and would cost
about the same,\6\ the negative impact on consumer utility, if any, is
unlikely to be significant.
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\6\ Dive rings appeared to retail for approximately the same
price per package as dive sticks, but there are generally fewer dive
rings per package than dive sticks. For example, packages of dive
sticks often contained 6 dive sticks; packages of dive rings seldom
contain more than 4 rings. The retail prices of dive disks appear to
be roughly equal to the retail prices of dive sticks. Modified dive
sticks (that are either not rigid or that do not stand upright)
retail for close to the prices of the banned dive sticks.
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4. Alternatives Considered
The Commission considered several alternatives to issuing this rule
to ban certain dive sticks. These included (1) taking no action and
relying on a voluntary standard or section 15 actions, (2) a labeling
only requirement, and (3) changing the scope of the products subject to
the ban.
(a) Taking No Action and Relying on a Voluntary Standard or Section
15 Activities. The Office of Compliance has successfully negotiated
recalls with many of the firms that manufactured or imported the dive
sticks. Other firms for which recalls were not negotiated have
voluntarily ceased distributing these dive sticks. However, since it is
relatively easy for firms to enter this market, new firms could begin
selling non-complying dive sticks in the absence of a standard. CPSC is
aware of at least one firm that was not involved in the June 1999
recall but was distributing dive sticks after June 1999.
The Commission could continue to use its Section 15 authority to
recall hazardous dive sticks when they are found instead of banning
them outright. However, this approach would require the CPSC staff to
make a determination that a product was hazardous each time a new dive
stick was introduced to the market. Additionally, without a standard,
potentially hazardous products would be available to consumers while
CPSC staff were making this determination.
There is no voluntary standard for dive sticks that addresses the
impalement hazard, nor was a proposed standard submitted in response to
the NPR. Even if one were developed, it would be difficult to enforce
since dive sticks are relatively easy to manufacture and new firms
could easily begin distributing the product. Therefore, compliance with
a voluntary standard may be low.
(b) Labeling Only Requirement. The staff explored the possibility
of a warning label instead of a ban. However, according to the
Commission's Human Factors staff, a warning label is the least
effective approach to reducing the number of injuries. A label that is
highly visible and clearly communicates the hazard could have a
significant impact at the point of purchase. However, a label on the
package would not remain with the product after the sale, and because
the product is intended for use in the water, it is likely that any
label attached to the product itself would not last the life of the
product. Moreover, the surface area on a dive stick is not conducive to
designing an effective warning label.
(c) Changing the Scope. The scope of the rule could be modified so
that it applies only to pre-weighted dive sticks. However, the staff
found that consumers could weight some unweighted dive sticks so that
they stood vertically in water. These products would then present
exactly the same impalement hazard as the pre-weighted dive sticks.
5. Significant Issues Raised by Comments on Preliminary Regulatory
Analysis
The Commission did not receive any comments concerning the
preliminary regulatory analysis.
H. Regulatory Flexibility Certification
Under the Regulatory Flexibility Act (``RFA''), when an agency
issues a proposed rule it generally must prepare an initial regulatory
flexibility analysis describing the impact the proposed rule is
expected to have on small entities. 5 U.S.C. 603. The RFA does not
require a regulatory flexibility analysis if the head of the agency
certifies that the rule will not have a significant effect on a
substantial number of small entities. 5 U.S.C. 605(b). For the reasons
discussed below, the Commission made this certification in the NPR.
Although most of the firms that manufactured or imported dive
sticks are small businesses, staff analysis suggests that the rule is
unlikely to have a significant effect on any businesses, large or
small. Most manufacturers removed their dive sticks from the market in
response to the 1999 recalls. Some manufacturers have already taken
steps to redesign their products. If the redesigned products conform to
the rule, the manufacturers would not incur any additional costs. In
addition, as discussed above, the costs of the rule are likely to be
small. Finally, dive sticks probably account for only a small
percentage of any individual firm's sales. Several dive stick
manufacturers market various types of pool or other toys. Others have
additional product lines such as pool supplies and equipment.
Additionally, most of the firms that manufactured or imported dive
sticks also distribute similar toys (such as dive rings and disks and
certain dive eggs that do not rest vertically on the bottom) that would
not be covered by the ban. If firms stopped producing and selling dive
sticks, sales of these substitute products may increase, offsetting any
loss due to a ban on dive sticks.[8,12]
[[Page 13650]]
I. Environmental Considerations
Pursuant to the National Environmental Policy Act, and in
accordance with the Council on Environmental Quality regulations and
CPSC procedures for environmental review, the Commission assessed the
possible environmental effects associated with the rule banning certain
dive sticks.
