[Federal Register Volume 66, Number 148 (Wednesday, August 1, 2001)]
[Proposed Rules]
[Pages 39692-39699]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-19072]


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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1500


Baby Bath Seats and Rings; Advance Notice of Proposed Rulemaking; 
Request for Comments and Information

AGENCY: Consumer Product Safety Commission.

ACTION: Advance notice of proposed rulemaking.

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SUMMARY: The Commission has reason to believe that baby bath seats and 
rings, as currently designed, may present an unreasonable risk of 
injury. The Commission is aware of 78 deaths and 110 non-fatal 
incidents and complaints from January 1983 through May 2001 involving 
baby bath seats and rings. Forty-one of these non-fatal incidents/
complaints occurred when a caregiver was present. In July 2000, the 
Commission received a petition from the Consumer Federation of America 
and eight other organizations asking the Commission to ban baby bath 
seats. This advance notice of proposed rulemaking (``ANPR'') initiates 
a rulemaking proceeding under the Federal Hazardous Substances Act. The 
Commission solicits written comments concerning the risks of injury 
associated with baby bath seats and rings, the regulatory alternatives 
discussed in this notice, other possible ways to address these risks, 
and the economic impacts of the various regulatory alternatives. The 
Commission also invites interested persons to submit an existing 
standard, or a statement of intent to modify or develop a voluntary 
standard, to address

[[Page 39693]]

the risk of injury described in this notice. During the decision 
meeting, the Commission stated that the staff should undertake an 
aggressive, ongoing information and education initiative to inform new 
caregivers about the danger of leaving babies unattended in the bath or 
any source of water. The Commission solicits comments on this 
initiative.

DATES: Written comments and submissions in response to this notice must 
be received by October 1, 2001.

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) 504-0800. Comments also may be 
filed by telefacsimile to (301)504-0127 or by email to [email protected]. Comments should be captioned ``ANPR for Baby Bath Seats.''

FOR FURTHER INFORMATION CONTACT: Patricia Hackett, Directorate for 
Engineering Sciences, Consumer Product Safety Commission, Washington, 
DC 20207; telephone (301) 504-0494, ext. 1309.

SUPPLEMENTARY INFORMATION:

A. Background

    In 1994, the CPSC staff prepared for the Commission a briefing 
package discussing options for baby bath seats. At that time, the staff 
was aware of 13 infant deaths and seven non-fatal injury incidents that 
were associated with baby bath seats and rings. Most of the victims 
were between 6 and 11 months of age. The Commission also had reports of 
approximately 30 incidents in which the seats tipped over or the 
children slipped down in their seats, but for which no injuries were 
reported. The 1994 briefing package reported that in 1992, sales of 
bath seats/rings were around 660,000 units with a retail value of $9 
million. Bath seats were owned by an estimated 28 percent of mothers 
with infants, with an estimated 1.4 million available for use in homes 
with infants in 1992.
    Approximately 10 out of 66 firms that manufactured or imported 
bathing accessories for infants were identified as suppliers of baby 
bath seats/rings. In 1994, staff was not aware of any voluntary or 
mandatory safety standards for bath seats/rings.
    In 1994, the Commission staff recommended that the Commission begin 
a rulemaking with the publication of an advance notice of proposed 
rulemaking (``ANPR''). On June 15, 1994, the Commission voted 2-1 
against initiating a rulemaking, but instructed the staff to work with 
industry on a public information campaign. The staff asked the Juvenile 
Products Manufacturers Association (``JPMA'') to disseminate the 
message that caregivers should never leave a baby unattended in a tub 
of water. The staff also produced two safety alerts on the hazard and 
included the message in some safety publications.
    In July 2000, the Consumer Federation of America and eight 
additional organizations petitioned the Commission to ban baby bath 
seats.\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. The petition was docketed under the Federal 
Hazardous Substances Act (``FHSA'') (Petition No. HP 00-4), and a 
notice requesting comments was published on August 22, 2000 in the 
Federal Register, 65 FR 50968.
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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.
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    The petitioners state that at least eight babies a year die due to 
drowning associated with baby bath seats. They state that these 
drownings ``typically occur when the infant tips over, climbs out of, 
or slides through the product.''
    The petitioners also argue that the bath seats create a ``false 
sense of security,'' which ``leads to increased risk-taking behavior 
among those using the product even when the irresponsible nature of the 
caregivers is taken into account.''

