[Federal Register Volume 74, Number 170 (Thursday, September 3, 2009)]
[Proposed Rules]
[Pages 45719-45723]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-20948]
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1215
[CPSC Docket No. CPSC-2009-0064]
Safety Standard for Infant Bath Seats
AGENCY: Consumer Product Safety Commission.
ACTION: Notice of proposed rulemaking.
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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'') 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. The Commission is proposing a
safety standard for infant bath seats in response to the direction
under section 104(b) of the CPSIA.
DATES: Written comments must be received by November 17, 2009.
ADDRESSES: You may submit comments, identified by Docket No. CPSC-2009-
0064, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov. Follow the
instructions for submitting comments. To ensure timely processing of
comments, the Commission is no longer accepting comments submitted by
electronic mail (e-mail) except through http://www.regulations.gov.
Written Submissions
Submit written submissions in the following way:
Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions), preferably in five copies, to: Office of the Secretary,
Consumer Product Safety Commission, Room 502, 4330 East West Highway,
Bethesda, MD 20814; telephone (301) 504-7923.
Instructions: All submissions received must include the agency name
and docket number for this rulemaking. All comments received may be
posted without change, including any personal identifiers, contact
information, or other personal information provided, to http://www.regulations.gov. Do not submit confidential business information,
trade secret information, or other sensitive or protected information
electronically. Such information should be submitted in writing.
Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Patricia Edwards, Project Manager,
Directorate for Engineering Sciences, Consumer Product Safety
Commission, 4330 East West Highway, Bethesda, MD 20814; telephone (301)
504-7577; [email protected].
SUPPLEMENTARY INFORMATION:
A. Background and Statutory Authority
1. The Consumer Product Safety Improvement Act
The Consumer Product Safety Improvement Act of 2008 (``CPSIA,''
Pub. L. 110-314) was enacted on August 14, 2008. Section 104(b) of the
CPSIA requires the Commission 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. Section 104(b)(2) of the CPSIA
directs the Commission to begin rulemaking for two standards by August
14, 2009. In this document the Commission proposes a safety standard
for bath seats. The proposed standard is 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 Specifications for Infant Bath Seats,'' but
the Commission is proposing some modifications to strengthen the
standard.
2. Previous Commission Rulemaking Concerning Bath Seats
The Commission has been engaged in regulatory efforts for infant
bath seats for several years. In July 2000, several consumer
organizations petitioned the Commission to ban bath seats under the
Federal Hazardous Substances Act (``FHSA''). The consumer organizations
asserted that bath seats presented an unreasonable risk of injury and
death due to drowning. On August 1, 2001, the Commission published an
advance notice of proposed rulemaking (``ANPR'') in the Federal
Register initiating a rulemaking proceeding on bath seats (66 FR
39692). The Commission issued a notice of proposed rulemaking that was
published in the Federal Register on December 29, 2003 (68 FR 74878)
proposing requirements for stability, leg openings, and warnings.
Elsewhere in this issue of the Federal Register, the Commission has
issued a notice that the Commission has terminated the bath seat
rulemaking proceeding that it began under the FHSA because it has been
superseded by this rulemaking required under section 104(b) of the
CPSIA.
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 three manufacturers and one importer of
bath seats active in the United States. 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. A 2005 survey by the American Baby Group indicated annual sales
of bath seats of about 1.5 million and about 1.7 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 include requirements
that the Commission proposed in its 2003 NPR and to exclude tub-like
products.
In response to changes in the ASTM standard, product design changed
significantly. The new designs use an arm that clamps onto the side of
the
[[Page 45720]]
bath tub rather than relying on suction cups for stability. The current
voluntary standard for bath seats, ASTM F 1967-08a, was published in
December 2008. The current version contains the same labeling,
stability and leg opening requirements as the 2007 version.
JPMA provides certification programs for juvenile products,
including bath seats. Manufacturers submit their products to an
independent test laboratory to test the product for conformance to the
ASTM standard. Currently only one bath seat model is certified to ASTM
F 1967-08a.
The current ASTM standard includes 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. The standard also contains labeling requirements to address
the child coming out of the bath seat.
