Safety Standard for Infant Bath Tubs, 48769-48782 [2015-19668]
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Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Proposed Rules
Issued in College Park, Georgia, on August
5, 2015.
Gerald E. Lynch
Acting Manager, Operations Support Group
Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2015–19950 Filed 8–13–15; 8:45 am]
BILLING CODE 4910–13–P
CONSUMER PRODUCT SAFETY
COMMISSION
16 CFR Parts 1112 and 1234
[CPSC Docket No. 2015–0019]
Safety Standard for Infant Bath Tubs
Consumer Product Safety
Commission.
ACTION: Notice of proposed rulemaking.
AGENCY:
The Danny Keysar Child
Product Safety Notification Act, Section
104 of the Consumer Product Safety
Improvement Act of 2008 (‘‘CPSIA’’)
requires the United States Consumer
Product Safety Commission
(‘‘Commission,’’ ‘‘CPSC,’’ or ‘‘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. The Commission is
proposing a safety standard for infant
bath tubs in response to the direction
under Section 104(b) of the CPSIA. In
addition, the Commission is proposing
an amendment to include the proposed
standard in the list of notices of
requirements (NORs) issued by the
Commission.
SUMMARY:
DATES:
Submit comments by October 28,
2015.
Comments related to the
Paperwork Reduction Act aspects of the
marking, labeling, and instructional
literature requirements of the proposed
mandatory standard for infant bath tubs
should be directed to the Office of
Information and Regulatory Affairs, the
Office of Management and Budget, Attn:
CPSC Desk Officer, FAX: 202–395–6974,
or emailed to oira_submission@
omb.eop.gov.
Other comments, identified by Docket
No. CPSC 2015–0019, may be submitted
electronically or in writing:
Electronic Submissions: Submit
electronic comments to the Federal
eRulemaking Portal at: https://
www.regulations.gov. Follow the
instructions for submitting comments.
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ADDRESSES:
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The Commission does not accept
comments submitted by electronic mail
(email), except through
www.regulations.gov. The Commission
encourages you to submit electronic
comments by using the Federal
eRulemaking Portal, as described above.
Written Submissions: Submit written
submissions by mail/hand delivery/
courier to: Office of the Secretary,
Consumer Product Safety Commission,
Room 820, 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 proposed
rulemaking. All comments received may
be posted without change, including
any personal identifiers, contact
information, or other personal
information provided, to: https://
www.regulations.gov. Do not submit
confidential business information, trade
secret information, or other sensitive or
protected information that you do not
want to be available to the public. If
furnished at all, such information
should be submitted in writing.
Docket: For access to the docket to
read background documents or
comments received, go to: https://
www.regulations.gov, and insert the
docket number CPSC–2015–0019, into
the ‘‘Search’’ box, and follow the
prompts.
FOR FURTHER INFORMATION CONTACT:
Celestine T. Kish, Project Manager,
Directorate for Engineering Sciences,
U.S. Consumer Product Safety
Commission, 5 Research Place,
Rockville, MD 20850; email: ckish@
cpsc.gov; telephone: (301) 987–2547.
SUPPLEMENTARY INFORMATION:
I. Background and Statutory Authority
The CPSIA was enacted on August 14,
2008. Section 104(b) of the CPSIA, part
of the Danny Keysar Child Product
Safety Notification Act, requires the
Commission to: (1) Examine and assess
the effectiveness of voluntary consumer
product safety standards for durable
infant or toddler products, in
consultation with representatives of
consumer groups, juvenile product
manufacturers, and independent child
product engineers and experts; and (2)
promulgate consumer product safety
standards for durable infant and toddler
products. Standards issued under
section 104 are to be ‘‘substantially the
same as’’ the applicable voluntary
standards or more stringent than the
voluntary standard if the Commission
concludes that more stringent
requirements would further reduce the
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48769
risk of injury associated with the
product.
The term ‘‘durable infant or toddler
product’’ is defined in section 104(f)(1)
of the CPSIA as ‘‘a durable product
intended for use, or that may be
reasonably expected to be used, by
children under the age of 5 years.’’
Section 104(f)(2) of the CPSIA lists
examples of durable infant or toddler
products, including products such as
‘‘bath seats’’ and ‘‘infant carriers.’’
Although section 104(f)(2) does not
specifically identify infant bath tubs, the
Commission has defined infant bath
tubs as a ‘‘durable infant or toddler
product’’ in the Commission’s product
registration card rule under CPSIA
section 104(d).1
Pursuant to section 104(b)(1)(A), the
Commission consulted with
manufacturers, retailers, trade
organizations, laboratories, consumer
advocacy groups, consultants, and
members of the public in the
development of this notice of proposed
rulemaking (‘‘NPR’’), largely through the
standards development process of
ASTM International (formerly the
American Society for Testing and
Materials) (‘‘ASTM’’). The proposed rule
is based on the voluntary standard
developed by ASTM, ASTM F2670–13,
Standard Consumer Safety
Specification for Infant Bath Tubs
(‘‘ASTM F2670–13’’), with several
modifications to strengthen the
standard.
The testing and certification
requirements of section 14(a) of the
Consumer Product Safety Act (‘‘CPSA’’)
apply to product safety standards
promulgated under section 104 of the
CPSIA. Section 14(a)(3) of the CPSA
requires the Commission to publish an
NOR for the accreditation of third party
conformity assessment bodies (test
laboratories) to assess conformity with a
children’s product safety rule to which
a children’s product is subject. The
infant bath tub standard, if issued as a
final rule, will be a children’s product
safety rule that requires the issuance of
an NOR. To meet the requirement that
the Commission issue an NOR for the
infant bath tub standard, this NPR
proposes to amend 16 CFR part 1112 to
include 16 CFR part 1234, the CFR
section where the infant bath tub
standard will be codified if the standard
becomes final.
1 Requirements for Consumer Registration of
Durable Infant or Toddler Products; Final Rule, 74
FR 68668, 68669 (December 29, 2009); 16 CFR
1130.2(a)(16).
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II. Product Description
A. Definition of Infant Bath Tub
ASTM F2670–13 defines an ‘‘infant
bath tub’’ as a ‘‘tub, enclosure, or other
similar product intended to hold water
and be placed into an adult bath tub,
sink, or on top of other surfaces to
provide support or containment, or
both, for an infant in a reclining, sitting,
or standing position during bathing by
a caregiver.’’ ASTM F2670–13 section
3.1.2. Falling within this definition are
products of various designs, including
‘‘bucket style’’ tubs that support a child
sitting upright, tubs with an inclined
seat for infants too young to sit
unsupported, inflatable tubs, folding
tubs, and tubs with spa features, such as
handheld shower attachments and even
whirlpool settings. The ASTM standard
permits infant bath tubs to have ‘‘a
permanent or removable passive crotch
restraint as part of their design,’’ but
does not permit ‘‘any additional
restraint system(s) which requires action
on the part of the caregiver to secure or
release.’’ Id. section 6.1. ASTM F2670–
13 excludes from its scope ‘‘products
commonly known as bath slings,
typically made of fabric or mesh.’’ Id.
sec. 1.1.
B. Market Description
CPSC staff is aware of at least 26 firms
that supply infant bath tubs to the U.S.
market. Twenty-three of these firms are
domestic, including 14 manufacturers,
eight importers, and one with an
unknown supply source. Three foreign
companies export directly to the United
States via Internet sales or to U.S.
retailers.
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III. Incident Data
CPSC staff has received detailed
reports from various sources of 202
incidents related to infant bath tubs
from January 1, 2004 through May 20,
2015. Thirty-one of these incidents
(15%) were fatal. Of the 146 victims
whose age could be determined, 141
(97%) were under 2 years of age. In the
168 incidents in which the sex of the
child was reported, 54 percent of the
victims were male, and 46 percent of the
victims were female.
A. Fatalities
Thirty-one fatalities were reported to
have been associated with infant bath
tubs from January 1, 2004 through May
20, 2015. Drowning was the reported
cause of death for 30 of the fatalities
(97%); the remaining fatality involved a
child with a heart defect, whose death
was attributed to pneumonia. Twentynine of the fatality victims (94%) were
between 4 months and 11 months of
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age; the remaining two fatality victims
were 23 months and 3 years of age. In
all but one of the drowning fatalities, a
parent or caregiver left the victim alone
in the infant bath tub, and returned to
find the child submerged. Sixteen of the
fatalities (52%) were male, while 15
(48%) were female.
B. Nonfatal Injuries
One hundred seventy-one nonfatal
incidents associated with infant bath
tubs were reported to have occurred
from January 1, 2004 through May 20,
2015. The 171 reports included 30
reports of injuries requiring
hospitalization (nine reports),
emergency room treatment (nine
reports), treatment by a medical
professional (eight reports), or first aid
(four reports). The nine incidents
requiring hospitalization included eight
near-drowning incidents in which a
child almost died from suffocation
under water, and one scalding water
burn. All eight near-drowning incidents
resulting in hospitalization occurred
while the parent or caregiver was not
present. The nine incidents requiring
emergency room treatment consisted of
five near-drowning incidents, a head
injury caused by a bath toy detaching
from a tub, a concussion from a fall from
a tub located on a counter when a tub
leg collapsed, one rash, and an injury
caused by mold on a tub. The eight
injury reports requiring a visit to a
medical professional consisted of one
laceration, one rash, and six injuries
involving mold. The four incidents
requiring home first aid resulted from
finger, hand, and foot entrapments.
C. Hazard Pattern Identification
CPSC staff considered all 202 (31 fatal
and 171 nonfatal) reported infant bath
tub incidents to identify the hazard
patterns associated with infant bath tubrelated incidents. Staff grouped the
hazard patterns into the following
categories in order of frequency:
1. Drowning/Near Drowning incidents
account for 43 out of 202 (21%) of the
reported incidents. Thirty of these 43
incidents were drowning fatalities; the
remaining 13 incidents involved neardrownings. In 38 of the 43 drowning or
near-drowning incidents (88%), the
parent or guardian was not present at
the time the incident occurred. Because
there were no witnesses to a majority of
drowning or near-drowning incidents,
determining exactly what happened is
difficult. Generally, the child was found
floating, but exactly what transpired
was unclear. One incidental fatality was
attributed to pneumonia rather than
drowning; this incident is discussed in
the ‘‘Miscellaneous Issues’’ category.
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2. Protrusion/Sharp/Laceration issues
accounted for 39 out of 202 (19%) of the
reported incidents. In most of these
incidents, the child made contact with
a part that protrudes from the tub,
causing red marks, cuts, or bruising. The
body parts reportedly injured were toes,
feet, bottom, genitalia, and back. In 29
of the 39 incidents, a protrusion
described as a ‘‘bump’’ or ‘‘hump’’
caused a red mark or discomfort to the
infant. In many of these protrusion
incidents, a ‘‘hammock/sling’’
attachment was involved.
Only one of the 39 ‘‘protrusion’’
incident reports required a hospital
visit; in that incident, a child’s back was
scratched by a screw that penetrated the
tub wall. The remaining 38 incidents in
this category resulted in a minor injury
or no injury.
3. Product failures accounted for 53
out of 202 (26%) of the reported
incidents. In 28 incidents, the
‘‘hammock’’ or ‘‘sling’’ collapsed or
broke, and in eight incidents the tub’s
locking mechanism failed or broke. The
remaining 17 ‘‘product failure’’
incidents involved various tub parts
breaking. In two of the 53 ‘‘product
failure’’ incidents a child was treated at
a hospital and released; in the
remaining incidents, there was either no
injury or a minor injury. In one of the
incidents requiring a hospital visit, a toy
attached to a tub fell and caused a deep
cut on a child’s forehead. In the second
incident, the leg of a tub collapsed,
causing a child to fall from the counter
top supporting the tub onto the floor,
resulting in a concussion.
4. Entrapment issues accounted for 20
out of 202 (10%) of the reported
incidents. Entrapment incidents
involved fingers, arms, feet, legs, or
genitalia caught or stuck on parts of the
tub, mostly in a pinching manner. Many
of these injuries occurred in tubs that
fold. Hinges, holes, and the foot area
inside a tub were common areas of
entrapment. These entrapment incidents
resulted in no injury or minor injury;
there were no reported hospitalizations.
5. Slippery tub surface issues
accounted for 14 of 202 (7%) of the
reported incidents. These incidents
resulted in minor skin abrasions or
scratches, and potential submersions.
These incidents resulted in no injury or
minor injury.
6. Mold/Allergy issues accounted for
12 of 202 (6%) of the reported incidents.
Eight incidents were attributed to mold,
and four were allergy related. The
reported issues included itching, rashes,
foul odor, respiratory issues, and a
urinary tract infection. Eight of these
incidents, six involving mold issues and
two involving allergy issues, involved a
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single infant tub make and model. The
12 reported incidents included two
emergency room visits, one for an upper
respiratory issue, and one for a rash on
the child’s back. In seven additional
incidents, children were seen by a
medical professional for itching and
rashes (four incidents), a urinary tract
infection, a severe cold with fever, and
the presence of mold spores on the
genitalia.
7. Miscellaneous issues accounted for
21 out of 202 (10%) of the reported
incidents. The issues included falling
out of a tub, an unstable tub, missing
pieces, batteries leaking or overheating,
rust, and scalding. Miscellaneous issues
resulted in one fatality and one hospital
admission. The fatality involved a child
with a ventricular septal defect whose
death was attributed to pneumonia. The
hospital visit was caused by scalding
when a parent poured hot water from a
stove onto a tub’s foam cushion and
then placed the child in the tub. The
rest of the reports involved no injury or
a minor injury.
D. National Injury Estimates
CPSC also evaluates data reported
through the National Electronic Injury
Surveillance System (NEISS), which
gathers summary injury data from
hospital emergency departments
selected as a probability sample of all
the U.S. hospitals with emergency
departments. This surveillance
information enables CPSC staff to make
timely national estimates of the number
of injuries associated with specific
consumer products. Based on a review
of emergency department visits related
to infant bath tubs for the years 2004 to
2014, staff estimates that there were
2,200 injuries treated in U.S. hospital
emergency rooms over that 11-year
period associated with infant bath tubs
(sample size = 82, coefficient of
variation = 0.18).2 The NEISS data
included one infant death, which has
been included in the fatality statistics
reported above. Approximately 94
percent of the victims were 12 months
of age or younger and only one of the
82 reported NEISS cases involved a
child older than 24 months.
For the injuries reported through
NEISS, the most prominent hazard was
falling, which occurred in 33 percent of
the incidents. Drowning or neardrowning occurred in 22 percent of the
incidents. Head injuries were common
2 NEISS reports for infant bath tub incidents are
summary in nature and provide limited detail for
determining hazard scenarios. For that reason,
NEISS incident data are not included in our
analysis and discussion of overall hazard patterns,
unless a NEISS incident report was supplemented
by further investigation.
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(35%), as were body injuries (22%), and
face injuries (18%). In more than 80
percent of the NEISS cases, the victim
was treated at the emergency room and
released, while 15 percent were
admitted or transferred to a hospital.
IV. The ASTM Infant Bath Tub
Standard
A. History of ASTM 2670–13
Section 104(b)(1)(A) of the CPSIA
requires the Commission to consult
representatives of ‘‘consumer groups,
juvenile product manufacturers, and
independent child product engineers
and experts’’ to ‘‘examine and assess the
effectiveness of any voluntary consumer
product safety standards for durable
infant or toddler products.’’ As a result
of incidents arising from infant bath
tubs, CPSC staff requested that ASTM
develop voluntary requirements to
address the hazard patterns related to
their use. Through the ASTM process,
CPSC staff consulted with
manufacturers, retailers, trade
organizations, laboratories, consumer
advocacy groups, consultants, and
members of the public, and the infant
bath tub standard was developed.
