Overview

The Animals in(Scientific ScienceProcedures) RegulationAct Unit1986 (ASRUASPA) guidanceis andthe regulatorymain advicelegislation that protects animals used for scientific purposes.

YouThe cangovernment readis ASRUcommitted guidanceto thatthe explainsprotection howof animals through the actimplementation isof administeredthe 3Rs (reduction, replacement and enforcedrefinement) includingacross detailedall regulatorylicensed adviceprojects forinvolving licenceanimals holdersin science.

• HouseholdIn productsEngland, testingScotland banand Wales, you need 3 licences from the Home Office before you can carry out procedures using living animals:

  • an establishment licence for the place where the work is carried out

  • Guidanceproject onlicences for the useprogrammes of humanwork

  • personal materiallicences infor each person carrying out procedures on animals

  Use,The keepingAnimals alivein andScience re-useRegulation Unit (ASRU) is part of the Home Office and is responsible for issuing licences and making sure establishments comply with ASPA.

• Harm-benefitIn analysisNorthern Ireland, the Department of Health is responsible for licensing and compliance.

• Re-homingASRU has 2 teams who support establishments with licensing and settingcompliance. freeRead the bridging ways of working guidance for more information.

• WorkingAll withlicence animalsapplications takenshould frombe made in the wildAnimals in Science Procedures e-Licensing (ASPeL) system. 

• Minimum legal standards and guidance

  CodeASPA ofsets practiceout the framework for regulating the careuse of animals in science and accommodationresearch. ofThe animals

• Efficientfollowing breedingset ofout geneticallyminimum alteredlegal animalsstandards and guidance under ASPA.

• Code of practice

  SeveritySection classification2 of geneticallythe alteredcode animalsof practice

• Recording anddescribes reportingthe minimum legal standards for the actualhousing severityand care of regulatedanimals procedures

• Processbred, andsupplied standardsor used for establishmentscientific fullpurposes. systemSection audits

• Standard3 geneticallyprovides alterednon-mandatory rodentsadvice protocols (PDF,to 280encourage KB,establishments 40to pages)
• Standardcontinuously geneticallyimprove alteredtheir zebrafishstandards protocols (PDF,of 263housing KB,and 28care pages)
• for better animal welfare.

  Standard conditions for licences

  GuidanceASRU ongrants thelicences usesubject ofto standard geneticallyconditions, alteredwhich animalsare protocols (PDF,the 104minimum KB,legal 5requirements pages)of a licence.

  There are:

  • establishment licence standard conditions
  • Guidanceproject noteslicence forstandard projectconditions
  • personal licence applicationsstandard conditions

  From

  Guidance 5on Julythe 2021,operation ASRUof ASPA

  The nowguidance provideson regulatorythe deliveryoperation throughof 2ASPA teamsexplains coveringhow differentthe areasact eachis ofoverseen whichand hasenforced, aand dedicatedsets inbox.out Read the Bridgingresponsibilities ways of workingthose guidancewith forroles advice.under ASPA.

  Apply

  It forprovides licences

  Threedetailed licencesguidance areto requiredlicence byholders theand Animalsapplicants (Scientificon Procedures)topics Actincluding 1986minimum (ASPA)legal beforestandards, testingseverity classifications and humane killing.

  Guidance on animalstraining isand allowed.continuous professional development under ASPA

  The 3guidance licenceson neededtraining are:and continuous professional development under ASPA sets:

  • personalthe licencegovernance framework for eachtraining personand carryingcontinuous outprofessional procedures on animals

    development

  • projectspecific licencetraining requirements for thelicensing programmeunder of work

    ASPA

  • establishmentthe licencelearning foroutcomes of the placetraining atrequired

  It whichincludes theboth workminimum islegal carriedstandards outand guidance.

Technical advice notes

YouThe shouldtechnical useadvice thenotes Animalsprovide infurther Sciencedetailed Proceduresadvice e-Licensingon (ASPeLhow to comply with ASPA). system(Reference forto alleach personalspecific andadvice projectnote licenceis applications.

Contactincluded yourwhere establishment’sit Homeis Officerelevant liaisonin contact/administratorthe to‘apply startfor youra applicationproject online.licence’ section of this page.)

Apply for an establishment licence (PEL)

If you are from an establishment that is not yet licensed, email ASPELTechnicalQueries@homeoffice.gov.ukemail aspeltechnicalqueries@homeoffice.gov.uk.

