Detailed guide: Research and testing using animals

Detailed guide: Research and testing using animals


Details of the law on scientific research and testing involving animals, and guidance on applying for licences.


<p><em>Updated:</em> Added 2016 scientific procedures on living animals report.</p><div class="govspeak"><h2 id="overview">Overview</h2>

<p>The government is committed to the replacement, reduction, and refinement of the use of animals in research - the ‘<abbr title="the replacement, reduction, and refinement of the use of animals in research">3Rs</abbr>’.</p>

<p>The use of animals in scientific research remains a vital tool in improving our understanding of how biological systems work both in health and disease, and in the development of new medicines, treatments and technologies. Underpinning this research is a strong commitment to maintaining a rigorous regulatory system which ensures that animal research is carried out only where no practicable alternative exists and under controls which keep suffering to a minimum. This is achieved through robustly applying the principles of the <abbr title="the replacement, reduction, and refinement of the use of animals in research">3Rs</abbr> to all research proposals involving the use of animals.</p>

<p>Implementing the <abbr title="the replacement, reduction, and refinement of the use of animals in research">3Rs</abbr> requires that, in every research proposal, animals are replaced with non-animal alternatives wherever possible; that the number of animals is reduced to the minimum needed to achieve the results sought; and that, for those animals which must be used, procedures are refined as much as possible to minimise their suffering. The government is committed to ensuring that any licence we grant under the Animals (Scientific Procedures) Act 1986 must rigorously and demonstrably apply the <abbr title="the replacement, reduction, and refinement of the use of animals in research">3Rs</abbr> principles.</p>

<p>In 2010, the coalition government made a commitment to work to reduce the use of animals in scientific research and a <a href="https://www.gov.uk/government/publications/working-to-reduce-the-use-of-animals-in-research-delivery-plan">delivery plan</a> has been published. The plan shows how alternative methods can deliver fast, high-quality research that also boosts economic growth. We have now published a <a href="https://www.gov.uk/government/publications/working-to-reduce-the-use-of-animals-in-research-delivery-report">delivery report</a> which describes the progress made on actions set out in the delivery plan.</p>

<h2 id="animals-scientific-procedures-act-1986">Animals (Scientific Procedures) Act 1986</h2>

<p>The use of animals in experiments and testing is regulated under the <a href="https://www.gov.uk/government/publications/consolidated-version-of-aspa-1986">Animals (Scientific Procedures) Act 1986</a> (<abbr title="Animals (Scientific) Procedures Act 1986">ASPA</abbr>). <abbr title="Animals (Scientific) Procedures Act 1986">ASPA</abbr> has recently been revised to transpose European Directive 2010/63/EU on the protection of animals used for scientific purposes. The revised legislation came into force on 1 January 2013.</p>

<p>We have prepared this document for our own internal purposes and are making it available for information. Please do not take the document to be a definitive statement of the law.</p>

<p><abbr title="Animals (Scientific) Procedures Act 1986">ASPA</abbr> is implemented by the Home Office in England, Scotland and Wales and by the Department for Health, Social Security and Public Safety in Northern Ireland.</p>

<p>You can <a rel="external" href="http://ec.europa.eu/environment/chemicals/lab_animals/pubs_guidance_en.htm">read EU guidance, statistics and publications relating to animals used for scientific purposes under the European Directive 2010/63/EU</a>.</p>

<h3 id="guidance-on-the-operation-of-the-animals-scientific-procedures-act-1986">Guidance on the operation of the Animals (Scientific Procedures) Act 1986</h3>

<p><a href="https://www.gov.uk/government/publications/operation-of-aspa">Guidance on the Operation of <abbr title="Animals (Scientific) Procedures Act 1986">ASPA</abbr></a> was published on 13 March 2014.</p>

<p>The guidance is intended to be a reference document that explains how the act is administered and enforced and provides detailed guidance to holders of establishment licences, project licences and personal licences and new licence applicants. In developing the guidance we consulted widely with stakeholders and the Animals in Science Committee. Copies of the <a rel="external" href="http://www.tsoshop.co.uk/bookstore.asp?FO=1159966&action=SearchResults">guidance can be purchased</a> from TSO bookshop using the ISBN 9780108560316.</p>

<p>An <a href="https://www.gov.uk/government/publications/explanatory-memorandum">explanatory memorandum</a> was also laid in Parliament.</p>