ASTM F2670 was first approved in
2009, and then revised in 2010, 2011,
2012, and 2013. The current version,
ASTM F2670–13, was approved on
February 15, 2013, and was published
in March 2013.
B. Description of the Current ASTM
Voluntary Standard-ASTM 2670–13
ASTM F2670–13 contains both
general and performance requirements
to address the hazards associated with
infant bath tubs. ASTM F2670–13
includes the following key provisions:
scope, terminology, general
requirements, performance
requirements, test methods, marking
and labeling, and instructional
literature.
Scope. This section states the scope of
the standard, which: ‘‘establishes
performance requirements, test
methods, and labeling requirements to
promote the safe use of infant bath
tubs.’’ As stated in section II.A. of this
preamble, ASTM F2670–13 defines an
‘‘infant bath tub’’ as a ‘‘tub, enclosure,
or other similar product intended to
hold water and be placed into an adult
bath tub, sink, or on top of other
surfaces to provide support or
containment, or both, for an infant in a
reclining, sitting, or standing position
during bathing by a caregiver.’’ This
description includes ‘‘bucket style’’ tubs
that support a child sitting upright, tubs
with an inclined seat for infants too
young to sit unsupported, inflatable
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tubs, folding tubs, and tubs with more
elaborate designs including handheld
shower attachments and even whirlpool
settings. ASTM F2670–13 excludes from
its scope ‘‘products commonly known
as bath slings, typically made of fabric
or mesh.’’ Id. sec. 1.1.
Terminology. This section provides
definitions of terms specific to this
standard.
Requirements and Test Methods.
These sections set both general and
performance requirements to address
several hazards, many of which are also
found in the other ASTM juvenile
product standards. These requirements
and test methods address:
• Sharp edges or points
(incorporating CPSC standards for sharp
edges and sharp points); 3
• Small parts (incorporating CPSC
standards for small parts); 4
• Lead in paint and surface coatings
(incorporating CPSC lead and surface
coating standards); 5
• Passive restraints;
• Size and safety requirements for
attached toys (incorporating CPSC toy
standards); 6
• Resistance to collapse or
displacement in use;
• Durability and strength of locking
components;
• Displacement of protective
components;
• Adherence of suction cups;
• Permanence of labels and warnings;
• Protection from scissoring, shearing
and pinching;
• Limits on openings; and
• Labeling.
Marking and Labeling. This section
contains various requirements related to
warnings, labeling, and required
markings for infant bath tubs. This
section prescribes various substance,
format, and prominence requirements
for such information.
Instructional Literature. This section
requires that instructions provided with
infant bath tubs be easy to read and
understand. Additionally, the section
contains requirements for instructional
literature contents and format, as well as
prominence of certain language.
V. Assessment of Voluntary Standard
ASTM F2670–13
Staff considered the fatalities,
injuries, and non-injury incidents
associated with infant bath tubs, and
evaluated ASTM F2670–13 to determine
3 See 16 CFR 1500.48 (sharp point standard) and
1500.49 (sharp edge standard).
4 See 16 CFR part 1501 (small part limitations).
5 See 16 CFR part 1303 (limitations on lead in
paint and surface coatings).
6 See ASTM F963, Standard Consumer Safety
Specification for Toy Safety (ASTM F963).
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whether the ASTM standard adequately
addresses the incidents, or whether
more stringent standards would further
reduce the risk of injury associated with
these products. We discuss the staff’s
assessment in this section.
A. Warnings and the Risk of Drowning
Due to Inattention by Parent or
Caregiver
From 2004 to 2014, 30 drowning
fatalities and 13 near-drowning
incidents have been associated with
infant bath tubs. In 29 of the 30
drowning fatalities (97%), the caregiver
left a child alone in an infant bath tub.
In 38 of 43 total drowning or neardrowning incidents (88%), the child
was left alone when the incident
occurred.
From the perspective of setting
product standards, the only way
caregiver behavior, such as leaving an
infant unattended in an infant bath tub,
can be addressed is through warnings
and instructions to caregivers. Staff
reviewed the warnings and instructions
required by ASTM F2670–13 to
determine whether the ASTM
standard’s provisions are adequate, or
whether a more stringent standard
would reduce the risk of drowning and
near-drowning associated with these
products. The currently required
warnings include the phrases:
‘‘WARNING—DROWNING HAZARD,’’
in bold capital letters, ‘‘Infants have
DROWNED in infant bath tubs’’ (with
the word ‘‘DROWNED’’ in bold capital
letters), and ‘‘ALWAYS keep infant
within adult’s reach.’’
Staff determined that these current
warning requirements allow for
considerable variation in the
conspicuity and format of the warnings
presented to consumers. Staff’s research
suggests that the impact of these
warnings would be improved by
providing specific guidance for a more
consistent and prominent presentation
of hazard information. Staff’s research
also indicates that changes to the size,
color, content, and format of required
warnings and instructions could
augment the impact of the warnings and
instructions for infant bath tubs,
resulting in a higher level of caregiver
compliance.
Staff developed suggested wording
and formatting changes for infant bath
tubs that staff believed would improve
the warning and instructions sections of
the voluntary standard. Staff circulated
these proposed wording and formatting
changes to the ASTM subcommittee
responsible for ASTM F2670–13, and
discussed the proposed changes at a
public ASTM meeting in May 2015. In
response to feedback received from
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ASTM and stakeholders, staff made
adjustments to staff’s proposed
warnings and instructions.
The Commission now proposes to
adopt ASTM F2670–13 with
modifications to some of the warnings
and instructions for infant bath tubs. In
particular, the Commission proposes the
following modifications:
• Increasing the size of the text in the
on-product warnings to make the
warnings for infant bath tubs consistent
with Commission requirements for
warnings for a similar product, infant
bath seats;
• Requiring the use of a ‘‘hazard
color’’ in the on-product and retail
package warnings;
• Revising the warning content to
simplify and clarify the language and to
add specific language to address the risk
of falls; and
• Specifying the format of the
warnings on the product, on the retail
packaging, and in the accompanying
instructions to increase the potential
impact of the warnings and provide a
more consistent presentation of hazard
information.
Based on research relating to the
efficacy of warnings and instructions,
staff believes that these changes will
help capture and maintain caregiver
attention, personalize the tone of the
warnings, be simpler to comprehend
than the current warnings, and provide
consistency with the warnings regarding
baby bath seats, a similar product. These
changes, plus the new required warning
of the risk of falls, may result in
increased caretaker comprehension of,
and compliance with, product warnings
and instructions. The Commission
believes that these changes constitute
more stringent warning and labeling
requirements than the current standard,
and will further reduce the risk of injury
to infants and toddlers associated with
infant bath tubs.
B. Hazards Related to Protrusion/Sharp/
Laceration Issues
Protrusion issues were involved in 39
of 202 (19%) of the reported incidents.
In one incident, a protruding screw
scratched a child, resulting in a hospital
visit; other incidents involved red
marks, cuts, or bruising from rough or
protruding edges. However, staff found
no trends in the incident data involving
scrapes or cuts.
In most of the ‘‘protrusion’’ incidents,
a ‘‘hump’’ or ‘‘bump’’ in the tub,
designed to help older infants sit
upright, caused a red mark or
discomfort for the infant, typically when
the infant bath tub was used with a
hammock or sling attachment and the
child made contact with the ‘‘hump.’’
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As discussed in more detail in section
V.C. of this preamble, ASTM has formed
two task groups to develop new infant
sling performance requirements.
C. Hazards Related to ‘‘Bath Sling’’
Products
The current ASTM standard
specifically excludes bath slings, which
are net or mesh products that do not
hold water, are attached to an infant
bath tub or a frame, and are used for
bathing newborn babies and young
infants. Several infant bath tub models
include bath slings as part of the tub, or
as an accessory.
Staff is aware that 28 of the 53
‘‘product failure’’ incidents involved
bath hammocks or slings. Staff and
ASTM are working to investigate how
the observed risks of bath slings should
be addressed. In addition, ASTM
formed two task groups to address the
risks of bath slings. One group is
developing performance requirements
for infant slings that can only be used
with infant bath tubs, which will be
addressed in the infant bath tub
standard. A second group is developing
requirements for bath slings that are
used separately or as tub accessories,
which will be addressed under a new,
separate standard.
D. Latching or Locking Mechanism
Testing
A number of incidents involved tub
locking mechanisms that failed or broke.
Staff believes the current standard for
latch mechanism testing in ASTM
F2670–13, section 7.1.2., which requires
that latches be tested more than 2,000
cycles, is appropriately stringent.
However, staff also has observed that
some complex locking and latching
mechanisms are difficult to test within
the required ‘‘cycle time’’ of 12 cycles
per minute. Staff has worked with
ASTM to find an alternate method of
conducting this test to make testing
results for infant bath tubs more
accurate and consistent. Staff has
determined that requiring the 2,000cycle testing to be conducted on a
‘‘continuous basis’’ will allow more
designs of infant bath tubs to be tested
consistently and accurately to the
standard of section 7.1.2. Moreover,
ASTM is currently considering adopting
the change that staff suggested to ASTM,
but has not yet done so.
In this NPR, the Commission proposes
to modify section 7.1.2 to improve the
accuracy and consistency of the
mandatory product testing. The
Commission also proposes adding an
Appendix regarding section 7.1.2, to
clarify that although the cadence of
testing has changed to accommodate a
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broader variety of infant bath tub
designs, the intent of the standard is to
require continuous testing while
maintaining a rate as close to 12 cycles
per minute as can reasonably be
achieved. The Commission believes
these changes will augment product
safety by improving the accuracy,
consistency, and repeatability of
durability testing.
E. Static Load Testing.
The static load testing requirement
and the testing for resistance to collapse
in the infant bath tub standard is
intended to address the issue of breaks.
Infant bath tubs are required to support
a load of 50 lbs. (22.7 kg.), or three times
the maximum weight recommended by
the manufacturer, whichever is greater,
for 20 minutes. Staff believes that the
current load testing provides an
appropriate level of protection from
breakage. However, staff also has
determined that the current testing
standard, which mandates the use of a
6″ x 6″ block of high-density
polyethylene to provide the required
weight, may damage some infant bath
tub designs, which could create
additional risks. Staff recommended to
ASTM that the required polyethylene
block be rounded on the corners; but
ASTM decided to replace the block with
a bag of steel shot for static load testing.
This matter was addressed at an ASTM
public meeting, was balloted and
approved by ASTM, and will be added
to the next published edition of the
ASTM standard. The Commission
believes that including this modification
in the NPR will augment product safety
by improving the accuracy, consistency,
and repeatability of static load testing.
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F. Entrapment
Entrapments accounted for 20 of 202
reported incidents (10%). Most of the
incidents involved body parts becoming
stuck or caught in a tub, and most of
those incidents involved pinching.
Many of the incidents involved folding
tubs. However, staff found no trends in
this incident data. The Commission
believes that the current infant bath tub
standard’s requirements for scissoring,
shearing, and pinching (section 5.5) and
Openings (section 5.6) are appropriate
to protect the public.
G. Slippery Surfaces
Slippery tub surfaces accounted for 14
of the 202 reported incidents (7%),
resulting in abrasions and submersions
but no injuries. Most of these incidents
contain little detail. Therefore, the
Commission is not proposing any
modifications to the ASTM infant bath
tub standard regarding this issue. Staff
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will continue to monitor, collect, and
study details on slip-related fall and
submersion incidents in infant tubs. In
addition, staff will work with ASTM, if
warranted, to develop appropriate
performance requirements to address
slip-related fall and submersion
incidents.
H. Mold/Allergy Issues
The mold and allergy issues involved
itching, rashes, foul odor, respiratory
issues, and a urinary tract infection.
This is a difficult issue to address
through performance requirements
because the issue arises from the
consumer’s inability to clean and dry
the infant tub to prevent mold.
Therefore, the Commission is not
proposing any modifications to the
ASTM infant bath tub standard
regarding this issue. However, CPSC
staff will continue to review the
incident data. If warranted, staff will
address this matter through the ASTM
process to determine whether additional
instructions or warnings would be
effective in reducing this risk.
I. Miscellaneous Issues
Miscellaneous issues included falling
out of the tub, unstable tubs, missing
pieces, batteries leaking or overheating,
rust and scalding. Incidents in this
category included one fatality that was
attributed to pneumonia and one
hospitalization from scalding. The rest
of the reports were incidents with no
injury or a minor injury. Staff’s review
of these miscellaneous incidents did not
result in any recommendations to
change the infant bath tub standard.
VI. Proposed CPSC Standard for Infant
Bath Tubs
The Commission is proposing to
incorporate by reference ASTM F2670–
13, with certain modifications to
strengthen the standard. As discussed in
the previous section, the Commission
concludes that these modifications will
further reduce the risk of injury
associated with infant bath tubs.
Section 1234.1 would state the scope
of the rule; infant bath tubs. The
definition of ‘‘infant bath tub’’ is
provided in ASTM F2670–13 section
3.1.2.
Section 1234.2(a) would incorporate
by reference ASTM F2670–13, with the
exception of certain provisions that the
Commission proposes to modify.
Section 1234.2(b) would detail the
changes and modifications to ASTM
F2670–13 that the Commission has
determined would further reduce the
risk of injury from infant bath tubs. In
particular:
D Section 7.1.2, Latching or Locking
Mechanism Durability, would be
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changed to permit continuous testing of
infant bath tub latches through 2,000
cycles. An Appendix regarding section
7.1.2 would be added to clarify that the
cadence of testing has been changed to
accommodate tubs that could not be
tested at the previous rate of 12 cycles
per minute, but that testing is to be
conducted continuously while
maintaining a rate as close to the
previous standard as possible.
D Section 7.4.2 would be changed to
require that a 50 lb. (22.7 kg) bag of steel
shot is to be used to test infant bath tubs
in the required static load testing, rather
than a block of high-density
polyethylene, which might damage or
puncture some tubs. Additionally, the
text of this section would be changed to
make the required weight equivalent,
whether stated in pounds or kilograms.
D Section 8.4 would be changed to
require warning statements on infant
bath tubs and infant bath tub retail
packaging to have prescribed warning
language, and for the warning
statements to be permanent,
conspicuous, in contrasting color(s),
bordered, and in type larger than
currently required. Section 8.4 will also
require additional warnings for infant
bath tubs with suction cups. The
changes would be accompanied by
exemplar warnings.
D Section 9 would be changed to
require that instructional literature for
infant bath tubs contain new prescribed
warnings regarding the risks of
drowning or falling; explain the proper
use of the product; and emphasize the
safety practices stated in the warnings.
The instructions must also address
appropriate temperature ranges for bath
water, and instruct users to discontinue
use of infant bath tubs that become
damaged, broken, or disassembled. The
changes would be accompanied by an
exemplar warning.
VII. Incorporation by Reference
Section 1234.2(a) of the proposed rule
incorporates by reference ASTM F2670–
13. The Office of the Federal Register
(‘‘OFR’’) has regulations concerning
incorporation by reference. 1 CFR part
51. The OFR recently revised these
regulations to require that, for a
proposed rule, agencies must discuss in
the preamble to the NPR ways that the
materials the agency proposes to
incorporate by reference are reasonably
available to interested persons, or
explain how the agency worked to make
the materials reasonably available. In
addition, the preamble to the proposed
rule must summarize the material. 1
CFR 51.5(a).
In accordance with the OFR’s
requirements, section IV.B. of this
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preamble summarizes the provisions of
ASTM F2670–13 that the Commission
proposes to incorporate by reference.
ASTM F2670–13 is copyrighted. By
permission of ASTM, the standard can
be viewed as a read-only document
during the comment period on this NPR,
at: https://www.astm.org/cpsc.htm.
