Safety Standard for Infant Bath Seats: Final Rule, 31691-31699 [2010-13073]

Agencies

• Consumer Product Safety Commission

[Federal Register Volume 75, Number 107 (Friday, June 4, 2010)]
[Rules and Regulations]
[Pages 31691-31699]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-13073]


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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1215

[CPSC Docket No. CPSC-2009-0064]


Safety Standard for Infant Bath Seats: Final Rule

AGENCY: Consumer Product Safety Commission.

ACTION: Final rule.

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SUMMARY: Section 104(b) of the Consumer Product Safety Improvement Act 
of 2008 (``CPSIA'') requires the United States Consumer Product Safety 
Commission (``Commission,'' ``CPSC,'' ``we'') to promulgate consumer 
product safety standards for durable infant or toddler products. These 
standards are to be ``substantially the same as'' applicable voluntary 
standards or more stringent than the voluntary standard if the 
Commission concludes that more stringent requirements would further 
reduce the risk of injury associated with the product. We are issuing a 
safety standard for infant bath seats in response to the direction 
under section 104(b) of the CPSIA.

DATES: The rule will become effective on December 6, 2010 and apply to 
products manufactured or imported on or after that date. The 
incorporation by reference of the publication listed in this rule is 
approved by the Director of the Federal Register as of December 6, 
2010.

FOR FURTHER INFORMATION CONTACT: Carolyn Manley, Office of Compliance 
and Field Operations, Consumer Product Safety Commission, 4330 East 
West Highway, Bethesda, MD 20814; telephone (301) 504-7607; 
cmanley@cpsc.gov.

SUPPLEMENTARY INFORMATION: 

A. Background and Statutory Authority

    Section 104(b) of the Consumer Product Safety Improvement Act of 
2008 (``CPSIA,'' Public Law 110-314) requires the Commission to 
promulgate consumer product safety standards for durable infant or 
toddler products. Section 104 includes infant bath seats among these 
products. See CPSIA, section 104(f). The standards developed under 
section 104 of the CPSIA are to be ``substantially the same as'' 
applicable voluntary standards or more stringent than the voluntary 
standard if the Commission concludes that more stringent requirements 
would further reduce the risk of injury associated with the product. 
Section 104(b)(2) of the CPSIA directs the Commission to begin 
rulemaking for two standards by August 14, 2009. Under this provision, 
the Commission published a notice of proposed rulemaking (``NPR'') in 
the Federal Register of September 3, 2009 (74 FR 45719) proposing a 
safety standard for bath seats. The proposed standard was substantially 
the same as a voluntary standard developed by ASTM International 
(formerly known as the American Society for Testing and Materials), 
ASTM F 1967-08a, ``Standard Consumer Safety Specification for Infant 
Bath Seats,'' with some modifications to strengthen the standard in 
order to reduce the risk of injury associated with bath seats. The 
Commission is now issuing a final standard for infant bath seats that 
is almost the same as the proposed standard it published in September 
2009.

B. The Product

    Infant bath seats are used in a tub or sink to support a seated 
infant while he or she is being bathed. They are marketed for use with 
infants between the age of approximately 5 months (the time at which 
infants can sit up unassisted) to the age of approximately 10 months 
(the time at which infants begin pulling themselves up to a standing 
position). Currently, there are two manufacturers and one importer of 
bath seats active in the United States (one fewer than at the time the 
Commission published its proposed rule). All are members of the 
Juvenile Products Manufacturers Association (``JPMA''), which is the 
major United States trade association representing juvenile product 
manufacturers and importers. All produce a variety of children's 
products in addition to bath seats.
    The exact number of bath seats currently sold or in use is not 
known. Data from a 2005 survey by the American Baby Group (2006 Baby 
Products Tracking Study), in conjunction with Centers for Disease 
Control (``CDC'') birth data, indicated annual sales of bath seats of 
about 1.5 million and about 1.8 million bath seats in use. In 2000, 
JPMA estimated annual sales of bath seats at about one million and 
estimated up to 2 million bath seats in use for infants under one year 
of age.

C. ASTM Voluntary Standard

    ASTM F 1967, ``Standard Consumer Safety Specification for Infant 
Bath Seats,'' was first published in 1999. Between 2003 and 2007, the 
ASTM standard was subsequently revised several times to exclude tub-
like products and to include requirements that the Commission had 
proposed in a notice of proposed rulemaking it issued in 2003, 68 FR 
74878 (December 29, 2003).
    In response to changes in the ASTM standard, the design of bath 
seats changed significantly. The new designs use an arm that clamps 
onto the side of the bath tub rather than relying on suction cups for 
stability. In its proposed rule, the Commission referenced ASTM F 1967-
08a, which was published in December 2008, and contains the same 
labeling, stability and leg opening requirements as the 2007 version. 
In April 2010, ASTM published a new version of ASTM F 1967. The 
differences between the 2008 and 2010 standards are insubstantial (one 
word in section 8.1.1). The 2010 version adopted none of the changes 
the Commission proposed. Thus, the final standard continues to 
reference ASTM F 1967-08a.
    JPMA provides certification programs for juvenile products, 
including bath seats. Manufacturers submit their products to an 
independent testing laboratory to test the product for conformance to 
the ASTM standard.

[[Page 31692]]

Currently only one bath seat model is certified to ASTM F 1967-08a.
    The ASTM standard includes general requirements common to many ASTM 
standards for children's products; performance requirements specific to 
bath seats to address the hazards of the bath seat tipping over or the 
child becoming entrapped and/or submerged in the leg openings; and 
labeling requirements to address the child coming out of the bath seat.
    General requirements in the ASTM standard, none of which the 
Commission is modifying, include:
     Requiring compliance with CPSC's standards concerning 
sharp points and edges, small parts, and lead paint (16 CFR parts 1303, 
1500.48, 1500.49, 1500.50, 1500.51, and 1501);
     Requirements for latching and locking mechanisms;
     Requirements to prevent scissoring, shearing and pinching;
     Entrapment testing for accessible holes and openings;
     Torque/tension test for graspable components; and
     A requirement that warning labels be permanent.
    The ASTM standard's requirements specifically related to hazards 
posed by bath seats (as discussed in part F of this preamble, the 
Commission's rule modifies aspects of some of these requirements) 
include:
     A test for stability performed on a test platform 
containing both a slip resistant surface and a smooth surface to test 
whether the bath seat may tip over during use;
     Requirements for restraint systems requiring passive 
crotch restraint to prevent a child from sliding through front or sides 
of the seat;
     Static load test to test whether the bath seat may break 
or become damaged during use;
     A requirement that suction cups (if used) adhere to the 
bath seat and the surface;
     A leg opening requirement to prevent children from sliding 
through these openings;
     A leg opening requirement restricting the expansiveness of 
the seating area to prevent the child from slumping and becoming 
entrapped in a reclined position; and
     Requirements for warning labels and instruction manual.