<h2 id="applying-for-licences">Applying for licences</h2>

<p>Three licences are required by the <abbr title="Animals (Scientific) Procedures Act 1986">ASPA</abbr> before testing on animals is permitted:</p>

<ul>
<li>personal licence for each person carrying out procedures on animals</li>
<li>project licence for the programme of work</li>
<li>establishment licence for the place at which the work is carried out</li>
</ul>

<p>Our e-licensing system ASPeL should now be used for all personal and project licence applications.</p>

<p>Before applying, please read the standard conditions for <a href="https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/193122/Personal_Licence_-_Standard_Conditions.pdf">personal licences</a>, <a href="https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/193124/Project_Licence_-_Standard_Conditions.pdf">project licences</a> and <a href="https://www.gov.uk/government/publications/establishment-licence-standard-conditions">establishment licences</a>.</p>

<h2 id="personal-licences">Personal licences</h2>

<p>Personal licences are needed for all individuals carrying out procedures on animals.</p>

<h3 id="apply-for-a-personal-licence">Apply for a personal licence</h3>

<p>To apply for a personal licence, please use our e-licensing system ASPeL. Your local Home Office liaison contact can give you access to ASPeL. For more information about ASPeL please read our <span id="attachment_2231036" class="attachment-inline">
<a href="/government/uploads/system/uploads/attachment_data/file/356377/ASPeL_User_Guidance_140903_v1.2.pdf">ASPeL user guidance</a>
(<span class="type"><abbr title="Portable Document Format">PDF</abbr></span>, <span class="file-size">545KB</span>, <span class="page-length">63 pages</span>)
</span>
.</p>

<h4 id="applying-for-a-personal-licence-quick-start-guides">Applying for a personal licence: quick start guides</h4>

<p>The following quick start guides will help you with your application:</p>

<ul>
<li>
<p><span id="attachment_2231052" class="attachment-inline">
<a href="/government/uploads/system/uploads/attachment_data/file/554671/Personal-Licence-QuickStart-Guide-Applicants.pdf">personal licence: quick start guide for applicants</a>
(<span class="type"><abbr title="Portable Document Format">PDF</abbr></span>, <span class="file-size">182KB</span>, <span class="page-length">5 pages</span>)
</span></p>
</li>
<li>
<p><span id="attachment_2231053" class="attachment-inline">
<a href="/government/uploads/system/uploads/attachment_data/file/554725/Personal-Licence-QuickStart-Guide-NTCO.pdf">personal licence: quick start guide for named training and competency officers</a>
(<span class="type"><abbr title="Portable Document Format">PDF</abbr></span>, <span class="file-size">162KB</span>, <span class="page-length">4 pages</span>)
</span></p>
</li>
<li>
<p><span id="attachment_2231054" class="attachment-inline">
<a href="/government/uploads/system/uploads/attachment_data/file/554726/Personal-and-Project-Quick-Start-Guide-HOLCs.pdf">personal and project licences: quick start guide for Home Office liaison contacts</a>
(<span class="type"><abbr title="Portable Document Format">PDF</abbr></span>, <span class="file-size">154KB</span>, <span class="page-length">5 pages</span>)
</span></p>
</li>
</ul>

<h2 id="project-licences">Project licences</h2>

<p>Project licences are for the programme of work you are carrying out.</p>

<h3 id="apply-for-a-project-licence">Apply for a project licence</h3>

<p>To apply for a project licence, please use our e-licensing system ASPeL. Your local Home Office liaison contact can give you access to ASPeL. For more information about ASPeL please read our <span id="attachment_2231036" class="attachment-inline">
<a href="/government/uploads/system/uploads/attachment_data/file/356377/ASPeL_User_Guidance_140903_v1.2.pdf">ASPeL user guidance</a>
(<span class="type"><abbr title="Portable Document Format">PDF</abbr></span>, <span class="file-size">545KB</span>, <span class="page-length">63 pages</span>)
</span>
.</p>

<p>To amend an existing licence that is not on ASPeL, complete the <a href="https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/148533/project-licence-change.doc">application form for changing a project licence</a>.</p>

<p>For projects where work is carried out at more than one licensed establishment (known as ‘additional availabilities’), complete the <span id="attachment_2231062" class="attachment-inline">
<a href="/government/uploads/system/uploads/attachment_data/file/563320/Project-Licence-Additional_Availablilty-Template.odt">additional availabilities form</a>
(<span class="type"><abbr title="OpenDocument Text document">ODT</abbr></span>, <span class="file-size">16.1KB</span>)
</span>
.</p>