The Commission's regulations state that rules providing design or
performance requirements for products normally have little or no
potential for affecting the human environment. 16 CFR 1021.5(c)(1).
Nothing in this rule alters that expectation. Therefore, because the
rule would have no adverse effect on the environment, neither an
environmental assessment nor an environmental impact statement is
required.[8,12]
J. Executive Orders
According to Executive Order 12988 (February 5, 1996), agencies
must state the preemptive effect, if any, of new regulations.
The FHSA provides that, generally, if the Commission issues a
banning rule under section 2(q) of the FHSA to protect against a risk
of illness or injury associated with a hazardous substance, ``no State
or political subdivision of a State may establish or continue in effect
a requirement applicable to such substance and designed to protect
against the same risk of illness or injury unless such requirement is
identical to the requirement established under such regulations.'' 15
U.S.C. 1261n(b)(1)(B). Upon application to the Commission, a State or
local standard may be excepted from this preemptive effect if the State
or local standard (1) provides a higher degree of protection from the
risk of injury or illness than the FHSA standard and (2) does not
unduly burden interstate commerce. In addition, the Federal government,
or a State or local government, may establish and continue in effect a
non-identical requirement that provides a higher degree of protection
than the FHSA requirement for the hazardous substance for the Federal,
State or local government's own use. 15 U.S.C. 1261n(b)(2).
Thus, with the exceptions noted above, the rule banning certain
dive sticks would preempt non-identical state or local requirements
applicable to dive sticks designed to protect against the same risk of
injury.
The Commission has also evaluated this rule in light of the
principles stated in Executive Order 13132 concerning federalism, even
though that Order does not apply to independent regulatory agencies
such as CPSC. The Commission does not expect that the rule will have
any substantial direct effects on the States, the relationship between
the national government and the States, or the distribution of power
and responsibilities among various levels of government.
K. Effective Date
The rule will become effective 30 days from publication in the
Federal Register and will apply to dive sticks entering the chain of
distribution on or after that date. As stated in the NPR, the
Commission believes a 30-day effective date is appropriate because (1)
due to the 1999 recalls, few, if any, hazardous dive sticks should be
currently on the market; (2) redesigning products to comply with the
rule should be fairly simple; and (3) substitute products are readily
available.[1,8,9]
L. Commission Findings
For the Commission to issue a rule under section 2(q)(1) of the
FHSA classifying a substance or article as a banned hazardous
substance, the Commission must make certain findings and include these
findings in the regulation. 15 U.S.C. 1262(i)(2). Accordingly, the
Commission makes the following findings.
Voluntary standard. The FHSA requires the Commission to make
certain findings concerning compliance with and adequacy of a voluntary
standard if a relevant voluntary standard has been adopted and
implemented. Id. The Commission is not aware of any voluntary standards
addressing the risk of injury posed by dive sticks. Therefore, no
findings concerning voluntary standards are necessary.
Relationship of benefits to costs. The FHSA requires the Commission
to find that the benefits expected from a regulation bear a reasonable
relationship to its costs. Id. The Commission estimates the potential
benefits of removing hazardous dive sticks from the market to be 2 to 4
cents per dive stick. With the availability of substitutes and the
expected low cost of modifying dive sticks to conform to the rule, the
Commission anticipates that necessary changes will be minimal. The
Commission estimates that the costs of the rule will be no more than 2
to 4 cents per dive stick. Thus, the Commission finds that there is a
reasonable relationship between the expected benefits of the rule and
its costs.
Least burdensome requirement. The FHSA requires the Commission to
find that a regulation imposes the least burdensome alternative that
would adequately reduce the risk of injury. 15 U.S.C. 1262(i)(2). The
Commission considered pursuing voluntary recalls, following a voluntary
standard, requiring labeling or changing the scope of the rule. A
banning rule would be more effective than case-by-case recalls because
the impalement hazard affects all dive sticks, not a specific brand or
model. Awaiting recalls would allow these hazardous items on the market
until the Commission obtained recalls. As explained above, no
applicable voluntary standard exists, and compliance may be low if one
did. Although labeling could help reduce the risk of injuries from dive
sticks, it would be less effective than a banning rule. It may be
difficult for a label to convey the necessary information at the time
of use. Modifying the scope so that the rule would only apply to pre-
weighted dive sticks would continue to permit hazardous items because
the unweighted dive sticks can easily be weighted to stand vertically
at the bottom of the water. Thus, the Commission finds that a ban of
dive sticks with the hazardous characteristics it has identified is the
least burdensome alternative that would adequately reduce the risk of
injury.
List of Subjects in 16 CFR Part 1500
Consumer protection, Hazardous materials, Hazardous substances,
Imports, Infants and children, Labeling, Law enforcement, and Toys.
