Animals in Science Regulation Unit annual reports 2019 to 2021 (accessible version)

Animals in Science Regulation Unit annual reports 2019 to 2021 (accessible version)

Foreword

High quality UK life science research brings economic and educational benefits as well as a direct benefit from research outcomes.

Some of this research still necessitates the use of animals. It is vital that we afford appropriate protections to the animals that are used, and retain public confidence that animals are only used in scientific research when there is a justified requirement. The protections start from ensuring that: animals are only used in research where there are no alternatives; they are only used to the extent needed to meet the objectives of the research; and harms are minimised. The Animals in Science Regulation Unit (ASRU; the Regulator) is committed to assuring that full compliance is maintained with the ‘3Rs’ (replacement, reduction and refinement of the use of animals), keeping it at the heart of our regulatory delivery. Thereby we will continue to assure protections to animals in science through maintaining compliance with the Animals (Scientific Procedures) Act 1986.

Science, including regulatory and animal welfare science, is constantly changing. It is vital that we continue to seek opportunities for regulatory reform to ensure that we are following best practice in regulatory delivery. In 2020 we began a review process with the aim of ensuring that ASRU, and the regulated community, have strong systems for compliance. Our review aimed to continuously improve how we assess the standards and processes used by licence applicants to ensure the benefit from their research is maximised while minimising the harms to animals.

The years 2019, 2020 and 2021 were defined by the significant events of the UK’s exit from the EU and the COVID-19 pandemic. While there were significant perturbations in the external environment, we maintained high standards of regulatory delivery and our focus on the protections to animals.

The pandemic changed the landscape both for those we regulate and ourselves as the regulatory authority. In 2020 the requirements of the national measures meant that our operating model of on-site inspection had to change.

From a total of 470 on-site inspections in 2019 we moved to 712 remote inspections in 2020. Between 16 March and 7 September 2020, compliance was evaluated using a number of methods for assurances of compliance with the legislation. From January to July 2021, remote inspection activity was continued, with the addition of on-site inspections when national lockdowns were lifted in May 2021. An interim operating model, ‘Bridging Ways of Working’, was launched in July 2021 which was underpinned by modern regulatory practice.

Audit systems were developed throughout 2021, and a pilot of full systems audits was initiated at the end of 2021. Although all regulatory staff moved to a home-based working model during the pandemic, we maintained the expected levels of delivery of our licensing service to establishments.

The success of being able to transition smoothly from an on-site and office-based model to a remote and home-based one was largely due to our e-licensing system (ASPeL (Animals in Scientific Procedures e-Licensing)). Since the initial launch of ASPeL in 2014 and the move away from a paper-based system, we have iterated for continuous improvement and reinforced our commitment to better regulation. Both 2019 and 2020 saw major investment into the system with the aims of improving the ability for establishments to be compliant and reducing the overall administrative burden. ASPeL ensures that licence and duty holders can easily access the information they need to do their work, helping to reduce instances of accidental non-compliance. Nevertheless, we recognise the ongoing needs for improvement. In 2021 to 2022 we will continue the development of project licence functionality to ensure the production of legally sound licences alongside the minimum administration required.

In 2013 the UK legislation that delivers protections for animals used in science was harmonised with EU legislation. The harmonisation provided opportunities to improve protections through new legislation and strengthened regulatory delivery. The aim of the UK’s exit from the EU in this policy space was to only remove the mandatory requirements that tied us to the EU. The preparation for exit and the legislative process we conducted achieved a smooth process of legal and regulatory trat successfully met our aims, thus retaining all of the standards, scrutiny and rigour of the current framework.

In 2020, ASRU benchmarked its regulatory performance against the ‘Regulators’ Code’ and the National Audit Office’s ‘Good practice guidance: Principles of effective regulation’.

This exercise identified areas for improvement. Insights were also gained from internal review, external commentary and the independent advisory body – the Animals in Science Committee.

A programme of transformational regulatory change was then initiated to improve the performance of ASRU. Specifically, 10 strategic shifts were identified that underpinned the regulatory reform programme – these are provided at Annex 5. By delivering on these strategic shifts, the regulatory reform programme will provide greater protections for animals used in science and overall improved assurances to the public.

Kate Chandler, Head of the Animals in Science Regulation Unit, April 2022 to present

Section 1: The Animals in Science Regulation Unit

Introduction

The purpose of animals in science regulation is to:

while maximising protection for those animals in line with the law.

The purpose of the Animals in Science Regulation Unit (ASRU) is to protect animals in science by maintaining compliance with the

Animals (Scientific Procedures) Act (ASPA). This is done by focusing on governance of ourselves and the Regulated community.

ASRU is a part of the Home Office Science Directorate and is responsible for the regulatory delivery of ASPA in England, Scotland and Wales. In Northern Ireland, this responsibility is devolved to Northern Ireland’s Department of Health, which reports its activities separately.

The use of animals in science is regulated through a 3-tier system of licensing which licenses each establishment, project, and individual involved in undertaking regulated procedures on animals. All establishments are required to have dedicated individuals, including veterinary surgeons, with legal responsibilities for the care and welfare of animals, and an ethical review body, which reviews any proposals for the use of animals and promotes the 3Rs (replacement, reduction and refinement) of animal use in science. ASRU assesses the compliance of all licence holders through compliance assurance activities that include on-site inspections. ASRU has published and enforces standards for the care and accommodation of all animals bred, supplied or used for scientific purposes.

ASRU delivers through the following functions:

Policy and legislation functions

In 2019, 2020 and 2021 ASRU had a dedicated Policy Team responsible for and providing direct support to ministers to advance and deliver the government’s policy objectives. The team’s work included:

  • contributions to the UK’s approach and negotiating positions regarding the regulation of the use of animals in science, as the UK exited from the EU and during the transition period

  • supporting the delivery of secondary legislation, such as statutory instruments relating to fee increases

  • developing operational policy to deliver ASPA and protect animals in science

  • publication of statistics and project licence non-technical summaries

  • delivery of judicial reviews and tribunal processes relating to animals in science

  • co-ordinating engagement and communications with stakeholders, including the Animals in Science Committee

The Policy Team responds to Parliamentary questions, Freedom of Information requests and all correspondence.

In 2019, 2020 and 2021 the team comprised 2 policy advisers who reported to the Head of Policy.

Business support and IT functions

ASRU’s Business Support Team provides business support to all ASRU colleagues, including managers and leaders.

In 2019, 2020 and 2021, the Business Support Team comprised the following specific functions:

  • risk management activities, including health and safety

  • organising internal and external recruitment

  • organising ASRU training, events and conferences, including external stakeholder events

  • providing a secretariat function and publication of newsletters

  • administering and collecting the return of procedures for publication of the annual statistics

  • managing procurement and finance

  • collecting licence fees

  • maintaining our e-licensing system (ASPeL (Animals in Scientific Procedures e-Licensing)) and IT resources within ASRU

In 2019, 2020 and 2021 the team comprised one senior manager supported by one higher executive officer and one executive officer. In addition, IT activities were overseen by one higher executive officer and one executive officer. The teams reported to the Head of Operations in 2019 and 2020, and to the Head of Business Support in 2021.

Licensing function

The UK’s 3-tier licensing system provides a framework for authorising research using animals. It ensures that animal research and testing is only undertaken:

In 2019, 2020 and 2021, the Licensing Team’s work included:

  • issuing establishment, personal and project licences, and amending these

  • handling appeals against decisions taken

  • taking action in cases of non-compliance

  • leading on the technology for e-licensing

  • At the end of both 2019 and 2020, the team comprised the Head of Licensing (reporting to the Head of Operations), 4 licensing managers and 2 licensing officers. In 2021 the licensing operating model was updated

– this is described in more detail later in this report.

  • ASRU inspectors evaluate licence applications against the requirements of ASPA and use a harm-benefit analysis process to determine whether a licence should be authorised.

Compliance

In 2019 to 2021, non-compliance cases were dealt with by a dedicated Compliance Team with the aim of promoting a robust, proportionate and consistent national approach to cases. The team advised on the appropriate investigation of cases and the proportionate application of sanctions, as described in the published compliance policy. In 2021, the compliance assurance function was created, incorporating enforcement (previously known as non-compliance), inspection and audit. The function reviews reports submitted to ASRU, including Standard Condition 18 and other reports required under ASPA.

Section 2: Regulatory Reform Programme

In 2020, the Animals in Science Regulation Unit (ASRU) benchmarked its regulatory performance against the ‘Regulators’ Code’ and the National Audit Office’s ‘Good practice guidance: Principles of effective regulation’ and identified areas for improvement. This evidence was complemented by various insights gained from internal review, external commentary and the independent advisory body – the Animals in Science Committee.

A programme of transformational regulatory change was initiated to improve the performance of ASRU. Specifically, benchmarking identified 10 strategic shifts that underpinned the Change Programme and are provided at Annex 5. By delivering on these strategic shifts, the Change Programme would deliver alignment of the Regulator with the following expectations:

  • improved ability for licensed establishments to be compliant with the Animals (Scientific Procedures) Act 1986

  • greater protections for animals used in science

  • improved assurances to the public

  • greater openness and transparency of the Home Office in how it meets its regulatory obligations

  • improved value for money

The extent of the reforms required supported the initiation of transformational change. Three broad pillars of change were identified:

  • the requirement for a policy function to which the Regulator would be structurally aligned

  • delivery of a new regulatory operating model that is aligned to leading practice

  • organisational redesign of the Regulator, mapped to the operating model

Creation of a policy function

This government identified that the integrated co-ordination of policy for the use of animals in science could be optimised and that greater clarity and direction given to the Regulator.

Therefore, a function will be created by Quarter 2 of 2022 to provide high-quality cross- government policy leadership on the use of animals in science. This will support the delivery of an effective regulatory framework with clarity of accountabilities.

The new policy function will have the following broad responsibilities that will be transferred from ASRU:

  • ownership of the Animals (Scientific Procedures) Act 1986

  • development of policy relating to the regulation of the use of animals in science by advising ministers through:

  • engaging with the regulated sector and other life science and animal welfare stakeholders

  • working with other government departments with relevant policy crossover

  • commissioning and interpreting advice from the independent advisory body – the Animals in Science Committee

  • sponsorship of the GB regulator (ASRU) by setting policy direction, ensuring operational independence, and holding it to account for delivery

  • working in Partnership with Northern Ireland’s policy function

Delivery of a new regulatory operating model that is aligned to leading practice

In 2021, we identified that fundamental changes to ASRU’s operating model were required to align with leading regulatory practice and in accordance with strategic shifts. A new operating model, ‘Bridging Ways of Working’, was launched in July 2021, which was more aligned with modern regulatory requirements (Section 3). In the new model: inspectors are no longer assigned to establishments; compliance assurance and licensing functions are separated; and regulatory queries are handled centrally.

Organisational redesign of the regulator – mapped to the operating model

The process of organisational design is scheduled for starting 2023, once the operating model has been finalised.

Section 3: Regulatory operating model – ‘Bridging Ways of Working’

In July 2021, the Animals in Science Regulation Unit (ASRU) made changes to the regulatory operating model to align ways of working with leading regulatory practice and modern regulatory systems. In line with leading regulatory practice, the new operating model separates compliance assurance and licensing functions, and inspectors are no longer assigned to specific establishments.

In the new model, ASRU provides regulatory delivery through 2 teams; one covering licensing activities and the other, compliance assurance activities.

Licensing

Under ‘Bridging Ways of Working’, the principles, processes and standards used in licence assessment, in accordance with the requirements of the Animals (Scientific Procedures) Act 1986 (ASPA), remain unchanged.

Licences are no longer assessed by an inspector assigned to a specific establishment. Applications are assessed by an inspector in the order they are submitted through our electronic licensing system (ASPeL (Animals in Scientific Procedures e-Licensing)). Licence applications are prioritised using typical timelines that are aligned within the statutory timelines defined in ASPA. Typical timelines can vary, based on the complexity of the application and level of incoming applications to the Regulator.

Compliance assurance

Compliance activities are dealt with separately to licensing. All compliance assurance functions have been brought together in a co-ordinated compliance function. Compliance assurance comprises the following activities which provide oversight and assurance of licence holder compliance with ASPA and their licence conditions:

  • provision of facility, systems and thematic audits

  • enforcement activities through investigation and management of potential cases of non-compliance

  • reviewing reports submitted which are part of compliance assurance (such as Standard Condition 18 reports, retrospective assessments, other reports required by a specific licence)

Requests to keep animals alive

The compliance assurance function deals with requests to keep animals alive when the severity limits in a project licence and/or observance of any other controls appear to have been, or are likely to be, breached.

Standard Condition 18 reports

Notification to ASRU under PPL Standard Condition 18 relates to breaches or likely breaches of either severity limits or any other controls set in the licence. Notification provides an important opportunity for the licence holder, the establishment and ASRU to review whether any changes need to be made to licence authorities and is an important source of data for ASRU compliance assurance. Notification under PPL Standard Condition 18 is not the same as reporting a non-compliance.

The requirement for reporting under PPL Standard Condition 18 is described in more detail in an ASRU advice note. This will be superseded by updated advice to be published in 2022.

Enforcement

Cases of non-compliance are managed in line with existing processes within the compliance assurance function. Management of non-compliance is described in more detail in this report. Cases from 2019 to 2021 are summarised in Annexes 1, 2 and 3.

Audit

Under ‘Bridging Ways of Working’, an audit programme was initiated, which is aligned with ASRU’s strategic focus on establishment governance.

An audit is a process which verifies conformance to standards through review of objective evidence. The purpose of ASRU’s audit process is to assess compliance against ASPA and associated licence conditions, and to objectively measure the risk of non-compliance within the establishment by assessing the robustness of governance systems.

Audits are conducted primarily in 3 ways:

  • facility audit: based on the facility itself to ensure it meets the ‘Code of Practice for the Housing and Care of Animals Bred, Supplied or Used for Scientific Purposes’

  • systems audit: evaluating governance systems within an establishment or a project to understand how robust they are at maintaining compliance

  • thematic audit: evaluating one particular area of compliance across the regulated community to assess the overall approach to maintaining compliance in this area

Culture and tone of audit

The purpose of audit is primarily supportive and aims to recognise areas where systems are strong to maintain compliance as well as identifying areas where improvements could be made. Although non-compliance may be detected during an audit, it is not primarily an enforcement activity but a monitoring and educational activity.

ASRU’s full systems audit process is published in full here: Full System Audit Process – ASRU (publishing.service.gov.uk)

Regulatory advice

Under ‘Bridging Ways of Working’, answers to regulatory queries are provided centrally through the compliance assurance and licensing functions, depending on the nature of the query. Central provision of advice ensures that queries are dealt with in a timely consistent manner.

Common types of queries can be identified, and this will inform future published advice with the aim of making it easier to comply.

Relationship management

Under ‘Bridging Ways of Working’, the relationship management function was created with the purpose of engaging with the regulated community in a more co-ordinated and centralised way. In 2021, ASRU commenced quarterly meetings between Home Office liaison contacts at establishments and ASRU’s operational management lead. Complaints from the regulated community about regulatory delivery are also managed through the relationship management function. A new ASRU complaints process will be published in 2022.

For more information on ‘Bridging Ways of Working’, refer to our published Bridging Ways of Working advice note.

Section 4: Regulatory framework

The standards associated with the Animals (Scientific Procedures) Act 1986 (ASPA) and the guidance on its administration and enforcement are provided in the Code of Practice for the Housing and Care of Animals Bred, Supplied or Used for Scientific Purposes (the Code of Practice) and the Guidance on the Operation of the Animals (Scientific Procedures) Act 1986 (the Guidance) respectively. Both documents are publicly available and support establishments in both understanding ASPA and being compliant with the requirements.

Publications

Advice notes complement the published guidance and provide further explanation where required (Animal testing and research – GOV.UK (www.gov.uk)).

In 2020, the Animals in Science Regulation Unit (ASRU) published a guidance document highlighting the need for establishment licence holders to have prepared in advance robust internal governance (systems and processes) and be able to activate these in the event of a significant disruption to business activities over a prolonged period of time. The requirement remains on the establishment licence holder to demonstrate how they will fulfil their legal responsibilities in compliance with ASPA and their licence authorities, including the licence standard conditions. However, all licensees and other duty holders under ASPA should review the robustness of the processes and systems governing their work with protected animals, particularly those areas in the standard conditions of their ASPA licences.

Working with the EU Commission

The Directorate-General for the Environment in the EU Commission is responsible for ensuring the Europe-wide implementation of Directive 2010/63/EU. During 2019, senior representatives from ASRU, as the UK competent authority, attended 2 meetings in Brussels. At these meetings, updates were provided by each EU member state on their transposition of the Directive. Following the UK’s exit from the EU on 31 January 2020, ASRU has not attended these meetings.

EU exit

EU Directive 2010/63/EU on the protection of animals used for scientific purposes was transposed into UK law through an amendment to ASPA in 2012. This means that the UK has harmonised legislation for animals in science regulation with all EU member states. In 2018, arrangements were made for EU exit by preparing secondary legislation to amend ASPA and deliver EU exit. The legislation was enacted on 31 January 2020, the day of EU exit. The legislation had the result of removing mandatory requirements to work with the EU Commission and other member states (Directive 2010/63/EU).

