Safety Standard for Infant Walkers: Final Rule, 35266-35279 [2010-14323]
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Federal Register / Vol. 75, No. 118 / Monday, June 21, 2010 / Rules and Regulations
CONSUMER PRODUCT SAFETY
COMMISSION
16 CFR Part 1216
[CPSC Docket No. CPSC–2009–0066]
Safety Standard for Infant Walkers:
Final Rule
AGENCY: Consumer Product Safety
Commission.
ACTION: Final rule.
SUMMARY: Section 104(b) of the
Consumer Product Safety Improvement
Act of 2008 (‘‘CPSIA’’) requires the
United States Consumer Product Safety
Commission (‘‘CPSC’’ or ‘‘Commission’’)
to promulgate consumer product safety
standards for durable infant or toddler
products. These standards are to be
‘‘substantially the same as’’ applicable
voluntary standards or more stringent
than the voluntary standard if the
Commission concludes that more
stringent requirements would further
reduce the risk of injury associated with
the product. The Commission is issuing
a safety standard for infant walkers in
response to the direction under section
104(b) of the CPSIA.1
DATES: The rule will become effective
on December 21, 2010 and apply to
products manufactured or imported on
or after that date. The incorporation by
reference of the publication listed in
this rule is approved by the Director of
the Federal Register as of December 21,
2010.
FOR FURTHER INFORMATION CONTACT:
Carolyn Manley, Office of Compliance
and Field Operations, Directorate for
Engineering Sciences, Consumer
Product Safety Commission, 4330 East
West Highway, Bethesda, MD 20814;
telephone (301) 504–7607;
cmanley@cpsc.gov.
SUPPLEMENTARY INFORMATION:
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A. Background and Statutory Authority
The Consumer Product Safety
Improvement Act of 2008 (‘‘CPSIA’’,
Pub. L. 110–314) was enacted on August
14, 2008. Section 104(b) of the CPSIA
requires the Commission to promulgate
consumer product safety standards for
durable infant or toddler products.
These standards are to be ‘‘substantially
the same as’’ applicable voluntary
standards or more stringent than the
voluntary standard if the Commission
1 The Commission voted 5–0 to approve
publication of this rule. Commissioner Thomas
Moore filed a statement concerning this action
which may be viewed on the Commission’s Web
site at https://www.cpsc.gov/pr/statements.html or
obtained from the Commission’s Office of the
Secretary.
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concludes that more stringent
requirements would further reduce the
risk of injury associated with the
product. Section 104(b)(2) of the CPSIA
directs the Commission to begin
rulemaking for two standards by August
14, 2009. Under this provision, the
Commission published a proposed
standard for infant walkers in the
Federal Register on September 3, 2009.
74 FR 45704. The standard is
substantially the same as a voluntary
standard developed by ASTM
International (formerly known as the
American Society for Testing and
Materials), ASTM F 977–07, Standard
Consumer Safety Specification for
Infant Walkers, but with several
modifications that strengthen the
standard in order to reduce the risk of
injury associated with walkers.
There are existing mandatory
regulations applicable to baby bouncers,
walker-jumpers, and baby walkers,
which were originally issued in 1971 by
the Food and Drug Administration. 16
CFR 1500.18(a)(6) and 16 CFR
1500.86(a)(4). These regulations do not
address hazards associated with falls
down stairs, structural integrity,
occupant retention, or loading/stability
issues. The ASTM F 977–07 standard
contains provisions that the mandatory
regulations lack or requirements that are
more stringent than the mandatory
standard. On September 3, 2009, the
Commission proposed to revoke the
existing CPSC regulations for baby
bouncers, baby jumpers and walkers. As
explained elsewhere in this issue of the
Federal Register, the Commission has
determined to revoke the existing
regulations only with regard to walkers.
They will remain in effect for baby
bouncers and baby jumpers.
B. The Product
Infant walkers are used to support
very young children before they are
walking (usually 6 to 15 months old).
ASTM F 977–07 defines ‘‘walker’’ as ‘‘a
mobile unit that enables a child to move
on a horizontal surface when propelled
by the child sitting or standing within
the walker, and that is in the
manufacturer’s recommended use
position.’’ Children may use walkers to
sit, recline, bounce, jump, and use their
feet to move around. Walkers typically
consist of fabric seats attached to rigid
trays. The trays are fastened to bases
that have wheels or casters to make
them mobile.
Currently, there are at least seven
manufacturers or importers supplying
walkers to the United States market
(four domestic manufacturers, two
foreign manufacturers with divisions in
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the United States, and one domestic
importer).
All known suppliers of infant walkers
are members of the Juvenile Products
Manufacturers Association (‘‘JPMA’’),
the major United States trade
association that represents juvenile
product manufacturers and importers.
Each supplies a variety of children’s
products, of which walkers are only a
small proportion. Infant walkers are
available in many countries besides the
United States, including China, the
United Kingdom, and Australia.
Therefore, any foreign manufacturer is a
potential supplier to the United States
market, either directly or indirectly
through an importer.
Infant walkers made by all of the
domestic manufacturers supplying
walkers to the United States market are
JPMA certified as compliant with the
ASTM voluntary standard. Based on
limited CPSC staff testing, CPSC staff
does not believe that the two foreign
manufacturers and the domestic
importer are making walkers that are
compliant with the voluntary standard.
Sales of infant walkers peaked in the
early 1990s at less than 2 million
annually. By 2005, however, annual
walker sales had fallen to around
600,000. Following a similar pattern,
walkers in use (the number of walkers
estimated to still be in use, regardless of
when sold) peaked in the mid-1990s,
but have since fallen sharply as well (by
55 percent between 1996 and 2005). As
of 2005, the estimated number of
walkers in use was probably less than 2
million.
C. Incident Data
The preamble to the proposed rule
summarized incident data involving
walkers. There has been no change in
the fatality reports or injury estimates
related to walkers since publication of
the proposed rule. That information is
repeated below.
1. Injury Estimates
There were an estimated total of
14,900 (an annual average of 3,000)
injuries related to infant walkers among
children under the age of 15 months
that were treated in hospital emergency
departments in the United States over
the five-year period 2004–2008.2 (This
estimate has been adjusted to exclude
jumpers from the walker code.) No
deaths were reported through NEISS.
2 The source of injury estimates is the National
Electronic Injury Surveillance System (‘‘NEISS’’), a
statistically valid injury surveillance system based
on data gathered from emergency departments of
hospitals selected as a probability sample of all the
United States hospitals with emergency
departments.
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There was no statistically significant
increase or decrease observed in the
estimated injuries from one year to the
next, nor was there any statistically
significant trend observed over the
2004–2008 period. For injuries requiring
emergency department treatment that
were related to infant walkers, the
following characteristics occurred most
frequently based on an annual average:
• Hazard—falls either out of the
walker or down stairs/to a lower level
while in the walker (62%).
• Injured body part—head (45%) and
face (27%).
• Injury type—contusions/abrasions
(37%) and internal organ injury (28%).
• Disposition—treated and released
(90%) and hospitalized (5%).
For approximately 72 percent of the
injuries reported, the walker was
directly involved in the incident (such
as the walker falling down stairs,
tipping over, collapsing). However,
many (nearly 20 percent) of the injuries
treated in emergency departments were
not necessarily caused by failures of the
walkers.
As discussed in the preamble to the
proposed rule (74 FR at 45705), the stair
fall protection provisions in the ASTM
standard dramatically affected incidents
related to walkers (an 88% decrease in
estimated incidents related to walkers
treated in emergency rooms from 1994
to 2008). However, the stair fall hazard
remains the most prevalent hazard in
incidents related to walkers with some
of these incidents involving walkers that
do not comply with the voluntary
standard, damaged or worn walkers, or
children who are strong enough to lift
the walker and defeat the stair fall
protection.
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2. Fatalities
CPSC staff has reports of eight fatal
incidents involving an infant in a
walker during the five year period 2004
to 2008.3 One of these appears to
involve a stair fall incident. The walker
involved did not conform to the ASTM
walker standard’s stair fall performance
requirements and had been under recall
at the time of the death (due to the lack
of stair fall protection). There were three
deaths that resulted from accidental
drowning when the child moved in a
walker into a residential pool or spa.
Two of these three deaths involved
walkers that were certified to the JPMA
standard, though pictures showed that
one of the walkers was missing a wheel.
The physical condition of the other
3 The reported fatalities and non-fatalities are
neither a complete count of all incidents that
occurred during the period nor a sample of known
probability of selection.
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walker is unknown. The circumstances
of the remaining four deaths varied and
involved circumstances unrelated to
falls (i.e., a slow cooker overturned on
an infant in a walker who pulled the
cord of the cooker, an infant pulled a
heavy dining chair on himself, an infant
rolled down a driveway and struck a
moving vehicle, and an infant aspirated
a screw while seated in a walker).
3. Non-Fatal Injuries
A total of 78 non-fatal injuries were
reported to have occurred between 2004
and 2008. All of these injuries occurred
when the infant was seated in a walker.
The leading cause of injury (about 42%
of the injuries) was falls down the stairs
or to a lower level. The next major cause
of injury was product failure, either
structural or mechanical failure of the
walker, and these accounted for another
37% of the incidents. The attached toys,
toy bars, or toy trays on the walker
caused another 17% of the injuries,
such as lacerations, abrasions, pinching,
etc. Three percent of the non-fatal
reported injuries were serious burn
injuries resulting from infants pulling
cords of small cooking appliances and
spilling hot liquids onto themselves.
Finally, one percent of the reported
incidents did not specify the injury.
D. Voluntary Standards
1. ASTM Voluntary Standard
ASTM F 977, Standard Consumer
Safety Specification for Infant Walkers,
was first published in 1986 and was
revised in 1997 to address the stair fall
hazard. The Commission’s proposed
rule, published September 3, 2009, was
based on the 2007 version of the ASTM
standard, ASTM F 977–07. In December
2009, ASTM published a revision to the
infant walker standard, F 977–09. This
revision included some of the changes
in the Commission’s proposed rule, but
not the majority of them. The 2009
revision of the ASTM standard also
included a significant change to the
rearward facing stair fall test procedure
for open back frame walker models.
This test procedure was different from
the test procedure the Commission
proposed for these types of walkers. The
proposed rule would require using a 1inch aluminum angle firmly attached to
the walker frame. The ASTM ’09 version
uses loops of cord and a lightweight
floating bar. Because this method of
attachment may not remain taut
throughout the stair fall test, this
procedure in the ASTM ’09 version is
not as stringent as the test method the
Commission proposed for these types of
walkers. For this reason, the final rule
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incorporates by reference ASTM F 977–
07 rather than the 2009 revision.
JPMA provides certification programs
for juvenile products, including infant
walkers. Manufacturers submit their
products to an independent testing
laboratory to test the product for
conformance to the ASTM standard.
Currently, infant walkers from five
manufacturers are JPMA certified as
being in compliance with the ASTM
standard.
The ASTM standard includes
performance requirements specific to
infant walkers, general performance
requirements, and labeling
requirements. The key provisions of the
ASTM infant walker standard include
the following:
• Prevention of falls down stairs—
intended to ensure that a walker will
not fall down stairs when facing front,
back, and sideways.
• Tipping resistance—intended to
ensure that walkers are stable and do
not tip over when on a flat surface;
includes tests for forward and rear tip
resistance, as well as for the occupant
leaning over the front.
• Dynamic and static load testing on
seating area—intended to ensure that
the child remains fully supported while
stationary and while bouncing/jumping.
• Occupant retention—intended to
prevent entrapment by setting
requirements for leg openings.
The ASTM standard also includes: (1)
Torque and tension tests to assure that
components cannot be removed; (2)
requirements for several walker features
to prevent entrapment and cuts
(minimum and maximum opening size,
accessible coil springs, leg openings,
and edges that can scissor, shear, or
pinch); (3) latching/locking mechanism
requirements to assure that walkers do
not accidentally fold while in use; (4)
requirements for the permanency and
adhesion of labels; and (5) requirements
for instructional literature.
The stair fall protection requirement,
also called the step test, is the key
provision in the ASTM standard. For
this test, a walker with a Civil
Aeromedical Institute infant dummy
(Mark II) (subsequently referred to as
‘‘CAMI dummy’’) is placed in the
walker’s seat which is propelled with a
horizontal dynamic force by means of a
pulley, rope, and a falling 8-pound
weight on a hardwood floor surface. The
walker passes the test if it stays on the
test table which has a hardwood floor
surface. It fails the test if the walker
completely falls off the table surface.
The step test in the ASTM F 977–07
standard is based on the assumption
that an average walker weighs 8 pounds.
However, when CPSC staff weighed five
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2008 to 2009 model walkers, the weight
values ranged from 11 to 14 pounds.
Computing the launching distance ‘‘d’’
as described in section 7.6 of ASTM F
977–07 depends on the weight of the
walker, the weight of the CAMI dummy,
the weight of the CAMI vest, the
coefficient of friction between the
walker wheels and the test table surface,
and the maximum velocity at the edge
of the test table platform (4 ft/sec or 2
ft/sec). According to section 7.6 of
ASTM F 977–07, the d value for the
forward and rearward directions with
only the CAMI dummy seated in the
walker is 14.6 inches. The d value for
the forward and rearward directions
with the CAMI dummy fitted with the
11-pound vest seated in the walker is
21.2 inches. The values of 14.6 inches
and 21.2 inches were based on the
assumption that the walker weight is 8
pounds. As in the proposed rule, the
final rule requires calculation of the
launching distance using the actual
weight of the walker.
In the ASTM F 977–07 standard, most
of the hardware and test apparatus
components are not specified.
Variability in the type and size of the
pulley, rope type, test table flexure etc.
can lead to different test results. Two
different labs could test the same model
walker and obtain different results. As
in the proposed rule, the final rule adds
specificity to these requirements.
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2. European Standard EN 1273:2005
CPSC staff evaluated EN 1273:2005
European Standard and its two
performance tests that are not in the
ASTM F 977–07: the 30° incline plane
stability test and the parking device test.
The Commission proposed adding the
30° incline plane test, which is a
standard stability test common in
several EN children’s product safety
standards, to the walker mandatory
standard. In this test, the walker,
occupied by a 26.4 lb (12 kg) test mass
is placed on a sloping platform inclined
at 30° to the horizontal with a stop on
the lower edge of the slope. The walker
must not tip over. As explained in part
F.2 of the preamble, the Commission is
not including this test in the final rule.
The parking device test is only
applicable to walkers that are equipped
with a parking brake. It essentially
requires conducting a semi-static
version of the stair fall test, but with the
parking device engaged. The walker
must not move more than 1.97 inches
(50 mm) in order to pass. The
Commission proposed adding this test,
and the final rule retains this addition.
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E. Response to Comments on the
Proposed Rule
CPSC received seven comments
regarding the proposed rule for infant
walkers, including five from
individuals, one from JPMA, and one
from various consumer groups,
including Consumers Union, Consumer
Federation of America, and Kids in
Danger. These comments and the
Commission’s responses are discussed
below.
1. Parking Brake Requirement and
Warning
a. Comment: One commenter
remarked that the parking brake
requirement should be more stringent
because parking brakes should keep the
walker completely stationary and also
commented that the proposed warning
in the proposed rule is contradictory to
the perception of a parking brake’s
function. Another commenter
recommended requiring parking brakes
for all infant walkers.
