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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Children’s Protection Act of 2020’’. 

6 (b) TABLE OF CONTENTS.—The table of contents for 

7 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. 

1 SEC. 2. INITIAL REGULATORY CHILDREN’S ANALYSIS. 

2 (a) PUBLICATION AND PUBLIC COMMENT RE3 QUIRED.—Except as provided for in subsections (a) and 

4 (b) of section 4, with respect to any proposed applicable 

5 rule, the head of an agency shall include an initial regu6 latory children’s analysis, or a summary of the analysis, 

7 in the general notice of proposed rulemaking published in 

8 the Federal Register under section 553 of title 5, United 

9 States Code, or other applicable law, and make such anal10 ysis or summary available for public comment. 

11 (b) CONTENTS OF INITIAL ANALYSIS.—Each initial 

12 regulatory children’s analysis required under this section 

13 shall describe the impact of the proposed applicable rule 

14 on children and contain the following: 

15 (1) An estimate of the number of children 

16 whose health outcomes may be directly or indirectly 

17 negatively affected and how children’s health may be 

18 negatively affected by the proposed applicable rule, 

19 including the following: 

20 (A) The unique vulnerabilities of children 

21 including unique behaviors, how children may 


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1 be exposed to chemicals, developing bodies, and 

2 dependence on adults for their care. 

3 (B) Data sources and a description of any 

4 uncertainties. 

5 (C) A description of the demographic 

6 groups of children negatively affected. 

7 (2) Any reasonably foreseeable projected in8 crease in negative health or educational outcomes for 

9 children, including reduced access to health insur10 ance, health care, and behavioral health care serv11 ices. 

12 (3) Any significant alternatives to the proposed 

13 applicable rule that could accomplish the stated ob14 jectives of the proposed applicable rule and that 

15 minimize any negative health impacts to children or 

16 that provide greater benefits to children. 

17 (c) REQUIREMENTS BEFORE PUBLICATION OF INI18 TIAL ANALYSIS.—Before the publication of an initial regu19 latory children’s analysis by an agency: 

20 (1) The head of the agency shall convene a re21 view panel for the proposed applicable rule con22 sisting of full-time Federal employees of the office 

23 within the agency responsible for carrying out the 

24 proposed applicable rule, 3 children’s representa25 tives, a board certified pediatrician, a member of the 


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1 National Academy of Sciences with expertise in chil2 dren’s health, a licensed early childhood educator, 

3 and 1 career employee from the Office of Informa4 tion and Regulatory Affairs. 

5 (2) The review panel convened pursuant to 

6 paragraph (1) shall review any material related to 

7 the applicable rule that the agency has prepared in 

8 connection with the requirements of this Act, includ9 ing any draft proposed applicable rule, and collect 

10 advice and recommendations of each individual rep11 resentative identified by the agency on issues de12 scribed in subsection (b). 

13 (3) Not later than 60 days after the date on 

14 which an agency convenes a review panel pursuant 

15 to paragraph (1), the review panel shall submit to 

16 the head of the agency a report on the comments of 

17 the children’s representatives and any findings on 

18 issues described in subsection (b). Such report shall 

19 be made public as part of the rulemaking record. 

20 (4) Where appropriate, the agency shall publish 

21 any modification of the proposed applicable rule, the 

22 initial regulatory children’s analysis, or the decision 

23 on whether an initial regulatory children’s analysis is 

24 required. 


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1 (d) WAIVER OF REQUIREMENTS.—In consultation 

2 with the individuals identified in subsection (c)(1), the Ad3 ministrator may waive the requirements of paragraph (2), 

4 (3), or (4) of subsection (c) by including in the rulemaking 

5 record a written finding with reasons therefor that those 

6 requirements would not advance the effective participation 

7 of children’s representatives in the rulemaking process. 

8 For purposes of this subsection, the factors to be consid9 ered in making such a finding are as follows: 

10 (1) In developing a proposed applicable rule, 

11 the extent to which the agency consulted with indi12 viduals representing and advocating for affected chil13 dren with respect to the potential impacts of the ap14 plicable rule and took such concerns into consider15 ation. 

16 (2) Special circumstances requiring prompt 

17 issuance of the applicable rule. 

