[Federal Register Volume 87, Number 80 (Tuesday, April 26, 2022)]
[Rules and Regulations]
[Pages 24414-24417]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-08804]


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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1235

[Docket No. CPSC-2016-0023]


Safety Standard for Baby Changing Products

AGENCY: Consumer Product Safety Commission.

ACTION: Direct final rule.

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SUMMARY: In June 2018, the U.S. Consumer Product Safety Commission 
(CPSC or Commission) published a consumer product safety standard for 
baby changing products under section 104 of the Consumer Product Safety 
Improvement Act of 2008 (CPSIA). The standard incorporated by reference 
the 2018 ASTM International (ASTM) voluntary standard for baby changing 
products that was in effect at the time. The CPSIA sets forth a process 
for updating mandatory standards for durable infant or toddler products 
that are based on a voluntary standard, when a voluntary standards 
organization revises the standard. Consistent with the CPSIA update 
process, this direct final rule updates the mandatory standard for baby 
changing products to incorporate by reference ASTM's 2021 version of 
the voluntary standard.

DATES: The rule is effective on July 31, 2022, unless CPSC receives a 
significant adverse comment by May 26, 2022. If CPSC receives such a 
comment, it will publish a notification 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 July 31, 2022.

ADDRESSES: You can submit comments, identified by Docket No. CPSC-2016-
0023, by any of the following methods:
    Electronic Submissions: Submit electronic comments to the Federal 
eRulemaking Portal at: https://www.regulations.gov. Follow the 
instructions for submitting comments. CPSC does not accept comments 
submitted by electronic mail (email), except through https://www.regulations.gov, and as described below. CPSC encourages you to 
submit electronic comments by using the Federal eRulemaking Portal, as 
described above.
    Mail/hand delivery/courier Written Submissions: Submit comments by 
mail/hand delivery/courier to: Division of the Secretariat, Consumer 
Product Safety Commission, 4330 East-West Highway, Bethesda, MD 20814; 
telephone: (301) 504-7479. Alternatively, as a temporary option during 
the COVID-19 pandemic, you may email such submissions to: [email protected].
    Instructions: All submissions must include the agency name and 
docket number for this direct final rule. CPSC may post all comments 
without change, including any personal identifiers, contact 
information, or other personal information provided, to: https://www.regulations.gov. Do not submit electronically: Confidential 
business information, trade secret information, or other sensitive or 
protected information that you do not want to be available to the 
public. If you wish to submit such information, please submit it 
according to the instructions for mail/hand delivery/courier written 
submissions.
    Docket: For access to the docket to read background documents or 
comments received, go to: https://www.regulations.gov, and insert the 
docket number, CPSC-2016-0023, into the ``Search'' box, and follow the 
prompts.

FOR FURTHER INFORMATION CONTACT: Keysha Walker, Compliance Officer, 
U.S. Consumer Product Safety Commission, 4330 East-West Highway, 
Bethesda, MD 20814; telephone: (301) 504-6820; email: [email protected].

SUPPLEMENTARY INFORMATION: 

A. Background

1. Statutory Authority

    Section 104(b)(1) of the CPSIA requires the Commission to assess 
the effectiveness of voluntary standards for durable infant or toddler 
products and adopt mandatory standards for those products. 15 U.S.C. 
2056a(b)(1). The mandatory standard must be ``substantially the same 
as'' the voluntary standard, or it may be ``more stringent than'' the 
voluntary standard, if the Commission determines that more stringent 
requirements would further reduce the risk of injury associated with 
the product. Id.
    Section 104(b)(4)(B) of the CPSIA specifies the process for 
updating the Commission's rules when a voluntary standards organization 
revises a standard that the Commission incorporated by reference under 
section 104(b)(1). First, the voluntary standards organization must 
notify the Commission of the revision. Once the Commission receives 
this notification, the Commission may reject or accept the revised 
standard. The Commission may reject the revised standard by notifying 
the voluntary standards organization, within 90 days of receiving 
notice of the revision, that it has determined that the revised 
standard does not improve the safety of the consumer product and that 
it is retaining the existing standard. If the Commission does not take 
this action to reject the revised standard, the revised voluntary 
standard will be considered a consumer product safety standard issued 
under section 9 of the Consumer Product Safety Act (15 U.S.C. 2058), 
effective 180 days after the Commission received notification of the 
revision or on a later date specified by the Commission in the Federal 
Register. 15 U.S.C. 2056a(b)(4)(B).