Response: CPSC believes that the
purpose of the parking brake warning is
to alert the caregiver that the parking
brake is used for temporarily preventing
the walker from moving. In several
ASTM meetings, some infant walker
manufacturers have characterized the
purpose of the parking brakes as such,
and that the child in the walker must
always be kept in view. The parking
brake feature is added on some models
for convenience to the caregiver. The
parking brake is not meant to keep a
child in the walker indefinitely without
supervision. Also, the warning is meant
to prevent any false sense of security by
the caregiver. CPSC believes the
proposed warning and the performance
requirements as they appeared in the
proposed rule are adequate.
b. Comment: One commenter
supported the concept for having a
performance test for walkers with
parking brakes, but disagreed with the
proposal to adopt the EN 1273:2005
European Standard’s test for parking
brakes. The performance test is similar
to that of the stair fall test, except that
the 8-pound weight guided by a rope
and pulley is released gradually and
there is no set launching distance. Upon
completion of the gradual 8-pound force
application, the maximum allowable
displacement (i.e., movement) of the
walker is 1.97 inches. The commenter
argued that a lack of incidents involving
parking devices supports its argument.
In addition, the commenter compared
the proposed parking device test to the
ASTM F 2012, Standard for Stationary
Activity Centers. The commenter
asserted that a stationary activity center
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is similar to that of an infant walker
with its parking brakes engaged. Based
on this comparison to stationary activity
centers, the commenter advocated
increasing the maximum allowable
displacement to 6 inches in accordance
with ASTM F 2012.
Response: CPSC believes that if a
product is equipped with a feature, such
as a parking brake, that feature should
function properly and safely. Although
CPSC is not aware of any incidents
involving parking devices in the United
States, the Commission believes that
requiring the parking brake test is
appropriate for the following reasons.
There are important distinctions
between walkers and stationary activity
centers. An infant in a walker tends to
exert a horizontal force to propel
himself or herself horizontally, whereas
a child in a stationary activity center
may not necessarily exert the same type
of horizontally concentrated forces
because the infant may be preoccupied
jumping up and down, spinning about
the seat, and playing with toys. The
parking brake performance test should
set limits on the displacement of the
walker in the horizontal direction to
resist motion when the parking brakes
are engaged. The appropriate amount of
force should be applied. Furthermore,
upon comparison between ASTM F
2012 and EN 1273:2005, CPSC staff
noted the following observations:
• A force gauge is used to apply the
8-pound force in ASTM F 2012 instead
of a rope and pulley guided 8-pound
weight as specified in EN 1273:2005. In
the EN 1273:2005 test, the 8-pound
weight is released gradually over a 5
second period and then hung from the
test assembly for 1 minute. Arguably,
the force of gravity is more consistent
than a test technician applying a
consistent rate of 8 pounds over a 10
second period (as in the ASTM F 2012
test). The longer duration of 1 minute is
more stringent than 10 seconds.
• The location application of the 8pound force in ASTM F 2012 has
infinite variability as it is any location
2 inches above the floor level. The EN
1273:2005 standard requires the rope to
be secured onto the bottom frame
member of the infant walker which is
arguably more consistent.
• In the ‘‘Rationale’’ section of ASTM
F 2012, there is no mention of how the
maximum allowable limit for
displacement of 6 inches per minute
was obtained.
EN 1273:2005’s maximum allowable
1.97-inch displacement is more
stringent than ASTM F 2012’s 6 inches.
Moreover, CPSC’s adoption of this
performance test would harmonize with
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the European EN 1273:2005 Standard
for this requirement.
The Commission notes that this
performance test is required only for
infant walker models equipped with
parking devices. Manufacturers can
choose to exclude parking devices from
their product.
The final rule retains the EN
1273:2005 performance test and
maximum allowable displacement for
1.97 inches (CPSC staff assumes the
commenter referred to 2 inches in its
discussions for convenience) for parking
devices as it was proposed in the
proposed rule, except for an editorial
change (discussed in the next response)
to address some walkers that have fixed
direction rear wheels.
c. Comment: The same commenter
observed that the parking brake test, as
written in the proposed rule, may
present problems for measuring the
displacement for walkers that have fixed
direction wheels in the rear of the
walker. With these types of wheels, the
walker has a natural tendency to travel
in a curved path instead of in a straight
path. A walker with four casters does
not have this issue.
Response: To address this subset of
walkers, the final rule adds the
following new paragraph to the
language the Commission previously
proposed for the sideward facing test of
parking devices:
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If the walker is equipped with fixed
direction rear wheels and the walker is
displaced in a curved path, establish the
location of the rope attachment as the
reference point and measure the linear
displacement of that reference point after
performing the procedure as described in
paragraph (c)(3)(iii)(A) and (B).
2. The 30° Incline Plane Test
Comment: One commenter favored
maintaining the cantilevered stability
test as described in Section 7.3.4 of the
ASTM F 977–07 Standard for infant
walkers, and advocated eliminating the
additional CPSC proposed 30° incline
plane stability test to address tip over
hazards.
Response: From the time CPSC staff
recommended the 30° incline plane test
(based on EN 1273:2005), numerous
discussions about the added benefits of
the 30° incline plane stability test have
occurred among CPSC staff and ASTM.
Over the past year, these discussions
have taken place at ASTM headquarters,
as well as in conference calls. A JPMA
member was tasked to perform analyses
on the two test methods to determine if
the 30° incline plane test is needed.
During ASTM’s presentation at the
October 13, 2009 meeting, the JPMA
member demonstrated using real
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examples that Section 7.3.4 stability test
of the ASTM F 977–07 Standard is
adequate and that the 30° incline plane
test is not needed. The analyses
included a comparison of the two
stability test methods using the
dimensions of an exemplar walker and
concluded that the 30° incline plane test
was not as severe as the Section 7.3.4
stability test. CPSC staff concurred with
this presentation and the comparison of
stability test methods. Therefore, the
final rule does not include the 30°
incline plane test that was in the
proposed rule.
3. Adding Calculation To Determine
Launching Distance To Step Test
Procedures
Comment: One commenter objected to
the proposed rule’s proposal to change
the fixed distances in the step test to a
computed value for d which will vary
due to the weight of the test sample
walkers. The commenter asserted that
increasing the launching distance for
heavier walkers is not necessary or is
‘‘self correcting’’ because a child seated
in the heavier walker will naturally not
move as fast. The commenter requested
keeping the launching distances as they
are in Table 1 of Section 7.6 of the
ASTM F 977–07 Standard. The
commenter also commented that no
incident data indicates a need to change
velocities in the step test.
Response: As discussed in the
preamble to the proposed rule (74 FR at
45706), the Commission believes that
the step test requirements should be
modified to account for heavier modern
walkers. The 8-pound walker used to
develop the ASTM step requirement for
the original 1997 standard is now
outdated because the average modern
walker is heavier than 8 pounds.
The critical parameter of the step test
is the velocity of a walker with a child
in it. CPSC staff believes that it would
be more robust to assume that the child
maintains a 4 feet/second top speed,
regardless of the walker’s weight. CPSC
staff showed that children can achieve
4 feet/second in an 8-pound walker
(1996 ASTM Working Group) and in a
10.5-pound walker (2000 Austrian
study 4). (Both of these studies were
based on small sample sizes of 7 and 5
children, respectively.) Stair fall
incidents continue to occur, and some
involve modern walkers that meet the
ASTM requirements. Since the child/
walker speed is the critical factor in
4 ‘‘Baby Walking Frames—Final Report,’’
Consumer Council Austrian Standards Institute in
co-operation with Association for Consumer
Information, European Committee For
Standardization, CEN/TC 252/WG 1 N. 255
February 2001.
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determining stopping distance of a
moving walker at the edge of the step,
CPSC staff believes that a 4 feet/second
velocity should be maintained
regardless of the walker’s weight. This
necessitates using the walker’s actual
weight in the calculation for the stair
fall test.
With regard to incident data
supporting the change, a special study
conducted by CPSC indicates that
several reported incidents involved
walkers that were manufactured to
comply with the ASTM stair step
requirement and were reported to have
been in good condition at the time of the
incident. In addition, a review of a list
compiled by CPSC staff of over 200
incidents (reported through sources
other than NEISS) involving infant
walkers from 1999 to 2008 indicates that
over 40 percent of those incidents
involved stair falls, including one death
which occurred due to a fractured skull.
CPSC staff’s review of the data has
also shown that popular larger, heavier
models (greater than 8 pounds)
manufactured after 1998 were involved
in stair falls. For example, in incident
081112HEP9038, a 10-month old male
fell down a set of steps when he
traveled past an unlatched gate; the
child required a trip to the emergency
room. In incident 081113HEP9029, an
11-month old male fell down a set of
stairs and was found upside down still
in the walker. Both incidents involved
walkers made by a leading
manufacturer. Both incidents occurred
from 2007 to 2008, and both walkers
were equipped with friction strips.
Therefore, the data show that modern
walkers continue to be involved in stair
fall incidents. If a walker is traveling too
fast, even if it is equipped with friction
strips, it may fall down a set of steps.
By increasing this launching distance,
the Commission is making the standard
stricter, which should result in walkers
that are made to be safer when traveling
at faster speeds.
4. Impact of Change to Step Test
Comment: The same commenter
stated that using a calculation in the
step test would be a substantial change
and would affect the outcome of the test
results for walkers that pass the
requirement.
Response: Based on limited testing by
CPSC staff, the Commission believes
that some manufacturers will not need
to make changes to their product. CPSC
staff agrees that some manufacturers
will have to modify their product.
However, these changes are feasible.
Possible modifications could include
increasing the rolling friction within the
walker’s wheels, reducing the walker
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weight, or refining the friction strip
design.
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5. CAMI Dummy Head Position
Comment: One commenter requested
CPSC to consider specifying how the
CAMI dummy is to ‘‘be positioned and
restrained during testing so that the
center of gravity will be consistent from
lab to lab.’’
Response: CPSC agrees in principle
that it is plausible that a CAMI dummy’s
flexibility properties may change over
time and use. Last year, round robin
testing was done by CPSC staff, several
manufacturers, and a testing laboratory.
In addition to pass/fail testing,
quantitative measurements were made,
measuring the displacement of the
walker relative to the edge of the test
table. Testing done by CPSC staff did
not show any substantial variability in
the CPSC test results when the CAMI
dummy’s head was not secured.
However, many other parameters, such
as rope type, pulley type, and the spring
rate for the pulley mounting bracket,
were standardized. Furthermore, the
CPSC standard provides additional
specificity concerning the CAMI
positioning: arms positioned on top of
the toy tray, use of the standardized
military rope to secure the legs, etc.
Securing the CAMI head in a most
rearward or forward position could
possibly produce different results,
depending on the flexibility of the
dummy. Thus, CPSC staff believes that
the CAMI head should not be secured.
When the CAMI is positioned as
described in the proposed (and final)
procedure, the CAMI head movement,
while it exists, is minimized to the
extent possible. Thus, the final rule, like
the proposed rule, provides for the
CAMI head to remain unrestrained
during all the step tests.
6. Friction Pad Wear and Tear
Comment: The same commenter
asked the CPSC to consider the affect of
wear and tear as well as dirt and dust
on the walker’s compliance with the
step test.
Response The final rule does not
include any additional performance
requirements involving step tests with
worn friction strips. Although CPSC
recognizes that friction pad wear may
reduce the pad’s effectiveness, this may
not be the case for all walker friction
pads. Some pads may last longer than
others. Assessing the amount of wear
and standardizing the wear
characteristics may be somewhat
subjective. Given the variation between
friction pad vendors and the changing
compositions of the rubber used in the
friction pads, it may be difficult to
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standardize this aspect of the test. The
final standard includes other changes
that address the stair fall hazard, such
as increasing the input kinetic energy
for heavier walkers (i.e., walkers heavier
than 8 pounds would need to be
launched from a longer distance to
achieve the target terminal velocities).
In an indirect way, setting the higher
input kinetic energy requirement for
heavier walkers creates revised design
criteria for walker manufacturers. One
area where those manufacturers can
address the resistance to stair falls may
lie in revisions to the friction pad
design. CPSC staff believes
standardizing the target velocity will
have an important impact on the actual
test, as the kinetic energy of the walker
and CAMI dummy is proportional to the
square of the velocity. Furthermore,
each walker will be subjected to 18
impacts which will sufficiently subject
the sample walkers to abuse (3
directions × 2 configurations with and
without vest × 3 replicates). For these
reasons, CPSC staff believes there is
insufficient data and rationale to add
performance requirements involving
stair fall tests with worn friction strips.
F. Assessment of Voluntary Standard
ASTM F 977–07 and Description of
Final Rule
1. Section 104(b) of the CPSIA:
Consultation and CPSC Staff Review
Section 104(b) of the CPSIA requires
the Commission to assess the
effectiveness of the voluntary standard
in consultation with representatives of
consumer groups, juvenile product
manufacturers, and other experts. This
consultation process began in October
2008 during the ASTM subcommittee
meeting regarding the ASTM infant
walker voluntary standard.
Consultations between Commission staff
and members of this subcommittee have
continued and are still ongoing.
As discussed in the preamble to the
proposed rule (74 FR at 45706), CPSC
staff conducted testing on JPMA
certified walkers in order to evaluate the
ASTM infant walker standard and
develop recommendations for changes
to it. The testing focused on the stair fall
test in the ASTM standard, a stability
performance requirement, and a parking
brake requirement (the latter two both
taken from EN 1273:2005).
Consistent with section 104(b) of the
CPSIA, this rule establishes a new 16
CFR part 1216, ‘‘Safety Standard for
Infant Walkers.’’ The new part
incorporates by reference the
requirements for infant walkers in
ASTM F 977–07 with certain changes to
specific provisions to strengthen the
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ASTM standard, as discussed in the
next section of this preamble, to further
reduce the risk of injury. These
modifications are similar to the changes
the Commission proposed in its
September 3, 2009 proposed rule.
Differences from the proposed rule are
noted in the following section of this
preamble.
2. Description of Final Rule Including
Changes to the ASTM Standard’s
Requirements
While most requirements of the
ASTM F 977–07 standard are sufficient
to reduce the risk of injury posed by
infant walkers, the Commission has
modified several provisions in the
standard to make them more stringent
and clarified the test procedures. The
following discussion describes the final
rule, including changes to the ASTM
requirements, and notes any changes
from the proposed rule. In addition,
some editing and formatting changes
have been made which make the final
text different from the proposed rule.
The Commission made these editing
and formatting changes to respond to
concerns raised by the Office of the
Federal Register; the editing and
formatting changes do not alter the
substance of the rule.
a. Scope (§ 1216.1)
The final rule states that part 1216
establishes a consumer product safety
standard for infant walkers
manufactured or imported on or after a
date which would be six months after
the date of publication of a final rule in
the Federal Register.
The Commission received no
comments on this provision in the
proposed rule and is finalizing it
without change.
b. Incorporation by Reference
(§ 1216.2(a))
Section 1216.2(a) explains that,
except as provided in § 1216.2(b), each
infant walker must comply with all
applicable provisions of ASTM F 977–
07, ‘‘Standard Consumer Safety
Specification for Infant Walkers,’’ which
is incorporated by reference. Section
1216.2(a) also provides information on
how to obtain a copy of the ASTM
standard or to inspect a copy of the
standard at the CPSC.
