Animal testing regulations
Encyclopedia
Animal testing
regulations vary around the world. Most governments aim to control the number of times individual animals may be used; the overall numbers used; and the degree of pain that may be inflicted without anesthetic.
animals in the European Union
are subject to Directive 86/609/EEC on the protection of Animals used for Experimental and other scientific purposes, adopted in 1986. There is considerable variation in the manner member countries choose to exercise the directive: compare, for example, legislation from Sweden
, The Netherlands, and Germany
.
, legislation (principally the decree of October 19, 1980) requires an institutional and project licence before testing on vertebrates is carried out. An institution must submit details of their facilities and the reason for the experiments, after which a five-year licence may be granted following an inspection of the premises. The project licensee must be trained and educated to an appropriate level. Personal licences are not required for individuals working under the supervision of a project license holder. These regulations do not apply to research using invertebrates.
hospitals (0.9%); public health laboratories (0.6%); other public bodies (15.8%).
The Animals (Scientific Procedures) Act 1986
requires experiments to be regulated by three licences: a project licence for the scientist in charge of the project, which details the numbers and types of animals to be used, the experiments to be performed, and the purpose of them; a certificate for the institution to ensure it has adequate facilities and staff; and a personal licence for each scientist or technician who carries out any procedure. In deciding whether to grant a licence, the Home Office
refers to the Act's cost-benefit analysis
, which is defined as "the likely adverse effects on the animals concerned against the benefit likely to accrue as a result of the programme to be specified in the licence" (Section 5(4)). A licence should not be granted if there is a "reasonably practicable method not entailing the use of protected animals" (Section 5(5) (a)). The experiments must use "the minimum number of animals, involve animals with the lowest degree of neurophysiological
sensitivity, cause the least pain, suffering, distress, or lasting harm, and [be the] most likely to produce satisfactory results" (Section 5(5) (b)).
During a 2002 House of Lords select committee inquiry into animal testing in the UK, witnesses stated that the UK has the tightest regulatory system in the world, and is the only country to require a cost-benefit assessment of every licence application. http://www.publications.parliament.uk/pa/ld200102/ldselect/ldanimal/150/15004.htm#a4 There are 29 qualified inspectors covering 230 establishments, which are visited on average 11–12 times a year. http://scienceandresearch.homeoffice.gov.uk/animal-research/publications/publications/reports-and-reviews/annual-report
A campaign document by Animal Aid
alleges that the Animals (Scientific Procedures) Act 1986 is a "vivisectors' charter," allowing researchers to do as they please and making them practically immune from prosecution. The document claims that licences to perform experiments are obtained on the basis of a "nod of approval" from the Home Office Inspectorate, and that the Home Office relies on the researchers' own opinions of the cost-benefit assessment regarding the value of the experiment versus the amount of suffering it will cause.
is one of self-regulation. Animal experiments are regulated by the 2000 Law for the Humane Treatment and Management of Animals, which was amended in 2006. This law requires those using animals to follow the principles outlined in the 3Rs and use as few animals as possible, and cause minimal distress and suffering. Regulation is at a local level based on national guidelines, but there are no governmental inspections of institutions and no reporting requirement for the numbers of animals used. A 1988 survey published by the Japanese Association for Laboratory Animal Science reported that eight million animals had been used that year.
, animal testing on vertebrates is primarily regulated by the Animal Welfare Act of 1966 (AWA), which is enforced by the Animal Care division of the Animal and Plant Health Inspection Service
(APHIS) of the United States Department of Agriculture
(USDA). The AWA contains provisions to ensure that individuals of covered species used in research receive a certain standard of care and treatment, provided that the standard of care and treatment does not interfere with "the design, outlines, or guidelines of actual research or experimentation." Currently, AWA only protects mammals. In 2002, the Farm Security Act of 2002, the fifth amendment to the AWA, specifically excluded purpose-bred birds, rats, and mice (as opposed to wild-captured mice, rats, and birds) from regulations. Thus, relatively few animals used in research in the U.S. are covered by this legislation. The AWA requires each institution using covered species to maintain an Institutional Animal Care and Use Committee
(IACUC), which is responsible for local compliance with the Act.