The delivery of the animals in science regulatory framework has continued with the same standards of oversight, rigour and scrutiny following the UK’s exit from the EU. There have been no changes made to the UK regulatory framework, including the standards of animal welfare or housing and care as set out in the Code of Practice.

Working with the Animals in Science Committee

The Animals in Science Committee (ASC) is an independent, non-departmental public body convened under sections 19 and 20 of ASPA. The ASC is responsible for providing independent, balanced and objective advice to the Secretary of State on issues relating to the regulation of animals in science. At all times, the ASC must consider both the legitimate requirements of science and industry and the protection of animals from avoidable suffering and unnecessary use in scientific procedures.

The ASC has a website detailing its activities.

The ASC also provides advice on specific categories of project licences, including those seeking authority for:

  • the use of wild-caught non-human primates

  • the use of cats, dogs, equidae or non-human primates in severe procedures

  • the use of endangered species

  • projects with major animal welfare or ethical implications

  • projects of any kind raising novel or contentious issues, or giving rise to serious societal concerns

  • projects involving the use of admixed embryos as advised in the Guidance on the use of Human Material in Animals

  • projects that may invoke any of the ‘safeguard clauses’ in Directive 2010/63/ EU with respect to the purpose of primate use, proposals for the use of a great ape, or proposals to cause long-lasting pain, suffering or distress that cannot be ameliorated

ASPA requires that the ASC engages in the promotion of good practice through knowledge sharing between the animal welfare and ethical review bodies (AWERBs). The ASC has set up a regional network of AWERB hubs to facilitate knowledge transfer and introduced a secure information-sharing platform open only to AWERB members. The ASC hosts an annual workshop to enable the ASC AWERB subgroup to meet with the Chairs of AWERB hubs to discuss key aspects of the role and operation of AWERBs. Reports of the 2019, 2020 and 2021 ASC annual AWERB Hub Chair workshops can be found on the ASC website. ASRU welcomes these initiatives as a means of improving communication of good practice.

Section 5: Licensing

The framework

The UK’s 3-tier licensing system provides a framework for authorising research using animals.

The licensing system ensures that animal research and testing is only undertaken:

The Animals in Science Regulation Unit (ASRU) administers the licensing function under the Animals (Scientific Procedures) Act 1986 (ASPA), which comprises the following requirements:

  • the place at which the work is carried out must hold an ‘establishment licence’ (PEL)

  • the programme of work in which the procedures are carried out must be authorised in a ‘project licence’ (PPL)

  • those carrying out procedures must hold a ‘personal licence’ (PIL), which ensures that those working with the animals are qualified and suitable

In 2019, ASRU licensed and regulated 152 establishments. These establishments included universities, pharmaceutical companies and contract research laboratories. At the end of 2019 there were 2,537 active PPLs, with 3,044 PPLs active at some point in 2019. At the end of 2019 there were 16,009 active PILs.

In 2020 ASRU licensed and regulated 144 establishments. These establishments include universities, pharmaceutical companies and contract research laboratories. At the end of 2020 there were 2,429 active PPLs, with 3,088 PPLs active at some point in 2020. At the end of 2020 there were 14,796 active PILs.

In 2021 ASRU licensed and regulated 137 establishments. These establishments include universities, pharmaceutical companies and contract research laboratories. At the end of 2021 there were 2,423 active PPLs, with 2920 PPLs active at some point in 2021. At the end of 2021 there were 14,402 active PILs.

Licensing activities

Establishment licences

During 2019, 2 PELs were granted and a total of 2,297 amendments were made to PELs.

This was a large increase compared with 2018, predominantly due to administrative changes such as the change in layout of ‘approved areas’ within the establishment licence in the new e-licence format.

During 2020, 3 PELs were granted and a total of 2,612 amendments were made to PELs.

During 2021, no PELs were granted and a total of 2,678 amendments were made to PELs.

Project licences

During 2019, a total of 481 new PPLs were granted. There was an 11% decrease in the number of PPLs granted in 2019 compared with 2018.

During 2020, a total of 471 new PPLs were granted.

During 2021, a total of 493 new PPLs were granted.

Personal licences

During 2019, 2,792 new PILs and 564 PIL amendments were granted. This was a 19% decrease on new PILs compared with 2018.

During 2020, 1,732 new PILs and 679 PIL amendments were granted. This was a 38% decrease on new PILs compared with 2019 and was likely due to the impact of the COVID-19 pandemic.

During 2021, 2,327 new PILs and 789 PIL amendments were granted.

Licensing Team

In 2019, 2020 and 2021 each establishment was assigned a single point of contact from within the Licensing Team to assist with any queries that may arise and to process all licensing recommendations made by the assigned inspector.

Animals in Scientific Procedures e-Licensing

In 2019, ASRU rolled out a refreshed digital e-licensing system ASPeL (Animals in Scientific Procedures e-Licensing) to improve:

This system replaced the earlier version of ASPeL, which was decommissioned in August 2019.

The new ASPeL website is built on the government’s principle of user-centred design. Over 500 research sessions have been conducted with users of ASPeL to ensure that its design meets user needs and completes tasks without the need for further guidance. The new ASPeL system ensures that licence and duty holders can easily access the information they need to do their work, helping to reduce instances of accidental non-compliance.

Previously, approximately 40% of licences remained on paper files with limited access.

The new ASPeL system is more transparent and auditable. It allows applicants to easily track the progress of their applications and see when mandatory actions are required, such as when a PIL is due for review. The enhanced auditability also enables ASRU to continually review and improve the service.

The system has a robust, secure architecture. It provides a single-source of truth, giving establishments and ASRU the confidence that the information being viewed is correct and up to date.

Changes to the licence application and amendment processes have been designed to assist applicants and reduce the administrative burden. More PPL applications are now complete and correct upon first submission and the average number of iterations per application has reduced. Previously, the mean number of iterations required for a PPL application was 4.6; the revised application form has reduced this mean to 2.6 iterations. ASRU recognises that the new project application form can continue to be improved. Further improvements to the form and the performance of ASPeL continued in 2021.

PELs are now easier to view and amend. This facilitates all authorised users to review the list of approved areas to view their contemporaneous authorisations. Similarly, all PILs are visible quickly and easily to all administrators and named people, enabling all duty holders to ensure that the appropriate authorisations are held. The time taken to authorise a PIL application or amendment has been reduced from up to 20 days to the next working day, with many applications processed on the same day.

Further features have been added to ASPeL during 2019, 2020 and 2021. Establishments are automatically alerted when the mandatory 5-year PIL reviews are required and provides an improved workflow to enable reporting of the completed reviews. The ability to submit and add a retrospective assessment to an expired or revoked PPL is now embedded for those licences that are required to supply them.

The introduction of financial and invoicing information for PELs and PILs, which began in January, has provided establishments greater transparency over their financial data.

The new ASPeL has passed all the Government Digital Service standard assessments required by the Cabinet Office and is seen as an exemplar of good service design. It has been built in such a way that it can be continually improved and upgraded as technology moves on. ASRU has committed to the ongoing development of ASPeL to ensure its continued development to meet user needs, both internally and externally.

The progress and development of the e-licensing software is made publicly available.

Work with the National Centre for the 3Rs

The National Centre for the Replacement, Reduction and Refinement of Animals in Research (NC3Rs) is the UK’s national organisation for the discovery and application of new technologies and approaches to replace, reduce and refine the use of animals for scientific purposes. The Animals in Science Regulation Unit (ASRU) and the NC3Rs have a shared aim of maximising 3Rs (replacement, reduction and refinement) delivery.

In 2018 ASRU signed a Memorandum of Understanding (MoU) with the NC3Rs. The MoU represents a bilateral agreement for the mutual exchange of information, thus supporting ASRU in its legislative requirement to implement fully the delivery of the 3Rs.

From 2019, ASRU and the NC3Rs met regularly to work together to advance the 3Rs. ASRU has supported the use of the NC3Rs self- assessment tool in establishments and provided representation at NC3Rs events. ASRU has also promoted NC3Rs events and opportunities to establishments being regulated under the

Animals (Scientific Procedures) Act 1986 (ASPA).

In 2019, themed inspection activity was undertaken in the following areas:

  • how the reuse of hypodermic needles can be avoided to reduce suffering during injection procedures

  • using more refined mouse-handling procedures

  • how to reduce non-compliance associated with the failure to give animals food and water, and to understand why such cases still arise. Details relating to this activity can be found in Section 9 of this report – Management of non-compliance

Reuse of hypodermic needles

The practice of hypodermic needle reuse has negative implications for animal welfare and data quality in scientific studies. The point of the needle is deformed from a single use and this deformity increases with each reuse of the needle. Use of deformed needles will cause more pain and tissue damage than a new needle. Furthermore, tissue products adhere to needles so the reuse of needles is likely to result in transfer of these products between animals. Data quality may be affected due to the increased chances of spreading infection between animals and the increased pain from using a deformed needle. Consequently, reuse of needles should be avoided to ensure compliance with 3Rs expectations, in line with ASPA 2A(2)(c), establishment licence (PEL)

Standard Condition 1 and personal licence (PIL) Standard Condition 1.

ASRU conducted inspections between November 2018 to March 2019 to investigate needle reuse in establishments. Using a structured questionnaire-based approach, this allowed ASRU to assess the level of needle reuse across establishments as well as identify instances where it may be justifiable, and determine barriers to adopting good practice.

A total of 98 questionnaires were returned from 86 establishments. These indicated that the majority (73%) of surveyed establishments were aware of needle reuse as an issue.

Where needle reuse did occur, establishments were asked the reasons for this. The most frequent reasons for needle reuse were due to resource, culture within the establishment, and health and safety concerns. To gain a better quantitative understanding of the level of needle reuse awareness within establishments, the number of establishments with either formal or informal needle reuse policies was recorded. The majority of establishments had a needle reuse policy, and, within these establishments, the incidence of needle reuse was found to be less than in those establishments without a policy.

In summary, the themed inspection in needle reuse found that this practice does occur within GB establishments and a large proportion of this reuse could justifiably be reduced without impacting on scientific outcomes. One way of potentially reducing reuse could be through the application of a needle reuse policy within an establishment. ASRU continues to challenge any needle reuse observed on inspection or reported as occurring in an establishment.

To reduce the risk of non-compliance and nurture a good culture of care, licensed establishments should institute a policy on needle reuse where relevant and potential exemptions from single use should be considered on a case-by-case basis by the establishment’s Animal Welfare and Ethical Review Board (AWERB). Potential example exemptions may relate to health and safety considerations, use of automated systems and species-specific considerations.

AWERBs should consider the occurrence of and reasons for needle reuse within the establishment and should record the decisions and evidence considered around requests for such exemptions.

Refined mouse-handling procedures

The NC3Rs promoted the use of refined mouse- handling methods (cup and tunnel handling).

There is scientific evidence that use of these techniques:

  • reduce anxiety of the mice being handled

  • have a positive impact on their metabolic parameters

  • alter hedonistic value of reward

  • decrease experimental variation

Thus, these techniques are beneficial both for animal welfare and scientific reproducibility.

The mice can still be effectively restrained, as needed for procedures, and habituate to the techniques quickly. Once skilled there is no difference in the time taken by technicians or researchers to use these techniques. Within establishments it is the high-level support that is considered a critical success factor for this type of change, such as:

There are resources available to support the transition to these techniques on the NC3Rs website (https://www.nc3rs.org.uk/how‑to‑ pick‑up‑a‑mouse). Despite this evidence there has been patchy uptake and implementation of these techniques. ASRU prioritised engagement with licensed establishments to improve the handling of mice in line with best practice.

Following refresher training for inspectors on mouse-handling techniques, during 2019 inspectors engaged with establishments through a variety of mechanisms and during inspection visits to assess their current strategies for the uptake of these techniques. Inspectors used a structured questionnaire-based approach when gathering information from the establishments.

Data were collected from 110 establishments out of a total of 134 establishments that held mice, representing 82% of establishments.

Overall, 68% of responding establishments were only using non-aversive methods. Of the respondents, 48% reported that they were in the process of implementing non-aversive methods and 6% had not yet started the implementation process.

The success factors for implementation were largely related to the degree to which technicians owned the initiative.

These data showed a higher take-up rate of non-aversive mouse handling techniques than was expected prior to the start of the themed inspection programme. The NC3Rs had previously reported that in their experience researchers and animal care staff were not always aware of the underpinning research studies into the benefits of using these techniques.5 Potential reasons for this are:

  • that all data were self-reported and thus the rate of progress may have been overstated

  • the focus on mouse handling was shared by ASRU with establishments via multiple methods prior to the start of data collection

  • the existence of the themed inspection itself may have improved or sped up implementation activities

All establishments should have a clear strategy for the implementation and monitoring of refined mouse-handling techniques. The strategy and implementation plan must be owned by those using and directly responsible for the use of the animals, including technicians and named role holders within the establishment. This strategy should be reviewed by the AWERB, which should have accountability for monitoring its implementation.

Section 7: Stakeholder engagement

Communications

In 2019, 2020 and 2021, The Animals in Science Regulation Unit (ASRU) responded to Freedom of Information Act 2000 (FOI) requests and correspondence from the general public on issues related to the regulation of the use of animals in science. Correspondence is an important way in which the government communicates current policy and thinking in an open and transparent way.

Correspondence

During 2019, ASRU handled 23 FOI requests, 60 items of ministerial correspondence and 39 other pieces of correspondence.

In 2020, ASRU handled 24 FOI requests, 18 items of ministerial correspondence and 58 other pieces of correspondence.

In 2021, ASRU handled 32 FOI requests, 215 items of ministerial correspondence and 67 other pieces of correspondence.

Correspondents were concerned with a breadth of issues. Among these the main topics were:

  • the phasing out of the use of animals in research

  • the use of primates in research

  • the use of non-animal alternatives in research

  • the use of dogs in research

  • the welfare of animals during the COVID-19 pandemic

Freedom of information requests

In line with the government’s policy on openness and transparency, ASRU’s approach is to act with a presumption to openness to assist public understanding of the use of animals in science. Topics for requests for the release of information included:

Nevertheless, it is essential that ASRU protects all information that is legally exempt from disclosure, such as personal details and information given to the Home Office in confidence. Such protected information includes intellectual property, commercially sensitive information and that which could identify people or places.

Meetings with stakeholders

Over the last 3 years ASRU has continued to engage with stakeholders both face to face and virtually. Meetings were held with a wide range of stakeholders. Maintaining these relationships is vital to help understand the expectations and perspectives of ASRU’s stakeholders and receive valuable feedback in the performance of the unit and the effective implementation of the Animals (Scientific Procedures) Act 1986 (ASPA).

The meetings were with representatives from:

  • the animal-using community, such as industry, academia, government research institutes, medical research charities and research funders

  • organisations devoted to the replacement, reduction and refinement of the use of animals in research (the 3Rs)

  • animal welfare and animal protection groups

  • ASPA-named persons and others performing functions under ASPA

  • the Animals in Science Committee and professional organisations

  • other government departments

Relationship management

In 2019 and 2020, the Home Office met 3 to 4 times a year with counterparts in establishments through the Home Office Liaison and Training Information Forum (HOLTIF). The meetings are an opportunity to discuss service delivery, for ASRU to receive feedback and to solve any associated issues. The main external attendees are the Home Office Liaison Contacts (HOLCs), who undertake many of the administrative functions required under ASPA at each establishment and support licence applicants and existing licence holders.

HOLTIF is attended by up to 60 HOLCs. In 2020 and 2021 the frequency of meetings was reduced due to COVID-19 restrictions. The virtual meetings focused on service delivery and continued improvements to our ASPeL (Animals in Scientific Procedures e-Licensing) system.

In 2021, the role of operational management lead was created with the purpose of engaging with the regulated community in a co-ordinated and centralised way. We commenced quarterly meetings between HOLCs and ASRU’s operational management lead with the aim of gathering feedback on ASRU’s regulatory delivery.

External representation

External representation and engagement with stakeholders is an important aspect of ASRU’s work. Examples of engagement with stakeholders in 2019, 2020 and 2021 included attendance and presentations at the:

  • Institute of Animal Technology Congress

  • Animal Welfare and Ethical Review Bodies Forum

  • Establishment Licence Holders Forum

  • Laboratory Animals Veterinary Association Conference

  • Laboratory Animal Science Association Conference

  • Royal Society of Biology Annual Science meeting

Section 8: Inspection and audit

The Animals in Science Regulation Unit (ASRU) inspects and audits establishments licensed to breed or supply animals, or to undertake regulated procedures on animals under the Animals (Scientific Procedures) Act 1986 (ASPA) in England, Scotland and Wales. The purpose of inspection and audit is to provide assurance to ministers and the public that there are systems in place to ensure care of animals and that the experiments undertaken comply with the requirements of ASPA and the relevant conditions specified in licences. ASRU provides advice to duty holders on how to comply with the requirements of ASPA and will apply enforcement where non-compliance is detected.

