HEARTS Act of 2019

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. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Humane and Existing 4 Alternatives in Research and Testing Sciences Act of 5 2019’’ or the ‘‘HEARTS Act of 2019’’. 6 VerDate Sep 11 2014 23:46 Feb 26, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H1209.IH H1209 pbinns on DSK79D2C42PROD with BILLS 2 •HR 1209 IH SEC. 2. FINDINGS. 1 Congress finds the following: 2 (1) The National Institutes of Health has sup- 3 ported life-saving research that has greatly improved 4 the health and well-being not only of Americans but 5 also of people around the world. 6 (2) Much of this research has relied on animals. 7 It is estimated that between 17 million and 22 mil- 8 lion animals are used annually in the United States 9 in research, education, and testing. 10 (3) At the same time, however, a great deal of 11 research that utilized animal studies yielded no ben- 12 efits for humans. For example, according to NIH 13 itself, ‘‘approximately 30 percent of promising medi- 14 cations have failed in human clinical trials because 15 they are found to be toxic despite promising pre-clin- 16 ical studies in animal models. About 60 percent of 17 candidate drugs fail due to lack of efficacy’’. 18 (4) The laboratory use of animals has also long 19 been an issue of public concern because animals will, 20 in most cases, experience fear, pain, disease or sur- 21 gery, and early death. 22 (5) Much more has become known about the 23 unsuitability of animal models for studying human 24 disease and many more humane, cost-effective, and 25 VerDate Sep 11 2014 23:46 Feb 26, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H1209.IH H1209 pbinns on DSK79D2C42PROD with BILLS 3 •HR 1209 IH scientifically suitable non-animal methods are avail- 1 able. 2 (6) Under the system of oversight established 3 by the Animal Welfare Act (Public Law 89–544), re- 4 searchers are supposed to consider alternatives to 5 animal use or painful procedures and should not un- 6 necessarily duplicate previous experiments. However, 7 oversight is generally weak and little heed is paid to 8 the use of non-animal methods or the avoidance of 9 duplication, thereby unnecessarily subjecting animals 10 to pain, suffering, and death. 11 (7) A system of active incentives is needed to 12 encourage researchers to utilize humane, cost-effec- 13 tive, and scientifically suitable non-animal methods. 14 SEC. 3. ANIMALS IN RESEARCH. 15 Section 495 of the Public Health Service Act (42 16 U.S.C. 289d) is amended to read as follows: 17 ‘‘SEC. 495. ANIMALS IN RESEARCH. 18 ‘‘(a) IN GENERAL.—The Secretary, acting through 19 the Director of NIH, shall, with respect to all research 20 conducted or supported by the National Institutes of 21 Health, do the following: 22 ‘‘(1) Establish a system of meaningful incen- 23 tives to encourage the use of existing humane and 24 VerDate Sep 11 2014 23:46 Feb 26, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H1209.IH H1209 pbinns on DSK79D2C42PROD with BILLS 4 •HR 1209 IH scientifically satisfactory non-animal methods in re- 1 search proposals. 2 ‘‘(2) Ensure that, before any research involving 3 the use of animals is approved or performed— 4 ‘‘(A) all scientifically satisfactory non-ani- 5 mal methods for obtaining the results sought 6 have been fully evaluated; and 7 ‘‘(B) a detailed explanation and an anal- 8 ysis of the harms and benefits of such use of 9 animals have been completed. 10 ‘‘(3) Ensure that— 11 ‘‘(A) research proposals are reviewed by at 12 least one person who has expertise in non-ani- 13 mal research methods; and 14 ‘‘(B) reviewers of the research proposals 15 have access to a reference librarian with exper- 16 tise in evaluating the adequacy of the searches 17 for non-animal methods described in the re- 18 search proposals. 19 ‘‘(4) Establish and maintain research proposal 20 guidelines for the following: 21 ‘‘(A) Conducting thorough searches for 22 non-animal alternatives to the use of animals 23 for biomedical and behavioral research. 24 VerDate Sep 11 2014 23:46 Feb 26, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H1209.IH H1209 pbinns on DSK79D2C42PROD with BILLS 5 •HR 1209 IH ‘‘(B) Carrying out analyses of the harms 1 and benefits of the use of animals in proposed 2 research to assess whether the harms that 3 would be caused to animals in terms of suf- 4 fering, pain, and distress are justified by the 5 expected outcomes, taking into account ethical 6 considerations and the expected benefits to 7 human beings, animals, or the environment. 8 ‘‘(5) Establish and maintain animal care guide- 9 lines for the following: 10 ‘‘(A) The proper care of animals to be 11 used in biomedical and behavioral research. 12 ‘‘(B) The proper treatment of animals 13 while being used in such research. Guidelines 14 under this paragraph shall require— 15 ‘‘(i) the appropriate use of tranquil- 16 izers, analgesics, anesthetics, paralytics, 17 and euthanasia for animals in such re- 18 search; and 19 ‘‘(ii) appropriate pre-surgical and 20 post-surgical veterinary medical and nurs- 21 ing care for animals in such research. 22 Such guidelines shall not be construed to pre- 23 scribe methods of research. 24 VerDate Sep 11 2014 23:46 Feb 26, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H1209.IH H1209 pbinns on DSK79D2C42PROD with BILLS 6 •HR 1209 IH ‘‘(C) The organization and operation of 1 animal care committees in accordance with sub- 2 section (b). 3 ‘‘(b) ANIMAL CARE COMMITTEES.— 4 ‘‘(1) IN GENERAL.