ANIMAL CARE AND USE
Sections
14.02.07 Delegations of Authority
Appendix A - Utilization and Care of Vertebrate Animals Used in Testing, Research and Training
Appendix B - Health Research Extension Act of
1985: "Animals in Research"
14.02.01
PURPOSE
This subchapter establishes responsibility for humane care and use
of animals within the NIST program.
14.02.02
SCOPE
This policy is applicable to all NIST-conducted or supported activities
involving animals, whether the activities are performed at NIST, an awardee
institution, or any other institution, and conducted in the United States,
the Commonwealth of Puerto Rico, or any territory or possession of the
United States. The requirements of this policy are effective for applications
and proposals for NIST research involving animals that are submitted for
NIST consideration, and for all NIST-conducted or -supported research involving
animals. Institutions in foreign countries receiving NIST support for activities
involving animals shall comply with this policy, or provide evidence to
NIST that acceptable standards for the humane care and use of the animals
in the NIST-conducted or supported activities will be met. No NIST support
for an activity involving animals will be provided to an individual unless
that individual is affiliated with or sponsored by an institution which
can and does assume responsibility for compliance with this subchapter,
unless the individual makes other arrangements with the NIST. This policy
does not affect applicable state or local laws or regulations which impose
more stringent standards for the care and use of laboratory animals. All
NIST components, contractors, or institutions with which NIST has collaborative
or cooperative agreements are required to comply, as applicable, with all
federal statutes and regulations relating to animals. This policy is also
applicable to the transportation of experimental animals on NIST property,
between buildings or facilities, to or from commercial carriers, or in
any other manner.
14.02.03
POLICY
The NIST policy is that each investigator or person involved in the
care or use of animals adhere to the
Principles, the Guide,
and applicable humane and ethical policies as established or referenced
herein, including the Animal Welfare Act, the Health Research Extension
Act of 1985, and the Endangered Species Act of 1973. Adequate veterinary
care shall conform to the standards set forth in the Guide and in
Adequate
Veterinary Care. The NIST-Animal Care and Use Committee (NIST-ACUC)
will suspend any activity involving animals that has been previously approved
if it is determined that the activity is not being conducted in accordance
with the previously approved animal study proposal or provisions cited
in this subchapter.
(1) Animal Welfare Act (7 U.S.C. 2131 et seq).
(2) The Endangered Species Act of 1973 (16 U.S.C. 1531 et seq).
(3) Health Research Extension Act of 1985 (Pub.L. 99-158, November 20,
1985).
b. Regulations -
(1) Good Laboratory Practice for Nonclinical Laboratory Studies (FDA
Regulations Title 21, CFR, Part 58, 1976).
(2) Procurements Involving the Use of Laboratory Animals (Federal Acquisition
Regulations Supplement, Clause 52.235-7003).
c. Policies -
(1) Guide for the Care and Use of Laboratory Animals (DHHS Publication
No. NIH 85-23).
(2) PHS Policy on Humane Care and Use of Laboratory Animals, Sept. 1986.
(3) Report of the AVMA Panel on Euthanasia,
JAVMA 183 (3): 252-268,
February 1, 1986.
(4) Biosafety in Microbiological and Biomedical Laboratories, March
1984. DHHS Publication No. (CDC) 84-8395.
(5) The National Institutes of Health Radiation Safety Guide (DHHS Publication
No. (NIH) 79-18).
(6) Institutional Administrator's Manual for Laboratory Animal Care
and Use (DHHS Publication No. (NIH) 88-2959).
d. Guidelines -
Report of the American College of Laboratory Animal Medicine (ACLAM)
on Adequate Veterinary Care, October 1986.
14.02.05
DEFINITIONS
a. Accreditation - Recognition by the American Association for
Accreditation of Laboratory Animal Care or other NIST-approved accrediting
body that the animal facilities and management practices of a research
institution are in accordance with the Public Health Service/National
Institutes of Health Guide for Care and Use of Animals (Guide).
b. Adequate Veterinary Care - Care conforming to the standards
set forth in the Guide and in Adequate Veterinary Care by
the American College of Laboratory Animal Medicine.
c. Animal - Any live, vertebrate animal used or intended for
use in research, experimentation, testing, training, or related purposes.
(The acquisition and transportation of certain invertebrates and of parts
of certain vertebrates are also subject to federal regulation.)
d. Animal Facility - Any and all buildings, rooms, areas, enclosures,
or vehicles, including satellite facilities, used for animal confinement,
transport, maintenance, breeding, or experiments inclusive of surgical
manipulation. A satellite facility is any containment outside of a core
facility or centrally designated or managed area in which animals are housed
for more than 24 hours.
e. Form NIST-1258, Contractor/Grantee Animal Study Proposal, and
Form NIST-1259, Intramural Animal Study Proposal - supplied by the
NIST Animal Care and Use Committee (NIST-ACUC), completed by an intramural
or extramural Principal Investigator and submitted for approval to the
Chair of the NIST-ACUC prior to the ordering of animals or initiation of
study. (Copies of these forms are available from the NIST-ACUC).