The Commission received no
comments on this provision in the
proposed rule and is finalizing it
without change.
c. Summary of Changes to ASTM F 977–
07
The more substantive modifications to
the ASTM standard for walkers are
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discussed in greater detail in part F.2.d.
of this preamble below. A summary of
these changes along with the other,
more editorial/technical changes that
the rule makes to the ASTM standard
follows. The final rule:
• Updates the illustration of types of
models of walkers in Figure 1 of the
ASTM standard to include an open back
design (§ 1216.2(b)(1));
• Revises equipment specifications in
section 4.6 of the ASTM standard to
eliminate brand and model of force
gauge and provide performance
specifications instead. The proposed
rule would have a one year calibration
interval. However, the final rule
provides a more general interval
because a force gauge could go out of
calibration before one year. Appropriate
calibrations are necessary to maintain
accuracy. (§ 1216.2(b)(2));
• Revises Figure 10 of the ASTM
standard to show specific rope, other
equipment and procedures for the step
test (§ 1216.2(b)(15));
• In step test procedures, adds a
calculation (discussed below) using the
actual weight of the walker to determine
the launching distance rather than
assuming an 8-pound walker.
(§ 1216.2(b)(5)(i), (6)(i), (8)(i), (9)(i)(11),
(13)(i), (16)(i), (18)(i));
• In step test procedures, specifies the
position for walker wheels
(§ 1216.2(b)(6)(i), (11)(i), (16)(i));
• In step test procedures, specifies the
position for the CAMI dummy.
(§ 1216.2(b)(7)(i));
• In step test procedures, specifies
rope type, pulley type, and force to be
applied. (§ 1216.2(b)(4)(i), (8)(i), (12)(i),
(17)(i));
• In step test procedures, requires
each aspect of the test (forward,
sideward, and rearward) three times to
make it consistent with EN 1273:2005
and allow more confidence in the test
results. (§ 1216.2(b)(10)(i), (14)(i),
(19)(i));
• Adds the following warning
concerning the parking brake if a walker
has a parking brake: ‘‘WARNING:
Parking brake use does not totally
prevent walker movement. Always keep
child in view when in the walker, even
when using the parking brakes.’’
(§ 1216.2(b)(21)(i));
• Revises the stair hazard warning to
state: ‘‘Block stairs/steps securely before
using walker, even when using parking
brake.’’ (§ 1216.2(b)(22)(i)); and
• Adds parking device test
(§ 1216.2(b)(20)).
d. More Detailed Description of Changes
to the ASTM Standard’s Step Test
Specification of equipment and
procedures. The ASTM F 977–07
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standard’s step test lacks numerous
details which allow for variability in
testing that could result in different test
results. The Commission proposed
specifying the equipment and procedure
needed for the test (e.g., type of rope
and pulley to be used, orientation of
wood grain in the floor). The final rule
retains these changes. Additionally, the
Commission proposed modifying the
test procedure language in several
provisions, such as specifying a
tolerance for the term ‘‘horizontal’’ (0° ±
0.5°). The final rule retains these
changes.
The final rule removes a specification
that the test table be 48 inches. This
specification appears in a notation in
Figure 10 of the ASTM standard. The
proposed rule showed figure 10 with the
noted 48-inch length table. However,
the final rule leaves the length of the
test table unspecified so that a test
laboratory may use a table of adequate
length to accommodate the maximum
calculated launching distance d. A test
table length of 48 inches may not be
sufficient for all walkers once the
calculation is based on the actual weight
of the walker.
Calculation of launching distance.
The Commission proposed a change in
the calculation of the launching
distance used in the step test. The
Commission proposed weighing the
walker and computing the appropriate
launching distances using the actual
weight of the walker.
As discussed in the preamble to the
proposed rule (74 FR at 45704) and in
this preamble, the launching distances
may vary depending on the weight of
the walker and the maximum velocity of
the walker at the edge of the platform (4
ft/sec or 2 ft/sec). If the walker weight
is not appropriately accounted for, then
it is possible the target maximum
velocity cannot be achieved. For
example, if the scenario involved
computing distance d where the walker
is tested in the forward direction with
the CAMI dummy and the walker
weight is 14 pounds, distance d would
equal 18.0 inches (instead of 14.6 inches
if the walker weight value is 8 pounds).
The longer distance is needed to achieve
the target velocity of 4 feet/second. If a
14-pound walker is launched from 14.6
inches, the walker may not achieve the
maximum velocity of 4 feet/second. The
final rule retains the distance d
calculation with a slight modification
that requires the testing lab to measure
the weight of the CAMI dummy and
vest. This will account for variations in
the weight of CAMI dummies and vests.
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e. More Detailed Description of Parking
Brake Test
The Commission proposed adding the
parking brake test of the European
Standard EN 1273:2005. The final rule
retains this test. It applies to infant
walkers that provide parking brakes, but
it does not require walkers to have
parking brakes. Under this test, the
walker is set up to run a quasi-static
version of the step test, but with the
parking device activated. If the walker
moves a distance greater than 1.97
inches (50 mm), the walker fails the
requirement. The parking brake test will
ensure that, if a walker has a parking
brake, it will work effectively.
f. Elimination of 30° Incline Plane Test
The Commission proposed adding the
30° incline plane test from the European
Standard EN 1273:2005 for walkers. As
discussed more fully in the response to
a comment in part E of this preamble,
the final rule eliminates this additional
requirement because testing and
analysis by a JPMA member
demonstrated the adequacy of the
stability test in the ASTM F 977–07
standard.
G. Effective Date
The Commission proposed that the
standard would become effective 6
months after publication of a final rule.
The Commission received no comments
on the proposed effective date. The final
rule provides that the rule will become
effective six months after publication
and thus will require that infant walkers
manufactured or imported on or after
that date must meet this standard.
H. Paperwork Reduction Act
Sections 8 and 9 of ASTM F 977–07
contain requirements for marking,
labeling and instructional literature that
are considered ‘‘information collection
requirements’’ under the Paperwork
Reduction Act, 44 U.S.C. 3501–3520. In
a separate notice elsewhere in this issue
of the Federal Register, the Commission
is publishing a notice requesting
comments on this collection of
information.
I. Regulatory Flexibility Act
The Regulatory Flexibility Act
(‘‘RFA’’) generally requires that agencies
review rules for their potential
economic impact on small entities,
including small businesses. 5 U.S.C.
604.
1. The Market
There are currently at least seven
manufacturers or importers supplying
infant walkers to the United States
market (four domestic manufacturers,
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two foreign manufacturers with
divisions in the United States, and one
domestic importer). Under Small
Business Administration (SBA)
guidelines, a manufacturer of infant
walkers is small if it has 500 or fewer
employees and an importer is
considered small if it has 100 or fewer
employees. Two domestic
manufacturers (a third small
manufacturer also sells infant walkers,
but based on their current product list
is no longer manufacturing them) and
one domestic importer known to be
supplying the United States market
qualify as small businesses under these
guidelines. However, CPSC staff
believes that there are probably other
unknown small importers operating in
the United States market as well.
All domestic manufacturers supplying
infant walkers to the United States
market certify their products as
compliant with the ASTM voluntary
standard through the JPMA certification
program. Based on limited CPSC staff
testing, the two foreign manufacturers
and the domestic importer are not
believed to be complying with the
voluntary standard.
2. Impact of the Rule
The changes to the existing stair fall
test requirements would reduce
variability across manufacturers. Also,
because the specific test modifications
have been selected to minimize the
friction associated with the test
procedure, they may effectively add
stringency to the tests. It is unknown the
extent (if any) to which the modification
in the existing stair fall requirements of
the voluntary standard will affect infant
walkers that now comply with the
voluntary standard. However, initial
testing shows that the requirements
impact the test results of a few walkers.
Therefore, it is possible that some
manufacturers might need to make
walker modifications to comply. Based
on staff estimates of the costs of
complying with the 1997 stair fall
requirements, this cost is unlikely to
exceed more than several dollars per
unit. Possible modifications include:
Increasing the rolling friction within the
walker’s wheels; reducing the walker
weight; and refining the friction strip
design.
Infant walkers are not currently
required to have parking brakes, nor
would they be required to have them
under the standard. However, the final
rule includes a test of parking brakes, if
a walker has them, to assure that they
work properly. Initial testing finds that
existing walkers have no difficulty in
passing this requirement. Therefore, the
Commission does not expect it to
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represent a burden to current
manufacturers. However, its inclusion
would minimize the risk of walkers
with ineffective brakes entering the
United States market in the future.
Of the seven firms currently known to
be marketing infant walkers in the
United States, three are small firms—
two small domestic manufacturers and
a small domestic importer. We discuss
the possible impact of the rule on these
entities immediately below.
Small manufacturers. One small
domestic manufacturer has annual sales
of approximately $31–72.5 million. It
currently produces seven walker models
and approximately 57 other juvenile
products, one of which is a substitute
for infant walkers. The second is a small
domestic manufacturer with annual
sales of approximately $2.5–5 million.
Although its annual sales are lower, it
is currently producing only one infant
walker model and approximately 110
other juvenile products.
The two small domestic
manufacturers (which are JPMA
certified as compliant with the
voluntary standard) may not need to
make product modifications. If they do,
it will most likely be due to changes
needed to comply with the modified
stair fall requirements. The costs to
these manufacturers are not likely to be
substantial, but may increase by as
much as several dollars per unit.
Small importers. The only known
small domestic importer has annual
sales of approximately $2.5–5 million
and is not believed to be in compliance
with the voluntary standard. Therefore,
some product modifications would be
necessary. The impact of the infant
walker requirements on this importer is
unclear, because little is known about
the walkers sold by this company.
However, the impact is unlikely to be
large. Even if the company responded to
the rule by discontinuing the import of
its non-complying walkers, either
replacing them with a complying
product or another juvenile product,
deciding to import an alternative
product would be a reasonable and
realistic way to offset any lost revenue
from walker sales.
There also may be additional
importers of walkers that the staff has
been unable to identify. However, the
impacts of the rule on these firms, if
any, are unknown.
3. Alternatives
Under section 104 of the CPSIA, the
primary alternative that would reduce
the impact on small entities is to make
the voluntary standard mandatory with
no modifications. Because the two small
domestic manufacturers already meet
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the requirements of the voluntary
standard, adopting the standard without
modifications may reduce their costs,
but only marginally. Similarly, limiting
the requirements of the standard to
those already contained in the voluntary
standard would probably have little
beneficial impact on small importers
that do not currently meet the
requirements of the voluntary standard.
This is because, to these firms, most of
the infant walker cost increases would
be associated with meeting the
requirements of the voluntary standard,
rather than the minor additions
associated with the Commission’s
modification of the standard.
4. Conclusion of Final Regulatory
Flexibility Analysis
It is not expected that the standard
will have a substantial effect on a large
number of small firms. In some cases,
small firms may not need to make any
product modifications to achieve
compliance. Even if modifications were
necessary, and the cost of developing a
compliant product proved to be a barrier
for individual firms, the loss of infant
walkers as a product category is
expected to be minor and would likely
be mitigated by increased sales of
competing products, such as activity
centers, or entirely different juvenile
products.
J. Environmental Considerations
The Commission’s regulations
provide a categorical exclusion for the
Commission’s rules from any
requirement to prepare an
environmental assessment or an
environmental impact statement as they
‘‘have little or no potential for affecting
the human environment.’’ 16 CFR
1021.5(c)(1). This rule falls within the
categorical exclusion.
K. Preemption
Section 26(a) of the CPSA, 15 U.S.C.
2075(a), provides that where a
‘‘consumer product safety standard
under [the CPSA]’’ is in effect and
applies to a product, no State or
political subdivision of a State may
either establish or continue in effect a
requirement dealing with the same risk
of injury unless the State requirement is
identical to the Federal standard.
(Section 26(c) of the CPSA also provides
that States or political subdivisions of
States may apply to the Commission for
an exemption from this preemption
under certain circumstances.) Section
104(b) of the CPSIA refers to the rules
to be issued under that section as
‘‘consumer product safety rules,’’ thus
implying that the preemptive effect of
section 26(a) of the CPSA would apply.
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Therefore, a rule issued under section
104 of the CPSIA will invoke the
preemptive effect of section 26(a) of the
CPSA when it becomes effective.
L. Certification
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Section 14(a) of the Consumer
Product Safety Act (‘‘CPSA’’) imposes
the requirement that products subject to
a consumer product safety rule under
the CPSA, or to a similar rule, ban,
standard, or regulation under any other
act enforced by the Commission, must
be certified as complying with all
applicable CPSC requirements. 15
U.S.C. 2063(a). Such certification must
be based on a test of each product or on
a reasonable testing program or, for
children’s products, on tests on a
sufficient number of samples by a third
party conformity assessment body
accredited by the Commission to test
according to the applicable
requirements. As discussed above in
part K of this preamble, section
104(b)(1)(B) of the CPSIA refers to
standards issued under that section,
such as the rule for infant walkers
established in this final rule, as
‘‘consumer product safety standards.’’ By
the same reasoning, such standards also
would be subject to section 14 of the
CPSA. Therefore, any such standard
would be considered to be a consumer
product safety rule to which products
subject to the rule must be certified.
Because infant walkers are children’s
products, they must be tested by a third
party conformity assessment body
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whose accreditation has been accepted
by the Commission. The Commission is
issuing a separate notice of
requirements to explain how
laboratories can become accredited as
third party conformity assessment
bodies to test to the new safety standard.
(Infant walkers also must comply with
all other applicable CPSC requirements,
such as the lead content requirements of
section 101 of the CPSIA, potentially the
phthalate content requirements in
section 108 of the CPSIA if the walker
incorporates a toy component, the
tracking label requirement in section
14(a)(5) of the CPSA, and the consumer
registration form requirements in
section 104 of the CPSIA.)
List of Subjects in 16 CFR 1216
Consumer protection, Incorporation
by reference, Imports, Infants and
children, Labeling, Law enforcement,
and Toys.
Therefore, the Commission amends
Title 16 of the Code of Federal
Regulations by adding part 1216 to read
as follows:
■
PART 1216—SAFETY STANDARD FOR
INFANT WALKERS
Sec.
1216.1
1216.2
Scope.
Requirements for infant walkers.
Authority: The Consumer Product Safety
Improvement Act of 2008, Pub. L. 110–314,
§ 104, 122 Stat. 3016 (August 14, 2008).
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§ 1216.1
35273
Scope.
This part 1216 establishes a consumer
product safety standard for infant
walkers manufactured or imported on or
after December 21, 2010.
§ 1216.2
Requirements for infant walkers.
(a) Except as provided in paragraph
(b) of this section, each infant walker
shall comply with all applicable
provisions of ASTM F 977–07, Standard
Consumer Safety Specification for Infant
Walkers, approved April 1, 2007. The
Director of the Federal Register
approves this incorporation by reference
in accordance with 5 U.S.C. 552(a) and
1 CFR part 51. You may obtain a copy
from ASTM International, 100 Bar
Harbor Drive, P.O. Box 0700, West
Conshohocken, PA 19428; telephone
610–832–9585; https://www.astm.org.