<h3 id="project-licences-quick-start-guides">Project licences: quick start guides</h3>

<p>The following quick start guides will help you with your application:</p>

<ul>
<li>
<p><span id="attachment_2231055" class="attachment-inline">
<a href="/government/uploads/system/uploads/attachment_data/file/579962/PPL-Quick-Start-Guide-Applicants.pdf">project licence: quick start guide for applicants</a>
(<span class="type"><abbr title="Portable Document Format">PDF</abbr></span>, <span class="file-size">579KB</span>, <span class="page-length">13 pages</span>)
</span></p>
</li>
<li>
<p><span id="attachment_2231054" class="attachment-inline">
<a href="/government/uploads/system/uploads/attachment_data/file/554726/Personal-and-Project-Quick-Start-Guide-HOLCs.pdf">personal and project licences: quick start guide for Home Office liaison contacts</a>
(<span class="type"><abbr title="Portable Document Format">PDF</abbr></span>, <span class="file-size">154KB</span>, <span class="page-length">5 pages</span>)
</span></p>
</li>
<li>
<p><span id="attachment_2231063" class="attachment-inline">
<a href="/government/uploads/system/uploads/attachment_data/file/559027/Project-Licence-Quick-Start-Guide-Establishment-Licence-Holders.pdf">project licence: quick start guide for establishment licence holders</a>
(<span class="type"><abbr title="Portable Document Format">PDF</abbr></span>, <span class="file-size">222KB</span>, <span class="page-length">5 pages</span>)
</span></p>
</li>
</ul>

<h3 id="project-licences-practical-help">Project licences: practical help</h3>

<p>Applicants are strongly advised to contact their local should contact their Home Office inspector before you begin.</p>

<ul>
<li>
<span id="attachment_2231057" class="attachment-inline">
<a href="/government/uploads/system/uploads/attachment_data/file/579960/Annotated-Project-licence-application-form.pdf">annotated project licence application form</a>
(<span class="type"><abbr title="Portable Document Format">PDF</abbr></span>, <span class="file-size">681KB</span>, <span class="page-length">48 pages</span>)
</span>
for help with the application</li>
<li>
<span id="attachment_2231061" class="attachment-inline">
<a href="/government/uploads/system/uploads/attachment_data/file/558751/Project-Licence-Word-Template.odt">project licence application template</a>
(<span class="type"><abbr title="OpenDocument Text document">ODT</abbr></span>, <span class="file-size">58KB</span>)
</span>
if you want to complete your application in word format before copying it into our online application form</li>
<li>
<p><span id="attachment_2231050" class="attachment-inline">
<a href="/government/uploads/system/uploads/attachment_data/file/528369/DOC2_-_Notes_of_GA_Breeding_protocol.pdf">use of standard breeding protocols</a>
(<span class="type"><abbr title="Portable Document Format">PDF</abbr></span>, <span class="file-size">101KB</span>, <span class="page-length">2 pages</span>)
</span></p>
</li>
<li>
<p><span id="attachment_2231049" class="attachment-inline">
<a href="/government/uploads/system/uploads/attachment_data/file/533651/GAA_standard_breeding_protocols_30_Juneodt.odt">standard breeding protocols for genetically altered mice (and other species with modification)</a>
(<span class="type"><abbr title="OpenDocument Text document">ODT</abbr></span>, <span class="file-size">56.6KB</span>)
</span></p>
</li>
<li>
<p><span id="attachment_2231058" class="attachment-inline">
<a href="/government/uploads/system/uploads/attachment_data/file/554730/Annotated-genetically-altered-breeding-protocols.pdf">annotated genetically altered breeding protocols</a>
(<span class="type"><abbr title="Portable Document Format">PDF</abbr></span>, <span class="file-size">278KB</span>, <span class="page-length">23 pages</span>)
</span></p>
</li>
<li><span id="attachment_2231059" class="attachment-inline">
<a href="/government/uploads/system/uploads/attachment_data/file/554731/checklist-for-project-applications-using-wild-animals.pdf">checklist for project applications using wild animals</a>
(<span class="type"><abbr title="Portable Document Format">PDF</abbr></span>, <span class="file-size">101KB</span>, <span class="page-length">6 pages</span>)
</span></li>
</ul>

