[Federal Register: December 29, 2003 (Volume 68, Number 248)]
[Proposed Rules]
[Page 74878-74892]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29de03-18]
[[Page 74878]]
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1500
Bath Seats; Notice of Proposed Rulemaking
AGENCY: Consumer Product Safety Commission.
ACTION: Notice of proposed rulemaking.
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SUMMARY: The Commission is proposing a rule to ban bath seats that do
not meet certain requirements under the authority of the Federal
Hazardous Substances Act. Bath seats are used to support infants in a
tub or sink while they are bathed. The Commission is aware of 106
deaths and 163 non-fatal incidents and complaints from January 1983
through October 2003 involving bath seats. The Commission proposes
three requirements with which bath seats must comply.
DATES: Written comments in response to this document must be received
by March 15, 2004.
ADDRESSES: Comments should be mailed, preferably in five copies, to the
Office of the Secretary, Consumer Product Safety Commission,
Washington, DC 20207-0001, or delivered to the Office of the Secretary,
Consumer Product Safety Commission, Room 502, 4330 East-West Highway,
Bethesda, Maryland; telephone (301) 504-7923. Comments also may be
filed by telefacsimile to (301) 504-0127 or by e-mail to cpsc-
os@cpsc.gov. Comments should be captioned ``NPR for Bath Seats.''
FOR FURTHER INFORMATION CONTACT: Patricia Hackett, Directorate for
Engineering Sciences, Consumer Product Safety Commission, Washington,
DC 20207; telephone (301) 504-7577.
SUPPLEMENTARY INFORMATION:
A. Background
In July 2000, the Consumer Federation of America and eight
additional organizations petitioned the Commission to ban bath seats
under the Federal Hazardous Substances Act (``FHSA'').\1\ In August
2000, an additional organization, U.S. Public Interest Research Group,
submitted a letter requesting to be added to the list of petitioners.
On May 30, 2001, the Commission voted to grant the petition and issue
an advance notice of proposed rulemaking (``ANPR'') to begin a
rulemaking proceeding. The ANPR was published in the Federal Register
on August 1, 2001. 66 FR 39692. The Commission received 10 comments on
the ANPR. The Commission held a public briefing on bath seats on July
28, 2003. Four people submitted written testimony and gave oral
testimony at the briefing. Since the briefing, the Commission received
six additional written comments. Significant issues raised by these
comments and the Commission's responses are discussed in section G
below. On October 16, 2003, the Commission voted to issue a notice of
proposed rulemaking (``NPR'') proposing that bath seats meet
requirements for stability, leg openings and labeling or be considered
banned hazardous substances.\2\
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\1\ The other petitioners are Drowning Prevention Foundation;
Danny Foundation for Crib and Child Product Safety; Intermountain
Injury Control Research Center; California Coalition for Children's
Safety and Health; California Drowning Prevention Network; Contra
Costa County Childhood Injury Prevention Coalition; Greater
Sacramento SAFE KIDS Coalition; and Kids in Danger.
\2\ Commissioners Mary Sheila Gall and Thomas H. Moore issued
statements. Copies of these statements are available from the
Commission's Office of the Secretary or from the Commission's Web
site, http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cpsc.gov.
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When the ANPR was published, the Commission had reports of 78
deaths and 110 non-fatal incidents and complaints associated with bath
seats (or bath rings, which are no longer marketed in the U.S.) between
January 1983 and May 2001. 66 FR 39693. When the staff presented a
briefing package to the Commission in May 2003, the Commission had
reports of 96 deaths and 153 non-fatal incidents involving bath seats
that occurred from January 1983 to December 2002.[2] \3\ As of October
2003, the Commission has reports of 106 deaths and 163 non-fatal
incidents involving bath seats. As discussed more fully below, the
staff identified three major scenarios that were related to the bath
seats' design and materials: (1) The bath seat tipping over during use;
(2) the child coming out of the bath seat; and (3) the child becoming
entrapped and/or submerged in the leg openings of the bath seat.
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\3\ Numbers in brackets refer to documents listed at the end of
this notice.
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B. Statutory Authority
This proceeding is conducted pursuant to the 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 can include a risk of injury or illness
``(3) from points or other protrusions, surfaces, edges, openings, or
closures, * * * or (8) because of instability, or (9) 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 provided in section 3(f), this proceeding began with
an ANPR. 66 FR 39692. After considering the comments submitted in
response to the ANPR, the Commission is now issuing a proposed rule and
a preliminary regulatory analysis in accordance with section 3(h) of
the FHSA. The Commission will then consider the comments received in
response to the proposed rule and decide whether 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
Bath seats are used in a tub or sink to support a seated infant
while he/she is bathed. They are marketed for use only by infants
capable of sitting upright unassisted and who cannot yet pull to a
standing position. Current bath seats contain a seating area and are
usually held in place by suction cups located at the bottom of the
seat. When the Commission first began looking at this issue, bath rings
were also being manufactured and marketed in the U.S. Bath rings
consisted of a plastic ring with three or four legs with suction cups.
The infant would sit directly on the tub or on a sponge pad that was
fitted within the ring. Such bath rings are no longer manufactured for
the U.S. market, but they would be covered
[[Page 74879]]
under the proposed definition of ``bath seat'' if they were to be re-
introduced into the U.S. market.[2] As used in this NPR, the term
``bath seat'' includes bath rings.
Current bath seats provide a molded plastic seat for the infant to
sit on. They provide support to a seated infant. In addition, there are
now some infant bathtubs that convert to bath seats. These convertible
bath seats would also be included in the proposed rule's definition of
``bath seat'' because, in the bath seat configuration, they provide
support to the front and back of a seated infant.[2]
The traditional infant bath tubs that are used to bathe a reclining
infant are not within the scope of the proposed rule. Essential to the
proposed definition of ``bath seat'' is that the item provides support
at least to the back and front of an infant in a seated position.
Although there have been drowning incidents involving infant bath tubs,
the hazard scenarios are different from incidents involving bath seats.
The bath tub incidents do not involve tipovers, leg opening entrapments
and children coming out of the products as the bath seat incidents do.
Bath seats are produced and/or marketed by juvenile product
manufacturers and distributors. At the present time, there are two
manufacturers and one importer of bath seats active in the U.S.
market.[2&8]
In 2000, the Juvenile Products Manufacturers Association (``JPMA'')
estimated that there may be up to two million bath seats in use. This
is generally consistent with an estimate derived from the American Baby
Group's Baby Products Tracking Study, 2000. According to the Tracking
Study, about 33 percent of new mothers own bath seats or rings. Given
the approximately four million annual births in the U.S., the 33
percent ownership rate suggests about 1.3 million bath seats are
available for use for infants under the age of one. Including bath
seats used by infants older than one, the total number of bath seats in
use may be close to two million, as estimated by JPMA.
Retail sales of new bath seats may range from 700,000 to 1,000,000
annually. The American Baby Group survey indicated that 46 percent of
bath seats or rings owned by new or expectant mothers were obtained
after being used for an older child or borrowed. This suggests that
about 54 percent of the bath seats were acquired new, resulting in
annual sales of about 700,000 (.54 x 1.3 million). The JPMA estimate of
sales is somewhat higher, about 1 million annually.
Bath seats currently sell for about $10 to $16. Bath seats which
convert from an infant bath tub to a bath seat sell for about $20 to
$25.
D. The Risk of Injury
1. Incident Data
The Commission has reports of 106 deaths and 163 non-fatal
incidents and complaints associated with bath seats between January
1983 and October 2003. One hundred-three of the deaths occurred in the
absence of a caregiver. In many incidents it is difficult to know the
amount of time the caregiver was out of the room. Some reasons that
caregivers have cited for leaving children unattended are answering
unexpected phone calls, retrieving towels, tending to another child in
the home, performing household chores, or watching television. The
victims involved in fatal drowning incidents ranged in age from 5
months to 20 months.[2&3]
2. Hazard Scenarios
After examining the bath seat incident reports, the Commission
staff identified three major hazard scenarios that were related to the
bath seats' design and materials. These are: (1) The bath seat tipping
over during use; (2) the child coming out of the bath seat; and (3) the
child becoming entrapped and/or submerged in the leg openings of the
bath seat.[2&3]
Bath seat tipping over. The staff identified 32 fatalities and 85
non-fatal incidents or complaints involving bath seats tipping over
that were reported from January 1983 through October 2003. The children
involved ranged from 4 months to 15 months in age. In most of the fatal
incidents, a caregiver was not present. However, a caregiver was
present in two of the fatalities. The majority of non-fatal incidents
were supervised.[2&3]
In many of the tip-over incidents, it appears that the suction cups
may not have completely adhered to the tub's surface. It is often
difficult to determine the type of surface involved in individual
incidents.[2]
Child coming out of bath seat. The staff identified 22 fatalities
and 13 non-fatal incidents and complaints involving children coming out
of bath seats that were reported from January 1983 through October
2003. In these incidents, the children were found out of the bath seat
in the bath water, and the bath seat was still in its upright position.
