S.I. No. 543/2012 - European Union (Protection of Animals used for Scientific Purposes) Regulations 2012

• (3) A member of the National Committee shall be appointed for such term (not exceeding five years) as shall be specified by the Minister when appointing him or her and on such terms and conditions as the Minister determines, and a member whose term of office expires by the effluxion of time shall be eligible for reappointment.

• (4) A member of the National Committee shall be paid such remuneration, if any, and such allowances for expenses, if any, as the Minister, with the consent of the Minister for Public, Expenditure and Reform, determines.

• (5) A member of the National Committee may resign from office by letter addressed to the Minister.

• (6) The Minister may at any time remove from office a member of the National Committee if he or she has committed stated misbehaviour or if his or her removal appears necessary for the effective performance by the National Committee of its functions.

• (7) Where a member of the National Committee is—

• (a) nominated as a member of Seanad Éireann,

• (b) elected as a member of either House of the Oireachtas or of the European Parliament,

• (c) regarded, pursuant to Part XIII of the Second Schedule to the European Parliament Elections Act 1997 , as having been elected to such parliament to fill a vacancy, or

• (d) elected or co-opted as a member of a local authority

he or she shall thereupon cease to be a member of the Committee.

• (8) A person who is for the time being entitled under the Standing Orders of either House of the Oireachtas to sit therein or is a member of the European Parliament or a local authority shall, while he or she is so entitled or is such a member, be disqualified from becoming a member of the National Committee.

Functions of National Committee

• (2) In carrying out its function, the National Committee shall consider the following issues, where appropriate:

• (a) animal care and welfare, and

• (b) the principles of replacement, reduction and refinement.

• (3) The National Committee shall exchange information on the operation of animal welfare bodies and project evaluation and share best practice with other national committees established pursuant to Article 49 of the Directive.

• (4) The National Committee shall be independent in the performance of its functions, and the committee and its members shall not be subject to the direction of any other person in the performance of their duties.

• (5) The National Committee shall, subject to these Regulations, regulate its own procedure and business.

• (6) The Minister may, from time to time, with the consent of the Minister for Public Expenditure and Reform, advance to the National Committee out of monies provided by the Oireachtas, such sums as the Minister may determine for the purposes of expenditure by the National Committee in the performances of its functions.

Meetings of National Committee

• (2) At a meeting of the National Committee—

• (a) the chairperson of the committee shall, if present, be the chairperson of the meeting, and

• (b) if and so long as the chairperson of the committee is not present or if the office of chairperson is vacant, the members of the committee who are present shall choose one of their number to be chairperson of the meeting.

• (3) The chairperson of the National Committee and each ordinary member of the committee present at a meeting thereof shall have a vote.

• (4) In the event of a vote being required on a question arising at a meeting of the National Committee such question shall be determined by a majority of the votes of the members present and voting on the question and, in the case of an equal division of votes, the chairperson of the meeting shall have a second or casting vote.

• (5) The National Committee may act notwithstanding one or more than one vacancy among its members, provided there is a quorum.

PART 10 RECORDS AND INFORMATION

Animal records

• (a) the number and the species of animals bred, acquired, supplied, used in procedures, set free or rehomed;

• (b) the origin of the animals, including whether they are bred for use in procedures;

• (c) the dates on which the animals are acquired, supplied, released or rehomed;

• (d) from whom the animals are acquired;

• (e) the name and address of the recipient of animals;

• (f) the number and species of animals which died or were killed in each establishment. For animals that have died, the cause of death shall, when known, be noted;

• (g) in the case of users, the projects in which animals are used; and

• (h) in the case of users, any deviations which negatively impact on animal health or welfare and which vary from the terms and conditions of a project authorisation.

• (2) The records referred to in paragraph (1) shall be kept for a minimum of 5 years and made available to the IMB upon request.

• (3) The records referred to in paragraph (1) shall be provided to the animal welfare body.

Information on dogs, cats and non-human primates

• (a) identity;

• (b) place and date of birth, when available;

• (c) whether it is bred for use in procedures; and

• (d) in the case of a non-human primate, whether it is the offspring of non-human primates that have been bred in captivity.

• (2) Breeders, suppliers and users shall keep, in respect of each dog, cat and non-human primate, an individual history file, which follows the animal as long as it is kept for the purposes of these Regulations.

• (3) Breeders, suppliers and users of dogs, cats and non-human primates shall establish the individual history file referred to in paragraph (2) at birth, or as soon as possible thereafter, and shall cover any relevant reproductive, veterinary and social information on the individual animal and the projects in which it has been used.

• (4) The information referred to in this Regulation shall be kept for a minimum of 3 years after the death or rehoming of the animal and shall be made available to the IMB upon request.

• (5) In the case of the rehoming of a dog, cat or non-human primate, the breeder, supplier or user shall ensure that relevant veterinary care and social information from the individual history file referred to in paragraph (2) shall accompany the animal.

Marking and identification of dogs, cats and non-human primates

• (2) Where a dog, cat or non-human primate is transferred from one breeder, supplier or user to another before it is weaned, and it is not practicable to mark it beforehand, a record, specifying in particular its mother, must be maintained by the receiver until it is marked.

• (3) Where an unmarked dog, cat or non-human primate, which is weaned, is received by a breeder, supplier or user, the receiver shall, as soon as possible and in the least painful manner possible, permanently mark the animal.

