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Legislation & Regulation

Legislation & Regulation

Legislation and regulations on the use of animals in testing and research differ across the world.
Below, details of the current legislation and regulations in the UK, Europe, the Americas, Asia, Oceania, and Africa, have been outlined.

UK 

The UK was the first country in the world to enforce specific restrictions and regulations on using animals for research. The Cruelty to Animals Act came into force in 1876, and made it an offence to perform experiments, on a living animal, that would cause pain, unless for advancing physiological knowledge, saving or prolonging life, or alleviating suffering. Other regulations included allowing only scientists to perform experiments, and requiring licenses before experiments were permitted. This Act stood alone in regulating animal research in the UK until the Animals (Scientific Procedures) Act 1986 (A(SP)A) was introduced. A(SP)A was an extension and revision of the Cruelty to Animals Act 1876 with stricter regulations. A(SP)A was revised in 2013 to include the EU Directive 2010/63/EU – a directive that aimed to improve the welfare standards of animals in science across EU member states (Directive 2010/63/EU 2010).

ASPA currently regulates:

  • Procedures that are carried out on ‘protected animals’ for scientific or educational purposes that may cause pain, suffering, distress or lasting harm.
  • The breeding and supply of certain species of animals for use in regulated procedures or for the scientific use of their organs or tissues.
  • The methods used to kill protected animals.

In March 2014, a document called the Guidance on the Operation of the Animals (Scientific Procedures) Act 1986 was produced after a public consultation. This document gives detailed guidance on how ASPA should be administered and enforced.

This includes further details on:

  • What constitutes a regulated procedure
  • Which animals are protected under ASPA, and animals that acquire a higher level of protection (dogs, cats, primates, etc)
  • Licensing requirements
  • The principle of the 3R’s – which is a major component of ASPA
  • Species specific methods of humane euthanasia
  • Rehoming and re-release procedures for animals
  • Housing and husbandry facilities
  • Animal Welfare and Ethical Review Bodies
  • Inspections
  • Penalties for non-compliance

amongst other aspects.

Under ASPA, a regulated procedure is defined as any procedure applied to a protected animal that will cause a level of pain, suffering, harm or distress, equivalent to or higher than that of a needle being inserted under good veterinary practice.

A protected animals, as defined by ASPA, is any living vertebrate other than man, and any living cephalopod. ASPA also extends protection to any vertebrate in foetal, larval or embryonic form, if, in the case of mammals, birds and reptiles, they are two thirds of the way through gestation or incubation period, or in other cases, when they become capable of independent feeding. Early life stage protection is not extended to cephalopods.

ASPA regulates animal experimentation through a three tier licensing system. This means that an establishment license for the premises, a personal license for the person conducting the experiment, and a project license for the specific programme of research that the project being carried out under, must all be in place. Licenses are issued by the Home Office in England, Scotland and Wales, and by the Department of Health, Social Service and Public Safety in Northern Ireland.

Brexit

As of January 2021 the UK has officially left the European Union. As a result of this, most legislation has been transposed from the EU back into domestic UK law. The UK is now operating under the following regulations and regulatory bodies:

 

Europe (excluding the UK)

In member states of the European Union, animal experimentation is controlled by the European Directive 2010/63/EU.

The directive sets out rules on:

  • The 3R’s
  • The origin, breeding, marking, care and accommodation and killing of animals
  • The operations of breeders, suppliers and users
  • The evaluation and authorisation of projects
  • Reporting obligations

Each Member State of the European Union had to revise or introduce new legislation in order to comply with this Directive. 

The 3Rs are now an integral part of the Directive so Member States have to ensure: 

  • wherever possible, a scientifically satisfactory method or testing strategy, not using live animals, should be used instead of an animal procedure. 
  • the number of animals used in projects is reduced to a minimum without compromising the objectives of the project. 
  • refinement of breeding, accommodation and care, and of methods used in procedures, eliminating or reducing to the minimum any possible pain, suffering, distress or lasting harm to the animals. 

The directive applies to all live vertebrates, namely all species of mammals, birds, amphibians and fish, and live cephalopods. Like ASPA, protection is also extended to specific early life-stages of some species.

Cosmetics and their ingredients which have been tested on animals are banned from being sold or advertised within the EU, under the Cosmetics Directive Regulation (EC) No 1223/2009.

