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Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 2001

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Statutory Rules of Northern Ireland

2001 No. 295

HEALTH AND SAFETY

Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 2001

Made

6th August 2001

Coming into operation

25th September 2001

The Department of Enterprise, Trade and Investment(1), being a Department designated(2) for the purpose of section 2(2) of the European Communities Act 1972(3) in relation to the control and regulation of genetically modified organisms, in the exercise of the powers conferred on it by the said section 2(2) and, being the Department concerned(4), in exercise of the powers conferred by Articles 2(5), 17(1), (2), (3), (4) and (5)(5), 40(2) and (4) and 55(2) of, and paragraphs 1(1), (2), (4) and (5), 3(1), 4, 5(1), 7(2), 8, 10, 12(1) and (3), 13, 14(1), 15 and 19 of Schedule 3 to, the Health and Safety at Work (Northern Ireland) Order 1978(6) and of every other power enabling it in that behalf, and for the purpose of giving effect without modifications to proposals submitted to it by the Health and Safety Executive for Northern Ireland under Article 13(1A) of that Order(7) after the carrying out by the said Executive of consultations in accordance with Article 46(3) of that Order(8), hereby makes the following Regulations:

Part IInterpretation and General

Citation and commencement

1.  These Regulations may be cited as the Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 2001 and shall come into operation on 25th September 2001.

Interpretation

2.—(1) In these Regulations—

“the 1978 Order” means the Health and Safety at Work (Northern Ireland) Order 1978;

“accident” means an incident involving a significant and unintended release of genetically modified organisms in the course of an activity involving genetic modification which presents an immediate or delayed hazard to human health or to the environment;

“activity involving genetic modification” means a contained use;

“class”, in relation to an activity involving genetic modification of micro-organisms, means one of the four classes described in Schedule 1;

“competent authority” means the Department of the Environment and the Executive, acting jointly;

“contained use” means an activity in which organisms are genetically modified or in which genetically modified organisms are cultured, stored, transported, destroyed, disposed of or used in any other way and for which physical, chemical or biological barriers, or any combination of such barriers, are used to limit their contact with, and to provide a high level of protection for, humans and the environment;

EEA State” means a State, other than the United Kingdom, which is a Contracting Party to 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(9) and adopted as respects the United Kingdom by the European Economic Area Act 1993(10);

“emergency plan” means a plan required by virtue of regulation 20;

“emergency services” means the police, fire and ambulance services;

“the Executive” means the Health and Safety Executive for Northern Ireland;

“genetic modification” in relation to an organism means the altering of the genetic material in that organism in a way that does not occur naturally by mating or natural recombination or both and within the terms of this definition—

(a)

genetic modification occurs at least through the use of the techniques listed in Part I of Schedule 2; and

(b)

the techniques listed in Part II of Schedule 2 are not considered to result in genetic modification,

and “genetically modified” shall be construed accordingly;

“the Great Britain competent authority” means the joint competent authority defined in regulation 2(1) of the Genetically Modified Organisms (Contained Use) Regulations 2000(11);

“micro-organism” means a microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material, and includes a virus, a viroid, and an animal or plant cell in culture;

“notifier” means a person who has submitted a notification to the competent authority pursuant to regulation 9(1), 10(1), 11(1) or 12(1);

“organism” means a biological entity capable of replication or of transferring genetic material and includes a micro-organism, but does not include a human or a human embryo;

“territorial waters” means United Kingdom territorial waters adjacent to Northern Ireland and “within territorial waters” includes on, over and under them; and

“working day” means any day other than a Saturday, a Sunday, Christmas Day or Good Friday, or a bank holiday within the meaning given by the Banking and Financial Dealings Act 1971(12).

(2) In these Regulations—

(a)in relation to an activity involving genetic modification, any reference to an appropriate containment level is a reference to the containment level assigned to that activity in accordance with paragraphs 3(h) and 4 of Part II of Schedule 3; and

(b)any reference to an activity involving genetic modification in a numbered class is a reference to an activity involving genetic modification of micro-organisms which has been classified as belonging to the class of that number in accordance with paragraph 3(i) and (j) of Part II of Schedule 3.

(3) The provisions in—

(a)Part II of Schedule 8 shall be applied in accordance with Part I of that Schedule; and

(b)Tables 1a, 1b and 1c in Part II of Schedule 8 shall be applied in accordance with the notes set out at the end of the Table in question.

(4) The Interpretation Act (Northern Ireland) 1954(13) shall apply to these Regulations as it applies to an Act of the Northern Ireland Assembly.

Application

3.—(1) These Regulations shall have effect with a view to—

(a)protecting persons against risks to their health, whether immediate or delayed, arising from activities involving genetic modification of organisms; and

(b)protecting the environment against harm from activities involving genetic modification of micro-organisms.

(2) These Regulations (except regulation 17) shall not apply to the genetic modification of organisms solely by any of the techniques referred to in Part III of Schedule 2 nor to any organisms so modified.

(3) These Regulations shall not apply to any activity in which—

(a)genetically modified organisms are cultured, stored, transported, destroyed, disposed of or used, 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 under Article 8(1) of the Genetically Modified Organisms (Northern Ireland) Order 1991(14), or

(bb)a written consent given by the competent authority of an EEA State in accordance with Article 13(4) of Council Directive 90/220/EEC(15) on the deliberate release into the environment of genetically modified organisms,

and, in either case, that activity is conducted in accordance with any conditions or limitations attached to that consent,

(ii)a medicinal product for human or veterinary use marketed in accordance with Council Regulation (EEC) No. 2309/93(16), or

(iii)a novel food or novel food ingredient marketed in accordance with the provisions of Regulation (EC) No. 258/97 of the European Parliament and of the Council(17); or

(b)genetically modified organisms are released or marketed in cases or circumstances in which the consent of the Department of the Environment is required under Article 8(1) of the Genetically Modified Organisms (Northern Ireland) Order 1991.

(4) Regulations 8 to 15, 17(2) and (3), 18 and 19 shall not apply to the transport of genetically modified organisms by road, rail, inland waterway, sea or air.

(5) Regulation 6 shall apply to the transport of genetically modified organisms by road, rail, inland waterway, sea or air, except that, in making the assessment required by regulation 6(1), the person undertaking that assessment shall not be required to include the steps set out in paragraph 3(h) to (j) of Part II of Schedule 3.

(6) In this regulation, “product” means a product consisting of or containing a genetically modified organism or a combination of genetically modified organisms.

Meaning of “work” and “at work”

4.  For the purpose of these Regulations and Parts I and II of the 1978 Order, the meaning of “work” shall be extended to include any activity involving genetic modification and the meaning of “at work” shall be extended accordingly.

