The Foot-and-Mouth Disease (Control of Vaccination) (Wales) Regulations 2006

Made: 31 January 2006

Coming into force: 1 February 2006

The National Assembly for Wales, being designated for the purposes of section 2(2) of the European Communities Act 1972 in relation to the common agricultural policy of the European Community , exercising the powers conferred upon it by that section hereby makes the following Regulations:

PART 1 — Introduction

Title, application and commencement

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• (1) The title of these Regulations is the Foot-and-Mouth Disease (Control of Vaccination) (Wales) Regulations 2006.

• (2) They apply in relation to Wales and come into force on 1 February 2006.

Interpretation

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• (1) In these Regulations—

• “the Act” means the Animal Health Act 1981 ;

• “animal product” means anything originating or made (whether in whole or in part) from an animal or from a carcase;

• “border inspection post” means a place specified as a border inspection post in Schedule 2 to the Animal and Animal Products (Import and Export) (Wales) Regulations 2005 ;

• “bovine animal” includes buffalo and bison;

• “carcase” means the carcase of an animal and includes part of a carcase, and the meat, bones, hide, skin, hooves, offal or other part of an animal, separately or otherwise, or any portion thereof;

• “disease” means foot-and-mouth disease;

• “fresh meat” means meat (including offal and any meat preparation) that has not undergone any preserving process other than chilling, freezing or quick-freezing, including meat that is vacuum wrapped or wrapped in a controlled atmosphere;

• “health marked” (“yn dwyn marc iechyd”) means bearing the health mark as defined in Article 3(51) of Regulation (EU) 2017/625 of the European Parliament and of the Council on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products;

• “identification marked” means bearing the identification mark required by article 5(1) of Regulation (EC) No. 853/2004 of the European Parliament and the Council laying down specific hygiene rules for food of animal original ;

• “infected premises” means any premises declared to be infected premises under the Order;

• “keeper” means any person responsible for animals, whether on a permanent or temporary basis, but does not include a person who is responsible for animals solely because he or she is transporting them;

• “inspector” means an inspector appointed under the Act;

• “local authority” has the meaning assigned to that term by section 50(1) of the Act;

• “meat preparation” means fresh meat, including meat that has been reduced to fragments, which has had foodstuffs, seasonings or additives added to it or which has undergone processes insufficient to modify the internal muscle fibre structure of the meat and thus to eliminate the characteristics of fresh meat;

• “mechanically separated meat” means the product obtained by removing meat from flesh-bearing bones after boning, using mechanical means resulting in the loss or modification of the muscle fibre structure;

• “milk” includes cream, separated milk, skimmed milk and buttermilk;

• “milk product” includes butter, cheese, whey, yoghurt and any other product the main constituent of which is milk;

• “minced meat” means boned meat that has been minced into fragments and contains less than 1% salt;

• “National Assembly” means the National Assembly for Wales;

• “occupier” means, in relation to any premises, the person in charge of those premises;

• “the Order” means the Foot-and-Mouth Disease (Wales) Order 2006 ;

• “overstamped” means, in relation to a health marked or identification marked item bearing an additional diagonal cross consisting of two straight lines intersecting at the centre of the health or identification mark and allowing the information there to remain legible (irrespective of whether that additional cross is applied by the same stamp as the mark);

• “phase 1” means, in respect of a vaccination zone, the period of time commencing with declaration of that vaccination zone and ending with a declaration under regulation 16(2);

• “phase 2” means, in respect of a vaccination zone, the period of time commencing with the end of phase 1 and ending with a declaration under regulation 16(3);

• “phase 3” means, in respect of a vaccination zone, the period of time commencing with the end of phase 2 and ending with a declaration under regulation 16(5);

• “premises” includes any land, building or other place;

• “protection zone” means a protection zone declared under the Order;

• “protective vaccination” means vaccination carried out to protect susceptible animals against airborne spread or spread through fomites of the disease virus and where the vaccinated animals are not intended to be slaughtered to prevent the spread of disease;

• “public highway” means a highway maintainable at the public expense;

• “reactor premises” means premises declared to be reactor premises under regulation 25(1)(b)(ii);

• “sell” means sell to the final consumer or user;

• “slaughterhouse” has the meaning given to that term in regulation 5(6) of the Food Hygiene (Wales) Regulations 2006 ;

• “slaughter” means any process which causes the death of an animal;

• “suppressive vaccination” means vaccination carried out on premises or in an area where there is an urgent need to prevent the spread of disease outside the premises or area by reducing the quantity of circulating disease virus there and where the vaccinated animals are intended for slaughter to prevent the spread of disease;

