80 FR 48769 - Safety Standard for Infant Bath Tubs

CONSUMER PRODUCT SAFETY COMMISSION

Federal Register Volume 80, Issue 157 (August 14, 2015)

Page Range		48769-48782
FR Document		2015-19668
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.
Federal Register, Volume 80 Issue 157 (Friday, August 14, 2015)
[Federal Register Volume 80, Number 157 (Friday, August 14, 2015)]
[Proposed Rules]
[Pages 48769-48782]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-19668]


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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.

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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 [email protected].
    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: http://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: http://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: http://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: 
[email protected]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.
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    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\
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    \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: http://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; http://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: http://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; http://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: http://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
48770 Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Proposed Rules

II. Product Description age; the remaining two fatality victims 2. Protrusion/Sharp/Laceration issues
were 23 months and 3 years of age. In accounted for 39 out of 202 (19%) of the
A. Definition of Infant Bath Tub
all but one of the drowning fatalities, a reported incidents. In most of these
ASTM F2670–13 defines an ‘‘infant parent or caregiver left the victim alone incidents, the child made contact with
bath tub’’ as a ‘‘tub, enclosure, or other in the infant bath tub, and returned to a part that protrudes from the tub,
similar product intended to hold water find the child submerged. Sixteen of the causing red marks, cuts, or bruising. The
and be placed into an adult bath tub, fatalities (52%) were male, while 15 body parts reportedly injured were toes,
sink, or on top of other surfaces to (48%) were female. feet, bottom, genitalia, and back. In 29
provide support or containment, or of the 39 incidents, a protrusion
both, for an infant in a reclining, sitting, B. Nonfatal Injuries
described as a ‘‘bump’’ or ‘‘hump’’
or standing position during bathing by One hundred seventy-one nonfatal caused a red mark or discomfort to the
a caregiver.’’ ASTM F2670–13 section incidents associated with infant bath infant. In many of these protrusion
3.1.2. Falling within this definition are tubs were reported to have occurred incidents, a ‘‘hammock/sling’’
products of various designs, including from January 1, 2004 through May 20, attachment was involved.
‘‘bucket style’’ tubs that support a child 2015. The 171 reports included 30 Only one of the 39 ‘‘protrusion’’
sitting upright, tubs with an inclined reports of injuries requiring incident reports required a hospital
seat for infants too young to sit hospitalization (nine reports), visit; in that incident, a child’s back was
unsupported, inflatable tubs, folding emergency room treatment (nine scratched by a screw that penetrated the
tubs, and tubs with spa features, such as reports), treatment by a medical tub wall. The remaining 38 incidents in
handheld shower attachments and even professional (eight reports), or first aid this category resulted in a minor injury
whirlpool settings. The ASTM standard (four reports). The nine incidents or no injury.
permits infant bath tubs to have ‘‘a requiring hospitalization included eight 3. Product failures accounted for 53
permanent or removable passive crotch near-drowning incidents in which a out of 202 (26%) of the reported
restraint as part of their design,’’ but child almost died from suffocation incidents. In 28 incidents, the
does not permit ‘‘any additional under water, and one scalding water ‘‘hammock’’ or ‘‘sling’’ collapsed or
restraint system(s) which requires action burn. All eight near-drowning incidents broke, and in eight incidents the tub’s
on the part of the caregiver to secure or resulting in hospitalization occurred locking mechanism failed or broke. The