Interested persons may also purchase a
copy of ASTM F2670–13 from ASTM
International, 100 Bar Harbor Drive,
P.O. Box 0700, West Conshohocken, PA
19428; https://www.astm.org. One may
also inspect a copy at CPSC’s Office of
the Secretary, U.S. Consumer Product
Safety Commission, Room 820, 4330
East West Highway, Bethesda, MD
20814, telephone 301–504–7923.
VIII. Amendment of 16 CFR Part 1112
To Include NOR for Infant Bath Tubs
The CPSA establishes certain
requirements for product certification
and testing. 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). Certification of
children’s products subject to a
children’s product safety rule must be
based on testing conducted by a CPSCaccepted third party conformity
assessment body. Id. 2063(a)(2). The
Commission must publish an NOR for
the accreditation of third party
conformity assessment bodies to assess
conformity with a children’s product
safety rule to which a children’s product
is subject. Id. 2063(a)(3). Thus, the
proposed rule for 16 CFR part 1234,
Safety Standard for Infant Bath Tubs, if
issued as a final rule, would be a
children’s product safety rule requiring
the issuance of an NOR.
The Commission published a final
rule, Requirements Pertaining to Third
Party Conformity Assessment Bodies, 78
FR 15836 (March 12, 2013), codified at
16 CFR part 1112 (‘‘part 1112’’) and
effective on June 10, 2013, establishing
requirements for CPSC acceptance of
third party conformity assessment
bodies to test for conformance with a
children’s product safety rule in
accordance with section 14(a)(2) of the
CPSA. Part 1112 also codifies all of the
NORs previously issued by the
Commission.
All new NORs for new children’s
product safety rules, such as the infant
bath tub standard, require an
amendment to part 1112. To meet the
requirement that the Commission issue
an NOR for the proposed infant bath tub
standard, as part of this NPR, the
Commission proposes to amend the
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existing rule that codifies the list of all
NORs issued by the Commission to add
infant bath tubs to the list of children’s
product safety rules for which the CPSC
has issued an NOR.
Test laboratories applying for
acceptance as a CPSC-accepted third
party conformity assessment body to
test to the new standard for infant bath
tubs would be required to meet the third
party conformity assessment body
accreditation requirements in part 1112.
When a laboratory meets the
requirements as a CPSC-accepted third
party conformity assessment body, the
laboratory can apply to the CPSC to
have 16 CFR part 1234, Standard
Consumer Safety Specification for
Infant Bath Tubs, included in the
laboratory’s scope of accreditation of
CPSC safety rules listed for the
laboratory on the CPSC Web site at:
www.cpsc.gov/labsearch.
IX. 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.
5 U.S.C. 553(d). The Commission is
proposing an effective date of 6 months
after publication of the final rule in the
Federal Register for products
manufactured or imported on or after
that date. The proposed rule does not
require manufacturers to make design or
manufacturing changes; rather, the
proposed rule requires only that
manufacturers create and print new
labels. The two product testing
recommendations require a simple
change in equipment (replacing a block
of high-density polyethylene with a 50lb. shot bag), and a timing change in the
cycle testing for latches or locking
mechanisms. Similar equipment and
testing methods are already used in
child product testing, so the testing
changes can be made without delay. The
6-month period will allow ample time
for manufacturers and importers to
arrange for third party testing, and this
is consistent with the timeframe
adopted in a number of other section
104 rules.
We also propose a 6-month effective
date for the amendment to part 1112.
We ask for comments on the proposed
6-month effective date.
X. Regulatory Flexibility Act
A. Introduction
The Regulatory Flexibility Act
(‘‘RFA’’) requires agencies to consider
the impact of proposed rules on small
entities, including small businesses. The
RFA generally requires agencies to
review proposed rules for their potential
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impact on small entities and prepare an
initial regulatory flexibility analysis
(‘‘IRFA’’) unless the agency certifies that
the rule, if promulgated, will not have
a significant economic impact on a
substantial number of small entities. 5
U.S.C. 603 and 605. Because staff was
unable to estimate precisely all costs of
the draft proposed rule, staff conducted
such an analysis. The IRFA must
describe the impact of the proposed rule
on small entities and identify any
alternatives that may reduce the impact.
Specifically, the IRFA must contain:
• A description of, and where
feasible, an estimate of the number of
small entities to which the proposed
rule will apply;
• A description of the reasons why
action by the agency is being
considered;
• A succinct statement of the
objectives of, and legal basis for, the
proposed rule;
• A description of the projected
reporting, recordkeeping, and other
compliance requirements of the
proposed rule, including an estimate of
the classes of small entities subject to
the requirements and the type of
professional skills necessary for the
preparation of reports or records;
• Identification, to the extent
possible, of all relevant federal rules
that may duplicate, overlap, or conflict
with the proposed rule; and
• A description of any significant
alternatives to the proposed rule that
accomplish the stated objectives of
applicable statutes and minimize the
rule’s economic impact on small
entities.
B. Market Description
CPSC staff is aware of at least 26 firms
that supply infant bath tubs to the U.S.
market. Twenty-three of these firms are
domestic. Of the domestic firms, 14 are
manufacturers, eight are importers, and
one has an unknown supply source.
Seventeen of the domestic firms qualify
as ‘‘small firms’’ under the guidelines of
the U.S. Small Business Administration
(‘‘SBA’’). Three foreign companies
export to the United States via Internet
sales or to U.S. retailers.
C. Reason for Agency Action and Legal
Basis for Proposed Rule
The Danny Keysar Child Product
Safety Notification Act, section 104 of
the CPSIA, requires the CPSC to
promulgate mandatory standards that
are substantially the same as or more
stringent than, the voluntary standards
for durable infant or toddler products.
The proposed rule implements that
congressional direction.
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D. Other Federal Rules
Section 14(a)(2) of the CPSA requires
every manufacturer and private labeler
of a children’s product that is subject to
a children’s product safety rule to
certify, based on third party testing
conducted by a CPSC-accepted
laboratory that the product complies
with all applicable children’s product
safety rules. Section 14(i)(2) of the CPSA
requires the Commission to establish
protocols and standards requiring
children’s products to be tested
periodically and when there has been a
material change in the product, and
safeguarding against any undue
influence on a conformity assessment
body by a manufacturer or private
labeler. A final rule implementing these
requirements, Testing and Labeling
Pertaining to Product Certification (16
CFR part 1107) became effective on
February 13, 2013 (the ‘‘1107 Rule’’). If
a final children’s product safety rule for
infant bath tubs is adopted by the
Commission, infant bath tubs will be
subject to the third party testing
requirements, including record keeping,
when the final rule becomes effective.
Section 14(a)(3) of the CPSA requires
the Commission to publish an NOR for
the accreditation of third party
conformity assessment bodies (i.e.,
testing laboratories) for each children’s
product safety rule. The NORs for
existing rules are set forth in 16 CFR
part 1112. If the Commission adopts a
final rule on infant bath tubs,
publication of a NOR establishing
requirements for the accreditation of
testing laboratories will be required.
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E. Impact of the New Standards and
Testing Requirements on Small
Businesses
Under SBA guidelines, a
manufacturer of infant bath tubs is
categorized as ‘‘small’’ if it has 500 or
fewer employees, and importers and
wholesalers are considered ‘‘small’’ if
they have 100 or fewer employees.
Based on these guidelines, 17 of the 23
domestic firms known to be supplying
infant bath tubs to the U.S. market are
small firms: 10 manufacturers, six
importers, and one firm with an
unknown supply source.
Small Domestic Manufacturers. The
impact of the proposed rule is not likely
to be significant for small
manufacturers. Based on information on
firms’ Web sites, staff believes six
domestic manufacturers already comply
with the current infant bath tub
standard. This includes two infant bath
tub manufacturers that are certified by
the Juvenile Products Manufacturers
Association (‘‘JPMA’’), the major U.S.
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trade association that represents
juvenile product manufacturers and
importers, as compliant with the
voluntary standard. Firms already in
compliance with the infant bath tub
standard will not need to make physical
modifications to their products, but will
have to make modifications regarding
the warnings and instructions with their
products. The costs of modifying
existing labeling are usually small.
The four domestic manufacturers who
do not appear to be in compliance with
the infant bath tub standard might need
to modify their products. However,
these modifications are likely to be
minor because the products are not
complex; infant bath tubs generally are
composed of one or two pieces of hard
or soft plastic molded together.
Modifications would primarily involve
adjusting the size of grooves or openings
on the side of the product to avoid
finger entrapment. Therefore, the impact
of the proposed rule is likely to be small
for producers who do not yet comply
with the infant bath tub standard.
Under section 14 of the CPSA, should
the Commission adopt the infant bath
tub standard as a final rule, all
manufacturers will be subject to the
additional costs associated with the
third party testing and certification
requirements under the testing and
labeling rule (16 CFR part 1107). Third
party testing will include any physical
and mechanical test requirements
specified in the final infant bath tub rule
that may be issued; lead testing is
already required. Third party testing
costs are in addition to the direct costs
of meeting the infant bath tub standard.
Based on testing costs for similar
juvenile products, staff estimates that
testing to the infant bath tub standard
could cost approximately $500–$600
per model sample. On average, each
small domestic manufacturer supplies
three different models of infant bath
tubs to the U.S. market annually.
Therefore, if third party testing were
conducted every year on a single sample
for each model, third party testing costs
for each manufacturer would be about
$1,500–$1,800 annually. Based on a
review of firms’ revenues, which were,
on average, about $29 million annually,
it seems unlikely that the impacts of the
rule will be economically significant for
small producers.
Small Domestic Importers. Staff
believes that four of the six small
importers are compliant with the
current infant bath tub standard, and
would only need to assure that their
suppliers make the label modifications
to comply with the proposed rule. The
two remaining importers might need to
find an alternate source of infant bath
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tubs if their existing suppliers do not
come into compliance with the
requirements of the proposed rule.
Alternatively, these firms may
discontinue importing infant bath tubs
altogether and perhaps substitute
another product.
Importers of infant bath tubs will be
subject to third party testing and
certification requirements, and will
experience the associated costs if their
supplier(s) does not perform third party
testing. Based upon review of the firms’
revenues, which were, on average, about
$4.0 million annually, the impact of the
testing requirements could exceed 1
percent of revenues if the firms needed
to test more than one unit per model.
Hence, staff cannot rule out a significant
economic impact on small domestic
importers due to the testing
requirements.
As mentioned above, one small
domestic firm has an unknown supply
source. However, the firm has a diverse
product line and claims to be compliant
with various standards for several of its
other infant products. It is possible that
its infant bath tub is already compliant
with ASTM F2670–13, and thus, would
only have to modify existing labels.
Regardless, this firm should not
experience large impacts because infant
bath tubs are only one of many products
this firm supplies.
In summary, staff concluded that the
impact of the proposed rule is unlikely
to be economically significant for most
firms, but is unable to conclude that the
proposed rule would not have a
significant economic impact on small
importers.
Alternatives. Under section 104 of the
CPSIA, the Commission is required to
promulgate a standard that is either
substantially the same as the voluntary
standard or more stringent. The
Commission could promulgate the
existing voluntary standard without
revision. However, the proposed
warning labels and testing procedures
are not expected to have a substantial
impact on costs to small businesses.
Another alternative that would reduce
the impact on small entities is to set an
effective date later than the proposed 6
months. This would allow
manufacturers additional time to modify
and/or develop compliant infant bath
tubs, thus spreading the costs associated
with compliance over a longer period of
time.
F. Impact of Proposed 16 CFR Part 1112
Amendment on Small Businesses
As required by the RFA, staff
conducted a Final Regulatory Flexibility
Analysis (‘‘FRFA’’) when the
Commission issued the part 1112 rule
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(78 FR 15836, 15855–58). Briefly, the
FRFA concluded that the accreditation
requirements would not have a
significant adverse impact on a
substantial number of small testing
laboratories because no requirements
were imposed on test laboratories that
did not intend to provide third party
testing services. The only test
laboratories that were expected to
provide such services were those that
anticipated receiving sufficient revenue
from the mandated testing to justify
accepting the requirements as a business
decision.
Based on similar reasoning, amending
16 CFR part 1112 to include the NOR for
the infant bath tub standard will not
have a significant adverse impact on
small test laboratories. Moreover, based
upon the number of test laboratories in
the United States that have applied for
CPSC acceptance of accreditation to test
for conformance to other mandatory
juvenile product standards, we expect
that only a few test laboratories will
seek CPSC acceptance of their
accreditation to test for conformance
with the infant bath tub standard. Most
of these test laboratories will have
already been accredited to test for
conformance to other mandatory
juvenile product standards, and the only
costs to them would be the cost of
adding the infant bath tub standard to
their scope of accreditation. As a
consequence, the Commission certifies
that the NOR amending 16 CFR part
1112 to include the infant bath tub
standard will not have a significant
impact on a substantial number of small
entities.
XI. Environmental Considerations
The Commission’s regulations address
whether we are required to prepare an
environmental assessment or an
environmental impact statement. Under
these regulations, a rule that has ‘‘little
or no potential for affecting the human
environment’’ is categorically exempt
from this requirement. 16 CFR
1021.5(c)(1). The proposed rule falls
within the categorical exemption.
XII. Paperwork Reduction Act
This proposed rule contains
information collection requirements that
are subject to public comment and
review by the Office of Management and
Budget (‘‘OMB’’) under the Paperwork
Reduction Act of 1995 (‘‘PRA’’) (44
U.S.C. 3501–3521). In this document,
pursuant to 44 U.S.C. 3507(a)(1)(D), we
set forth:
• A title for the collection of
information;
• A summary of the collection of
information;
• A brief description of the need for
the information and the proposed use of
the information;
• A description of the likely
respondents and proposed frequency of
response to the collection of
information;
• An estimate of the burden that shall
result from the collection of
information; and
• Notice that comments may be
submitted to the OMB.
Title: Safety Standard for Infant Bath
Tubs.
Description: The proposed rule would
require each infant bath tub to comply
with ASTM F2670–13, with the changes
proposed in this Notice, which contains
requirements for marking, labeling, and
instructional literature. These
requirements fall within the definition
of ‘‘collection of information,’’ as
defined in 44 U.S.C. 3502(3).
Description of Respondents: Persons
who manufacture or import infant bath
tubs.
Estimated Burden: We estimate the
burden of this collection of information
as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
Number of
respondents
Frequency of
responses
Total annual
responses
Hours per
response
Total burden
hours
1234.2 ....................................................
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16 CFR Section
26
3
78
1
78
Our estimate is based on the
following:
Section 8.1 of the infant bath tub
standard requires that the name of the
manufacturer, distributor, or seller, and
either the place of business (city, state,
and mailing address, including zip
code) or telephone number, or both, to
be marked clearly and legibly on each
product and its retail package. Section
8.1.2 requires a code mark or other
means that identifies the date (month
and year, as a minimum) of
manufacture. Section 8.4 describes
required safety labeling.
There are 26 known entities
supplying infant bath tubs to the U.S.
market. All firms are assumed to use
labels already on both their products
and their packaging, but they may need
to make some modifications to their
existing labels. Based on an informal
survey by staff, the estimated time
required to make these modifications is
about 1 hour per model. Each entity
supplies an average of three different
models of infant bath tubs; therefore, the
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estimated burden associated with labels
is 1 hour per model × 26 entities × 3
models per entity = 78 hours. We
estimate the hourly compensation for
the time required to create and update
labels is $30.19 (U.S. Bureau of Labor
Statistics, ‘‘Employer Costs for
Employee Compensation,’’ March 2015,
Table 9, total compensation for all sales
and office workers in goods-producing
private industries: https://www.bls.gov/
ncs/). Therefore, the estimated annual
cost to industry associated with the
labeling requirements is $2,354.82
($30.19 per hour × 78 hours =
$2,354.82). No other operating,
maintenance, or capital costs are
associated with the collection.