B. The Product

    This rulemaking covers baby bath rings and baby bath seats. Bath 
rings typically consist of a plastic ring with three or four legs 
equipped with suction cups. The infant sits directly on the bathtub 
surface or on a fitted sponge pad within the ring, straddling a bath 
ring leg. As defined here, bath rings are no longer manufactured for 
the U.S. market. However, they may still be available in the secondhand 
market. Baby bath seats are similar to bath rings, but provide a molded 
plastic seat for the infant to sit on. Suction cups are attached to the 
underside of the molded plastic seat.
    Bath seats and rings are not intended to be used with textured or 
non-skid bathtub surfaces. Textured and non-skid bathtubs represent a 
substantial portion of the residential tubs sold today.
    The Juvenile Products Manufacturers Association (``JPMA''), a trade 
association of manufacturers, importers, and distributors of juvenile 
products, noted in its comments on the petition that ``bath seats and 
rings are generally not recommended for use until six months of age or 
when the children can sit upright unassisted. They are usually 
discontinued in use when a child seeks to escape the confines of the 
product or can stand up while holding onto other objects. Theses [sic] 
products have a useful product life of several months with both lower 
and upper limits being determined by the development and ability of the 
child.'' Developmental literature indicates that infants begin to pull 
up on objects around 9 months of age. Based on this information, and 
allowing for developmental differences in individual children, bath 
seats/rings are most appropriate with infants from about 5 to 10 months 
of age.
    At the time of the 1994 Commission briefing there were 
approximately 10 firms supplying baby bath seats/rings. Currently, 
however, there are only two manufacturers of bath seats in the U.S. 
market, with one of these controlling the majority of the market. Their 
estimated retail sales of new baby bath seats may range from 700,000 to 
1,000,000 annually.
    Commission staff estimates that there are between 1.3 and 2 million 
bath seats available for use in homes with infants. This estimate is 
based on 1999 survey results that indicated 33 percent of new mothers 
own bath seats or rings, census data that show about 4 million infants 
born per year in the United States, and an industry estimate of 2 
million bath seats/rings in use.
    Prices for infant bath seats range from about $10 to $16. Seats 
that convert from an infant bathtub to an infant bath seat sell for 
about $20 to $25.

C. The Risk of Injury

1. Incident Data

    The Commission has reports of 78 deaths and 110 non-fatal incidents 
and complaints associated with baby bath rings or seats between January 
1983 and May 2001.\2\ Forty-one non-fatal incidents/complaints occurred 
while the caregiver was present.
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    \2\ The identified cases do not represent a complete count nor a 
sample of known probability of selection. The cases do provide 
information about the types of incidents associated with baby 
bathing aids.
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    The victims involved in the fatal incidents ranged in age from 5 
months old to 20 months old. Sixty-eight of the

[[Page 39694]]

victims were between 5 and 10 months of age. The age of victims most 
frequently involved in the fatal incidents was 7 months (22 of the 78). 
Seventy-five of the 78 deaths took place when the victim was left 
unattended (by the caregiver) in the bathtub for a few minutes or 
longer. The times that the caregiver was out of the room varied from a 
reported 2 minutes to over one hour. Some of the reasons stated for 
leaving the child unattended were to respond to unexpected phone calls 
or company, to retrieve towels or clothing, or to tend to another child 
in the home. Some caregivers left the victims unattended for more 
deliberate reasons such as performing household chores, playing video 
games, or watching television.
    The remaining three deaths reportedly occurred while the caregiver 
was with the child in the bathroom. In two of these cases, the 
caregivers reportedly turned away momentarily and looked back at the 
victims to find them face down in the water. In the other case, the 
caregiver saw the incident occur but panicked briefly.
    In 31 of the 78 deaths (40%), the victim was put into the bathtub 
with another child (or children). However, not all of these other 
children were still in the bathtub when the drownings occurred.
    Most of the caregivers involved in the reported incidents were 
parents. Sixty-six of the victims were being cared for by a parent or a 
parent and another family member. The remaining twelve children died 
while under the supervision of a baby sitter. The youngest caregiver 
was 11 years old.

2. Hazard Scenarios

    The Commission staff has identified six main hazard scenarios 
associated with bath seat/ring deaths and incidents. While not all of 
the deaths and near misses under each listed hazard scenario would be 
addressable due to the unusual circumstances in some of the cases, six 
identified hazard scenarios are discussed below.
    Bath seat tipping over. In 24 fatalities and 56 non-fatal incidents 
and complaints the bath seat/ring was reported to have tipped over 
submerging the child in the water or allowing the child to escape the 
confines of the seat. In the incidents in which the seat was reported 
to have tipped over, the suction cups may have contributed because they 
failed to adhere to the tub surface; they adhered but the legs of the 
seat separated from the suction cups; or the suction cups were missing. 
It does not appear that one manufacturer's products were involved in 
significantly more fatal tip-over incidents than any other 
manufacturer's products.
    Infant came out of the seat. In 14 fatalities and eight non-fatal 
incidents it was reported that the infant was found outside of the 
upright seat. Presumably in these incidents the child came over the top 
of the seat.
    Entrapment and submersion. In 3 deaths and 15 non-fatal incidents 
and complaints it was reported that the infant slid through the leg 
opening, becoming trapped and submerged in the water. In the 3 
fatalities the leg openings on the bath seats were large enough for the 
infants to fit both legs through one opening but not large enough to 
allow the shoulders and head to pass through. The infants died because 
their faces were partially or completely submerged in the bath water.
    Infant slumped over bath seat. In 8 fatalities and 2 non-fatal 
incidents and complaints the infant was reported to have ``slumped 
over'' the bath seat rim. Although the water depth data provided in 
these cases is limited, water depth could have played a role in these 
incidents.
    Overflowing water. In 2 fatalities and one non-fatality the bath 
water was reported to have overflowed. One death involved a 5-month-old 
child in a laundry tub. The other death involved an 8-month-old victim 
in a bathtub.
    Bath seat breaking. The Commission received 11 complaints of bath 
seats breaking during use. The complaints included bath seat legs 
breaking or detaching, the rings around the child breaking, mats 
ripping away from the legs/suction cups and the bath seat cracking.
    No scenario determined. In the remaining 27 fatalities and 17 non-
fatal incidents and complaints, information was insufficient to 
determine a hazard scenario. These include incidents where children 
were found in water, but the position of the bath seat was unknown; 
incidents where the bath seat was upright, but the position of the 
child was unknown, and incidents where the circumstances were unknown 
or uncertain.