The scenario suggests that the bath seat was unable to restrain the
child in the seat. Children involved in these incidents ranged in age
from 6 months to 14 months. In all of the fatal incidents and in the
majority of non-fatal incidents no caregiver was present.[2&3]
Entrapment and submersion. The staff identified 3 fatalities and 18
non-fatal incidents and complaints involving children entrapped or
submerged in bath seats that were reported from January 1983 through
October 2003. The children involved in these incidents ranged in age
from 3 to 16 months. In one of the fatalities the child was supervised.
In the other two, no caregiver was present. The majority of non-fatal
incidents were supervised.[2&3]
E. Voluntary Standard
Currently, there is a voluntary standard for bath seats, ASTM F
1967-03. The standard was first published in June 1999. At that time,
the standard included marking, labeling, and literature requirements as
well as performance requirements addressing stability, static load,
latching/locking mechanisms, restraint systems, leg opening sizes and
other requirements commonly found in juvenile product standards. A
revised standard with requirements for suction cup integrity and a
durability requirement for latching/locking mechanisms was published in
June 2001. The current version of the standard, ASTM F 1967-03,
contains additional revisions that were approved in March 2003 and
published in April 2003.[2]
Following is a summary of the performance requirements and their
respective test methods specified in ASTM F 1967-03.[2]
Restraint System: If the seat provides back support and side or
front support, then a passive crotch restraint must be provided. The
ASTM standard does not allow additional restraints that require any
action on the part of the caregiver to secure the restraint.
Stability: The bath seat is tested on a smooth surface, in 2 inches
of water. A 17-pound force (lbf.) is applied horizontally from the
seat. The bath seat complies with the voluntary standard if it does not
tip over. Testing is not required on slip-resistant surfaces unless the
manufacturer recommends use on slip-resistant surfaces (the Commission
is unaware of any bath seats currently sold that are recommended for
slip-resistant surfaces).
Static Load: A 30-pound load is placed in the seat for 20 minutes.
There shall be no breakage or deformation of the product.
Requirements for Suction Cups (added in 2001): Seats with suction
cups
[[Page 74880]]
are tested as follows. After soaking in water, a 25-pound vertical pull
test is performed in an attempt to remove the suction cups from the
seat. After soaking in water, a 25-pound pull test is performed on a
seat installed on a smooth bathing surface, in an attempt to disengage
the suction cups from the bathing surface. The seat is installed and
removed 2000 times on a smooth bathing surface and the second pull test
is repeated.
Leg Openings (added in 2003): A torso probe is inserted in the most
adverse orientation into each opening of the bath seat from the
direction of the occupant seating surface. A 15-pound force is applied.
To comply, the bath seat must not permit passage of the torso probe.
The tapered end of a shoulder probe is inserted in the most adverse
orientation into each opening of the bath seat from the direction of
the occupant seating surface. A 15-pound force is applied to the probe
in the direction of the major axis. The force is released and a 10-
pound force is applied to the top 1.0 inch perimeter of the probe in a
direction vertically toward the seating surface. To comply, the 1.0
inch perimeter shall not be permitted to contact the seating surface of
the bath seat.
October 2003 ASTM Meeting. On October 1, 2003, the ASTM Bath Seat
Subcommittee met and voted to issue a concurrent Main and Subcommittee
ballot that will include proposed new stability and labeling
requirements.[1] The proposed stability requirement is identical to the
stability requirement the Commission is proposing in this NPR. The
proposed labeling requirement being balloted is similar to the first
two lines of the label the Commission proposes in this NPR. The ASTM
proposed label states:
WARNING
Children have drowned when left unattended in bath seats. ALWAYS keep
child within arm's reach.
The ballot with these two proposals was issued on November 3, 2003,
and results are due back December 8, 2003. The results should be
reviewed and discussed at the next ASTM Bath Seat Subcommittee meeting
in March 2004.[1]
F. The Proposed Ban
The proposed rule would ban bath seats that do not meet specified
requirements for stability, leg openings, and labeling. After
considering the incident reports, the Commission believes that these
proposed requirements will address the major hazard scenarios involved
in bath seat drownings.
1. Stability Requirement
As discussed above, 117 reported incidents involved the bath seat
tipping over (32 deaths and 85 non-fatal incidents or complaints). Bath
seats currently on the market depend on suction cups for all or part of
their stability. If the suction cups fail, either by detaching from the
product or detaching from the tub surface, the bath seat can become
unstable and tip over.[2]
Most of the reports concerning bath seats tipping over were based
on incidents where suction cups on the bottom of the bath seat failed
to adhere to the bathtub surface during a child's entire bath. This can
happen for several reasons including degradation of the suction cups
over time, or dirty or soapy surfaces that affect adhesion of the cups
to the tub. In addition, suction cups will not reliably adhere to slip-
resistant tubs. In these incidents, failure of the bath seat to
continuously adhere to the surface results in an unstable product.[2]
The ASTM subcommittee for bath seats identified this problem, and
the current ASTM F 1167-03 requires that manufacturers include warnings
against using bath seats on slip-resistant surfaces. However, the
current voluntary standard does not require testing on slip-resistant
surfaces.[2]
It can be difficult for a consumer to identify a ``slip-resistant''
tub. Although many slip-resistant tubs have texturing that is easily
identified (such as a sandpaper-like finish, a pattern of ridges, or
consumer-added appliques) some slip-resistant surfaces have a very
subtle finish. A convenience sampling of slip-resistant tubs at a home
improvement store by CPSC staff showed some tubs that appeared to be
smooth, even though they were ``slip-resistant.'' During testing, CPSC
staff noted that suction cups can temporarily form a seal on some
abrasive surfaces if the surface has already been flooded with water,
but the seal does not last.[2]
Because identifying slip-resistant tubs might be difficult, and
testing can be misleading, the Commission believes that warning against
the use of bath seats on slip-resistant surfaces will not be effective
at preventing incidents. Therefore, the Commission proposes that bath
seats' stability be tested on slip-resistant surfaces.