BeforeTo applying,help pleaseyou readapply theonline standardfor conditionsa forPEL, personalor licencesamendment to a PEL, projectread licencessection and3 establishmentof licencesthe guidance on the operation of ASPA.

YouAll canlicensed alsoestablishments readmust guidancehave on:

• dataa protectionPEL impactholder. assessmentThe PEL holder or Named Person Responsible for theCompliance Animalswill inbe Scienceresponsible Proceduresfor e-Licensingcompliance, systemincluding meeting the establishment licence standard conditions

.

Add a named person role

People in named person roles are responsible for specific activities under the establishment licence (PEL),, and youtheir names must addbe theiradded names to the the PEL in  in ASPeL. For example, the Named Animal Care and Welfare Officer (NACWO) oversees the care and welfare of animals.

Read about the requirements for named person roles inin:

• section 3.8 and  and section 8 of inthe Guidanceguidance on the operation of of ASPA.

• Guidanceguidance foron training and continuous professional development under under ASPA

When you add a named person tois aadded to a PEL, this is classed as an amendment.

Find out how to nominate someone for a:

• Named Animal Care and Welfare Officer role
• Named Veterinary Surgeon role

Any named person responsible for animal welfare on the the PEL will will need to complete a conflict of interest declaration form.

ProspectiveApply authorityfor licensinga requestsproject licence (PPL)

AnimalContact studiesyour carriedestablishment’s outHome Office liaison contact or administrator to meetstart regulatoryyour requirementsonline willPPL beapplication.

To performedhelp inyou complianceapply withfor UKa andPPL, EUor legislativeamendment bodies.to a PPL, read:

Where

• section studies5 areof performedthe forguidance otheron regulatorythe bodies,operation of ASPA
• guidance notes for examplePPL theapplications
• information US,on ASRU’s harm-benefit analysis process and criteria they use when assessing an application (appendix I of the studyguidance requirementson exceedthe operation of ASPA)
• guidance on the UKfate orof EUanimals regulatoryat requirements,the youend of procedures:
  • section 6 on humane killing of animals in the guidance on the operation of ASPA
  • use, keeping alive and reuse (PDF, 123KB, 21 pages)

Every licensed project must submithave a prospectivePPL authorisationholder, requestwho formwill tobe ASRUresponsible for compliance, including meeting the PPL standard conditions.

Using genetically altered animals

TheIf projectyou licenceare holderapplying atto theuse establishmentgenetically shouldaltered completeanimals, use the relevant standard protocols in your PPL application:

Prospective
• standard authorisationprotocols formfor using genetically altered rodents (PDF, 280KB, 40 pages) (MS
• standard Wordprotocols Document,for 107using KB).genetically Submitaltered thezebrafish completed(PDF, form263KB, to28 asrulicensing@homeoffice.gov.ukpages).

Project

Read Licenceguidance Standardon Conditionusing 18standard notification

protocols (PDF, 104KB, 5 pages) for using genetically altered animals.

AllThere projectis licencesalso areguidance subjecton:

• efficient tobreeding aof setgenetically altered animals
• severity classification of standardgenetically conditions.altered Standardanimals Condition(when 18you requiresare thatcompleting theyour projectannual licencereturn holderon (PPLh)procedures)

Testing notifieshousehold theproducts

The Secretarytesting of Statefinished ashousehold soonproducts asis possiblebanned ifunder constraintsASPA. onRead the severityhousehold limits,products ortesting observanceban ofadvice othernote controlsfor describedadvice inon the licence,requirements havefor beentesting breachedingredients orfor arehousehold likelyproducts.

Using tohuman havematerial beenin breached.

animals

YouIf canyou readare theapplying Adviceto noteuse -human Projectmaterial Licencein Standardanimals, Conditionread 18the Notificationguidance (PDF,on 544using KB,human 22material pages),in andanimals.

Working usewith animals taken from the formwild

If Projectyou Licenceare Standardapplying Conditionto 18work Notificationwith form (ODT,animals 31.8taken KB)from tothe makewild, reports.

Annualread returnsthe guidance on working with animals taken from the usewild ofand protectedsetting animals

free.

Research for regulatory bodies outside the UK

StatisticsIf you are collectedcarrying annuallyout inresearch for regulatory bodies outside the UKUK, tofor meetexample the USA, and the study requirements ofexceed the AnimalsUK (Scientificregulatory Procedures)requirements, Actyou 1986must tosubmit collecta andprospective publishauthorisation statisticalrequest informationto ASRU.

The onPPL holder should complete the prospective authorisation form (MS Word document, 107KB) and send the usecompleted ofform protectedto asrulicensing@homeoffice.gov.uk.