D. 1993 Focus Group

    In preparation for the 1994 Commission briefing on bath seats/
rings, Human Factors staff worked with a contractor to conduct consumer 
focus groups to learn more about how consumers use bath seats/rings. 
The groups provided a variety of information regarding bathing 
children, bath time supervision habits, and use of bath seats/rings. 
The following points summarize participants' responses regarding 
leaving children in the bathtub for a short period of time:
    (1) Despite an intellectual knowledge of the hazard of drowning, 
and agreement that children should never be left alone in the bath, 
some participants acknowledged having done so, albeit infrequently, and 
typically for only a few moments.
    (2) Responses suggested that, although emergency situations occur, 
they are not the primary reason that caregivers turn away from a child 
in the bath. Participants reported that practical, non-emergency 
reasons, such as needing a towel, pajamas, or a diaper were more likely 
reasons for leaving the child.
    (3) Participants' responses indicated that uneventful experiences 
with leaving a child unattended in the bath tended to encourage 
repetition of this behavior.
    (4) In general, participants perceived bath rings as convenience 
items rather than as safety devices. However, responses suggested that 
some users gained a sense of security from the sets/rings, and believed 
the child was safer in a bath seat/ring. These included comments that 
they believed their child was less likely to stand up or slip around if 
they were restrained in a bath seat/ring.
    (5) The sturdier, more luxurious-looking bath rings/seats were 
preferred by most participants, and were perceived to be safer than 
more basic models.
    (6) Young children are frequently bathed with their older siblings. 
Therefore, the bathtub is typically filled to meet the needs of the 
oldest child in the tub. In addition, the presence of older siblings, 
especially those considered mature, increases parents' confidence that 
their young child will be safe if they must leave the bathroom for a 
moment. Participants were unable to come to any consensus regarding at 
what age a child can be trusted in the bath alone or at what age a 
sibling is old enough to supervise a younger child in the bath.

E. Research reported by Dr. N. Clay Mann

    Petitioners refer to recent research conducted by Dr. N. Clay Mann 
under the auspices of a co-petitioner, the Intermountain Injury Control 
Research Center at the University of Utah. Dr. Mann compared infant 
drowning deaths in bathtubs with infant drowning deaths in bathing aids 
in bathtubs. The petitioners cite two main conclusions from Dr. Mann's 
presentation. First, Dr. Mann characterized caregivers' recollections 
as to why they left a child unattended in the bathtub as more likely

[[Page 39695]]

to be willful as opposed to impulsive when there was a bath seat 
present in the bathtub. Second, Dr. Mann's analysis found that the 
water at the time of the fatal incident was deeper in incidents 
involving baby bath seats than in bathtubs without a bath seat, and 
that the difference was statistically significant.
    CPSC staff analyzed the bath seat and bathtub data Dr. Mann used in 
his research. Although the staff's analysis yielded slightly different 
results, the basic conclusions were the same. CPSC staff found that 
when a bath seat was involved caregivers were more likely to cite a 
conscious or willful decision for leaving the child alone than when 
there was a bathtub drowning with no bath seat involved. Staff also 
found a slightly higher water depth for those deaths where children 
were in bath seats.
    According to CPSC staff's analysis of the hazard scenarios, the 
water depth may be an issue in the situations in which the bath seat is 
upright and the infant slumps over the seat rim or when the infant 
comes out over the top of the seat; however, the water depth data was 
very limited and therefore no conclusions could be made.

F. Relevant Statutory Provisions

    The petition was docketed under 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 ``in normal use or when subjected to 
reasonably foreseeable damage or abuse, its design or manufacture 
presents an unreasonable risk of personal injury or illness.'' 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 is 
commenced by issuance of this ANPR. After considering any comments 
submitted in response to this ANPR, the Commission will decide whether 
to issue a proposed rule and a preliminary regulatory analysis in 
accordance with section 3(h) of the FHSA. If a proposed rule is issued, 
the Commission would then consider the comments received in response to 
the proposed rule in deciding whether to issue a final rule and a final 
regulatory analysis. 15 U.S.C. 1262(i).

