[Federal Register Volume 89, Number 12 (Thursday, January 18, 2024)]
[Rules and Regulations]
[Pages 3344-3351]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-00741]
=======================================================================
-----------------------------------------------------------------------
CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Parts 1112 and 1250
[Docket No. CPSC-2017-0010]
Safety Standard Mandating ASTM F963 for Toys
AGENCY: Consumer Product Safety Commission.
ACTION: Direct final rule.
-----------------------------------------------------------------------
SUMMARY: Section 106 of the Consumer Product Safety Improvement Act
(CPSIA) made ASTM F963-07[egr]1, Standard Consumer Safety Specification
for Toy Safety, a mandatory consumer product safety standard. Section
106 also provides procedures for revisions to the ASTM F963 standard.
In accordance with those procedures, the Consumer Product Safety
Commission (CPSC or Commission) has allowed the revised standard, ASTM
F963-23, to become the mandatory toy standard. This direct final rule
incorporates by reference ASTM F963-23 and updates the existing notice
of requirements (NOR) that provide the criteria and processes for
Commission acceptance of accreditation of third-party conformity
assessment bodies for testing to ASTM F963.
DATES: The rule is effective on April 20, 2024, unless CPSC receives a
significant adverse comment by February 20, 2024. If CPSC receives such
a significant adverse comment, it will publish a document in the
Federal Register withdrawing this direct final rule before its
effective date. The incorporation by reference of the publication
listed in this rule is approved by the Director of the Federal Register
as of April 20, 2024.
ADDRESSES: You can submit comments, identified by Docket No. CPSC-2017-
0010, by any of the following methods:
Electronic Submissions: Submit electronic comments to the Federal
eRulemaking Portal at: www.regulations.gov. Follow the instructions for
submitting comments. Do not submit through this website: confidential
business information, trade secret information, or other sensitive or
protected information that you do not want to be available to the
public. CPSC typically does not accept comments submitted by email
except as described below.
Mail/Hand Delivery/Courier/Confidential Written Submissions: CPSC
encourages you to submit electronic comments by using the Federal
eRulemaking Portal. You may, however, submit comments by mail, hand
delivery, or courier to: Office of the Secretary, Consumer Product
Safety Commission, 4330 East West Highway, Bethesda, MD 20814;
telephone: (301) 504-7479.
Instructions: All submissions must include the agency name and
docket number. CPSC may post all comments without change, including any
personal identifiers, contact information, or other personal
information provided, to: www.regulations.gov. If you wish to
[[Page 3345]]
submit confidential business information, trade secret information, or
other sensitive or protected information that you do not want to be
available to the public, you may submit such comments by mail, hand
delivery, or courier, or you may email them to: [email protected].
Docket: For access to the docket to read background documents or
comments received, go to: www.regulations.gov, and insert the docket
number, CPSC-2017-0010, into the ``Search'' box, and follow the
prompts.
FOR FURTHER INFORMATION CONTACT: Will Cusey, Small Business Ombudsman,
U.S. Consumer Product Safety Commission, 4330 East West Highway,
Bethesda, MD 20814; telephone (301) 504-7945 or (888) 531-9070; email:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Section 106(a) of CPSIA mandated that beginning on February 10,
2009, ASTM F963-07[egr]1, Standard Consumer Safety Specifications for
Toy Safety,\1\ shall be considered a mandatory consumer product safety
standard issued by CPSC. 15 U.S.C. 2056b(a). Since then, there have
been five revisions to the ASTM F963 standard: ASTM F963-08, ASTM F963-
11, ASTM F963-16, ASTM F963-17, and ASTM F963-23. Currently, the
provisions of ASTM F963-17 are considered a consumer product safety
standard issued by the Commission under section 9 of the Consumer
Product Safety Act (CPSA), with an exception stated in 16 CFR 1250.2(c)
that ASTM F963-17's provision for testing sound-producing toys is not
incorporated. 16 CFR 1250.2; 82 FR 57119 (Dec. 4, 2017).
---------------------------------------------------------------------------
\1\ Except for section 4.2 and Annex 4 of the voluntary standard
or any provision that restates or incorporates an existing mandatory
standard or ban promulgated by the Commission or by statute.
---------------------------------------------------------------------------
Under section 106(g) of the CPSIA, ASTM must notify the Commission
when it revises ASTM F963. 15 U.S.C. 2056b(g). The revised standard
shall be considered a consumer product safety standard issued by CPSC
under section 9 of the CPSA (15 U.S.C. 2058), effective 180 days after
the date on which ASTM notifies the Commission of the revision, unless,
within 90 days after receiving that notice, the Commission notifies
ASTM that it has determined that the proposed revision does not improve
the safety of toys covered by the standard.
On October 23, 2023, ASTM notified CPSC of ASTM's approval and
publication of revisions to ASTM F963-17 in a revised standard, ASTM
F963-23, Standard Consumer Safety Specification for Toy Safety. The
Commission published in the Federal Register a notice of availability
regarding the revised voluntary standard and sought comments on the
effect of the revisions on the safety of the standard for toys. 88 FR
75280 (Nov. 2, 2023). Two comments were submitted. The Consumer
Federation of America and Kids in Danger submitted a joint comment
stating that the revision to ASTM F963 should be accepted as the
mandatory standard and urging continued efforts to address emerging
hazards, including expanding materials in toys, to make the standard
more protective of safety.
