The Aquatic Animal Health (England and Wales) Regulations 2009

Made: 3rd March 2009

Laid before Parliament: 5th March 2009

Laid before the National Assembly for Wales: 5th March 2009

Coming into force in accordance with regulation 1

The Secretary of State and the Welsh Ministers are each 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.

These Regulations make provision for purposes mentioned in that section and it appears to the Secretary of State and the Welsh Ministers that it is expedient for any reference to the following Community instruments to be construed as a reference to those instruments as amended from time to time:

(a) Commission Decision 2004/453/EC on implementing Council Directive 91/67/EEC as regards measures against certain diseases in aquaculture animals;

(b) Council Directive 2006/88/EC on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals; and

(c) Commission Regulation (EC) No.1251/2008 on implementing Council Directive 2006/88/EC as regards conditions and certification requirements for the placing on the market and the import into the Community of aquaculture animals and products thereof and laying down a list of vector species.

The Secretary of State in relation to England and the Welsh Ministers in relation to Wales make these Regulations under the powers conferred by section 2(2) of, as read with paragraph 1A of Schedule 2 to, the European Communities Act 1972.

PART 1 — General

Title and commencement

1

• (1) These Regulations may be cited as the Aquatic Animal Health (England and Wales) Regulations 2009.

• (2) These Regulations come into force—

• (a) for the purposes of regulation 5(1), on 1st May 2009;

• (b) for the purposes of regulation 12(1), on 1st August 2009;

• (c) for all other purposes, on 27th March 2009.

Extent and application

2

• (1) These Regulations extend to England and Wales.

• (2) These Regulations do not apply to—

• (a) any ornamental aquatic animal reared in a non-commercial aquarium;

• (b) any aquatic animal caught for the purpose of production of fishmeal, fish feed, fish oil or any similar product;

• (c) any wild aquatic animal harvested or caught for direct entry into the food chain other than one which is to be treated as an aquaculture animal under regulation 18(3).

Interpretation

3

• (1) In these Regulations—

• “Commission Decision 2009/177/EC” means Commission Decision 2009/177/EC implementing Council Directive 2006/88/EC as regards surveillance and eradication programmes and disease-free status of Member States, zones and compartments;

• “the competent authority” has the meaning given in regulation 3A;

• “Decision 2015/1554” means Commission Implementing Decision (EU) 2015/1554 laying down rules for the application of Directive 2006/88/EC as regards requirements for surveillance and diagnostic methods;

• ...

• “Directive 2006/88/EC” means Council Directive 2006/88/EC on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals;

• “England” includes the sea adjacent to England to a distance of 12 nautical miles from the baselines from which the breadth of the territorial sea is measured;

• “inspector” means any person authorised by the competent authority to be an inspector for the purposes of these Regulations;

• “listed disease” means—a disease listed in the second column of Annex 1A to Regulation (EC) No 1251/2008; ora disease listed in ...Schedule 1 to these Regulations;

• “non-commercial installation” means any aquaculture production business in which aquatic animals are kept with no intention of placing them on the market;

• “operator”, in relation to an aquaculture production business, a specialist transport business, processing establishment, non-commercial installation or put and take fishery, means any person who is responsible for the management of that business, establishment, installation or fishery;

• “processing establishment” means any food business which is approved for processing aquaculture animals for food purposes in accordance with Article 4 of Regulation (EC) No. 853/2004 laying down specific hygiene rules for food of animal origin, and which processes aquaculture animals under Part 4 of these Regulations or any provision in any Regulations made in relation to Scotland or Northern Ireland which has equivalent effect to that Part;

• “Regulation (EC) No.1251/2008” means Commission Regulation (EC) No.1251/2008 on implementing Directive 2006/88/EC as regards conditions and certification requirements for the placing on the market and the import into the Community of aquaculture animals and products thereof and laying down a list of vector species;

• “specialist transport business” means a business or undertaking which wholly or mainly transports live aquaculture animals in a mode of transport specially designed or adapted for that purpose; and

• “Wales” has the meaning given in section 158 of the Government of Wales Act 2006.