release.’’ Id. section 6.1. ASTM F2670– while the parent or caregiver was not remaining 17 ‘‘product failure’’
13 excludes from its scope ‘‘products present. The nine incidents requiring incidents involved various tub parts
commonly known as bath slings, emergency room treatment consisted of breaking. In two of the 53 ‘‘product
typically made of fabric or mesh.’’ Id. five near-drowning incidents, a head failure’’ incidents a child was treated at
sec. 1.1. injury caused by a bath toy detaching a hospital and released; in the
from a tub, a concussion from a fall from remaining incidents, there was either no
B. Market Description a tub located on a counter when a tub injury or a minor injury. In one of the
CPSC staff is aware of at least 26 firms leg collapsed, one rash, and an injury incidents requiring a hospital visit, a toy
that supply infant bath tubs to the U.S. caused by mold on a tub. The eight attached to a tub fell and caused a deep
market. Twenty-three of these firms are injury reports requiring a visit to a cut on a child’s forehead. In the second
domestic, including 14 manufacturers, medical professional consisted of one incident, the leg of a tub collapsed,
eight importers, and one with an laceration, one rash, and six injuries causing a child to fall from the counter
unknown supply source. Three foreign involving mold. The four incidents top supporting the tub onto the floor,
companies export directly to the United requiring home first aid resulted from resulting in a concussion.
States via Internet sales or to U.S. finger, hand, and foot entrapments. 4. Entrapment issues accounted for 20
retailers. out of 202 (10%) of the reported
C. Hazard Pattern Identification incidents. Entrapment incidents
III. Incident Data CPSC staff considered all 202 (31 fatal involved fingers, arms, feet, legs, or
CPSC staff has received detailed and 171 nonfatal) reported infant bath genitalia caught or stuck on parts of the
reports from various sources of 202 tub incidents to identify the hazard tub, mostly in a pinching manner. Many
incidents related to infant bath tubs patterns associated with infant bath tub- of these injuries occurred in tubs that
from January 1, 2004 through May 20, related incidents. Staff grouped the fold. Hinges, holes, and the foot area
2015. Thirty-one of these incidents hazard patterns into the following inside a tub were common areas of
(15%) were fatal. Of the 146 victims categories in order of frequency: entrapment. These entrapment incidents
whose age could be determined, 141 1. Drowning/Near Drowning incidents resulted in no injury or minor injury;
(97%) were under 2 years of age. In the account for 43 out of 202 (21%) of the there were no reported hospitalizations.
168 incidents in which the sex of the reported incidents. Thirty of these 43 5. Slippery tub surface issues
child was reported, 54 percent of the incidents were drowning fatalities; the accounted for 14 of 202 (7%) of the
victims were male, and 46 percent of the remaining 13 incidents involved near- reported incidents. These incidents
victims were female. drownings. In 38 of the 43 drowning or resulted in minor skin abrasions or
near-drowning incidents (88%), the scratches, and potential submersions.
A. Fatalities parent or guardian was not present at These incidents resulted in no injury or
Thirty-one fatalities were reported to the time the incident occurred. Because minor injury.
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have been associated with infant bath there were no witnesses to a majority of 6. Mold/Allergy issues accounted for
tubs from January 1, 2004 through May drowning or near-drowning incidents, 12 of 202 (6%) of the reported incidents.
20, 2015. Drowning was the reported determining exactly what happened is Eight incidents were attributed to mold,
cause of death for 30 of the fatalities difficult. Generally, the child was found and four were allergy related. The
(97%); the remaining fatality involved a floating, but exactly what transpired reported issues included itching, rashes,
child with a heart defect, whose death was unclear. One incidental fatality was foul odor, respiratory issues, and a
was attributed to pneumonia. Twenty- attributed to pneumonia rather than urinary tract infection. Eight of these
nine of the fatality victims (94%) were drowning; this incident is discussed in incidents, six involving mold issues and
between 4 months and 11 months of the ‘‘Miscellaneous Issues’’ category. two involving allergy issues, involved a