The proposed performance requirement is similar to the stability
requirement in ASTM F 1967-03, but instead of testing on a smooth
surface, it requires the product to be tested on a slip-resistant
surface. The Commission proposes that the slip-resistant test surface
be defined as a surface on which commercially available, adhesive
backed, slip-resistant tread strips have been applied. Slip-resistant
tread strips are used in many applications such as walkways and stairs,
as well as bathtubs, to provide traction against slipping. The
Commission is not aware of any standard for slip-resistant tread
strips, but the desired result of an uneven surface is an inherent
characteristic of any slip-resistant tread.[2&4]
A performance requirement that requires all products to remain
stable on slip-resistant bathing surfaces should reduce the likelihood
of tip-over incidents that are due to surface adhesion failure. A bath
seat that is stable on slip-resistant surfaces could depend on its
geometry and construction for stability rather than on suction cups. An
object will fall over when its center of gravity lies outside its
supporting base. The supporting base of bath seats could be designed to
be wide enough to prevent tip-overs. Another potential approach might
be a bath seat that attaches to one or both of the tub sides.[2&4]
2. Leg Opening Requirement
As discussed above, 21 reported incidents involved children
submerged or entrapped in bath seats (3 deaths and 18 non-fatal
incidents or complaints). Over the last two years, CPSC staff worked as
part of an ASTM task group to develop a performance requirement to
address the entrapment and submersion hazard. The performance
requirement the task group developed tests all side and leg openings
with two test probes--a torso probe and a shoulder probe. To comply
with the requirement, the torso probe must not pass through any side or
leg openings, and the shoulder probe must not slide through any side or
leg openings nor be able to rotate in a manner that allows the upper
end of the probe to touch the seating surface.[2&4]
The torso probe is identical to the probe used in the current high
chair standard, ASTM F 404-99a, since high chairs are intended for the
same minimum developmental stage occupants. Prohibiting passage of the
probe is intended to prevent the torso of the occupant from sliding
through a side or leg opening. The design of current bath seats can be
modified to eliminate openings that are large enough for an infant to
slide through, for example by adding more vertical ``bars'' or
increasing the width of existing ``bars.''[2&4]
[[Page 74881]]
The dimensions of the shoulder probe represent the shoulder breadth
and buttock depth of the smallest intended occupant. During the test,
the shoulder probe is inserted into each leg opening and a force is
applied to the ``shoulder'' end of the probe in an attempt to push it
through the opening, or to have it touch the seat base. Prohibiting the
probe from contacting the seating surface is intended to prevent an
occupant from sliding and rotating in the bath seat to a point where
the occupant's shoulder and face is under water. The interior volume of
current bath seats can be reduced to prevent an infant from lying down
(and possibly becoming entrapped underwater) without preventing older
users from occupying the seat.[2&4]
This leg opening performance requirement was recently approved by
ASTM and is included in ASTM F 1967-03, published in April of 2003.[2]
The Commission is including it in this NPR because, at this time, the
leg opening requirement of the voluntary standard has not been
implemented. According to relevant legislative history, a voluntary
standard is implemented when ``substantial industrywide production of
products that comply with the standard has begun.'' H.R. Cong. Rep. No.
208, at 875; U.S. code cong. & Admin. News, 97th Cong., 1st Sess. 1982,
Vol. 2 at 1237. This has not yet occurred.
3. Labeling Requirement
As discussed above, 35 reported incidents involved children coming
out of bath seats (22 deaths and 13 non-fatal incidents or complaints).
The Commission staff considered the incident reports to determine
whether performance criteria could be developed that would address this
hazard scenario. For the reasons explained below, the staff concluded
that no performance criteria could effectively address the hazard
scenario of children coming out of the bath seats at this time.
The Commission is concerned that adding an effective restraint
system to the seat may change the utility of the bath seat. It could
change the product from a bath aid to a bath restraint, making it
impractical for its intended purpose of aiding caregivers when bathing
children. Essentially, current bath seats maintain the children's
seated posture as loosely as possible, so that caregivers have room for
their hands to wash children without worrying that the children will
fall over or slip down. Bath seats are ``loose supports.'' They are
poorly adapted to restraining functions because it is difficult to make
an effective ``loose restraint.'' Preventing children from coming out
of a bath seat requires a restraint system that is reasonably
comfortable and still allows washing. Moreover, in a bathing
environment it is easier for children to escape because they are naked
and wet. Restraining their slippery bodies comfortably, with room to
wash, is extremely difficult because humans are so flexible and
jointed.[2&5]
The Commission is also concerned that making the bath seat's
seating area smaller by requiring a standard size will not prevent all
users from coming out of the bath seat. One approach for a restraint
might be simply to reduce the occupant retention area so that it is
``tighter'' on the child. However, this would not be effective for all
users because children who may use the bath seat range greatly in size.
For example, bath seats that fit large 6-month-old children may still
allow small 10-month-old children ample clearance to fit into the seat
and come out. Moreover, the large variability in sizes among same-age
children in this age range is greater than the growth from age 5 months
to 10 months. Thus, requiring that bath seats be made in a smaller,
standardized size would be insufficient to create an effective passive
restraint system for bath seats.[2&5]
Because a restraint performance requirement does not appear to be a
practical approach for preventing children from coming out of a bath
seat, the Commission proposes a forceful warning label to warn about
the need for constant caregiver attendance.
The Commission believes that the label currently specified in the
ASTM standard (see above) needs to be stronger so that consumers
understand that the danger of drowning is a real possibility. Some
consumers report that leaving a child unattended momentarily is
``understandable,'' to get a towel, answer the phone or doorbell, or
help another child, even though some admit they understand that it is a
risk to the infant. They may rationalize that they are still
``attending'' to the child if they can ``hear what's going on,'' or if
they are ``just in the next room'' and will soon return. Caregivers
reading the current warning label may admit that drowning is possible,
but may rationalize that it has never happened before. Since they think
the event is unlikely, they feel comfortable ignoring the warning and
believing the hazard is unlikely. They trust the bath seat and over-
apply the success of their prior experiences with it when their child
did not come out. A strong warning may counteract some of this
behavior. The Commission proposes strengthening the ASTM warning label
with statements that expressly explain the danger. The Commission
proposes the following language:
[GRAPHIC] [TIFF OMITTED] TP29DE03.001
G. Response to Comments
The Commission received ten comments from nine individuals during
the ANPR comment period. Eight of the 10 comments supported a ban of
the product. One of the 10 supported a mandatory performance standard,
and the other commenter supported the development of a voluntary
standard. In addition, four individuals submitted written testimony
before the Commission's public briefing and gave oral testimony at the
briefing. Three of these supported a ban of all bath seats and one
supported voluntary standards. After the briefing, the Commission
received six additional comments, two supporting a ban of all bath
seats, one supporting a mandatory standard, and one supporting
terminating the rulemaking (the other two did not express support for
any of the options).
Responses to the primary issues raised by the comments follow. The
numbers found in parentheses after a comment refer to the commenter
number assigned by the Office of the Secretary.
[[Page 74882]]
1. Adequacy of Bath Seat Designs and the Voluntary Standard
Comment: Several comments (CH 01-5-3; 5; 6; 7; 8) stated that no
standard can adequately address the risk of death and injury associated
with bath seats and that ASTM F 1967-01 does not adequately address
these issues. Some commenters (CH 01-5-1; 4; 5; 6) specifically pointed
out that the size of the leg openings was hazardous.
Response: The Commission believes that the proposed leg opening
requirement will address incidents that involve entrapment/submersion,
and that the proposed stability requirement can adequately address tip-
over incidents.
Comment: Comment CH 01-5-9 asserted that certain design safety
measures can be added to make bath seats safer, including the addition
of user-activated restraints, and that ASTM should include these safety
measures in the voluntary standard.
Response: The Commission agrees that bath seats can be made safer
by implementing design safety measures to address the tip-over hazard
and the entrapment and submersion hazard. However, a user-activated
restraint system that prevents a child from coming out of a seat could
make the bath seat impractical for its intended purpose. In addition,
the Commission is concerned that caregivers may not use such
restraints. As a result, a performance requirement for a restraint
system is not a viable approach at this time. The Commission proposes
that the coming out hazard be addressed with a forceful warning label
to stress the need for constant caregiver attendance.
2. Bath Seat Suction Cups and Performance on Slip-Resistant Surfaces
Comment: Several commenters (CH 01-5-3; 3a; 5; 6) were concerned
about the compatibility of bath seats with slip-resistant surfaces, and
they stated that ASTM F 1967-01 is not compatible with slip-resistant
surfaces. Three comments (CH 01-5-1; 2; 6) concentrated on the poor
performance of suction cups in terms of ability to adhere to surfaces.
Response: Current bath seat designs that rely on suction cups for
stability will not reliably adhere to non-smooth surfaces such as
textured tub surfaces, non-slip abrasive surfaces, or surfaces on which
non-slip adhesive treads have been applied. Bath seats that do not rely
on suction cups or any kind of surface adhesion for stability should
not encounter the same stability problems identified with current bath
seats when used on slip-resistant surfaces. The Commission proposes
that stability tests on bath seats be performed on a slip-resistant
surface.
The ASTM bath seat voluntary standard does not require testing bath
seats on slip-resistant surfaces if the manufacturer's instructions
state that the product should only be used on a smooth surface. The
Commission is not aware of any current bath seat where the instructions
state the product can be used on slip-resistant surfaces.
Comment: Comment CH 01-5-2 stated ``if the suction works well
enough to keep the seat always upright, it will also work to hold the
child underwater, even with a parent struggling to free the child, if
the child submarines or slips out of the bath seat.''
Response: The danger of being unable to free a child in a stable,
upright seat is only possible if the child can submarine and become
entrapped in the seat. The proposed leg opening requirement should
prevent this from occurring.