G. Regulatory Alternatives

    One or more of the following alternatives could be used to reduce 
the identified risks associated with baby bath seats and rings.
    1. Mandatory standard. The Commission could issue a standard that 
would ban any baby bath seats or rings that did not comply with the 
specified standard. Thus, if the Commission found that some 
modifications to baby bath seats/rings were possible that would 
adequately reduce or eliminate the risk of injury associated with the 
current product, the Commission could issue such a standard-setting 
rule.
    2. Mandatory labeling rule. Similarly, the Commission could issue a 
rule banning bath seats and rings that did not contain specified 
warnings if it found that such warnings could sufficiently reduce the 
risk of injury associated with baby bath seats/rings.
    3. Voluntary standard. If the Commission determined that a 
voluntary standard was adequate to address the risk of injury 
associated with the product, the Commission could defer to the 
voluntary standard in lieu of issuing a mandatory rule.
    4. Banning rule. The Commission could issue a rule declaring baby 
bath seats and bath rings to be banned hazardous substances.

H. Existing Standards

    When the Commission first examined baby bath seats in 1994, no 
mandatory, voluntary or international standards addressed drowning 
while using baby bath seats and rings. Currently, the Commission is 
aware of one voluntary standard relating to bath seats, the ASTM F1967-
99 Standard Consumer Safety Specification for Infant Bath Seats (first 
published in June 1999). During August and September 1999, additional 
requirements for improved performance of suction cups and latching/
locking mechanisms were balloted; ASTM estimates that the revised 
standard will be published by July 2001.

1. Provisions of the Bath Seat Voluntary Standard

    According to the statement of scope in the standard, ``This 
consumer safety specification establishes performance requirements, 
test methods, and labeling requirements to promote the safe use of 
infant bath seats.'' A summary of the major requirements in this 
standard follows:
    Stability. This requirement addresses the bath seat's resistance to 
tipping over during normal use. The provision is intended to ensure 
that new bath seats' suction cups properly attach to the bathtub 
surface.
    Restraint. Bath seats must provide a passive crotch restraint to 
prevent the occupant from sliding out through the product. For bath 
seats on the market this requirement is met by a fixed vertical bar 
between the infant's legs. The standard also specifies that bath seats 
shall not include additional restraints that require action by the 
user. The rationale for this requirement was that a redundant system 
would give the caregiver a false sense of security.
    Resistance to Folding. If the bath seat folds, it is required to 
have a latch or locking mechanism to prevent the unit from 
unintentionally folding during use.
    Labeling. The standard requires a warning label on the product, 
instructions, and packaging consisting of the safety alert symbol (an 
equilateral triangle surrounding an exclamation point), the signal word 
WARNING in all capital letters and the following two sentences: 
``Prevent drowning. ALWAYS keep baby within arms reach.'' The signal 
word and all other capital letters shall be in san serif type-face with 
letters not less than 5 mm (0.2 inches) in height, with all remainder 
of the text not less than 2.5 mm (0.1 inches) in height. The warning 
must be located on the product so that it is visible to the adult 
caregiver and must be a contrasting color to the background. If the 
bath seat is not recommended for use on a slip-resistant surface, an 
additional warning label stating this is required only on the package.

2. Concerns About the Bath Seat Voluntary Standard

    After reviewing the voluntary standard, the staff is concerned that 
provisions for stability of the seat, suction cup operation, occupant 
retention and labeling may not adequately address the drowning hazard.
    All bath seats currently on the market rely on suction cups to keep 
the seat stable. The stability of the seat is greatly affected by the 
existence or performance of the suction cups. If suction cups are 
missing or detach from the tub surface or the bath seat, it is more 
likely that the bath seat will tip over when the occupant leans out 
over the rail. The stability test in the voluntary standard addresses 
suction cup performance but not performance over time or on non-smooth 
or dirty surfaces. The suction

[[Page 39696]]

cups operate by creating an air or watertight seal between the bathtub 
surface and the bottom of the suction cup material. A leak in the seal 
between the suction cup and bathtub surface allows air or water to leak 
under the suction cup resulting in detachment of the suction cup from 
the tub surface. A rough tub surface would allow such a leak to occur. 
The suction cups used on bath seats will not adhere to textured bath 
surfaces or slip resistant surfaces. Dirt or soap scum build up could 
also degrade the performance of the suction cups.
    The occupant retention system currently required by the ASTM F1967 
standard for bath seats is a passive crotch restraint. A center post is 
the most common form of passive restraint used on bath seats and is 
intended to prevent the infant from slipping down and out of the bath 
seat. However, the standard does not have any leg opening size 
requirements, and staff is aware of three deaths when infants got both 
legs through a leg opening and became trapped and submerged under water 
because their shoulders and head could not pass through the opening.
    Moreover, this type of passive restraint does not prevent the 
infant from climbing out of the bath seat. Also, the ASTM F1967 bath 
seat standard does not allow additional user activated restraints 
because the subcommittee believed that this would provide the caregiver 
with a false sense of security and could increase the likelihood that a 
parent might leave a child unattended.
    According to the Division of Human Factors, warning labels have 
limited effectiveness on user behavior when the product is familiar and 
perceived to be benign. Warning labels are the least effective way to 
address a hazard and, if possible, should not be relied upon as the 
sole means of preventing deaths and injuries. This is particularly true 
when the product is familiar and perceived to be benign.
    The voluntary standard also requires a label on the packaging of 
the product, but not the bath seat itself, advising consumers not to 
use the product on non-skid bathtub surfaces. This label is likely to 
have limited effectiveness because (1) it fails to explain to the user 
the hazard of using the product on a slip-resistant surface (i.e., 
suction cup failure), and (2) the product's packaging is not likely to 
remain with the product and the message is lost to anyone who does not 
see the packaging. This type of product is likely to be handed down to 
family and friends with young children or sold at garage sales without 
the packaging.