D. Incident Data

    Since publication of the NPR in the Federal Register of September 
3, 2009, the CPSC staff identified five new fatalities and five new 
non-fatal incidents, all of which occurred in 2009. Three deaths and 
three additional non-fatal incidents involved bath seat products (not 
combination infant bath tub-bath seat products) meeting the stability 
requirements of either F 1967-04 or F 1967-07. One death involved an 
earlier pre-2004 bath seat product and the remaining death involved a 
combination infant bath tub-bath seat product that was certified to the 
2004 edition of the bath seat and bath ring standard (F 1967-04) but is 
no longer being produced. (Combination bath tub-bath seat products are 
no longer covered by F 1967 and will be covered by a new separate 
infant bath tub-specific standard.) This fatality is not included in 
the frequency statistics. The data update for the final rule also 
located additional information enabling CPSC staff to identify two 2005 
fatality case reports, previously considered to be independent, as 
being a single case.
    Taking into account these changes in the data, from 1983 through 
November 30, 2009, there have been 174 reported fatalities involving 
bath seats, although more fatalities may have occurred because fatality 
reporting is not considered to be complete for 2006, 2007, 2008, and 
2009. All of these fatalities were submersions.
    There were 300 non-fatal bath seat incidents reported to CPSC staff 
in this 1983 through November 30, 2009 time frame. A submersion hazard 
was identified in 154 of these non-fatal incidents of which 117 were 
actual submersion incidents. (Submersion is defined as the act of 
placing, or the condition of being, under water. A submersion hazard 
indicates that submersion is possible, as a direct result of the 
incident. An actual submersion is when the victim actually became 
submerged as a result of the incident.) The remaining 146 reports were 
non-submersion hazards such as lacerations and limb entrapments.
    None of the identifiable products involved in the fatal bath seat 
incidents were certified to meet ASTM F 1967-08a or its predecessor, 
ASTM F 1967-07. Four of the non-fatal incidents involved products 
certified to ASTM F 1967-07, neither of which were submersion hazards, 
and thus were not life threatening.
    Of the 174 fatal incidents, 23 involved products that were 
identified as being certified to the 2004 version of the ASTM standard. 
Three of these were due to the arm of the bath seat disengaging from 
the bath tub. Fifty-four of the non-fatal incidents involved bath seats 
certified to the 2004 version of the ASTM voluntary standard.

E. Response to Comments on the NPR of September 3, 2009

    The Commission received seven comments on the NPR of September 3, 
2009. Four comments from individual consumers supported a mandatory 
safety standard for infant bath seats. In addition, the Commission 
received three specific comments on various aspects of the NPR. These 
three comments were from IISG (an international testing laboratory); 
the Juvenile Products Manufacturers Association (JPMA); and one comment 
from various consumer groups (Consumers Union, Kids in Danger, and 
Consumer Federation of America). These comments and the Commission's 
responses to them are discussed below.

1. Leg Opening Requirement

    a. Comment: One commenter asked that the rule be clarified to 
indicate that the torso probe shall be inserted in a straight direction 
and it is not allowed to be inserted partially and then rotated along 
some minor axis to make it pass through the hole.
    Response: In the NPR, the Commission proposed a change to the 
voluntary standard that called for the torso probe to be inserted in 
all orientations of the leg openings to determine if any position can 
create a slip through and/or entrapment hazard. This change was 
proposed because the language in the ASTM standard, which stated that 
the probe should be inserted in the most adverse orientation, was open 
to interpretation by the person performing the test. The language the 
commenter suggests would actually make the requirement less restrictive 
than what is already in the voluntary standard. For this reason, the 
Commission disagrees with the recommendation.
    b. Comment: One commenter argued that the proposed change to the 
leg opening torso probe would not have prevented the two incidents 
discussed in the NPR when children fit both their legs and hips through 
a single leg hole of the bath seat. The commenter asserted that 
reducing the leg opening might exacerbate entrapment and ingress and 
egress conditions. The commenter believes that the ASTM standard has 
optimized this probe size, is consistent with other standards that 
provide similar submarining protection, and should not be changed.
    Response: Although in these two incidents children did become 
entrapped in the leg holes, of more concern is the fact the victims' 
pelvis and torso were able to penetrate the leg openings. Once the 
pelvis goes through

[[Page 31693]]

the leg hole, the victim is in serious danger of submersion because the 
waist and upper torso are more malleable and therefore more capable of 
squeezing through the leg holes. Therefore, contrary to the commenter's 
characterization of the incidents, the leg holes failed to prevent a 
potential submersion condition. The infants were not endangered by the 
entrapment as much as they were endangered by their position during 
their entrapment. These incidents show a failure in the design of the 
torso probe and the leg opening test which was developed to prevent the 
manufacture of leg holes that allow a pelvis to fit through them. As a 
photograph taken of the actual victim from one of the incidents clearly 
shows, in that incident the pelvis had fit through the leg opening. The 
current bath seat torso probe used to test the leg openings was based 
on probes from other juvenile products that do not normally entail use 
with wet, naked babies. The data associated with these two incidents 
suggest that the unique use of a bath seat in a watery, soapy 
environment requires a smaller probe. Reducing the size of leg openings 
by making the torso probe more rounded at the corners and slightly 
smaller will prevent future submersion incidents.
    The issue of entrapment during ingress and egress is irrelevant to 
the leg hole opening test method. The Commission is aware that 
consumers have encountered difficulties with getting infants in and out 
of some models of bath seats currently sold in the United States. 
However, the size and shape of the leg hole opening is only one factor 
in the overall design of a bath seat's occupant retention space. Such 
features as the shape of the seat, the slope of the supports, and the 
thickness and the type of materials used to make the bath seat are not 
determined by the performance requirements of the standard. The leg 
hole opening test does not dictate any other dimensional or design 
requirements for bath seats, leaving the designer ample freedom to 
design a bath seat that allows easy entry and exit.
    c. Comment: One commenter approved of the proposed change to the 
torso probe and conducting testing in all orientations, but stated that 
incident data indicate that leg openings on models currently meeting 
the ASTM standard may still pose this hazard.
    Response: The Commission concurs. The Commission's changes to the 
torso probe are intended to address such incidents.

