Update on the New ASPA
What has stayed the same, what's changed, and what's new
The Animals (Scientific Procedures) Act 1986 was amended in January 2013 to transpose the requirements of the new EU Directive, 2010/63. A summary of the major changes is listed below. For full details, see the draft Guidance on the Operation of the Animals (Scientific Procedures) Act 1986 (as amended), available on the Home Office website.
What has stayed the same?
The central concepts of the Act remain unchanged. The Act controls the performance of 'regulated procedures'. These are procedures carried out for a scientific purpose on 'protected animals', which may cause pain, suffering, distress or lasting harm. The system of control operates at three levels (person, project, place). It places emphasis on the three Rs of reduction, refinement and replacement, and requires that those carrying out procedures take personal responsibility for the welfare of the animals they use. Schedule 1 lists appropriate methods of humane killing, for which no licence authority is required. Some types of animals, listed in Schedule 2, must be purpose-bred for use in research.
Establishments where procedures are carried out must usually be licensed. The holder of this licence is ultimately responsible for the conduct of procedures at the establishment. He or she must identify individuals to be responsible for certain aspects (Named persons), and set up a local ethical review process.
Project licences are still in force for 5 years. They are assessed by the Home Office, and a harm-benefit analysis carried out. The minimum number of animals of least neurophysiological sensitivity must be used in procedures causing least pain suffering distress and lasting harm, that are most likely to produce satisfactory results. There are restrictions on the use of special species (cats, dogs, equidae and primates), and the purposes for which project licences may be granted (permissible purposes) are limited.
Personal licences are issues to persons over the age of 18 who have completed mandatory training requirements. These licences identify the procedures that can be carried out, and on what species. Personal licensees bear primary responsibility for the welfare of the animals they are working on.
What's changed?
The stage of development from which immature mammalian, avian and reptile forms become protected has moved to2/3 through gestation or incubation.
Weight limits for some of the methods of humane killing listed inSchedule 1have beenchanged slightly. Non-schedule 1 methods that are considered equally humane may be added to the Establishment licence, and no other licence authority would then be required to carry out such a method.
Animals listed inSchedule 2must be purpose bred for research, but thisno longer has to be from a licensed supplier in the UK.Home Office permission is no longer needed therefore to import these animals from abroad.
Establishment licenceshave replaced certificates of designation. Theregister of those competent to carry out humane killingmust now include all methods of killing, not just schedule 1 methods. The minimum standards of housing and care set out in theCode of Practice are now mandatory(previously these were advisory only). The ERP is now known as theAnimal Welfare and Ethical Review Body.
Project licences:Thepermissible purposesfor which project licences may be granted have changed. Project applications must be accompanied by anon-technical summary- this is now compulsory and must follow a set format. Project licences no longer have an overall severity band. Severity limits for procedures are now eithernon-recovery, mild, moderate or severe.
Personal licencesnow listtechniques in categories, corresponding to the level of training undertaken, rather than listing all the individual techniques. They must still have a primary availability specified, but areno longer tied to a specific establishment, making movement of personnel easier.
For all three licences, thestandard conditionshave changed.
What's new?
The definition ofprotected animalshas been extended to include not just all living vertebrates other than man, but alsolive cephalopods,from the end of their embryonic stage.
Athresholdhas been set for procedures to be regulated asequivalent to or higher than the introduction of a needle in accordance with good veterinary practice.
The use ofsedationprior to any other method of humane killing inSchedule 1is now permitted. The process of humane killing must be completed by a confirmatory method (even if cervical dislocation was used as the method of killing).
The number of species listed inSchedule 2has increased: chinese hamster, zebrafish,Ranaspp andXenopusspp. have been added to the list of animals which must now be purpose bred.
There are now more individuals named on theEstablishment licence- as before, there is a named veterinary surgeon, and named animal care and welfare officer, and these two have been joined by thenamed training and competence officer, named person responsible for compliance, and named information officer.
Theactual severity of procedures must be recorded by the project licence holderas of now, and will be required to be reported retrospectively from 2014.