Animal care and use in research in the United States are largely controlled by Institutional Animal Care and Use Committees.
Research suggests that the IACUC system is unreliable. A study conducted in 2001 by Psychology Professor Scott Plous
of Wesleyan University
that evaluated the reliability of IACUCs found little consistency between decisions made by IACUCs at different institutions. A Wesleyan University press release summarized part of the findings:
In response to the Plous study, a rebuttal letter to Science
written by animal researchers, animal care staff, and members of professional research societies stated:
Institutions are also subject to unannounced annual inspections from USDA APHIS Veterinarian inspectors. There are about 70 inspectors monitoring around 1100 research institutions. The inspectors also conduct pre-licensing checks for sites that do not engage in animal research or transportation, of which more than 4000 exist (e.g. dog kennels).
APHIS has been criticized by its own inspectors and the USDA Inspector General's office (OIG). Marshall Smith, an APHIS inspector for twelve years, resigned in 1997 recounting a litany of problems at the agency that impeded his duties. In a prepared statement, Smith made note of a 1992 OIG report citing the agency's inability to ensure the humane care of animals at dealers. In 2000, Isis Johnson-Brown D.V.M. – another APHIS inspector – quit because of problems she documented at the Oregon National Primate Research Center
, in Beaverton, Oregon. In a prepared statement Dr. Johnson said: In 2005, the USDA OIG issued another report on APHIS:
Another regulatory instrument is the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, which became statutory with the Health Research Extension Act 1985, and which is enforced by the Office of Laboratory Animal Welfare
(OLAW). This Act applies to any individual scientist or institution in receipt of federal funds and requires each institution to have an IACUC. OLAW enforces the standards of the Guide for the Care and Use of Laboratory Animalshttp://www.nap.edu/books/0309053773/html/index.html published by the Institute for Laboratory Animal Research,http://dels.nas.edu/ilar_n/ilarhome/ which includes all vertebrate species in its care protocols, including rodents and birdshttp://www.nap.edu/books/0309053773/html/1.html (Introduction, p.1). In 2004, the National Institutes of Health
provided funds to 3,180 different research institutions and universities.http://grants1.nih.gov/grants/award/awardtr.htm This means that IACUCs oversee the use of all vertebrate
species in research at facilities receiving federal funds, even if the species are not covered by the AWA. OLAW does not carry out scheduled inspections, but requires that "As a condition of receipt of PHS support for research involving laboratory animals, awardee institutions must provide a written Animal Welfare Assurance of Compliance (Assurance) to OLAW describing the means they will employ to comply with the PHS Policy." OLAW conducts inspections only when there is a suspected or alleged violation that cannot be resolved through written correspondence.
Accreditation from the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC), a non-governmental, nonprofit association, is regarded by the industry as the "gold standard" of accreditation. Accreditation is maintained through a prearranged AAALAC site visit and program evaluation hosted by the member institution once every three years. Accreditation is intended to ensure compliance with the standards in the Guide for the Care and Use of Laboratory Animals, as well as any other national or local laws on animal welfare
.
Animal testing
Animal testing, also known as animal experimentation, animal research, and in vivo testing, is the use of non-human animals in experiments. Worldwide it is estimated that the number of vertebrate animals—from zebrafish to non-human primates—ranges from the tens of millions to more than 100 million...
regulations vary around the world. Most governments aim to control the number of times individual animals may be used; the overall numbers used; and the degree of pain that may be inflicted without anesthetic.
