The TSE (England) Regulations 2002

Licensing for the use of specified risk material in production or research

57.—(1) The Secretary of State may licence the occupier of any premises to use the premises for—

(a) the use of specified risk material in relation to the production referred to in Article 2 of the Community TSE Regulation; or

(b) the use of specified risk material or other source of TSE infectivity in relation to keeping live animals used in or intended for research,

subject to such conditions as she believes are necessary to ensure the occupier of the premises is able to comply with the separation requirements of that Article which apply to the production or the keeping concerned.

(2) On an application made to her under this regulation for a licence the Secretary of State shall grant the licence if she is satisfied that—

(a) the occupier of the premises has in place facilities and procedures for tracing through the production or keeping to which the application relates to trace all specified risk material delivered to the premises sufficient to be able to show that—

(i) all specified risk material delivered to the premises is used for the purpose for which it was delivered or is disposed of in accordance with such conditions as she may specify in the licence; or

(ii) no product produced at the premises is used as, or in connection with or in the production of, any food or feedingstuff or any cosmetic, pharmaceutical or medical product; and

(b) the use of the specified risk material in the production or keeping concerned does not give rise to risk—

(i) to human health; or

(ii) with the exception of the health of the animals for whose keeping the licence is required, to animal health.

(3) The occupier of premises licensed under this regulation shall—

(a) ensure that the use of the premises for the licensed purpose is in accordance with—

(i) the conditions of the licence; and

(ii) the provisions of this Part of these Regulations and Schedule 5 below relating to that use; and

(b) ensure that any person employed by him, and any person invited to the premises, complies with these conditions.

(4) The occupier of any premises licensed under this regulation shall permit an inspector, or a person acting under the responsibility of an inspector, to—

(a) inspect any carcase, part carcase, blood or specified risk material on the premises to enable the inspector to check whether the requirements the observance of which member States are required to ensure under Part A of Annex XI to the Community TSE Regulation which apply to the premises are complied with there; and

(b) inspect any part of the premises, any facility or any operation at the premises in connection with the removal, collection, transport, disposal or destruction of specified risk material to enable the inspector to check whether the requirements the observance of which member States are required to ensure under Part A of Annex XI to the Community TSE Regulation which apply to the operation are complied with there,

and shall give to an inspector, or any person acting under the responsibility of the inspector, such reasonable assistance as he may require.

(5) No person shall carry out any operation in relation to specified risk material at premises licensed under this regulation except in accordance with any conditions specified in the licence and with the provisions of this Part of these Regulations and Schedule 5 below relating to that operation.