EU and national regulations for animal experimentation

EU regulations

The protection and welfare of animals is an area covered by a wide range of EU legislation. This includes the protection of wildlife, zoo animals, farm animals, animals in transport and animals used for scientific purposes. Animal studies, whether for the development or production of new medicines, for physiological studies, for studying environmental effects or for the testing of chemicals or new food additives, has to be carried out in compliance with EU legislation.

Since 1986, the EU has had in place specific legislation covering the use of animals for scientific purposes. On 22 September 2010 the EU adopted Directive 2010/63/EU which updates and replaces the 1986 Directive 86/609/EEC on the protection of animals used for scientific purposes. The aim of the new Directive is to strengthen legislation, and improve the welfare of those animals still needed to be used, as well as to firmly anchor the principle of the Three Rs, to Replace, Reduce and Refine the use of animals, in EU legislation. Directive 2010/63/EU will take full effect from 1 January 2013.

 

National regulations

For all partners involved in INFRAFRONTIER, all experiments must be authorized under national regulations. Licenses are given for the institutes and for individual areas of research. All partners operate a local ethical review procedure. Critical to ethical review is a cost / benefit analysis; the welfare cost to the animals must be balanced by the benefit of knowledge gained into gene function and the role of genes in human health and disease. These consider factors such as:

  • The design of the procedures and their relevance to human and / or animal health and their advancement of knowledge
  • The appropriate use of species, number and quantity of animals
  • Adherence to the principles of the 3Rs: reduction, refinement and replacement
  • Avoidance or minimisation of discomfort, distress and pain
  • Use of appropriate analgesia or anaesthetics
  • Appropriate animal husbandry

 

INFRAFRONTIER partners and their national regulations relating to the welfare of animals used in research

Austria - Veterinary University Vienna

Research will be undertaken in Austria. At the University of Veterinary Medicine Vienna, all animal experiments are subjected to a two-step evaluation procedure by two separate committees acting independently of each other. The first approving authority is the University of Veterinary Medicine Vienna's Ethics and Animal Welfare Committee. The second is the Ministry of Research and Science's Advisory Committee for Animal Experiments.

All animal experiments are continuously monitored by both committees by requesting annual status- and progress reports. Furthermore, unannounced regulatory controls are carried out by members of the committees.

Belgium - K.U.Leuven

Housing and caretaking of the mice at the K.U.Leuven partner is in accordance with the Belgian and European laws, guidelines and policies for animal experimentation, housing and care (as documented in the most recent legislation, i.e. the Belgian Royal Decree of 6 April 2010 and European Directive 2010/63/EU on the protection of animals used for scientific purposes of 20 October 2010). The laboratories at K.U.Leuven and their involved staff that work with laboratory animals such as knockout mice, and the Central Animal Facility that houses these animals, have the obligatory accreditation of the authorized Belgian Ministry and report on an annual basis the use of animals in their labs to the Ministry. The animals used are purpose-bred.
Czech Republic - Institute of Molecular Genetics (IMG)

Research institutes that use animals in Czech Republic comply with the Czech and European laws and regulations relating to the transport, housing and use of animals in research. The breeding and use of animals is regulated by Czech law No. 246/1992 Sb. on protection of animals against maltreatment issued by Ministry of Agriculture on 14. April 2004. The use of laboratory animals is further specified by the ministerial decree 207 on protection, breeding, and utilization of experimental animals, which was novelized on January 15, 2009 by the decree No. 39. This regulation ensures that persons working with animals are qualified, educated and knowledgeable, that the number of animals used for experiments is minimised and that any suffering of animals have been weighed against the potential benefits to humans or animals. In general, animal experiments can only be performed by accredited individuals or corporations and the allowance to carry out the experimental work is granted by a project licence and personal licences issued by governmental organizations, i.e. by Academy of Sciences and Ministry of Agriculture, respectively. The work with animals must be carried out at designated facilities, which meet criterions defined by the Czech law. The animal facilities at IMG and BIOCEV will also work according to recommendations of FELASA (Federation of European Laboratory Animal Science Associations) guidelines that are established in UMG. Animal breeding, housing, welfare, health and experimentation are under periodic monitoring from local and governmental institution. All work using animals is reviewed by local ethical committee.
Denmark - University of Copenhagen