Section 9.1 of the infant bath tub
standard requires instructions to be
supplied with the product. Infant bath
tubs are products that generally require
use and/or assembly instructions. Under
the OMB’s regulations (5 CFR
1320.3(b)(2)), the time, effort, and
financial resources necessary to comply
with a collection of information that
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would be incurred by persons in the
‘‘normal course of their activities’’ are
excluded from a burden estimate, where
an agency demonstrates that the
disclosure activities required to comply
are ‘‘usual and customary.’’ We are
unaware of infant bath tubs that
generally require use instructions, but
lack these instructions. Therefore, we
tentatively estimate that there are no
burden hours associated with section
9.1 of the infant bath tub standard,
because any burden associated with
supplying instructions with infant bath
tubs would be ‘‘usual and customary’’
and not within the definition of
‘‘burden’’ under the OMB’s regulations.
Based on this analysis, the proposed
standard for infant bath tubs would
impose a burden to industry of 78 hours
at a cost of $2,355 annually.
In compliance with the PRA (44
U.S.C. 3507(d)), we have submitted the
information collection requirements of
this rule to the OMB for review.
Interested persons are requested to
submit comments regarding information
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collection by September 14, 2015, to the
Office of Information and Regulatory
Affairs, OMB (see the ADDRESSES section
at the beginning of this notice).
Pursuant to 44 U.S.C. 3506(c)(2)(A),
we invite comments on:
• Whether the collection of
information is necessary for the proper
performance of the CPSC’s functions,
including whether the information will
have practical utility;
• The accuracy of the CPSC’s estimate
of the burden of the proposed collection
of information, including the validity of
the methodology and assumptions used;
• Ways to enhance the quality, utility,
and clarity of the information to be
collected;
• Ways to reduce the burden of the
collection of information on
respondents, including the use of
automated collection techniques, when
appropriate, and other forms of
information technology; and
• The estimated burden hours
associated with label modification,
including any alternative estimates.
asabaliauskas on DSK5VPTVN1PROD with PROPOSALS
XIII. Preemption
Section 26(a) of the CPSA, 15 U.S.C.
2075(a), provides that where a consumer
product safety standard 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.’’ Therefore, the
preemption provision of section 26(a) of
the CPSA would apply to a rule issued
under section 104.
XIV. Request for Comments
This NPR begins a rulemaking
proceeding under section 104(b) of the
CPSIA to issue a consumer product
safety standard for infant bath tubs, and
to amend part 1112 to add infant bath
tubs to the list of children’s product
safety rules for which the CPSC has
issued an NOR. We invite all interested
persons to submit comments on any
aspect of the proposed mandatory safety
standard for infant bath tubs and on the
proposed amendment to part 1112.
Specifically, the Commission requests
comments on the costs of compliance
with, and testing to, the proposed
mandatory infant bath tub standard, the
proposed 6-month effective date for the
new mandatory infant bath tub
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standard, and the amendment to part
1112.
Comments should be submitted in
accordance with the instructions in the
ADDRESSES section at the beginning of
this notice.
List of Subjects
16 CFR Part 1112
Administrative practice and
procedure, Audit, Consumer protection,
Reporting and recordkeeping
requirements, Third party conformity
assessment body.
16 CFR Part 1234
Consumer protection, Imports,
Incorporation by reference, Infants and
children, Labeling, Law enforcement,
Toys.
For the reasons discussed in the
preamble, the Commission proposes to
amend title 16 of the Code of Federal
Regulations as follows:
PART 1112—REQUIREMENTS
PERTAINING TO THIRD PARTY
CONFORMITY ASSESSMENT BODIES
1. The authority citation for part 1112
continues to read as follows:
■
Authority: Public Law 110–314, section 3,
122 Stat. 3016, 3017 (2008); 15 U.S.C. 2063.
2. Amend § 1112.15 by adding
paragraph (b)(41) to read as follows:
■
§ 1112.15 When can a third party
conformity assessment body apply for
CPSC acceptance for a particular CPSC rule
and/or test method?
*
*
*
*
*
(b) * * *
(41) 16 CFR part 1234, Safety
Standard for Infant Bath Tubs.
*
*
*
*
*
■ 3. Add part 1234 to read as follows:
PART 1234—SAFETY STANDARD FOR
INFANT BATH TUBS
Sec.
1234.1
1234.2
Scope.
Requirements for infant bath tubs.
Authority: Authority: Sec. 104, Public Law
110–314, 122 Stat. 3016.
§ 1234.1
Scope.
This part establishes a consumer
product safety standard for infant bath
tubs.
§ 1234.2
tubs.
Requirements for infant bath
(a) Except as provided in paragraph
(b) of this section, each infant bath tub
shall comply with all applicable
provisions of ASTM F2670–13,
Standard Consumer Safety
Specification for Infant Bath Tubs,
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approved February 15, 2013. 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; https://
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 ASTM F2670–13
with the following additions or
exclusions:
(1) Instead of complying with section
7.1.2 of ASTM F2670–13, comply with
the following:
(i) 7.1.2 Latching or Locking
Mechanism Durability—The latching or
locking mechanism(s) shall be cycled
through its normal operation a total of
2000 cycles. Each cycle shall consist of
opening and closing the mechanism and
erecting/folding the product. Cycling
shall be conducted on a continuous
basis.
(ii) [Reserved]
(2) Add as an Appendix to ASTM
F2670–13, the following:
(i) X1.2 Section 7.1.2—The timing of
the durability cycling was revised so as
to accommodate latching or locking
mechanisms on some products that may
require longer than 5 seconds to activate
and deactivate. Continuous cycling is
being prescribed to accommodate these
potential longer activation/deactivation
cycles, but the intent of the standard is
to cycle the latching or locking
mechanisms at a rate as close to 12
cycles per minute as can be reasonably
achieved for the specific mechanism.
(ii) [Reserved]
(3) Instead of complying with section
7.4.2 of ASTM F2670–13, comply with
the following:
(i) 7.4.2 Place a load on the center of
the seating surface using a 6 to 8 in. (150
to 200mm) diameter bag filled with steel
shot and which has a total weight of 50
lb (22.7kg) or three times the maximum
weight of the child recommended by the
manufacturer, whichever is greater, on
the center of the product.
(ii) [Reserved]
(4) Instead of complying with section
8.4 of ASTM F2670–13, including all
subsections of section 8.4, comply with
the following:
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asabaliauskas on DSK5VPTVN1PROD with PROPOSALS
and signal word ‘‘WARNING’’ shall be
orange, red, or yellow, whichever
provides best contrast against the
product background. The remainder of
the label text shall be black and in
upper and lower case letters on a white
background surrounded by a bold solid
line black border. Text within the
message panel shall be left-justified.
Precautionary statements shall be
indented from hazard statements and
preceded by bullet points. Message
panels within the label shall be
delineated with solid black lines
between sections addressing different
hazards. If an outer border is used to
surround the bold solid black lines of
the label, the outer border shall be white
and the corners may be radiused. An
example label in the format described in
this section is shown in Fig. 2.
(B) 8.4.2 The following warning
statement shall be included exactly as
stated below:
Drowning Hazard: Babies have
drowned while using infant bath tubs.
(C) 8.4.3 Additional warning
statements shall address the following:
D Stay in arm’s reach of your baby.
D Use in empty adult tub or sink.
D Keep drain open.
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and the word ‘‘WARNING’’ shall be at
least 0.2 in. (5 mm) high and the
remainder of the text shall be in
characters whose upper case shall be at
least 0.1 in. (2.5 mm) high. The
warnings and statements are not
required on the retail package if they are
on the product and visible in their
entirety and are not concealed by the
retail package. Cartons and other
materials used exclusively for shipping
the product are not considered retail
packaging.
(ii) [Reserved]
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EP14AU15.089
and signal word ‘‘WARNING’’ shall be
delineated with a bold solid line black
border. The background color behind
the safety alert symbol
and the signal word ‘‘WARNING’’ shall
be at least 0.2 in. (5 mm) in height and
the remainder of the text shall be at least
0.1 in. (2.5 mm) in height. The fall
hazard warning label shall not be
displayed above or before the drowning
hazard warning label.
(G) 8.4.7 Products utilizing suction
cups as an attachment mechanism to the
support surface, and which are not
intended by the manufacturer to be used
on any type of slip-resistant surface,
shall also include a warning to this
effect. In addition, if there are other
types of surfaces that the manufacturer
does not intend the product be used on,
then additional warning(s) shall be
given regarding such surface(s). Such
warning(s) shall use the signal word
WARNING preceded by the safety alert
symbol, and shall meet the requirements
described in 8.4.1.
(5) Instead of complying with section
8.5 of ASTM F2670–13, comply with
the following:
(i) 8.5 Each product’s retail package
shall be labeled on the principal display
panel as specified in 8.4 except that the
safety alert symbol
(6) Instead of complying with section
9 of ASTM F2670–13, including all
subsections of section 9, comply with
the following:
(i) 9. Instructional Literature
(A) 9.1 All products shall have
instructional literature enclosed that
explains the proper use of the product
and that shall be easy to read and
understand. Such literature shall
include instructions for assembly,
maintenance, cleaning, inspections, and
limitations of the product, as well as the
manufacturer’s recommended use
position(s).
(B) 9.2 Warning Statements in
Instructional Literature:
(1) 9.2.1 Instructional literature shall
include the warnings specified in 8.4.2
through 8.4.7. The phrase ‘‘To prevent
drowning’’ shall be added before the
bulleted statements in 8.4.3 and the
phrase ‘‘To prevent falls’’ shall be added
before the bulleted statements in 8.4.5.
(2) 9.2.2 Warning statements in
instructional literature shall also
address the following:
D Babies can drown in as little as 1
inch of water. Use as little water as
possible to bathe your baby.
D Never rely on a toddler or
preschooler to help your baby or alert
you to trouble. Babies have drowned
even with other children in or near bath
tub.
(3) 9.2.3 Warning statements in
instructional literature shall meet the
requirements described in 8.4 except
that the background and text in the
signal word panel need not be in color,
and the remaining text shall be in highly
contrasting colors, (e.g., black text on
white). An example label that meets the
requirements is shown in Fig. 3.
(C) 9.3 In addition to the warnings,
the instructional literature shall
emphasize and reinforce the safe
practices stated in the warnings.
(D) 9.4 Instructional literature shall
also advise to test the temperature of the
water in, or being put into, the infant
bath tub prior to placing the infant into
the product. Instructions shall also
indicate that the typical water
temperature for bathing a baby should
be between 90 and 100 °F (32.2 and
37.8°C).
(E) 9.5 Instructional literature shall
instruct to discontinue the use of the
product if it becomes damaged, broken,
or disassembled.
(F) 9.6 Instructional literature shall
include the information as specified in
8.3.
(G) 9.7 Warnings, statements, or
graphic pictorials shall not indicate or
imply that the infant may be left in the
product without a caregiver in
attendance.
EP14AU15.089
and the word ‘‘WARNING,’’ shall be at
least 0.4 in. (10 mm) high unless stated
otherwise, shall be the same size, and
shall be in bold capital letters. The
remainder of the text shall be in
characters whose upper case shall be at
least 0.2 in. (5 mm) high unless stated
otherwise. The safety alert symbol
(D) 8.4.4 The following warning
statement shall be included exactly as
stated below:
Fall Hazard: Babies have suffered
head injuries falling from infant tubs.
(E) 8.4.5 Additional warning
statements shall address the following:
D Use only [insert safe location(s), e.g.,
in adult tub, sink, or on floor; in adult
tub or on floor)].
D Never lift or carry baby in tub.
(F) 8.4.6 The drowning hazard
warning statements and the fall hazard
warning statements in 8.4.2 through
8.4.5 may be displayed on separate
labels. If the fall hazard warning
statements are displayed on a separate
label, the label shall comply with the
requirements of 8.4.1 except that the
safety alert symbol
EP14AU15.089
(i) 8.4 Each product shall be labeled
with warning statements. The warning
statements shall be in contrasting
color(s), permanent, conspicuous and in
non-condensed sans serif typeface. All
warning(s) shall be distinctively
separated from any other wording or
designs and shall appear in the English
language at a minimum. The specified
warning label may not be placed in a
location that allows the warnings to be
obscured or rendered inconspicuous
when in the manufacturer’s
recommended use position.
(A) 8.4.1 Warning Label Format—The
safety alert symbol
EP14AU15.089
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EP14AU15.089
48778
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48779
(7) Add the following Figure 2 to
ASTM F2670–13:
Drowning Hazard: Babies have drowned while
using infant bath tubs.
• Stay in arm's reach of your baby.
• Use in empty adult tub or sink.
• Keep drain open.
Fall Hazard: Babies have suffered head injuries
falling from infant bath tubs.
• Place tub only [insert manufacturer's
intended location(s) for safe use (e.g., in
adult tub, sink or on floor; in adult tub or
on floor)].
• Never lift or carry baby in tub.
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asabaliauskas on DSK5VPTVN1PROD with PROPOSALS
Fig. 2 Example label that meets the requirements of Section 8 with
the drowning and fall hazards combined in a single label.
48780
Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Proposed Rules
(8) Add the following Figure 3 to
ASTM F2670–13:
Drowning Hazard: Babies have drowned
while using infant bath tubs.
• Stay in arm's reach of your baby.
• Use in empty adult tub or sink.
• Keep drain open.
Fall Hazard: Babies have suffered head injuries falling from infant
bath tubs.
•
Place tub only [insert manufacturer's intended location(s) for
safe use (e.g., in adult tub, sink, or on floor; in adult tub or on
floor)}.
•
Never lift or carry baby in tub.
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EP14AU15.077
asabaliauskas on DSK5VPTVN1PROD with PROPOSALS
Fig. 3 Example labels that meet the requirements of Section 8 when the
drowning hazard warning and fall hazard warning are presented in
separate labels.
Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Proposed Rules
48781
(9) Add the following Figure 4 to
ASTM F2670–13:
WARNING
Drowning Hazard: Babies have drowned
while using infant bath tubs.
To prevent drowning: Stay in arm's
reach of your baby.
• Never rely on a toddler or preschooler
to help your baby or alert you to trouble.
Babies have drowned even with other
children in or near bath tub.
• Babies can drown in as little as 1 inch
of water. Use as little water as possible
to bathe your baby.
• Use in an empty adult tub or sink.
• Always keep drain open.
Fig. 4. Example label that meets the requirements of Section 9. Note: The fall
hazard warning need not be presented in 0.2 in. text if it is displayed separately
from the drowning hazard warning.
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EP14AU15.078
asabaliauskas on DSK5VPTVN1PROD with PROPOSALS
Fall Hazard: Babies have suffered head
injuries falling from infant bath tubs.
To prevent falls:
• Place tub only [insert manufacturer's
intended location(s) for safe use (e.g., in
adult tub, sink or on floor; in adult tub or
on floor)}.
• Never lift or carry baby in tub.
48782
Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Proposed Rules
BILLING CODE 6355–01–P
33 CFR Part 165
submitting comments. To avoid
duplication, please use only one of
these three methods.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this rule, call or
email Petty Officer Benjamin R. Colbert,
Sector Miami Prevention Department,
Coast Guard; telephone (305) 535–4317,
email Benjamin.R.Colbert@uscg.mil. If
you have questions on viewing or
submitting material to the docket, call
Cheryl Collins, Program Manager,
Docket Operations, telephone (202)
366–9826.
SUPPLEMENTARY INFORMATION:
[Docket Number USCG–2015–0561]
Table of Acronyms
RIN 1625–AA00
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Dated: August 6, 2015.
