E3C3C4Part VI Genetically Modified Organisms
Pt. VI (ss. 106-127): transfer of functions (16.2.2000) by S.I. 2000/253, art. 2, Sch. 1
Pt. VI (ss. 106-127) modified (E.) (temp. from 17.10.2002) by Genetically Modified Organisms (Deliberate Release) Regulations 2002 (S.I. 2002/2443), regs. 1(2)(3), 5(3), 39
Pt. VI (ss. 106-127) modified (S.) (temp. from 5.12.2002) by Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002 (S.S.I. 2002/541), reg. 5(3)
Pt. VI (ss. 106-127) modified (W.) (temp. from 31.12.2002) by Genetically Modified Organisms (Deliberate Release) (Wales) Regulations 2002 (S.I. 2002/3188), reg. 6(3)
Consents
I1111 Consents required by certain persons.
1
Subject to subsection (7) below, no person shall import or acquire, release or market any genetically modified organisms—
C1a
in such cases or circumstances as may be prescribed in relation to that act, or
b
in any case where he has been given directions under section 108(8)(a) above,
except in pursuance of a consent granted by the Secretary of State and in accordance with any limitations and conditions to which the consent is subject.
2
Subject to subsection (7) below, no person who has imported or acquired any genetically modified organisms (whether under a consent or not) shall continue to keep the organisms—
a
in such cases or circumstances as may be prescribed, after the end of the prescribed period, or
b
if he has been given directions under section 108(8)(b) above, after the date specified in the directions,
except in pursuance of a consent granted by the Secretary of State and in accordance with any limitations or conditions to which the consent is subject.
3
A person who is required under subsection (2) above to cease keeping any genetically modified organisms shall dispose of them as quickly and safely as practicable.
4
An application for a consent must contain such information and be made and advertised in such manner as may be prescribed and shall be accompanied by the fee required under section 113 below.
5
The applicant shall, in prescribed circumstances, give such notice of his application to such persons as may be prescribed.
C26
The Secretary of State may by notice to the applicant require him to furnish such further information specified in the notice, within such period F1and in such form and manner as may be so specified, as he may require for the purpose of determining the application; and if the applicant fails to furnish the information within the specified period F2and in the specified form and manner the Secretary of State may refuse to proceed with the application.
F3A notice under this subsection must state the reasons for requiring the further information specified in the notice.
F46ZA
A notice under subsection (6) must state the reasons for requiring the further information specified in the notice.
F56A
Where an applicant for consent for releasing or marketing genetically modified organisms becomes aware, before his application is either granted or rejected, of any new information with regard to any risks there are of damage to the environment being caused as a result of the organisms being released or marketed, he shall notify the Secretary of State of that new information forthwith.
7
Regulations under this section may provide for exemptions, or for the granting by the Secretary of State F6, or by the Secretary of State and the Food Standards Agency acting jointly, of exemptions to particular persons or classes of person, from—
a
any requirement under subsection (1) or (2) above to have a consent, or
b
any of the requirements to be fulfilled under the regulations by an applicant for a consent,
in such cases or circumstances as may be prescribed.
8
Where an application for a consent is duly made to him, the Secretary of State may grant the consent subject to such limitations and conditions as may be imposed under section 112 below or he may refuse the application.
9
The conditions attached to a consent may include conditions which are to continue to have effect notwithstanding that the holder has completed or ceased the act or acts authorised by the consent.
10
The Secretary of State may at any time, by notice given to the holder of a consent, revoke the consent or vary the consent (whether by attaching new limitations and conditions or by revoking or varying any limitations and conditions to which it is at that time subject).
11
Regulations under this section may make different provision for different cases and different circumstances; and in this section “prescribed” means prescribed in regulations under this section.
E1I2112 Consents: limitations and conditions.
