PIL A- L

Question 1

Prior to 1986 all work with animals was enabled by:

Answer 1

The Cruelty to Animals Act 1876

Question 2

Our work is now enabled by:

Answer 2

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

Question 3

The Animals (Scientific Procedures) Act 1986 Amendment Regulations 2012 (allows, states, specifies)

Answer 3

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 .

Question 4

Research would be controlled by ASPA if the following three criteria applied:

Answer 4

1. It must involve procedures that are carried out for experimental or other scientific purposes;
2. The procedures must be conducted, on a protected animal;
3. The procedures could cause pain, suffering, distress or lasting harm

Question 5

ASPA defines a protected animal as:

Answer 5

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)

Question 6

ASPA defines a regulated procedure as:

Answer 6

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.

Question 7

To what can pain, suffering, distress or lasting harm refer to?

Answer 7

The physiological and/or the psychological state of the animal.

Question 8

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?

Answer 8

Yes

Question 9

A procedure can be an act of:

Answer 9

Commission - (eg dosing).
Omission - (eg withholding food or water).
Permission – (eg breeding transgenic animals).

Question 10

What is the minimum threshold of pain/discomfort/distress defined as?

Answer 10

The skilled insertion of a hypodermic needle using good veterinary practices.

Question 11

How can a non-regulated procedure cross the threshold to be a regulated procedure?

Answer 11

A series or combination of non-regulated procedures can together cause an animal pain, suffering, distress or lasting harm may be regulated.

Question 12

Role of the home secretary

Answer 12

Regulatory responsibility; grants, suspends or revokes licenses.

Question 13

Inspectorate and the ASRU

Answer 13

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.

Question 14

The Animals in Science Committee

Answer 14

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.

Question 15

Establishment Licence (PEL)

Answer 15

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)

Question 16

Duties of PEL holder:

Answer 16

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.

Question 17

Schedule 1

Answer 17

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.

Question 18

Schedule 2

Answer 18

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.

Question 19

Project Licence (PPL)

Answer 19

Licences the scientific scope of the proposed work.
Authorises a programme of work.
Granted for 5 years maximum. 
Names licensee.
Names the licensed establishment.

Question 20

Permissible purposes for a PPL

Answer 20

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.

Question 21

Sections of the PPL

Answer 21

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.

Question 22

If an animal is no longer experiencing any adverse effects, then it may be permissible to:

Answer 22

1. Re-use it in other, unrelated studies, or
2. Release it from the controls of the Act and re-home it,
3. Return it to stock (for example farm animals) or
4. Return it to the wild (if it was a wild-caught animal).

Question 23

Responsibilities of the PPL holder

Answer 23

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.

Question 24

Assessment of actual severity

Answer 24

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).

Question 25

Before gaining a PPL, the home secretary must be satisfied a project:

Answer 25

is most likely to produce satisfactory results; uses the minimum number of animals with appropriate experimental design; uses animals of the lowest neurophysiological sensitivity; causes the least pain, suffering, distress or lasting harm; demonstrates that there is no alternative to using animals.

Question 26

Cost-benefit analysis

Answer 26

How are the 5 freedoms impacted (Freedom from: thirst, hunger; discomfort; pain, injury, disease; to behave normally; fear, distress.
Balanced against the benefits: value to society; likelihood of success
Central to these deliberations are the 3Rs–

1. Replacement: replacing animals in experimental and scientific procedures (6 categories: information mining, in silico, physico-chemical techniques; lower organisms or embryonic stages; in vitro; human studies)
2. Reduction: use as few animals as possible, maximise each one’s usefulness, employ experimental design to maximise power
3. Refinement: adopt experimental and husbandry techniques that minimise animal suffering and promote wellbeing – provide environmental enrichment, enhanced experimental technique, use earlier/more human endpoints, experimental design and effective reporting (ARRIVE Guidelines from NC3Rs)

Question 27

AWERB

Answer 27

Local panel.
Provides independent welfare and ethical advice to the PEL holder.
Support to Named Persons regarding ethics and welfare.
Promote 3Rs implementation.
Scrutinizes all PPL applications.
Undertakes retrospective review to confirm 3R. throughout lifetime of PPL.
Advise on training of all staff.
Membership: chaired by senior academic; NVS, NACWO and NTCO; rep from Institute of Medicine, Law and Ethics, rep from Media Relations, local religious figure and lay members.

Question 28

Personal Licence (PIL)

Answer 28

Licences individuals to conduct defined experimental procedures on protected species. PIL holders are those with primary responsibility in law for all aspects of compliance.
Gives availability (the Institution who will pay the fees).
Requires accredited training course qualifications.
Permits procedures to be carried on specified protected species NTCO signature.

The species is also stated on the Personal Licence

Question 29

Categories of PIL techniques are licensed as:

Answer 29

A. Procedures not requiring any anaesthesia
B. Procedures requiring simple anaesthesia for restraint or non-recovery C. Procedures requiring more complex anaesthesia plus surgery
D. Procedures requiring anaesthesia plus administration of Neuromuscular
Blocking Agents
E. Is specifically for education and training under a specific Project Licence
F. “Other procedures”. This category usually is combined with other types of PIL e.g. PIL ABF.

Question 30

The PIL licencing system:

Answer 30

The authority to conduct individual techniques unsupervised will be governed by the Personal Licensee’s Training Record.
All Personal Licensees must maintain and retain their Training and Competence Record.
PILs should maintain records of: all procedures conducted; training/supervision; outcome (positive and negative; morbidity/mortality); training/supervision should be agreed/recorded by the NTCO
All Personal Licensees must be supervised until they are deemed competent and this has been noted on their Competence Record.
This must be lodged with the NTCO.

Question 31

PIL responsibilities

Answer 31

You have primary responsibility for the care of your animals.
Ensure you have authority in both PIL and PPL to undertake a procedure.
Ensure room is designated for procedure.
Cage labelling.
Comply with conditions on licence.
Maintain records of all procedures.
Maintain records of all training in techniques (agreed with PPL holder).
ABIDE BY THE STANDARD CONDITIONS ON THE PERSONAL LICENCE.

Question 32

Infringements of PIL

Answer 32

A transgression will be deemed to have occurred if the holder of any licence fails to comply with a condition on that licence or a provision of the act.
In such a circumstance a ‘compliance notice’ will be issued stating the nature of the transgression and the required actions to rectify the situation.
Failure to comply with a ‘compliance notice’ may result in variation or revocation of the licence
However, the most severe infringements can result in up to £5000 fine and up to 2 years in prison.

Question 33

To ensure against infringements

Answer 33

Be familiar with contents of ASPA.
Know your personal training record, personal licence, project licence and establishment licence.
Understand the roles of all named persons and PIL/PPL holders.