Todd A. Stevenson,
Secretary, Consumer Product Safety
Commission.
[FR Doc. 2015–19668 Filed 8–13–15; 8:45 am]
BILLING CODE 6355–01–C
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
Safety Zone; Mack Cycle Escape to
Miami Triathlon, Biscayne Bay; Miami,
FL
Coast Guard, DHS.
Notice of proposed rulemaking.
AGENCY:
ACTION:
The Coast Guard proposes to
establish a temporary safety zone on the
waters of Biscayne Bay, east of Margaret
Pace Park, Miami, Florida during the
Mack Cycle Escape to Miami Triathlon
on September 20, 2015. The temporary
safety zone is necessary to provide for
the safety of the participants, participant
vessels, spectators, and the general
public during the event. Non-participant
persons and vessels are prohibited from
entering, transiting through, anchoring
in, or remaining within the safety zone
that encompasses the swim area unless
authorized by the Captain of the Port
Miami or a designated representative.
DATES: Comments and related material
must be received by the Coast Guard on
or before August 31, 2015.
Requests for public meetings must be
received by the Coast Guard on or before
September 14, 2015.
ADDRESSES: You may submit comments
identified by docket number using any
one of the following methods:
(1) Federal eRulemaking Portal:
https://www.regulations.gov.
(2) Fax: 202–493–2251.
(3) Mail or Delivery: Docket
Management Facility (M–30), U.S.
Department of Transportation, West
Building Ground Floor, Room W12–140,
1200 New Jersey Avenue SE.,
Washington, DC 20590–0001. Deliveries
accepted between 9 a.m. and 5 p.m.,
Monday through Friday, except federal
holidays. The telephone number is 202–
366–9329.
See the ‘‘Public Participation and
Request for Comments’’ portion of the
SUPPLEMENTARY INFORMATION section
below for further instructions on
asabaliauskas on DSK5VPTVN1PROD with PROPOSALS
SUMMARY:
VerDate Sep<11>2014
17:19 Aug 13, 2015
Jkt 235001
A. Public Participation and Request for
Comments
We encourage you to participate in
this rulemaking by submitting
comments and related materials. All
comments received will be posted
without change to https://
www.regulations.gov and will include
any personal information you have
provided.
1. Submitting Comments
If you submit a comment, please
include the docket number for this
rulemaking, indicate the specific section
of this document to which each
comment applies, and provide a reason
for each suggestion or recommendation.
You may submit your comments and
material online at https://
www.regulations.gov, or by fax, mail, or
hand delivery, but please use only one
of these means. If you submit a
comment online, it will be considered
received by the Coast Guard when you
successfully transmit the comment. If
you fax, hand deliver, or mail your
comment, it will be considered as
having been received by the Coast
Guard when it is received at the Docket
Management Facility. We recommend
that you include your name and a
mailing address, an email address, or a
telephone number in the body of your
document so that we can contact you if
we have questions regarding your
submission.
To submit your comment online, go to
https://www.regulations.gov, type the
docket number USCG–2015–0561 in the
‘‘SEARCH’’ box and click ‘‘SEARCH.’’
Click on ‘‘Submit a Comment’’ on the
line associated with this rulemaking.
If you submit your comments by mail
or hand delivery, submit them in an
unbound format, no larger than 81⁄2 by
11 inches, suitable for copying and
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electronic filing. If you submit
comments by mail and would like to
know that they reached the Facility,
please enclose a stamped, self-addressed
postcard or envelope. We will consider
all comments and material received
during the comment period and may
change the rule based on your
comments.
2. Viewing Comments and Documents
To view comments, as well as
documents mentioned in this preamble
as being available in the docket, go to
https://www.regulations.gov, type the
docket number (USCG–2015–0561) in
the ‘‘SEARCH’’ box and click
‘‘SEARCH.’’ Click on Open Docket
Folder on the line associated with this
rulemaking. You may also visit the
Docket Management Facility in Room
W12–140 on the ground floor of the
Department of Transportation West
Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m.
and 5 p.m., Monday through Friday,
except Federal holidays.
3. Privacy Act
Anyone can search the electronic
form of comments received into any of
our dockets by the name of the
individual submitting the comment (or
signing the comment, if submitted on
behalf of an association, business, labor
union, etc.). You may review a Privacy
Act notice regarding our public dockets
in the January 17, 2008, issue of the
Federal Register (73 FR 3316).
4. Public Meeting
We do not now plan to hold a public
meeting. But you may submit a request
for one, using one of the methods
specified under ADDRESSES. Please
explain why you believe a public
meeting would be beneficial. If we
determine that one would aid this
rulemaking, we will hold one at a time
and place announced by a later notice
in the Federal Register.
B. Regulatory History and Information
This is the first rule-making action in
regards to this year’s Mack Cyle Escape
to Miami Triathlon event.
C. Basis and Purpose
The legal basis for the rule is the
Coast Guard’s authority to establish
regulated navigation areas and other
limited access areas: 33 U.S.C. 1231; 50
U.S.C. 191; 33 CFR 1.05–1, 6.04–1,
6.04–6, and 160.5; Department of
Homeland Security Delegation No.
0170.1. The purpose of the rule is to
provide for the safety of life on the
navigable waters of the United States
E:\FR\FM\14AUP1.SGM
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Agencies
[Federal Register Volume 80, Number 157 (Friday, August 14, 2015)]
[Proposed Rules]
[Pages 48769-48782]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-19668]
=======================================================================
-----------------------------------------------------------------------
CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Parts 1112 and 1234
[CPSC Docket No. 2015-0019]
Safety Standard for Infant Bath Tubs
AGENCY: Consumer Product Safety Commission.
ACTION: Notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: The Danny Keysar Child Product Safety Notification Act,
Section 104 of the Consumer Product Safety Improvement Act of 2008
(``CPSIA'') requires the United States Consumer Product Safety
Commission (``Commission,'' ``CPSC,'' or ``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. The Commission
is proposing a safety standard for infant bath tubs in response to the
direction under Section 104(b) of the CPSIA. In addition, the
Commission is proposing an amendment to include the proposed standard
in the list of notices of requirements (NORs) issued by the Commission.
DATES: Submit comments by October 28, 2015.
ADDRESSES: Comments related to the Paperwork Reduction Act aspects of
the marking, labeling, and instructional literature requirements of the
proposed mandatory standard for infant bath tubs should be directed to
the Office of Information and Regulatory Affairs, the Office of
Management and Budget, Attn: CPSC Desk Officer, FAX: 202-395-6974, or
emailed to oira_submission@omb.eop.gov.
Other comments, identified by Docket No. CPSC 2015-0019, may be
submitted electronically or in writing:
Electronic Submissions: Submit electronic comments to the Federal
eRulemaking Portal at: https://www.regulations.gov. Follow the
instructions for submitting comments. The Commission does not accept
comments submitted by electronic mail (email), except through
www.regulations.gov. The Commission encourages you to submit electronic
comments by using the Federal eRulemaking Portal, as described above.
Written Submissions: Submit written submissions by mail/hand
delivery/courier to: Office of the Secretary, Consumer Product Safety
Commission, Room 820, 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 proposed rulemaking. All comments received
may be posted without change, including any personal identifiers,
contact information, or other personal information provided, to: https://www.regulations.gov. Do not submit confidential business information,
trade secret information, or other sensitive or protected information
that you do not want to be available to the public. If furnished at
all, such information should be submitted in writing.
Docket: For access to the docket to read background documents or
comments received, go to: https://www.regulations.gov, and insert the
docket number CPSC-2015-0019, into the ``Search'' box, and follow the
prompts.
FOR FURTHER INFORMATION CONTACT: Celestine T. Kish, Project Manager,
Directorate for Engineering Sciences, U.S. Consumer Product Safety
Commission, 5 Research Place, Rockville, MD 20850; email:
ckish@cpsc.gov; telephone: (301) 987-2547.
SUPPLEMENTARY INFORMATION:
I. Background and Statutory Authority
The CPSIA was enacted on August 14, 2008. Section 104(b) of the
CPSIA, part of the Danny Keysar Child Product Safety Notification Act,
requires the Commission to: (1) Examine and assess the effectiveness of
voluntary consumer product safety standards for durable infant or
toddler products, in consultation with representatives of consumer
groups, juvenile product manufacturers, and independent child product
engineers and experts; and (2) promulgate consumer product safety
standards for durable infant and toddler products. Standards issued
under section 104 are to be ``substantially the same as'' the
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 term ``durable infant or toddler product'' is defined in
section 104(f)(1) of the CPSIA as ``a durable product intended for use,
or that may be reasonably expected to be used, by children under the
age of 5 years.'' Section 104(f)(2) of the CPSIA lists examples of
durable infant or toddler products, including products such as ``bath
seats'' and ``infant carriers.'' Although section 104(f)(2) does not
specifically identify infant bath tubs, the Commission has defined
infant bath tubs as a ``durable infant or toddler product'' in the
Commission's product registration card rule under CPSIA section
104(d).\1\
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\1\ Requirements for Consumer Registration of Durable Infant or
Toddler Products; Final Rule, 74 FR 68668, 68669 (December 29,
2009); 16 CFR 1130.2(a)(16).
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Pursuant to section 104(b)(1)(A), the Commission consulted with
manufacturers, retailers, trade organizations, laboratories, consumer
advocacy groups, consultants, and members of the public in the
development of this notice of proposed rulemaking (``NPR''), largely
through the standards development process of ASTM International
(formerly the American Society for Testing and Materials) (``ASTM'').
The proposed rule is based on the voluntary standard developed by ASTM,
ASTM F2670-13, Standard Consumer Safety Specification for Infant Bath
Tubs (``ASTM F2670-13''), with several modifications to strengthen the
standard.
The testing and certification requirements of section 14(a) of the
Consumer Product Safety Act (``CPSA'') apply to product safety
standards promulgated under section 104 of the CPSIA. Section 14(a)(3)
of the CPSA requires the Commission to publish an NOR for the
accreditation of third party conformity assessment bodies (test
laboratories) to assess conformity with a children's product safety
rule to which a children's product is subject. The infant bath tub
standard, if issued as a final rule, will be a children's product
safety rule that requires the issuance of an NOR. To meet the
requirement that the Commission issue an NOR for the infant bath tub
standard, this NPR proposes to amend 16 CFR part 1112 to include 16 CFR
part 1234, the CFR section where the infant bath tub standard will be
codified if the standard becomes final.
[[Page 48770]]
II. Product Description
A. Definition of Infant Bath Tub
ASTM F2670-13 defines an ``infant bath tub'' as a ``tub, enclosure,
or other similar product intended to hold water and be placed into an
adult bath tub, sink, or on top of other surfaces to provide support or
containment, or both, for an infant in a reclining, sitting, or
standing position during bathing by a caregiver.'' ASTM F2670-13
section 3.1.2. Falling within this definition are products of various
designs, including ``bucket style'' tubs that support a child sitting
upright, tubs with an inclined seat for infants too young to sit
unsupported, inflatable tubs, folding tubs, and tubs with spa features,
such as handheld shower attachments and even whirlpool settings. The
ASTM standard permits infant bath tubs to have ``a permanent or
removable passive crotch restraint as part of their design,'' but does
not permit ``any additional restraint system(s) which requires action
on the part of the caregiver to secure or release.'' Id. section 6.1.
ASTM F2670-13 excludes from its scope ``products commonly known as bath
slings, typically made of fabric or mesh.'' Id. sec. 1.1.
B. Market Description
CPSC staff is aware of at least 26 firms that supply infant bath
tubs to the U.S. market. Twenty-three of these firms are domestic,
including 14 manufacturers, eight importers, and one with an unknown
supply source. Three foreign companies export directly to the United
States via Internet sales or to U.S. retailers.
III. Incident Data
CPSC staff has received detailed reports from various sources of
202 incidents related to infant bath tubs from January 1, 2004 through
May 20, 2015. Thirty-one of these incidents (15%) were fatal. Of the
146 victims whose age could be determined, 141 (97%) were under 2 years
of age. In the 168 incidents in which the sex of the child was
reported, 54 percent of the victims were male, and 46 percent of the
victims were female.
A. Fatalities
Thirty-one fatalities were reported to have been associated with
infant bath tubs from January 1, 2004 through May 20, 2015. Drowning
was the reported cause of death for 30 of the fatalities (97%); the
remaining fatality involved a child with a heart defect, whose death
was attributed to pneumonia. Twenty-nine of the fatality victims (94%)
were between 4 months and 11 months of age; the remaining two fatality
victims were 23 months and 3 years of age. In all but one of the
drowning fatalities, a parent or caregiver left the victim alone in the
infant bath tub, and returned to find the child submerged. Sixteen of
the fatalities (52%) were male, while 15 (48%) were female.
B. Nonfatal Injuries
One hundred seventy-one nonfatal incidents associated with infant
bath tubs were reported to have occurred from January 1, 2004 through
May 20, 2015. The 171 reports included 30 reports of injuries requiring
hospitalization (nine reports), emergency room treatment (nine
reports), treatment by a medical professional (eight reports), or first
aid (four reports). The nine incidents requiring hospitalization
included eight near-drowning incidents in which a child almost died
from suffocation under water, and one scalding water burn. All eight
near-drowning incidents resulting in hospitalization occurred while the
parent or caregiver was not present. The nine incidents requiring
emergency room treatment consisted of five near-drowning incidents, a
head injury caused by a bath toy detaching from a tub, a concussion
from a fall from a tub located on a counter when a tub leg collapsed,
one rash, and an injury caused by mold on a tub. The eight injury
reports requiring a visit to a medical professional consisted of one
laceration, one rash, and six injuries involving mold. The four
incidents requiring home first aid resulted from finger, hand, and foot
entrapments.
C. Hazard Pattern Identification
CPSC staff considered all 202 (31 fatal and 171 nonfatal) reported
infant bath tub incidents to identify the hazard patterns associated
with infant bath tub-related incidents. Staff grouped the hazard
patterns into the following categories in order of frequency:
1. Drowning/Near Drowning incidents account for 43 out of 202 (21%)
of the reported incidents. Thirty of these 43 incidents were drowning
fatalities; the remaining 13 incidents involved near-drownings. In 38
of the 43 drowning or near-drowning incidents (88%), the parent or
guardian was not present at the time the incident occurred. Because
there were no witnesses to a majority of drowning or near-drowning
incidents, determining exactly what happened is difficult. Generally,
the child was found floating, but exactly what transpired was unclear.
One incidental fatality was attributed to pneumonia rather than
drowning; this incident is discussed in the ``Miscellaneous Issues''
category.
2. Protrusion/Sharp/Laceration issues accounted for 39 out of 202
(19%) of the reported incidents. In most of these incidents, the child
made contact with a part that protrudes from the tub, causing red
marks, cuts, or bruising. The body parts reportedly injured were toes,
feet, bottom, genitalia, and back. In 29 of the 39 incidents, a
protrusion described as a ``bump'' or ``hump'' caused a red mark or
discomfort to the infant. In many of these protrusion incidents, a
``hammock/sling'' attachment was involved.
Only one of the 39 ``protrusion'' incident reports required a
hospital visit; in that incident, a child's back was scratched by a
screw that penetrated the tub wall. The remaining 38 incidents in this
category resulted in a minor injury or no injury.
3. Product failures accounted for 53 out of 202 (26%) of the
reported incidents. In 28 incidents, the ``hammock'' or ``sling''
collapsed or broke, and in eight incidents the tub's locking mechanism
failed or broke. The remaining 17 ``product failure'' incidents
involved various tub parts breaking. In two of the 53 ``product
failure'' incidents a child was treated at a hospital and released; in
the remaining incidents, there was either no injury or a minor injury.
