[Federal Register Volume 74, Number 170 (Thursday, September 3, 2009)]
[Proposed Rules]
[Pages 45704-45714]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-20946]
[[Page 45703]]
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Part III
Consumer Product Safety Commission
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16 CFR Parts 1215, 1216, and 1500
Safety Standard for Infant Walkers; Revocation of Regulation Banning
Certain Baby-Walkers, Walker-Jumpers, and Similar Products; Safety
Standard for Infant Bath Seats; Infant Bath Seats: Termination of
Rulemaking; Proposed Rules
Federal Register / Vol. 74, No. 170 / Thursday, September 3, 2009 /
Proposed Rules
[[Page 45704]]
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1216
[CPSC Docket No. CPSC-2009-0065]
Safety Standard for Infant Walkers
AGENCY: Consumer Product Safety Commission.
ACTION: Notice of proposed rulemaking.
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SUMMARY: Section 104(b) of the Consumer Product Safety Improvement Act
of 2008 (``CPSIA'') requires the United States Consumer Product Safety
Commission (``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 proposing a safety standard for infant walkers in response to the
direction under section 104(b) of the CPSIA.
DATES: Written comments must be received by November 17, 2009.
ADDRESSES: You may submit comments, identified by Docket No. CPSC-2009-
0065, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov. Follow the
instructions for submitting comments. To ensure timely processing of
comments, the Commission is no longer accepting comments submitted by
electronic mail (e-mail) except through http://www.regulations.gov.
Written Submissions
Submit written submissions in the following way:
Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions), preferably in five copies, to: Office of the Secretary,
Consumer Product Safety Commission, Room 502, 4330 East West Highway,
Bethesda, MD 20814; telephone (301) 504-7923.
Instructions: All submissions received must include the agency name
and docket number for this rulemaking. All comments received may be
posted without change, including any personal identifiers, contact
information, or other personal information provided, to http://www.regulations.gov. Do not submit confidential business information,
trade secret information, or other sensitive or protected information
electronically. Such information should be submitted in writing.
Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Patricia Edwards, Project Manager,
Directorate for Engineering Sciences, Consumer Product Safety
Commission, 4330 East West Highway, Bethesda, MD 20814; telephone (301)
504-7577; [email protected].
SUPPLEMENTARY INFORMATION:
A. Background and Statutory Authority
1. The Consumer Product Safety Improvement Act
The Consumer Product Safety Improvement Act of 2008 (``CPSIA'',
Pub. L. 110-314) was enacted on August 14, 2008. Section 104(b) of the
CPSIA requires the Commission to promulgate consumer product safety
standards for durable infant or toddler products. These standards are
to be ``substantially the same as'' applicable voluntary standards or
more stringent than the voluntary standard if the Commission concludes
that more stringent requirements would further reduce the risk of
injury associated with the product. Section 104(b)(2) of the CPSIA
directs the Commission to begin rulemaking for two standards by August
14, 2009. In this document, the Commission proposes a safety standard
for infant walkers. The proposed standard is substantially the same as
a voluntary standard developed by 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.
2. Existing Mandatory Regulations for Walkers
The Commission currently has regulations for infant walkers,
originally issued in 1971 by the Food and Drug Administration, at 16
CFR 1500.18(a)(6) and 16 CFR 1500.86(a)(4). These regulations apply to
items known as baby bouncers, walker-jumpers, and baby walkers. The
regulations declare as a banned hazardous substance such an item
``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.'' 16 CFR 1500.18(a)(6). The regulations set out mechanical,
labeling, and recordkeeping requirements with which such items must
comply in order to be exempt from the ban. 16 CFR 1500.86(a)(4). These
specifically address such hazards as scissoring, shearing or pinching;
exposed coil springs in which a child could become caught; holes in
plates or tubes; and accidental collapse of the item.
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.