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48772 Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Proposed Rules

whether the ASTM standard adequately ASTM and stakeholders, staff made As discussed in more detail in section
addresses the incidents, or whether adjustments to staff’s proposed V.C. of this preamble, ASTM has formed
more stringent standards would further warnings and instructions. two task groups to develop new infant
reduce the risk of injury associated with The Commission now proposes to sling performance requirements.
these products. We discuss the staff’s adopt ASTM F2670–13 with
modifications to some of the warnings C. Hazards Related to ‘‘Bath Sling’’
assessment in this section.
and instructions for infant bath tubs. In Products
A. Warnings and the Risk of Drowning particular, the Commission proposes the The current ASTM standard
Due to Inattention by Parent or specifically excludes bath slings, which
following modifications:
Caregiver • Increasing the size of the text in the are net or mesh products that do not
From 2004 to 2014, 30 drowning on-product warnings to make the hold water, are attached to an infant
fatalities and 13 near-drowning warnings for infant bath tubs consistent bath tub or a frame, and are used for
incidents have been associated with with Commission requirements for bathing newborn babies and young
infant bath tubs. In 29 of the 30 warnings for a similar product, infant infants. Several infant bath tub models
drowning fatalities (97%), the caregiver bath seats; include bath slings as part of the tub, or
left a child alone in an infant bath tub. • Requiring the use of a ‘‘hazard as an accessory.
In 38 of 43 total drowning or near- color’’ in the on-product and retail Staff is aware that 28 of the 53
drowning incidents (88%), the child package warnings; ‘‘product failure’’ incidents involved
was left alone when the incident • Revising the warning content to bath hammocks or slings. Staff and
occurred. simplify and clarify the language and to ASTM are working to investigate how
From the perspective of setting add specific language to address the risk the observed risks of bath slings should
product standards, the only way of falls; and be addressed. In addition, ASTM
caregiver behavior, such as leaving an • Specifying the format of the formed two task groups to address the
infant unattended in an infant bath tub, warnings on the product, on the retail risks of bath slings. One group is
can be addressed is through warnings packaging, and in the accompanying developing performance requirements
and instructions to caregivers. Staff instructions to increase the potential for infant slings that can only be used
reviewed the warnings and instructions impact of the warnings and provide a with infant bath tubs, which will be
required by ASTM F2670–13 to more consistent presentation of hazard addressed in the infant bath tub
determine whether the ASTM information. standard. A second group is developing
standard’s provisions are adequate, or Based on research relating to the requirements for bath slings that are
whether a more stringent standard efficacy of warnings and instructions, used separately or as tub accessories,
would reduce the risk of drowning and staff believes that these changes will which will be addressed under a new,
near-drowning associated with these help capture and maintain caregiver separate standard.
products. The currently required attention, personalize the tone of the
D. Latching or Locking Mechanism
warnings include the phrases: warnings, be simpler to comprehend
Testing
‘‘WARNING—DROWNING HAZARD,’’ than the current warnings, and provide
in bold capital letters, ‘‘Infants have consistency with the warnings regarding A number of incidents involved tub
DROWNED in infant bath tubs’’ (with baby bath seats, a similar product. These locking mechanisms that failed or broke.
the word ‘‘DROWNED’’ in bold capital changes, plus the new required warning Staff believes the current standard for
letters), and ‘‘ALWAYS keep infant of the risk of falls, may result in latch mechanism testing in ASTM
within adult’s reach.’’ increased caretaker comprehension of, F2670–13, section 7.1.2., which requires
Staff determined that these current and compliance with, product warnings that latches be tested more than 2,000
warning requirements allow for and instructions. The Commission cycles, is appropriately stringent.
considerable variation in the believes that these changes constitute However, staff also has observed that
conspicuity and format of the warnings more stringent warning and labeling some complex locking and latching
presented to consumers. Staff’s research requirements than the current standard, mechanisms are difficult to test within
suggests that the impact of these and will further reduce the risk of injury the required ‘‘cycle time’’ of 12 cycles
warnings would be improved by to infants and toddlers associated with per minute. Staff has worked with
providing specific guidance for a more infant bath tubs. ASTM to find an alternate method of
consistent and prominent presentation conducting this test to make testing
of hazard information. Staff’s research B. Hazards Related to Protrusion/Sharp/ results for infant bath tubs more
also indicates that changes to the size, Laceration Issues accurate and consistent. Staff has
color, content, and format of required Protrusion issues were involved in 39 determined that requiring the 2,000-
warnings and instructions could of 202 (19%) of the reported incidents. cycle testing to be conducted on a
augment the impact of the warnings and In one incident, a protruding screw ‘‘continuous basis’’ will allow more
instructions for infant bath tubs, scratched a child, resulting in a hospital designs of infant bath tubs to be tested
resulting in a higher level of caregiver visit; other incidents involved red consistently and accurately to the
compliance. marks, cuts, or bruising from rough or standard of section 7.1.2. Moreover,
Staff developed suggested wording protruding edges. However, staff found ASTM is currently considering adopting
and formatting changes for infant bath no trends in the incident data involving the change that staff suggested to ASTM,
asabaliauskas on DSK5VPTVN1PROD with PROPOSALS