Europe
Experiments on vertebrateVertebrate
Vertebrates are animals that are members of the subphylum Vertebrata . Vertebrates are the largest group of chordates, with currently about 58,000 species described. Vertebrates include the jawless fishes, bony fishes, sharks and rays, amphibians, reptiles, mammals, and birds...
animals in the European Union
European Union
The European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...
are subject to Directive 86/609/EEC on the protection of Animals used for Experimental and other scientific purposes, adopted in 1986. There is considerable variation in the manner member countries choose to exercise the directive: compare, for example, legislation from Sweden
Sweden
Sweden , officially the Kingdom of Sweden , is a Nordic country on the Scandinavian Peninsula in Northern Europe. Sweden borders with Norway and Finland and is connected to Denmark by a bridge-tunnel across the Öresund....
, The Netherlands, and Germany
Germany
Germany , officially the Federal Republic of Germany , is a federal parliamentary republic in Europe. The country consists of 16 states while the capital and largest city is Berlin. Germany covers an area of 357,021 km2 and has a largely temperate seasonal climate...
.
France
In FranceFrance
The French Republic , The French Republic , The French Republic , (commonly known as France , is a unitary semi-presidential republic in Western Europe with several overseas territories and islands located on other continents and in the Indian, Pacific, and Atlantic oceans. Metropolitan France...
, legislation (principally the decree of October 19, 1980) requires an institutional and project licence before testing on vertebrates is carried out. An institution must submit details of their facilities and the reason for the experiments, after which a five-year licence may be granted following an inspection of the premises. The project licensee must be trained and educated to an appropriate level. Personal licences are not required for individuals working under the supervision of a project license holder. These regulations do not apply to research using invertebrates.
United Kingdom
The types of institutions conducting animal research in the UK in 2004 were: universities (42.1%); commercial organizations (33.3%); non-profit organizations (4.9%); government departments (2.4%); National Health ServiceNational Health Service
The National Health Service is the shared name of three of the four publicly funded healthcare systems in the United Kingdom. They provide a comprehensive range of health services, the vast majority of which are free at the point of use to residents of the United Kingdom...
hospitals (0.9%); public health laboratories (0.6%); other public bodies (15.8%).
The Animals (Scientific Procedures) Act 1986
Animals (Scientific Procedures) Act 1986
The Animals Act 1986 is an Act of the Parliament of the United Kingdom passed in 1986, which regulates the use of laboratory animals in the UK. The Act permits experiments to be carried out on animals, including procedures involving vivisection, if certain criteria are met...
requires experiments to be regulated by three licences: a project licence for the scientist in charge of the project, which details the numbers and types of animals to be used, the experiments to be performed, and the purpose of them; a certificate for the institution to ensure it has adequate facilities and staff; and a personal licence for each scientist or technician who carries out any procedure. In deciding whether to grant a licence, the Home Office
Home Office
The Home Office is the United Kingdom government department responsible for immigration control, security, and order. As such it is responsible for the police, UK Border Agency, and the Security Service . It is also in charge of government policy on security-related issues such as drugs,...
refers to the Act's cost-benefit analysis
Cost-benefit analysis
Cost–benefit analysis , sometimes called benefit–cost analysis , is a systematic process for calculating and comparing benefits and costs of a project for two purposes: to determine if it is a sound investment , to see how it compares with alternate projects...
, which is defined as "the likely adverse effects on the animals concerned against the benefit likely to accrue as a result of the programme to be specified in the licence" (Section 5(4)). A licence should not be granted if there is a "reasonably practicable method not entailing the use of protected animals" (Section 5(5) (a)). The experiments must use "the minimum number of animals, involve animals with the lowest degree of neurophysiological
Neurophysiology
Neurophysiology is a part of physiology. Neurophysiology is the study of nervous system function...
sensitivity, cause the least pain, suffering, distress, or lasting harm, and [be the] most likely to produce satisfactory results" (Section 5(5) (b)).