You may inspect a copy at the Office of
the Secretary, U.S. Consumer Product
Safety Commission, Room 820, 4330
East West Highway, Bethesda, MD
20814, telephone 301–504–7923, or at
the National Archives and Records
Administration (NARA). For
information on the availability of this
material at NARA, call 202–741–6030,
or go to: https://www.archives.gov/
federal_register/code_of_federal_
regulations/ibr_locations.html.
(b) Comply with the ASTM F 977–07
standard with the following additions or
exclusions:
(1) Instead of Figure 1 of ASTM F
977–07, comply with the following:
BILLING CODE 6355–01–P
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BILLING CODE 6355–01–C
(2) Instead of complying with section
4.6 through 4.6.8 of ASTM F 977–07,
comply with the following:
(i) 4.6 The following guidelines shall
apply to force gauges used for testing:
(ii) 4.6.1 Equipment—Force gauge
with a range of 0 to 25 lbf (110 N),
tolerance of ± 0.25 lbf (1.1 N). A
calibration interval shall be maintained
for the force guage which will ensure
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that the accuracy does not drift beyond
the stated tolerance.
(iii) 4.6.2 Equipment—Force gauge
with a range 0 to 100 lbf (500 N)
tolerance of ± 1 lbf (4.44 N). A
calibration shall be maintained for the
force gauge which will ensure that the
accuracy does not drift beyond the
stated tolerance.
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(3) In addition to complying with
section 6.3 of ASTM F 977–07, comply
with the following:
(i) 6.4 Parking Device (applicable to
walkers equipped with parking
brakes)—The walker shall have a
maximum displacement of 1.97 inches
(50 mm) for each test in each direction
(forward, rearward, and sideward) when
tested in accordance with 7.7.
(ii) [Reserved]
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(i) 7.6.1.2 The dummy’s head shall
remain unrestrained for all the step
tests.
(ii) [Reserved]
7.6.3 ................................................
7.6.3.6 .............................................
7.6.4 ................................................
7.6.4.6 .............................................
7.6.5 ................................................
7.6.5.5 .............................................
Forward ..........................................
Forward ..........................................
Sideward .........................................
Sideward .........................................
Rearward ........................................
Rearward ........................................
(ii) [Reserved]
(6) Instead of complying with section
7.6.3.1 of ASTM F 977–07, comply with
the following:
Weight of CAMI dummy, lb.
17
28
17
28
17
28
(i) 7.6.3.1 Center the walker on the
test platform facing forward so that
Plane A is perpendicular to the front
edge of the platform and the walker is
dCAMI
(V
−
2
f
) (
2 g (W
Position the swivel wheels in such a way that
the walker moves forward in a straight line
parallel to Plane A.
(V
2
f
) (
2 g (W
mstockstill on DSKH9S0YB1PROD with RULES2
2
f
) (
2 g (W
− Vo2 ∗ WCAMI + Wwalker + Wdrop weight
drop weight
Jkt 220001
)
(ii) [Reserved]
(10) In addition to complying with
section 7.6.3.6 of ASTM F 977–07,
comply with the following:
(i) 7.6.3.7 Repeat tests in the
following sequence: Section 7.6.3.4,
section 7.6.3.5, and section 7.6.3.6 two
additional times.
(V
=
PO 00000
Frm 00011
Fmt 4701
− μk NCAMI
Sfmt 4725
)
Yes.
Yes.
Yes.
Yes.
No.
No.
means of a 7-strand military rope with 550
lb tensile strength (e.g., paracord 550) and a
stainless steel ball bearing pulley with an
outside diameter of 1.25 in (32mm) and
adjust the pulley so that the force is applied
horizontally (0 ± 0.5° with respect to the table
surface).
(ii) [Reserved]
(9) Instead of complying with section
7.6.3.6 of ASTM F 977–07, comply with the
following:
(i) 7.6.3.6 Repeat 7.6.3.1–7.6.3.5 using the
CAMI dummy with the weighted vest and
with distance d, computed using the
following equation:
of CAMI dummy + vest weight + walker
weight
g = acceleration of gravity = 32.2 ft/sec2
dCAMI
16:58 Jun 18, 2010
− μk NCAMI w/vest
4
4
2
2
4
4
)
− Vo2 ∗ WCAMI w/vest + Wwalker + Wdrop weight
drop weight
VerDate Mar<15>2010
)
(ii) [Reserved]
(7) Instead of complying with section
7.6.3.2 of ASTM F 977–07, comply with the
following:
(i) 7.6.3.2 Place a CAMI infant dummy
Mark II in the walker and position it as
shown in Fig. 11 with the torso contacting
the front of the occupant seating area and
arms placed on the walker tray.
(ii) [Reserved]
(8) Instead of complying with section
7.6.3.3 of ASTM F 977–07, comply with the
following:
(i) 7.6.3.3 While holding the walker
stationary, attach an 8 lb (3.6 kg) weight to
the front of the walker base at Plane A by
dCAMI w/vest −
Where
Vf = Maximum velocity of walker at edge of
platform = 4 ft/sec
Vo = Initial velocity = 0
WCAMI w/vest = Measured weight of CAMI
dummy and weighted vest
Wwalker = Weight of the walker
Wdrop weight = Drop weight = 8 lb
μk = Dynamic coefficient of friction = 0.05
NCAMI w/vest = Normal force (for CAMI dummy
fitted with 11 lb vest scenario) = weight
− μk NCAMI
Apply tipover
test
distance d from the center of the most
forward wheel(s) to the edge of the test
platform,
− Vo2 ∗ WCAMI + Wwalker + Wdrop weight
drop weight
Where
Vf = Maximum velocity of walker at edge of
platform = 4 ft/sec
Vo = Initial velocity = 0
WCAMI = Measured weight of CAMI dummy
Wwalker = Weight of the walker
Wdrop weight = Drop weight = 8 lb
μk = Dynamic coefficient of friction = 0.05
NCAMI = Normal force (for CAMI dummy
scenario) = weight of CAMI dummy and
walker
g = acceleration of gravity = 32.2 ft/sec2
....................................................
(vest) .........................................
....................................................
(vest) .........................................
....................................................
(vest) .........................................
Simulated
speed, ft/s
)
(ii) [Reserved]
(11) Instead of complying with 7.6.4.1
of ASTM F 977–07, comply with the
following:
(i) 7.6.4.1 Center the walker on the
test platform facing sideways so that
Plane B is perpendicular to the front
edge of the platform and the walker is
distance d from the center of the most
sideward wheel(s) to the edge of the test
platform,
)
E:\FR\FM\21JNR2.SGM
ER21JN10.005
Facing direction of walker
ER21JN10.004
Section No.
(5) Following section 7.6.2 of ASTM
F 977–07, use the following table
instead of Table 1 Summary of Step(s)
Tests:
(i) Table 1 Summary of Step(s) Tests
21JNR2
ER21JN10.003
(4) In addition to complying with
section 7.6.1.2 of ASTM F 977–07,
comply with the following:
Federal Register / Vol. 75, No. 118 / Monday, June 21, 2010 / Rules and Regulations
Where
Vf = Maximum velocity of walker at edge of
platform = 2 ft/sec
Vo = Initial velocity = 0
WCAMI = Measured weight of CAMI dummy
Wwalker = Weight of the walker
Wdrop weight = Drop weight = 8 lb
μk = Dynamic coefficient of friction = 0.05
NCAMI = Normal force (for CAMI dummy
scenario) = weight of CAMI dummy and
walker
g = acceleration of gravity = 32.2 ft/sec2
Position the swivel wheels in such a
way that the walker moves sideward in
a straight line parallel to Plane A.
(ii) [Reserved]
(12) Instead of complying with section
7.6.4.3 of ASTM F 977–07, comply with
the following:
(i) 7.6.4.3 While holding the walker
stationary, attach an 8 lb (3.6 kg) weight
to the side of the walker base at Plane
B by means of a rope (as specified in
7.6.3.3) and a pulley (as specified in
dCAMI w/vest =
(V
2
f
) (
2 g (W
− Vo2 ∗ WCAMI w/vest + Wwalker + Wdrop weight
drop weight
mstockstill on DSKH9S0YB1PROD with RULES2
Where
Vf = Maximum velocity of walker at edge of
platform = 2 ft/sec
Vo = Initial velocity = 0
WCAMI w/vest = Measured weight of CAMI
dummy and weighted vest
Wwalker = Weight of the walker
Wdrop weight = Drop weight = 8 lb
μk = Dynamic coefficient of friction = 0.05
VerDate Mar<15>2010
16:58 Jun 18, 2010
Jkt 220001
− μk NCAMI w/vest
)
NCAMI w/vest = Normal force (for CAMI dummy
fitted with 11 lb vest scenario) = weight
of CAMI dummy + vest weight + walker
weight
g = acceleration of gravity = 32.2 ft/sec2″
(ii) [Reserved]
(14) In addition to complying with
section 7.6.4.6 of ASTM F 977–07,
comply with the following:
PO 00000
7.6.3.3) and adjust the pulley so that the
force is applied horizontally (0 ± 0.5ß
with respect to the table surface).
(ii) [Reserved]
(13) Instead of complying with section
7.6.4.6 of ASTM F 977–07, comply with
the following:
(i) 7.6.4.6 Repeat 7.6.4.1 through
7.6.4.5 using the CAMI dummy with the
weighted vest (see Fig. 12) and with
distance d, computed using the
following equation:
Frm 00012
Fmt 4701
Sfmt 4700
)
(i) 7.6.4.7 Repeat tests in the
following sequence: section 7.6.4.4,
section 7.6.4.5, and section 7.6.4.6 two
additional times.
(ii) [Reserved]
(15) Instead of complying with Figure
10, use the following:
BILLING CODE 6355–01–P
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Federal Register / Vol. 75, No. 118 / Monday, June 21, 2010 / Rules and Regulations
(i) 7.6.5.1 Center the walker on the
test platform facing rearward so that
Plane A is perpendicular to the front
edge of the platform and the walker is
dCAMI =
(V
2
f
) (
2 g (W
− Vo2 ∗ WCAMI + Wwalker + Wdrop weight
drop weight
VerDate Mar<15>2010
16:58 Jun 18, 2010
Jkt 220001
PO 00000
Frm 00013
Fmt 4701
− μk NCAMI
Sfmt 4725
)
distance d from the center of the most
rearward wheel(s) to the edge of the test
platform,
ER21JN10.008
(16) Instead of complying with section
7.6.5.1 of ASTM F 977–07, comply with
the following:
)
E:\FR\FM\21JNR2.SGM
21JNR2
ER21JN10.007
mstockstill on DSKH9S0YB1PROD with RULES2
BILLING CODE 6355–01–C
35277
Federal Register / Vol. 75, No. 118 / Monday, June 21, 2010 / Rules and Regulations
Where
Vf = Maximum velocity of walker at edge of
platform = 4 ft/sec
Vo = Initial velocity = 0
WCAMI = Measured weight of CAMI dummy
Wwalker = Weight of the walker
Wdrop weight = Drop weight = 8 lb
μk = Dynamic coefficient of friction = 0.05
NCAMI = Normal force (for CAMI dummy
scenario) = weight of CAMI dummy and
walker
g = acceleration of gravity = 32.2 ft/sec2
Position the swivel wheels in such a
way that the walker moves rearward in
a straight line parallel to Plane A. If the
walker has an open back design, attach
the 1 in aluminum angle used in 7.3.4
to span the back frame.
(ii) [Reserved]
(17) Instead of complying with section
7.6.5.3 of ASTM F 977–07, comply with
the following:
(i) 7.6.5.3 While holding the walker
stationary, attach an 8 lb (3.6 kg) weight
to the rear of the walker base at Plane
A by means of a rope (as specified in
7.6.3.3) and a pulley (as specified in
dCAMI w/vest =
(V
2
f
) (
2 g (W
− Vo2 ∗ WCAMI w/vest + Wwalker + Wdrop weight
drop weight
mstockstill on DSKH9S0YB1PROD with RULES2
Where
Vf = Maximum velocity of walker at edge of
platform = 4 ft/sec
Vo = Initial velocity = 0
WCAMI w/vest = Measured weight of CAMI
dummy and weighted vest
Wwalker = Weight of the walker
Wdrop weight = Drop weight = 8 lb
μk = Dynamic coefficient of friction = 0.05
NCAMI w/vest = Normal force (for CAMI dummy
fitted with weighted vest scenario) =
Measured weight of CAMI dummy +
measured weight of vest + walker weight
g = acceleration of gravity = 32.2 ft/sec2″
(19) In addition to complying with
section 7.6.5.5 of ASTM F 977–07,
comply with the following:
(i) 7.6.5.6 Repeat tests in the
following sequence: section 7.6.5.3, and
section 7.6.5.5 two additional times.
(ii) [Reserved]
(20) In addition to complying with
section 7.6 of ASTM F 977–07, comply
with the following:
(i) 7.7 Parking Device Test (see 6.4):
(A) 7.7.1 Perform the parking device
test using a Test Mass that is A rigid
cylinder 6.30 in ± 0.04 in (160mm ± 1
mm) in diameter, 11.02 in ± 0.04 in (280
mm ± 1 mm) in height with a mass of
16.9 lb (7.65 kg), with its center of
gravity in the center of the cylinder.
(B) 7.7.2 Adjust the walker seat to
the highest position (if applicable).
Place the Test Mass vertically in the
walker seat. Set any manual speed
control to the fastest position (if
applicable). Establish a vertical plane A
that passes through the center of the
seating area and is parallel to the
direction the child faces. Establish a
vertical plane B that is perpendicular to
plane A and passes through the center
of the seating area.
(C) 7.7.3 Perform the parking device
test in the forward, sideward, and
rearward directions.
VerDate Mar<15>2010
16:58 Jun 18, 2010
Jkt 220001
− μk NCAMI w/vest
)
(D) 7.7.4 Forward facing test of
parking devices.
(E) 7.7.4.1 Position the walker
including the Test Mass facing forward
so that plane A is perpendicular to the
front edge of the platform (see fig. 10)
and passes through the center of the
pulley. Engage all parking devices in
accordance with the manufacturer’s
instructions.
(F) 7.7.4.2 Within one minute of
placing the walker with the Test Mass
on the platform, attach an 8 lb weight
gradually within 5 seconds to the
walker frame base at plane A by means
of a rope and a pulley per the test
apparatus specifications in the step test
procedure, adjusted so that the force is
applied horizontally (rope angle shall be
0 ± 0.5°). Remove the 8 lb weight after
1 minute. Measure the displacement.
(G) 7.7.5 Sideward facing test of
parking devices.
(H) 7.7.5.1 Position the walker
including the Test Mass facing sideward
so that plane B is perpendicular to the
front edge of the platform and passes
through the center of the pulley. Engage
all parking devices in accordance with
the manufacturer’s instructions.
(I) 7.7.5.2 Within one minute of
placing the walker with the Test Mass
on the platform, attach an 8 lb weight
gradually within 5 seconds to the
walker frame base at plane B by means
of a rope and a pulley per the test
apparatus specifications in the step test
procedure, adjusted so that the force is
applied horizontally (rope angle shall be
0 ± 0.5°). Remove the 8 lb weight after
1 minute. Measure the displacement.
(J) 7.7.5.3 If the walker is equipped
with fixed direction rear wheels and the
walker is displaced in a curved path,
establish the location of the rope
PO 00000
7.6.3.3) and adjust the pulley so that the
force is applied horizontally (0 ± 0.5°
with respect to the table surface).
(ii) [Reserved]
(18) Instead of complying with section
7.6.5.5 of ASTM F 977–07, comply with
the following:
(i) 7.6.5.5 Repeat 7.6.5.1 through
7.6.5.4 using the CAMI dummy with the
weighted vest (see Fig. 12) and with
distance d, computed using the
following equation:
Frm 00014
Fmt 4701
Sfmt 4700
)
attachment as the reference point and
measure the linear displacement of that
reference point after performing the
procedure as described in 7.7.5.1 and
7.7.5.2.
(K) 7.7.6 Rearward facing test of
parking devices.
(L) 7.7.6.1 Position the walker
including the Test Mass facing rearward
so that plane A is perpendicular to the
front edge of the platform and passes
through the center of the pulley. Engage
all parking devices in accordance with
the manufacturers’ instructions.
(M) 7.7.6.2 Within one minute of
placing the walker with the Test Mass
on the platform, attach an 8 lb weight
gradually within 5 seconds to the
walker frame base at plane A by means
of a rope and a pulley per the test
apparatus specifications in the step test
procedure, adjusted so that the force is
applied horizontally (rope angle shall be
0 ± 0.5°). Remove the 8 lb weight after
1 minute. Measure the displacement.
(ii) [Reserved]
(21) In addition to complying with
section 8.2.3.2 of ASTM F 977–07,
comply with the following:
(i) 8.2.3.3 A warning statement shall
address the following:
WARNING: Parking brake use does not
totally prevent walker movement.
Always keep child in view when in the
walker, even when using the parking
brakes.
(ii) [Reserved]
(22) Instead of complying with section
8.2.4.2 of ASTM F 977–07, comply with
the following:
(i) 8.2.4.2 The stairs warning shall
be stated exactly as follows:
E:\FR\FM\21JNR2.SGM
21JNR2
ER21JN10.009
35278
(ii) [Reserved]
Dated: June 9, 2010.
Todd Stevenson,
Secretary, U.S. Consumer Product Safety
Commission.
[FR Doc. 2010–14323 Filed 6–18–10; 8:45 am]
BILLING CODE 6355–01–P
CONSUMER PRODUCT SAFETY
COMMISSION
16 CFR Part 1500
RIN 3041–AC77
Revocation of Regulations Banning
Certain Baby-Walkers
AGENCY: Consumer Product Safety
Commission.
ACTION: Final rule.
mstockstill on DSKH9S0YB1PROD with RULES2
SUMMARY: In this document, the
Consumer Product Safety Commission
(‘‘CPSC’’ or ‘‘Commission’’) is revoking
its existing regulations pertaining to
baby-walkers because those regulations
are being replaced by a new and more
comprehensive safety standard
applicable to baby-walkers. The new
standard is being added by the
Commission in a separate document
published elsewhere in this issue of the
Federal Register.
DATES: Effective December 21, 2010.
FOR FURTHER INFORMATION CONTACT:
Carolyn Manley, Division of Regulatory
Enforcement, Office of Compliance,
Consumer Product Safety Commission,
4330 East West Highway, Bethesda, MD
20814, 301–504–7607,
cmanley@cpsc.gov.
SUPPLEMENTARY INFORMATION:
A. Background
1. The CPSC’s regulation for babywalkers. CPSC regulations at 16 CFR
1500.18(a)(6) and 1500.86(a)(4) ban any
‘‘baby-bouncer,’’ ‘‘walker-jumper,’’ ‘‘babywalker,’’ and ‘‘any other similar article’’
that does not meet specified safety
criteria. These regulations were issued
in 1971 by the Food and Drug
Administration (‘‘FDA’’) under the
Federal Hazardous Substances Act
(‘‘FHSA’’), 15 U.S.C. 1261–1278
(available at https://www.cpsc.gov/
businfo/fhsa.pdf). 36 FR 21809 (Nov. 16,
1971). On May 14, 1973, the functions
under the FHSA were transferred to the
then newly-created CPSC.
VerDate Mar<15>2010
16:58 Jun 18, 2010
Jkt 220001
Specifically, 16 CFR 1500.18(a)(6)
bans baby-walkers, baby-bouncers,
walker-jumpers and ‘‘any other similar
article’’ that is intended to support very
young children while ‘‘sitting walking,
bouncing, jumping, and/or reclining,’’
and which, because of its design, has
any exposed parts capable of causing
amputation, crushing, lacerations,
fractures, hematomas, bruises, or other
injuries to fingers, toes, or other parts of
the anatomy of young children. The
regulation describes the hazardous
design features of such articles
warranting the ban as including, but not
being limited to, one or more of the
following:
• Areas about the point on each side
of the article where the frame
components are joined together to form
an X-shape capable of producing a
scissoring, shearing, or pinching effect;
• Other areas where two or more
parts are joined in such a manner as to
permit rotational movement capable of
exerting a scissoring, shearing, or
pinching effect;
• Exposed coil springs which may
expand sufficiently to allow an infant’s
finger, toe, or other body part to be
inserted, in whole or in part, and
injured by being caught between the
coils of the spring or between the spring
and another part of the article;
• Holes in plates or tubes which also
provide the possibility of insertion of a
finger, toe, or other part of the anatomy
that could then be injured by the
movement of another part of the article;
or
• A design and construction that
permits accidental collapse while in
use.
Exemptions to the ban are at 16 CFR
1500.86(a)(4). These include any babywalker (or the other subject products)
where:
• The frames are designed and
constructed in a manner to prevent
injury from any scissoring, shearing, or
pinching when the members of the
frame or other components rotate about
a common axis or fastening point or
otherwise move relative to one another;
and
• Any coil springs which expand
when the article is subjected to a force
that will extend the spring to its
maximum distance so that a space
between successive coils is greater than
one-eighth inch (0.125 inch) are covered
PO 00000
Frm 00015
Fmt 4701
Sfmt 4700
35279
or otherwise designed to prevent
injuries; and
• All holes larger than one-eighth
inch (0.125 inch) in diameter, and slots,
cracks, or hinged components in any
portion of the article through which a
child could insert, in whole or in part,
a finger, toe, or any other part of the
anatomy, are guarded or otherwise
designed to prevent injuries; and
• The articles are designed and
constructed to prevent accidental
collapse while in use; and
• The articles are designed and
constructed in a manner that eliminates
from any portion of the article the
possibility of presenting a mechanical
hazard through pinching, bruising,
lacerating, crushing, breaking,
amputating, or otherwise injuring
portions of the human body when in
normal use or when subjected to
reasonably foreseeable damage or abuse;
and
• Any article which is introduced
into interstate commerce after the
effective date of [the regulation] is
labeled:
—With a conspicuous statement of
the name and address of the
manufacturer, packer, distributor, or
seller; and
—With a code mark on the article
itself and on the package containing the
article or on the shipping container, in
addition to the invoice(s) or shipping
document(s), which code mark will
permit future identification by the
manufacturer of any given model (the
manufacturer shall change the model
number whenever the article undergoes
a significant structural or design
modification);
and
• The manufacturer or importer of the
article shall make, keep, and maintain
for 3 years records of sale, distribution,
and results of inspections and tests
conducted in accordance with this
subparagraph and shall make such
records available at all reasonable hours
upon request by any officer or employee
of the Consumer Product Safety
Commission and shall permit such
officer or employee to inspect and copy
such records, to make such stock
inventories as such person deems
necessary, and to otherwise check the
correctness of such records.
The existing regulations do not
include any requirements specifically
E:\FR\FM\21JNR2.SGM
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Federal Register / Vol. 75, No. 118 / Monday, June 21, 2010 / Rules and Regulations
Agencies
[Federal Register Volume 75, Number 118 (Monday, June 21, 2010)]
[Rules and Regulations]
[Pages 35266-35279]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-14323]
[[Page 35265]]
-----------------------------------------------------------------------
Part III
Consumer Product Safety Commission
-----------------------------------------------------------------------
16 CFR Parts 1216 and 1500
Safety Standard for Infant Walkers; Revocation of Regulations Banning
Certain Baby-Walkers; Third Party Testing for Certain Children's
Products; Infant Walkers: Requirements for Accreditation of Third Party
Conformity Assessment Bodies and Agency Information Collection
Activities; Proposed Collection; Comment Request; Final Rules and
Notice
Federal Register / Vol. 75, No. 118 / Monday, June 21, 2010 / Rules
and Regulations
[[Page 35266]]
-----------------------------------------------------------------------
CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1216
[CPSC Docket No. CPSC-2009-0066]
Safety Standard for Infant Walkers: Final Rule
AGENCY: Consumer Product Safety Commission.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: Section 104(b) of the Consumer Product Safety Improvement Act
of 2008 (``CPSIA'') requires the United States Consumer Product Safety
Commission (``CPSC'' or ``Commission'') to promulgate consumer product
safety standards for durable infant or toddler products. These
standards are to be ``substantially the same as'' applicable voluntary
standards or more stringent than the voluntary standard if the
Commission concludes that more stringent requirements would further
reduce the risk of injury associated with the product. The Commission
is issuing a safety standard for infant walkers in response to the
direction under section 104(b) of the CPSIA.\1\
---------------------------------------------------------------------------
\1\ The Commission voted 5-0 to approve publication of this
rule. Commissioner Thomas Moore filed a statement concerning this
action which may be viewed on the Commission's Web site at https://www.cpsc.gov/pr/statements.html or obtained from the Commission's
Office of the Secretary.
DATES: The rule will become effective on December 21, 2010 and apply to
products manufactured or imported on or after that date. The
incorporation by reference of the publication listed in this rule is
approved by the Director of the Federal Register as of December 21,
---------------------------------------------------------------------------
2010.
FOR FURTHER INFORMATION CONTACT: Carolyn Manley, Office of Compliance
and Field Operations, Directorate for Engineering Sciences, Consumer
Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814;
telephone (301) 504-7607; cmanley@cpsc.gov.
SUPPLEMENTARY INFORMATION:
A. Background and Statutory Authority
The Consumer Product Safety Improvement Act of 2008 (``CPSIA'',
Pub. L. 110-314) was enacted on August 14, 2008. Section 104(b) of the
CPSIA requires the Commission to promulgate consumer product safety
standards for durable infant or toddler products. These standards are
to be ``substantially the same as'' applicable voluntary standards or
more stringent than the voluntary standard if the Commission concludes
that more stringent requirements would further reduce the risk of
injury associated with the product. Section 104(b)(2) of the CPSIA
directs the Commission to begin rulemaking for two standards by August
14, 2009. Under this provision, the Commission published a proposed
standard for infant walkers in the Federal Register on September 3,
2009. 74 FR 45704. The standard is substantially the same as a
voluntary standard developed by ASTM International (formerly known as
the American Society for Testing and Materials), ASTM F 977-07,
Standard Consumer Safety Specification for Infant Walkers, but with
several modifications that strengthen the standard in order to reduce
the risk of injury associated with walkers.
There are existing mandatory regulations applicable to baby
bouncers, walker-jumpers, and baby walkers, which were originally
issued in 1971 by the Food and Drug Administration. 16 CFR
1500.18(a)(6) and 16 CFR 1500.86(a)(4). These regulations do not
address hazards associated with falls down stairs, structural
integrity, occupant retention, or loading/stability issues. The ASTM F
977-07 standard contains provisions that the mandatory regulations lack
or requirements that are more stringent than the mandatory standard. On
September 3, 2009, the Commission proposed to revoke the existing CPSC
regulations for baby bouncers, baby jumpers and walkers. As explained
elsewhere in this issue of the Federal Register, the Commission has
determined to revoke the existing regulations only with regard to
walkers. They will remain in effect for baby bouncers and baby jumpers.
B. The Product
Infant walkers are used to support very young children before they
are walking (usually 6 to 15 months old). ASTM F 977-07 defines
``walker'' as ``a mobile unit that enables a child to move on a
horizontal surface when propelled by the child sitting or standing
within the walker, and that is in the manufacturer's recommended use
position.'' Children may use walkers to sit, recline, bounce, jump, and
use their feet to move around. Walkers typically consist of fabric
seats attached to rigid trays. The trays are fastened to bases that
have wheels or casters to make them mobile.
Currently, there are at least seven manufacturers or importers
supplying walkers to the United States market (four domestic
manufacturers, two foreign manufacturers with divisions in the United
States, and one domestic importer).
All known suppliers of infant walkers are members of the Juvenile
Products Manufacturers Association (``JPMA''), the major United States
trade association that represents juvenile product manufacturers and
importers. Each supplies a variety of children's products, of which
walkers are only a small proportion. Infant walkers are available in
many countries besides the United States, including China, the United
Kingdom, and Australia. Therefore, any foreign manufacturer is a
potential supplier to the United States market, either directly or
indirectly through an importer.
Infant walkers made by all of the domestic manufacturers supplying
walkers to the United States market are JPMA certified as compliant
with the ASTM voluntary standard. Based on limited CPSC staff testing,
CPSC staff does not believe that the two foreign manufacturers and the
domestic importer are making walkers that are compliant with the
voluntary standard.
Sales of infant walkers peaked in the early 1990s at less than 2
million annually. By 2005, however, annual walker sales had fallen to
around 600,000. Following a similar pattern, walkers in use (the number
of walkers estimated to still be in use, regardless of when sold)
peaked in the mid-1990s, but have since fallen sharply as well (by 55
percent between 1996 and 2005). As of 2005, the estimated number of
walkers in use was probably less than 2 million.
C. Incident Data
The preamble to the proposed rule summarized incident data
involving walkers. There has been no change in the fatality reports or
injury estimates related to walkers since publication of the proposed
rule. That information is repeated below.
1. Injury Estimates
There were an estimated total of 14,900 (an annual average of
3,000) injuries related to infant walkers among children under the age
of 15 months that were treated in hospital emergency departments in the
United States over the five-year period 2004-2008.\2\ (This estimate
has been adjusted to exclude jumpers from the walker code.) No deaths
were reported through NEISS.
[[Page 35267]]
There was no statistically significant increase or decrease observed in
the estimated injuries from one year to the next, nor was there any
statistically significant trend observed over the 2004-2008 period. For
injuries requiring emergency department treatment that were related to
infant walkers, the following characteristics occurred most frequently
based on an annual average:
---------------------------------------------------------------------------
\2\ The source of injury estimates is the National Electronic
Injury Surveillance System (``NEISS''), a statistically valid injury
surveillance system based on data gathered from emergency
departments of hospitals selected as a probability sample of all the
United States hospitals with emergency departments.
---------------------------------------------------------------------------
Hazard--falls either out of the walker or down stairs/to a
lower level while in the walker (62%).
Injured body part--head (45%) and face (27%).
Injury type--contusions/abrasions (37%) and internal organ
injury (28%).
Disposition--treated and released (90%) and hospitalized
(5%).
For approximately 72 percent of the injuries reported, the walker
was directly involved in the incident (such as the walker falling down
stairs, tipping over, collapsing). However, many (nearly 20 percent) of
the injuries treated in emergency departments were not necessarily
caused by failures of the walkers.