• (4) Breeders, suppliers and users shall provide, at the request of the IMB, the reasons why a dog, cat or non-human primate is not marked in accordance with this Regulation.

Information from breeders, suppliers and users

Information on implementation

Information on use of animals in procedures

• (a) the number and kinds of animals used in experiments,

• (b) the number of animals, in selected categories, used in the experiments referred to in Article 3 of Council Directive 86/609/EEC of 24 November 1986²² ,

• (c) the number of animals, in selected categories, used in experiments required by legislation.

• (2) The IMB shall submit the statistical information collected pursuant to paragraph (1) to the Commission by 10 November 2015 and every year thereafter using the common reporting format and detailed instructions set out in Annex II to Commission Implementing Decision 2012/707/EU of 14 November 20122.

• (3) Persons who carried out experiments in 2012 under a licence granted by the Minister for Health under s. 8 of the Cruelty to Animals Act 1876 (39 & 40 Vict., c. 7) shall submit the information referred to in paragraph (1)(a), (b) and (c) in respect of those experiments to the Department of Health on or before 31 March 2013.

Information on exemptions in relation to method of killing

Commercially sensitive information

PART 11 ENFORCEMENT, OFFENCES AND PENALTIES

Interpretation of Part 11

“authorised officer” means—

• (a) a person appointed under Regulation 72(1)(a),

• (b) a person who, immediately before the making of these Regulations, was an authorised officer within the meaning of the Cruelty to Animals Act 1876 (39 & 40 Vict., c.7), until such time as—

• (i) he or she ceases to be an employee of the Department of Agriculture, Food and the Marine, or

• (ii) the Minister, on the recommendation of the IMB, revokes the said appointment,

whichever is the earlier, or

• (c) an officer of Customs and Excise;

“inspect” includes search;

“record” includes, in addition to a record in writing—

• (a) a disc, tape, sound-track or other device in which information, sounds or signals are embodied so as to be capable, with or without the aid or some other instrument, of being reproduced in legible or audible form,

• (b) a film, tape or other device in which visual images are embodied so as to be capable, with or without the aid or some other instrument, of being reproduced in visual form, and

• (c) a photograph,

and any reference to a copy of a record includes—

• (a) in the case of a record to which paragraph (a) of this definition applies, a transcript of the sounds or signals embodied therein,

• (b) in the case of a record to which paragraph (b) of this definition applies, a still reproduction of the images embodied therein, and

• (c) in the case of a record to which paragraphs (a) and (b) of this definition apply, such a transcript together with such a still reproduction;

“relevant thing” means any article, substance, equipment, machinery or plant used in relation to an activity, and any carcass, animal product, animal by-product, or animal residue.

Authorised officers

• (a) may appoint such and so many persons as the IMB thinks fit to be authorised officers for the purposes of these Regulations, and

• (b) shall furnish each authorised officer appointed by it with a warrant of the authorised officer’s appointment.

• (2) An authorised officer, other than an authorised officer who is an officer of Customs and Excise, shall, when performing a function imposed under these Regulations on an authorised officer, produce his or her warrant for inspection if requested to do so by a person affected by the performance of that function.

• (3) For the purposes of enforcing compliance with these Regulations, including conducting inspections pursuant to Regulation 73, an authorised officer may—

• (a) subject to paragraph (5), enter, if necessary by the use of reasonable force, at all reasonable times, any establishment which he or she has reasonable grounds to believe that it is necessary to visit, including—

• (i) any establishment owned or managed by a breeder, supplier or user, or at which he, she or it carries out an activity, or any premises that is connected to the management, import or export of an animal or relevant thing,

• (ii) any establishment of any person who carries out any activity on behalf of, and pursuant to a contractual arrangement, with a breeder, supplier or user,

• (iii) where any facilities for an activity are in the establishment of any person or body other than a breeder, supplier or user, those facilities in that person’s establishment, and

• (iv) any establishment at which books, records or other documents, including financial documents and documents stored in non-legible form, relating to any activity are stored or kept,

• (v) any establishment at which activities requiring authorisation under these Regulations are to take place,

• (b) at such establishments inspect, and take copies of, any books, records, other documents, including documents stored in non-legible form, or extracts therefrom, which he or she finds in the course of his or her inspection,

• (c) remove any such books, records or other documents from such establishment and detain them for such period as he or she reasonably considers to be necessary for the purposes of his or her functions under these Regulations,

• (d) carry out, or have carried out, such tests, examinations, analyses, inspections and checks of—

• (i) an animal

• (ii) the establishment, or

• (iii) any relevant thing at the establishment,

as he or she reasonably considers to be necessary for the purposes of his or her functions under these Regulations,

• (e) require any person at the establishment or the owner or person in charge of the establishment, and any person employed there, to give to him or her such assistance and information and to produce to him or her such books, records or other documents (and in the case of documents stored in non-legible form, produce to him or her a legible reproduction thereof) that are in that person’s power or procurement, as he or she may reasonably require for the purposes of his or her functions under these Regulations, including information as to the ownership, identity and origin of an animal,

• (f) without payment, take samples of any animal or relevant thing found at the establishment for the purposes of any test, examination or analysis,