During a 2002 House of Lords select committee inquiry into animal testing in the UK, witnesses stated that the UK has the tightest regulatory system in the world, and is the only country to require a cost-benefit assessment of every licence application. http://www.publications.parliament.uk/pa/ld200102/ldselect/ldanimal/150/15004.htm#a4 There are 29 qualified inspectors covering 230 establishments, which are visited on average 11–12 times a year. http://scienceandresearch.homeoffice.gov.uk/animal-research/publications/publications/reports-and-reviews/annual-report
A campaign document by Animal Aid
Animal Aid
Animal Aid, founded in 1977, is a British animal rights organisation. The group campaigns peacefully against all forms of animal abuse and promotes a cruelty-free lifestyle. It also investigates and exposes animal cruelty....
alleges that the Animals (Scientific Procedures) Act 1986 is a "vivisectors' charter," allowing researchers to do as they please and making them practically immune from prosecution. The document claims that licences to perform experiments are obtained on the basis of a "nod of approval" from the Home Office Inspectorate, and that the Home Office relies on the researchers' own opinions of the cost-benefit assessment regarding the value of the experiment versus the amount of suffering it will cause.
Japan
The system in JapanJapan
Japan is an island nation in East Asia. Located in the Pacific Ocean, it lies to the east of the Sea of Japan, China, North Korea, South Korea and Russia, stretching from the Sea of Okhotsk in the north to the East China Sea and Taiwan in the south...
is one of self-regulation. Animal experiments are regulated by the 2000 Law for the Humane Treatment and Management of Animals, which was amended in 2006. This law requires those using animals to follow the principles outlined in the 3Rs and use as few animals as possible, and cause minimal distress and suffering. Regulation is at a local level based on national guidelines, but there are no governmental inspections of institutions and no reporting requirement for the numbers of animals used. A 1988 survey published by the Japanese Association for Laboratory Animal Science reported that eight million animals had been used that year.
United States
In the United StatesUnited States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
, animal testing on vertebrates is primarily regulated by the Animal Welfare Act of 1966 (AWA), which is enforced by the Animal Care division of the Animal and Plant Health Inspection Service
Animal and Plant Health Inspection Service
Animal and Plant Health Inspection Service is an agency of the United States Department of Agriculture responsible for protecting animal health, animal welfare, and plant health. APHIS is the lead agency for collaboration with other agencies to protect U.S. agriculture from invasive pests and...
(APHIS) of the United States Department of Agriculture
United States Department of Agriculture
The United States Department of Agriculture is the United States federal executive department responsible for developing and executing U.S. federal government policy on farming, agriculture, and food...
(USDA). The AWA contains provisions to ensure that individuals of covered species used in research receive a certain standard of care and treatment, provided that the standard of care and treatment does not interfere with "the design, outlines, or guidelines of actual research or experimentation." Currently, AWA only protects mammals. In 2002, the Farm Security Act of 2002, the fifth amendment to the AWA, specifically excluded purpose-bred birds, rats, and mice (as opposed to wild-captured mice, rats, and birds) from regulations. Thus, relatively few animals used in research in the U.S. are covered by this legislation. The AWA requires each institution using covered species to maintain an Institutional Animal Care and Use Committee
Institutional Animal Care and Use Committee
Institutional Animal Care and Use Committees are of central importance to the application of laws to animal research in the United States. Most research involving laboratory animals is funded by the United States National Institutes of Health or other federal agencies...
(IACUC), which is responsible for local compliance with the Act.
Animal care and use in research in the United States are largely controlled by Institutional Animal Care and Use Committees.
Research suggests that the IACUC system is unreliable. A study conducted in 2001 by Psychology Professor Scott Plous
Scott Plous
Scott Plous, Ph.D., is a Professor of Psychology at the Department of Psychology of Wesleyan University. He is also a Faculty Associate of the Tufts University Center for Animals and Public Policy and founder of the Social Psychology Network....
of Wesleyan University
Wesleyan University
Wesleyan University is a private liberal arts college founded in 1831 and located in Middletown, Connecticut. According to the Carnegie Foundation for the Advancement of Teaching, Wesleyan is the only Baccalaureate College in the nation that emphasizes undergraduate instruction in the arts and...
