Correspondence

ASRU operational newsletter, April 2025

Published 9 April 2025

Introduction

Dear all,

This ASRU operational update contains information for Home Office Liaison Contacts, licence holders, named persons and other role holders under ASPA.

The information aims to clarify the requirements of ASPA, help you understand how to comply and improve your experience of the regulatory services provided by ASRU.

If you have any feedback or requests on what would be helpful in this newsletter, please contact us via ASRUOperationalRelationshipManagement@homeoffice.gov.uk

Business Support

Fees

We would like to thank you for working with ASRU for payment of annual fees. Please don’t hesitate to contact us if you have any questions or require assistance.

Transfer window

We’ve recently received queries relating to the 2025 PIL transfer window. The transfer window will run from Monday 24 March – Friday 4 April 2025, during this period establishments can transfer PILs without being charged.

Please send your PIL transfer requests to ASRUBusiness@homeoffice.gov.uk.

Billing section

With the end of the financial year approaching, we would like to remind establishments to review and update the ‘Contact for billing information’ under the ‘Fees’ section in ASPeL. This information is vital to enable invoices to be raised each year. Without a confirmed billing address, email address and purchase order/alternate payment method, we cannot raise for invoice.

To aid both ASRU and establishments in this process, we introduced a reset function last year. ASPeL now automatically resets the following three fields ‘Do you have a purchase order number?’, ‘Other billing information (optional)’ and ‘I confirm these details are correct for the current billing period’ as well as a tick box prompt for ‘I confirm these details are correct for the current billing period’. These changes will help to ensure that the information provided by establishments is correct and up to date. The reset will take place annually on the 31 December each year.

Return of Procedures

We would like to thank everyone who has successfully submitted their ROPs on ASPeL.

The deadline for 2024 ROP submissions was Friday 31 January 2025. Please use the ‘Return of Procedures’ section on ASPeL to monitor and submit any outstanding returns.

We would like to remind you of the following to aid your submissions:

1. Please ensure you are fully submitting your return on ASPeL, including when initially submitting data or amending data later on. The final two sections both require you to ‘submit’ at the end of the ROP form.

2. Guidance on completing the ROP has been embedded within each section on ASPeL. If you require further information, a link to supplementary guidance is available Animal testing and research: annual returns and can also be found within the ROP form on ASPeL.

If there are any extenuating circumstances for the delay in submitting your 2024 return, please let us know as soon as possible at ROPReturns@homeoffice.gov.uk.

The 2025 ROP form is available on ASPeL and should be used for project licences which expired on or after 1 January 2025.

If you have any queries, please get in touch at ROPReturns@homeoffice.gov.uk.

Compliance

Standard Condition 18 (SC18) Notification

The processing of SC18 reports has been amended, please continue  to submit standard condition 18 reports where it is required. Please be reminded that you are required to notify the Home Office as soon as possible if constraints on the severity limits, or observance of other controls described in the licence, have been breached or, are likely to have been breached. Any additional information required to assist in processing this should be provided in a timely manner, and we will only be in touch if necessary. 

We also want to highlight the requirement to provide as much relevant information as possible to support the processing of reports. Requests for further information will cease with the expectation that establishments will provide sufficient information from the outset. Failure to do so may result in a decision being made based on the information provided or, we may request for a new SC18 report to be submitted with all the relevant information included.

Establishments who have not submitted any SC18 notifications within 6 months or more can expect to receive ASRU correspondence reminding them of their statutory obligations.

Licensing

Project licence amendments are currently being processed within 40 days. This service level will be reviewed later this year once recruitment has completed.

If you are submitting an urgent or very simple amendment, please email ASRULicensing@homeoffice.gov.uk This will enable us to process these more quickly where possible.

We are committed to delivering a quality service and sharing best practice to ensure your queries are resolved in a timely manner. To prevent delays we wanted to highlight a few  things you can adopt to help us make the application processes more efficient for you:

• Verify that the applicant’s training record is accurate and complete in ASPEL. Although this is a mandatory requirement before submitting an application, over 50% of applications lack this information.
• Please double check that you have not included information that could identify the applicant or the establishment in your Non-technical summaries. Failure to do this will result in applications being returned. Your AWERB reviewing process can support in ensuring this does not occur.

• Each question in the application process is crafted to direct you to the specific information required. Please take the time to read each question carefully. Avoid including unrequested information or repeating answers from other sections. Although copying and pasting answers may seem faster initially, it can significantly delay the assessment process and often necessitates revisions to the application. Brief answers are acceptable. As long as all questions are answered thoroughly, this will provide us with the necessary information, expedite the assessment process, and save you time.

• Using the standard protocol wording for Breeding and Maintenance of GA rodents and zebrafish can help expedite the application assessment process. The standard wording is recommended, unless there is a scientifically robust reason to deviate, as deviations can slow down the process. If a protocol step has an associated adverse effect, then it should have an associated Humane end point (and vice versa).

• Humane End Points (HEPs) should be clear, specific, and include a defined time limit. The actions to be taken should be easily understood without needing to refer to other sections within the application. To ensure efficiency and thoroughness, avoid copying and pasting HEPs across multiple steps unless they are relevant and detailed. This approach helps ensure that adverse effects and HEPs receive the attention they deserve, reducing the likelihood of the application being returned.