2. Safety Standard for Baby Changing Products

    Under section 104(b)(1) of the CPSIA, the Commission adopted a 
mandatory rule for baby changing products, codified in 16 CFR part 
1235. The rule incorporated by reference ASTM F2388-18, Standard 
Consumer Safety Specification for Baby Changing Products for Domestic 
Use, with no modifications. 83 FR 29672 (June 26, 2018). At the time 
the Commission published the final rule, ASTM F2388-18 was the current 
version of the voluntary standard.
    On February 1, 2022, ASTM notified CPSC that it had revised the 
voluntary standard for baby changing products, approving ASTM F2388-21 
on November 15, 2021.\1\ As discussed below, based on CPSC staff's 
review of

[[Page 24415]]

ASTM F2388-21,\2\ the Commission will allow the revised voluntary 
standard to become the mandatory standard because the revised 
requirements in the voluntary standard either improve the safety of 
baby changing products, or are neutral with respect to safety.\3\ 
Accordingly, by operation of law under section 104(b)(4)(B) of the 
CPSIA, ASTM F2388-21 will become the mandatory consumer product safety 
standard for baby changing products on July 31, 2022. 15 U.S.C. 
2056a(b)(4)(B). This direct final rule updates 16 CFR part 1235 to 
incorporate by reference the revised voluntary standard, ASTM F2388-21.
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    \1\ ASTM published ASTM F2388-21 in January 2022.
    \2\ CPSC staff's briefing memorandum regarding ASTM F2388-21 is 
available at: https://www.cpsc.gov/s3fs-public/ASTMs-Revised-Safety-Standard-for-Baby-Changing-Products.pdf?VersionId=AzvKHXTe8uo1ZNrug1TLhQ_3kyp0lWhc.
    \3\ The Commission voted 3-0-1 to approve this document. Chair 
Hoehn-Saric, Commissioner Baiocco, and Commissioner Feldman voted to 
approve this document. Commissioner Trumka abstained from the vote.
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B. Revisions to ASTM F2388

    The ASTM standard for baby changing products includes performance 
requirements, test methods, and requirements for warning labels and 
instructional literature, to address hazards to children associated 
with baby changing products, including structural integrity, stability, 
barriers, retention of contoured changing pads and add-on changing 
units, entrapment, self-closing steps, and restraints. This section 
describes the changes in ASTM F2388-21, as compared to ASTM F2388-18, 
which is the current mandatory standard, and includes an assessment of 
those changes. ASTM F2388-21 contains substantive revisions, as well as 
editorial, non-substantive revisions.

