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General controlsN.I.

Risk assessment and notification requirementsN.I.

5.—(1) Subject to paragraphs (2) and (7), no person shall import or acquire, release or market any genetically modified organisms unless, before doing that act—

(a)he has carried out an assessment of any risks there are (by reference to the nature of the organisms and the manner in which he intends to keep them after their importation or acquisition or, as the case may be, t o release or market them) of damage to the environment being caused as a result of doing that act; and

(b)in such cases as may be prescribed, he has given the Department such notice of his intention of doing that act and such information as may be prescribed.

(2) Paragraph (1) does not apply to a person proposing to do an act mentioned in that paragraph who is required under Article 8(1)(a) to have a consent before doing that act.

(3) Subject to paragraphs (4) and (7), a person who is keeping genetically modified organisms shall, in such cases and at such times or intervals as may be prescribed—

(a)carry out an assessment of any risks there are of damage to the environment being caused as a result of his continuing to keep them;

(b)give the Department notice of the fact that he is keeping the organisms and such information as may be prescribed.

(4) Paragraph (3) does not apply to a person who is keeping genetically modified organisms and is required under Article 8(2) to have a consent authorising him to continue to keep the organisms.

(5) It shall be the duty of a person who carries out an assessment under paragraph (1)(a) or (3)(a) to keep, for the prescribed period, such a record of the assessment as may be prescribed.

(6) A person required by paragraph (1)(b) or (3)(b) to give notice to the Department shall give the Department such further information as the Department may by notice in writing require.

(7) Regulations under this Article may provide for exemptions, or for the granting by the Department[F1,or by the Department and the Food Standards Agency acting jointly,]F1 of exemptions to particular persons or classes of person, from the requirements of paragraph (1) or (3).

(8) The Department may at any time—

(a)give directions to a person falling within paragraph (1) requiring that person to apply for a consent before doing the act in question; or

(b)give directions to a person falling within paragraph (3) requiring that person, before such date as may be specified in the direction, to apply for a consent authorising him to continue keeping the organisms in question;

and a person given directions under sub-paragraph (a) shall then, and a person given directions under sub-paragraph (b) shall from the specified date, be subject to Article 8 in place of the requirements of this Article.

(9) Regulations under this Article may—

(a)prescribe the manner in which assessments under paragraph (1) or (3) are to be carried out and the matters which must be investigated and assessed;

(b)prescribe minimum periods of notice between the giving of a notice under paragraph (1)(b) and the doing of the act in question;

(c)make provision allowing the Department to shorten or to extend any such period;

(d)prescribe maximum intervals at which assessments under paragraph (3)(a) must be carried out.

(10) In this Article “prescribed” means prescribed by the Department in regulations under this Article.

General duties relating to importation, acquisition, keeping, release or marketing of organismsN.I.

6.—(1) A person who—

(a)is proposing to import or acquire any genetically modified organisms, or

(b)is keeping any such organisms, or

(c)is proposing to release or market any such organisms,

shall, subject to paragraph (5), be subject to the duties specified in paragraph (2), (3) or (4), as the case may be.

(2) A person who proposes to import or acquire genetically modified organisms—

(a)shall take all reasonable steps to identify, by reference to the nature of the organisms and the manner in which he intends to keep them (including any precautions to be taken against their escaping or causing damage to the environment), what risks th ere are of damage to the environment being caused as a result of their importation or acquisition; and

(b)shall not import or acquire the organisms if it appears that, despite any precautions which can be taken, there is a risk of damage to the environment being caused as a result of their importation or acquisition.

(3) A person who is keeping genetically modified organisms—

(a)shall take all reasonable steps to keep himself informed of any damage to the environment which may have been caused as a result of his keeping the organisms and to identify what risks there are of damage to the environment being caused as a result of his continuing to keep them;

(b)shall cease keeping the organisms if, despite any additional precautions which can be taken, it appears, at any time, that there is a risk of damage to the environment being caused as a result of his continuing to keep them; and

(c)shall use the best available techniques not entailing excessive cost for keeping the organisms under his control and for preventing any damage to the environment being caused as a result of his continuing to keep the organisms;

and where a person is required by sub-paragraph (b) to cease keeping the organisms he shall dispose of them as safely and as quickly as practicable and sub-paragraph (c) shall continue to apply until he has done so.

(4) A person who proposes to release genetically modified organisms—

(a)shall take all reasonable steps to keep himself informed, by reference to the nature of the organisms and the extent and manner of the release (including any precautions to be taken against their causing damage to the environment), what risks there are of damage to the environment being caused as a result of their being released;

(b)shall not release the organisms if it appears that, despite the precautions which can be taken, there is a risk of damage to the environment bei ng caused as a result of their being released; and

(c)subject to sub-paragraph (b), shall use the best available techniques not entailing excessive cost for preventing any damage to the environment being caused as a result of their being released;

and this paragraph applies, with the necessary modifications, to a person proposing to market organisms as it applies to a person proposing to release organisms.

(5) This Article does not apply—

(a)to persons proposing to import or acquire, to release or to market any genetically modified organisms, in cases where, under Article 5, they are not required to carry out a risk assessment before doing that act;

(b)to persons who are keeping any genetically modified organisms and who—

(i)were not required under Article 5 to carry out a risk assessment before importing or acquiring them;

(ii)have not been required under that Article to carry out a risk a ssessment in respect of the keeping of those organisms since importing or acquiring them; or

(c)to holders of consents, in the case of acts authorised by those consents.

Prohibition noticesN.I.

7.—(1) The Department may serve a notice under this Article (a “prohibition notice”) on any person it has reason to believe—

(a)is proposing to import or acquire, release or market any genetically modified organisms; or

(b)is keeping any such organisms;

if it is of the opinion that doing any such act in relation to those organisms or continuing to keep them, as the case may be, would involve a risk of causing damage to the environment.

(2) A prohibition notice may prohibit a person from doing an act mentioned in paragraph (1)(a) in relation to any genetically modified organisms or from continuing to keep them.

(3) A prohibition notice shall—

(a)state that the Department is, in relation to the person on whom it is served, of the opinion mentioned in paragraph (1);

(b)specify what is, or is to be, prohibited by the notice; and

(c)if the prohibition is not to be effective on being served, specify the date on which the prohibition is to take effect;

and a notice may be served on a person notwithstanding that he may have a consent authorising any act which is, or is to be, prohibited by the notice.

(4) Where a person is prohibited by a prohibition notice from continuing to keep any genetically modified organisms, he shall dispose of them as quickly and safely as practicable or, if the notice so provides, as may be specified in the notice.

(5) The Department may at any time withdraw a prohibition notice served on any person by notice given to that person.