The TSE (Wales) Regulations 2002

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

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 any conditions he or she believes 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 the Secretary of State under this regulation for a licence the Secretary of State shall grant the licence if he or 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 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 the conditions that may be specified 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 feeding stuff 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 must—

(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 6 to these Regulations relating to that use; and

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

(4) The occupier of any premises licensed under this regulation must 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 must give to an inspector, or any person acting under the responsibility of the inspector, all reasonable assistance that he or she may require.

(5) No person may 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 6 relating to that operation.