I 

116TH CONGRESS 

1ST SESSION H. R. 1209 

To amend the Public Health Service Act to ensure that non-animal methods 

are prioritized, where applicable and feasible, in proposals for all research 

to be conducted or supported by the National Institutes of Health, 

and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 13, 2019 

Ms. ROYBAL-ALLARD (for herself and Mr. CALVERT) introduced the following 

bill; which was referred to the Committee on Energy and Commerce 

A BILL 

To amend the Public Health Service Act to ensure that 

non-animal methods are prioritized, where applicable and 

feasible, in proposals for all research to be conducted 

or supported by the National Institutes of Health, 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. 

4 This Act may be cited as the ‘‘Humane and Existing 

5 Alternatives in Research and Testing Sciences Act of 

6 2019’’ or the ‘‘HEARTS Act of 2019’’. 


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1 SEC. 2. FINDINGS. 

2 Congress finds the following: 

3 (1) The National Institutes of Health has sup4 ported life-saving research that has greatly improved 

5 the health and well-being not only of Americans but 

6 also of people around the world. 

7 (2) Much of this research has relied on animals. 

8 It is estimated that between 17 million and 22 mil9 lion animals are used annually in the United States 

10 in research, education, and testing. 

11 (3) At the same time, however, a great deal of 

12 research that utilized animal studies yielded no ben13 efits for humans. For example, according to NIH 

14 itself, ‘‘approximately 30 percent of promising medi15 cations have failed in human clinical trials because 

16 they are found to be toxic despite promising pre-clin17 ical studies in animal models. About 60 percent of 

18 candidate drugs fail due to lack of efficacy’’. 

19 (4) The laboratory use of animals has also long 

20 been an issue of public concern because animals will, 

21 in most cases, experience fear, pain, disease or sur22 gery, and early death. 

23 (5) Much more has become known about the 

24 unsuitability of animal models for studying human 

25 disease and many more humane, cost-effective, and 


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1 scientifically suitable non-animal methods are avail2 able. 

3 (6) Under the system of oversight established 

4 by the Animal Welfare Act (Public Law 89–544), re5 searchers are supposed to consider alternatives to 

6 animal use or painful procedures and should not un7 necessarily duplicate previous experiments. However, 

8 oversight is generally weak and little heed is paid to 

9 the use of non-animal methods or the avoidance of 

10 duplication, thereby unnecessarily subjecting animals 

11 to pain, suffering, and death. 

12 (7) A system of active incentives is needed to 

13 encourage researchers to utilize humane, cost-effec14 tive, and scientifically suitable non-animal methods. 

15 SEC. 3. ANIMALS IN RESEARCH. 

16 Section 495 of the Public Health Service Act (42 

17 U.S.C. 289d) is amended to read as follows: 

18 ‘‘SEC. 495. ANIMALS IN RESEARCH. 

19 ‘‘(a) IN GENERAL.—The Secretary, acting through 

20 the Director of NIH, shall, with respect to all research 

21 conducted or supported by the National Institutes of 

22 Health, do the following: 

23 ‘‘(1) Establish a system of meaningful incen24 tives to encourage the use of existing humane and 


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1 scientifically satisfactory non-animal methods in re2 search proposals. 

3 ‘‘(2) Ensure that, before any research involving 

4 the use of animals is approved or performed— 

5 ‘‘(A) all scientifically satisfactory non-ani6 mal methods for obtaining the results sought 

7 have been fully evaluated; and 

8 ‘‘(B) a detailed explanation and an anal9 ysis of the harms and benefits of such use of 

10 animals have been completed. 

11 ‘‘(3) Ensure that— 

12 ‘‘(A) research proposals are reviewed by at 

13 least one person who has expertise in non-ani14 mal research methods; and 

15 ‘‘(B) reviewers of the research proposals 

16 have access to a reference librarian with exper17 tise in evaluating the adequacy of the searches 

18 for non-animal methods described in the re19 search proposals. 

20 ‘‘(4) Establish and maintain research proposal 

21 guidelines for the following: 

22 ‘‘(A) Conducting thorough searches for 

23 non-animal alternatives to the use of animals 

24 for biomedical and behavioral research. 


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1 ‘‘(B) Carrying out analyses of the harms 

2 and benefits of the use of animals in proposed 

3 research to assess whether the harms that 

4 would be caused to animals in terms of suf5 fering, pain, and distress are justified by the 

6 expected outcomes, taking into account ethical 

7 considerations and the expected benefits to 

8 human beings, animals, or the environment. 

9 ‘‘(5) Establish and maintain animal care guide10 lines for the following: 

11 ‘‘(A) The proper care of animals to be 

12 used in biomedical and behavioral research. 

13 ‘‘(B) The proper treatment of animals 

14 while being used in such research. Guidelines 

15 under this paragraph shall require— 

16 ‘‘(i) the appropriate use of tranquil17 izers, analgesics, anesthetics, paralytics, 

18 and euthanasia for animals in such re19 search; and 

20 ‘‘(ii) appropriate pre-surgical and 

21 post-surgical veterinary medical and nurs22 ing care for animals in such research. 