2. Stability Issues

    a. Comment: One commenter states that the pass/fail criteria in the 
ASTM standard were specifically created to require that both the 
attachment disengage from the test platform and that the product fail 
to return to the manufacturer's intended use position after being 
tested. The commenter asserts that both conditions must be present in 
order to constitute a failure. The commenter argues that the proposal 
to consider a tilt angle of 12-degrees or more from the bath seat's 
initial starting position to be a failure is not indicative of an 
unsafe condition and ``is a departure from the primary intent of the 
requirement which is to determine if the bath seat tips.''
    Response: The two parts of the criteria were added to the ASTM 
standard at different times, and there is no language to suggest that 
both conditions must be met in order to constitute a failure. If that 
were the intent, then there would be no need to add the second pass/
fail criteria because if the bath seat disengaged from the test 
platform (condition 1), then obviously it would not return to 
the manufacturer's intended use position (condition 2). This 
second condition was added in the 2007 standard to address those 
situations where a bath seat started tipping, to a degree that could be 
hazardous, but did not fully disengage from the tub. The Commission's 
modification to the ASTM standard clarifies the intent, as well as 
ensuring that a bath seat which significantly tips during the stability 
test, but returns to a fully upright condition, is not in compliance 
with the requirement.
    b. Comment: The same commenter argues that the 12 degree tilt test 
``is unrelated to submersion risk and would not reduce the risk of 
injury and submersion incidences identified in the incident data. The 
risk of submersion presents itself when the position of the product 
indicates that the child's head area would be in a compromising 
position.''
    Response: CPSC agrees with the last statement presented above which 
is why the Commission is modifying the ASTM standard to provide a 
clearer definition of the pass/fail criteria. If the bath seat is 
tilted, children can slump over, lean over, and expose their faces to 
the water more easily than if the bath seat is not tilted.
    c. Comment: The same commenter states that the 17-pound force used 
in the stability testing in the ASTM standard was based on the 
assumption that the older user of a bath seat would apply his/her total 
weight in the head location when in a seated position. However, the 
commenter states, it is more likely that the child would exert only a 
percentage of his/her total body weight.
    Response: According to the rationale in the ASTM standard 
(Appendix, part X1.17), the original basis for the 17-pound force is 
that it represents 60 percent of the 95th percentile (27.8 pound) body 
weight for oldest users (which was for 12 to 15 month old children at 
the time the requirement was developed), not the child's total body 
weight. A review of the incident data shows that fatal incidents that 
occurred in the newer style bath seats (which are designed for children 
who cannot yet pull themselves to a standing position) involved babies 
whose weights ranged from 15 to 30 pounds, with at least two of the 
victims (ages 8 and 9 months) being 30 pounds at the time of their 
deaths. Thus, it is foreseeable that a child of this size may use the 
product and, as the commenter recognizes, exert a percentage of his/her 
body weight. Thus, the 17-pound force is still valid.
    d. Comment: The same commenter argues that the Commission's change 
to the failure definition (adding the 12 degree tilt angle test) would 
prohibit even ``infinitesimal movements'' of the bath seat with little 
affect on safety.
    Response: The Commission disagrees that this additional requirement 
would prohibit infinitesimal movement. The ASTM standard could be 
interpreted very strictly to not allow any movement or tilt of the bath 
seat from the original position. By adding the 12 degree tilt limit, 
the stability test allows bath seats some controlled flexibility.
    e. Comment: The same commenter asserts that the 12 degree tilt 
angle is random and lacks any rationale as to how exceeding this angle 
could result in a compromising unsafe condition.
    Response: In developing this requirement, CPSC staff conducted an 
analysis looking at various water levels and possible head positions of 
occupants vs. angles of bath seats to determine what level of tilt was 
potentially hazardous. In addition, CPSC staff looked at other ASTM 
standards, such as those for infant bouncer seats and toys which use a 
10 degree table or tilt when testing for stability. Lastly, staff 
acknowledged that the requirement must allow for the ductility of the 
aluminum rod test fixture combined with some expected ductility or 
flexing of the bath seat itself. Therefore, the staff conducted testing 
to determine the maximum level of tilt that might be expected solely 
due to the flexibility of the bath seat and the test rig. As a result 
of this work, staff

[[Page 31694]]