tubs that staff believed would improve scrapes or cuts. but has not yet done so.
the warning and instructions sections of In most of the ‘‘protrusion’’ incidents, In this NPR, the Commission proposes
the voluntary standard. Staff circulated a ‘‘hump’’ or ‘‘bump’’ in the tub, to modify section 7.1.2 to improve the
these proposed wording and formatting designed to help older infants sit accuracy and consistency of the
changes to the ASTM subcommittee upright, caused a red mark or mandatory product testing. The
responsible for ASTM F2670–13, and discomfort for the infant, typically when Commission also proposes adding an
discussed the proposed changes at a the infant bath tub was used with a Appendix regarding section 7.1.2, to
public ASTM meeting in May 2015. In hammock or sling attachment and the clarify that although the cadence of
response to feedback received from child made contact with the ‘‘hump.’’ testing has changed to accommodate a

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48774 Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Proposed Rules

preamble summarizes the provisions of existing rule that codifies the list of all impact on small entities and prepare an
ASTM F2670–13 that the Commission NORs issued by the Commission to add initial regulatory flexibility analysis
proposes to incorporate by reference. infant bath tubs to the list of children’s (‘‘IRFA’’) unless the agency certifies that
ASTM F2670–13 is copyrighted. By product safety rules for which the CPSC the rule, if promulgated, will not have
permission of ASTM, the standard can has issued an NOR. a significant economic impact on a
be viewed as a read-only document Test laboratories applying for substantial number of small entities. 5
during the comment period on this NPR, acceptance as a CPSC-accepted third U.S.C. 603 and 605. Because staff was
at: http://www.astm.org/cpsc.htm. party conformity assessment body to unable to estimate precisely all costs of
Interested persons may also purchase a test to the new standard for infant bath the draft proposed rule, staff conducted
copy of ASTM F2670–13 from ASTM tubs would be required to meet the third such an analysis. The IRFA must
International, 100 Bar Harbor Drive, party conformity assessment body describe the impact of the proposed rule
P.O. Box 0700, West Conshohocken, PA accreditation requirements in part 1112. on small entities and identify any
19428; http://www.astm.org. One may When a laboratory meets the alternatives that may reduce the impact.
also inspect a copy at CPSC’s Office of requirements as a CPSC-accepted third Specifically, the IRFA must contain:
the Secretary, U.S. Consumer Product party conformity assessment body, the • A description of, and where
Safety Commission, Room 820, 4330 laboratory can apply to the CPSC to feasible, an estimate of the number of
East West Highway, Bethesda, MD have 16 CFR part 1234, Standard small entities to which the proposed
20814, telephone 301–504–7923. Consumer Safety Specification for rule will apply;
VIII. Amendment of 16 CFR Part 1112 Infant Bath Tubs, included in the • A description of the reasons why
To Include NOR for Infant Bath Tubs laboratory’s scope of accreditation of action by the agency is being
CPSC safety rules listed for the considered;
The CPSA establishes certain laboratory on the CPSC Web site at: • A succinct statement of the
requirements for product certification www.cpsc.gov/labsearch. objectives of, and legal basis for, the
and testing. Products subject to a
consumer product safety rule under the IX. Effective Date proposed rule;
CPSA, or to a similar rule, ban, standard • A description of the projected
The Administrative Procedure Act reporting, recordkeeping, and other
or regulation under any other act (‘‘APA’’) generally requires that the
enforced by the Commission, must be compliance requirements of the
effective date of a rule be at least 30 proposed rule, including an estimate of
certified as complying with all days after publication of the final rule.
applicable CPSC-enforced requirements. the classes of small entities subject to