• (g) direct that such animal or relevant thing found at the establishment as he or she, upon reasonable grounds, believes does not comply with the requirements of these Regulations not be sold or distributed or moved from the establishment, without his or her consent,

• (h) secure for later inspection any establishment or part of any establishment in which an animal or relevant thing is found or ordinarily kept, or books, records or other documents are found or ordinarily kept, for such period as may reasonably be necessary for the purposes of his or her functions under these Regulations,

• (i) without payment, take possession of and remove from the establishment for any test, examination or analysis any animal or relevant thing found there, and detain it for such period as he or she considers reasonably necessary for the purposes of his or her functions under these Regulations,

• (j) without payment, take samples of any animal or relevant thing, detained pursuant to subparagraph (i), for the purposes of any test, examination, or analysis,

• (k) where the taking of samples of any animal or relevant thing pursuant to subparagraph (f) or (j) is, for whatever reason, not practicable, without payment take the animal or relevant thing concerned for the purposes of any test, examination or analysis,

• (l) stop any person, vehicle, vessel or container at the establishment,

• (m) board and search any such vehicle, vessel or container,

• (n) require the name and address of any person at the establishment, including the person to whom an animal or relevant thing is being delivered or who is causing it to be delivered,

• (o) make a record whether in writing, by photography or otherwise,

• (p) inspect and copy or extract information from any data within the meaning of the Data Protection Acts 1988 and 2003,

• (q) require a person, having authority to do so, to break open any container or package, or to permit him or her to do so, as he or she may reasonably require for the purposes of his or her functions under these Regulations, or

• (r) require a person, who makes available facilities such as post office boxes, telecommunications, electronic mail addresses, or electronic data storage, or other such like facilities, to give him or her such assistance and information as he or she may reasonably require for the purposes of his or her functions under these Regulations in any case where the officer has reasonable grounds for believing that an animal or any relevant thing is being supplied by mail.

• (4) When performing a function under these Regulations, an authorised officer may, subject to any warrant issued under paragraph (6), be accompanied by such number of—

• (a) other authorised officers,

• (b) members of the Garda Síochána, or

• (c) persons with expertise relating to any animal or relevant thing,

as he or she considers appropriate in the circumstances of the case.

• (5) An authorised officer shall not enter a dwelling, other than—

• (a) with the consent of the occupier, or

• (b) in accordance with a warrant issued under paragraph (6).

• (6) Upon the application of an authorised officer, a judge of the District Court, if satisfied that there are reasonable grounds for believing that—

• (a) an animal is to be found in any dwelling, or is being or has been subjected to any procedures or kept in any dwelling,

• (b) any relevant thing, books, records or other documents (including documents stored in non-legible form) referred to in paragraph (3)(a)(iv) are being stored or kept in any dwelling, any location, physical or virtual, connected to the dwelling or to persons occupying, associated with or using the dwelling, or

• (c) a dwelling is occupied in whole or in part by an undertaking carrying out an activity,

may issue a warrant authorising a named authorised officer, accompanied by such other authorised officers, members of the Garda Síochána, or persons with expertise relating to any animal or relevant thing as may be necessary, at any time or times, within one month of the date of issue of the warrant, to enter the dwelling and perform any of the functions of an authorised officer under paragraph (3)(b) to (r).

• (7) Where an authorised officer, upon reasonable grounds, believes that a person has committed an offence under these Regulations, he or she may require that person to provide him or her with his or her name, date of birth, and the address at which he or she ordinarily resides, and to produce corroborative evidence of same.

• (8) Where an authorised officer has reasonable cause to suspect that-

• (a) an offence is being or has been committed under these Regulations, or

• (b) evidence of an offence or contravention may be, is or has been on or in an establishment,

the authorised officer may, in addition to the powers exercisable by him or her under paragraph (3)—

• (i) search a person, where the authorised officer considers it necessary,

• (ii) seize and detain, an animal, vessel, vehicle, container or relevant thing, or

• (iii) dispose of, or require the owner or person in charge of or in possession of an animal, or relevant thing to deal with or dispose of it (or any other thing used in connection with, or that may have been in contact with, the animal, or relevant thing) in a manner that the authorised officer sees fit.

• (9) A statement or admission made by a person pursuant to a requirement under paragraph (3)(e) shall not be admissible as evidence in proceedings brought against that person for an offence (other than an offence under Regulation 84(2)(g)).

• (10) Nothing in this Regulation shall be taken to compel the production by any person of a document which he or she would be exempt from producing in proceedings in a court on the ground of legal professional privilege.

Inspections and requests for information

• (a) the breeders, suppliers and users comply with the requirements of these Regulations,

• (b) the establishments comply with the requirements of these Regulations,

• (c) the projects and procedures carried out at the establishment comply with the requirements of these Regulations,

• (d) documents or other records relating to the requirements of these Regulations are examined, and

• (e) problems relating to compliance with the requirements of these Regulations are identified.

• (2) The IMB shall adapt the frequency of inspections on the basis of a risk analysis for each establishment, taking account of:

• (a) the number and species of animals housed,

• (b) the record of the breeder, supplier or user in complying with the requirements of these Regulations,

• (c) the number and types of projects carried out by the user in question, and

• (d) any information that might indicate non-compliance.

• (3) The IMB shall carry out inspections on at least one third of the users operating in the State each year in accordance with the risk analysis referred to in paragraph (2).