selected a tilt angle of 12 degrees as the pass/fail criteria to insure 
passing products will remain in the manufacturer's intended use 
position.
    Thus, the 12 degree angle will allow for some inherent flexibility 
in the system (the product and the test rig) as a whole, but would fail 
a bath seat that: (1) Stayed firmly clamped to the bath tub but the 
bath seat itself experienced significant ductility (i.e., its ability 
to be fashioned into a new form or drawn out without breaking) or 
flexibility (12 degrees or more) during the testing; or (2) had a 
clamping mechanism that lost firm contact with the bath tub and allowed 
the bath seat to tilt 12 degrees or more during the test.
    f. Comment: The same commenter argues that, so long as the product 
remains attached, the angle at which it may tilt during testing does 
not affect the safety of the bath seat. The commenter asks, if the 
product were to reach a 15 degree angle, how would this angle result in 
an unsafe condition if the product remains attached?
    Response: CPSC disagrees with the commenter's assertion that the 
condition of the product during the test has no bearing on safety. In 
the test, a 17-pound load is applied and then released. In real life, 
if a child leans over a bath seat railing, he/she may not be able to 
sit back upright. Young infants do not have a good sense of balance, 
and the more the bath seat allows them to tilt forward, the less likely 
they will be able to return to an upright position. If a child's body 
remains tilted forward, this could result in his/her face becoming 
submerged in the water. Once an infant's face is submerged, the infant 
may not pull his/her face out of the water. Infants may be physically 
capable of lifting their heads, but they may not do so because they do 
not recognize the need to do so or because they breathe in a lungful of 
water before trying to lift their head. Bath seats should never allow 
an infant's face to be submerged under water. In addition, another 
argument against allowing any significant tilt during the test is that 
the more the seat tilts forward, the higher the likelihood for a child 
to crawl out of the seat. When the seat is far enough forward, even if 
it has not tipped over, the child can stand (hunched over) on his/her 
feet with legs still through the leg holes, and this would also make a 
tilted seat hazardous.
    g. Comment: One commenter agreed that the pass/fail criteria in the 
ASTM stability requirements need clarification, but recommended that 
the Commission consider any movement from the bath seat's originally 
fixed position to be a failure.
    Response: There are three ways that a bath seat can fail the 
stability requirement as proposed in the NPR (and finalized in the 
rule): (1) If the bath seat tips over (and remains tipped over after 
the test); (2) if any attachment point disengages from (is no longer in 
contact with) the test platform (bath tub) and the bath seat fails to 
return to the manufacturer's recommended use position after the test; 
and (3) if the measured tilt angle during the test ever exceeds 12 
degrees.
    The first two pass/fail criteria above were already required under 
the voluntary standard, and the third one was proposed by CPSC as a new 
additional requirement in the NPR, and is also in the final rule. With 
regard to the third criteria, there are two different ways in which a 
bath seat can tilt during stability testing. The first is the tilt that 
might occur when the bath seat attachment slips or moves from its 
original fixed position. The second is the tilt that can occur due to 
the flexibility between all the parts of the bath seat and the bath 
seat test fixture (the aluminum rod and clamping devices). Depending on 
the product, it is possible to have both factors contribute to the 
tilt, or just have the second factor contribute to the tilt.
    There is no way to eliminate the flexibility of the system (the 
bath seat and the test fixture) entirely. The flexibility of the 
aluminum rod itself can result in a two degree tilt. When the clamping 
fixtures and then the expected flexibility of the plastic used in the 
product are added, there is inherent flexibility in the system that 
cannot be totally eliminated. A tilt test must allow for this 
flexibility among all the components of the system. Twelve degrees 
allows for some practical amount of flexibility that is inherent in a 
bath seat and the test rig, but is still not a significant tilt angle 
that might compromise the safety of the occupant.

3. Changes to Test Platform Preparation

    Comment: One commenter stated that, while it agrees with the 
application of the soap solution inside and outside of the tub, it 
believes that the soap solution should be applied once the product has 
been installed, if manufacturers present this as a prerequisite to use 
in instructional literature because clamping mechanisms rely on a clean 
tub side surface for effectiveness.
    Response: Regardless of instructional literature or warnings, it is 
foreseeable that caregivers will install the bath seat on a wet and 
soapy tub; therefore, bath seats should be tested under such 
conditions.

4. Weighing the Seat Down

    Comment: One commenter recommended adding a statement requiring 
removal of the weight once the seat is flooded to eliminate the 
potential for a counterweight to be included during the test.
    Response: The Commission agrees with this comment and has included 
such a statement in the final rule.

5. Maximum Water Level

    Comment: One commenter recommended that all bath seats be labeled 
to indicate a maximum water level to be used. The comment stated that, 
because 96% of all deaths, injuries, and other incidents involve bath 
seats used in water depths greater than one or two inches, the fill 
line demarcation should be specified at depths of no greater than two 
inches.
    Response: The Commission is concerned that a water line could imply 
a safe water level. However, children can drown in very little water. 
In addition, because of various bath seat designs, some of which may 
elevate the bath seat, two inches of water in the tub can correspond to 
a water level insufficient to cover the occupant's legs. Thus, the 
maximum water level recommended would change based on the design of the 
bath seat, and would not necessarily reflect a ``safe level''. The 
Commission believes that the ASTM wording required in the user 
instruction, ``Babies can drown in as little as 1 inch of water. ALWAYS 
bathe your infant using as little water as necessary,'' describes the 
risk associated with any level of water in a more accurate manner. If 
there was a water line indicator that could visually express the 
increasing risk with increasing water depth without implying that a 
shallow level was ``safe,'' then CPSC staff may agree with the 
suggestion. At this time, CPSC staff does not believe a maximum water 
level requirement should be added to the standard, but does believe it 
is something that manufacturers could consider for their products. CPSC 
staff will continue to monitor this issue and the Commission could add 
such a requirement in the future if it is feasible.

6. Incident Data

    Comment: One comment notes that the numbers of fatalities stated in 
the NPR do not reflect the increased fatality rate of recent years. 
Although the 171 reported fatalities involving bath seats from 1983 
through 2008 represents an average of 6.6 reported deaths per year over 
the 26 year period, an analysis of the most recent years for which 
there is

[[Page 31695]]

complete data (1998 through 2007) shows an average of 9.7 reported 
deaths per year--nearly 50 percent more than stated. The commenter 
notes that, in comparison, baby bath tubs (a popular alternative) 
showed an average fatality rate of only 1.7 deaths per year during this 
same time period.
    Response: Some fatalities in recent years involved older products. 
Caution should be used in any analysis since this product, its 
standards, and markets have changed significantly over the years. 
Comparisons between bath seats and infant bath tubs are not 
straightforward due to differences in the product and target 
population. Also, incidents are voluntarily reported and represent a 
minimum count. An updated memorandum of incident data was provided as 
part of the briefing package for the final rule.

7. Risks Related to Bath Seats and Risks Related to Bath Tubs

    Comment: The same commenter noted that comparing the risks related 
to bath seats and those related to bath tubs indicates that the ASTM F 
1967 standard has not been effective in reducing infant deaths in bath 
seats and that bath seats are inherently more dangerous than infant 
bath tubs.
    Response: Risk analysis is very difficult to perform with these 
products due to changes in the market, standards, and product. Without 
accurate usage data, it was not possible for CPSC staff to perform this 
analysis. Comparisons between bath seats and infant bath tubs are not 
straightforward due to differences in the product and target 
population. Based on the ownership data that is available for infant 
bath seats and infant bath tubs, it is clear that infant bath tubs are 
far more prevalent than infant bath seats. It is also clear that many 
of those surveyed own both products, possibly using them at different 
stages in their child's development. It is also apparent that ownership 
rates for bath seats increased substantially between 1993 and 2002, but 
have since dropped off. In 2004, the ASTM standard was significantly 
modified (with additional changes made in 2007 and 2008), which means 
that determining the effectiveness of the voluntary standard requires 
examining the incidents with pre-2004 infant bath seats and comparing 
them to incidents involving post-2004 bath seats--in particular those 
that comply with the voluntary standard. Therefore, looking at only the 
number of annual incidents is insufficient to evaluate the voluntary 
standard's effectiveness or to evaluate its likely effectiveness, were 
it mandatory.

