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PIL > Animals (Scientific Procedures) Act 1986 > Flashcards

Animals (Scientific Procedures) Act 1986 Flashcards

1
Q

UoS Ethical Policy Statement on the Use of Animals

A

no practical alternatives
minimize the harms
smallest numbers of animals used
highest standards of care and welfare

meet national legislative requirements

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2
Q

New ASPA

A

The Home Office Guidance on the Operation of the Animals (Scientific Procedures) Act 1986

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3
Q

Scope of the New Animals (Scientific Procedures) Act 1986 [ASPA]

A

Implements Directive 2010/63/EU

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4
Q

What does the Act do………….?

A

Regulates any experimental or other scientific procedure to a “protected animal” that may have the effect of causing that animal pain, suffering, distress or lasting harm.

‘Regulated procedure’

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5
Q

Regulated Procedure

A

‘Experiment’ - for a scientific purpose

REQUIRES BOTH A PROJECT AND A PERSONAL LICENSE

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6
Q

Protected Animal

A

Any living vertebrate (other than man) and any cephalopod (Octopus, squid, cuttlefish and nautilus) from hatching

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7
Q

What is a protected animal?

A

Any adult vertebrate or cephalopod (other than humans).

Any vertebrate in its foetal, larval or embryonic form is also protected:

  • For mammals, birds or reptiles, from two thirds way through gestation or incubation period .
  • Fish - from the time it becomes capable of independent feeding.
  • Cephalopods – from hatching

Working with these requires a personal and project licence

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8
Q

However - Not every animal is ‘protected’:

Working with non-protected animals requires no project or personal licence

A

Mammals, birds, reptiles: before 2/3 way through gestation

Fish etc. before independent feeding

Cephalopds before hatching

Other Invertebrates: flies, worms etc.

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9
Q

Animals are only ‘protected’ if they are ‘living’
You need no PIL or PPL to work with animals which are dead.

‘Living’ is defined as

A

Alive until there is permanent cessation of the circulation or the complete destruction of the brain.

Anaesthetised or decerbrate animals count as ‘living’

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10
Q

Not all techniques are ‘regulated procedures’

You do not need a project or personal licence for the following:

A

Techniques used to identify animals

Breeding non GM animals

Euthanasia by approved/listed methods under Schedule 1 of ASPA

Recognised veterinary, agricultural or husbandry practices

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11
Q

The Act also regulates:

A

The breeding of genetically altered animals or animals with harmful mutations.

The breeding of animals for tissues for scientific purposes

The housing, care and supply of animals used in scientific procedures

Standards of housing and care are set out in specific Codes of Practice issued by the Home Office. New CoP based on Annex 3 of the Directive

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12
Q

Schedule 1:

A

A list of approved methods for killing animals.

Allows trained people to kill animals without getting a personal licence.

Killing methods NOT on the Schedule 1 list need a project and a personal licence.
- This is a ‘regulated procedure’

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13
Q

SCHEDULE 2

A 
ANIMALS TO BE OBTAINED ONLY FROM DESIGNATED BREEDING OR SUPPLYING ESTABLISHMENTS
Dog
Cat
Primate
Mouse
Ferret
Rabbit
Rat
Guinea-pig
Hamster
Gerbils
Any bird of the species Coturnix coturnix (quail)
*Zebrafish*
*Frogs (including Xenopus)*
Pigs (if genetically modified)
Sheep (if genetically modified)
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14
Q

Code of Practice

A

Specifications for rooms, cage or pen sizes, stocking densities, and animal care standards are all prescribed in the “Code of Practice” (Annex 3)

Environmental conditions [temperature, humidity, air flow rates etc] are also defined by the “Code of Practice”

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15
Q

Structure of ASPA

Before you start any experimental work (Regulated Procedures) you will need the following three authorisations:

A
  • Establishment Licence: Section 2C Licence [Licences the Place]
  • Project Licence: PPL [Licences the Programme of work]
  • Personal Licence: PIL [Licences the Individual]

Plus: Animal Welfare and Ethical Review Body [AWERB]

There is some work you can do without a PPL or PIL but you still need to be registered on the Establishment licence.