3. A False Sense of Security and Parental Absence
Comment: Several comments (CH 01-5-1; 2; 3; 4; 5; 6; 7; 8) asserted
that caregivers are more likely to leave a child alone in a bath seat
because the child looks safe in one and warning labels are insufficient
to prevent this behavior.
Response: If consumers believe that a bath seat is safe due to its
appearance or features, they may choose to ignore the warning. This
phenomenon, called ``risk compensation,'' can occur with many products,
even those not intended to be safety devices, if the user trusts the
device to prevent injury. However, strengthening the warning on the
product may help combat any appearance of safety in bath seats. For
this reason, the warning should be as powerfully worded as possible.
Comment: Comment CH-01-5-9 implied the problem is not with bath
seat designs, but with the people who leave children unattended. This
commenter also states ``If the bath seat/ring was `designed and
manufactured' to allow the caregiver to place the child in the tub and
walk away then I would heartily agree that these articles constitute a
``mechanical hazard''. But the fact is, these bath aides were not
designed or manufactured to be used in such a way.''
Response: As the Commission stated in the ANPR: ``Some caregivers
may perceive that the product provides a greater degree of safety than
it does. Leaving the child alone could be considered a reasonably
foreseeable abuse of the product.'' 66 FR 39697. Existing bath seats do
not appear to be adequately designed to protect children against the
consequences of this foreseeable misuse. In addition, some mechanical
failures--e.g., the seat tipping over or children slipping into leg
openings--have occurred in the presence of a caregiver.
4. Utility Age Range
Comment: Comment CH 01-5-8 questioned the age recommendation of 5
to 10 months for bath seats. The commenter suggests that ``6 to 8
months is a much more realistic age range for average children to sit
securely and to begin to pull up on objects.''
Response: The relevant developmental milestones for bath seat use
are ``sitting unassisted'' and ``pulling to a standing position.'' A
significant portion of the population will sit unassisted somewhere
between 5 months and 6 months of age, even though the average will fall
somewhere just after 6 months. As well, a significant portion of the
population will not be able to pull to a stand until sometime after
their 9-month birthday. To encompass a reasonable majority of typical
users, the Commission believes that bath seat usage will likely occur
in the 5- to 10-month age range. However, some users may well achieve
the milestones in shorter time spans.
ASTM recently approved a modification to its standard to include an
age recommendation for the product of between 5 and 10 months. In
addition, the revised standard also requires packaging and instructions
wording as follows: ``Product is suitable for children able to sit up
unassisted. Product is not suitable for children able to pull up to a
standing position who may attempt to climb out.'' The Commission
concurs with this recommendation.
5. Bath Seat Incident Rates
Comment: Two comments (CH 01-5-1 and 8) stated that the ``* * *
standard has done nothing to slow the bath seat mortality rate.'' and
``* * * the standard has failed to reduce the numbers of drowning and
near drowning incidents* * *''
Response: Because the date of manufacture of the bath seats
involved in the incidents is not recorded, the Commission cannot
determine if the bath seat was manufactured prior to the effective date
of a particular ASTM standard. However, as noted in this NPR, the
Commission has concerns about the adequacy of the current voluntary
standard in addressing deaths and incidents associated with bath seats.
[[Page 74883]]
6. Water Level Mark
Comment: Two statements submitted at the Commission briefing (by
Rachel Weintraub for CFA and Jack Walsh for the Danny Foundation)
recommended putting a water level mark on the bath seat to indicate
that the bath water should not be higher than that level. One of the
commenters discussed incident data that he claimed supported his
opinion. The other commenter recommended that the following be added to
the warning label or instructional literature: ``ALWAYS use the least
amount of water necessary when bathing a child.''
Response: The Commission is concerned that a water level mark may
be interpreted by some caregivers to mean there is a safe water level
at which children do not drown. There is no such level. Therefore, the
Commission does not support this recommendation. The current ASTM
standard requires the following wording on instructional literature:
``Babies can drown in as little as 1 inch of water. ALWAYS bathe your
infant using as little water as necessary.'' The Commission believes
this is adequate. With regard to incidents cited by the commenter, many
of those involved overflowing bath tubs where parents or siblings
turned on the water and failed to turn it off. The Commission does not
believe that the presence of a water level mark on the product would
have addressed these incidents.
7. Labeling
Comment: One statement at the Commission briefing (by Rachel
Weintraub for CFA) and one comment submitted after the briefing (by
Paul Ware, Chair of ASTM F15.20 Subcommittee) commented on the proposed
warning label for bath seats. One stated that it is counterintuitive to
come up with a warning label to address the coming out hazard. Another
commenter stated that he does not believe that there is adequate
rationale for changing the wording from what is currently in the ASTM
standard to the wording the Commission is proposing.
Response: As discussed in section F.3 above, the staff explored
whether a performance requirement could be developed that would address
the coming out hazard, but concluded that no practical and effective
performance criteria were possible. As for the need for improvements to
the label required by the ASTM standard, the Commission believes that
the current label allows parents to rationalize that children have not
actually drowned while using a bath seat. The Commission believes its
proposed warning label is an improvement because it uses language to
warn parents that children actually have drowned while using a bath
seat. Incidents involving the absence of caregivers continue to occur,
and no other strategy directly addresses this caregiver behavior. The
Commission believes that strengthening the label may more strongly
influence caregiver behavior and thereby reduce drowning incidents.
Comment: Two commenters (Ms. Weintraub of CFA and Heather Paul of
National Safe Kids Campaign) asked that the Commission require a label
on bath seats that indicates the product meets the mandatory rule.
Response: The Commission has included such a requirement in other
CPSC regulations, such as bike helmets, and believes that this is a
reasonable suggestion. Therefore the Commission proposes this
requirement in the NPR.
Comment: One commenter (Ms. Weintraub of CFA) requested that there
be a requirement that the warning label be ``readable'' when tested for
permanence. Another commenter recommended a stronger permanency test
for labels than what is currently required in the ASTM standard.
Response: The ASTM standard for bath seats contains a requirement
for labels to withstand submersion in water for 20 minutes. CPSC is not
aware of any consumer complaints or incidents with regard to illegible
labeling on bath seats. Therefore the Commission has no basis to
propose a change to the current ASTM test.
Comment: One commenter (Ms. Paul of Safe Kids Campaign) recommends
that the warning label on the product also be required to be on the
front and back of the packaging.
Response: The Commission believes this is a reasonable suggestion
to better ensure that consumers are made aware of the hazards
associated with bath seats. Therefore the Commission is including this
in the NPR.
8. Data Regarding Bathing Environments of Infants
Comment: One commenter (CH 03-3-5) presented data on bathing
environments for a group of children age 5 to 10 months old who drowned
in bath tubs from 1994-1999. From these data, she drew conclusions
about parental behavior, sibling presence, and the potential effects of
a ban of bath seats.
Response: The commenter puts forth the contention that bath seats
lead parents to leave their babies alone in the bath, which leads to
their greater risk of drowning. This conclusion cannot be drawn from
the data she presents. In order to draw conclusions about bath seats
leading parents to leave children unattended, we would need to have
data on how many bath seat users leave their children unattended and
how many non-bath seat users leave their children unattended. These
data do not exist.
In addition, in order to draw conclusions about whether bath seat
users are at greater or lesser risk of drowning (regardless of the
reason), we need data on the number of babies bathed in bath seats and
the number bathed without bath seats. These data are not presented by
the commenter. The only source of any data on this topic is the Baby
Products Tracking Study discussed in the staff's 2001 briefing package
and 2003 briefing package. CPSC staff has calculated death data and
risk estimates derived from this study.
These data indicate that the risk of drowning in a bathtub is
greater with a bath seat than without a bath seat for 5-7 month olds.
The risk of drowning with a bath seat is less than that of drowning
without a bath seat for 8-10 month olds. Given this analysis, and given
that this information alone cannot be used to predict what effect a ban
of bath seats may have on caregiver behavior, the Commission concluded
that available information cannot predict whether a ban of bath seats
would reduce bathtub related drownings.
The Commission is proposing requirements for bath seats that
address the mechanical design characteristics that contribute to bath
seat drowning incidents. By making bath seats safer, the Commission
believes that the number of drowning fatalities can be reduced.