8. Unattended Bath Seats

    Comment: One commenter stated that the bath seat standard must 
address the primary hazard pattern with these products--leaving an 
infant unattended--and encouraged the CPSC to ``explore technology to 
ensure that it would be difficult to use a bath seat unless a caregiver 
is in close proximity to the product.''
    Response: The Commission is open to suggestions to overcome the 
tendency of caregivers to feel confident leaving children unsupervised 
in bath seats. To date, no practical solutions to this serious problem 
have been developed, except for warning labels, which were last 
strengthened in the ASTM voluntary standard in 2007.

9. CPSIA Process

    a. Comment: One commenter stated that the Commission ``should not 
modify existing effective standards unless it can clearly substantiate 
on the record before it that such changes will provide a demonstrable 
reduction of injury.'' The commenter noted that the ASTM standard was 
originally published in 1999 and has undergone several revisions since 
then through the ASTM subcommittee and task group process and that CPSC 
has participated in this process. The commenter states that it sees 
``little value in revising the current requirements in this standard by 
using the NPR regulatory process'' and is ``concerned that the 
imposition of additional requirements without demonstrable evidence 
that they will both enhance bath safety and not create unintended 
entrapment related hazards, will restrict the availability of 
potentially lifesaving products.''
    Response: Section 104(b) of the CPSIA requires the Commission to 
use the notice and comment rulemaking process under the Administrative 
Procedure Act to promulgate consumer product safety standards for 
durable infant or toddler products. The CPSIA directs the Commission to 
issue a rule that is ``substantially the same as'' the applicable 
voluntary standard or ``more stringent than'' the voluntary standard if 
the more stringent standard ``would further reduce the risk of injury 
associated with the product.'' See section 104(b)(1)(B) of the CPSIA. 
The statute does not require that the Commission, in the commenter's 
words, ``clearly substantiate on the record before it that such change 
will provide a demonstrable reduction in injury.'' Section 104 of the 
CPSIA takes durable infant or toddler products out of the Commission's 
usual rulemaking procedure and all of the findings that would be 
required under sections 7 and 9 of the Consumer Product Safety Act 
(``CPSA''). For these products, Congress wanted ``the highest level of 
safety for such products that is feasible.'' See section 104(b)(2) of 
the CPSIA. The Commission recognizes that the ASTM standard has been in 
place for numerous years and has been refined through ASTM's standard-
setting process. Nevertheless, incidents continue to occur. Under the 
mandate of section 104 of the CPSIA, the Commission is promulgating 
more stringent requirements where necessary to address certain design 
features that CPSC staff believes contribute to some of these 
continuing deaths and torso entrapments. The staff has conducted 
testing and performed analyses to support the requirements that are 
different from the ASTM requirements and that it believes will reduce 
the risk of injury from infant bath seats.
    b. Comment: The same commenter states that it believes ``the most 
streamlined approach to following the primary congressional mandate 
that standards required to be developed are to be `substantially the 
same as' applicable voluntary standards, would be to adopt a regulation 
that wholly adopts the existing ASTM standard, with the ability to 
subject it to the ASTM update and review process. CPSC can assure 
itself veto authority as part of an implementing regulation, which 
provides it with the ability to restrict diminution of effective ASTM 
standard provisions, similar to the authority applicable under CPSIA 
Section 106, as a check to changes that reduce stringent protections.'' 
The commenter suggests that CPSC adopt ASTM F 1967-08a as a consumer 
product safety standard issued by the Commission under section 9 of the 
CPSA and that any additional changes to the pending ASTM standard be 
submitted to the ASTM standard setting process. The commenter states, 
``this process could also incorporate a provision by rule that a 
reservation of right to the CPSC to object to any subsequent revisions 
to the ASTM Standard, similar to that afforded under CPSIA Section 
106(g).''
    Response: The standard the Commission proposed for infant bath 
seats incorporates by reference most of ASTM F 1967-08a with a few 
modifications to strengthen the standard. Section 104(b) of the CPSIA 
sets forth the procedure for these standards for durable infant or 
toddler products, and it is different from what Congress provided in 
section 106 of the CPSIA. It is doubtful that the Commission, by rule, 
could change the procedure Congress provided for rules

[[Page 31696]]

under section 104 of the CPSIA to the one Congress provided for rules 
under section 106 of the CPSIA.

F. Assessment of Voluntary Standard ASTM F 1967-08a and Description of 
the Final Rule

1. Section 104(b) of the CPSIA: Consultation and CPSC Staff Review

    Section 104(b) of the CPSIA requires the Commission to assess the 
effectiveness of the voluntary standard in consultation with 
representatives of consumer groups, juvenile product manufacturers and 
other experts. This consultation process began in October 2008 during 
the ASTM subcommittee meeting regarding the ASTM infant bath seat 
voluntary standard. The Commission has reviewed the incident data and 
the ASTM F 1967-08a standard and conducted testing on bath seats to 
assess the ASTM standard.
    Consistent with section 104(b) of the CPSIA, this rule establishes 
a new 16 CFR part 1215, ``Safety Standard for Bath Seats.'' The new 
part incorporates by reference the requirements for bath seats in ASTM 
F 1967-08a with certain changes to specific provisions to strengthen 
the ASTM standard as discussed below. These modifications are almost 
identical to the changes the Commission proposed in the NPR of 
September 3, 2009. Differences from the NPR are noted in the discussion 
below.

