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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.
Experiments on vertebrate animals in the European Union are since January 1, 2013. [1] [2] 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. [3] Directive 86/609/EEC showed considerable variation in the manner member countries chose to exercise the directive: compare, for example, legislation from Sweden, [4] The Netherlands, [5] and Germany. [6]
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. [7] The amendment does not prohibit companies to use animal testing to fulfill regulatory requirements in other countries.
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. [8] These regulations do not apply to research using invertebrates. [9]
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%). [10]
The Animals (Scientific Procedures) Act 1986 [11] 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. [12] 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)). [13]
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. [14] There are 29 qualified inspectors covering 230 establishments, which are visited on average 11–12 times a year in both announced and unannounced inspections. [15]
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 [16] (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. [17] 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. [18]
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. [19] 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. [20]
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. [21]
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). [22]
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. [23]
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. [24]
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)." [25]
In the United States, animal testing on vertebrates is primarily regulated by the Animal Welfare Act of 1966 (AWA), [26] and the Animal Welfare Regulations [26] which is enforced by the Animal Care division [27] 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." [28] [29] 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. [30] 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. [31] 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. [32] The Guide (enforced by OLAW) also has requirements for IACUC responsibilities and program reviews. [33]
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:
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. [34]
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. [35]
Institutions are also subject to unannounced annual inspections from USDA APHIS Veterinarian inspectors. There are about 70 inspectors [36] monitoring around 1100 research institutions. [37] 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). [38]
Another regulatory instrument is the Office of Laboratory Animal Welfare (OLAW), [39] which is an office within the US National Institutes of Health. OLAW oversees all animal studies funded by the Public Health Service (including NIH). The Health Research Extension Act of 1985 directed the NIH to write the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals. This Policy applies to any individual scientist or institution in receipt of federal funds and requires each institution to have an IACUC, among other stipulations. OLAW enforces the recommendations in the Guide for the Care and Use of Laboratory Animals Guide for the Care and Use of Laboratory Animals: Eighth Edition published by the Institute for Laboratory Animal Research,Page Not Found : Division on Earth and Life Studies which covers all vertebrate species, including rodents, birds, fish, amphibians, and reptiles Guide for the Care and Use of Laboratory Animals: Eighth Edition 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." [40] 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), [41] a non-governmental, nonprofit association, is regarded by the industry as the "gold standard" of accreditation. [42] Accreditation is maintained through a prearranged AAALAC site visit and program evaluation hosted by the member institution once every three years. [43] 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.
The Canadian Council on Animal Care (CCAC) is set up to act in the interests of the people of Canada to ensure through programs of education, assessment and guidelines development that the use of animals, where necessary, for research, teaching and testing employs optimal physical and psychological care according to acceptable scientific standards, and to promote an increased level of knowledge, awareness and sensitivity to relevant ethical principles. At the inaugural meeting on January 30, 1968, the CCAC adopted the following statement of objective: "to develop guiding principles for the care of experimental animals in Canada, and to work for their effective application". [44]
The federal government does not have jurisdiction to pass laws that involve experiments on animals. The provinces have jurisdiction concerning that area. The federal government, however, is involved in three areas: the criminal law power, the health power, and the spending power.
Section 446 and 447 of the Criminal Code protect animals from cruelty, abuse and neglect. This section of the Criminal Code has been under review for several years.
The Health of Animals Act (1990) and its regulations are aimed primarily at protecting Canadian livestock from a variety of infectious diseases that would threaten both the health of the animals and people, and Canadian trade in livestock with other countries. This act is used both to deal with named disease outbreaks in Canada, and to prevent the entry of unacceptable diseases that do not exist in Canada.