9. Adequacy of ASTM F 1967-03
Comment: Two commenters (Mr. Ware, Chair of ASTM F15 Subcommittee
and Frederick Locker, Counsel for the Juvenile Products Manufacturers
Association) stated that they believed the existing voluntary standard
is adequate and addresses issues previously raised by the Commission.
Response: The Commission believes that the current ASTM standard
for bath seats (ASTM F 1967-03) is not adequate. Specifically, there
are no performance requirements to ensure that all bath seats are
stable on slip-resistant surfaces. This was an issue that was discussed
during the May 2001 Commission briefing, and it is not addressed in the
newest version of the standard. In addition, it is the Commission's
opinion that the labeling requirements of ASTM F 1967-03 need
[[Page 74884]]
to be strengthened to more effectively alert caregivers to possible
hazards associated with bath seats.[1]
H. Alternatives
The Commission has considered other alternatives to address the
drowning hazard posed by bath seats. As discussed below, the Commission
does not believe that any of these would adequately reduce the risk of
injury.
1. Propose only two requirements. The Commission could issue a
proposed rule that requires bath seats to comply only with a stability
requirement and labeling requirement (or else they would be banned
hazardous substances). The Commission considered proposing a rule
without a leg opening requirement because the ASTM standard approved in
March 2003 includes a leg opening requirement that is identical to the
one the staff recommended to the Commission.[2] However, the Commission
believes it is appropriate to propose all three requirements since the
industry has not had time yet to produce bath seats that comply with
the ASTM leg opening requirement. The Commission will re-examine the
question of including a leg opening requirement in its rule when the
Commission considers whether to issue a final rule.
2. Ban of all bath seats. The Commission considered proposing a
rule declaring that all bath seats are hazardous substances and
therefore banned. However, at this time, it is unclear what the effect
of removing all bath seats from the market would be. Available
information cannot predict whether fewer children would drown if bath
seats were unavailable or if more would drown. CPSC staff examined bath
seat-related deaths and bath tub-related deaths for the period 1994
through 1999. The staff's analysis suggests that children ages 5 to 7
months are more at risk from drowning when bathed in bath seats as
opposed to being bathed in a bathtub. However, children ages 8 to 10
months, as a group are at a higher risk of drowning when bathed in a
bathtub than when bathed in a bath seat. The staff concluded that it
could not measure the effect a ban would have on bathing-related
drowning because: (1) The analysis suggests that bathing while using a
bath seat is riskier for younger bathers, while bathing in bathtubs
without a bath seat is riskier for older bathers; (2) the staff
necessarily made assumptions to estimate a bath seat user population--
these assumptions could affect the accuracy of the results; and (3) the
analysis cannot be applied to children younger than 5 months and older
than 10 months, so deaths in those age groups are not addressed by the
analysis.[2&3]
In contrast to these questions about the possible effect of a total
ban on drowning deaths, the Commission believes that the three
requirements it proposes should make bath seats safer. The proposed
requirements are directed to addressing the specific hazard scenarios
that are identified in most fatal incidents.
3. Voluntary Standard. The current voluntary standard, ASTM F 1967-
03, contains many provisions that the CPSC staff has recommended,
including a leg opening requirement. However, it does not require
stability testing on slip-resistant surfaces. As discussed above, the
suction cups currently used to attach bath seats to a tub's surface do
not reliably adhere to slip-resistant surfaces. Many of today's bath
tubs have slip-resistant surfaces, and they can be difficult for
consumers to identify.[2] The Commission believes that bath seats
should be stable when used on the surfaces that are likely to be in
consumers' homes. The existing ASTM standard is not adequate in this
respect.
The label currently specified in the ASTM F 1967-03 standard may
not advise caregivers forcefully enough that a child can drown in a
bath seat. The Commission believes that the proposed label would send a
stronger message that the caregiver should remain with the child by
expressly stating that children have drowned in bath seats and that the
bath seat is not a safety device.
I. Preliminary Regulatory Analysis
The Commission has preliminarily determined to ban bath seats that
do not meet specified requirements for stability, leg openings, and
labeling. Section 3(h) of the FHSA requires the Commission to prepare a
preliminary regulatory analysis containing a preliminary description of
the potential benefits and costs of the proposed rule, including any
benefits or costs that cannot be quantified in monetary terms; an
identification of those likely to be affected; discussion of existing
or developing standards submitted in response to the ANPR; and a
description of reasonable alternatives. 15 U.S.C. 1261(h). The
following discussion addresses these requirements.[8] The preliminary
regulatory analysis is based on incident data that was reported in the
staff's briefing package of May 8, 2003. Since that time there have
been additional incidents reported which are included in the incident
data discussion at section D.1 of this notice.
Discussion of Proposed Rule
The proposed rule would require bath seats to meet certain
requirements, some of which are not currently covered by the voluntary
standard. The requirements involve additional criteria for stability,
openings, and labeling.
The proposed stability requirement will require the product to
resist tip-over when the bath seat is installed on a smooth surface to
which commercially available adhesive backed slip resistant tread
strips (for bathtub use) have been applied.
In addition to the stability requirement, two probe tests are being
proposed that would limit the size of the product's leg openings as
well as the seating space, to address the hazards of submersion and
entrapment below the water surface. This requirement is part of the
newly approved ASTM voluntary standard, but currently marketed bath
seats do not meet it.
The labeling requirement would change from what is currently
specified in the voluntary standard. The proposed labeling requirement
specifies that the product and its packaging be labeled with the safety
alert symbol (exclamation mark within an equilateral triangle), the
single word WARNING in all capital letters, as well as the following:
``Children have drowned while using bath seats. ALWAYS keep baby within
arm's reach. This bathing aid is NOT a safety device. Stop using when
child is able to pull up to a standing position.''
Potential Costs of the Proposed Rule
Efforts are underway by at least one U.S. manufacturer to develop a
bath seat that will conform to the requirements of the proposed rule.
Costs to manufacturers to meet the proposed rule include product
development costs and increased costs of production. Product
development costs involve costs associated with redesign of the product
and retooling of manufacturing equipment. According to an industry
representative, new molds for the redesigned product are estimated to
cost about $350,000. Product development overhead costs include product
design, development and marketing staff time, product testing and focus
group expenses. However, these ``product development costs'' will be
treated as with any new product development and be amortized over time.
Manufacturers report that there will be an increase in the cost of
production associated with additional material, labor and shipping.
According to an industry representative, its redesigned bath seat will
be larger, heavier, and
[[Page 74885]]
more complex to assemble. At the present time, most bath seats are
manufactured in the U.S. The proposed rule would require that bath
seats entering commerce meet the new requirements within a year of
publication of the final rule. Bath seats already in commerce (for
example, those on store shelves) will not be affected and will still be
saleable. According to one manufacturer, they plan to have bath seats
that meet the new voluntary standard leg opening requirement as well as
the stability requirement that is part of the proposed rule by the end
of 2003. Also, the second manufacturer will probably have bath seats
that meet the leg opening requirement by the end of 2003.
Revenues may be affected if sales do not match current levels.
Sales may be reduced because of price increases and possible reductions
in the utility of the new, safer bath seats. Consumer utility could be
reduced if the product is more difficult to use or the age range of
users is reduced. On the other hand, the added safety of the product
may increase the utility of the product to some consumers, a factor
that may be a positive influence on sales.
Currently, bath seats sell for about $10 to $16. Convertible seats,
which convert from an infant bathtub to an infant bath seat, sell for
about $20 to $25. Based on discussions with an industry representative,
bath seat prices will increase to reflect the increased cost associated
with producing a complying product. Although exact costs and price
increases are not known at this time, industry representatives estimate
that complying bath seats will retail for about $20 to $25, with a
likely price closer to $25.
All else equal, a price increase of $10 (which represents an
increase of more than 50 percent) may reduce the quantity of bath seats
demanded, and hence sales. The magnitude of such a reduction is
unknown, but would be affected by a number of other factors, including
the perceived usefulness of the product, the expected useful life of
the product, and other variables such as the number of births,
household incomes, and the availability of substitutes.
Despite the relatively large price increase over that of existing
bath seats, the reduction in sales may be small if consumers find the
product convenient and useful, and expect to use it for a long time.