18 SEC. 3. FINAL REGULATORY CHILDREN’S ANALYSIS. 

19 (a) PUBLICATION REQUIRED.—Except as provided 

20 for in subsections (a) and (b) of section 4, simultaneously 

21 with the promulgation of a final applicable rule under sec22 tion 553 of title 5, United States Code, or any other appli23 cable statue, the head of the agency shall publish a final 

24 regulatory children’s analysis, or a summary of the anal25 ysis, in the Federal Register. In a case in which only the 


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1 summary is published, the head of the agency shall make 

2 the final regulatory children’s analysis available on a pub3 lic website of the agency and include a link to that website 

4 in the summary. 

5 (b) CONTENTS OF FINAL ANALYSIS.—Each final reg6 ulatory children’s analysis required under this section 

7 shall contain the following: 

8 (1) A statement of the significant issues raised 

9 by the public comments in response to the initial 

10 regulatory children’s analysis including the impacts 

11 on children and the regulatory analysis, a statement 

12 of the assessment by the agency of such issues, and 

13 a statement of any changes made to the proposed 

14 applicable rule as a result of such comments. 

15 (2) An estimate of the number of children 

16 whose health the final applicable rule may directly or 

17 indirectly negatively impact and the basis of such es18 timate or a substantiated explanation of why such 

19 estimate is unavailable. 

20 (3) A description of the demographic groups of 

21 children impacted by the final applicable rule. 

22 (4) A description of the steps the agency has 

23 taken to minimize the negative impact on children’s 

24 health, and to maximize the benefits to children, in25 cluding a statement of the factual, policy, and legal 


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1 reasons for selecting any alternative adopted in the 

2 final applicable rule and why any other alternative 

3 that had less negative impact on children’s health 

4 was not adopted. 

5 (5) An appendix containing the following: 

6 (A) Any draft of the proposed applicable 

7 rule submitted by the agency to the Office of 

8 Management and Budget for any interagency 

9 review process prior to proposal of any such 

10 rule and each document accompanying any such 

11 draft. 

12 (B) Each written comment to any draft 

13 described in subparagraph (A) by any other 

14 agency and each written response to such writ15 ten comment by the Administrator. 

16 (C) Each draft of the final applicable rule 

17 submitted for such review process prior to pro18 mulgation and each written comment thereon 

19 and any document accompanying each such 

20 draft and any written response thereto. 

21 SEC. 4. EXCEPTION, DELAY, AND PREPARATION OF ANAL22 YSES. 

23 (a) EXCEPTION.—The requirements of sections 2 and 

24 3 do not apply if the head of an agency— 


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1 (1) certifies that an applicable rule will not 

2 have a negative impact on the health of a substantial 

3 number of children; and 

4 (2) publishes such certification in the Federal 

5 Register at the time of publication of general notice 

6 of proposed rulemaking for the applicable rule along 

7 with a statement providing details for the factual 

8 basis for such certification. 

9 (b) DELAYS.— 

10 (1) EMERGENCY.—The head of an agency may 

11 delay the completion of the requirements of section 

12 2 by publishing in the Federal Register, not later 

13 than the date of publication of the final applicable 

14 rule, a written finding that the final applicable rule 

15 is being promulgated in response to an emergency 

16 that makes timely compliance impracticable. 

17 (2) IMPRACTICABILITY.—The head of an agen18 cy may delay the completion of the requirements of 

19 section 3 for a period of not more than 180 days 

20 after the date of publication in the Federal Register 

21 of a final applicable rule by publishing in the Fed22 eral Register with the final applicable rule, a written 

23 finding that the final applicable rule is being pro24 mulgated in response to an emergency that makes 

25 timely compliance with the provisions of section 3 


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1 impracticable. If the agency has not prepared and 

2 published the final regulatory analysis as described 

3 in section 3 within 180 days after the date of publi4 cation of the final applicable rule, such applicable 

5 rule shall lapse and have no effect. 

6 (c) PREPARATION.— 

7 (1) IN GENERAL.—In complying with sections 2 

8 and 3, an agency shall include in any analysis— 

9 (A) a quantifiable or numerical description 

10 of the effects of a proposed and final applicable 

11 rule or alternatives to the proposed and final 

12 applicable rule; and 

13 (B) a qualitative analysis and description 

14 of the effects of a proposed and final applicable 

15 rule or alternatives to the proposed and final 

16 applicable rule. 