The Swiss company Soci[eacute]t[eacute] G[eacute]n[eacute]rale de
Surveillance (SGS) submitted a comment stating that the requirements
for expanding materials in section 4.40 of ASTM F963-23 could be more
stringent. While SGS's comment does not address whether the current
revision in ASTM F963-23 improves safety compared to the requirements
of F963-17, Commission staff continues to work with ASTM to improve the
safety requirements for expanding materials in ASTM F963 for any future
update to the standard. Specifically, CPSC's Fiscal Year 2024 Operating
Plan \2\ directs staff to develop a notice of proposed rulemaking under
section 106 of the CPSIA to further improve the standard for water
beads, which are ``expanding materials'' under the voluntary standard.
---------------------------------------------------------------------------
\2\ Available at: https://www.cpsc.gov/s3fs-public/FY2024OperatingPlan.pdf?VersionId=N46Kg9oFJtn_Slys4cdzuQYza29oFynS.
---------------------------------------------------------------------------
As discussed below, the Commission will allow the revised voluntary
standard to become the mandatory standard because it improves the
safety of toys.\3\ Accordingly, by operation of law under section
106(g) of the CPSIA as of April 20, 2024, ASTM F963-23 will become the
mandatory consumer product safety standard for toys. 15 U.S.C.
2056b(g). This direct final rule updates 16 CFR part 1250 to
incorporate by reference the revised voluntary standard, ASTM F963-23.
The rule also updates the existing NOR for ASTM F963 in 16 CFR part
1112.
---------------------------------------------------------------------------
\3\ The Commission voted 4-0 to approve publication of this
notification.
---------------------------------------------------------------------------
II. Revisions in ASTM F963-23
The ASTM F963 toy standard includes performance requirements and
test methods, as well as requirements for warning labels and
instructional literature, to reduce or prevent death or injuries to
children from mechanical, chemical, and other hazards subject to the
standard.
The 2023 revisions to the voluntary standard include new
performance requirements, clarifications, and corrections that will
increase toy safety and reduce test burden. Additionally, the standard
includes changes that do not affect safety, but instead enhance the
clarity and utility of the standard or reduce the burden of performance
testing. Numerous editorial changes were also made throughout the
standard, including formatting and numbering changes that do not impact
safety. The Commission finds the revisions to ASTM F963-23 to be an
improvement to the safety of toys, or to not impact safety. Below is a
brief description of the revisions and the Commission's assessment of
their impact on safety.
A. Revisions That Impact Safety
1. Battery Accessibility
Section 4.25 of ASTM F963 addresses the safety of battery-operated
toys. The requirements are intended to address hazards related to
battery overheating, leakage, explosion, and fire, and choking or
swallowing batteries. ASTM F963-17 specifically addresses the hazard of
choking or swallowing batteries in sections 4.25.4 and 4.25.5. Section
4.25.4 addresses the accessibility of batteries in toys for children
less than three years old; section 4.25.5 addresses the accessibility
of small part batteries (batteries that fit within the small parts
cylinder described in 16 CFR 1501.4, including button cell or coin
batteries and AAA batteries). Both sections of ASTM F963-17 require
that batteries remain inaccessible without the use of a ``coin,
screwdriver, or other household tool'' before and after the use and
abuse testing specified in sections 8.5-8.10.
ASTM F963-23 also incorporates changes to definitions, safety
requirements, and labeling requirements that strengthen the battery
accessibility requirements:
Section 3.1.17 of the 2023 standard changes the defined
term ``tool'' (previously in section 3.1.90) to ``common household
tool,'' and clarifies that common household tools include straight-
blade or Phillips-type screwdrivers, pliers, coins, or other objects
``commonly found in most households.''
Section 8.6 of the standard continues to specify that
``[u]nless otherwise specified, none of the abuse testing . . . applies
to toys intended for children over 96 months of age.'' New Note 22 to
section 4.25.4.2, however, clarifies the test parameters used to
conduct use and abuse testing (in
[[Page 3346]]
accordance with sections 8.5-8.10) on toys containing small part
batteries for children over 96 months (eight years) of age. These toys
are now subject to use and abuse requirements using the test parameters
for children above age 36 months up to age 96 months; because previous
versions of ASTM F963 did not specify test parameters for toys
containing small part batteries for children over 96 months, these toys
were not required to be abuse tested per the standard. Note 22 thus
extends use and abuse test requirements so that they apply to all toys
with small part batteries in scope of the standard, which improves the
security of battery compartments.
Section 4.25.4.3 adds a new requirement that fasteners
used to secure battery compartments shall remain attached to the toy or
battery compartment cover before and after use and abuse testing.
Section 4.25.4.4 allows specialty fasteners, such as
screws that use a Torx or hex drive, as an alternative to common
household tools if the appropriate tool is included with the toy and
instructional material conforming to section 6.9 is included (see
below).
Section 6.9 adds a new requirement that instructional
literature for toys that require a manufacturer-supplied specialty or
custom tool to access the battery shall direct parents to retain the
tool for future use, store the tool where the child cannot access it,
and state that the tool is not a toy.
The changes related to battery accessibility generally result in
more secure battery compartments or streamline existing requirements in
the standard without impacting safety. In particular, the addition of
Note 22 means that toys with small part batteries for children over 96
months of age are now required to undergo the use and abuse testing in
sections 8.5-8.10. Further, the addition of section 4.25.4.3 means that
fasteners such as screws used to secure batteries are less likely to be
removed or lost, meaning that fasteners are more likely to be used
effectively and will likely result in fewer incidents of unintended
battery access, thus improving safety.