Modification of the Health and Safety at Work (Northern Ireland) Order 1978

5.—(1) Articles 4(1), (2) and (3) and 8 of the 1978 Order shall be modified in relation to an activity involving genetic modification so as to have effect as if the reference to an employer therein includes a reference to an educational establishment providing a course of study, and the reference to an employee therein includes a reference to a student of that educational establishment and that student shall be treated as the employee of that educational establishment, to the extent that the activity involving genetic modification is under the control of that educational establishment

(2) Section 5(2) of the 1978 Order shall be modified in relation to an activity involving genetic modification so as to have effect as if the reference in that section to a self-employed person is a reference to any person (except a student) who is not an employer or an employee and the reference in that section to his undertaking includes a reference to such an activity.

(3) In this regulation—

(a)“educational establishment” means a university, college, school or similar educational or technical institute; and

(b)“student” means any person studying at an educational establishment.

Part IIRisk assessment and notification of activities involving Genetic Modification

Risk assessment of activities involving genetically modified micro-organisms

6.—(1) A person shall not undertake any activity involving genetic modification of micro-organisms unless, before commencing that activity, he has ensured that a suitable and sufficient assessment of the risks created thereby to human health and the environment has been carried out.

(2) The person carrying out an assessment required by paragraph (1) shall take into account the matters set out in Part I of, and include the steps set out in Part II of, Schedule 3.

Risk assessment of activities involving genetically modified organisms other than micro-organisms

7.—(1) A person shall not undertake any activity involving genetic modification of organisms other than micro-organisms unless, before commencing that activity, he has ensured that a suitable and sufficient assessment of the risks created thereby to human health has been carried out.

(2) The person carrying out an assessment required by paragraph (1) shall take into account the matters set out in Part I of, and include the steps set out in Part II of, Schedule 4.

Review and recording of risk assessments

8.—(1) Where—

(a)there is reason to suspect that an assessment is no longer valid; or

(b)there has been a significant change in the activity involving genetic modification to which an assessment relates,

the person undertaking the activity involving genetic modification to which the assessment relates shall ensure that the assessment is reviewed forthwith.

(2) The person undertaking an activity involving genetic modification—

(a)shall keep a record of the assessment relating to that activity, and any review of that assessment, for at least 10 years from the date of the cessation of that activity; and

(b)shall make such record available to the competent authority when requested to do so.

(3) In this regulation, “assessment” means an assessment carried out for the purposes of regulation 6 or regulation 7.

Notification of the intention to use premises for the first time for activities involving genetic modification

9.—(1) A person shall not use premises for the first time for the purpose of undertaking an activity involving genetic modification, unless—

(a)he has submitted to the competent authority a notification informing it of his intention to do so and containing the information specified in Schedule 5; and

(b)he has received an acknowledgement from the Executive of receipt of that notification.

(2) Within 10 working days of the competent authority receiving a notification submitted in accordance with paragraph (1), the Executive shall send to the notifier an acknowledgement of receipt.

Notification of class 2 activities involving genetic modification of micro-organisms

10.—(1) Subject to the following paragraphs, a person shall not undertake an activity involving genetic modification of micro-organisms in class 2 unless he has submitted a notification to the competent authority informing it of his intention to do so and containing the information specified in Part I of Schedule 6.

(2) Within 10 working days of the competent authority receiving a notification submitted in accordance with paragraph (1), the Executive shall send to the notifier an acknowledgement of receipt.

(3) The competent authority shall ensure that any emergency plan has been prepared.

(4) A person shall not undertake—

(a)for the first time an activity referred to in paragraph (1) at the premises referred to in a notification submitted in accordance with that paragraph unless—

(i)at least 45 days, or such shorter period of time as the competent authority may approve in writing, have elapsed since the date on which the acknowledgement was sent in accordance with paragraph (2) and the competent authority has not within the said period of 45 days or the shorter period of time approved by the competent authority, as the case may be, informed the notifier that he shall not undertake the activity in question, or

(ii)he has received the acknowledgement required by paragraph (2) and consent for activities involving genetic modification in class 3 or 4 has already been granted in respect of the premises to which the notification submitted in accordance with paragraph (1) refers;

(b)for the second or subsequent times an activity referred to in paragraph (1) at the premises referred to in a notification submitted in accordance with that paragraph unless he has received the acknowledgement required by paragraph (2).

(5) Where a person submits a notification in accordance with paragraph (1) in respect of an activity referred to in that paragraph which is not to be undertaken for the first time at the premises referred to in the notification, with the notification that person may request that the competent authority makes a decision whether or not to agree to his undertaking the activity in question.

(6) The competent authority shall make a decision requested in accordance with paragraph (5) within 45 days of the date on which the acknowledgement was sent in accordance with paragraph (2).

Notification of class 3 or class 4 activities involving genetic modification of micro-organisms

11.—(1) Subject to the following paragraphs, a person shall not undertake an activity involving genetic modification of micro-organisms in class 3 or class 4 unless he has—

(a)submitted to the competent authority a notification informing it of his intention to do so and containing the information specified in Part II of Schedule 6; and

(b)received the written consent of the competent authority to undertake the activity in question.

(2) Within 10 working days of the competent authority receiving a notification submitted in accordance with paragraph (1), the Executive shall send to the notifier an acknowledgement of receipt.

(3) Where a person proposes to undertake an activity referred to in paragraph (1) for the first time at the premises referred to in a notification submitted in accordance with that paragraph, the competent authority shall inform that person in writing of its decision to grant or refuse consent to undertake the activity in question not more than 90 days after the acknowledgement was sent in accordance with paragraph (2).

(4) Where a person proposes to undertake an activity referred to in paragraph (1) for the second or subsequent times at the premises referred to in a notification submitted in accordance with that paragraph, the competent authority shall inform that person in writing of its decision to grant or refuse consent to undertake the activity in question not more than 45 days after the acknowledgement was sent in accordance with paragraph (2).

(5) Before granting a consent under either paragraph (3) or paragraph (4), the competent authority shall ensure that any emergency plan has been prepared.

(6) Before deciding whether to grant or refuse a consent under either paragraph (3) or paragraph (4), the competent authority shall take into account any representations made to it by any person within 30 days of the date on which the Executive sent the acknowledgement of receipt in accordance with paragraph (2).

(7) A consent granted pursuant to this regulation may be granted subject to conditions.

Notification of activities involving genetic modification of organisms other than micro-organisms

12.—(1) Subject to the following paragraphs, a person shall not undertake an activity involving genetic modification of organisms other than micro-organisms unless he has submitted to the competent authority a notification informing it of his intention to do so and containing the information specified in Part III of Schedule 6.

