User Guide toUser Guide to Home Office Statistics of
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1. Type of procedure 3 16 The tables are divided into two groups Fundamental and applied studies other than toxicology Tables 6 8 Toxicity tests or other safety or efficacy evaluation Tables 9 16 3 17 If the purpose was non toxicological the licensee was asked to specify the field of research Table 6 the nature of the procedure with regard to production and breeding Table 7 and whether the technique was identified as being of particular interest Table 8 3 18 If the purpose of the procedure was toxicological the licensee was asked to report on the field of safety testing or efficacy evaluation Table 9 the type of test or procedure Table 11 and the legislative requirements if any under which the procedure was performed Table 10 3 19 The two strands of reporting are mutually exclusive as shown in the flowchart and form notes and it is not possible for instance to identify procedures using a technique of particular interest if the purpose of the procedure was toxicological Fundamental and applied studies other than toxicology 3 20 This group of tables is sub divided into three main areas of interest i Field of research Tables 6 6a 6 1 and 6 2 The headings are self explanatory but the following should be noted a pharmaceutical research and development excludes anti cancer agents where work is listed separately later in the table under cancer research b ecology excludes work done in toxicolog2. 3 10 The breeding of animals with potentially harmful genetic defects or GM animals is a regulated procedure under a project licence Animals that are identified as HM or GM animals may be used for further breeding or used subsequently in procedures The numbers also include some genetically normal animals that were subjected to regulated procedures such as tissue sampling or hormonal administration for the purpose of regulated breeding programmes 3 11 The classifications of procedures concerned with breeding distinguish between a animals used to generate founder GM animals for novel transgenic lines chimeras or clones b GM animals generated by recognised husbandry methods for maintenance of a breeding colony c GM animals used in research programmes not concerned with breeding d animals with a harmful mutation generated by recognised husbandry methods for the maintenance of breeding colonies e HM animals used in research programmes not concerned with breeding Target body system Table 4 3 12 Some of the headings in the tables are self explanatory but for the others further explanation is given below Abbreviated title Description studies in which interest centres on Nervous The central or peripheral nervous systems other than the special senses Senses Sight hearing smell or taste Alimentary The alimentary including liver and excretory systems Musculo skeletal The skeletal or muscle system Immune and r
3. A95 Procedures performed to meet legislative requirements of other countries e g USA Japan A96 Any combination of A91 A95 requirements A97 Toxicity tests carried out for purposes other than meeting legislative requirements please describe the procedure and its purpose in a separate note Safety testing to satisfy HSE regulations or similar legislation in other countries should be classified as a legislative requirement choosing from codes A9 A96 as appropriate COUNTRY LIST FOR CODE A92 ABOVE AND CODE 4 IN ROW 5 EU countries other than the UK Austria Germany Poland Belgium Greece Portugal Bulgaria Hungary Romania yprus i Irish Republic Slovakia Czech Republic Italy Slovenia Croatia Latvia Spain Denmark Lithuania Sweden Estonia Luxembourg Finland Malta France Netherlands COUNTRY LIST FOR CODE A94 ABOVE Council of Europe nations other than EU Albania Iceland Serbia Andorra Liechtenstein Switzerland Armenia Moldova Former Yugoslav Azerbaijan Monaco Rep of Macedonia Bosnia and Montenegro Turkey Herzegovina Norway Ukraine Genroia Russian Fed San Marino December 2013 LIST B ROW 10 FUNDAMENTAL AND APPLIED STUDIES OTHER THAN TOXICOLOGY If the procedure was carried out for a purpose other than toxicology or safety evaluation select the code from the list below which best describes the primary field of research Any of these studies e g clinical medicine clinical surgery pharmaceutical R amp D
4. OECD 403 or 203 Acute limit setting or dose ranging lethal toxicity tests Acute oral toxicity test e g OECD 420 OECD 423 OECD 425 Includes such tests as Fixed Dose Procedure Acute Toxic Class method Up and Down method Maximum Non Lethal Dose or Maximum Tolerated Dose Subacute limit setting e g OECD 407 or dose ranging toxicity test usually 14 to 28 days duration Subacute quantitative toxicity test e g OECD 407 usually 14 to 28 days duration Subchronic and chronic toxicity tests e g OECD 408 409 411 413 452 for 90 days or more A37 Carcinogenicity tests e g OECD 451 A38 Genetic toxicology tests e g OECD 474 475 includes mutagenicity tests and the Micronucleus test A39 Teratogenicity tests A40 Other reproductive toxicity tests including multigeneration studies Tests for clinical signs in eyes e g OECD 405 Tests for skin irritation e g OECD 404 Tests for skin sensitisation e g OECD 406 Please indicate if you have used either the Guinea Pig Maximisation Test or the Buehler Assay OECD 406 Toxicokinetics e g OECD 417 Pyrogenicity tests Biocompatibility tests Enzyme induction for in vitro tests Immunotoxicology tests Other toxicology tests these other tests may include collection of normal tissues such as blood for in vitro work and investigative procedures not compatible with other codes Please describe the procedure and its purpose in a separate note A32 A33 A34 A35 A3
5. 1 A35 e The study was needed to fulfil the requirements for safety evaluation of the product during the manufacturing process when material needs to be moved in bulk i e the testing was required under the regulations relating to the safety of substances used in industry for production within the EU ROW 8 4 ROW 9 12 ROW 10 A03 and ROW 12 A93 Column 3 90 domestic cats used in feeding studies of feline nutrition ROW C1 ROW 2 0 ROW 3 ROW 4 and ROW 13 90 Last year 40 new cats were purchased from a designated source in the UK and used ROW 5 2 This year 50 more cats were purchased from the same source and used ROW 5 2 The regulated procedures do not involve general anaesthesia ROW 6 0 The project licence authorises re use of the animals The 50 cats purchased this year were used for the first time ROW 14 50 The 40 cats used last year were re used in this experiment for the first time during this new calendar year ROW 15 40 ANNEX B Explanation of how to code Genetically Modified and Harmful Mutant animals ROW 4 Overall principles and definition Harmful Mutants HM whether deliberately generated or spontaneously arising are coded as 2 and Genetically Modified animals GM i e Transgenics Knockouts etc and combinations of GM and HM are coded as 3 e animals should be counted only once in their lifetime animals should be counted when they are born or develop to the appropri
6. including efficacy quality control or other regulatory purpose select the most appropriate code from the list below AOI A02 A03 A04 A05 Environmental pollution Substances used in agriculture Substances used in industry Substances used in the household Food additives other than those administered in food for health purposes Foodstuffs other than additives A07 Cosmetics and toiletries finished products A08 Cosmetics and toiletries ingredients PHARMACEUTICAL SAFETY EFFICACY EVALUATION INCLUDING BIOLOGICAL PRODUCTS E G CELLS All Safety testing AI2 Efficacy testing Al3 Quality control Al4 Absorption Distribution Metabolism and Excretion ADME and residue studies OTHER PURPOSE A2 Fundamental research in toxicology A22 Tobacco safety testing inducing alternatives A23 Safety Efficacy testing of medical appliances or devices A24 Method development or validation A25 Other toxicological purpose please describe the procedure and its purpose in a separate note A06 LIST A ROW I1 TYPE OF TEST OR PROCEDURE If the procedure was carried out for a toxicological or other safety related purpose i e you have used a code from A0 A25 in ROW 10 select the code from the list below which describes the procedure most accurately The OECD test references are examples and are given only for guidance A30 Acute quantitative lethal toxicity test LD50 A3 Acute quantitative lethal concentration tests LC50
7. provides additional provisions on statistics and reporting in order to comply with EU Directive 2010 63 EU These provisions will affect the substance and content of the statistics collection from 2014 onwards and will be described in detail in the July 2014 statistical release and user guide Legal definition of a regulated procedure 2 15 The 1986 Act defines a regulated procedure as follows i A regulated procedure is defined by Section 2 1 of the Act as any experimental or other scientific procedure applied to a protected animal which may have the effect of causing that animal pain suffering distress or lasting harm ii Pain suffering distress and lasting harm encompass any material disturbance to normal health defined as the physical mental and social well being of the animal They include disease injury and physiological or psychological discomfort whether immediately such as at the time of an injection or in the longer term such as the consequences of the application of a carcinogen extract from Guidance on the Operation of the Animals Scientific Procedures Act 1986 2 15 The threshold at which regulation is applied has been agreed at EU level to be the skilled insertion of a hypodermic needle This means for example that even a study that involves only the taking of blood samples is a procedure for the purposes of the annual statistics 2 16 Under this Act any scientific procedure carried out on any li
8. Associated codes for ROW 6 will usually be 1 3 or 4 ROW 8 PRIMARY PURPOSE OF THE PROCEDURE Select the appropriate code from the list below l Fundamental biological research studies of normal or abnormal structure or function of living organisms organs tissues cells or other systems including fundamental studies in toxicology Applied studies human medicine or dentistry research development or quality control of products or appliances including toxicological evaluation and safety or efficacy testing Applied studies veterinary medicine research development or quality control of products or appliances including toxicological evaluation and safety or efficacy testing Protection of man animals or environment by toxicological or other safety or environmental evaluation excluding medical or veterinary products or appliances This category is intended to cater for toxicological work which is not related either to fundamental research or to the solution of medical or veterinary problems as such Ecological studies may be included here with the appropriate codes in ROWs 0 12 A codes for toxicological testing or B codes for other investigative studies Education Training use of animals in acquisition of manual skills is permitted in microsurgery training only Forensic enquiries human or veterinary Direct diagnosis procedures for specific detection of human or veterinary pathogens or production of diagnostic reagen
9. Home Office Statistics 1st Floor Peel Building 2 Marsham Street London SW1P 4DF Definitions presentation and classification Introduction and counting rules 2 1 The statistics are compiled from forms submitted by project licence holders at the end of each year or on the termination of the licence when this occurs during the year A copy of the form notes can be found in this user guide see para 6 1 below including the detailed definition of a procedure and descriptions of the standard coding lists used for describing procedures The legal definition of a procedure which applied up to the end of 2012 appears in para 2 11 below 2 2 Each procedure which may consist of several stages for a given purpose on an animal is counted as one returnable procedure for the year in which it commenced A study involving a procedure using a number of animals is counted once for each animal Where an animal that has recovered fully from a completed procedure is used again for a further procedure it is counted as a separate procedure but the animal itself is not re counted The circumstances in which this re use of an animal is permitted are limited Presentation of the data 2 3 The figures given in the annual statistics publication refer to the numbers of procedures that were started in the latest calendar year rather than the numbers of animals compared with the previous calendar year unless indicated otherwise 2 4 Figures in the annual stat
10. Page 8 Details of previous annual publications 6 2 Electronic copies of the most recent editions can be found at https www gov uk government organisations home office series statistics of scientific procedures on living animals and older editions can be found at http webarchive nationalarchives gov uk 20100613204643 http rds homeoffice gov uk rds scientific1 html Annual publications giving detailed figures for scientific procedures under the Animals Scientific Procedures Act 1986 were published by TSO as Statistics of Scientific Procedures on Living Animals as follows Year Command House of Commons Year Command Paper Paper 2012 HC 549 2011 HC 345 2010 HC 1263 2009 HC 317 2008 HC 800 2007 HC 933 2006 Cm 7153 2005 Cm 6877 1995 Cm 3516 2004 Cm 6713 1994 Cm 3012 2003 Cm 6291 1993 Cm 2746 2002 Cm 5886 1992 Cm 2356 2001 Cm 5581 1991 Cm 2023 2000 Cm 5244 1990 Cm 1574 1999 Cm 4841 1989 Cm 1152 1998 Cm 4418 1988 Cm 743 1997 Cm 4025 1987 Cm 515 1996 Cm 3722 Detailed figures for experiments on living animals under the Cruelty to Animals Act 1876 were published by TSO as Statistics of experiments on living animals as follows Year Command Year Command Paper Paper 1986 Cm 187 1981 Cmnd 8657 1985 Cmnd 9839 1980 Cmnd 8301 1984 Cmnd 9574 1979 Cmnd 8069 1983 Cmnd 9311 1978 Cmnd 7628 1982 Cmnd 8986 1977 Cmnd 7333 Less detailed information about experiments on living animals
11. and sheep if GM Normal pigs and normal sheep remain outside the scope of this schedule The source of these species is tabulated according to whether it is within the UK within the remainder of the EU within certain Council of Europe but non EU countries that are signatories to the European Convention for the Protection of Vertebrate Animals used for Experimental and Other Scientific Purposes ETS 123 or elsewhere Animals that originate from non designated sources such as overseas breeding centres but that are acquired by the project licence holder via a designated supplying establishment in the UK are reported under the heading Animals acquired from other designated breeding or supplying establishments in the UK 3 5 Table 2 lists numbers of procedures by source of animal as described above Tables 2 1 and 2 2 list procedures by source for animals with a harmful but naturally occurring genetic defect and GM animals respectively The use of Schedule 2 listed species from non designated sources in the UK or from Europe or elsewhere is subject to prior approval by the Home Office Such use would be justified on the basis of scientific need or lack of availability of appropriate animals from designated breeding or supplying establishments Stage of development genetic status and breeding Tables 3 3 1 3 2 3 3 Stage of development 3 6 Details of procedures on animals in foetal larval or embryonic form are collected but no
12. appropriate body system group covered by primary purposes described in 11 above c Many of the procedures recorded under this category are required by UK law or by the laws and regulations of countries in which it is intended to use the substance concerned d The term food additives covers substances deliberately added to food as preservatives artificial colourants or flavouring agents but not studies on the nutritive value of food accidental contamination or infection of food or medicines administered to animals or humans in food iv Education and training these categories include procedures carried out under project licences for the purposes of education or training under the 1986 Act They also include the killing of animals by methods not included in Schedule 1 to the 1986 Act if the killing takes place for educational purposes at a designated establishment Such killing may be authorised to provide for example tissues subsequently used for education or training The use of animals for the acquisition of manual skills is currently permitted only for training in microvascular surgery and at present this is always carried out under general anaesthesia without recovery v Forensic enquiries may refer to animal use in human or veterinary enquiries relevant to potential legal proceedings vi Direct diagnosis investigation of disease including investigating suspected poisoning This caters for procedures carried out und
13. be zero ROW 13 entry is zero entries at ROW 14 ROW 15 must also be zero Sum of entries in ROW 14 and ROW 15 must not exceed the entry in ROW 13 Page 5 ANNEXA EXAMPLES OF COUNTING RE USE AND THE USE OF SOME TOXICOLOGY CODES Column Row Row 2 Row 3 Row 4 Row 5 Row 6 Row 7 Row 8 Row 9 Row 10 Row Row 12 Row 13 Row 14 Row 15 Column The whole series of techniques were carried out for a particular purpose and were covered by the description in a single 9 b protocol sheet of the project licence Fifteen 8 week old rats ROW R2 and ROW 3 1 Not CITES listed ROW 2 0 Normal genetic status ROW 4 1 Purchased from a commercial breeder in the UK ROW 5 2 Surgical implantation of vascular cannulae with recovery from general anaesthesia ROW6 without the use of neuromuscular blocking agents ROW 7 0 Subsequently the animals were dosed with a potential drug for cancer therapy ROW8 2 and ROW 9 I1 e Three timed blood samples are taken from the cannulae for a pharmacokinetic study ROW 10 A14 e Finally the animals were killed by perfusion of fixative under general anaesthesia Column 2 e 40 genetically normal six week old mice ROW RI ROW 3 and ROW 4 1 e Purchased from a commercial breeder in the UK ROW 5 2 e Used in a sub acute quantitative toxicity test 28 days study to provide data on a household product ROW
14. by phone on 020 7035 0583 8625 THANK YOU FOR YOUR ASSISTANCE Further guidance and code lists overleaf December 2013 Page 1 December 2013 CODE LISTS ROW I SPECIES Select the appropriate code from the list below MAMMAL use this code for rodenticide field trials only There is no need to complete the rest of the column you must provide a covering letter giving estimates of the number of each species which may have undergone pain suffering distress or lasting harm during the field trials Mouse Rat Guinea pig Hamsters Syrian Mesocricetus auratus Hamsters Chinese Cricetulus griseus Gerbil Other rodent please append a note indicating species used Rabbit Cat Dog beagle Dog Greyhound Dog other including cross bred Ferret Other carnivore please append a note indicating species used Horse donkey and cross bred equids Pig Goat Sheep Cattle Deer Camelid Other ungulate please append a note indicating species used PRIMATE Prosimians Prosimia Marmoset and tamarins Squirrel monkey Cynomolgus monkey Macaca ascicularis Rhesus monkey Macaca mulatta Vervets chlorocebus Baboons Apes Other species of non human primates please append a note indicating species used Other mammal please append a note indicating species used Domestic fowl Turkey Quail Coturnix coturnix Quail spp other than Coturnix coturnix Other bird please append a note indicating species used REPTILE DI Any rep
15. contact Definition of a regulated procedure A regulated procedure is defined by Section 2 1 of the Act as any procedure applied to a protected animal for a qualifying purpose which may have the effect of causing the animal a level of pain suffering distress or lasting harm equivalent to or higher than that caused by the introduction of a needle in accordance with good veterinary practice The use of a protected animal under project licence authorities extends from the time the first regulated procedure is applied to the animal up to the time when the observations or the collection of data or other products for a particular scientific purpose usually a single experiment or test are completed This is the use which should be reported as a single procedure in ROW 13 of the form Continued use between more than one project licence protocol should be returned as a single procedure Each re use as identified in the project licence should be reported as additional procedure s You may find it helpful to refer to paragraphs 2 6 to 2 33 of the Home Office Guidance on the Operation of the Animals Scientific Procedures Act 1986 Published in March 2000 by HMSO reference HC321 http www archive official documents co uk document hoc 321 321 htm before completing this section Queries If you have any queries about how to complete this form please contact the ASRU Business Support Team by email on ROPReturns homeoffice gsi gov uk or
16. i Safety and efficacy evaluation Tables 9 9a Some of the subdivisions have been described above at paragraph 3 3 iii with regard to general safety or efficacy evaluation e g pollution agriculture industry household food additives but the category also includes work done for pharmaceutical safety and efficacy evaluation and some other purposes such as toxicology research In line with current policies the reported figures show no procedures to test or develop cosmetics or cosmetic ingredients nor procedures using animals in research on tobacco ii Legislative requirements Table 10 This identifies medical dental and veterinary categories These include a b c procedures used in the initial development and selection of such products those required to satisfy specific legislation medical and non medical such as the Medicines Act 1968 and or equivalent overseas and international legislation or regulations for purposes such as the intention of registration or the intention of presenting batch quality control data and those carried out for other reasons The legislation is divided into seven groups a b c d e f g UK legislation only legislation specific to one EU country only excluding the UK general EU requirements including the European Pharmacopoeia non EU member country of Council of Europe legislation legislation of other countries any combination of a e purposes othe
17. other countries within EU other than the UK See list at LIST A ROW 12 If the animals were acquired from member countries of the Council of Europe which are parties to convention ETS 123 excluding EU member states See list below If the animals were acquired from other sources Non EU ETS 123 countries Code 5 above Switzerland Norway Turkey ROW 6 ANAESTHESIA Select the most appropriate numeric code from the list below 0 No anaesthesia throughout the procedure Include procedures without anaesthesia which end by a Schedule method of killing even if this consisted of an anaesthetic overdose Use this code also for the study of potential anaesthetic agents General anaesthesia with recovery Used at any stage of the procedure irrespective of other uses of anaesthesia Local or regional anaesthesia Used at any stage of the procedure General anaesthesia without recovery Used at the end of a procedure which did not otherwise involve anaesthesia See note below General anaesthesia without recovery Used throughout the procedure NOTE If the animal was killed by a method listed in Schedule of the Act using an overdose of an anaesthetic agent this was not part of the regulated procedure and should not be recorded as such Page 2 ROW 7 NEUROMUSCULAR BLOCKING AGENTS Select the appropriate code from the list below 0 No use of neuromuscular blocking agents NMBA NMBA used during the procedure at some stage
18. research and also subject to regulated procedures should be coded as in ROW 4 and codes B50 B56 or B79 as appropriate in this list Harmful mutant animals generated by recognised husbandry methods for maintenance of breeding colonies This may include animals with a fate set out in Annex B Normal animals which have not undergone any other regulated procedures do not need to be accounted for see Annex B Harmful mutant animals used in research programmes where they underwent regulated procedures other than those required for a breeding programme i e where the primary purpose was NOT breeding i e ROW 8 not 9 Normal or wild type animals used as controls in such research and also subject to regulated procedures should be coded as in ROW 4 and codes B50 B56 or B79 as appropriate in this list For all other types of animal use i e where GM or HM animals are not involved and the purpose is not production of biological materials use code B79 LIST B ROW 12 PARTICULAR TECHNIQUES If you used a code from BO to B32 in ROW 10 select a code from the list below which applies to the procedure described in this column B9 Direct interference with any part of the organs of special sense including the brain centres B92 Direct injection of micro organisms or material suspected of containing micro organisms into the brain B93 Other direct physical interference with the brain B94 Induction of psychological stress integral to th
19. using genetic engineering This involves the direct manipulation of the animal s DNA using biotechnology This could involve the removal of certain genes called knock outs or adding genetic material from another species to the host called transgenic Other ways of more indirect genetic modification have been practiced for centuries through selective or cross breeding but this is not what is meant by GM in this report 2 12 HM animals possess one or more genes that have undergone mutation which involves a change in their genetic structure This may be the result of the application of chemicals or radiation in order to cause the mutation and is distinct from GM where genetic material is either inserted or removed Further details of the coding of GM and HM animals are given in the form notes see para 6 1 below Legal purpose of the statistics 2 13 The annual statistics publication relates to scientific procedures performed using living animals subject to the provisions of the Animals Scientific Procedures Act 1986 The purpose of the publication is to meet the requirements of section 21 7 of the Act The Secretary of State shall in each year publish and lay before Parliament such information as he considers appropriate with respect to the use of protected animals in the previous year for experimental or other scientific purposes 2 14 The Animals Scientific Procedures Act 1986 Amendment Regulations 2012 section 21A
20. 6 A4l A42 A43 A44 A45 A46 A47 A48 A50 LIST A ROW 12 LEGISLATIVE REQUIREMENTS If the procedure was carried out for a toxicological or other safety related purpose i e you have used a code from AO A25 in ROW 10 select the code from the list below which most closely describes the legislative requirements for which the procedure was performed Note that legislative requirement includes a requirement imposed by a product or manufacturing licence of the country concerned Where a test was intended to satisfy both UK and other requirements and involved more animals than the UK minimum requirements two columns should be used to describe the tests The first column should record the number of animals used to satisfy UK requirements using Code A91 in ROW 12 and the second column should show the remainder using the most appropriate Code A92 or A93 in ROW 12 Dose ranging or other types of preliminary studies should also be classified as having a legislative requirement using the same code as for the related definitive study A9 Procedures performed to meet UK legislative requirements only A92 Procedures performed to meet national legislation specific to only one EU member state excluding the UK see list below A93 Procedures performed to meet EU legislative requirements including European Pharmacopoeia A94 Procedures performed to meet member country of Council of Europe excluding EU legislation see list below
21. 6a a TABLE 6 Field of toxicology Field of toxicolog Field of researc Field of research procedures animal animal procedures TABLE 7 Pr cna aa of TABLE 11 Type of test overall TABLE 8 echniques of intere Notes _Jnumber of animals used L number of procedures procedures by genetic status GM genetically modified HM harmful mutant w website only Li i i i i i i i TABLE 15 Type of e atey w w Or pharma a i i e extended version on website i i TABLE 16 w Type of test other safety w or toxicology testing w Explanatory Notes for published tables continuea Species of animal 3 1 Most tables except the online Time Series tables are classified by species of animal The full classification is used in Tables 1 la 6 6a 9 and 9a but the other tables use a condensed classification All the tables except la 6a and 9a give the number of procedures Tables la 6a and 9a give the actual number of animals used for the first and usually only time in the latest calendar year In these tables the classification is according to the first use The list of species or categories of animals is selective to avoid undue complications when collective terms are used it is because previous experience suggests that the category will contain a relatively small number or because further breakdown is of little interest In several of the tables rows that are completely zero have been om
22. Home Office User Guide to Home Office Statistics of Scientific Procedures on Living Animals Last updated July 2014 Animals t biological cra Proceduresmice sii a S ford research ee ing eScientific Statistics CONTENTS Introduction Definitions presentation and classification Explanatory notes for published tables Using the statistics Collection procedures coverage confidentiality and quality assurance Reference materials Form notes Details of previous annual publications Further information Page 15 t7 18 19 27 28 Introduction 1 1 This user guide accompanies the Home Office publication Annual Statistics of Scientific Procedures on Living Animals Great Britain 2013 Coverage 1 2 The statistics in the publication relate to scientific procedures performed using living animals subject to the provisions of the Animals Scientific Procedures Act 1986 Purpose of the collection 1 3 In the UK the use of animals in scientific procedures is regulated by the Animals Scientific Procedures Act 1986 an animal protection measure that requires licensing and oversight of all places projects and personnel involved in such work Under the 1986 Act the Home Office must inform Parliament of the authorised annual use made in Great Britain of animals in scientific procedures separate information is produced for Northern Ireland under devolved arrangements This is done t
23. al pathological pharmacological genetic and biochemical studies including toxicological evaluation ii Applied studies human medicine or dentistry and veterinary medicine consisting of research into development of and quality control of products or devices including toxicological evaluation and safety or efficacy testing iii Protection of man animals or the environment by toxicological or other safety or environmental evaluation This category is intended to cater for toxicological work that is not related to either fundamental research or the solution of medical and veterinary problems as such see 1 and ii above but also includes some non toxicological procedures e g ecological studies may be included This category is further divided into a number of subgroups listed in Tables 9 and 9a These are largely self explanatory but the following notes may be helpful in understanding the figures a While any one substance may be used in industry or in the home or may be an environmental pollutant a herbicide or a pesticide the project licence holder classifies the procedure in accordance with the particular context of the procedure and the expected primary use of the product b Animal pesticides distinct from plant pesticides are not included amongst the types of substances listed because a substance intended to kill pests that infest or attack animals would be regarded as a veterinary product These are included in the
24. ate stage see ROW 3 unless they have continued use beyond the breeding protocol in which case animals should be counted for the final use only on the Return of Procedures for the Project Licence covering the final use this may mean they are not counted in the year in which they are born Exclusions e Do not count the mating of 2 adults as a procedure regardless of the genetic status of the adults Animals subjected to somatic mutation e g by vector mediated gene delivery should be coded as for the starting status in ROW 4 e g code as I Normal animal if they are wild type at the start of the protocol December 2013 Page 6 ROW 8 How to Code the Primary Purpose for the use of GM and HM animals Record the primary purpose as Breeding Code 9 in ROW 8 only for animals used solely for generation or maintenance of a GM or HM breeding colony or e for any animals bred but never used on subsequent protocols and in these circumstances GM animals should be coded B or B62 in ROW I1 whilst HM animals should be coded B64 in ROW 11 When not to code as Breeding The primary purpose recorded at ROW 8 should be coded according to the final protocol and not coded as 9 in all other circumstances i e where GM and HM animals are bred and then used in a subsequent experimental protocol whether on the same or a different project licence and correspondingly GM animals should then be coded as B63 in ROW I 1 whilst HM
25. ble to collect accurate figures on the number of animals affected in field trials of rodenticide substances Such field trials are rare e g there was one return from a licensee that indicated that such field trials occurred in the calendar year 2010 as part of the work carried out under that licence 2 8 Similarly it is not possible to collect accurate figures on the numbers of embryonic or larval animals used the number of returns reporting only such non countable procedures is shown in Table 19 of the annual statistics Classifications 2 9 The current classification system coding lists dates from 1995 and was modified in 1999 in those areas relating to e source of animals e production and breeding to produce genetically modified GM animals or harmful mutants HM e toxicology and e legislation During the collection and verification process forms that have been recognised as being incorrectly coded are referred back to the licensees for correction 2 10 The format of information provided relating to the latest calendar year broadly follows that used for the publication of previous statistics relating to the previous calendar year Where particular types of procedures have been disallowed under administrative provisions subsequent to the inception of the Act footnotes indicate this Definitions of genetic modification GM and harmful mutant HM 2 11 GM animals are those whose genetic characteristics have been altered
26. colleagues in the Communications Development Section who assisted in preparing the report for publication Last but not least the contribution of licensees who provide the returns used to compile the annual statistical report is also acknowledged Further information available 1 11 The following information is available from the Internet site https www gov uk government organisations home office series statistics of scientific procedures on living animals e the bulletin Annual Statistics of Scientific Procedures on Living Animals Great Britain e the accompanying Supplementary Tables and the Time Series Tables and e this document User Guide to Home Office Statistics of Scientific Procedures on Living Animals 1 12 The dates of future editions are pre announced and can be found via the UK National Statistics Publication Hub http www statistics gov uk hub release calendar index html Home Office Responsible Statistician David Blunt Chief Statistician and Head of Profession for Statistics 1 12 Information on how Home Office Statistics outputs are published independently as part of the Code of Practice for Official Statistics is available at http homeoffice gov uk science research about home office science official statistics Enquiries 1 13 If you have any enquiries about this publication please email asp statistics homeoffice gsi gov uk or write to Policing and Other Section