3. Voluntary Standard for Slip Resistant Tub Surfaces

    The Commission is aware of an ASTM standard for slip-resistant 
bathtub surfaces, ASTM F 462-79 (reapproved 1999) ``Standard Consumer 
Safety Specification for Slip-Resistant Bathing Facilities.'' According 
to the Plumbing Manufacturers Institute (``PMI''), this standard is 
used for most enameled-coated steel tubs but not for plastic tubs. 
Suction cups will not adhere to slip resistant surfaces. Therefore, 
this standard could affect the performance of bath seat suction cups.

I. Public Comments on the Petition

    The Commission published a Federal Register notice asking for 
comments on the petition when it docketed the petition. 65 FR 50968 
(August 22, 2000). The Commission received 66 comments in response to 
the notice. Of those 66 comments, 45 were a form letter expressing the 
same concerns as those of the petitioner and asking the Commission to 
support the petition to ban bath seats. Seventeen other comments also 
supported the petition and expressed concerns about the hazards 
involving bath seats. Three comments discussed in-depth why the CPSC 
should deny the petition. Finally, one consumer provided information 
both supporting and opposing the petition.
    Discussed below are the eight primary issues raised in the comments 
and the Commission's responses to those issues. The numbers found in 
parentheses after a comment refer to the commenter number assigned by 
the Office of the Secretary. The letters ``FL'' refer to the form 
letter used by many of the commenters.

1. Unreasonable Risk

    Comment: According to most commenters, 66 deaths from January 1983 
to June 2000 and 37 near-drownings are too many. They note that when 
the Commission first looked into the hazards involving bath seats there 
had been 13 deaths in 10 years. In the following 6 years, 53 additional 
deaths occurred. They viewed this as an unreasonable risk because of 
the ``alarming'' number of deaths with a product that they stated had a 
useful life of only 2 months. (FL, #20, 24, 28, 56, 58, 60)
    CPSC Response: The Commission is also concerned about the number of 
deaths. CPSC staff has identified 78 deaths and 110 non-fatal incidents 
from January 1983 to May 2001. However, the large number of incidents 
reported to CPSC from 1995 through 2001 are not necessarily due to an 
increase in frequency of the events. After the Commission's actions in 
1994, staff increased data collection efforts by investigating all 
bathtub drowning deaths. Media attention increased public awareness of 
the hazard and number of deaths, thus increasing the reporting of the 
incidents. Because of the increased efforts of data collection on 
infant drownings, CPSC staff is confident in the completeness of the 
bathtub drowning data. These continued efforts should allow for trend 
analysis in bath seat-related drowning deaths. Death data prior to 1994 
and incident data are anecdotal and should not be used to suggest 
trends.

2. False Sense of Security

    Comment: Many commenters quoted research conducted by Dr. N. Clay 
Mann that suggests parents and caregivers of infants who use bath seats 
engage in more risk-taking behavior than non-bath seat users. These 
commenters argue that bath seats are viewed as safety devices and 
thereby provide the user with a false sense of security. The 
petitioners and almost all of the comments from consumers in favor of 
granting the petition indicated that the product leads the user to 
believe that the child is ``safe'' in the bath seat in the water. (FL, 
#1, 54, 56, 59, 60, 62)
    Some commenters stated that the product may not claim to be a 
``safety device'' but it certainly gives the impression it is, 
especially those with the brand name ``Safety 1st'' on the package. 
(#13, 16, 28, 40, 64)
    One commenter, who opposes the petition, stated that the product 
does not cause a false sense of security, but rather the caregiver 
undertakes risky behavior because previous behavior resulted in no 
injury. (#53)
    Another commenter, who also opposes the petition, stated, ``The 
unreasonable actions of caregivers who leave infants unattended in 
bathtubs, whether or not a bath seat or ring is used, results in the 
hazards, with tragic consequences. This behavior itself defies the 
common sense approach used by 99.999% of the population and is 
unreasonable. As we have noted, the products themselves performed 
properly and as intended. It was not the normal or even foreseeable 
misuse of the product that creates the hazard, but rather the 
unreasonable behavior of the caregiver. No standard, whether mandatory 
or voluntary, can address this risk.'' (#63)

[[Page 39697]]