General requirements in the current ASTM standard, none of which
the Commission is proposing to modify, 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 (some of which the Commission is proposing to
modify as discussed in part E of this preamble) include:
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
From 1983 through 2008, there were 295 non-fatal bath seat
incidents reported to CPSC staff. A submersion hazard was identified in
151 of these non-fatal incidents of which 116 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 143 reports were non-submersion hazards
such as lacerations, limb entrapments, etc. There have been 171
reported fatalities involving bath seats for this same time frame,
although more fatalities may have occurred because fatality reporting
is not considered to be complete for 2006, 2007, and 2008. All of these
fatalities were submersions. 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. Two of the non-fatal incidents
involved products certified to ASTM F 1967-07, neither of which were
submersion hazards, thus were not life threatening.
Of the 171 fatal incidents, 20 involved products that were
identified as being certified to the 2004 version of the ASTM standard.
Two of the 20 were due to the arm of the bath seat disengaging from the
bath tub and 17 were due to other causes such as the child slumped over
the side of the bath seat (four incidents), children found out of the
bath seat in the water (seven incidents), miscellaneous causes, such as
consumers not attaching the clamp to the tub side (four incidents), and
overflowing bathtubs (two incidents). There was also an unknown cause
for one incident.
Fifty-one of the non-fatal incidents involved bath seats certified
to the 2004 version of the ASTM voluntary standard. Fifteen of these
non-fatal incidents involved a bath seat that was the subject of a
safety alert issued in 2005 due to component failures occurring when
the bath seat was installed on non-traditional tubs. Of the remaining
36 incidents, five were considered submersion hazards, and thus could
have resulted in a fatality had a caregiver not been present. These
five include three arm disengagements, one entrapment where the child's
torso slipped completely into one leg opening, and one case where a
child was found out of the bath seat in the water. In addition, there
has been another recent torso entrapment incident reported to CPSC
staff in 2009.
E. Assessment of Voluntary Standard ASTM F 1967-08a and Description of
Proposed Changes and the Proposed 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. Consultations between Commission staff and members
of this subcommittee are still ongoing.
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. CPSC staff tested three products to the current version of
ASTM F 1967-08a: Two bath seats that use only suction cups to provide
stability and a third that primarily uses a clamping mechanism located
on an arm that secures the bath seat to the side of the tub. The bath
seat with the arm was labeled as being certified by JPMA to the ASTM
standard.
Initial testing results indicated that all three products failed
the stability test requirements in ASTM F 1967-08a. The two non-
certified seats that use only suction cups for stability could not
affix themselves to the slip-resistant surface, and thus failed.
During the testing of the JPMA certified bath seat, the arm rest of
the clamping mechanism lifted up from the top surface of the side of
the tub. The clamp did not disengage from the tub, but the arm rest
contact points were no longer in contact with the tub surface. The bath
seat remained in a tilted position from the installed and presumed
``manufacturer's intended use position.'' A strict interpretation of
the pass-fail criteria suggests that this bath seat, as tested by CPSC
staff, also does not meet the standard, but the clamp, while not in the
initial position, remained clamped to the side of the bath tub. Thus,
one could assert that, because the product did not tip over and did not
disengage from the platform, the product complied with the standard.
This result indicates that the pass/fail criteria are ambiguous and
could result
[[Page 45721]]
in passing a bath seat that could nevertheless pose a stability hazard
to an infant.
The current 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. 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.
Consistent with section 104(b) of the CPSIA, the Commission,
through this proposed rule, would establish a new 16 CFR part 1215,
``Safety Standard for Bath Seats.'' The new part would incorporate 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.
2. Proposed Changes to the ASTM Standard's Requirements
While most of the requirements of the current ASTM standard are
sufficient to reduce the risk of injury posed by bath seats, the
Commission concludes that several provisions should be modified to make
them more stringent and further reduce the risk of injury and to
clarify the test procedures.