Elsewhere in this issue of the Federal Register, the Commission is
proposing to revoke the existing CPSC regulations for walkers. As
explained in the proposed revocation notice, the existing regulations
are based on incomplete and outdated anthropometric data. Revoking the
existing regulations will also avoid confusion about what requirements
apply to infant walkers. The Commission is concerned, however, that the
existing mandatory regulations may cover products not covered by the
ASTM F 977-07 standard (or other voluntary standards) and that
revocation of the mandatory requirements may leave a gap in regulation.
The Commission's proposal to revoke the existing CPSC regulations for
walkers invites comments on this issue.
3. Previous Rulemaking Concerning Stair Fall Hazard
In August 1994, the Commission published an advance notice of
proposed rulemaking (``ANPR'') in the Federal Register (59 FR 39306)
initiating a rulemaking proceeding on infant walkers under the Federal
Hazardous Substances Act (``FHSA''). The Commission stated at that time
that it had reason to believe that walkers presented an unreasonable
risk of injury due to the hazard of walkers falling down steps or
stairs. After the ANPR was published, CPSC staff worked with ASTM to
develop new requirements that could be added to the existing voluntary
standard to address the stair-fall hazard. A revised ASTM standard
including such provisions was published in early 1997 as ASTM F 977-07.
In May 2002, the Commission voted to terminate the FHSA walker
rulemaking because it could not make the findings necessary to issue a
mandatory rule in light of the revised voluntary standard. 67 FR 31165
(May 9, 2002).
B. The Product
Infant walkers are used to support very young children before they
are
[[Page 45705]]
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
baby walkers to the United States market are JPMA certified as
compliant with the current 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 current 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
1. Injury Estimates
There were an estimated total of 14,900 (an annual average of
3,000) infant walker-related injuries 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.\1\ (This estimate
has been adjusted to exclude jumpers from the walker code.) No deaths
were reported through NEISS. 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 the emergency department-treated
injuries related to infant walkers, the following characteristics
occurred most frequently based on an annual average:
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\1\ 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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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 emergency department-treated injuries were not necessarily caused
by failures of the walkers.
The stair-fall protection provisions in the ASTM standard have
dramatically affected walker-related incidents. From 1994 to 2008 there
has been an 88% decrease in estimated walker-related incidents treated
in emergency rooms (from 24,000 to 2,800). Nevertheless, the stair fall
hazard is the most prevalent hazard in walker-related incidents. Some
of these incidents involve non-compliant walkers, 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.\2\ 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 non-fall related circumstances (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).
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\2\ 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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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. ASTM Voluntary Standard
ASTM F 977 Standard Consumer Safety Specification for Infant
Walkers was first published in 1986. As mentioned above in part A.3 of
the preamble, it was revised in 1997 to address the stair-fall hazard.
JPMA provides certification programs for juvenile products,
including walkers. Manufacturers submit their products to an
independent test laboratory to test the product for conformance to the
ASTM standard. Currently walkers from five manufacturers are JPMA
certified as being in compliance with the ASTM standard.
The current ASTM standard includes performance requirements
specific to walkers, general performance requirements, and labeling
requirements. The key provisions of the current ASTM walker standard
include the following:
Prevention of falls down stairs--intended to ensure that a
walker will
[[Page 45706]]
not fall over 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 current 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 Commission believes that the ASTM standard's performance tests
for evaluating the stability and structural integrity of infant walkers
are adequate. However, the Commission believes that changes to the
stair fall requirement are needed to better control testing variability
and consistency. As discussed below, the Commission also is proposing
to add a 30[deg] incline plane test and a parking brake test from the
European standard for walkers (EN 1273: 2005), and making editorial
text changes to ASTM F 977-07 to clarify several provisions.
E. Assessment of Voluntary Standard ASTM F 977-07
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.
To evaluate the ASTM infant walker standard and develop
recommendations for changes to it, CPSC staff conducted testing on
JPMA-certified walkers. The testing focused on the stair fall test in
the current ASTM standard, a stability performance requirement, and a
parking brake requirement (the latter two both taken from a European
standard on walkers, EN 1273:2005).