17 (2) SPECIAL ATTENTION TO UNIQUE

18 VULNERABILITIES.—An agency shall consider the 

19 unique vulnerabilities of children, including the 

20 unique behaviors, exposure routes, developing bodies, 

21 and dependence on adults for their care, in pre22 paring the analysis and description described in 

23 paragraph (1). 


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1 SEC. 5. PROCEDURES FOR GATHERING COMMENTS. 

2 For any applicable rule, the head of the agency pro3 mulgating the applicable rule shall assure that children’s 

4 representatives have been given an opportunity to partici5 pate in the rulemaking for the applicable rule through rea6 sonable use of techniques, including the following: 

7 (1) The inclusion in an advanced notice of pro8 posed rulemaking, if issued, of a statement that the 

9 proposed applicable rule may have a negative effect 

10 on the health of a substantial number of children. 

11 (2) The issuance of the notice through an easily 

12 accessible publicly available press release or official 

13 statement. 

14 (3) The conduct of an open conference or a 

15 public hearing concerning the applicable rule for 

16 children’s representatives, including soliciting and 

17 receiving comments through the internet. 

18 SEC. 6. AVOIDANCE OF DUPLICATIVE OR UNNECESSARY 

19 ANALYSES. 

20 (a) IN GENERAL.—An agency may perform the anal21 yses required by sections 2 and 3 in conjunction with any 

22 other required analysis, such as subchapter I of chapter 

23 35 of title 44, United States Code (commonly referred to 

24 as the Paperwork Reduction Act), or Executive Order 

25 12866 (relating to regulatory planning and review). 


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1 (b) CONSOLIDATION OF RULES.—In order to avoid 

2 duplicative action, an agency may consider a series of 

3 closely related applicable rules as one rule for the purposes 

4 of sections 2, 3, 4, and 5. 

5 SEC. 7. REPORTS. 

6 (a) OIRA REPORT ON COMPLIANCE.—The Adminis7 trator shall monitor agency compliance with this Act and 

8 not less frequently than annually submit to the President, 

9 the Committee on Homeland Security and Governmental 

10 Affairs of the Senate, and the Committee on Oversight 

11 and Reform of the House of Representatives a report on 

12 such compliance. 

13 (b) AGENCY BIANNUAL SUBMISSION TO OFFICE OF

14 INFORMATION AND REGULATORY AFFAIRS.— 

15 (1) IN GENERAL.—On a biannual basis, the 

16 head of each agency shall submit to the Adminis17 trator, in such a manner as the Administrator may 

18 reasonably require, a report on the following infor19 mation: 

20 (A) For each rule that the agency expects 

21 to propose or finalize during the following 6- 

22 month period: 

23 (i) A summary of the nature of the 

24 rule and justification for whether or not 


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1 the rule will require an initial or final reg2 ulatory children’s analysis, including— 

3 (I) the regulation identifier num4 ber and the docket number for the 

5 rule; and 

6 (II) the objectives of and legal 

7 basis for the issuance of the rule, in8 cluding any statutory or judicial dead9 line and whether the agency plans to 

10 conduct an initial regulatory chil11 dren’s analysis during the rulemaking. 

12 (ii) The stage of the rulemaking as of 

13 the date on which the report is submitted. 

14 (iii) Whether the rule is subject to re15 view under section 3. 

16 (2) PUBLIC AVAILABILITY.—Not later than 30 

17 days after the date on which the report is submitted 

18 pursuant to paragraph (1), the Administrator shall 

19 make such report publicly available on the internet. 

20 (c) OFFICE OF INFORMATION AND REGULATORY AF21 FAIRS PUBLICATIONS.— 

22 (1) CUMULATIVE ASSESSMENT OF AGENCY

23 RULEMAKING PUBLISHED ANNUALLY.— 

24 (A) PUBLICATION IN THE FEDERAL REG25 ISTER.—Not later than October 1 of each year, 


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1 the Administrator shall publish in the Federal 

2 Register, for the previous year a report on the 

3 following: 

4 (i) Each report the Administrator re5 ceived from the head of each agency under 

6 subsection (b)(1). 