27. e procedure B95 Use of aversive training stimuli B96 Exposure to ionising radiation at doses intended to produce a potentially adverse effect on the animal B97 Inhalation do not use for fish B98 Thermal injury q Only use these codes where the study B99 Physical trauma J was the main purpose of the procedure BOO None of the above December 2013 ROW 13 NUMBER OF PROCEDURES STARTED IN 2013 Please read definition of Procedure on page before completing this row Each separate use of one animal counts as one procedure Only procedures started during the year should be included and not procedures reported in returns for previous years that have continued into 2013 Do not include foetal larval or embryonic animals enter 0 in ROW 13 for these animals i e if you have entered 2 at ROW 3 Also enter 0 in ROW 13 if you have entered RO in ROW ROW 14 NUMBER OF ANIMALS USED FOR THE FIRST TIME EVER IN 2013 NEVER USED IN A PREVIOUS YEAR Where animals are used in more than one separate procedure i e re use see below only the first use counts towards the total which you should enter in ROW 14 This is true whether or not the second and or subsequent procedures are described in the same column or any other columns of the return or on another return ROW 15 NUMBER OF ANIMALS RE USED IN 2013 In ROW 15 count the number of animals that were re used not the number of times they were re used in 2013 even if they
28. er the 1986 Act for the purpose of diagnosing disease in an individual human or animal patient or a group of such patients There is no research function these are essentially applied studies predominantly involving the production of biological reagents for example antibodies and clotting factors vii Breeding a category for recording the production and breeding of animals with harmful genetic defects and genetically modified animals The numbers recorded in this category include those animals that are identified as possessing a harmful mutation or are genetically modified but not used subsequently on procedures that are recorded elsewhere in the tables The numbers also include some genetically normal animals that were subjected to regulated procedures such as tissue sampling or hormonal administration for the purpose of regulated breeding programmes see also Tables 3 3 1 3 2 3 3 Source of animals Tables 2 2 1 2 2 3 4 Sections 7 and 10 3 of the Act require unless a specific exemption is granted that certain animals listed in Schedule 2 to the Act be obtained from designated breeding or supplying establishments certified as such by the Secretary of State The species so listed during the calendar year were mouse rat guinea pig hamster gerbil rabbit cat dog ferret primate quail Coturnix coturnix any frog of the species Xenopus laevis and tropicalis or Rana temporaria and pipiens and zebra fish also pigs if GM
29. eticulo endothelial The understanding and operation of the immune system Other system A single body system not separately listed in the table Multiple systems More than one system of primary interest System not relevant The system or systems affected were not predictable or not relevant Use of anaesthesia Table 5 3 13 The codes for anaesthesia distinguish procedures involving one or more stages in which there was anaesthesia with recovery and from procedures in which the only anaesthesia was terminal They also include the use of local or regional anaesthesia The categories are listed below a No anaesthesia used throughout the procedure this will include procedures without anaesthesia even where the subject animal may have been killed by use of an anaesthetic overdose at the end of the procedure It also includes studies of potential anaesthetic agents b General anaesthesia with recovery c Local or regional anaesthesia d General anaesthesia without recovery at the end of the procedure only e General anaesthesia without recovery throughout the procedure 3 14 The killing of an animal by the administration of an overdose of an anaesthetic agent a recognised humane method as cited in Schedule 1 to the Act is not a regulated procedure and is not recorded as such in the above table 3 15 The use of neuromuscular blocking agents NMBA is uncommon and for this reason such use is not shown in the table except as a footnote
30. evious versions of these guidance notes or of the form ii make sure you are clear what is meant by a regulated procedure see definition below iii if you have carried out any work using harmful mutant or genetically modified animals please first read Annex B at pages 6 8 of these guidance notes iv if the procedures started included the re use of animals irrespective of whether the first use was in 2013 or earlier please first read the definitions of re use under ROW 15 at page 5 of these guidance notes v complete SECTION 2 one column at a time in line with the sequence shown by the arrows For each entry in a column i e each box select the most appropriate code from the code list for that ROW using the code lists at pages 2 3 of these guidance notes entering only one code in any one box Complete as many columns as necessary to describe fully the use of different groups of animals in a particular procedure vi each completed column should record all the procedures for any animal or group of animals of the same species which are de scribed by that particular combination of codes If your project requires more than 50 columns to describe it please contact the Animals in Science Regulation Unit vii where procedures are carried out on multiple sites under a licence please check that all procedures have been included viii complete the declaration in SECTION and return the form as soon as possible to your Home Office
31. for the years prior to 1977 was published in the form of a Return to an Address of the Honourable the House of Commons 27 Further information 6 3 Some sources of further information are detailed below i ii iii iv v vi vii Information about the work of the Animals in Science Regulation Unit can be found in the latest Annual Report of the Home Office Animals in Science Regulation Unit at https www gov uk government publications animals in science regulation unit annual report 2011 Guidance on the Operation of the Animals Scientific Procedures Act 1986 at http www archive official documents co uk document hoc 321 321 xa htm Information about the Animal Procedures Committee can be found at https www gov uk search q animal procedures committee Information about the National Centre for the Replacement Refinement and Reduction of Animals in research NC3Rs can be found at http www nc3rs org uk Information relating to Northern Ireland is published by the Department of Health Social Services and Public Safety and can be found at http www dhsspsni gov uk healthprotection animalscience Information relating to the EU is available on the European Commission s website http ec europa eu environment chemicals lab_animals reports_en htm Information on public attitudes to animal testing is available from MORI at http www ipsos mori com researchspecialisms socialresea
32. hrough the presentation of a detailed annual statistical report 1 4 Formally the purpose of the publication is to meet the requirements of the Animals Scientific Procedures Act 1986 section 21 7 The Secretary of State shall in each year publish and lay before Parliament such information as he considers appropriate with respect to the use of protected animals in the previous year for experimental or other scientific purposes The system of control under the 1986 Act is explained in detail in Appendix A of the annual publication 1 5 The data collection along with corresponding collection of data for Northern Ireland by DHSSPS enables the UK to meet requirements for data to be supplied to the EU The latest EU seventh report provides an overview on the number of animals used in the EU in 2011for experimental and other scientific purposes The EU report includes data from all 27 Member States submitted in the agreed format by all countries and is available at http ec europa eu environment chemicals lab_animals reports_en htm 1 6 The objective of the EU report is to present to the European Council and European Parliament in accordance with Article 26 of Directive 86 609 EEC of 24 November 1986 on the approximation of laws regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes the statistical data on the number of animals used for ex
33. ibia from the stage when 4 limbs have developed including Axolotls Larval embryonic foetal animal Do not count these animals enter 0 in ROWs 13 14 and I5 ROW 4 GENETIC STATUS Select the most appropriate code from the list below l Normal animal 2 Animal with harmful genetic defect e g harmful mutants 3 Genetically modified animal e g transgenic knock out Important guidance on coding and counting of harmful mutants or genetically modified animals is given in Annex B ROW 5 SOURCE OF ANIMALS Schedule 2 of the Act lists the following species any mouse of the species Mus musculus any rat of the species Rattus norvegicus guinea pig any hamster of the species Mesocricetus auratus or Cricetulus griseus any gerbil of the species Meriones unguiculatus any rabbit of the species Oryctolagus cuniculus cat dog ferrets primate any bird of the species Coturnix coturnix quail any frog of the species Xenopus laevis and tropicalis Rana temporaria and pipiens zebra fish pigs if genetically modified and sheep if genetically modified Enter 0 If the species is NOT listed in Schedule 2 For Schedule 2 species enter l If the animals were acquired from within own designated establishment If the animals were acquired from another designated establishment in the UK e g a university or commercial breeder If the animals were acquired from non designated sources in the UK If the animals were acquired from