Inspection is undertaken for the following purposes:

  • determine whether licence holders are compliant or to advise how to be compliant with the legal requirements of ASPA

  • inspect areas included on establishment where animals may be kept or used under ASPA to ensure that they comply with the standards laid down in the ‘Code of Practice for the Housing and Care of Animals Bred, Supplied or Used for Scientific Purposes’

  • determine whether animals are being or have been used in procedures, or being used for breeding or supply, in areas not included on establishment licences

  • determine whether the breeding, supply and/ or use of animals in procedures is compliant with licence authorities and conditions on licences

  • determine whether people named in the establishment licence understand and are fulfilling their required duties, and to advise on these roles

The risk-based programme of inspection is based on consideration of the factors specified in section 18 (2C) of ASPA. These are:

  • compliance history of an establishment

  • any information relating to potential non-compliance

  • number and species of animals kept

  • number and type of regulated procedures carried out

On-site and remote inspection during the COVID-19 pandemic

In 2019, ASRU undertook 470 inspections to places holding establishment licences, or places other than licensed establishments (POLEs) where scientific work on animals was conducted. Of the inspections to animal units, 169 were unannounced.

In 2020, following the implementation of national lockdown measures, assessment of compliance was undertaken remotely in most cases between 16 March and 7 September, using remote inspection activities rather than on-site inspection visits. Inspectors evaluated compliance remotely using telephone interviews, assessment of records and information, online meetings, and video inspection of areas.

On-site inspection activity resumed between 7 September 2020 and 4 January 2021 and was again paused between 5 January and 4 May 2021, in response to national lockdowns.

Throughout 2020 and 2021, remote inspection activity was used to evaluate compliance where the inspection objectives could be achieved without on-site visits.

In 2020, ASRU undertook 790 inspections of licensed establishments where scientific work on animals was conducted; 712 were undertaken remotely and 78 were undertaken on-site.

In 2021, ASRU launched the ‘Bridging Ways of Working’ operating model and introduced a more rigorous full systems audit process as part of compliance assurance activity, which consisted of longer and more rigorous on-site audit visits. These involved teams of ASRU officials assessing selected establishments in depth. The numbers of inspection visits undertaken are therefore not comparable between 2018, 2019, 2020 and 2021.

In 2021, ASRU undertook 214 inspection visits and audits to licensed establishments; 41 were undertaken on-site and 170 were undertaken remotely. On-site inspections were not routinely undertaken between 5 January and 3 May due to national lockdowns. Overall, fewer number of on-site visits were undertaken in 2021 compared to 2019 and 2020. This was due to 2 main factors:

  • national lockdowns between 5 January and 3 May 2021 during which compliance assurance and inspection activity was undertaken remotely. On-site visits were still conducted for serious non-compliance cases or serious animal welfare concerns that could not be evaluated remotely

  • launch of the ‘Bridging Ways of Working’ from 5 July 2021 which consolidated and expanded compliance assurance activity.

The new operating model introduced full systems audits which are extended, structured compliance visits requiring teams of ASRU officials evaluating selected establishments in depth. ASRU also updated the Standard Condition 18 system leading to increased compliance oversight of all GB establishments through collection and analysis of Standard Condition 18 reports. Standard Condition is applied to all project licences to ensure that the licence holder adheres to the specific severity limits (the scientific and humane endpoints that set limits on pain) in each licence

Changes to Inspection and audit programme throughout the COVID-19 pandemic

2020 1 January 2020 to 15 March 2020 16 March to 6 September 2020 7 September 2020 to 31 December 2020

External events

n/a

National lockdowns

Reduced lockdown restrictions

ASRU ways of working

Risk-based inspection programme

Remote inspection

On-site and remote inspection

Inspection and audit priorities

Risk-based inspection programme

On-site visits for serious non-compliance cases or serious animal welfare concerns that could not be evaluated remotely

On-site visits for serious non-compliance cases or serious animal welfare concerns that could not be evaluated remotely
2021 5 January 2021 to 3 May 2021 4 May 2021 to 4 July 2021 5 July to 31 December 2021

External events

National lockdowns

Reduced lockdown restrictions

Reduced lockdown restrictions

ASRU ways of working

Remote inspection

On-site and remote inspection

Launch of ‘Bridging Ways of Working’

Inspection and audit priorities

On-site visits for serious

non-compliance cases or serious animal welfare concerns that could not be evaluated remotely


On-site visits where desired outcomes could not be met by remote inspection

Full systems audit pilots

Establishments were selected for audit on a risk-basis taking into account their non-compliance data

Risk management

ASRU’s establishment risk management process comprises a review of the national risk profile and local establishment factors. ASRU undertakes reviews periodically throughout the year.

Evaluation of risk includes:

  • the incidence and nature of non-compliance cases

  • any significant low-level concerns

  • procedures and species

  • any other relevant information

Inspections and audit programmes are planned taking these factors into account.

Themed inspections

Themed inspections are targeted activities intended to focus efforts on issues that have implications across many establishments.

For example, where particular issues require closer examination or evidence gathering to assist with the development of policy, or the provision of advice on the implementation of the replacement, reduction and refinement of the use of animals in science (the 3Rs).

A review of non-compliance cases reported in our 2018 Annual Report identified common themes and associated risk factors. The most common theme was a failure to provide adequate food and water. Failure to provide food and water accounted for between 15% and 22% of non-compliance cases between 2015 and 2018. Examples of causes of the failure of the provision of food and water include recent changes in housing or failure to effectively communicate the change-over of responsibility for care of the animals, such as when undertaking procedures, or at weekends.

In 2019, a themed inspection programme was undertaken to review the arrangements in establishments for the provision of food and water.

As in 2015 to 2018, the risks inspectors identified as most likely to be associated with inadequate provision of food and water were:

  • recent changes in housing

  • the care of animals whilst undergoing regulated procedures

  • failure to provide at weekends

Changes in housing typically occur following transportation or delivery of animals, weaning or separating animals into different cages.

Risks associated with procedures typically reflect failures of communication and responsibility, for example between duty holders and technicians. Similarly, changes in staff numbers and routines at weekends increases the risk of failures in the adequate provision of food and water.

To identify effective strategies for the uninterrupted provision of food and water, ASRU attended meetings with stakeholders and engaged with establishments during inspection activities. Strategies were disseminated to and between stakeholders, including licensed establishments and the Institute of Animal Technology, through presentations and publication[footnote 1] to encourage their adoption across establishments. Inspectors were also provided with the outcomes to inform their inspection activities regarding the provision of food and water.

Successful animal care strategies included:

  • twice daily (morning and afternoon) checks (ideally by different staff members)

  • physically touching the food or water bottle

  • adequate labelling to alert staff to at-risk cages, for example, post-weaning or transport

No thematic inspections were conducted in 2020 and 2021 due to changes in ways of working during the pandemic. An updated thematic audit system will be developed as part of the regulatory reform programme.

Investigating allegations made to ASRU

ASRU periodically receives allegations about potential breaches of ASPA, commonly referred to as ‘whistle-blowing’ allegations. These are taken seriously, and where sufficient information is provided, they are followed up by the most appropriate means, including inspection or audit if appropriate. Where it appears that there may have been a lack of compliance with ASPA, these are investigated in accordance with ASRU’s non-compliance policy.

Section 9: Management of non-compliance

Compliance policy

The Animals in Science Regulation Unit’s (ASRU’s) compliance policy focuses on the delivery of a proportionate, consistent, and outcome-based approach to incidents of non-compliance.

Every establishment licensed under the Animals (Scientific Procedures) Act 1986 (ASPA) has a named person responsible for compliance (NPRC). This individual is responsible for ensuring compliance with the conditions placed on their establishment licence. A good culture of compliance at an establishment reflects evidence of effective governance over the use of animals in science. The NPRC must maintain robust systems and frameworks that support and assist all licensees to comply with their licence conditions.

Inspectors determine whether establishments and licensees are complying with the provisions of ASPA and the conditions of their licences through various inspection activities. Inspectors gather sufficient information to determine whether there is a case that merits investigation and reports initial findings of any potential non-compliance to the ASRU Compliance Team within 5 working days of discovery. In the report, the inspector provides details of the case and recommendations to support the delivery of appropriate sanctions and necessary actions aimed at the prevention of repeating similar incidents.

Licensees and the establishment are notified in writing by the Compliance Team when a non-compliance investigation is being conducted and are given an opportunity to provide any information that they wish to be considered before ASRU takes a decision regarding the appropriate sanction(s). Complex or serious cases may take longer to resolve than the suggested timescales above. In rare cases, ASRU may take a view that an offence has been committed that is sufficiently serious to merit referral for prosecution.

Potential remedies for non-compliance

Cases are considered on an individual basis. The most appropriate remedy is applied considering the severity of the non-compliance and the aggravating and mitigating circumstances. The resulting measures and sanctions are taken with the aim of deterring or preventing recurrence.

Factors considered when determining suitable remedy include:

  • the extent of any unnecessary animal suffering

  • evidence and extent of governance and systems failures

  • the timeliness of any remedies applied by the establishment

  • the risk of recurrence

  • evidence of dishonesty or attempts to evade responsibility

The range of remedies available, as set out in the published compliance policy, benchmark and help to determine the outcome associated with each breach. They are briefly outlined below.

1. Inspector advice

Where there is a minor breach an inspector will provide advice stating what provision was breached and what is expected in future to prevent a recurrence. A minor breach is one where:

  • there are no or minor avoidable adverse animal welfare consequences

  • the facts are agreed

  • there was no intention to subvert the controls of ASPA

  • the risk of a recurrence is judged to be low

Inspector advice has been recorded centrally since 2019. Prior to this, records of inspector advice were not recorded centrally.

2. Compliance letters

Where provision of inspector advice is not considered sufficient, most cases of non-compliance are dealt with by a letter from ASRU, with or without a variation of the relevant licence(s). Where a breach has been committed by a licensee, a letter of reprimand is sent. Where a non-licensee has contributed significantly to the breach, a letter of censure may be sent.

Letters note the breach(es) that have occurred and summarise the evidence for those breaches. These letters are formal records of non-compliance and may be used as evidence should there be a further breach within 5 years. All letters are copied to the NPRC so that local practices and processes can be reviewed, as appropriate.

3. Variation of licence

Requirement for retraining

Retraining is required where a licensee has demonstrated that they do not have the expected level of knowledge of their legal responsibilities or to undertake procedures.

Requirement for reporting

Where action is required to improve weaknesses identified by a breach, including poor record keeping, a report may be required to monitor progress. Reports are also useful to formally monitor enhanced animal welfare, the implementation of refinements or improved scientific outcomes.

Suspension

Where a breach has been identified, licences may be suspended as a sanction. Licences may also be suspended when there are urgent animal welfare concerns. Suspensions are appropriate where there is a risk to animal welfare and significant urgent action is required to protect it. When a suspension is required, ASRU must ensure that the suspension itself does not result in an adverse impact on animal welfare.

4. Compliance Notices

A Compliance Notice is issued where ASRU requires action to be taken to prevent further non-compliance. Such a notice will specify:

  • the licence condition(s) or ASPA provision(s) that have been breached

  • the action that must be taken to ensure that the failure does not continue or is not repeated

  • any action that must be taken to eliminate or reduce any consequential risk of harms caused by the breach

The Compliance Notice will set out the consequences of failing to comply. In this eventuality, the licence holder may then be sanctioned with suspension, variation or revocation of their licence.

This type of remedy is particularly effective where weaknesses in governance have been identified or where cultural change in attitudes towards welfare or compliance is needed.

Over time, it provides a formal mechanism for assuring and monitoring improvements.

Such changes may take some time to remedy; for example, increases in staffing, facility refurbishment or embedding an improved culture of care.

5. Revocation of a licence

Revocation of any type of licence issued under ASPA is only used in the most serious cases.

It is appropriate where a licensee has shown a disregard for the controls of the ASPA and has caused avoidable suffering. It may also be appropriate where significant avoidable suffering has been caused through negligence or ignorance, or where the licensee otherwise appears to be unsuitable for the role. ASRU has a duty to ensure that the welfare of animals is not adversely affected by the revocation of a licence.

6. Prosecution

Extremely serious cases of non-compliance are referred to the prosecuting authorities to make a judgment as to whether it would be in the public interest to prosecute. Prosecution could lead to a fine or imprisonment.

Summary of non-compliance cases in 2019, 2020 and 2021

In 2019, 115 cases of non-compliance were finalised. These included 57 cases where the sole remedy was inspector advice; the remainder included other remedies. These 115 cases occurred in 44 different establishments. Of the total cases, 52 (45%) were related to the failure to have or adhere to licence authorities, while the other 63 (55%) were related to the failure to provide appropriate care (including food, water and suitable facilities).

In 2020, 92 cases of non-compliance were finalised. These included 50 cases where the sole remedy was inspector advice; the remainder included other remedies. Of the total cases, 51 (55%) were related to the failure to have or adhere to licence authorities, while the other 41 (45%) were related to the failure to provide appropriate care (including food, water and suitable facilities).

In 2021, 122 cases of non-compliance were finalised. These included 61 cases where the sole remedy was inspector advice; the remainder included other remedies. Of the total cases, 68 (56%) were related to the failure to have or adhere to licence authorities, while the other 54 (44%) were related to the failure to provide appropriate care (including food, water and suitable facilities).

A further breakdown of the types of non-compliance is shown in Figure 9.1.

Figure 9.1: Types of non-compliance between 2019 and 2021

See PDF for figure 9.1

Number and type of animals

In 2019, of the 115 cases of non-compliance, 105 involved a total of 21,242 animals, of which 12,407 were fish, 8,343 were mice, 217 were rabbits, 182 were rats, 46 were unhatched birds, 31 were dogs, and 4 were non-human primates. There were an additional 12 animals of the same species where the species type is not disclosed as it may reveal the establishment at which the non-compliance occurred.

These numbers are significantly impacted by 8 cases where there was overbreeding of large numbers of genetically altered animals.

In all these cases, had requests been made to authorise the additional numbers of animals bred this would have been granted. Of total animals reported, 19,642 (92%) were from cases involving overbreeding beyond the licence authorities.

In 10 out of 115 cases, the total number of animals involved were not reported. Of these, in 3 cases regulated procedures were undertaken competently by an individual who did not have the correct category of personal licence (PIL) and in 3 cases regulated procedures were undertaken competently in an area of the establishment that was not designated for this purpose on the establishment licence (PEL). The other cases were:

  • one case where terminally anaesthetised fish were used to teach additional procedures that were not authorised

  • one case where fish were anaesthetised more often than was authorised in the project licence (PPL)

  • one case where zebrafish larvae were inadvertently left to develop beyond the age at which they can be kept without the provision of food

  • one case where rabbits were held for up to 3 hours in transport cages that did not meet the requirements of the ‘Code of Practice for the Housing and Care of Animals Bred, Supplied or Used for Scientific Purposes’

In 2020, of the 92 cases of non-compliance, animal numbers were reported in 73. These 73 cases involved a total of 2,692 animals of which 2,052 were fish, 389 were mice, 235 were rats, 10 were non-human primates, 3 were birds and there was one each of cattle and rabbit. One other animal of another species was also involved but the species type is not disclosed as it may reveal the establishment at which the non-compliance occurred.

These numbers were not as influenced, as has been the case in previous years, by the inclusion of large number of animals that had been bred without authority.

In 19 cases, the number of animals involved was either not relevant or not known. The reasons for this are as follows:

  • one case that involved failure of establishment governance systems

  • one case that involved failing to keep adequate records

  • one case of failing to use most refined killing methods

  • one case where blood was not taken by the most refined method

  • 2 cases where more animals were bred than were authorised

  • 2 cases where animals suffered unauthorised adverse events

  • 2 cases where rooms were not included on the establishment schedule of premises

  • one case where a room was not checked on one day

  • one case where environmental measurements were not taken as required

  • one case where aseptic technique was not used

  • 3 cases of late submission of required reports

  • one case where a PPL was not revoked when the holder left the establishment

  • one case of unauthorised breeding of animals

  • one case where procedures were conducted without the correct PIL

In 2021, of the 122 cases, animal numbers were reported in 114. These 114 cases involved a total of 4,519 animals of which 2,228 were fish, 2,147 were mice, 107 were rats, 2 were non-human primates, 2 were dogs, 24 were sheep, 6 were horses, 2 were guinea pigs and one of cattle.

These numbers were not as influenced, as had been the case in 2019, by the inclusion of large number of animals that had been bred without authority.

In 8 cases, the number of animals involved was either not relevant or not known. The reasons for this are as follows:

  • one case of late submission of required reports

  • one case where procedures were conducted without the correct PIL authority

  • one case where environment was not maintained as required

  • one case where a room was not checked over a weekend

  • 4 cases where rooms were either not included on the establishment schedule of premises or were used for a purpose not permitted by the designated holding code

The number of animals involved in non-compliance cases, by type, from 2018 to 2021, are shown in Tables 9.1 and 9.2.

Table 9.1: Number of animals involved in non-compliance cases, 2019 to 2021 (1)

Animal type 2019 2020 2021

Fish

12,407

2,052

2,228

Birds

46

3

0

Mice

8,343

389

2,147

Rats

182

235

107

Pigs

0

0

0

Rabbits

217

1

0

Dogs

31

0

2

Non-human primates

4

10

2

Cattle

0

1

1

Guinea pig

0

0

2

Horses

0

0

6

Sheep

0

0

24

Not specified (2)

12

1

0

Total

21,242

2,692

4,519

Notes:

(1) Totals are taken from cases where the numbers of animals involved were reported (that is, 24 of 28 cases in 2018, 105 of 115 cases in 2019, 73 of 92 cases in 2020 and 114 of 122 cases in 2021).

