Regulation 21 Decisions by the Secretary of State on applications for consent to release

(1)

The Secretary of State shall not grant consent to release genetically modified organisms under section 111(1) of the Act as it relates to the protection of human health without the agreement of the Health and Safety Executive M1.

F1(2)

the Secretary of State shall not grant or refuse consent to release genetically modified organisms before the end of the period specified for representations in accordance with regulations 20(b) and (f) above and, if any comments referred to in regulation 20(f) are received within that period, before she has considered those comments.

(3)

The Secretary of State shall communicate her decision on an application for a consent to release genetically modified organisms to the applicant F2... before the end of a period of 90 days beginning with the day on which the application was received and shall include in any refusal of consent the reasons for the decision.

(4)

The period prescribed in paragraph (3) shall not include—

(a)

any period beginning with the day on which the Secretary of State gives notice in writing under section 111(6) of the Act that further information in respect of the application is required and ending on the day on which that information is received by the Secretary of State, or

(b)

any period of time during which the Secretary of State is considering representations submitted by any persons in accordance with regulation 20(b), provided that this consideration shall not prolong the 90 day period referred to in paragraph (3) by more than 30 days.

(5)

A consent to release genetically modified organisms shall require the applicant to send any information which might be relevant to assessing the risk of damage being caused to the environment, with, where appropriate, particular reference to any product which it is intended to market in the future, to the Secretary of State as soon as reasonably practicable after completion of the release and thereafter, at such intervals as the Secretary of State shall consider appropriate on the basis of the results of the environmental risk assessment.

F3(6)

Information submitted in accordance with paragraph (5) must be provided in the format set out in the Annex to Commission Decision 2003/701/EC.

Annotations

Textual amendments

F1: Reg. 21(2) substituted (8.10.2004) by The Genetically Modified Organisms (Deliberate Release) (Amendment) Regulations 2004 (S.I. 2004/2411), regs. 1, 2(5)
F2: Words in reg. 21(3) omitted (31.12.2020) by virtue of The Genetically Modified Organisms (Amendment) (England) (EU Exit) Regulations 2019 (S.I. 2019/88), regs. 1(2)(b), 3(8)(a); 2020 c. 1, Sch. 5 para. 1(1)
F3: Reg. 21(6) substituted (31.12.2020) by The Genetically Modified Organisms (Amendment) (England) (EU Exit) Regulations 2019 (S.I. 2019/88), regs. 1(2)(b), 3(8)(b); 2020 c. 1, Sch. 5 para. 1(1)

Marginal citations

M1: See section 10 of the Health and Safety at Work etc Act 1974 (c. 37).