111.—F231[(1) The Minister, after consultation with the Minister for Enterprise, Trade and Employment and any other Minister of the Government who in the opinion of the Minister is concerned, may—

(a) for the purposes of—

(i) environmental protection,

(ii) the prevention of danger to health or damage to property, or

(iii) the preservation of amenities,

and

(b) without prejudice to the generality of the foregoing, for the purposes of giving full effect to any act adopted by an institution of the European Communities that relates to any of the matters mentioned in this section,

make regulations for the control, management, regulation or prohibition of any process or action or class of processes or actions, involving a genetically modified organism.]

(2) Without prejudice to the generality of subsection (1), regulations may provide for all or any of the following—

(a) assignment of functions for the purposes of subsection (1), to such person (including the Minister) as may be specified,

(b) placing of duties, obligations or responsibilities on a person engaged in genetically modifying any organism or who is importing, acquiring, keeping, using or releasing to the environment any genetically modified organism or on any other person in relation to genetically modified organisms,

(c) consultation with such person, whether in or outside the State, (if any) as may be specified,

(d) licensing of a person engaged in genetically modifying any organism or who is importing, acquiring, keeping, using or releasing to the environment any genetically modified organism and prohibiting the engagement in any such actions of a person other than a licensed person,

(e) regulating, including licensing, the establishment and operation of any process or action involving a genetically modified organism and prohibiting any such process or action unless a licence has been obtained,

(f) the information including information on personnel, premises and waste management, to be furnished with an application for a licence and provision for seeking additional information as necessary to determine the application,

(g) the conditions that may or shall be attached to a licence under paragraph (d) or (e) including—

(i) the period for which the licence shall be valid,

(ii) the organisms covered by the licence,

(iii) any limitations or prohibitions regarding any process or action involving any specified organisms,

(iv) the continuation of specified conditions after a licence expires, is cancelled or suspended, or after the process or action for which a person is licensed is completed,

(v) restrictions or limits on any releases to the environment or any emissions arising from any process or action involving a genetically modified organism or specifying the methods of treatment or disposal of any releases or emissions to any environmental medium, or

(vi) arrangements for monitoring and for making available to the Minister or such other person as may be specified the results of such monitoring,

(h) specifying procedures for the grant, review, cancellation or suspension of a licence, for the making of representations relating to these matters and for the consideration of such representations,

(i) the studies and assessments to be carried out on the nature of, or the process or action involving, a genetically modified organism, the possible risks to the environment from the organism or the process or action involving the organism and the potential effects of a release of such organism whether planned or accidental,

(j) the precautions to be taken, including the setting up of bio-safety committees, the information to be provided to the public, emergency response arrangements (both on-site and off-site), the notification of emergency incidents to the proper authorities, the taking of urgent measures by those authorities for the purposes of environmental protection, for the prevention of danger to health or damage to property or for the preservation of amenities, and the recovery of the costs of such measures by those authorities, and the controls to be observed either generally or in relation to particular organisms or classes of organisms, processes or classes of processes or actions or classes of actions, involving a genetically modified organism,

(k) providing for an application to the High Court by the Minister or such other person as may be prescribed under subsection (1) for an order prohibiting or restricting any process or action involving a genetically modified organism in such circumstances as may be specified,

(l) prohibiting any specified process or action involving, or any importation, acquisition, keeping, using or releasing to the environment of, a specified genetically modified organism, or any specified genetic modification of an organism,

(m) the grant of exemptions—

(i) to a specified class of persons,

(ii) for specified research or in specified circumstances, or

(iii) as regards specified organisms or classes of organisms, processes or classes of processes or actions or classes of actions involving specified organisms or classes of organisms,

from any of the requirements of the regulations in such circumstances as are specified in relation to specified processes or actions involving a genetically modified organism and subject to such conditions as may be specified,

(n) requiring the giving of notice, the information to be included in such notice, and the period within which such notice shall be given, to the Minister or such other person, whether in or outside the State, as may be specified, regarding the introduction or modification of such process or action involving a genetically modified organism as may be specified,

(o) the keeping of records and the provision of such information as may be specified to the Minister or such other person, whether in or outside the State, as may be specified,

(p) the maintenance of a register including the information related to licences and other matters to be contained in such register, and the provision of public access to such register and any restrictions as regards confidential information,

(q) the provision of advice and the preparation and publication, or approval of guidelines and codes of practice, or

(r) the imposition of charges or the payment of fees for the purposes of the regulations or the services provided thereunder.

(3) It shall be an offence not to comply with any condition attached to a licence issued pursuant to regulations made under this section.

(4) F232[…]

(5) Regulations under this section may contain such incidental, supplementary, consequential and transitional provisions (including provisions modifying any provision of this Act or of any other enactment) as appear to the Minister to be necessary for the purposes of, in consequence of, or to give full effect to, the regulations.

(6) For the purposes of this section an authorised person, in addition to the powers given under section 13, may require, in relation to any premises or part of a premises which he has power to enter or in relation to any process or action or part of a process or action on such premises, or in relation to anything in or on such premises, that it should be maintained without disturbance or in such a manner as he may specify for so long as is reasonable in order to carry out his investigations or tests.

(7) In this section—

“genetically modified organism” means—

(a) an organism derived from the formation of a combination of genetic material by artificial techniques, or

(b) an organism inheriting such combination of genetic material, or

(c) an organism that results from the replication of an organism described in paragraph (a), or

(d) such other matter as may be prescribed by the Minister;

“organism” means any multicellular, unicellular, subcellular or acellular entity capable of replication or of transferring genetic material whether by natural or artificial processes or such other matter as may be prescribed by the Minister;

“environment” includes atmosphere, land, soil, water and all living organisms;

“licence” includes a consent or any other form of authorisation and cognate words shall be construed accordingly.