Federal Regulations and Guidance
- Background
- Federal Regulations
- State Codes and Regulations
- Guidance in the Ethical and Humane Use of Animals
- Other Useful References
Background
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 the Animal 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, APHIS, AC).
- 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 Animal Care Policies.
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.
- The Office of Laboratory Animal Welfare (OLAW) is responsible for assuring compliance with PHS policy
- DHHS-funded institutions must adhere to the 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.
Federal Regulations
Animal Welfare Regulations for registered research facilities apply to all warm-blooded animals, with the exception of rats (genus Rattus), mice (genus Mus) and birds.
Public Health Service Policy on Humane Care and Use of Laboratory Animals applies to all live vertebrate animals.
UCI 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.
UCI 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. UCI’s AAALAC accreditation letter is available to view and print online.
State Codes and Regulations
Four parts of the California Health and Safety Codes also apply to the use of animals in research, testing and teaching:
- Article 1, General Provisions
- Article 2, Administration and Regulation
- Article 3, Application of the Chapter
- Article 4, Offenses Against the Chapter
California Department of Fish and Game as well as the equivalent departments in other states and foreign countries may apply to field studies, live catching of wild species and other uses of wild animals in research.
Guidance in the Ethical and Humane Use of Animals
- The 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.
- The American Veterinary Medical Association Guidelines on Euthanasia contains information regarding humane endpoints and preferred euthanasia methods for all animals used in research, including ectothermic, aquatic and fur-bearing animals.
- The 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.
- The 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.
Other Useful References
- Animal Welfare Information Center
- National Association for Biomedical Research
- California Biomedical Research Association
- Public Responsibility in Medicine & Research (PRIM&R)
