User guide to Home Office statistics of scientific procedures on living animals

51 Pages·2017·1.04 MB·English

by  Home Office

User guide to
Annual statistics of Scientific Procedures on
Living Animals, Great Britain

Contents
Page
1 Introduction ........................................................................................ 2
2 Data coverage and source ................................................................. 3
3 Quality and methodology .................................................................. 5
4 Related statistics and reports… ........................................................ 8

Last updated: July 2019
1. Introduction
This user guide accompanies the Home Office collection ‘Statistics of Scientific Procedures on
Living Animals, Great Britain’. The statistics in the collection relate to regulated scientific
procedures performed using living animals under the Animals (Scientific Procedures) Act 1986
(ASPA).
The latest statistics, for 2018, can be accessed here.
Uses of the statistics
The expected uses of the statistics are listed below using the standard categorisation for Official
Statistics (as shown in the United Kingdom Statistics Authority (UKSA) monitoring brief 6/2010,
‘The Use Made of Official Statistics’):
a) Informing the general public’s choices:

• about the state of the economy, society and the environment, e.g. via Parliament
and the media.
• about the performance of government and public bodies, e.g. via Parliament and the
media.

b) Government policy making and monitoring

c) Resource allocation – typically by central and local government

d) Supporting third sector activity, e.g. lobbying and funding applications

e) Facilitating academic research.

Users of the statistics
As well as Parliament, the media, the general public and individual licensees, there is a wide
range of organisations with an interest in these statistics; some examples are listed below (the
list is illustrative and not meant to be exhaustive).
Animals in Science Committee: https://www.gov.uk/government/organisations/animals-in-
science-committee
Animals in Science Regulation Unit, Home Office: https://www.gov.uk/guidance/research-and-
testing-using-animals
Cruelty Free International: https://www.crueltyfreeinternational.org/
European Commission: http://ec.europa.eu/environment/chemicals/lab_animals/reports_en.htm
Federation of European Laboratory Animal Science Associations: http://www.felasa.eu/
Fund for the Replacement of Animals in Medical Experiments: http://www.frame.org.uk/
Institute of Animal Technology: http://www.iat.org.uk/
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2. Data coverage and source
Legislation and purpose of collection
The annual statistics publication relates to scientific procedures performed using living animals
subject to the provisions of the Animals (Scientific Procedures) Act 1986. The 1986 Act requires
licensing and oversight of all places, projects and personnel seeking to conduct scientific
procedures on living animals, as well as publishing and laying before parliament, annual
statistics on the use of protected animals in regulated procedures.
These statistics meet the requirement of the European Directive 2010/63/EU3 and UK law,
which requires member states to submit information on the use of animals for scientific
purposes to the European Commission (see ‘Quality and methodology’ for more detail).
Data source
All scientific procedures carried out on living animals in the UK, subject to the 1986 Act, must be
authorised under a project licence, granted by the Home Secretary. The statistics are collected
via data returns submitted by project licence holders at the end of each year, or within 28 days
of the termination of the licence when this occurs during the year.
Data coverage
Within the UK, the Home Office collects and publishes information on regulated procedures for
Great Britain, while in Northern Ireland the Department of Health separately collects and
publishes this information under devolved arrangements.
Regulated procedures are defined in the 1986 Act as any procedure applied to a protected
animal for an experimental or other scientific purpose, or for an educational purpose, that may
have the effect of causing an animal pain, suffering, distress or lasting harm equivalent to, or
higher than, that caused by the introduction of a needle in accordance with good veterinary
practice. Protected animals are defined in the 1986 Act as any living vertebrate other than man
and any living cephalopod. As the 1986 Act indicates, the breeding of an animal is a regulated
procedure if the animal is bred from, or is the descendant of, an animal whose genes have
mutated or been modified.
The annual statistics publication predominately focuses on experimental procedures and
procedures counted under the creation and breeding of genetically altered ( GA) animals
separately.
Experimental procedures include all animals used in basic research, regulatory use,
translational/applied research, protection of the natural environment, higher education and
training, preservation of species and forensic enquiries.
The creation and breeding of GA animals includes some animals that were bred with the
intention of producing GA animals, but resulted in non-GA animals being born. In addition, some
animals used for the creation of a new genetic line would also have been genetically normal
animals e.g. those used for superovulation. These animals were not used in experimental
procedures.
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Counting rules
The figures provided in the statistical report refer to the numbers of procedures (completed)
rather than the numbers of animals used (for the first time), unless indicated otherwise.
However, in most cases, the number of procedures corresponds to the number of animals used.
In instances where the number of procedures is higher than the number of animals used, this is
due to a re-use of animals.
Each procedure (which may consist of several stages) is counted once for the year in which it
was completed.
A study involving procedures on a number of animals is counted once for each animal. Where
an animal that has previously been used in a completed procedure is used again for a further
procedure (‘re-use’) it is counted as a separate procedure, but the animal itself is not recounted.
The circumstances in which the re-use of an animal is permitted are limited.
Procedures on adult or free-living animals (including neonatal and juvenile mammals, and newly
hatched birds) are counted. Details of procedures on immature forms (e.g. larvae, embryos) are
not counted unless they have reached the free-feeding stage (e.g. zebrafish from five days
post-fertilisation and tadpoles).
Animals in the wild involved in rodenticide trials are also not counted. A rodenticide trial is the
testing of any substance that is used to kill rats, mice, and other rodent pests. Information is
collected on the number of project licences which undertake rodenticide trials.
Exclusions
The controls of the 1986 Act, and therefore the statistics in the annual release, exclude:
• non-experimental agricultural practices;
• non-experimental clinical veterinary practices;
• practices undertaken for recognised animal husbandry;
• the administration of any substance or article to an animal for research purposes in
accordance with an animal test certificate granted under the Veterinary Medicines
1
Regulations 2013 .
The annual statistics also exclude ‘genetically normal’ (i.e. non-GA) animals that were bred for
scientific procedures but were killed or died without being used in procedures, and animals that
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were subject to procedures for the purposes of genotyping . The Home Office published this
data for 2017 here.