    CPSC Response: Various sources \3\ indicate that many consumers 
purchase the product for safe handling of babies and convenience 
reasons. Consumers may not be ready to bathe their infants in a regular 
size bathtub and, therefore, are looking for a device to help them 
contain a wet, slippery, squirmy infant.
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    \3\ Sources included: CPSC focus groups results, IDIs, consumer 
opinions on internet website and marketing information.
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    In determining whether a product presents a mechanical hazard, the 
Commission considers the product's normal use and reasonably 
foreseeable abuse. See 15 U.S.C. 1261(s). 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.
    The Commission agrees that babies should never be left alone in 
water, whether with a bath seat or not and intends to undertake an 
aggressive information and education campaign to reinforce this 
message. In some incidents, the hazard scenario was unclear. However, 
the available information indicates that some aspects of bath seat 
design appear to have been a factor in the deaths of a number of 
infants. In the course of rulemaking, the Commission will examine ways 
to address these design-related hazards.

3. Bath Seat Incompatible With Bathtubs

    Comment: Several comments pertained to the current voluntary 
standard, ASTM F 462-79 (reapproved 1999) ``Standard Consumer Safety 
Specification for Slip-Resistant Bathing Facilities.'' This standard 
establishes slip-resistance surface requirements to minimize injuries 
in tubs and showers. The commenters indicated that suction cups that 
are used to adhere the bath seats to the tub surface do not work on 
slip-resistant surfaces. (FL, #2, 28, 59, 60, 64)
    Another commenter, who opposes the petition, stated, ``As we have 
noted, the products themselves performed properly and as intended.'' 
However, that same commenter indicated that the data show suction cups 
on the seats failed on smooth surface bathtubs not just slip-resistant 
surfaces. (#63)
    CPSC Response: According to CPSC Engineering Sciences staff, 
adherence of the suction cup to the bathtub surface requires an 
adequate seal between the mating surfaces. Suction cups used on bath 
seats will not adhere to textured bath surfaces or slip-resistant 
surfaces. Dirt or soap scum build up could also degrade the performance 
of the suction cup. However, dissolved or suspended particles in the 
bath water such as oils and soap should not affect the suction cup 
adherence to the tub.
    The Commission disagrees with the commenter's statement that the 
``products themselves performed properly and as intended.'' In certain 
of the incidents, the products did not perform as intended. In 24 of 
the 78 fatalities and 56 reported non-fatalities, the bath seats 
detached from the tub surface and tipped over. In addition, many 
consumers reported on an opinion website that they were using the bath 
seat when all of a sudden, without any warning the seat tipped over and 
the child was under the water. In some of these incidents the consumers 
stated that they had used the product a number of times before and 
occasionally had difficulty removing the suction cups when bath time 
was over. Other consumers indicated that right from the start they had 
trouble with the suction cups only working some of the time.
    CPSC data are inconclusive about the types of surfaces on which the 
tip-overs occurred, so CPSC is unable to verify the commenter's 
assertion that data show seats failed on smooth surface tubs. However, 
there were a number of comments on the Internet in which consumers 
specifically state that their tubs had smooth surfaces and the suction 
cups failed.

4. Labeling--Slip Resistant Surfaces

    Comment: A few commenters stated that the label warning against the 
use of the bath seat on non-skid tubs should be on the product, not 
just the package. Due to the short useful life of the product, the bath 
seat is likely to be passed on to other family members or friends 
without the box. This makes the label ineffective for these other 
users. (#2, 59)
    CPSC Response: CPSC agrees with the comments that a warning label 
only on the packaging and not on the product is likely to be less 
effective than a label placed on the product. The effectiveness of this 
label is limited for two reasons. First, it fails to explain to the 
user why the product should not be used on non-skid bathtub surfaces 
(suction cup failure). Second, the product's packaging is not likely to 
remain with the product; therefore, the message is lost to anyone who 
does not see the packaging.

5. Labeling--Keep Child Within Arm's Reach

    Comment: Regarding the labeling warning to keep the child within 
arm's reach, a commenter who is against the petition, referenced 
information from CPSC focus groups that were conducted in 1993. The 
commenter states ``Almost all of the parents surveyed recalled the 
warnings on the product, packaging or instructions and view it as an 
important reminder that the consequences of leaving an infant alone in 
the bathtub could be drowning. This fact undercuts the Petitioners' 
argument that the warnings are not noticed and are ineffective.'' (#63)
    CPSC Response: The Commission disagrees with the commenter's 
conclusion that the focus group results which showed that consumers 
recalled the warning label are evidence that undercuts the arguments 
that warnings are not noticed and ineffective. According to the focus 
groups, consumers were able to recall the warning not to leave a child 
unattended. However, the focus group members also reported situational 
variables that made them comfortable leaving a child unattended. Those 
variables include using a bath ring/seat, having an older sibling in 
the bath, and being able to see and hear the child even though they had 
physically left the bathroom.\4\ Judging from the focus group's 
comments and the actions of the caregivers in the fatal and non-fatal 
incident data who left the child alone in bath rings/seats, in those 
instances the warnings were ineffective.
---------------------------------------------------------------------------