To best understand the proposed standard, it is helpful to view the
current ASTM F 1967-08a standard for bath seats at the same time as the
Commission's proposed modifications. The ASTM standard is available for
viewing for this purpose during the comment period through this link:
http://www.astm.org/cpsc.htm.
a. Definition of Bath Seat (Proposed Sec. 1215.2(b)(1))
The Commission's 2003 NPR defined a bath seat as 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 believes that this
definition is preferable to that used by ASTM which does not define the
type of support because the proposed definition better clarifies what
is (or is not) a bath seat.
b. Stability Requirement
Limiting the tilt of the bath seat (proposed Sec. 1215.2(b)(2),
(6) and (7)). As discussed above, during testing the Commission staff
found that the clamping mechanism on one bath seat lifted from the side
of the tub and continued to tip backward when force was applied, but it
did not tip over. To prevent possible misinterpretation of the ASTM
standard's pass/fail criteria, the Commission proposes a requirement
that limits the allowable tilt angle of the bath seat during the
stability test. This proposed modification would be added to sections
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 of the ASTM standard. The Commission proposes 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. Staff also considered other ASTM
standards such as those for infant bouncer seats and toys. These use a
10 degree table or tilt when testing stability. The Commission is
proposing a tilt angle just above that level.
Test solution application (proposed Sec. 1215.2(b)(4)). 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. Thus, the Commission proposes that a test solution be applied
to all areas where the product may make contact while in use.
Measuring water levels (proposed Sec. 1215.2(b)(5)). When testing
the stability of bath seats, Commission 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 proposes 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.''
c. Leg opening requirement (Proposed Sec. 1215.2(b)(8) through (10))
In recent incident reports, children have fit both legs and their
hips through a single leg hole of a bath seat that complies with the
current ASTM standard. The torso probe specified in the current ASTM
standard used to test the size of the leg openings is not sufficiently
analogous to the human infant. This has resulted in a child's torso
fitting through a leg hole when the ASTM torso probe does not. Because
modeling the pliable features of a child's torso is not practical, the
Commission proposes decreasing the size of the current rigid wood torso
probe specified in the ASTM standard and specifying a larger radius on
the corners. The proposal would decrease the length of the vertical and
horizontal axes of the current probe by approximately 5% and round the
corners more resulting in a 1.45'' radius rather than the current 1''
radius. This proposed change is accomplished through modifications to
Figure 4 in the ASTM standard that shows the torso probe. 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 that which would accommodate large children.
An additional proposed change (at proposed Sec. 1215.2(b)(8) and
(9)) related to the torso probe concerns 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.'' This language is open to interpretation as it may not always
be intuitive what `the most' adverse position is. Therefore, the
Commission proposes changing this wording to say that the probe needs
to be inserted ``in all orientations to determine if any position can
create a slip through and/or entrapment hazard.''
d. Editorial and clarifying changes (proposed Sec. 1215.2(b)(3) and
(5))
Other proposed changes clarify the order of steps to be performed
when conducting the stability test. For clarification of testing
procedures, the Commission proposes re-ordering the steps specified in
the ASTM standard for preparing the test surface and installing the
bath seat. This change would clarify that the test platform should be
flooded before installing the bath seat.
F. Request for Comments
The issuance of this proposed rule begins a rulemaking proceeding
under section 104(b) of the CPSIA to issue a consumer product safety
standard for infant bath seats. All interested persons are invited to
submit comments on any aspect of the proposed rule. Comments should be
submitted in accordance with the instructions in the ADDRESSES section
at the beginning of this notice.
G. Effective Date
The Administrative Procedure Act (``APA'') generally requires that
the effective date of a rule be at least 30 days after publication of
the final rule. Id. 553(d). To allow time for bath seats to come into
compliance, the Commission proposes that the standard would become
effective six months after publication of a final rule.
H. Regulatory Flexibility Act
The Regulatory Flexibility Act (``RFA'') generally requires that
agencies review proposed rules for their potential economic impact on
small entities,
[[Page 45722]]
including small businesses. 5 U.S.C. 603.
Four firms currently market infant bath seats in the United States:
A large domestic manufacturer, a small foreign manufacturer, a small
domestic manufacturer, and a small domestic importer. All of these
companies' bath seats are expected to require modifications to meet the
proposed standard.
Modifying existing bath seats to meet the proposed standard would
result in one-time product development costs and possible increased
costs of production that could amount to approximately $5 to $10 per
bath seat. A price increase associated with these modifications will
likely reduce the quantity of bath seats demanded and hence unit sales.
