Care and Use Program
Federal Regulations and Guidance
The two federal laws governing the care and use of
live animals in research, research training, experimentation,
biological testing and all other related purposes are
Welfare Act and the Health Research Extension Act.
The Animal Welfare Act is enforced and administered
by United States Department of Agriculture, Animal and
Plant Health Inspection Service, Animal Care (USDA,
- USDA enforces the AWA through the Animal Welfare
Regulations (AWRs) 9 CFR Chapter 1, Parts 1-3
- Interpretation of the AWRs is provided through the
The Health Research Extension Act (HREA) directs the
DHHS Secretary to establish policy and guidelines for
the proper care and treatment of animals used in research
and the organization and operation of animal care and
use committees. HREA is the legislative mandate for
Public Health Service (PHS) policy.
There are also many other important guidelines and
ethical principles that apply to the humane care and
ethical use of animals in research, testing and teaching.
Animal Welfare Regulations for registered research
facilities apply to all warm-blooded animals, with the
exception of rats (genus Rattus), mice (genus Mus) and
Health Service Policy on Humane Care and Use of Laboratory
Animals applies to all live vertebrate animals.
Montana State University is an institution that accepts
federal funding for research and complies with the Public
Health Service Policy via its Assurance of Compliance
with Public Health Service Policy with NIH-OLAW.
Montana State University is also fully accredited as
a research institution with the Association for the
Assessment and Accreditation of Laboratory Animal Care,
International (AAALAC). AAALAC is a private nonprofit
organization that promotes the humane treatment of animals
in science through a voluntary accreditation program.
Guidance in the Ethical and Humane Use of Animals
Guide for the Care and Use of Laboratory Animals,
a publication of the National Research Council, is considered
the "gold standard" for all issues related to the welfare
of animals used in research. The Guide contains detailed
specifications for all aspects of a good laboratory
animal program, and is the basis for AAALAC accreditation.
2000 Report of the American Veterinary Medical Association
Panel on Euthanasia contains information regarding
humane endpoints and preferred euthanasia methods for
all animals used in research, including ectothermic,
aquatic and fur-bearing animals.
NASA Principles for the Ethical Care and Use of Animals
articulate the three basic principles behind ethical
animal use: respect for life, societal benefit and non-maleficence.
Principles of Humane Experimental Technique, a book
written in 1959 by two scientists, W. M. S. Russell
and R. L. Birch, first applied the concept of the Three
R's - Replacement, Reduction, and Refinement - to the
use of live animals in research, and remains a cornerstone
of responsible research.