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
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;
- 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
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
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