• (4) The IMB shall inspect breeders, suppliers and users of non-human primates and their establishments at least once a year.

• (5) The IMB shall carry out an appropriate proportion of the inspections without prior warning.

• (6) The IMB shall keep records of all inspections for at least 5 years.

• (7) The IMB may conduct such additional inspections, which may be announced or unannounced, of the establishments of breeders, suppliers and users as it considers necessary for the purpose of ensuring compliance with the requirements of these Regulations.

• (8) A person shall not obstruct or interfere with the IMB carrying out inspections under this Regulation.

• (9) The IMB may serve a notice on a breeder, supplier or user, or any person connected with a breeder, supplier or user, requiring that he, she or it furnish the IMB with such information concerning compliance with these Regulations and within such period as shall be specified in the notice.

• (10) Any person who receives a request for information in accordance with paragraph (9) shall provide the information requested within the period specified in the notice.

• (11) In the event of actual or suspected non-compliance with these Regulations, the IMB shall take appropriate remedial action or require such action to be taken in accordance with these Regulations, as it shall consider appropriate.

• (12) Any reference to an inspection of an establishment which the IMB is required or empowered to conduct by virtue of this Regulation, shall be construed so as to include an inspection of any establishment within the State at which any of the activities are carried out, or suspected of being carried out, by any person on behalf of, and pursuant to a contractual arrangement with a breeder, supplier or user.

• (13) For the avoidance of doubt, it is hereby declared that the IMB’s functions under this Regulation in relation to an establishment are also applicable in the case of an establishment of a person seeking any authorisation under these Regulations.

• (14) The IMB, on receipt of a duly justified request from the competent authority in another EEA State, shall organise such inspection or other control measures as are reasonably required.

• (15) The IMB shall cooperate with the officials designated by the Commission to carry out controls under Article 35 of the Directive and shall give all the necessary assistance to enable them to accomplish their tasks.

• (16) The IMB shall permit the officials referred to in paragraph (15), and may permit officials from a competent authority in another EEA State, to accompany an authorised officer while carrying out inspections under these Regulations.

• (17) The IMB shall take measures to take account of the results of controls undertaken by the Commission under Article 35 of the Directive.

Compliance notice

• (a) a person has failed, in any material respect, to comply with the requirements of these Regulations, or

• (b) the information given by a person pursuant to Regulation 25(2), 36(2) or 53(2) was false or incomplete in any material respect,

and the IMB considers that the failure in question is not sufficiently serious to warrant suspension or revocation of the relevant authorisation granted under these Regulations, in the first instance, it may serve a notice on the person concerned in accordance with paragraph (2).

• (2) A notice served under this Regulation shall—

• (a) identify the requirements of these Regulations with which the person has failed to comply, or, in the case of false or incomplete information, the further information which is required,

• (b) identify the action which the person is required to take, and

• (c) give the timescale within which the person must take the action identified in subparagraph (b).

• (3) Where a person fails to comply with the requirements set out in a notice served under this Regulation within the specified timescale, the IMB may, by a further notice served on that person, suspend or revoke the authorisation concerned.

Suspension or revocation of authorisation

• (a) the failure of the holder of the authorisation to comply with the requirements of these Regulations;

• (b) the failure of the holder of the authorisation to carry out the authorised activities or role in accordance with the authorisation;

• (c) the information provided pursuant to Regulation 25(2), 36(2) or 53(2) was false or incomplete in any material respect;

• (d) the holder of the authorisation is not carrying out, or has indicated by a notice in writing that he, she or it no longer intends to carry out, the activities or role to which the authorisation relates;

• (e) the holder of the authorisation does not have the staff, establishment, equipment or facilities necessary for carrying out properly the activities or role to which the authorisation relates;

• (f) the failure to comply with a compliance notice.

• (2) Where the IMB proposes to suspend or revoke an authorisation under this Regulation, it shall serve a notice on the holder of the authorisation of the proposal and the reasons for same, and shall, if any representations are made by that person within 21 working days after the date of such notice, consider such representations.

• (3) Where the IMB, having considered the representations (if any) made in response to a notice under paragraph (2), decides to suspend or revoke an authorisation, it shall notify in writing the holder of the authorisation stating the reasons on which its decision is based.

• (4) A suspension of an authorisation under this Regulation shall be for such period as the IMB shall consider necessary having regard to the reasons for the suspension.

• (5) A suspension or revocation of an authorisation under this Regulation may be total, or may be limited to a particular activity or to one or more activities carried out at a particular establishment or establishments.

• (6) Where, after a suspension has taken effect, the IMB considers that the authorisation should be further suspended or revoked, the IMB shall proceed in accordance with the provisions of this Regulation.

• (7) Subject to Regulation 73(11), where an authorisation is suspended or revoked under this Regulation, the holder of the authorisation shall ensure that the welfare of the animals housed in his, her or its establishment is not adversely affected.