Conclusion
For the reasons stated above, the Commission concludes that the
dive sticks described in this rule are hazardous substances under
section 2(f)(1)(D) of the FHSA. They are intended for children and
present a mechanical hazard because their design or manufacture
presents an unreasonable risk of injury. 15 U.S.C. 1261(s). Therefore,
the Commission amends title 16 of the Code of Federal Regulations as
follows:
PART 1500--HAZARDOUS SUBSTANCES AND ARTICLES: ADMINISTRATION AND
ENFORCEMENT REGULATIONS
1. The authority for part 1500 continues to read as follows:
Authority: 15 U.S.C. 1261-1278.
2. Section 1500.18 is amended to add a new paragraph (a)(18) to
read as follows:
Sec. 1500.18 Banned toys and other banned articles intended for use by
children.
(a) * * *
[[Page 13651]]
(18)(i) Dive sticks, and other similar articles, that are used in
swimming pools or other water environments for such activities as
underwater retrieval games or swimming instruction, and which, when
placed in the water, submerge and rest at the bottom of the pool. This
includes products that are pre-weighted to sink to the bottom and
products that are designed to allow the user to adjust the weight. Dive
sticks and similar articles that come to rest underwater at an angle
greater than 45 degrees from vertical when measured under the test at
Sec. 1500.86(a)(7) and dive sticks and similar articles that maintain a
compressive force of less than 5-lbf under the test at
Sec. 1500.86(a)(8) are exempt from this banning rule. Articles that
have a continuous circular shape, such as dive rings and dive disks are
also exempt.
(ii)(A) Findings. In order for the Commission to issue a rule under
section 2(q)(1) of the FHSA classifying a substance or article as a
banned hazardous substance, the Commission must make certain findings
and include these findings in the regulation. 15 U.S.C. 1262(i)(2).
These findings are discussed in paragraphs (a)(18)(ii)(B) through (D)
of this section.
(B) Voluntary standard. No findings concerning compliance with and
adequacy of a voluntary standard are necessary because no relevant
voluntary standard addressing the risk of injury posed by dive sticks
has been adopted and implemented.
(C) Relationship of benefits to costs. The Commission estimates the
potential benefits of removing hazardous dive sticks from the market to
be 2 to 4 cents per dive stick. With the availability of substitutes
and the expected low cost of modifying dive sticks to conform to the
rule, the Commission anticipates that necessary changes will be
minimal. The Commission estimates that the costs of the rule will be no
more than 2 to 4 cents per dive stick. Thus, the Commission finds that
there is a reasonable relationship between the expected benefits of the
rule and its costs.
(D) Least burdensome requirement. The Commission considered
pursuing voluntary recalls, following a voluntary standard, requiring
labeling or changing the scope of the rule. A banning rule would be
more effective than case-by-case recalls because the impalement hazard
affects all dive sticks, not a specific brand or model. Awaiting
recalls would allow these hazardous items on the market until the
Commission obtained recalls. No applicable voluntary standard exists,
and compliance may be low if one did. Although labeling could help
reduce the risk of injuries from dive sticks, it would be less
effective than a banning rule. It may be difficult for a label to
convey the necessary information at the time of use. Modifying the
scope so that the rule would only apply to pre-weighted dive sticks
would continue to permit hazardous items because the unweighted dive
sticks can easily be weighted to stand vertically at the bottom of the
water. Thus, the Commission finds that a ban of dive sticks with the
hazardous characteristics it has identified is the least burdensome
alternative that would adequately reduce the risk of injury.
* * * * *
3. Section 1500.86 is amended to add new paragraphs (a)(7) and (8)
to read as follows:
Sec. 1500.86 Exemptions from classification as a banned toy or other
banned article for use by children.
(a) * * *
(7) Dive sticks and similar articles described in
Sec. 1500.18(a)(18) that come to rest at the bottom of a container of
water in a position in which the long axis of the article is greater
than 45 degrees from vertical when measured in accordance with the
following test method:
(i) Test equipment.
(A) A container that is filled with tap water to a depth at least 3
inches [76 mm] greater than the longest dimension of the dive stick.
The container shall:
(1) Be sufficiently wide to allow the dive stick to lie along the
bottom with its long axis in a horizontal position,
(2) Have clear side walls to permit observation of the dive stick
under water, and
(3) Be placed on a level surface and have a flat bottom.
(B) A protractor or other suitable angle measurement device that
has an indicator for 45 degrees from vertical.
(ii) Testing procedure
(A) If the dive stick is sold such that the consumer is required to
attach an additional component(s) to the dive stick, then the product
shall be tested both with and without the attachment(s).
(B) From just above the water surface, drop the dive stick into the
container.