(2) Paragraph (1) shall not apply to an activity involving genetic modification of organisms where that genetic modification results in a genetically modified organism (other than a micro-organism) which poses no greater risk to humans than its unmodified parental organism.

(3) Within 10 working days of the competent authority receiving a notification submitted in accordance with paragraph (1), the Executive shall send to the notifier an acknowledgement of receipt.

(4) A person shall not undertake any activity referred to in paragraph (1), unless at least 45 days, or such shorter period of time as the competent authority may approve in writing, have elapsed since the date on which the acknowledgement was sent in accordance with paragraph (3) and the competent authority has not within the said period of 45 days or the shorter period of time approved by the competent authority, as the case may be, informed the notifier that he shall not undertake the activity in question.

Notification of connected programmes of work

13.—(1) The competent authority may accept a single notification submitted under regulation 10(1), 11(1) or 12(1) in respect of a connected programme of work undertaken by the same person at—

(a)one site; or

(b)more than one site.

(2) The competent authority may accept a single notification submitted under regulation 10(1), 11(1) or 12(1) in respect of a single activity involving genetic modification undertaken by the same person at more than one site.

(3) In this regulation—

(a)“connected programme of work” means a series of activities involving genetic modification which form a coherent and integrated programme;

(b)“site” means premises of which the competent authority has been notified in accordance with regulation 9(1).

Duties on receiving notifications and additional information

14.—(1) The competent authority shall examine a notification submitted under regulation 9(1), 10(1), 11(1) or 12(1) for—

(a)conformity with the requirements of these Regulations;

(b)the accuracy and completeness of the information provided;

(c)the correctness of the assessment carried out pursuant to regulation 6(1) or 7(1) and submitted to the competent authority with the notification;

(d)the adequacy of the waste management and emergency response measures submitted with the notification; and

(e)in the case of a notification submitted under regulation 10(1) or regulation 11(1), the correctness of the class assigned to the activity involving genetic modification of micro-organisms.

(2) For the purpose of carrying out an examination of a notification in accordance with paragraph (1), the Executive may in writing request the notifier to provide such additional information relating to the notification as it may specify, and, in such a case, when so requested by the Executive, the notifier shall not begin nor, subject to paragraph (3), continue, as the case may be, the activity involving genetic modification until the competent authority has given its approval in writing.

(3) Where the person who submitted a notification pursuant to regulation 9(1), 10(1), or 12(1) has commenced the activity involving genetic modification before the Executive requests additional information in accordance with paragraph (2)—

(a)the Executive may give to that person instructions concerning the cessation of the activity involving genetic modification;

(b)that person shall comply with any such instructions;

(c)subject to any such instructions, that person shall continue the activity involving genetic modification only to the extent necessary in order to store or destroy all genetically modified organisms resulting from the activity since its commencement.

(4) If requested to do so by the Department of the Environment, the Executive shall request additional information under paragraph (2).

(5) Within 10 working days, the Executive shall acknowledge receipt of all additional information provided in response to a request made by the Executive under paragraph (2).

(6) The period of time between the date when the Executive requests additional information in accordance with paragraph (2) and the date when the Executive receives that additional information shall not be taken into account in calculating the period of days referred to in regulations 10(4), 10(6), 11(3), 11(4) or 12(4), as the case may be.

(7) Where—

(a)a notifier under regulation 9(1) has not commenced any activity involving genetic modification, or a notifier under regulation 10(1), 11(1) or 12(1), has not commenced the activity relating to genetic modification to which his notification relates; and

(b)the Executive requests additional information pursuant to paragraph (2); and

(c)the notifier in question does not provide that information within a period of six months of the date on which the Executive sent the request,

the competent authority may return the notification to that notifier.

Additional provisions relating to notifications

15.—(1) The competent authority may at any time by notice in writing to the person undertaking or proposing to undertake an activity involving genetic modification—

(a)set a limit of time for, or impose conditions with regard to, that activity;

(b)require that person to suspend, to terminate or not to commence that activity, as the case may be;

(c)revoke or vary a consent granted to that person under regulation 11,

and the person to whom the notice is addressed shall comply with that notice.

(2) A notifier shall forthwith send to the competent authority full details in writing of—

(a)any change in the information specified in paragraphs (a), (d) or (e) of Schedule 5 and provided by him in accordance with regulation 9(1);

(b)any new building—

(i)added by the notifier to the premises notified by him in accordance with regulation 9(1), and

(ii)under his control;

(c)any decision by him no longer to use premises notified by him in accordance with regulation 9(1) for the purposes of undertaking any activity involving genetic modification;

(d)any cessation for the time being of all activity involving genetic modification at premises notified by him in accordance with regulation 9(1);

(e)any cessation of an activity involving genetic modification notified by him in accordance with regulation 10(1), 11(1) or 12(1);

(f)any re-commencement by him of an activity involving genetic modification at premises in respect of which details of a cessation had previously been given by him under sub-paragraph (d);

(g)any change in the information specified in—

(i)paragraphs (b) and (c) of Schedule 5 and provided by him in accordance with regulation 9(1), or

(ii)paragraph 1(c) or (d) of Part I of Schedule 6 and provided by him in accordance with regulation 10(1).

(3) Without prejudice to regulation 9(1) a notifier shall, in addition to the details referred to in paragraph (2), send full details in writing of any use by him of additional premises in connection with a single activity involving genetic modification carried on solely by him at more than one site, on condition that a notification has been submitted by him in accordance with regulation 9(1) in respect of the additional premises;

(4) Subject to paragraphs (5) and (6), where a notifier subsequently—

(a)makes a change in the premises or the activity involving genetic modification to which his notification relates which may have significant consequences for the risks arising from that activity; or

(b)becomes aware of any new information which may have significant consequences for the risks arising from that activity,

he shall forthwith send to the competent authority in writing full details of the change or the new information, as the case may be.

(5) Subject to paragraph (6), where a change referred to in paragraph (3)(a) would require a person to submit a notification in accordance with regulation 11(1), that person shall not make the change until—

(a)he has submitted a notification in accordance with that regulation; and

(b)he has received the written consent of the competent authority pursuant to regulation 11(1)(b).

(6) Paragraph (5) shall not apply where a person undertakes an activity involving genetic modification with the written consent of the competent authority granted pursuant to regulation 11(1)(b) and the change referred to in paragraph (4) would require that person to make a further notification under regulation 11(1).

(7) A notifier may withdraw his notification by giving written notice to the competent authority, provided that the notifier has not commenced the activity involving genetic modification to which the notification relates.

