Public Law 99-198, Food Security Act of 1985, Subtitle F - Animal Welfare
Summary: Also called "The Improved Standards for Laboratory Animals Act" and enacted December 23, 1985, this section clarifies what is meant by "humane care" by mentioning specifics such as sanitation, housing, and ventilation. It directs the Secretary of Agriculture to establish regulations to provide exercise for dogs and an adequate physical environment to promote the psychological well-being of nonhuman primates. It specifies that pain and distress must be minimized in experimental procedures and that alternatives to such procedures be considered by the principle investigator. It also defines practices that are considered to be painful. No animal can be used in more than one major operative experiment with recovery (exceptions are listed). The establishment of the Institutional Animal Care and Use Committee (IACUC) is introduced with a description of its roles, composition, and responsibilities to the Animal and Plant Health Inspection Service (APHIS). Also included is the formation of an information service at the National Agricultural Library to assist those regulated by the act in prevention of unintended duplication of research, employee training, searching for ways to reduce or replace animal use, and to provide information on how to decrease pain and distress. The final section explains the penalties for release of trade secrets by regulators and the regulated community.
SUBTITLE F - ANIMAL WELFARE
SEC. 1751.[7 USC 2131 note.] For the purposes of this subtitle, the Congress finds that-
[Research and development.] (1) the use of animals is instrumental in certain research and education for advancing knowledge of cures and treatment for diseases and injuries which afflict both humans and animals;
(2) methods of testing that do not use animals are being and continue to be developed which are faster, less expensive, and more accurate than traditional animal experiments for some purposes and further opportunities exist for the development of these methods of testing;
(3) measures which eliminate or minimize the unnecessary duplication of experiments on animals can result in more productive use of Federal funds; and
(4) measures which help meet the public concern for laboratory animal care and treatment are important in assuring that research will continue to progress.
STANDARDS AND CERTIFICATION PROCESS
SEC. 1752. (a) Section 13 of the Animal Welfare Act (7 U.S.C. 2143) is amended by-
(1) redesignating subsections (b) through (d) as subsections (f) through (h) respectively; and
(2) striking out the first two sentences of subsection (a) and inserting in lieu thereof the following new sentences:"(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;
[Prohibition.] "(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 Care Committee.".
[7 USC 2143.] (b) Section 13(a) of such Act is further amended-
(1) by designating the third and fourth sentences as paragraph (4);
(2) by designating the fifth sentence as paragraph (5); and
(3) by striking out the last sentence and inserting in lieu thereof the following:
[Prohibition.] "(6)(A) Nothing in this Act-
"(i) except as provided in paragraphs (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;
[Regulations.] "(ii) except as provided 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
[Research and development.] "(iii) shall authorize the Secretary, during inspection, to interrupt the conduct of actual research or experimentation.
[Prohibition.] "(B) No rule, regulation, order, or part of this Act 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.
[Research and development.] "(7)(A) The Secretary shall require each research facility to show upon inspection, and to report at least annually, that the provisions of this Act 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.
[Prohibition.] "(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).".
[Ante, p.1645] (c) Section 13 of such Act is further amended by inserting after subsection (a) the following new subsections:
"(b)(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--
[Prohibitions.] "(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 Act 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.
[Reports.] "(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;
[Research and development.] "(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.
[Report.] "(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 Act. 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.
[Records. Reports.] "(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) In 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) Each 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) The 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.
[Research and development.] "(f) In any case in which a Federal agency funding a research project determines that conditions of animal care, treatment, or practice in a particular project have not been in compliance with standards promulgated under this Act, despite notification by the Secretary or such Federal agency to the research facility and an opportunity for correction, such agency shall suspend or revoke Federal support for the project. Any research facility losing Federal support as a result of actions taken under the preceding sentence shall have the right of appeal as provided in sections 701 through 706 of title 5, United States Code."
SEC. 1753. Section 16(a) of the Animal Welfare Act (7 U.S.C. 2146(a)) is amended by inserting after the first sentence the following: "The Secretary shall inspect each research facility at least once each year and, in the case of deficiencies or deviations from the standards promulgated under this Act, shall conduct such follow-up inspections as may be necessary until all deficiencies or deviations from such standards are corrected."
