Animal testing regulations are guidelines that permit and control the use of non-human animals for scientific experimentation. They vary greatly around the world, but 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 vertebrate animals in the European Union are since January 1, 2013 subject to Directive 2010/63/EU on the protection of animals used for scientific purposes, which was finalized in November 2010 and updated and replaced the Directive 86/609/EEC on the protection of Animals used for Experimental and other scientific purposes, adopted in 1986."Directive 86/609/EEC on the protection of Animals used for Experimental and other scientific purposes" European Commission, 1986. Retrieved February 8, 2007 Directive 86/609/EEC showed considerable variation in the manner member countries chose to exercise the directive: compare, for example, legislation from Sweden,"Laboratory animal research legislation in Sweden" , EBRA. Retrieved February 8, 2007 The Netherlands,Animal experimentation legislations and it is very complicated in The Netherlands , EBRA, Retrieved February 8, 2007 and Germany.Animal experimentation legislations in Germany , EBRA. Retrieved February 8, 2007
With a 2004 amendment to the Cosmetics Directive, the animal testing for cosmetic products is forbidden in the EU. Also animal testing for cosmetic ingredients is prohibited since March 2009. The amendment also prohibited, since 11 March 2009, to market cosmetic products containing ingredients which have been tested on animals. The amendment does not prohibit companies to use animal testing to fulfill regulatory requirements in other countries.
France In France, legislation (principally the decree of October 19, 1980) requires an institutional and project license 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 license may be granted following an inspection of the premises. The project licensee must be trained and educated to an appropriate level. Personal licenses are not required for individuals working under the supervision of a project license holder.Introduction: Regulation in France , Select Committee on Animals In Scientific Procedures Report, 16 July 2002. Retrieved February 8, 2007 These regulations do not apply to research using invertebrates.French animal protection legislation and animal research , EBRA. Retrieved February 8, 2007
United Kingdom
The types of institutions conducting animal research in the UK in 2015 were: universities (47.7%); commercial organizations (25.1%); government departments and other public bodies (13.8%); non-profit organizations (12.4%); National Health Service hospitals (0.7%); public health laboratories (0.2%).Statistics of Scientific Procedures on Living Animals Great Britain 2015 , UK Home Office Report, 2015. Retrieved June 20, 2017
The Animals (Scientific Procedures) Act 1986Animals (Scientific Procedures) Act 1986 , House of Commons Stationery Office, 23 March 2000. Retrieved February 8, 2007 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 their purpose; 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.Animal Law - Regulation , Understanding Animal Research. Retrieved June 20, 2017 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)).Select Committee on Animals In Scientific Procedures – Report Chapter 1: Introduction
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. There are 29 qualified inspectors covering 230 establishments, which are visited on average 11–12 times a year in both announced and unannounced inspections.
As a result of the transposition of Directive 2010/63/EU, changes were made to the way research is reviewed and approved in the UK. All licensed establishments must have an Animal Welfare and Ethical Review Body co (commonly referred to as AWERBs) which considers and monitors project applications for the site. The assessment of severity has also changed under the amendments to the Animals (Scientific Procedures) Act (1986). Working examples of severity bands are provided by European Commission Expert Working Group. The assessment of severity must also be conducted retrospectively, which results in severity being assigned on the basis of the actual suffering experienced by the animals, rather than what is presumed during study design. This in turn leads to more accurate prospective assignment of severity bands.
Germany The German Animal Welfare Act, 1972, is designed to enforce the utilitarian principle that there must be good reason for one to cause an animal harm and identifies that it is the responsibility of human beings to protect the lives and well-being of their fellow creatures. The Animal Welfare Act is supplemented by the Animal Protection Laboratory Animal Regulations, 2013, and the European Directive 2010/63/EU. All animal research facilities must be inspected at least every three years, with facilities conducting primate research being inspected at least once per year.Briefing Notes on Animal Research in Germany 2017 , Speaking of Research, retrieved 20 June 2017
Japan Animal Experimentation in Japan is regulated by several documents - the Law for the Humane Treatment and Management of Animals, 2005, The Standards Relating to the Care and Management, and Alleviation of Pain and Distress of Experimental Animals, 2006, and guidelines by various ministries and organizations.
The law states that causing distress to animals is not allowed without due cause (Article 2), and that when conducting animal experiments, methods that reduce the pain and distress of the animals as much as possible shall be used. It also states that consideration shall be given as to the appropriate use of animals, for example by reducing the number of animals used when possible (Article 41).
The Standards state that usage of animals for scientific purpose is necessary. They include regulations for the refinement of experiments, in order to reduce the pain and distress of the experimental animals, and consideration for replacing animal experiments with alternatives or reducing the number of animals used.
MEXT (The Ministry of Education, Culture, Sports, Science and Technology) and MHLW (The Ministry of Health, Labor and Welfare) established the guidelines named "Basic policies on animal experimentation" as quasi-regulations on June 1, 2006. The SCJ (Science Council of Japan) formulated more detailed guidelines, also in 2006, to be used when institutions formate their local regulations.
The SCJ's guidelines state that the director of each research institution bears the responsibility for animal experiments conducted at their facilities, that animal experiments are indispensable, and that each institution should formulate voluntary in-house regulations for proper scientific conduct of animal experiments based on the guidelines. As well, they state that each institution should form an in-house review committee in order to inspect the experiments at that institution, from the standpoint of scientific rationale, with consideration to the Law and Standards mentioned above.
However, ALIVE Foundation conducted a survey of Japanese universities and research facilities in 2011, and concluded that:
"There appears to be little consciousness about the use of animals in experiments. Although there is an official guideline that should be followed, national universities are not complying with the guideline (in particular, in choosing particular kinds of animal, self-assessment and care/management of animals)."
United States
In the United States, animal testing on vertebrates is primarily regulated by the Animal Welfare Act of 1966 (AWA), and the Animal Welfare Regulations which is enforced by the Animal Care divisionAnimal Care USDA Animal and Plant Health Inspection Service, Accessed 06 September 2007 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.""Appendix C: Some Federal Laws Relevant to Animal Care and Use" , Guide for the Care and Use of Laboratory Animals (1996), Institute for Laboratory Animal Research. 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. Even though most animals used in research are mice, rats, and fish, over a million other research animals per year are covered by the Animal Welfare Act and Animal Welfare Regulations. 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. In addition, the IACUC reviews and approves each animal use protocol, which is a written description the researchers submit describing all procedures to be done with laboratory animals. Researchers must consult with a veterinarian for each procedure that may cause more than momentary pain or distress to the animals. In addition a written justification for these procedures, as well as documentation of a search for alternatives to these procedures, must be included with the protocol. The IACUC must review and approve these protocols at least annually. The IACUC also inspects all the animal facilities, including satellite facilities, every 6 months. As a part of this semi-annual inspection the committee also reviews the entire animal care and use program, and submits a "semi-annual report" to the Institutional Official. The Guide (enforced by OLAW) also has requirements for IACUC responsibilities and program reviews.
Animal care and use in research in the United States are largely controlled by Institutional Animal Care and Use Committees.
The following information is based on IACUC activity in the United States over 15 years ago. In addition, the purpose of an IACUC is not to provide "consistent" oversight across studies or institutions. Each institution has its own culture, priorities, and interpretations. 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: