Cecily Zamora
Animal testing regulations vary across countries and are often influenced by government policies, non-profit organizations, and public sentiment. In the United States, the Animal Welfare Act of 1966 and its subsequent amendments play a pivotal role in regulating animal testing, with the USDA being the federal agency responsible for oversight and inspection. However, challenges arise due to underfunding and inadequate staffing within the USDA. Various non-profit organizations, such as PETA and the Animal Legal Defense Fund, actively advocate for animal rights and promote alternative testing methods. Other countries, like Canada and New Zealand, have their own regulatory bodies and laws governing animal welfare in research, with some provinces or states taking jurisdiction over experiments involving animals. The scientific community is also recognizing the limitations of animal testing and is exploring more humane, non-animal testing approaches.
| Characteristics | Values |
|---|---|
| Country | United States, Canada, New Zealand, Taiwan, Japan |
| Federal Agency | USDA, APHIS, AAALAC, CCAC, CONCEA, MPI, NAEAC |
| Federal Laws | Laboratory Animal Welfare Act, Animal Welfare Act, Health of Animals Act, Health Research Extension Act, Criminal Code |
| State Laws | Massachusetts, Canadian provinces |
| Regulatory Bodies | Association for Assessment and Accreditation of Laboratory Animal Care, Institutional Animal Care and Use Committee |
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What You'll Learn
The United States Department of Agriculture (USDA)
The USDA's regulatory authority does not extend to farm animals used for food, fiber, or other agricultural purposes, which are typically governed by state and local laws. However, the USDA does have the authority to make regulations to implement and enforce the AWA. The Animal Welfare Regulations, found in the Code of Federal Regulations (C.F.R.), provide detailed guidance and standards drafted and adopted by the USDA to implement the AWA.
The USDA's Office of Inspector General has found that the Animal and Plant Health Inspection Service (APHIS) is not adequately inspecting facilities or enforcing the AWA. The USDA employs a limited number of inspectors (around 100-120) to oversee thousands of facilities, including animal experimentation labs. As a result, labs housing many animals may only receive one day of inspection. The USDA heavily relies on laboratories' own Institutional Animal Care and Use Committees (IACUCs) to enforce the AWA locally. These committees are often criticized for being too closely aligned with researchers, leading to lax self-regulation.
The USDA's role in animal testing regulation involves ensuring compliance with standards for the care and use of laboratory animals. Accreditation from the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) is considered the "gold standard" in this regard. While AAALAC is a non-governmental organization, its accreditation ensures compliance with national and local laws on animal welfare.
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The Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC)
The history of AAALAC dates back to the 1950s when the Professional Standards Committee of the Animal Care Panel (ACP), now the American Association for Laboratory Animal Science (AALAS), recognised the need for assuring the public that laboratory animal research was conducted professionally. In 1965, leading veterinarians and researchers organised the American Association for Accreditation of Laboratory Animal Care (AAALAC). Over the years, AAALAC accredited hundreds of organisations across the United States, setting new benchmarks for laboratory animal care. In 1996, the organisation changed its name to AAALAC International, reflecting its expansion and commitment to enhancing life sciences and animal care globally.
Today, more than 1,100 organisations in 50 countries/regions have earned AAALAC accreditation, showcasing their dedication to responsible animal care and use. The accreditation process involves an extensive internal review, where institutions create a comprehensive "Program Description" detailing their animal care and use programs, including policies, housing, management, veterinary care, and facilities. This document is submitted to AAALAC, whose evaluators then conduct an on-site assessment. The site visit report is reviewed by the Council on Accreditation, and if deficiencies are found, the institution is given time to correct them before accreditation is awarded.
AAALAC accreditation is a valuable tool for research institutions, as it demonstrates their commitment to high standards of animal care and use, enhancing their reputation and attracting top talent. It provides assurance to stakeholders and the public that the institution conducts its animal research responsibly and humanely. AAALAC also provides educational resources, such as videos and career pathway guides, to promote the welfare of animals in science and improve practices globally.
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The Animal Welfare Act (AWA)
The AWA is a regulatory law that controls who can possess or sell certain animals and outlines the living conditions under which these animals must be kept. The animals covered by the Act include dogs, cats, primates, and other mammals, but it notably excludes birds, rats, mice, horses, and farm animals. The individuals who must obtain a permit to buy and sell listed animals or register for their use include animal dealers, exhibitors, carriers, and research facilities. However, pet owners, agricultural use, and retail pet stores are not under the control of the law.
The AWA provides for criminal and civil penalties, as well as revocation of permits, for violations. For example, in the case of Animal Legal Defense Fund v. Daniel Glickman in 1998, a man named Marc Jurnove filed a suit against the USDA for their failure to meet the minimum standards under the AWA in the inhumane treatment of a primate named Barney. Investigations supported Jurnove's allegations, and his suit was argued on behalf of the Animal Legal Defense Fund.
