Safety Standard for Stationary Activity Centers, 28205-28212 [2019-12804]
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Federal Register / Vol. 84, No. 117 / Tuesday, June 18, 2019 / Rules and Regulations
(ii) If the results of the BSI are
’’unsatisfactory’’ using the criteria in
Accomplishment Instructions, paragraph
5.B.(6)(g), of CFM SB LEAP–1B–72–00–0222–
01A–930A–D, Issue 007, dated May 17, 2019,
then you must continue the repetitive
inspections required by paragraphs
(g)(1)(i)(B) or (g)(1)(ii)(B) of this AD.
(2) [Reserved]
(j) Definition
For the purpose of this AD, ‘‘flight hours
(FHs) since new’’ are the FHs accumulated
on the RDS bearings on new engines
delivered from production and on engines
that have had the RDS bearing replaced
during an engine shop visit.
(k) No Reporting Requirement
The reporting requirement in paragraph
5.A.(6) in CFM SB LEAP–1B–72–00–0222–
01A–930A–D, Issue 007, dated May 17, 2019,
is not required by this AD.
(l) Credit for Previous Actions
You may take credit for the inspections
that are required by paragraph (g)(1) of this
AD, if you performed those actions before the
effective date of this AD using CFM SB
LEAP–1B–72–00–0222–01A–930A–D, Issue
006, dated March 22, 2019, or an earlier
revision. You may also take credit for the
optional BSI in paragraphs (h)(1) or the
optional terminating inspection in paragraph
(i)(1) of this AD, if you performed that action
before the effective date of this AD using
CFM SB LEAP–1B–72–00–0256–01A–930A–
D, Issue 002, dated May 6, 2019, or an earlier
revision.
(m) Alternative Methods of Compliance
(AMOCs)
(1) The Manager, ECO Branch, FAA, has
the authority to approve AMOCs for this AD,
if requested using the procedures found in 14
CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector
or local Flight Standards District Office, as
appropriate. If sending information directly
to the manager of the certification office,
send it to the attention of the person
identified in paragraph (n) of this AD. You
may email your request to: ANE-AD-AMOC@
faa.gov.
(2) Before using any approved AMOC,
notify your appropriate principal inspector,
or lacking a principal inspector, the manager
of the local flight standards district office/
certificate holding district office.
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(n) Related Information
For more information about this AD,
contact Christopher McGuire, Aerospace
Engineer, ECO Branch, FAA, 1200 District
Avenue, Burlington, MA, 01803; phone: 781–
238–7120; fax: 781–238–7199; email:
chris.mcguire@faa.gov.
(o) Material Incorporated by Reference
(1) The Director of the Federal Register
approved the incorporation by reference
(IBR) of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR
part 51.
(2) You must use this service information
as applicable to do the actions required by
this AD, unless the AD specifies otherwise.
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(i) CFM Service Bulletin LEAP–1B–72–00–
0222–01A–930A–D, Issue 007, dated May 17,
2019.
(ii) [Reserved]
(3) For CFM service information identified
in this AD, contact CFM International Inc.,
Aviation Operations Center, 1 Neumann
Way, M/D Room 285, Cincinnati, OH, 45125;
phone: 877–432–3272; fax: 877–432–3329;
email: aviation.fleetsupport@ge.com.
(4) You may view this service information
at FAA, Engine & Propeller Standards
Branch, 1200 District Avenue, Burlington,
MA, 01803. For information on the
availability of this material at the FAA, call
781–238–7759.
(5) You may view this service information
that is incorporated by reference at the
National Archives and Records
Administration (NARA). For information on
the availability of this material at NARA, call
202–741–6030, or go to: https://
www.archives.gov/federal-register/cfr/ibrlocations.html.
Issued in Burlington, Massachusetts, on
June 14, 2019.
Karen M. Grant,
Acting Manager, Engine & Propeller
Standards Branch, Aircraft Certification
Service.
[FR Doc. 2019–13022 Filed 6–17–19; 8:45 am]
BILLING CODE 4910–13–P
CONSUMER PRODUCT SAFETY
COMMISSION
16 CFR Parts 1112 and 1238
[Docket No. CPSC–2018–0015]
Safety Standard for Stationary Activity
Centers
Consumer Product Safety
Commission.
ACTION: Final rule.
AGENCY:
SUMMARY: The Consumer Product Safety
Improvement Act of 2008 (CPSIA)
requires the United States Consumer
Product Safety Commission (CPSC) to
adopt safety standards for durable infant
or toddler products. To comply with the
CPSIA, the Commission is issuing a
safety standard for stationary activity
centers (SACs). This rule incorporates
by reference ASTM F2012–18ε1,
Standard Consumer Safety Performance
Specification for Stationary Activity
Centers (ASTM F2012–18ε1). This rule
also amends the regulations for third
party conformity assessment bodies to
include the safety standard for SACs in
the list of notices of requirements
(NORs).
DATES: The rule will become effective
on December 18, 2019. The
incorporation by reference of the
publication listed in this rule is
approved by the Director of the Federal
Register as of December 18, 2019.
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28205
FOR FURTHER INFORMATION CONTACT:
Keysha Walker, Office of Compliance
and Field Operations, U.S. Consumer
Product Safety Commission; 4330 EastWest Highway, Bethesda, MD 20814;
telephone: (301) 504–6820; email:
KWalker@cpsc.gov.
SUPPLEMENTARY INFORMATION:
I. Background and Statutory Authority
Congress enacted the CPSIA (Pub. L.
110–314, 122 Stat. 3016), including the
Danny Keysar Child Product Safety
Notification Act, on August 14, 2008.
Section 104(b) of the CPSIA 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)
issue consumer product safety standards
for durable infant or toddler products.
15 U.S.C. 2056a(b)(1). Any standard the
Commission adopts under this mandate
must be ‘‘substantially the same as’’ the
voluntary standard, or more stringent
than the voluntary standard if the
Commission determines that more
stringent requirements would further
reduce the risk of injury associated with
the product. Id. Section 104(f)(1) of the
CPSIA defines the term ‘‘durable infant
or toddler product’’ as ‘‘a durable
product intended for use, or that may be
reasonably expected to be used, by
children under the age of 5 years,’’ and
lists SACs as a durable infant or toddler
product. Id. 2056a(f).
On June 19, 2018, the Commission
issued a notice of proposed rulemaking
(NPR), proposing to incorporate by
reference the voluntary standard for
SACs, ASTM F2012–18ε1, without
modifications. 83 FR 28390. ASTM
F2012–18ε1 is still the current version of
the standard.
In this final rule, the Commission
incorporates by reference ASTM F2012–
18ε1, with no modifications, as the
mandatory safety standard for SACs.
CPSC staff consulted with
manufacturers, retailers, trade
organizations, laboratories, consumer
advocacy groups, consultants, and the
public to develop this standard, largely
through the ASTM standarddevelopment process. In addition, this
final rule amends the list of NORs in 16
CFR part 1112 to include the standard
for SACs. This rule is based on
information in CPSC staff’s briefing
package, ‘‘Staff’s Draft Final Rule for
Stationary Activity Centers Under the
Danny Keysar Child Product Safety
Notification Act,’’ which is available on
CPSC’s website.
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II. Product Description
ASTM F2012–18ε1 defines a SAC as
‘‘a freestanding product intended to
remain stationary that enables a sitting
or standing occupant whose torso is
completely surrounded by the product
to walk, rock, play, spin or bounce, or
all of these, within a limited range of
motion.’’ ASTM F2012–18ε1, section
3.1.12. This definition does not include
doorway jumpers.
SACs are intended for children who
are not yet able to walk, but who are
able to hold up their heads unassisted.
SACs vary in style and design
complexity, but typically consist of a
seat that is suspended from a frame by
springs or supported from the bottom by
a fixed base. ASTM F2012–18ε1 defines
three types of SACs: Closed-base SACs,
open-base SACs, and spring-supported
SACs. The standard defines each of
these terms, as follows:
• A closed-base SAC is ‘‘a stationary
activity center that does not allow the
occupant’s feet to contact the floor when
the product is in any manufacturer’s
recommended use position’’ (section
3.1.1.);
• an open-base SAC is ‘‘a stationary
activity center that allows the
occupant’s feet to contact the floor’’
(section 3.1.7); and
• a spring-supported SAC is ‘‘a
stationary activity center in which the
sitting or standing platform is supported
from below or suspended from above by
springs (or equivalent resilient
members)’’ (section 3.1.10).
III. Market Description
SACs typically range in price from
$40 to $150, with spring-supported
SACs typically ranging from $70 to
$150. Some manufacturers produce
multiple models, and several produce
models that are similar in design, but
with different accessories. SACs
typically accommodate children who
weigh less than 25 pounds and have a
maximum height of 32 inches.
There were approximately 7.5
million 1 SACs in U.S. households with
children under 5 years old in 2013,
according to CPSC’s 2013 Durable
Nursery Product Exposure Survey.
However, only about 4.1 million of
these SACs were actually in use.2
CPSC staff identified 11 domestic
firms that currently supply SACs to the
U.S. market. These firms primarily
specialize in manufacturing children’s
products. According to the U.S. Small
Business Administration’s (SBA)
1 95% confidence interval between 6.2 million
and 8.8 million.
2 95% confidence interval between 3.1 million
and 5.2 million.
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standards,3 7 of the 11 firms are small
businesses. All seven firms manufacture
SACs; staff did not identify any small
domestic importers of SACs. Of the
seven small manufacturers, three
produce spring-supported SACs. The
Juvenile Products Manufacturers
Association (JPMA) certifies the SACs of
all seven firms, which indicates that
these SACs comply with the ASTM
standard and undergo third party
testing.
IV. Incident Data and Recalls
CPSC receives data about productrelated injuries from several sources.
One source is the National Electronic
Injury Surveillance System (NEISS),
from which CPSC may obtain estimates
based on a probability sample,
determined by sampling weights from
NEISS hospitals projected to national
estimates. Other sources include reports
from consumers and others through the
Consumer Product Safety Risk
Management System (which also
includes some NEISS data) and reports
from retailers and manufacturers
through CPSC’s Retailer Reporting
System—CPSC refers to these sources
collectively as Consumer Product Safety
Risk Management System data
(CPSRMS).
CPSC staff reviewed the NEISS and
CPSRMS databases for incidents
involving SACs. For the NPR, staff
reviewed incident data reported to have
occurred between January 1, 2013 and
September 30, 2017. For the final rule,
staff updated this review to include
incident data received from October 1,
2017 through February 20, 2019. This
updated review includes additional
incident data reported to have occurred
between January 1, 2013 and September
30, 2017, as well as new incidents that
occurred between October 1, 2017 and
February 20, 2019. Because reporting is
ongoing, the number of reported
incidents may change. For both the NPR
and updated data periods, the number
of injuries associated with SACs treated
in U.S. EDs was insufficient for staff to
derive reportable national estimates.4
For this reason, staff has not provided
injury estimates. However, injuries
associated with SACs treated in U.S.
EDs are included in the total count of
reported incidents presented below.
