Animal testing regulations

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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 anaesthetic.

[edit] Europe

Experiments on vertebrate 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.^[1] There is considerable variation in the manner member countries choose to exercise the directive: compare, for example, legislation from Sweden,^[2] The Netherlands, ^[3] and Germany.^[4]

[edit] France

In France, legislation (principally the decree of October 19, 1987) 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.^[5] These regulations do not apply to research using invertebrates.^[6]

[edit] United Kingdom

See also: Animal Procedures Committee and Animals (Scientific Procedures) Act 1986

Technician assessing the health status of transgenic mice in a UK laboratory, 2000. Provided by RDS/Wellcome Trust Photographic Library^[7]

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 Service hospitals (0.9%); public health laboratories (0.6%); other public bodies (15.8%).^[8]

The Animals (Scientific Procedures) Act 1986^[9] 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)).^[10]

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. [7] There are 29 qualified inspectors covering 230 establishments, which are visited on average 11-12 times a year. [8]

A report 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 report says 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.^[11]

[edit] Japan

The system in Japan 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.^[12] 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.^[13] A 1988 survey published by the Japanese Association for Laboratory Animal Science reported that eight million had been used that year.^[14]

[edit] United States

Main article: Animal testing regulations in the United States

Further information: Institutional Animal Care and Use Committee

In the United States, animal testing on vertebrates is primarily regulated by the 1966 Animal Welfare Act (AWA),^[15] which is enforced by the Animal Care division^[16] 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."^[17][18] 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.^[19] Thus, relatively few animals used in research in the U.S. are covered by this legislation.^[20] 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:

The investigation, which took three years to complete, compared judgments made by 50 randomly selected animal care and use committees drawn from U.S. colleges and universities. To assess the consistency of approval decisions, 150 recent research proposals from these institutions were each independently evaluated by two different animal care and use committees.

The results showed that approval decisions were statistically unrelated. In most cases, proposals that were disapproved by one committee were approved by the second committee.

The study also explored whether reviews were more reliable when the experiment involved certain types of animals or procedures. For example, reliability was assessed for proposals that involved dogs, cats, and primates, or for experiments involving drugs, surgery, animal pain, or death. Even in these cases, independent reviews did not agree beyond chance levels.^[21]

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:

That the masked protocols would be rated more negatively was predictable for the following reasons. First, IACUCs rely on knowing the experience of the investigators and staff, information that was not included for the unofficial IACUCs. Not surprisingly, most of the negative shifts (84 of 118) were to categories calling for more information. Second, withholding approval had no practical consequence. Third, participants might have felt scrutinized by researchers with an "animal rights" agenda, and erred on the side of deferral or rejection. Fourth, navigating another institution's forms can be difficult. And fifth, IACUCs unfamiliar with particular species or procedures are less likely to understand a protocol. These factors make it almost impossible to compare the actions of the original and unofficial IACUCs and thus call into question the major premises and conclusions of this study. ^[22]

Institutions are also subject to unannounced annual inspections from USDA APHIS Veterinarian inspectors. There are about 70 inspectors^[23] monitoring around 1100 research institutions.^[24] 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).^[25]

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.^[26] 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:

More than once, I was instructed by a supervisor to make a personal list of violations of the law, cut that list in half, and then cut that list in half again before writing up my inspection reports. My willingness to uphold the law during my site visits at the Primate Center led to me being 'retrained' several times by higher-ups in the USDA.^[27]

In 2005, the USDA OIG issued another report on APHIS:

Of particular concern, AC management in the Eastern Region is not aggressively pursuing enforcement actions against violators of the AWA. The Eastern Region significantly reduced its referrals of suspected violators to the Investigative and Enforcement Services (IES) unit—from an average of 209 cases in fiscal years (FYs) 2002-2003 to 82 cases in FY 2004. When the region did refer cases to IES, management declined to take enforcement action against 126 of 475 violators (27 percent).

When violators are assessed stipulated fines, the fines are usually minimal and not always effective in preventing subsequent violations. Under current APHIS policy, AC gives an automatic 75-percent discount to almost all violators as a means of amicably reaching an agreement on the amount of the fines and avoiding court.

Finally, we noted that some VMOs when inspecting research facilities do not verify the number of animals used in medical research or adequately review the facilities’ protocols and other records.^[28]

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 Animals[9] published by the Institute for Laboratory Animal Research,[10] which includes all vertebrate species in its care protocols, including rodents and birds[11] (Introduction, p.1). In 2004, the National Institutes of Health provided funds to 3,180 different research institutions and universities.[12] 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."^[29] 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),^[30] a non-governmental, nonprofit association, is regarded by the industry as the "gold standard" of accreditation.^[31] Accreditation is maintained through a prearranged AAALAC site visit and program evaluation hosted by the member institution once every three years.^[32] 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.

[edit] Notes