34. iments General Committee debate 3 December 2012 on Animals Scientific Procedures Act 1986 Amendment Regulations 2012 http www publications parliament uk pa cm201213 cmgeneral deleg6 121203 121203s01 htm Replies to Parliamentary questions PQs Replies to around 20 written PQs were provided by the Home Office during 2013 Topics included overall numbers of procedures and a range of questions relating to Wales and Scotland Media coverage for the report on 2012 data BBC http www bbc co uk news science environment 23325821 Guardian http www theguardian com science 2013 jul 16 research animals rises 4m procedures Users As well as Parliament the media the general public and individual licensees there is a wide range of organisations with an interest in these statistics some examples are listed below The list is illustrative and not meant to be exhaustive Animals in Science Regulation Unit Home Office https www gov uk research and testing using animals APC Animal Procedures Committee NC3Rs NC3Rs National Centre for the Replacement Refinement and Reduction of Animals in Research FRAME FRAME Fund for the Replacement of Animals in Medical Experiments BUAV http www buav org National Anti Vivisection Society NAVS UAR Understanding Animal Research RSPCA www rspca org uk Research funders e g Wellcome Trust www wellcome org and Medical Research Council www mre ac uk E
35. ing that all licensees expected to provide returns have done so all licensees providing returns for previous year s exercise where not revoked in the previous year plus all licences granted during the year e identifying forms containing invalid or missing data e identifying invalid combinations of codes e g Schedule 2 species indicated by Row5 entry but Row 5 entry is not a Schedule 2 species e identifying returns containing unusual or rare combinations of codes e checking data on specific issues e g all returns indicating use of species covered by the Convention on International Trade in Endangered Species CITES are checked e variance checking i e investigating substantial changes in figures compared with the previous year Reference materials Form Notes 6 1 A copy of the form notes is given below and overleaf 18 Animals Scientific Procedures Act 1986 NOTES FOR RETURN OF PROCEDURES For each project licence held the licence holder should complete a separate form by 31 January for all regulated procedures on living animals started in the previous year including the work of all personal licensees performing regulated procedures on their project as part of the conditions for the licence NB Failure to provide a return constitutes a breach of the Act and can be considered as an infringement This can affect other licences held and any future licence applications NOTES ON COMPLETING THE FORM a checklist i discard any pr
36. istics publication Summary and Commentary have sometimes been rounded to the nearest 1000 or 100 procedures or to 2 significant figures depending on the size of the figures in a particular section of commentary For given sections all figures are presented in an unrounded form where some figures are less than 1 000 and all figures are presented to the nearest 100 where all figures are in their thousands All figures in millions are presented as millions to two decimal places e g 4 36 million This practice is taken in order to simplify the explanation presentation therefore the figures shown will not be identical to the figures in the tables However percentage changes given are calculated using the unrounded data available in the tables 2 5 The data presented in the tables and commentary in the annual statistical publication relate to either e the number of procedures started in the year most tables adult animals only i e excluding foetal larval or embryonic animals or e the number of animals used for the first time tables appended with suffix a e g Table la Table 6a Table 9a as part of the procedures started in the year adult animals only 2 6 In most cases the number of procedures started corresponds to the number of animals used Where the number of procedures started is higher than the number of animals used then by implication there has been re use of animals Non countable procedures 2 7 It is impractica
37. itted and if a species is not mentioned it is because the row or rows pertaining to that species is blank Genetic status of animal 3 2 Table 2 source Table 3 genetic status and Table 6 non toxicological work by field of research are subdivided to give more information about animals with abnormal genetic constitutions Table 2 shows procedures using all animals Table 2 1 shows the number of procedures using animals with harmful but naturally occurring genetic defects and table 2 2 shows the number of procedures using genetically modified animals Table 6 follows the same pattern Table 3 is subdivided into three supplementary tables 3 1 3 2 and 3 3 to present in detail the use of normal animals harmful mutants HM and genetically modified GM animals respectively in breeding programmes or research Primary purpose Table 1 3 3 The use of animals for regulated procedures is limited by section 5 3 of the Act to one of the following primary purposes i Fundamental biological research carried out with the primary intention of increasing knowledge of the structure function and malfunction of man and other animals or plants Such studies may be aimed solely at an increase in knowledge application of that knowledge being beyond the scope of the investigation or with a view to providing a practical solution to a medical or veterinary problem once the issues are more clearly defined and understood This category includes physiologic
38. m returns have been received Those who fail to do so are reminded of their obligation under the Animals Scientific Procedures Act 1986 5 3 To ensure that the published data are as complete as possible the Home Office will not publish the statistics unless the number of missing returns represents less than 0 5 percent of all the returns expected Confidentiality 5 4 Detailed information on the work of individual project licence holders is not readily identifiable in this publication Where a further breakdown of the other species categories are not given in the commentary this is to safeguard the confidentiality of the establishment and the licence holder 5 5 The current classification system coding lists dates from 1995 and was modified in 1999 in those areas relating to the source of animals production and breeding to produce genetically modified GM animals or harmful mutants HM toxicology and legislation During the collection and verification process forms that have been incorrectly coded are referred back to the licensees for clarification and correction as needed Further details of the coding of GM and HM animals are given in the form notes para 6 1 Quality assurance 5 6 There is a wide variety of quality assurance checks carried out with the expert assistance of colleagues in the Animals in Science Regulation Unit and with follow up contact with licensees as needed for example e checking for duplicates e check
39. or cancer research may apply to either veterinary or medical science the appropriate code for the primary purpose of the animal use would have been given in ROW 8 BOI Anatomy and developmental biology B02 Physiology B03 Biochemistry B04 Psychology Behaviour BO5 Pathology B06 Immunology B07 Microbiology B08 Parasitology B09 Pharmacology BIO Pharmaceutical Research and Development except for anti cancer agents code B17 BII Therapeutics BI2 Clinical Medicine BI3 Clinical Surgery including technique development BI4 Dentistry BI5 Genetics BI6 Molecular Biology BI7 Cancer Research including therapy BI8 Nutrition BI9 Zoology Botany and plant pathology Agricultural Animal Science not included in codes above Ecology and environmental studies other than toxicology or other safety evaluation Animal welfare studies not included in the codes above Other purpose if you use this code you must provide a separate note describing the procedure Tobacco research Use these codes for research on tobacco Alcohol research f or alcohol or their constituents Do not use these codes for use of these substances as pharmacological tools or standards REMEMBER Do not mix codes from lists A and B in the same column Page 4 LIST B ROW II PRODUCTION AND BREEDING If you used a code from BO to B32 in ROW 10 select a code from the list below which applies to the procedure described in this column Production of biological materials B50 Asci
