This page is designed to answer questions about how biomedical research using animals is regulated by the Animal Welfare Act. To the student, journalist, and even the researcher, dissecting the law to find what is regulated, how it is regulated, and what the responsibilities of regulated parties are can be a daunting task. The staff of the Animal Welfare Information Center (AWIC) at the USDA National Agricultural Library (U.S. Department of Agriculture) hope that the questions below, linked to specific sections of the regulations, will help patrons better understand the legislation.
The Animal Welfare Act was signed into law in 1966. While its original intent was to regulate the care and use of animals in the laboratory, it has become the only Federal law in the United States that regulates the treatment of animals in research, exhibition, transport, and by dealers. Other laws, policies, and guidelines may include additional species coverage or specifications for animal care and use, but all refer to the Animal Welfare Act as the minimum acceptable standard. The Act was amended four times (1970, 1976, 1985, 1990) and can be found in United States Code, Title 7, Sections 2131 to 2156.
The Act is enforced by the U.S. Department of Agriculture, Animal and Plant Health Inspection Service (APHIS), Animal Care (AC). AC develops regulations that interpret the Act with each amendment. Proposed rules are published in the Federal Regist er and open for public comment. Comments can be presented at public hearings, sent via mail, fax, or email. After comments are analyzed, AC develops final rules which are also published in the Federal Register. The final rules include a description of the public comments and the Department's response to them followed by how the new rules will appear as regulations.
The regulations for the Animal Welfare Act are really the manual for complying with the Act. Each year they are published in Code of Federal Regulations, Title 9, Chapter 1, Subchapter A - Animal Welfare which is popularly known as 9CFR. The regulations are divided into 4 sections: Definitions, Regulations, Standards, and Rules of Practice Governing Proceedings Under the Animal Welfare Act. The Definitions section describes exactly what is meant by terms used in the legislation. This section is very important as the legal definitions include exemptions which may differ from how the word is commonly used. For example, the term "Animal", includes specific species in some, but not all, situations and specifically excludes rats of the genus Rattus and mice of the genus Mus as well as birds used in research. The Regulations section includes subparts for licensing, registration, research facilities, attending veterinarians and adequate veterinary care, stolen animals, records, compliance with standards and holding periods, and miscellaneous topics such as confiscation and destruction of animals and access and inspection of records and property. Most of the subchapter is the third section which provides standards for specific species or groups of species. Included are sections for cats and dogs, guinea pigs and hamsters, rabbits, nonhuman primates, marine mammals, and the general category of "other warm-blooded animals". Standards include those for facilities and operations, health and husbandry systems, and transportation. The final section sets forth the Rules of Practice applicable to adjudicating administrative proceedings under Section 19 of the Animal Welfare Act.
It is important to note that the answers to the questions are mostly excerpts from the regulations. The complete regulations are updated annually and can be found on the APHIS/AC website at http://www.aphis.usda.gov/animal_welfare/publications_and_reports.shtml
Who is the Attending Veterinarian and what are his/her roles at the institution?
Who is the Institutional Official and what are his/her responsibilities?
What are the responsibilities of the Primary Investigator (PI)?
What are the responsibilities of the Institutional Animal Care and Use Committe (IACUC) such as who serves, animal protocol review, and reporting?
What is an adequate veterinary care program at the research facility?
What are the responsibilities of the Primary Investigator and Attending Veterinarian to minimize pain and distress to animals before, during, and after operative procedures such as surgery?
What are the qualifications and training required for research facility personnel?
What are the facility responsibilities to visiting APHIS officials?
How is field research, studies done on free-living animals in their natural habitat, regulated?
What reports, notifications, certifications, and record keeping is required of research facilities?
What reports, notifications, certifications, and record keeping is required of animal dealers and exhibitors?
How should dogs and cats be housed?
How should nonhuman primates be housed?
What are the requirements for environmental enhancement and psychological well-being of nonhuman primates?
What is the requirement for exercise in dogs?
What are the primary enclosure requirements for dogs and cats, guinea pigs and hamsters, rabbits, and nonhuman primates?