(8) In this regulation, the word “site” has the same meaning as it has in regulation 13.

(9) Anything required to be submitted or sent to the competent authority pursuant to these Regulations shall be submitted or sent in writing to the competent authority at 83 Ladas Drive, Belfast BT6 9FR.

Part IIIConduct of activities involving Genetic Modification

Establishment of a genetic modification safety committee

16.  A person who carries out an assessment pursuant to regulation 6 or 7 shall establish a genetic modification safety committee to advise him in relation to that assessment.

Principles of occupational and environmental safety

17.—(1) A person who undertakes an activity involving genetic modification shall ensure that—

(a)the exposure of humans and the environment to genetically modified micro-organisms is reduced to the lowest level that is reasonably practicable; and

(b)harm to humans arising from an activity involving genetic modification of organisms other than micro-organisms is reduced to the lowest level that is reasonably practicable.

(2) For any activity involving genetic modification of micro-organisms, the measures to be taken in order to comply with the duty under paragraph (1) shall include the general principles of good microbiological practice and of good occupational safety and hygiene set out in Schedule 7.

(3) For any activity involving genetic modification of organisms other than micro-organisms, the general principles set out in Schedule 7 shall be applied insofar as they are appropriate.

Containment and control measures for activities involving genetic modification of micro-organisms

18.—(1) Subject to paragraph (2), a person who undertakes an activity involving genetic modification of micro-organisms shall apply the containment measures set out in the applicable Table in Schedule 8, where and to the extent required in the column of the appropriate containment level.

(2) Where a risk assessment, or any review of that assessment carried out in accordance with regulation 8, shows that a particular containment measure of the appropriate containment level is not necessary for the activity involving genetic modification of micro-organisms to which the assessment relates, the person undertaking that activity, after providing full justification to, and with the written agreement of, the competent authority, need not apply that containment measure for the activity in question.

(3) A person who undertakes an activity involving genetic modification of micro-organisms shall review the containment measures applied by him in accordance with paragraph (1)—

(a)at suitably regular intervals; and

(b)forthwith if that person suspects that—

(i)the containment measures are no longer adequate,

(ii)the class in relation to the activity involving genetic modification of micro-organisms identified in the risk assessment is no longer appropriate, or

(iii)in the light of new scientific or technical knowledge, the risk assessment is no longer valid.

(4) In this regulation, “risk assessment” means an assessment carried out pursuant to regulation 6.

Containment and control measures for activities involving genetic modification of organisms other than micro-organisms

19.—(1) A person who undertakes an activity involving genetic modification of organisms other than micro-organisms shall apply the containment measures selected in accordance with the assessment made pursuant to regulation 7(1).

(2) That person shall review the containment measures applied by him in accordance with paragraph (1)—

(a)at suitably regular intervals; and

(b)forthwith if that person suspects that—

(i)the containment measures applied are no longer adequate, or

(ii)in the light of new scientific or technical knowledge, the assessment referred to in paragraph (1) is no longer valid.

Emergency plans

20.—(1) Where an assessment carried out pursuant to regulation 6(1) shows that, as a result of any reasonably foreseeable accident—

(a)the health or safety of persons outside the premises in which an activity involving genetic modification is carried on is liable to be seriously affected; or

(b)there is a risk of serious damage to the environment,

the person undertaking that activity shall ensure that, before the activity to which the assessment relates begins, a suitable plan is prepared with a view to securing the health and safety of those persons and the protection of the environment.

(2) Where an assessment carried out pursuant to regulation 7(1) shows that, as a result of any reasonably foreseeable accident, the health or safety of persons outside the premises in which an activity involving genetic modification is undertaken is liable to be seriously affected, the person undertaking that activity shall ensure that, before the activity to which the assessment relates begins, a suitable plan is prepared with a view to securing the health and safety of those persons.

(3) Every emergency plan—

(a)shall include the measures to be taken in the event of an accident to which the plan relates; and

(b)shall be reviewed and, where necessary, revised at suitably regular intervals.

(4) The person undertaking the activity involving genetic modification which is the subject of an emergency plan shall—

(a)inform the emergency services and any body or authority liable to be affected by an accident to which the plan relates of the contents of the plan and of any relevant revisions made in pursuance of paragraph (3); and

(b)make the plan and any such revisions publicly available.

Information relating to accidents

21.—(1) Where an accident occurs, the person undertaking the activity involving genetic modification shall forthwith inform the competent authority of the accident and shall provide the following information—

(a)the circumstances of the accident;

(b)the identity and quantity of the genetically modified organisms concerned;

(c)any information necessary to assess the effects of the accident on the health of the general population and on the environment; and

(d)any measures taken in response to the accident.

(2) Where the competent authority is informed of an accident in pursuance of paragraph (1), it shall—

(a)ensure that any necessary measures are taken;

(b)immediately inform those EEA States which could be affected by the accident;

(c)collect, where possible, the information necessary for a full analysis of the accident and, where appropriate, make recommendations to avoid similar accidents in the future and to limit their effects; and

(d)send to the European Commission—

(i)the information provided under paragraph (1)(a), (b) and (d),

(ii)information on the effectiveness of the measures taken in response to the accident, and

(iii)an analysis of the accident, including recommendations to limit its effects and to avoid similar accidents in the future.

Part IVDisclosure of Information and Publicity

Disclosure of information provided pursuant to regulations 9 to 15

22.—(1) The information provided pursuant to regulations 9 to 15 shall not be treated as relevant information for the purposes of Article 30 of the 1978 Order(18).

(2) Subject to paragraph (3), where, either in a notification submitted under regulation 9(1), 10(1), 11(1) or 12(1), or in response to a request made in pursuance of regulation 14(2) or when providing information in accordance with regulation 15(2), 15(3) or 15(4), a person indicates that he is providing information which should be kept confidential on one or more of the grounds set out in regulation 5(2)(a) to (c) and (e) of the Environmental Information Regulations (Northern Ireland) 1993(19)—

(a)that person shall give full justification for that indication to the competent authority; and

(b)after consulting that person, the competent authority shall decide which, if any, information shall be kept confidential and shall inform him of its decision.

(3) Subject to paragraph (8), paragraph (2) shall not apply to the following information, which shall not be kept confidential—

(a)the name and address of the notifier;

(b)in the case of a notification relating to an activity involving genetic modification of a micro-organism—

(i)the location of the activity,

(ii)the general characteristics of the genetically modified micro-organism,

(iii)the class of the activity involving genetic modification of the micro-organism,

(iv)the containment measures, and

(v)the evaluation of foreseeable effects, in particular any harmful effects on human health and the environment.