<h2 id="establishment-licences">Establishment licences</h2>

<p>The following forms should be submitted in hardcopy to the address below:</p>

<ul>
<li><a href="https://www.gov.uk/government/publications/establishment-licence-application-form">application form for getting a new licence</a></li>
<li><a href="https://www.gov.uk/government/publications/application-for-a-change-to-an-establishment-licence">application form for changing an existing licence</a></li>
<li>
<a href="https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/148525/conflict-of-interest.doc">declaration of interest form</a> to be completed by all individuals responsible for animal welfare</li>
</ul>

<p>Return completed applications to the following address:</p>

<div class="address"><div class="adr org fn"><p>

Home Office
<br>Animals in Science Regulation Unit
<br>1st floor Peel Building, North East Quarter
<br>2 Marsham Street
<br>London
<br>SW1P 4DF
<br>
</p></div></div>

<h3 id="contact-us">Contact us</h3>

<p>If you have any questions about applying for a licence please get in touch with your single point of contact.</p>

<p>If you are from an establishment that is not yet licensed, please contact us on aspa.london@homeoffice.gsi.gov.uk or 020 7035 5650.</p>

<h2 id="dealing-with-disagreements">Dealing with disagreements</h2>

<h3 id="referral-processes">Referral processes</h3>

<p>We aim to deal with disputes or disagreements fairly and openly. The process for requesting a second opinion on decisions, which can be started by an Animals in Science Regulation Unit (<abbr title="Animals in Science Regulation Unit">ASRU</abbr>) inspector or an individual, is described in our <a href="https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/256857/Dealing_with_disagreements.pdf">;‘route map’ document</a>.</p>

<p>When this approach is unsuitable or has not worked, it may be necessary to use the formal appeals process as described in section 12 of <abbr title="Animals (Scientific) Procedures Act 1986">ASPA</abbr>. It is intended to be used when the Secretary of State proposes to refuse, vary or revoke an authorisation.  </p>

<h2 id="annual-returns">Annual returns</h2>

<p>Always check this page to ensure that you are using the most up-to-date returns and guidance notes. We welcome feedback on these documents.</p>

<h4 id="return">2017 return</h4>
<p>The <span id="attachment_2231066" class="attachment-inline">
<a href="/government/uploads/system/uploads/attachment_data/file/589997/FOR_2017_ONLY_-_annual_return_of_procedures_FINAL.xlsm">return of procedures - animal use data 2017 </a>
(<span class="type"><abbr title="MS Excel Macro-Enabled Workbook">XLSM</abbr></span>, <span class="file-size">472KB</span>)
</span>
form should only be used for procedures completed during 2017.</p>

<p>Refer to the guidance documents below when you complete your form. After clicking on the link for the form, click ‘save’, choose an appropriate folder, and click ‘save’ again. This will ensure that macros are automatically enabled when opening the form, which will ensure that the form functions properly.</p>

<p>Guidance:</p>

<ul>
<li>
<p><span id="attachment_2231065" class="attachment-inline">
<a href="/government/uploads/system/uploads/attachment_data/file/589847/Instructions_for_annual_return_of_procedures_2017_FINAL.pdf">Instructions for completing 2017 annual return of procedures</a>
(<span class="type"><abbr title="Portable Document Format">PDF</abbr></span>, <span class="file-size">319KB</span>, <span class="page-length">27 pages</span>)
</span></p>
</li>
<li>
<span id="attachment_2231031" class="attachment-inline">
<a href="/government/uploads/system/uploads/attachment_data/file/276014/NotesActualSeverityReporting.pdf">Advisory notes on actual severity reporting of regulated procedures</a>
(<span class="type"><abbr title="Portable Document Format">PDF</abbr></span>, <span class="file-size">165KB</span>, <span class="page-length">19 pages</span>)
</span>
sets out the general principles to enable project licence holders, and those appointed by them, to accurately and consistently assign severity assessments on completion of regulated procedures</li>
<li>
<span id="attachment_2231032" class="attachment-inline">
<a href="/government/uploads/system/uploads/attachment_data/file/276015/AdviceSeverityAssessmentGA.pdf">Advice on severity assessment of genetically altered animals</a>
(<span class="type"><abbr title="Portable Document Format">PDF</abbr></span>, <span class="file-size">87.6KB</span>, <span class="page-length">10 pages</span>)
</span>
advises on the specific issues relevant to the assessment of severity of animals on ‘breeding and maintenance’ protocols.</li>
</ul>

<h2 id="additional-data-collection-for-2017">Additional data collection for 2017</h2>

<p>Once every 5 years, and in accordance with PEL Standard Condition 8, PEL Holders are required to provide information relating to:</p>