that evaluated the reliability of IACUCs found little consistency between decisions made by IACUCs at different institutions. A Wesleyan University press release summarized part of the findings:
In response to the Plous study, a rebuttal letter to Science
Science (journal)
Science is the academic journal of the American Association for the Advancement of Science and is one of the world's top scientific journals....
written by animal researchers, animal care staff, and members of professional research societies stated:
Institutions are also subject to unannounced annual inspections from USDA APHIS Veterinarian inspectors. There are about 70 inspectors monitoring around 1100 research institutions. The inspectors also conduct pre-licensing checks for sites that do not engage in animal research or transportation, of which more than 4000 exist (e.g. dog kennels).
APHIS has been criticized by its own inspectors and the USDA Inspector General's office (OIG). Marshall Smith, an APHIS inspector for twelve years, resigned in 1997 recounting a litany of problems at the agency that impeded his duties. In a prepared statement, Smith made note of a 1992 OIG report citing the agency's inability to ensure the humane care of animals at dealers. In 2000, Isis Johnson-Brown D.V.M. – another APHIS inspector – quit because of problems she documented at the Oregon National Primate Research Center
Oregon National Primate Research Center
The Oregon National Primate Research Center is one of eight federally funded National Primate Research Centers in the United States and has been affiliated with Oregon Health and Science University since 1998. The center is located on of land west of Portland, Oregon, in Hillsboro...
, in Beaverton, Oregon. In a prepared statement Dr. Johnson said: In 2005, the USDA OIG issued another report on APHIS:
Another regulatory instrument is the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, which became statutory with the Health Research Extension Act 1985, and which is enforced by the Office of Laboratory Animal Welfare
Office of Laboratory Animal Welfare
The Office of Laboratory Animal Welfare oversees the care and use of research animals in Public Health Service -funded research...
(OLAW). This Act applies to any individual scientist or institution in receipt of federal funds and requires each institution to have an IACUC. OLAW enforces the standards of the Guide for the Care and Use of Laboratory Animalshttp://www.nap.edu/books/0309053773/html/index.html published by the Institute for Laboratory Animal Research,http://dels.nas.edu/ilar_n/ilarhome/ which includes all vertebrate species in its care protocols, including rodents and birdshttp://www.nap.edu/books/0309053773/html/1.html (Introduction, p.1). In 2004, the National Institutes of Health
National Institutes of Health
The National Institutes of Health are an agency of the United States Department of Health and Human Services and are the primary agency of the United States government responsible for biomedical and health-related research. Its science and engineering counterpart is the National Science Foundation...
provided funds to 3,180 different research institutions and universities.http://grants1.nih.gov/grants/award/awardtr.htm This means that IACUCs oversee the use of all vertebrate
Vertebrate
Vertebrates are animals that are members of the subphylum Vertebrata . Vertebrates are the largest group of chordates, with currently about 58,000 species described. Vertebrates include the jawless fishes, bony fishes, sharks and rays, amphibians, reptiles, mammals, and birds...
species in research at facilities receiving federal funds, even if the species are not covered by the AWA. OLAW does not carry out scheduled inspections, but requires that "As a condition of receipt of PHS support for research involving laboratory animals, awardee institutions must provide a written Animal Welfare Assurance of Compliance (Assurance) to OLAW describing the means they will employ to comply with the PHS Policy." OLAW conducts inspections only when there is a suspected or alleged violation that cannot be resolved through written correspondence.
Accreditation from the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC), a non-governmental, nonprofit association, is regarded by the industry as the "gold standard" of accreditation. Accreditation is maintained through a prearranged AAALAC site visit and program evaluation hosted by the member institution once every three years. Accreditation is intended to ensure compliance with the standards in the Guide for the Care and Use of Laboratory Animals, as well as any other national or local laws on animal welfare
Animal welfare
Animal welfare is the physical and psychological well-being of animals.The term animal welfare can also mean human concern for animal welfare or a position in a debate on animal ethics and animal rights...
.