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16
Q

Establishment Licence

Licences the Place

A

Defines the type of establishment:
Scientific Procedures
Breeding (animals for procedures or tissues)
Supplying (animals or tissues)

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17
Q

Establishment Licence

Certain Officers must be nominated:
These are named on the Establishment Licence itself

A

Named Compliance Officer (NCO) (Previously the Certificate Holder)
responsible for ensuring compliance with the conditions of the establishment licence & who represents the governing authority of the institution.

Named Veterinary Surgeon (NVS)
advising on the welfare and treatment of the animals

Named Animal Care and Welfare Officer (NACWO)
overseeing the welfare and care of the animals

Named Training and Competency Officer (NTCO)
ensuring that those dealing with animals are adequately educated, trained and supervised until they are competent and that appropriate further training continues

Named Information Officer (NIO)
ensuring that those dealing with animals have access to any information they need

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18
Q

Named Compliance Officer (NCO) (Previously the Certificate Holder)

A

responsible for ensuring compliance with the conditions of the establishment licence & who represents the governing authority of the institution

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19
Q

Named Veterinary Surgeon (NVS)

A

advising on the welfare and treatment of the animals

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20
Q

Named Animal Care and Welfare Officer (NACWO)

A

overseeing the welfare and care of the animals

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21
Q

Named Training and Competency Officer (NTCO)

A

ensuring that those dealing with animals are adequately educated, trained and supervised until they are competent and that appropriate further training continues

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22
Q

Named Information Officer (NIO)

A

ensuring that those dealing with animals have access to any information they need

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23
Q

Establishment Licence Holder

A

All establishments must also keep a register of all individuals involved in animal work to ensure adequate training in the following functions:

(a) Persons carrying out experimental procedures on animals (PIL’s)
(b) Persons designing procedures and projects (PPL’s)
(c) Persons taking care of animals
(d) Persons killing animals. (Sched. 1 users)

Can be listed in more than one category – or all four.

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24
Q

Establishment License

List all rooms registered on the 2C license

A

Defines what the rooms can be used for:

The species
Holding rooms (short/long term)
Non sterile procedures/sterile procedures

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25
Q 
Establishment license
Things involved (overview)
A

Defines the type of establishment

Named officers (NCO, NVS, NACWO, NTCO, NIO)

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26
Q

Project Licences [PPL]

A

Defines a programme of work

Subject to specified conditions

Defines the place of work

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27
Q

Project Licences [PPL]

Defines a programme of work

A

Part C - Purpose (Previously sec 17)

Part D - Plan (of work) (Previously sec 18)

Part E - Protocols [Previously Q19b]

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28
Q

Project Licences [PPL]

Subject to specified conditions

A

Standard (New for 2013) 25 conditions – end of all PPL’s

Additional/Special - in covering letter – only certain PPL’s

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29
Q

Project Licences [PPL]

Defines the place of work

A

Primary/Secondary availability/podes

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30
Q

Project Licences [PPL]

Arranged and managed by a Project Licence Holder (PPL Holder)

A

Personally responsible for compliance

Responsible for supervision of Personal Licensees

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31
Q

Project Licences [PPL]

Record keeping requirements

A

Detailed records on the use of all animals

Submission of an official Annual Return (Now a digital spreadsheet)

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32
Q

Project Licences [PPL]

Duration

A

Up to 5 years

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33
Q

Project Licences - General

A

Regulated programmes of work and procedures will only be authorised if there are no scientifically suitable alternatives that could replace animal use, could reduce the number of animals used or could refine the procedures used to cause less suffering. [These are the principles of the “3Rs”].

The likely benefits (to humans, other animals or the environment) must be weighed against the likely welfare costs to the animals involved. [Cost/Benefit analysis].

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34
Q

Project Licences - General

Important things to remember:
Project licenses are split into sections

A

Sec C: Scientific Background (including benefits)

Sec D: Programme of Work (including purpose of work)

Sec E: Protocols (how you are going to do the work)

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35
Q

Project Licences [PPL]

Sec C

A

Scientific Background (including benefits)

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36
Q

Project Licences [PPL]

Sec D

A

Programme of Work (including purpose of work)

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37
Q

Project Licences [PPL]

Sec E

A

Protocols (how you are going to do the work)

38
Q

Project Licences [PPL]

Protocols – Section E (19b)

