Correspondence

ASRU operational newsletter, July 2024

Published 2 August 2024

Introduction

Dear all,

I am pleased to present the July 2024 ASRU operational newsletter. This newsletter provides the latest updates on ASRU’s regulatory functions and is an important part of how we maintain open and transparent communication.

We restarted the ASRU reform programme in May 2023, and we are continuing to improve the business as part of reform. These operational newsletters will keep you updated if and when there are upcoming changes to the way ASRU operates. I would like to reassure you that throughout reform, ASRU is committed to maintaining a quality service through our regulatory functions.

We are looking forward to our regular stakeholder engagement meetings later this year which provide important opportunities for ASRU to hear from the regulated sector and to answer any questions you may have about ASRU’s work and any upcoming changes.

Since our last newsletter, we have had the general election and new ministers are being appointed. This is a busy time for government departments as officials start working with new Ministers. We will keep you informed if we expect any changes to ASRU’s work.

I hope you find this newsletter helpful and informative.

Kate Chandler

Head of Unit, ASRU

Compliance

Publication of updated potential non-compliance notification form

A new version of the potential non-compliance notification form has been released and published on GOV.UK.

The form is now slightly shorter and contains an instruction to return the filled in form to ASRU as a Word document, this will assist us in processing the case efficiently.

Please remember the following.

• delete any previous versions, you may have stored offline.
• provide as much information on the form as possible.

If we contact you to ask for further information, please send this to ASRUEnforcement@homeoffice.gov.uk within 10 working days, to allow us to process your case as quickly as possible.

Update to standard condition 18 (SC 18) notification form

Thank you for the valuable feedback you provided during the pilot phase of the SC18 notification form.

The primary purpose of the pilot was to gather your perspectives and ensure that the SC18 notification form aligns with your needs and streamlines the process of providing the required information. Based on your feedback, we will be updating the form and will share the link to the final version of the SC18 notification form once published on GOV.UK.

Once again, thank you for your valuable contributions during the pilot phase. Your input has been instrumental in shaping a form that will better meet your needs and support efficient compliance process.

Licensing

Standard genetically altered mice and fish breeding and maintenance standard templates

Thank you for the many suggestions we have received on how to improve the standard genetically altered mice and fish breeding and maintenance standard templates. We are embedding these in ASPeL and will be seeking further input.

If you are interested in working with us, please contact ASRULicensing@homeoffice.gov.uk before 31 August 2024.

Update to conflict-of-interest declaration process and form, for named persons and PEL holders/NPRCs

We have published a revised Conflict of Interest Declaration template. This brings the wording into line with ASPA Guidance and makes clearer who should use it and how. You may find this different from current practice. A conflict-of-interest declaration is expected from:

• Proposed Named Veterinary Surgeon (NVS) and Named Animal Care and Welfare Officer (NACWOs), who should submit the declaration to their Project Establishment Licence Holder (PEL) holder. Please confirm in the Animals Scientific Procedures e- Licensing (ASPeL) application that a declaration has been made and accepted. PEL holders must make records available to ASRU Inspectors on request.
• Proposed PEL holders or Named Person for Compliance (NPRC), who should submit the declaration to ASRULicensing@homeoffice.gov.uk.
• Existing holders of these roles should submit a revised declaration, in the same way, should their circumstances change.

Schedule 1 killing of pregnant dams/embryos beyond 2/3rds gestation.

Foetuses of pregnant mammals are protected animals and therefore should be killed separately to the Dam via a Schedule 1 Table B killing method and death confirmed by a method in Schedule 1 Section 1. However, a Section 2C licence may specify an alternative method of killing for an animal, provided that the Secretary of State is satisfied (based on presented evidence) that the method is at least as humane as one of the Schedule 1 methods of killing (as per Section 15A (6)).