The testing of chemicals in Europe is controlled by the REACH legislation. REACH (Registration, Evaluation, Authorisation and restriction of Chemicals) is a regulation of the European Union, adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals, while enhancing the competitiveness of the EU chemicals industry. It also promotes alternative methods for the hazard assessment of substances in order to reduce the number of tests on animals. Whilst the Cosmetic Regulation bans the testing of cosmetic ingredients on animals, in some instances REACH overrules this and requires animal tests, for example when chemicals for cosmetics have other, non-cosmetic uses, and for evaluating the risk of exposure of new (cosmetic) chemicals to protect those working with them. REACH states animal testing as a last resort to obtain relevant safety data, but non-animal tests in some areas do not yet exist.

United States of America

In the US, the Animal Welfare Act 1966 sets out the minimum standards of care and treatment for animals used in research, across the country. This was first enacted in 1966, and also includes regulations on other animal uses and practices, such as the pet trade. It is enforced by the US Department of Agriculture, through the Animal Care Programme of the Animal and Plant Health Inspection Service.

In terms of animals protected under the Animal Welfare Act, birds, rats (of the genus Rattus) and mice (of the genus Mus) are explicitly excluded. There is also no mention of fish, amphibians and reptiles, meaning that none of these species are protected either. The exclusion of these species, particularly birds, rats and mice, is a major limitation of the Act, as they are the most commonly used species within research in the US – estimated to be around 90% of all animals used.

In terms of regulation, the Animal Welfare Act sets out:

  • Minimum standards of veterinary care and animal husbandry
  • Requirements for licensing of research procedures, but not individuals
  • Requirements for the provision of anesthesia and pain relieving medication
  • Requirements for facilities to provide dogs with opportunities for exercise
  • Requirements to promote the psychological well-being of primates
  • Forbiddance of unnecessary duplication of experiments
  • Requirements for the establishment of Institutional Animal Care and Use Committees to oversee the use of animals

In 2015, the Humane Cosmetics Act was introduced to phase out cosmetic animal testing and the sale of cosmetics that have been tested on animals.

 

Canada 

The Canadian Council on Animal Care (CCAC) is an independent body that oversees animals use in scientific research throughout Canada. As an organisation, they have established requirements for institutions to follow, under the Guide to the Care and Use of Experimental Animals. This was most recently revised in April 2020. These guidelines provide details on:

  • Animal facilities and housing
  • Behavioural requirements and welfare or each species
  • Transportation
  • Breeding
  • Health and safety
  • Controls of animal pain and anaesthetic
  • Euthanasia
  • 3R’s
  • Animal Care Committees and Research Ethics Boards

The use of animals in research in Canada is regulated on a Provincial basis, rather than nationally, with each province having their own animal welfare laws. Out of the 10 provinces in Canada, 8 of them have incorporated the CCAC guide into their own legislation, meaning that despite the guide not being legally binding on it’s own, the guidelines it has set out now must be followed in:

 

Brazil 

In Brazil, the Brazilian National Council for the Control of Animal Experimentation (CONCEA) is the legal authority responsible for regulating the use of animals in research. CONCEA was set up in 2008, and issued Law No. 11794, Brazilian Federal Law on Animal Experimentation, in the same year. This piece of legislation details responsibilities such as licensing, what animals are protected, classification of procedures, ethical review bodies, penalties for non-compliance, etc. Law No. 11794 was enacted in 2009 by federal Decree No. 6899 of 2009. CONCEA also produce a range of species specific guidance documents that provide comprehensive detail on housing and husbandry requirements.

Ethical reviews are conducted on a national scale by CONCEA, and institutionally through Ethics Committees on the Use of Animals (CEUA). These involve accrediting institutes for animal use, reviewing projects prior to taking place and throughout, maintaining records of animal use, and monitoring for alternatives

In 2012 Brazil set up the Brazilian Centre for Validation of Alternative Methods (BraCVAM) and The National Network of Alternative Methods (RENAMA). BraCVAM is a partnership between the National Institute of Health Quality Control (INCQS/Fiocruz) and the National Health Surveillance Agency (ANVISA). Two years later BraCVAM recommended 17 validated alternative methods published by the OECD that were accepted by the CONCEA after hearing the Brazilian regulatory agencies. In July 2015, the ANVISA Executive Board decided that all alternative methods recognised by CONCEA will be immediately accepted by ANVISA.