<ul>
<li>
<p>the number of animals that were bred for scientific procedures and were killed during the target year but not used in procedures and not included in the annual return of procedures</p>
</li>
<li>
<p>Tissue sampling and its refinements for genotyping of animals.</p>
</li>
</ul>

<p>These <span id="attachment_2231072" class="attachment-inline">
<a href="/government/uploads/system/uploads/attachment_data/file/623481/2017_5-yr_animal_use_tables_v2__2_.ods">draft summary tables</a>
(<span class="type"><abbr title="OpenDocument Spreadsheet">ODS</abbr></span>, <span class="file-size">8.33KB</span>)
</span>
show what data each establishment will need to provide by 31 January 2018. Later in the year we will provide the final version of the tables that should be used to return your data. Please read the <span id="attachment_2231071" class="attachment-inline">
<a href="/government/uploads/system/uploads/attachment_data/file/623477/Additional_2017_data_collection_explanatory_notes_v2.pdf">additional explanatory notes </a>
(<span class="type"><abbr title="Portable Document Format">PDF</abbr></span>, <span class="file-size">502KB</span>, <span class="page-length">5 pages</span>)
</span>
carefully.</p>

<p>If you have any queries about this data collection please email <a href="mailto:ASRUBusiness@homeoffice.gsi.gov.uk">ASRUBusiness@homeoffice.gsi.gov.uk</a></p>

<h2 id="publications">Publications</h2>

<h3 id="code-of-practice-for-the-care-and-accommodation-of-animals">Code of practice for the care and accommodation of animals</h3>

<p>The code of practice sets out the standards of care and accommodation of animals required by <abbr title="Animals (Scientific) Procedures Act 1986">ASPA</abbr>, and provides advice about the way in which those responsible under <abbr title="Animals (Scientific) Procedures Act 1986">ASPA</abbr> may comply with those requirements.</p>

<p>The intention of the code is to ensure that the design, construction and function of the installations and equipment of licensed establishments – along with their staffing, care and practices – provides for scientific procedures to be carried out as effectively as possible.</p>

<p>The code is in 3 sections covering both general and species specific indications:</p>

<ul>
<li>section 1 describes the legal minimum standards applicable until 31 December 2016</li>
<li>section 2 describes the legal minimum standards applicable from 1 January 2017</li>
<li>section 3 provides non-mandatory advice to assist licensees to comply with the standards and covers a broader range of subjects than sections 1 and 2 alone</li>
</ul>

<p>The <a href="https://www.gov.uk/government/publications/code-of-practice-for-the-housing-and-care-of-animals-bred-supplied-or-used-for-scientific-purposes">full version and the short guide to the code</a> are available to download. Personal copies of the code of practice can be purchased from TSO bookshop <a rel="external" href="http://www.tsoshop.co.uk/bookstore.asp?FO=1159966&action=SearchResults">TSO bookshop</a> using the ISBN 9780108561290.</p>

<p>The code of practice is also available to download split by species:</p>

<ul>
<li><a href="https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/389807/44389_unact_animals_Rodents_and_Rabbits.pdf">rodents and rabbits</a></li>
<li><a href="https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/389810/44389_unact_animals_Dogs_Cats_and_Ferrets.pdf">dogs, cats and ferrets</a></li>
<li><a href="https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/389821/44389_unact_animals_Non-human_primates_Farm_animals_and_Birds.pdf">non-human primates, farm animals and birds</a></li>
<li><a href="https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/389817/44389_unact_animals_Fish_Amphibians_Reptiles_and_Cephalopod.pdf">fish, amphibians, reptiles and cephalopods</a></li>
</ul>

<p>You can read the <span id="attachment_2231037" class="attachment-inline">
<a href="/government/uploads/system/uploads/attachment_data/file/388896/CoPanimalsExplanatoryMemorandum.pdf">Explanatory memorandum: code of practice for the care and accommodation of animals</a>
(<span class="type"><abbr title="Portable Document Format">PDF</abbr></span>, <span class="file-size">75.6KB</span>, <span class="page-length">3 pages</span>)
</span>
or <span id="attachment_2231038" class="attachment-inline">
<a href="/government/uploads/system/uploads/attachment_data/file/388897/CoPanimalsExplanatoryMemorandumPrint.pdf">(print-ready version)</a>
(<span class="type"><abbr title="Portable Document Format">PDF</abbr></span>, <span class="file-size">68.6KB</span>, <span class="page-length">4 pages</span>)
</span>
.</p>