The project will be carried out following the Danish law about animal experiments (lovbekendtgørelse nr 726, September 9th, 1993) and the law about cloning and genetical modification of animals (lovbekendtgørelse nr. 550, 24. June, 2005). Ethical permits for the experiments will be obtained from the Council for Animal Research (Rådet for Dyreforsøg), which is part of the Ministry of Justice. All experiments will be performed under constant monitoring from an independent governmental institution.

In addition, the care and well-being of all animals will be ensured by carrying out all research in compliance with all EU legislation and directives (233/88, March 14th; BOE No. 67, Ratification of the European Treaty. 18.03. 1986; BOE No. 256, 25.10. 1990).

Finland - University of Oulu

Part of project will be carried out in Finland, at UOULU. The experimental licence for the project has been applied from and accepted by the National Animal Experiment Board in Finland; the licence number ESAVI-2010-08486/Ym-23. The animals under the project are listed in the register of gene manipulated mice in the Laboratory Animal Centre at the University of Oulu, according to the Law 377/1995 for gene modified organisms.

The use of animals in research and scientific procedures in Finland is regulated by the Law 62/2006 and the Decree 36/EEO/2006, given by the Ministry of Agriculture and Forestry, both enforced 1st of August 2006. This law follows and expands the European Union Directive 86/609/ETY, to be updated in the 1st of January 2012 according to the revised Directive 2010/63/EU. Furthermore, the animal experimentation follows the European Convention for the protection of vertebrate animals used for experimental and other scientific purposes (ETS No. 123) with its appendix A. All animal experiments are and will be carried out in full accordance with the Law and the Decree, which state that the work with animals is carried out only under specific authorizations that include licenses for the personnel, housing of the animals, and also individual experiments. Constant monitoring of animal welfare, experimentation and housing is carried out by an independent governmental institution. In addition, Law 377/1995 and the Decrees 928/2004 and 184/2005 regulate the use and storage of gene modified organisms. According to these regulations, gene modified animals are housed in specific units, their use is registered and reported to the authorities, and inspections are performed on a regular basis.

In this project, live animals will be sent from European and other countries to Finland and in some cases live animals will be transported from Finland to the second countries. In such cases, the international transport regulations and the Finnish regulations for GM animals will be followed.

France - ICS, CNRS and INSERM

CERBM-GIE (ICS)

Animal housing, welfare and experimentation: Replacement, Refinement and Reduction of Animals in research

The CERBM-GIE also complies with the following French national and European laws and regulations relating to the transport, housing and use of animals in research:

i. French law N° 76-629 of July 10th 1976 concerning the protection of wildlife and natural reserves. A corresponding text of application of November 23rd 1988 (published in the Official Journal of the French Republic December 16th 1988) concerns the inspection of animal facilities.

ii. European directive 86/609/CEE of November 26th 1986, unifying CEE regulations concerning the protection of animals used for scientific purposes, incorporated into French law by the decrees N° 87-848 of October 19th 1987 and N° 2001-464 published on May 29th 2001.

This Directive has been revised under 2010/63/EU and was adopted by the European Commission on 22 September 2010. Ratification and adoption by the French authorities is anticipated.

Three texts of application of the above French law dated April 19th 1988 were published in the Official Journal of the French Republic April 27th 1988:

• The supply of animals to authorized animal facilities for experimental of scientific research.

• The rules for the authorization of individuals for the undertaking of experiments using animals.