5 U.S.C. 553(d). The Commission is the requirements and the type of
15 U.S.C. 2063(a). Certification of proposing an effective date of 6 months
children’s products subject to a professional skills necessary for the
after publication of the final rule in the preparation of reports or records;
children’s product safety rule must be Federal Register for products
based on testing conducted by a CPSC- • Identification, to the extent
manufactured or imported on or after possible, of all relevant federal rules
accepted third party conformity that date. The proposed rule does not
assessment body. Id. 2063(a)(2). The that may duplicate, overlap, or conflict
require manufacturers to make design or with the proposed rule; and
Commission must publish an NOR for manufacturing changes; rather, the
the accreditation of third party • A description of any significant
proposed rule requires only that alternatives to the proposed rule that
conformity assessment bodies to assess manufacturers create and print new
conformity with a children’s product accomplish the stated objectives of
labels. The two product testing applicable statutes and minimize the
safety rule to which a children’s product recommendations require a simple
is subject. Id. 2063(a)(3). Thus, the rule’s economic impact on small
change in equipment (replacing a block entities.
proposed rule for 16 CFR part 1234, of high-density polyethylene with a 50-
Safety Standard for Infant Bath Tubs, if B. Market Description
lb. shot bag), and a timing change in the
issued as a final rule, would be a
cycle testing for latches or locking CPSC staff is aware of at least 26 firms
children’s product safety rule requiring
mechanisms. Similar equipment and that supply infant bath tubs to the U.S.
the issuance of an NOR.
The Commission published a final testing methods are already used in market. Twenty-three of these firms are
rule, Requirements Pertaining to Third child product testing, so the testing domestic. Of the domestic firms, 14 are
Party Conformity Assessment Bodies, 78 changes can be made without delay. The manufacturers, eight are importers, and
FR 15836 (March 12, 2013), codified at 6-month period will allow ample time one has an unknown supply source.
16 CFR part 1112 (‘‘part 1112’’) and for manufacturers and importers to Seventeen of the domestic firms qualify
effective on June 10, 2013, establishing arrange for third party testing, and this as ‘‘small firms’’ under the guidelines of
requirements for CPSC acceptance of is consistent with the timeframe the U.S. Small Business Administration
third party conformity assessment adopted in a number of other section (‘‘SBA’’). Three foreign companies
bodies to test for conformance with a 104 rules. export to the United States via Internet
children’s product safety rule in We also propose a 6-month effective sales or to U.S. retailers.
accordance with section 14(a)(2) of the date for the amendment to part 1112.
We ask for comments on the proposed C. Reason for Agency Action and Legal
CPSA. Part 1112 also codifies all of the
6-month effective date. Basis for Proposed Rule
NORs previously issued by the
asabaliauskas on DSK5VPTVN1PROD with PROPOSALS

Commission. X. Regulatory Flexibility Act The Danny Keysar Child Product
All new NORs for new children’s Safety Notification Act, section 104 of
product safety rules, such as the infant A. Introduction the CPSIA, requires the CPSC to
bath tub standard, require an The Regulatory Flexibility Act promulgate mandatory standards that
amendment to part 1112. To meet the (‘‘RFA’’) requires agencies to consider are substantially the same as or more
requirement that the Commission issue the impact of proposed rules on small stringent than, the voluntary standards
an NOR for the proposed infant bath tub entities, including small businesses. The for durable infant or toddler products.
standard, as part of this NPR, the RFA generally requires agencies to The proposed rule implements that
Commission proposes to amend the review proposed rules for their potential congressional direction.