In one of the incidents requiring a hospital visit, a toy attached to a
tub fell and caused a deep cut on a child's forehead. In the second
incident, the leg of a tub collapsed, causing a child to fall from the
counter top supporting the tub onto the floor, resulting in a
concussion.
4. Entrapment issues accounted for 20 out of 202 (10%) of the
reported incidents. Entrapment incidents involved fingers, arms, feet,
legs, or genitalia caught or stuck on parts of the tub, mostly in a
pinching manner. Many of these injuries occurred in tubs that fold.
Hinges, holes, and the foot area inside a tub were common areas of
entrapment. These entrapment incidents resulted in no injury or minor
injury; there were no reported hospitalizations.
5. Slippery tub surface issues accounted for 14 of 202 (7%) of the
reported incidents. These incidents resulted in minor skin abrasions or
scratches, and potential submersions. These incidents resulted in no
injury or minor injury.
6. Mold/Allergy issues accounted for 12 of 202 (6%) of the reported
incidents. Eight incidents were attributed to mold, and four were
allergy related. The reported issues included itching, rashes, foul
odor, respiratory issues, and a urinary tract infection. Eight of these
incidents, six involving mold issues and two involving allergy issues,
involved a
[[Page 48771]]
single infant tub make and model. The 12 reported incidents included
two emergency room visits, one for an upper respiratory issue, and one
for a rash on the child's back. In seven additional incidents, children
were seen by a medical professional for itching and rashes (four
incidents), a urinary tract infection, a severe cold with fever, and
the presence of mold spores on the genitalia.
7. Miscellaneous issues accounted for 21 out of 202 (10%) of the
reported incidents. The issues included falling out of a tub, an
unstable tub, missing pieces, batteries leaking or overheating, rust,
and scalding. Miscellaneous issues resulted in one fatality and one
hospital admission. The fatality involved a child with a ventricular
septal defect whose death was attributed to pneumonia. The hospital
visit was caused by scalding when a parent poured hot water from a
stove onto a tub's foam cushion and then placed the child in the tub.
The rest of the reports involved no injury or a minor injury.
D. National Injury Estimates
CPSC also evaluates data reported through the National Electronic
Injury Surveillance System (NEISS), which gathers summary injury data
from hospital emergency departments selected as a probability sample of
all the U.S. hospitals with emergency departments. This surveillance
information enables CPSC staff to make timely national estimates of the
number of injuries associated with specific consumer products. Based on
a review of emergency department visits related to infant bath tubs for
the years 2004 to 2014, staff estimates that there were 2,200 injuries
treated in U.S. hospital emergency rooms over that 11-year period
associated with infant bath tubs (sample size = 82, coefficient of
variation = 0.18).\2\ The NEISS data included one infant death, which
has been included in the fatality statistics reported above.
Approximately 94 percent of the victims were 12 months of age or
younger and only one of the 82 reported NEISS cases involved a child
older than 24 months.
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\2\ NEISS reports for infant bath tub incidents are summary in
nature and provide limited detail for determining hazard scenarios.
For that reason, NEISS incident data are not included in our
analysis and discussion of overall hazard patterns, unless a NEISS
incident report was supplemented by further investigation.
---------------------------------------------------------------------------
For the injuries reported through NEISS, the most prominent hazard
was falling, which occurred in 33 percent of the incidents. Drowning or
near-drowning occurred in 22 percent of the incidents. Head injuries
were common (35%), as were body injuries (22%), and face injuries
(18%). In more than 80 percent of the NEISS cases, the victim was
treated at the emergency room and released, while 15 percent were
admitted or transferred to a hospital.
IV. The ASTM Infant Bath Tub Standard
A. History of ASTM 2670-13
Section 104(b)(1)(A) of the CPSIA requires the Commission to
consult representatives of ``consumer groups, juvenile product
manufacturers, and independent child product engineers and experts'' to
``examine and assess the effectiveness of any voluntary consumer
product safety standards for durable infant or toddler products.'' As a
result of incidents arising from infant bath tubs, CPSC staff requested
that ASTM develop voluntary requirements to address the hazard patterns
related to their use. Through the ASTM process, CPSC staff consulted
with manufacturers, retailers, trade organizations, laboratories,
consumer advocacy groups, consultants, and members of the public, and
the infant bath tub standard was developed.
ASTM F2670 was first approved in 2009, and then revised in 2010,
2011, 2012, and 2013. The current version, ASTM F2670-13, was approved
on February 15, 2013, and was published in March 2013.
B. Description of the Current ASTM Voluntary Standard-ASTM 2670-13
ASTM F2670-13 contains both general and performance requirements to
address the hazards associated with infant bath tubs. ASTM F2670-13
includes the following key provisions: scope, terminology, general
requirements, performance requirements, test methods, marking and
labeling, and instructional literature.
Scope. This section states the scope of the standard, which:
``establishes performance requirements, test methods, and labeling
requirements to promote the safe use of infant bath tubs.'' As stated
in section II.A. of this preamble, ASTM F2670-13 defines an ``infant
bath tub'' as a ``tub, enclosure, or other similar product intended to
hold water and be placed into an adult bath tub, sink, or on top of
other surfaces to provide support or containment, or both, for an
infant in a reclining, sitting, or standing position during bathing by
a caregiver.'' This description includes ``bucket style'' tubs that
support a child sitting upright, tubs with an inclined seat for infants
too young to sit unsupported, inflatable tubs, folding tubs, and tubs
with more elaborate designs including handheld shower attachments and
even whirlpool settings. ASTM F2670-13 excludes from its scope
``products commonly known as bath slings, typically made of fabric or
mesh.'' Id. sec. 1.1.
Terminology. This section provides definitions of terms specific to
this standard.
Requirements and Test Methods. These sections set both general and
performance requirements to address several hazards, many of which are
also found in the other ASTM juvenile product standards. These
requirements and test methods address:
Sharp edges or points (incorporating CPSC standards for
sharp edges and sharp points); \3\
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\3\ See 16 CFR 1500.48 (sharp point standard) and 1500.49 (sharp
edge standard).
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Small parts (incorporating CPSC standards for small
parts); \4\
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\4\ See 16 CFR part 1501 (small part limitations).
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Lead in paint and surface coatings (incorporating CPSC
lead and surface coating standards); \5\
---------------------------------------------------------------------------
\5\ See 16 CFR part 1303 (limitations on lead in paint and
surface coatings).
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Passive restraints;
Size and safety requirements for attached toys
(incorporating CPSC toy standards); \6\
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\6\ See ASTM F963, Standard Consumer Safety Specification for
Toy Safety (ASTM F963).
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Resistance to collapse or displacement in use;
Durability and strength of locking components;
Displacement of protective components;
Adherence of suction cups;
Permanence of labels and warnings;
Protection from scissoring, shearing and pinching;
Limits on openings; and
Labeling.
Marking and Labeling. This section contains various requirements
related to warnings, labeling, and required markings for infant bath
tubs. This section prescribes various substance, format, and prominence
requirements for such information.
Instructional Literature. This section requires that instructions
provided with infant bath tubs be easy to read and understand.
Additionally, the section contains requirements for instructional
literature contents and format, as well as prominence of certain
language.
V. Assessment of Voluntary Standard ASTM F2670-13
Staff considered the fatalities, injuries, and non-injury incidents
associated with infant bath tubs, and evaluated ASTM F2670-13 to
determine
[[Page 48772]]
whether the ASTM standard adequately addresses the incidents, or
whether more stringent standards would further reduce the risk of
injury associated with these products. We discuss the staff's
assessment in this section.
A. Warnings and the Risk of Drowning Due to Inattention by Parent or
Caregiver
From 2004 to 2014, 30 drowning fatalities and 13 near-drowning
incidents have been associated with infant bath tubs. In 29 of the 30
drowning fatalities (97%), the caregiver left a child alone in an
infant bath tub. In 38 of 43 total drowning or near-drowning incidents
(88%), the child was left alone when the incident occurred.
From the perspective of setting product standards, the only way
caregiver behavior, such as leaving an infant unattended in an infant
bath tub, can be addressed is through warnings and instructions to
caregivers. Staff reviewed the warnings and instructions required by
ASTM F2670-13 to determine whether the ASTM standard's provisions are
adequate, or whether a more stringent standard would reduce the risk of
drowning and near-drowning associated with these products. The
currently required warnings include the phrases: ``WARNING--DROWNING
HAZARD,'' in bold capital letters, ``Infants have DROWNED in infant
bath tubs'' (with the word ``DROWNED'' in bold capital letters), and
``ALWAYS keep infant within adult's reach.''
Staff determined that these current warning requirements allow for
considerable variation in the conspicuity and format of the warnings
presented to consumers. Staff's research suggests that the impact of
these warnings would be improved by providing specific guidance for a
more consistent and prominent presentation of hazard information.
Staff's research also indicates that changes to the size, color,
content, and format of required warnings and instructions could augment
the impact of the warnings and instructions for infant bath tubs,
resulting in a higher level of caregiver compliance.
Staff developed suggested wording and formatting changes for infant
bath tubs that staff believed would improve the warning and
instructions sections of the voluntary standard. Staff circulated these
proposed wording and formatting changes to the ASTM subcommittee
responsible for ASTM F2670-13, and discussed the proposed changes at a
public ASTM meeting in May 2015. In response to feedback received from
ASTM and stakeholders, staff made adjustments to staff's proposed
warnings and instructions.
The Commission now proposes to adopt ASTM F2670-13 with
modifications to some of the warnings and instructions for infant bath
tubs. In particular, the Commission proposes the following
modifications:
Increasing the size of the text in the on-product warnings
to make the warnings for infant bath tubs consistent with Commission
requirements for warnings for a similar product, infant bath seats;
Requiring the use of a ``hazard color'' in the on-product
and retail package warnings;
Revising the warning content to simplify and clarify the
language and to add specific language to address the risk of falls; and
Specifying the format of the warnings on the product, on
the retail packaging, and in the accompanying instructions to increase
the potential impact of the warnings and provide a more consistent
presentation of hazard information.
Based on research relating to the efficacy of warnings and
instructions, staff believes that these changes will help capture and
maintain caregiver attention, personalize the tone of the warnings, be
simpler to comprehend than the current warnings, and provide
consistency with the warnings regarding baby bath seats, a similar
product. These changes, plus the new required warning of the risk of
falls, may result in increased caretaker comprehension of, and
compliance with, product warnings and instructions. The Commission
believes that these changes constitute more stringent warning and
labeling requirements than the current standard, and will further
reduce the risk of injury to infants and toddlers associated with
infant bath tubs.
B. Hazards Related to Protrusion/Sharp/Laceration Issues
Protrusion issues were involved in 39 of 202 (19%) of the reported
incidents. In one incident, a protruding screw scratched a child,
resulting in a hospital visit; other incidents involved red marks,
cuts, or bruising from rough or protruding edges. However, staff found
no trends in the incident data involving scrapes or cuts.
In most of the ``protrusion'' incidents, a ``hump'' or ``bump'' in
the tub, designed to help older infants sit upright, caused a red mark
or discomfort for the infant, typically when the infant bath tub was
used with a hammock or sling attachment and the child made contact with
the ``hump.'' As discussed in more detail in section V.C. of this
preamble, ASTM has formed two task groups to develop new infant sling
performance requirements.
C. Hazards Related to ``Bath Sling'' Products
The current ASTM standard specifically excludes bath slings, which
are net or mesh products that do not hold water, are attached to an
infant bath tub or a frame, and are used for bathing newborn babies and
young infants. Several infant bath tub models include bath slings as
part of the tub, or as an accessory.
Staff is aware that 28 of the 53 ``product failure'' incidents
involved bath hammocks or slings. Staff and ASTM are working to
investigate how the observed risks of bath slings should be addressed.
In addition, ASTM formed two task groups to address the risks of bath
slings. One group is developing performance requirements for infant
slings that can only be used with infant bath tubs, which will be
addressed in the infant bath tub standard. A second group is developing
requirements for bath slings that are used separately or as tub
accessories, which will be addressed under a new, separate standard.
D. Latching or Locking Mechanism Testing
A number of incidents involved tub locking mechanisms that failed
or broke. Staff believes the current standard for latch mechanism
testing in ASTM F2670-13, section 7.1.2., which requires that latches
be tested more than 2,000 cycles, is appropriately stringent. However,
staff also has observed that some complex locking and latching
mechanisms are difficult to test within the required ``cycle time'' of
12 cycles per minute. Staff has worked with ASTM to find an alternate
method of conducting this test to make testing results for infant bath
tubs more accurate and consistent. Staff has determined that requiring
the 2,000-cycle testing to be conducted on a ``continuous basis'' will
allow more designs of infant bath tubs to be tested consistently and
accurately to the standard of section 7.1.2. Moreover, ASTM is
currently considering adopting the change that staff suggested to ASTM,
but has not yet done so.
In this NPR, the Commission proposes to modify section 7.1.2 to
improve the accuracy and consistency of the mandatory product testing.
The Commission also proposes adding an Appendix regarding section
7.1.2, to clarify that although the cadence of testing has changed to
accommodate a
[[Page 48773]]
broader variety of infant bath tub designs, the intent of the standard
is to require continuous testing while maintaining a rate as close to
12 cycles per minute as can reasonably be achieved. The Commission
believes these changes will augment product safety by improving the
accuracy, consistency, and repeatability of durability testing.
E. Static Load Testing.
The static load testing requirement and the testing for resistance
to collapse in the infant bath tub standard is intended to address the
issue of breaks. Infant bath tubs are required to support a load of 50
lbs. (22.7 kg.), or three times the maximum weight recommended by the
manufacturer, whichever is greater, for 20 minutes. Staff believes that
the current load testing provides an appropriate level of protection
from breakage. However, staff also has determined that the current
testing standard, which mandates the use of a 6'' x 6'' block of high-
density polyethylene to provide the required weight, may damage some
infant bath tub designs, which could create additional risks. Staff
recommended to ASTM that the required polyethylene block be rounded on
the corners; but ASTM decided to replace the block with a bag of steel
shot for static load testing. This matter was addressed at an ASTM
public meeting, was balloted and approved by ASTM, and will be added to
the next published edition of the ASTM standard. The Commission
believes that including this modification in the NPR will augment
product safety by improving the accuracy, consistency, and
repeatability of static load testing.
F. Entrapment
Entrapments accounted for 20 of 202 reported incidents (10%). Most
of the incidents involved body parts becoming stuck or caught in a tub,
and most of those incidents involved pinching. Many of the incidents
involved folding tubs. However, staff found no trends in this incident
data. The Commission believes that the current infant bath tub
standard's requirements for scissoring, shearing, and pinching (section
5.5) and Openings (section 5.6) are appropriate to protect the public.
G. Slippery Surfaces
Slippery tub surfaces accounted for 14 of the 202 reported
incidents (7%), resulting in abrasions and submersions but no injuries.
Most of these incidents contain little detail. Therefore, the
Commission is not proposing any modifications to the ASTM infant bath
tub standard regarding this issue. Staff will continue to monitor,
collect, and study details on slip-related fall and submersion
incidents in infant tubs. In addition, staff will work with ASTM, if
warranted, to develop appropriate performance requirements to address
slip-related fall and submersion incidents.
H. Mold/Allergy Issues
The mold and allergy issues involved itching, rashes, foul odor,
respiratory issues, and a urinary tract infection. This is a difficult
issue to address through performance requirements because the issue
arises from the consumer's inability to clean and dry the infant tub to
prevent mold. Therefore, the Commission is not proposing any
modifications to the ASTM infant bath tub standard regarding this
issue. However, CPSC staff will continue to review the incident data.
If warranted, staff will address this matter through the ASTM process
to determine whether additional instructions or warnings would be
effective in reducing this risk.