According to the ASPA Guidance, in requesting an alternative method of killing, the establishment licence holder should provide:

• Scientific evidence to support the claim that the method is at least as humane as the Schedule 1 killing methods.
• A rationale for requesting the additional method Detail of the method (including the provision and maintenance of necessary equipment).

Where relevant to your establishment licence, you may submit a request by email to ASRU Licensing to add the condition outlined below to your PEL. Your request should provide evidence to show that the killing methods used in pregnant dams and their foetuses are at least as humane as one of the Schedule 1 methods of killing. Once ASRU has received satisfactory evidence, further applications to place this condition on establishment licences will not need to provide evidence but need only to request the condition. ASRU will let the regulated community know when it has received satisfactory evidence.

Condition wording

“Killing a pregnant animal by a Schedule 1 method in the later stages of gestation normally leads to death of the foetus. The resulting death of the foetus in-utero does not need to be confirmed by a Schedule 1 method. There is no evidence to suggest that the death of the unborn animal would be distressful and inhumane provided direct physical injury to the foetus is avoided. Killing the pregnant dam by a Schedule 1 method does not require licence authority.”

Urgent amendments

Urgent amendments can be prioritised. ASRU licensing should be emailed at ASRULicensing@homeoffice.gov.uk with details of the project licence and a reason for the urgency.

Project licence applications that are referred to the Animals in Science Committee (ASPA Guidance Section 13.5).

Under ASPA section 9(1), the Secretary of State may refer project licence applications to the Animals in Science Committee for advice. We seek specific or general advice, as appropriate, on applications involving:

• the use of wild-caught non-human primates;
• the use of cats, dogs, Equidae or non-human primates in severe procedures;
• use of endangered species;
• projects with major animal welfare or ethical implications;
• projects involving the use of admixed embryos falling into category 3 of the AMS report on Animals Containing Human Material (ACHM) and category 2 where the predominance of an admixed embryo is unclear or uncertain (see Section 5.18.2);
• projects which may invoke any of the ‘safeguard clauses’ in the Directive 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 6; or
• projects of any kind raising novel or contentious issues or giving rise to serious societal concerns.

Please notify ASRU licensing as soon as these applications are submitted in ASPeL so that they can be prioritised.

Tips for New Project Applications and Amendments

• The wording in protocols for creation, breeding and maintenance of genetically altered animal protocols should not differ from the ASRU standard unless there is a good scientific justification for the deviation. Please refer to the guidance on the use of these protocols. Further information on genetically altered breeding and maintenance standard protocols can be accessed on Genetically altered rodent protocols and Genetically altered zebrafish protocols. We expect most breeding and maintenance of genetically altered fish and rodents can be carried out under a “Mild” severity protocol.
• New project applications and amendments should be drafted taking into account Guidance for Project Licence Applicants.
• The relevant fate of animals in the NTS should be ticked whether the fate applies at the end of the project or at the end of the protocol. Changes to this section will be rolled out soon.
• The rationale for each step in the protocol should be clear. The rationale can be provided alongside the step or in the justification section of the protocol. This also applies to project amendments.
• The final step in the protocol should describe the fate because the fate section of the application does not get replicated in the licence.
• Unexpected adverse effects should not be described in the adverse effects section of the protocol. If unexpected adverse effects occur these should be reported using the Project Licence Standard Condition 18 notification form.
• Protocol adverse effects: We have noticed in some project licence applications that instead of all of the procedural adverse effects and humane end points being in the appropriate procedural step they are in the animal experience descriptive section or in the general adverse effects. If there is a procedural adverse effect, it should be only in the step for that procedure. As outlined in our project licence guidance, the animal experience is for you to explain what combination of steps an animal may typically or extremely experience. The general humane end point section is for general cumulative effects from various steps or general humane end points you will apply between procedural steps if the animal is being maintained. Please refer to guidance on the use of these protocols.

Use of personal protective equipment (PPE) on site visits

As we continue with our annual audit programme, safety of our inspectors is an important requirement. All establishments have already been informed and agreed to the PPE requirements for the ongoing site visits.

