Regulations, Policies, and Principles Governing the Care and Use of Laboratory Animals

The Animal Welfare Act (AWA) and Animal Welfare Regulations (AWR)

• The Animal Welfare Act (AWA) is the primary federal mandate governing the care of non-farm animals in the United States. It was first passed in $1966$ and signed into law by President Lyndon B. Johnson.

• Originally named the Laboratory Animal Welfare Act, the legislation has been amended multiple times in $1970$, $1976$, $1985$, $1990$, $2002$, $2007$, and $2008$ to reflect advancements in animal care knowledge.

• The AWA standards are codified in the Code of Federal Regulations and are enforced by the United States Department of Agriculture (USDA).

• Administrative oversight is provided by the Animal and Plant Health Inspection Service (APHIS), a division of the USDA.

• The USDA Animal Care branch periodically issues policies to clarify the intent of the regulations. These documents are available to the public and researchers as free PDF files by searching for USDA Animal Care policies.

• The USDA performs unannounced inspections at research facilities at least once per year ($annually$). These surprise visits are designed to ensure that facilities are constantly prepared and maintaining standards without the opportunity to hide violations.

• Entities required to follow AWA regulations include:

  • Animal research facilities.

  • Animal dealers and exhibitors.

  • Operators of animal auction sales.

  • Carriers and transporters of animals used in research, exhibition, and teaching.

• Retail pet stores are generally exempt from the AWA unless they function as a Class B dealer by selling animals for research purposes.

Species Coverage Under the Animal Welfare Act

• Specifically covered species include:

  • Dogs and cats.

  • Non-human primates.

  • Guinea pigs and hamsters.

  • Rabbits.

  • Large animals used in biomedical research, such as pigs, sheep, goats, and cows.

  • Other warm-blooded animals as designated by the Secretary of Agriculture.

• Specifically excluded species (not covered by the AWA):

  • Birds, mice, and rats specifically bred for research, teaching, or testing.

  • Horses not used for research purposes.

  • Farm animals used for studies intended to improve animal nutrition, breeding, management, production efficiency, or the quality of food or fiber.

Historical Progression and Major Amendments

• The Original $1966$ Act: The Laboratory Animal Welfare Act was prompted by public outcry over pet theft, notably a case involving a stolen Dalmatian sold to a research facility. Its initial focus was protecting pet owners and ensuring humane care for animals before and after research.

• $1970$ Amendment: Renamed the legislation to the Animal Welfare Act. Expanded the list of regulated species and extended care standards to cover animals throughout their entire stay at a facility, not just before and after studies. Required facilities to register and submit annual reports to the USDA regarding animal numbers and the use of anesthetics, analgesics, or tranquilizers.

• $1985$ Improved Standards for Laboratory Animals Act: This amendment was a major milestone. It mandated the creation of the Institutional Animal Care and Use Committee (IACUC) at research facilities, required training for all personnel, and established exercise standards for dogs. It also introduced standards for the psychological well-being of non-human primates and created the Animal Welfare Information Center (AWIC).

• $2002$ Farm Security and Rural Investment Act: Changed the legal definition of "animal" to specifically exclude research-bred birds, rats, and mice. It also began addressing animal fighting as a federal concern.

• $2008$ Food Conservation and Energy Act: Made animal fighting a felony. Strengthened penalties and restricted the transport/resale of dogs unless they are at least $6\,months$ of age, in good health, and vaccinated (with specific exemptions for research or veterinary treatment).

The Institutional Animal Care and Use Committee (IACUC)

• Under the AWA, the IACUC is appointed by the Chief Executive Officer (CEO) of the research facility.

• Membership (AWA Minimum): Must consist of at least $3\,members$.

  • One member must be a veterinarian with experience in laboratory animal medicine.

  • One member must be a public member (not affiliated with the institution) to provide external perspective.

• Responsibilities:

  • Inspect all animal facilities, research areas, and procedure rooms at least once every $6\,months$.

