8. The failure of control8.1. Despite <strong>the</strong> foregoing issues, <strong>the</strong>re remain many people who believe that <strong>the</strong> best, perhaps <strong>the</strong> only, wayof securing <strong>the</strong> protection of animals in laboratories is through more legal controls and better regulations. Whilenot denying that some legal restrictions – for example, <strong>the</strong> move against cosmetic testing on animals and testingfor household products – are to be welcomed (Thew, 2013a, 2013b), we have to question whe<strong>the</strong>r many of <strong>the</strong>even well-meaning controls are effective in terms of preventing suffering. We provide five examples: inspection,licensing, supervised self-regulation, <strong>the</strong> Three Rs, and care and ethics committees. To avoid <strong>the</strong> charge ofselecting <strong>the</strong> worst examples, we mainly focus on <strong>the</strong> UK, which, as we have noted, purportedly provides <strong>the</strong>most protection for animals.Inspection8.2. The first issue of questionable effectiveness concerns <strong>the</strong> inspection of experiments and compliance withregulations in <strong>the</strong> UK. To monitor compliance with <strong>the</strong> provisions of <strong>the</strong> Animals (Scientific Procedures) Act,(hereafter ‘ASPA’), <strong>the</strong> inspectorate of <strong>the</strong> Animals in Science Regulation Unit (hereafter ‘ASRU’, formerly <strong>the</strong>Animals Scientific Procedures Inspectorate) is required to visit establishments to ensure compliance with <strong>the</strong> termsof <strong>the</strong> licence issued. In <strong>the</strong> event of any breach of licence conditions, <strong>the</strong> inspectorate should report to and advise<strong>the</strong> Secretary of State on <strong>the</strong> action to be taken. Since 2006, <strong>the</strong>re has been a steady but noticeable decline in <strong>the</strong>number of inspections carried out and, conversely, a steady but noticeable increase in <strong>the</strong> number of infractionsnoted (ASRU, 2011, pp. 29–32; ASRU, 2012, pp. 35–38). This statistical anomaly aside, it might appear – whenwe consider <strong>the</strong> figures in isolation – that <strong>the</strong> system of inspection works fairly well: year on year, <strong>the</strong> inspectorsunearth (or are informed of) around thirty violations of licence conditions, and in all cases, some form of actionis taken against <strong>the</strong> licence holders (ASRU, 2011, p. 29; ASRU, 2012, p. 35) 9 . A more critical analysis of <strong>the</strong>inspectorate’s own reports, on <strong>the</strong> o<strong>the</strong>r hand, reveals that <strong>the</strong> ASRU must institutionalise a working definition ofwelfare that is at odds with normal practice.8.3. When dealing with violations, <strong>the</strong> inspectorate classifies infractions as falling between Category A (leastserious) and Category D (most serious). According to <strong>the</strong> most recent available data, in 2011 and 2012, <strong>the</strong>re weretwenty-eight Category A infringements (fifteen in 2011 and thirteen in 2012), twenty-one Category B infringements(eleven in 2011 and ten in 2012), nine Category C infringements (six in 2011 and three in 2012) and one CategoryD infringement (in 2011). Insofar as Category A infringements are concerned, it is clear that <strong>the</strong>se are deemed sominor as to be almost trivial: <strong>the</strong>se cases, according to ASRU guidelines, are those which are characterised, interalia, as having ‘no animal welfare implications’ and are typically dealt with as requiring ‘no fur<strong>the</strong>r action’ beyondnoting and recording <strong>the</strong> infraction (ASRU, 2011, p. 27; ASRU, 2012, p. 33). When <strong>the</strong> (albeit scant) reports of whathappened in <strong>the</strong>se cases of Category A infringements are compared against <strong>the</strong> Home Office’s categorisation,a particularly telling picture emerges of exactly what <strong>the</strong> Home Office inspectorate’s view of ‘no animal welfareimplications’ actually means. For instance, <strong>the</strong> ‘unexpected’ exceeding of a severity band assessment – frommoderate to substantial – did not, according to <strong>the</strong> inspectors, result in any animal welfare implications (ASRU,2011, p. 11; ASRU, 2012, pp. 13–14) despite <strong>the</strong> fact that a moderate level of suffering was at <strong>the</strong> time deemed toinclude those ‘protocols that have <strong>the</strong> potential to cause greater suffering but include controls which minimiseseverity’, and a substantial level of suffering was ‘a major departure from <strong>the</strong> animal’s usual state of health orwell-being’ according to <strong>the</strong> Home Office’s own classifications (Home Office, 2000, para 5.42) 10 . Nor, accordingto <strong>the</strong> ASRU, were <strong>the</strong>re any animal welfare implications resulting from ‘animals being left in a scanner overnight’(ASRU, 2011, p. 11) (presumably without any of <strong>the</strong> most basic and mandatory requirements of welfare, such asfood, water, and bedding).9Over half of all breaches of licensing conditions are incidents of ‘self-reporting’ by <strong>the</strong> licence holders <strong>the</strong>mselves. In <strong>the</strong>secircumstances, <strong>the</strong> inspectorate’s role becomes one of advising <strong>the</strong> Home Secretary of appropriate action to be taken.10This guidance has been superseded under <strong>the</strong> new ASPA. There is no equivalent definition.48 <strong>Normalising</strong> <strong>the</strong> <strong>Unthinkable</strong>: The Ethics of Using Animals in Research