    \4\ ``A Focus Group Study to Evaluate Consumer Use and 
Perceptions of Baby Bath Rings/Seats CPSC-R-93-5839'' by Shugoll 
Research.
---------------------------------------------------------------------------

6. Water Depth

    Comment: A couple of commenters expressed the belief that if 
parents are not given proper guidance they will fill the tub with more 
water than is necessary. They stated that the bath seats should be 
marked with a ``water line'' so caregivers don't fill the water higher 
than the ``safe level'', since too much water increases chances of 
drowning. (#2, 64)
    One comment from a consumer against the petition states, ``The 
marker should be set at a point where in case the baby fell out of the 
seat, he or she would not be in danger of drowning.'' (#53)
    CPSC Response: The Commission will consider the merits of having a 
``waterline'' on the product. There is no ``safe'' water level to 
prevent drownings that occur in the tub, but outside of the bath seat 
(or in cases where a seat tips over with the child still in it). 
However, a maximum water level mark, as reflected by guidance on the 
product, could help prevent drownings that occur when overly deep water 
either causes infants to come out of the seat or

[[Page 39698]]

covers their faces if they slump forward or backward in the seat.

7. Bath Seat vs. Bathtub

    Comment: One of the comments against the petition states that on 
average 4 children per year drown in bath seats while ``in excess of 50 
infants under one year of age are estimated to drown because caregivers 
fail to watch infants in bathtubs.'' This commenter believes that 
``statistically, it seems that children are safer when caregivers use 
bath seats compared to when they are not in use.'' (#63) Another 
comment, also against the petition, stated that on average there are 9 
bath seat drownings and 41 bathtub drownings as a result of the primary 
caregiver leaving the child alone. (#61)
    CPSC Response: Averaging the 78 deaths over 18 years produces an 
average of 4 bath seat deaths a year. However, due to incomplete 
reporting, especially in the first years of data collection on this 
subject, this average is not an adequate statistic. The commenter fails 
to incorporate the number of users into his comparison of bathtub 
deaths and bath seat deaths. Since more children are bathed in a 
bathtub than in a bath seat, one would expect the number of children 
who die in bathtubs to be greater than the number of children who die 
in bath seats. In addition, the quoted 50 deaths per year includes bath 
seat deaths and deaths in bathtubs with other products.
    The Commission staff has performed a more detailed analysis in an 
attempt to calculate the relative risk of children drowning in bathtubs 
with and without a bath seat. Staff analyzed drowning data from 1994 
through 1998 in conjunction with bath seat ownership rates from the 
Baby Products Tracking Study. The focus was on children between 5 and 
10 months old and children who were placed in the bathtub or seat by 
the caregiver for the purposes of receiving a bath.
    Based on this analysis, the overall risk of death of drowning for 
children between 5 and 10 months old is slightly lower when a bath seat 
is present than when no additional bath aid is present. Due to the 
developmental differences in children between 5 and 10 months, staff 
felt it necessary to look at the risk of drowning for each month of age 
of the recommended user. This data showed similarities among 5, 6, and 
7 month old children and similarities among children 8, 9, and 10 month 
olds. The data suggest that children 5 to 7 months old may be more at 
risk of death when bathed in a bath seat than when bathed in a bathtub. 
At 8 to 10 months, the risk of death is greater in a bathtub than in a 
bath seat. The Commission cautions that the small numbers and the use 
of ownership data as opposed to usage data make it difficult to draw 
firm conclusions about relative risk.
    The Commission reviewed data from the National Center for Health 
Statistics (``NCHS'') on bathtub drowning deaths to children under one 
year of age to look at long-term drowning data. The number of bathtub 
drowning deaths and the risk of death per live birth slightly increased 
through the 1980's and has declined in the 1990's. These data, however, 
include incidents with bath seats, other bathing products, and 
incidents where children climbed or fell into bathtubs, as well as 
incidents where children drowned while taking a bath. Therefore, we 
cannot extract trends in bath seat deaths over this time period. The 
Commission does not have information from which to attribute a cause of 
the decline in infant bathtub drowning deaths.