The changes allowing for the use of ``specialty fastener[s]'' in
section 4.25.4.4 of the ASTM F963-23 standard are consistent with their
use for other toys (see section 4.17 of the standard), and their use
provides children less opportunity to gain access to the battery
compartment using a substitute common household tool. Special tools do
introduce potential additional risks. The consumer must store and keep
track of an additional tool; if the tool is lost or not passed along or
sold with the toy for secondhand use, caregivers can no longer access
the compartment as intended, which may lead to battery leakage (if
never removed) or damaged or ineffective battery compartments (if the
consumer attempts to access the compartment using the inappropriate
tool). The new section 6.9 mitigates these possible hazards introduced
by section 4.25.4.4 by requiring that instructional literature for toys
that require a manufacturer-supplied specialty or custom tool to access
the battery shall direct parents to retain the tool for future use and
store the tool where the child cannot access it and shall state the
tool is not a toy. Additionally, a battery compartment that is
inaccessible due to a lost tool is a safer alternative than a battery
compartment that is easily opened. Therefore, the changes allowing for
specialty fasteners are, overall, an improvement to safety.
2. Expanding Materials
ASTM F963-16 added new definitions, performance requirements, a
test methodology, and a test fixture to address gastrointestinal (GI)
blockage from expanding materials. Expanding materials are defined in
ASTM F963 as ``any material used in a toy which expands greater than
50% in any dimension from its as-received state.'' New Annex A14.6
explains the basis for the new requirements for expanding materials.
Since the time of the ASTM F963-16 revision, items have been identified
in the marketplace that are not small parts as received by the
consumer, and therefore fall outside the scope of the original
requirement but present the same GI blockage hazard. The revisions in
ASTM F963-23 are intended to increase the scope of the standard to
cover these products.
Below is a summary of changes made in ASTM F963-23 that may apply
to expanding materials.
Section 3.1.28 removes the time intervals for conditioning
and instead refers to the test method section, where the same time
intervals are already stated.
Section 3.1.73 adds a definition of a ``removable
component,'' as ``a component of a toy which is intended or likely to
be removed by the child during normal use.''
Section 4.40 adds ``removable'' to components as defined.
It also removes conditions identifying the expanding materials, and
instead directly references the definition and relevant test method in
section 8.30.8. Section 4.40.1 increases the scope to include the
following:
[cir] Section 4.40.1.1--components of toys which are small parts
but encased in an outer shell that is not a small part and intended to
be dissolved, opened, or broken to access the expanding component; and
[cir] Section 4.40.1.2--components sold in an expanded state, which
are not small parts, but could contract to yield a re-expandable small
part.
The expanded scope of the ASTM F963-23 standard represents an
improvement in toy safety that should help reduce the hazard of
potentially fatal intestinal blockages caused by ingestion of toys and
toy components made of superabsorbent materials. The changes to the
provisions for expanding materials are an improvement in safety, as
noted above. However, as noted, the Commission also has directed staff
to develop a notice of proposed rulemaking under section 106 of the
CPSIA to further improve the safety standard for water beads.
3. Sound-Producing Toys
In 2017, the Commission incorporated ASTM F963-17 into the
mandatory toy standard at 16 CFR part 1250 with one exception related
to sound-producing toys, codified at 16 CFR 1250.2(c). The requirements
for sound-producing toys in section 4.5 of ASTM F963 are intended to
reduce the risk of hearing loss caused by exposure to sound produced by
toys. When it adopted the exception, the Commission rejected one clause
in the sound-producing toys test method in section 8.20.1.5 (5) of ASTM
F963-17 that functionally exempted push or pull toys from an 85 dB A-
weighted maximum sound pressure level (LAFmax)
requirement.\4\ The Commission concluded that this clause, which had
been added without ballot during the 2017 ASTM process, decreased
safety because it exempted push or pull toys from a previously
applicable sound limit. 82 FR 57119 (Dec. 4, 2017). With the
Commission's rejection of the relevant clause, as stated in 16 CFR
1250.2(c), the mandatory toy standard based on ASTM F973-17 retained
the same level of safety for push or pull toys as was provided by ASTM
F963-16.
---------------------------------------------------------------------------
\4\ A-weighting or C-weighting is typically applied to sounds to
represent more accurately the frequency response of the human ear by
reducing the contribution of lower and higher frequencies in
calculation of overall sound level.
---------------------------------------------------------------------------
As explained below, ASTM F963-23 provides a new sound limit for
push or pull toys that eliminates the deficiency in ASTM F963-17 and
provides the same level of safety as the sound limit in ASTM F963-16.
Therefore, because the incorporation of ASTM F963-23
[[Page 3347]]
maintains the same level of safety as ASTM F963-16, the exception to
ASTM F963-17 that is made by Sec. 1250.2(c) is no longer needed, and
the Commission is removing that exception by deleting Sec. 1250.2(c).
Specifically, section 4.5.1.6(1) of ASTM F963-23 adds a 94 dB A-
weighted sound limit (LAFmax) for push or pull toys in user-
propelled modes (the child is moving the toy), where the sound is
caused as a result of translational motion imparted on the toy by the
user (for example, a mechanism attached to the wheel of a push toy that
clicks when the wheel rotates).\5\ Push or pull toys are defined in
ASTM F963-23 as, ``a toy with a cord, tether, or handle attached to the
toy and where the toy is intended for use on the floor or ground with
the child in a standing/upright position, typically walking, while
using pushing or pulling the toy.'' CPSC Age Determination Guidelines
state that push toys with high upright handles or rigid rods with
large, attached handles are appropriate for children starting at 12
months old, and pull toys with cords are appropriate for children
starting at 19 months old because they do not provide support, so they
require more advanced walking and body skills to operate.\6\
---------------------------------------------------------------------------
\5\ Push or pull toys in stationary or self-propelled modes are
still subject to the 85 dB A-weighted sound limit, as in previous
versions of the standard.
\6\ Age Determination Guidelines 2020, p. 47. Available at
https://www.cpsc.gov/content/2020-Age-Determination-Guidelines.
