2.—(1) The Bluetongue Regulations (Northern Ireland) 2008(1) are amended as follows.
(2) In regulation 2 (interpretation)—
(a)after the definition of “Divisional Veterinary Officer” insert—
““inactivated vaccines” means vaccines that are not live attenuated vaccines;”;
(b)after the definition of “keeper” insert—
““live attenuated vaccines” means vaccines which are produced by adapting bluetongue virus field isolates through serial passages in tissue culture or in embryonated hens’ eggs;”.
(3) For regulation 3 (exemptions) substitute—
“3. These Regulations do not apply to—
(a)anything a person is authorised to do by licence granted under the Specified Animal Pathogens Order (Northern Ireland) 2008(2);
(b)administration of a vaccine for research purposes in accordance with an animal test certificate granted under the Veterinary Medicines Regulations 2011(3).”.
(4) In regulation 10 (restrictions in protection and surveillance zones) after paragraph (1) insert—
“(1A) A surveillance zone demarcated by the Department shall not contain any animals that have been vaccinated with live attenuated vaccines within the last 12 months.”.
(5) For regulation 18 (obtaining vaccine) substitute—
“18. No person other than the holder of a marketing authorisation, a manufacturing authorisation or a wholesale dealer’s authorisation granted by the Secretary of State under the Veterinary Medicines Regulations 2011 may obtain a vaccine except—
(a)a person obtaining such a vaccine following a decision of the Department under regulation 19A (decision to allow the use of such vaccines) within an area not subject to any bluetongue restrictions; or
(b)under the authority of a licence granted by the Department.”.
(6) For regulation 19 (prohibition on vaccination) substitute—
“19.—(1) Except where regulations 19A (decision to allow the use of vaccines) or 20 (compulsory vaccination) apply, a person shall not vaccinate an animal against bluetongue except under the authority of a licence granted by the Department.
(2) Any vaccination against bluetongue using live attenuated vaccines is prohibited in the surveillance zone.”.
(7) After regulation 19 (prohibition on vaccination) insert—
19A.—(1) The Department may decide to allow the use of inactivated or live attenuated vaccines against bluetongue provided that—
(a)such decision is based on the result of a specific risk assessment; and
(b)the EU Commission is informed of that decision before the vaccination is carried out.
(2) When live attenuated vaccines are used, the Department must declare—
(a)a protection zone consisting of at least the vaccination area; and
(b)a surveillance zone extending beyond the limit of the protection zone.”.