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.
DEC. 23, 1985
FOOD SECURITY ACT OF 1985
TITLE XVII-RELATED AND MISCELLANEOUS MATTERS
Note: In this HTML version of the amendment, brackets, [ ], indicate notes found in the corresponding margin of the hardcopy document.
SUBTITLE F - ANIMAL WELFARE
FINDINGS
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 researchshall 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."
INSPECTIONS
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".
DEFINITIONS
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."
TECHNICAL AMENDMENT
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.
EFFECTIVE DATE
[7 USC 2131 note.] SEC. 1759. This subtitle shall take effect 1 year
after the date of the enactment of this Act.