I. Miscellaneous Issues
Miscellaneous issues included falling out of the tub, unstable
tubs, missing pieces, batteries leaking or overheating, rust and
scalding. Incidents in this category included one fatality that was
attributed to pneumonia and one hospitalization from scalding. The rest
of the reports were incidents with no injury or a minor injury. Staff's
review of these miscellaneous incidents did not result in any
recommendations to change the infant bath tub standard.
VI. Proposed CPSC Standard for Infant Bath Tubs
The Commission is proposing to incorporate by reference ASTM F2670-
13, with certain modifications to strengthen the standard. As discussed
in the previous section, the Commission concludes that these
modifications will further reduce the risk of injury associated with
infant bath tubs.
Section 1234.1 would state the scope of the rule; infant bath tubs.
The definition of ``infant bath tub'' is provided in ASTM F2670-13
section 3.1.2.
Section 1234.2(a) would incorporate by reference ASTM F2670-13,
with the exception of certain provisions that the Commission proposes
to modify.
Section 1234.2(b) would detail the changes and modifications to
ASTM F2670-13 that the Commission has determined would further reduce
the risk of injury from infant bath tubs. In particular:
[ssquf] Section 7.1.2, Latching or Locking Mechanism Durability,
would be changed to permit continuous testing of infant bath tub
latches through 2,000 cycles. An Appendix regarding section 7.1.2 would
be added to clarify that the cadence of testing has been changed to
accommodate tubs that could not be tested at the previous rate of 12
cycles per minute, but that testing is to be conducted continuously
while maintaining a rate as close to the previous standard as possible.
[ssquf] Section 7.4.2 would be changed to require that a 50 lb.
(22.7 kg) bag of steel shot is to be used to test infant bath tubs in
the required static load testing, rather than a block of high-density
polyethylene, which might damage or puncture some tubs. Additionally,
the text of this section would be changed to make the required weight
equivalent, whether stated in pounds or kilograms.
[ssquf] Section 8.4 would be changed to require warning statements
on infant bath tubs and infant bath tub retail packaging to have
prescribed warning language, and for the warning statements to be
permanent, conspicuous, in contrasting color(s), bordered, and in type
larger than currently required. Section 8.4 will also require
additional warnings for infant bath tubs with suction cups. The changes
would be accompanied by exemplar warnings.
[ssquf] Section 9 would be changed to require that instructional
literature for infant bath tubs contain new prescribed warnings
regarding the risks of drowning or falling; explain the proper use of
the product; and emphasize the safety practices stated in the warnings.
The instructions must also address appropriate temperature ranges for
bath water, and instruct users to discontinue use of infant bath tubs
that become damaged, broken, or disassembled. The changes would be
accompanied by an exemplar warning.
VII. Incorporation by Reference
Section 1234.2(a) of the proposed rule incorporates by reference
ASTM F2670-13. The Office of the Federal Register (``OFR'') has
regulations concerning incorporation by reference. 1 CFR part 51. The
OFR recently revised these regulations to require that, for a proposed
rule, agencies must discuss in the preamble to the NPR ways that the
materials the agency proposes to incorporate by reference are
reasonably available to interested persons, or explain how the agency
worked to make the materials reasonably available. In addition, the
preamble to the proposed rule must summarize the material. 1 CFR
51.5(a).
In accordance with the OFR's requirements, section IV.B. of this
[[Page 48774]]
preamble summarizes the provisions of ASTM F2670-13 that the Commission
proposes to incorporate by reference. ASTM F2670-13 is copyrighted. By
permission of ASTM, the standard can be viewed as a read-only document
during the comment period on this NPR, at: https://www.astm.org/cpsc.htm. Interested persons may also purchase a copy of ASTM F2670-13
from ASTM International, 100 Bar Harbor Drive, P.O. Box 0700, West
Conshohocken, PA 19428; https://www.astm.org. One may also inspect a
copy at CPSC's Office of the Secretary, U.S. Consumer Product Safety
Commission, Room 820, 4330 East West Highway, Bethesda, MD 20814,
telephone 301-504-7923.
VIII. Amendment of 16 CFR Part 1112 To Include NOR for Infant Bath Tubs
The CPSA establishes certain requirements for product certification
and testing. 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).
Certification of children's products subject to a children's product
safety rule must be based on testing conducted by a CPSC-accepted third
party conformity assessment body. Id. 2063(a)(2). The Commission must
publish an NOR for the accreditation of third party conformity
assessment bodies to assess conformity with a children's product safety
rule to which a children's product is subject. Id. 2063(a)(3). Thus,
the proposed rule for 16 CFR part 1234, Safety Standard for Infant Bath
Tubs, if issued as a final rule, would be a children's product safety
rule requiring the issuance of an NOR.
The Commission published a final rule, Requirements Pertaining to
Third Party Conformity Assessment Bodies, 78 FR 15836 (March 12, 2013),
codified at 16 CFR part 1112 (``part 1112'') and effective on June 10,
2013, establishing requirements for CPSC acceptance of third party
conformity assessment bodies to test for conformance with a children's
product safety rule in accordance with section 14(a)(2) of the CPSA.
Part 1112 also codifies all of the NORs previously issued by the
Commission.
All new NORs for new children's product safety rules, such as the
infant bath tub standard, require an amendment to part 1112. To meet
the requirement that the Commission issue an NOR for the proposed
infant bath tub standard, as part of this NPR, the Commission proposes
to amend the existing rule that codifies the list of all NORs issued by
the Commission to add infant bath tubs to the list of children's
product safety rules for which the CPSC has issued an NOR.
Test laboratories applying for acceptance as a CPSC-accepted third
party conformity assessment body to test to the new standard for infant
bath tubs would be required to meet the third party conformity
assessment body accreditation requirements in part 1112. When a
laboratory meets the requirements as a CPSC-accepted third party
conformity assessment body, the laboratory can apply to the CPSC to
have 16 CFR part 1234, Standard Consumer Safety Specification for
Infant Bath Tubs, included in the laboratory's scope of accreditation
of CPSC safety rules listed for the laboratory on the CPSC Web site at:
www.cpsc.gov/labsearch.
IX. 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. 5 U.S.C. 553(d). The Commission is proposing an
effective date of 6 months after publication of the final rule in the
Federal Register for products manufactured or imported on or after that
date. The proposed rule does not require manufacturers to make design
or manufacturing changes; rather, the proposed rule requires only that
manufacturers create and print new labels. The two product testing
recommendations require a simple change in equipment (replacing a block
of high-density polyethylene with a 50-lb. shot bag), and a timing
change in the cycle testing for latches or locking mechanisms. Similar
equipment and testing methods are already used in child product
testing, so the testing changes can be made without delay. The 6-month
period will allow ample time for manufacturers and importers to arrange
for third party testing, and this is consistent with the timeframe
adopted in a number of other section 104 rules.
We also propose a 6-month effective date for the amendment to part
1112.
We ask for comments on the proposed 6-month effective date.
X. Regulatory Flexibility Act
A. Introduction
The Regulatory Flexibility Act (``RFA'') requires agencies to
consider the impact of proposed rules on small entities, including
small businesses. The RFA generally requires agencies to review
proposed rules for their potential impact on small entities and prepare
an initial regulatory flexibility analysis (``IRFA'') unless the agency
certifies that the rule, if promulgated, will not have a significant
economic impact on a substantial number of small entities. 5 U.S.C. 603
and 605. Because staff was unable to estimate precisely all costs of
the draft proposed rule, staff conducted such an analysis. The IRFA
must describe the impact of the proposed rule on small entities and
identify any alternatives that may reduce the impact. Specifically, the
IRFA must contain:
A description of, and where feasible, an estimate of the
number of small entities to which the proposed rule will apply;
A description of the reasons why action by the agency is
being considered;
A succinct statement of the objectives of, and legal basis
for, the proposed rule;
A description of the projected reporting, recordkeeping,
and other compliance requirements of the proposed rule, including an
estimate of the classes of small entities subject to the requirements
and the type of professional skills necessary for the preparation of
reports or records;
Identification, to the extent possible, of all relevant
federal rules that may duplicate, overlap, or conflict with the
proposed rule; and
A description of any significant alternatives to the
proposed rule that accomplish the stated objectives of applicable
statutes and minimize the rule's economic impact on small entities.
B. Market Description
CPSC staff is aware of at least 26 firms that supply infant bath
tubs to the U.S. market. Twenty-three of these firms are domestic. Of
the domestic firms, 14 are manufacturers, eight are importers, and one
has an unknown supply source. Seventeen of the domestic firms qualify
as ``small firms'' under the guidelines of the U.S. Small Business
Administration (``SBA''). Three foreign companies export to the United
States via Internet sales or to U.S. retailers.
C. Reason for Agency Action and Legal Basis for Proposed Rule
The Danny Keysar Child Product Safety Notification Act, section 104
of the CPSIA, requires the CPSC to promulgate mandatory standards that
are substantially the same as or more stringent than, the voluntary
standards for durable infant or toddler products. The proposed rule
implements that congressional direction.
[[Page 48775]]
D. Other Federal Rules
Section 14(a)(2) of the CPSA requires every manufacturer and
private labeler of a children's product that is subject to a children's
product safety rule to certify, based on third party testing conducted
by a CPSC-accepted laboratory that the product complies with all
applicable children's product safety rules. Section 14(i)(2) of the
CPSA requires the Commission to establish protocols and standards
requiring children's products to be tested periodically and when there
has been a material change in the product, and safeguarding against any
undue influence on a conformity assessment body by a manufacturer or
private labeler. A final rule implementing these requirements, Testing
and Labeling Pertaining to Product Certification (16 CFR part 1107)
became effective on February 13, 2013 (the ``1107 Rule''). If a final
children's product safety rule for infant bath tubs is adopted by the
Commission, infant bath tubs will be subject to the third party testing
requirements, including record keeping, when the final rule becomes
effective.
Section 14(a)(3) of the CPSA requires the Commission to publish an
NOR for the accreditation of third party conformity assessment bodies
(i.e., testing laboratories) for each children's product safety rule.
The NORs for existing rules are set forth in 16 CFR part 1112. If the
Commission adopts a final rule on infant bath tubs, publication of a
NOR establishing requirements for the accreditation of testing
laboratories will be required.
E. Impact of the New Standards and Testing Requirements on Small
Businesses
Under SBA guidelines, a manufacturer of infant bath tubs is
categorized as ``small'' if it has 500 or fewer employees, and
importers and wholesalers are considered ``small'' if they have 100 or
fewer employees. Based on these guidelines, 17 of the 23 domestic firms
known to be supplying infant bath tubs to the U.S. market are small
firms: 10 manufacturers, six importers, and one firm with an unknown
supply source.
Small Domestic Manufacturers. The impact of the proposed rule is
not likely to be significant for small manufacturers. Based on
information on firms' Web sites, staff believes six domestic
manufacturers already comply with the current infant bath tub standard.
This includes two infant bath tub manufacturers that are certified by
the Juvenile Products Manufacturers Association (``JPMA''), the major
U.S. trade association that represents juvenile product manufacturers
and importers, as compliant with the voluntary standard. Firms already
in compliance with the infant bath tub standard will not need to make
physical modifications to their products, but will have to make
modifications regarding the warnings and instructions with their
products. The costs of modifying existing labeling are usually small.
The four domestic manufacturers who do not appear to be in
compliance with the infant bath tub standard might need to modify their
products. However, these modifications are likely to be minor because
the products are not complex; infant bath tubs generally are composed
of one or two pieces of hard or soft plastic molded together.
Modifications would primarily involve adjusting the size of grooves or
openings on the side of the product to avoid finger entrapment.
Therefore, the impact of the proposed rule is likely to be small for
producers who do not yet comply with the infant bath tub standard.
Under section 14 of the CPSA, should the Commission adopt the
infant bath tub standard as a final rule, all manufacturers will be
subject to the additional costs associated with the third party testing
and certification requirements under the testing and labeling rule (16
CFR part 1107). Third party testing will include any physical and
mechanical test requirements specified in the final infant bath tub
rule that may be issued; lead testing is already required. Third party
testing costs are in addition to the direct costs of meeting the infant
bath tub standard.
Based on testing costs for similar juvenile products, staff
estimates that testing to the infant bath tub standard could cost
approximately $500-$600 per model sample. On average, each small
domestic manufacturer supplies three different models of infant bath
tubs to the U.S. market annually. Therefore, if third party testing
were conducted every year on a single sample for each model, third
party testing costs for each manufacturer would be about $1,500-$1,800
annually. Based on a review of firms' revenues, which were, on average,
about $29 million annually, it seems unlikely that the impacts of the
rule will be economically significant for small producers.
Small Domestic Importers. Staff believes that four of the six small
importers are compliant with the current infant bath tub standard, and
would only need to assure that their suppliers make the label
modifications to comply with the proposed rule. The two remaining
importers might need to find an alternate source of infant bath tubs if
their existing suppliers do not come into compliance with the
requirements of the proposed rule. Alternatively, these firms may
discontinue importing infant bath tubs altogether and perhaps
substitute another product.
Importers of infant bath tubs will be subject to third party
testing and certification requirements, and will experience the
associated costs if their supplier(s) does not perform third party
testing. Based upon review of the firms' revenues, which were, on
average, about $4.0 million annually, the impact of the testing
requirements could exceed 1 percent of revenues if the firms needed to
test more than one unit per model. Hence, staff cannot rule out a
significant economic impact on small domestic importers due to the
testing requirements.
As mentioned above, one small domestic firm has an unknown supply
source. However, the firm has a diverse product line and claims to be
compliant with various standards for several of its other infant
products. It is possible that its infant bath tub is already compliant
with ASTM F2670-13, and thus, would only have to modify existing
labels. Regardless, this firm should not experience large impacts
because infant bath tubs are only one of many products this firm
supplies.
In summary, staff concluded that the impact of the proposed rule is
unlikely to be economically significant for most firms, but is unable
to conclude that the proposed rule would not have a significant
economic impact on small importers.
Alternatives. Under section 104 of the CPSIA, the Commission is
required to promulgate a standard that is either substantially the same
as the voluntary standard or more stringent. The Commission could
promulgate the existing voluntary standard without revision. However,
the proposed warning labels and testing procedures are not expected to
have a substantial impact on costs to small businesses. Another
alternative that would reduce the impact on small entities is to set an
effective date later than the proposed 6 months. This would allow
manufacturers additional time to modify and/or develop compliant infant
bath tubs, thus spreading the costs associated with compliance over a
longer period of time.
F. Impact of Proposed 16 CFR Part 1112 Amendment on Small Businesses
As required by the RFA, staff conducted a Final Regulatory
Flexibility Analysis (``FRFA'') when the Commission issued the part
1112 rule
[[Page 48776]]
(78 FR 15836, 15855-58). Briefly, the FRFA concluded that the
accreditation requirements would not have a significant adverse impact
on a substantial number of small testing laboratories because no
requirements were imposed on test laboratories that did not intend to
provide third party testing services. The only test laboratories that
were expected to provide such services were those that anticipated
receiving sufficient revenue from the mandated testing to justify
accepting the requirements as a business decision.
Based on similar reasoning, amending 16 CFR part 1112 to include
the NOR for the infant bath tub standard will not have a significant
adverse impact on small test laboratories. Moreover, based upon the
number of test laboratories in the United States that have applied for
CPSC acceptance of accreditation to test for conformance to other
mandatory juvenile product standards, we expect that only a few test
laboratories will seek CPSC acceptance of their accreditation to test
for conformance with the infant bath tub standard. Most of these test
laboratories will have already been accredited to test for conformance
to other mandatory juvenile product standards, and the only costs to
them would be the cost of adding the infant bath tub standard to their
scope of accreditation. As a consequence, the Commission certifies that
the NOR amending 16 CFR part 1112 to include the infant bath tub
standard will not have a significant impact on a substantial number of
small entities.