3 Under SBA size standards, a SAC manufacturer
is ‘‘small’’ if it has 500 or fewer employees, and an
importer is ‘‘small’’ if it has 100 or fewer
employees.
4 According to NEISS publication criteria, an
estimate must be 1,200 or greater, the sample size
must be 20 or greater, and the coefficient of
variation must be 33% or smaller.
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A. Fatalities
CPSC is not aware of any fatalities
associated with SACs that occurred
between January 1, 2013 and February
20, 2019.
B. Nonfatal Injuries
CPSC is aware of 4,035 nonfatal
incidents related to SACs that
reportedly occurred between January 1,
2013 and February 20, 2019. CPSC had
received reports of 3,488 of these
incidents at the time of the NPR; since
the NPR, CPSC received 547 additional
reports of SAC incidents that reportedly
occurred between January 1, 2013 and
February 20, 2019. Of the 4,035 total
incidents, 359 reportedly resulted in
injuries (CPSC had received reports of
304 of these injury incidents at the time
of the NPR, and received 55 additional
injury reports since the NPR). The
remaining 3,676 incidents either did not
result in injuries, or did not include
sufficient information to determine
whether an injury occurred (CPSC had
received reports of 3,184 of these
incidents at the time of the NPR, and
received 492 additional reports since
the NPR). Although these reports did
not indicate that an injury occurred,
many of the incident descriptions
indicated the potential for a serious
injury.
Of the 304 incidents that had
reportedly resulted in injuries at the
time of the NPR, 24 of the injured
children were treated and released from
a U.S. ED. A majority of the injured
children suffered a fall, resulting in
head injuries, limb fractures, and
contusions. A few children treated in
U.S. EDs suffered foot, leg, or pelvic
bruising, or fractures or swelling while
jumping in the product. One child had
an allergic reaction to the product’s
finish or materials, and the limbs of two
children became entrapped in the
product. Among the remaining 280
injury reports, some identified the type
of injury sustained, while others only
mentioned an injury, but provided no
specifics about the injury. Some of the
commonly reported injuries were
fractures, head injuries, concussions,
teeth injury, abrasions, contusions, and
lacerations.
Of the 55 injury incidents reported
since the NPR, there were reports of
head contusions; arm and leg
contusions, abrasions, and lacerations;
hand contusions, abrasions, lacerations,
and blisters; finger entrapments; mouth
lacerations; torso abrasions; a nose
contusion; a torso abrasion; a leg
fracture; and a skull fracture. Three
children suffered allergic reactions to
the product finish or material, and one
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child experienced a choking episode.
Three children suffered multiple
injuries.
The majority of reported incidents
and injuries involved children between
6 months old and 11 months old. Of the
4,035 total incidents, 13 percent
involved children under 6 months old;
60 percent involved children between 6
and 11 months old; 7 percent involved
children between 12 and 17 months old;
1 percent involved children between 18
and 23 months old; and 18 percent did
not report the age of the victim.5 Of the
359 incidents that reportedly resulted in
injuries, 20 percent involved children
under 6 months old; 60 percent
involved children between 6 and 11
months old; 6 percent involved children
between 12 and 17 months old; 1
percent involved children between 18
28207
and 23 months old; and 12 percent did
not report the age of the victim.6
C. Hazard Patterns
The hazards reported in the new
incidents are consistent with the hazard
patterns staff identified in the incidents
presented in the NPR. Table 1 lists the
number and percentage of the 4,035
total reported incidents within each
hazard pattern.
TABLE 1—REPORTED INCIDENTS BY HAZARD PATTERN
[January 1, 2013 to February 20, 2019]
Number of
incidents
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Hazard
Percentage of
total
incidents
Spring Issues ...........................................................................................................................................................
Problems with Toy Accessories ..............................................................................................................................
Strap Issues .............................................................................................................................................................
Structural Integrity Problems ...................................................................................................................................
Problems with Seats/Seat Pads ..............................................................................................................................
Stability Issues .........................................................................................................................................................
Design Issues ..........................................................................................................................................................
Electrical Problems ..................................................................................................................................................
Miscellaneous/Other Problems ................................................................................................................................
Multiple Problems ....................................................................................................................................................
Unspecified/Unknown Problems ..............................................................................................................................
1,756
1,166
513
166
136
112
59
38
31
32
26
44
29
13
4
3
3
1
1
1
1
1
Total ..................................................................................................................................................................
4,035
7 101
Spring issues. These incidents
involved problems with the springs that
attach the seat of the SAC to the frame.
A total of 1,756 incident reports CPSC
received between January 1, 2013 and
February 20, 2019 involved spring
issues (CPSC received 1,617 of these
reports before the NPR and 139 after the
NPR). Thirty of these incidents
reportedly resulted in injuries,
including 1 injury treated in a U.S. ED
(CPSC received 27 of these reports
before the NPR and 3 after the NPR).
Problems with toy accessories. These
incidents involved problems with the
toy accessories attached to SACs,
including detached small parts posing a
choking hazard, toys striking children in
the face, toys pinching or entrapping
children’s fingers, and laceration
hazards caused by sharp edges or
surfaces. A total of 1,166 incident
reports CPSC received between January
1, 2013 and February 20, 2019 involved
toy accessory issues (CPSC received
1,075 of these before the NPR and 91
after the NPR). Of these 1,166 incidents,
169 reportedly resulted in injuries,
including 15 injuries treated in U.S. EDs
(CPSC received 156 of these reports
before the NPR and 91 after the NPR).
Strap issues. These incidents
involved torn, fraying, twisted, or
detached straps. Typically, the strap
system on a SAC is attached to a
support spring and serves as the
primary means of support for most
spring-supported SACs. If the strap fails,
the SAC may be unsupported on one
side and often results in a child falling.
A total of 513 incident reports CPSC
received between January 1, 2013 and
February 20, 2019, involved strap issues
(CPSC received 306 of these before the
NPR and 207 after the NPR). Of these
513 incidents, 42 reportedly resulted in
injuries, including one injury treated in
a U.S. ED (CPSC received 30 of these
reports before the NPR and 12 after the
NPR).
Structural integrity problems. These
incidents involved a problem with
structural components, such as frame
tube damage, broken battery cover tabs,
loose screws or small parts, broken
activity bars, and problems with locks,
which led to product collapse,
detachment of the top and bottom parts
of the SAC, or failure of the height
adjustment mechanism. A total of 166
incident reports CPSC received between
January 1, 2013 and February 20, 2019,
involved structural integrity issues
(CPSC received 158 of these before the
NPR and 8 after the NPR). Twelve of
these incidents reportedly resulted in
injuries (CPSC received all 12 of these
reports before the NPR).
Problems with seats or seat pads.
These incidents included stitching on
the seat pad fraying or tearing; tabs used
to attach the pad to the seat frame
breaking, tearing, or separating;
attachments disassembling and causing
the seat pad to fall; inadequately
constrictive leg openings; seat fabric
detaching from pegs; ripped seat pads;
and rough seat pad material. A total of
136 incident reports CPSC received
between January 1, 2013 and February
20, 2019, involved seat or seat pad
issues (CPSC received 122 of these
before the NPR and 214 after the NPR).
Thirteen of these incidents reportedly
resulted in injuries (CPSC received 12 of
these reports before the NPR and 1 after
the NPR).
Stability issues. These incidents
involved SACs leaning to one side,
lifting off the floor, or tipping over
during use. A total of 112 incident
reports CPSC received between January
1, 2013 and February 20, 2019, involved
stability issues (CPSC received 76 of
these before the NPR and 36 after the
NPR). Thirteen of these incidents
reportedly resulted in injuries,
including two injuries treated in U.S.
5 Total does not sum to 100 percent due to
rounding.
6 Total does not sum to 100 percent due to
rounding.
7 Total does not sum to 100 percent due to
rounding.
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EDs (CPSC received four of these reports
before the NPR and nine after the NPR).
Design issues. These incidents
involved problems with the design of
the SAC, such as entrapment of limbs or
extremities, failure of the seat to contain
a child, placement of structural
components that made it easier for a
child to get hurt during routine use,
mold buildup in a wire compartment,
the base of the product disassembling
while a child jumped in it, and straps
that loosen when a baby kicks them. A
total of 59 incident reports CPSC
received between January 1, 2013 and
February 20, 2019, involved design
issues (CPSC received 32 of these before
the NPR and 27 after the NPR). Of these
59 incidents, 26 reportedly resulted in
injuries, including two injuries treated
in U.S. EDs (CPSC received 20 of these
reports before the NPR and six after the
NPR).
Electrical problems. These incidents
involved melting, leaking, or corroded
batteries, or failure of the circuit board
on the product. A total of 38 incident
reports CPSC received between January
1, 2013 and February 20, 2019, involved
electrical issues (CPSC received 36 of
these before the NPR and 2 after the
NPR). Two of these incidents reportedly
resulted in injuries (CPSC received both
of these reports before the NPR).
Miscellaneous or other problems.
These incidents involved the product
falling from an elevated surface; a rough
surface, sharp edges, or protrusions;
problems with the paint or finish;
problems with the product packaging;
allergic reactions to the product; and a
loose unraveling string. A total of 31
incident reports CPSC received between
January 1, 2013 and February 20, 2019,
involved miscellaneous or other issues
(CPSC received 22 of these before the
NPR and 9 after the NPR). Eighteen of
these incidents reportedly resulted in
injuries, including five injuries treated
in U.S. EDs (CPSC received 13 of these
reports before the NPR and 5 after the
NPR).
Multiple problems. These incidents
involved more than one of the hazard
patterns listed above. CPSC staff could
not determine the priority of the hazard
patterns involved. A total of 32 incident
reports CPSC received between January
1, 2013 and February 20, 2019, involved
multiple issues (CPSC received 20 of
these before the NPR and 12 after the
NPR). Nine of these incidents reportedly
resulted in injuries (CPSC received five
of these reports before the NPR and four
after the NPR).
Unspecified or unknown problems.
These reports provided incomplete or
unclear descriptions of the incident. A
total of 26 incident reports CPSC
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received between January 1, 2013 and
February 20, 2019, involved unspecified
or unknown issues (CPSC received 24 of
these before the NPR and 2 after the
NPR). Twenty-five of these incidents
reportedly resulted in injuries, mostly
resulting from falls, and included 17
injuries treated in U.S. EDs (CPSC
received 23 of these reports before the
NPR and 2 after the NPR).
D. Recalls
In the preamble to the NPR, the
Commission reported that one
consumer-level recall between January
2013 and March 2018, involved a SAC.8
The hazard that prompted the recall was
a toy attachment on the SAC, which
posed an impact hazard when it
rebounded. The firm received 100
reports of incidents, including 61
reported injuries. The injuries included
bruises and lacerations to the face, a 7month-old child who sustained a lineal
skull fracture, and an adult who
sustained a chipped tooth. The recall
involved 400,000 units in the United
States. There have not been any
additional consumer-level recalls of
SACs since the NPR.