8.4. When Category B infringements are considered along <strong>the</strong> same lines – that is, <strong>the</strong> categorisation ofcompromised animal well-being compared to what actually happened – a similar picture emerges. CategoryB violations are those which are ‘not sufficiently serious for referral for prosecution, revocation of licences orwithdrawal of a certificate to be considered’ and are characterised as having ‘animal welfare implications thatdo not necessarily involve avoidable or unnecessary pain, suffering, distress or lasting harm’ (ASRU, 2011, p.28; ASRU, 2012, p. 33). When <strong>the</strong>re are, in <strong>the</strong> opinion of <strong>the</strong> inspectorate, ‘serious animal welfare implicationsinvolving avoidable pain, suffering, distress or lasting harm’, <strong>the</strong>se should be classified as Category C or D.Hence, it is clear that <strong>the</strong> inspectorate did not consider that <strong>the</strong> deaths of 474 fish, over a period of twenty-fourto forty-eight hours, as a result of being kept in ‘water inappropriate to <strong>the</strong>ir needs’, necessarily resulted in any‘avoidable or unnecessary pain, suffering, distress or lasting harm’. Likewise, it was not necessarily <strong>the</strong> case thatlasting harm or unnecessary suffering was felt by <strong>the</strong> two rats ‘inadvertently left in an unattended procedure roomwithout access to water from Friday to Sunday’ or by <strong>the</strong> eleven mice who died when <strong>the</strong> severity limit imposedby <strong>the</strong> licence was unexpectedly exceeded or by <strong>the</strong> three rats who died after being left in a ‘warming box toprepare <strong>the</strong>m for a procedure’ but were promptly forgotten about (ASRU, 2011, pp. 11–13).8.5. Similarly, according to Home Office classifications, no lasting harm was done to <strong>the</strong> mouse abandoned to dieunattended over <strong>the</strong> course of a weekend following an ectopic heart transplant, and no avoidable suffering wasfelt by <strong>the</strong> five rats who, because of an ‘oversight’ by <strong>the</strong> project licence holder, were not given any pain relief fortwo weeks following spinal surgery (ASRU, 2012, pp. 14–15). In all of <strong>the</strong> afore-cited examples, <strong>the</strong> inspectoratewas content that only a Category B infringement (‘not necessarily involving avoidable pain, suffering, distress orlasting harm’) had taken place.8.6. The point to be made here is that in <strong>the</strong> context of scientific procedures, <strong>the</strong> regulators have <strong>the</strong>ir owndefinition of welfare, and this definition appears to rule out individual instances of suffering as relevant factors.How else would it be possible to state, as <strong>the</strong> Home Office inspectorate did, that <strong>the</strong> preceding accounts involve‘animal welfare implications that do not necessarily involve avoidable or unnecessary pain, suffering, distressor lasting harm’, unless one were to ascribe a meaning to ‘avoidable or unnecessary pain, suffering, distress orlasting harm’ that does not include individual animal suffering?8.7. This interpretation of ‘welfare’ might be understandable if <strong>the</strong>re was no statutory guidance determining <strong>the</strong>manner in which animals should be cared for and housed before, during, and after a procedure. But of course,<strong>the</strong>re is statutory guidance in <strong>the</strong> form of <strong>the</strong> ASPA. While ASPA underwent significant changes in January 2013 toincorporate <strong>the</strong> EU’s Directive 2010/63, <strong>the</strong> incidents referred to previously should be considered under <strong>the</strong> versionof <strong>the</strong> act in force at <strong>the</strong> time of <strong>the</strong>se incidents.8.8. For any project (i.e., series of individual procedures and protocols) to be authorised, a licence must beissued by <strong>the</strong> Secretary of State. In her determination of whe<strong>the</strong>r <strong>the</strong> project is justified, <strong>the</strong> Secretary of Statemust first engage in <strong>the</strong> cost-benefit analysis referred to earlier in this report. Second, she is to ensure that allestablishments using animals for scientific purposes ensure that minimum levels of welfare and pre- and postprocedurecare are adhered to, so as to avoid what Russell and Burch called <strong>the</strong> ‘contingent inhumanity’ ofimperfect husbandry by which suffering is inflicted upon an animal ‘as an incidental and inadvertent by-product… of <strong>the</strong> procedure, which is not necessary for its success’ (Russell and Burch, 1959, p. 54).8.9. Consequently, numerous provisions are found in ASPA regulating all aspects of <strong>the</strong> experimental‘process’. For instance, subject to <strong>the</strong> exercise of <strong>the</strong> Home Secretary’s discretion (Home Office, 1986, s.6[2]), allexperimentation must take place in a designated ‘scientific procedure establishment’ (Home Office, 1986, s.6[1]).Under <strong>the</strong> terms of any licence granted, all establishments should have ‘a person to be responsible for <strong>the</strong> day-A <strong>Report</strong> by <strong>the</strong> Working Group of <strong>the</strong> Oxford Centre for Animal Ethics49
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