1. What is changing?
The Home Office Animals in Science Regulation Unit is changing the way that it is structured and operates as a regulator, to provide greater consistency, clarity and a more structured approach to inspections via a new audit system.
In practice this means that there will be new ways of communicating with ASRU, removing the dependence upon one-to-one communication with local inspectors in favour of dedicated teams for different regulatory activities.
2. When will the changes come into effect?
The changes take effect from 5th July 2021. Any currently planned Inspector visits after that date are likely to be cancelled, unless these related to a specific ongoing matter.
These changes form part of a transitionary period for ASRU, so it is important to provide regular feedback on how they are working in your establishments.
3. Will there be changes to The Animals (Scientific Procedures) Act 1986?
No changes to the primary legislation governing animal research are expected. However, there will be updates made to key guidance documents, including the Guidance on the Operation of the Animals (Scientific Procedures) Act 1986 and the Code of Practice for the Housing and Care of Animals Bred, Supplied or Used for Scientific Purposes.
4. How will the new audits differ from previous inspections?
Routine inspections by the Animals in Science Regulation Unit are no longer going to be conducted by a local Inspector. Instead, there will be three different types of formal audit carried out by dedicated members of the new Compliance Assurance team:
- Facility audits – Focusing on ensuring facilities meet Code of Practice and other required standards.
- Systems audits – Focusing on governance systems.
- Thematic audits – Quarterly, focusing on areas of high risk across the regulated community and primarily by remote surveys.
It is expected that more than one member of the Compliance Assurance team will attend each audit, to ensure objectivity. Each audit will provide a clear outcome and contribute to the establishment’s overall risk profile.
5. How will this impact on how we communicate with the Home Office?
You will no longer direct queries to a single allocated Inspector or Single Point of Contact (SPoC). There will be dedicated teams for Regulatory Advice, Compliance Assurance and Licensing. All queries will be sent to dedicated inboxes for each team and will receive centralised, consistent responses. Urgent matters should be marked as such and will be triaged by dedicated staff.
Need help with these changes or more information?
Get in touch with Agenda today, we can help you prepare your facility for these changes.