2. Current Stair Fall Requirement in ASTM F 977-07
The stair fall requirement 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 lb weight on
a hardwood floor surface. The walker passes the test if it stays on the
hardwood floor table surface. It fails the test if the walker
completely falls off the table surface.
The current ASTM standard is based on the assumption that an
average walker weighs 8 pounds. However, the average weight of recent
model walkers is greater than 8 pounds, the typical weight of earlier
models. CPSC staff weighed five 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.
In the current ASTM 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.
CPSC staff participated in various round robin tests and conducted
its own tests to evaluate the effects of test apparatus components and
test conditions related to the stair fall test requirement. As a result
of this testing, the Commission is proposing changes to the current
ASTM test procedure to reduce test variability. These proposed changes
are discussed in part F of this preamble.
CPSC staff also performed a modified version of the stair fall
performance test on the decking of various residential pools to assess
if any changes to the ASTM standard were necessary to address the two
fatal incidents involving children using JPMA-certified walkers that
fell into residential pools. The test results indicated that JPMA-
certified walkers passed (i.e., did not fall in the pool) when tested
to the same conditions as the ASTM standard (terminal velocity of 4 ft/
sec, CAMI dummy fitted with the 11 pound vest seated in the walker).
CPSC staff did not recommend any changes to the ASTM standard as a
result of this testing at pools, and the Commission is not proposing
any.
3. European Standard EN 1273:2005
CPSC staff evaluated another existing standard related to infant
walkers to determine if any aspects of that standard should be
considered for the future CPSC safety standard. The EN 1273:2005
European Standard contains two performance tests that are currently not
in the ASTM F 977-07: the 30[deg] incline plane stability test and the
parking devices test.
The 30[deg] incline plane test is a standard stability test which
is common in several EN children's product safety standards. 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.
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.
Available incident data does not clearly demonstrate whether
inclusion of these two performance tests would improve the safety of
walkers. CPSC staff tested selected walkers that currently pass the
ASTM standard to these additional tests. The walkers also passed these
tests. As discussed further in part F of this preamble, however, based
on our sound engineering judgment, inclusion of these provisions may
provide some additional safety.
F. Description of Proposed Changes to ASTM F 977-07
As discussed at part E.2 of this preamble, CPSC staff conducted
tests and evaluations of infant walkers to determine any modification
that might
[[Page 45707]]
be needed to the ASTM standard. Based on this assessment and
consultations with others, the Commission proposes as a consumer
product safety standard for infant walkers the ASTM F 977-07 standard
with the following modifications.
To best understand the proposed standard it is helpful to view the
current ASTM F 977-07 standard for walkers at the same time as the
Commission's proposed modifications. The ASTM standard is available for
viewing for this purpose during the comment period through this link:
http://www.astm.org/cpsc.htm.
1. Changes to the Stair Step Fall Test
Specification of equipment and procedures. Currently, the ASTM
stair fall test lacks numerous details. This allows for variability in
testing that could result in different test results. The Commission is
proposing to specify 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).
Additionally, the Commission proposes to modify the test procedure
language in several provisions, such as specifying a tolerance for the
term ``horizontal'' (0[deg] 0.5[deg]). These modifications
would make the proposed standard more stringent than the ASTM standard
if, due to the lack of clarity in the ASTM standard, some test
laboratories are currently passing some walkers that do not in fact
comply with the standard. In addition, minimizing friction in the test
apparatus and flexure in the test table would maximize the transfer of
dynamic energy to the walker and CAMI dummy, hence creating more
stringent performance requirements.
Calculation of launching distance. The Commission is also proposing
a change in the calculation of the launching distance used in the stair
fall test. The Commission proposes weighing the walker and computing
the appropriate launching distances using the equations below.