V. ASTM F2012–18ε1
A. History of ASTM F2012
ASTM F2012 addresses the hazard
patterns associated with SACs. ASTM
first approved and published the
standard in 2000, as ASTM F2012–00,
Standard Consumer Safety
Specification for Stationary Activity
Centers. ASTM has revised the standard
several times since then. In the NPR, the
Commission proposed to incorporate by
reference the then-current version of the
standard, ASTM F2012–118ε1, with no
modifications. ASTM approved ASTM
F2012–18ε1 on March 1, 2018, and
published it in March 2018. ASTM
F2012–18ε1 is still the current version of
the standard.
B. Assessment of ASTM F2012–18ε1
ASTM F2012–18ε1adequately
addresses the risk of injuries and deaths
associated with SACs. The standard
addresses multiple hazards, including
the hazard patterns that make up the
majority of incidents and injuries in the
SAC incident data. ASTM F2012–18ε1
includes requirements to address the
following hazards:
• Sharp edges and points;
• small parts;
• latching or locking mechanisms to
prevent unintentional folding;
• openings;
8 CPSC website link to the recalled product:
https://www.cpsc.gov/Recalls/2013/Kids-II-RecallsBaby-Einstein-Activity-Jumpers/.
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• scissoring, shearing, and pinching;
• exposed coil springs;
• toy accessories sold with SACs;
• protective components;
• spring failures on spring-supported
SACs;
• structural integrity;
• leg openings;
• stability (including tip overs and
seat tilt); and
• motion resistance.
The standard also includes
requirements for warning labels and
instructional literature. On-product
warning labels inform caretakers of the
risks of strangulation and occupants
falling from SACs; the potential severity
of resulting injuries; and how to avoid
these hazards. The instructions that
accompany SACs also include these
warnings, as well as developmental
criteria to explain when to begin using
the product and when to discontinue
use.
ASTM F2012–18ε1 addresses the four
primary hazard patterns associated with
SACs in the incident data. These are: (1)
Spring issues (44 percent of incidents);
(2) problems with toy accessories (29
percent of incidents); (3) strap issues (13
percent of incidents); and (4) structural
integrity problems (4 percent of
incidents). This section discusses how
ASTM F2012–18ε1 addresses each of
these hazard patterns.
Spring issues. Spring issues typically
involve SACs in which the activity tray
and child hang from springs at multiple
points. These incidents often involve
one or more parts of the spring system
failing, which can result in the child
falling out of the SAC when it tilts, tips,
topples, or leans from the
manufacturer’s recommended-use
position. ASTM F2012–18ε1 addresses
this hazard with a performance
requirement that support springs
withstand 100 drops from a 33-pound
weight from a height of at least 1 inch.
In addition, based on input from CPSC
staff, ASTM F2012–18ε1 requires a
secondary support for load-bearing
springs, so that there is a redundant
system to prevent the seat from falling
if a spring fails. CPSC concludes that
these requirements adequately address
the spring issues indicated in the
incident data.
Problems with toy accessories. The
majority of reported problems with toy
accessories involve detached small parts
causing choking or gagging, toys striking
children in the face, pinch or
entrapment points created by small
gaps, and lacerations from sharp edges.
ASTM F2012–18ε1 addresses these
hazards by requiring toy accessories for
SACs, and their means of attachment, to
meet relevant requirements in ASTM
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F963–17, Standard Consumer Safety
Specification for Toy Safety (ASTM
F963). ASTM F963 includes
requirements that address the hazards
evident in the injury data, including
choking, ingestion, and inhalation
hazards from small objects; sharp edges,
hazardous points, and hazardous
projections; folding mechanisms and
hinges; and entanglement and
strangulation hazards from cords, straps,
and elastics. CPSC concludes that
ASTM F963 adequately addresses the
majority of hazards related to toy
accessories on SACs.
Strap issues. The strap system on a
SAC supports the occupant’s weight and
allows the occupant to bounce. The
strap system is the primary means of
support for most spring-supported
SACs. A typical spring-supported SAC
includes a strap system that connects at
the top to the frame structure, and at the
bottom to the side or underside of the
carrier, to support the occupant. The
length of the strap system typically
consists of an upper segment that serves
as the frame support strap, a lower
segment that serves as the occupant
support strap, and a middle section that
consists of a spring to allow the
occupant to bounce. Because the strap
system serves as the primary means of
support for most spring-supported
SACs, if the strap fails, the SAC may be
unsupported on one side, resulting in a
child falling. Incidents involving strap
issues include torn, fraying, twisted, or
detached straps.
To address this hazard, ASTM F2012–
18ε1 requires dynamic and static loading
at the seat of the product to evaluate the
durability of the support structures for
the seat. This testing also stresses the
structural integrity components of the
product, such as straps. The standard
requires that the product show no
failure of seams, material breakage, or
changes of adjustments that could cause
the product to not fully support the
child. CPSC staff concludes that these
provisions adequately address the strap
issues indicated in the incident data.
As the NPR discussed, while
preparing the NPR, CPSC staff learned
of one product in which the occupant
support strap frayed and broke because
the strap rubbed against a metal buckle
during normal use. The support
structure durability requirements in
ASTM F2012–18ε1 do not address this
scenario. On April 27, 2018, CPSC staff
requested that ASTM address this
hazard scenario, and ASTM created a
task group to review the issue. The NPR
requested comments about this issue,
but CPSC received none. CPSC staff is
participating in the ASTM task group,
and the task group is making progress
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toward developing a requirement to
address fraying straps. In this final rule,
the Commission is not adopting an
additional requirement to address this
hazard because: (1) The ASTM task
group has made progress toward
developing a requirement to address
fraying straps; (2) CPSC is aware of only
one product that involved this issue;
and (3) the one product has been
redesigned with parts that will not
cause the strap to fray.
Structural integrity problems.
Incidents involving structural integrity
problems include frame tube damage;
loose screws; broken activity bars; and
problems with locks that lead to the
product collapsing, the top and bottom
parts of the product detaching, or the
height adjustment mechanism failing.
To address these issues, ASTM F2012–
18ε1 requires dynamic and static loading
at the seat of the SAC to evaluate the
durability of the support structures for
the seat. This testing also stresses the
structural integrity components of the
SAC. The standard requires that the
product show no failure of seams,
material breakage, or changes of
adjustments that could cause the
product to not fully support the
occupant. CPSC concludes that these
requirements are adequate to address
the structural integrity issues indicated
in the incident data.
VI. Comments Filed in Response to the
NPR
CPSC received two comments in
response to the NPR. The comments are
available in the docket for this
rulemaking, CPSC–2018–0015, at:
www.regulations.gov.
The first comment, from JPMA (a
national non-profit trade association
that represents producers, importers,
and distributors of childcare articles),
expressed support for the proposed rule
and CPSC staff’s collaboration with
ASTM. The second comment also
expressed general support for the
proposed rule, but stated that there
should be oversight of small
manufacturers and importers. It appears
that the commenter misunderstood the
Regulatory Flexibility Act (RFA)
analysis to mean that the rule would not
apply to small entities; this is incorrect.
The rule applies to all manufacturers
and importers of SACs sold in the
United States.
VII. Incorporation by Reference
The Office of the Federal Register
(OFR) has regulations regarding
incorporation by reference. 1 CFR part
51. These regulations require the
preamble to a final rule to summarize
the material the agency is incorporating
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by reference, discuss how the material
is reasonably available to interested
parties, and explain how to obtain the
material. 1 CFR 51.5(b). This section
summarizes ASTM F2012–18ε1, and
describes how to obtain a copy of the
standard.
ASTM F2012–18ε1 contains test
methods and requirements regarding:
• Sharp edges or points;
• small parts;
• latching or locking mechanisms to
prevent unintentional folding;
• openings;
• scissoring, shearing, or pinching;
• exposed coil springs;
• toy accessories sold with SACs;
• protective components;
• spring failures on spring-supported
SACs;
• structural integrity;
• leg openings;
• stability (including tip overs and
seat tilt);
• motion resistance;
• warnings and labels; and
• instructional literature.
Interested parties may obtain a copy
of ASTM F2012–18ε1 from ASTM,
through its website (https://
www.astm.org), or by mail from ASTM
International, 100 Bar Harbor Drive,
P.O. Box 0700, West Conshohocken, PA
19428. Alternatively, interested parties
may inspect a copy of the standard at
CPSC’s Division of the Secretariat.
VIII. Final Rule
Section 1238.2 of the final rule
requires SACs to comply with ASTM
F2012–18ε1 and incorporates the
standard by reference. Section VII of
this preamble describes the OFR
requirements for incorporating material
by reference. To comply with those
requirements, section VII summarizes
ASTM F2012–18ε1, explains how the
standard is reasonably available to
interested parties, and indicates how to
obtain a copy of the standard.
The final rule also amends 16 CFR
part 1112 to add a new § 1112.15(b)(48)
that lists 16 CFR part 1238, Safety
Standard for Stationary Activity
Centers, as a children’s product safety
rule for which the Commission has
issued an NOR. Section XV of this
preamble provides additional
information about certifications and
NORs.
IX. Effective Date
The Administrative Procedure Act (5
U.S.C. 551–559) generally requires that
agencies set an effective date for a final
rule that is at least 30 days after the
Federal Register publishes the final
rule. Id. 553(d). The NPR proposed that
the final rule for SACs, and the
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amendment to part 1112, would take
effect 6 months after publication. CPSC
did not receive any comments about this
timeline. Six months is generally
enough time for firms to modify their
products to meet a new standard, it is
consistent with other CPSIA section 104
rules, and JPMA typically allows six
months for products in its certification
program to shift to a new standard. For
these reasons, this rule will take effect
6 months after publication in the
Federal Register, and will apply to
products manufactured or imported on
or after that date.
X. Paperwork Reduction Act
This rule contains information
collection requirements that are subject
to public comment and Office of
Management and Budget (OMB) review
under the Paperwork Reduction Act of
1995 (PRA; 44 U.S.C. 3501–3521).
Under the PRA, CPSC must estimate the
‘‘burden’’ associated with each
‘‘collection of information.’’ 44 U.S.C.
3506(c).
In this rule, section 8 of ASTM
F2012–18ε1 contains labeling
requirements that meet the definition of
‘‘collection of information’’ in the PRA.
Id. 3502(3). In addition, section 9 of
ASTM F2012–18ε1 requires instructions
be provided with SACs; however, CPSC
staff believes this requirement can be
excluded from the PRA burden estimate.
OMB allows agencies to exclude from
the PRA burden estimate any ‘‘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,’’ if the disclosure activities
required to comply are ‘‘usual and
customary.’’ 5 CFR 1320.3(b)(2). CPSC
staff is not aware of SACs that require
use or assembly instructions but lack
such instructions, so staff believes that
providing instructions with SACs is
‘‘usual and customary.’’ For this reason,
the burden estimate includes only the
labeling requirements.
The preamble to the NPR discussed
the information collection burden of the
proposed rule and requested comments
on the accuracy of CPSC’s estimates. 83
FR 28395. CPSC did not receive any
comments about the information
collection burden of the proposed rule.