<h3 id="transparency-going-forward">Transparency going forward</h3>

<p>In the 2013 annual report of the Animals in Science Regulation Unit, we set out details of plans to start publishing anonymised reports of substantial investigations.</p>

<p>The publication of such investigations may be triggered by a number of factors including, but not limited to:</p>

<ul>
<li>an exposé making allegations in the public domain</li>
<li>a cluster of non-compliances or ‘near misses’ triaged by an inspector to <abbr title="Animals in Science Regulation Unit">ASRU</abbr> management</li>
<li>a non-compliance apparently involving significant animal harm</li>
<li>a published paper that appears to describe unjustified pain, suffering or distress</li>
<li>concern raised by inspectors or others that a particular procedure may not optimally implement the <abbr title="the replacement, reduction, and refinement of the use of animals in research">3Rs</abbr>
</li>
</ul>

<p>We believe the early publication of these investigations is in the interests of transparency and openness. We believe that this will also help ensure that all stakeholders can learn from the outcomes of these investigations as early as possible and enable them to address any potential weaknesses in their own management systems, creating a cycle of continuous improvement. These reports will also provide the public with an insight into this important aspect of <abbr title="Animals in Science Regulation Unit">ASRU</abbr>’s work.</p>

<p>You can read <a href="https://www.gov.uk/government/publications/compliance-investigations-by-the-animals-in-science-regulation-unit">anonymised reports of the <abbr title="Animals in Science Regulation Unit">ASRU</abbr> investigations into compliance</a>.</p>

<h3 id="animals-in-science-committee">Animals in Science Committee</h3>

<p>The government’s <a href="https://www.gov.uk/government/publications/lessons-to-be-learnt">response</a>; to the Animals In Science Committee’s review on investigations into non-compliance.</p>

<h3 id="annual-report-of-the-animals-in-science-regulation-unit">Annual report of the Animals in Science Regulation unit</h3>

<p>The <a href="https://www.gov.uk/government/publications/animals-in-science-regulation-unit-annual-report-2015">2015 annual report</a> describes the work of the unit during 2015 in regulating work under <abbr title="Animals (Scientific) Procedures Act 1986">ASPA</abbr> as amended in 2012.</p>

<p>You can also read previous annual reports in the <a href="https://www.gov.uk/government/collections/animals-in-science-regulation-unit-annual-reports">Animals in Science Regulation Unit annual reports</a> collection.</p>

<h3 id="household-products-testing-ban">Household products testing ban</h3>

<p>The <span id="attachment_2231042" class="attachment-inline">
<a href="/government/uploads/system/uploads/attachment_data/file/470007/Advice_Note_on_Household_Products_Ban.pdf">Household products testing ban advice note</a>
(<span class="type"><abbr title="Portable Document Format">PDF</abbr></span>, <span class="file-size">99.8KB</span>, <span class="page-length">15 pages</span>)
</span>
describes the implementation of a policy ban on the testing of finished household products and the requirements in relation to the testing of ingredients for household products on live animals under the terms of <abbr title="Animals (Scientific) Procedures Act 1986">ASPA</abbr>. The policy concerns tests on animals for the assessment of the safety of household products for humans, animals and the environment.</p>

<h3 id="guidance-on-the-use-of-human-material-in-animals">Guidance on the use of human material in animals</h3>

<p>The Academy of Medical Sciences (<abbr title="Academy of Medical Sciences">AMS</abbr>) published a report in 2011 that considered research involving the introduction of human DNA sequences into animals, or the mixing of human and animal cells or tissues. Such procedures create entities which are termed ‘animals containing human material’ (<abbr title="Animals containing human material">ACHM</abbr>). Within this report the <abbr title="Academy of Medical Sciences">AMS</abbr> recommended that the Home Office develop <a href="https://www.gov.uk/government/publications/guidance-on-the-use-of-human-material-in-animals">guidance on the use of human material in animals</a> that details the authorities required when considering work with <abbr title="Animals containing human material">ACHM</abbr>.</p>

<p>This guidance brings together information on the various regulations and guidance surrounding the use of animals containing human materials and the relevant authorities. It has been created in collaboration with the Human Tissue Authority, the Human Fertilisation and Embryology Authority and the Academy of Medical Sciences.</p>