• “surveillance zone” means a surveillance zone declared under the Order;

• “susceptible animal” means a cow, bull, sheep, goat, deer, camel, llama, alpaca, guanaco, vicuna, any other ruminant, any swine (that is, a member of the suborder Suina of the order Artiodactyla), elephant or rodent (other than a pet rodent);

• “temporary control zone” means a temporary control zone declared under the Order;

• “vaccinate” means treat a susceptible animal with hyperimmune serum or vaccine against disease;

• “vaccination surveillance zone” means a vaccination surveillance zone declared under regulation 13;

• “vaccination zone” means a vaccination zone declared under regulation 13;

• “vehicle” includes—a trailer, semi-trailer or other thing which is designed or adapted to be towed by another vehicle;a detachable part of a vehicle;a container or other structure designed or adapted to be carried by or on a vehicle;

• “veterinary inspector” means a veterinary inspector appointed under the Act.

• (2) In these Regulations “specified for vaccination” means specified as an animal to be vaccinated in a decision to undertake a vaccination programme made in accordance with regulation 9(2).

• (3) References in these Regulations to “animals originating in” a vaccination zone mean—

• (a) animals kept in the vaccination zone, and

• (b) animals which were kept within the boundaries of the vaccination zone at any time during the period—

• (i) beginning 21 days before the declaration of the vaccination zone, and

• (ii) ending with that declaration.

Premises comprising common or unenclosed land

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In these Regulations—

• (a) common or unenclosed land forms separate premises from other land unless—

• (i) the parcels of land adjoin, and

• (ii) all animals kept on each parcel of land are in the charge of the same keeper;

• (b) a notice which is to be served on the occupier of premises wholly or partially comprising any common or unenclosed land is validly served if served on every keeper of animals kept there (so far as those persons are reasonably ascertainable);

• (c) a requirement or restriction imposed on the occupier of premises wholly or partially comprising any common or unenclosed land applies to every keeper of animals kept there.

Licences and declarations

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• (1) Licences granted under these Regulations—

• (a) must be in writing,

• (b) may, in addition to any conditions required by these Regulations, be made subject to such conditions as the National Assembly considers necessary to prevent the spread of disease, and

• (c) may be amended, suspended or revoked in writing at any time.

• (2) Except where otherwise directed by the National Assembly, a licence granted in England or Scotland for the same purpose as a licence which may be granted under these Regulations is valid for that purpose in Wales and its conditions apply in Wales as if it was a licence granted under these Regulations.

• (3) Declarations under these Regulations must be in writing and any amendment or revocation of a declaration must be made by further declaration.

Notices

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• (1) Notices issued under these Regulations—

• (a) must be in writing; and

• (b) may be amended or revoked in writing at any time.

• (2) Notices whose service on the occupier of any premises results in any requirement or restriction in relation to those premises must contain a description of those premises sufficient to ascertain their extent.

• (3) Such a description may be amended by a veterinary inspector if he or she is satisfied that it does not describe a single epidemiological unit in respect of disease.

Dissemination of information concerning restrictions and requirements

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The National Assembly must take such steps as it considers necessary to ensure that licences, declarations and notices are brought to the attention of those who may be affected by them and in particular must ensure that the extent of any zone declared under these Regulations, the nature of the restrictions and requirements applicable within it and the dates of its declaration and withdrawal are publicised.

Disinfection

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Disinfection under these Regulations must be carried out with a disinfectant which is —

• (a) approved for use for the purpose of Foot-and-Mouth Disease Orders by the Diseases of Animals (Approved Disinfectants) Order 1978 ,

• (b) used at the concentration specified in that Order, and

• (c) used in accordance with the manufacturer's instructions or recommendations (if any) and in particular, if use is recommended before any date, used before that date.

PART 2 — The vaccination programme

Prohibition on vaccination except under licence

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• (1) No person is permitted to vaccinate an animal except under the authority of a licence granted by the National Assembly permitting suppressive or protective vaccination.

• (2) The prohibition in this regulation does not apply to—

• (a) anything done under the authority of a licence granted under article 4 of the Specified Animal Pathogens Order 1998 ; or

• (b) administration of a vaccine in accordance with an animal test certificate granted under regulation 8 of the Veterinary Medicines Regulations 2005 .

