Animal research: technical advice

Household products testing ban

The Household products testing ban advice note (PDF, 99.8 KB, 15 pages) describes the implementation of a policy ban on the testing of finished household products and the requirements in relation to the testing of ingredients for household products on live animals under the terms of ASPA. The policy concerns tests on animals for the assessment of the safety of household products for humans, animals and the environment.

Guidance on the use of human material in animals

The Academy of Medical Sciences (AMS) published a report in 2011 that considered research involving the introduction of human DNA sequences into animals, or the mixing of human and animal cells or tissues. Such procedures create entities which are termed ‘animals containing human material’ (ACHM). Within this report the AMS recommended that the Home Office develop guidance on the use of human material in animals that details the authorities required when considering work with ACHM.

This guidance brings together information on the various regulations and guidance surrounding the use of animals containing human materials and the relevant authorities. It has been created in collaboration with the Human Tissue Authority, the Human Fertilisation and Embryology Authority and the Academy of Medical Sciences.

Use, keeping alive and re-use

The Use, keeping alive and re-use advice note (PDF, 123 KB, 21 pages) explains the interpretations of the terms ‘use’, ‘re-use’ and ‘continued use’ under ASPA. It also provides advice on the criteria that must be satisfied to keep animals alive at the end of a series of regulated procedures.

Harm-benefit analysis

The harm-benefit analysis process (PDF, 2.08 MB, 37 pages) conducted by Home Office inspectors, is the cornerstone of the licensing system for the use of animals in science and judges whether the likely harms to animals can be justified by the likely benefits. The Home Office has already published a paper on the purpose of the harm - benefit analysis as an appendix of the operational guidance. This advice note describes how the harm-benefit analysis is conducted operationally.

Re-homing and setting free

The purpose of this Advice note on re-homing and setting free (PDF, 686 KB, 49 pages) is to provide information on the legal requirements and guidance on current best practice in re-homing and setting free. The Home Office expects that every opportunity will be taken to re-home animals where it is appropriate to do so. This advice note explains the criteria required for the Secretary of State to consent for the re-homing or setting free at the end of procedures of relevant protected animals that have been bred, supplied, kept or used in regulated procedures.

Working with animals taken from the wild

The working with animals taken from the wild (PDF, 949 KB, 63 pages) advice note provides information about how the ASPA requirements affect scientific or educational work using animals taken from the wild, including feral and stray animals. This includes information about:

• methods of capture
• identification (ringing, tagging or marking animals)
• working with animals at places which are not ASPA licensed establishments
• setting animals free in the course of regulated procedures which have not yet ended
• legal and licensing requirements

Code of practice for the care and accommodation of animals

The code of practice sets out the standards of care and accommodation of animals required by ASPA, and provides advice about the way in which those responsible under ASPA may comply with those requirements.

The intention of the code is to ensure that the design, construction and function of the installations and equipment of licensed establishments – along with their staffing, care and practices – provides for scientific procedures to be carried out as effectively as possible.

The code is in 3 sections covering both general and species specific indications:

• section 1 describes the legal minimum standards applicable until 31 December 2016
• section 2 describes the legal minimum standards applicable from 1 January 2017
• section 3 provides non-mandatory advice to assist licensees to comply with the standards and covers a broader range of subjects than sections 1 and 2 alone

The full version and the short guide to the code are available to download. Personal copies of the code of practice can be purchased from TSO bookshop TSO bookshop using the ISBN 9780108561290.

The code of practice is also available to download split by species:

• rodents and rabbits
• dogs, cats and ferrets
• non-human primates, farm animals and birds
• fish, amphibians, reptiles and cephalopods

You can read the Explanatory memorandum: code of practice for the care and accommodation of animals (PDF, 75.6 KB, 3 pages) or (print-ready version) (PDF, 68.6 KB, 4 pages).

Efficient breeding of genetically altered animals

This advice note on Efficient breeding of genetically altered animals (PDF, 754 KB, 27 pages) is intended to assist establishments that breed genetically altered animals ensure efficient breeding programmes. This document was created in consultation with breeding experts and provides background information, lines of enquiry, examples of acceptable findings, underlying performance standards and potential performance outcomes that establishments may wish to use to measure their standards. This assessment framework is designed for the breeding of GA mice, although the principles will apply to many species.

Severity classification of genetically altered animals

From 2014 the actual severity of all regulated procedures must be reported as part of the annual Returns of Procedures. This guidance provides advice on severity classification of genetically altered animals under the Animals (Scientific Procedures) Act 1986 (ASPA) (PDF, 83.4 KB, 10 pages)

Recording and reporting the actual severity of regulated procedures

From January 2013 all regulated procedures carried out on animals under the Animals (Scientific Procedures) Act 1986 (ASPA) must have the actual severity of the procedure recorded. This guidance provides advice on recording and reporting the actual severity of regulated procedures (PDF, 165 KB, 19 pages).

Process and standards for establishment full system audits

In October 2021 ASRU will commence a system of full system audits of licensed establishments.

The purpose of these audits is to assess all important systems are in place to ensure compliance with ASPA and all licence conditions.

These audits form part of an integrated system to assess compliance across the regulated community.

Full system audit process (PDF, 221 KB, 12 pages)

Evidence for assessment of compliance against ASPA and licence conditions (PDF, 298 KB, 33 pages)

Guidance notes for project licence applications

The Guidance notes for project licence applications (PDF, 1.72631 MBKB, 5457 pages) is intended to assist project licence applicants, named people and AWERB members on the process for preparing an application for a new project licence or amendment.

Please send any feedback relating to this guidance to ASRUOperationalRelationshipManagement@homeoffice.gov.uk.