<h3 id="use-keeping-alive-and-re-use">Use, keeping alive and re-use</h3>

<p>The <span id="attachment_2231043" class="attachment-inline">
<a href="/government/uploads/system/uploads/attachment_data/file/470008/Use__Keeping_Alive_and_Re-use_Advice_Note.pdf">Use, keeping alive and re-use advice note</a>
(<span class="type"><abbr title="Portable Document Format">PDF</abbr></span>, <span class="file-size">123KB</span>, <span class="page-length">21 pages</span>)
</span>
explains the interpretations of the terms ‘use’, ‘re-use’ and ‘continued use’ under <abbr title="Animals (Scientific) Procedures Act 1986">ASPA</abbr>. It also provides advice on the criteria that must be satisfied to keep animals alive at the end of a series of regulated procedures.</p>

<h3 id="patterns-of-low-level-concerns">Patterns of low level concerns</h3>

<p>The <span id="attachment_2231045" class="attachment-inline">
<a href="/government/uploads/system/uploads/attachment_data/file/512098/Patterns_low-level_concerns.pdf">Patterns of low-level concern</a>
(<span class="type"><abbr title="Portable Document Format">PDF</abbr></span>, <span class="file-size">334KB</span>, <span class="page-length">16 pages</span>)
</span>
describes the approach that is taken when inspectors identify low-level concerns. The identification of low-level concerns in an establishment are not in themselves breaches of <abbr title="Animals (Scientific) Procedures Act 1986">ASPA</abbr> or licence conditions but, taken together, form a pattern which could indicate that a management and/or welfare regime may have weaknesses which could pose an increased risk of non-compliance or adverse animal welfare.</p>

<h3 id="harm-benefit-analysis">Harm-benefit analysis</h3>

<p><span id="attachment_2231046" class="attachment-inline">
<a href="/government/uploads/system/uploads/attachment_data/file/487914/Harm_Benefit_Analysis__2_.pdf">The harm–benefit analysis process</a>
(<span class="type"><abbr title="Portable Document Format">PDF</abbr></span>, <span class="file-size">2.08MB</span>, <span class="page-length">37 pages</span>)
</span>
conducted by Home Office inspectors, is the cornerstone of the licensing system for the use of animals in science and judges whether the likely harms to animals can be justified by the likely benefits. The Home Office has already published a paper on the purpose of the harm - benefit analysis as an appendix of the <a href="https://www.gov.uk/government/publications/operation-of-aspa">operational guidance</a>. This advice note describes how the harm-benefit analysis is conducted operationally.</p>

<h3 id="re-homing-and-setting-free">Re-homing and setting free</h3>

<p>The purpose of this <span id="attachment_2231044" class="attachment-inline">
<a href="/government/uploads/system/uploads/attachment_data/file/470146/Advice_Note_Rehoming_setting_free.pdf">Advice note re-homing and setting free</a>
(<span class="type"><abbr title="Portable Document Format">PDF</abbr></span>, <span class="file-size">686KB</span>, <span class="page-length">49 pages</span>)
</span>
is to provide information on the legal requirements and guidance on current best practice in re-homing and setting free. The Home Office expects that every opportunity will be taken to re-home animals where it is appropriate to do so. This advice note explains the criteria required for the Secretary of State to consent for the re-homing or setting free at the end of procedures of relevant protected animals that have been bred, supplied, kept or used in regulated procedures.</p>

<h3 id="working-with-animals-taken-from-the-wild">Working with animals taken from the wild</h3>

<p>The <span id="attachment_2231051" class="attachment-inline">
<a href="/government/uploads/system/uploads/attachment_data/file/535574/working-with-wild-animals-160706.pdf">working with animals taken from the wild</a>
(<span class="type"><abbr title="Portable Document Format">PDF</abbr></span>, <span class="file-size">949KB</span>, <span class="page-length">63 pages</span>)
</span>
advice note provides information about how the <abbr title="Animals (Scientific) Procedures Act 1986">ASPA</abbr> requirements affect scientific or educational work using animals taken from the wild, including feral and stray animals. This includes information about:</p>

<ul>
<li>methods of capture</li>
<li>identification (ringing, tagging or marking animals)</li>
<li>working with animals at places which are not <abbr title="Animals (Scientific) Procedures Act 1986">ASPA</abbr> licensed establishments</li>
<li>setting animals free in the course of regulated procedures which have not yet ended</li>
<li>legal and licensing requirements</li>
</ul>

<h3 id="statistics">Statistics</h3>

<p>The full report of the <a href="https://www.gov.uk/government/statistics/statistics-of-scientific-procedures-on-living-animals-great-britain-2016">2016 statistics on scientific procedures on living animals</a> was published on 13 July 2017.</p>