(4) Information which a notifier has indicated should be kept confidential and in relation to which the competent authority has not yet made a decision under paragraph (2)(b) and information which the competent authority has decided shall be kept confidential shall not be disclosed except—

(a)to the extent necessary to evaluate the notification;

(b)to the Department of Agriculture and Rural Development;

(c)to the Department of Enterprise, Trade and Investment;

(d)to the Great Britain competent authority; and

(e)to the European Commission.

(5) Where the competent authority has made a decision under paragraph (2)(b) that certain information shall not be kept confidential, that information shall not be disclosed until there has elapsed a period of 14 days following the day on which the competent authority informed the person providing the information of its decision except—

(a)to the extent necessary to evaluate the notification;

(b)to the Department of Agriculture and Rural Development;

(c)to the Department of Enterprise, Trade and Investment;

(d)to the Great Britain competent authority; or

(e)to the European Commission.

(6) A person who receives information by virtue of paragraph (4)(a) or (5)(a) shall not use that information except for the purposes of the competent authority.

(7) Information contained in a notification which has been withdrawn shall not be disclosed after the competent authority has received written notice in accordance with regulation 15(7).

(8) Notwithstanding paragraph (3), where the competent authority is satisfied on the basis of evidence submitted to it by the notifier and, where appropriate, after consultation with the notifier, that it is necessary to withhold, for the time being, certain of the information specified in paragraph (3) in order to protect his intellectual property rights, the competent authority shall withhold that information to the extent that, and for so long as, it is necessary to protect those rights.

(9) Subject to paragraph (10), where, pursuant to paragraph (2) or (8), a notifier has indicated that—

(a)he has provided confidential information; or

(b)withholding information is necessary in order to protect his intellectual property rights,

he shall forthwith inform the competent authority in writing of any change in circumstances which may affect the justification given under paragraph (2)(a) or the evidence submitted under paragraph (8), as the case may be.

(10) Paragraph (9) shall not apply if the competent authority has informed the notifier that the information in question is not to be kept confidential or withheld.

(11) Where—

(a)the competent authority has decided to keep information confidential pursuant to paragraph (2)(b) or has withheld information pursuant to paragraph (8); and

(b)the notifier has informed the competent authority of any change in circumstances pursuant to paragraph (9),

the competent authority shall, after consulting the notifier where appropriate, review whether the information in question should continue to be kept confidential or withheld and shall inform the notifier of the result of that review.

(12) For the purposes of this regulation, “general characteristics” in relation to a genetically modified micro-organism, means characteristics other than genus, species, genotype, serotype and strain.

Disclosure of information provided pursuant to regulation 21

23.—(1) The information provided pursuant to regulation 21 shall not be treated as relevant information for the purposes of Article 30 of the 1978 Order.

(2) Subject to paragraph (3), where a person indicates that information provided by him pursuant to regulation 21 should be kept confidential on one or more of the grounds set out in regulation 5(2)(a) to (c) and (e) of the Environmental Information Regulations (Northern Ireland) 1993—

(a)he shall give full justification for that indication to the competent authority; and

(b)after consulting that person, the competent authority shall decide which, if any, information shall be kept confidential and shall inform that person of its decision.

(3) Subject to paragraph (7), paragraph (2) shall not apply to the following information, which shall not be kept confidential—

(a)the name and address of the person providing the information;

(b)in the case of an accident relating to an activity involving genetic modification of a micro-organism—

(i)the location of the accident,

(ii)the general characteristics of genetic modification of the micro-organism,

(iii)the class of the activity involving genetic modification of the micro-organism,

(iv)the containment measures, and

(v)the evaluation of actual and foreseeable effects, in particular any harmful effects on human health and the environment.

(4) Information which the person providing that information has indicated should be kept confidential and in relation to which the competent authority has not yet made a decision under paragraph (2)(b) and information which the competent authority has decided shall be kept confidential shall not be disclosed except to the extent necessary to enable the competent authority to comply with its obligations under regulation 21(2).

(5) Where the competent authority has made a decision under paragraph (2)(b) that certain information shall not be kept confidential, that information shall not be disclosed until there has elapsed a period of 14 days following the day on which the competent authority informed the person providing the information of its decision, except to the extent necessary to enable the competent authority to comply with its obligations under regulation 21(2).

(6) A person who receives information by virtue of paragraph (4) or (5) shall not use that information except for the purposes of the competent authority.

(7) Notwithstanding paragraph (3), where the competent authority is satisfied on the basis of detailed evidence submitted to it by the person providing the information and, where appropriate, after consultation with that person, that it is necessary to withhold, for the time being, certain of the information specified in paragraph (3) in order to protect his intellectual property rights, the competent authority shall withhold that information to the extent that, and for so long as, it is necessary to protect those rights.

(8) Subject to paragraph (9), where, pursuant to paragraph (2) or (7), a person has indicated—

(a)that certain information is confidential; or

(b)withholding information is necessary in order to protect his intellectual property rights,

he shall forthwith inform the competent authority in writing of any change in circumstances which may affect the justification given under paragraph (2)(a) or the evidence submitted under paragraph (7), as the case may be.

(9) Paragraph (8) shall not apply if the competent authority has informed the person providing the information that the information in question is not be be kept confidential or withheld.

(10) Where—

(a)the competent authority has decided to keep information confidential pursuant to paragraph (2)(b) or has withheld information pursuant to paragraph (7); and

(b)the person who provided the information has informed the competent authority of a change in circumstances pursuant to paragraph (8),

the competent authority shall, after consulting that person where appropriate, review whether the information in question should continue to be kept confidential, and shall inform that person of the result of that review.

(11) In this regulation, “general characteristics” in relation to a genetically modified micro-organism has the same meaning as it has in regulation 22.

Register of notifications

24.—(1) The competent authority shall maintain a register of every notification submitted under regulations 9 to 12.

(2) The register referred to in paragraph (1) shall contain—

(a)in relation to every notification submitted under regulations 9 to 12—

(i)the name, address and telephone number and any fax number and any e-mail address of the notifier,

(ii)the date on which the receipt of the notification was acknowledged by the Executive, and

(iii)if the competent authority receives details of a matter referred to in sub-paragraphs (a) to (f) of regulation 15(2) or in regulation 15(3) or regulation 15(4), confirmation that such details have been received;

(b)in relation to each notification submitted under regulation 10(1), 11(1) or 12(1), the date of any cessation of the activity involving genetic modification to which the notification relates.