PENALTY FOR RELEASE OF TRADE SECRETS
[7 USC 2157] SEC. 1754. The Animal Welfare Act (7 U.S.C. 2131-2156) is amended by adding at the end thereof the following section:
"Sec. 27. (a) It shall be unlawful for any member of an Institutional Animal Committee to release any confidential information of the research facility including information that concerns or relates to--
"(1) the trade secrets, processes, operations, style of work, or apparatus; or
"(2) the identity, confidential statistical data, amount or source of any income, profits, losses, or expenditures, of the research facility.
"(b) It shall be unlawful for any member of such Committee--
"(1) to use or attempt to use to his advantages; or
"(2) to reveal to any other person, any information which is entitled to protection as confidential information under subsection (a).
"(c) A violation of subsection (a) or (b) is punishable by--
"(1) removal from such Committee; and
"(2)(A) a fine of not more than $1,000 and imprisonment of not more than a year; or
"(B) if such violation is willful, a fine of not more than $10,000 and imprisonment of not more than three years.
"(d) Any person, including any research facility, injured in its business or property by reason of a violation of this section may recover all actual and consequential damages sustained by such person and the cost of the suit including a reasonable attorney's fee.
[Prohibition.] "(e) Nothing in this section shall be construed to affect any other rights of a person injured in its business or property by reason of a violation of this section. Subsection (d) shall not be construed to limit the exercise of any such rights arising out of or relating to a violation of subsections (a) and (b).".
INCREASED PENALTIES FOR VIOLATION OF THE ACT
SEC. 1755. (a) Subsection (b) of section 19 of the Animal Welfare Act (7 U.S.C. 2149 (b)) is amended--
(1) in the first sentence by striking out "$1,000 for each such violation" and inserting in lieu thereof "$2,500 for each such violation"; and
(2) in the sixth sentence by striking out "$500 for each offense" and inserting in lieu thereof "$1,500 for each offense".
(b) Subsection (d) of such section is amended by striking out "$1,000" and inserting in lieu thereof "$2,500".
SEC. 1756. (a) Section 2 of the Animal Welfare Act (7 U.S.C. 2132) is amended by--
(1) striking out "and" after the semicolon in subsection (i);
(2) striking out the period at the end of subsection (j) and inserting in lieu thereof a semicolon; and
(3) adding after subsection (j) the following new subsections:
[Animals.] "(k) The term 'Federal agency' means an Executive agency as such term is defined in section 105 of title 5, United States Code, and with respect to any research facility means the agency from which the research facility receives a Federal award for the conduct of research, experimentation, or testing, involving the use of animals;
[Research and development. Grant. Loan. Contract. ] "(l) The term 'Federal award for the conduct of research experimentation, or testing, involving the use of animals' means any mechanism (including a grant, award, loan, contract, or cooperative agreement) under which Federal funds are provided to support the conduct of such research.
"(m) The term "quorum" means a majority of the Committee members;
[Ante, p.1647.] "(n) The term 'Committee' means the Institutional Animal Committee established under section 13(b); and
[Research and development.] "(o) The term 'Federal research facility' means each department, agency, or instrumentality of the United States which uses live animals for research or experimentation.".
[7 USC 2131 note.] (B) For purposes of this Act, the term "animal" shall have the same meaning as defined in section 2(g) of the Animal Welfare Act (7 U.S.C. 2132(g)).
CONSULTATION WITH THE SECRETARY OF HEALTH AND HUMAN SERVICES
[Regulations.] SEC. 1757. Section 15(a) of the Animal Welfare Act (7 U.S.C. 2145(a)) is amended by adding after the first sentence the following: "The Secretary shall consult with the Secretary of Health and Human Services prior to issuance of regulations."
SEC. 1758. Section 14 of the Animal Welfare Act (7 U.S.C. 2144) is amended by changing "section 13" to "sections 13 (a),(f),(g), and (h)" wherever it appears.
[7 USC 2131 note.] SEC. 1759. This subtitle shall take effect 1 year after the date of the enactment of this Act.