  • Report inspection findings to the Institutional Official (IO).

  • Review and approve animal use protocols (proposed activities).

  • Investigate concerns regarding animal welfare (often prompted by anonymous reports from staff).

Animal Use Protocols and Standards of Care

• Principal Investigators (PIs) must submit detailed protocols for IACUC approval. These must include:

  • The specific species and approximate animal counts.

  • The rationale for using that species and the statistical justification for the number of animals.

  • A full description of procedures and drugs used to limit pain or distress.

  • The method of euthanasia, which must align with the American Veterinary Medical Association (AVMA) Guidelines on Euthanasia.

• Veterinarians must be consulted whenever a procedure has the potential to cause pain or distress. If a procedure is painful in humans, it is assumed to be painful in animals.

• PIs must provide written documentation and search sources to prove that non-animal alternatives are unavailable and that the research does not unnecessarily duplicate previous experiments.

• Survival surgeries must employ aseptic techniques. Multiple survival surgeries on a single animal require explicit justification.

• Medical records for animals must document adequate health care and be retained for at least $1\,year$ after the animal's disposition or euthanasia.

Public Health Service (PHS) Policy and OLAW

• The Public Health Service Policy on Humane Care and Use of Laboratory Animals is based on the Health Research Extension Act of $1985$.

• Coverage: Applies to all live vertebrate animals involved in research funded by the U.S. Public Health Service (PHS) or the Department of Health and Human Services (HHS). This includes mice, rats, and birds which are excluded by the AWA.

• Office of Laboratory Animal Welfare (OLAW): The body responsible for interpreting the PHS policy, evaluating compliance, and providing instruction to institutions.

• Animal Welfare Assurance: Institutions must file a document with OLAW describing their care program, including occupational designations and credentials for all IACUC members.

• IACUC Membership (PHS Policy): Requires a minimum of $5\,members$, including a veterinarian, a practicing scientist, a non-scientist, and a non-affiliated public member.

• Protocol Review Cycle: Protocols must be reviewed at least once every $3\,years$.

• Additional Requirements: Requires an Occupational Health and Safety Program for personnel and a semi-annual review of the animal program.

The Guide and Specialized Guidelines

• The Guide for the Care and Use of Laboratory Animals ("The Guide"): Published by the Institute for Laboratory Animal Research (ILAR). First published in $1963$ and currently in its $8^{th}$ edition (updated around $2019$-$2020$). It is the reference for housing, environment (e.g., suggesting $30-70\%$ relative humidity), veterinary care, and physical plant management.

• Performance-Oriented Standards: The Guide specifies goals (e.g., humidity levels) but allows institutions flexibility in how to achieve them to maintain a free market.

• The Ag Guide: A supplemental guide specifically for agricultural animals used in research and teaching, covering husbandry and facility maintenance separate from commercial farming.

• Good Laboratory Practice (GLP) Regulations: Framework for safety studies funded by the FDA or EPA. Requires a Quality Assurance Unit (QAU), adherence to Standard Operating Procedures (SOPs), and extreme record-keeping (e.g., documenting every phone call with a vet word-for-word).

• CHIMP Act ($2000$): The Chimpanzee Health Improvement Maintenance and Protection Act created a sanctuary system (like Chimp Haven) for chimpanzees retired from federal research. It prohibits invasive research on these animals, allowing only non-invasive behavioral studies.

Voluntary Organizations and State Laws

• AAALAC International: A non-profit established in $1965$. It offers voluntary accreditation which is considered the "gold standard" of the industry. Accredited facilities undergo site visits every $3\,years$ by consultants to ensure they exceed basic federal regulations.

• AWIC (Animal Welfare Information Center): Part of the USDA National Agricultural Library. It assists PIs with literature searches to find research alternatives and avoid duplication.

• State Regulations: All $50\,states$ and the District of Columbia have individual laws regarding animal treatment, primarily focusing on the provision of food, water, and shelter from extreme weather. Researchers must be aware of their specific state's requirements.