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Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Proposed Rules 48775

D. Other Federal Rules trade association that represents tubs if their existing suppliers do not
Section 14(a)(2) of the CPSA requires juvenile product manufacturers and come into compliance with the
every manufacturer and private labeler importers, as compliant with the requirements of the proposed rule.
of a children’s product that is subject to voluntary standard. Firms already in Alternatively, these firms may
a children’s product safety rule to compliance with the infant bath tub discontinue importing infant bath tubs
certify, based on third party testing standard will not need to make physical altogether and perhaps substitute
conducted by a CPSC-accepted modifications to their products, but will another product.
have to make modifications regarding Importers of infant bath tubs will be
laboratory that the product complies
the warnings and instructions with their subject to third party testing and
with all applicable children’s product
products. The costs of modifying certification requirements, and will
safety rules. Section 14(i)(2) of the CPSA
existing labeling are usually small. experience the associated costs if their
requires the Commission to establish The four domestic manufacturers who supplier(s) does not perform third party
protocols and standards requiring do not appear to be in compliance with testing. Based upon review of the firms’
children’s products to be tested the infant bath tub standard might need revenues, which were, on average, about
periodically and when there has been a to modify their products. However, $4.0 million annually, the impact of the
material change in the product, and these modifications are likely to be testing requirements could exceed 1
safeguarding against any undue minor because the products are not percent of revenues if the firms needed
influence on a conformity assessment complex; infant bath tubs generally are to test more than one unit per model.
body by a manufacturer or private composed of one or two pieces of hard Hence, staff cannot rule out a significant
labeler. A final rule implementing these or soft plastic molded together. economic impact on small domestic
requirements, Testing and Labeling Modifications would primarily involve importers due to the testing
Pertaining to Product Certification (16 adjusting the size of grooves or openings requirements.
CFR part 1107) became effective on on the side of the product to avoid As mentioned above, one small
February 13, 2013 (the ‘‘1107 Rule’’). If finger entrapment. Therefore, the impact domestic firm has an unknown supply
a final children’s product safety rule for of the proposed rule is likely to be small source. However, the firm has a diverse
infant bath tubs is adopted by the for producers who do not yet comply product line and claims to be compliant
Commission, infant bath tubs will be with the infant bath tub standard. with various standards for several of its
subject to the third party testing Under section 14 of the CPSA, should other infant products. It is possible that
requirements, including record keeping, the Commission adopt the infant bath its infant bath tub is already compliant
when the final rule becomes effective. tub standard as a final rule, all with ASTM F2670–13, and thus, would
Section 14(a)(3) of the CPSA requires manufacturers will be subject to the only have to modify existing labels.
the Commission to publish an NOR for additional costs associated with the Regardless, this firm should not
the accreditation of third party third party testing and certification experience large impacts because infant
conformity assessment bodies (i.e., requirements under the testing and bath tubs are only one of many products
testing laboratories) for each children’s labeling rule (16 CFR part 1107). Third this firm supplies.
product safety rule. The NORs for party testing will include any physical In summary, staff concluded that the
existing rules are set forth in 16 CFR and mechanical test requirements impact of the proposed rule is unlikely
part 1112. If the Commission adopts a specified in the final infant bath tub rule to be economically significant for most
final rule on infant bath tubs, that may be issued; lead testing is firms, but is unable to conclude that the
publication of a NOR establishing already required. Third party testing proposed rule would not have a
requirements for the accreditation of costs are in addition to the direct costs significant economic impact on small
testing laboratories will be required. of meeting the infant bath tub standard. importers.
Based on testing costs for similar Alternatives. Under section 104 of the
E. Impact of the New Standards and
juvenile products, staff estimates that CPSIA, the Commission is required to
Testing Requirements on Small
testing to the infant bath tub standard promulgate a standard that is either
Businesses
could cost approximately $500–$600 substantially the same as the voluntary
Under SBA guidelines, a per model sample. On average, each standard or more stringent. The
manufacturer of infant bath tubs is small domestic manufacturer supplies Commission could promulgate the
categorized as ‘‘small’’ if it has 500 or three different models of infant bath existing voluntary standard without
fewer employees, and importers and tubs to the U.S. market annually. revision. However, the proposed
wholesalers are considered ‘‘small’’ if Therefore, if third party testing were warning labels and testing procedures
they have 100 or fewer employees. conducted every year on a single sample are not expected to have a substantial
Based on these guidelines, 17 of the 23 for each model, third party testing costs impact on costs to small businesses.
domestic firms known to be supplying for each manufacturer would be about Another alternative that would reduce
infant bath tubs to the U.S. market are $1,500–$1,800 annually. Based on a the impact on small entities is to set an
small firms: 10 manufacturers, six review of firms’ revenues, which were, effective date later than the proposed 6
importers, and one firm with an on average, about $29 million annually, months. This would allow
unknown supply source. it seems unlikely that the impacts of the manufacturers additional time to modify
Small Domestic Manufacturers. The rule will be economically significant for and/or develop compliant infant bath
impact of the proposed rule is not likely small producers. tubs, thus spreading the costs associated
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to be significant for small Small Domestic Importers. Staff with compliance over a longer period of
manufacturers. Based on information on believes that four of the six small time.
firms’ Web sites, staff believes six importers are compliant with the
domestic manufacturers already comply current infant bath tub standard, and F. Impact of Proposed 16 CFR Part 1112
with the current infant bath tub would only need to assure that their Amendment on Small Businesses
standard. This includes two infant bath suppliers make the label modifications As required by the RFA, staff
tub manufacturers that are certified by to comply with the proposed rule. The conducted a Final Regulatory Flexibility
the Juvenile Products Manufacturers two remaining importers might need to Analysis (‘‘FRFA’’) when the
Association (‘‘JPMA’’), the major U.S. find an alternate source of infant bath Commission issued the part 1112 rule

