Question to the Home Office:

To ask the Secretary of State for the Home Department, whether a non-animal method that is scientifically satisfactory for a particular purpose but has not undergone formal (a) validation and (b) qualification must be used in place of a regulated procedure under section 2A(2)(a) of the Animals (Scientific Procedures) Act 1986.

Under section 2A of the Animals (Scientific Procedures) Act 1986 (“ASPA”), a regulated procedure must not be used where a scientifically satisfactory alternative method or testing strategy that does not entail the use of a protected animal is available for the intended purpose. Formal validation or qualification are not specified in section 2A as separate legal preconditions or thresholds.

Whether a method is scientifically satisfactory and applicable in the particular circumstances is assessed on the available scientific evidence. Validation or qualification may provide relevant evidence in making that assessment, including where results must meet wider regulatory requirements, but the absence of either does not, by itself, permit animal use where the non-animal method is otherwise scientifically satisfactory for the intended purpose.