• The licensing, construction and functioning of animal facilities for experimental scientific research.

iii. French law N° 2001-486 of June 6th 2001 being the official French publication of the European Convention concerning the protection of vertebrates used in experiments or for other scientific purposes (convention adopted in Strasbourg March 18th 1986 and signed by France on September 2nd 1987).

The ICS/IGBMC animal facility is approved by the French Ministry of Agriculture and Fisheries' veterinary services (D67-218-5 - notification of 13/10/2008). If the project contains experiments involving animals these will be conducted under the general supervision of a staff member holding an animal experimentation authorization from the Ministry of Agriculture and Fisheries: having followed the obligatory national training programs for animal handling, including procedures of euthanasia.

Beyond Europe, the CERBM holds a recently renewed certification from the Office of Laboratory Animal Welfare granted 31 August 2011 (N° A5403-01). This assurance is submitted in compliance with the American Public Health Service (PHS), Policy on Humane Care and Use of Laboratory Animals and is an obligatory requirement for participation and financing in National Institutes of Health projects.


CNRS – TAAM, and INSERM (CIPHE)

In France, to experiment on animals, we have to dispose of several documents:

- Agreement of the structure to practice animal experimentation (renewable each 5 years).

The SEAT, located in Villejuif, dispose of the agreement n°94-076-32 in date of 11/26/09 and the CDTA+CIPA, located in Orleans, dispose of the agreement n° C45-234-6 in date of 09/18/08.

-Agreement of each experimentator to practice experimentation on animals (2 levels importants: Level 1 (renewable each 5 years): for experiment responsible; Level2: for experiment technicians); In TAAM, all experimentators dispose of Level 1 or Level 2 dependant of his position.

All experiments taken place in the TAAM must be submitted beforehand to an ethical committee. A local ethical committee (Comité Local du Campus CNRS d'Orleans CLCCO) was created in March 2009 by the sign of a convention of creation between the TAAM Orleans and another structure practicing animal experimentation on the CNRS Campus (CBM-CNRS). By this sign, the 2 structure declare to adhere to "the national chart about ethic in animal experimentation". This local committee is recognized and registered by the "Comité National de Reflexion sur l'Ethique en Expérimentation animale" (CNREEA). The projects must be evaluated each year.

The ethical committee, during the evaluation of the experimentation project, give a particular attention to the respect of 3R rule: replace animals each time it is possible, reduce the number of animal used, respect of the European Directive (EU 86/609-STE123) according to the animal housing, animal transport, animal sacrifice and reduction of pain.

Germany - Helmholtz Zentrum München and Helmholtz Zentrum für Infektionsforschung

The German "Tierschutzgesetz" TierSchG from 25.05.1998 (BGBI IS.1105) complies with the German laws and regulation regarding ethical considerations, transport, housing and experimental use of (transgenic) animals in research as well as on the biotechnological procedures on animals. All animal experiments will be carried out in full accordance with the laws governing the use of animals for research in Germany. In addition the care and well-being of all animals will be ensured by carrying out all such research in compliance with all EU and member state legislation and directives (233/88, March 14th; BOE N°. 67. Ratification of the European Treaty, 18.03.1986; BOE N°. 256, 25.10.1990). All work is carried out under specific authorisations for personnel, individual projects establishment and animal facility licences. Every person handling animals holds a special permission / licence from the independent local governmental administration. Animal housing, welfare and experimentation are under constant monitoring from an independent governmental institution.

All local or national requirements for ethical committee approval were or will be obtained. For experimentation on existing mouse lines including ethical considerations, the approvals of the government of higher Bavaria (Munich) or respectively of lower Saxonia were obtained for the HMGU and the HZI. The relevant contract numbers are Munich / GSF 209.1/211-2531-112/02, for Braunschweig / HZI 509.42502/07-06.02, 509.42502/07-07-03, and 509.42502/07-05.02. This permission includes phenotyping of mice as described in the proposal. All animal experiments are described in research plans and must obtain a positive advice and permission from the independent institutional and local-governmental ethical Committee to perform these experiments.