The information collection burden has
not changed since the NPR. The
estimated burden of this collection of
information is as follows:
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TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN
16 CFR section
Number of
respondents
Frequency of
responses
Total annual
responses
Hours per
response
Total burden hours
1238.2 ....................
11
4
44
1
44
CPSC staff is aware of 11 suppliers of
SACs to the U.S. market. This estimated
reporting burden assumes that all 11
suppliers may need to modify their
labels to comply with the final rule.
CPSC staff estimates that it will take
about one hour per model to make these
modifications and, based on staff’s
evaluation of product lines, that each
firm supplies an average of four models
of SACs. Therefore, CPSC staff estimates
that the burden associated with the
labeling requirements is: 11 entities × 1
hour per model × 4 models per entity =
44 hours. CPSC staff estimates that the
hourly compensation for the time
required to create and update labels is
$34.50 (U.S. Bureau of Labor Statistics,
‘‘Employer Costs for Employee
Compensation,’’ Dec. 2018, total
compensation for all sales and office
workers in goods-producing private
industries: https://www.bls.gov/ncs/).
Therefore, the estimated annual cost
associated with the labeling
requirements is: $34.50 per hour × 44
hours = $1,518. CPSC staff does not
expect there to be operating,
maintenance, or capital costs associated
with this information collection.
As the PRA requires, CPSC has
submitted the information collection
requirements of this final rule to OMB.
44 U.S.C. 3507(d). OMB has assigned
control number 3041–0179 to this
information collection.
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involved in manufacturing or importing
SACs.
XI. Regulatory Flexibility Act
A. Introduction
The RFA (5 U.S.C. 601–612) requires
agencies to consider the potential
economic impact of a proposed and
final rule on small entities, including
small businesses. An agency must
prepare and publish a final regulatory
flexibility analysis (FRFA) when it
issues a final rule, unless the head of the
agency certifies that the rule will not
have a significant economic impact on
a substantial number of small entities. 5
U.S.C. 604(a), 605(b). If, rather than
publishing a FRFA, the head of the
agency makes the above certification,
the agency must publish the
certification and a statement of the
factual basis for it in the Federal
Register with the final rule. Id. 605(b).
The Commission made the above
certification in the NPR because staff
found that the cost of modifying
products to meet the standard would
not be significant, and the SACs of all
seven small manufacturers were JPMA
certified. JPMA certification indicates
that the products comply with the
ASTM standard and undergo third party
testing. The Commission does not have
any new information that would change
that conclusion. Therefore, the
Commission certifies that this rule,
incorporating by reference ASTM
F2012–18ε1 as a CPSC standard, will not
have a significant economic impact on
a substantial number of small entities
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B. Comments Relevant to the RFA
Analysis
CPSC did not receive any comments
addressing the RFA analysis or from the
Chief Counsel for Advocacy of the SBA,
but did receive one comment regarding
small entities. The commenter stated
that there should be oversight of small
manufacturers or importers if the rule
does not apply to them. It appears that
the commenter misunderstood the RFA
analysis to mean that the rule would not
apply to small entities; this is not
correct. The rule applies to all
manufacturers and importers of SACs
sold in the United States.
XII. Congressional Review Act
The Congressional Review Act (CRA;
5 U.S.C. 801–808) states that, before a
rule may take effect, the agency issuing
the rule must submit the rule, and
certain related information, to each
House of Congress and the Comptroller
General. 5 U.S.C. 801(a)(1). The
submission must indicate whether the
rule is a ‘‘major rule.’’ The CRA states
that the Office of Information and
Regulatory Affairs (OIRA) determines
whether a rule qualifies as a ‘‘major
rule.’’
Pursuant to the CRA, OIRA
designated this rule as not a ‘‘major
rule,’’ as defined in 5 U.S.C. 804(2). In
addition, to comply with the CRA, the
Office of the General Counsel will
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submit the required information to each
House of Congress and the Comptroller
General.
XIII. Environmental Considerations
CPSC’s regulations list categories of
agency actions that ‘‘normally have little
or no potential for affecting the human
environment.’’ 16 CFR 1021.5(c). Such
actions qualify as ‘‘categorical
exclusions’’ under the National
Environmental Policy Act (42 U.S.C.
4321–4370m–12), which do not require
an environmental assessment or
environmental impact statement. One
categorical exclusion listed in CPSC’s
regulations is for rules or safety
standards that ‘‘provide design or
performance requirements for
products.’’ 16 CFR 1021.5(c)(1). Because
the final rule for SACs creates design or
performance requirements, the rule falls
within the categorical exclusion.
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XIV. Preemption
Under section 26(a) of the CPSA, no
state or political subdivision of a state
may establish or continue in effect a
requirement dealing with the same risk
of injury as a Federal consumer product
safety standard under the CPSA unless
the state requirement is identical to the
Federal standard. 15 U.S.C. 2075(a).
However, states or political subdivisions
of states may apply to CPSC for an
exemption, allowing them to establish
or continue such a requirement if the
state requirement ‘‘provides a
significantly higher degree of protection
from [the] risk of injury’’ and ‘‘does not
unduly burden interstate commerce.’’
Id. 2075(c).
Section 104 of the CPSIA requires the
Commission to issue consumer product
safety standards for durable infant or
toddler products. As such, consumer
product safety standards that the
Commission creates under CPSIA
section 104 are covered by the
preemption provision in the CPSA.
Therefore, the preemption provision in
section 26 of the CPSA applies to the
mandatory safety standard for SACs.
XV. Testing, Certification, and
Notification of Requirements
Section 14(a) of the CPSA requires the
manufacturer or private labeler of a
children’s product that is subject to a
children’s product safety rule to certify
that, based on a third party conformity
assessment body’s (i.e., third party
laboratory’s) testing, the product
complies with the relevant children’s
product safety rule. 15 U.S.C.
2063(a)(2)(A), 2063(a)(2)(B). The
Commission must publish an NOR for a
third party laboratory to obtain
accreditation to assess conformity with
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a children’s product safety rule. 15
U.S.C. 2063(a)(3)(A).
Effective June 10, 2013, the
Commission adopted 16 CFR part 1112,
which sets out the general requirements
and criteria concerning third party
laboratories. 78 FR 15836 (Mar. 12,
2013). Part 1112 includes procedures for
CPSC to accept a third party laboratory’s
accreditation and lists the children’s
product safety rules for which the
Commission has published NORs. When
the Commission issues a new NOR, it
must amend part 1112 to include that
NOR.
Because this final rule is a children’s
product safety rule, the Commission is
amending part 1112 to include an NOR
for the SACs standard. Third party
laboratories that apply for CPSC
acceptance to test SACs for compliance
with the new SAC rule will have to
meet the requirements in part 1112.
When a laboratory meets the
requirements of a CPSC-accepted third
party conformity assessment body, the
laboratory can apply to CPSC to include
16 CFR part 1238, Safety Standard for
Stationary Activity Centers, in the
laboratory’s scope of accreditation of
CPSC safety rules listed on the CPSC
website at: www.cpsc.gov/labsearch.
As the RFA requires, CPSC staff
prepared a FRFA for the Commission’s
part 1112 rulemaking. 78 FR 15836,
15855 (Mar. 12, 2013). The FRFA
concluded that the accreditation
requirements would not have a
significant economic impact on a
substantial number of small laboratories
because no requirements applied to
laboratories that did not intend to
provide third party testing services. The
only laboratories CPSC 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.
For the same reasons, adding an NOR
for the SACs standard to part 1112 will
not have a significant economic impact
on small test laboratories. Because only
a small number of laboratories in the
United States have applied for
accreditation to test for conformance to
existing juvenile product standards,
CPSC expects that only a few
laboratories will seek accreditation to
test for compliance with the SACs
standard. Of those that seek
accreditation, CPSC expects that most
already will have accreditation to test
for conformance to other juvenile
product standards. The only costs to
those laboratories will be the cost of
adding the SACs standard to their
scopes of accreditation. For these
reasons, CPSC certifies that amending
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16 CFR part 1112 to include an NOR for
the SACs standard will not have a
significant economic impact on a
substantial number of small entities.
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 1238
Consumer protection, Imports,
Incorporation by reference, Infants and
children, Labeling, Law enforcement,
Toys.
For the reasons discussed in the
preamble, the Commission amends 16
CFR chapter II as follows:
PART 1112—REQUIREMENTS
PERTAINING TO THIRD PARTY
CONFORMITY ASSESSMENT BODIES
1. The authority citation for part 1112
continues to read as follows:
■
Authority: 15 U.S.C. 2063; Pub. L. 110–
314, section 3, 122 Stat. 3016, 3017 (2008).
2. Amend § 1112.15 by adding
paragraph (b)(48) to read as follows:
■
§ 1112.15 When can a third party
conformity assessment body apply for
CPSC acceptance for a particular CPSC rule
or test method?
*
*
*
*
*
(b) * * *
(48) 16 CFR part 1238, Safety
Standard for Stationary Activity
Centers.
*
*
*
*
*
■ 3. Add part 1238 to read as follows:
PART 1238—SAFETY STANDARD FOR
STATIONARY ACTIVITY CENTERS
Sec.
1238.1 Scope.
1238.2 Requirements for Stationary Activity
Centers.
Authority: 15 U.S.C. 2056a.
§ 1238.1
Scope.
This part establishes a consumer
product safety standard for stationary
activity centers.
§ 1238.2 Requirements for stationary
activity centers.
Each stationary activity center shall
comply with all applicable provisions of
ASTM F2012–18ε1Standard Consumer
Safety Performance Specification for
Stationary Activity Centers, approved
on March 1, 2018. The Director of the
Federal Register approves this
incorporation by reference in
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accordance with 5 U.S.C. 552(a) and 1
CFR part 51. You may obtain a copy
from ASTM International, 100 Bar
Harbor Drive, P.O. Box 0700, West
Conshohocken, PA 19428; https://
www.astm.org. You may inspect a copy
at the Division of the Secretariat, U.S.
Consumer Product Safety Commission,
Room 820, 4330 East-West Highway,
Bethesda, MD 20814, telephone 301–
504–7923, or at the National Archives
and Records Administration (NARA).
For information on the availability of
this material at NARA, call 202–741–
6030, or go to: https://
www.archives.gov/federal-register/cfr/
ibr-locations.html.
Administration (DEA) receives
notification from the Department of
Health and Human Services (HHS) that
the Secretary has indexed a drug under
section 572 of the Federal Food, Drug,
and Cosmetic Act (FDCA), the DEA is
required to issue an interim final rule,
with opportunity for public comment
and to request a hearing, controlling the
drug not later than 90 days after
receiving such notification from HHS
and subsequently to issue a final rule.
21 U.S.C. 811(j). When controlling a
drug pursuant to section 811(j), the DEA
must apply the scheduling criteria of
subsections 811(b), (c), and (d) and
section 812(b). 21 U.S.C. 811(j)(3).
Alberta E. Mills,
Secretary, Consumer Product Safety
Commission.