Alternatively, it is possible that manufacturers may not be able to (or
may choose not to) produce a commercially viable bath seat that meets
the proposed standard. For the small domestic manufacturer, the impact
of discontinuing baby bath seat production is unlikely to be large
since bath seats make up only a small portion of its juvenile products.
Since importers do not manufacture bath seats, the effect of the
regulation on them 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.
Hence, even if the cost of developing a compliant product proves 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 exemption for
the Commission's rules 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)(2). This proposed rule falls within the categorical
exemption.
J. Paperwork Reduction Act
The Commission is not proposing any collections of information in
this rulemaking. Therefore, the Paperwork Reduction Act, 44 U.S.C.
3501-3520, does not apply.
List of Subjects in 16 CFR Part 1215
Consumer protection, Imports, infants and children, Labeling, Law
enforcement, and Toys.
Therefore, the Commission proposes to amend Title 16 of the Code of
Federal Regulations by adding part 1215 to read as follows:
PART 1215--SAFETY STANDARD FOR BATH SEATS
Sec.
1215.1 Scope, application and effective date.
1215.2 Requirements for bath seats.
Authority: The Consumer Product Safety Improvement Act of 2008,
Pub. L. 110-314, 104, 122 Stat. 3016 (August 14, 2008).
Sec. 1215.1 Scope.
This part 1215 establishes a consumer product safety standard for
bath seats manufactured or imported on or after (date 6 months after
date of publication of a final rule in the Federal Register).
Sec. 1215.2 Requirements for bath seats.
(a) Except as provided in paragraph (b) of this section, each 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; http://www.astm.org.
You may inspect a copy at the Office of the Secretary, U.S. Consumer
Product Safety Commission, Room 502, 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: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(b) The following provisions replace, or are added to, the
indicated sections of the ASTM F 1967-08a standard.
(1) Instead of section 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.''
(2) Instead of section 6.1: ``Stability--For bath seats which
provide support for an occupant's back and support for the sides or
front of the occupant, or both, the geometry and construction of the
product shall not allow for any parts of the product to become
separated from it, shall not sustain permanent damage, and shall not
allow the product to tip over after being tested in accordance with
7.4. In addition, if any attachment point disengages from (is no longer
in contact with) the test platform and then fails to return to its
manufacturer's intended use position after being tested in accordance
with 7.4, it fails the requirement. This test shall be conducted after
the Mechanisms Durability test in 7.1.3. 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.''
(3) Instead of section 7.4.1.2: ``Prepare the test surface as
follows:''
(4) Instead of section 7.4.1.4: ``Using a spray bottle containing a
1:25 mixture of test solution (see table Z) 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.''
(5) Instead of section 7.4.1.5: ``Flood the test platform with
clear water that is at an initial temperature of 100 to 105[ordm] F
(37.8 to 10.6[ordm] 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.''
(6) Between section 7.4.2.2 and section 7.4.2.3: ``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.''
(7) Between section 7.4.2.3 and section 7.4.2.4: ``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).''
(8) Instead of section 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
[[Page 45723]]
Probe (see Fig. 4a) in all orientations into each opening. The probe
should be inserted from the direction of the occupant seating surface.
Gradually apply a force of 15 lbf (67 N) in the direction of the major
axis of the probe within a period of 5s. Maintain this force for an
additional 10s (see Fig. 5).''
(9) Instead of section 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. The probe should be inserted from the direction of the
occupant seating surface. Gradually apply a force of 15 lbf (67 N) in
the direction of the major axis of the probe within a period of 5s.
Maintain this force for an additional 10s (see Fig. 7). Release and
apply a force of 10 lbf (44 N) to the top 1.0-in. (25-mm) perimeter of
the probe in a direction vertically downward toward the seating surface
over a period of 5s. Maintain this force for an additional 10s (see
Fig. 8).''
(10) Instead of Figure 4:
[GRAPHIC] [TIFF OMITTED] TP03SE09.010
Dated: August 25, 2009.
Todd Stevenson,
Secretary, U.S. Consumer Product Safety Commission.
[FR Doc. E9-20948 Filed 9-2-09; 8:45 am]
BILLING CODE 6355-01-P