Joint Committee on Statutory Instruments First Report



APPENDIX 5

Memorandum by the Department of the Environment, Transport and the Regions

GENETICALLY MODIFIED ORGANISMS(CONTAINED USE) REGULATIONS 2000 (S.I. 2000/2831)

1. The Committee has asked for a memorandum on the following points—

    1.  Regulation 13(1)(a) requires a single notification to be submitted to the joint competent authority under regulation 9(1) where such a notification is required "in respect of premises which are situated in both England and Scotland". Confirm that the reference here is to premises which straddle the border between England and Scotland.

2. This is confirmed

    2.  Regulation 13(1)(b) requires a single notification to the joint competent authority under regulation 10(1), 11(1) or 12(1) in respect of an activity which is to take place in both England and Scotland. Explain why such notification is not required in respect of an activity which is to take place in both Wales and Scotland.

3. The purpose of this provision is to deal with the situation where an activity is to be carried on in premises which have been notified under regulation 13(1)(a).

    3.  Explain the purpose and effect of the proviso in regulation 15(2)(g). Is the intention that regulation 15(2)(g) should be without prejudice to the requirement to submit a notification under regulation 9(1)?

4. The purpose of regulation 15(2)(g) is to allow a person, who carries on a contained use activity permitted under the Regulations at one site notified under regulation 9(1), to extend that activity to an additional site (provided that site is also notified under regulation 9(1)) by informing the competent authority of such extension, rather than having to submit a further notification in respect of an activity which has already been notified under regulations 10(1), 11(1) or 12(1).

5. The effect is to remove the requirement of a person involved in the contained use activities having to submit a second notification, and pay a further fee in respect of the same activity which would be identical to the first notification save that the details of the premises would be different.

    4.  Given the effect of regulation 11, which prohibits a person from undertaking any activity in class 3 or class 4 without his having submitted a notification and received consent under that regulation, explain the purpose and effect of paragraphs (4) and (5) of regulation 15.

6. By regulation 15(4), where a person carries on a contained use activity and that person wants to make a significant change to that activity such as would require him to submit a notification under regulation 11(1), he cannot make that change until he has submitted the new notification and he has received the consent of the competent authority to carry on the activity in question. Thus, where a person carrying on a Class 2 activity wants to change that activity to a Class 3 activity, he must submit a notification under regulation 11(1) and obtain the consent of the competent authority.

7. However, by regulation 15(5), where a person is carrying on, say, a Class 3 activity and he wants to make a significant change such that the activity falls within Class 4, then he does not need to submit a further notification under regulation 11(1). The person in question must submit full written details of the change in accordance with regulation 15(3).

    5.  Are the characteristics listed in regulation 22(12) ones which would normally be described as general? If so, what in the Directive justifies this provision? If not, give examples of characteristics which would normally be described as general.

8. The characteristics listed in regulation 22(12) are highly specific and are not in any way general. Article 19(3) of the Directive provides that the general characteristics of a genetically modified micro-organism may not be kept confidential. However, the Directive did not explain what is meant by "general characteristics". Because the term "general characteristics" is so broad it is not possible to define the term accurately. Therefore it was thought that the term should be defined by excluding those characteristics which are specific. A few examples of general characteristics of a genetically modified micro-organism are—

  • human, plant, or animal pathogen;
  • soil living;
  • enteric;
  • saprophytic;
  • bacillus, virus, fungus;
  • Gram positive, Gram negative, acid fast;
  • anaerobic, aerobic, obligate aerobic;
  • thermophilic, acidophilic, alkalinophilic.

There are many more. Guidance will be issued on this point.

    6.  Given that the Secretary of State and the Scottish Ministers respectively form part of the competent authority as regards England and Wales and the competent authority as regards Scotland, explain why regulation 29(8) provides for appeals from those competent authorities to be made to them.