1
Statutory Instrument 2013/2033; see Part 1, Sect 3(2)(b) http://www.legislation.gov.uk/uksi/2013/2033/contents.
2
Genotyping is the process of investigating the genetic make-up of an animal.
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3. Data quality and methodology
Data quality
The UK Statistics Authority has designated these statistics as National Statistics, in accordance
with the Statistics and Registration Service Act 2007, signifying compliance with the Code of
Practice for Official Statistics.
NATIONAL STATISTICS STATUS
National Statistics status means that our statistics meet the highest standards of
trustworthiness, quality and public value, and it is our responsibility to maintain compliance with these
standards.
The designation of these statistics as National Statistics was confirmed in 2007 following a compliance
check by the Office for Statistics Regulation. The statistics last underwent a full assessment against the
Code of Practice in 2012.
Since the latest review by the Office for Statistics Regulation, we have continued to comply with the
Code of Practice for Statistics, and have made the following improvements:

• Easier, more intuitive data entry with pop-up messages alerting suppliers to incompatible combinations
of data being entered;

• For the 2017 data onwards, data collected on ‘other’ species is subject to data quality checks which
have allowed for further analyses of the animals returned under ‘other’ (non -Schedule 2) species
categories;

• Each year, we consult with colleagues in the Animals in Science Regulation Unit to ensure the
collection remains suitable for its purpose.

Quality assurance
These statistics are compiled by statisticians within the Home Office. They undertake a wide
range of quality assurance checks with the expert assistance of colleagues in the Animals in
Science Regulation Unit, and with follow-up contact with data suppliers as needed. The checks
include:
• querying incomplete data, or invalid data/combinations of data, provided in returns
• ensuring all returns are accounted for, and that no duplicate returns are provided
• investigating returns which contain unusual data or unusual combinations of data
• variance checks, i.e. investigating substantial changes in figures compared with the
previous year
Data quality issues
Changes to data collection from 2014
Following the European Directive 2010/63/EU being transposed into UK law in January 2013,
the 2014 collection underwent substantial changes. As a result, some inconsistencies were
expected in the reporting of the 2014 information as project licence holders (i.e. data suppliers)
became familiar with the new reporting requirements and data collection format .
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Due to the change from counting ‘procedures started’ to ‘procedures completed’, all procedures
started before 2014 but completed in 2014 should have been reported in both the pre-2014 and
2014 figures.

There were some additional discrepancies with the 2014 data including a small number of
duplicate returns and misclassifications of reported severity. Home Office statisticians have
since reviewed their processes and quality assurance checks in light of these issues.