Background
On August 26, 2016, the DEA
published an interim final rule with
request for comments [81 FR 58834] to
make thiafentanil (including its salts) a
schedule II controlled substance(s). See
21 CFR 1308.12(c)(29) (DEA Controlled
Substance Code 9729).
Over time, alternative chemical names
have been used to describe this same
specific substance. In the preamble to
the interim final rule, the DEA provided
‘‘4-(methoxycarbonyl)-4-(Nphenmethoxyacetamido)-1-[2(thienyl)ethyl]piperidine’’ 1 as the
chemical name for thiafentanil.
However, the DEA believes it is more
accurate to use ‘‘methyl 4-(2-methoxyN-phenylacetamido)-1-(2-(thiophen-2yl)ethyl)piperidine-4-carboxylate)’’ 2 in
the preamble of this final rule. It bears
emphasis that the chemical that is the
subject of this final rule is the same
substance that was the subject of the
interim final rule. The DEA simply is
using an alternative chemical
description to refer to that same
substance in this preamble.
Thiafentanil, a potent opioid, is an
analogue of fentanyl. In June 2016, the
Food and Drug Administration (FDA)
reviewed and determined that the
product Thianil (thiafentanil oxalate, a
salt form of thiafentanil) met the
requirements for addition to the Index
[FR Doc. 2019–12804 Filed 6–17–19; 8:45 am]
BILLING CODE 6355–01–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Parts 1301, 1305, and 1308
[Docket No. DEA–375]
Schedules of Controlled Substances:
Placement of Thiafentanil in Schedule
II
Drug Enforcement
Administration, Department of Justice.
ACTION: Final rule.
AGENCY:
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SUMMARY: On August 26, 2016, the Drug
Enforcement Administration (DEA)
published in the Federal Register an
interim final rule with request for
comments placing the substance
thiafentanil, including its isomers,
esters, ethers, salts and salts of isomers,
esters and ethers, in schedule II of the
Controlled Substances Act. This final
rule adopts that interim final rule
without change.
DATES: The effective date of this rule is
June 18, 2019.
FOR FURTHER INFORMATION CONTACT:
Lynnette M. Wingert, Regulatory
Drafting and Policy Support Section,
Diversion Control Division, Drug
Enforcement Administration; Mailing
Address: 8701 Morrissette Drive,
Springfield, Virginia 22152; Telephone:
(202) 598–6812.
SUPPLEMENTARY INFORMATION:
Legal Authority
Under the Controlled Substances Act
(CSA), as amended in 2015 by the
Improving Regulatory Transparency for
New Medical Therapies Act (Pub. L.
114–89), where the Drug Enforcement
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1 The interim final rule also mentioned the other
chemical name, 4-(methoxycarbonyl)-4-(Nphenylmethoxyacetamido)-1-[2-(2thienyl)ethyl]piperidine in the section entitled
‘‘Background, Legal Authority, and Basis for This
Scheduling Action’’.
2 Other chemical names have been used for
thiafentanil. The HHS referred to the substance as
‘‘4-(methoxycarbonyl)-4-(Nphenymethoxyacetamido)-1-[2(thienyl)ethyl]piperidine’’ and ‘‘4methoxycarbonyl-4(N-phenyl-methoxyacetamido)1-(2′-(2″-thienyl)ethyl]-piperidine’’ in its November
2011 scientific and medical evaluation and
scheduling recommendation, and as ‘‘4(methoxycarbonyl)-4-(N-phenmethoxyacetamido)-1[2-(thienyl)ethyl]piperidium’’ in its March 2016
supplemental analysis.
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of Legally Marketed Unapproved New
Animal Drugs for Minor Species (the
Index) (21 U.S.C. 360ccc–1) as set forth
by the Minor Use and Minor Species
Animal Health Act of 2004 (MUMS
Act).3 As discussed in the preamble to
the interim final rule, the HHS provided
the requisite notification to DEA that
HHS/FDA added Thianil (thiafentanil
oxalate) to the Index (Minor Species
Index File (MIF) 900000) under section
572 of the FDCA.
The DEA based its scheduling
decision, and issuance of the interim
final rule, on 21 U.S.C. 811(j), the HHS’s
November 2011 scientific and medical
evaluation and scheduling
recommendation, the HHS’s March 2016
supplemental analysis, the MUMS Act
indication by the HHS/FDA, and the
DEA’s determination. The interim final
rule provided an opportunity for
interested persons to file written
comments, as well as a request for
hearing or waiver of hearing, on or
before September 26, 2016.
Comments Received
The DEA received one comment from
the American Veterinary Medical
Association supporting the interim final
rule to control thiafentanil as a schedule
II substance of the CSA.
DEA Response. The DEA appreciates
the support for this rulemaking.
The DEA did not receive any requests
for hearing or waiver of hearing. Based
on the rationale set forth in the interim
final rule, the DEA adopts the interim
final rule, without change.
Requirements for Handling
Thiafentanil
As indicated above, thiafentanil has
been a schedule II controlled substance
for more than two years by virtue of the
interim final rule issued by the DEA in
2016. Thus, this final rule does not alter
the regulatory requirements applicable
to handlers of thiafentanil that have
been in place since that time.
Nonetheless, for informational
purposes, we restate here those
requirements. Thiafentanil is subject to
the CSA’s schedule II regulatory
controls and administrative, civil, and
criminal sanctions applicable to the
manufacture, distribution, reverse
distribution, dispensing, importing,
exporting, research, and conduct of
instructional activities and chemical
analysis with, and possession involving
schedule II substances, including the
following:
1. Registration. Any person who
desires to handle thiafentanil
3 The MUMS Act amended the FDCA to allow for
the legal marketing of unapproved new animal
drugs intended for use in minor species.
E:\FR\FM\18JNR1.SGM
18JNR1
Agencies
[Federal Register Volume 84, Number 117 (Tuesday, June 18, 2019)]
[Rules and Regulations]
[Pages 28205-28212]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12804]
=======================================================================
-----------------------------------------------------------------------
CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Parts 1112 and 1238
[Docket No. CPSC-2018-0015]
Safety Standard for Stationary Activity Centers
AGENCY: Consumer Product Safety Commission.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Consumer Product Safety Improvement Act of 2008 (CPSIA)
requires the United States Consumer Product Safety Commission (CPSC) to
adopt safety standards for durable infant or toddler products. To
comply with the CPSIA, the Commission is issuing a safety standard for
stationary activity centers (SACs). This rule incorporates by reference
ASTM F2012-18[epsiv]\1\, Standard Consumer Safety Performance
Specification for Stationary Activity Centers (ASTM F2012-
18[epsiv]\1\). This rule also amends the regulations for third party
conformity assessment bodies to include the safety standard for SACs in
the list of notices of requirements (NORs).
DATES: The rule will become effective on December 18, 2019. The
incorporation by reference of the publication listed in this rule is
approved by the Director of the Federal Register as of December 18,
2019.
FOR FURTHER INFORMATION CONTACT: Keysha Walker, Office of Compliance
and Field Operations, U.S. Consumer Product Safety Commission; 4330
East-West Highway, Bethesda, MD 20814; telephone: (301) 504-6820;
email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background and Statutory Authority
Congress enacted the CPSIA (Pub. L. 110-314, 122 Stat. 3016),
including the Danny Keysar Child Product Safety Notification Act, on
August 14, 2008. Section 104(b) of the CPSIA 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) issue consumer product safety standards for durable infant or
toddler products. 15 U.S.C. 2056a(b)(1). Any standard the Commission
adopts under this mandate must be ``substantially the same as'' the
voluntary standard, or more stringent than the voluntary standard if
the Commission determines that more stringent requirements would
further reduce the risk of injury associated with the product. Id.
Section 104(f)(1) of the CPSIA defines the term ``durable infant or
toddler product'' as ``a durable product intended for use, or that may
be reasonably expected to be used, by children under the age of 5
years,'' and lists SACs as a durable infant or toddler product. Id.
2056a(f).
On June 19, 2018, the Commission issued a notice of proposed
rulemaking (NPR), proposing to incorporate by reference the voluntary
standard for SACs, ASTM F2012-18[epsiv]\1\, without modifications. 83
FR 28390. ASTM F2012-18[epsiv]\1\ is still the current version of the
standard.
In this final rule, the Commission incorporates by reference ASTM
F2012-18[epsiv]\1\, with no modifications, as the mandatory safety
standard for SACs. CPSC staff consulted with manufacturers, retailers,
trade organizations, laboratories, consumer advocacy groups,
consultants, and the public to develop this standard, largely through
the ASTM standard-development process. In addition, this final rule
amends the list of NORs in 16 CFR part 1112 to include the standard for
SACs. This rule is based on information in CPSC staff's briefing
package, ``Staff's Draft Final Rule for Stationary Activity Centers
Under the Danny Keysar Child Product Safety Notification Act,'' which
is available on CPSC's website.
[[Page 28206]]
II. Product Description
ASTM F2012-18[epsiv]\1\ defines a SAC as ``a freestanding product
intended to remain stationary that enables a sitting or standing
occupant whose torso is completely surrounded by the product to walk,
rock, play, spin or bounce, or all of these, within a limited range of
motion.'' ASTM F2012-18[epsiv]\1\, section 3.1.12. This definition does
not include doorway jumpers.
SACs are intended for children who are not yet able to walk, but
who are able to hold up their heads unassisted. SACs vary in style and
design complexity, but typically consist of a seat that is suspended
from a frame by springs or supported from the bottom by a fixed base.
ASTM F2012-18[epsiv]\1\ defines three types of SACs: Closed-base SACs,
open-base SACs, and spring-supported SACs. The standard defines each of
these terms, as follows:
A closed-base SAC is ``a stationary activity center that
does not allow the occupant's feet to contact the floor when the
product is in any manufacturer's recommended use position'' (section
3.1.1.);
an open-base SAC is ``a stationary activity center that
allows the occupant's feet to contact the floor'' (section 3.1.7); and
a spring-supported SAC is ``a stationary activity center
in which the sitting or standing platform is supported from below or
suspended from above by springs (or equivalent resilient members)''
(section 3.1.10).
III. Market Description
SACs typically range in price from $40 to $150, with spring-
supported SACs typically ranging from $70 to $150. Some manufacturers
produce multiple models, and several produce models that are similar in
design, but with different accessories. SACs typically accommodate
children who weigh less than 25 pounds and have a maximum height of 32
inches.
There were approximately 7.5 million \1\ SACs in U.S. households
with children under 5 years old in 2013, according to CPSC's 2013
Durable Nursery Product Exposure Survey. However, only about 4.1
million of these SACs were actually in use.\2\
---------------------------------------------------------------------------
\1\ 95% confidence interval between 6.2 million and 8.8 million.
\2\ 95% confidence interval between 3.1 million and 5.2 million.
---------------------------------------------------------------------------
CPSC staff identified 11 domestic firms that currently supply SACs
to the U.S. market. These firms primarily specialize in manufacturing
children's products. According to the U.S. Small Business
Administration's (SBA) standards,\3\ 7 of the 11 firms are small
businesses. All seven firms manufacture SACs; staff did not identify
any small domestic importers of SACs. Of the seven small manufacturers,
three produce spring-supported SACs. The Juvenile Products
Manufacturers Association (JPMA) certifies the SACs of all seven firms,
which indicates that these SACs comply with the ASTM standard and
undergo third party testing.