The other mechanism through which the federal government has lent its support to the humane treatment of animals is not strictly speaking legislative in nature, but in many respects it is one of the most powerful instruments available to the federal government for setting national standards. The federal government's power to provide for grants subject to conditions imposed on the recipients, be they provincial governments or individual or corporate recipients, may take a variety of different forms. One form is that of the conditional federal grant or contract. This manifestation of the federal power is what currently underpins the imposition of CCAC standards on facilities receiving funding from the Canadian Institutes of Health Research and the Natural Sciences and Engineering Research Council. Where the government itself awards a contract on an academic or non-academic institution, clause A9015C of Public Works Standard Acquisition Clauses and Conditions Manual imposes conditions related to the care and use of experimental animals in public works and government services. [44]
All of the provinces in Canada have created and passed laws that pertain to animal welfare, but only certain provinces have made their own laws. These provinces are Alberta, Manitoba, Saskatchewan, Ontario, New Brunswick, Nova Scotia, and Prince Edward Island.
In 2006, the Alberta Animal Protection Act was revised and declared. Previously in Alberta, only academic institutions were subject to provincial regulations referencing CCAC standards, as these standards were referenced exclusively in the Alberta Universities Act. In 2005, the Universities Act and two other laws were examined by the Alberta Agriculture, Food and Rural Development Ministry (AAFRD), in hopes of combining them and update their content. Article 2(1) of the Animal Protection Regulations was revised by the CCAC and AAFRD and now states that "a person who owns or has custody, care or control of an animal for research activities must comply with the following Canadian Council on Animal Care documents", and lists all 22 CCAC standards, including the CCAC Guide to the Care and Use of Experimental Animals and the various guidelines and policies published by the CCAC. [44]
In Prince Edward Island, the Animal Protection Regulations made under the Animal Health and Protection Act state that the rules controlling the care of animals used for medical or scientific research can be found in Volumes 1 and 2 of the Guide to the Care and Use of Experimental Animals published by the CCAC. in the Prince Edward Islands [44]
In the province of Manitoba, according to the Animal Care Act, it is not allowed for a person to cause suffering to an animal. The use of animals for research and teaching is acceptable as long as it follows the rules set out in the Act. All institutions that use animals for research and teaching purposes have to submit to obey the system put in place by the CCAC. Failing to do so, any harm done to an animal in a research or teaching program will be regarded as an offense under the Act. [45]
All of the research facilities in Ontario must be registered and licensed based on the legislation Animals for Research Act. Among the provisions of the Animals for Research Act, one should note the duty to establish an animal care committee, the responsibilities and powers of which are similar to those required under the CCAC system, and the requirement for any operator of a research facility to submit to the person designated by the Minister of Agriculture, Food and Rural Affairs a report respecting the animals used in the research facility for research. [44] Regulation 24 governs the housing and care of the animals. Regulation 25 controls the conditions for transportation of the animals that are used or going to be used by a research facility.
In Australia, Animal Ethics Committees (AECs) determine whether the use of an animal is valid or not. AECs must follow the Code in order to ensure the wellbeing of the animals used for research. The Code emphasizes the responsibilities of investigators, teachers and institutions using animals to:
scientific and teaching activities;
Scientific and teaching activities using animals may be performed only when they are essential:
Researchers can only conduct their studies once it has approved the validity of the use of the animals and that there is more educational or scientific gain that outweighs the possible effects on the welfare of the animals. The researchers must submit a written proposal to an AEC stating what is to be accomplished, a defense for the study, and the ethical and wellbeing of the animals used reflecting the 3Rs.
New Zealand's Animal Welfare Act 1999 [47] requires owners and people in charge of animals to ensure the physical, health and behavioural needs of animals are met, and that pain and distress are alleviated. In New Zealand, as in many countries, laboratory animals (mainly rodents) and farm animals (mainly cattle and sheep) are used in research, testing and teaching – commonly referred to as RTT. Animal use in RTT is strictly controlled under the Animal Welfare Act 1999 [47] and organisations using animals must follow an approved code of ethical conduct. This sets out the policies and procedures that need to be adopted and followed by the organisation and its animal ethics committee.
Every project must be approved and monitored by an animal ethics committee. These committees must have three external members:
Code holders and their animal ethics committees are independently reviewed (by MPI accredited reviewers) at least once every five years. All code holders have to submit annual animal use statistics on the number of animals used in research, testing or teaching, and its impact on them, from little or none to severe.