A

List the techniques that can be used on the animals

May not have to complete every step

Important to read the document carefully before starting work

39
Q

Project Licences [PPL]
Protocols
Each separate protocol has a severity limit

A

Defines the maximum severity allowed under a particular protocol sheet

Steps used to minimise p/s/d/lh must be described and adhered to

40
Q

Severity Limits - Guidelines

A

Mild
Slight or minimal or transitory effects (e.g. blood sampling)

Moderate
Potential to cause greater suffering (e.g. toxicity tests, minor surgery)

Severe
Welfare likely to be seriously compromised (e.g. major surgery, acute toxicity tests with significant morbidity)

Non-Recovery
Entire protocol performed under deep non-recovery anaesthesia

41
Q

Severity Limits

Mild

A

Slight or minimal or transitory effects (e.g. blood sampling)

42
Q

Severity Limits

Moderate

A

Potential to cause greater suffering (e.g. toxicity tests, minor surgery)

43
Q

Severity Limits

Severe

A

Welfare likely to be seriously compromised (e.g. major surgery, acute toxicity tests with significant morbidity)

44
Q

Severity Limits

Non-Recovery

A

Entire protocol performed under deep non-recovery anaesthesia

45
Q

Project Licences [PPL]

Protocols (Additional parts)

A

Adverse effects: What harm may come to the animals and how will you deal with them.

Humane end points: At what defined point will a procedure be terminated on humane grounds.

These are legally binding conditions of the PPL

46
Q

Adverse effects

A

What harm may come to the animals and how will you deal with them

47
Q

Humane end points

A

At what defined point will a procedure be terminated on humane grounds

48
Q

Legally binding conditions of the PPL

A

Adverse effects

Humane end points

49
Q

PPL

Individual Study Plans (ISP’S)

A

Required for every separate study performed under a PPL.

For every new batch of animals.

More specific than the general PPL but must represent what the PPL specifies.

May be different for each study.

PPL holder, all PIL’s unit manager and NACWO must sign before work starts.

50
Q

PPL New for 2013

Actual Severity

A

Severity classification based on the whole lifetime experience of individual animals

Death = severe unless it is not related to the study or animal can be shown to have not suffered

Autopsy is likely to be required to establish cause of death

51
Q

PPL New for 2013
Actual Severity
Whole lifetime experience

A

Records the ‘Actual Severity’ to each animal – not just the severity limit on the protocol

The worst event the animal experiences defines the severity, not just the condition of the animal at the end of the procedure

52
Q

PPL New for 2013
Actual Severity

You may need advice or information from a number of sources to get an accurate result:

A

NACWO’s
Technicians
Veterinary staff/Named Vet

53
Q

Re-Use of Animals in Scientific Procedures

A

Requires specific permission under a PPL

Occurs where, following the use of the animal in a series of regulated procedures making up [the first] protocol, the animal is used in a subsequent [the second] protocol but where a naïve animal could otherwise have been used

There is NO automatic requirement to kill a healthy animal at the conclusion of a protocol
- Options include, continuing to look after the animal at the establishment, releasing the animal as a pet

54
Q

Project Licences [PPL]

Personal license holders

A

All Personal Licence holders must be able to have access to the Project Licence under which they are working

All Personal Licence holders should understand what the Project Licence covers

All Personal Licence holders must have the permission of the Project Licence holder to work under their Project Licence

55
Q

Compliance with ASPA

A

Legal Requirement

56
Q

ASPA summary

A

A ‘regulated procedure’ (experiment) needs both an establishment, project and personal licence if:

  • The procedure is for a scientific purpose which may cause P/D/S/LH
  • The animal is ‘protected’ (a vertebrate (or cephalopod) over the prescribed age)
  • The animal is ‘alive’ (including terminal anaesthesia or dead by a non-schedule 1 method)

All regulated procedures require an:

  • Establishment licence
  • Project licence
  • Personal licence
  • *NO regulated procedure can take place without all three**
57
Q

ASPA summary

When do you NOT require the PIL and PPL licenses?