(3) The register referred to in paragraph (1) shall also contain—

(a)in relation to each notification submitted under regulation 9(1)—

(i)the information specified in paragraphs (d) to (g), (h)(ii) and (h)(iii) of Schedule 5, and

(ii)if the competent authority has been informed of an accident under regulation 21 at the premises to which the notification relates, confirmation that the information has been received;

(b)in relation to each nofication submitted under regulation 10(1), the information specified in paragraph 1(e) to (l) of Part I of Schedule 6;

(c)in relation to each notification submitted under regulation 11(1)—

(i)the information specified in paragraph 2(e) to (m) of Part II of Schedule 6 and,

(ii)if appropriate, confirmation that a consent under regulation 11(3) or regulation 11(4), as the case may be, has been granted;

(d)in relation to each notification submitted under regulation 12(1), the information specified in paragraph 3(e) to (k) of Part III of Schedule 6,

but the register shall not contain any information which the competent authority has decided shall be kept confidential under regulation 22(2)(b) or shall be withheld under regulation 22(8).

(4) Information shall be entered in the register within 14 days of its receipt by the competent authority, except that, where a notifier has requested that certain information—

(a)be kept confidential in accordance with regulation 22(2); or

(b)be withheld in accordance with regulation 22(8),

that information shall be entered in the register not less than 14 days and not more than 28 days following the day on which the competent authority informed the notifier of its decision not to keep that information confidential or not to withhold that information, as the case may be.

(5) Where a person withdraws a notification under regulation 15(7), information relating to that notification, which has been entered in the register, shall be removed from the register by the competent authority.

(6) The competent authority may remove from the register—

(a)information relating to an activity involving genetic modification ten years after being notified in accordance with regulation 15(2)(d) or (e) that the activity has ceased; and

(b)information relating to premises ten years after being notified in accordance with regulation 15(2)(c) of a decision no longer to use such premises for the purposes of undertaking any activity involving genetic modification.

(7) Copies of the register shall be maintained at the offices of the Executive at 83 Ladas Drive, Belfast BT6 9FR.

(8) The copies of the register shall be open to inspection by members of the public at any reasonable time.

Part VMiscellaneous and General

Exemption certificates

25.—(1) Subject to paragraph (2), the competent authority may, by a certificate in writing, exempt—

(a)any person or class of persons; or

(b)any genetically modified organism or class of genetically modified organisms,

from all or any of the requirements of, or prohibitions imposed by, these Regulations and any such exemption may be granted subject to conditions and to a limit of time and may be revoked by a certificate in writing at any time.

(2) The competent authority shall not grant an exemption unless, having regard to the circumstances of the case and in particular to—

(a)the conditions, if any, that it proposes to attach to the exemption; and

(b)any requirements imposed by or under any enactments which apply to the case,

it is satisfied about the matters referred to in paragraph (3).

(3) The matters about which the competent authority shall be satisfied for the purposes of paragraph (2) are—

(a)that the health and safety of persons who are likely to be affected by the exemption will not be prejudiced in consequence of it; and

(b)that the environment will not be prejudiced in consequence of the exemption where the exemption is concerned with a requirement of, or a prohibition imposed by, these Regulations which relates to an activity involving genetic modification of a micro-organism.

Enforcement and civil liability

26.—(1) Subject to paragraph (2) and to the extent they would not otherwise do so, the provisions of—

(a)Articles 18 to 28 (approved codes of practice and enforcement), Articles 31 to 39 (provisions as to offences) and Article 43 (civil liability) of the 1978 Order(20); and

(b)the Health and Safety (Training for Employment) Regulations (Northern Ireland) 1994(21),

shall apply to these Regulations as if they were health and safety regulations for the purposes of that Order.

(2) A failure to discharge a duty placed on the competent authority or the Executive by these Regulations shall not be an offence, and Article 31(1)(c) of the 1978 Order shall have effect accordingly.

(3) Notwithstanding regulation 4 of the Health and Safety (Enforcing Authority) Regulations (Northern Ireland) 1999(22), the enforcing authority for these Regulations shall be the Executive.

Fees for notifications and applications

27.—(1) The fee specified in column 2 of the table in Schedule 9 shall be payable by a notifier to the competent authority in relation to any notification or application referred to in the corresponding entry in column 1 of that table.

(2) No fee shall be returned to a notifier where the competent authority returns a notification pursuant to regulation 14(7) or a notifier withdraws his notification pursuant to regulation 15(7).

Transitional provisions

28.  Schedule 10 shall have effect.

Appeals

29.—(1) Any person who is aggrieved by a decision of the competent authority—

(a)that he shall not undertake an activity involving genetic modification referred to in regulation 10(1), 11(1) or 12(1);

(b)not to agree pursuant to regulation 18(2) that he need not apply a particular containment measure for the activity involving genetic modification in question;

(c)to revoke an exemption certificate granted to him pursuant to regulation 25(1);

(d)to grant to him an exemption certificate subject to a condition or a limit of time pursuant to regulation 25(1),

may appeal to the Department of Enterprise, Trade and Investment.

(2) Any person who is aggrieved by—

(a)a request to him made pursuant to regulation 14(2);

(b)an instruction given to him pursuant to regulation 14(3);

(c)a notice given to him pursuant to regulation 15(1),

may appeal to the Department of Enterprise, Trade and Investment.

(3) Any person who is aggrieved by a decision of the competent authority—

(a)made pursuant to regulation 22(2)(b) or regulation 23(2)(b), not to keep confidential information provided by that person to the competent authority in accordance with these Regulations;

(b)made pursuant to regulation 22(8) or regulation 23(7), not to withhold information,

may appeal to the Department of Enterprise, Trade and Investment.

(4) Chapter I of the Schedule to the Deregulation (Model Appeal Provisions) Order (Northern Ireland) 1997(23) shall apply to any appeal made under paragraphs (1) to (3).

(5) Where an appeal is brought under this regulation, none of the following, that is to say—

(a)a decision of the competent authority other than a decision referred to in paragraph (3);

(b)an instruction given pursuant to regulation 14(3);

(c)the operation of paragraphs (2) or (6) of regulation 14;

(d)a notice given pursuant to regulation 15(1),

shall be suspended pending the final determination of the appeal.

(6) Where an appeal is brought under paragraph (3) in respect of any information provided pursuant to regulation 21, pending the final determination of the appeal, the information shall not be disclosed except to the extent necessary to enable the competent authority to comply with its obligations under paragraph (2)(a), (b) and (d) of that regulation.

(7) Where an appeal is brought under paragraph (3) in respect of information provided pursuant to regulations 9 to 15—

(a)pending the final determination of the appeal, the information shall not be disclosed except—

(i)to the extent necessary to evaluate the notification;

(ii)to the Department of Agriculture and Rural Development;

(iii)to the Great Britain competent authority; or

(iv)to the European Commission.