Factors informing a decision to permit suppressive or protective vaccination

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• (1) The National Assembly must take into account the following factors in deciding whether to permit suppressive or protective vaccination—

• (a) the risk of an outbreak—

• (i) in the United Kingdom becoming widespread in any part of the country,

• (ii) spreading to Wales with imported susceptible animals, carcases or other things liable to spread disease,

• (iii) spreading from Wales with exported susceptible animals, carcases or other things liable to spread disease, or

• (iv) spreading to or from Wales because of the prevailing meteorological conditions;

• (b) any threat from disease to animals in—

• (i) a laboratory, zoo, wildlife park or other premises where susceptible animals are kept principally for the purposes of display and education of the public, or an enclosed area principally used for shooting;

• (ii) premises not falling within (i) of a body, institute or centre which—

• (aa) keeps susceptible animals only for the purposes of conservation, display and education of the public, or scientific research or breeding of such animals for research, and

• (bb) is approved in relation to those animals under regulation 9 of the Animal and Animal Products (Import and Export) (Wales) Regulations 2005;

• (iii) other premises where susceptible animals are kept for scientific purposes or purposes related to conservation of species or farm animal genetic resources;

• (c) the criteria in Annex X of Council Directive 2003/85/EC on Community measures for the control of foot-and-mouth disease repealing Directive 85/511/EEC and Decisions 89/531/EEC and 91/665/EEC and amending Directive 92/46/EEC ;

• (d) other means of preventing the spread of disease available to it;

• (e) in the case of suppressive vaccination, whether such vaccination is necessary urgently to prevent the spread of disease from premises or a geographical area by reducing the quantity of circulating disease virus there; and

• (f) in the case of protective vaccination—

• (i) whether such vaccination will protect susceptible animals in the proposed vaccination zone against airborne spread or spread through fomites of the disease virus, and

• (ii) the effect of the measures which would apply in the vaccination zone and vaccination surveillance zone on persons and animals there.

• (2) Where, having taken those factors into account, the National Assembly considers that permitting suppressive or protective vaccination is the most appropriate means of preventing the spread of disease, it must decide to undertake a vaccination programme.

• (3) If the National Assembly decides to undertake a vaccination programme it will grant one or more licences permitting suppressive or protective vaccination.

• (4) For the purposes of paragraph (1)(c), point 3.2 of Annex X of Council Directive 2003/85/EC is to be read as if—

• (a) the reference to “Member States” were a reference to “the Welsh Ministers”;

• (b) Article 2(u) of Directive 2001/89/EC as it applies to point 3.2 were modified so that—

• (i) for the words “region, as defined in Article 2(2)(p) of Council Directive 64/432/EEC”, there were substituted “county or county borough in Wales”;

• (ii) for “such a region” there were substituted “such a county or county borough

Form of the decision to undertake a vaccination programme

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• (1) The decision to undertake a vaccination programme must be stated in writing.

• (2) The decision must contain the following information about the vaccination programme—

• (a) whether it is a programme of suppressive or of protective vaccination;

• (b) the place or geographical area where it is to be undertaken;

• (c) specification of the animals to be vaccinated (including their species and age);

• (d) the intended duration of the programme;

• (e) notice of the prohibition on movement of animals and animal products in regulation 12(2);

• (f) the form of the eartag to be affixed and vaccination records to be made under regulation 19;

• (g) such other information (if any) as the National Assembly considers necessary to inform those who may be affected by the vaccination programme.

• (3) Any decision of the National Assembly which results in a change to the information in sub-paragraph (2) must also be stated in writing.

• (4) The National Assembly must take such steps as it considers necessary to bring any decision required to be in writing by this regulation to the attention of those who may be affected by it.

Licences permitting suppressive or protective vaccination

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• (1) No licence permitting suppressive vaccination is to authorise vaccination outside a protection zone.

• (2) No licence permitting protective vaccination is to authorise vaccination in a vaccination surveillance zone.

• (3) A licence permitting suppressive or protective vaccination is not to be interpreted as having the effect of requiring any person to vaccinate any animal.

Facilitation of vaccination

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• (1) The keeper of any animal specified in a decision to undertake a vaccination programme must, where required by an inspector or a person acting at his or her direction—

• (a) state (if required, in writing) the species, ages, and numbers of the animals for which he or she is responsible; and

• (b) submit any such animal for vaccination at such time and in such place as required.

• (2) No person is permitted to move the following from any premises where any animal specified in a decision to undertake a vaccination programme is kept before all such animals have been vaccinated except under the authority of a licence granted by the National Assembly—

• (a) any animal, or

• (b) any animal product produced on the premises from a susceptible animal.