Animals (Scientific Procedures) Act 1986 Flashcards
UoS Ethical Policy Statement on the Use of Animals
no practical alternatives
minimize the harms
smallest numbers of animals used
highest standards of care and welfare
meet national legislative requirements
New ASPA
The Home Office Guidance on the Operation of the Animals (Scientific Procedures) Act 1986
Scope of the New Animals (Scientific Procedures) Act 1986 [ASPA]
Implements Directive 2010/63/EU
What does the Act do………….?
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’
Regulated Procedure
‘Experiment’ - for a scientific purpose
REQUIRES BOTH A PROJECT AND A PERSONAL LICENSE
Protected Animal
Any living vertebrate (other than man) and any cephalopod (Octopus, squid, cuttlefish and nautilus) from hatching
What is a protected animal?
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
However - Not every animal is ‘protected’:
Working with non-protected animals requires no project or personal licence
Mammals, birds, reptiles: before 2/3 way through gestation
Fish etc. before independent feeding
Cephalopds before hatching
Other Invertebrates: flies, worms etc.
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
Alive until there is permanent cessation of the circulation or the complete destruction of the brain.
Anaesthetised or decerbrate animals count as ‘living’
Not all techniques are ‘regulated procedures’
You do not need a project or personal licence for the following:
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
The Act also regulates:
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
Schedule 1:
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’
SCHEDULE 2
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)
Code of Practice
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”
Structure of ASPA
Before you start any experimental work (Regulated Procedures) you will need the following three authorisations:
- 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.
Establishment Licence
Licences the Place
Defines the type of establishment:
Scientific Procedures
Breeding (animals for procedures or tissues)
Supplying (animals or tissues)
Establishment Licence
Certain Officers must be nominated:
These are named on the Establishment Licence itself
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
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
Establishment Licence Holder
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.
Establishment License
List all rooms registered on the 2C license
Defines what the rooms can be used for:
The species
Holding rooms (short/long term)
Non sterile procedures/sterile procedures
Establishment license Things involved (overview)
Defines the type of establishment
Named officers (NCO, NVS, NACWO, NTCO, NIO)
Project Licences [PPL]
Defines a programme of work
Subject to specified conditions
Defines the place of work
Project Licences [PPL]
Defines a programme of work
Part C - Purpose (Previously sec 17)
Part D - Plan (of work) (Previously sec 18)
Part E - Protocols [Previously Q19b]
Project Licences [PPL]
Subject to specified conditions
Standard (New for 2013) 25 conditions – end of all PPL’s
Additional/Special - in covering letter – only certain PPL’s
Project Licences [PPL]
Defines the place of work
Primary/Secondary availability/podes
Project Licences [PPL]
Arranged and managed by a Project Licence Holder (PPL Holder)
Personally responsible for compliance
Responsible for supervision of Personal Licensees
Project Licences [PPL]
Record keeping requirements
Detailed records on the use of all animals
Submission of an official Annual Return (Now a digital spreadsheet)
Project Licences [PPL]
Duration
Up to 5 years
Project Licences - General
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].
Project Licences - General
Important things to remember:
Project licenses are split into sections
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)
Project Licences [PPL]
Sec C
Scientific Background (including benefits)
Project Licences [PPL]
Sec D
Programme of Work (including purpose of work)
Project Licences [PPL]
Sec E
Protocols (how you are going to do the work)
Project Licences [PPL]
Protocols – Section E (19b)
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
Project Licences [PPL]
Protocols
Each separate protocol has a severity limit
Defines the maximum severity allowed under a particular protocol sheet
Steps used to minimise p/s/d/lh must be described and adhered to
Severity Limits - Guidelines
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
Severity Limits
Mild
Slight or minimal or transitory effects (e.g. blood sampling)
Severity Limits
Moderate
Potential to cause greater suffering (e.g. toxicity tests, minor surgery)
Severity Limits
Severe
Welfare likely to be seriously compromised (e.g. major surgery, acute toxicity tests with significant morbidity)
Severity Limits
Non-Recovery
Entire protocol performed under deep non-recovery anaesthesia
Project Licences [PPL]
Protocols (Additional parts)
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
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
Legally binding conditions of the PPL
Adverse effects
Humane end points
PPL
Individual Study Plans (ISP’S)
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.
PPL New for 2013
Actual Severity
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
PPL New for 2013
Actual Severity
Whole lifetime experience
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
PPL New for 2013
Actual Severity
You may need advice or information from a number of sources to get an accurate result:
NACWO’s
Technicians
Veterinary staff/Named Vet
Re-Use of Animals in Scientific Procedures
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
Project Licences [PPL]
Personal license holders
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
Compliance with ASPA
Legal Requirement
ASPA summary
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**
ASPA summary
When do you NOT require the PIL and PPL licenses?
Culling using schedule 1 methods
Animals below the age of protection
Husbandry techniques/breeding non GM animals
Veterinary procedures (subject to Vet Surgeons act)
Personal Licences [PIL]
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
Personal Licences [PIL]
Defines the
place to which the license is issued
Personal Licences [PIL]
Can be used in connection with ANY PPL
Subject to permission from the Project Licence holder
Subject to the technique being required by that authorised programme of work
Personal Licences [PIL]
Species
Species groupings may be licence (rather than individual species):
NB: Many still using individual species as previously
Personal Licences [PIL]
Species groupings
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
Personal Licences [PIL]
Defines authorised regulated techniques
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
Personal Licences [PIL]
Defines authorised regulated techniques
A
Procedures not requiring any anaesthesia
Personal Licences [PIL]
Defines authorised regulated techniques
B
Procedures requiring simple anaesthesia for restraint or non-recovery
Personal Licences [PIL]
Defines authorised regulated techniques
C
Procedures requiring more complex anaesthesia plus surgery
Personal Licences [PIL]
Defines authorised regulated techniques
D
Procedures requiring anaesthesia plus administration of Neuromuscular Blocking Agents
Personal Licences [PIL]
Subject to certain conditions:
Standard conditions (New for 2013) - 3R’s, Welfare, prevention of pain etc.
Additional/special conditions, including supervision conditions
Personal Licences [PIL]
Requires detailed record keeping
Details of all procedures performed
Details of supervision [Training Records – now mandatory]
Cage labels + ISP’s
Personal Licences [PIL]
Duration
Open ended but can be revoked at any time
Personal Licences [PIL]
Fees
Annual fee payable – currently £242
Billed via the Establishment Licence Holder via BSU
Personal Licence Application
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
Personal Licensee Responsibilities
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
Personal Licensee Responsibilities
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
Personal Licensee Responsibilities
Before starting any procedure check:
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.
Personal Licensee Responsibilities
Important: The training records now replace the detailed personal licences of the past.
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
Personal Licensee Responsibilities
Take primary responsibility for your animals
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
Personal Licensee Responsibilities
Take primary responsibility for your animals: Anaesthetics
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
Personal Licensee Record Keeping Responsibilities
All animals (individually or cages) MUST be labelled with information including
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
Personal Licensee Record Keeping Responsibilities
Personal Records (e.g. Lab Book) must be kept of all procedures performed including:
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.
Personal Licensee Responsibilities - General
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
Animal Welfare and Ethical Review Body [AWERB] (Replaces ERP)
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.
Named Animal Care & Welfare Officer
Duties of the NACWO include:
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
Named Veterinary Surgeon
Duties of the NVS include:
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
Schedule 1
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
Schedule 1
Schedule 1 methods MUST be confirmed by one of the following:
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
Schedule 1
3 R’s
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
Home Office Inspectors
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
Animals in Science Committee
[formally APC]
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
Some Other Animal Related Legislation
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