---------------------------------------------------------------------------
Sound level generally decreases with increasing distance from the
sound source; a quieter toy used closer to a child's ear can produce
the same sound exposure as a louder toy used farther from the child's
ear. The previously applicable 85 dB(A) sound-limit for push or pull
toys in ASTM F963-16 was based on a 25 cm sound exposure distance
(assumed distance from the sound source to the child's ear) for
tabletop, floor and crib toys.\7\ The 94 dB(A) sound limit for push or
pull toys in ASTM F963-23 is based on a sound exposure distance of 63.5
cm that more accurately reflects the distance between the sound-
producing element of a push or pull toy and a standing child's ear.
Based on anthropometric data, staff estimate that the fifth percentile
ear height for a 19-24 month old child is 66.7 cm.\8\ For a push toy
with a sound source located 5 cm from the floor and 15 cm horizontally
from the ear, which is an estimate for a sound source located on a rear
wheel of a push toy, the estimated distance from the sound source to a
fifth percentile 19-24 month old standing child's ear is 63.5 cm.
---------------------------------------------------------------------------
\7\ See Annex A9.2 in ASTM F963-23 for more information.
\8\ Based on ear to top-of-head distance and stature data from
Schneider, L.W., Lehman, R.J., Pflug, M.A., & Owings, C.L. (1986).
(rep.). Size and Shape of the Head and Neck from Birth to Four Years
(p. 111). Ann Arbor, MI: University of Michigan.
---------------------------------------------------------------------------
Using the standard equations for the distance-related decrease of
sound level in a free field sound environment,\9\ with the 63.5 cm
sound exposure distance, the 50 cm measurement distance (distance from
the sound source or surface of the toy to the microphone during
testing), and an allowable sound exposure at the ear of 92.3 dB(A),\10\
the allowable sound level at the measurement distance is 94.4 dB(A),
which rounds to 94 dB(A), the sound limit in ASTM F963-23.
---------------------------------------------------------------------------
\9\ See Annex A14.4.2 in ASTM F963-23 for more information.
\10\ This is the allowable sound exposure based on the National
Institute for Occupational Safety and Health 85 dB(A) recommended
exposure limit and 3 dB exchange rate for an assumed 1.5 hours of
play, as described in Annex A9.2 in ASTM F963-23. Note that 92.3
dB(A) is higher than the 90 dB(A) used to calculate the 85 dB(A)
sound limit but is one of the listed recommended values (Annex
A9.2.1.4). More information on the recommended exposure limit and
noise dose calculations can be found in Centers for Disease Control
and Prevention (1998). Occupational noise exposure; criteria for a
recommended standard. Available at Occupational noise exposure;
criteria for a recommended standard (cdc.gov).
---------------------------------------------------------------------------
Table 1 shows the A-weighted sound limit, measurement distance,
sound exposure distance, and sound level at the ear by toy category in
ASTM F963. This table shows that the new sound limit for push or pull
toys produces a similar sound level at the ear to the other toy limits
in the toy standard and is below the generally applicable limit of 92.3
dB at the ear.
Table 1--A Weighted Sound Limit, Measurement Distance, Sound Exposure Distance, and Sound Level at the Ear by
Toy Category
----------------------------------------------------------------------------------------------------------------
Sound
Measurement exposure Sound level
Toy category A-weighted sound limit distance distance at the ear
(cm) (cm) (dBA)
----------------------------------------------------------------------------------------------------------------
Close-to-the ear toys................. 65 dB (LAeq).................... 50 2.5 91.02
Hand-held toys........................ 85 dB (LAeq).................... 50 25 91.02
Tabletop, Floor, or Crib Toys in 85 dB (LAeq).................... 50 25 91.02
stationary or self-propelled modes.
Tabletop, Floor, or Crib Toys in user- 85 dB (LAFmax).................. 50 25 91.02
propelled modes.
Push or Pull Toys in stationary or 85 dB (LAeq).................... 50 25 91.02
self-propelled modes.
Push or Pull Toys in user-propelled 94 dBA (LAFmax)................. 50 63.5 91.92
modes.
----------------------------------------------------------------------------------------------------------------
Although the revised 94 dB(A) sound limit for push or pull toys is
higher than the 85 dB(A) sound limit in ASTM F963-16, the change does
not negatively impact safety because the sound exposure distance on
which the revised limit is now based more accurately reflects the
expected distance between the push or pull toy sound source and the
child's ear when the child is using the toy, and because the 94 dB(A)
sound limit is within the margin of safety based on the assumptions
used in the sound-producing toys section of the standard. This revision
in ASTM F963-23 thus resolves the issue that required the Commission to
provide the exception in 16 CFR 1250.2(c). Therefore, the direct final
rule removes the codified text in 16 CFR 1250.2(c) because it is no
longer necessary.
B. Revisions Not Impacting Safety
ASTM F963-23 contains numerous non-substantive changes, including
editorial changes such as correcting typographical errors,
reformatting, renumbering, and restructuring provisions, that do not
impact the safety of toys. Below is a discussion of those revisions.
1. Sound-Producing Toys
In addition to the substantive change discussed above, the
revisions for sound producing toys reflected in ASTM F963-23 also
include changes to sound-producing toy definitions, performance
requirements, and test methods to improve clarity. Most of the changes
clarify categories of toys, applicable requirements, and the
relationship
[[Page 3348]]
between the definitions in section 3, the requirements in section 4,
and the test methods in section 8.
Clarifying changes were made to improve the precision of
definitions related to sound-producing toys and provide additional
examples--for example in sections 3.1.14, 3.1.37, 3.1.69, and 3.1.89.