1. Substantive Revisions

    ASTM F238-21 includes two substantive changes. The first revision 
is in Figure 9, Webbing Tension Pull Device, which is in section 7 of 
the standard. Section 7 specifies test methods to address hazards 
associated with baby changing products. Section 7.8 provides tests to 
assess restraint systems, which include components of the baby changing 
product that contribute to the capability to restrict upward or lateral 
movement of an occupant's torso within the product. Part of the 
restraint system test involves using a webbing tension pull device to 
adjust the restraint before applying a specified pull force to the 
restraint. Figure 9 depicts the webbing tension pull device that must 
be used. In ASTM F2388-21, two notes have been added to Figure 9 to 
provide the overall width and length dimensions for the tool, and a 
metric equivalent dimension has been added for one of the dimensions 
shown in the figure. CPSC staff considers these revisions neutral with 
respect to the safety of baby changing products because they provide 
dimension notes and equivalent metric measurements, which clarify how 
to fabricate the test tool, but do not change the test tool or test 
procedure. Moreover, the revisions are consistent with figures of 
similar webbing tension devices used in other ASTM standards, such as 
ASTM F833-21, Standard Consumer Safety Performance Specification for 
Carriages and Strollers.
    The second revision is in section 9.5 of the standard, which 
provides warning statements that must be addressed on product labels 
and requires that the warnings align with the format and text 
requirements illustrated in the standard. The warning statements 
provided in section 9.5.1 address fall hazards, including the hazard 
statement, ``Fall Hazard,'' at the beginning of the warning statement. 
In ASTM F2388-21, this hazard statement has been revised to be 
capitalized as ``FALL HAZARD.'' Likewise, the warning statements 
provided in section 9.5.3 address suffocation hazards, including the 
hazard statement, ``Suffocation Hazard,'' at the beginning of the 
warning statement. In ASTM F2388-21, this warning statement has also 
been revised to be capitalized as ``SUFFOCATION HAZARD.'' CPSC staff 
considers these revisions an improvement to the safety of baby changing 
products because capitalization emphasizes the hazard statements and 
makes them more conspicuous, thereby increasing the likelihood that a 
caregiver will pay attention to the warning statements.

2. Non-Substantive Revisions

    ASTM F2388-21 also includes minor revisions that are editorial and 
do not alter any substantive requirements in the standard. These 
changes are as follows:
     Footnote 1 has been revised to include ``baby changing 
products,'' instead of ``changing tables,'' as part of the correct name 
for the subcommittee that developed the standard and has been revised 
to include the approval and publication dates of the revised standard.
     Figure 11, which provides examples of left-aligned warning 
label text, has been renumbered as Figure X1.1 and relocated from 
section 9, Marking and Labeling, to section X1, Rationale. This 
revision has not changed the figure content or illustration. Although 
section 9 is a mandatory portion of the standard and section X1 is not 
mandatory, moving Figure 11 is a non-substantive change because the 
figure merely provides examples of the mandatory message panel text 
layout specified in section 9.4.6.1, and already was not mandatory.
     ASTM F2388-21 includes minor wording changes and 
grammatical corrections, including changing ``example warning labels'' 
to ``example warning statements'' (section 9.4.7); changing the warning 
label statement regarding fall hazards from ``stay within arms reach'' 
to ``stay in arm's reach of your child'' (section 9.5.1); and 
correcting the title of updated Figure X1.1 from ``Example of Left 
Aligned Text'' to ``Example of Left-aligned Text.''
     In section 9, Marking and Labeling, and section 10, 
Instructional Literature, several figure names have been revised, 
including changing ``sample label'' to ``example warning statements'' 
(revised Figures 11 through 15), and changing ``Sample Warning in 
Instructions--for example, Changing Table'' to ``Example Warning 
Statement in Instructions--e.g., Changing Table'' (updated Figure 16). 
These revisions are consistent with wording that was already in the 
standard, which describes these figures as ``examples'' (sections 9.4.7 
and 10.4).
    Because these revisions do not change any substantive requirements, 
they are neutral with respect to the safety of baby changing products.

C. Incorporation by Reference

    Section 1235.2 of the direct final rule incorporates by reference 
ASTM F2388-21. 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, 
ways in which the material the agency incorporates by reference is 
reasonably available to interested parties, and how interested parties 
can obtain the material. In addition, the preamble to the final rule 
must summarize the material. 1 CFR 51.5(b).
    In accordance with the OFR regulations, section B. Revisions to 
ASTM F2388 of this preamble summarizes the major provisions of ASTM 
F2388-21 that the Commission here incorporates by reference into 16 CFR 
part 1235. The standard is reasonably available to interested parties. 
Until the direct final rule takes effect, a read-only copy of ASTM 
F2388-21 is available for viewing, at no cost, on ASTM's website at: 
https://www.astm.org/CPSC.htm. Once the rule

