8. home office regulations and licensing for animal experiments

What are the key elements of the 1986 Animals (Scientific Procedures) Act (ASPA)?

• ASPA regulates procedures on protected animals likely to cause pain, suffering, distress, or lasting harm.

• It requires 3 types of licences: Establishment, Project, and Personal.

• It mandates ethical review processes and adherence to the 3Rs: Replacement, Reduction, Refinement.

• Covers use of animals in research, testing, and education.

• Updated via EU Directive 2010/63/EU (enacted in the UK in 2013).

• Includes inspection, enforcement, and penalties for non-compliance.

What is a ‘protected animal’ under the ASPA?

A protected animal is any:

• Living vertebrate (excluding humans)

• Cephalopod (e.g., octopus)

• Mammals, birds, and reptiles once halfway through gestation or incubation

• Fish and amphibians once they can feed independently

what are specially protected species

• cats

• dogs

• horse

• non-human primates

What defines a 'regulated procedure' under ASPA?

A regulated procedure is one likely to cause pain, suffering, distress, or lasting harm equivalent to or greater than a needle insertion under good veterinary practice.

e.g.

• dosing or sampling

• witholding food/water

• breeding of animals w. genetic defects

what 4 procedures are regulated

1. modifying the genes of a protected animal

   • e.g. breeding mice w. harmful genetic defects if u intend to keep the animals produced 2/3s of way through their gestation period

2. those performed under anaesthesia or analgesia

3. administering an anaesthetic/an analgesic

   • to sedate or dull the perception of pain in a protected animal

4. removing organs, blood or other tissue

   • under general anaesthesia even if animal isn’t allowed to recover consciousness as neither has the circulation nor has the brain been destroyed, the animal is still lviing

What are the ‘severity limits’ used in regulated procedures?

The severity limits classify the expected degree of suffering:

• Non-recovery: Animal never wakes from anaesthesia.

  • includes unintened death of animals on recovery protocals

• Mild: Short-term mild impact (e.g., injection)

  • animal returns to its normal state within short period of time

• Moderate: Noticeable but reversible distress (e.g., surgery with recovery)

  • under general anesthesia and with good post-operature analgesia (pain relief)

• Severe: Significant and prolonged suffering (only used with strong justification)

  • long term diseases

  • assistance w. normal activities such as feeding

  • significant deficits in behaviours/activities persist

what licences are needed to use animals in research in UK

1. personal licence - for the person

2. project licence - for the project

   • specifies the programme of work

3. establishment licence - for the place

What is humane Schedule 1 killing under the ASPA?

approved humane ways of killing animals without the need for a project licence, often used for tissue collection or disposal.

what are some methods for humane schedule 1 killing for animals

1. overdose of an anaesthetic - all animals

2. exposure to CO2 gas in a rising concentrations - birds and rodents up to 1.5kg

3. dislocation of neck - rodents (<500g), rabbits (<1kg) birds (<1kg)

4. concussion of the brain by stiking the cranium

what are some methods for humane schedule 1 killing for foetal, larval, and embryonic forms

1. overdose of an anaesthetic - all animals

2. refrigeration/disruption of membrane/ exposure to co2 until they’re dead

   • birds and reptiles

3. cooling of foetuses followed by immersion in cold tissue fixative

   • mice, rats and rabbits

4. decapitation

   • mammals and birds up to 50g

Who is the NACWO and what is their role?

The Named Animal Care and Welfare Officer (NACWO) is:

• Responsible for daily welfare of animals

• Oversees husbandry, housing, and care

• Provides input on animal use and welfare during procedures

• A legal requirement in licensed establishments

What is an Establishment Licence?

Issued to a facility (e.g., university, lab) allowing it to house and use animals for research.
It must:

• Meet Home Office standards

• Employ trained staff (NACWO, NVS, etc.)

• Have ethical review processes in place

• Include specific rooms/areas for animal use

what housing policies should be constructed under the establishment licence

• strict on how many animals/cage

• strict light/dark cycles, constant temp

• screening animals: specific pathogen free

• males housed alone after weaning, undless littermates

• isolated air supply: reduces risk of allergic response

• breed for 7-8months, gestation at 21 days

• aldult: 5-8 weeks old

• litter size 3-12

What is a Personal Licence (PIL)?

It requires:

• Completion of accredited training modules (e.g., PIL A–C)

• Demonstrated competence

• Ongoing supervision until experienced

• Must work under a valid Project Licence

who can hold a personal licence

• >18 years old

• met minimum educational standards

• have completed training modules

• experience of handling protected animals

what do you need to obtain a home office personal licence

• personal information for indentification

• details of the establishment

• type(s) of animal(S) you wish to work with

• evidence of completed training e.g. anaesthesia

what type of things are covered in the training for a personal licence (elements - 5 things)

1. ethics and animal welfare (food and bedding)

2. biology & husbandry of species

3. recognition of wellbeing, pain, suffering or distress in species

4. handling and restraint of species

5. animal care and management

what is a project licence

species a programme of work & authorises the application

• needs involvement of establishment licence holder, the home office and the HO vet

• Justification of animal use

• Ethical harm-benefit analysis

• Defined protocols and severity limits

• Must detail use of 3Rs and endpoints

during the application evaluation, what would the secretary of state consider (4 things)

1. expertise in area of science

   • inc. replacement, refinement, reduction

2. expertise in experimental design

   • inc. statistics

3. espertise in veterinary practice

   • laboratory animal

4. expertise in animal husbandry

what are the 2 inspector duties of a home office inspector

1. advice the secretary of state on applictions for licenses under this act

2. to comply w. any direction given by secretary of state

what would the secretary state direct the inspector to do (2 things)

1. req. the inspector to visit the place without notice anytime to ensure whether holder is complying w. provisions

2. if inspector considers that a protected animal is undergoing excessive suffering, they maay require it to be killed immediately in accordance with section 15a

evaluation: What legal and ethical permissions are needed to conduct an animal experiment under ASPA?

Legally, you need:

1. Establishment Licence (place)

2. Project Licence (scientific programme)

3. Personal Licence (individual doing the work)

Ethically, you must:

• Justify animal use through harm-benefit analysis

• Follow the 3Rs

• Pass ethical review (e.g., AWERB)

• Demonstrate necessity and humane practice