7 (ii) The number of rules and a list of 

8 each such rule— 

9 (I) that was proposed by each 

10 agency, including, for each such rule, 

11 an indication of whether the issuing 

12 agency conducted an initial regulatory 

13 children’s analysis of the rule; and 

14 (II) that was finalized by each 

15 agency, including for each such rule 

16 an indication of whether— 

17 (aa) the issuing agency con18 ducted a final regulatory chil19 dren’s analysis of the rule; 

20 (bb) the agency claimed an 

21 exception from the procedures 

22 under section 4(a); or 

23 (cc) the rule was issued pur24 suant to a statutory mandate or 


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1 the rulemaking is committed to 

2 agency discretion by law. 

3 (B) PUBLICATION ON THE INTERNET.— 

4 Not later than October 1 of each year, the Ad5 ministrator shall make publicly available on the 

6 internet the following: 

7 (i) The initial and final regulatory 

8 children’s analysis, if conducted, for each 

9 proposed rule or final rule issued by an 

10 agency for the previous year. 

11 (ii) The docket number and regulation 

12 identifier number for each proposed or 

13 final rule issued by an agency for the pre14 vious year. 

15 (iii) The number of rules and a list of 

16 each rule reviewed by the Director of the 

17 Office of Management and Budget for the 

18 previous year, and the authority under 

19 which each such review was conducted. 

20 SEC. 8. APPLICABILITY. 

21 This Act shall apply with respect to any proposed ap22 plicable rule within the year before the date of enactment 

23 of this Act that has not been finalized as of the date of 

24 the enactment of this Act and any proposed applicable rule 

25 on or after the date of the enactment of this Act. 


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1 SEC. 9. JUDICIAL REVIEW. 

2 In the case of an action brought under chapter 7 of 

3 title 5, United States Code, alleging that the head of an 

4 agency did not comply with the requirement under section 

5 2(a) or that the head of an agency’s determination that 

6 a rule was not an applicable rule was arbitrary, capricious, 

7 an abuse of discretion, or otherwise not in accordance with 

8 law, the reviewing court may not vacate a rule but may 

9 only remand the rule to the agency to comply with such 

10 section or review the determination, as applicable. 

11 SEC. 10. DEFINITIONS. 

12 In this Act: 

13 (1) ADMINISTRATOR.—The term ‘‘Adminis14 trator’’ means the Administrator of the Office of In15 formation and Regulatory Affairs. 

16 (2) AGENCY.—The term ‘‘agency’’ has the 

17 meaning given that term in section 551 of title 5, 

18 United States Code. 

19 (3) APPLICABLE RULE.—The term ‘‘applicable 

20 rule’’ means a rule that may negatively affect, di21 rectly or indirectly, the health of a substantial num22 ber of children. 

23 (4) CHILD.—The term ‘‘child’’ means a human 

24 from the moment immediately after birth up to an 

25 age of 18 years. 


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1 (5) CHILDREN’S REPRESENTATIVE.—The term 

2 ‘‘children’s representative’’— 

3 (A) means a nonprofit organization or a 

4 municipal, State, or Federal agency, or Federal 

5 advisory committee that has the mission of pro6 tecting all children’s health and welfare or pro7 viding healthcare services to all children despite 

8 race, ethnicity, socioeconomic class, sexual ori9 entation, or other identification markers; and 

10 (B) does not include any trade association 

11 or for-profit entities. 

12 (6) NONPROFIT ORGANIZATION.—The term 

13 ‘‘nonprofit organization’’ means an organization that 

14 is described in section 501(c)(3) of the Internal Rev15 enue Code of 1986 and is exempt from taxation 

16 under section 501(a) of such Code. 

17 (7) RULE.—The term ‘‘rule’’ has the meaning 

18 given that term in section 551 of title 5, United 

19 States Code, to which section 553 of title 5, United 

20 States Code, applies. 

21 (8) STATE.—The term ‘‘State’’ means each 

22 State of the United States, the District of Columbia, 

23 each commonwealth, territory, or possession of the 

24 United States, and each federally recognized Indian 

25 Tribe. 


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1 (9) SUBSTANTIAL NUMBER OF CHILDREN.— 

2 The term ‘‘substantial number of children’’ means at 

3 least 500 children. 

Æ 


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