[[Page 24416]]

takes effect, a read-only copy of the standard will be available for 
viewing, at no cost, on the ASTM website at: https://www.astm.org/READINGLIBRARY/. Interested parties can also schedule an appointment to 
inspect a copy of the standard at CPSC's Division of the Secretariat, 
U.S. Consumer Product Safety Commission, Room 820, 4330 East West 
Highway, Bethesda, MD 20814, telephone: (301) 504-7479; email: [email protected]. Interested parties can purchase a copy of ASTM F2388-21 
from ASTM International, 100 Barr Harbor Drive, P.O. Box C700, West 
Conshohocken, PA 19428-2959 USA; telephone: (610) 832-9585; 
www.astm.org.

D. Certification

    Section 14(a) of the Consumer Product Safety Act (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, standards issued 
under section 104(b)(1)(B) of the CPSIA, such as the present rule on 
baby changing products, are ``consumer product safety standards.'' 
Thus, they are subject to the testing and certification requirements of 
section 14 of the CPSA.
    Because baby changing products are children's products, a CPSC-
accepted third party conformity assessment body must test samples of 
the products. Products subject to part 1235 also must comply with all 
other applicable CPSC requirements, such as the lead content 
requirements in section 101 of the CPSIA,\4\ the phthalates 
prohibitions in section 108 of the CPSIA \5\ and 16 CFR part 1307, the 
tracking label requirements in section 14(a)(5) of the CPSA,\6\ and the 
consumer registration form requirements in section 104(d) of the 
CPSIA.\7\
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    \4\ 15 U.S.C. 1278a.
    \5\ 15 U.S.C. 2057c.
    \6\ 15 U.S.C. 2063(a)(5).
    \7\ 15 U.S.C. 2056a(d).
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E. Notice of Requirements

    In accordance with section 14(a)(3)(B)(iv) of the CPSIA, the 
Commission previously published a notice of requirements (NOR) for 
accreditation of third party conformity assessment bodies for testing 
baby changing products. 83 FR 29672 (June 26, 2018). The NOR provided 
the criteria and process for CPSC to accept accreditation of third 
party conformity assessment bodies for testing baby changing products 
to 16 CFR part 1235. The NORs for all mandatory standards for durable 
infant or toddler products are listed in the Commission's rule, 
``Requirements Pertaining to Third Party Conformity Assessment 
Bodies,'' codified in 16 CFR part 1112. Id.
    ASTM F2388-21 includes revised requirements for baby changing 
products. However, these revisions do not require additional equipment 
or test protocols beyond those that already exist in the standard. The 
revisions to the figure depicting the webbing tension pull device 
clarify the test equipment dimensions, without changing the 
specifications of the test tool or test method. The change to the 
capitalization of warning text does not necessitate a change in the way 
that third party conformity assessment bodies test products. 
Accordingly, the revisions do not change the way that third party 
conformity assessment bodies test these products for compliance with 
the safety standard for baby changing products. Laboratories will begin 
testing to the new standard when ASTM F2388-21 goes into effect, and 
the existing accreditations that the Commission has accepted for 
testing to this standard will cover testing to the revised standard. 
Therefore, the Commission considers the existing CPSC-accepted 
laboratories for testing to ASTM F2388-18 to be capable of testing to 
ASTM F2388-21 as well. Accordingly, the existing NOR for this standard 
will remain in place, and CPSC-accepted third party conformity 
assessment bodies are expected to update the scope of the testing 
laboratories' accreditations to reflect the revised standard in the 
normal course of renewing their accreditations.