The Ministry for Primary Industries (MPI) [50] administers the Act and leads animal welfare policy and practice in New Zealand. The National Animal Ethics Advisory Committee (NAEAC) [51] was established under the Animal Welfare Act [47] to provide independent advice to the Minister for Primary Industries about:
The federal law for the scientific use of animals was passed in 2008. The law established the National Council for the Control of Animal Experimentation (CONCEA) and demanded that institutions create an ethics committee on the use of animals.
In 2009, Decree 6899/2009 defined CONCEA as the governing and advisory body, under the Ministry of Science and Technology, to authorize accreditation to registered institutions and to license those institutions to use animals in research. The same decree also states that an electronic database be developed to allow breeding and research facilities to register in order to apply for CONCEA accreditation. [52]
Brazil also reinforces the 3Rs.
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Animal welfare is the well-being of non-human animals. Formal standards of animal welfare vary between contexts, but are debated mostly by animal welfare groups, legislators, and academics. Animal welfare science uses measures such as longevity, disease, immunosuppression, behavior, physiology, and reproduction, although there is debate about which of these best indicate animal welfare.
Animal testing, also known as animal experimentation, animal research, and in vivo testing, is the use of non-human animals in experiments that seek to control the variables that affect the behavior or biological system under study. This approach can be contrasted with field studies in which animals are observed in their natural environments or habitats. Experimental research with animals is usually conducted in universities, medical schools, pharmaceutical companies, defense establishments, and commercial facilities that provide animal-testing services to the industry. The focus of animal testing varies on a continuum from pure research, focusing on developing fundamental knowledge of an organism, to applied research, which may focus on answering some questions of great practical importance, such as finding a cure for a disease. Examples of applied research include testing disease treatments, breeding, defense research, and toxicology, including cosmetics testing. In education, animal testing is sometimes a component of biology or psychology courses. The practice is regulated to varying degrees in different countries.
Vivisection is surgery conducted for experimental purposes on a living organism, typically animals with a central nervous system, to view living internal structure. The word is, more broadly, used as a pejorative catch-all term for experimentation on live animals by organizations opposed to animal experimentation, but the term is rarely used by practising scientists. Human vivisection, such as live organ harvesting, has been perpetrated as a form of torture.
An animal model is a living, non-human, often genetic-engineered animal used during the research and investigation of human disease, for the purpose of better understanding the disease process without the risk of harming a human. Although biological activity in an animal model does not ensure an effect in humans, many drugs, treatments and cures for human diseases are developed in part with the guidance of animal models. Animal models representing specific taxonomic groups in the research and study of developmental processes are also referred to as model organisms. There are three main types of animal models: Homologous, Isomorphic and Predictive. Homologous animals have the same causes, symptoms and treatment options as would humans who have the same disease. Isomorphic animals share the same symptoms and treatments, only. Predictive models are similar to a particular human disease in only a couple of aspects. However, these are useful in isolating and making predictions about mechanisms of a set of disease features.
The Animals Act 1986, sometimes referred to as ASPA, is an Act of the Parliament of the United Kingdom passed in 1986, which regulates the use of animals used for research in the UK. The Act permits studies to be conducted using animals for procedures such as breeding genetically modified animals, medical and veterinary advances, education, environmental toxicology and includes procedures requiring vivisection, if certain criteria are met. Revised legislation came into force on 1 January 2013. The original act related to the 1986 EU Directive 86/609/EEC which was updated and replaced by EU Directive 2010/63/EU
The regulation of science refers to use of law, or other ruling, by academic or governmental bodies to allow or restrict science from performing certain practices, or researching certain scientific areas.
The Animal Welfare Act was signed into law by President Lyndon B. Johnson on August 24, 1966. It is the main federal law in the United States that regulates the treatment of animals in research and exhibition. Other laws, policies, and guidelines may include additional species coverage or specifications for animal care and use, but all refer to the Animal Welfare Act as the minimally acceptable standard for animal treatment and care. The USDA and APHIS oversee the AWA and the House and Senate Agriculture Committees have primary legislative jurisdiction over the Act. Animals covered under this Act include any live or dead cat, dog, hamster, rabbit, nonhuman primate, guinea pig, and any other warm-blooded animal determined by the Secretary of Agriculture for research, pet use or exhibition. Excluded from the Act are birds, rats of the genus Rattus, mice of the genus Mus, farm animals, and all cold-blooded animals.