As discussed in the preamble to the proposed rule (74 FR at 45705),
the stair fall protection provisions in the ASTM standard dramatically
affected incidents related to walkers (an 88% decrease in estimated
incidents related to walkers treated in emergency rooms from 1994 to
2008). However, the stair fall hazard remains the most prevalent hazard
in incidents related to walkers with some of these incidents involving
walkers that do not comply with the voluntary standard, damaged or worn
walkers, or children who are strong enough to lift the walker and
defeat the stair fall protection.
2. Fatalities
CPSC staff has reports of eight fatal incidents involving an infant
in a walker during the five year period 2004 to 2008.\3\ One of these
appears to involve a stair fall incident. The walker involved did not
conform to the ASTM walker standard's stair fall performance
requirements and had been under recall at the time of the death (due to
the lack of stair fall protection). There were three deaths that
resulted from accidental drowning when the child moved in a walker into
a residential pool or spa. Two of these three deaths involved walkers
that were certified to the JPMA standard, though pictures showed that
one of the walkers was missing a wheel. The physical condition of the
other walker is unknown. The circumstances of the remaining four deaths
varied and involved circumstances unrelated to falls (i.e., a slow
cooker overturned on an infant in a walker who pulled the cord of the
cooker, an infant pulled a heavy dining chair on himself, an infant
rolled down a driveway and struck a moving vehicle, and an infant
aspirated a screw while seated in a walker).
---------------------------------------------------------------------------
\3\ The reported fatalities and non-fatalities are neither a
complete count of all incidents that occurred during the period nor
a sample of known probability of selection.
---------------------------------------------------------------------------
3. Non-Fatal Injuries
A total of 78 non-fatal injuries were reported to have occurred
between 2004 and 2008. All of these injuries occurred when the infant
was seated in a walker. The leading cause of injury (about 42% of the
injuries) was falls down the stairs or to a lower level. The next major
cause of injury was product failure, either structural or mechanical
failure of the walker, and these accounted for another 37% of the
incidents. The attached toys, toy bars, or toy trays on the walker
caused another 17% of the injuries, such as lacerations, abrasions,
pinching, etc. Three percent of the non-fatal reported injuries were
serious burn injuries resulting from infants pulling cords of small
cooking appliances and spilling hot liquids onto themselves. Finally,
one percent of the reported incidents did not specify the injury.
D. Voluntary Standards
1. ASTM Voluntary Standard
ASTM F 977, Standard Consumer Safety Specification for Infant
Walkers, was first published in 1986 and was revised in 1997 to address
the stair fall hazard. The Commission's proposed rule, published
September 3, 2009, was based on the 2007 version of the ASTM standard,
ASTM F 977-07. In December 2009, ASTM published a revision to the
infant walker standard, F 977-09. This revision included some of the
changes in the Commission's proposed rule, but not the majority of
them. The 2009 revision of the ASTM standard also included a
significant change to the rearward facing stair fall test procedure for
open back frame walker models. This test procedure was different from
the test procedure the Commission proposed for these types of walkers.
The proposed rule would require using a 1-inch aluminum angle firmly
attached to the walker frame. The ASTM '09 version uses loops of cord
and a lightweight floating bar. Because this method of attachment may
not remain taut throughout the stair fall test, this procedure in the
ASTM '09 version is not as stringent as the test method the Commission
proposed for these types of walkers. For this reason, the final rule
incorporates by reference ASTM F 977-07 rather than the 2009 revision.
JPMA provides certification programs for juvenile products,
including infant walkers. Manufacturers submit their products to an
independent testing laboratory to test the product for conformance to
the ASTM standard. Currently, infant walkers from five manufacturers
are JPMA certified as being in compliance with the ASTM standard.
The ASTM standard includes performance requirements specific to
infant walkers, general performance requirements, and labeling
requirements. The key provisions of the ASTM infant walker standard
include the following:
Prevention of falls down stairs--intended to ensure that a
walker will not fall down stairs when facing front, back, and sideways.
Tipping resistance--intended to ensure that walkers are
stable and do not tip over when on a flat surface; includes tests for
forward and rear tip resistance, as well as for the occupant leaning
over the front.
Dynamic and static load testing on seating area--intended
to ensure that the child remains fully supported while stationary and
while bouncing/jumping.
Occupant retention--intended to prevent entrapment by
setting requirements for leg openings.
The ASTM standard also includes: (1) Torque and tension tests to
assure that components cannot be removed; (2) requirements for several
walker features to prevent entrapment and cuts (minimum and maximum
opening size, accessible coil springs, leg openings, and edges that can
scissor, shear, or pinch); (3) latching/locking mechanism requirements
to assure that walkers do not accidentally fold while in use; (4)
requirements for the permanency and adhesion of labels; and (5)
requirements for instructional literature.
The stair fall protection requirement, also called the step test,
is the key provision in the ASTM standard. For this test, a walker with
a Civil Aeromedical Institute infant dummy (Mark II) (subsequently
referred to as ``CAMI dummy'') is placed in the walker's seat which is
propelled with a horizontal dynamic force by means of a pulley, rope,
and a falling 8-pound weight on a hardwood floor surface. The walker
passes the test if it stays on the test table which has a hardwood
floor surface. It fails the test if the walker completely falls off the
table surface.
The step test in the ASTM F 977-07 standard is based on the
assumption that an average walker weighs 8 pounds. However, when CPSC
staff weighed five
[[Page 35268]]
2008 to 2009 model walkers, the weight values ranged from 11 to 14
pounds. Computing the launching distance ``d'' as described in section
7.6 of ASTM F 977-07 depends on the weight of the walker, the weight of
the CAMI dummy, the weight of the CAMI vest, the coefficient of
friction between the walker wheels and the test table surface, and the
maximum velocity at the edge of the test table platform (4 ft/sec or 2
ft/sec). According to section 7.6 of ASTM F 977-07, the d value for the
forward and rearward directions with only the CAMI dummy seated in the
walker is 14.6 inches. The d value for the forward and rearward
directions with the CAMI dummy fitted with the 11-pound vest seated in
the walker is 21.2 inches. The values of 14.6 inches and 21.2 inches
were based on the assumption that the walker weight is 8 pounds. As in
the proposed rule, the final rule requires calculation of the launching
distance using the actual weight of the walker.
In the ASTM F 977-07 standard, most of the hardware and test
apparatus components are not specified. Variability in the type and
size of the pulley, rope type, test table flexure etc. can lead to
different test results. Two different labs could test the same model
walker and obtain different results. As in the proposed rule, the final
rule adds specificity to these requirements.
2. European Standard EN 1273:2005
CPSC staff evaluated EN 1273:2005 European Standard and its two
performance tests that are not in the ASTM F 977-07: the 30[deg]
incline plane stability test and the parking device test.
The Commission proposed adding the 30[deg] incline plane test,
which is a standard stability test common in several EN children's
product safety standards, to the walker mandatory standard. In this
test, the walker, occupied by a 26.4 lb (12 kg) test mass is placed on
a sloping platform inclined at 30[deg] to the horizontal with a stop on
the lower edge of the slope. The walker must not tip over. As explained
in part F.2 of the preamble, the Commission is not including this test
in the final rule.
The parking device test is only applicable to walkers that are
equipped with a parking brake. It essentially requires conducting a
semi-static version of the stair fall test, but with the parking device
engaged. The walker must not move more than 1.97 inches (50 mm) in
order to pass. The Commission proposed adding this test, and the final
rule retains this addition.
E. Response to Comments on the Proposed Rule
CPSC received seven comments regarding the proposed rule for infant
walkers, including five from individuals, one from JPMA, and one from
various consumer groups, including Consumers Union, Consumer Federation
of America, and Kids in Danger. These comments and the Commission's
responses are discussed below.
1. Parking Brake Requirement and Warning
a. Comment: One commenter remarked that the parking brake
requirement should be more stringent because parking brakes should keep
the walker completely stationary and also commented that the proposed
warning in the proposed rule is contradictory to the perception of a
parking brake's function. Another commenter recommended requiring
parking brakes for all infant walkers.
Response: CPSC believes that the purpose of the parking brake
warning is to alert the caregiver that the parking brake is used for
temporarily preventing the walker from moving. In several ASTM
meetings, some infant walker manufacturers have characterized the
purpose of the parking brakes as such, and that the child in the walker
must always be kept in view. The parking brake feature is added on some
models for convenience to the caregiver. The parking brake is not meant
to keep a child in the walker indefinitely without supervision. Also,
the warning is meant to prevent any false sense of security by the
caregiver. CPSC believes the proposed warning and the performance
requirements as they appeared in the proposed rule are adequate.
b. Comment: One commenter supported the concept for having a
performance test for walkers with parking brakes, but disagreed with
the proposal to adopt the EN 1273:2005 European Standard's test for
parking brakes. The performance test is similar to that of the stair
fall test, except that the 8-pound weight guided by a rope and pulley
is released gradually and there is no set launching distance. Upon
completion of the gradual 8-pound force application, the maximum
allowable displacement (i.e., movement) of the walker is 1.97 inches.
The commenter argued that a lack of incidents involving parking devices
supports its argument. In addition, the commenter compared the proposed
parking device test to the ASTM F 2012, Standard for Stationary
Activity Centers. The commenter asserted that a stationary activity
center is similar to that of an infant walker with its parking brakes
engaged. Based on this comparison to stationary activity centers, the
commenter advocated increasing the maximum allowable displacement to 6
inches in accordance with ASTM F 2012.
Response: CPSC believes that if a product is equipped with a
feature, such as a parking brake, that feature should function properly
and safely. Although CPSC is not aware of any incidents involving
parking devices in the United States, the Commission believes that
requiring the parking brake test is appropriate for the following
reasons.
There are important distinctions between walkers and stationary
activity centers. An infant in a walker tends to exert a horizontal
force to propel himself or herself horizontally, whereas a child in a
stationary activity center may not necessarily exert the same type of
horizontally concentrated forces because the infant may be preoccupied
jumping up and down, spinning about the seat, and playing with toys.
The parking brake performance test should set limits on the
displacement of the walker in the horizontal direction to resist motion
when the parking brakes are engaged. The appropriate amount of force
should be applied. Furthermore, upon comparison between ASTM F 2012 and
EN 1273:2005, CPSC staff noted the following observations:
A force gauge is used to apply the 8-pound force in ASTM F
2012 instead of a rope and pulley guided 8-pound weight as specified in
EN 1273:2005. In the EN 1273:2005 test, the 8-pound weight is released
gradually over a 5 second period and then hung from the test assembly
for 1 minute. Arguably, the force of gravity is more consistent than a
test technician applying a consistent rate of 8 pounds over a 10 second
period (as in the ASTM F 2012 test). The longer duration of 1 minute is
more stringent than 10 seconds.
The location application of the 8-pound force in ASTM F
2012 has infinite variability as it is any location 2 inches above the
floor level. The EN 1273:2005 standard requires the rope to be secured
onto the bottom frame member of the infant walker which is arguably
more consistent.
In the ``Rationale'' section of ASTM F 2012, there is no
mention of how the maximum allowable limit for displacement of 6 inches
per minute was obtained.
EN 1273:2005's maximum allowable 1.97-inch displacement is more
stringent than ASTM F 2012's 6 inches. Moreover, CPSC's adoption of
this performance test would harmonize with
[[Page 35269]]
the European EN 1273:2005 Standard for this requirement.
The Commission notes that this performance test is required only
for infant walker models equipped with parking devices. Manufacturers
can choose to exclude parking devices from their product.
The final rule retains the EN 1273:2005 performance test and
maximum allowable displacement for 1.97 inches (CPSC staff assumes the
commenter referred to 2 inches in its discussions for convenience) for
parking devices as it was proposed in the proposed rule, except for an
editorial change (discussed in the next response) to address some
walkers that have fixed direction rear wheels.
c. Comment: The same commenter observed that the parking brake
test, as written in the proposed rule, may present problems for
measuring the displacement for walkers that have fixed direction wheels
in the rear of the walker. With these types of wheels, the walker has a
natural tendency to travel in a curved path instead of in a straight
path. A walker with four casters does not have this issue.
Response: To address this subset of walkers, the final rule adds
the following new paragraph to the language the Commission previously
proposed for the sideward facing test of parking devices:
If the walker is equipped with fixed direction rear wheels and
the walker is displaced in a curved path, establish the location of
the rope attachment as the reference point and measure the linear
displacement of that reference point after performing the procedure
as described in paragraph (c)(3)(iii)(A) and (B).
2. The 30[deg] Incline Plane Test
Comment: One commenter favored maintaining the cantilevered
stability test as described in Section 7.3.4 of the ASTM F 977-07
Standard for infant walkers, and advocated eliminating the additional
CPSC proposed 30[deg] incline plane stability test to address tip over
hazards.
Response: From the time CPSC staff recommended the 30[deg] incline
plane test (based on EN 1273:2005), numerous discussions about the
added benefits of the 30[deg] incline plane stability test have
occurred among CPSC staff and ASTM. Over the past year, these
discussions have taken place at ASTM headquarters, as well as in
conference calls. A JPMA member was tasked to perform analyses on the
two test methods to determine if the 30[deg] incline plane test is
needed. During ASTM's presentation at the October 13, 2009 meeting, the
JPMA member demonstrated using real examples that Section 7.3.4
stability test of the ASTM F 977-07 Standard is adequate and that the
30[deg] incline plane test is not needed. The analyses included a
comparison of the two stability test methods using the dimensions of an
exemplar walker and concluded that the 30[deg] incline plane test was
not as severe as the Section 7.3.4 stability test. CPSC staff concurred
with this presentation and the comparison of stability test methods.
Therefore, the final rule does not include the 30[deg] incline plane
test that was in the proposed rule.
3. Adding Calculation To Determine Launching Distance To Step Test
Procedures
Comment: One commenter objected to the proposed rule's proposal to
change the fixed distances in the step test to a computed value for d
which will vary due to the weight of the test sample walkers. The
commenter asserted that increasing the launching distance for heavier
walkers is not necessary or is ``self correcting'' because a child
seated in the heavier walker will naturally not move as fast. The
commenter requested keeping the launching distances as they are in
Table 1 of Section 7.6 of the ASTM F 977-07 Standard. The commenter
also commented that no incident data indicates a need to change
velocities in the step test.
Response: As discussed in the preamble to the proposed rule (74 FR
at 45706), the Commission believes that the step test requirements
should be modified to account for heavier modern walkers. The 8-pound
walker used to develop the ASTM step requirement for the original 1997
standard is now outdated because the average modern walker is heavier
than 8 pounds.
The critical parameter of the step test is the velocity of a walker
with a child in it. CPSC staff believes that it would be more robust to
assume that the child maintains a 4 feet/second top speed, regardless
of the walker's weight. CPSC staff showed that children can achieve 4
feet/second in an 8-pound walker (1996 ASTM Working Group) and in a
10.5-pound walker (2000 Austrian study \4\). (Both of these studies
were based on small sample sizes of 7 and 5 children, respectively.)
Stair fall incidents continue to occur, and some involve modern walkers
that meet the ASTM requirements. Since the child/walker speed is the
critical factor in determining stopping distance of a moving walker at
the edge of the step, CPSC staff believes that a 4 feet/second velocity
should be maintained regardless of the walker's weight. This
necessitates using the walker's actual weight in the calculation for
the stair fall test.