Greece - Biomedical Sciences Research Centre Alexander Fleming

The project shall conform to all current national and European legislation*. The PI shall implement the research project in full respect of the legal and ethical national requirements and code of practice.

Relevant legislation:

• The Presidential Decree No 160/1991 (Governmental Gazette No A' 64) applicable in Greece, which is the implementation of the EEC Directive 86/609/EEC. It sets out all the guidelines referring to the protection of animals used for experimental and other scientific purposes. It also lays out the requirements for the issue of project licences by the local veterinary authorities, including the insuring of the use of alternatives to animals wherever possible as well as the use of the minimum number of animals under optimum conditions. In addition, it ensures that all approved projects can only be carried out at designated establishments which meet high standards and are authorised by the local veterinary authorities. Special provisions about the environmental conditions and cage dimensions are also included.

• Law No 2015/1992 (Governmental Gazette No A' 30) applicable in Greece, which is the implementation of the European Convention concerning the protection of vertebrates used in experimental or other scientific purposes.

• Presidential Decree No 184/1996 (Governmental Gazette No A' 137) applicable in Greece, which is the implementation of the EC Directive 92/65 concerning the conditions of Market of various animal species within the European Union. The part applicable to experimental units is the Annex III of the Decree referring to the hygiene conditions and the necessary health controls by the local authorities in order to issue and preserve the licence of them.

• The Revised Ministerial Decision No 96287/1893/13-12-1995 regulating the release into the environment of genetically modified organisms, which is the implementation of the EEC Directive 90/219/EEC/23.04.1990, as amended by the EC Directive 94/51/EEC/07.11.1994.

• Recommendations 2007/526 EEC

Israel - Tel Aviv University

TAU has established an Institutional Animal Care and Use Committee (IACUC), which follows the international regulations and guidelines for use of experimental animals by researchers. TAU follows the European regulations for use animals and IACUC members are trained on these regulations.
Italy - CNR-Monterotondo

The Italian animal welfare and veterinary health rules and regulations (law n. 116/1992 and derived laws and decrees, in application of EU guideline 86/609/EEC) concerning the care and utilization of laboratory animals, require the following:

1) License for breeding, importation and exportation of laboratory animals.

- Application submitted to local Veterinarian Authority (Monterotondo) and local Custom Authority

(Roma Fiumicino).

Veterinarian license issued on 03/11/1997, ref. n. 32962

Custom license issued on 25/09/1998, ref. n. 269/RM

2) Facility license for experimental utilization and care of vertebrate animals in research and training (mandatory for all experimental manipulations requiring anaesthesia).

- Application submitted to Veterinary Health Dept. of the Italian Ministry of Health (Roma).

It preliminary requires the issued license for breeding and transportation (1).

Facility license issued on 02/02/1998, ref. n. 2/98

3) License for application and execution of specific experimental protocol, issued on 25/01/2010, ref. n. 13/2010-B

- CNR has applied for and obtained the ethical and sanitary approval of the planned experimental activities with laboratory mice, including those to be carried out as part of the INFRAFRONTIER- project.

Official approval issued by the Veterinary Health Dept. of the Italian Ministry of Health; ref. n.

13/2010-B, 25/01/2010 (3-years validity)

4) Registration of experimental and clinical use of veterinarian drugs

- Registration submitted to and approved by local Veterinarian Authority (Monterotondo).

5) Periodic duties:

Annual report to the Veterinary Health Dept. of the Italian Ministry of Health of official records of animal breeding, importation, disposal and experimental use

Annual review report to Veterinary Health Dept. of the Italian Ministry of Health of applied experimental protocols, to verify compliance to the issued licenses

Application to Veterinary Health Dept. of the Italian Ministry of Health for licensing of new experimental projects; extensions, variations of existing licenses, as needed etc

Other official veterinary duties (e.g. application for licensing of new drug treatment protocols)

Netherlands - Netherlands Cancer Institute

The Netherlands has an advanced and sophisticated policy on animal experiments. The animal experiments are subject to strict legal controls:

These are described in the law and regulations below:

• Directive 86/609/EEC on the protection of animals used for experimental and other scientific purposes.