Animal welfare notice

• (a) an animal is being caused unnecessary pain, suffering or injury,

• (b) an animal is at risk of being caused unnecessary pain, suffering or injury,

• (c) there is a serious risk to the welfare of an animal, or

• (d) the conditions under which an animal is being bred or kept contravene these Regulations,

he or she may serve or cause to be served on the breeder, supplier or user, or other person responsible for the animal, a notice (“an animal welfare notice”) stating that opinion and directing that—

• (i) an ill or injured animal be cared for in an appropriate manner,

• (ii) veterinary or other specialist advice be obtained in respect of an ill or injured animal,

• (iii) an animal be supplied with feed appropriate to its age and species and in such quantity as will maintain it in good health,

• (iv) an animal be given access to such a supply of suitable liquid as will enable it to fulfil its fluid intake needs,

• (v) one or more animals be moved to and kept in such place as the officer specifies in the notice,

• (vi) one or more animals be re-homed, set free, killed or otherwise disposed of in such manner and at such place (if any) as the officer may specify in the notice,

• (vii) such alterations or additions be made to the establishment at which the animal is kept, or to any relevant thing or facilities found there, as the officer may specify in the notice,

• (viii) such alterations be made to the manner in which the animal is kept as the authorised officer may specify in the notice, or

• (ix) such other measures be taken as are necessary to ensure that the animal is kept in a manner that complies with these Regulations.

• (2) An animal welfare notice may specify one or more requirements or refer to one or more animals or species of animal.

• (3) A requirement contained in an animal welfare notice may specify a time limit within which it is to be complied with.

• (4) An animal welfare notice may require the person served with the notice to choose between two or more of the requirements specified in the notice.

• (5) A requirement specified in an animal welfare notice (in this Regulation referred to as “the earlier animal welfare notice”) may be modified or withdrawn in a further animal welfare notice and in that event the earlier animal welfare notice shall have effect subject to such modification or withdrawal.

• (6) A person, including a person served with an animal welfare notice, shall not deal with an animal to which the notice relates other than in accordance with the terms of the notice.

• (7) In the event of an appeal made pursuant to Regulation 78, a person, including the person appealing, shall not deal with an animal to which an animal welfare notice relates pending the determination of the appeal other than in accordance with such directions as shall be given in writing to the appellant by an authorised officer.

• (8) If the terms of an animal welfare notice are confirmed with or without modification on appeal under Regulation 78, a person including the person who made the appeal shall not deal with an animal to which the notice relates other than in accordance with the notice as confirmed.

• (9) Any costs pertaining to action required to comply with an animal welfare notice shall be borne by the person served with the notice.

Closure order

• (a) state that the authorised officer is of the opinion that the establishment or part thereof to which the order relates should be closed,

• (b) specify the matters which in his or her opinion give or, as the case may be, are likely to give rise to the said risk,

• (c) where in his or her opinion any of those matters involves or, as the case may be, will involve a contravention of these Regulations, state that he or she is of that opinion, specify the provision or provisions as to which he or she is of that opinion, and give particulars of the reasons why he or she is of that opinion, and

• (d) direct that the establishment be closed unless and until the matters specified in the order in pursuance of subparagraph (b) and any associated contravention of provisions so specified in pursuance of subparagraph (c) have been remedied.

• (2) A closure order shall take effect—

• (a) where the order so declares, immediately the closure order is received by the person served with the closure order, or

• (b) in any other case—

• (i) where no appeal is taken against the closure order, on the expiration of the period during which such an appeal may be taken or the day specified in the closure order as the day on which it is to come into effect, whichever is the later, or

• (ii) in case such an appeal is taken, on the day next following the day on which the closure order is confirmed on appeal or the appeal is withdrawn or the day specified in the closure order as that on which it is to come into effect, whichever is the later.

• (3) The chief executive of the IMB may, for stated reasons, revoke or vary a closure order made in accordance with this Regulation.

• (4) Where a closure order has been served and activities are carried on in contravention of the order, the High Court may, on the application of an authorised officer, by order prohibit the continuance of the activities and order the closure of the premises.

• (5) An application to the High Court for an order under this subsection shall be by motion and the court, when considering the matter, may make such interim or interlocutory order (if any) as it considers appropriate and the order by which an application under this paragraph is determined may contain such terms and conditions (if any) as to the payment of costs as the court considers appropriate.

• (6) Any costs pertaining to action required to comply with a closure order shall be borne by the person served with the notice.

Appeals

• (a) a compliance notice,

• (b) a suspension order,

• (c) a revocation order,

• (d) an animal welfare notice,

• (e) a closure order, or

• (f) a refusal to grant an authorisation under these Regulations,

may appeal the decision of the IMB to grant the notice or order, or refuse to grant the authorisation.

• (2) The IMB shall publish guidelines in relation to the procedure for appeals under paragraph (1) and shall inform any person who is the subject of a decision in relation to a matter referred to in paragraph (1) of his or her right to appeal.

Power to seize and dispose of an animal

• (a) a person fails to comply with the terms of a notice or order under these Regulations within the time limit specified therein,

• (b) an authorised officer has reasonable grounds for believing that the terms of a notice or order under these Regulations will not be complied with,

• (c) a notice or order under these Regulations has been confirmed with or without modification under Regulation 78 and the notice or order has not been complied with,

• (d) an authorised officer has reasonable grounds for believing that the terms of a notice or order under these Regulations which has been confirmed with or without modification under Regulation 78 will not be complied with, or

• (e) pending the determination of an appeal made under Regulation 78, an authorised officer has reasonable grounds for believing that—

• (i) a notice or order under these Regulations, or

• (ii) a direction given pursuant to Regulation 72,

has not been or will not be complied with, an authorised officer may at any time seize the animal at such establishment as he or she thinks fit.

