[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1209 Introduced in House (IH)]

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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 Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Humane and Existing Alternatives in 
Research and Testing Sciences Act of 2019'' or the ``HEARTS Act of 
2019''.

SEC. 2. FINDINGS.

    Congress finds the following:
            (1) The National Institutes of Health has supported life-
        saving research that has greatly improved the health and well-
        being not only of Americans but also of people around the 
        world.
            (2) Much of this research has relied on animals. It is 
        estimated that between 17 million and 22 million animals are 
        used annually in the United States in research, education, and 
        testing.
            (3) At the same time, however, a great deal of research 
        that utilized animal studies yielded no benefits for humans. 
        For example, according to NIH itself, ``approximately 30 
        percent of promising medications have failed in human clinical 
        trials because they are found to be toxic despite promising 
        pre-clinical studies in animal models. About 60 percent of 
        candidate drugs fail due to lack of efficacy''.
            (4) The laboratory use of animals has also long been an 
        issue of public concern because animals will, in most cases, 
        experience fear, pain, disease or surgery, and early death.
            (5) Much more has become known about the unsuitability of 
        animal models for studying human disease and many more humane, 
        cost-effective, and scientifically suitable non-animal methods 
        are available.
            (6) Under the system of oversight established by the Animal 
        Welfare Act (Public Law 89-544), researchers are supposed to 
        consider alternatives to animal use or painful procedures and 
        should not unnecessarily duplicate previous experiments. 
        However, oversight is generally weak and little heed is paid to 
        the use of non-animal methods or the avoidance of duplication, 
        thereby unnecessarily subjecting animals to pain, suffering, 
        and death.
            (7) A system of active incentives is needed to encourage 
        researchers to utilize humane, cost-effective, and 
        scientifically suitable non-animal methods.

SEC. 3. ANIMALS IN RESEARCH.

    Section 495 of the Public Health Service Act (42 U.S.C. 289d) is 
amended to read as follows:

``SEC. 495. ANIMALS IN RESEARCH.