<p>You can also view previous reports in the <a href="https://www.gov.uk/government/collections/statistics-of-scientific-procedures-on-living-animals">Statistics of scientific procedures on living animals</a> collection. </p>

<h3 id="non-technical-summaries-abstracts">Non-technical summaries (abstracts)</h3>

<p>Publication of non-technical summaries is a legal requirement under Article 43 of EU Directive 2010/63. This mandatory requirement will help put the debate on the use of animals in research and testing on a much better informed footing.</p>

<p>You can view:</p>

<ul>
<li><a href="https://www.gov.uk/government/collections/non-technical-summaries-granted-in-2015">non-technical summaries granted in 2015</a></li>
<li><a href="https://www.gov.uk/government/collections/non-technical-summaries-granted-in-2014">non-technical summaries granted in 2014</a></li>
<li><a href="https://www.gov.uk/government/collections/non-technical-summaries-granted-during-2013">non-technical summaries granted in 2013</a></li>
</ul>

<p>Details of project licences granted under <abbr title="Animals (Scientific) Procedures Act 1986">ASPA</abbr> in 2010 to 2012 are available on <a rel="external" href="http://webarchive.nationalarchives.gov.uk/+/http://www.homeoffice.gov.uk/publications/science-research-statistics/animals/">The National Archives</a>.</p>

<p>Abstracts before March 2010 are on the archived version of the <a rel="external" href="http://tna.europarchive.org/20100413151426/http://scienceandresearch.homeoffice.gov.uk/animal-research/index.html">Animals in Scientific Procedures website</a>.</p>

<h2 id="newsletters">Newsletters</h2>

<p>These are the newsletters sent out by the Animals in Science Regulation Unit. If you have any questions regarding their content please email <a href="mailto:ASRUBusiness@homeoffice.gsi.gov.uk">ASRUBusiness@homeoffice.gsi.gov.uk</a></p>

<ul>
<li>
<p><span id="attachment_2231070" class="attachment-inline">
<a href="/government/uploads/system/uploads/attachment_data/file/622390/ASRU_Operational_Newsletter_3.pdf"><abbr title="Animals in Science Regulation Unit">ASRU</abbr> operational newsletter, June 2017</a>
(<span class="type"><abbr title="Portable Document Format">PDF</abbr></span>, <span class="file-size">264KB</span>, <span class="page-length">7 pages</span>)
</span></p>
</li>
<li>
<p><span id="attachment_2231068" class="attachment-inline">
<a href="/government/uploads/system/uploads/attachment_data/file/590678/Establishment_Licence_Holder_s_Newsletter_February_2017.pdf">Establishment licence holder's newsletter, February 2017</a>
(<span class="type"><abbr title="Portable Document Format">PDF</abbr></span>, <span class="file-size">130KB</span>, <span class="page-length">3 pages</span>)
</span></p>
</li>
<li>
<p><span id="attachment_2231069" class="attachment-inline">
<a href="/government/uploads/system/uploads/attachment_data/file/590940/ASRU_Operational_Newsletter_2_February_2017.pdf"><abbr title="Animals in Science Regulation Unit">ASRU</abbr> operational newsletter, February 2017</a>
(<span class="type"><abbr title="Portable Document Format">PDF</abbr></span>, <span class="file-size">178KB</span>, <span class="page-length">4 pages</span>)
</span></p>
</li>
<li>
<p><span id="attachment_2231067" class="attachment-inline">
<a href="/government/uploads/system/uploads/attachment_data/file/590677/Establishment_Licence_Holder_s_Newsletter_December_2016.pdf">Establishment licence holder's newsletter, December 2016</a>
(<span class="type"><abbr title="Portable Document Format">PDF</abbr></span>, <span class="file-size">106KB</span>, <span class="page-length">2 pages</span>)
</span></p>
</li>
<li>
<p><span id="attachment_2231064" class="attachment-inline">
<a href="/government/uploads/system/uploads/attachment_data/file/579969/ASRU-Operational-Newsletter-edition-1.pdf"><abbr title="Animals in Science Regulation Unit">ASRU</abbr> operational newsletter, October 2016</a>
(<span class="type"><abbr title="Portable Document Format">PDF</abbr></span>, <span class="file-size">163KB</span>, <span class="page-length">5 pages</span>)
</span></p>
</li>
</ul>

</div>
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