• (2) An authorised officer may dispose of or kill a seized animal, or cause it to be disposed of or killed, in such manner and at such place as the authorised officer considers appropriate in the circumstances of the case.

• (3) Any profits arising out of the disposal of an animal under this Regulation shall be paid to the owner of the animal less any expenses incurred in connection with seizure, maintenance, disposal or destruction of the animal.

• (4) The costs (including ancillary costs) of seizure, maintenance, disposal or destruction of an animal under Regulation 72, this Regulation or Regulation 80 are, subject to paragraph (3), recoverable-

• (a) by deducting the costs from any sum that is or becomes payable by the IMB to the owner of the animal, or

• (b) as a simple contract debt in any court of competent jurisdiction from the person who was the owner of the animal at the time of seizure, disposal or destruction took place.

Emergency measures

• (a) is suffering a degree of pain, suffering or injury in breach of the relevant project authorisation, or

• (b) is seriously at risk of being subject to a degree of pain, suffering or injury in breach of the relevant project authorisation,

and that emergency measures should be taken immediately to relieve its pain or suffering or risk of pain or suffering or injury, he or she may seize, dispose of or destroy, or may arrange for the disposal or destruction of, the animal.

• (2) Notwithstanding Regulation 76(1), if an authorised officer is of the opinion that an animal has been abandoned by a breeder, supplier or user and that emergency measures should be taken immediately, he or she may seize, dispose of or destroy, or may arrange for the disposal or destruction of, the animal.

Fixed penalty notice

• (a) that the person is alleged to have committed the offence,

• (b) when and where the offence is alleged to have been committed,

• (c) that the person may during the period of 28 days from the date of the notice make to the IMB a payment of €250 accompanied by the notice, and

• (d) that a prosecution in respect of the alleged offence will not be instituted during the period specified in the notice and, if the payment specified in the notice is made during that period, no prosecution in respect of the alleged offence will be instituted.

• (2) If notice is given under paragraph (1)—

• (a) a person to whom the notice applies may, during the period specified in the notice, make to the IMB, at the address specified in the notice, the payment specified in the notice,

• (b) the IMB may receive the payment, issue a receipt for it and retain the money so paid, and any payment so received shall not be recoverable in any circumstances by the person who made it, and

• (c) a prosecution in respect of the alleged offence shall not be instituted in the period specified in the notice, and if the payment so specified is made during that period, no prosecution in respect of the alleged offence shall be instituted.

• (3) In a prosecution for an offence under these Regulations, the onus of proving that a payment pursuant to a notice under this Regulation has been made lies on the accused.

Taking of samples by authorised officers

• (a) divide the sample into 3 approximately equal parts,

• (b) place each part into separate containers, and

• (c) forthwith seal and mark each such container in such a manner as to identify it as part of the sample taken by that authorised officer.

• (2) Where an authorised officer has complied with paragraph (1), he or she shall—

• (a) offer one of the sealed containers to the owner or person for the time being in charge or possession of the animal or relevant thing from which the sample concerned was taken,

• (b) retain one of the sealed containers, and

(c)forward, or cause to be forwarded, one of the sealed containers for test, examination or analysis of the sample concerned by a person mentioned in Regulation 83.

• (3) Where an animal or relevant thing is contained in a container and its division into parts pursuant to paragraph (1) is, for whatever reason, not practicable, an authorised officer, who wishes to take samples of the animal or relevant thing for the purposes of any test, examination or analysis, shall take possession of 3 such containers belonging to the same batch, and each such container shall be deemed to be part of a sample for the purposes of paragraph (1), and the provisions of paragraphs (1) and (2) shall apply thereto accordingly.

• (4) Where an authorised officer takes an animal or relevant thing pursuant to Regulation 72(3)(i), he or she shall—

• (a) place the animal or relevant thing in a container,

• (b) forthwith seal and mark the container in such a manner as to identify it as an animal or relevant thing taken pursuant to that section, and

(c)forward, or cause to be forwarded, the sealed container for test, examination or analysis of the animal or relevant thing by a person mentioned in Regulation 83.

Certificate of result of test, examination or analysis of sample, etc

• (a) the State Chemist,

• (b) another chemist employed or engaged at the State Laboratory and authorised by the State Chemist to sign the certificate,

• (c) a chemist or analyst appointed by the IMB,

stating the result of any test, examination or analysis of a sample of any animal or relevant thing, as the case may be, forwarded under Regulation 82 shall, with regard to that sample of the animal or relevant thing, as the case may be, be evidence of the matters stated in the certificate unless the contrary is proved.