The Office of Laboratory Animal Welfare (OLAW) oversees the care and use of research animals in any public or private organization, business, or agency. The Public Health Service consists of the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the Agency for Healthcare Research and Quality (AHRQ), the Indian Health Service (IHS), and the Substance Abuse and Mental Health Services Administration (SAMHSA). The agencies of the PHS are a part of the U.S. Department of Health and Human Services.
Institutional Animal Care and Use Committees (IACUCs) are centrally important in applying laws about animal research in the United States. Similar systems operate in other countries, but generally under different titles; for example, in Canada a typical title would be the University Animal Care Committee (UACC), while in the United Kingdom it would be the Animal Welfare and Ethical Review Body (AWERB).
Experiments involving non-human primates (NHPs) include toxicity testing for medical and non-medical substances; studies of infectious disease, such as HIV and hepatitis; neurological studies; behavior and cognition; reproduction; genetics; and xenotransplantation. Around 65,000 NHPs are used every year in the United States, and around 7,000 across the European Union. Most are purpose-bred, while some are caught in the wild.
Alternatives to animal testing are the development and implementation of test methods that avoid the use of live animals.
The Boyd Group is a Britain-based, independent think tank considering issues relating to animal testing.
Animals used by laboratories for testing purposes are largely supplied by dealers who specialize in selling them to universities, medical and veterinary schools, and companies that provide contract animal-testing services. It is comparatively rare that animals are procured from sources other than specialized dealers, as this poses the threat of introducing disease into a colony and confounding any data collected. However, suppliers of laboratory animals may include breeders who supply purpose-bred animals, businesses that trade in wild animals, and dealers who supply animals sourced from pounds, auctions, and newspaper ads. Animal shelters may also supply the laboratories directly. Some animal dealers, termed Class B dealers, have been reported to engage in kidnapping pets from residences or illegally trapping strays, a practice dubbed as bunching.
Public Responsibility in Medicine and Research (PRIM&R) is a 501(c)(3) nonprofit organization based in Boston, Massachusetts. The organization was formed in 1974 by a group of researchers who sought to ensure that the concerns and experiences of those working in biomedical research would be reflected in the growing body of federal regulations governing the field.
The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) coordinates U.S. federal government evaluation of new, revised, and alternative test methods. Alternative methods are methods for safety testing of chemicals and chemical products that use fewer or no animals or that minimize or prevent animal pain and distress.
Various organizations have created guidelines for human subject research for various kinds of research involving human subjects and for various situations.
A Designated Member Review (DMR) or Designated Subcommittee Review (DSR), also known as Designated Review, is a review of a protocol where a committee designates one or more members of the committee to review a decisionmaking process or a protocol or procedure, a review which would ordinarily require the full committee's review. Typically this pertains to IACUCs.
Animal welfare in the United States relates to the treatment of non-human animals in fields such as agriculture, hunting, medical testing and the domestic ownership of animals. It is distinct from animal conservation.
The University of Washington practices animal testing for a variety of purposes, including biomedical testing and paramedic training. Testing is performed by faculty from various departments across the university, and is conducted on animals including dogs, rabbits, primates, pigs, sheep, gerbils, bobcats, ferrets, and coyotes. Testing on primates is done through the Washington National Primate Research Center, which is located on campus. Animal testing at UW is overseen by the university's Institutional Animal Care and Use Committee (IACUC).
The European Convention for the Protection of Vertebrate Animals used for Experimental and other Scientific Purposes, sometimes simply referred to as the animal experimentation convention or laboratory animals convention, is an animal welfare treaty of the Council of Europe regarding animal testing, adopted on 18 March 1986 in Strasbourg, and effective since 1 January 1991.
