1996 No. 250
Genetically Modified Organisms (Contained Use) (Amendment) Regulations (Northern Ireland) 1996
Made
Coming into operation
The Department of Economic Development, the Department of Agriculture and the Department of the Environment being Departments designated1 for the purposes of section 2(2) of the European Communities Act 19722 in relation to the control and regulation of genetically modified organisms, acting jointly in the exercise of the powers conferred on them by the said section 2(2), the Department of Economic Development, acting as the Department concerned3, in exercise of the powers conferred by Articles 17(1), (2), (4) and (5) of, and paragraphs 1(1) and (5), 3(1), and 14(1) of Schedule 3 to, the Health and Safety at Work (Northern Ireland) Order 19784 and those Departments, in exercise of every other power enabling them in that behalf, after consultation with the Health and Safety Agency for Northern Ireland and such other bodies as appeared to them to be appropriate, hereby make the following Regulations:—
Citation and commencement1
These Regulations may be cited as the Genetically Modified Organisms (Contained Use) (Amendment) Regulations (Northern Ireland) 1996 and shall come into operation on 29th July 1996.
Interpretation2
1
In these Regulations, “the principal Regulations” means the Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 19945.
2
The Interpretation Act (Northern Ireland) 19546 shall apply to these Regulations as it applies to a Measure of the Northern Ireland Assembly.
Amendments to the principal Regulations3
1
The principal Regulations shall be amended in accordance with Schedule 1 to these Regulations.
2
The Schedule set out in Schedule 2 to these Regulations shall be substituted for Schedule 2 to the principal Regulations.
Sealed with the Official Seal of the Department of Economic Development on
Sealed with the Official Seal of the Department of Agriculture for Northern Ireland on
Sealed with the Official Seal of the Department of the Environment for Northern Ireland on
SCHEDULE 1Amendments to the Principal Regulations
1
The principal Regulations shall be amended in accordance with the following paragraphs of this Schedule.
2
In regulation 2—
a
in paragraph (1)—
i
after the definition of “activity involving genetic modification” there shall be inserted the following definition—
“the Agreement” means the Agreement on the European Economic Area signed at Oporto on 2nd May 1992, as adjusted by the Protocol signed at Brussels on 17th March 1993 and adopted as respects the United Kingdom by the European Economic Area Act 19937;
ii
after the definition of “the Department” there shall be inserted the following definition—
“the European Economic Area” means the Area referred to in the Agreement;
iii
after the definition of “genetic modification safety committee” there shall be inserted the following definition—
“member State” means a State which is a Contracting Party to the Agreement;
iv
for the definition of “organism” there shall be substituted the following definition—
“organism” means a biological entity capable of replication or transferring genetic material and includes a micro-organism, but does not include a human or a human embryo;
b
for paragraph (2), there shall be substituted the following paragraph—
2
Genetically modified organisms shall be classified—
a
in the case of micro-organisms—
i
as Group I micro-organisms if they satisfy all of the criteria set out in Part I of Schedule 2, or
ii
as Group II micro-organisms if they do not satisfy all of the said criteria; or
b
in the case of genetically modified organisms other than micro-organisms, as satisfying the criteria set out in Part II of Schedule 2 if they so satisfy those criteria.
3
For sub-paragraph (a) of paragraph (2) of regulation 6 there shall be substituted the following sub-paragraph—
a
genetically modified organisms are cultured, stored, used, transported, destroyed or disposed of, where such organisms are or are contained in—
i
a product marketed in pursuance of either—
aa
a consent granted by the Department of the Environment for Northern Ireland under Article 8(1) of the Genetically Modified Organisms (Northern Ireland) Order 19918; or
bb
a written consent given by another competent authority of a member State in accordance with Article 13(4) of Council Directive 90/220/EEC9 on the deliberate release into the environment of genetically modified organisms; and
in either case, the operation is conducted in accordance with any conditions or limitations attached to that consent, or
ii
a medicinal product for human or veterinary use marketed in accordance with Council Regulation (EEC) No. 2309/9310; or
4
At the end of paragraph (2) of regulation 8 but before the full stop, there shall be inserted a comma followed by the words—
except that a separate notification shall not be required—
- a
where a consent has already been given under paragraph (3) for activities involving Group II micro-organisms and the premises are to be used for activities involving Group I micro-organisms; or
- b
where simultaneous notification is being given of an intention to use premises for activities involving both Group I and Group II micro-organisms
5
In sub-paragraphs (2)(b) and (4)(b) of regulation 9 for the words “Part III” in each place where they occur there shall be substituted the words “Part II”.
6
In paragraph 3(e) of Schedule 1 for the words “fulfil the criteria of Part III” there shall be substituted the words “satisfy the criteria of Part II”.
SCHEDULE 2Schedule to be Substituted as Schedule 2 to the Principal Regulations
SCHEDULE 2Criteria for the Classification of Genetically Modified Organisms
Part ICriteria for the classification of genetically modified organisms into Group I
A genetically modified micro-organism is classified into Group I when all of the following criteria are satisfied:—
1
The recipient or parental micro-organism is unlikely to cause disease to humans, animals or plants.
2
The nature of the vector and the insert is such that they do not endow the genetically modified micro-organism with a phenotype likely to cause disease to humans, animals or plants, or likely to cause adverse effects in the environment.
3
The genetically modified micro-organism is unlikely to cause disease to humans, animals or plants and is unlikely to cause adverse effects in the environment.
Part IICriteria for the classification of organisms other than micro-organisms
An organism which satisfies the criteria of this Part is a genetically modified organism—
a
which is not a micro-organism; and
b
which is as safe in the containment facility as any recipient or parental organism.
(This note is not part of the Regulations.)