China

In China, animal use in research is regulated nationally by the Ministry of Science and Technology (MOST). In 1988 they produced the Regulations for the Administration of Affairs Concerning Experimental Animals. These regulations included details on:

  • Animal welfare standards
  • Breeding
  • Licensing
  • Disease control
  • Transportation of animals
  • Training of researchers

Under these regulations, a laboratory animal is defined as any animals bred and reared according to relevant standards and intended to be used in experiments or for other scientific purposes. This does not, however, provide much detail on the species that are covered. Also, unlike other countries, these regulations do not define what is classed as a regulated procedure when conducting research. Any research using animals must be licensed, with licensing regulated by MOST, and provincial under Provincial Bureaus of Science and Technology (BOST). Ethical review bodies can be established at different administrative levels, and may belong to a local/regional laboratory animal ethical review board, or an individual institution.

China also set out housing standards for animals used in research under the Laboratory Animals – Requirements of Environment and Housing Facilities 2010. These regulations require that housing is species specific and meets each species needs, in terms of husbandry requirements and behavioural needs.

In 2018, the Guidelines for the Ethical Review of Laboratory Animal Welfare – Peoples Republic of China National Standard, was issued. This is the most recent piece of legislation regarding laboratory animal use in China. It is a comprehensive document outlining the requirements of ethical review and animal welfare management when producing, transporting and using laboratory animals, providing considerable detail on humane endpoints, the 3R’s, the Five Freedoms, review bodies, and training, amongst many other aspects.

Cosmetics

In China the State Food and Drug Administration requires animal toxicity (safety) test reports before it will license new cosmetics. They place cosmetics into two groups:

  • Ordinary cosmetics (e.g. hair care, nail care, skin care and perfume) – these tend to be licensed at provincial level often without needing to be tested on animals
  • Special cosmetics (e.g. hair growth, hair colour, hair removal and sun block) – these require State registration which includes animal tests for eye and skin irritation.

In recent years safety concerns have led to many ordinary cosmetics being re-categorised as special cosmetics. However, the cosmetics regulations have been under review, leading to some improvements. From June 2014, companies manufacturing “ordinary” cosmetics inside China will no longer be required to provide samples of new products to the government to be animal-tested. Instead, they will be given the option to conduct their own product risk assessment using ingredient safety data, including the possibility to rely on the results of non-animal test methods, provided the test methods are deemed scientifically valid by the European Union. However, cosmetics produced outside China and special cosmetics still require animal testing.

 

Japan 

The Law for the Humane Treatment and Management of Animals 1973 (also known as the Act on Welfare and Management of Animals), a piece of general animal welfare legislation, also sets out some provisions for the use of animals in scientific research. Article 41 states that consideration should be given to appropriate alternatives in order to reduce the number of animals used, if the same outcome can be attained. Whilst this doesn’t fully imply application of the 3R’s, the 2005 amendment of the act now incorporates the 3R’s principle as a whole. This section also states that methods used throughout the research should minimise pain and distress to the animal, and that humane methods (although no examples provided) should be used to euthanise animals when necessary. The Minister of the Environment has the power to set standards for these methods.

Overall, control of animal experimentation in Japan is done on an institutional basis, rather than being regulated nationally. To achieve this, the Science Council of Japan issued Guidelines for Proper Conduct of Animal Experiments in 2006. These guidelines provide details on the responsibilities of institutions. This includes the formation of Institutional Animal Care and Use Committees, care and management of laboratory animals, animal health, facilities management, inspections, and training, amongst others. The guidelines also state that each institution should formulate voluntary in-house regulations for proper scientific conduct of animal experiments based on the guidelines.  These guidelines define ‘laboratory animal’ as any animal of mammalian, avian or reptilian species used within animal experiments. Notably, this excludes any species of fish from protection, as well as species of cephalopod.

In terms of testing chemicals Japan has been influenced by other international legislation such as OECD guidelines and the EU REACH legislation. This has led to increasing participation in international efforts to find and validate alternatives to animal tests.

Australia

In Australia, animal use in scientific research is regulated by the Australian Code of Practice for the Care and Use of Animals for Scientific Purposes. This is a national document, first produced by the National Health and Medical Research Council in 2013. The purpose of this code is to promote humane and responsible care of animals used within research, and provide details of responsibilities for institutions, animal carers, ethics committees and investigators.

Under the code, all living non-human vertebrates and cephalopods are protected. In terms of early life stage protection, the code states that decisions surrounding their welfare should be based on evidence of their neurobiological development, on a case to case basis, with their gestational/incubational progress taken into account too.

The 3R’s is one of the governing principles of the National Code. Replacement, refinement and reduction should be applied throughout all stages of animal use during research. Before research using animals is considered, existing information on the proposed aims of the project must be examined closely. This includes looking at available alternative methods and pre-existing data.