—The guidelines under sub- 5 section (a)(5)(C) shall require animal care commit- 6 tees at each entity which conducts biomedical and 7 behavioral research with funds provided under this 8 Act (including the National Institutes of Health and 9 the national research institutes) to assure compli- 10 ance with the guidelines established under sub- 11 section (a)(5). 12 ‘‘(2) APPOINTMENT OF MEMBERS.—Each ani- 13 mal care committee shall— 14 ‘‘(A) be appointed by the chief executive 15 officer of the entity for which the committee is 16 established; 17 ‘‘(B) be composed of not fewer than three 18 members; and 19 ‘‘(C) include at least one individual who 20 has no association with such entity and at least 21 one doctor of veterinary medicine. 22 ‘‘(3) REQUIREMENTS.—Each animal care com- 23 mittee of a research entity shall— 24 VerDate Sep 11 2014 23:46 Feb 26, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H1209.IH H1209 pbinns on DSK79D2C42PROD with BILLS 7 •HR 1209 IH ‘‘(A) review the care and treatment of ani- 1 mals in all animal study areas and facilities of 2 the research entity at least semiannually to 3 evaluate compliance with applicable guidelines 4 established under subsection (a)(5) for appro- 5 priate animal care and treatment; 6 ‘‘(B) keep appropriate records of reviews 7 conducted under subparagraph (A); and 8 ‘‘(C) for each review conducted under sub- 9 paragraph (A), file with the Director of NIH at 10 least annually— 11 ‘‘(i) a certification that the review has 12 been conducted; and 13 ‘‘(ii) reports of any violations of the 14 guidelines under subsection (a)(5) or as- 15 surances required under paragraph (1) 16 which were observed in such review and 17 which have continued after notice by the 18 committee to the research entity involved 19 of the violations. 20 ‘‘(4) MINORITY VIEWS.—Reports filed under 21 paragraph (3)(C) shall include any minority views 22 filed by members of the committee. 23 ‘‘(c) APPLICATIONS AND CONTRACTS.— 24 VerDate Sep 11 2014 23:46 Feb 26, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H1209.IH H1209 pbinns on DSK79D2C42PROD with BILLS 8 •HR 1209 IH ‘‘(1) CONTENTS.—The Director of NIH shall 1 require each applicant for a grant, contract, or coop- 2 erative agreement involving research on animals 3 which is administered by the National Institutes of 4 Health or any national research institute to include 5 in its application or contract proposal— 6 ‘‘(A) assurances satisfactory to the Direc- 7 tor of NIH that— 8 ‘‘(i) the applicant meets the require- 9 ments under paragraphs (2), (3), (4), and 10 (5) of subsection (a) and has an animal 11 care committee which meets the require- 12 ments of subsection (b); and 13 ‘‘(ii) scientists, animal technicians, 14 and other personnel involved with animal 15 care, treatment, and use by the applicant 16 have available to them instruction or train- 17 ing in— 18 ‘‘(I) the humane practice of ani- 19 mal maintenance and experimen- 20 tation; and 21 ‘‘(II) the concept, availability, 22 and use of research or testing meth- 23 ods that replace the use of animals, 24 VerDate Sep 11 2014 23:46 Feb 26, 2019 Jkt 089200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H1209.IH H1209 pbinns on DSK79D2C42PROD with BILLS 9 •HR 1209 IH limit the use of animals, or limit ani- 1 mal distress; 2 ‘‘(B) a statement of the reasons for the 3 use of animals in the research to be conducted 4 with funds provided under such grant or con- 5 tract; 6 ‘‘(C) a statement of assurance that a sci- 7 entifically satisfactory non-animal method of 8 obtaining the result sought is not available; and 9 ‘‘(D) an analysis of the harms and benefits 10 of the use of animals in the proposed research 11 assessing whether the harms that would be 12 caused to animals in terms of suffering, pain, 13 and distress is justified by the expected out- 14 comes, taking into account ethical consider- 15 ations and the expected benefits to human 16 beings, animals, or the environment. 17 ‘‘(2) REGULATORY PROCESS.—Notwithstanding 18 subsection (a)(2) of section 553 of title 5, United 19 States Code, regulations under this subsection shall 20 be promulgated in accordance with the notice and 21 comment requirements of such section. 22 ‘‘(d) SUSPENSION OR REVOCATION.—If the Director 23 of NIH determines that— 24 VerDate Sep 11 2014 23:46 Feb 26, 2019 Jkt 089200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H1209.IH H1209 pbinns on DSK79D2C42PROD with BILLS 10 •HR 1209 IH ‘‘(1) the conditions of animal care, treatment, 1 or use in an entity which is receiving a grant, con- 2 tract, or cooperative agreement involving research on 3 animals under this title do not meet applicable 4 guidelines established under subsection (a)(5); 5 ‘‘(2) the entity has been notified by the Direc- 6 tor of NIH of such determination and has been 7 given a reasonable opportunity to take corrective ac- 8 tion; and 9 ‘‘(3) no action has been taken by the entity to 10 correct such conditions, 11 the Director of NIH shall suspend or revoke such grant, 12 contract, or cooperative agreement under such conditions 13 as the Director determines appropriate. 14 ‘‘(e) PROTECTION OF CERTAIN INFORMATION.—No 15 guideline or regulation promulgated under subsection 16 (a)(5) or (c) may require a research entity to disclose pub- 17 licly trade secrets or commercial or financial information 18 which is privileged or confidential.’’. 19 Æ VerDate Sep 11 2014 23:46 Feb 26, 2019 Jkt 089200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6301 E:\BILLS\H1209.IH H1209 pbinns on DSK79D2C42PROD with BILLS