(2) Species not specified where people or places could be identified.

Table 9.2: Number of animals involved in non-compliance cases, excluding those where there was unauthorised overbreeding, 2019 to 2021 (1)

Animal type 2019 2020 2021

Fish

682

875

2,228

Birds

46

3

0

Mice

638

284

1,028

Rats

182

235

107

Pigs

0

0

0

Rabbits

5

1

0

Dogs

31

0

2

Non-human primates

4

10

2

Cattle

0

1

1

Guinea pigs

0

0

2

Horses

0

0

6

Sheep

0

0

24

Not specified (2)

12

1

0

Total

1,600

1,410

3,400

Notes:

(1) Totals are taken from cases where the numbers of animals involved were known (that is, 24 of 28 cases in 2018, 105 of 115 cases in 2019, 73 of 92 cases in 2020 and 114 of 122 cases in 2021).

(2) Species not specified where people or places could be identified.

It is of concern that in 2019, 2020 and 2021, although few, there are cases of non-compliance involving species specially protected under ASPA (that is, dogs, non-human primates and horses) including some with adverse welfare outcomes. Also, that the number of cases involving non-human primates increased from 2019 to 2020 and all with adverse welfare outcomes. The 2 cases where numbers were known (one animal in each case) involving non-human primates in 2021 did not result in adverse welfare outcomes. A third case in 2021 involved non-human primates and related to late submission of required reports. The number of animals involved in this case was not known; however, there were no adverse welfare outcomes.

Adverse welfare outcomes

An animal was assessed as having an adverse welfare outcome as the result of a non-compliance if they experienced more pain, distress, suffering or lasting harm than was authorised, or would have been authorised had it been requested. Animals that were overbred in excess of the authorised numbers, but that were required to achieve the scientific objectives were not considered to have experienced an adverse welfare outcome.

In 2019, 1,160 animals experienced adverse welfare outcomes because of non-compliance; in 2020 there was a total of 1,068 animals; and in 2021, 2,328 animals experienced adverse welfare outcomes. as shown in Table 9.3. A large proportion of the increase in adverse welfare outcomes in 2021 is attributable to 2 cases in which 300 and 440 fish died due to draining of tanks and a third case where a chlorine tablet was added into the incorrect tank during system cleaning, resulting in the death of 1,300 fish.

Table 9.3: Number of animals with adverse welfare outcomes, 2019 to 2021 (1)

Animal type 2019 2020 2021

Fish

669

832

2,047

Birds

0

3

0

Mice

322

81

223

Rats

157

142

54

Pigs

0

0

0

Rabbits

5

0

0

Dogs

4

0

0

Non-human primates

3

10

0

Cattle

0

0

0

Guinea pigs

0

0

0

Horses

0

0

0

Sheep

0

0

4

Not specified (2)

0

0

0

Total

1,160

1,068

2,328

Notes:

(1) Totals are taken from cases where the numbers of animals involved were known (that is, 24 of 28 cases in 2018, 105 of 115 cases in 2019, 73 of 92 cases in 2020 and 114 of 122 cases in 2021).

(2) Species not specified where people or places could be identified.

Reporting of non-compliance cases

In 2019, of the 115 cases, 110 (96%) were self-reported by the PEL and/or PPL holder, 3 (3%) were identified by the inspector during an inspection and one (1%) was reported to ASRU from an external source.

In 2020, of the 92 cases, 87 (95%) were self-reported by the PEL and/or PPL holder, 2 (2%) were identified by the inspector during an inspection and 3 (3%) were reported to ASRU from an external source.

In 2021, of the 122 cases, 119 (98%) were self-reported by the PEL and/or PPL holder, and 3 (2%) were identified by ASRU.

It should be noted that when a case is self-reported it does not always mean that the PEL and/or PPL holder have reported the events as potential non-compliance, merely that they have reported the incidents to ASRU proactively.

Self-reporting is generally indicative of an establishment that is committed to a culture of compliance. It indicates that an establishment is aware of its responsibilities under ASPA and is committed to building a good culture of care. Self-reporting is expected to be normal practice within establishments and forms part of robust governance frameworks. It continues to be encouraging that a significant proportion of cases are self-reported.

Remedies

It should be noted that in a single case of non-compliance there can be a number of different remedies applied to a variety of individuals. Therefore, the number of remedies is not the same as the number of cases. The number of remedies issued in 2019, 2020 and 2021 is shown in Figure 9.2.

Summaries of all the non-compliance cases completed in 2019 can be found in Annex 1, all 92 non-compliance cases completed in 2020 can be found in Annex 2 and all 122 non-compliance cases completed in 2021 can be found in Annex 3. Please note the exact number of cases and animals does not fully align between the appendices and this summary text due to:

  • consolidation of case reports

  • cases involving multiple species

  • cases where exact species are not disclosed as it would potentially identify the establishment

Figure 9.2: Remedies, 2019, 2020 and 2021

See PDF for figure 9.2

Trends in non-compliance cases over time

The number of non-compliance cases by principal breach of licence by year from 2019 is shown in Figure 9.3.

Figure 9.3: Non-compliance, by principal breach of licence, by year, 2019 to 2021

See PDF for figure 9.3

Key learnings from 2019, 2020 and 2021

non-compliance cases

Failure to comply with project licence authorities

This was the most frequent cause of non-compliance cases in 2019, 2020 and 2021; 38 (33%) of the 115 cases in 2019, 45 (49%) of the 92 cases in 2020 and 60 (49%) of the 122 cases in 2021.

The main root causes of these types of non-compliances were:

  • PPL and PIL holders failing to understand the authorities granted on the relevant PPL

  • PPL and PIL holders failing to stay within the limits for procedures stipulated within the PPL (for example, the number of procedures permitted or route of administration permitted)

  • inadequate monitoring of animals in line with measures stipulated on the PPL

  • PPL holders failing to be aware of and/or comply with the Standard Conditions on their PPL

  • PEL holders failing to have adequate systems in place to prevent unauthorised procedures being undertaken

The following recommendations are made to reduce cases of the failure to comply with PPL authorities:

  • PPL holders must ensure that all individuals working under their PPL authority are fully aware of the exact authorities granted

  • PPL holders should have in place processes to review planned experiments to ensure compliance with PPL authorities

  • PEL holders must ensure that robust processes are in place to prevent unauthorised procedures from being conducted

Failure to provide food and/or water

Failing to provide sufficient food and/or water to animals, as part of basic husbandry and care, is unacceptable. Establishments must always have robust procedures in place to ensure the adequate provision of food and water to animals kept under the provisions of ASPA.

In 2019, of the 115 cases of non-compliance, 50 (43%) were due to the failure to provide adequate food and/or water and resulted in adverse welfare outcomes. In 2020, there were 23 cases (25%), which is a marked decrease. This decrease was continued in 2021, where there were 14 cases (11%).

In 2019, increased awareness due to a focus by ASRU on educating establishments about the importance of checking food and water may have led to the increased reporting of these cases. This is evidenced by the high number of non-compliance without welfare impact involving the failure to provide food and water, where inspector advice only was required. These can be interpreted as ‘near-miss’ scenarios and most often occurred when a duty holder failed to give food and water, but the establishment checks discovered this before there were welfare impacts.

The most common scenario where food and water issues occurred was where an activity was performed but the food and water were not reinstated properly, for example where an animal was moved to undertake a procedure. It was more common that this occurred when the activity was conducted by a PIL holder rather than a member of technical staff.

Cases in which there was a welfare impact always involved the failure of establishment processes to ensure that the necessary daily checks were performed adequately, since if these were performed competently, the absence of food and water would be detected prior to adverse welfare outcomes occurring. All the cases in which inspector advice was given involved the establishment’s daily checks spotting an absence of food and water prior to adverse welfare outcomes occurring and are recorded as ‘near misses’ from a welfare perspective.

The following recommendations are made to reduce the number of cases where there was a failure to provide food and water:

  • PEL holders must ensure adequate staffing levels to perform daily checks competently, especially at weekends

  • PEL holders should implement processes to ensure that the system of daily checks is robust

  • PEL holders should identify high-risk situations that may result in the failure to provide adequate food and water and implement specific actions to mitigate these

  • PIL holders and other staff performing duties under ASPA must be explicitly trained and reminded to ensure that they check for the presence of food and water after any activities involving animals

Failure to provide adequate care

In 2019, there were 31 cases of inadequate care, which involved the greatest number of animals experiencing an adverse welfare outcome. These numbers were heavily impacted by 3 cases that involved 669 fish as follows:

  • one case where miscommunication between PIL holders led to 500 zebrafish larvae inadvertently being allowed to develop beyond the age when the conditions of care did not support their needs

  • one case where the failure to close a tank valve after flushing led to the death of 120 fish

  • one case where water drained from an apparatus resulted in the death of 49 fish

Another significant incident involved the inadvertent movement of boxes containing 112 live rats to the compactor where they were crushed. This case resulted from a failure to follow the establishment’s standard operating procedures on one occasion when an item of equipment failed. This might have been avoided had a mechanism been followed that quickly identified when animals were missing.

There were also 6 cases where rodents escaped from cages primarily due to the failure to close cages properly after checks or procedures had been completed, and 2 other cases where rodents were trapped in food hoppers or lids.

In 2020, there were 18 cases of inadequate care. These included:

  • one case where a non-human primate died due to being trapped behind a device for restraint and the animal was not noticed to be missing from the main enclosure

  • 2 cases involved animals whose tails became trapped in cage lids

  • 2 cases where a head restraint was applied too forcefully while taking blood, causing injury to the animal

  • one case where an isolator fan and alarm were accidentally switched off, resulting in the death of 16 animals

  • 4 cases in which the authorised, or the most humane killing methods, were not used

In 2021, there were 34 cases of inadequate care. These included:

  • 3 cases where water either drained from tanks or a toxic substance was added to a tank, resulting in the death of 2,040 fish across the 3 cases

  • 2 cases where inadequate analgesia was provided to rats after surgery

  • one case involving an animal whose tail became trapped in a cage lid

  • 2 cases where the most refined method of regulated procedure was not used

  • 2 cases where animals exceeded weight loss humane endpoints

  • 2 cases where animals exhibited adverse effects not authorised by the project licence and action was not taken

Recommendations to reduce the number of cases where there was a failure to provide adequate care are as follows:

  • PEL holders must ensure that fish facility equipment and tanks are properly maintained, and that the risks associated with manipulation of tanks are identified and provision made to mitigate these

  • PEL holders must implement processes to ensure that animals are present in the cage and not trapped after any intervention inside the cage

Failure to have appropriate personal licence authority

Section 3(a) of ASPA requires that no person shall apply a regulated procedure as part of an authorised project to an animal unless they hold a relevant PIL.

In 2019, 2020 and 2021, 17 (21%), 4 (4%) and 8 (7%) cases respectively were recorded where the principal breach was either the failure to hold a PIL or to have the relevant authorities on their PIL to conduct the regulated procedures. In all but one case, there was a degree of confusion by potential PIL holders about the difference between receiving the certificate for completion of their modular training and holding a PIL. A certificate of completion of the modular training is provided by the relevant training body and is required before an individual can apply for a PIL. Thus, the reduction from 2019 to 2020 may be linked to a reduction in new PIL applications occurring during the first national lockdown as a result of COVID-19. In line with this, the number of cases of this type of non-compliance has Increased from 2020 to 2021. In all of these cases, the procedures performed by those without PILs were competently performed and no adverse welfare outcomes were identified.

Recommendations to prevent this type of non-compliance:

  • providers of modular training should reinforce that, following the successful completion of the module training, a PIL must be applied for and held before they undertake regulated procedures

  • establishments must ensure that processes are in place to ensure that appropriate PIL authorities are held by those undertaking regulated procedures. This includes appropriate checks of the PIL authorities of individuals visiting an establishment to perform regulated procedures

Section 10: Financial report

Since the financial year 2014 to 2015, the Animals in Science Regulation Unit (ASRU) has been operating on a full cost recovery basis, meaning that the licence fee income should cover all expenditure incurred in delivering the service. As a full cost recovery unit, ASRU receives all its income from the licence fees it charges. It is only permitted to spend this income on its regulatory duties and associated business costs.

Finance is reported and discussed with key stakeholders throughout the year to maintain the openness and transparency within ASRU’s accounts. These reports are presented in meetings with key duty holders. Updates on predicted licence fees are shared with stakeholders throughout the year to assist with future financial planning within establishments.

The summary of income and fee-funded expenditure for the last 7 years is shown in Table 10.1.

Table 10.1: Summary of income and fee-funded expenditure, by budgeting year, including capital spend, 2014 to 2015 through to 2021 to 2022

Year Income Expenditure Variance
   
Running budget

Capital (2)
 

2014 to 2015

£4,380,206

£4,378,929


£1,277

2015 to 2016

£4,692,833

£4,207,503


£485,330

2016 to 2017

£4,482,578

£4,467,404


£15,174 (1)

2017 to 2018

£4,421,361

£4,777,455


£356,094

2018 to 2019

£4,752,912

£4,579,303

£1,625,492 (3)

£173,609

2019 to 2020

£4,943,224

£4,947,844

£1,800,230 (4)

-£4,620

2020 to 2021

£5,012,744

£5,408,987


£396,243

2021 to 2022

£5,067,060

£5,163,588

-£100,992 (5)

-£96,528

Notes:

(1) This figure has previously been reported as £14,596.

(2) In addition to the annual running budget of ASRU, there was additional capital expenditure which occurred for the replacement of our e-licensing system (ASPeL).

(3) In 2018 to 2019, £1,625,492 of agreed capital expenditure occurred for the replacement of the ASPeL system.

(4) In 2019 to 2020, £1,800,230 of agreed capital expenditure occurred for the replacement of the ASPeL system.

(5) In 2021 to 2022, ASRU received a credit of £100,992 for the replacement of the ASPeL system due to a previous administrative error.

ASRU income and expenditure for the years 2019 to 2020, 2020 to 2021 and 2021 to 2022

Income

In 2019 to 2020, ASRU had a delegated budget from the Home Office in anticipation of the fee income of £4.94 million; by the close of the year ASRU remained within 0.01% of the assigned budget.

In 2020 to 2021, ASRU had a delegated budget from the Home Office in anticipation of the fee income of £5.49 million. However, ASRU had to reduce the expected fee income to £5.01 million due to fewer licence applications being made as a result of the impact of the COVID-19 pandemic on the activities within the establishments.

In 2021 to 2022, ASRU had a delegated budget from the Home Office in anticipation of the fee income of £5.06 million; by the close of the year ASRU remained within 1.90% of the assigned budget.

Fee income

Increases in licence fees are necessary to ensure that fee income continues to cover all expenditure incurred in delivering the ASRU service.

Table 10.2: Annual licence fees, 2014 to 2015 through to 2021 to 2022

Annual fee (1) 2015 to 2018 2018 to 2019 2019 to 2020 2020 to 2021 2021 to 2022

Personal licence

£242

£257

£275

£299

£299

Establishment licence

£631

£757

£826

£915

£915

Note:

(1) From 2018 fees are charged from the 6 April each year, which is the common commencement date and is in line with practices in other government departments. Prior to 2018, fees were charged from 1 April.

Invoices are raised in arrears, so the income for the financial year 2020 to 2021 will be collected in the 2021 to 2022 financial year.

The 2021 to 2022 fees have remained the same as 2020 to 2021.

Expenditure

Details of the expenditure for the years 2019 to 2020, 2020 to 2021 and 2021 to 2022 are shown in Table 10.3.

Table 10.3: Summary of expenditure, by budgeting year, 2019 to 2020 through to 2021 to 2022

Category 2019 to 2020 2020 to 2021 2021 to 2022

Pay (1)

£3,338,623

£3,397,001

£3,187,412

Overheads (2)

£901,311

£700,000

£516,556

IT and telecommunication (3)

£437,556

£1,231,632

£775,639

IT capital (4)

£1,800,230

£0

-£100,992

Travel (5)

£143,858

£7,742

£29,933

Estates (6)

£56,667

£56,903

£1,771

Training and events (7)

£17,509

-£5,171

£13,667

Legal (8)

£15,496

£12,143

£24,453

Other (9)

£36,824

£8,738

£14,158

Depreciation (10)



£600,000

Expenditure TOTAL

£4,947,844

£5,408,987

£5,163,588

Income TOTAL

£4,943,224

£5,012,744

£5,067,060

Variance

£4,620

£396,243

‑£96,528

Notes:

(1) In 2019 to 2020, approximately £3.34 million of the total pay costs were salary costs, of which £160,995 was transferred to other teams in the Home Office for the use of their staff on ASRU’s work, for example for the provision of statistical and legal advice.

In 2020 to 2021, approximately £3.40 million of the total pay costs were salary costs, of which £164,500 was transferred to other teams in the Home Office for the use of their staff on ASRU’s work, for example for the provision of statistical and legal advice.

In 2021 to 2022, approximately £3.19 million of the total pay costs were salary costs, of which £202,695 was transferred to other teams in the Home Office for the use of their staff on ASRU’s work, for example for the provision of statistical and legal advice.

