I 
116TH CONGRESS 
2D SESSION 
H. R. 8565 
To require agencies to analyze how certain rules impact children, and for 
other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
OCTOBER 9, 2020 
Mrs. CAROLYN B. MALONEY of New York (for herself and Ms. PRESSLEY) 
introduced the following bill; which was referred to the Committee on the 
Judiciary, and in addition to the Committee on Oversight and Reform, 
for a period to be subsequently determined by the Speaker, in each case 
for consideration of such provisions as fall within the jurisdiction of the 
committee concerned 
A BILL 
To require agencies to analyze how certain rules impact 
children, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Children’s Protection Act of 2020’’. 
(b) TABLE OF CONTENTS.—The table of contents for 
this Act is as follows: 
Sec. 1. Short title; table of contents. 
Sec. 2. Initial regulatory children’s analysis. 
Sec. 3. Final regulatory children’s analysis. 
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Sec. 4. Exception, delay, and preparation of analyses. 
Sec. 5. Procedures for gathering comments. 
Sec. 6. Avoidance of duplicative or unnecessary analyses. 
Sec. 7. Reports. 
Sec. 8. Applicability. 
Sec. 9. Judicial review. 
Sec. 10. Definitions. 
SEC. 2. INITIAL REGULATORY CHILDREN’S ANALYSIS. 
(a) PUBLICATION
AND
PUBLIC
COMMENT
RE-
QUIRED.—Except as provided for in subsections (a) and 
(b) of section 4, with respect to any proposed applicable 
rule, the head of an agency shall include an initial regu-
latory children’s analysis, or a summary of the analysis, 
in the general notice of proposed rulemaking published in 
the Federal Register under section 553 of title 5, United 
States Code, or other applicable law, and make such anal-
ysis or summary available for public comment. 
(b) CONTENTS OF INITIAL ANALYSIS.—Each initial 
regulatory children’s analysis required under this section 
shall describe the impact of the proposed applicable rule 
on children and contain the following: 
(1) An estimate of the number of children 
whose health outcomes may be directly or indirectly 
negatively affected and how children’s health may be 
negatively affected by the proposed applicable rule, 
including the following: 
(A) The unique vulnerabilities of children 
including unique behaviors, how children may 
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be exposed to chemicals, developing bodies, and 
dependence on adults for their care. 
(B) Data sources and a description of any 
uncertainties. 
(C) A description of the demographic 
groups of children negatively affected. 
(2) Any reasonably foreseeable projected in-
crease in negative health or educational outcomes for 
children, including reduced access to health insur-
ance, health care, and behavioral health care serv-
ices. 
(3) Any significant alternatives to the proposed 
applicable rule that could accomplish the stated ob-
jectives of the proposed applicable rule and that 
minimize any negative health impacts to children or 
that provide greater benefits to children. 
(c) REQUIREMENTS BEFORE PUBLICATION OF INI-
TIAL ANALYSIS.—Before the publication of an initial regu-
latory children’s analysis by an agency: 
(1) The head of the agency shall convene a re-
view panel for the proposed applicable rule con-
sisting of full-time Federal employees of the office 
within the agency responsible for carrying out the 
proposed applicable rule, 3 children’s representa-
tives, a board certified pediatrician, a member of the 
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National Academy of Sciences with expertise in chil-
dren’s health, a licensed early childhood educator, 
and 1 career employee from the Office of Informa-
tion and Regulatory Affairs. 
(2) The review panel convened pursuant to 
paragraph (1) shall review any material related to 
the applicable rule that the agency has prepared in 
connection with the requirements of this Act, includ-
ing any draft proposed applicable rule, and collect 
advice and recommendations of each individual rep-
resentative identified by the agency on issues de-
scribed in subsection (b). 
(3) Not later than 60 days after the date on 
which an agency convenes a review panel pursuant 
to paragraph (1), the review panel shall submit to 
the head of the agency a report on the comments of 
the children’s representatives and any findings on 
issues described in subsection (b). Such report shall 
be made public as part of the rulemaking record. 
(4) Where appropriate, the agency shall publish 
any modification of the proposed applicable rule, the 
initial regulatory children’s analysis, or the decision 
on whether an initial regulatory children’s analysis is 
required. 