2. Description of the Final Rule, Including Changes to the ASTM 
Standard's Requirements

    While most requirements of the ASTM standard are sufficient to 
reduce the risk of injury posed by bath seats, the Commission has 
determined to modify several provisions in the standard to make them 
more stringent and further reduce the risk of injury and to clarify the 
test procedures. The following discussion describes the final rule, 
including changes to the ASTM requirements, and notes any changes from 
the NPR. In addition, some editing and formatting changes have been 
made which make the final text different from the NPR. These changes 
were made at the request of the Office of the Federal Register and do 
not alter the substance of the rule.
a. Scope (Sec.  1215.1)
    The final rule states that part 1215 establishes a consumer product 
safety standard for infant bath seats manufactured or imported on or 
after a date which would be six months after the date of publication of 
a final rule in the Federal Register.
    The Commission received no comments on this provision in the NPR 
and is finalizing it without change.
b. Incorporation by Reference (Sec.  1215.2(a))
    Section 1215.2(a) explains that, except as provided in Sec.  
1215.2(b), each infant bath seat must comply with all applicable 
provisions of ASTM F 1967-08a, ``Standard Consumer Safety Specification 
for Infant Bath Seats,'' which is incorporated by reference. Section 
1215.2(a) also provides information on how to obtain a copy of the ASTM 
standard or to inspect a copy of the standard at the CPSC.
    The Commission received no comments on this provision in the NPR 
and is finalizing it without change.
c. Definition of Bath Seat (Sec.  1215.2(b)(1)(i))
    In the NPR, the Commission proposed changing the definition of bath 
seat to the definition in a previous NPR the Commission had issued in 
2003--``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 * * *.''
    The Commission received no comments on this provision and is 
finalizing it without change.
d. Stability Requirement
    Limiting the tilt of the bath seat (Sec.  1215.2(b)(2)(i), 
(b)(4)(i), and (b)(5)(i)). As discussed in the preamble to the proposed 
rule (74 FR at 45720 through 45721), when testing bath seats, CPSC 
staff found that the clamping mechanism on the JPMA-certified bath seat 
lifted from the side of the tub and continued to tip when force was 
applied. The clamp did not disengage from the tub, but the arm rest 
contact points were no longer in contact with the tub surface. This 
situation allows for possible misinterpretation of the ASTM standard's 
pass/fail criteria because the bath seat tilted from its original 
position while the clamp remained attached to the side of the tub. 
Moreover, this scenario could present a hazard to an infant using a 
bath seat. As explained in greater detail in the response to comments 
in section E of this preamble above, with the bath seat in this 
position an infant could submerge his/her face in the water, and the 
tilt of the seat could increase the likelihood the infant will crawl 
out of the seat. Thus, the NPR proposed a requirement to limit the 
allowable tilt angle of the bath seat during the stability test. This 
modification is added in several places of the ASTM standard: To 
section 6.1, between sections 7.4.2.2 and 7.4.2.3, and between sections 
7.4.2.3 and 7.4.2.4. The Commission proposed that a bath seat capable 
of tilting 12 degrees or more during testing be considered a failure. 
This limit was determined after measuring, and allowing for the 
flexibility of, current products. CPSC staff also considered other ASTM 
standards such as those for infant bouncer seats and toys. These 
standards use a 10 degree table or tilt when testing stability, and so 
the Commission proposed a tilt angle just above that level.
    The final rule retains the 12 degree tilt limit. (We discussed 
comments relating to stability at part E of this preamble.)
    The final rule also clarifies the language in section 6.1 of the 
ASTM standard to make it consistent with the definition of bath seat. 
This is a change from the NPR. Thus, the final rule removes the 
beginning phrase in section 6.1: ``for bath seats which provide support 
for an occupant's back and support for the sides or front of the 
occupant or both.'' Given the definition of bath seat in the final 
rule, this phrase is redundant, and the final rule, therefore, 
eliminates it.
    Clarifying the order of steps in the stability test (Sec.  
1215.2(b)(3)). The final rule retains other proposed changes clarifying 
the order of steps to be performed when conducting the stability test. 
The Commission proposed re-ordering the steps specified in the ASTM 
standard for preparing the test surface and installing the bath seat to 
clarify that the test platform should be flooded before installing the 
bath seat.
    Test solution application (Sec.  1215.2(b)(3)(i)(B)). The 
Commission proposed that a test solution be applied to all areas where 
the product may make contact while in use. As explained in the NPR's 
preamble (74 FR at 45721), the ASTM standard requires that a soapy test 
solution ``thoroughly saturate the coverage area'' which is defined in 
the ASTM standard as any internal surface of the tub well or tub bottom 
that makes contact with the product. In its testing of bath seats, CPSC 
staff found that spraying the soap solution on the top and outer 
surface contact points as well as the interior surfaces affected the 
final position of the bath seat and therefore could affect the results 
of the test. The Commission recognizes that the outside of a tub may 
become wet, and this may affect the ability of a bath seat's attachment 
arm to remain stable. The final rule retains this requirement. (We 
discussed comments relating to test platform preparation at part E of 
this preamble.)

[[Page 31697]]

    Measuring water levels (Sec.  1215.2(b)(3)(i)(D)). When testing the 
stability of bath seats, CPSC staff noted that it can be difficult to 
obtain accurate water level measurements because the unoccupied bath 
seat may float when the test platform is flooded. To address this, the 
Commission proposed to add a clarifying statement: ``For the purpose of 
measuring the water level, the product's seating surface can be 
temporarily weighed down to prevent the seat from floating.''
    In response to a comment to the NPR (see part E of this preamble), 
the final rule retains this change, but also adds the following 
clarifying language: ``The weight shall be removed following the 
measurement of the water level and prior to conducting the test.''
e. Leg Opening Requirement (Sec.  1215.2(b)(6)(i) Through (8))
    According to recent incident reports, children have fit both legs 
and their hips through a single leg hole of a bath seat that complies 
with the ASTM standard. The torso probe specified in the ASTM standard 
used to test the size of the leg openings is not sufficiently analogous 
to the human infant in this wet environment. This has resulted in a 
child's torso fitting through a leg hole when the ASTM torso probe does 
not. The Commission proposed decreasing the length of the vertical and 
horizontal axes of the wood torso probe specified in the ASTM standard 
by approximately five percent and rounding the corners of the probe 
resulting in a 1.45'' radius rather than the current 1'' radius size of 
the probe. To accomplish this, the Commission proposed modifications to 
Figure 4 in the ASTM standard that shows the torso probe. As explained 
in the preamble to the NPR (see 74 FR at 45721) and in the response to 
comments in section E above, the Commission believes that changes in 
the test probe would not restrict the utility of the product, but would 
still allow many possible designs for bath seats, even ones which would 
accommodate large children.
    The NPR also proposed changing (at Sec.  1215.2(b)(6)(i) and 
(7)(i)) the ASTM standard's instruction in section 7.7.1 and 7.7.2 of 
the ASTM standard to insert the test probe ``* * * in the most adverse 
orientation into each opening.'' The Commission proposed changing this 
language because the terms ``the most'' appearing with respect to 
adverse orientation is open to interpretation. The final rule retains 
the proposed wording that the probe needs to be inserted ``in all 
orientations to determine if any position can create a slip through 
and/or entrapment hazard.''
f. Size of Warning Label Requirement (Sec.  1215.2(b)(9) and(10))
    According to the incident data, one hazard associated with almost 
all of the deaths that are reported involving bath seats is caregivers 
leaving children unattended in the bath seat. For example, of the 23 
deaths reported from 2004-2009, where the bath seat product was 
certified to meet the stability requirements of ASTM F 1967-04, 21, or 
more than 91%, occurred when caregivers reported leaving the child for 
as little as 1 minute. (This data, collected by CPSC staff only 
reflects full reporting of deaths through 2006.)
    While ASTM 1967-07 updated the language of the warning label (see 
1967-07 section 8.1), the size of the warning label has not changed in 
any of the prior four updates to this standard. (The previous standards 
required letters not less than 0.2 in. (5 mm) in height for the safety 
alert symbol, the signal word, and all other words that are all capital 
letters, with all remaining text not less than 0.1 in. (2.5 mm) in 
height.) The warning label explains, among other things, caregivers 
should ``ALWAYS keep baby within adult's reach.'' The final rule 
doubles the size of this warning in order to raise the visibility of 
this vital information to caregivers.