[GRAPHIC] [TIFF OMITTED] TP03SE09.000
[GRAPHIC] [TIFF OMITTED] TP03SE09.001
Where:
Vf = Maximum velocity of walker at edge of platform = 4
ft/sec (for forward and rearward directions); 2 ft/sec (for sideward
direction)
Vo = Initial velocity = 0
WCAMI = Weight of CAMI dummy = 17 lb
WCAMI w/vest = Weight of CAMI dummy with 11 lb vest = 28
lbs
Wwalker = Weight of the walker
Wdrop weight = 8 lb
[mu]k = Dynamic coefficient of friction = 0.05
NCAMI = Normal force (for CAMI dummy scenario) = weight
of CAMI dummy and walker
NCAMI w/vest = Normal force (for CAMI dummy fitted with
11 lb vest scenario) = weight of CAMI dummy + vest + walker
g = Acceleration of gravity = 32.2 ft/sec\2\
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). The appropriate launching distances
need to be computed for each walker model, in each direction, with and
without the 11 pound vest. CPSC staff believes that 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 ft/sec. If a 14-pound walker is
launched from 14.6 inches, the walker may not achieve the maximum
velocity of 4 ft/sec. The proposed change will mean that each walker
will be subjected to the same target maximum velocity even if the
weight of the walkers varies. This proposed change may create more
stringent performance requirements.
2. Addition of 30[deg] Incline Plane Test and Parking Brake Test
As discussed above in part E.3 of this preamble, the Commission is
proposing to add to the ASTM standard two provisions currently in the
European Standard EN 1273:2005 for walkers.
The 30[deg] incline plane test. Under this test, as explained
above, a walker with a 26.4 pound (12 kg) test mass is placed on a
sloping platform that is inclined at 30 degrees to the horizontal with
a stop on the lower edge of the slope. In order to pass, the walker
must not tip over. The current ASTM standard contains a provision to
address children leaning out over the edge of the walker. The ASTM
provision concerning leaning over the edge of the walker requires a
cantilevered 17-pound force with approximately a 6 to 7 inch moment arm
on a level surface. The 30[deg] test uses a 26.4-pound test mass seated
on a (up to) 14-pound walker on an incline plane. In certain scenarios,
the 30[deg] test may be more stringent.
The parking brake test. The parking brake test would apply to
walkers that have parking brakes. It would not require walkers to have
parking brakes. Under this test, the walker is set up to run a quasi-
static version of the stair fall performance 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. This could affect safety because, if a parking brake is
present, caregivers may rely on it to temporarily stop the walker.
3. Summary of Proposed Changes to ASTM F 977-07
The more substantive proposed modifications to the ASTM standard
for walkers have been discussed above in parts F.1 and F.2 of this
preamble. A summary of these proposed changes and the other, more
editorial/technical changes the Commission is proposing follows:
Update the illustration of types of models of walkers in
Figure 1 of the ASTM standard to include an open back design (proposed
Sec. 1216.2(b)(1)).
Revise equipment specifications in section 4.6 of ASTM
standard to eliminate brand and model of force gauge and provide
performance
[[Page 45708]]
specification instead (proposed Sec. 1216.2(b)(2) through (5)).
Revise Figure 10 of the ASTM standard to show specific
rope, other equipment and procedures for stair step test (proposed
Sec. 1216.2(b)(17)).
In stair step test procedures, add a calculation
(discussed above) to determine launching distance rather than assuming
an 8-pound walker. (proposed Sec. 1216.2(b)(7), (8), (11), (13), (15),
(18), (20)).
In stair step test procedures, specify the position for
walker wheels (proposed Sec. 1216.2(b)(7), (13), (18)).
In stair step test procedures, specify the position for
CAMI dummy. (proposed Sec. 1216.2(b)(9)).
In stair step test procedures, specify rope type, pulley
type, and force to be applied. (proposed Sec. 1216.2(b)(6), (10),
(14), (19)).
In stair step test procedures, require each aspect of test
(forward, sideward, and rearward) three times to make it consistent
with the European Standard EN 1273:2005 and allow more confidence in
the test results. (proposed Sec. 1216.2(b)(12), (16), (21)).
Add 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.'' (proposed Sec.
