Animal testing regulations

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Animal testing regulations are laws or 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 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]

In November 2010, "Directive 2010/63/EU on the protection of animals used for scientific purposes", which updates and replaces the 1986 Directive 86/609/EEC, was finalized and came into force. Full implementation of the new EU directive starts January 1, 2013.^[5][6]

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.^[7] These regulations do not apply to research using invertebrates.^[8]

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 Service hospitals (0.9%); public health laboratories (0.6%); other public bodies (15.8%).^[9]

The Animals (Scientific Procedures) Act 1986^[10] requires experiments to be regulated by three licenses: a project license 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 license for each scientist or technician who carries out any procedure. In deciding whether to grant a license, 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 license" (Section 5(4)). A license 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)).^[11]

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 license application.^[12] There are 29 qualified inspectors covering 230 establishments, which are visited on average 11–12 times a year.^[13]

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 licenses 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.^[14]

Germany

The German Animal Welfare Act 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.^[15] There are thirteen sections in the Animal Welfare Act, each containing Articles that go into detail of the specific sections.

Japan

The system in Japan is one of self-regulation; all animal experiments are regulated by the Law for Humane Treatment and Management of Animals. This law was amended in June of 2005 and enforced in June of 2006. The Management of Animals is responsible for administering the newly amended law.^[16] The amendment of this law was the conceptual idea of self-regulation and not being restricted by legislative constraints, it was approved by the members of the Japanese Diet who saw that care for laboratory animals and the use of laboratory animals are two different concepts that were concerned with science and animal welfare, respectively. This law requires those using animals to follow the principles outlined in the 3Rs. The principle idea behind the 3Rs was to insure that fewer animals were used; by following this principle, minimal distress and suffering could be achieved through monitoring and controlling the animals by the scientist themselves.^[17]

Conceptual framework

Buddhist and Christian values are combined to form an idea that humans should take sole responsibility for the treatment of laboratory animals so good Karma can be attained while using animals for scientific research. In Japan the religious influence comes for fear of Samsara.^[18] For this Japanese scientist can achieve the 3Rs principle without the strict regulations that are used throughout the rest of the world. Currently strategies are being discussed so that compromises with the Western system can be made since the need to collaborate with Western colleagues often arises.^[18]

At the moment there is a stalemate over weather or not to enact more stringent regulation to follow those of European countries or to stay the course and continue in the direction of the self-regulation system that is in current use. This is the same system that is used in the United States and Canada as well. In the future to maintain a solid and ethical self-regulation system, clarification on responsibilities need to be addressed for people who conduct research on animals as well as implementation of good animal welfare practices to ensure compatibility with scientific needs.^[17]

3Rs

The 3R principle of animal experimentations was introduced to the world by Russell and Burch in 1959.^[19] In terms of ethics in animal experimentation, it gave detailed information on the guidelines that were formulated through the concerns of the ministries and the Science Council of Japan. The 3Rs: Replacement, Reduction, and Refinement, which are also known as "the standards relating to the care and management of laboratory animals and relief of pain", are covered in a detailed guideline based on the current law. The replacement and reduction parts of the principle are related scientifically to animal experimentation and the technical methods of animal experimentation are emphasized. In 1985 the 3Rs were outlined into 11 principles by the Council of International Organizations for Medical Sciences (CIOMS) which have become the international standard to govern animal experimentation.

Regulation at the local level, or "in house", is based on national government guidelines. There is however no governmental inspections of the institutions and no reporting requirement on the number of animals used.^[20] A 1988 survey published by the Japanese Association for Laboratory Animal Science reported that eight million animals had been used that year.^[21] The self-control systems are managed by each institution itself and based on the belief that most animal testing is "the public act" that brings good to humans in the future. Such science, they believe, should not be regulated and the proper treatment of animals is a just consideration in weighing the benefits against the disadvantages. Due to the role-sharing between animal welfare and science, Japanese animal experimentation regulations are considered to be very reasonable worldwide.

Japanese law

An amendment was passed in 1999 to update a law enacted in 1973. This amendment updated the Law Concerning the Protection and Control of Animals, during this time the name of the law was changed to the Law for the Humane Treatment and Management of Animals. This new amendment added verbiage to protect all species of animal from animal cruelty.^[22]

This new law placed a strong emphasis on the responsibility of the owners of animals as well as alleviation of pain, distress, companionship, well-being, and respect for life. The new law also called for humane deaths to all animals used for scientific purposes. In 1980 a specific set of standards was outlined and set for the Standards Relating to the Care and Management of Experimental Animals. Although these standards laid the ground work for care and management of laboratory animals it did not specify the use of the animals. The Prime Minister was also advised at this time by The Science Council of Japan who submitted a recommendation titled "Establishment of Animal Experimentation Guidelines" as a guide to set up formal administrative guidelines for the use of animals for scientific research.^[23]

As a reaction to this recommendation the Ministry of Education sent out a notification titled "Establishment of Animal Testing Guidelines" to all Universities and private institutions to voluntary come up with guidelines on animal experimentation. In response private research institutions along with Universities established policies and submitted their own guidelines, manuals, principles, and materials to comply with the laws and the direction of the administration. This led to other scientific association to submitted guidelines for the individual fields of research; this was a way to show encouragement for other members in the field of scientific research to balance science and animal welfare.^[23]

Current status

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The three categories regarding current regulations on animal experimentation in Japan are:

1) LAWS - Law for the Humane Treatment and Management of Animals — Standards Relating to the Care and Management, etc. of Experimental Animals — Guide for the Disposal of Animals

2) ADMINISTRATIVE GUIDANCE Notification Concerning Animal Experimentation Conducted by Universities, etc.

