View all text of Chapter 54 [§ 2131 - § 2160]
§ 2143. Standards and certification process for humane handling, care, treatment, and transportation of animals
(a) Promulgation of standards, rules, regulations, and orders; requirements; research facilities; State authority
(1) The Secretary shall promulgate standards to govern the humane handling, care, treatment, and transportation of animals by dealers, research facilities, and exhibitors.
(2) The standards described in paragraph (1) shall include minimum requirements—
(A) for handling, housing, feeding, watering, sanitation, ventilation, shelter from extremes of weather and temperatures, adequate veterinary care, and separation by species where the Secretary finds necessary for humane handling, care, or treatment of animals; and
(B) for exercise of dogs, as determined by an attending veterinarian in accordance with general standards promulgated by the Secretary, and for a physical environment adequate to promote the psychological well-being of primates.
(3) In addition to the requirements under paragraph (2), the standards described in paragraph (1) shall, with respect to animals in research facilities, include requirements—
(A) for animal care, treatment, and practices in experimental procedures to ensure that animal pain and distress are minimized, including adequate veterinary care with the appropriate use of anesthetic, analgesic, tranquilizing drugs, or euthanasia;
(B) that the principal investigator considers alternatives to any procedure likely to produce pain to or distress in an experimental animal;
(C) in any practice which could cause pain to animals—
(i) that a doctor of veterinary medicine is consulted in the planning of such procedures;
(ii) for the use of tranquilizers, analgesics, and anesthetics;
(iii) for pre-surgical and post-surgical care by laboratory workers, in accordance with established veterinary medical and nursing procedures;
(iv) against the use of paralytics without anesthesia; and
(v) that the withholding of tranquilizers, anesthesia, analgesia, or euthanasia when scientifically necessary shall continue for only the necessary period of time;
(D) that no animal is used in more than one major operative experiment from which it is allowed to recover except in cases of—
(i) scientific necessity; or
(ii) other special circumstances as determined by the Secretary; and
(E) that exceptions to such standards may be made only when specified by research protocol and that any such exception shall be detailed and explained in a report outlined under paragraph (7) and filed with the Institutional Animal Committee.
(4) The Secretary shall also promulgate standards to govern the transportation in commerce, and the handling, care, and treatment in connection therewith, by intermediate handlers, air carriers, or other carriers, of animals consigned by any dealer, research facility, exhibitor, operator of an auction sale, or other person, or any department, agency, or instrumentality of the United States or of any State or local government, for transportation in commerce. The Secretary shall have authority to promulgate such rules and regulations as he determines necessary to assure humane treatment of animals in the course of their transportation in commerce including requirements such as those with respect to containers, feed, water, rest, ventilation, temperature, and handling.
(5) In promulgating and enforcing standards established pursuant to this section, the Secretary is authorized and directed to consult experts, including outside consultants where indicated.
(6)
(A) Nothing in this chapter—
(i) except as provided in paragraphs 1
1 So in original. Probably should be “paragraph”.
(7) of this subsection, shall be construed as authorizing the Secretary to promulgate rules, regulations, or orders with regard to the design, outlines, or guidelines of actual research or experimentation by a research facility as determined by such research facility;(ii) except as provided 2
2 So in original. Probably should be followed by “in”.
subparagraphs (A) and (C)(ii) through (v) of paragraph (3) and paragraph (7) of this subsection, shall be construed as authorizing the Secretary to promulgate rules, regulations, or orders with regard to the performance of actual research or experimentation by a research facility as determined by such research facility; and(iii) shall authorize the Secretary, during inspection, to interrupt the conduct of actual research or experimentation.
(B) No rule, regulation, order, or part of this chapter shall be construed to require a research facility to disclose publicly or to the Institutional Animal Committee during its inspection, trade secrets or commercial or financial information which is privileged or confidential.
(7)
(A) The Secretary shall require each research facility to show upon inspection, and to report at least annually, that the provisions of this chapter are being followed and that professionally acceptable standards governing the care, treatment, and use of animals are being followed by the research facility during actual research or experimentation.
(B) In complying with subparagraph (A), such research facilities shall provide—
(i) information on procedures likely to produce pain or distress in any animal and assurances demonstrating that the principal investigator considered alternatives to those procedures;
(ii) assurances satisfactory to the Secretary that such facility is adhering to the standards described in this section; and
(iii) an explanation for any deviation from the standards promulgated under this section.
(8) Paragraph (1) shall not prohibit any State (or a political subdivision of such State) from promulgating standards in addition to those standards promulgated by the Secretary under paragraph (1).
(b) Research facility Committee; establishment, membership, functions, etc.