If, for example, a consumer would use a bath seat for a year or more
(i.e., for one or more children) the price increase would amount to
less than $1 per month. Moreover, all else is not equal. The product
will change--it will presumably be safer than the earlier models. If
consumers perceive the increased safety, and if safety is an important
factor when they purchase products for use with their infant children,
the demand for bath seats could increase. Thus, product improvements
can conceivably mitigate or even offset the reduction in the quantity
demanded associated with the price increase.
Although product design is not specified by the proposed
requirement, consumer utility could be affected if changes intended to
make bath seats safer also make them more difficult to use, or if the
changes tend to limit the age of children that can use them. The
analysis by Human Factors indicates that bath seats meeting the
proposed requirements could still accommodate the current user
population, without a loss of utility. However, since the design is not
specified, and we do not know how manufacturers will modify the seats
to meet the proposed requirements, we cannot predict if the new designs
will provide the same level of usefulness or convenience to caregivers.
Any reductions in utility could lead to the reduced use of bath seats,
either by reducing sales or actual amount of use. While reduced use
would also reduce the risk of drowning in bath seats, the overall risk
of drowning would not be eliminated since other modes of bathing
children also present a drowning risk.
Potential Benefits of the Proposed Rule
The benefits of the proposed rule will result from a reduction in
deaths and injuries due to product failure from tip-over, entrapment
and submersion. CPSC is aware of 96 deaths associated with bath seats
from January 1983 through December 2002. Eighty-three of these reported
deaths occurred in the past ten years (1993 through 2002), a period
during which about one-third of all new mothers owned bath seats and
the number of bath seats in use remained relatively constant at about
two million.\4\ Of the 83 reported deaths since 1993, the hazard
scenario is known in 57 of the deaths (leaving 26 with unknown
scenarios).
---------------------------------------------------------------------------
\4\ The benefits assessment is limited to the 1993 to 2002 time
frame because the number of baby bath seats in use, which is needed
to calculate the risk that will be addressed by the proposed rule,
was less clear prior to 1993. In addition, there has been improved
reporting and collecting of death data in the later years.
---------------------------------------------------------------------------
Of the 57 deaths in which the scenario is known, 28 (about 50
percent) involved hazards addressed by the performance requirements of
the proposed rule (26 involved the tip-over hazard and two involved
entrapment/submersion). While we do not know the hazard scenarios in
the remaining 26 deaths, if we assume that they are distributed
proportionally to the known cases, another 13 deaths (i.e. 50 percent)
might be also be addressed by the proposed rule. This amounts to about
2.8 to 4.1 deaths annually (i.e. 28 deaths/10 years to 41 deaths/10
years), or about 1.4 to 2.05 deaths per million bath seats in use
(since about two million were in use annually).
Comparison of Costs and Benefits
As described above, the proposed rule may result in an increase in
the retail price of bath seats by about $10. Assuming a $10 price
increase, the costs of the proposed rule (i.e., the costs of making
bath seats safer) will increase consumer outlays by $10 million per
million bath seats sold. Additionally, according to the Baby Products
Tracking Study, about half of the bath seats were acquired used and
therefore are likely used for more than one child. If we assume that
bath seats are used for an average of about two years (i.e. more than
one use cycle), and there are about 1.4 to 2.05 deaths per million bath
seats in use annually, each million bath seats would be associated with
about 2.8 to 4.1 deaths over their two-year product life.
If the proposed rule eliminates all of these tip-over deaths and
entrapment and submersion deaths (i.e., is 100 percent effective in
preventing the deaths addressed), then the cost per life saved would
range from about $2.4 million to about $3.6 million ($10 million/4.1
deaths to $10 million/2.8 deaths). If the rule were 50 percent
effective in preventing the tip-over and entrapment/submersion deaths,
then the cost per life saved would range from about $4.9 to $7.1
million per death prevented ($10 million/(4.1 x .5) deaths to $10
million/(2.8 x .5) deaths). Based on current economic literature,
empirical estimates of the statistical value of life have generally
ranged from about $3 million to $7 million. Thus, for purposes of cost-
benefit analysis, even the high estimates of the cost per life saved
are generally within the accepted range and suggest that the benefits
of the rule would be in line with the costs, even if the standard were
only 50 percent effective in preventing addressable deaths.
The proposed rule has the potential to bring about a reduction in
deaths from tip-over and entrapment/submersion hazards. However, it is
not clear at this time whether manufacturers will design baby bath
seats that are safer, while maintaining the current level of
[[Page 74886]]
consumer utility. If some consumers do not accept the redesigned seats,
or use them less frequently (or for a shorter period), and decide
instead to bathe their children by other means, the risk of drowning
from these alternative bathing methods will be substituted for the bath
seat drowning risk.
Alternatives
As discussed above, alternatives to the regulation include a total
ban of infant bath seats, relying on a voluntary standard, promulgating
a subset of the requirements of the above proposed rule and taking no
action.
Option To Ban
The Commission considered the option of proposing a ban that would
eliminate bath seats from the marketplace entirely. With this option,
the costs would consist of the lost use value, or utility, that
consumers derive from the product. Money not spent on bath seats will
be spent on other products that provide utility, but there is expected
to be some loss in utility that cannot be quantified.
The benefits of a total ban would be the net reduction in deaths
that would be prevented by the action. The primary alternative to a ban
is the proposed rule for baby bath seats already discussed. Since the
proposed rule addresses about half of the child drownings, the
additional drownings addressed by a ban would be only a subset of all
bath seat drownings--the remaining half.
Furthermore, while a ban would effectively address (on net) only
about half of the bath seat drownings, it would expose all bath seat
users (i.e., those who would be precluded from using bath seats) to the
drowning risks in alternative bathing settings. The risk in alternative
settings is not trivial. For example, the analysis by the Directorate
for Epidemiology suggests that, for some restricted age groups (e.g.,
drownings involving children age 8-10 months), the risk of drowning in
a bath seat may be substantially lower than in alternative bathing
settings. Moreover, when all children age 5-10 months were grouped
together in the analysis (the age group for which bath seats are
generally recommended), the average bath seat drowning risk was almost
40 percent lower than that of alternative bathtub scenarios. While
grouping children across the 5 to 10 month age categories may mask the
drowning risk disparities associated with the developmental differences
between the younger and older children, as noted by the Directorate for
Epidemiology, it nonetheless highlights the fact that the risks
associated with alternative bathing methods are substantial and should
not be ignored.
If the proposed rule were fully effective in preventing the deaths
it addresses, it would likely reduce the risk of drowning in a bath
seat by about 50 percent. On the other hand, while a ban would address
all bath seat drownings (by eliminating bath seats), it would also
expose all the children who would have been bathed in bath seats to the
drowning risks in other bathing settings.
In summary, a ban of all bath seats from the marketplace would
result in some reduction in consumer utility; however, the impact on
child drownings is uncertain, and fatalities could increase.
A Subset of the Performance Requirements: Excluding the Leg Opening
Requirement in the Proposed Rule
The Commission considered a subset of the three requirements
developed by the staff and discussed earlier as a proposed rule. One
reasonable alternative is to publish as a proposed rule the stability
and labeling requirements and not the leg opening performance
requirement.
If this alternative were proposed, the costs and benefits which
were discussed in the foregoing analysis of the proposed rule would
change little. Because the entrapment and submarining deaths accounted
for only two of the 57 deaths for which the cause was known, exclusion
of the leg opening requirement would reduce the benefits by only about
3.5 percent (i.e., 2/57). At the same time, the elimination of the leg
opening requirement will not reduce the costs of the proposed rule by
much. Based on discussions with the manufacturers of bath seats, the
stability requirement requires product redesign and will drive most, if
not all, the cost increase associated with the proposed rule. The leg
opening requirement, by itself, would not necessitate a product
redesign, but would require ``modification'' to the current design,
resulting in perhaps a small increase in the product's retail price.
Therefore, the elimination of the leg opening requirement would have,
at most, a very small impact on the overall cost of the proposed rule
as well as on its potential benefits.
No Action
A decision by the Commission to take no action would eliminate the
retail price increase associated with making baby bath seats safer. At
the same time (and assuming no change in the voluntary standard),
absent any intervention by the Commission, additional preventable
deaths will likely continue as new parents buy and use baby bath seats
that are currently available in the marketplace.