Offences

• (2) A person who—

• (a) in purported compliance with a request or requirement under these Regulations gives information to the IMB that he or she knows to be false or misleading in any material respect,

• (b) fails to comply with a notice or order under these Regulations, except where the operation of that notice or order has been suspended or has been withdrawn or revoked by the IMB,

• (c) knowingly supplies an animal which is not marked and identified in accordance with the requirements of Regulation 65,

• (d) discloses any confidential information to which he or she has access by virtue of these Regulations, otherwise than in accordance with these Regulations,

• (e) obstructs or interferes with the IMB, an authorised officer, a member of the Garda Síochána or a person with expertise relating to any animal or relevant thing, in the course of performing a function conferred on him or her by these Regulations or a warrant under Regulation 72(6),

• (f) impedes the performance by the officer, member of the Garda Síochána, or person with expertise, as the case may be, referred to in subparagraph (d), of such function or fails or refuses to comply with a request or requirement of, or to answer a question asked by, the officer, member, or person with expertise, as the case may be, pursuant to Regulation 72,

• (g) in purported compliance with a request or requirement referred to in subparagraph (e), or in answer to a question referred to in subparagraph (e), gives information to the officer, member, or person with expertise, as the case may be, that he or she knows to be false or misleading in any material respect,

• (h) falsely represents himself or herself to be an authorised officer,

• (i) forges, or utters knowing it to be forged, a certificate of analysis or other document purporting to be issued, granted or given under these Regulations or required for the purposes of these Regulations (in this Regulation referred to as “a forged document”),

• (j) alters with intent to defraud or deceive, or utters knowing it to be so altered, a certificate of analysis or other document issued, granted or given under these Regulations, or required for the purposes of these Regulations (in this Regulation referred to as “an altered document”),

• (k) without lawful authority, has in his or her possession a forged document or an altered document, knowing it to be a forged or altered document as the case may be,

• (l) with the intent to defraud or deceive, tampers with any substance or thing with the result that a sample taken pursuant to these Regulations does not correctly represent the substance sampled, or

• (m) with the intent to defraud or deceive, tampers or interferes with any sample taken under these Regulations.

is guilty of an offence.

• (3) For the purposes of these Regulations, every contravention of a provision of these Regulations shall be deemed a separate contravention and every contravention of a paragraph or a subparagraph of such provision shall also be deemed to be a separate contravention and shall carry the same penalty as for a single contravention of any such provision.

• (4) Where a body corporate, or a person acting on behalf of a body corporate, commits an offence under these Regulations and the offence is committed with the consent, connivance or approval of, or is attributable to any neglect or default on the part of, any director, manager, secretary or any other officer of such body, or a person purporting to act in any such capacity, such person is also guilty of an offence and is liable to be proceeded against and punished as if he or she were guilty of the first-mentioned offence.

• (5) Where the affairs of a body corporate are managed by its members, paragraph (4) applies as if the reference to a director in that subsection were a reference to a member of the body corporate.

• (6) In proceedings for an offence under these Regulations, it is a defence for a person charged with the offence to prove both of the following—

• (a) commission of the offence was due to a reasonable mistake or the reliance on information supplied to him or her, or to the act or default of another person, an accident or some other cause beyond his or her control, and

• (b) he or she exercised due diligence and took all reasonable precautions to avoid commission of the offence.

• (7) If reliance on the defence provided by paragraph (6) involves the allegation that the commission of the offence was due to reliance on information supplied by another person or to the act or default of another person, the person charged with the offence shall not, without leave of the court, be entitled to rely on that defence unless, not less than 7 working days before the hearing, he or she has served on the prosecutor written notice providing information identifying, or assisting in the identification of, that other person.

Penalties

• (a) on summary conviction to a class A fine or at the discretion of the Court to imprisonment for a term not exceeding one year or both, or

• (b) on conviction on indictment—

• (i) in the case of a first offence, to a fine not exceeding €120,000 or imprisonment for a term not exceeding 3 years or both, and

• (ii) in the case of any subsequent offence, to a fine not exceeding €300,000 or imprisonment for a term not exceeding 3 years or both.

• (2) Where a person is convicted of an offence under these Regulations, the court shall, unless it is satisfied that there are special and substantial reasons for not so doing, order the person to pay to the IMB, as the case may be, the costs and expenses, measured by the court, incurred by the IMB in relation to the investigation, detection and prosecution of the offence, including costs and expenses incurred in the taking of samples, the carrying out of tests, examinations and analyses and in respect of the remuneration and other expenses of employees, consultants and advisors engaged by the IMB.

• (3) On conviction for an offence under these Regulations, the court may, in addition to any other penalty or costs—

• (a) order any animal or relevant thing or any vehicle, vessel or container to which the offence relates to be forfeited to the IMB for sale, destruction or disposal as the IMB thinks fit, and

• (b) upon application made to it by or on behalf of the IMB, order the person convicted of the offence to pay to the IMB all or part of the costs of the destruction or disposal of such animal or relevant thing or any vehicle, vessel or container, subject to such conditions, if any, as are specified in the order.

• (4) An order for costs and expenses under paragraph (2) or (3) is in addition to, and not instead of, any fine or penalty the court may impose under paragraph (1).

• (5) In any proceedings for an offence under these Regulations, where no conviction is recorded, the court may, upon application made to it by or on behalf of the IMB, order any animal or relevant thing to which the offence relates to be forfeited to the IMB for sale, destruction or disposal.

Summary proceedings may be brought by IMB

PART 12 TRANSITIONAL PROVISIONS AND PROVISIONAL SAFEGUARD MEASURES

Transitional provisions

• (a) where the licence expires on or before 1 January 2018, the person may carry out the licensed experiments without a project authorisation until such licence expires;

• (b) where the licence expires after 1 January 2018, the person may only continue carrying out the licensed experiments in accordance with that licence until 1 January 2018 and thereafter may only carry out the relevant activities under a project authorisation;

• (c) where the person wishes to make a change in the licensed experiments, he or she shall apply for a project authorisation under Part 5.