1216.2(b)(22)).
Revise the stair hazard warning to state: ``Block stairs/
steps securely before using walker, even when using parking brake.''
(proposed Sec. 1216.2(b)(23)).
Add 30[deg] incline plane test (proposed Sec. 1216.2(c)).
Add parking device test (proposed Sec. 1216.2(d)).
G. Request for Comments
This NPR begins a rulemaking proceeding under section 104(b) of the
CPSIA to issue a consumer product safety standard for walkers. All
interested persons are invited to submit their comments to the
Commission on any aspect of the proposed rule. Comments should be
submitted in accordance with the instructions in the ADDRESSES section
at the beginning of this notice.
H. Effective Date
The Administrative Procedure Act (``APA'') generally requires that
the effective date of a rule be at least 30 days after publication of
the final rule. Id. 553(d). To allow time for infant walkers to come
into compliance the Commission proposes that the standard would become
effective 6 months after publication of a final rule.
I. Paperwork Reduction Act
The Commission is not proposing any collections of information in
this regulation. Therefore, the Paperwork Reduction Act, 44 U.S.C.
3501-3520, does not apply.
J. Regulatory Flexibility Act
The Regulatory Flexibility Act (``RFA'') generally requires that
agencies review proposed rules for their potential economic impact on
small entities, including small businesses. 5 U.S.C. 603.
1. The Market
As mentioned above, there are currently at least seven
manufacturers or importers supplying infant walkers to the U.S. market
(four domestic manufacturers, 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 baby 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.
As noted above, all domestic manufacturers supplying infant walkers
to the United States market certify their products as compliant with
the current 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 current voluntary standard.
2. Impact of the Proposal
As stated above, the proposed 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 proposed modification in the existing stair fall requirements of
the voluntary standard will affect walkers that now comply with the
current voluntary standard. However, initial testing shows that the
proposed 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.
Infant walkers are not currently required to have parking brakes,
nor would they be required to have them under the proposed standard.
However, the Commission proposes including 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.
The 30[deg] incline plane test that the Commission proposes adding
to the ASTM standard is comparable to, and may be duplicative of, the
``Occupant Leaning Outward Over Edge Test'' in the current voluntary
standard. Like the existing requirement, it tests walker vulnerability
to tip-over. The safety impact of this inclusion is unclear, but may
provide additional safety to walkers over and above the existing
requirement. Based on limited testing, it appears that several walkers
would pass these added tests without modifications.
As noted before, 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. Below is a
discussion of the possible impact of the proposal on these entities.
Small manufacturers. 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 proposed modifications to the
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 is not
believed to be compliant with the current voluntary standard;
therefore, at least some product modifications would be necessary. The
impact of the proposed 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
[[Page 45709]]
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 importers of walkers that we have been unable to
identify. However, the impacts of the proposed 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 current voluntary
standard, rather than the minor add-ons associated with the proposed
standard.
4. Conclusion of initial regulatory flexibility analysis
It is not expected that the proposed 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.
K. Environmental Considerations
The Commission's regulations provide a categorical exemption for
the Commission's rules from any requirement to prepare an environmental
assessment or an environmental impact statement as they ``have little
or no potential for affecting the human environment.'' 16 CFR
1021.5(c)(2). This proposed rule falls within the categorical
exemption.
List of Subjects in 16 CFR Part 1216
Consumer protection, Imports, infants and children, Labeling, Law
enforcement, and Toys.
Therefore, the Commission proposes to amend Title 16 of the Code of
Federal Regulations by adding part 1216 to read as follows:
PART 1216--SAFETY STANDARD FOR INFANT WALKERS
Sec.
1216.1 Scope, application and effective date.
1216.2 Requirements for infant walkers.
Authority: The Consumer Product Safety Improvement Act of 2008,
Pub. L. 110-314, 104, 122 Stat. 3016 (August 14, 2008).
Sec. 1216.1 Scope, application and effective date.