Voluntary Standards
As an alternative to a proposed rule, the Commission has the option
of finding that the voluntary standard is adequate and terminating
rulemaking. ASTM has recently revised the voluntary standard to address
hazards associated with bath seat submersion and entrapment. It is
possible that later revisions might incorporate tip-over and labeling
requirements that are similar to the proposed rule. If the voluntary
standard addresses the same tip-over hazards that are addressed in the
proposed rule with equivalent effectiveness, and all suppliers of baby
bath seats comply with the voluntary standard, the net benefits of the
voluntary standard would be virtually the same as those of the proposed
rule. However, at this time, the voluntary standard does not address
the tip-over deaths. Nor does it require the stronger label that the
staff recommended.
J. 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 that 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. Id. 605(b).
No available information indicates that the proposed bath seat
requirements will have a significant adverse impact on a substantial
number of small businesses. Currently, three companies, two U.S.
manufacturers and one importer, are known to supply bath seats in the
U.S. Two of the firms (one of the manufacturers and the one importer)
are small, meeting the U.S. Small Business Administration's definition
of small businesses. The two U.S. manufacturers are aware of the
progress of this rulemaking, and at least one manufacturer is in the
process of developing bath seats to meet the requirements of the
proposed rule. The third firm, an importer, may have to find another
source for baby bath seats that would meet the proposed rule.[8]
For these reasons, the Commission certifies that the proposed rule
banning bath seats that do not meet the specified requirements would
not have a
[[Page 74887]]
significant effect on a substantial number of small entities.
K. Environmental Considerations
Pursuant to the National Environmental Policy Act, 15 U.S.C. 4321-
4347, and in accordance with the Council on Environmental Quality
regulations and CPSC procedures for environmental review, 40 CFR part
1500 and 16 CFR part 1021, the Commission has assessed the possible
environmental effects associated with the proposed rule banning certain
bath seats.
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 proposed rule alters that expectation.
The transition to bath seats that meet the proposed rule is not
expected to have an adverse environmental impact, especially if the
effective date of a rule enables the firms to substantially deplete
existing non-complying inventory. The U.S. manufacturers are already
aware of the Commission's actions, and since there is a proposed one-
year lead-time (after issuance of a final rule) before the rule becomes
effective, no environmental impact is expected. Moreover, any existing
inventory in manufacturers' stocks has the potential to be recycled,
i.e. reground in order to reuse the plastic components, which
constitute the bulk of the seat's construction.[8]
Therefore, because the proposed rule would have no adverse effect
on the environment, neither an environmental assessment nor an
environmental impact statement is required.
L. 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 proposed rule banning
certain bath seats would preempt non-identical State or local
requirements applicable to bath seats designed to protect against the
same risk of injury.
The Commission has also evaluated this proposed 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 proposed
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.
M. Effective Date
The rule would become effective one year from publication of a
final rule in the Federal Register and would apply to bath seats
entering the chain of distribution on or after that date. The two U.S.
manufacturers are aware of the Commission's proposed requirements. At
least one manufacturer has begun product development on a bath seat
that meets the proposed requirements. Thus, one year should allow
sufficient time for the manufacturers to develop a product that meets
the requirements.[2&8]
N. Proposed Findings
When the Commission issues 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). The Commission proposes 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. 15 U.S.C. 1262(i)(2). The voluntary standard, ASTM F 1967-
03, as it is currently adopted and implemented does not adequately
reduce the risk of injury. The current stability provisions do not
require testing on slip-resistant surfaces. The current label
prescribed by the ASTM standard does not state a strong enough warning.
The leg opening requirement has been adopted, but at this time has not
yet been implemented. Thus, the Commission proposes to find that the
voluntary standard, as it is currently adopted and implemented, does
not adequately reduce the risk of injury.
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. The Commission estimates the potential
benefits of its proposed changes to bath seats to be elimination of 2.8
to 4.1 deaths annually. The Commission estimates that the costs of the
rule will be about $10 million per million bath seats sold. If the
proposed rule eliminates all of the tipover and entrapment/submersion
deaths, the cost per life saved would range from about $2.4 million to
about $3.6 million. Even if the proposal were only 50% effective, then
the cost per life saved would be from about $4.9 to $7.1 million. Thus,
the Commission proposes to find 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. Id. The Commission
considered proposing only two requirements (stability and labeling
requirements, but not a leg opening requirement), banning all bath
seats, or taking no action and following the ASTM voluntary standard.
The Commission is proposing three requirements because at this time,
the leg opening requirement in the ASTM standard has not been fully
implemented. The Commission will reconsider this issue when it
considers a final rule. As discussed above, it is not clear that a ban
of all bath seats would reduce drowning deaths any more than the
proposed three requirements, and could have the effect of increasing
bathtub-related drowning deaths. Thus, the Commission proposes that a
ban of bath seats that do not meet the proposed requirements for
stability, leg openings and labeling 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.
[[Page 74888]]
Conclusion
For the reasons stated above, the Commission preliminarily
concludes that infant bath seats that do not meet the requirements for
stability, leg openings, and labeling that are specified in the
proposed rule are hazardous substances under section 2(f)(1)(D) of the
FHSA. Such bath seats are intended for children and present a
mechanical hazard under section 2(s) of the FHSA because in normal use
or when subjected to reasonably foreseeable damage or abuse their
design or manufacture presents an unreasonable risk of injury. 15
U.S.C. 1261(s). The risk of injury is from the bath seats' instability,
openings, and other aspects of their design or manufacture. Therefore,
the Commission proposes to amend 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) * * *
(20) Any bath seat (as defined in Sec. 1514.2 of this chapter)
that does not comply with the requirements of part 1514 of this
chapter.
* * * * *
3. Add part 1514 to read as follows:
PART 1514--REQUIREMENTS FOR BATH SEATS
Sec.
1514.1 Scope.
1514.2 Definitions.
1514.3 Requirements.
1514.4 Test Methods.
1514.5 Marking and Labeling.
FIGURE 1 TO PART 1514--DIAGRAM OF FORCE APPLICATION
FIGURE 2 TO PART 1514--BATH SEAT TORSO PROBE
FIGURE 3 TO PART 1514--BATH SEAT SHOULDER PROBE
Authority: 15 U.S.C. 1261, 1262.
Sec. 1514.1 Scope.
This part 1514 sets forth the requirements for a bath seat as
defined in Sec. 1514.2. Bath seats meeting these requirements are
exempted from 16 CFR 1500.18(a)(20).
Sec. 1514.2 Definitions.
As used in this part 1514:
(a) Bath seat means an article that is used in a bath tub, sink, or
similar bathing enclosure and that provides support, at a minimum, to
the front and back of a seated infant during bathing by a caregiver.
(b) Most adverse means a test condition that produces the most
severe result that would indicate a failure of the test.
(c) Test surface means a smooth surface (cleaned thoroughly with an
alcohol or other solvent-based cleaner and dried) upon which
commercially available adhesive backed safety tread strips (for bath
use) have been applied over the Test Surface Coverage Area in the
following manner. The safety tread strips shall be rectangular in
shape, approximately .75 inch (1.9 cm) wide by 7 inches (17.8 cm) or
greater in length, and evenly applied from edge to edge so that they
are .5 inch (1.3 cm) or less apart from each other.
(d) Test Surface Coverage Area means the area of the test surface
that extends a minimum of 1 inch (2.5 cm) beyond the perimeter outlined
by any part of the bath seat that is designed to contact a surface.
Sec. 1514.3 Requirements.
(a) Stability. The geometry and construction of the bath seat shall
not allow the bath seat to tip over after being tested in accordance
with Sec. 1514.4(a).
(b) Leg openings. (1) All openings on the sides of the bath seat
through which a seated occupant can slide or otherwise insert any
extremity shall not permit the passage of the Bath Seat Torso Probe
when tested in accordance with Sec. 1514.4(b)(1).
(2) All openings on the sides of the bath seat through which a
seated occupant can slide or otherwise insert any extremity shall not
permit any portion of the top 1 inch (2.5 cm) perimeter of the shoulder
breadth end of the Bath Seat Shoulder Probe to contact the seating
surface of the bath seat when tested in accordance with Sec.
1514.4(b)(2).
Sec. 1514.4 Test methods.