Territorial legislation

As well as the Code of Practice, each territory has their own laws regulating animals in research, mainly focusing on licensing and approval of research. All territories have very similar licensing approaches within their individual acts. The National Code of Practice is enforced into all territorial legislation, making it legally binding and mandatory to follow throughout Australia.

New South Wales are the only territory to have a dedicated piece of legislation for animals in research with the Animal Research Act 1995. This act requires those carrying out research using animals, and those supplying animals for research, to be authorised to do so and be an accredited research establishment.

In the Australian Capital Territory, the Animal Welfare Act 1992 has a section regarding animal research, teaching and breeding. Those conducting research must have obtained a license from the Animal Welfare Authority. This also applies to the breeding of animals for research.

In Western Australia, the Animal Welfare Act 2002 states research can only be conducted at an establishment that holds a license, or by a member of staff/student that holds a license authorising their specific use for animals in research. On top of the Animal Welfare Act, Western Australia also have the Animal Welfare (Scientific Purposes) Regulations 2003, which requires that all animal use for scientific research must comply with the nation code of practice.

Northern Territory, part 4 of the Animal Protection Act 2018  is dedicated to the regulation of scientific users of animals, and states that licenses must be obtained from the relevant ethics committee, subject to the conditions of the act and the national code of practice.

In Queensland, under the Animal Care and Protection Act 2001, anyone that wishes to use animals in scientific research must register with Biosecurity Queensland, get approval from an animal ethics committee and keep the relevant documentation ready at all times.

In South Australia, the Animal Welfare Act 1985 requires that animal ethics committees approve any licensing requests for animal use in experimentation and teaching.

In Victoria, the Prevention of Cruelty to Animal Act 1986 regulates compliance with the nation code, and requires that any research must be licensed, with licenses issues by an animal ethics committee, within an authorised premises.

In Tasmania, the Animal Welfare Act 1993 requires that institutions in which animal research is to take place must be licensed by the Minister, and all projects involving animals must be approved and monitored by Animal Ethics Committees.

 

New Zealand

In New Zealand, the Animal Welfare Act 1999 sets out regulations for animals used in research. This is not a piece of legislation that is specific to animals used in research, and covers a number of different animal practices.  A government framework called the Good Practice Guide for Research, Testing and Teaching 2019 also provides comprehensive details of how research involving animals should be conducted. This includes:

  • What animals are protected in research
  • Project approval and licensing
  • Responsibilities of National Animal Ethics Advisory Committees
  • Housing and husbandry facilities
  • Non-compliance procedures
  • Breeding
  • Inspections

As well as the Animal Welfare Act and Good Practice Guide, New Zealand also have the Animal Welfare (Records and Statistics) Regulations. These regulations require in-depth record keeping to be conducted when using animals in research. This includes project applications, any procedures carried out, the animals and species used, the source of each individual animal, any site visits that have taken place, and any complaints that have been made.

The Animal Welfare Act 1999 defines an animal as “any live member of the animal kingdom that is mammal, bird, reptile, amphibian, fish, octopus, squid, crab, lobster, crayfish or any other member of the animal kingdom which is declared from time to time by the governor-general.” Like ASPA, some species are protected during early life stages. This includes any mammalian foetus, or any avian or reptilian pre-hatched young that are in the last half of its gestation or development period, and any marsupial pouch young.

In New Zealand, research is defined as any work that involves manipulation of any animal, or any routine breeding of animals that may result in the birth or production of an animal that is more susceptible to pain or distress.

Cosmetic testing

The testing of finished cosmetic products and ingredients indented for cosmetic products has been banned in New Zealand since 2015. An amendment stating the ban has been written into the Animal Welfare Act.

Africa, as a whole, has very limited legislation with regards to animals used in research. Some countries, for example Nigeria, do not any formal regulations or laws surrounding animals used in research, despite having a high number of tertiary institutions that conduct animal research. Despite this, an organisation called Animal Care and Use in Research, Education and Testing (ACURET) has been started in Nigeria in order to promote humane care and use of animals in research, and to develop training for researchers in conjunction with the 3R’s. This does, however, have no legal basis.

South Africa have a government framework that covers animals used in research, the South African National Standard – The Care and Use of Animals for Scientific Purposes. This document sets out minimum standards and husbandry practices, as well as requiring the 3R’s to be followed, and Animal Ethics Committees to give approval to all experiments before they take place. It is however, not legally binding so can only be followed as advice.

The Animal Protection Act 1962 applies to animals used in research, however no examples are given specifically to research throughout the legislation, making this piece of legislation quite vague and unfit for regulating research.

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