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(d) WAIVER
OF REQUIREMENTS.—In consultation 
with the individuals identified in subsection (c)(1), the Ad-
ministrator may waive the requirements of paragraph (2), 
(3), or (4) of subsection (c) by including in the rulemaking 
record a written finding with reasons therefor that those 
requirements would not advance the effective participation 
of children’s representatives in the rulemaking process. 
For purposes of this subsection, the factors to be consid-
ered in making such a finding are as follows: 
(1) In developing a proposed applicable rule, 
the extent to which the agency consulted with indi-
viduals representing and advocating for affected chil-
dren with respect to the potential impacts of the ap-
plicable rule and took such concerns into consider-
ation. 
(2) Special circumstances requiring prompt 
issuance of the applicable rule. 
SEC. 3. FINAL REGULATORY CHILDREN’S ANALYSIS. 
(a) PUBLICATION REQUIRED.—Except as provided 
for in subsections (a) and (b) of section 4, simultaneously 
with the promulgation of a final applicable rule under sec-
tion 553 of title 5, United States Code, or any other appli-
cable statue, the head of the agency shall publish a final 
regulatory children’s analysis, or a summary of the anal-
ysis, in the Federal Register. In a case in which only the 
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summary is published, the head of the agency shall make 
the final regulatory children’s analysis available on a pub-
lic website of the agency and include a link to that website 
in the summary. 
(b) CONTENTS OF FINAL ANALYSIS.—Each final reg-
ulatory children’s analysis required under this section 
shall contain the following: 
(1) A statement of the significant issues raised 
by the public comments in response to the initial 
regulatory children’s analysis including the impacts 
on children and the regulatory analysis, a statement 
of the assessment by the agency of such issues, and 
a statement of any changes made to the proposed 
applicable rule as a result of such comments. 
(2) An estimate of the number of children 
whose health the final applicable rule may directly or 
indirectly negatively impact and the basis of such es-
timate or a substantiated explanation of why such 
estimate is unavailable. 
(3) A description of the demographic groups of 
children impacted by the final applicable rule. 
(4) A description of the steps the agency has 
taken to minimize the negative impact on children’s 
health, and to maximize the benefits to children, in-
cluding a statement of the factual, policy, and legal 
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reasons for selecting any alternative adopted in the 
final applicable rule and why any other alternative 
that had less negative impact on children’s health 
was not adopted. 
(5) An appendix containing the following: 
(A) Any draft of the proposed applicable 
rule submitted by the agency to the Office of 
Management and Budget for any interagency 
review process prior to proposal of any such 
rule and each document accompanying any such 
draft. 
(B) Each written comment to any draft 
described in subparagraph (A) by any other 
agency and each written response to such writ-
ten comment by the Administrator. 
(C) Each draft of the final applicable rule 
submitted for such review process prior to pro-
mulgation and each written comment thereon 
and any document accompanying each such 
draft and any written response thereto. 
SEC. 4. EXCEPTION, DELAY, AND PREPARATION OF ANAL-
YSES. 
(a) EXCEPTION.—The requirements of sections 2 and 
3 do not apply if the head of an agency— 
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(1) certifies that an applicable rule will not 
have a negative impact on the health of a substantial 
number of children; and 
(2) publishes such certification in the Federal 
Register at the time of publication of general notice 
of proposed rulemaking for the applicable rule along 
with a statement providing details for the factual 
basis for such certification. 
(b) DELAYS.— 
(1) EMERGENCY.—The head of an agency may 
delay the completion of the requirements of section 
2 by publishing in the Federal Register, not later 
than the date of publication of the final applicable 
rule, a written finding that the final applicable rule 
is being promulgated in response to an emergency 
that makes timely compliance impracticable. 
(2) IMPRACTICABILITY.—The head of an agen-
cy may delay the completion of the requirements of 
section 3 for a period of not more than 180 days 
after the date of publication in the Federal Register 
of a final applicable rule by publishing in the Fed-
eral Register with the final applicable rule, a written 
finding that the final applicable rule is being pro-
mulgated in response to an emergency that makes 
timely compliance with the provisions of section 3 
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impracticable. If the agency has not prepared and 
published the final regulatory analysis as described 
in section 3 within 180 days after the date of publi-
cation of the final applicable rule, such applicable 
rule shall lapse and have no effect. 