F. 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.'' Id. 553(b)(B). The Commission concludes that 
when it updates a reference to an ASTM standard that the Commission 
incorporated by reference under section 104(b) of the CPSIA, notice and 
comment are not necessary.
    Specifically, under the process set out in section 104(b)(4)(B) 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 will become the new CPSC standard, unless the 
Commission determines that ASTM's revision does not improve the safety 
of the product and so notifies ASTM. Thus, unless the Commission makes 
such a determination, the ASTM revision becomes CPSC's standard by 
operation of law. The Commission is allowing ASTM F2388-21 to become 
CPSC's new standard because its provisions either improve product 
safety or are neutral with respect to safety. The purpose of this 
direct final rule is to update the reference in the Code of Federal 
Regulations (CFR) so that it reflects the version of the standard that 
takes effect by statute. This rule updates the reference in the CFR, 
but under the terms of the CPSIA, ASTM F2388-21 takes effect as the new 
CPSC standard for baby changing products, even if the Commission does 
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 104(b) of the CPSIA. 
Under these circumstances, notice and comment are unnecessary.
    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 that are 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, by operation of 
law, on July 31, 2022. 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

[[Page 24417]]

the rule ``would be ineffective or unacceptable without a change.'' 60 
FR 43108, 43111 (Aug. 18, 1995). As noted, this rule merely updates a 
reference in 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.

G. 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 prepare regulatory flexibility analyses. 5 U.S.C. 603, 
604. The RFA applies to any rule that is subject to notice and comment 
procedures under section 553 of the APA. Id. As discussed in section F. 
Direct Final Rule Process 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 
under section 104 of the CPSIA.

H. Paperwork Reduction Act

    The current mandatory standard for baby changing products 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 revised mandatory 
standard does not alter these requirements. The Commission took the 
steps required by the PRA for information collections when it adopted 
16 CFR part 1235, including obtaining approval and a control number. 
Because the information collection is unchanged, the revision does not 
affect the information collection requirements or approval related to 
the standard.

I. Environmental Considerations

    The Commission's regulations provide a categorical exclusion for 
the Commission's rules from any requirement to prepare an environmental 
assessment or an environmental impact statement 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.

J. 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 104(b) of the 
CPSIA deems rules issued under that provision ``consumer product safety 
standards.'' Therefore, once a rule issued under section 104 of the 
CPSIA takes effect, it will preempt in accordance with section 26(a) of 
the CPSA.

K. Effective Date

    Under the procedure set forth in section 104(b)(4)(B) of the CPSIA, 
when a voluntary standards organization revises a standard that the 
Commission adopted as a mandatory standard, the revision becomes the 
CPSC standard within 180 days of notification to the Commission, unless 
the Commission notifies the standards organization that it has 
determined that the revision does not improve the safety of the 
product, or the Commission sets a later date in the Federal Register. 
15 U.S.C. 2056a(b)(4)(B). The Commission is taking neither of those 
actions with respect to the standard for baby changing products. 
Therefore, ASTM F2388-21 will take effect as the new mandatory standard 
for baby changing products on July 31, 2022, 180 days after February 1, 
2022, when the Commission received notice of the revision.

L. 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, this rule does not qualify as 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.

List of Subjects in 16 CFR Part 1235

    Consumer protection, Imports, Incorporation by reference, Infants 
and children, Labeling, Law enforcement, Toys.

    For the reasons discussed in the preamble, the Commission amends 16 
CFR chapter II as follows:

PART 1235--SAFETY STANDARD FOR BABY CHANGING PRODUCTS

0
1. Revise the authority citation for part 1235 to read as follows:

    Authority: 15 U.S.C. 2056a; Sec 3, Pub. L. 112-28, 125 Stat. 
273.

0
2. Revise Sec.  1235.2 to read as follows:


Sec.  1235.2   Requirements for baby changing products.

    Each baby changing product shall comply with all applicable 
provisions of ASTM F2388-21, Standard Consumer Safety Specification for 
Baby Changing Products for Domestic Use, approved on November 15, 2021. 
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. 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) 832-9585; www.astm.org. 
You may inspect a copy at the Division of the Secretariat, U.S. 
Consumer Product Safety Commission, Room 820, 4330 East West Highway, 
Bethesda, MD 20814, telephone (301) 504-7479, email [email protected], 
or at the National Archives and Records Administration (NARA). For 
information on the availability of this material at NARA, email 
[email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

Alberta E. Mills,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2022-08804 Filed 4-25-22; 8:45 am]
BILLING CODE 6355-01-P