• (2) Any expression used in these Regulations which is also used in Directive 2006/88/EC (except for the definitions of “operator” and “processing establishment” in paragraph (1) and “wild aquatic animal” in regulation 18(5)) has the meaning it bears in that Directive.

• (3) References to ...... and Regulation (EC) No.1251/2008 are references to that instrument as amended from time to time.

• (4) Schedule 1 (list of diseases) has effect.

PART 2 — Authorisation and registration requirements

Application of Part 2

4

This Part does not apply where any ornamental aquatic animal is kept in any pet shop, garden centre, garden pond, commercial aquarium or with any wholesaler—

• (a) without any direct contact with natural waters; or

• (b) that is equipped with an effluent treatment system reducing the risk of transmitting diseases to such waters to an acceptable level;

unless the animal is kept by a person who has introduced it into England or Wales.

Authorisation

5

• (1) Subject to regulation 14, it is an offence to operate an aquaculture production business or a processing establishment unless the business or establishment is authorised by the competent authority.

• (2) The competent authority may grant an authorisation in relation to two or more aquaculture production businesses which are situated in one mollusc farming area, provided the businesses relate exclusively to molluscs.

• (3) But a dispatch centre, purification centre or similar business in a mollusc farming area must be separately authorised.

• (4) The requirement for a non-commercial installation or put and take fishery to be authorised under paragraph (1) only applies where the competent authority—

• (a) considers that authorisation is necessary to prevent or limit the spread of disease; and

• (b) serves the operator with a written notice to that effect.

• (5) Where the operator is served with a notice under paragraph (4)(b), the operator must apply for authorisation under regulation 8(1) within 28 days of the service.

• (6) Where the operator so applies, the operator is to be treated as having, as from the date of the application, an interim authorisation to carry on the activity to which the application relates until the interim authorisation lapses on the earliest of the dates mentioned in regulation 14(3).

Authorisation conditions for aquaculture production businesses

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• (1) The competent authority may grant an authorisation to an aquaculture production business, subject to such conditions as it considers appropriate, where it is satisfied that the operation of the business will not lead to an unacceptable risk of spreading disease.

• (2) It is a condition of an authorisation that the aquaculture production business must—

• (a) keep a record, in such form and manner as the competent authority may specify, of—

• (i) the movement of any aquaculture animal or any aquaculture animal product into or out of the premises of the business;

• (ii) the number of any aquaculture animals that have died in each epidemiological unit within the premises;

• (iii) the results of any surveillance carried out by the business; and

• (iv) the results of any surveillance carried out by the competent authority which have been notified to the business;

• (b) follow good hygiene practice; and

• (c) comply with any surveillance requirement imposed by the authority.

Authorisation conditions for processing establishments

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• (1) The competent authority may grant an authorisation to a processing establishment, subject to such conditions as it considers appropriate, where it is satisfied that the operation of the establishment will not lead to an unacceptable risk of spreading disease.

• (2) It is a condition of an authorisation that the processing establishment must—

• (a) keep a record, in such form and manner as the competent authority may specify, of the movement of any aquaculture animal or any aquaculture animal product into or out of the premises of the establishment; and

• (b) follow good hygiene practice.

Application for an authorisation

8

• (1) An application for an authorisation must be in such form and contain such information as the competent authority may reasonably require.

• (2) The competent authority must serve an applicant with a written notice of the result of the application within 90 days of receiving it.

• (3) Where the competent authority grants an authorisation, it must notify the applicant of the following—

• (a) the duration of the authorisation;

• (b) any condition to which it is subject; and

• (c) an authorisation number.

• (4) Where the competent authority refuses to grant an authorisation, or grants an authorisation subject to any condition, it must—

• (a) give reasons for the refusal or the imposition of the condition; and

• (b) inform the applicant of the right of appeal under regulation 37.

• (5) It is an offence for a person to make a statement in an application that is false and which that person knows or suspects is false.

Amendment of an authorisation

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• (1) The competent authority may amend an authorisation, including any condition to which it is subject.

• (2) The amendment may be made—

• (a) on the initiative of the competent authority; or

• (b) on application by an operator.

• (3) An application under paragraph (2)(b) must be in such form and contain such information as the competent authority may reasonably require.