Clarifying changes were also made to sections 4.5, 4.5.1, 4.5.1.1, and
4.5.1.7.
New language based on existing section 4.5 was added to
sections 4.5.1.2 (Hand-held toys), 4.5.1.3 (Rattles), 4.5.1.4
(Stationary or Self-propelled Tabletop, Floor, or Crib Toys), 4.5.1.5
(User-propelled Tabletop, Floor, or Crib Toys), and 4.5.1.6 (Push or
Pull Toys).
A new Note 13 relating to modes of tabletop, floor, or
crib toys was added to section 4 of the standard.
Both clarifying and editorial changes were made to the
test methods in section 8.20, 8.20.1, 8.20.1.1, 8.20.1.2, 8.20.1.3,
8.20.1.4, 8.20.1.5, 8.20.1.6, 8.20.2.1, 8.20.2.4, 8.20.2.5, and
8.20.2.6 of the standard. Sections 8.20.2.2 (Hand-held Toys) and
8.20.2.3 (Rattles) were moved, in addition to such clarifying and
editorial changes.
Note 52, concerning use and abuse testing, was added to
the test methods section.
ASTM F963-23 also contains a new Annex A14.4 that explains
the technical basis for the revision to the A-weighted sound limit for
push or pull toys, and rationale for the other changes to the sound-
producing toys section.
The changes to the sound-producing toy definitions, performance
requirements, and test methods improve clarity but do not affect the
scope of toys covered by the standard, the performance requirements for
these toys, or the test methods applicable to these toys. In addition,
these clarifying changes will likely increase consistency in testing of
sound-producing toys between test laboratories, which could improve
safety.
2. Drop Test Floor Specification
Section 8.7 of ASTM F963-23, which is unchanged from the 2017
version of the standard, describes a drop test in which a toy is
dropped a certain number of times in random orientations from heights
based on the ages and expected heights of certain children, onto a
specified impact surface. After testing, the toy is examined for
mechanical hazards such as hazardous sharp points and sharp edges, and
for ingestion hazards such as small, liberated components, chips, or
fragments. In ASTM F963-17 and previous versions of the standard, the
impact surface was specified in a referenced federal standard SS-T-
312B, Tile, Floor: Asphalt, Rubber, Vinyl, Vinyl-Asbestos. The SS-T-
312B standard, however, has been withdrawn and replaced with ASTM
F1066, Specification for Vinyl Composition Floor Tile. The impact
medium now specified in ASTM F1066 is the same one formerly specified
in SS-T-312B. Accordingly, while ASTM F963-23, section 2 Referenced
Documents has been revised to replace the standard SS-T-312B with ASTM
F1066, there is no change to the test method or subsequent results.
Therefore, this change does not impact safety.
3. Toxicology
Section 4.3 addresses the safety of substances and materials used
in toys. Below is a brief description of the non-substantive changes to
the following provisions.
a. Section 4.3.5.2--Toy Substrate Materials
Section 4.3.5.2 of ASTM F963-23 addresses requirements and test
methods for specified chemical substances in the substrate materials of
toys, where substrate refers to the materials used in toys other than
the paints and surface coatings. Changes were made to improve the
text's clarity and flow and to update references to CPSC regulations.
Among the clarifications is a new section, 4.3.5.2(1)(e), which
indicates that paper and paperboard are not included in the scope of
the requirements of section 4.3.5.2. The information in this new
section was previously included in Note 5 in the F963-17 standard.
Thus, the change is a non-substantive rearrangement of the existing
text and is not a change in any requirements.
b. Section 4.3.8--Phthalates
Section 4.3.8 of ASTM F963-23 was retitled ``Phthalates'' from the
previous ``DEHP(DOP)'' and updates the provision to be consistent with
the requirements for specified phthalates contained in 16 CFR part
1307. The revised section also references the current CPSC test method
and Commission determinations related to requirements for third-party
testing. The changes reflect current regulation and practice. While the
revisions are intended to avoid stakeholder confusion by providing an
up-to-date description of CPSC's mandatory phthalates requirements,
revised section 4.3.8 and the accompanying notes are restatements of
existing CPSC rules. Under section 106(a) of the CPSIA, restatements of
other CPSC regulations are not considered to be part of the mandatory
toy standard and thus are not part of the section 106 standard-revision
process.
c. Section 4.3.6.1--Most Recent Version of USP 35
Section 4.3.6.1 provides information on the bacteriological
standards for water used in the manufacturing and filling of toys. This
section references USP 35, which is the current version of the standard
established by United States Pharmacopeial Convention (USP) General
Chapter 1231 (identified in the standard as USP <1231>). ASTM F963-23
revises section 4.3.6.1 to allow for the use of the current version of
the USP standard (USP 35) or the most recent version of USP <1231>), if
the USP standard is updated to a version beyond USP 35. Because USP
<1231>) addresses water used for pharmaceutical purposes, any future
revisions should continue to provide a high level of safety for toys.
Should a future update to USP <1231>) result in a reduction to toy
safety, the Commission has authority under sections 106(c) and (d) of
the CPSIA to address such an issue.
4. Section 5.1.2--Tracking Labels
ASTM F963-23 adds a new section 5.1.2, restating CPSC regulations
for tracking labels and adding Notes 26 and 27 restating CPSC guidance
regarding tracking labels. While this addition assists stakeholders in
understanding the applicable policies, under section 106(a) of the
CPSIA it is a restatement of existing Commission requirements and not
considered to be part of the mandatory toy standard.