In line with established safety measures, inspectors should be provided with agreed PPE for all audit visits. To prevent any risk of cross-contamination, inspectors do not carry their own PPE.

To enhance safety of our inspectors, a standardised provision of masks for establishments has been established. This ensures consistency and mitigates risks across all locations.

If the establishment fails to provide the necessary face-fit PPE, inspectors have been instructed not to enter the premises. This measure is crucial in maintaining safe working environment for all the parties involved.

Animals in Science Procedures e-Licensing (ASPeL) Updates

From January to April 2024

We improved and automated the reset of annual billing information for establishments.

What did we change?

We added a check box to the establishment details page, which ensures that establishments can confirm that their information is up to date and usable in the new financial year.

Why did we make this change?

In the past this information could be incorrect or out of date and carried over into the next financial year, causing errors on reports that had to be manually corrected. To work around this, all billing information was manually cleared each year. Adding this check box means that information that is likely to stay the same each year no longer needs to be re- entered.

Further improvements are the automation of the clearance and reset of information that changes annually on a scheduled date in readiness for the next financial year.

An automated message or notification will also go out to establishments on the day of the reset.

Return of Procedures (RoP) Bugs fixed

We fixed a bug that made the current year’s RoPs inaccessible to users.

Yearly tasks

Bank holidays for 2025, and fees data for the next financial year have been added, so that ASPeL will continue to calculate due dates and licence fees correctly.

PPL transfer bug fixed

We had reports from some users about an error message saying “large size of request entity” when attempting to transfer a PPL. The cause of this is a limit on the size of the data associated with a PPL. The “entity” is all of the data on the PPL form. We found that having a large number of collaborators (guests) on a PPL can exceed this limit. We released a fix to increase the size limit and stop the error message appearing in future.

There are also several hidden fields which store metadata which add to the size of the form entity. As a long-term improvement, we will investigate storing that data in a different way, so it doesn’t contribute to the size of the form.

Update on the reusable steps

We apologise for the challenges that you may have encountered whilst using some of the features of reusable steps in protocols. We have identified that the “Edit just this step” option, which creates a copy of the step you can edit separately, also detaches the step from any comments and its history in previous versions of the application or licence.

We have taken the decision to remove the “Edit just this step” option for the foreseeable future while considering changes in the long term. You will still be able to edit all instances of a reusable step or create a new step.

We plan to keep improving your user experience of ASPeL, so please bear with us while we make ongoing upgrades to project licence applications.

User research Volunteers required

Thank you again for all the interest expressed in the ASPeL system, and in helping us with User Research. We have research on Named Person applications coming up in the next couple of months and will have numerous research rounds happening throughout this year.

If you are interested in taking part, please email Rachel Cholerton (Senior User Researcher).

Relationship Management

Stakeholder meetings

On 7 March, ASRU and Animals in Science Regulatory Policy unit (ASRP) colleagues presented at the Animals in Science Committee (ASC) Away Day to introduce ASC’s new committee members to ASRP, ASRU, and the reform programme.

On 11 March ASRU attended the Establishment Licence holder (Pelh) committee virtual meeting. The presentation included a strategic update by ASRU, followed by a question-and-answer session.

ASRU and ASRP attended the annual Institute of Animal Technology Congress in Aberdeen on 13th March and gave a joint presentation covering policy, ASRU business and regulatory reform. The event was useful for engaging with the regulated sector and updating them on animals in science regulation and policy.

On 14 March the Home Office Liaison Training Information Forum (HOLTIF) meeting took place on MS Teams. The agenda included operational updates from ASRU and the ASPeL Enablers team, followed by a question-and-answer session.

Publications

ASRU has published the 2022 annual report. We also have taken proactive steps to address any discrepancies in our previous annual reports. We’ve identified and corrected data errors in the reports from 2019 to 2021. An explanatory note accompanying these corrections has been included for clarity and transparency. Both annual report and an explanatory note on corrections to the 2019 to 2021 reports are available on the GOV.UK.