• (4) The competent authority must serve a written notice on the operator which—

• (a) specifies the amendment or any decision not to make the amendment;

• (b) gives the reason for the amendment or any decision not to make it; and

• (c) informs the applicant of the right of appeal under regulation 37.

Suspension of an authorisation

10

• (1) The competent authority may suspend an authorisation by serving an operator with a written notice where it considers that an aquaculture production business, processing establishment, non-commercial installation or put and take fishery authorised under this Part has not complied with, is not complying with, or is not likely to comply with, a condition of its authorisation or a requirement in these Regulations.

• (2) The notice must—

• (a) give the date on which the suspension is to take effect and its duration;

• (b) give the reason for the suspension; and

• (c) inform the operator of the right of appeal under regulation 37.

Revocation of an authorisation

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• (1) The competent authority may revoke an authorisation by serving an operator with a written notice where it considers that an aquaculture production business, processing establishment, non-commercial installation or put and take fishery authorised under this Part has not complied with, is not complying with, or is not likely to comply with, a condition of its authorisation or a requirement in these Regulations.

• (2) The notice must—

• (a) give the date on which the revocation is to take effect;

• (b) give the reason for the revocation; and

• (c) inform the operator of the right of appeal under regulation 37.

Registration

12

• (1) It is an offence to operate a non-commercial installation, put and take fishery or specialist transport business unless it is registered by the competent authority.

• (2) An application for registration must be in such form and contain such information as the competent authority may reasonably require.

• (3) On receipt of the information, the competent authority must—

• (a) undertake the registration; and

• (b) serve the operator with a written notice of a registration number.

• (4) An operator must notify the competent authority in writing of any change in the information provided under paragraph (2) within 90 days of the change.

• (5) It is an offence to fail to comply with paragraph (4).

• (6) It is an offence for a person to provide information to the competent authority that is false and which that person knows or suspects is false.

• (7) This regulation does not apply where a non-commercial installation or put and take fishery is required to be authorised by virtue of regulation 5(1) and (4).

Public record of aquaculture production businesses and processing establishments

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• (1) The competent authority must establish and maintain a record of—

• (a) any aquaculture production business authorised under regulation 6; and

• (b) any processing establishment authorised under regulation 7.

• (2) The record must contain the information set out in Part I of Annex II to Directive 2006/88/EC for a business authorised under regulation 6.

• (3) The record must contain the information set out in Part II of that Annex for an establishment authorised under regulation 7.

• (4) The record must be publicly available for inspection free of charge at all reasonable times and at such place as determined by the competent authority.

• (5) The competent authority must make arrangements for the provision of a copy of an entry in the record on request.

• (6) Those arrangements may include payment of a reasonable fee by the person making the request.

• (7) The reference in paragraph (2) to Part 1 of Annex 2 to Directive 2006/88/EC is to be read in accordance with paragraph 2 of Schedule 1A to these Regulations.

• (8) The reference in paragraph (3) to Part 2 of Annex 2 to Directive 2006/88/EC is to be read in accordance with paragraph 3 of Schedule 1A to these Regulations.

Transitional provision

14

• (1) This regulation applies where—

• (a) a person operates an aquaculture production business or a processing establishment on 27th March 2009; and

• (b) makes an application for an authorisation under regulation 8 which has not been finally decided before 1st May 2009.

• (2) The operator is to be treated as having, as from 1st May 2009, an interim authorisation to carry on the activity to which the application relates until the interim authorisation lapses in accordance with paragraph (3).

• (3) It lapses on the earliest of the following dates—

• (a) when the application is withdrawn;

• (b) when the competent authority grants an authorisation under regulation 6 or 7;

• (c) where the competent authority refuses to grant an authorisation under regulation 6 or 7 and the applicant does not appeal, on the date on which the right of appeal lapses under regulation 37;

• (d) where the competent authority refuses to grant an authorisation under regulation 6 or 7 and the applicant does appeal, on the date on which the appeal is finally decided.

PART 3 — Placing on the market

Application of Part 3

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• (1) This Part does not apply to any person who—

• (a) places on the market any aquaculture animal or any aquaculture animal product for scientific purposes; and

• (b) has obtained the prior written consent of the competent authority.