5. Section 8.3.2.1--Apparatus Metal Sieve
ASTM F963 calls for the use of a metal sieve consisting of
stainless-steel wire mesh held in a round metal frame, as a screen
tool. Section 8.3.2.1 requires the use of a 0.5 mm (500 [mu]m) standard
sieve, also known as a No. 35 sieve (U.S. Alternative). Revised section
8.3.2.1 in ASTM F963-23 corrects a typographical error regarding the
nominal wire diameter and the maximum size deviation for an individual
opening of a No. 35 sieve, which are both listed incorrectly in units
of micrometers ([mu]m) in ASTM F963-17. Revised section 8.3.2.1 uses
millimeters (mm)--the correct unit of measurement. Because the No. 35
sleeve was specified previously and remains specified, this correction
does not impact safety.
6. Section 8.14--Projectile Toys
Several changes were made to the test method for projectile toys in
section 8.14 of ASTM F963-23. Section 8.14.3
[[Page 3349]]
reorders the conditions of the bow used for testing, placing the 70 cm
pullback distance condition ahead of the 150 Newtons (N) pull force
condition when stretching the bow to determine the velocity of the
arrow. Section 8.14.5.4 reorders the test conditions to determine the
velocity of the projectile in a more logical sequence. Sections
8.14.5.4 and 8.14.5.5 of ASTM F963-17 have been renumbered to sections
8.14.5.5 and 8.14.5.6 in ASTM F963-23. Section 8.14.6.2 also places the
70 cm pullback distance condition ahead of the 150 N pull force
condition when stretching the bow to determine the velocity of the
arrow. These changes do not change the substantive performance
requirements or otherwise affect toy safety.
III. Incorporation by Reference
Section 1250.2 of the direct final rule incorporates by reference
ASTM F963-23. The Office of the Federal Register (OFR) has regulations
regarding incorporation by reference. 1 CFR part 51. Under these
regulations, agencies must discuss in the preamble to a final rule, how
the material the agency incorporates by reference is reasonably
available to interested parties. In addition, the preamble to the final
rule must summarize the material. 1 CFR 51.5(b).
In accordance with the OFR regulations, section II of this preamble
summarizes the major provisions of ASTM F963-23 that the Commission
incorporates by reference into 16 CFR part 1250. Until the direct final
rule takes effect, a read-only copy of ASTM F963-23 is available for
viewing, at no cost, on ASTM's website at: www.astm.org/CPSC.htm. Once
the rule takes effect, a read-only copy of the standard will be
available for viewing, at no cost, on the ASTM website at:
www.astm.org/READINGLIBRARY/. Interested parties can also schedule an
appointment to inspect a copy of the standard at the Office of the
Secretary, U.S. Consumer Product Safety Commission, 4330 East West
Highway, Bethesda, MD 20814, telephone: (301) 504-7479; email: [email protected]. Interested parties can purchase a copy of ASTM F963-23
from ASTM International, 100 Barr Harbor Drive, P.O. Box C700, West
Conshohocken, PA 19428-2959, telephone: (610) 832-9500; website:
www.astm.org.
IV. Certification
Section 14(a) of the CPSA (15 U.S.C. 2051-2089) requires
manufacturers of 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, to certify that the
products comply 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
of a sufficient number of samples by a third-party conformity
assessment body accredited by CPSC to test according to the applicable
requirements. As noted, rules issued under section 106 of the CPSIA are
``consumer product safety standards.'' 15 U.S.C. 2056b(f). Thus, they
are subject to the testing and certification requirements of section 14
of the CPSA.
Because toys are children's products, a CPSC-accepted third-party
conformity assessment body must test samples of the products. Products
subject to part 1250 also must comply with all other applicable CPSC
requirements, such as the lead content requirements in section 101 of
the CPSIA (15 U.S.C. 1278a), the tracking label requirements in section
14(a)(5) of the CPSA (15 U.S.C. 2063(a)(5)), and the consumer
registration form requirements in section 104(d) of the CPSIA (15
U.S.C. 2056a(d)). ASTM F963-23 makes no changes to ASTM F963-17 that
would impact any of these existing requirements.
V. Notice of Requirements
In accordance with section 14(a)(3)(B)(vi) of the CPSA, the
Commission has previously published four NORs for accreditation of
third-party conformity assessment bodies for testing toys. See 76 FR
46598 (Aug. 3, 2011); 78 FR 15836 (Mar. 12, 2013); 82 FR 8989 (Feb. 2,
2017); 82 FR 57119 (Dec. 4, 2017). The 2013 NOR provided the criteria
and process for the Commission's acceptance of accreditation of third-
party conformity assessment bodies for testing toys to ASTM F963-11.
The two updates published in 2017 addressed the revisions in ASTM F963-
16 and ASTM F963-17. The current NOR for ASTM F963-17 is listed in the
Commission's rule, ``Requirements Pertaining to Third Party Conformity
Assessment Bodies.'' 16 CFR part 1112.
The previous NOR for the toy safety standard addressed testing to
37 provisions of ASTM F963. The Commission will require third party
testing for the same 37 provisions. To that end, this rule revises
Sec. 1112.15(b)(32) introductory text, (b)(32)(ii) introductory text,
and (c)(1)(iii) of 16 CFR part 1112 by updating the incorporations by
reference to reflect the numbering in ASTM F963-23. Additionally, Sec.
1112.15(b)(32)(ii)(C) is revised to include ``Items of Avian Feather
Origin'' in the title for section 4.3.6 of the voluntary standard,
which was inadvertently not included in the previous NOR in part 1112.
Some of the revised sections of ASTM F963 include changes to test
methods discussed in section II of the preamble. These changes do not
involve a change in scientific discipline or significant increases in
complexity. Therefore, CPSC will accept testing to support product
certifications for sections in ASTM F963-23 if the test laboratory is
already CPSC-accepted to the corresponding provisions in ASTM F963-17.