---------------------------------------------------------------------------
\3\ Under SBA size standards, a SAC manufacturer is ``small'' if
it has 500 or fewer employees, and an importer is ``small'' if it
has 100 or fewer employees.
---------------------------------------------------------------------------
IV. Incident Data and Recalls
CPSC receives data about product-related injuries from several
sources. One source is the National Electronic Injury Surveillance
System (NEISS), from which CPSC may obtain estimates based on a
probability sample, determined by sampling weights from NEISS hospitals
projected to national estimates. Other sources include reports from
consumers and others through the Consumer Product Safety Risk
Management System (which also includes some NEISS data) and reports
from retailers and manufacturers through CPSC's Retailer Reporting
System--CPSC refers to these sources collectively as Consumer Product
Safety Risk Management System data (CPSRMS).
CPSC staff reviewed the NEISS and CPSRMS databases for incidents
involving SACs. For the NPR, staff reviewed incident data reported to
have occurred between January 1, 2013 and September 30, 2017. For the
final rule, staff updated this review to include incident data received
from October 1, 2017 through February 20, 2019. This updated review
includes additional incident data reported to have occurred between
January 1, 2013 and September 30, 2017, as well as new incidents that
occurred between October 1, 2017 and February 20, 2019. Because
reporting is ongoing, the number of reported incidents may change. For
both the NPR and updated data periods, the number of injuries
associated with SACs treated in U.S. EDs was insufficient for staff to
derive reportable national estimates.\4\ For this reason, staff has not
provided injury estimates. However, injuries associated with SACs
treated in U.S. EDs are included in the total count of reported
incidents presented below.
---------------------------------------------------------------------------
\4\ According to NEISS publication criteria, an estimate must be
1,200 or greater, the sample size must be 20 or greater, and the
coefficient of variation must be 33% or smaller.
---------------------------------------------------------------------------
A. Fatalities
CPSC is not aware of any fatalities associated with SACs that
occurred between January 1, 2013 and February 20, 2019.
B. Nonfatal Injuries
CPSC is aware of 4,035 nonfatal incidents related to SACs that
reportedly occurred between January 1, 2013 and February 20, 2019. CPSC
had received reports of 3,488 of these incidents at the time of the
NPR; since the NPR, CPSC received 547 additional reports of SAC
incidents that reportedly occurred between January 1, 2013 and February
20, 2019. Of the 4,035 total incidents, 359 reportedly resulted in
injuries (CPSC had received reports of 304 of these injury incidents at
the time of the NPR, and received 55 additional injury reports since
the NPR). The remaining 3,676 incidents either did not result in
injuries, or did not include sufficient information to determine
whether an injury occurred (CPSC had received reports of 3,184 of these
incidents at the time of the NPR, and received 492 additional reports
since the NPR). Although these reports did not indicate that an injury
occurred, many of the incident descriptions indicated the potential for
a serious injury.
Of the 304 incidents that had reportedly resulted in injuries at
the time of the NPR, 24 of the injured children were treated and
released from a U.S. ED. A majority of the injured children suffered a
fall, resulting in head injuries, limb fractures, and contusions. A few
children treated in U.S. EDs suffered foot, leg, or pelvic bruising, or
fractures or swelling while jumping in the product. One child had an
allergic reaction to the product's finish or materials, and the limbs
of two children became entrapped in the product. Among the remaining
280 injury reports, some identified the type of injury sustained, while
others only mentioned an injury, but provided no specifics about the
injury. Some of the commonly reported injuries were fractures, head
injuries, concussions, teeth injury, abrasions, contusions, and
lacerations.
Of the 55 injury incidents reported since the NPR, there were
reports of head contusions; arm and leg contusions, abrasions, and
lacerations; hand contusions, abrasions, lacerations, and blisters;
finger entrapments; mouth lacerations; torso abrasions; a nose
contusion; a torso abrasion; a leg fracture; and a skull fracture.
Three children suffered allergic reactions to the product finish or
material, and one
[[Page 28207]]
child experienced a choking episode. Three children suffered multiple
injuries.
The majority of reported incidents and injuries involved children
between 6 months old and 11 months old. Of the 4,035 total incidents,
13 percent involved children under 6 months old; 60 percent involved
children between 6 and 11 months old; 7 percent involved children
between 12 and 17 months old; 1 percent involved children between 18
and 23 months old; and 18 percent did not report the age of the
victim.\5\ Of the 359 incidents that reportedly resulted in injuries,
20 percent involved children under 6 months old; 60 percent involved
children between 6 and 11 months old; 6 percent involved children
between 12 and 17 months old; 1 percent involved children between 18
and 23 months old; and 12 percent did not report the age of the
victim.\6\
---------------------------------------------------------------------------
\5\ Total does not sum to 100 percent due to rounding.
\6\ Total does not sum to 100 percent due to rounding.
---------------------------------------------------------------------------
C. Hazard Patterns
The hazards reported in the new incidents are consistent with the
hazard patterns staff identified in the incidents presented in the NPR.
Table 1 lists the number and percentage of the 4,035 total reported
incidents within each hazard pattern.
Table 1--Reported Incidents by Hazard Pattern
[January 1, 2013 to February 20, 2019]
------------------------------------------------------------------------
Percentage of
Hazard Number of total
incidents incidents
------------------------------------------------------------------------
Spring Issues........................... 1,756 44
Problems with Toy Accessories........... 1,166 29
Strap Issues............................ 513 13
Structural Integrity Problems........... 166 4
Problems with Seats/Seat Pads........... 136 3
Stability Issues........................ 112 3
Design Issues........................... 59 1
Electrical Problems..................... 38 1
Miscellaneous/Other Problems............ 31 1
Multiple Problems....................... 32 1
Unspecified/Unknown Problems............ 26 1
-------------------------------
Total............................... 4,035 \7\ 101
------------------------------------------------------------------------
Spring issues. These incidents involved problems with the springs
that attach the seat of the SAC to the frame. A total of 1,756 incident
reports CPSC received between January 1, 2013 and February 20, 2019
involved spring issues (CPSC received 1,617 of these reports before the
NPR and 139 after the NPR). Thirty of these incidents reportedly
resulted in injuries, including 1 injury treated in a U.S. ED (CPSC
received 27 of these reports before the NPR and 3 after the NPR).
---------------------------------------------------------------------------
\7\ Total does not sum to 100 percent due to rounding.
---------------------------------------------------------------------------
Problems with toy accessories. These incidents involved problems
with the toy accessories attached to SACs, including detached small
parts posing a choking hazard, toys striking children in the face, toys
pinching or entrapping children's fingers, and laceration hazards
caused by sharp edges or surfaces. A total of 1,166 incident reports
CPSC received between January 1, 2013 and February 20, 2019 involved
toy accessory issues (CPSC received 1,075 of these before the NPR and
91 after the NPR). Of these 1,166 incidents, 169 reportedly resulted in
injuries, including 15 injuries treated in U.S. EDs (CPSC received 156
of these reports before the NPR and 91 after the NPR).
Strap issues. These incidents involved torn, fraying, twisted, or
detached straps. Typically, the strap system on a SAC is attached to a
support spring and serves as the primary means of support for most
spring-supported SACs. If the strap fails, the SAC may be unsupported
on one side and often results in a child falling. A total of 513
incident reports CPSC received between January 1, 2013 and February 20,
2019, involved strap issues (CPSC received 306 of these before the NPR
and 207 after the NPR). Of these 513 incidents, 42 reportedly resulted
in injuries, including one injury treated in a U.S. ED (CPSC received
30 of these reports before the NPR and 12 after the NPR).
Structural integrity problems. These incidents involved a problem
with structural components, such as frame tube damage, broken battery
cover tabs, loose screws or small parts, broken activity bars, and
problems with locks, which led to product collapse, detachment of the
top and bottom parts of the SAC, or failure of the height adjustment
mechanism. A total of 166 incident reports CPSC received between
January 1, 2013 and February 20, 2019, involved structural integrity
issues (CPSC received 158 of these before the NPR and 8 after the NPR).
Twelve of these incidents reportedly resulted in injuries (CPSC
received all 12 of these reports before the NPR).
Problems with seats or seat pads. These incidents included
stitching on the seat pad fraying or tearing; tabs used to attach the
pad to the seat frame breaking, tearing, or separating; attachments
disassembling and causing the seat pad to fall; inadequately
constrictive leg openings; seat fabric detaching from pegs; ripped seat
pads; and rough seat pad material. A total of 136 incident reports CPSC
received between January 1, 2013 and February 20, 2019, involved seat
or seat pad issues (CPSC received 122 of these before the NPR and 214
after the NPR). Thirteen of these incidents reportedly resulted in
injuries (CPSC received 12 of these reports before the NPR and 1 after
the NPR).
Stability issues. These incidents involved SACs leaning to one
side, lifting off the floor, or tipping over during use. A total of 112
incident reports CPSC received between January 1, 2013 and February 20,
2019, involved stability issues (CPSC received 76 of these before the
NPR and 36 after the NPR). Thirteen of these incidents reportedly
resulted in injuries, including two injuries treated in U.S.
[[Page 28208]]
EDs (CPSC received four of these reports before the NPR and nine after
the NPR).
Design issues. These incidents involved problems with the design of
the SAC, such as entrapment of limbs or extremities, failure of the
seat to contain a child, placement of structural components that made
it easier for a child to get hurt during routine use, mold buildup in a
wire compartment, the base of the product disassembling while a child
jumped in it, and straps that loosen when a baby kicks them. A total of
59 incident reports CPSC received between January 1, 2013 and February
20, 2019, involved design issues (CPSC received 32 of these before the
NPR and 27 after the NPR). Of these 59 incidents, 26 reportedly
resulted in injuries, including two injuries treated in U.S. EDs (CPSC
received 20 of these reports before the NPR and six after the NPR).
Electrical problems. These incidents involved melting, leaking, or
corroded batteries, or failure of the circuit board on the product. A
total of 38 incident reports CPSC received between January 1, 2013 and
February 20, 2019, involved electrical issues (CPSC received 36 of
these before the NPR and 2 after the NPR). Two of these incidents
reportedly resulted in injuries (CPSC received both of these reports
before the NPR).
Miscellaneous or other problems. These incidents involved the
product falling from an elevated surface; a rough surface, sharp edges,
or protrusions; problems with the paint or finish; problems with the
product packaging; allergic reactions to the product; and a loose
unraveling string. A total of 31 incident reports CPSC received between
January 1, 2013 and February 20, 2019, involved miscellaneous or other
issues (CPSC received 22 of these before the NPR and 9 after the NPR).
Eighteen of these incidents reportedly resulted in injuries, including
five injuries treated in U.S. EDs (CPSC received 13 of these reports
before the NPR and 5 after the NPR).
