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21.—(1) The Scottish Ministers 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.
(2) The Scottish Ministers shall not determine an application to release genetically modified organisms before the end of a period of sixty days beginning on the day on which the application for consent was received.
(3) The Scottish Ministers shall–
(a)communicate in writing their decision on an application for a consent to release genetically modified organisms to the applicant; and
(b)ensure that the Commission is informed of their decision,
before the end of a period of ninety days beginning with the day on which the application was received and shall include in any refusal of consent the reason for the decision.
(4) The period prescribed in paragraph (3) shall not include–
(a)any period beginning with the day on which the Scottish Ministers give 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 Scottish Ministers; or
(b)any period of time during which the Scottish Ministers are considering representations submitted by any persons in accordance with regulation 20(b), provided that this consideration shall not prolong the ninety day period referred to in paragraph (3) by more than thirty 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 Scottish Ministers as soon as reasonably practicable after completion of the release and thereafter, at such intervals as the Scottish Ministers shall consider appropriate on the basis of the results of the environmental risk assessment.
(6) The Scottish Ministers shall ensure that the information submitted to them in accordance with paragraph (5) is sent to the Commission.
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