3) VOLUNTARY GUIDELINES More than 12 guidelines on animal experiments formulated by individual scientific associations.

Laboratory animal scientist reviewed and observed all three categories of regulations in Japan. An explanatory handbook was established for each category of regulation. The new handbook was then edited by 7 laboratory animal scientist, 1 medical doctor, and 1 representative of the Japanese Animal Welfare Society to ensure that the opinions of animal advocates were heard and reflected within the guidelines.^[23]

A set of ethical principles known as the 3Rs which closely resembles the ideas of Western Countries on the ethics of animal testing was used as the basis for establishing law and regulation of animal testing in Japan. The large emphasis of the law is placed on the refinement so that all the focus is placed on the alleviation of pain, distress, and a humane death to all animals used in laboratory experiments.^[23]

Characteristics of Regulations on Animal Experiments in Japan:

• Laws specify the responsibility of the owner of the animal.
• Laws call for 3Rs emphasizing the alleviation of pain and distress as well as humane death of animals used for scientific purposes.
• Administrative guidance encourages the ethical use of animals.
• Self-regulation system similar to the US and Canada.
• Recommendation for designating Institutional Animal Care and Use Committee (IACUC).
• Exemption from legal registration/inspection.

Like in Western Countries Japanese law is based on the idea of a self-regulation system for the use of animals in laboratory experimentation. Due to this, notification only recommends designation of an Institutional Animal Care and Use Committee (IACUC). Although not required by law almost all pharmaceutical companies as well as medical schools have established IACUCs; livestock and laboratory animal facilities are exempt from registration with the IACUC and legal inspection. Due to this the Japanese Association for Laboratory Animal Science voluntarily does a survey every 3 years on the number of animals used for scientific study. This has brought about a trend in Japan where scientists who use animals in the laboratory have placed a high value on reduction and replace of live animals in the research lab.^[23]

The Western viewpoint views the regulation of animal research in Japan as very lenient. Japanese scientists have been annoyed by this over the years when jointly collaborating with their Western counterparts. The handling of animals for research in Japan is heavily influenced by religion and culture. Religious implications form an important foundation for the ethical treatment of animals when it comes to experimentation.^[23]

United States

In the United States, animal testing on vertebrates is primarily regulated by the Animal Welfare Act of 1966 (AWA),^[24] which is enforced by the Animal Care division^[25] 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."^[26][27] 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.^[28] Thus, relatively few animals used in research in the U.S. are covered by this legislation.^[29] 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.^[30]

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. ^[31]

Institutions are also subject to unannounced annual inspections from USDA APHIS Veterinarian inspectors. There are about 70 inspectors^[32] monitoring around 1100 research institutions.^[33] 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).^[34]

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.^[35] 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.^[36]

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.^[37]

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[10] published by the Institute for Laboratory Animal Research,[11] which includes all vertebrate species in its care protocols, including rodents and birds[12] (Introduction, p.1). In 2004, the National Institutes of Health provided funds to 3,180 different research institutions and universities.[13] 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."^[38] 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),^[39] a non-governmental, nonprofit association, is regarded by the industry as the "gold standard" of accreditation.^[40] Accreditation is maintained through a prearranged AAALAC site visit and program evaluation hosted by the member institution once every three years.^[41] 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.

Canada

The Canadian Council on Animal Care (CCAC) is setup 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".^[42]

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.

The Criminal Code of Canada 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 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 Spending Power 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.^[42]

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. Theses provinces are Alberta, Manitoba, Saskatchewan, Ontario, New Brunswick, Nova Scotia, and Prince Edward Island.

Alberta

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.^[42]

Prince Edward Island

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.^[42]

Manitoba

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.^[43]

Ontario

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.^[42] 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.

Australia

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:

• ensure that the use of animals is justified, taking into consideration the scientific or educational benefits and the potential effects on the welfare of the animals;
• ensure that the welfare of animals is always considered;
• promote the development and use of techniques that replace the use of animals in

scientific and teaching activities;

• minimise the number of animals used in projects; and
• refine methods and procedures to avoid pain or distress in animals used in scientific and teaching activities.^[44]

Scientific and teaching activities using animals may be performed only when they are essential:

• to obtain and establish significant information relevant to the understanding of humans and/or animals;
• for the maintenance and improvement of human and/or animal health and welfare;
• for the improvement of animal management or production;
• to obtain and establish significant information relevant to the understanding, maintenance or improvement of the natural environment; or
• for the achievement of educational objectives.^[44]

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.

Brazil

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. ^[45]

Brazil also reinforces the 3Rs.

Notes