1
2
Without prejudice to the generality of subsection (1) above, the conditions included in a consent may—
a
require the giving of notice of any fact to the Secretary of State; or
b
prohibit or restrict the keeping, releasing or marketing of genetically modified organisms under the consent in specified cases or circumstances;
and where, under any condition, the holder of a consent is required to cease keeping any genetically modified organisms, he shall dispose of them, if no manner is specified in the conditions, as quickly and safely as practicable.
3
Subject to subsection (6) below, there is implied in every consent for the importation or acquisition of genetically modified organisms a general condition that the holder of the consent shall—
a
take all reasonable steps to keep himself informed (by reference to the nature of the organisms and the manner in which he intends to keep them after their importation or acquisition) of any risks there are of damage to the environment being caused as a result of their importation or acquisition; and
b
if at any time it appears that any such risks are more serious than were apparent when the consent was granted, notify the Secretary of State forthwith.
4
Subject to subsection (6) below, there is implied in every consent for keeping genetically modified organisms a general condition that the holder of the consent shall—
a
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 of any risks there are of such damage being caused as a result of his continuing to keep them;
b
if at any time it appears that any such risks are more serious than were apparent when the consent was granted, notify the Secretary of State forthwith; and
c
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 them.
5
Subject to subsection (6) below, there is implied in every consent for releasing or marketing genetically modified organisms a general condition that the holder of the consent shall—
a
take all reasonable steps to keep himself informed (by reference to the nature of the organisms and the extent and manner of the release or marketing) of any risks there are of damage to the environment being caused as a result of their being released or, as the case may be, marketed;
F9b
notify the Secretary of State F10forthwith of—
i
any new information which becomes available with regard to any risks there are of damage to the environment being so caused, and
ii
F11the effects of any releases by him for the assessment of any risks there are of damage to the environment being so caused by such organisms being released or marketed;
F12iii
any unforeseen event, occurring in connection with a release by him, which might affect the risks there are of damage to the environment being caused as a result of their being released;
F13c
take such measures as are necessary to prevent damage to the environment being caused as a result of the release or, as the case may be, the marketing of the organisms;
F14d
notify the Secretary of State F15or, in relation to Wales, the National Assembly for Wales of the measures (if any) taken as a result of new information becoming available or an unforeseen event occurring as described in paragraph (b)(iii) above; and
e
in a case where new information becomes available or an unforeseen event so occurs, revise the information contained in his application for a consent accordingly and supply the revised information to the Secretary of State F15or, in relation to Wales, the National Assembly for Wales.
6
The general condition implied into a consent under subsection (3), (4) or (5) above has effect subject to any conditions imposed under subsection (1) above; and the obligations imposed by virtue of subsection (4)(c) or (5)(c) above shall not apply to any aspect of an act authorised by a consent which is regulated by such a condition.
7
There shall be implied in every consent for keeping, releasing or marketing genetically modified organisms of any description a general condition that the holder of the consent—
a
shall take all reasonable steps to keep himself informed of developments in the techniques which may be available in his case for preventing damage to the environment being caused as a result of the doing of the act authorised by the consent in relation to organisms of that description; and
b
if it appears at any time that any better techniques are available to him than is required by any condition included in the consent under subsection (1) above, shall notify the Secretary of State of that fact forthwith.
But this general condition shall have effect subject to any conditions imposed under subsection (1) above.
E2I2112 Consents: limitations and conditions.
1
2
Without prejudice to the generality of subsection (1) above, the conditions included in a consent may—
a
require the giving of notice of any fact to the Secretary of State; or
b
prohibit or restrict the keeping, releasing or marketing of genetically modified organisms under the consent in specified cases or circumstances;
and where, under any condition, the holder of a consent is required to cease keeping any genetically modified organisms, he shall dispose of them, if no manner is specified in the conditions, as quickly and safely as practicable.