(a) Stability. (1) Install the bath seat according to the
manufacturer's instructions onto the prepared Test Surface. Flood the
Test Surface with water that is at an initial temperature of 100 to
105[deg] F (37.8 to 10.6[deg] C) and a depth of 2 inch (51 mm) above
the highest point of the occupant seating surface.
(2) Rigidly attach a 1 by \1/4\-inch (25 x 6-mm) aluminum flat bar
to the inside edge of the occupant seating space in a vertical
orientation at the most adverse position of the bath seat. The length
of the flat bar must be such that it extends beyond the uppermost edge
or surface of the bath seat at least as far as the maximum distance D
as shown in Figure 1.
(3) Calculate the distance D for a tip-over force to be applied to
the aluminum bar using the following formula:
D = (20.4 inch-H)/2; [(518 mm-H)/2]
(4) Apply a force of 17.0 lbf. (76.5 N) to the aluminum bar at this
distance D above the height H. Apply the force in a horizontal plane
and outward from the center of the bath seat over a period of 5 seconds
(see Figure 1). Maintain this force for an additional 10 seconds. If
the bath seat begins to release from the test surface, continue to
maintain this force and its orientation relative to the aluminum bar
until the bath seat tips over or the 10 second time limit is attained.
If necessary, to prevent the bath seat from sliding horizontally on the
test surface during this test protocol, the bottom edge of the bath
seat may be blocked or wedged to prevent such sliding. However, such
blocking should in no way move the fulcrum point of the tip-over to a
location that increases the tip-over force.
(5) Repeat this test protocol three additional times at 90 degree
increments, including the re-calculation of the distance D.
(6) Repeat this test protocol with the bath seat in each of the use
positions recommended by the bath seat's manufacturer.
(b) Leg openings. (1) For each of the use positions recommended by
the bath seat's manufacturer, insert the tapered end of the Bath Seat
Torso Probe (Figure 2) in the most adverse orientation into each
opening from the direction of the occupant seating surface. Apply a
force of 15 lbf (67 N) in the direction of the major axis of the probe.
The force shall be applied gradually within 5 seconds and maintained
for an additional 10 seconds.
(2) For each of the use positions recommended by the bath seat's
manufacturer, insert the tapered end of the Bath Seat Shoulder Probe
(Figure 3) in the most adverse orientation into each opening from the
direction of the occupant seating surface. Apply a force of 15 lbf (67
N) in the direction of the major axis of the probe. The force shall be
applied gradually within 5 seconds and maintained for an additional 10
seconds. Release the force, leaving the probe in position. Apply a
force of 10 lbf (44.4 N) to the highest point on the probe, in a
direction vertically
[[Page 74889]]
downward toward the seating surface. The force shall be applied
gradually within 5 seconds and maintained for an additional 10 seconds.
Sec. 1514.5 Marking and labeling.
(a) Each bath seat, and the front and back of its packaging, shall
be labeled with the safety alert symbol (exclamation mark in an
equilateral triangle), the word WARNING, and the following warning:
[GRAPHIC] [TIFF OMITTED] TP29DE03.002
(b) The signal word shall be written in capital letters using a
sans serif type face with letters not less than 0.2 inches (5 mm) in
height, with all the remainder of text not less than 0.1 inch (2.5 mm)
in height. The words shall also be in contrasting color to the
background on which they are located. The words ``ALWAYS'' and ``NOT''
in the list of warnings shall be capitalized. The word ``drowned''
shall be underlined.
(c) The specified warning label shall be located so that it is
visible to the caregiver when the bath seat is in the use position
recommended by the manufacturer and the occupant is in the bath seat.
(d) Each bath seat and its packaging shall display a label stating
that the bath seat complies with U.S. CPSC Requirements for Bath Seats.
[GRAPHIC] [TIFF OMITTED] TP29DE03.003
[[Page 74890]]
[GRAPHIC] [TIFF OMITTED] TP29DE03.004
[[Page 74891]]
[GRAPHIC] [TIFF OMITTED] TP29DE03.005
BILLING CODE 6355-01-C
Dated: December 12, 2003.
Todd Stevenson,
Secretary, Consumer Product Safety Commission.
List of Relevant Documents
1. Memorandum from Jacqueline Elder, AED, Office of Hazard
Identification and Reduction and Patricia L. Hackett, Project
Manager, Directorate for Engineering Sciences, to the Commission,
``Rulemaking Options for Bath Seats--Response to Comments,'' October
7, 2003.
2. Briefing memorandum from Jacqueline Elder, AED, Office of
Hazard Identification and Reduction and Patricia L. Hackett, Project
Manager, Directorate for Engineering Sciences, to the Commission,
``Rulemaking Options for Bath Seats,'' May 8, 2003.
3. Memorandum from Debra Sweet, Division of Hazard Analysis, to
Patricia L. Hackett, Project Manager, Directorate for Engineering
Sciences, ``Hazard Analysis Memorandum for Bath Seat NPR Briefing
Package,'' April 8, 2003.
4. Memorandum from Caroleene Paul, Directorate for Engineering
Sciences, to Patricia L. Hackett, Project Manager, Directorate for
Engineering Sciences, ``Draft Proposed Requirements for Bath
Seats,'' April 7, 2003.
5. Memorandum from Jonathan Midgett, Ph.D, Division of Human
Factors, to Patricia L. Hackett, Project Manager, Directorate for
Engineering Sciences, ``Human Factors Issues in Bath Seat Design and
Use,'' April 10, 2003.
6. Memorandum from Caroleene Paul, Directorate for Engineering
Sciences, to Patricia L. Hackett, Project Manager, Directorate for
Engineering Sciences, ``Response to ANPR Comments on Baby Bath
Seats,'' January 27, 2003.
7. Memorandum from Jonathan Midgett, Ph.D, Division of Human
Factors, to Patricia L. Hackett, Project Manager, Directorate for
Engineering Sciences, ``Human Factors Staff Responses to Comments
about Bath Seats,'' April 10, 2003.
8. Memorandum from Mary Donaldson, Directorate for Economic
Analysis, to Patricia L. Hackett, Project Manager, Directorate for
Engineering Sciences, ``Preliminary Regulatory Analysis of Proposed
Rule for Baby Bath Seats,'' April 9, 2003.
9. Briefing memorandum from Ronald Medford, Assistant Executive
Director, Office of Hazard Identification and Reduction and
Celestine Kiss, Project Manager, Division of Human Factors, to the
Commission, March 30, 2001.
10. Petition HP 00-4 from the Consumer Federation of America,
The Drowning Prevention Foundation, et al. to Ban Baby Bath Seats,
July 25, 2000.
11. Memorandum from Mary F. Donaldson, Directorate for Economic
Analysis, ``Baby Bath Seat Petition, HP-00-4,'' February 16, 2001.
12. Memorandum from Suad W. Nakamura, Ph.D., Physiologist and
Sandra E. Inkster, Ph.D., Pharmacologist, Directorate for Health
Sciences, ``The Pathophysiology of Drowning,'' December 7, 2000.
13. Memorandum from Debra Sweet, Division of Hazard Analysis,
``Hazard Analysis Memorandum for Bath Seat Petition,'' January 29,
2001.
14. Memorandum from Celestine T. Kiss, Division of Human
Factors, ``Human Factors Response to Bath Rings/Seats Petition (HP-
00-04),'' January 25, 2001.
15. Memorandum from M. Kumagai, Directorate for Engineering
Sciences, ``Review of BATH SEAT ASTM STANDARD
[[Page 74892]]
F1967 and Response to Comments to Petition HP 00-4,'' March 2, 2001.
16. Memorandum from M. Kumagai, Directorate for Engineering
Sciences, ``Evaluation of Bath Seat Design,'' March 2, 2001.
17. Letter dated May 7, 2001 from Dr. Kimberly Thompson to
Chairman Ann Brown re: Comments on Briefing Package Petition No. HP
00-4, Request to Ban Baby Bath Seats.
18. Memorandum dated May 21, 2001 to the Commission from Debra
Sweet, Statistician, Division of Hazard Analysis, re: Comments from
Kimberly M. Thompson, Sc.D., on Briefing Package for Petition HP 00-
4, Request to Ban Baby Bath Seats.
[FR Doc. 03-31135 Filed 12-24-03; 8:45 am]
BILLING CODE 6355-01-P