---------------------------------------------------------------------------
\4\ ``Baby Walking Frames--Final Report,'' Consumer Council
Austrian Standards Institute in co-operation with Association for
Consumer Information, European Committee For Standardization, CEN/TC
252/WG 1 N. 255 February 2001.
---------------------------------------------------------------------------
With regard to incident data supporting the change, a special study
conducted by CPSC indicates that several reported incidents involved
walkers that were manufactured to comply with the ASTM stair step
requirement and were reported to have been in good condition at the
time of the incident. In addition, a review of a list compiled by CPSC
staff of over 200 incidents (reported through sources other than NEISS)
involving infant walkers from 1999 to 2008 indicates that over 40
percent of those incidents involved stair falls, including one death
which occurred due to a fractured skull.
CPSC staff's review of the data has also shown that popular larger,
heavier models (greater than 8 pounds) manufactured after 1998 were
involved in stair falls. For example, in incident 081112HEP9038, a 10-
month old male fell down a set of steps when he traveled past an
unlatched gate; the child required a trip to the emergency room. In
incident 081113HEP9029, an 11-month old male fell down a set of stairs
and was found upside down still in the walker. Both incidents involved
walkers made by a leading manufacturer. Both incidents occurred from
2007 to 2008, and both walkers were equipped with friction strips.
Therefore, the data show that modern walkers continue to be involved in
stair fall incidents. If a walker is traveling too fast, even if it is
equipped with friction strips, it may fall down a set of steps. By
increasing this launching distance, the Commission is making the
standard stricter, which should result in walkers that are made to be
safer when traveling at faster speeds.
4. Impact of Change to Step Test
Comment: The same commenter stated that using a calculation in the
step test would be a substantial change and would affect the outcome of
the test results for walkers that pass the requirement.
Response: Based on limited testing by CPSC staff, the Commission
believes that some manufacturers will not need to make changes to their
product. CPSC staff agrees that some manufacturers will have to modify
their product. However, these changes are feasible. Possible
modifications could include increasing the rolling friction within the
walker's wheels, reducing the walker
[[Page 35270]]
weight, or refining the friction strip design.
5. CAMI Dummy Head Position
Comment: One commenter requested CPSC to consider specifying how
the CAMI dummy is to ``be positioned and restrained during testing so
that the center of gravity will be consistent from lab to lab.''
Response: CPSC agrees in principle that it is plausible that a CAMI
dummy's flexibility properties may change over time and use. Last year,
round robin testing was done by CPSC staff, several manufacturers, and
a testing laboratory. In addition to pass/fail testing, quantitative
measurements were made, measuring the displacement of the walker
relative to the edge of the test table. Testing done by CPSC staff did
not show any substantial variability in the CPSC test results when the
CAMI dummy's head was not secured. However, many other parameters, such
as rope type, pulley type, and the spring rate for the pulley mounting
bracket, were standardized. Furthermore, the CPSC standard provides
additional specificity concerning the CAMI positioning: arms positioned
on top of the toy tray, use of the standardized military rope to secure
the legs, etc. Securing the CAMI head in a most rearward or forward
position could possibly produce different results, depending on the
flexibility of the dummy. Thus, CPSC staff believes that the CAMI head
should not be secured. When the CAMI is positioned as described in the
proposed (and final) procedure, the CAMI head movement, while it
exists, is minimized to the extent possible. Thus, the final rule, like
the proposed rule, provides for the CAMI head to remain unrestrained
during all the step tests.
6. Friction Pad Wear and Tear
Comment: The same commenter asked the CPSC to consider the affect
of wear and tear as well as dirt and dust on the walker's compliance
with the step test.
Response The final rule does not include any additional
performance requirements involving step tests with worn friction
strips. Although CPSC recognizes that friction pad wear may reduce the
pad's effectiveness, this may not be the case for all walker friction
pads. Some pads may last longer than others. Assessing the amount of
wear and standardizing the wear characteristics may be somewhat
subjective. Given the variation between friction pad vendors and the
changing compositions of the rubber used in the friction pads, it may
be difficult to standardize this aspect of the test. The final standard
includes other changes that address the stair fall hazard, such as
increasing the input kinetic energy for heavier walkers (i.e., walkers
heavier than 8 pounds would need to be launched from a longer distance
to achieve the target terminal velocities). In an indirect way, setting
the higher input kinetic energy requirement for heavier walkers creates
revised design criteria for walker manufacturers. One area where those
manufacturers can address the resistance to stair falls may lie in
revisions to the friction pad design. CPSC staff believes standardizing
the target velocity will have an important impact on the actual test,
as the kinetic energy of the walker and CAMI dummy is proportional to
the square of the velocity. Furthermore, each walker will be subjected
to 18 impacts which will sufficiently subject the sample walkers to
abuse (3 directions x 2 configurations with and without vest x 3
replicates). For these reasons, CPSC staff believes there is
insufficient data and rationale to add performance requirements
involving stair fall tests with worn friction strips.
F. Assessment of Voluntary Standard ASTM F 977-07 and Description of
Final Rule
1. Section 104(b) of the CPSIA: Consultation and CPSC Staff Review
Section 104(b) of the CPSIA requires the Commission to assess the
effectiveness of the voluntary standard in consultation with
representatives of consumer groups, juvenile product manufacturers, and
other experts. This consultation process began in October 2008 during
the ASTM subcommittee meeting regarding the ASTM infant walker
voluntary standard. Consultations between Commission staff and members
of this subcommittee have continued and are still ongoing.
As discussed in the preamble to the proposed rule (74 FR at 45706),
CPSC staff conducted testing on JPMA certified walkers in order to
evaluate the ASTM infant walker standard and develop recommendations
for changes to it. The testing focused on the stair fall test in the
ASTM standard, a stability performance requirement, and a parking brake
requirement (the latter two both taken from EN 1273:2005).
Consistent with section 104(b) of the CPSIA, this rule establishes
a new 16 CFR part 1216, ``Safety Standard for Infant Walkers.'' The new
part incorporates by reference the requirements for infant walkers in
ASTM F 977-07 with certain changes to specific provisions to strengthen
the ASTM standard, as discussed in the next section of this preamble,
to further reduce the risk of injury. These modifications are similar
to the changes the Commission proposed in its September 3, 2009
proposed rule. Differences from the proposed rule are noted in the
following section of this preamble.
2. Description of Final Rule Including Changes to the ASTM Standard's
Requirements
While most requirements of the ASTM F 977-07 standard are
sufficient to reduce the risk of injury posed by infant walkers, the
Commission has modified several provisions in the standard to make them
more stringent and clarified the test procedures. The following
discussion describes the final rule, including changes to the ASTM
requirements, and notes any changes from the proposed rule. In
addition, some editing and formatting changes have been made which make
the final text different from the proposed rule. The Commission made
these editing and formatting changes to respond to concerns raised by
the Office of the Federal Register; the editing and formatting changes
do not alter the substance of the rule.
a. Scope (Sec. 1216.1)
The final rule states that part 1216 establishes a consumer product
safety standard for infant walkers manufactured or imported on or after
a date which would be six months after the date of publication of a
final rule in the Federal Register.
The Commission received no comments on this provision in the
proposed rule and is finalizing it without change.
b. Incorporation by Reference (Sec. 1216.2(a))
Section 1216.2(a) explains that, except as provided in Sec.
1216.2(b), each infant walker must comply with all applicable
provisions of ASTM F 977-07, ``Standard Consumer Safety Specification
for Infant Walkers,'' which is incorporated by reference. Section
1216.2(a) also provides information on how to obtain a copy of the ASTM
standard or to inspect a copy of the standard at the CPSC.
The Commission received no comments on this provision in the
proposed rule and is finalizing it without change.
c. Summary of Changes to ASTM F 977-07
The more substantive modifications to the ASTM standard for walkers
are
[[Page 35271]]
discussed in greater detail in part F.2.d. of this preamble below. A
summary of these changes along with the other, more editorial/technical
changes that the rule makes to the ASTM standard follows. The final
rule:
Updates the illustration of types of models of walkers in
Figure 1 of the ASTM standard to include an open back design (Sec.
1216.2(b)(1));
Revises equipment specifications in section 4.6 of the
ASTM standard to eliminate brand and model of force gauge and provide
performance specifications instead. The proposed rule would have a one
year calibration interval. However, the final rule provides a more
general interval because a force gauge could go out of calibration
before one year. Appropriate calibrations are necessary to maintain
accuracy. (Sec. 1216.2(b)(2));
Revises Figure 10 of the ASTM standard to show specific
rope, other equipment and procedures for the step test (Sec.
1216.2(b)(15));
In step test procedures, adds a calculation (discussed
below) using the actual weight of the walker to determine the launching
distance rather than assuming an 8-pound walker. (Sec.
1216.2(b)(5)(i), (6)(i), (8)(i), (9)(i)(11), (13)(i), (16)(i),
(18)(i));
In step test procedures, specifies the position for walker
wheels (Sec. 1216.2(b)(6)(i), (11)(i), (16)(i));
In step test procedures, specifies the position for the
CAMI dummy. (Sec. 1216.2(b)(7)(i));
In step test procedures, specifies rope type, pulley type,
and force to be applied. (Sec. 1216.2(b)(4)(i), (8)(i), (12)(i),
(17)(i));
In step test procedures, requires each aspect of the test
(forward, sideward, and rearward) three times to make it consistent
with EN 1273:2005 and allow more confidence in the test results. (Sec.
1216.2(b)(10)(i), (14)(i), (19)(i));
Adds the following warning concerning the parking brake if
a walker has a parking brake: ``WARNING: Parking brake use does not
totally prevent walker movement. Always keep child in view when in the
walker, even when using the parking brakes.'' (Sec. 1216.2(b)(21)(i));
Revises the stair hazard warning to state: ``Block stairs/
steps securely before using walker, even when using parking brake.''
(Sec. 1216.2(b)(22)(i)); and
Adds parking device test (Sec. 1216.2(b)(20)).
d. More Detailed Description of Changes to the ASTM Standard's Step
Test
Specification of equipment and procedures. The ASTM F 977-07
standard's step test lacks numerous details which allow for variability
in testing that could result in different test results. The Commission
proposed specifying the equipment and procedure needed for the test
(e.g., type of rope and pulley to be used, orientation of wood grain in
the floor). The final rule retains these changes. Additionally, the
Commission proposed modifying the test procedure language in several
provisions, such as specifying a tolerance for the term ``horizontal''
(0[deg] 0.5[deg]). The final rule retains these changes.
The final rule removes a specification that the test table be 48
inches. This specification appears in a notation in Figure 10 of the
ASTM standard. The proposed rule showed figure 10 with the noted 48-
inch length table. However, the final rule leaves the length of the
test table unspecified so that a test laboratory may use a table of
adequate length to accommodate the maximum calculated launching
distance d. A test table length of 48 inches may not be sufficient for
all walkers once the calculation is based on the actual weight of the
walker.
Calculation of launching distance. The Commission proposed a change
in the calculation of the launching distance used in the step test. The
Commission proposed weighing the walker and computing the appropriate
launching distances using the actual weight of the walker.
As discussed in the preamble to the proposed rule (74 FR at 45704)
and in this preamble, the launching distances may vary depending on the
weight of the walker and the maximum velocity of the walker at the edge
of the platform (4 ft/sec or 2 ft/sec). If the walker weight is not
appropriately accounted for, then it is possible the target maximum
velocity cannot be achieved. For example, if the scenario involved
computing distance d where the walker is tested in the forward
direction with the CAMI dummy and the walker weight is 14 pounds,
distance d would equal 18.0 inches (instead of 14.6 inches if the
walker weight value is 8 pounds). The longer distance is needed to
achieve the target velocity of 4 feet/second. If a 14-pound walker is
launched from 14.6 inches, the walker may not achieve the maximum
velocity of 4 feet/second. The final rule retains the distance d
calculation with a slight modification that requires the testing lab to
measure the weight of the CAMI dummy and vest. This will account for
variations in the weight of CAMI dummies and vests.
e. More Detailed Description of Parking Brake Test
The Commission proposed adding the parking brake test of the
European Standard EN 1273:2005. The final rule retains this test. It
applies to infant walkers that provide parking brakes, but it does not
require walkers to have parking brakes. Under this test, the walker is
set up to run a quasi-static version of the step test, but with the
parking device activated. If the walker moves a distance greater than
1.97 inches (50 mm), the walker fails the requirement. The parking
brake test will ensure that, if a walker has a parking brake, it will
work effectively.
f. Elimination of 30[deg] Incline Plane Test
The Commission proposed adding the 30[deg] incline plane test from
the European Standard EN 1273:2005 for walkers. As discussed more fully
in the response to a comment in part E of this preamble, the final rule
eliminates this additional requirement because testing and analysis by
a JPMA member demonstrated the adequacy of the stability test in the
ASTM F 977-07 standard.
G. Effective Date
The Commission proposed that the standard would become effective 6
months after publication of a final rule. The Commission received no
comments on the proposed effective date. The final rule provides that
the rule will become effective six months after publication and thus
will require that infant walkers manufactured or imported on or after
that date must meet this standard.
H. Paperwork Reduction Act
Sections 8 and 9 of ASTM F 977-07 contain requirements for marking,
labeling and instructional literature that are considered ``information
collection requirements'' under the Paperwork Reduction Act, 44 U.S.C.
3501-3520. In a separate notice elsewhere in this issue of the Federal
Register, the Commission is publishing a notice requesting comments on
this collection of information.
I. Regulatory Flexibility Act
The Regulatory Flexibility Act (``RFA'') generally requires that
agencies review rules for their potential economic impact on small
entities, including small businesses. 5 U.S.C. 604.
1. The Market
There are currently at least seven manufacturers or importers
supplying infant walkers to the United States market (four domestic
manufacturers,
[[Page 35272]]
two foreign manufacturers with divisions in the United States, and one
domestic importer). Under Small Business Administration (SBA)
guidelines, a manufacturer of infant walkers is small if it has 500 or
fewer employees and an importer is considered small if it has 100 or
fewer employees. Two domestic manufacturers (a third small manufacturer
also sells infant walkers, but based on their current product list is
no longer manufacturing them) and one domestic importer known to be
supplying the United States market qualify as small businesses under
these guidelines. However, CPSC staff believes that there are probably
other unknown small importers operating in the United States market as
well.
All domestic manufacturers supplying infant walkers to the United
States market certify their products as compliant with the ASTM
voluntary standard through the JPMA certification program. Based on
limited CPSC staff testing, the two foreign manufacturers and the
domestic importer are not believed to be complying with the voluntary
standard.
2. Impact of the Rule
The changes to the existing stair fall test requirements would
reduce variability across manufacturers. Also, because the specific
test modifications have been selected to minimize the friction
associated with the test procedure, they may effectively add stringency
to the tests. It is unknown the extent (if any) to which the
modification in the existing stair fall requirements of the voluntary
standard will affect infant walkers that now comply with the voluntary
standard. However, initial testing shows that the requirements impact
the test results of a few walkers. Therefore, it is possible that some
manufacturers might need to make walker modifications to comply. Based
on staff estimates of the costs of complying with the 1997 stair fall
requirements, this cost is unlikely to exceed more than several dollars
per unit. Possible modifications include: Increasing the rolling
friction within the walker's wheels; reducing the walker weight; and
refining the friction strip design.