(b)if—

(i)the appeal is finally determined in favour of the competent authority, and

(ii)the information is required to be entered in the register maintained in accordance with regulation 24,

the information shall be entered in that register within 14 days following the day on which the appeal is finally determined.

Application within territorial waters

30.  Within territorial waters these Regulations shall apply only to or in relation to the premises and activities to which any of paragraphs 2 to 6 of Schedule 11 applies.

Revocations, amendments and savings

31.—(1) The following are revoked—

(a)the Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 1994(24);

(b)the Genetically Modified Organisms (Contained Use) (Amendment) Regulations (Northern Ireland) 1996(25);

(c)the Genetically Modified Organisms (Contained Use) (Amendment) Regulations (Northern Ireland) 1999(26).

(2) In paragraph (3)(d) of regulation 8 of the Genetically Modified Organisms (Deliberate Release) Regulations (Northern Ireland) 1994(27), for the words “under regulation 11 of the Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 1994”, there shall be substituted the words “under regulation 16 of the Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 2001”.

(3) The Genetically Modified Organisms (Risk Assessment) (Records and Exemptions) Regulations (Northern Ireland) 1996(28) shall be amended as follows—

(a)in regulation 2(1), in the definition of “the Contained Use Regulations”, for the words “the Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 1994”, there shall be substituted the words “the Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 2001”;

(b)in paragraph (2)(b)(i) of regulation 4, for the words “Schedule 1”, there shall be substituted the words “Schedule 2”; and

(c)in paragraph (2)(b)(ii) of regulation 4, for the words “regulation 3(3) of, and Part III of Schedule 1” there shall be substituted the words “regulation 3(2) of, and Part III of Schedule 2”.

(4) In the Health and Safety (Fees) Regulations (Northern Ireland) 1998(29), regulation 10 and Schedule 7 shall be omitted.

(5) In paragraph 12(5) of Schedule 3 to the Control of Substances Hazardous to Health Regulations (Northern Ireland) 2000(30), for the words “Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 1994”, there shall be substituted the words “Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 2001”.

(6) Every record required to be kept under regulation 7(5) of the Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 1994 shall, notwithstanding paragraph (1), be kept in the same manner and for the same period as specified in that regulation as if these Regulations had not been made.

Sealed with the Official Seal of the Department of Enterprise, Trade and Investment on 6th August 2001.

L.S.

Michael J. Bohill

A senior officer of the

Department of Enterprise, Trade and Investment

Regulation 2(1)

SCHEDULE 1Classes of activity involving genetic modification

ClassDescription
1Activities of no or negligible risk, for which containment level 1 is appropriate to protect human health and the environment
2Activities of low risk, for which containment level 2 is appropriate to protect human health and the environment
3Activities of moderate risk, for which containment level 3 is appropriate to protect human health and the environment
4Activities of high risk, for which containment level 4 is appropriate to protect human health and the environment.

Regulations 2(1) and 3(2)

SCHEDULE 2

Part IExamples of techniques constituting genetic modification

1.  Examples of the techniques which constitute genetic modification which are referred to in sub-paragraph (a) of the definition of “genetic modification” in regulation 2(1) are—

(a)recombinant nucleic acid techniques involving the formation of new combinations of genetic material by the insertion of nucleic acid molecules, produced by whatever means outside an organism, into any virus, bacterial plasmid or other vector system and their incorporation into a host organism in which they do not naturally occur but in which they are capable of continued propagation;

(b)techniques involving the direct introduction into an organism of heritable genetic material prepared outside the organism, including micro-injection, macro-injection and micro-encapsulation;

(c)cell fusion or hybridization techniques where live cells with new combinations of heritable genetic material are formed through the fusion of two or more cells by means of methods that do not occur naturally.

Part IITechniques which are not considered to result in genetic modification

2.  The following techniques are not considered to result in genetic modification provided that they do not involve the use of genetically modified organisms made by techniques other than those listed in Part III or the use of recombinant nucleic acid molecules, namely—

(a)in vitro fertilisation;

(b)natural processes including conjugation, transduction or transformation;

(c)polyploidy induction.

Part IIITechniques to which these regulations do not apply

3.  These Regulations (except regulation 17) shall not apply to the following techniques of genetic modification, provided that they do not involve the use of recombinant nucleic acid molecules or of genetically modified organisms other than those recombinant nucleic acid molecules or genetically modified organisms produced by one or more of the following techniques of genetic modification—

(a)mutagenesis;

(b)cell fusion (including protoplast fusion) of prokaryotic species which can exchange genetic material through homologous recombination;

(c)cell fusion (including protoplast fusion) of cells of any eukaryotic species, including production of hybridomas and plant cell fusions;

(d)self-cloning, where the resulting organism is unlikely to cause disease or harm to humans, animals or plants.

4.  In paragraph 3—

(a)“self-cloning” means the removal of nucleic acid sequences from a cell of an organism which may or may not be followed by reinsertion of all or part of that nucleic acid (or a synthetic equivalent), whether or not altered by enzymic or mechanical processes, into cells of the same species or into cells of phylogenetically closely related species which can exchange genetic material by homologous recombination; and

(b)self-cloning may include the use of recombinant vectors, with an extended history of safe use in the particular organism, to manipulate and reinsert the nucleic acid sequences, but the vectors shall not consist of any genetic elements other than those designed for vector structure, vector replication, vector maintenance or marker genes.

Regulations 2(2), 3(5) and 6(2)

SCHEDULE 3

Part IMatters to be taken into account in carrying out an assessment for the purposes of regulation 6

1.  The following matters shall be taken into account in carrying out an assessment for the purposes of regulation 6—

(a)any potentially harmful effects, in particular those associated with—

(i)the recipient micro-organism,

(ii)the inserted genetic material (originating from the donor organism),

(iii)the vector,

(iv)the donor micro-organism (where that donor micro-organism is used during the activity involving genetic modification), and

(v)the resulting genetically modified micro-organism;

(b)the characteristics of the activity;

(c)the severity of the potentially harmful effects; and

(d)the likelihood of the potentially harmful effects being realised.

2.  In paragraph 1, “potentially harmful effects” includes—

(a)disease to humans including allergenic or toxic effects;

(b)disease to animals or plants;

(c)adverse effects resulting from the inability to treat disease or offer an effective prophylaxis;

(d)adverse effects resulting from establishment or dissemination of the genetically modified micro-organisms in the environment;

(e)adverse effects resulting from the natural transfer of genetic material to or from other organisms;

(f)adverse effects resulting from the likely interaction of the genetically modified micro-organism with other organisms at the premises where the activity involving genetic modification is to be conducted.