A

Culling using schedule 1 methods

Animals below the age of protection

Husbandry techniques/breeding non GM animals

Veterinary procedures (subject to Vet Surgeons act)

58
Q

Personal Licences [PIL]

A

Defines the place to which the license is issued

Can be used in connection with ANY PPL

Species groupings may be licensed (rather than individual species)

Defines authorized regulated techniques (categories of techniques will be licensed)

Subject to certain conditions (standard, additional/special inc supervision conditions)

Requires detailed record keeping

Duration

Fees

59
Q

Personal Licences [PIL]

Defines the

A

place to which the license is issued

60
Q

Personal Licences [PIL]

Can be used in connection with ANY PPL

A

Subject to permission from the Project Licence holder

Subject to the technique being required by that authorised programme of work

61
Q

Personal Licences [PIL]

Species

A

Species groupings may be licence (rather than individual species):
NB: Many still using individual species as previously

62
Q

Personal Licences [PIL]

Species groupings

A

Rodents (inc. mice, rats, guinea pigs, hamsters and gerbils) and rabbits
Small carnivores (inc. dogs, cats and ferrets)
Non-human primates (old world, e.g. macaques, and new world, e.g. marmosets)
Farm animals (inc. pigs, goats, sheep and cattle)
Horses
Birds
Reptiles
Amphibians
Fish
Cephalopods

63
Q

Personal Licences [PIL]

Defines authorised regulated techniques

A

Categories of techniques will be licenced (rather than a
list specifying separate techniques):

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

64
Q

Personal Licences [PIL]
Defines authorised regulated techniques
A

A

Procedures not requiring any anaesthesia

65
Q

Personal Licences [PIL]
Defines authorised regulated techniques
B

A

Procedures requiring simple anaesthesia for restraint or non-recovery

66
Q

Personal Licences [PIL]
Defines authorised regulated techniques
C

A

Procedures requiring more complex anaesthesia plus surgery

67
Q

Personal Licences [PIL]
Defines authorised regulated techniques
D

A

Procedures requiring anaesthesia plus administration of Neuromuscular Blocking Agents

68
Q

Personal Licences [PIL]

Subject to certain conditions:

A 
Standard conditions (New for 2013)
- 3R’s, Welfare, prevention of pain etc.

Additional/special conditions, including supervision conditions

69
Q

Personal Licences [PIL]

Requires detailed record keeping

A

Details of all procedures performed

Details of supervision [Training Records – now mandatory]

Cage labels + ISP’s

70
Q

Personal Licences [PIL]

Duration

A

Open ended but can be revoked at any time

71
Q

Personal Licences [PIL]

Fees

A

Annual fee payable – currently £242

Billed via the Establishment Licence Holder via BSU

72
Q

Personal Licence Application

A

Applicants must be at least 18 years old

Must have minimum educational qualifications

Must complete a Modular Training Programme

Must complete an Application Form
- NB Modular Training Certificate is NOT a licence to work

73
Q

Personal Licensee Responsibilities

A

Appreciate that competence in performing techniques is gained through practical experience not theory

Must have good understanding of:
Biology of the relevant species
Handling and husbandry of the relevant species
How to perform techniques correctly
Recognize illness/pain/suffering/distress and what action to take

MUST be supervised by PPLH or experienced licensee until “signed off as competent” using mandatory Training Records

74
Q

Personal Licensee Responsibilities

Must have good understanding of:

A

Biology of the relevant species
Handling and husbandry of the relevant species
How to perform techniques correctly
Recognize illness/pain/suffering/distress and what action to take

75
Q

Personal Licensee Responsibilities

Before starting any procedure check:

A

The place/room where you are about to perform your technique is licenced

The Project Licence [PPL] authorises the technique, the purpose for which it is being done and you have the agreement of the Project Licence holder.

Your Personal Licence [PIL] authorises the categories of technique and the species.

Your Personal Training and Competency Record form is available and is up to date.

76
Q

Personal Licensee Responsibilities

Important: The training records now replace the detailed personal licences of the past.

A

All work must be initially supervised and signed.
No unsupervised work can be carried out until training records are signed off

No work can be taught to others until considerable experience has been gained and this section is signed on your training record

77
Q

Personal Licensee Responsibilities

Take primary responsibility for your animals

A

Animals need to be checked daily unless alternative arrangements have been made.

Take veterinary and welfare advice if in any doubt your animals.