This part 1216 establishes a consumer product safety standard for
infant walkers manufactured or imported on or after March 3, 2010.
Sec. 1216.2 Requirements for infant walkers.
(a) Except as provided in paragraphs (b), (c) and (d) 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, PO Box 0700, West Conshohocken, PA
19428; http://www.astm.org. You may inspect a copy at the Office of the
Secretary, U.S. Consumer Product Safety Commission, Room 502, 4330 East
West Highway, Bethesda, MD 20814, telephone 301-504-7923, or at the
National Archives and Records Administration (NARA). For information on
the availability of this material at NARA, call 202-741-6030, or go to:
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(b) The following provisions replace, or are added to, the
indicated sections of the ASTM F 977-07 standard.
(1) Instead of Figure 1:
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[[Page 45710]]
[GRAPHIC] [TIFF OMITTED] TP03SE09.002
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(2) Instead of section 4.6.1: ``Equipment--Force gauge with a range
of 0 to 25 lbf (110 N), tolerance of 1 Div., and a
calibration interval of 1 year.''
(3) Delete sections 4.6.2 through 4.6.4.
(4) Instead of section 4.6.5: ``Equipment--Force gauge with a range
0 to 100 lbf (500 N) tolerance of 1 Div., and a
calibration interval of 1 year.''
(5) Delete sections 4.6.6 through 4.6.8.
(6) Instead of section 7.6.1.2: ``The dummy may be secured to the
tray to maintain contact during the test. Raise the dummy's legs just
enough so its feet do not touch the platform during the performance of
the test and position using the rope specified in Figure 10.''
(7) Instead of section 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,
[[Page 45711]]
[GRAPHIC] [TIFF OMITTED] TP03SE09.011
Where:
Vf = Maximum velocity of walker at edge of platform = 4
ft/sec
Vo = Initial velocity = 0
WCAMI = Weight of CAMI dummy = 17 lb
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.''
(8) Instead of Table 1 Summary of Step(s) Tests:
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.
----------------------------------------------------------------------------------------------------------------
(9) Instead of section 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.''
(10) Instead of section 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).''
(11) Instead of section 7.6.3.6: ``Repeat 7.6.3.1-7.6.3.5 using the
CAMI dummy with the weighted vest (see Fig. 12) and with distance d,
computed using the following equation:
[GRAPHIC] [TIFF OMITTED] TP03SE09.003
Where:
Vf = Maximum velocity of walker at edge of platform = 4
ft/sec
Vo = Initial velocity = 0
WCAMI w/vest = Weight of CAMI dummy with 11 lb vest = 28
lbs
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\
(12) After section 7.6.3.6, add a new section 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.''
(13) Instead of 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] TP03SE09.004
Where:
Vf = Maximum velocity of walker at edge of platform = 2
ft/sec
Vo = Initial velocity = 0
WCAMI = Weight of CAMI dummy =17 lb
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 sideward
in a straight line parallel to Plane A.''
(14) Instead of section 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[deg] with respect to
the table surface).''
(15) Instead of section 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:
[[Page 45712]]
[GRAPHIC] [TIFF OMITTED] TP03SE09.005
Where:
Vf = Maximum velocity of walker at edge of platform = 2
ft/sec
Vo = Initial velocity = 0
WCAMI w/vest = Weight of CAMI dummy with 11 lb vest = 28
lbs
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\''
(16) After section 7.6.4.6, add a new section 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.''
(17) Instead of Figure 10:
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[GRAPHIC] [TIFF OMITTED] TP03SE09.006
[[Page 45713]]
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(18) Instead of section 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 distance d from the center of
the most rearward wheel(s) to the edge of the test platform,
[GRAPHIC] [TIFF OMITTED] TP03SE09.007
Where:
Vf = Maximum velocity of walker at edge of platform = 4
ft/sec
Vo = Initial velocity = 0
WCAMI = Weight of CAMI dummy = 17 lb
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 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.''