• If you intend to use a scoresheet in your protocol it can be helpful to provide it to ASRUlicensing@homeoffice.gov.uk. so that the inspector assessing your application has all the information at hand.

• Procedure Establishment Licence holder (PELh) transfers require an interview with an inspector, it is recommended that applications are submitted to ASRU as early as possible to reduce the risk of delays in licensing decision and provision of licence authorities. Applications should be submitted at least two months before authority is required.

• When submitting amendments, please consider providing supporting evidence such as:

  • Photographs of newly refurbished rooms to demonstrate compliance with the Code of Practice (COP).
  • Statements from the Named Veterinary Surgeon (NVS) confirming that the room meets the required standards.
• This will facilitate the completion of due diligence checks before applications can be accepted. This evidence should be sent to ASRUlicensing@homeoffice.gov.uk advising the team that it is for a recently submitted PEL amendment.

Keep Alive Request/Request to remain in breach temporarily

Keep Alive requests are now termed “Requests to remain in breach temporarily”.

Although the terminology has changed to align to ASPA, the process for requesting these remains the same, via the SC18 notification. When we receive requests to keep animals alive, we will assume you are obtaining ASRU ‘authorisation’ to remain in breach temporarily. The 14-day period is for ASRU to decide whether the benefits justify the newly notified severity of harm, if the harm is minor, transient and likely to resolve within 14 days, and if not, whether the licence needs to be amended, or the animals killed (refer to ASPA Guidance s5.12.4).

Animals in Science Procedures e-Licensing (ASPeL) Updates

Over the last 3 months with thanks to your participation in our user research, we have implemented:

• improvements to the PIL E process, which included functionalities for creating detailed course purpose for both Training and Higher Education, mandatory fields, hint texts, a word count limit on free text fields, and ensuring that course purpose displays in the PIL-E personal licence screen
• fixes to all outstanding reported issues with the Return of Procedures (RoPs) procedure process. We have:
  • ensured that when endangered species have been selected on the form, this information cannot be changed later
  • simplified the Return of Procedures procedure response to ‘Yes’ or ‘No’, for the  question regarding endangered species
• Updated the NTS download option to ensure other species details appear in the species list

Publications

We are excited to announce that we are in the process of enhancing the navigation and information-finding experience on our gov.uk web pages. The first improvements have been rolled out and are aimed at helping you get to the information you need more quickly.

We’ve been reviewing key guidance pages and using user insight to:

• rewrite page titles and page summaries so that they’re clearer and more descriptive
• add introductions for context and to tell you what the page is for
• reorder information in a more logical way and adding simple, meaningful headings to help you scan pages to find the specific information you need to know
• add context to links so that you know what they’re for
• review language to make sure it’s as clear as possible
• withdraw old information so it’s not getting in the way of what you’re trying to find
• improve the accessibility and findability of information in PDF guidance publications by converting them to HTML (web page format).

We’d really appreciate your feedback on these improvements, including future improvements you’d like to see. Please send your feedback to ASRUOperationalRelationshipManagement@homeoffice.gov.uk

Recently published documents

• Guidance to nominate someone for a Named Animal Care and Welfare Officer (NACWO)
• Guidance to nominate someone for a Named Veterinary Surgeon (NVS)
• ASRU 2023 annual report

Stakeholder Engagement

Stakeholder meetings

On Monday 10 February ASRU met with the Home Office Liaison Training Information Forum (HOLTIF). The agenda included operational updates from ASRU, followed by a question-and-answer session.

On Monday 24 February ASRU met with the Establishment Licence Holder (PELh) Committee. The agenda included regulatory updates, ASRUs new operating model, delivery timelines and a question-and-answer session.

External stakeholder news

The Establishment Licence Holders (PELh) Committee and the Home Office Liaison, Training and Information Forum (HOLTIF) are sections of the Laboratory Animals Science Association (LASA), set up to provide representation between the Home Office, and licensed named people under the Animal (Scientific Procedures) Act 1986.

ASRU meets quarterly with the PELh Committee and HOLTIF to give regulatory updates and answer questions from the sector. If you would like to know more about joining either the PELh Committee or HOLTIF please contact ASRUOperationalRelationshipManagement@homeoffice.gov.uk

Upcoming HOLTIF meetings:

Monday 9 June, 14:00 – 16:30

Tuesday 11 November, 14:00 – 16:30

Upcoming PEL Holder Committee meetings:

Monday 16 June, 11:00 – 13:00

Monday 3 November, 11:00 – 13:00

PEL Holder Training

The PELh Autumn Forum will be held on Tuesday 21 October, at Francis Crick Institute, Midland Road, London. The workshop will provide an in-depth discussion on the challenges and future directions in replacement methodologies under the Animal (Scientific Procedures) Act 1986, as regulated by ASRU.

The training session is for new PELh, NPRCs, and prospective PELhs. Please visit the Laboratory Animal Science Association (LASA) for more information and to register for the event.

The 2025 Establishment Licence Holders’ Induction will be held on Tuesday 18 November 2024.

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.

If you are interested in finding out more, please contact the LASA at info@lasa.co.uk.

Regards,
Animals in Science Regulation Unit