G. Effective Date

    In the NPR, the Commission proposed that the standard would become 
effective six months after publication of a final rule. The Commission 
received no comments on the proposed effective date. The final rule 
provides that the rule will become effective six months after 
publication and thus will require that bath seats manufactured or 
imported on or after that date must meet this standard.

H. Regulatory Flexibility Act

    The Regulatory Flexibility Act (``RFA'') generally requires that 
agencies review final rules for their potential economic impact on 
small entities, including small businesses. 5 U.S.C. 604.
    Three firms currently market infant bath seats in the United 
States: One large domestic manufacturer, one small foreign manufacturer 
and one small domestic importer. All of these companies' bath seats are 
expected to require modifications to meet the bath seat standard. This 
final regulatory flexibility analysis focuses on the small domestic 
importer.
    As noted in the NPR preamble (see 74 FR at 45722), the effect of 
the regulation on importers of bath seats would be felt indirectly, 
requiring a shift in suppliers rather than the design and production of 
a different product. The impact on the small domestic importer is 
expected to be small. The small domestic importer would most likely 
respond by discontinuing the import of its non-complying bath seat, 
either replacing the bath seat with a complying product or another 
juvenile product (the firm currently imports approximately 165 juvenile 
products, of which three are substitutes for its imported bath seat).
    Hence, even if the cost of developing a compliant product did prove 
to be a barrier for individual small firms, the loss of bath seats as a 
product category is expected to be minor and would likely be mitigated 
by increased sales of competing products, such as multi-stage infant 
bathtubs, or entirely different juvenile products.

I. Environmental Considerations

    The Commission's regulations provide a categorical exclusion for 
the Commission's safety standards from any requirement to prepare an 
environmental assessment or an environmental impact statement as they 
``have little or no potential for affecting the human environment.'' 16 
CFR 1021.5(c)(1). This rule falls within the categorical exclusion.

J. Paperwork Reduction Act

    Sections 8 and 9 of ASTM F 1967-08 contain requirements for 
marking, labeling and instructional literature that are considered 
``information collection requirements'' under the Paperwork Reduction 
Act, 44 U.S.C. 3501-3520. In a separate notice in this issue of the 
Federal Register, the Commission is publishing a notice requesting 
comments on this collection of information.

K. Preemption

    Section 26(a) of the CPSA, 15 U.S.C. 2075(a), provides that where a 
``consumer product safety standard under [the CPSA]'' is in effect and 
applies to a product, no State or political subdivision of a State may 
either establish or continue in effect a requirement dealing with the 
same risk of injury unless the State requirement is identical to the 
Federal standard. (Section 26(c) of the CPSA also provides that States 
or political subdivisions of States may apply to the Commission for an 
exemption from this preemption under certain circumstances.) Section 
104(b) of the CPSIA refers to the rules to be issued under that section 
as ``consumer product safety rules,'' thus implying that the preemptive 
effect of section 26(a) of the CPSA would apply. Therefore, a rule 
issued under section

[[Page 31698]]

104 of the CPSIA will invoke the preemptive effect of section 26(a) of 
the CPSA when it becomes effective.

L. Certification

    Section 14(a) of the CPSA imposes the requirement that products 
subject to a consumer product safety rule under the CPSA, or to a 
similar rule, ban, standard, or regulation under any other act enforced 
by the Commission, must be certified as complying with all applicable 
CPSC-enforced requirements. 15 U.S.C. 2063(a). Such certification must 
be based on a test of each product or on a reasonable testing program 
or, for children's products, on tests on a sufficient number of samples 
by a third party conformity assessment body recognized by the 
Commission to test according to the applicable requirements. As 
discussed above in section K, section 104(b)(1)(B) of the CPSIA refers 
to standards issued under that section, such as the rule for infant 
bath seats established in this notice, as ``consumer product safety 
standards.'' By the same reasoning, such standards would also be 
subject to section 14 of the CPSA. Therefore, any such standard would 
be considered to be a consumer product safety rule to which products 
subject to the rule must be certified.
    Because infant bath seats are children's products, they must be 
tested by a third party conformity assessment body accredited by the 
Commission. The Commission is issuing a separate notice of requirements 
to explain how laboratories can become accredited as a third party 
conformity assessment bodies to test to this new infant bath seat 
safety standard. (Infant bath seats also must comply with all other 
applicable CPSC requirements, such as the lead content requirements of 
section 101 of the CPSIA and potentially the phthalate content 
requirements in section 108 of the CPSIA should the bath seat 
incorporate a toy component, the tracking label requirement in section 
14(a)(5) of the CPSA, and the consumer registration form requirements 
in section 104 of the CPSIA.)