(2) Central overheads are calculated on a headcount basis and cover core Home Office central functions and services such as central IT infrastructure, human resources and finance. They also cover an apportionment of the accommodation and facilities costs of the London Head Office at 2 Marsham Street and the Croydon Campus at Lunar House.

(3) The majority of IT and telecommunication costs for 2019 to 2020, 2020 to 2021 and 2021 to 2022 include the hosting and support of the legacy e-licensing system (ASPeL). Legacy ASPeL closed in late summer 2019 with additional cost associated with the permanent destruction of the servers and data. It was replaced by the new e-licensing system, which went live in August 2019. The remainder of the IT costs for all 3 years is for VAT and telecoms, for example secure mobile phones.

(4) ASRU only had an IT capital budget for 2019 to 2020. ASRU continued its contract with Marvell Consulting Ltd to develop the new version of ASPeL. Research and development spend in 2019 totalled £1.8 million. The new system moved into public beta in August 2019.

(5) Travel and subsistence costs were mostly incurred by inspectors during their visits to establishments. All travel occurred within Home Office policy guidance, which aims to balance speed and efficiency of travel against minimal cost. For 2020 to 2021, ASRU’s travel costs were greatly reduced following the implementation of national lockdown measures to control COVID-19, following which most inspection was undertaken remotely.

For 2021 to 2022, travel costs increased due to the easements of COVID-19 restrictions.

(6) During 2019 to 2020 and 2020 to 2021, ASRU paid other parts of the Home Office and other government departments for the use of office space in Glasgow, Dundee and Swindon.

From 2021 to 2022, ASRU no longer holds any direct commercial leases.

(7) Training costs in 2019 to 2020 were mostly incurred by training new inspectors or by existing inspectors completing their continuous professional development, as required by their professional bodies. This includes the costs incurred in running 4 annual training events for all staff. The 2020 to 2021 figure represents refunds for events that were cancelled because of the COVID-19 pandemic; these events had been booked and paid for in 2019 to 2020.

In 2021 to 2022 training was aligned with the requirements of the change programme.

(8) Legal costs for 2019 to 2020, 2020 to 2021 and 2021 to 2022 included the costs of handling appeals against licensing decisions taken. In 2019 to 2020 there were additional costs relating to an appeal, which led to a tribunal.

(9) Other costs include publications, fees, subscriptions to professional bodies – for example, the Royal College of Veterinary Surgeons – and office costs such as couriers and supplies.

(10) Financial year 2021 to 2022 Is the first year that ASRU paid for depreciation for the ASPeL asset; this will be £600,000 for the next 3 years.

Annex 1: Non-compliance cases 2019

Glossary of terms

ASPA: Animals (Scientific Procedures) Act 1986

NVS: Named veterinary surgeon

PEL: Establishment licence

PIL: Personal licence

PPL: Project licence

SC: Standard Condition

Failure to provide food and/or water

Description Animal type involved Animal numbers involved Section of ASPA or SC breached* Regulator action taken

Primary breach

Other breach(es)

Water bottles were turned the wrong way round during cage clean, resulting in animals with no access to water for more than 36 hours. The establishment’s daily check failed to detect this.

Rat

2

PEL SC 4(3)

Compliance
Notice

Failure to replace water bottles at the establishment’s daily check, resulting in water being withheld overnight.

Rat

6

PEL SC 4(3)

Compliance
Notice

Food removed from home cages and not replaced. The establishment’s checks failed to notice absence of food for more than 24 hours. Animals suffered harm but did not die.

Mouse

8

PIL SC 2

PEL SC 4(3)

Compliance
Notices

Food hopper not placed in cage; omission not noticed at the establishment’s daily checks.

Mouse

1

PEL SC 4(3)

Letter of reprimand

Water bottle not replaced after cage change resulting in no water being available overnight.

Rat

3

PEL SC 4(3)

Letter of reprimand

Animals left overnight in transport cage without food and water.

Rat

3

PEL SC 4(3)

Letter of reprimand

Failure to kill zebrafish larvae before weekend, resulting in them being left without food.

Fish

Not known

PI SC 2

Letter of reprimand

Failure to provide water for a period of 43 hours.

Mouse

1

PIL SC 2

PEL SC 4(3)

Letters of reprimand

Animals left in a heat box overnight without food and water.

Mouse

2

PIL SC2

PEL SC 4(3)

Letters of reprimand

Food and water were not replaced for animals after a period of authorised withdrawal for a period of more than 16 hours. Animals experienced harm but did not die.

Non- human primate

2

PEL SC 4(3)

Letter of reprimand

Water bottles were not placed on cages at cage change. Found at the establishment’s regular check after more than 16 hours when animals were noted to be alive but dehydrated.

Mouse

14

PEL SC 4(3)

PEL SC 5

Letter of reprimand

Failure to reconnect watering system following disconnection for maintenance resulting in
no water being provided for 45 hours.

Rabbit

5

PEL SC 4(3)

Letter of reprimand

Food not placed in new cage following mating. The establishment’s daily check
failed to detect this so it was not noticed for more than 24 hours. Animals experienced harm but did not die.

Mouse

2

PEL SC 4(3)

Letter of reprimand

Animals were left without food and water, which was not noticed for 28 hours. The establishment’s daily check failed to detect this.

Mouse

28

PEL SC 4(3)

PEL SC 5, PEL SC 21

Letter of reprimand

Animals were left without food and water, which was not noticed for 30 hours. The establishment’s daily check failed to detect this.

Rat

6

PEL SC 4(3)

PEL SC 5, PEL SC 21

Letter of reprimand

Water was not provided after a period of approved water
restriction. The establishment’s daily check failed to detect this so water was restricted for more than 16 hours.

Non- human primate

1

PEL SC 4(3)

PEL SC 5, PEL SC 21

Letter of reprimand

Animals were left without food for 29 hours. The establishment’s daily check failed to detect this.

Mouse

2

PEL SC 4(3)

Letter of reprimand

Animals were left without water for 28 hours. The establishment’s daily check failed to detect this.

Mouse

17

PEL SC 4(3)

PEL SC 4(1)
PEL SC 4(5)

Letter of reprimand

Food withheld from animals in error and picked up at next scheduled check.

Mouse

2

PIL SC 2

Inspector
advice

Water withheld from animals in error and detected at next scheduled check.

Rat

2

PIL SC 2

Inspector
advice

Food withheld from animal in error and detected within 36 hours.

Mouse

1

PIL SC 2

Inspector
advice

Water withheld from animals in error and detected by the
establishment’s checking system.

Mouse

3

PEL SC 4(3)

Inspector
advice

Water withheld from animals in error and detected by the
establishment’s checking system.

Mouse

28

PIL SC 2

Inspector
advice

Animals inadvertently left without food but detected at the next scheduled check.

Mouse

2

PIL SC 2

Inspector
advice

Animals not provided with water but corrected at the next scheduled check.

Mouse

6

PEL SC 4(3)

Inspector
advice

PIL holder did not provide food and water to animals after conducting procedures. The establishment’s checks picked this up and corrected it at the next scheduled check.

Mouse

6

PIL SC 2

Inspector
advice

Water failed to be replaced by PIL holder following conduct of task. Picked up and corrected at the next scheduled check.

Mouse

8

PIL SC 2

Inspector
advice

Animal left in transport box without food and water. Noted and addressed at the next scheduled check.

Mouse

1

PIL SC 2

Inspector
advice

Animals left without food by PIL holder. Noted and addressed at the establishment’s daily check.

Fish

13

PIL SC 2

Inspector
advice

Animals left without food and water. Noted and addressed at the next scheduled check.

Mouse

4

PIL SC 2

Inspector
advice

Animal left without access to water. Noted and addressed at the next scheduled check.

Mouse

1

PEL SC 4(3)

Inspector
advice

Animals left without food. Noticed and addressed by the next scheduled check.

Rat

6

PEL SC 4(3)

Inspector
advice

Food hopper not placed in cage; omission not noticed at the establishment’s daily checks.

Mouse

1

PEL SC 4(3)

Letter of reprimand

Water bottle not replaced after cage change resulting in no water being available overnight.

Rat

3

PEL SC 4(3)

Letter of reprimand

Animals left overnight in transport cage without food and water.

Rat

3

PEL SC 4(3)

Letter of reprimand

Failure to kill zebrafish larvae before weekend, resulting in them being left without food.

Fish

Not known

PI SC 2

Letter of reprimand

Failure to provide water for a period of 43 hours.

Mouse

1

PIL SC 2

PEL SC 4(3)

Letters of reprimand

Animals left in a heat box overnight without food and water.

Mouse

2

PIL SC2

PEL SC 4(3)

Letters of reprimand

Food and water were not replaced for animals after a period of authorised withdrawal for a period of more than 16 hours. Animals experienced harm but did not die.

Non- human primate

2

PEL SC 4(3)

Letter of reprimand

Water bottles were not placed on cages at cage change. Found at the establishment’s regular check after more than 16 hours when animals were noted to be alive but dehydrated.

Mouse

14

PEL SC 4(3)

PEL SC 5

Letter of reprimand

Failure to reconnect watering system following disconnection for maintenance resulting in

no water being provided for 45 hours.


Rabbit

5

PEL SC 4(3)

Letter of reprimand

Food not placed in new cage following mating. The establishment’s daily check

failed to detect this so it was not noticed for more than 24 hours. Animals experienced harm but did not die.


Mouse

2

PEL SC 4(3)

Letter of reprimand

Animals were left without food and water, which was not noticed for 28 hours. The establishment’s daily check failed to detect this.

Mouse

28

PEL SC 4(3)

PEL SC 5, PEL SC 21

Letter of reprimand

Animals were left without food and water, which was not noticed for 30 hours. The establishment’s daily check failed to detect this.

Rat

6

PEL SC 4(3)

PEL SC 5, PEL SC 21

Letter of reprimand

Water was not provided after a period of approved water

restriction. The establishment’s daily check failed to detect this so water was restricted for more than 16 hours.


Non- human primate

1

PEL SC 4(3)

PEL SC 5, PEL SC 21

Letter of reprimand

Animals were left without food for 29 hours. The establishment’s daily check failed to detect this.

Mouse

2

PEL SC 4(3)

Letter of reprimand

Animals were left without water for 28 hours. The establishment’s daily check failed to detect this.

Mouse

17

PEL SC 4(3)

PEL SC 4(1)

PEL SC 4(5)


Letter of reprimand

Food withheld from animals in error and picked up at next scheduled check.

Mouse

2

PIL SC 2

Inspector

advice


Water withheld from animals in error and detected at next scheduled check.

Rat

2

PIL SC 2

Inspector

advice


Food withheld from animal in error and detected within 36 hours.

Mouse

1

PIL SC 2

Inspector

advice


Water withheld from animals in error and detected by the

establishment’s checking system.


Mouse

3

PEL SC 4(3)

Inspector

advice


Water withheld from animals in error and detected by the

establishment’s checking system.


Mouse

28

PIL SC 2

Inspector

advice


Animals inadvertently left without food but detected at the next scheduled check.

Mouse

2

PIL SC 2

Inspector

advice


Animals not provided with water but corrected at the next scheduled check.

Mouse

6

PEL SC 4(3)

Inspector

advice


PIL holder did not provide food and water to animals after conducting procedures. The establishment’s checks picked this up and corrected it at the next scheduled check.

Mouse

6

PIL SC 2

Inspector

advice


Water failed to be replaced by PIL holder following conduct of task. Picked up and corrected at the next scheduled check.

Mouse

8

PIL SC 2

Inspector

advice


Animal left in transport box without food and water. Noted and addressed at the next scheduled check.

Mouse

1

PIL SC 2

Inspector

advice


Animals left without food by PIL holder. Noted and addressed at the establishment’s daily check.

Fish

13

PIL SC 2

Inspector

advice


Animals left without food and water. Noted and addressed at the next scheduled check.

Mouse

4

PIL SC 2

Inspector

advice


Animal left without access to water. Noted and addressed at the next scheduled check.

Mouse

1

PEL SC 4(3)

Inspector

advice


Animals left without food. Noticed and addressed by the next scheduled check.

Rat

6

PEL SC 4(3)

Inspector

advice

*Section of ASPA or SC breached: Personal licence: standard conditions, Project licence: standard conditions, Establishment licence: standard conditions

Failure to provide adequate care

Description Animal type involved Animal numbers involved Section of ASPA or SC breached Regulator action taken

Primary breach

Other breach(es)

Boxes containing animals mistakenly moved to compactor where they were crushed.

This occurred as a result of individual error, despite the establishment’s robust systems and process.


Rat

112

PEL SC 4(1)

Letter of reprimand (associated

internal personnel

action taken by establishment)


Failure of the establishment’s daily checks on 4 separate occasions. Failure to maintain killing register accurately.

Mouse

5

PEL SC 4(3)

PEL SC 4(5),

PEL SC 2 (1)


Compliance

Notice


Two animals were not given analgesia for abdominal discomfort as advised by NVS. Seven animals not weighed on one day as required by PPL. PPL holder not advised of animal exceeding severity limit.

Mouse

7

PIL SC 12

PIL SC 2,

PIL SC 13


Letter of reprimand and retraining

Lack of communication between 2 PPL holders resulting in failure to kill fish larvae prior to them reaching protected status as defined in law.

Fish

500

PIL SC 14

PPL SC 1

Letters of reprimand and retraining

Animals left in dark chamber for longer than authorised on PPL.

Mouse

10

PIL SC 2

PIL SC 2,

PIL SC 4(19)


Letter of reprimand

Human error led to failure to close tank valve after flush, resulting in death of the fish.

Fish

120

PEL SC 4(1)

Letter of reprimand

Failure to calculate weight loss of animals, with subsequent loss of weight exceeding authorised limits.

Mouse

17

PIL SC 2

PIL SC 13

Letter of reprimand

Animal cage not closed properly, resulting in the animals escaping.

Mouse

10

PEL SC 5

Letter of reprimand

Animal left out of cage following health check.

Rat

1

PIL SC 2

Letter of reprimand

PIL holder dropped animal from trolley onto the floor.

Mouse

1

PIL SC 2

Letter of reprimand

Water drained from apparatus, resulting in death of animals.

Equipment was known to have risk associated with its use that was not adequately mitigated.


Fish

49

PIL SC 2

PEL SC 4(4)

Letters of reprimand

PIL holder failed to weigh or assess animals in immediate post-operative period

as was required under licence authorities.


Mouse

4

PIL SC 14

Letter of reprimand

Failure to ensure equipment was properly maintained, resulting in heat damage to animals.

Mouse

12

PEL SC 4(4)

PIL SC 2

Letters of reprimand

Animal found outside cage – uncertain how it escaped.

Mouse

1

PEL SC 4(3)

Letter of reprimand

Animals left in quarantine room were not checked.

Mouse

30

PEL SC 4(5)

Letter of reprimand

Mother instead of male cage- mate removed from cage of neonatal pups, resulting in the death of the pups

Mouse

8

PIL SC 2

Letter of reprimand

Adequate checks not performed on animals by the establishment’s staff or licence holder.

Mouse

2

PIL SC 2

PEL SC 4(5)

Letters of reprimand

Animal found trapped between hopper and cage.

Mouse

1

PEL SC 4(1)

PEL SC 4(5),

PIL SC 2


Letters of reprimand

Failure to adequately monitor eggs, resulting in death of protected animals.

Unhatched

bird


46

PIL SC 2

PPL SC 1

Letters of reprimand

Animals left in hot box longer than authorised.

Rat

5

PIL SC 2

PIL SC 19

Inspector

advice


Animals not monitored appropriately.

Mouse

6

PIL SC 2

PIL SC 14

Inspector

advice


Animals not monitored appropriately.

Mouse

6

PIL SC 2

Inspector

advice


Animals not killed as planned and transported alive to screening laboratory.

Mouse

3

PEL SC 4(1)

Inspector

advice


PIL holder did not seek appropriate veterinary advice for animals experiencing adverse events, resulting in animals experiencing adverse events for longer than was necessary.

Mouse

2

PIL SC 15

Inspector

advice


Animals moved into a new room and did not receive the establishment’s daily checks.

Mouse

26

PEL SC 4(5)

Inspector

advice


Experiments conducted in environmental conditions that were not appropriate.

Rat

6

PIL SC 2

Inspector

advice


Animal held in necroscopy area in transport cages for up to

3 hours.


Rabbit

1

PEL SC 4(1)

PEL SC 4(2)

Inspector

advice


Failure to complete the establishment’s daily check properly, but no adverse welfare outcome.

Mouse

6

PEL SC 4(5)

Inspector

advice


Failure to monitor animals appropriately, but no adverse welfare outcome.

Rat

7

PIL SC 2

PIL SC 12,

PIL SC 1


Inspector

advice


Animal escaped from cage.

Mouse

1

PIL SC 2

Inspector

advice

Failure to comply with authorisations and/or conditions on project licence

Description Animal type involved Animal numbers involved Section of ASPA or SC breached Regulator action taken

Primary breach

Other breach(es)

PIL holder completed procedures without sufficient training and supervision, and failed to use

the most refined methods. PIL holder did not hold correct licence category for procedures undertaken. Further investigation revealed other breaches within the conduct of the PPL including: failure to ensure adequate training and competence; conduct of unauthorised procedures; failure to stay within the controls of the licence;

and conduct of procedures not authorised in terms of the

purpose of the licence. Failings at the establishment included failure to have a robust system for ensuring adequate training and competence, and inadequate systems for preventing unauthorised procedures.


