HEARTS Act of 2021

I 117TH CONGRESS 1ST SESSION H. R. 4101 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 JUNE 23, 2021 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 2021’’ or the ‘‘HEARTS Act of 2021’’. 6 VerDate Sep 11 2014 01:48 Jul 10, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H4101.IH H4101 kjohnson on DSK79L0C42PROD with BILLS 2 •HR 4101 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 01:48 Jul 10, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H4101.IH H4101 kjohnson on DSK79L0C42PROD with BILLS 3 •HR 4101 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— 17 (1) in subsection (a)— 18 (A) in paragraph (2)— 19 (i) in the matter preceding subpara- 20 graph (A), by striking ‘‘paragraph’’ and in- 21 serting ‘‘subparagraph’’; and 22 (ii) by redesignating subparagraphs 23 (A) and (B) as clauses (i) and (ii), respec- 24 tively, and moving the margins of such 25 VerDate Sep 11 2014 01:48 Jul 10, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H4101.IH H4101 kjohnson on DSK79L0C42PROD with BILLS 4 •HR 4101 IH clauses (as so redesignated) two ems to the 1 right; 2 (B) by redesignating paragraphs (1), (2) 3 (as so amended), and (3) as subparagraphs (A), 4 (B), and (C), respectively, and moving the mar- 5 gins of such subparagraphs (as so redesignated) 6 two ems to the right; 7 (C) in the matter preceding subparagraph 8 (A) (as so redesignated), by striking ‘‘shall es- 9 tablish guidelines for the following:’’ and insert- 10 ing the following: ‘‘, with respect to all research 11 conducted or supported by the National Insti- 12 tutes of Health, do the following: 13 ‘‘(1) Establish and maintain animal care guide- 14 lines for the following:’’; and 15 (D) by adding at the end the following: 16 ‘‘(2) Establish a system of meaningful incen- 17 tives to encourage the use of existing humane and 18 scientifically satisfactory non-animal methods in re- 19 search proposals. 20 ‘‘(3) Ensure that, before any research involving 21 the use of animals is approved or performed all sci- 22 entifically satisfactory non-animal methods for ob- 23 taining the results sought have been fully evaluated. 24 ‘‘(4) Ensure that— 25 VerDate Sep 11 2014 01:48 Jul 10, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H4101.IH H4101 kjohnson on DSK79L0C42PROD with BILLS 5 •HR 4101 IH ‘‘(A) research proposals are reviewed by at 1 least one person who has expertise in non-ani- 2 mal research methods; and 3 ‘‘(B) reviewers of the research proposals 4 have access to a reference librarian with exper- 5 tise in evaluating the adequacy of the searches 6 for non-animal methods described in the re- 7 search proposals. 8 ‘‘(5) Establish and maintain research proposal 9 guidelines for conducting thorough searches for non- 10 animal alternatives to the use of animals for bio- 11 medical and behavioral research.’’; and 12 (2) in subsection (c)(1)— 13 (A) in subparagraph (A), by striking 14 ‘‘and’’ at the end; and 15 (B) by adding at the end the following: 16 ‘‘(C) a statement of assurance that a sci- 17 entifically satisfactory non-animal method of 18 obtaining the result sought is not available; 19 and’’. 20 Æ VerDate Sep 11 2014 01:48 Jul 10, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6301 E:\BILLS\H4101.IH H4101 kjohnson on DSK79L0C42PROD with BILLS