Test laboratories that conduct testing to support product
certifications to ASTM F963-23 must show in their test reports ``ASTM
F963-23'' and the specific section numbers in the standard to which the
product was evaluated.
When test laboratories seek CPSC acceptance for one or more ASTM
F963-23 sections, they will be required to update their accreditation
scope. CPSC will open the application process for all sections of ASTM
F963-23 when this document is published in the Federal Register. To be
CPSC-accepted for sections in ASTM F963-23, a test laboratory's scope
of accreditation must include the reference to ``ASTM F963-23'' and a
specific reference to one or more of the 37 sections listed in the NOR.
Test laboratories that are currently accepted to ASTM F963-17 are
instructed to update their accreditation scope to include ASTM F963-23
sections as soon as possible and submit their ASTM F963-23 application
for CPSC acceptance within two years. Test laboratories that were not
previously CPSC-accepted to sections of ASTM F963-17 and that wish to
request CPSC acceptance to ASTM F963-23 should work with their
accreditation bodies to include ``ASTM F963-23'' sections in their
scope of accreditation. This approach will avoid disruption to third
party testing to the toy safety standard and allow for a practicable
transition from ASTM F963-17 to ASTM F963-23 for testing laboratories,
the toy industry, consumers, and other interested parties.
VI. Direct Final Rule Process
The Commission is issuing this rule as a direct final rule.
Although the Administrative Procedure Act (APA; 5 U.S.C. 551-559)
generally requires agencies to provide notice of a rule and an
opportunity for interested parties to comment on it, section 553 of the
APA provides an exception when the agency ``for good cause finds'' that
notice and comment are ``impracticable, unnecessary, or contrary to the
public interest.'' 5 U.S.C. 553(b)(B).
[[Page 3350]]
Under the process set out in section 106(g) of the CPSIA, when ASTM
revises a standard that the Commission has previously incorporated by
reference under section 104(b)(1)(B) of the CPSIA, that revision
becomes the new CPSC standard by operation of law, unless the
Commission determines that ASTM's revision does not improve the safety
of the product. The Commission is allowing ASTM F963-23 to become
CPSC's new standard because its provisions improve product safety. This
rule updates the Code of Federal Regulations so that it reflects the
version of the standard that takes effect by statute, but under the
terms of the CPSIA, ASTM F963-23 would take effect as the new CPSC
standard for toys even if the Commission did not issue this rule. Thus,
public comments would not alter substantive changes to the standard or
the effect of the revised standard as a consumer product safety
standard under section 106(g) of the CPSIA. Under these circumstances,
notice and comment are unnecessary under the APA.
In Recommendation 95-4, the Administrative Conference of the United
States (ACUS) endorses direct final rulemaking as an appropriate
procedure to expedite rules that are noncontroversial and not expected
to generate significant adverse comments. See 60 FR 43108 (Aug. 18,
1995). ACUS recommends that agencies use the direct final rule process
when they act under the ``unnecessary'' prong of the good cause
exemption in 5 U.S.C. 553(b)(B). Consistent with the ACUS
recommendation, the Commission is publishing this rule as a direct
final rule, because CPSC does not expect any significant adverse
comments.
Unless CPSC receives a significant adverse comment within 30 days
of this notification, the rule will become effective on April 20, 2024.
In accordance with ACUS's recommendation, the Commission considers a
significant adverse comment to be ``one where the commenter explains
why the rule would be inappropriate,'' including an assertion
challenging ``the rule's underlying premise or approach'' or a claim
that the rule ``would be ineffective or unacceptable without a
change.'' 60 FR 43108, 43111 (Aug. 18, 1995). As noted, this rule
merely updates the CFR to reflect a change that occurs by statute, and
public comments should address this specific action.
If the Commission receives a significant adverse comment, the
Commission will withdraw this direct final rule. Depending on the
comment and other circumstances, the Commission may then incorporate
the adverse comment into a subsequent direct final rule or publish a
notice of proposed rulemaking, providing an opportunity for public
comment.
VII. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA; 5 U.S.C. 601-612) generally
requires agencies to review proposed and final rules for their
potential economic impact on small entities, including small
businesses, and to prepare regulatory flexibility analyses. The RFA
applies to any rule that is subject to notice and comment procedures
under section 553 of the APA. 5 U.S.C. 603, 604. As discussed in
section VI of this preamble, the Commission has determined that notice
and the opportunity to comment are unnecessary for this rule.
Therefore, the RFA does not apply. CPSC also notes the limited nature
of this document, which merely updates the incorporation by reference
to reflect the mandatory CPSC standard that takes effect by operation
of CPSIA section 106.
VIII. Paperwork Reduction Act
The current mandatory standard for toys includes requirements for
marking, labeling, and instructional literature that constitute a
``collection of information'' as defined in the Paperwork Reduction Act
(PRA; 44 U.S.C. 3501-3521). The Office of Management and Budget (OMB)
has approved the collection of information for ASTM F963-17 under OMB
Control No. 3041-0159. ASTM F963-23 updates the requirement for
instructional literature to add an instruction for toys that require a
manufacturer-supplied specialty or custom tool to access batteries,
which directs parents to retain the tool for future use, to store it
where the child cannot access it, and state that the tool is not a toy.
This change to the instructional literature is within the scope of the
information collection approved by OMB in 2022.