If severity limits (defined in protocol sheets) or anticipated adverse effects are exceeded, notify the PPLH immediately

Act in accordance with principle of the 3R’s

78
Q

Personal Licensee Responsibilities

Take primary responsibility for your animals: Anaesthetics

A

Always use anaesthetics when performing techniques, unless the anaesthetic itself is more traumatic than the actual technique

NEVER use neuromuscular blocking agents without additional specific PPL and PIL authority
- These are NOT anaesthetics, must be used in conjunction with an anaesthetic and the HO inspector normally requires at least 48 hours notice of their use

79
Q

Personal Licensee Record Keeping Responsibilities

All animals (individually or cages) MUST be labelled with information including

A

Animal identity (strain, sex, source etc)

Personal Licence Holder,

Name, number or code

Project Licence number

Procedure/Protocol Sheet Number

Principal techniques applied and dates

Principal adverse effects expected

80
Q

Personal Licensee Record Keeping Responsibilities

Personal Records (e.g. Lab Book) must be kept of all procedures performed including:

A

Animal identification details

Techniques performed by date

Whether techniques supervised and by whom

Any morbidity or mortality encountered and action taken

Fate of animal at end of procedure

Personal Training and Competency records must be kept updated.

81
Q

Personal Licensee Responsibilities - General

A

Delegation of Personal Licence is NOT generally allowed

  • Only permitted if additionally authorised on the Personal Licence
  • Only applies to certain simple techniques such as withholding of food or water, feeding special diets, placement of animals in restraining devices, pairing of genetically altered animals

Performance in public is NOT permitted

Animals may NOT be moved from one designated establishment to another without additional permissions

Animals may NOT be released from the controls of ASPA (e.g. into the wild or as pets) without additional permissions

82
Q

Animal Welfare and Ethical Review Body [AWERB] (Replaces ERP)

A

Provides ethical and operational advice to the institution, particularly with respect to project licence applications and standards of animal care and welfare.

Promotes the use of ethical analysis to increase awareness of animal welfare issues and develop initiatives leading to the widest possible application of the 3Rs.

83
Q

Named Animal Care & Welfare Officer

Duties of the NACWO include:

A

Providing advice on animal care and welfare to researchers

Ensuring day to day care of animals

Participating in the AWERB Process

Responsibility for defined areas on the Establishment Licence

Currently 6 in BSU

84
Q

Named Veterinary Surgeon

Duties of the NVS include:

A

Providing veterinary advice to researchers

Providing 24/7 veterinary cover

Prescribing, supplying and controlling the use of POM medicines (Veterinary Medicines Act – no longer legal to use human drugs on animals)

Maintaining animal health records

Participating in the AWERB Process

85
Q

Schedule 1

A

List of approved methods of humane killing of protected animals

  • Species specific
  • Stage of development specific

Does not require PIL or PPL authority (as the technique is unregulated)

NB: Everyone using Schedule 1 techniques MUST be registered on the Establishment Licence (including current PIL holders)

Appropriate training needed (Currently PIL AB of HO Course)
List of trained personnel held by the Institution

Someone competent to kill must be available at all times

From Jan 13 allowed to use anaesthesia/sedation prior to culling technique

86
Q

Schedule 1

Schedule 1 methods MUST be confirmed by one of the following:

A

Confirmation of permanent cessation of the circulation

Destruction of the brain

Dislocation of the neck

Exsanguination

Confirming the onset of rigor mortis

Instant destruction of the body in a macerator

87
Q

Schedule 1

3 R’s

A

Principles of the 3R’s must be applied even when using schedule 1 methods only.

If you are in any doubt about Schedule 1 issues (or any other procedure) please contact a NACWO or NVS

88
Q

Home Office Inspectors

A

Medical or veterinary qualifications

Advise the Secretary of State on applications for Licences and Certificates

Make visits of inspection to determine compliance with Certificates, Licences and their conditions
- Majority of visits are unannounced

Report infringements

89
Q

Animals in Science Committee

[formally APC]

A

Independent body that separately advises the Secretary of State + animal welfare and ethical review bodies on matters relating to acquisition, breeding, accommodating, care and use of protected animals

Advise on certain severe protocols, primate work etc.
- Membership includes animal welfare activists, scientists, licence holders, lawyers and lay people

Details still to be confirmed

90
Q

Some Other Animal Related Legislation

A

Animal Welfare Act 2006

The Veterinary Surgeons Act 1966

Agriculture (miscellaneous Provision) Act 1968

Endangered Species (Import & Export) Act 1968

Wildlife & Countryside Act 1981

Transit of Animals (amendment) Order 1988

International Air Transport Association (IATA) Live Animals Regulations

The Welfare of Animals during Transport Order 1994

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