Mouse

14

ASPA

3(a)

ASPA

3(b)


PIL SC 6,

PIL SC 13,

PIL SC 14,

PIL SC 15,

PIL SC 16,

PIL SC 17,

PIL SC 19,

PIL SC 20, PPL SC

18,

PPL SC 6,

PPL SC 1, PPL SC

19, PEL SC

20,

PEL SC 21


Revocation

of PIL Suspension

of PIL Suspension

of PPL

Compliance Notices to PPL holder and PEL holder Letters of reprimand

and retraining Inspector

advice


Animals transferred from one project to another without the appropriate authority.

Inadequate knowledge of ASPA demonstrated.


Mouse

4

ASPA 15(1)

PIL SC 19, PPL SC

11, PPL SC

19,

PEL SC 20


Suspension of PIL Letter of reprimand

and retraining


Procedures undertaken that were unauthorised in a PPL.

Mouse

3

ASPA

3(b)


PIL SC 14,

PIL SC 19


Letter of reprimand

and retraining


Failure to kill animals when they reached humane endpoint.

Mouse

13

PIL SC 5

PPL SC 8

Letters of reprimand

and retraining


Animals fed a high-fat diet for 2 weeks without authorisation. No adverse effects noted.

Mouse

20

ASPA

3(b)


PPL SC 1

PIL SC 19,

PEL SC 20


Letters of reprimand

and retraining


Over the first 3 years of a PPL, greater than 3-fold more zebrafish were bred and used

than were authorised on the PPL. Inadequate control demonstrated over the conduct of the licence.


Fish

11,725

ASPA

3(b)


PEL SC 20

Letter of reprimand

and retraining


Humane endpoints exceeded with no action taken.

Mouse

4

PIL SC

5


PIL SC 1,

PIL SC 15,

PIL SC 19


Letters of reprimand

and retraining


PIL holder performed anaesthesia to remove wound clips and sham surgery, neither of which were authorised on the project licence.

Mouse

69

ASPA

3(b)


PIL SC 19 PPL SC

23(a) PPL SC 1

PEL SC 15

PEL SC 20


Letters of reprimand

and retraining


Failure to implement known refinements to study and failure to provide adequate supervision to PIL holders.

Mouse

20

PPL SC 6

PIL SC 16

Letter of reprimand

and retraining


Five cranial implants were performed on one animal when authority was only for a maximum of 4.

Non- human primate

1

ASPA

3(b)


PPL SC 1,

PIL SC 19


Letter of reprimand

and inspector

advice


A small pilot study using minimum dose of agent was not used as required in PPL. Animals were administered substance doses higher than required for scientific outcome.

Rat

24

PPL SC

1


Letter of reprimand

Repeat injections of substance were given without authority.

Mouse

6

PIL SC

2


Letter of reprimand

Animal anaesthetised for purpose not authorised on PPL.

Mouse

1

ASPA

3(b)


PIL SC 19

Letter of reprimand

Animals received substance not authorised on PPL.

Mouse

7

ASPA

3(b)


Letter of reprimand

Tail tipping performed without PPL authorisation.

Mouse

11

ASPA

3(b)


PIL SC 19

Letter of reprimand

Animals not weighed in line with licence authority.

Mouse

53

PIL SC 19

Letter of reprimand

Animals anaesthetised more often than was authorised on PPL.

Fish

Not known

ASPA

3(b)


PPL SC 23,

PIL SC 19


Letter of reprimand

Cage labelling error led to animals being reused for breeding inadvertently.

Mouse

4

ASPA 14(1)

Letter of reprimand

Animal had regulated procedure undertaken on one protocol when it had already undergone a regulated procedure on another protocol; no permission was present for reuse.

Dog

1

ASPA

3(b)


PIL SC 19

Letter of reprimand

Animals administered substance that was not authorised for testing.

Dog

4

PPL SC 1

PIL SC 19

Letter of reprimand

and inspector

advice


Animals administered substance that was not authorised for testing.

Mouse

7

ASPA

3(b)


PIL SC 19

Letter of reprimand

The number of animals used exceeded that permitted on PPL. Evidence of lack of adequate control over licence conduct.

Mouse

3,834

PPL SC 1

Letter of reprimand

Animal administered substance that was not authorised on PPL.

Mouse

1

ASPA

3(b)


Inspector

advice


Animals were blood sampled from tail, which was not authorised on project licence.

Mouse

25

ASPA

3(b)


Inspector

advice


Animal kept alive after surgery longer than authorised.

Mouse

1

PIL SC 19

Inspector

advice


Number of animals used on one protocol exceeded that authorised on PPL.

Mouse

130

PPL SC 1

Inspector

advice


Animals not checked in accordance with PPL requirements.

Mouse

4

PPL SC 6

PPL SC 1

Inspector

advice


Substance administered by an unauthorised route.

Mouse

2

ASPA

3(b)


PIL SC 19

Inspector

advice


Animals not monitored in accordance with PPL requirements.

Mouse

2

PIL SC 2

Inspector

advice


Substance administered by an unauthorised route.

Mouse

4

ASPA

3(b)


PIL SC 19

Inspector

advice


Number of animals used exceeded that authorised on PPL.

Rabbit

212

PPL SC 1

PPL SC 20

Inspector

advice


Substance administered via route not authorised on PPL.

Mouse

3

ASPA

3(b)


Inspector

advice


Number of animals used on one protocol exceeded that authorised on PPL.

Mouse

3,000

PPL SC 1

Inspector

advice


Number of animals used exceeded that authorised on PPL.

Mouse

300

PPL SC 1

Inspector

advice


Terminally anaesthetised animals were used to teach blood sampling. Blood sampling for the purpose of training not authorised on PPL.

Fish

Not known

ASPA

3(b)


Inspector

advice


Number of animals used exceeded that authorised on PPL.

Mouse

350

PPL SC 1

Inspector

advice


Number of animals used exceeded that authorised on PPL.

Mouse

91

ASPA

3(b)


Inspector

advice

Failure to have correct personal licence

Description Animal type involved Animal numbers involved Section of ASPA or SC breached Regulator action taken
     
Primary breach

Other breach(es)
 

Regulated procedures conducted by person without PIL authority.

Dog

26

ASPA

3(a)


Letter of censure and letter of reprimand

Regulated procedures conducted by person without PIL authority.

Mouse

6

ASPA

3(a)


PPL SC 6

Letter of censure

PIL holder carried out surgery on animals without suitable category PIL.

Mouse

6

ASPA

3(a)


PIL SC 19

Letter of reprimand

Procedure undertaken without PIL. PPL holder aware that person conducting procedure did not hold a PIL.

Mouse

2

ASPA

3(a)


PPL SC 1

Letter of reprimand

and retraining


Regulated procedures conducted by person without PIL authority.

Mouse

10

ASPA

3(a)


PEL SC 20

Letter of censure

PIL holder undertook surgery without correct category

PIL licence.


Mouse

37

ASPA

3(a)


Letter of reprimand

PIL holder completed surgery without a category C licence.

Mouse

Not known

ASPA

3(a)


PIL SC 19

Letter of reprimand

Person previously holding a PIL at one establishment conducted regulated procedures at another establishment without ensuring the PIL was correctly moved to reflect the new establishment.

Mouse

Not known

ASPA

3(a)


PEL SC 20

Inspector

advice


Regulated procedures conducted by person without PIL authority.

Withheld*

12

ASPA

3(a)


Inspector

advice


Person previously holding a PIL at one establishment conducted one regulated procedure at another establishment without ensuring the PIL was correctly moved to reflect the new establishment.

Mouse

1

ASPA

3(a)


Inspector

advice

  • Detail of species withheld to prevent disclosure of establishment or persons.

Performing procedures or keeping animals in area not correctly specified on PEL

Description Animal type involved Animal numbers involved Section of ASPA or SC breached Regulator action taken
     
Primary breach

Other breach(es)
 

Procedure performed competently but in an area not licensed for regulated work.

Fish

Not known

ASPA 2B(1)

PIL SC 19

Letter of reprimand

Animal supplied kept in an area not licensed on PEL.

Various

Not known

ASPA 2B(1)

PEL SC 13

Letter of reprimand

Regulated procedure carried out in a room not on PEL.

Mouse

1

ASPA 2B(1)

Inspector

advice


Animals undergoing regulated procedures in areas not licensed for this purpose.

Mouse

Not known

ASPA 2B(1)

Inspector

advice

Annex 2: Non-compliance cases 2020

Glossary of terms

ASPA: Animals (Scientific Procedures) Act 1986

NACWO: Named animal care and welfare officer

PEL: Establishment licence

PIL: Personal licence

PPL: Project licence

SC: Standard Condition

Failure to provide food and/or water

Description Animal type involved Animal numbers involved Section of ASPA or SC breached Regulator action taken
     
Primary breach

Other breach(es)
 

Systemic deficiencies in establishment systems including: failure to monitor environmental conditions; failure to maintain killing register accurately;

failure of systems to prevent unauthorised procedures; deficiencies in named persons’ skills and knowledge; and failing to oversee training and competency.


Not applicable

Not applicable

for full range of breaches identified


PEL SC 4(3)

PEL SC

4(5),

PEL SC 8,

PEL SC 17,

PEL SC 21


Compliance

Notice followed by suspension of

PEL


Water bottle found missing from pair of breeding animals. Signs of dehydration present and animals were humanely killed.

Weekend checks found to be inadequate


Mouse

2

PEL SC 4(3)

Letter of reprimand

Food missing from cage and 2 animals found dead. Food not replaced after PIL holder intervention and not picked up

by the establishment’s checks.


Mouse

2

PIL SC 2

PEL SC 4(3),

PEL SC 5


Letters of reprimand

Mismatch between size of food particles and size of openings in aperture so food was not

accessible by animals. Failure of the establishment’s checks to detect this omission, leading to the death of 2 animals.


Mouse

2

PEL SC 4(3)

PIL 2,

PEL 4(1),

PEL 4(5)


Letters of reprimand

PIL holder failed to replace food in cages after conducting procedures. Absence of food was not detected by the establishment’s checks, leading to the death of animals.

Mouse

16

PIL SC 2

PEL SC

4(3),

PEL SC (1),

PEL SC

4(5)


Letters of reprimand

PIL holder failed to replace food in cage after conducting procedures. Absence of food was not detected by the establishment’s checks for greater than 24 hours, resulting in unnecessary suffering.

Mouse

3

PIL SC 2

PEL SC

4(3)


Letters of reprimand

Cage of animals not provided with food after weaning. The establishment’s checks failed to detect the absence of food, leading to the death of animals.

Mouse

4

PEL SC 4(3)

PEL SC 4(1)

Letter of reprimand

Animal found without food and water in heat box in an area outside core animal unit following surgery the previous day.

Mouse

1

PIL SC 2

PPL SC 6

Letters of reprimand

Failure of watering system leading to the death of animals.

Bird

3

PEL SC 4(3)

PEL SC

4(1),

PEL SC 15


Letter of reprimand

and inspector

advice


Cage of animals not provided with food or water after weaning. The establishment’s checks failed to detect the absence of food or water, leading to the death of animals.

Mouse

6

PIL SC 2

PEL SC 4(3)

Letters of reprimand

Animal placed in metabolism cage without water. The establishment’s checks failed to detect the absence for over 40 hours and animal was humanely killed.

Mouse

1

PIL SC 2

PEL SC

4(3),

PEL SC 5


Letters of reprimand

Hydropac bag (designed to deliver water to animals) was not working properly, resulting in the absence of water provision. Not picked up by the

establishment’s checks. Animals were humanely killed.


Mouse

4

PEL SC 4(3)

PEL SC 4(1)

Letter of reprimand

Cage sent for washing with animal still inside in error.

Animal left without water and subsequently humanely killed.


Mouse

1

PEL SC 4(3)

PEL SC 4(1),

PEL SC 4(4)


Letter of reprimand

PIL holder placed pair of animals in cage but omitted food in error. This was not picked up by the establishment’s checks over

the weekend.


Mouse

2

PIL SC 2

PEL SC 4(3)

Letters of reprimand

Water valve failure resulted in failure of water supply.

This was not noticed by the establishment’s checks.


Mouse

2

PEL SC 4(3)

PEL SC 5,

PEL SC 21


Letter of reprimand

Animals failed to be fed. Detected at the next scheduled establishment check.

Withheld*

Not known

PEL SC 4(3)

Inspector

advice


Animals left without water for 6 hours in error. Detected at the next establishment check.

Rat

6

PEL SC 4(3)

Inspector

advice


Food was withheld from an animal in order to take a fasting blood sample as required for scientific purposes. The blood sample was not taken, and food was not reintroduced. Detected by the establishment at the next scheduled check.

Mouse

Not known

PIL SC 2

PIL SC 19

Inspector

advice


PIL holder failed to provide food to animals after a procedure.

Detected by the establishment at the next scheduled check.


Mouse

4

PIL SC 2

Inspector

advice


PIL holder failed to provide food to animals after a procedure.

Detected by the establishment at the next scheduled check.


Mouse

2

PIL SC 2

Inspector

advice


Animal due to be humanely killed left without water due to changeover of staff at the

end of a shift. Detected by the establishment prior to adverse welfare impact.


Mouse

1

PEL SC 4(3)

Inspector

advice


Mouse left overnight without water but detected at the next scheduled establishment check.

Mouse

1

PEL SC 4(3)

Inspector

advice


Water bottle was not placed correctly so animals could not access water. Detected at the next establishment check.

Mouse

3

PEL SC 4(3)

Inspector

advice

  • Detail of species withheld to prevent disclosure of establishment or persons.

Failure to provide adequate care

Description Animal type involved Animal numbers involved Section of ASPA or SC breached Regulator action taken
     
Primary breach

Other breach(es)
 

An animal was able to crawl behind the crush back in its enclosure and became trapped and died. The absence of the animal was not noticed at the establishment’s checks for several days. Root causes included lack of adequate maintenance and use of an enclosure in which it was difficult to count animals accurately.

Non- human primate

1

PEL SC 4(5)

PEL SC 4(4)

Letter of reprimand and Compliance Notice (included decommissioning

of the room)


Failure to confirm death following an attempt to humanely kill animals, resulting in animals being alive after initial killing step. In addition, animals killed and dissected in the presence of live animals.

Mouse

9

ASPA 15A

Revocation of licence and removal from the killing register

Failure to confirm death after initial humane killing method, resulting in the animal escaping after the initial overdose of anaesthetic.

Rat

1

ASPA 15A

Letter of reprimand and

retraining


Failure to kill adult animals by the most humane method

Mouse

Unknown

ASPA

3(a)


ASPA 3(b) PPL SC 1

Letter of reprimand and

retraining


Isolator alarm and fan switched off in error, resulting in the death of 16 animals from suffocation.

Rat

16

PEL SC 4(1)

Letter of reprimand

Failure of the system for securing cages, resulting in animals reaching others and fighting, causing wounds that required repair.

Non- human primate

4

PEL SC 4(1)

Letter of reprimand (upgrade of cage security system)

Killing an animal by a method other than a Schedule 1 method without authorisation.

Rat

1

ASPA 15A

PEL SC 2

Letter of reprimand

Animal died due to a head restraint being applied too hard while a blood sample was taken.

Rat

1

PIL SC 2

PIL SC 5

Letter of reprimand

Animal died due to a head restraint being applied too hard while a blood sample was taken.

Rat

1

PIL SC 2

Letter of reprimand

Failure of water pumping system, resulting in turbid water.

Fish

6

PEL SC 4(1)

PIL 2

Letters of reprimand

Animals damaged by being released in sump and subsequently killed.

Fish

2

PIL SC 2

Letter of reprimand

On 3 separate occasions, one animal was sent to the cage wash area by mistake.

Mouse

3

PEL SC 4(1)

Letter of reprimand

Thermal injury to animals during surgery due to contact with heat mat.

Rat

2

PIL SC 2

Inspector advice

Inadequate supervision of animal while under general anaesthesia.

Rat

1

PIL SC 2

Inspector advice

Animals trapped tail in cage lid – discovered by routine checks.

Mouse

2

PEL SC 5

Inspector advice

Animals trapped tail in cage lid – discovered by routine checks.

Mouse

2

PEL SC 5

Inspector advice

An establishment check was missed for one room, which was not checked on one day. No adverse welfare outcomes to animals.

Mouse

Not known

PEL SC 4(5)

Inspector advice

Failure to monitor environmental conditions on several days in different rooms.

Various

Not known

PEL SC 4(4)

Inspector advice

Failure to comply with authorisations and/or conditions on project licence

Description Animal type involved Animal numbers involved Section of ASPA or SC breached Regulator action taken
     
Primary breach

Other breach(es)
 

PIL holder unable to demonstrate an understanding of their responsibilities under ASPA.

PIL holder failed to keep adequate contemporaneous records of regulated procedures undertaken, as required.


Various

Not known

PIL SC 19

PIL SC 20,

PPL SC 6,

PEL SC 15,

PEL SC 20


Revocation

of PIL, Compliance Notice and letters of reprimand.


Flask containing fish larvae due to be humanely killed left on bench area outside of licensed animal holding areas.