• Dutch Act on animal health and welfare 1992 – Decree Biotechnology

• Dutch Act on Laboratory Animal Experiments

The acts and regulations include that:

• Institutes must hold licenses to perform animal experiments and to breed laboratory animals.

• The institutes are required to employ an animal experiment expert (animal welfare officer) to oversee the welfare of the animals.

• People involved in organizing and performing animal experiment must meet requirements concerning their expertise.

• Animal experiments must be submitted for pre-examination to an independent official Animal Experiment Committee and need a positive advice before conducting the experiment.

• Licences are required by law to keep records of all animals and animal experiment and must submit annually the details of those experiments to the Inspectorate

• All animals must be treated with respect and the highest consideration should be given for their health and welfare consistent with meeting our scientific objectives.

• All research involving animals shall be designed and undertaken so as to minimize and preferably avoid, pain, suffering and distress.

• All studies should use the minimum numbers of the most appropriate species and strain of animal to achieve the scientific objectives.

The NKI is in compliance with these regulations.

At present the Netherlands is working on a new animal protection law to fulfil the requirements of the new EU directive (2010/63/EU).

Portugal - Gulbenkian Institute

The Animal Facility of the Fundação Calouste Gulbenkian/ Instituto Gulbenkian de Ciência (FGC/ IGC) is licensed by the Portuguese official veterinary department (Direcção Geral de Veterinária) in what concerns laboratory animal breeding, housing, transportation, and scientific use (Nº of identification and registration: PT 05 052 OICB)

This Facility complies with the Portuguese law (Portaria 1005/02 and Portaria 1131/97), which transcribes the European Guideline 86/609/EC, and with the Council Regulation (EC) No. 2005/01 EC regarding animal transit. It also follows the FELASA (Federation of European Laboratory Animal Science Associations) guidelines and recommendations concerning animal welfare in the care and use of laboratory animals, and in the design and conduct of research projects in which animals are used, including the proper education and training of the persons involved in all animal work. Animal housing, welfare and experimentation are under constant monitoring from the IGC veterinary service.

Research projects conducted -or to be conducted- at the IGC have been approved by - or will be submitted to- the local IGC ethical committee and in addition to the Portuguese official veterinary department. Every person handling experimental animals holds a license accorded by the independent local governmental administration, the Portuguese official veterinary department (Direcção Geral de Veterinária).

Spain - Universitat Autonoma de Barcelona and Centro Nacional de Biotecnologia (CNB-CSIC)

Universitat Autonoma de Barcelona, Catalonia

The facility, personnel involved and experiments with animals at UAB should comply with the legislation on experimentation with animals and working with genetically modified organisms at the European Level (Directive 86/609/CEE, 98/81/CEE, 2003/65/CE) and at National Level (Spanish Law 9/2003, April 25th; Real Decreto 178/2004, January 30th; and Real Decreto 1201/2005, October 10th).

Regulations that cover animal housing, welfare and experimentation in Catalonia (Spain) specifically are contained in Decret 214/1997 of 30th of July and Llei 5/1995 of 21st of June, both from the Generalitat de Catalunya. They apply the European Directive 86/609/CEE to the Spanish law in Catalonia.

At the institutional level, work will be done under the supervision of the Ethics Commission on Animal and Human Experimentation of the Autonomous University of Barcelona (Comissió d'Ètica en l'Experimentació Animal i Humana de la Universitat Autònoma de Barcelona).

Use of transgenic animals in the study has been approved by the Biosafety Committee of the Universitat Autònoma de Barcelona.