Infant walkers are not currently required to have parking brakes,
nor would they be required to have them under the standard. However,
the final rule includes a test of parking brakes, if a walker has them,
to assure that they work properly. Initial testing finds that existing
walkers have no difficulty in passing this requirement. Therefore, the
Commission does not expect it to represent a burden to current
manufacturers. However, its inclusion would minimize the risk of
walkers with ineffective brakes entering the United States market in
the future.
Of the seven firms currently known to be marketing infant walkers
in the United States, three are small firms--two small domestic
manufacturers and a small domestic importer. We discuss the possible
impact of the rule on these entities immediately below.
Small manufacturers. One small domestic manufacturer has annual
sales of approximately $31-72.5 million. It currently produces seven
walker models and approximately 57 other juvenile products, one of
which is a substitute for infant walkers. The second is a small
domestic manufacturer with annual sales of approximately $2.5-5
million. Although its annual sales are lower, it is currently producing
only one infant walker model and approximately 110 other juvenile
products.
The two small domestic manufacturers (which are JPMA certified as
compliant with the voluntary standard) may not need to make product
modifications. If they do, it will most likely be due to changes needed
to comply with the modified stair fall requirements. The costs to these
manufacturers are not likely to be substantial, but may increase by as
much as several dollars per unit.
Small importers. The only known small domestic importer has annual
sales of approximately $2.5-5 million and is not believed to be in
compliance with the voluntary standard. Therefore, some product
modifications would be necessary. The impact of the infant walker
requirements on this importer is unclear, because little is known about
the walkers sold by this company. However, the impact is unlikely to be
large. Even if the company responded to the rule by discontinuing the
import of its non-complying walkers, either replacing them with a
complying product or another juvenile product, deciding to import an
alternative product would be a reasonable and realistic way to offset
any lost revenue from walker sales.
There also may be additional importers of walkers that the staff
has been unable to identify. However, the impacts of the rule on these
firms, if any, are unknown.
3. Alternatives
Under section 104 of the CPSIA, the primary alternative that would
reduce the impact on small entities is to make the voluntary standard
mandatory with no modifications. Because the two small domestic
manufacturers already meet the requirements of the voluntary standard,
adopting the standard without modifications may reduce their costs, but
only marginally. Similarly, limiting the requirements of the standard
to those already contained in the voluntary standard would probably
have little beneficial impact on small importers that do not currently
meet the requirements of the voluntary standard. This is because, to
these firms, most of the infant walker cost increases would be
associated with meeting the requirements of the voluntary standard,
rather than the minor additions associated with the Commission's
modification of the standard.
4. Conclusion of Final Regulatory Flexibility Analysis
It is not expected that the standard will have a substantial effect
on a large number of small firms. In some cases, small firms may not
need to make any product modifications to achieve compliance. Even if
modifications were necessary, and the cost of developing a compliant
product proved to be a barrier for individual firms, the loss of infant
walkers as a product category is expected to be minor and would likely
be mitigated by increased sales of competing products, such as activity
centers, or entirely different juvenile products.
J. Environmental Considerations
The Commission's regulations provide a categorical exclusion for
the Commission's rules from any requirement to prepare an environmental
assessment or an environmental impact statement as they ``have little
or no potential for affecting the human environment.'' 16 CFR
1021.5(c)(1). This rule falls within the categorical exclusion.
K. Preemption
Section 26(a) of the CPSA, 15 U.S.C. 2075(a), provides that where a
``consumer product safety standard under [the CPSA]'' is in effect and
applies to a product, no State or political subdivision of a State may
either establish or continue in effect a requirement dealing with the
same risk of injury unless the State requirement is identical to the
Federal standard. (Section 26(c) of the CPSA also provides that States
or political subdivisions of States may apply to the Commission for an
exemption from this preemption under certain circumstances.) Section
104(b) of the CPSIA refers to the rules to be issued under that section
as ``consumer product safety rules,'' thus implying that the preemptive
effect of section 26(a) of the CPSA would apply.
[[Page 35273]]
Therefore, a rule issued under section 104 of the CPSIA will invoke the
preemptive effect of section 26(a) of the CPSA when it becomes
effective.
L. Certification
Section 14(a) of the Consumer Product Safety Act (``CPSA'') imposes
the requirement that products subject to a consumer product safety rule
under the CPSA, or to a similar rule, ban, standard, or regulation
under any other act enforced by the Commission, must be certified as
complying with all applicable CPSC requirements. 15 U.S.C. 2063(a).
Such certification must be based on a test of each product or on a
reasonable testing program or, for children's products, on tests on a
sufficient number of samples by a third party conformity assessment
body accredited by the Commission to test according to the applicable
requirements. As discussed above in part K of this preamble, section
104(b)(1)(B) of the CPSIA refers to standards issued under that
section, such as the rule for infant walkers established in this final
rule, as ``consumer product safety standards.'' By the same reasoning,
such standards also would be subject to section 14 of the CPSA.
Therefore, any such standard would be considered to be a consumer
product safety rule to which products subject to the rule must be
certified.
Because infant walkers are children's products, they must be tested
by a third party conformity assessment body whose accreditation has
been accepted by the Commission. The Commission is issuing a separate
notice of requirements to explain how laboratories can become
accredited as third party conformity assessment bodies to test to the
new safety standard. (Infant walkers also must comply with all other
applicable CPSC requirements, such as the lead content requirements of
section 101 of the CPSIA, potentially the phthalate content
requirements in section 108 of the CPSIA if the walker incorporates a
toy component, the tracking label requirement in section 14(a)(5) of
the CPSA, and the consumer registration form requirements in section
104 of the CPSIA.)
List of Subjects in 16 CFR 1216
Consumer protection, Incorporation by reference, Imports, Infants
and children, Labeling, Law enforcement, and Toys.
0
Therefore, the Commission amends Title 16 of the Code of Federal
Regulations by adding part 1216 to read as follows:
PART 1216--SAFETY STANDARD FOR INFANT WALKERS
Sec.
1216.1 Scope.
1216.2 Requirements for infant walkers.
Authority: The Consumer Product Safety Improvement Act of 2008,
Pub. L. 110-314, Sec. 104, 122 Stat. 3016 (August 14, 2008).
Sec. 1216.1 Scope.
This part 1216 establishes a consumer product safety standard for
infant walkers manufactured or imported on or after December 21, 2010.
Sec. 1216.2 Requirements for infant walkers.
(a) Except as provided in paragraph (b) of this section, each
infant walker shall comply with all applicable provisions of ASTM F
977-07, Standard Consumer Safety Specification for Infant Walkers,
approved April 1, 2007. The Director of the Federal Register approves
this incorporation by reference in accordance with 5 U.S.C. 552(a) and
1 CFR part 51. You may obtain a copy from ASTM International, 100 Bar
Harbor Drive, P.O. Box 0700, West Conshohocken, PA 19428; telephone
610-832-9585; https://www.astm.org. You may inspect a copy at the Office
of the Secretary, U.S. Consumer Product Safety Commission, Room 820,
4330 East West Highway, Bethesda, MD 20814, telephone 301-504-7923, or
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: https://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(b) Comply with the ASTM F 977-07 standard with the following
additions or exclusions:
(1) Instead of Figure 1 of ASTM F 977-07, comply with the
following:
BILLING CODE 6355-01-P
[[Page 35274]]
[GRAPHIC] [TIFF OMITTED] TR21JN10.002
BILLING CODE 6355-01-C
(2) Instead of complying with section 4.6 through 4.6.8 of ASTM F
977-07, comply with the following:
(i) 4.6 The following guidelines shall apply to force gauges used
for testing:
(ii) 4.6.1 Equipment--Force gauge with a range of 0 to 25 lbf (110
N), tolerance of 0.25 lbf (1.1 N). A calibration interval
shall be maintained for the force guage which will ensure that the
accuracy does not drift beyond the stated tolerance.
(iii) 4.6.2 Equipment--Force gauge with a range 0 to 100 lbf (500
N) tolerance of 1 lbf (4.44 N). A calibration shall be
maintained for the force gauge which will ensure that the accuracy does
not drift beyond the stated tolerance.
(3) In addition to complying with section 6.3 of ASTM F 977-07,
comply with the following:
(i) 6.4 Parking Device (applicable to walkers equipped with parking
brakes)--The walker shall have a maximum displacement of 1.97 inches
(50 mm) for each test in each direction (forward, rearward, and
sideward) when tested in accordance with 7.7.
(ii) [Reserved]
[[Page 35275]]
(4) In addition to complying with section 7.6.1.2 of ASTM F 977-07,
comply with the following:
(i) 7.6.1.2 The dummy's head shall remain unrestrained for all the
step tests.
(ii) [Reserved]
(5) Following section 7.6.2 of ASTM F 977-07, use the following
table instead of Table 1 Summary of Step(s) Tests:
(i) Table 1 Summary of Step(s) Tests
----------------------------------------------------------------------------------------------------------------
Facing direction of Weight of CAMI Simulated
Section No. walker dummy, lb. speed, ft/s Apply tipover test
----------------------------------------------------------------------------------------------------------------
7.6.3........................... Forward............ 17................. 4 Yes.
7.6.3.6......................... Forward............ 28 (vest).......... 4 Yes.
7.6.4........................... Sideward........... 17................. 2 Yes.
7.6.4.6......................... Sideward........... 28 (vest).......... 2 Yes.
7.6.5........................... Rearward........... 17................. 4 No.
7.6.5.5......................... Rearward........... 28 (vest).......... 4 No.
----------------------------------------------------------------------------------------------------------------
(ii) [Reserved]
(6) Instead of complying with section 7.6.3.1 of ASTM F 977-07,
comply with the following:
(i) 7.6.3.1 Center the walker on the test platform facing forward
so that Plane A is perpendicular to the front edge of the platform and
the walker is distance d from the center of the most forward wheel(s)
to the edge of the test platform,
[GRAPHIC] [TIFF OMITTED] TR21JN10.003
Where
Vf = Maximum velocity of walker at edge of platform = 4
ft/sec
Vo = Initial velocity = 0
WCAMI = Measured weight of CAMI dummy
Wwalker = Weight of the walker
Wdrop weight = Drop weight = 8 lb
[mu]k = Dynamic coefficient of friction = 0.05
NCAMI = Normal force (for CAMI dummy scenario) = weight
of CAMI dummy and walker
g = acceleration of gravity = 32.2 ft/sec\2\
Position the swivel wheels in such a way that the walker moves
forward in a straight line parallel to Plane A.
(ii) [Reserved]
(7) Instead of complying with section 7.6.3.2 of ASTM F 977-07,
comply with the following:
(i) 7.6.3.2 Place a CAMI infant dummy Mark II in the walker and
position it as shown in Fig. 11 with the torso contacting the front
of the occupant seating area and arms placed on the walker tray.
(ii) [Reserved]
(8) Instead of complying with section 7.6.3.3 of ASTM F 977-07,
comply with the following:
(i) 7.6.3.3 While holding the walker stationary, attach an 8 lb
(3.6 kg) weight to the front of the walker base at Plane A by means
of a 7-strand military rope with 550 lb tensile strength (e.g.,
paracord 550) and a stainless steel ball bearing pulley with an
outside diameter of 1.25 in (32mm) and adjust the pulley so that the
force is applied horizontally (0 0.5[deg] with respect
to the table surface).
(ii) [Reserved]
(9) Instead of complying with section 7.6.3.6 of ASTM F 977-07,
comply with the following:
(i) 7.6.3.6 Repeat 7.6.3.1-7.6.3.5 using the CAMI dummy with the
weighted vest and with distance d, computed using the following
equation:
[GRAPHIC] [TIFF OMITTED] TR21JN10.004
Where
Vf = Maximum velocity of walker at edge of platform = 4
ft/sec
Vo = Initial velocity = 0
WCAMI w/vest = Measured weight of CAMI dummy and weighted
vest
Wwalker = Weight of the walker
Wdrop weight = Drop weight = 8 lb
[mu]k = Dynamic coefficient of friction = 0.05
NCAMI w/vest = Normal force (for CAMI dummy fitted with
11 lb vest scenario) = weight of CAMI dummy + vest weight + walker
weight
g = acceleration of gravity = 32.2 ft/sec\2\
(ii) [Reserved]
(10) In addition to complying with section 7.6.3.6 of ASTM F 977-
07, comply with the following:
(i) 7.6.3.7 Repeat tests in the following sequence: Section
7.6.3.4, section 7.6.3.5, and section 7.6.3.6 two additional times.
(ii) [Reserved]
(11) Instead of complying with 7.6.4.1 of ASTM F 977-07, comply
with the following:
(i) 7.6.4.1 Center the walker on the test platform facing sideways
so that Plane B is perpendicular to the front edge of the platform and
the walker is distance d from the center of the most sideward wheel(s)
to the edge of the test platform,
[GRAPHIC] [TIFF OMITTED] TR21JN10.005
[[Page 35276]]
Where
Vf = Maximum velocity of walker at edge of platform = 2
ft/sec
Vo = Initial velocity = 0
WCAMI = Measured weight of CAMI dummy
Wwalker = Weight of the walker
Wdrop weight = Drop weight = 8 lb
[micro]k = Dynamic coefficient of friction = 0.05
NCAMI = Normal force (for CAMI dummy scenario) = weight
of CAMI dummy and walker
g = acceleration of gravity = 32.2 ft/sec\2\
Position the swivel wheels in such a way that the walker moves sideward
in a straight line parallel to Plane A.
(ii) [Reserved]
(12) Instead of complying with section 7.6.4.3 of ASTM F 977-07,
comply with the following:
(i) 7.6.4.3 While holding the walker stationary, attach an 8 lb
(3.6 kg) weight to the side of the walker base at Plane B by means of a
rope (as specified in 7.6.3.3) and a pulley (as specified in 7.6.3.3)
and adjust the pulley so that the force is applied horizontally (0
0.5[ordm] with respect to the table surface).
(ii) [Reserved]
(13) Instead of complying with section 7.6.4.6 of ASTM F 977-07,
comply with the following:
(i) 7.6.4.6 Repeat 7.6.4.1 through 7.6.4.5 using the CAMI dummy
with the weighted vest (see Fig. 12) and with distance d, computed
using the following equation:
[GRAPHIC] [TIFF OMITTED] TR21JN10.006
Where
Vf = Maximum velocity of walker at edge of platform = 2
ft/sec
Vo = Initial velocity = 0
WCAMI w/vest = Measured weight of CAMI dummy and weighted
vest
Wwalker = Weight of the walker
Wdrop weight = Drop weight = 8 lb
[micro]k = Dynamic coefficient of friction = 0.05
NCAMI w/vest = Normal force (for CAMI dummy fitted with
11 lb vest scenario) = weight of CAMI dummy + vest weight + walker
weight
g = acceleration of gravity = 32.2 ft/sec2''
(ii) [Reserved]
(14) In addition to complying with section 7.6.4.6 of ASTM F 977-
07, comply with the following:
(i) 7.6.4.7 Repeat tests in t