8. Current Bath Seat Voluntary Standard

    Comment: Three of the comments supporting the petition stated that 
the current ASTM F1967-99 ``Standard Consumer Safety Specification for 
Infant Bath Seats'' is ineffective in addressing the hazard of bath 
seat drownings. One consumer called the standard a ``performance'' 
standard rather than a ``safety'' standard. (#40) Another stated that 
the standard failed to adequately address the leg opening problem, the 
efficacy of suction cups, the lack of a water line, and the failure to 
label the product regarding non-skid surfaces. (#2) The third consumer 
felt the standard was inadequate because it called for ``no significant 
structural changes to existing bath seat designs.'' (#54)
    One comment against the petition states that ``the voluntary 
standard addressed most of all of the CPSC staff recommendations.'' 
(#63)
    CPSC Response: The Commission agrees that there are concerns with 
the adequacy of the voluntary standard. These concerns are discussed in 
detail in section H.2. above. The current voluntary standard was not 
intended to address all hazard scenarios. As noted, the current 
voluntary standard does not address leg-opening requirements. CPSC is 
aware of 3 fatalities and 15 non-fatalities in which infants slipped 
partially through the leg opening and became trapped and submerged 
under water. Although the voluntary standard has requirements for 
testing the stability of the seat, the test is performed using a new 
bath seat on a simulated bathtub surface and does not address suction 
cup performance over time or suction cup performance on non-smooth or 
dirty surfaces. CPSC data show 24 fatalities and 56 non-fatalities 
occurred when the seat tipped over. In most of these cases the suction 
cups played a part in the tip-over by either failing to adhere to the 
tub surface; adhering to the surface but separating from the seat legs; 
or from being missing. The adequacy of the requirement for labeling on 
the package concerning non-skid surfaces is also questionable because 
it does not specifically identify the hazard and because the label is 
only required for the package.
    The voluntary standard does not require a waterline, and Commission 
staff in the past has agreed with this approach. While there is no 
``safe'' water level for children who are in the tub but outside of 
their bath seat (or where the seat tips over and the child remains in 
it), encouraging less water in the tub through some mark on the product 
could reduce the incidents of infants drowning by coming out of the 
bath seat or when they slump over in their seats.
    The staff recommendations that were provided to the voluntary 
standards' working group were intended to make bath rings/seats less 
dangerous. The staff's position as reported in the May 1994 briefing 
package stated: ``Based on current research, labeling is known to have 
limited effect on user behavior, particularly when the product is 
familiar and perceived to be benign. Judging from the IDIs, the 
effectiveness of the current label is questionable, but for the sake of 
those who may read and heed it, a more specific and direct warning such 
as `Stay in arm's reach of baby in bath seat * * *' was recommended.'' 
The ASTM committee did adopt the staff recommended labeling and adopted 
certain requirements for suction cups at the Commission staff's 
request. Also, staff recommended leg-opening requirements that were not 
included in the standard.

J. Solicitation of Information and Comments

    This ANPR is the first step of a proceeding that could result in a 
mandatory rule for baby bath seats and rings to address the described 
risk of injury. All interested persons are invited to submit to the 
Commission their comments on any aspect of the alternatives discussed 
above. In accordance with section 3(f) of the FHSA, the Commission 
solicits:
    1. Written comments with respect to the risk of injury identified 
by the Commission, the regulatory alternatives

[[Page 39699]]

being considered, and other possible alternatives for addressing the 
risk.
    2. Any existing standard or portion of a standard which could be 
issued as a proposed regulation.
    3. A statement of intention to modify or develop a voluntary 
standard to address the risk of injury discussed in this notice, along 
with a description of a plan (including a schedule) to do so.
    In addition, the Commission solicits the following specific 
information:
    1. Information on the useful life of currently produced bath seats;
    2. Information on the potential effect of any regulatory action on 
firms, including small entities;
    3. Information on potential loss of consumer utility from any 
regulatory action;
    4. Information on mechanisms to enhance stability/retention, 
especially in tubs with non-skid surfaces;
    5. Information on the appropriate mechanisms to prevent infants 
from sliding through the bath seat (``submarining'');
    6. Any exposure data and/or any calculations relative to the risk 
of drowning in bath tubs with or without bath seats;
    7. Any other information available related to the potential costs 
and benefits of a rule.
    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 20814; telephone (301) 504-0800. Comments also may be filed by 
telefacsimile to (301) 504-0127 or by email to [email protected]. 
Comments should be captioned ``ANPR for baby bath seats.'' All comments 
and submissions should be received no later than October 1, 2001.

    Dated: July 26, 2001.
Todd Stevenson,
Acting Secretary, Consumer Product Safety Commission.

List of Relevant Documents

    1. 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.
    2. Petition HP 00-4 from the Consumer Federation of America, The 
Drowning Prevention Foundation, et al. to Ban Baby Bath Seats, July 
25, 2000.
    3. Memorandum from Mary F. Donaldson, Directorate for Economic 
Analysis, ``Baby Bath Seat Petition, HP-00-4,'' February 16, 2001.
    4. 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.
    5. Memorandum from Debra Sweet, Division of Hazard Analysis, 
``Hazard Analysis Memorandum for Bath Seat Petition,'' January 29, 
2001.
    6. Memorandum from Celestine T. Kiss, Division of Human Factors, 
``Human Factors Response to Bath Rings/Seats Petition (HP-00-04),'' 
January 25, 2001.
    7. Memorandum from M. Kumagai, Directorate for Engineering 
Sciences, ``Review of BATH SEAT ASTM STANDARD F1967 and Response to 
Comments to Petition HP 00-4,'' March 2, 2001.
    8. Memorandum from M. Kumagai, Directorate for Engineering 
Sciences, ``Evaluation of Bath Seat Design,'' March 2, 2001.
    9. 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.
    10. 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. 01-19072 Filed 7-31-01; 8:45 am]
BILLING CODE 6355-01-P