(1) The Secretary shall require that each research facility establish at least one Committee. Each Committee shall be appointed by the chief executive officer of each such research facility and shall be composed of not fewer than three members. Such members shall possess sufficient ability to assess animal care, treatment, and practices in experimental research as determined by the needs of the research facility and shall represent society’s concerns regarding the welfare of animal subjects used at such facility. Of the members of the Committee—
(A) at least one member shall be a doctor of veterinary medicine;
(B) at least one member—
(i) shall not be affiliated in any way with such facility other than as a member of the Committee;
(ii) shall not be a member of the immediate family of a person who is affiliated with such facility; and
(iii) is intended to provide representation for general community interests in the proper care and treatment of animals; and
(C) in those cases where the Committee consists of more than three members, not more than three members shall be from the same administrative unit of such facility.
(2) A quorum shall be required for all formal actions of the Committee, including inspections under paragraph (3).
(3) The Committee shall inspect at least semiannually all animal study areas and animal facilities of such research facility and review as part of the inspection—
(A) practices involving pain to animals, and
(B) the condition of animals,
to ensure compliance with the provisions of this chapter to minimize pain and distress to animals. Exceptions to the requirement of inspection of such study areas may be made by the Secretary if animals are studied in their natural environment and the study area is prohibitive to easy access.
(4)
(A) The Committee shall file an inspection certification report of each inspection at the research facility. Such report shall—
(i) be signed by a majority of the Committee members involved in the inspection;
(ii) include reports of any violation of the standards promulgated, or assurances required, by the Secretary, including any deficient conditions of animal care or treatment, any deviations of research practices from originally approved proposals that adversely affect animal welfare, any notification to the facility regarding such conditions, and any corrections made thereafter;
(iii) include any minority views of the Committee; and
(iv) include any other information pertinent to the activities of the Committee.
(B) Such report shall remain on file for at least three years at the research facility and shall be available for inspection by the Animal and Plant Health Inspection Service and any funding Federal agency.
(C) In order to give the research facility an opportunity to correct any deficiencies or deviations discovered by reason of paragraph (3), the Committee shall notify the administrative representative of the research facility of any deficiencies or deviations from the provisions of this chapter. If, after notification and an opportunity for correction, such deficiencies or deviations remain uncorrected, the Committee shall notify (in writing) the Animal and Plant Health Inspection Service and the funding Federal agency of such deficiencies or deviations.
(5) The inspection results shall be available to Department of Agriculture inspectors for review during inspections. Department of Agriculture inspectors shall forward any Committee inspection records which include reports of uncorrected deficiencies or deviations to the Animal and Plant Health Inspection Service and any funding Federal agency of the project with respect to which such uncorrected deficiencies and deviations occurred.
(c) Federal research facilities; establishment, composition, and responsibilities of Federal CommitteeIn the case of Federal research facilities, a Federal Committee shall be established and shall have the same composition and responsibilities provided in subsection (b), except that the Federal Committee shall report deficiencies or deviations to the head of the Federal agency conducting the research rather than to the Animal and Plant Health Inspection Service. The head of the Federal agency conducting the research shall be responsible for—
(1) all corrective action to be taken at the facility; and
(2) the granting of all exceptions to inspection protocol.
(d) Training of scientists, animal technicians, and other personnel involved with animal care and treatment at research facilitiesEach research facility shall provide for the training of scientists, animal technicians, and other personnel involved with animal care and treatment in such facility as required by the Secretary. Such training shall include instruction on—
(1) the humane practice of animal maintenance and experimentation;
(2) research or testing methods that minimize or eliminate the use of animals or limit animal pain or distress;
(3) utilization of the information service at the National Agricultural Library, established under subsection (e); and
(4) methods whereby deficiencies in animal care and treatment should be reported.
(e) Establishment of information service at National Agricultural Library; service functionsThe Secretary shall establish an information service at the National Agricultural Library. Such service shall, in cooperation with the National Library of Medicine, provide information—
(1) pertinent to employee training;
(2) which could prevent unintended duplication of animal experimentation as determined by the needs of the research facility; and
(3) on improved methods of animal experimentation, including methods which could—
(A) reduce or replace animal use; and
(B) minimize pain and distress to animals, such as anesthetic and analgesic procedures.
(f)3
3 So in original. Two subsecs. (f) have been enacted.
Suspension or revocation of Federal support for research projects; prerequisites; appeal procedure(f)3 Veterinary certificate; contents; exceptions
(g) Age of animals delivered to registered research facilities; power of Secretary to designate additional classes of animals and age limits
(h) Prohibition of C.O.D. arrangements for transportation of animals in commerce; exceptions
(Pub. L. 89–544, § 13, Aug. 24, 1966, 80 Stat. 352; Pub. L. 91–579, § 14, Dec. 24, 1970, 84 Stat. 1562; Pub. L. 94–279, §§ 9, 10, Apr. 22, 1976, 90 Stat. 418, 419; Pub. L. 99–198, title XVII, § 1752, Dec. 23, 1985, 99 Stat. 1645.)