9. A person aggrieved by a decision of a competent authority may appeal to the Secretary of State or, in appropriate cases to the Scottish Ministers. However, that is a first step in the appeals procedure. Once a person so appeals, then the Secretary of State, or the Scottish Ministers, must appoint a person under paragraph 2 of Schedule 11 to determine the appeal. By paragraph 4 of that Schedule, that person may give directions to give effect to his determination. Neither the Secretary of State, nor as the case may be, the Scottish Ministers, determine an appeal.

    7.  Explain why regulation 29(8)(b)(ii) does not provide for appeals to be made in accordance with that provision in respect of the undertaking of an activity in both Wales and Scotland.

10. Regulation 28(b)(ii) is aimed at an appeal in the case where a notification has been submitted to the joint competent authority under regulation 13(1).

    8.  Identify the competent authority in relation to the premises and activities outside Great Britain referred to in regulation 30.

11. The Department regrets the fact that it is not made clear who the competent authority is for the purposes of regulation 30. The Regulations will be amended at the earliest opportunity.

    9.  Paragraphs 1(b), 2(b) and 3(b) of Schedule 6 require a notification under regulations 10(1), 11(1) and 12(1) respectively to contain the centre number allocated by the competent authority in respect of the premises at which the activity is to be undertaken and the date of the notification required by regulation 9(1) relating to those premises. Explain how these requirements can be complied with where a notification under regulation 10(1), 11(1) or 12(1) is submitted simultaneously with a notification under regulation 9(1), as described in the 3rd, 5th, 7th and 9th entries in Schedule 9.

12. It is intended that before an applicant submits a notification under regulation 9(1) together with a notification under regulation 10(1), 11(1) or 12(1), he will obtain details of the centre number from the competent authority which he will then include in his notification under regulation 10(1), 11(1) or 12(1). Guidance will be issued to make this clear.

    10.  Given the provisions of the Courts and Legal Services Act 1990, explain why paragraph 9(4) of Schedule 11 permits a body corporate to appear only by its clerk, secretary or other officer or by counsel or a solicitor. Why, in the case of Scotland, is a body corporate not permitted to appear by an advocate?

13. Schedule 11 of the Regulations is based on the provisions of the Health and Safety Licensing Appeals (Hearings Procedure) Rules 1974 (S.I. 1974/2040) and the Health and Safety Licensing Appeals (Hearings Procedure) (Scotland) Rules 1974 (S.I. 1974/2068). Consideration was given, when drafting the regulations, to incorporating both sets of Rules by reference. However, in view of the number of amendments which would have had to be made referentially, the Department took the view that incorporation of the Rules by reference would not be appropriate and could lay the Department open to criticism by the Committee. Consequently it was decided to set out the appeals procedure in full, drawing on both sets of Rules, and incorporating such amendments as were necessary. The wording in both sets of the 1974 Rules is almost identical. The provision in paragraph 9(4) of Schedule 11 is based on rule 6(3) in each version of the 1974 Rules. With regard to the second part of this question, the Department's view, having received the benefit of the advice of Scots lawyers is that, in Scotland, the word "counsel" in paragraph 9(4) of Schedule 11 includes an advocate.

    11.  In paragraph 9(5) of Schedule 11, what, given the fact that a person may be represented by "any other person", is the purpose and effect of providing that he may be represented by counsel or a solicitor?

14. The Department refers the Committee to the answer given to point 10 above. Paragraph 9(5) of Schedule 11 is based on rule 6(3) in each version of the 1974 Rules. In addition, the Department considers that the provision assists the reader by making clear who may represent him.

    12.  Paragraph 9(6) of Schedule 11 permits the appointed person to allow one or more persons to appear for the benefit of some or all persons having a similar interest. Explain the purpose and effect of this provision.

15. The Department refers the Committee to the answer given to point 10 above. Paragraph 9(6) of Schedule 11 is based on rule 6(4) in each version of the 1974 Rules. In addition, the Department considers that the provision assists the reader by making clear what the appointed person may allow with regard to representation where two or more parties have a similar interest in the subject matter of the proceedings.

4 December 2000


 
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