Fish

824

PIL SC 1

PPL SC 1,

PIL SC 1,

PEL SC 4(1),

PEL SC 4(3)


Letters of reprimand

and retraining


Substances administered in a combination that was not authorised on PPL

Mouse

20

ASPA

3(b)


PPL SC 23,

PIL SC 19,

PEL SC 20


Letters of reprimand

and retraining


Animals not humanely killed at end of experiment as required, and then reused in another experiment without authorisation.

Mouse

4

ASPA

15


PIL SC 8,

PIL SC 19,

PPL SC 11,

PPL SC 23


Letters of reprimand

and retraining


Animals died due to an overdose of substance administered.

Error made by PPL holder in calculation of dose.


Rat

60

PPL SC 6

PPL SC 17,

PEL SC 5


Letters of reprimand

Animal received accidental injury during surgery, was kept alive and underwent further regulated procedures while exhibiting adverse events that were not authorised in the PPL.

Non- human primate

1

PPL SC 18

PEL SC 15,

PEL SC 20,

PIL SC 19


Letters of reprimand

Animal experienced adverse events (prolonged noisy breathing following extubation at the end of an anaesthetic) which were not authorised.

Non- human primate

1

PPL SC 18

PEL SC 15,

PPL SC 8,

PIL SC 19,

PIL SC 13


Letters of reprimand

and inspector advice.


Substance administered to incorrect animal.

Non- human primate

1

PIL SC 19

PEL SC 5,

PEL SC 10,

PEL SC 20


Letters of reprimand

Animals breached severity limit authorised on PPL but were kept alive.

Mouse

8

PIL SC 13

PPL SC 1,

PIL SC 15,

PIL SC 19


Letters of reprimand

and inspector advice.


Animals using for breeding after undergoing regulated procedures without required PPL authority for reuse.

Mouse

Not known

ASPA 14(1)

PPL SC 11

Letter of reprimand

Animals exceeded authorised reduction in weight.

Mouse

1

PIL SC 2

Letter of reprimand

Animals exceeded authorised reduction in weight.

Mouse

5

PIL SC 2

PEL SC 5

Letters of reprimand

Number of animals bred exceeded that authorised on PPL.

Mouse

105

ASPA

3(b)


PPL SC 1

Letter of reprimand

Animals exceeded age limit authorised on PPL.

Mouse

31

ASPA

3(b)


PPL SC 1,

PIL SC 1,

PEL SC 20


Letters of reprimand

Failure to kill animals having reached their humane endpoint following direction by NACWO.

Mouse

2

PIL SC 2

Letter of reprimand

Animals administered substances in error, which were not authorised to be administered.

Mouse

5

ASPA

3(b)


PIL SC 19

Letter of reprimand

Topical administration of substances to animals in error.

Mouse

58

ASPA

3(b)


Letters of reprimand

Administration of incorrect substances to animals resulting in unauthorised reuse.

Rat

26

ASPA 14(1)

PEL SC 20,

PPL SC 1


Letters of reprimand

Procedure carried out without PPL authority to conduct that specific procedure.

Fish

42

ASPA

3(b)


PPL SC 19

Letter of reprimand

Substance administered via unauthorised route.

Mouse

1

PIL SC 19

PIL SC 5

Letter of reprimand

Substance administered that was not authorised.

Mouse

Not known

ASPA

3(b)


Letter of reprimand

Number of animals bred exceeded that authorised on PPL.

Fish

1,177

ASPA

3(b)


Inspector

advice


Number of animals bred exceeded that authorised on PPL.

Mouse

Not known

ASPA

3(b)


Inspector

advice


Incorrect cage labelling.

Mouse

2

PIL SC 16

Inspector

advice


Calculation and recording of weight loss not performed correctly.

Mouse

2

PPL SC 18

PPL SC 1

Inspector

advice


Weight loss not monitored correctly.

Mouse

1

PIL SC 2

Inspector

advice


Delay in reporting unexpected death of animal.

Mouse

1

PPL SC 18

Inspector

advice


Restraint frequency of animals beyond that authorised on PPL.

Non- human primate

2

PIL SC 19

Inspector

advice


Unauthorised procedures conducted on terminally anaesthetised mice.

Mouse

12

PIL SC 19

Inspector

advice


Live animals exported from UK without required authorisation.

Mouse

70

PPL SC 1

Inspector

advice


Unauthorised identification procedure conducted on an animal.

Withheld*

1

ASPA

3(b)


PPL SC 19

Inspector

advice


Reports required under PPL SC 18 not submitted in required timeframe.

Various

Not known

PPL SC 18

Inspector

advice


Number of animals bred exceeded that authorised on PPL.

Mouse

36

PPL SC 19

PPL SC 1

Inspector

advice


Animal kept alive and rehomed after regulated procedure without the required veterinary assessment.

Cattle

1

ASPA

15


ASPA 17(a)

Inspector

advice


Number of animals bred exceeded that authorised on PPL.

Mouse

Not known

ASPA

3(b)


Inspector

advice


Inadvertent reuse of an animal by performing additional procedures to those authorised under terminal anaesthesia.

Mouse

1

ASPA 14(1)

Inspector

advice


Additional day of dosing performed than was required.

Rat

6

PEL SC 20

Inspector

advice


Permission to keep animals alive with unauthorised adverse events not requested in a timely way.

Mouse

Not known

PPL SC 18

Inspector

advice


Genotyping carried out by an unauthorised method.

Rat

1

PIL SC 19

PPL SC 1

Inspector

advice


PPL not revoked at the time of PPL holder’s departure from the establishment.

Not applicable

Not applicable

PEL SC 22

PEL SC 20

Inspector

advice


Failure to use aseptic technique during surgical procedure.

Various

Not known

PIL SC 1

Inspector

advice


Failure to monitor animal in accordance with PPL requirements.

Mouse

1

PIL SC 2

Inspector

advice


Animals kept beyond age limit authorised on PPL.

Mouse

4

ASPA

3(b)


PPL SC 18,

PIL SC 19


Inspector

advice


Blood sampling performed by method that was not the most refined.

Mouse

Not known

PPL SC 4

Inspector

advice


Surgical procedure delayed due to problem with substance to be administered but animal had already been administered pre-medication.

Rabbit

1

PEL SC 20

Inspector

advice

  • Detail of species withheld to prevent disclosure of establishment or persons.

Failure to have correct personal licence

Description Animal type involved Animal numbers involved Section of ASPA or SC breached Regulator action taken
     
Primary breach

Other breach(es)
 

Conduct of regulated procedures without PIL. Procedure performed competently.

Fish

1

ASPA

3(a)


Inspector

advice


PIL holder took blood sample on terminally anaesthetised animal with incorrect category of PIL. Procedure performed competently.

Rat

1

ASPA

3(a)


Inspector

advice


Regulated procedures conducted by person with incorrect category of PIL. Procedures performed competently.

Mouse

6

ASPA

3(a)


Inspector

advice


Regulated procedures performed after completing modular

training but before receiving PIL. Procedures performed competently.


Mouse

Not known

ASPA

3(a)


Inspector

advice

Performing procedures or keeping animals in area not correctly specified on PEL

Description Animal type involved Animal numbers involved Section of ASPA or SC breached Regulator action taken
     
Primary breach

Other breach(es)
 

Conduct of regulated procedures without PIL. Procedure performed competently.

Fish

1

ASPA

3(a)


Inspector

advice


PIL holder took blood sample on terminally anaesthetised animal with incorrect category of PIL. Procedure performed competently.

Rat

1

ASPA

3(a)


Inspector

advice


Regulated procedures conducted by person with incorrect category of PIL. Procedures performed competently.

Mouse

6

ASPA

3(a)


Inspector

advice


Regulated procedures performed after completing modular

training but before receiving PIL. Procedures performed competently.


Mouse

Not known

ASPA

3(a)


Inspector

advice

Annex 3: Non-compliance cases 2021

Glossary of terms

ASPA: Animals (Scientific Procedures) Act 1986

NVS: Named veterinary surgeon

PEL: Establishment licence

PIL: Personal licence

PPL: Project licence

SC: Standard Condition

Failure to provide food and/or water

Description Animal type involved Animal numbers involved Section of ASPA or SC breached Regulator action taken
     
Primary breach

Other breach(es)
 

A cage of mice was left without water for 24 hours.

Mouse

4

PEL SC 4(3)

Inspector

advice


A cage of mice was left without food for 5 days.

Mouse

5

PEL SC 4(3)

PEL SC 5

Letters of reprimand

A cage of neonatal mice was left without food and water for 2 days.

Mouse

2

PIL SC 2

Letters of reprimand

A mouse did not have access to water overnight.

Mouse

1

PEL SC 4(3)

Inspector

advice


A mouse was left without food or water for approximately

48 hours.


Mouse

1

PEL SC 4(3)

PEL SC 4(5)

Inspector

advice


Four mice were left without water for 4 days after the automatic watering system in the cage failed to function properly.

Mouse

4

PEL SC 4(3)

PEL SC 4(5)

Letters of reprimand

A mouse was left without water for 24 hours.

Mouse

1

PEL SC 4(3)

Inspector

advice


Three sheep were left without food and water for approximately 24 hours.

Sheep

3

PEL SC 4(3)

Inspector

advice


Three mice were left without water for 3 days after the automatic watering system in the cage failed to function properly.

Mouse

3

PEL SC 4(3)

PEL SC 4(5)

Letters of reprimand

A transport error led to 17 mice being left in a transport box with limited food and water for 6 days.

Mouse

17

PEL SC 4(3)

PEL SC 4(1),

PEL SC 4(5)


Letters of reprimand

A PIL holder did not replace an animal in its cage correctly, resulting in it being unable to

access water for approximately 14 hours.


Mouse

1

PIL SC 2

PEL SC 4(1),

PEL SC 4(3)


Inspector

advice


A food hopper was placed in a cage in the incorrect orientation, resulting in the animals in the cage not having access to food for 3 days.

Rats

3

PEL SC 4(3)

PEL SC 4(5)

Letters of reprimand

A cage of 2 mice was set up without a food hopper.

This was not identified by the establishment’s checks for

3 days.


Mice

2

PEL SC 4(3)

Letters of reprimand

A mouse was left in a cage without food and water for less than 24 hours.

Mice

1

PEL SC 4(3)

PEL SC 4(1)

Inspector

advice

Failure to provide adequate care

Description Animal type involved Animal numbers involved Section of ASPA or SC breached Regulator Action taken
     
Primary breach

Other breach(es)
 

Seven fish jumped out of gaps in the lids of 2 tanks and died.

Fish

7

PEL SC 4(1)

PEL SC 4(4)

Letters of reprimand

and inspector

advice


A licence holder did not monitor animals adequately after applying regulated procedures and did not take action to prevent avoidable suffering.

Mice

2

PIL SC 2

PIL SC 5,

PIL SC 13,

PIL SC 19


Suspension

A licence holder failed to provide adequate care during and after applying regulated procedures and did not prevent avoidable suffering for these animals. The licence holder was inadequately supervised by the PPL holder.

Rats

12

PIL SC 2

PPL SC 6,

PIL SC 1,

PIL SC 5,

PIL SC 14,

PIL SC 15,

PIL SC 19


Suspension

A system drain tap was left open, leading to unobserved drainage of a tank overnight and the death of 300 fish.

Fish

300

PEL SC 4(1)

PEL SC 4(7)

Letters of reprimand

A drain valve in an aquarium tank was not properly closed. Consequently, the tank drained overnight, resulting in the death of 440 fish.

Fish

440

PEL SC 4(1)

Letters of reprimand

Cage of neonatal mice were left in a cage wash area.

Mice

8

PEL SC 4(1)

PEL SC 4(4),

PEL SC 13


Inspector

advice


Four mice died after receiving intra-venously an injection containing fragments from a faulty pestle and mortar.

Mice

4

PIL SC 13

PPL SC 1,

PPL SC 18,

PIL SC 15


Letters of reprimand

Two rats escaped from their cage during transport between buildings.

Rats

2

PEL SC 4(6)

PEL SC 5

Letters of reprimand

A mouse became trapped during a cage change and was discovered dead 5 days later.

Mice

1

PEL SC 4(1)

PEL SC 4(5)

Letters of reprimand

Procedures not authorised by the PPL were applied to

rats, insufficient analgesia was provided for 7 of the animals and monitoring of the animals after procedures were applied was inadequate. The training and competency of the responsible PIL holder was inadequate.


Rats

18

PPL SC 8

ASPA 3(b), PPL SC 1,

PPL SC 6,

PPL SC 18,

PIL SC 1,

PIL SC 12,

PIL SC 17


Suspension

A mouse was kept alive having exceeded the weight loss limit that constituted a humane endpoint in the PPL.

Mice

1

PIL SC 2

Letters of reprimand

Two mice escaped from their cages and were unaccounted for. Establishment checks initially failed to identify their absence.

Mice

2

PEL SC 4(5)

PEL SC 17

Letters of reprimand

1,300 fish died when a chlorine tablet was accidentally added into the reservoir tank, feeding directly into the fish tanks.

Fish

1,300

PEL SC 4(1)

Letters of reprimand

A mouse underwent blood sampling via a method that was not the most refined than could have been applied.

Mice

1

PIL SC 1

Inspector

advice


The incorrect test substance was administered, resulting in a requirement to repeat the study (to fulfil regulatory requirements) and the use of an additional

5 animals.


Rats

5

PEL SC 1

Letters of reprimand

The incorrect dose of test substance was administered to a group of mice, resulting in a requirement to repeat the study and the use of an additional

8 animals.


Mice

8

PIL SC 1

Inspector

advice


An electrical failure at the establishment led to the lights in 3 animal holding rooms being left on for 3 nights.

Not specified

Not known

PEL SC 4(5)

Inspector

advice


A PIL holder performed a hepatectomy procedure in 6 mice without having adequate training and competency records. The absence of these records was not identified by the establishment. In addition, the PPL holder’s oversight of the programme of work was insufficient.

Mice

6

PEL SC 15

PPL SC 1,

PIL SC 20


Letters of reprimand

A cage of neonatal mice was left in a cage wash area.

Mice

4

PEL SC 4(1)

Inspector

advice


A mouse with overgrown teeth was not detected at weaning and the animal was subsequently found dead.

Mice

1

PEL SC 4(5)

Inspector

advice


A PIL holder failed to ensure that they had been assessed for competency in a regulated procedure (brain fibre implantation) prior to performing the procedure.

Mice

1

PIL SC 17

PEL SC 15

Letters of reprimand

A nephrectomy procedure was performed on a rat without adequate analgesia being provided and without veterinary advice being sought for

the animal.


Rats

1

PIL SC 15

PEL SC 1,

PPL SC 1,

PIL SC 11,

PIL SC 12


Retraining and letters of reprimand

A malfunctioning heat mat led to thermal injuries to the tails of 4 mice. Issues with the functioning of heat mats had previously been identified at the establishment, but no effective action had

been taken.


Mice

4

PEL SC 4(4)

PEL SC 15,

PEL SC 21


Letters of reprimand

The incorrect dosage of a test substance was administered to 18 rats, resulting in the required benefits of the study not being achieved.

Rats

18

PPL SC 1

Inspector

advice


A mandated daily check of mice in a temperature-controlled cabinet was missed.

Mice

33

PEL SC 4(5)

Inspector

advice


A PIL holder forgot to inform other staff that the animals on which they had performed surgery required analgesia, although requirement for analgesia was identified by the establishment’s staff and administered.

Rats

4

PIL SC 14

Inspector

advice


A mouse escaped from a behavioural testing box.

Mice

1

PEL SC 17

Inspector

advice


A PIL holder failed to accurately monitor weight loss in 4 mice and, as a result, they exceeded the weight loss humane endpoint specified in the PPL.

Mice

4

PIL SC 2

PPL SC 1,

PIL SC 13


Retraining and letters of reprimand

Mice underwent surgery using a method that was not the most refined and some experienced unauthorised adverse effects. In addition, veterinary advice for the animals was not sought.

Mice

27

PPL SC 4

PPL SC 1,

PIL SC 1,

PIL SC 15


Letters of reprimand

A mouse experienced unauthorised adverse effects and was not culled. In addition, the PIL holder did not inform the PPL holder that the constraints of the licence had been exceeded.

Mice

1

PIL SC 13

PIL SC 1,

PIL SC 19


Inspector

advice


A mouse exhibited adverse effects after stereotaxic surgery, but the PIL holder failed to seek veterinary advice for the animal.

Mice

1

PIL SC 15

Letters of reprimand

Stock zebrafish held at an establishment were not checked over a weekend.

Fish

Not known

PEL SC 4(5)

Inspector

advice


An additional blood sample was erroneously taken from 18 rats.

Rats

18

PIL SC 1

Inspector

advice


Ten mice were dosed with a test substance for an insufficient number of days to ensure benefits of the study were met. Regulatory requirements meant the study was repeated with an additional 10 animals.

Mice

10

PPL SC 1

PEL SC 1

Inspector

advice

Failure to comply with authorisations and/or conditions on project licence

Description Animal type involved Animal numbers involved Section of ASPA or SC breached Regulator Action taken
     
Primary breach

Other breach(es)
 

A licence holder failed to provide 3 annual reports required under a condition of their PPL.