40. perimental and other scientific purposes in the Member States of the EU Confidentiality and data quality 1 7 Detailed information on the work of individual project licence holders is not readily identifiable in the annual statistics Where a further breakdown of the other species categories are not given in the commentary this is to safeguard the confidentiality of the establishment and the licence holder Revisions to data 1 8 Data for the latest calendar year may be revised in due course It is the authors standard practice to incorporate revisions for previous years in the latest release Corrections and revisions follow the Home Office corporate revisions policy https www gov uk government publications statement of compliance with code of practice for official statistics page 5 Revisions analysis 1 9 There have been no revisions to the 2012 figures first published in July 2013 Any errors in the 2012 returns were discovered in time to be corrected in the July 2013 report There have been no subsequent re submissions Acknowledgements 1 10 This publication has been prepared by staff in the Home Office Statistics unit of the Home Office Science Group They are grateful for the support of colleagues in Policing Data Collection Section for data input the Animals in Science Regulation Unit for their assistance with the collection processing and quality assurance processes involved in preparing the report and
41. r than legislative requirements The following are examples of specific legislative requirements that may be included Medicines Act 1968 Workplace safety e g Health and Safety at Work Act 1974 COSHH Regulations Substances used in agriculture e g Control of Pesticides Regulations 1986 EU Pesticides Directives Substances used in foodstuffs e g Food Safety Act 1990 iii Specific types of toxicity tests Table 11 The table shows a acute and subacute dose ranging or limit setting lethal toxicity tests b acute quantitative lethal toxicity tests c acute and subacute non lethal clinical sign toxicity tests d subchronic and chronic toxicity tests e carcinogen teratogen mutagen tests other reproductive toxicity tests g tests for clinical signs in the eye b tests for clinical signs on the skin including irritation or sensitisation 1 toxicokinetics pyrogenicity biocompatibility and other toxicology tests iv Tables showing some selected work in greater detail There are three further tables that examine some aspects of toxicological work in greater detail Table 12 Non pharmaceuticals list A row 10 codes AO1 A06 Table 15 Pharmaceuticals list A row 10 codes Al 1 A14 Table 16 Other safety or toxicology list A row 10 codes A21 A25 Using the statistics v 4 1 The following list of uses of official statistics was produced October 2010 by the UK Statistics Authority The
42. rch specareas nhspublichealth attitudestowardsani malexperimentation aspx Home Office Statistics July 2014 28
43. se on another protocol 1 8 based on further B63 or B65 procedures Do not code as 9 December 2013 Page 7 Scenario How to ROW 4 Genetic Status ROW 8 Primary ROW II Production and breeding GM or HM animals generated on one project licence but transferred to another PPL 10 If used only for breeding on the second PPL count only on the originators return when born 2 or 3 9 B62 or B64 If used in an experiment do not count at all on the originators return count on the recipient s final use protocol as appropriate 1 8 based on further procedures Do not code as 9 B63 or B65 12 GM or HM animals generated on a PPL but then exported released from ASPA e g by a transfer form Count on the originator s return 9 B62 or B64 Imported GM or HM animals 13 Imported and used solely for breeding Count in the year when first obtained B62 or B64 14 Imported and used in a non breeding procedure 1 8 based on procedures B63 or B65 Other scenarios 15 Used for production of biological material or 2 or 3 1 8 based on procedures B50 to B56 as appropriate 16 Normal mice crossed with GM or HM mice in breeding protocol Do not count 17 All other animals i e neither GM or HM not used for the generation of founders and not used for production of biological materials December 2013
44. should be coded B65 in ROW II ROW II How to code Production and Breeding Harmful mutant and Genetically modified animal use generally falls under B Codes rarely are they used in safety evaluation work where A codes would be applicable Code B79 should be used if none of the previous codes are applicable ie animals not used for production of biological materials and neither GM nor HM animals How to Code Common Scenarios How to code ROW 4 Genetic ROW II Production and Scenario Status ROW 8 Primary Purpose breeding Generation of founders I Normal animals used to generate founder colony 2 GM or HM animals used to generate founder colony Offspring that are Normal animals and Not Biopsied Do not count Biopsied l B61 if from founders B62 or B64 if from breeding colony Used in further procedures e g as controls 1 8 based on further B79 for GM and HM animals procedures Do not code as 9 Offspring that are GM or HM offspring and 6 Used exclusively for maintenance of B62 or B64 breeding colony Intercurrent deaths or animals not used B62 or B64 for breeding or anything else Killed by a Schedule listed method Animals whether used for breeding or not 1 8 based on further use B63 B65 but afterwards killed by a Schedule listed Do not code as 9 method and tissues used post mortem ie scientific use made of the animal but outside ASPA Continued u
45. t shown in any of the published tables This is because it may be impracticable in some cases to count such procedures e g a foetus resorbed during gestation or fish fry that are very small and fast moving Genetic status 3 7 Only the number of animals in which a harmful genetic defect actually manifested itself has been recorded for spontaneously arising mutants All GM animals are recorded Additional information on counting animals in those categories is provided in Annex A at the end of Appendix B 3 8 The detailed online Table 3 1 shows the use of genetically normal animals in breeding programmes for both HM and GM animals The number of procedures is shown for e normal animals used to generate founder GM animals which themselves will be further used in breeding programmes e normal animals within GM breeding colonies and e normal animals within breeding colonies of animals with naturally occurring harmful mutations 3 9 The detailed online Tables 3 2 and 3 3 show the use of HM and GM animals respectively in breeding programmes or research The structure of these two tables is similar They show respectively for HM and GM animals e procedures undertaken for maintenance of the breeding colony e procedures undertaken for research analysis post mortem e further regulated procedures following on from the breeding programme e procedures used for production and e procedures for toxicological safety evaluation purposes Breeding
46. tes model for production of monoclonal antibodies B51 Production and maintenance of infectious agents B52 Production and maintenance of vectors e g insects B53 Production and maintenance of neoplasms B54 Initial immunisation for subsequent in vitro or in vivo production of monoclonal antibodies B55 Production of polyclonal antibodies B56 Production of other biological material e g plasma tissues Use of Genetically Modified or Harmful Mutant Animals Please read Annex B pages 6 8 to ensure correct use of the following codes B6 Animals used to generate founder genetically modified animals for novel transgenic lines chimeras or clones This includes normal animals used in such programmes e g superovulation vasectomy pseudopregnant recipients as well as those animals culled as not being of the appropriate genetic status but which have undergone regulated biopsy procedures Genetically modified animals generated by recognised husbandry methods for the maintenance of a breeding colony This may include normal animals which have undergone regulated biopsy procedures produced by using heterozygote parents as well as animals with a fate as set out in Annex B Genetically modified animals used in research programmes where they underwent regulated procedures other than those required for a breeding programme i e where the primary purpose was NOT breeding i e ROW 8 not 9 Normal or wild type animals used as controls in such
47. tilian species please append a note indicating species used AMPHIBIAN MI Rana temporaria M2 Rana pipiens M3 Xenopus laevis M4 Xenopus tropicalis M5 Other amphibian species please append a note indicating species used FISH FI Zebra fish F2 Other fish please append a note indicating species used CEPHALOPOD F5 Any Cephalopod please append a note indicating species used ROW 2 CITES Animals of endangered species listed in Appendix of the Convention on International Trade in Endangered Species of Flora and Fauna CITES or in Annex C I to the Council Regulation EEC 3626 82 a are subject to special controls and information is required on their use Most species and strains of animals used in the laboratories are NOT included in the CITES lists Please consult your Inspector for further information Select the appropriate code from the list below 0 the species is not so listed l the species used in this procedure is listed in Appendix or Annex C 1 please give both common and Latin name for species Some examples of CITES codes 0 Common marmosets macaca spp except M silenus Cotton top tamarins Saguinus oedipus some birds of prey such as Peregrine falcon Falco peregrinus ROW 3 STAGE OF DEVELOPMENT Select the appropriate code from the list below l Adult animal free living including neonatal and juvenile mammals and newly hatched birds Use this code for Zebra fish fry from 6 days post fertilisation and amph