IX. Effective Date
Under the procedure set forth in section 106(g) of the CPSIA, when
ASTM revises ASTM F963, the revision becomes the CPSC standard within
180 days of notification to the Commission, unless the Commission
determines that the revision does not improve the safety of the
product. In accordance with this provision, this rule establishes an
effective date that is 180 days after the Commission received
notification from ASTM of revisions to the standard. As discussed in
section VI of this preamble, this is a direct final rule. Unless we
receive a significant adverse comment within 30 days, the rule will
become effective on April 20, 2024. The effective date for the NOR is
likewise April 20, 2024, the same date that the provisions of ASTM
F963-23 become effective.
X. Preemption
Section 26(a) of the CPSA provides that where a consumer product
safety standard is in effect and applies to a product, no state or
political subdivision of a state may either establish or continue in
effect a requirement dealing with the same risk of injury unless the
state requirement is identical to the federal standard. 15 U.S.C.
2075(a). Section 26(c) of the CPSA also provides that states or
political subdivisions of states may apply to CPSC for an exemption
from this preemption under certain circumstances. Section 106(f) of the
CPSIA deems rules issued under that provision ``consumer product safety
standards.'' Therefore, once a rule issued under section 106 of the
CPSIA takes effect, it will preempt in accordance with section 26(a) of
the CPSA.
XI. Environmental Considerations
Commission rules are categorically excluded from any requirement to
prepare an environmental assessment or an environmental impact
statement where they ``have little or no potential for affecting the
human environment.'' 16 CFR 1021.5(c)(2). This rule falls within the
categorical exclusion, so no environmental assessment or environmental
impact statement is required.
XII. Congressional Review Act
The Congressional Review Act (CRA; 5 U.S.C. 801-808) states that
before a rule may take effect, the agency issuing the rule must submit
the rule, and certain related information, to each House of Congress
and the Comptroller General. 5 U.S.C. 801(a)(1). The CRA submission
must indicate whether the rule is a ``major rule.'' The CRA states that
the Office of Information and Regulatory Affairs determines whether a
rule qualifies as a ``major rule.''
Pursuant to the CRA, OMB's Office of Information and Regulatory
Affairs has determined that this rule is not a ``major rule,'' as
defined in 5 U.S.C. 804(2). To comply with the CRA, CPSC will submit
the required information to each House of Congress and the Comptroller
General.
[[Page 3351]]
List of Subjects
16 CFR Part 1112
Administrative practice and procedure, Audit, Consumer protection,
Incorporation by reference, Reporting and recordkeeping requirements,
Third party conformity assessment body.
16 CFR Part 1250
Consumer protection, Imports, Incorporation by reference, Imports,
Infants and children, Law enforcement, Safety, Toys.
For the reasons discussed in the preamble, the Commission amends 16
CFR chapter II as follows:
PART 1112--REQUIREMENTS PERTAINING TO THIRD PARTY CONFORMITY
ASSESSMENT BODIES
0
1. Revise the authority citation for part 1112 to read as follows:
Authority: 15 U.S.C. 2063.
0
2. Amend Sec. 1112.15 by revising paragraphs (b)(32) introductory
text, (b)(32)(ii) introductory text, (b)(32)(ii)(C), and (c)(1)(ii) to
read as follows:
Sec. 1112.15 When can a third-party conformity assessment body apply
for CPSC acceptance for a particular CPSC rule or test method?
* * * * *
(b) * * *
(32) 16 CFR part 1250, safety standard for toys. CPSC only requires
certain provisions of ASTM F963-23 to be subject to third party
testing; therefore, CPSC only accepts the accreditation of third-party
conformity assessment bodies for testing under the following toy safety
standards:
* * * * *
(ii) ASTM F963-23:
* * * * *
(C) Section 4.3.6, Cleanliness of Liquids, Pastes, Putties, Gels,
and Powders, and Items of Avian Feather Origin (except for cosmetics
and tests on formulations used to prevent microbial degradation).
* * * * *
(c) * * *
(1) * * *
(ii) ASTM F963-23, ``Standard Consumer Safety Specification for Toy
Safety,'' August 1, 2023.
* * * * *
PART 1250--SAFETY STANDARD MANDATING ASTM F9623 FOR TOYS
0
3. Revise the authority citation for part 1250 to read as follows:
Authority: 15 U.S.C. 2056b.
0
4. Revise Sec. 1250.2 to read as follows:
Sec. 1250.2 Requirements for toy safety.
(a) Each toy must comply with all applicable provisions of ASTM
F963-23 Standard Consumer Safety Specification for Toy Safety, approved
on August 1, 2023. 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. This incorporation by reference (IBR) material is available
for inspection at the U.S. Consumer Product Safety Commission and at
the National Archives and Records Administration (NARA). Contact the
U.S. Consumer Product Safety Commission at: Office of the Secretary,
U.S. Consumer Product Safety Commission, 4330 East West Highway,
Bethesda, MD 20814, telephone (301) 504-7479, email [email protected].
For information on the availability of this material at NARA, email
[email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations. A read-only copy of the standard is available for
viewing on the ASTM website at https://www.astm.org/READINGLIBRARY/.
You may obtain a copy from ASTM International, 100 Barr Harbor Drive,
P.O. Box C700, West Conshohocken, PA 19428-2959; telephone (610) 832-
9500; www.astm.org.
(b) Pursuant to section 106(a) of the Consumer Product Safety
Improvement Act of 2008, section 4.2 and Annex 5 or any provision of
ASTM F963 that restates or incorporates an existing mandatory standard
or ban promulgated by the Commission or by statute or any provision
that restates or incorporates a regulation promulgated by the Food and
Drug Administration or any statute administered by the Food and Drug
Administration are not part of the mandatory standard incorporated in
paragraph (a) of this section.
Alberta E. Mills,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2024-00741 Filed 1-17-24; 8:45 am]
BILLING CODE 6355-01-P