f. Guide - The Public Health Service (PHS)/National Institutes
of Health (NIH) Guide for the Care and Use of Laboratory Animals, which
serves as the standard by which animal care and use programs are developed
and assessed. The Guide is available from the NIST-ACUC or the Office
of Animal Care and Use (OACU), O.D., NIH, Building 12A, Room 4003, Bethesda,
MD 20892, (301) 496-5424.
g. NIST Animal Care and Use Committee (NIST-ACUC) - The NIST
Animal Care and Use Committee which is appointed by the NIST Director and
composed of a Chair and members as defined in Subchapter 3.01, Appendix
A.
h. NIST Veterinary Advisor - A Doctor of Veterinary Medicine, with training or experience in laboratory animal science and medicine, who is a member of the NIST-ACUC and provides advice for activities involving animals at NIST.
i. Principles - U.S. Government Principles for the Utilization
and Care of Vertebrate Animals Used in Testing, Research and Training
(See Appendix A).
j. Principal Investigator - The scientist responsible for conducting
an animal study in compliance with this subchapter and the Guide,
and who certifies acceptance of this responsibility by signing Form NIST-1259.
"Intramural" Principal Investigators are NIST employees who are responsible
for such research performed in NIST facilities. "Extramural" Principal
Investigators are employees of institutions who are responsible for such
research in non-NIST facilities as a result of a grant or contract with
NIST.
k. Proposal - A research or contract plan containing a description
of the research, the necessity for the study, a detailed work plan, and
budget.
l. Technical Officer - The NIST scientist or engineer who is
responsible for and provides technical oversight for a research project
carried out under a NIST grant or contract. In the case of NIST grants,
this individual is commonly known as the "Scientific Officer." In the case
of NIST contracts, this individual is commonly known as the "Contracting
Officer's Technical Representative (COTR)."
14.02.06
RESPONSIBILITIES
a. The NIST Director - Responsible for ensuring compliance with
this subchapter by all NIST employees, contractors, grantees, and others
that are funded by NIST or use NIST facilities; for implementing and administering
this subchapter; and for taking appropriate action regarding recommendations
from the NIST-ACUC.
b. Intramural Principal Investigators - The NIST Principal Investigator
shall:
(1) Secure the division chief's approval of the scientific merit and
funding for any research involving animals.
(2) Sign and submit a completed Form NIST-1259 along with a copy of
the division chief-approved research proposal, to the OU and the ACUC for
review before requesting animals or initiating animal studies.
(3) Attend the course, Using Animals in Research: Guidelines for
Investigators or participate in a comparable training experience approved
by the ACUC, prior to approval of Form NIST-1259. (This policy may be waived
by the ACUC until the next offering of the course.)
(4) Ensure all personnel working with animals on the project receive
training in the appropriate techniques for the species of animals that
they use.
(5) Comply with this subchapter and the Guide.
(6) Ensure that the NIST-ACUC is informed in writing of proposed significant deviations from procedures described on Form NIST-1259.
c. Extramural Principal Investigator - The Extramural Principal
Investigator shall submit to the NIST Technical Officer:
(1) A grant or contract Proposal.
(2) A completed Form NIST-1258 with signed approval by the Institutional
ACUC.
(3) Copies of other governmental approvals for their animal care and
use procedures and showing the current status of their assurance by PHS/NIH,
and copies of animal care facility accreditation.
(4) Certification that the Principal Investigator and other personnel
involved in the care and use of the animals are trained as required by
this subchapter and the Guide.
During the course of the research, the Extramural Principal Investigator
must inform the NIST Technical Officer in writing of any proposed deviation
from procedures involving animals described on Form NIST-1258, any change
in personnel and their training, any change in the status of their PHS/NIH
assurance or other governmental inspecting bodies; and the results of any
inspections of their animal care facilities that take place during the
course of the contract or grant.
d. NIST Technical Officer - The NIST Technical Officer shall:
(1) Secure scientific and management approval of the extramural research
Proposal via normal NIST procedures.
(2) Forward the approved Proposal to the NIST-ACUC for its review and
approval.
(3) Inform the NIST-ACUC of any information from the Contractor/Grantee that deviates from the animal-related information supplied in the Proposal or on Form NIST-1258, throughout the duration of the contract or grant.
e. NIST Veterinary Advisor - The NIST Veterinary Advisor shall:
(1) Advise on implementation of the NIST Animal Care and Use Program.
(2) Help the NIST-ACUC evaluate compliance with this subchapter and
the Guide in the animal facility(ies).
(3) Advise the Principal Investigator or Technical Officer, the NIST-ACUC,
and the NIST Director on activities involving animals at NIST, to ensure
compliance with this subchapter and the Guide.
14.02.07
DELEGATIONS OF AUTHORITY
The NIST Director delegates authority to:
a. The NIST Animal Care and Use Committee (NIST-ACUC) to monitor implementation;
b. The NIST OU Directors to implement and administer this policy on
a day-to-day basis for each organizational unit that uses animals in research,
and for taking appropriate action regarding recommendations from the NIST-ACUC;
c. The Principal Investigator to ensure compliance in every day operations,
such as the experimental setting and procedures, veterinary care, husbandry,
and provision of supplies and equipment; and
d. The NIST Veterinary Advisor to evaluate veterinary compliance with this NIST subchapter and the Guide.