23 Such guidelines shall not be construed to pre24 scribe methods of research. 


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1 ‘‘(C) The organization and operation of 

2 animal care committees in accordance with sub3 section (b). 

4 ‘‘(b) ANIMAL CARE COMMITTEES.— 

5 ‘‘(1) IN GENERAL.—The guidelines under sub6 section (a)(5)(C) shall require animal care commit7 tees at each entity which conducts biomedical and 

8 behavioral research with funds provided under this 

9 Act (including the National Institutes of Health and 

10 the national research institutes) to assure compli11 ance with the guidelines established under sub12 section (a)(5). 

13 ‘‘(2) APPOINTMENT OF MEMBERS.—Each ani14 mal care committee shall— 

15 ‘‘(A) be appointed by the chief executive 

16 officer of the entity for which the committee is 

17 established; 

18 ‘‘(B) be composed of not fewer than three 

19 members; and 

20 ‘‘(C) include at least one individual who 

21 has no association with such entity and at least 

22 one doctor of veterinary medicine. 

23 ‘‘(3) REQUIREMENTS.—Each animal care com24 mittee of a research entity shall— 


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1 ‘‘(A) review the care and treatment of ani2 mals in all animal study areas and facilities of 

3 the research entity at least semiannually to 

4 evaluate compliance with applicable guidelines 

5 established under subsection (a)(5) for appro6 priate animal care and treatment; 

7 ‘‘(B) keep appropriate records of reviews 

8 conducted under subparagraph (A); and 

9 ‘‘(C) for each review conducted under sub10 paragraph (A), file with the Director of NIH at 

11 least annually— 

12 ‘‘(i) a certification that the review has 

13 been conducted; and 

14 ‘‘(ii) reports of any violations of the 

15 guidelines under subsection (a)(5) or as16 surances required under paragraph (1) 

17 which were observed in such review and 

18 which have continued after notice by the 

19 committee to the research entity involved 

20 of the violations. 

21 ‘‘(4) MINORITY VIEWS.—Reports filed under 

22 paragraph (3)(C) shall include any minority views 

23 filed by members of the committee. 

24 ‘‘(c) APPLICATIONS AND CONTRACTS.— 


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1 ‘‘(1) CONTENTS.—The Director of NIH shall 

2 require each applicant for a grant, contract, or coop3 erative agreement involving research on animals 

4 which is administered by the National Institutes of 

5 Health or any national research institute to include 

6 in its application or contract proposal— 

7 ‘‘(A) assurances satisfactory to the Direc8 tor of NIH that— 

9 ‘‘(i) the applicant meets the require10 ments under paragraphs (2), (3), (4), and 

11 (5) of subsection (a) and has an animal 

12 care committee which meets the require13 ments of subsection (b); and 

14 ‘‘(ii) scientists, animal technicians, 

15 and other personnel involved with animal 

16 care, treatment, and use by the applicant 

17 have available to them instruction or train18 ing in— 

19 ‘‘(I) the humane practice of ani20 mal maintenance and experimen21 tation; and 

22 ‘‘(II) the concept, availability, 

23 and use of research or testing meth24 ods that replace the use of animals, 


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1 limit the use of animals, or limit ani2 mal distress; 

3 ‘‘(B) a statement of the reasons for the 

4 use of animals in the research to be conducted 

5 with funds provided under such grant or con6 tract; 

7 ‘‘(C) a statement of assurance that a sci8 entifically satisfactory non-animal method of 

9 obtaining the result sought is not available; and 

10 ‘‘(D) an analysis of the harms and benefits 

11 of the use of animals in the proposed research 

12 assessing whether the harms that would be 

13 caused to animals in terms of suffering, pain, 

14 and distress is justified by the expected out15 comes, taking into account ethical consider16 ations and the expected benefits to human 

17 beings, animals, or the environment. 

18 ‘‘(2) REGULATORY PROCESS.—Notwithstanding 

19 subsection (a)(2) of section 553 of title 5, United 

20 States Code, regulations under this subsection shall 

21 be promulgated in accordance with the notice and 

22 comment requirements of such section. 

23 ‘‘(d) SUSPENSION OR REVOCATION.—If the Director 

24 of NIH determines that— 


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1 ‘‘(1) the conditions of animal care, treatment, 

2 or use in an entity which is receiving a grant, con3 tract, or cooperative agreement involving research on 

4 animals under this title do not meet applicable 

5 guidelines established under subsection (a)(5); 

6 ‘‘(2) the entity has been notified by the Direc7 tor of NIH of such determination and has been 

8 given a reasonable opportunity to take corrective ac9 tion; and 

10 ‘‘(3) no action has been taken by the entity to 

11 correct such conditions, 

12 the Director of NIH shall suspend or revoke such grant, 

13 contract, or cooperative agreement under such conditions 

14 as the Director determines appropriate. 

15 ‘‘(e) PROTECTION OF CERTAIN INFORMATION.—No 

16 guideline or regulation promulgated under subsection 

17 (a)(5) or (c) may require a research entity to disclose pub18 licly trade secrets or commercial or financial information 

19 which is privileged or confidential.’’. 

Æ 


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