(c) PREPARATION.— 
(1) IN GENERAL.—In complying with sections 2 
and 3, an agency shall include in any analysis— 
(A) a quantifiable or numerical description 
of the effects of a proposed and final applicable 
rule or alternatives to the proposed and final 
applicable rule; and 
(B) a qualitative analysis and description 
of the effects of a proposed and final applicable 
rule or alternatives to the proposed and final 
applicable rule. 
(2) 
SPECIAL
ATTENTION
TO
UNIQUE 
VULNERABILITIES.—An agency shall consider the 
unique vulnerabilities of children, including the 
unique behaviors, exposure routes, developing bodies, 
and dependence on adults for their care, in pre-
paring the analysis and description described in 
paragraph (1). 
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SEC. 5. PROCEDURES FOR GATHERING COMMENTS. 
For any applicable rule, the head of the agency pro-
mulgating the applicable rule shall assure that children’s 
representatives have been given an opportunity to partici-
pate in the rulemaking for the applicable rule through rea-
sonable use of techniques, including the following: 
(1) The inclusion in an advanced notice of pro-
posed rulemaking, if issued, of a statement that the 
proposed applicable rule may have a negative effect 
on the health of a substantial number of children. 
(2) The issuance of the notice through an easily 
accessible publicly available press release or official 
statement. 
(3) The conduct of an open conference or a 
public hearing concerning the applicable rule for 
children’s representatives, including soliciting and 
receiving comments through the internet. 
SEC. 6. AVOIDANCE OF DUPLICATIVE OR UNNECESSARY 
ANALYSES. 
(a) IN GENERAL.—An agency may perform the anal-
yses required by sections 2 and 3 in conjunction with any 
other required analysis, such as subchapter I of chapter 
35 of title 44, United States Code (commonly referred to 
as the Paperwork Reduction Act), or Executive Order 
12866 (relating to regulatory planning and review). 
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(b) CONSOLIDATION OF RULES.—In order to avoid 
duplicative action, an agency may consider a series of 
closely related applicable rules as one rule for the purposes 
of sections 2, 3, 4, and 5. 
SEC. 7. REPORTS. 
(a) OIRA REPORT ON COMPLIANCE.—The Adminis-
trator shall monitor agency compliance with this Act and 
not less frequently than annually submit to the President, 
the Committee on Homeland Security and Governmental 
Affairs of the Senate, and the Committee on Oversight 
and Reform of the House of Representatives a report on 
such compliance. 
(b) AGENCY BIANNUAL SUBMISSION TO OFFICE OF 
INFORMATION AND REGULATORY AFFAIRS.— 
(1) IN
GENERAL.—On a biannual basis, the 
head of each agency shall submit to the Adminis-
trator, in such a manner as the Administrator may 
reasonably require, a report on the following infor-
mation: 
(A) For each rule that the agency expects 
to propose or finalize during the following 6- 
month period: 
(i) A summary of the nature of the 
rule and justification for whether or not 
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the rule will require an initial or final reg-
ulatory children’s analysis, including— 
(I) the regulation identifier num-
ber and the docket number for the 
rule; and 
(II) the objectives of and legal 
basis for the issuance of the rule, in-
cluding any statutory or judicial dead-
line and whether the agency plans to 
conduct an initial regulatory chil-
dren’s analysis during the rulemaking. 
(ii) The stage of the rulemaking as of 
the date on which the report is submitted. 
(iii) Whether the rule is subject to re-
view under section 3. 
(2) PUBLIC AVAILABILITY.—Not later than 30 
days after the date on which the report is submitted 
pursuant to paragraph (1), the Administrator shall 
make such report publicly available on the internet. 