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48776 Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Proposed Rules

(78 FR 15836, 15855–58). Briefly, the costs to them would be the cost of • A title for the collection of
FRFA concluded that the accreditation adding the infant bath tub standard to information;
requirements would not have a their scope of accreditation. As a • A summary of the collection of
significant adverse impact on a consequence, the Commission certifies information;
substantial number of small testing that the NOR amending 16 CFR part • A brief description of the need for
laboratories because no requirements 1112 to include the infant bath tub the information and the proposed use of
were imposed on test laboratories that standard will not have a significant the information;
did not intend to provide third party impact on a substantial number of small • A description of the likely
testing services. The only test entities. respondents and proposed frequency of
laboratories that were expected to response to the collection of
provide such services were those that XI. Environmental Considerations information;
anticipated receiving sufficient revenue • An estimate of the burden that shall
The Commission’s regulations address
from the mandated testing to justify result from the collection of
whether we are required to prepare an
accepting the requirements as a business information; and
environmental assessment or an
decision. • Notice that comments may be
environmental impact statement. Under
Based on similar reasoning, amending submitted to the OMB.
these regulations, a rule that has ‘‘little
16 CFR part 1112 to include the NOR for Title: Safety Standard for Infant Bath
the infant bath tub standard will not or no potential for affecting the human Tubs.
have a significant adverse impact on environment’’ is categorically exempt Description: The proposed rule would
small test laboratories. Moreover, based from this requirement. 16 CFR require each infant bath tub to comply
upon the number of test laboratories in 1021.5(c)(1). The proposed rule falls with ASTM F2670–13, with the changes
the United States that have applied for within the categorical exemption. proposed in this Notice, which contains
CPSC acceptance of accreditation to test XII. Paperwork Reduction Act requirements for marking, labeling, and
for conformance to other mandatory instructional literature. These
juvenile product standards, we expect This proposed rule contains requirements fall within the definition
that only a few test laboratories will information collection requirements that of ‘‘collection of information,’’ as
seek CPSC acceptance of their are subject to public comment and defined in 44 U.S.C. 3502(3).
accreditation to test for conformance review by the Office of Management and Description of Respondents: Persons
with the infant bath tub standard. Most Budget (‘‘OMB’’) under the Paperwork who manufacture or import infant bath
of these test laboratories will have Reduction Act of 1995 (‘‘PRA’’) (44 tubs.
already been accredited to test for U.S.C. 3501–3521). In this document, Estimated Burden: We estimate the
conformance to other mandatory pursuant to 44 U.S.C. 3507(a)(1)(D), we burden of this collection of information
juvenile product standards, and the only set forth: as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
Number of Frequency of Total annual Hours per Total burden
16 CFR Section respondents responses responses response hours

