[Federal Register Volume 68, Number 248 (Monday, December 29, 2003)]
[Proposed Rules]
[Pages 74878-74892]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-31135]



[[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 [email protected]. 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://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