Apply animalsfor ina regulatedpersonal procedures.licence (PIL)

Contact your establishment’s Home Office liaison contact or administrator to start your online PIL application.

IfTo help you areapply for a projectPIL, licenceor holder,amendment to a PIL, read section 4 of the guidance on the annualoperation returnsof processASPA.

PIL holders must comply with the personal licence standard conditions.

NewslettersSubmit your annual return

TheUnder AnimalsASPA, inASRU Sciencemust Regulationcollect Unitand newsletterspublish annual statistics areon sentthe outuse byof theprotected ASRUanimals in regulated procedures .

PPL. Ifholders youmust record and provide data each year on procedures that have anybeen questionscarried aboutout as part of their content,project email- asruoperationalrelationshipmanagement@homeoffice.gov.ukan annual return on procedures. Data returns must be completed in ASPeL at the end of the calendar year.

RegisterPrepare for updatesan audit

SignASRU upcarries forout emaila updatesrange onof thisaudits topic.

Contactat information

Uselicensed asrulicensing@homeoffice.gov.ukestablishments. for:

• specificThe queriestype relatingof audit is decided by ASRU. The purpose is to anassess individualwhether licence application

• evidenceholders toare supportcomplying anwith exemptionASPA, fromlicence mandatoryconditions training

• requestsand the code of practice, and to re-homeprovide animalsfeedback whereto notguide alreadyongoing authorisedcompliance.

• adviceYou oncan interpretationread ofmore licenceabout authorities

• guidancethe onaudit becomingprocess anand establishmentthe criteria inspectors use in:

  • advicefull onsystem whetheraudit workprocess needs(PDF, to221KB, be12 regulated

    pages)

  • adviceevidence onfor applyingassessment forof licences

  • guidancecompliance onagainst howASPA weand willlicence assessconditions applications

    (PDF, 298KB, 33 pages

   Report non-compliance

  informationProject, topersonal supportand aestablishment PELlicence applicationholders orshould amendmentself-report notificationnon-compliance ofto AWERBASRU datesrelating to potential breaches of:

  • ASPA

  • AWERBa termslicence condition

  • the code of reference
    practice

  UseTo asruenforcement@homeoffice.gov.ukself-report, for:

  • reportscomplete ofthe potential non-compliance

  • reports requirednotification byform a(MS licenceWord conditiondocument, or85.4KB) and email it, as a resultWord ofdocument, enforcementto actionasruenforcement@homeoffice.gov.uk.

  • adviceProvide onas whethermuch ainformation non-complianceas maypossible, haveso occurredASRU can assess the case quickly and accurately.

  • contactSelf-reporting duringdemonstrates that licence holders are aware of their responsibilities and are committed to creating a non-complianceculture investigationof compliance in their establishments.

  UseASRU asrustandardcondition18@homeoffice.gov.ukexpects for:that:

  • requestsself-reporting tois keeppart animalsof alive

    an establishment’s governance frameworks and culture of care

  • Standardemployees Conditionknow 18how reports

  Useto asruaudit@homeoffice.gov.ukraise for:

  • auditconcerns relatedwithin queriestheir establishment

  UseASRU’s aspeltechnicalQueries@homeoffice.gov.ukfull expectations are set out in their compliance policy for:

  • technicaland advicein section 12 of the guidance on the useoperation of ASPeLASPA
   .

  Use

  Report ASRUOperationalRelationshipManagement@homeoffice.gov.uka for:

  potential or actual breach of licensed severity limits (standard condition 18 notification)

  • raisingPPL concernsstandard aboutcondition 18 (SC18) requires the timelinessPPL orholder completenessto ofcomply responsewith fromthe anyseverity limits (and other controls) set out in the PPL to limit the suffering of ouranimals.

    PPL teamsholders ormust anynotify otherASRU concernsas aboutsoon anyas individualpossible request(within or72 interactionhours) if:

    • raisingadverse concernseffects aboutfrom theprocedures timelinesshave resulted in, or completenessare oflikely responseto fromresult anyin, higher levels of oursuffering teamsthan orset anyout otherin concernsthe aboutPPL

    • controls anyset individualout requestin the PPL, such as humane endpoints, have been, or interactionare fromlikely theto regulatedbe, community
      breached
    • there have been adverse effects that are not set out in the PPL

    UseFor asrupolenotification@homeoffice.gov.ukfurther information, read the advice note (PDF, 544KB, 22 pages) for:on SC18 notifications. To report a potential or actual breach, email the SC18 notification form (ODT, 31.8KB) to ASRUStandardCondition18@homeoffice.gov.uk.