1234.2 .................................................... 26 3 78 1 78

Our estimate is based on the estimated burden associated with labels would be incurred by persons in the
following: is 1 hour per model × 26 entities × 3 ‘‘normal course of their activities’’ are
Section 8.1 of the infant bath tub models per entity = 78 hours. We excluded from a burden estimate, where
standard requires that the name of the estimate the hourly compensation for an agency demonstrates that the
manufacturer, distributor, or seller, and the time required to create and update disclosure activities required to comply
either the place of business (city, state, labels is $30.19 (U.S. Bureau of Labor are ‘‘usual and customary.’’ We are
and mailing address, including zip Statistics, ‘‘Employer Costs for unaware of infant bath tubs that
code) or telephone number, or both, to Employee Compensation,’’ March 2015, generally require use instructions, but
be marked clearly and legibly on each Table 9, total compensation for all sales lack these instructions. Therefore, we
product and its retail package. Section and office workers in goods-producing tentatively estimate that there are no
8.1.2 requires a code mark or other private industries: http://www.bls.gov/ burden hours associated with section
means that identifies the date (month ncs/). Therefore, the estimated annual 9.1 of the infant bath tub standard,
and year, as a minimum) of cost to industry associated with the because any burden associated with
manufacture. Section 8.4 describes labeling requirements is $2,354.82 supplying instructions with infant bath
required safety labeling. ($30.19 per hour × 78 hours = tubs would be ‘‘usual and customary’’
There are 26 known entities $2,354.82). No other operating, and not within the definition of
supplying infant bath tubs to the U.S. maintenance, or capital costs are ‘‘burden’’ under the OMB’s regulations.
market. All firms are assumed to use associated with the collection. Based on this analysis, the proposed
asabaliauskas on DSK5VPTVN1PROD with PROPOSALS

labels already on both their products Section 9.1 of the infant bath tub standard for infant bath tubs would
and their packaging, but they may need standard requires instructions to be impose a burden to industry of 78 hours
to make some modifications to their supplied with the product. Infant bath at a cost of $2,355 annually.
existing labels. Based on an informal tubs are products that generally require In compliance with the PRA (44
survey by staff, the estimated time use and/or assembly instructions. Under U.S.C. 3507(d)), we have submitted the
required to make these modifications is the OMB’s regulations (5 CFR information collection requirements of
about 1 hour per model. Each entity 1320.3(b)(2)), the time, effort, and this rule to the OMB for review.
supplies an average of three different financial resources necessary to comply Interested persons are requested to
models of infant bath tubs; therefore, the with a collection of information that submit comments regarding information

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Document Created: 2018-02-23 10:59:21
Document Modified: 2018-02-23 10:59:21
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Proposed Rules
Action		Notice of proposed rulemaking.
Dates		Submit comments by October 28, 2015.
Contact		Celestine T. Kish, Project Manager, Directorate for Engineering Sciences, U.S. Consumer Product Safety Commission, 5 Research Place, Rockville, MD 20850; email: [email protected]; telephone: (301) 987-2547.
FR Citation		80 FR 48769
CFR Citation		16 CFR 1112 16 CFR 1234
CFR Associated		Administrative Practice and Procedure; Audit; Consumer Protection; Reporting and Recordkeeping Requirements; Third Party Conformity Assessment Body; Imports; Incorporation by Reference; Infants and Children; Labeling; Law Enforcement and Toys