PIL A- L Flashcards
Prior to 1986 all work with animals was enabled by:
The Cruelty to Animals Act 1876
Our work is now enabled by:
The Animals (Scientific Procedures) Act 1986 Amendment Regulations 2012 Comprising of: a framework for national legislation; permitted uses; the three Rs; competence of all people involved and minimum training standard; standards for general care & accommodation; requires statistics of use to be kept
The Animals (Scientific Procedures) Act 1986 Amendment Regulations 2012 (allows, states, specifies)
Allows regulated procedures to be conducted on protected animals for defined experimental or scientific purposes.
States that regulated procedures can only be carried out at licensed establishments.
Specifies codes of conduct for animal care establishments and stipulates what premises can breed, supply and use certain protected species .
Research would be controlled by ASPA if the following three criteria applied:
- It must involve procedures that are carried out for experimental or other scientific purposes;
- The procedures must be conducted, on a protected animal;
- The procedures could cause pain, suffering, distress or lasting harm
ASPA defines a protected animal as:
Any living vertebrate, other than man, and all cephalopods (added in 2012).
Protection extends to certain immature forms from the following stages of development: mammals, birds and reptiles - from two thirds through the gestation or incubation period; fish and amphibia - from the time at which they become capable of independent feeding; cephalopods - from when they hatch (ie after development beyond the larval and paralarval stages)
ASPA defines a regulated procedure 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.
To what can pain, suffering, distress or lasting harm refer to?
The physiological and/or the psychological state of the animal.
If a procedure is carried out at an early stage of development but causes lasting harm to the animal still present after it reaches the stage at which it would be protected, is the procedure still regulated?
Yes
A procedure can be an act of:
Commission - (eg dosing).
Omission - (eg withholding food or water).
Permission – (eg breeding transgenic animals).
What is the minimum threshold of pain/discomfort/distress defined as?
The skilled insertion of a hypodermic needle using good veterinary practices.
How can a non-regulated procedure cross the threshold to be a regulated procedure?
A series or combination of non-regulated procedures can together cause an animal pain, suffering, distress or lasting harm may be regulated.
Role of the home secretary
Regulatory responsibility; grants, suspends or revokes licenses.
Inspectorate and the ASRU
Inspectors: vet/med qualified, ensure compliance with ASPA via un/announced inspections; scrutinize all PPL applications and reviews; advise Secretary of State whether a license should be granted or altered/revoked. Can require an animal to be killed immediately.
The Animals in Science Committee
Independent of HO, provides advice to Home Secretary.
Representatives from animal welfare orgs, the scientific community and the legal profession.
Provide advice on the acquisition, breeding accommodation & care and use of protected animals.
Establishment Licence (PEL)
Licences the establishment at which procedures are conducted on protected species.
Issued to governing authority of the establishment or a representative.
Type of licence: breeding; supply or scientific procedures.
Schedule of premises: lists all rooms where animals are held and regulated procedures conducted.
List named persons: Named Veterinary Surgeon
(advises on animal care and health, available 24 hours a day, 7 days a week); Named Animal Care and Welfare Officer (legal responsibility for environmental controls & animals husbandry); Named Training and Competency Officer (ensures staff are adequately educated, trained and supervised until they are competent); Named Information Officer (provide staff access to all relevant information); Named Compliance Officer
(all PEL compliance)
Duties of PEL holder:
Ensure all conditions of the Licence are adhered to.
Ensure the fabric of the establishment is maintained in accordance with Codes of Practice.
Ensure all procedures are authorised by PPLs and PILs, with appropriate records.
Maintain schedule 1 register.
Animals only obtained from appropriate sources (schedule 2).
Local Animal Welfare and Ethical Review Body.
Countersign PPL applications.
Allow HO inspector access.
Implement and apply 3Rs.
PROMOTE A CULTURE OF CARE.
Schedule 1
Lists appropriate methods of humanely killing protected animals.
E.g. for tissue or organ removal; to enact a humane endpoint; an animal is in severe pain that cannot be controlled; an animal’s wellbeing gives rise to concern and the Personal Licensee cannot be contacted (NACWO and NVS responsibility).
A personal licence is not required, but prior training in each method is.
Schedule 2
Suppliers of the following Relevant Protect Species must have an Establishment Licence in order to use the animals in regulated procedures or to harvest their tissues or to breed or supply them for these purposes.
Mouse; Rat; Guinea-pig; Hamster; Rabbit; Dog; Cat; Primate; Any bird of the species Coturnix coturnix (quail); Ferrets; Gerbils; Any frog of the species Xenopus laevis, Xenopus tropicalis, Rana temporaria or Rana pipiens; Zebra fish; Pigs, if genetically modified; Sheep, if genetically modified.
Project Licence (PPL)
Licences the scientific scope of the proposed work. Authorises a programme of work. Granted for 5 years maximum. Names licensee. Names the licensed establishment.
Permissible purposes for a PPL
A project licence must not be granted unless the Secretary of State has verified that the programme of work to be specified in the licence is to be carried out for one of the following purposes-
(a) basic research;
(b) translational or applied research with one of the following aims— (i) the avoidance, prevention, diagnosis or treatment of disease; (ii) the assessment, detection, regulation or modification of physiological conditions; (iii) the improvement of the welfare of animals;
(c) the development/testing of substances or products, with one of the aims mentioned in paragraph (b);
(d) the protection of the natural environment;
(e) research aimed at preserving a species;
(f) higher education or training of vocational skills;
(g) forensic inquiries.
Sections of the PPL
Describes background, objectives and potential benefits (section C): providing justification for using animals; no alternative; perform analysis of cost to the animals versus benefit to society; demonstrate adoption of 3Rs;
Gives project plan (section D); Techniques to be used in each procedure (section E)…
Section E
with regard to protocols - working document
index of protocols, species/stage of development, severity and estimated numbers
severity limits: non-recovery (eg terminal anaesthesia); mild (eg diet modification); moderate (eg recovery surgery where any pain is transitory and managed) or severe (eg induction of cerebral haemorrhage)
description of protocol
with anaesthetics codes – AA, AB, AC, AD (no anaes., anaes. with recovery, terminal anaes., neuromusc blocking agents)
likely adverse effects, humane end-points, any mitigating actions.
If an animal is no longer experiencing any adverse effects, then it may be permissible to:
- Re-use it in other, unrelated studies, or
- Release it from the controls of the Act and re-home it,
- Return it to stock (for example farm animals) or
- Return it to the wild (if it was a wild-caught animal).
Responsibilities of the PPL holder
Programme of work is strictly adhered to.
Only specified species used.
Severity controls are implemented,
Severity conditions are met.
Inform HO if severity limits will be exceeded (Section 18 reports).
Maintain full records of usage, including actual severity of procedures experienced by each animal.
Provide annual returns to HO of procedures
completed.
Provide appropriate training and supervision to PIL holders.
Assessment of actual severity
Evaluated after the completion of experiments.
Every procedure has a severity classification/limit/condition, predicted at the start.
PIL holder responsible makes the assessment, with input from NVS and NACWO.
Protocol severity category should be disregarded – severity of a procedure can go down or up. Could even mean the procedure is judged sub-threshold (below mild).
