Office of Laboratory Animal Welfare
HEALTH RESEARCH EXTENSION ACT OF 1985
PUBLIC LAW 99-158, November 20, 1985
"ANIMALS IN RESEARCH"
Sec.495. (a) The Secretary, acting through the Director of NIH, shall establish
guidelines for the following:
"(1) The proper care of animals to be used in biomedical and behavioral research.
"(2) The proper treatment of animals while being used in such research. Guidelines
under this paragraph shall require-
"(A) the appropriate use of tranquilizers, analgesics, anesthetics, paralytics,
and euthanasia for animals in such research; and
"(B) 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.
"(3) The organization and operation of animal care committees in accordance
with subsection (b).
"(b)(1) Guidelines of the Secretary under subsection (a)(3) 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).
"(2) Each animal care committee shall be appointed by the chief executive officer
of the entity for which the committee is established, shall be composed of not
fewer than three members, and shall include at least one individual who has
no association with such entity and at least one doctor of veterinary medicine.
"(3) 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) for appropriate
animal care and treatment;
"(B) keep appropriate records of reviews conducted under sub-paragraph (A);
"(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 guidelines established under subsection
(a) 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.
Reports filed under subparagraph (C) shall include any minority views filed
by members of the committee.
"(c) 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, submitted after the expiration of the
twelve-month period beginning on the date of enactment of this section-
"(1) assurances satisfactory to the Director of NIH that-
"(A) the applicant meets the requirements of the guidelines established under
paragraphs (1) and (2) of subsection (a) and has an animal care committee
which meets the requirements of subsection (b); and
"(2) a statement of the reasons for the use of animals in the research to be
conducted with funds provided under such grant or contract. 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.
"(B) scientists, animal technicians, and other personnel involved with animal
care, treatment, and use by the applicant have available to them instruction
or training in the humane practice of animal maintenance and experimentation,
and the concept, availability, and use of research or testing methods that
limit the use of animals or limit animal distress; and
"(d) 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
"(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 or contract under such conditions
as the Director determines appropriate.
"(e) No guideline or regulation promulgated under subsection (a) or (c) may
require a research entity to disclose publicly trade secrets or commercial or
financial information which is privileged or confidential."