Multiple problems. These incidents involved more than one of the
hazard patterns listed above. CPSC staff could not determine the
priority of the hazard patterns involved. A total of 32 incident
reports CPSC received between January 1, 2013 and February 20, 2019,
involved multiple issues (CPSC received 20 of these before the NPR and
12 after the NPR). Nine of these incidents reportedly resulted in
injuries (CPSC received five of these reports before the NPR and four
after the NPR).
Unspecified or unknown problems. These reports provided incomplete
or unclear descriptions of the incident. A total of 26 incident reports
CPSC received between January 1, 2013 and February 20, 2019, involved
unspecified or unknown issues (CPSC received 24 of these before the NPR
and 2 after the NPR). Twenty-five of these incidents reportedly
resulted in injuries, mostly resulting from falls, and included 17
injuries treated in U.S. EDs (CPSC received 23 of these reports before
the NPR and 2 after the NPR).
D. Recalls
In the preamble to the NPR, the Commission reported that one
consumer-level recall between January 2013 and March 2018, involved a
SAC.\8\ The hazard that prompted the recall was a toy attachment on the
SAC, which posed an impact hazard when it rebounded. The firm received
100 reports of incidents, including 61 reported injuries. The injuries
included bruises and lacerations to the face, a 7-month-old child who
sustained a lineal skull fracture, and an adult who sustained a chipped
tooth. The recall involved 400,000 units in the United States. There
have not been any additional consumer-level recalls of SACs since the
NPR.
---------------------------------------------------------------------------
\8\ CPSC website link to the recalled product: https://www.cpsc.gov/Recalls/2013/Kids-II-Recalls-Baby-Einstein-Activity-Jumpers/.
---------------------------------------------------------------------------
V. ASTM F2012-18[epsiv]\1\
A. History of ASTM F2012
ASTM F2012 addresses the hazard patterns associated with SACs. ASTM
first approved and published the standard in 2000, as ASTM F2012-00,
Standard Consumer Safety Specification for Stationary Activity Centers.
ASTM has revised the standard several times since then. In the NPR, the
Commission proposed to incorporate by reference the then-current
version of the standard, ASTM F2012-118[epsiv]\1\, with no
modifications. ASTM approved ASTM F2012-18[epsiv]\1\ on March 1, 2018,
and published it in March 2018. ASTM F2012-18[epsiv]\1\ is still the
current version of the standard.
B. Assessment of ASTM F2012-18[epsiv]\1\
ASTM F2012-18[epsiv]\1\adequately addresses the risk of injuries
and deaths associated with SACs. The standard addresses multiple
hazards, including the hazard patterns that make up the majority of
incidents and injuries in the SAC incident data. ASTM F2012-
18[epsiv]\1\ includes requirements to address the following hazards:
Sharp edges and points;
small parts;
latching or locking mechanisms to prevent unintentional
folding;
openings;
scissoring, shearing, and pinching;
exposed coil springs;
toy accessories sold with SACs;
protective components;
spring failures on spring-supported SACs;
structural integrity;
leg openings;
stability (including tip overs and seat tilt); and
motion resistance.
The standard also includes requirements for warning labels and
instructional literature. On-product warning labels inform caretakers
of the risks of strangulation and occupants falling from SACs; the
potential severity of resulting injuries; and how to avoid these
hazards. The instructions that accompany SACs also include these
warnings, as well as developmental criteria to explain when to begin
using the product and when to discontinue use.
ASTM F2012-18[epsiv]\1\ addresses the four primary hazard patterns
associated with SACs in the incident data. These are: (1) Spring issues
(44 percent of incidents); (2) problems with toy accessories (29
percent of incidents); (3) strap issues (13 percent of incidents); and
(4) structural integrity problems (4 percent of incidents). This
section discusses how ASTM F2012-18[epsiv]\1\ addresses each of these
hazard patterns.
Spring issues. Spring issues typically involve SACs in which the
activity tray and child hang from springs at multiple points. These
incidents often involve one or more parts of the spring system failing,
which can result in the child falling out of the SAC when it tilts,
tips, topples, or leans from the manufacturer's recommended-use
position. ASTM F2012-18[epsiv]\1\ addresses this hazard with a
performance requirement that support springs withstand 100 drops from a
33-pound weight from a height of at least 1 inch. In addition, based on
input from CPSC staff, ASTM F2012-18[epsiv]\1\ requires a secondary
support for load-bearing springs, so that there is a redundant system
to prevent the seat from falling if a spring fails. CPSC concludes that
these requirements adequately address the spring issues indicated in
the incident data.
Problems with toy accessories. The majority of reported problems
with toy accessories involve detached small parts causing choking or
gagging, toys striking children in the face, pinch or entrapment points
created by small gaps, and lacerations from sharp edges. ASTM F2012-
18[epsiv]\1\ addresses these hazards by requiring toy accessories for
SACs, and their means of attachment, to meet relevant requirements in
ASTM
[[Page 28209]]
F963-17, Standard Consumer Safety Specification for Toy Safety (ASTM
F963). ASTM F963 includes requirements that address the hazards evident
in the injury data, including choking, ingestion, and inhalation
hazards from small objects; sharp edges, hazardous points, and
hazardous projections; folding mechanisms and hinges; and entanglement
and strangulation hazards from cords, straps, and elastics. CPSC
concludes that ASTM F963 adequately addresses the majority of hazards
related to toy accessories on SACs.
Strap issues. The strap system on a SAC supports the occupant's
weight and allows the occupant to bounce. The strap system is the
primary means of support for most spring-supported SACs. A typical
spring-supported SAC includes a strap system that connects at the top
to the frame structure, and at the bottom to the side or underside of
the carrier, to support the occupant. The length of the strap system
typically consists of an upper segment that serves as the frame support
strap, a lower segment that serves as the occupant support strap, and a
middle section that consists of a spring to allow the occupant to
bounce. Because the strap system serves as the primary means of support
for most spring-supported SACs, if the strap fails, the SAC may be
unsupported on one side, resulting in a child falling. Incidents
involving strap issues include torn, fraying, twisted, or detached
straps.
To address this hazard, ASTM F2012-18[epsiv]\1\ requires dynamic
and static loading at the seat of the product to evaluate the
durability of the support structures for the seat. This testing also
stresses the structural integrity components of the product, such as
straps. The standard requires that the product show no failure of
seams, material breakage, or changes of adjustments that could cause
the product to not fully support the child. CPSC staff concludes that
these provisions adequately address the strap issues indicated in the
incident data.
As the NPR discussed, while preparing the NPR, CPSC staff learned
of one product in which the occupant support strap frayed and broke
because the strap rubbed against a metal buckle during normal use. The
support structure durability requirements in ASTM F2012-18[epsiv]\1\ do
not address this scenario. On April 27, 2018, CPSC staff requested that
ASTM address this hazard scenario, and ASTM created a task group to
review the issue. The NPR requested comments about this issue, but CPSC
received none. CPSC staff is participating in the ASTM task group, and
the task group is making progress toward developing a requirement to
address fraying straps. In this final rule, the Commission is not
adopting an additional requirement to address this hazard because: (1)
The ASTM task group has made progress toward developing a requirement
to address fraying straps; (2) CPSC is aware of only one product that
involved this issue; and (3) the one product has been redesigned with
parts that will not cause the strap to fray.
Structural integrity problems. Incidents involving structural
integrity problems include frame tube damage; loose screws; broken
activity bars; and problems with locks that lead to the product
collapsing, the top and bottom parts of the product detaching, or the
height adjustment mechanism failing. To address these issues, ASTM
F2012-18[epsiv]\1\ requires dynamic and static loading at the seat of
the SAC to evaluate the durability of the support structures for the
seat. This testing also stresses the structural integrity components of
the SAC. The standard requires that the product show no failure of
seams, material breakage, or changes of adjustments that could cause
the product to not fully support the occupant. CPSC concludes that
these requirements are adequate to address the structural integrity
issues indicated in the incident data.
VI. Comments Filed in Response to the NPR
CPSC received two comments in response to the NPR. The comments are
available in the docket for this rulemaking, CPSC-2018-0015, at:
www.regulations.gov.
The first comment, from JPMA (a national non-profit trade
association that represents producers, importers, and distributors of
childcare articles), expressed support for the proposed rule and CPSC
staff's collaboration with ASTM. The second comment also expressed
general support for the proposed rule, but stated that there should be
oversight of small manufacturers and importers. It appears that the
commenter misunderstood the Regulatory Flexibility Act (RFA) analysis
to mean that the rule would not apply to small entities; this is
incorrect. The rule applies to all manufacturers and importers of SACs
sold in the United States.
VII. Incorporation by Reference
The Office of the Federal Register (OFR) has regulations regarding
incorporation by reference. 1 CFR part 51. These regulations require
the preamble to a final rule to summarize the material the agency is
incorporating by reference, discuss how the material is reasonably
available to interested parties, and explain how to obtain the
material. 1 CFR 51.5(b). This section summarizes ASTM F2012-
18[epsiv]\1\, and describes how to obtain a copy of the standard.
ASTM F2012-18[epsiv]\1\ contains test methods and requirements
regarding:
Sharp edges or points;
small parts;
latching or locking mechanisms to prevent unintentional
folding;
openings;
scissoring, shearing, or pinching;
exposed coil springs;
toy accessories sold with SACs;
protective components;
spring failures on spring-supported SACs;
structural integrity;
leg openings;
stability (including tip overs and seat tilt);
motion resistance;
warnings and labels; and
instructional literature.
Interested parties may obtain a copy of ASTM F2012-18[epsiv]\1\
from ASTM, through its website (https://www.astm.org), or by mail from
ASTM International, 100 Bar Harbor Drive, P.O. Box 0700, West
Conshohocken, PA 19428. Alternatively, interested parties may inspect a
copy of the standard at CPSC's Division of the Secretariat.
VIII. Final Rule
Section 1238.2 of the final rule requires SACs to comply with ASTM
F2012-18[epsiv]\1\ and incorporates the standard by reference. Section
VII of this preamble describes the OFR requirements for incorporating
material by reference. To comply with those requirements, section VII
summarizes ASTM F2012-18[epsiv]\1\, explains how the standard is
reasonably available to interested parties, and indicates how to obtain
a copy of the standard.
The final rule also amends 16 CFR part 1112 to add a new Sec.
1112.15(b)(48) that lists 16 CFR part 1238, Safety Standard for
Stationary Activity Centers, as a children's product safety rule for
which the Commission has issued an NOR. Section XV of this preamble
provides additional information about certifications and NORs.
IX. Effective Date
The Administrative Procedure Act (5 U.S.C. 551-559) generally
requires that agencies set an effective date for a final rule that is
at least 30 days after the Federal Register publishes the final rule.
Id. 553(d). The NPR proposed that the final rule for SACs, and the
[[Page 28210]]
amendment to part 1112, would take effect 6 months after publication.
CPSC did not receive any comments about this timeline. Six months is
generally enough time for firms to modify their products to meet a new
standard, it is consistent with other CPSIA section 104 rules, and JPMA
typically allows six months for products in its certification program
to shift to a new standard. For these reasons, this rule will take
effect 6 months after publication in the Federal Register, and will
apply to products manufactured or imported on or after that date.