• (2) Notwithstanding Part 6, a person carrying out the activities of a breeder, supplier or user in an establishment granted a registration before 1 January 2013 by the Minister for Health under s. 7 of the Cruelty to Animals Act 1876 (39 & 40 Vict., c. 7), as amended by the European Communities (Amendment of Cruelty to Animals Act 1876) Regulations 2002 ( S.I. No. 566 of 2002 ), may continue to carry out such activities under the said registration until the earlier of—

• (a) 31December 2014, or

• (b) the date on which the IMB makes a decision in relation to an application for an authorisation under Part 6 in respect of the said establishment.

• (3) Notwithstanding Part 8—

• (a) a person listed in a licence granted before 1 January 2013 by the Minister for Health under s. 8 of the Cruelty to Animals Act 1876 (39 & 40 Vict., c. 7), as amended by the European Communities (Amendment of Cruelty to Animals Act 1876) Regulations 2002 ( S.I. No. 566 of 2002 ), may continue to perform the duties or activities for which he or she is listed in the said licence, in respect of the licensed experiments, until the expiry of the said licence, or 1 January 2018, whichever is the earlier, and

• (b) a person listed in an establishment registration granted before 1 January 2013 by the Minister for Health under s. 7 of the Cruelty to Animals Act 1876 (39 & 40 Vict., c. 7), as amended by the European Communities (Amendment of Cruelty to Animals Act 1876) Regulations 2002 ( S.I. No. 566 of 2002 ), may continue to perform the duties or activities for which he or she is listed in the said registration until the earlier of the dates referred to in paragraph (2).

• (4) A licence or registration remaining in effect under this Regulation, and any person carrying out an activity or role under such licence or registration, shall be subject to the enforcement, offences and penalties provisions in Part 11, as if the licence or registration was an authorisation granted under these Regulations.

Provisional safeguard measures

• (2) Subject to paragraph (3), the Minister, after consultation with the IMB, and in accordance with Article 55(2) of the Directive, may by order adopt a provisional measure allowing the use of great apes in procedures having one of the purposes referred to in Regulation 7(b)(i), (c) or (e), provided that the purpose of the procedure cannot be achieved by the use of species other than great apes or by the use of alternative methods.

• (3) The reference in paragraph (2) to Regulation 7(b)(i) shall not be taken to include the reference to animals and plants.

• (4) The Minister, after consultation with the IMB, and in accordance with Article 55(3) of the Directive, may by order adopt a provisional measure providing an exemption from Regulation 20(3), in the case of species other than non-human primates.

• (5) Where the Minister adopts a provisional measure in accordance with paragraph (1), (2) or (4), he or she shall immediately inform the Commission and the other EEA States thereof, giving reasons for his or her decision and submitting evidence of the situation on which the provisional measure is based.

• (6) The Minister shall by order revoke any order made under this Regulation where—

• (a) the time period defined by the Commission in accordance with Article 55(4)(a) of the Directive has expired, or

• (b) the Commission requires its revocation in accordance with Article 55(4)(b) of the Directive.

PART 13 REPEALS AND REVOCATIONS

Repeal of Cruelty to Animals Act 1876

Revocations

• (a) the European Communities (Amendment of Cruelty to Animals Act 1876) Regulations 2002 ( S.I. No. 566 of 2002 ), and

• (b) the European Communities (Amendment of Cruelty to Animals Act 1876) Regulations 2005 ( S.I. No. 613 of 2005 ).

Regulation 83

SCHEDULE

Form of official certificate of result of test, examination or analysis of sample, etc

European Union (Protection of Animals Used for Scientific Purposes) Regulations 2012

Certificate Stating Results of Test, Examination or Analysis

This certificate is issued by me, the undersigned, for the purpose of Regulation 83 of the European Union (Protection of Animals Used for Scientific Purposes) Regulations 2012 being—

I hereby certify that I received on the .............. day of .......................................,

from 2. .................................................

of ........................................................................... a sample of the relevant thing/the relevant thing*,

being 3. .................................................

for test, examination or analysis; which was undamaged, duly sealed and marked

I further certify that the said sample/relevant thing* has been tested, examined or analysed by me or under my direction and that the results are as follows—

5.

Signature ..............................................

Date ..............................................

Address ..............................................

..............................................

..............................................

*Delete whichever is inapplicable.

GIVEN under my Official Seal,

20 December 2012.

JAMES REILLY,

Minister for Health.

EXPLANATORY NOTE

(This note is not part of the Instrument and does not purport to be a legal interpretation.)

These Regulations give effect to Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes and give full effect to Commission Implementing Decision 2012/707/EU of 14 November 2012.

These Regulations repeal the Cruelty to Animals Act 1876 and revoke the European Communities (Amendment of Cruelty to Animals Act 1876) Regulations 2002 ( S.I. No. 566 of 2002 ), and the European Communities (Amendment of Cruelty to Animals Act 1876) Regulations 2005 ( S.I. No. 613 of 2005 ).

These Regulations may be cited as the European Union (Protection of Animals Used for Scientific Purposes) Regulations 2012.

Footnotes