List of Subjects in 16 CFR 1215

    Consumer protection, Incorporation by reference, Imports, Infants 
and children, Labeling, Law enforcement, and Toys.

0
Therefore, the Commission amends Title 16 of the Code of Federal 
Regulations by adding part 1215 to read as follows:
PART 1215--SAFETY STANDARD FOR INFANT BATH SEATS
Sec.
1215.1 Scope.
1215.2 Requirements for infant bath seats.

    Authority: The Consumer Product Safety Improvement Act of 2008, 
Pub. Law 110-314, Sec.  104, 122 Stat. 3016 (August 14, 2008).


Sec.  1215.1  Scope.

    This part 1215 establishes a consumer product safety standard for 
infant bath seats manufactured or imported on or after December 6, 
2010.


Sec.  1215.2  Requirements for infant bath seats.

    (a) Except as provided in paragraph (b) of this section, each 
infant bath seat shall comply with all applicable provisions of ASTM F 
1967-08a, Standard Consumer Safety Specification for Infant Bath Seats, 
approved November 1, 2008. The Director of the Federal Register 
approves this incorporation by reference in accordance with 5 U.S.C. 
552(a) and 1 CFR part 51. You may obtain a copy from ASTM 
International, 100 Bar Harbor Drive, P.O. Box 0700, West Conshohocken, 
PA 19428; telephone 610-832-9585; www.astm.org. You may inspect a copy 
at the Office of the Secretary, U.S. Consumer Product Safety 
Commission, Room 820, 4330 East West Highway, Bethesda, MD 20814, 
telephone 301-504-7923, or at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: https://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
    (b) Comply with the ASTM F 1967-08a standard with the following 
additions or exclusions:
    (1) Instead of complying with section 3.1.1 of ASTM F 1967-08a, 
comply with the following:
    (i) 3.1.1 Bath seat, n--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. This does not include products that are designed or intended 
to retain water for bathing.
    (ii) [Reserved]
    (2) In addition to section 6.1 of ASTM F 1967-08a, comply with the 
following:
    (i) 6.1 Stability--* * * If any time during the application of 
force, the seat is no longer in the initial `intended use position' and 
is tilted at an angle of 12 degrees or more from its initial starting 
position, it shall be considered a failure.
    (ii) [Reserved]
    (3) Instead of complying with section 7.4.1. of ASTM F 1967-08a, 
comply with the following:
    (i) 7.4.1 Surface Preparation and Product Installation:
    (A) 7.4.1.1 Prepare the test surface as follows:
    (B) 7.4.1.2 For all surfaces on the test platform where the product 
makes contact, clean the coverage area (as defined in 7.4.3.3) with a 
commercial cleaner intended for bath tubs, then wipe the coverage area 
with alcohol and allow to dry.
    (C) 7.4.1.3 Using a spray bottle containing a 1:25 mixture of test 
solution (see table 1) to distilled water, immediately before each test 
run, thoroughly saturate all test platform surfaces above the water 
line where the product makes contact and where contact might be 
expected.
    (D) 7.4.1.4 Flood the test platform with clear 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 in. (51 mm) above the highest point of the occupant seating 
surface. Install the product according to the manufacturer's 
instructions onto the test platform specified in 7.4.3. For the purpose 
of measuring the water level, the product's seating surface can be 
temporarily weighed down to prevent the seat from floating. The weight 
shall be removed following the measurement of the water level and prior 
to conducting the test.
    (ii) [Reserved]
    (4) After section 7.4.2.2 and before section 7.4.2.3 of ASTM F 
1967-08a, comply with the following:
    (i) Rigidly install an inclinometer to the test bar above the 
location where force is to be applied. The weight of the inclinometer 
and the fastening method shall be less than or equal to 2.2 pounds. The 
inclinometer shall have a measurement tolerance of less than or equal 
to 0.5 degrees. Measure and record the pre-test angle of the test bar.
    (ii) [Reserved]
    (5) Between section 7.4.2.3 (including Note 2) and section 7.4.2.4 
of ASTM F 1967-08a, comply with the following:
    (i) Measure and record the maximum angle of the test bar during the 
application of the 17.0 lbf load. Calculate the absolute value of the 
Change in Angle in degrees. Change in Angle = (Angle measured during 
test)--(Angle measured pre-test).
    (ii) [Reserved]
    (6) Instead of complying with the first sentence in section 7.7.1 
of ASTM F 1967-08a, comply with the following:
    (i) 7.7.1 With the bath seat in each of the manufacturer's 
recommended use position(s), insert the tapered end of the Bath Seat 
Torso Probe (see Fig. 4) in all orientations into each opening. * * *
    (ii) [Reserved]
    (7) Instead of complying with the first sentence in section 7.7.2 
of ASTM F 1967-08a, comply with the following:

[[Page 31699]]

    (i) 7.7.2 With the bath seat in each of the manufacturer's 
recommended use position(s), insert the tapered end of the Bath Seat 
Shoulder Probe (see Fig. 6) in all orientations into each opening. * * 
*
    (ii) [Reserved]
    (8) Instead of Figure 4 of ASTM F 1967-08a, use the following:
    [GRAPHIC] [TIFF OMITTED] TR04JN10.000
    
    (9) Instead of complying with section 8.1.1 of ASTM F 1967-08a, 
comply with the following:
    (i) 8.1.1 The safety alert symbol, the signal word, and all other 
words that are all capital letters shall be in sans serif type face 
with letters not less than 0.4 in. (10 mm) in height, with all 
remainder of the text not less than 0.2 in. (5 mm) in height. Specified 
warning(s) on both the product and the package shall be distinctively 
separated from any other wording or designs and shall appear in the 
English language at a minimum. They shall also be highly visible and in 
a contrasting color to the background on which they are located.
    (ii) [Reserved]
    (10) In addition to complying with section 8.2 of ASTM F 1967-08a, 
comply with the following:
    (i) 8.2 * * * The specified warnings may not be placed in a 
location that allows the warning(s) to be obscured or rendered 
inconspicuous when in the manufacturer's recommended use position.
    (ii) [Reserved]

    Dated: May 25, 2010.
Todd Stevenson,
Secretary, U.S. Consumer Product Safety Commission.
[FR Doc. 2010-13073 Filed 6-3-10; 8:45 am]
BILLING CODE 6355-01-P