X. Paperwork Reduction Act
This rule contains information collection requirements that are
subject to public comment and Office of Management and Budget (OMB)
review under the Paperwork Reduction Act of 1995 (PRA; 44 U.S.C. 3501-
3521). Under the PRA, CPSC must estimate the ``burden'' associated with
each ``collection of information.'' 44 U.S.C. 3506(c).
In this rule, section 8 of ASTM F2012-18[epsiv]\1\ contains
labeling requirements that meet the definition of ``collection of
information'' in the PRA. Id. 3502(3). In addition, section 9 of ASTM
F2012-18[epsiv]\1\ requires instructions be provided with SACs;
however, CPSC staff believes this requirement can be excluded from the
PRA burden estimate. OMB allows agencies to exclude from the PRA burden
estimate any ``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,'' if the disclosure
activities required to comply are ``usual and customary.'' 5 CFR
1320.3(b)(2). CPSC staff is not aware of SACs that require use or
assembly instructions but lack such instructions, so staff believes
that providing instructions with SACs is ``usual and customary.'' For
this reason, the burden estimate includes only the labeling
requirements.
The preamble to the NPR discussed the information collection burden
of the proposed rule and requested comments on the accuracy of CPSC's
estimates. 83 FR 28395. CPSC did not receive any comments about the
information collection burden of the proposed rule. The information
collection burden has not changed since the NPR. The estimated burden
of this collection of information is as follows:
Table 2--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Frequency of Total annual Hours per Total burden
16 CFR section respondents responses responses response hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
1238.2................................................... 11 4 44 1 44
--------------------------------------------------------------------------------------------------------------------------------------------------------
CPSC staff is aware of 11 suppliers of SACs to the U.S. market.
This estimated reporting burden assumes that all 11 suppliers may need
to modify their labels to comply with the final rule. CPSC staff
estimates that it will take about one hour per model to make these
modifications and, based on staff's evaluation of product lines, that
each firm supplies an average of four models of SACs. Therefore, CPSC
staff estimates that the burden associated with the labeling
requirements is: 11 entities x 1 hour per model x 4 models per entity =
44 hours. CPSC staff estimates that the hourly compensation for the
time required to create and update labels is $34.50 (U.S. Bureau of
Labor Statistics, ``Employer Costs for Employee Compensation,'' Dec.
2018, total compensation for all sales and office workers in goods-
producing private industries: https://www.bls.gov/ncs/). Therefore, the
estimated annual cost associated with the labeling requirements is:
$34.50 per hour x 44 hours = $1,518. CPSC staff does not expect there
to be operating, maintenance, or capital costs associated with this
information collection.
As the PRA requires, CPSC has submitted the information collection
requirements of this final rule to OMB. 44 U.S.C. 3507(d). OMB has
assigned control number 3041-0179 to this information collection.
XI. Regulatory Flexibility Act
A. Introduction
The RFA (5 U.S.C. 601-612) requires agencies to consider the
potential economic impact of a proposed and final rule on small
entities, including small businesses. An agency must prepare and
publish a final regulatory flexibility analysis (FRFA) when it issues a
final rule, unless the head of the agency certifies that the rule will
not have a significant economic impact on a substantial number of small
entities. 5 U.S.C. 604(a), 605(b). If, rather than publishing a FRFA,
the head of the agency makes the above certification, the agency must
publish the certification and a statement of the factual basis for it
in the Federal Register with the final rule. Id. 605(b).
The Commission made the above certification in the NPR because
staff found that the cost of modifying products to meet the standard
would not be significant, and the SACs of all seven small manufacturers
were JPMA certified. JPMA certification indicates that the products
comply with the ASTM standard and undergo third party testing. The
Commission does not have any new information that would change that
conclusion. Therefore, the Commission certifies that this rule,
incorporating by reference ASTM F2012-18[epsiv]\1\ as a CPSC standard,
will not have a significant economic impact on a substantial number of
small entities involved in manufacturing or importing SACs.
B. Comments Relevant to the RFA Analysis
CPSC did not receive any comments addressing the RFA analysis or
from the Chief Counsel for Advocacy of the SBA, but did receive one
comment regarding small entities. The commenter stated that there
should be oversight of small manufacturers or importers if the rule
does not apply to them. It appears that the commenter misunderstood the
RFA analysis to mean that the rule would not apply to small entities;
this is not correct. The rule applies to all manufacturers and
importers of SACs sold in the United States.
XII. Congressional Review Act
The Congressional Review Act (CRA; 5 U.S.C. 801-808) states that,
before a rule may take effect, the agency issuing the rule must submit
the rule, and certain related information, to each House of Congress
and the Comptroller General. 5 U.S.C. 801(a)(1). The submission must
indicate whether the rule is a ``major rule.'' The CRA states that the
Office of Information and Regulatory Affairs (OIRA) determines whether
a rule qualifies as a ``major rule.''
Pursuant to the CRA, OIRA designated this rule as not a ``major
rule,'' as defined in 5 U.S.C. 804(2). In addition, to comply with the
CRA, the Office of the General Counsel will
[[Page 28211]]
submit the required information to each House of Congress and the
Comptroller General.
XIII. Environmental Considerations
CPSC's regulations list categories of agency actions that
``normally have little or no potential for affecting the human
environment.'' 16 CFR 1021.5(c). Such actions qualify as ``categorical
exclusions'' under the National Environmental Policy Act (42 U.S.C.
4321-4370m-12), which do not require an environmental assessment or
environmental impact statement. One categorical exclusion listed in
CPSC's regulations is for rules or safety standards that ``provide
design or performance requirements for products.'' 16 CFR 1021.5(c)(1).
Because the final rule for SACs creates design or performance
requirements, the rule falls within the categorical exclusion.
XIV. Preemption
Under section 26(a) of the CPSA, no state or political subdivision
of a state may establish or continue in effect a requirement dealing
with the same risk of injury as a Federal consumer product safety
standard under the CPSA unless the state requirement is identical to
the Federal standard. 15 U.S.C. 2075(a). However, states or political
subdivisions of states may apply to CPSC for an exemption, allowing
them to establish or continue such a requirement if the state
requirement ``provides a significantly higher degree of protection from
[the] risk of injury'' and ``does not unduly burden interstate
commerce.'' Id. 2075(c).
Section 104 of the CPSIA requires the Commission to issue consumer
product safety standards for durable infant or toddler products. As
such, consumer product safety standards that the Commission creates
under CPSIA section 104 are covered by the preemption provision in the
CPSA. Therefore, the preemption provision in section 26 of the CPSA
applies to the mandatory safety standard for SACs.
XV. Testing, Certification, and Notification of Requirements
Section 14(a) of the CPSA requires the manufacturer or private
labeler of a children's product that is subject to a children's product
safety rule to certify that, based on a third party conformity
assessment body's (i.e., third party laboratory's) testing, the product
complies with the relevant children's product safety rule. 15 U.S.C.
2063(a)(2)(A), 2063(a)(2)(B). The Commission must publish an NOR for a
third party laboratory to obtain accreditation to assess conformity
with a children's product safety rule. 15 U.S.C. 2063(a)(3)(A).
Effective June 10, 2013, the Commission adopted 16 CFR part 1112,
which sets out the general requirements and criteria concerning third
party laboratories. 78 FR 15836 (Mar. 12, 2013). Part 1112 includes
procedures for CPSC to accept a third party laboratory's accreditation
and lists the children's product safety rules for which the Commission
has published NORs. When the Commission issues a new NOR, it must amend
part 1112 to include that NOR.
Because this final rule is a children's product safety rule, the
Commission is amending part 1112 to include an NOR for the SACs
standard. Third party laboratories that apply for CPSC acceptance to
test SACs for compliance with the new SAC rule will have to meet the
requirements in part 1112. When a laboratory meets the requirements of
a CPSC-accepted third party conformity assessment body, the laboratory
can apply to CPSC to include 16 CFR part 1238, Safety Standard for
Stationary Activity Centers, in the laboratory's scope of accreditation
of CPSC safety rules listed on the CPSC website at: www.cpsc.gov/labsearch.
As the RFA requires, CPSC staff prepared a FRFA for the
Commission's part 1112 rulemaking. 78 FR 15836, 15855 (Mar. 12, 2013).
The FRFA concluded that the accreditation requirements would not have a
significant economic impact on a substantial number of small
laboratories because no requirements applied to laboratories that did
not intend to provide third party testing services. The only
laboratories CPSC 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.
For the same reasons, adding an NOR for the SACs standard to part
1112 will not have a significant economic impact on small test
laboratories. Because only a small number of laboratories in the United
States have applied for accreditation to test for conformance to
existing juvenile product standards, CPSC expects that only a few
laboratories will seek accreditation to test for compliance with the
SACs standard. Of those that seek accreditation, CPSC expects that most
already will have accreditation to test for conformance to other
juvenile product standards. The only costs to those laboratories will
be the cost of adding the SACs standard to their scopes of
accreditation. For these reasons, CPSC certifies that amending 16 CFR
part 1112 to include an NOR for the SACs standard will not have a
significant economic impact on a substantial number of small entities.
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 1238
Consumer protection, Imports, Incorporation by reference, Infants
and children, Labeling, Law enforcement, Toys.
For the reasons discussed in the preamble, the Commission amends 16
CFR chapter II 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: 15 U.S.C. 2063; Pub. L. 110-314, section 3, 122
Stat. 3016, 3017 (2008).
0
2. Amend Sec. 1112.15 by adding paragraph (b)(48) to read as follows:
Sec. 1112.15 When can a third party conformity assessment body apply
for CPSC acceptance for a particular CPSC rule or test method?
* * * * *
(b) * * *
(48) 16 CFR part 1238, Safety Standard for Stationary Activity
Centers.
* * * * *
0
3. Add part 1238 to read as follows:
PART 1238--SAFETY STANDARD FOR STATIONARY ACTIVITY CENTERS
Sec.
1238.1 Scope.
1238.2 Requirements for Stationary Activity Centers.
Authority: 15 U.S.C. 2056a.
Sec. 1238.1 Scope.
This part establishes a consumer product safety standard for
stationary activity centers.
Sec. 1238.2 Requirements for stationary activity centers.
Each stationary activity center shall comply with all applicable
provisions of ASTM F2012-18[epsiv]\1\Standard Consumer Safety
Performance Specification for Stationary Activity Centers, approved on
March 1, 2018. The Director of the Federal Register approves this
incorporation by reference in
[[Page 28212]]
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a
copy from ASTM International, 100 Bar Harbor Drive, P.O. Box 0700, West
Conshohocken, PA 19428; https://www.astm.org. You may inspect a copy at
the Division of the Secretariat, U.S. Consumer Product Safety
Commission, Room 820, 4330 East-West Highway, Bethesda, MD 20814,
telephone 301-504-7923, or at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call 202-741-6030, or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.
Alberta E. Mills,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2019-12804 Filed 6-17-19; 8:45 am]
BILLING CODE 6355-01-P