(19) Instead of section 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 7.6.3.3) and adjust the pulley so that the
force is applied horizontally (0 0.5[deg] with respect to
the table surface).''
(20) Instead of section 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:
[GRAPHIC] [TIFF OMITTED] TP03SE09.008
Where:
Vf = Maximum velocity of walker at edge of platform = 4
ft/sec
Vo = Initial velocity = 0
WCAMI w/vest = Weight of CAMI dummy with 11 lb vest = 28
lbs
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\
(21) After section 7.6.5.5, add a new section 7.6.5.6: ``Repeat
tests in the following sequence: section 7.6.5.3, and section 7.6.5.5
two additional times.''
(22) Between section 8.2.3.2 and section 8.2.4, add a new section
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.''
(23) Instead of section 8.2.4.2: ``The stairs warning shall be
stated exactly as follows:
[GRAPHIC] [TIFF OMITTED] TP03SE09.012
(c) Static stability 30 [deg] incline plane test--
(1) Requirement. When tested to the procedure described in
paragraph (c)(3) of this section, the infant walker shall not overturn.
(2) Test equipment. (i) A sloping platform inclined at 30[deg] to
the horizontal with a stop fitted to the lower edge of the slope. The
height of the stop shall be 3.94 in (100 mm). See Figure 15.
(ii) Test Mass A: A rigid cylinder 6.30 in 0.04 in
(160 mm 1 mm) in diameter, 11.02 in 0.04 in
(280 mm 1 mm) in height with a mass of 26.4 lb (12 kg),
with its center of gravity in the center of the cylinder. All edges
shall have a radius of 0.79 in 0.04 in (20 mm
1mm).
(iii) Test Mass B: A rigid cylinder 6.30 in 0.04 in
(160 mm 1 mm) in diameter, 11.02 in 0.04 in
(280 mm 1 mm) in height with a mass of 16.8 lb (7.65 kg),
with its center of gravity in the center of the cylinder.
(3) Test method. (i) Adjustable seats shall be adjusted to their
highest position. Place Test Mass A vertically in the center of the
walker seat. To restrict movement of the test mass, packing of
negligible mass may be used. Position the castors or wheels in their
most onerous position. Place the walker on the slope against the stop.
Carry out the test in the forward, sideward, and rearward directions.
[[Page 45714]]
[GRAPHIC] [TIFF OMITTED] TP03SE09.009
(d) Parking device test (applicable to walkers equipped with
parking brakes)--
(1) Requirement. When tested to the procedures in paragraph (d) of
this section, the infant walker shall have a maximum displacement of
1.97 inches (50 mm) for each test in each direction (forward, rearward,
and sideward).
(2) Test equipment. (i) A test platform as specified in Figure 10
with a hardwood floor pre-finished with polyurethane.
(ii) Test Mass A and Test Mass B as specified in paragraph
(c)(2)(ii) and (iii) of this section.
(3) Test method. (i) Preparation and procedure.
(A) Adjust the walker seat to the highest position (if applicable).
Place Test Mass A 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.
(B) Perform the parking device test in the forward, sideward, and
rearward directions.
(ii) Forward facing test of parking devices.
(A) Position the walker including Test Mass B facing forward 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 manufacturer's instructions.
(B) Within one minute of placing the walker with Test Mass B 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[deg]). Remove the 8 lb weight after 1 minute. Measure the
displacement.
(iii) Sideward facing test of parking devices.
(A) Position the walker including Test Mass B 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.
(B) Within one minute of placing the walker with Test Mass B 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[deg]). Remove the 8 lb weight after 1 minute. Measure the
displacement.
(iv) Rearward facing test of parking devices.
(A) Position the walker including Test Mass B 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.
(B) Within one minute of placing the walker with Test Mass B 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[deg]). Remove the 8 lb weight after 1 minute. Measure the
displacement.
Dated: August 25, 2009.
Todd Stevenson,
Secretary, U.S. Consumer Product Safety Commission.
[FR Doc. E9-20946 Filed 9-2-09; 8:45 am]
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