Development of the legislation Part 1 EU Flashcards
What was the earliest anti-cruelty law?
1634 – “An Act against Ploughing by the
Taile, and Pulling the Wooll off Living
Sheepe”
Enacted by the Parliament of Ireland
Activities described as a “barbarous custome”
Punishable by fines & imprisonment
What is the ASPA?
Animals (Scientific Procedures) Act, 1986
this was amended by Regulations in 2012 to give effect to Directive 2010/63/EU. ASPA is often more detailed or more restrictive than EU/Irish legislation
What is the name of the Irish regulations for the use of animals in research?
Ireland SI 17 of 1994 and SI 566 of 2002
Both amending Cruelty to Animals Act 1876
What are the 8 Annexes of the Directive 2010/63/EU
I. List of species that must be purpose-bred If they are to be used in research
II. Non-human primates
III. Care & accommodation - requirements
IV. Methods of killing
V. Training of personnel - syllabus
VI. Applications for project authorisations
VII. EU Reference Laboratory
VIII. Severity classification of procedures
Which of the annexes are most important for researchers.
I. List of species that must be purpose-bred If they are to be used in research
IV. Methods of killing
VIII. Severity classification of procedures
What does SI 543 of 2012 do?
Protects any “Animal”, defined as…any live non-human vertebrate animal, including— an independently feeding larval form, a foetal form of mammal as from the last third of its normal development any animal at an earlier stage of development that will be allowed to live, any live cephalopod, tadpoles.
It also regulates procedures.
How does SI 543 of 2012 regulate procedures?
o “No person may carry out procedures on animals otherwise than in accordance with an appropriate authorisation granted by the IMB… (“a procedures authorisation”), including any conditions to which the procedures authorisation is subject”
o any use, invasive or non-invasive, of an animal for experimental or other scientific purposes, with known or unknown outcome, or educational purposes, which may cause 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
o includes any course of action intended, or liable, to result in the birth or hatching of an animal or the creation and maintenance of a genetically modified animal line in any such condition.
What are the 3 types of Authorisations of SI 543.
o Establishment Authorisation
Breeder / Supplier / User
o Individual Authorisation
Project managing
Carrying out procedures on animals
Performing euthanasia (“killing authorisation”)
o Project Authorisation
“Procedures authorisation
What type of authorisation does killing for tissues require?
Killing for tissues only requires establishment authorisation, and the individual has individual killing authorisation as no procedures being carried out.
How many designated roles are there under SI 543?
At least 5 designated roles
o Compliance Officer
o Animal Care & Welfare Officer (ACWO)
o Information Officer
o Training Officer
o Designated Veterinarian or Expert
o Project Manager(s)
What is the function of the Compliance officer?
Responsible for ensuring compliance with the provisions of these regulations. – must have budgetary control – often a director or vice-president for research.
What is the function of the Animal Care & Welfare Officer (ACWO)?
Responsible for overseeing the welfare and care of animals in the establishment.
Must be on site and a member of the animal welfare body.
What is the function of the information Officer?
Must ensure the staff dealing with animals have access to information. – species specific.
On site
What is the function of the training officer?
Ensuring staff sufficiently educated, competent, and continuously trained. That they are supervised until they have demonstrated the requisite competence.
On site
What is the function of the designated Vet?
Vet with expertise in lab medicine.
Advisory duties in relation to well-being and treatment of the animals.
Assistant animal welfare body with tasks.
What are the functions of project managers?
Required only by “User” establishments
responsible for the overall implementation of the project and its compliance with the project authorisation”
Named on Project Authorisation
…shall ensure that: - any unnecessary pain, suffering, distress or lasting harm that is being inflicted on an animal in the course of a procedure is stopped
What are Scientific Endpoints?
A (pre-determined) point at which (it is expected that) the scientific aims of the project will have been achieved and at which the process or procedure will be terminated
What are Humane Endpoints?
The earliest indicator in an animal experiment of (potential) pain and/or distress that can be used to avoid or limit pain and/or distress by taking actions such as humane killing or terminating or alleviating the pain and distress.
What is the Animal welfare body?
- Consist of at least the ACWO a scientific member and the DV
- Give advice on animal welfare, the 3 Rs and technical & scientific developments in the field.
- Records of advice given by the AWB must be retained for three years
- Advice on animal welfare
- Advice on the 3Rs, and on technical & scientific developments
- Internal monitoring, reporting and follow up regarding welfare
- Monitor projects, and advise…
- Advice on rehoming
- Facilitate sharing of tissues & organs
Basic description of the ASPA 1986
- Protects “any living vertebrate other than man and any living cephalopod” Also protects foetal, larval or embryonic forms of “a mammal, bird or reptile [when] two-thirds of the gestation or incubation period for the relevant species has elapsed”…and in the run-up to that period, if it will survive to that period.
- Personal licences
o Specify procedures that may be performed
o Training must be completed before licence will be issued - Killing animals
o Different criteria (weight limits and methods) - Duties of named personnel (NVS, NACWO)
o Minor differences
