Question to the Home Office:

To ask the Secretary of State for the Home Department, what criteria the Animals in Science Regulation Unit uses to determine that a non-animal method is not scientifically satisfactory before granting an animal project licence under ASPA 1986, particularly for acute toxicity endpoints where validated NAMs already exist; and whether those individual assessments can be made available to independent scientific scrutiny without violating Section 24.

The Government’s first responsibility is to protect public health. Animals continue to play an important role in research and safety testing where no scientifically satisfactory alternative exists, helping to ensure medicines and other products are safe. At the same time, the Government is determined to phase out the use of animals wherever scientifically possible.

Under the Animals (Scientific Procedures) Act 1986, a project licence cannot be granted where the scientific objective can be achieved using a scientifically satisfactory method or testing strategy that does not involve protected animals. This requirement supports both robust protection of human and animal health and the Government’s commitment to replace the use of animals wherever scientifically possible.

Applicants must demonstrate how they have considered replacement, reduction and refinement, including the non-animal methods and testing strategies available. The Animals in Science Regulation Unit (ASRU) assesses each application on its merits, considering whether an alternative is relevant to the substance, endpoint and route of exposure; falls within its validated applicability domain; is sufficiently reliable and reproducible; is accepted for the relevant scientific or regulatory purpose; and, alone or as part of an integrated testing strategy, can provide the evidence needed to achieve the project’s objective. The existence of a validated new approach methodology does not necessarily mean that it is suitable for every acute toxicity question. However, where a scientifically satisfactory non-animal method or testing strategy can achieve the proposed purpose, animal use cannot be authorised.

The Home Office is committed to transparency and publishes information about licensed activity, including non-technical summaries of project licences. Information in individual licence applications and regulatory assessments may include material protected by section 24 of ASPA, including confidential commercial, safety or security information, and cannot be disclosed unless there is a lawful basis to do so. This does not prevent ASRU from drawing on appropriate independent scientific expertise in carrying out its statutory functions. Any wider external disclosure of an individual assessment would need to be considered case by case within the statutory framework, including whether information could lawfully be provided in an anonymised, aggregated or redacted form.