3
Subject to subsection (6) below, there is implied in every consent for the importation or acquisition of genetically modified organisms a general condition that the holder of the consent shall—
a
take all reasonable steps to keep himself informed (by reference to the nature of the organisms and the manner in which he intends to keep them after their importation or acquisition) of any risks there are of damage to the environment being caused as a result of their importation or acquisition; and
b
if at any time it appears that any such risks are more serious than were apparent when the consent was granted, notify the Secretary of State forthwith.
4
Subject to subsection (6) below, there is implied in every consent for keeping genetically modified organisms a general condition that the holder of the consent shall—
a
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 of any risks there are of such damage being caused as a result of his continuing to keep them;
b
if at any time it appears that any such risks are more serious than were apparent when the consent was granted, notify the Secretary of State forthwith; and
c
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 them.
5
Subject to subsection (6) below, there is implied in every consent for releasing or marketing genetically modified organisms a general condition that the holder of the consent shall—
a
take all reasonable steps to keep himself informed (by reference to the nature of the organisms and the extent and manner of the release or marketing) of any risks there are of damage to the environment being caused as a result of their being released or, as the case may be, marketed;
F9b
notify the Secretary of State F17forthwith of—
i
any new information which becomes available with regard to any risks there are of damage to the environment being so caused, and
ii
F18. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F19iii
any unforeseen event, occurring in connection with a release by him, which might affect the risks there are of damage to the environment being caused as a result of their being released;
F20c
take such measures as are necessary to prevent damage to the environment being caused as a result of the release, or, as the case may be, the marketing of the organisms;
F21d
notify the Scottish Ministers forthwith of the measures (if any) taken as a result of new information becoming available or an unforeseen event occurring as described in paragraph (b)(iii); and
e
in a case where new information becomes available or an unforeseen event so occurs, revise the information contained in his application for a consent accordingly and supply the revised information to the Scottish Ministers in such form and manner as they may specify.
6
The general condition implied into a consent under subsection (3), (4) or (5) above has effect subject to any conditions imposed under subsection (1) above; and the obligations imposed by virtue of subsection (4)(c) or (5)(c) above shall not apply to any aspect of an act authorised by a consent which is regulated by such a condition.
7
There shall be implied in every consent for keeping, releasing or marketing genetically modified organisms of any description a general condition that the holder of the consent—
a
shall take all reasonable steps to keep himself informed of developments in the techniques which may be available in his case for preventing damage to the environment being caused as a result of the doing of the act authorised by the consent in relation to organisms of that description; and
b
if it appears at any time that any better techniques are available to him than is required by any condition included in the consent under subsection (1) above, shall notify the Secretary of State of that fact forthwith.
But this general condition shall have effect subject to any conditions imposed under subsection (1) above.
I3113 Fees and charges.
1
The Secretary of State may, with the approval of the Treasury, make and from time to time revise a scheme prescribing—
a
fees payable in respect of applications for consents; and
b
charges payable by persons holding consents in respect of the subsistence of their consents;
and it shall be a condition of any such consent that any applicable prescribed charge is paid in accordance with that scheme.
2
A scheme under this section may, in particular—
a
provide for different fees or charges to be payable in different cases or circumstances;
b
provide for the times at which and the manner in which payments are to be made; and
c
make such incidental, supplementary and transitional provision as appears to the Secretary of State to be appropriate.
3
The Secretary of State shall so frame a scheme under this section as to secure, so far as practicable, that the amounts payable under it will be sufficient, taking one financial year with another, to cover the expenditure of the Secretary of State in discharging his functions under this Part in relation to consents.
4
The Secretary of State shall, on making or revising a scheme under this section, lay a copy of the scheme or of the scheme as revised before each House of Parliament.
F225
The Scottish Ministers may, with the consent of the Secretary of State, provide in a scheme under this section for any functions under the scheme to be performed by a Minister of the Crown or government department where they consider it expedient to do so in relation to the implementation of Council Directive 90/220/EECM1.
Pt VI: for extent of this Part see s. 164(4) below.