48. ts Breeding of harmful mutants or genetically modified animals Before selecting this code please read the guidance in Annex B If using this code ROW must be B61 B62 or B64 ROW 9 BODY SYSTEM Select the code from the list below which most closely describes the primary target body system for the procedure Ol Respiratory 02 Cardiovascular Nervous work directed towards central or peripheral nervous systems other than the special senses Special Senses sight hearing smell taste Alimentary including liver and excretory Skin Musculo skeletal Reproductive Immune and reticulo endothelial Other system where the target was a single system not listed Multiple systems where more than one system was of primary interest e g respiratory and immune system System not relevant where the system or systems affected were not predictable or not relevant e g safety studies ROW 10 11 amp 12 Codes from EITHER list A OR LIST B should be used to complete these rows within a column A mixture of A and B codes within a column is not permitted Use list A if the primary purpose of the procedure described in the column was a toxicological or other regulatory or safety purpose including efficacy quality control ADME Use list B for any other primary purpose December 2013 Page 3 LIST A ROW 10 TOXICOLOGY OR OTHER SAFETY OR EFFICACY EVALUATION If the procedure was carried out for a toxicological or other safety related purpose
49. uropean Commission http ec europa eu environment chemicals lab_animals reports_en htm LAVA Laboratory Animals Veterinary Association LASA Laboratory Animal Science Association IAT Institute of Animal Technology Federation of European Laboratory Animal Science Associations www felasa eu Collection procedures coverage confidentiality and quality assurance Collection and coverage 5 1 The statistics are compiled from returns submitted by project licence holders at the end of each year or on the termination of the licence when this occurs during the year A copy of the form instructions can be found in this user guide including the detailed definition of a procedure and descriptions of the standard coding lists used for describing procedures Each procedure which may consist of several stages for a given purpose on an animal is counted as one returnable procedure for the year in which it commenced A study involving a procedure using a number of animals is counted once for each animal Where an animal that has recovered fully from a completed procedure is used again for a further procedure it is counted as a separate procedure but the animal itself is not re counted The circumstances in which this re use of an animal is permitted are limited 5 2 Licence holders are required as a condition of their licence to submit a return even if no work has been undertaken nil returns A record is kept of all licensees from who
50. use made of official statistics A range of the expected uses of the statistics is given below and the examples marked with a tick Y i Informing the general public s choices a about investment decisions b about service providers c about lifestyle choices d about the state of the economy society and the environment Ye g via Parliament amp the media and e about the performance of government and public bodies e g via Parliament amp the media ii Government decision making about policies and associated decisions about related programmes and projects a policy making and vw b policy monitoring Y iii Resource allocation typically by central and local government ve iv Informing private sector commercial choices Y a targeting local markets b targeting households and individuals and c designing market research surveys v Informing public marketing campaigns vi Supporting third sector activity a lobbying vy b funding applications Y vii Facilitating academic research Y Examples of use of the annual statistics 4 2 Below are some examples of uses made of the statistics Parliamentary debates Westminster Hall debate 24 February 2009 24 Feb 2009 Column 25WH http www publications parliament uk pa cm200809 cmhansrd cm090224 halltext 90224h0004 htm 09022447000459 House of Commons Library Standard Note SN SG 2720 animal experiment statistics Last updated 19 February 2009 note on animal exper
51. ving vertebrate animal or one species of octopus Octopus vulgaris which is likely to cause that animal pain suffering distress or lasting harm is a regulated procedure requiring licence authority Recognised veterinary agricultural or animal husbandry practice and the administration of medicines under an Animal Test Certificate granted under Veterinary Medicines Regulations 2008 are excluded from the controls of the 1986 Act 2 17 The system of control under the 1986 Act is explained in detail in Appendix A of the annual statistics publication Some information previously included is now published via the Annual Report of the Home Office Animals in Science Regulation Unit available at https www gov uk government publications animals in science regulation unit annual report 2012 Explanatory notes for published tables Definitions All tables refer to numbers of scientific procedures started on adult animals in the calendar year unless indicated otherwise Tables suffixed with an a e g Tables la 6a 9a relate to numbers of animals used Symbols used in tables 5 not available nil NA not applicable r revised Organisation Chart Relationship between the tables 2012 TABLE 1 i TABLE 1a Species by purpose Species by purpose procedures anima TABLE 2 e of anima i ZZZ Anaesthesia F Toxicology Non toxicology re ree ere Cee ne ee ee eee ge renee ge dee eee ee ee ee ee ee eee eee ee 1 TABLE 9 od TABLE 9a TABLE
52. were re used before in 2012 If the figure in ROW 13 Number of procedures exceeds the figure in ROW 14 Number of animals used for the first time in 2013 then some animals must have been re used Definition Re use s a term used where after completion of one series of regulated procedures an animal is used again in the same or a different protocol where a previously unused animal would have equally sufficed to meet the objectives of the second and subsequent use See the HO Website for further guidance on the definition of Re use chi hom tna FOA an or Nial researe jpu 26 http sc scienceandresear rer Vuka eee Ications a referen D animals tview ang pu Example of re use An animal is bled three times per year for the collection of normal blood starting in 2012 and continuing in 2013 For the return on 2012 procedures the entries for ROW 13 ROW 14 and ROW I5 would be 3 I respectively For the return of 2013 procedures the entries for ROW 13 ROW 14 and ROW 15 would be 3 0 respectively In the first year the animal is used it would be counted once in ROW 14 three procedures would be recorded in ROW 13 and one procedure in ROW I5 for the first re use In subsequent years the figures would be ROW 13 3 ROW 14 0 and ROW 15 1 See also the worked example in column 3 on page 6 CHECKS ON ROW 13 ROW 14 ROW I5 Please check as follows bd ROW 3 entry is 2 entries at ROW 13 ROW 14 ROW 15 must
53. y and other safety evaluation c tobacco and alcohol research lists only those procedures done for research on the effects of tobacco or alcohol and not those where these substances are used as experimental tools or standards note also that tobacco safety procedures would be reported in Table 9 ii Production of biological materials Table 7 The table shows procedures for a production and maintenance of infectious agents excluding those causing neoplasms b production and maintenance of vectors e g parasites c production and maintenance of neoplasms d the ascites model for the production of monoclonal antibodies e initial immunisation for subsequent in vitro or in vivo production of monoclonal antibodies f production of polyclonal antibodies g production of other biological material e g plasma tissues iii Techniques of particular interest Table 8 This table provides a selective list that identifies those procedures in which a technique is of itself of particular interest as for example the application of a substance to the eye or exposure to ionising radiation The procedures recorded in this table do not include those undertaken for toxicology or safety evaluation However few of these techniques would be used in routine regulatory toxicology or safety assessments Toxicity tests or other safety or efficacy evaluation 3 21 This group of tables is sub divided into four main areas of interest
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