    • notifying

      Request to keep animals alive following a breach

      If you plan to keep animals alive following a breach of licensed severity limits, you need authorisation from ASRU.

      You ofmust upcomingsubmit worka atrequest immediately using the SC18 notification form (ODT, 31.8KB). The 72-hour deadline for SC18 reports does not apply, because it is unlawful to keep animals alive when severity limits (or any other controls) in a POLEPPL -have pleasebeen ensurebreached.

      Email the form to ASRUStandardCondition18@homeoffice.gov.uk and label your email subject line includes‘Urgent the- PPLRequest number,to PPLkeep holder’sanimals surnamealive andSC18’. Ensure you include the namescientific ofjustification for keeping the establishment

    animals alive.

    ReportBusiness acontinuity non-complianceplanning

    PleaseBusiness usecontinuity thisplanning formguidance tofor notifyestablishments ASRU(PDF, 185KB, 13 pages) provides advice to PEL ofholders anyon incidentsthe whererequirements therefor hascontingency beenplanning, aemergency potentialresponse breachand ofbusiness ASPAcontinuity planning.

    Keep updated

    Newsletters

    If you want to receive newsletters from ASRU, or aif licenceyou condition,have thisany includesquestions theabout codetheir ofcontent, practiceemail asruoperationalrelationshipmanagement@homeoffice.gov.uk.

    PotentialRegister non-compliancefor notificationupdates

    Sign formup for email updates (MS Wordwhen Document,there 85.4are KB)changes to the content on animals in science licensing and compliance on GOV.UK.

    Contact ASRU

    ProvideTo ashelp muchASRU informationhandle your query quickly, ensure you only email the relevant inbox, as possible.set Incidentsout ofbelow.

    Licence non-complianceapplications 

    This shouldincludes getting advice on:

    • whether work needs to be reportedregulated
    • becoming an establishment
    • applying for licences or amendments, including what information to provide
    • providing evidence to support exemptions from mandatory training
    • how ASRU. Self-reportingwill indicatesassess thatapplications
    • re-homing ananimals establishmentwhere isnot makingalready effortsauthorised
    • working towith ensureanimals compliance.taken Itfrom demonstratesthe thatwild
    • how roleto holdersinterpret areauthorisations awarein ofthe theirlicence
    • Animal responsibilitiesWelfare and areEthical committedReview toBody terms buildingof areference

    Email: compliant culture.asrulicensing@homeoffice.gov.uk

    ASRU

    Enforcement expectsand self-reportingcompliance

    This toincludes:

    • reports beof embeddedpotential withinnon-compliance
    • reports goodrequired governanceby frameworksa andlicence thatcondition employeesor areas awarea result of theenforcement processaction
    • advice foron raisingwhether concernsa withinnon-compliance theirmay establishment.have Thisoccurred
    • contact isduring seta outnon-compliance ininvestigation

    Email: ASRUasruenforcement@homeoffice.gov.uk

    SC18’s

    This publishedincludes:

    • requests complianceto policykeep andanimals guidancealive
    • SC18 onreports

    Email: theasrustandardcondition18@homeoffice.gov.uk

    Audit

    Email: operationasruaudit@homeoffice.gov.uk

    Technical ofadvice theon ASPAusing ASPeL.

    Email: aspeltechnicalqueries@homeoffice.gov.uk

    Complaints

    Places feedback

    other than licensed establishments

    IfTo youtell wantASRU toabout giveupcoming feedbackwork onat howplaces weother handledthan yourlicensed complaint,establishments, please email asruoperationalrelationshipmanagement@homeoffice.gov.ukasrupolenotification@homeoffice.gov.uk.

    Make sure the email subject line includes the PPL number, PPL holder’s surname and establishment name.

    Make a complaint

    PleaseTo onlyraise completeany thisconcerns about complaintsprocess formor iftimeliness youof wishresponses to applications or queries, email the team using the relevant email address.

    If you are not satisfied with the response, you can make a formal complaint.complaint by completing the online complaints form and emailing it to: asruoperationalrelationshipmanagement@homeoffice.gov.uk.

    Complaints feedback

    PleaseTo sendgive thefeedback completedon formhow toASRU handled your complaint, email asruoperationalrelationshipmanagement@homeoffice.gov.uk.

    Data protection

    You can read the data protection impact assessment for ASPeL.