Non- human primates

Not known

PPL SC 1

Inspector

advice


Unauthorised procedures were carried out in a manner not consistent with the principle of refinement and not causing the least pain, suffering, distress or lasting harm required to fulfil the benefits of the study. Failure to ensure animals used in the study were properly monitored.

Mice

15

PEL SC 20

ASPA 3(b), PEL SC 1,

PEL SC 15,

PPL SC 1,

PPL SC 4


Letters of reprimand

Four mice were singly housed without PPL authority.

Mice

4

PIL SC 19

Letters of reprimand

Twelve mice experienced adverse effects not authorised in the PPL, humane endpoints were not applied in a timely fashion and

no authority was sought to keep the animals alive when humane endpoints were reached.


Mice

12

PIL SC 19

PPL SC 18,

PIL SC 5


Letters of reprimand

Procedures were performed for a purpose (training) that was not authorised by the PPL.

Mice

20

ASPA

3(b)


PEL SC 5

Letters of reprimand

A PIL holder implanted electrocardiogram devices into 2 mice in a site not authorised in the PPL.

Mice

2

PEL SC 20

PIL SC 19

Compliance Notice and inspector

advice


An animal was kept alive with an unauthorised adverse effect without permission from the Secretary of State and without veterinary advice being sought.

Mice

1

PPL SC 18

PIL SC 15,

PIL SC 16


Retraining and letters of reprimand

Procedures were conducted incorrectly resulting in the incorrect limb bone being operated on and the animal subsequently suffering a fracture.

Sheep

1

ASPA

3(b)


PEL SC 20,

PPL SC 1


Retraining and letters of reprimand

Procedures were performed on 6 mice for a purpose not authorised in the PPL.

Mice

6

ASPA

3(b)


PPL SC 1,

PIL SC 19


Letters of reprimand

Thirty-five mice that had undergone stereotaxic surgery to apply head implants exceeded

a time constraint specified in the PPL.


Mice

35

PPL SC 1

ASPA 3(b),

ASPA 15(1)(b), PPL SC 6,

PIL SC 19


Retraining

A mouse underwent surgery for a purpose not authorised in the PPL.

Mice

1

ASPA

3(b)


ASPA 14,

PIL SC 19


Retraining and letters of reprimand

An animal experienced adverse effects that were not authorised in the PPL was kept alive for 10 days without permission from the Home Office.

Rats

1

PPL SC 18

PPL SC 8

Letters of reprimand

320 mice underwent a temporary withdrawal of anaesthesia

during application of regulated procedures when this was not authorised by the PPL.


Mice

320

ASPA

3(b)


PPL SC 1,

PIL SC 19


Letters of reprimand

Two mice underwent wound reclosure on 2 occasions when only a single wound closure was authorised by the PPL.

Mice

2

ASPA

3(b)


Retraining

A PIL holder anaesthetised mice to measure subcutaneous tumours with callipers. The use

of anaesthesia for this purpose is not authorised by the PPL.


Mice

33

ASPA

3(b)


PIL SC 19

Letters of reprimand

A mouse underwent 2 intraplantar injections when PPL authority permitted application of only one.

Mice

1

ASPA

3(b)


Inspector

advice


A mouse underwent wound repair more than 48 hours after surgery, when wound repair was only permitted within 48 hours by the authorities of the PPL.

Mice

1

ASPA

3(b)


Inspector

advice


Twenty-five mice exceeded the maximum age limit of 12 months authorised by the PPL.

Mice

25

PPL SC 1

Inspector

advice


A mouse underwent a second administration of anaesthetic after the first anaesthetic induction failed. A repeat anaesthetic induction was not authorised by the PPL.

Mice

1

ASPA

14


PIL SC 10

Inspector

advice


An animal was re-used between protocols on the PPL without the re-use being authorised.

Mice

1

ASPA

14


Inspector

advice


A mouse was implanted with a microchip and then killed for

training purposes. Training was not an authorised purpose under the PPL.


Mice

1

ASPA

3(b)


Inspector

advice


Animals exceeded a weight loss humane endpoint specified in the PPL and no permission was sought from the Secretary of State to keep them alive.

The training of personnel in the measurement of weight loss and identification of associated humane endpoints was inadequate.


Mice

17

PEL SC 5

PPL SC 1,

PPL SC 18


Inspector

advice


Procedures that were not authorised by the PPL were performed in 16 rats. In addition, a responsible PIL holder

had inadequate training and competency records in the procedures.


Rats

16

ASPA

3(b)


PEL SC 1,

PEL SC 15,

PPL SC 1,

PIL SC 19,

PIL SC 20


Suspension and letters of reprimand

Two mice underwent cranial surgery over the course of 2 procedures rather than the single surgery authorised by the PPL.

Mice

2

ASPA

3(b)


PEL SC 21,

PIL SC 19


Inspector

advice


A PPL holder failed to report the deaths of 8 mice in a breeding colony to the Secretary of State as soon as possible.

Mice

8

PPL SC 18

Inspector

advice


A guinea pig was killed by a method not authorised by a PPL.

Guinea

pig


1

ASPA 15A

Inspector

advice


Eight mice exceeded the maximum age limit of 12 months authorised by the PPL.

Mice

8

ASPA

3(b)


Inspector

advice


A PPL holder failed to report the deaths of 6 genetically altered mice which died as a result of the genetic alteration.

Mice

6

PPL SC 18

Letters of reprimand

A mouse was allowed to age to 21 months, exceeding the

maximum age limit of 12 months authorised by the PPL.


Mice

1

ASPA

3(b)


PPL SC 1

Inspector

advice


More mice were bred than was authorised by the PPL.

Mice

1,043

ASPA

3(b)


Inspector

advice


Sixty-one fish exceeded the maximum age limit of 18 months authorised by the PPL.

Fish

61

PPL SC 1

Inspector

advice


Unauthorised procedures for an unauthorised (training) purpose were performed in 4 mice; all animals subsequently died or were culled due to adverse effects associated with the procedures.

Mice

4

ASPA

3(b)


PPL SC 1,

PPL SC 6,

PIL SC 19


Retraining

Unauthorised procedures were carried out in 51 mice.

Mice

51

ASPA

3(b)


PPL SC 1

Inspector

advice


A PIL holder performed oral gavage in 2 mice for training purposes. Training was not an authorised purpose under the PPL.

Mice

2

Letters of reprimand

Mice underwent vasectomy via a laparotomy approach rather than the scrotal approach authorised by the PPL.

Mice

120

ASPA

3(b)


PPL SC 1,

PIL SC 19


Letters of reprimand

A PIL holder did not cull an animal after it had reached a weight loss humane endpoint and did not notify either the PPL holder or the NVS that the endpoint had been exceeded.

Rats

1

PIL SC 2

PIL SC 3,

PIL SC 15


Retraining

A mouse was ear clipped for genotyping purposes without authority under the PPL.

Mice

1

ASPA

3(b)


PIL SC 19

Inspector

advice


Twelve mice received a dose of test substance via the intra- peritoneal route that exceeded

the maximum permitted volume under the PPL authorities.


Mice

12

PIL SC 19

Inspector

advice


An individual took a blood sample from a dog for a scientific purpose without PIL or pPPL authority at a place not specified in a PPL.

Dogs

1

ASPA

3


Letters of reprimand

70 fish exceeded the maximum age limit of 18 months authorised by the PPL.

Fish

70

ASPA

3(b)


Inspector

advice


A PIL holder decapitated 3 mice without PPL authority and did not use the most refined method for the procedure.

Mice

3

ASPA

3(b)


PPL SC 1,

PIL SC 19


Suspension

A PIL holder performed procedures on 3 mice for a purpose not authorised in the PPL.

Mice

3

ASPA

3(b)


Retraining

A second person was not present during surgical procedures when a neuromuscular blocking agent was being used, as required by an additional condition of the PPL.

Guinea

pig


1

PPL SC 1

PIL SC 19

Inspector

advice


Six mice exceeded the weight loss humane endpoint mandated by the PPL.

Mice

6

PEL SC 5

PPL SC 1,

PIL SC 18


Letters of reprimand

Fourteen mice had blood samples taken that exceeded the maximum volume permitted by the PPL.

Mice

14

PIL SC 2

Letters of reprimand

The incorrect animal underwent a blood sample while under terminal anaesthesia.

Rats

1

ASPA

3(b)


Inspector

advice


A PIL holder did not cull an (otherwise clinically well) mouse after it had reached a weight loss humane endpoint specified in the PPL.

Mice

1

PIL SC 2

Inspector

advice


A PPL holder knowingly allowed a mouse to exceed the maximum age permitted by the authorities of the PPL.

Mice

1

PPL SC 1

Retraining

A PIL holder exceeded the maximum limit specified in the PPL for number of daily intra-peritoneal injections.

Mice

6

PIL SC 19

Inspector

advice


Mice underwent subcutaneous implantation of microchips for a scientific purpose. This was not specifically authorised by the PPL.

Mice

24

ASPA

3(b)


PPL SC 1

Inspector

advice


A PIL holder failed to identify that a mouse had reached a tumour size humane endpoint, as mandated by the PPL.

Mice

1

PIL SC 2

Letters of reprimand

Three mice exceeded the maximum age limit authorised by the PPL.

Mice

3

PPL SC 1

Inspector

advice


A PIL holder removed blood from 12 mice by tail snipping while they were under terminal anaesthesia without PPL authority and without documented training and competency records.

Mice

12

ASPA

3(b)


PPL SC 1,

PPL SC 6,

PIL SC 17


Inspector

advice


The processes for identifying animals being used under a PPL was inadequate, resulting in one mouse exceeding a mandated humane endpoint due to misidentification.

Mice

1

PPL SC 1

Letters of reprimand

A PPL holder failed to ensure that a cow was examined by a NVS prior to release from the controls of ASPA.

Cattle

1

PPL SC 1

Inspector

advice


More mice were bred than was authorised by the PPL.

Mice

76

PPL SC 1

Inspector

advice


A mouse exceeded the maximum age limit of 12 months authorised by the PPL.

Mice

1

PPL SC 1

Inspector

advice


A mouse exceeded the maximum age limit of 12 months authorised by the PPL.

Mice

1

PPL SC 1

Inspector

advice


Mice were housed in cages that did not meet minimum requirements of the ‘Code of Practice for the Housing and Care of Animals Bred, Supplied or Used for Scientific Purposes’ for 22 hours longer than was authorised by the PPL.

Mice

20

PIL SC 19

Inspector

advice


Twenty-four mice were kept alive under a PPL authority for 6 months longer than was authorised by the PPL.

Mice

24

PPL SC 1

PPL SC 18

Inspector

advice

Failure to have correct personal licence

Description Animal type involved Animal numbers involved Section of ASPA or SC breached Regulator Action taken
     
Primary breach

Other breach(es)
 

Blood samples were taken from 20 lambs for a scientific purpose by an individual without PIL authority.

Sheep

20

PEL SC 20

ASPA 3(a)

Compliance notice and letters of reprimand

Imaging procedures were carried out on 50 fish for a scientific purpose by an individual without PIL authority.

Fish

50

ASPA

3(a)


Inspector

advice


Procedures were performed by an individual without

PIL authority.


Mice

Not known

ASPA

3(a)


Letters of reprimand

An individual performed regulated procedures (administration of

pre-medication and implantation of a telemetry device) in a dog for a scientific purpose without PIL authority.


Dogs

1

ASPA

3(a)


Letter of censure

A PIL holder performed procedures (a subcutaneous and an intra-venous injection) on a non-human primate.

The processes in place at the establishment failed to identify that the PIL holder did not have the application of procedures to non-human primates authorised by their PIL.


Non- human primates

1

PEL SC 20

ASPA 3(a)

Letters of reprimand

and inspector

advice


A PIL holder performed procedures (intra-peritoneal injections) on 5 rats. The processes in place at the establishment failed to identify that the PIL holder did not have the application of procedures to rats authorised by their PIL.

Rats

5

PEL SC 20

ASPA 3(a), PIL SC 19

Letters of reprimand

An individual performed procedures (intra-muscular injection) on a non-human primate without PIL authority.

Non- human primates

1

ASPA

3(a)


Letter of censure

A PIL holder performed regulated procedures (intra-peritoneal injections) in 32 mice without having the correct PIL authority.

Mice

32

PEL SC 20

ASPA 3(a), PPL SC 6,

PIL SC 19


Inspector

advice

Performing procedures or keeping animals in area not correctly specified on PEL

Description Animal type involved Animal numbers involved Section of ASPA or SC breached Regulator Action taken
     
Primary breach

Other breach(es)
 

Six horses were housed in an area not specified on the PEL schedule of premises.

Horses

6

PEL SC 3(g)

PEL SC 13(b)

Inspector

advice


Animals were used under ASPA in a room (albeit fit for purpose) that was not authorised for use under the PEL.

Not specified

N/A

ASPA 2B(1)

Inspector

advice


Two rats were kept overnight in a room designated as ‘no overnight holding’ by the PEL.

Rats

2

PEL SC 13(b)

Inspector

advice


Zebrafish were used in procedures in 3 rooms that were not listed on the schedule of premises at the establishment.

Fish

Not known

PEL SC 13(b)

Inspector

advice


Two rooms were used for a purpose not authorised by the designated holding code for the areas on the PEL.

Not specified

Not known

PEL SC 3(g)

Inspector

advice


Animals were used under ASPA in a room (albeit fit for purpose) that was not authorised for use under the PEL.

Not specified

Not known

PEL SC 13(b)

Inspector

advice

Annex 4: Tables and figures

Glossary of terms

ASPA: Animals (Scientific Procedures) Act 1986

FTE: Full-time equivalent

PEL: Establishment licence

PIL: Personal licence

PPL: Project licence

SC: Standard Condition

Table 4.1: Licence applications and amendments, 2019, 2020 and 2021

Total Per inspector (FTE)

2021

2020

2019

2021

2020

2019

PILs (2) granted

2,327

1,732

2,792

102.6

74.6

125.7

PILs amended

789

679

564

34.8

29.2

25.3

PILs in force at year-end

14,402

14,796

16,009

634.7

637.4

720.8

PELs (3) granted

0

3

2

0

0

0

PELs amended

20

27

1,146

0.9

1.1

51.5 (4)

PELs in force at year-end

137

144

152

6.0

4.9

6.8

PPLs (5) granted

497

478

481

21.9

20.5

21.6

PPLs amended

1,109

1,053

685

48.9

45.3

30.8

PPLs in force at year-end

2,423

2,429

2,537

106.8

104.6

112.3

Inspectors (FTE)

22.69

23.21

22.21



Notes:

(1) FTE = full-time equivalent averaged across the year.

(2) PIL = personal licence.

(3) PEL = establishment licence.

(4) Due to the change in licensing software there were a large number of administrative changes undertaken on PELs to better align the data of approved areas into the new licence format.

(5) PPL = project licence.

Figure A4.1: Inspectorate resource, 2011 to 2021

See PDF for figure A4.1

Figure A4.2: Project licences granted, 2011 to 2021

See PDF for figure A4.2

Figure A4.3: Project licence application processing, 2011 and 2018

Due to the development of the new e-licensing system (ASPeL), not all reporting functions have been developed and therefore, some statistics are unavailable and will not be produced going forwards. The graph for the period up to 2018 is included in our 2018 Annual Report.

Figure A4.4: Inspections and audits, 2019 to 2021

See PDF for figure A4.4

Figure A4.4: Inspections and audits, 2019 to 2021

Overall, fewer number of on-site visits were undertaken in 2021 compared to 2019 and 2020. This was due to 2 main factors:

  • national lockdowns between 5 January and 3 May 2021 during which compliance assurance and inspection activity was undertaken remotely. On-site visits were still conducted for serious non-compliance cases or serious animal welfare concerns that could not be evaluated remotely

  • Launch of ‘Bridging Ways of Working’ operating model from 5 July 2021 which consolidated and expanded compliance assurance activity. The new operating model introduced full systems audits which are extended, structured compliance visits requiring teams of officials from the Animals in Science Regulation Unit (ASRU) evaluating selected establishments in depth. ASRU also updated the Standard Condition 18 system (described further in Section 3 of the operating model) leading to increased compliance oversight of all GB establishments through collection and analysis of Standard Condition 18 reports. Standard Condition 18 is applied to all project licences to ensure that the licence holder adheres to the specific severity limits (the scientific and humane endpoints that set limits on pain) in each licence.

More detail is provided in Section 8: Inspections and audits.

Annex 5: Strategic shifts

  • Relationship management of regulated establishments is separated from regulatory decision making.

  • Establishment of the Animals in Science Regulation Unit’s (ASRU’s) clear role as a regulator with associated training and ongoing career and professional development.

  • Clear written regulatory guidance will be available on ASRU’s website to cover all key areas.

  • Additional regulatory queries will be answered through a formal centralised process.

  • There will be an increased ASRU focus on the assessment of the suitability of all licence holders (establishment licences, project licences and personal licences), including standards for licence holder training.

  • There will be an increased focus in ASRU’s assessment of project licences on legal requirements and integration of expert assessments.

  • There will be an integrated assessment of compliance by teams of inspectors with formal documented outcomes.

  • There will be increased and pro-active issue of information and insights from data in near real time.

  • There will be increased horizon scanning and proactive policy development.

  • There will be increased focus and capability in information and systems management within ASRU.

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