Centro Nacional de Biotecnologia (CNB-CSIC)

The animal house and animal facilities at the CNB-CSIC have been registered at the Ministry of Agriculture, Fisheries and Food, regarding the use of animals in experimentation, with nº 28079-29-A; and at the Ministry for the Environment, through the National Commission on Biosafety, regarding the experiments with genetically modified mice (both transgenic and knockout) under risk type II, with nº A/ES/03/I-5. The facility, personnel involved and experiments with animals at CNB-CSIC comply with the legislation on experimentation with animals and work with genetically modified organisms at the European Level (Directive 86/609/CEE, 98/81/CEE, 2003/65/CE) and at National Level (Spanish Law 9/2003, April 25th, Real Decreto 178/2004, January 30th; and Real Decreto 1201/2005; October 10th). In particular, all procedures involving animal experimentation are supervised by a person with the C-level certificate and carried out by people with at least B-level certificate, according to FELASA categories.

The CNB-CSIC has an internal Ethical Committee on Animal Experimentation, bound to the institutional Commission on Bioethics at CSIC, under the supervision and approval of which all procedures involving animal experimentation are being authorised. All animal experiments are being addressed with the maximum respect and ethical consideration to the animals, minimising the pain and using standardised and approved procedures for surgery, biopsia, analgesia and euthanasia, according to the Law and as recommended by FELASA, under the strict supervision of the veterinarian doctor, person in charge of the welfare of the animals and head of the animal house Angel Naranjo Pino, VMD. The CNB-CSIC animal facility has undergone all the relevant inspections and provides all relevant data on animal experimentation to the Spanish authorities, as stipulated by Spanish and European laws.

Sweden - Karolinska Institute

The Swedish Board of Agriculture (Jordbruksverket) regulates the protection for animals in research. On 27 May 1988, the Swedish Parliament adopted regulations on the use of animals for research purposes (prop. 1987/88:93, JoU 22, rskr 327). After a parliamentary decision, the animal protection law was adopted (1988:534 – revised 2009 / SFS 2009:1256), the animal protection ordinance (djurskyddsförordningen 1988:539 – revised 2011 / SFS 2011:510) and ordinance for The Swedish National Board for Laboratory Animals (1988:541 – revised 2003 / SFA 2003:1125).

At present Sweden is working on a new animal protection law to fulfill the requirements of the new EU directive (2010/63/EU)

Genetically modified organisms: Regulations and recommendations are provided by the Arbetsmiljöverket (Swedish Work Environment Agency) recommendations (AFS 2000:5 – revised 2006 / AFS 2006:2). A guide for risk assessment has been modified as to March 2000 considering the EU Directive 90/219 adopted on June 2000. It also takes into consideration the new requirements of the Genetically Modified Organisms (Contained Use) Regulations 2000 (which consider the amendments of the EU directive).

KI follows a strict policy for animal research, which fulfills the following criteria:

- All animals must be treated with respect and the highest consideration should be given for their health and welfare consistent with meeting our scientific objectives.

- All research involving animals shall be designed and undertaken so as to minimize and preferably avoid, pain, suffering and distress.

- All studies should use the minimum numbers of the most appropriate species and strain of animal to achieve the scientific objectives.

- All employees must be adequately trained and competent in the procedures they are to perform (revision of education is ongoing)

- All work involving animals will be undertaken strictly in accordance with:

The Animal Protection Act (SFS 2009:1256)

The Statutory Order on Animal Protection (2011:510)