(c) OFFICE OF INFORMATION AND REGULATORY AF-
FAIRS PUBLICATIONS.— 
(1) CUMULATIVE
ASSESSMENT
OF
AGENCY 
RULEMAKING PUBLISHED ANNUALLY.— 
(A) PUBLICATION IN THE FEDERAL REG-
ISTER.—Not later than October 1 of each year, 
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the Administrator shall publish in the Federal 
Register, for the previous year a report on the 
following: 
(i) Each report the Administrator re-
ceived from the head of each agency under 
subsection (b)(1). 
(ii) The number of rules and a list of 
each such rule— 
(I) that was proposed by each 
agency, including, for each such rule, 
an indication of whether the issuing 
agency conducted an initial regulatory 
children’s analysis of the rule; and 
(II) that was finalized by each 
agency, including for each such rule 
an indication of whether— 
(aa) the issuing agency con-
ducted a final regulatory chil-
dren’s analysis of the rule; 
(bb) the agency claimed an 
exception from the procedures 
under section 4(a); or 
(cc) the rule was issued pur-
suant to a statutory mandate or 
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the rulemaking is committed to 
agency discretion by law. 
(B) PUBLICATION
ON
THE
INTERNET.— 
Not later than October 1 of each year, the Ad-
ministrator shall make publicly available on the 
internet the following: 
(i) The initial and final regulatory 
children’s analysis, if conducted, for each 
proposed rule or final rule issued by an 
agency for the previous year. 
(ii) The docket number and regulation 
identifier number for each proposed or 
final rule issued by an agency for the pre-
vious year. 
(iii) The number of rules and a list of 
each rule reviewed by the Director of the 
Office of Management and Budget for the 
previous year, and the authority under 
which each such review was conducted. 
SEC. 8. APPLICABILITY. 
This Act shall apply with respect to any proposed ap-
plicable rule within the year before the date of enactment 
of this Act that has not been finalized as of the date of 
the enactment of this Act and any proposed applicable rule 
on or after the date of the enactment of this Act. 
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SEC. 9. JUDICIAL REVIEW. 
In the case of an action brought under chapter 7 of 
title 5, United States Code, alleging that the head of an 
agency did not comply with the requirement under section 
2(a) or that the head of an agency’s determination that 
a rule was not an applicable rule was arbitrary, capricious, 
an abuse of discretion, or otherwise not in accordance with 
law, the reviewing court may not vacate a rule but may 
only remand the rule to the agency to comply with such 
section or review the determination, as applicable. 
SEC. 10. DEFINITIONS. 
In this Act: 
(1) ADMINISTRATOR.—The term ‘‘Adminis-
trator’’ means the Administrator of the Office of In-
formation and Regulatory Affairs. 
(2) AGENCY.—The term ‘‘agency’’ has the 
meaning given that term in section 551 of title 5, 
United States Code. 
(3) APPLICABLE RULE.—The term ‘‘applicable 
rule’’ means a rule that may negatively affect, di-
rectly or indirectly, the health of a substantial num-
ber of children. 
(4) CHILD.—The term ‘‘child’’ means a human 
from the moment immediately after birth up to an 
age of 18 years. 
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(5) CHILDREN’S REPRESENTATIVE.—The term 
‘‘children’s representative’’— 
(A) means a nonprofit organization or a 
municipal, State, or Federal agency, or Federal 
advisory committee that has the mission of pro-
tecting all children’s health and welfare or pro-
viding healthcare services to all children despite 
race, ethnicity, socioeconomic class, sexual ori-
entation, or other identification markers; and 
(B) does not include any trade association 
or for-profit entities. 
(6) NONPROFIT
ORGANIZATION.—The term 
‘‘nonprofit organization’’ means an organization that 
is described in section 501(c)(3) of the Internal Rev-
enue Code of 1986 and is exempt from taxation 
under section 501(a) of such Code. 
(7) RULE.—The term ‘‘rule’’ has the meaning 
given that term in section 551 of title 5, United 
States Code, to which section 553 of title 5, United 
States Code, applies. 
(8) STATE.—The term ‘‘State’’ means each 
State of the United States, the District of Columbia, 
each commonwealth, territory, or possession of the 
United States, and each federally recognized Indian 
Tribe. 
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(9) SUBSTANTIAL
NUMBER
OF
CHILDREN.— 
The term ‘‘substantial number of children’’ means at 
least 500 children. 
Æ 
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