XI. Environmental Considerations
The Commission's regulations address whether we are required to
prepare an environmental assessment or an environmental impact
statement. Under these regulations, a rule that has ``little or no
potential for affecting the human environment'' is categorically exempt
from this requirement. 16 CFR 1021.5(c)(1). The proposed rule falls
within the categorical exemption.
XII. Paperwork Reduction Act
This proposed rule contains information collection requirements
that are subject to public comment and review by the Office of
Management and Budget (``OMB'') under the Paperwork Reduction Act of
1995 (``PRA'') (44 U.S.C. 3501-3521). In this document, pursuant to 44
U.S.C. 3507(a)(1)(D), we set forth:
A title for the collection of information;
A summary of the collection of information;
A brief description of the need for the information and
the proposed use of the information;
A description of the likely respondents and proposed
frequency of response to the collection of information;
An estimate of the burden that shall result from the
collection of information; and
Notice that comments may be submitted to the OMB.
Title: Safety Standard for Infant Bath Tubs.
Description: The proposed rule would require each infant bath tub
to comply with ASTM F2670-13, with the changes proposed in this Notice,
which contains requirements for marking, labeling, and instructional
literature. These requirements fall within the definition of
``collection of information,'' as defined in 44 U.S.C. 3502(3).
Description of Respondents: Persons who manufacture or import
infant bath tubs.
Estimated Burden: We estimate the burden of this collection of
information as follows:
Table 1--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Frequency of Total annual
16 CFR Section respondents responses responses Hours per response Total burden hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
1234.2.............................................. 26 3 78 1 78
--------------------------------------------------------------------------------------------------------------------------------------------------------
Our estimate is based on the following:
Section 8.1 of the infant bath tub standard requires that the name
of the manufacturer, distributor, or seller, and either the place of
business (city, state, and mailing address, including zip code) or
telephone number, or both, to be marked clearly and legibly on each
product and its retail package. Section 8.1.2 requires a code mark or
other means that identifies the date (month and year, as a minimum) of
manufacture. Section 8.4 describes required safety labeling.
There are 26 known entities supplying infant bath tubs to the U.S.
market. All firms are assumed to use labels already on both their
products and their packaging, but they may need to make some
modifications to their existing labels. Based on an informal survey by
staff, the estimated time required to make these modifications is about
1 hour per model. Each entity supplies an average of three different
models of infant bath tubs; therefore, the estimated burden associated
with labels is 1 hour per model x 26 entities x 3 models per entity =
78 hours. We estimate the hourly compensation for the time required to
create and update labels is $30.19 (U.S. Bureau of Labor Statistics,
``Employer Costs for Employee Compensation,'' March 2015, Table 9,
total compensation for all sales and office workers in goods-producing
private industries: https://www.bls.gov/ncs/). Therefore, the estimated
annual cost to industry associated with the labeling requirements is
$2,354.82 ($30.19 per hour x 78 hours = $2,354.82). No other operating,
maintenance, or capital costs are associated with the collection.
Section 9.1 of the infant bath tub standard requires instructions
to be supplied with the product. Infant bath tubs are products that
generally require use and/or assembly instructions. Under the OMB's
regulations (5 CFR 1320.3(b)(2)), the time, effort, and financial
resources necessary to comply with a collection of information that
would be incurred by persons in the ``normal course of their
activities'' are excluded from a burden estimate, where an agency
demonstrates that the disclosure activities required to comply are
``usual and customary.'' We are unaware of infant bath tubs that
generally require use instructions, but lack these instructions.
Therefore, we tentatively estimate that there are no burden hours
associated with section 9.1 of the infant bath tub standard, because
any burden associated with supplying instructions with infant bath tubs
would be ``usual and customary'' and not within the definition of
``burden'' under the OMB's regulations.
Based on this analysis, the proposed standard for infant bath tubs
would impose a burden to industry of 78 hours at a cost of $2,355
annually.
In compliance with the PRA (44 U.S.C. 3507(d)), we have submitted
the information collection requirements of this rule to the OMB for
review. Interested persons are requested to submit comments regarding
information
[[Page 48777]]
collection by September 14, 2015, to the Office of Information and
Regulatory Affairs, OMB (see the ADDRESSES section at the beginning of
this notice).
Pursuant to 44 U.S.C. 3506(c)(2)(A), we invite comments on:
Whether the collection of information is necessary for the
proper performance of the CPSC's functions, including whether the
information will have practical utility;
The accuracy of the CPSC's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used;
Ways to enhance the quality, utility, and clarity of the
information to be collected;
Ways to reduce the burden of the collection of information
on respondents, including the use of automated collection techniques,
when appropriate, and other forms of information technology; and
The estimated burden hours associated with label
modification, including any alternative estimates.
XIII. Preemption
Section 26(a) of the CPSA, 15 U.S.C. 2075(a), provides that where a
consumer product safety standard 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.'' Therefore, the preemption provision of section
26(a) of the CPSA would apply to a rule issued under section 104.
XIV. Request for Comments
This NPR begins a rulemaking proceeding under section 104(b) of the
CPSIA to issue a consumer product safety standard for infant bath tubs,
and to amend part 1112 to add infant bath tubs to the list of
children's product safety rules for which the CPSC has issued an NOR.
We invite all interested persons to submit comments on any aspect of
the proposed mandatory safety standard for infant bath tubs and on the
proposed amendment to part 1112. Specifically, the Commission requests
comments on the costs of compliance with, and testing to, the proposed
mandatory infant bath tub standard, the proposed 6-month effective date
for the new mandatory infant bath tub standard, and the amendment to
part 1112.
Comments should be submitted in accordance with the instructions in
the ADDRESSES section at the beginning of this notice.
List of Subjects
16 CFR Part 1112
Administrative practice and procedure, Audit, Consumer protection,
Reporting and recordkeeping requirements, Third party conformity
assessment body.
16 CFR Part 1234
Consumer protection, Imports, Incorporation by reference, Infants
and children, Labeling, Law enforcement, Toys.
For the reasons discussed in the preamble, the Commission proposes
to amend title 16 of the Code of Federal Regulations as follows:
PART 1112--REQUIREMENTS PERTAINING TO THIRD PARTY CONFORMITY
ASSESSMENT BODIES
0
1. The authority citation for part 1112 continues to read as follows:
Authority: Public Law 110-314, section 3, 122 Stat. 3016, 3017
(2008); 15 U.S.C. 2063.
0
2. Amend Sec. 1112.15 by adding paragraph (b)(41) to read as follows:
Sec. 1112.15 When can a third party conformity assessment body apply
for CPSC acceptance for a particular CPSC rule and/or test method?
* * * * *
(b) * * *
(41) 16 CFR part 1234, Safety Standard for Infant Bath Tubs.
* * * * *
0
3. Add part 1234 to read as follows:
PART 1234--SAFETY STANDARD FOR INFANT BATH TUBS
Sec.
1234.1 Scope.
1234.2 Requirements for infant bath tubs.
Authority: Authority: Sec. 104, Public Law 110-314, 122 Stat.
3016.
Sec. 1234.1 Scope.
This part establishes a consumer product safety standard for infant
bath tubs.
Sec. 1234.2 Requirements for infant bath tubs.
(a) Except as provided in paragraph (b) of this section, each
infant bath tub shall comply with all applicable provisions of ASTM
F2670-13, Standard Consumer Safety Specification for Infant Bath Tubs,
approved February 15, 2013. 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; https://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 ASTM F2670-13 with the following additions or
exclusions:
(1) Instead of complying with section 7.1.2 of ASTM F2670-13,
comply with the following:
(i) 7.1.2 Latching or Locking Mechanism Durability--The latching or
locking mechanism(s) shall be cycled through its normal operation a
total of 2000 cycles. Each cycle shall consist of opening and closing
the mechanism and erecting/folding the product. Cycling shall be
conducted on a continuous basis.
(ii) [Reserved]
(2) Add as an Appendix to ASTM F2670-13, the following:
(i) X1.2 Section 7.1.2--The timing of the durability cycling was
revised so as to accommodate latching or locking mechanisms on some
products that may require longer than 5 seconds to activate and
deactivate. Continuous cycling is being prescribed to accommodate these
potential longer activation/deactivation cycles, but the intent of the
standard is to cycle the latching or locking mechanisms at a rate as
close to 12 cycles per minute as can be reasonably achieved for the
specific mechanism.
(ii) [Reserved]
(3) Instead of complying with section 7.4.2 of ASTM F2670-13,
comply with the following:
(i) 7.4.2 Place a load on the center of the seating surface using a
6 to 8 in. (150 to 200mm) diameter bag filled with steel shot and which
has a total weight of 50 lb (22.7kg) or three times the maximum weight
of the child recommended by the manufacturer, whichever is greater, on
the center of the product.
(ii) [Reserved]
(4) Instead of complying with section 8.4 of ASTM F2670-13,
including all subsections of section 8.4, comply with the following:
[[Page 48778]]
(i) 8.4 Each product shall be labeled with warning statements. The
warning statements shall be in contrasting color(s), permanent,
conspicuous and in non-condensed sans serif typeface. All warning(s)
shall be distinctively separated from any other wording or designs and
shall appear in the English language at a minimum. The specified
warning label may not be placed in a location that allows the warnings
to be obscured or rendered inconspicuous when in the manufacturer's
recommended use position.
(A) 8.4.1 Warning Label Format--The safety alert symbol
[GRAPHIC] [TIFF OMITTED] TP14AU15.089
and the word ``WARNING,'' shall be at least 0.4 in. (10 mm) high unless
stated otherwise, shall be the same size, and shall be in bold capital
letters. The remainder of the text shall be in characters whose upper
case shall be at least 0.2 in. (5 mm) high unless stated otherwise. The
safety alert symbol
[GRAPHIC] [TIFF OMITTED] TP14AU15.089
and signal word ``WARNING'' shall be delineated with a bold solid line
black border. The background color behind the safety alert symbol
[GRAPHIC] [TIFF OMITTED] TP14AU15.089
and signal word ``WARNING'' shall be orange, red, or yellow, whichever
provides best contrast against the product background. The remainder of
the label text shall be black and in upper and lower case letters on a
white background surrounded by a bold solid line black border. Text
within the message panel shall be left-justified. Precautionary
statements shall be indented from hazard statements and preceded by
bullet points. Message panels within the label shall be delineated with
solid black lines between sections addressing different hazards. If an
outer border is used to surround the bold solid black lines of the
label, the outer border shall be white and the corners may be radiused.
An example label in the format described in this section is shown in
Fig. 2.
(B) 8.4.2 The following warning statement shall be included exactly
as stated below:
Drowning Hazard: Babies have drowned while using infant bath tubs.
(C) 8.4.3 Additional warning statements shall address the
following:
[ssquf] Stay in arm's reach of your baby.
[ssquf] Use in empty adult tub or sink.
[ssquf] Keep drain open.
(D) 8.4.4 The following warning statement shall be included exactly
as stated below:
Fall Hazard: Babies have suffered head injuries falling from infant
tubs.
(E) 8.4.5 Additional warning statements shall address the
following:
[ssquf] Use only [insert safe location(s), e.g., in adult tub,
sink, or on floor; in adult tub or on floor)].
[ssquf] Never lift or carry baby in tub.
(F) 8.4.6 The drowning hazard warning statements and the fall
hazard warning statements in 8.4.2 through 8.4.5 may be displayed on
separate labels. If the fall hazard warning statements are displayed on
a separate label, the label shall comply with the requirements of 8.4.1
except that the safety alert symbol
[GRAPHIC] [TIFF OMITTED] TP14AU15.089
and the signal word ``WARNING'' shall be at least 0.2 in. (5 mm) in
height and the remainder of the text shall be at least 0.1 in. (2.5 mm)
in height. The fall hazard warning label shall not be displayed above
or before the drowning hazard warning label.
(G) 8.4.7 Products utilizing suction cups as an attachment
mechanism to the support surface, and which are not intended by the
manufacturer to be used on any type of slip-resistant surface, shall
also include a warning to this effect. In addition, if there are other
types of surfaces that the manufacturer does not intend the product be
used on, then additional warning(s) shall be given regarding such
surface(s). Such warning(s) shall use the signal word WARNING preceded
by the safety alert symbol, and shall meet the requirements described
in 8.4.1.
(5) Instead of complying with section 8.5 of ASTM F2670-13, comply
with the following:
(i) 8.5 Each product's retail package shall be labeled on the
principal display panel as specified in 8.4 except that the safety
alert symbol
[GRAPHIC] [TIFF OMITTED] TP14AU15.089
and the word ``WARNING'' shall be at least 0.2 in. (5 mm) high and the
remainder of the text shall be in characters whose upper case shall be
at least 0.1 in. (2.5 mm) high. The warnings and statements are not
required on the retail package if they are on the product and visible
in their entirety and are not concealed by the retail package. Cartons
and other materials used exclusively for shipping the product are not
considered retail packaging.
(ii) [Reserved]
(6) Instead of complying with section 9 of ASTM F2670-13, including
all subsections of section 9, comply with the following:
(i) 9. Instructional Literature
(A) 9.1 All products shall have instructional literature enclosed
that explains the proper use of the product and that shall be easy to
read and understand. Such literature shall include instructions for
assembly, maintenance, cleaning, inspections, and limitations of the
product, as well as the manufacturer's recommended use position(s).
(B) 9.2 Warning Statements in Instructional Literature:
(1) 9.2.1 Instructional literature shall include the warnings
specified in 8.4.2 through 8.4.7. The phrase ``To prevent drowning''
shall be added before the bulleted statements in 8.4.3 and the phrase
``To prevent falls'' shall be added before the bulleted statements in
8.4.5.
(2) 9.2.2 Warning statements in instructional literature shall also
address the following:
[ssquf] Babies can drown in as little as 1 inch of water. Use as
little water as possible to bathe your baby.
[ssquf] Never rely on a toddler or preschooler to help your baby or
alert you to trouble. Babies have drowned even with other children in
or near bath tub.
(3) 9.2.3 Warning statements in instructional literature shall meet
the requirements described in 8.4 except that the background and text
in the signal word panel need not be in color, and the remaining text
shall be in highly contrasting colors, (e.g., black text on white). An
example label that meets the requirements is shown in Fig. 3.
(C) 9.3 In addition to the warnings, the instructional literature
shall emphasize and reinforce the safe practices stated in the
warnings.
(D) 9.4 Instructional literature shall also advise to test the
temperature of the water in, or being put into, the infant bath tub
prior to placing the infant into the product. Instructions shall also
indicate that the typical water temperature for bathing a baby should
be between 90 and 100[emsp14][deg]F (32.2 and 37.8[deg]C).
(E) 9.5 Instructional literature shall instruct to discontinue the
use of the product if it becomes damaged, broken, or disassembled.
(F) 9.6 Instructional literature shall include the information as
specified in 8.3.
(G) 9.7 Warnings, statements, or graphic pictorials shall not
indicate or imply that the infant may be left in the product without a
caregiver in attendance.
[[Page 48779]]
(7) Add the following Figure 2 to ASTM F2670-13:
[GRAPHIC] [TIFF OMITTED] TP14AU15.076
[[Page 48780]]
(8) Add the following Figure 3 to ASTM F2670-13:
[GRAPHIC] [TIFF OMITTED] TP14AU15.077
[[Page 48781]]
(9) Add the following Figure 4 to ASTM F2670-13:
[GRAPHIC] [TIFF OMITTED] TP14AU15.078
[[Page 48782]]
BILLING CODE 6355-01-P
Dated: August 6, 2015.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2015-19668 Filed 8-13-15; 8:45 am]
BILLING CODE 6355-01-C