Rounding
Data may be rounded to simplify the presentation of the figures. However, all numeric and
percentage calculations are based on unrounded data. Where data are rounded, they may not
sum to the totals shown, or, in the case of percentages, to 100%, because they have been
rounded independently.
The rounding conventions used in the release, unless otherwise stated, are as follows:
Figure Rounding convention
Over 1 million Presented as millions and rounded to two decimal places
e.g. 2,121,582 = 2.12 million
10,000 to 999,999 Rounded to the nearest thousand
e.g. 343,465 = 343,000
1,000 to 9,999 Rounded to the nearest hundred
e.g. 8,465 = 8,500
10 to 999 Rounded to the nearest ten
e.g. 47 = 50
Less than 10 Unrounded, whole numbers

Percentages greater than 1% Rounded to the nearest percent
e.g. 1.43% = 1%
Percentages less than 1% Rounded to one significant figure
e.g. 0.43% = 0.4%, and 0.043% = 0.04%

The data in the data tables are unrounded. All percentages in the data tables are rounded to the
nearest 0.1%.
Revisions
It is standard practice across all Home Office statistical releases to incorporate revisions to
previous years’ data in the latest release. Corrections and revisions followth e Home Office’s
statement of compliance with the Code of Practice for Official Statistics .
During the production of the 2017 annual statistics, quality assurance checks revealed a small
number of misclassifications within the 2014, 2015 and 2016 datasets. See Appendix A of the
2017 statistical report for details of all revisions to the 2014, 2015 and 2016 datam ade since
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the 2016 release.
In addition to the revisions listed in the 2017 statistical report, further revisions were made to the
2015 data. The generation of eight marmosets/tamarins, originally classified as ‘F0 wild caught’,
were revised to ‘self-sustaining colony’ and 31 breeding procedures involving mice were
removed.
Following the publication of the 2017 annual statistics, a revision was made to one of the return
of procedures. The genetic status of four rhesus monkeys, originally classified as ‘genetically
altered without a harmful phenotype’ were revised to ‘not genetically altered’.
The time series data tables published in the 2018 statistical report include any revisions that
have been made to previously published data for the years 2014 to 2017.

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4. Related statistics and reports
Great Britain
On 8 November 2018 the Home Office published ‘Additional statistics on breeding and
genotyping of animals for scientific procedures, Great Britain 2017’. These experimental
statistics were collected by the Home Office under the EU Directive (2010/63/EU) and cover the
number of ‘genetically normal’ (i.e. non -genetically altered (non -GA)) animals that were bred for
scientific procedures but were k illed or died without being used in procedures, and the number
of animals (GA and non -GA) subject to tissue sampling for the purposes of genotyping.

Previous releases dating back to 2001 for this statistical collection can be found on the GOV.UK
website. Data was collected under different categories prior to 2014, meaning some of the data
(e.g. for species, purpose, genetic status, severity) is not comparable or does not exist. Older
editions of this statistical release may be found in the national archives. However, not all
previous publications are available online.

Annual publications giving detailed figures for scientific procedures under the Animals (Scientific
Procedures) Act 1986 have been published as ‘Statistics of Scientific Procedures on Living
Animals’ since 1987. Detailed figures for experiments on living animals under the Cruelty to
Animals Act 1876 were published as ‘Statistics of experiments on living animals’ between 1977
and 1986. Less detailed information about experiments on living animals for the years prior to
1977 was published in the form of a ‘Return to an Address of the Honourable the House of
Commons’.

Forthcoming publications are pre-announced on the ‘Statistics: release calendar’ on the
GOV.UK website.
Northern Ireland
Statistics for scientific procedures in Northern Ireland can be found on the Northern Ireland
Department for Health website. The data for Northern Ireland are collected in the same manner
and undergo similar quality assurance processes as the data for Great Britain, meaning the two
datasets can be used for comparison.
European Union
Since 2014, all EU member states are required to submit information on scientific procedures to
the European Commission (EC) in a common format. These national reports can be accessed
on the EC website. Each member state is responsible for the collection and quality assurance of
their data. As such, caution should be used if comparing datasets, as they may have been
collected and/or quality assured in different ways and to varying standards.
Reports from the EC on procedures on living animals in the EU can be found here. The latest
(seventh) report provides an overview on the number of animals used in the EU in 2011 for
experimental and other scientific purposes. The EC is due to publish the compiled EU data
following the new format (i.e. 2014 onwards) in November 2019.
Other related information
A consolidated version of ASPA can be found on the GOV.UK website, as well as the guidance
on the operation of ASPA.
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Information about the work of the Home Office Animals in Science Regulation Unit can be found
in their latest Annual Report.
Information about the Animals in Science Committee can be found on the GOV.UK website.
Information about the National Centre for the Replacement, Refinement and Reduction of
Animals in Research (NC3Rs) can be found on the NC3Rs website.
Feedback and enquiries
We welcome feedback on the annual statistics release.
If you have any feedback or enquiries about this publication, please contact the Fire, Licensing
and Public Order Analysis Unit, the Home Office Unit which produced the statistics, via