The United States Department of Agriculture (USDA) is the federal agency responsible for overseeing and inspecting laboratories that experiment on animals, as well as those who breed and sell them. However, the USDA has faced criticism for being underfunded and understaffed, with only 120 inspectors responsible for over 12,000 facilities.
In addition to the USDA, there are other regulatory bodies that aim to protect laboratory animals. The Association for Assessment and Accreditation of Laboratory Animal Care (AALAC) is a private, nonprofit accreditation organization that seeks to improve the humane care of laboratory animals. Institutions conducting experiments on covered animals are also required to convene an Institutional Animal Care and Use Committee (IACUC), which includes a veterinarian and someone unaffiliated with the institution, to review and approve protocols and ensure compliance.
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The Health of Animals Act
Animal testing is regulated by various laws and agencies that differ from country to country. In the United States, for example, animal testing on vertebrates is primarily regulated by the Animal Welfare Act of 1966 (AWA) and the Animal Welfare Regulations, which are enforced by the Animal Care division of the Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture (USDA). The USDA is responsible for overseeing and inspecting laboratories that experiment on animals, as well as those who breed and sell animals for laboratory use.
In Canada, each province has created and passed laws pertaining to animal welfare, but only certain provinces have made their own laws. The federal government is involved in three areas: criminal law power, health power, and spending power. The Health of Animals Act, enacted in 1990, is one such federal law. Its primary purpose is to protect Canadian livestock from infectious diseases that could harm both animal and human health, as well as Canadian trade in livestock with other countries.
- Control and elimination of diseases and toxic substances
- Maintaining and improving bird stock health
- Sanitary and health measures for establishments dealing with animal semen and embryos
- Regulation of the conduct and operation of zoos and game farms
- Prohibition or regulation of testing for diseases
- Prohibition or regulation of the importation, exportation, preparation, manufacturing, preservation, packaging, labelling, storage, testing, transportation, sale, advertising for sale, use, and disposal of veterinary biologics
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The Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy)
The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, also known as the NIH Policy, was established in 1985 and updated in 2002 and 2015. This policy applies to any institution, public or private, that receives PHS funding for research involving animals. These institutions must submit detailed information about their animal care and use programs to the Office of Laboratory Animal Welfare (OLAW). This information is in the form of an Animal Welfare Assurance Statement, which must be resubmitted at least every four years.
The PHS Policy outlines the role and responsibilities of institutional animal care and use committees. These committees must include at least five members: an individual unaffiliated with the institution, a veterinarian with relevant experience and training, a practicing scientist experienced in animal research, and a member with non-scientific concerns. The committees are responsible for reviewing and approving sections of PHS grant applications related to animal care and use, as well as conducting semi-annual assessments of the institution's programs based on the Guide for the Care and Use of Laboratory Animals.
The Guide for the Care and Use of Laboratory Animals, published by the Institute of Laboratory Animal Resources, serves as a reference for institutions to ensure proper care and use of animals in research. It is updated periodically, with the Eighth Edition being released in 2011. The PHS Policy also requires institutions to establish and maintain proper measures for the humane care and use of laboratory animals, including appropriate veterinary medical and nursing care.
In addition to the PHS Policy, other regulatory bodies and accreditation organizations, such as the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) and the Canadian Council on Animal Care (CCAC), also work towards improving the humane care and treatment of laboratory animals. While the federal government in Canada and the US does not have direct jurisdiction over laws involving animal experiments, they are involved in areas such as criminal law, health, and spending powers.
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Frequently asked questions
The Animal Welfare Act is a federal law that regulates the care and use of animals in research, teaching, testing, transportation, exhibition, and commercial breeding. The law also provides for the licensing of animal dealers to prevent pet theft and their sale to research facilities.
The Animal Welfare Act is enforced by the Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture (USDA). The USDA has the authority to make regulations to implement and enforce the law.
The USDA is responsible for overseeing and inspecting laboratories that experiment on animals, as well as those who breed and sell animals for laboratory use. The USDA employs inspectors to ensure compliance with animal welfare regulations.
Yes, there are other regulatory bodies and standards that pertain to animal testing, such as the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) and the Institutional Animal Care and Use Committee (IACUC). These organizations work to improve the humane care and treatment of animals in laboratories.
Yes, in addition to federal laws, individual states, provinces, or municipalities may have their own laws and regulations governing animal testing and welfare within their jurisdictions. For example, Massachusetts has its own laws governing the care of research animals, and Canada's provinces have passed laws pertaining to animal welfare.