(C) Let the dive stick sink and come to rest at the bottom of the
container. If the dive stick is designed so that the weight can be
adjusted by adding water or other substance, adjust the weight so that
the dive stick sinks and comes to rest with its long axis positioned as
close to vertical as possible.
(D) Align the angle measurement device alongside the dive stick
underwater and wait for the dive stick to come to rest if there is any
water disturbance. Determine whether the long axis of the dive stick is
greater than or less than 45 degrees from vertical.
(8) Dive sticks and similar articles described in
Sec. 1500.18(a)(18) in which the maximum force measured in the
following test method is less than 5-lbf [22N]. The test shall be
conducted in the ambient environment of the laboratory and not under
water.
(i) Test equipment.
(A) A compression rig that has a force gauge or equivalent device
that is calibrated for force measurements within a minimum range of 0
to 5 lbf [0-22 N] and with an accuracy of 0.1 lbf
[0.44 N] or better. The test rig shall have a system to
guide this force application in the vertical direction and shall have a
means to adjust the rate of load application.
(B) Compression disk--the loading device that is attached to the
force gauge shall be a rigid metal disk with a minimum diameter of
1.125 inches [29 mm].
(C) Vise or other clamping device.
(ii) Testing procedure
(A) Position the bottom of the dive stick in the clamping device so
that the longest axis of the dive stick is vertical. The bottom end of
the dive stick is the end that sinks to the bottom of a pool of water.
Secure the bottom of the dive stick in the clamp such that the clamping
mechanism covers no more than the bottom \1/2\ inch [13 mm] of the dive
stick.
(B) Apply a downward force at a rate of 0.05 in/sec
(0.01 in/sec) [1.3 mm.sec 0.3 mm/sec] at the
top of the dive stick with the compression disk positioned so that the
plane of the disk contact surface is perpendicular to the long axis of
the dive stick.
(C) Apply the load for a period of 40 seconds or until the maximum
recorded force exceeds 5-lbf [22 N].
(D) Record the maximum force that was measured during the test.
Dated: March 1, 2001.
Sadye E. Dunn,
Secretary, Consumer Product Safety Commission.
List of Relevant Documents
1. Briefing memorandum from Ronald Medford, AED, Office of
Hazard Identification and Reduction and Scott Heh, Project Manager,
Directorate for Engineering Sciences, to the Commission, ``Dive
Sticks,'' June 8, 2000.
2. Memorandum from Debra Sweet, Directorate for Epidemiology, to
Scott Heh, Project Manager, ``Injury Data Related to Dive Sticks,''
March 21, 2000.
3. Memorandum from Catherine A. Sedney, Division of Human
Factors, to Scott
[[Page 13652]]
Heh, Project Manager, ``Human Factors Assessment of Dive Sticks,''
April 10, 2000.
4. Comment Received in Response to the ANPR, Steve Hutchison,
Department of Fair Trading, NSW Consumer Protection Agency,
Australia, dated August 30, 1999.
5. Memorandum from Scott Heh, Project Manager, to File,
``Banning Definition and Test Methods for Dive Sticks,'' May 3,
2000.
6. Memorandum from Catherine A. Sedney, Division of Human
Factors, to Scott Heh, Project Manager, ``Prevention of Impalement
Injuries: Specification of the Position of Dive Sticks in Water,''
January 27, 2000.
7. Memorandum from Suad Nakamura, Ph.D., Physiologist, Division
of Health Sciences, and Scott Heh, Mechanical Engineer, Directorate
for Engineering Sciences, to File, ``Development of an Exemption for
Non-rigid Dive Sticks,'' May 3, 2000.
8. Memorandum from Robert Franklin, Economist, Directorate for
Economic Analysis, to Scott Heh, Project Manager, ``Preliminary
Regulatory Analysis: Dive Sticks,'' May 18, 2000.
9. Briefing memorandum from Ronald Medford, AED, Office of
Hazard Identification and Reduction and Scott Heh, Project Manager,
Directorate for Engineering Sciences, to the Commission, ``Dive
Sticks,'' February 15, 2001.
10. Memorandum from Debra Sweet, Directorate for Epidemiology,
to Scott Heh, Project Manager, ``Injury Data Related to Dive
Sticks,'' January 30, 2001.
11. Memorandum from Scott Heh, Project Manager, to File,
``Comment Responding to the NPR on Dive Sticks,'' January 24, 2001.
12. Memorandum from Robert Franklin, Economist, Directorate for
Economic Analysis, to Scott Heh, Project Manager, ``Final Regulatory
Analysis: Dive Sticks,'' February 14, 2001.
[FR Doc. 01-5478 Filed 3-6-01; 8:45 am]
BILLING CODE 6355-01-P