The authorization for animal experimentation by local authorities

United Kingdom - MRC and Sanger Institute


United Kingdom, MRC

The use of animals in scientific procedures in the United Kingdom is regulated by the Animals (Scientific Procedures) Act 1986. It puts into effect, and in some ways exceeds, European Union Directive 86/609/EEC (regarding the protection of animals used for experimental and other scientific purposes) and offers a high level of protection to animals whilst recognising the need to use animals in medical research, the development of new medicines and scientific testing. It also has sufficient flexibility to allow the latest ideas and technology to be taken into account when deciding whether the use of animals is justified. Under the 1986 Act, both personal and project licences are required. These ensure that those doing the work are qualified and suitable; that alternatives to animals are used wherever possible; that the number of animals used is minimised; and that any suffering or other harmful effects experienced by the animals have been weighed against the potential benefits (to humans or animals). Special conditions control and minimise any pain or suffering. In addition, work can only be carried out at designated establishments which meet high standards and which have suitable veterinary and animal welfare personnel. Work to be carried out under this proposal will be covered by a project licence and personal licences. For genetically modified organisms work will follow the guidelines for "contained use" as detailed in the European Directive 98/81/EEC on the contained use of genetically modified micro-organisms. In addition the UK is currently consulting on implementation of the new EC directive 2010/63/EU "Protection of animals used for scientific purposes" and members of MRC-Harwell are part of these consultations.


United Kingdom, Sanger Institute

The use of animals in scientific procedures in the United Kingdom is regulated by the Animals (Scientific Procedures) Act 1986. It puts into effect, and in some ways exceeds European Union Directive 2010/63/EU (regarding the protection of animals used for experimental and other scientific purposes) and offers a high level of protection to animals whilst recognising the need to use animals in medical research, the development of new medicines and scientific testing. It also has sufficient flexibility to allow the latest ideas and technology to be taken into account when deciding whether the use of animals is justified. Under the 1986 Act, both personal and project licences are required. These ensure that those doing the work are qualified and suitable; that alternatives to animals are used wherever possible; that the number of animals used is minimised; and that any suffering or other harmful effects experienced by the animals have been weighed against the potential benefits (to humans or animals). Special conditions control and minimise any pain or suffering. In addition, work can only be carried out at designated establishments which meet high standards and which have suitable veterinary and animal welfare personnel. Work to be carried out under this project will be covered by a project licence and personal licences. For genetically modified organisms work will follow the guidelines for "contained use" as detailed in the European directive 98/81/EC. e) Use of animals and generation of transgenic animals. All work using animals is reviewed by local ethical review panels. The Animals (Scientific Procedures) Act 1986 will be superseded by the transposition of the new European directive by January 1st 2013.

Canada - Toronto Centre for Phenogenomics (TCP)

Regulatory organizations and ethical committee requirements:

1. Canadian Council on Animal Care (CCAC) - The CCAC is the national peer review agency responsible for setting and maintaining standards for the ethical use and care of animals used in science (research, teaching and testing) throughout Canada. The CCAC ensures that the use of animals, where necessary, for research, teaching and testing employs optimal care according to acceptable scientific standards and promote an increased level of knowledge, awareness and sensitivity to relevant ethical principles. The CCAC delivers its mandate through four complementary and mutually supportive programs: the Assessment and Certification Program (that involves inspection of facilities every 3 years), the Guidelines Program, the Three Rs Program, and the Education, Training, and Communications Program. It is a requirement that the TCP maintains its certification and Certificate of Compliance from the CCAC in order to continue its operation.

2. Ontario Ministry of Agriculture, Food, and Rural Affairs (OMAFRA) – Under the provisions of the Animals for Research Act (R.S.O 1990, Chapter A.22), all facilities performing research using animals in the Province of Ontario must be licensed annually and are subject to unannounced visits by veterinary inspectors at any time. It is a requirement that the TCP maintains its annual license from the Ministry in order to continue its operation.

3. TCP Animal Care Committee (ACC) – The ACC reviews, advises, approves, or rejects Animal Use Protocols (AUP) that support animal work at the TCP. All work with animals at the TCP requires an approved AUP. Furthermore, both the CCAC and OMAFRA require that the TCP's ACC operates in accordance with their required Terms of Reference for institutional Animal Care Committees. It is a requirement that any Infrafrontier-I3 Project animal work performed at the TCP will be done on an AUP approved by the TCP ACC.