ASRU has republished the Non-Technical Summaries (NTSs) for every project licence granted between 2019 to 2021 to provide a complete record of ASRU in an improved and more accessible format to aid usability and identification of those projects that require a retrospective assessment. The NTSs are now presented in two documents: one for those that do not require a retrospective assessment and another for those that require a retrospective assessment. The republished NTSs are available on GOV.UK.

The NTSs for Project licences and Retrospective Assessments granted from April to June 2024 have been published and can be viewed on GOV.UK.

External Establishment Licence Holders’ (Pelh) news

The 2024 Establishment Licence Holders’ Autumn Forum will be held on 28 October 2024, at Francis Crick Institute, Midland Road, London. The bespoke training is for PELhs within scientific organisations, focusing on vital strategies for maintaining compliance with the Animal Scientific Procedures Act 1986 in biomedical research. Under Establishment Licence Standard Condition 15 of the Act, “licence holders must nominate and ensure the performance of Named Persons, pivotal figures with distinct legal responsibilities concerning animal welfare and good practice”. The agenda will look into empowering these Named Persons while aligning with the principles of the 3 Rs replacement, reduction, and refinement in research practices.

The Establishment Licence Holders’ Induction Training will be Tuesday 19th November 2024. the training session for new Establishment Licence Holders, NPRCs, prospective ELHs is open for registration.

If you are interested in finding more, please contact the Laboratory Animal Science Association (LASA) at info@lasa.co.uk or 020 3627 9587.

Business support

Fee increase

As you will be aware, from 6 April 2024, the Animals in Science Regulation Unit increased its fees for establishment and personal licences granted under the Animals (Scientific Procedures) Act 1986 (ASPA). The new fees associated with licence applications as of this date will be:

• Establishment licence fee: £1,007
• Personal licence fee from: £329

This increase will ensure that ASRU is resourced to continue to provide the rigorous and robust requirements set out under the regulatory framework; assuring the compliance, quality science and engendering of public trust that is fundamental in the delivery of the UK life sciences.

This fee increase has been updated on ASPeL.

Contacting ASRU

Compliance assurance

Audit:

• audit related queries

ASRUAudit@homeoffice.gov.uk

Standard Condition 18:

• requests to keep animals alive
• Standard Condition 18 reports

ASRUStandardCondition18@homeoffice.gov.uk

POLE notification:

• notifying ASRU of upcoming work at a POLE - please ensure the email subject line includes the PPL number, PPL holder’s surname and the name of the establishment

ASRUPOLEnotification@homeoffice.gov.uk

Enforcement:

• reports of potential non-compliance
• reports required by a licence condition or as a result of enforcement action
• advice on whether a non-compliance may have occurred
• contact during a non-compliance investigation

ASRUEnforcement@homeoffice.gov.uk

Licensing:

• specific queries relating to an individual licence application
• evidence to support an exemption from mandatory training
• requests to re-home animals where not already authorised
• advice on interpretation of licence authorities
• guidance on becoming an establishment
• advice on whether work needs to be regulated
• advice on applying for licences
• guidance on how we will assess applications
• information to support a PEL application or amendment notification of AWERB dates
• AWERB terms of reference

ASRULicensing@homeoffice.gov.uk

ASPeL Technical Queries:

• technical advice on the use of ASPeL

ASPELTechnicalQueries@homeoffice.gov.uk

Home Office liaison contacts (HOLCs) and complaints inbox:

• raising concerns about the timeliness or completeness of response from any of our teams or any other concerns about any individual request or interaction
• raising concerns about the timeliness or completeness of response from any of our teams or any other concerns about any individual request or interaction from the regulated community

ASRUOperationalRelationshipManagement@Homeoffice.gov.uk

Fees or business enquiries

ASRUBusiness@homeoffice.gov.uk