    ``(a) In General.--The Secretary, acting through the Director of 
NIH, shall, with respect to all research conducted or supported by the 
National Institutes of Health, do the following:
            ``(1) Establish a system of meaningful incentives to 
        encourage the use of existing humane and scientifically 
        satisfactory non-animal methods in research proposals.
            ``(2) Ensure that, before any research involving the use of 
        animals is approved or performed--
                    ``(A) all scientifically satisfactory non-animal 
                methods for obtaining the results sought have been 
                fully evaluated; and
                    ``(B) a detailed explanation and an analysis of the 
                harms and benefits of such use of animals have been 
                completed.
            ``(3) Ensure that--
                    ``(A) research proposals are reviewed by at least 
                one person who has expertise in non-animal research 
                methods; and
                    ``(B) reviewers of the research proposals have 
                access to a reference librarian with expertise in 
                evaluating the adequacy of the searches for non-animal 
                methods described in the research proposals.
            ``(4) Establish and maintain research proposal guidelines 
        for the following:
                    ``(A) Conducting thorough searches for non-animal 
                alternatives to the use of animals for biomedical and 
                behavioral research.
                    ``(B) Carrying out analyses of the harms and 
                benefits of the use of animals in proposed research to 
                assess whether the harms that would be caused to 
                animals in terms of suffering, pain, and distress are 
                justified by the expected outcomes, taking into account 
                ethical considerations and the expected benefits to 
                human beings, animals, or the environment.
            ``(5) Establish and maintain animal care guidelines for the 
        following:
                    ``(A) The proper care of animals to be used in 
                biomedical and behavioral research.
                    ``(B) The proper treatment of animals while being 
                used in such research. Guidelines under this paragraph 
                shall require--
                            ``(i) the appropriate use of tranquilizers, 
                        analgesics, anesthetics, paralytics, and 
                        euthanasia for animals in such research; and
                            ``(ii) appropriate pre-surgical and post-
                        surgical veterinary medical and nursing care 
                        for animals in such research.
                Such guidelines shall not be construed to prescribe 
                methods of research.
                    ``(C) The organization and operation of animal care 
                committees in accordance with subsection (b).
    ``(b) Animal Care Committees.--
            ``(1) In general.--The guidelines under subsection 
        (a)(5)(C) shall require animal care committees at each entity 
        which conducts biomedical and behavioral research with funds 
        provided under this Act (including the National Institutes of 
        Health and the national research institutes) to assure 
        compliance with the guidelines established under subsection 
        (a)(5).
            ``(2) Appointment of members.--Each animal care committee 
        shall--
                    ``(A) be appointed by the chief executive officer 
                of the entity for which the committee is established;
                    ``(B) be composed of not fewer than three members; 
                and
                    ``(C) include at least one individual who has no 
                association with such entity and at least one doctor of 
                veterinary medicine.
            ``(3) Requirements.--Each animal care committee of a 
        research entity shall--
                    ``(A) review the care and treatment of animals in 
                all animal study areas and facilities of the research 
                entity at least semiannually to evaluate compliance 
                with applicable guidelines established under subsection 
                (a)(5) for appropriate animal care and treatment;
                    ``(B) keep appropriate records of reviews conducted 
                under subparagraph (A); and
                    ``(C) for each review conducted under subparagraph 
                (A), file with the Director of NIH at least annually--
                            ``(i) a certification that the review has 
                        been conducted; and
                            ``(ii) reports of any violations of the 
                        guidelines under subsection (a)(5) or 
                        assurances required under paragraph (1) which 
                        were observed in such review and which have 
                        continued after notice by the committee to the 
                        research entity involved of the violations.
            ``(4) Minority views.--Reports filed under paragraph (3)(C) 
        shall include any minority views filed by members of the 
        committee.
    ``(c) Applications and Contracts.--
            ``(1) Contents.--The Director of NIH shall require each 
        applicant for a grant, contract, or cooperative agreement 
        involving research on animals which is administered by the 
        National Institutes of Health or any national research 
        institute to include in its application or contract proposal--
                    ``(A) assurances satisfactory to the Director of 
                NIH that--
                            ``(i) the applicant meets the requirements 
                        under paragraphs (2), (3), (4), and (5) of 
                        subsection (a) and has an animal care committee 
                        which meets the requirements of subsection (b); 
                        and
                            ``(ii) scientists, animal technicians, and 
                        other personnel involved with animal care, 
                        treatment, and use by the applicant have 
                        available to them instruction or training in--
                                    ``(I) the humane practice of animal 
                                maintenance and experimentation; and
                                    ``(II) the concept, availability, 
                                and use of research or testing methods 
                                that replace the use of animals, limit 
                                the use of animals, or limit animal 
                                distress;
                    ``(B) a statement of the reasons for the use of 
                animals in the research to be conducted with funds 
                provided under such grant or contract;
                    ``(C) a statement of assurance that a 
                scientifically satisfactory non-animal method of 
                obtaining the result sought is not available; and
                    ``(D) an analysis of the harms and benefits of the 
                use of animals in the proposed research assessing 
                whether the harms that would be caused to animals in 
                terms of suffering, pain, and distress is justified by 
                the expected outcomes, taking into account ethical 
                considerations and the expected benefits to human 
                beings, animals, or the environment.
            ``(2) Regulatory process.--Notwithstanding subsection 
        (a)(2) of section 553 of title 5, United States Code, 
        regulations under this subsection shall be promulgated in 
        accordance with the notice and comment requirements of such 
        section.
    ``(d) Suspension or Revocation.--If the Director of NIH determines 
that--
            ``(1) the conditions of animal care, treatment, or use in 
        an entity which is receiving a grant, contract, or cooperative 
        agreement involving research on animals under this title do not 
        meet applicable guidelines established under subsection (a)(5);
            ``(2) the entity has been notified by the Director of NIH 
        of such determination and has been given a reasonable 
        opportunity to take corrective action; and
            ``(3) no action has been taken by the entity to correct 
        such conditions,
the Director of NIH shall suspend or revoke such grant, contract, or 
cooperative agreement under such conditions as the Director determines 
appropriate.
    ``(e) Protection of Certain Information.--No guideline or 
regulation promulgated under subsection (a)(5) or (c) may require a 
research entity to disclose publicly trade secrets or commercial or 
financial information which is privileged or confidential.''.
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