Part IISteps to be included when carrying out an assessment for the purposes of regulation 6

3.  An assessment carried out for the purposes of regulation 6 shall include—

(a)identification of any harmful properties of the recipient and, where appropriate, the donor micro-organism;

(b)identification of any harmful properties associated with the vector or inserted material, including any alteration in the recipient’s existing properties;

(c)consideration of relevant Community legislation, including Council Directive 90/679/EEC(31) on the protection of workers from risks related to exposure to biological agents at work, other classification schemes referring to plant and animal pathogens, and other international and national classification schemes for genetically modifed micro-organisms;

(d)identification of the provisional level of risk associated with the genetically modified micro-organism;

(e)consideration of—

(i)the characteristics of the environment likely to be exposed,

(ii)the characteristics of the activity involving genetic modification of micro-organisms, and

(iii)any activities involving genetic modification of micro-organisms which cannot be adequately controlled by standard laboratory procedures, and which present risks which require controls for each individual case;

(f)adjustment of the provisional level of risk in the light of the matters referred to in sub-paragraph (e);

(g)selection of the appropriate containment measures from those specified in the applicable Table in Schedule 8 on the basis of the provisional level of risk as adjusted in accordance with sub-paragraph (f);

(h)assignment of the activity involving genetic modification of micro-organisms to the appropriate containment level, in accordance with paragraph 4;

(i)classification of that activity in the class of the same number as that of the appropriate containment level; and

(j)review and reconsideration of that classification in the light of the completed assessment.

4.  To assign an activity involving genetic modification of micro-organisms to the appropriate containment level for the purposes of paragraph 3(h), the person carrying out the assessment for the purposes of regulation 6 shall—

(a)first identify for each selected containment measure the column in the applicable Table in Schedule 8 having the lowest number in which that selected containment measure is shown as being required, regardless of whether or not such requirement is subject to any qualification;

(b)then select the highest number of all the columns identified in accordance with sub-paragraph (a); and

(c)then assign the activity involving genetic modification in question to the containment level of that highest number.

5.  In paragraph 4, “selected containment measure” means an appropriate containment measure selected in accordance with paragraph 3(g).

Regulation 7(2)

SCHEDULE 4

Part IMatters to be taken into account in carrying out an assessment for the purposes of regulation 7

1.  The following matters shall be taken into account in carrying out an assessment for the purposes of regulation 7—

(a)the identification of any potentially harmful effects, in particular those associated with—

(i)the recipient organism,

(ii)the inserted genetic material (originating from the donor organism),

(iii)the vector,

(iv)the donor organism, and

(v)the resulting genetically modified organism;

(b)the characteristics of the activity involving genetic modification;

(c)the severity of the potentially harmful effects; and

(d)the likelihood of the potentially harmful effects being realised.

2.  In paragraph 1, “potentially harmful effects” includes—

(a)disease to humans including allergenic or toxic effects;

(b)acting as a human disease vector or reservoir;

(c)adverse effects to humans arising from change in behaviour or in physical nature;

(d)adverse effects arising from the inability to treat human disease or offer effective prophylaxis.

Part IISteps to be included when carrying out an assessment for the purposes of regulation 7

3.  An assessment carried out for the purposes of regulation 7 shall include—

(a)identification of the harmful properties of the recipient and, where appropriate, the donor organism;

(b)identification of any harmful properties associated with the vector or inserted material, including any alteration in the existing properties of the recipient;

(c)identification of the provisional level of risk associated with the genetically modified organisms;

(d)selection of containment and other protective measures on the basis of—

(i)the provisional level of risk, and

(ii)the characteristics of the activity involving genetic modification;

(e)adjustment of the level of risk in the light of the matters referred to in sub-paragraph (d); and

(f)review and reconsideration of the containment and other protective measures in the light of the steps required by sub-paragraphs (a) to (e).

Regulations 9(1), 15(2), 15(3) and 24(3)

SCHEDULE 5Information required for a notification under regulation 9(1)

A notification required for the purposes of regulation 9(1) shall contain the following information—

(a)the name, address and telephone number and any fax number and any e-mail address of the notifier;

(b)the name of the employee of the notifier with specific responsibility for the supervision and safety of activities involving genetic modification;

(c)information on the training and qualifications of that employee;

(d)details of the genetic modification safety committee established pursuant to regulation 16;

(e)the address of the premises where the activity involving genetic modification is to be carried out and a general description of the premises;

(f)the nature of the work to be undertaken;

(g)the class of any activity involving genetic modification of micro-organisms;

(h)where the first activity to be carried out in those premises is an activity involving genetic modification in class 1—

(i)a summary of the assessment of that activity made for the purposes of regulation 6(1),

(ii)any advice received in relation to that assessment from the genetic modification safety committee established pursuant to regulation 16,

(iii)information on waste management, and

(iv)confirmation that the emergency services and any body or authority liable to be affected by an accident to which any emergency plan relates will be informed of the contents of the emergency plan and of any relevant revisions made in pursuance of regulation 20(3); and

(i)where the first activity to be carried out in those premises involves genetic modification of organisms which are not micro-organisms and that activity is not notifiable under regulation 12(1)—

(i)a copy of the assessment made for the purposes of regulation 7(1), and

(ii)confirmation that the emergency services and any body or authority liable to be affected by an accident to which any emergency plan relates will be informed of the contents of the plan and of any relevant revisions made in pursuance of regulation 20(3).

Regulations 10(1), 11(1), 12(1), 15(2), 15(3) and 24(3)

SCHEDULE 6

Part IInformation required for a notification under regulation 10(1)

1.  A notification required for the purposes of regulation 10(1) shall contain the following information—

(a)the name, address and telephone number and any fax number and any e-mail address of the notifier;

(b)the centre number allocated by the competent authority in respect of the premises at which the activity involving genetic modification of micro-organisms is to be undertaken and the date of the notification required by regulation 9(1) relating to those premises;

(c)the name of the employee of the notifier with specific responsibility for supervision and safety;

(d)information on the training and qualifications of that employee;

(e)the recipient or parental micro-organism to be used;

(f)the donor micro-organism to be used;

(g)where applicable, the host-vector system to be used;

(h)the source and intended function of the genetic material involved in the modification;

(i)the identity and characteristics of the genetically modified micro-organism;

(j)the purpose of the activity involving genetic modification of micro-organisms, including its expected results;

(k)the approximate culture volumes to be used;

(l)a description of the containment and other protective measures to be applied, including—

(i)information on waste management, including the type and form of wastes to be generated, their treatment, ultimate form and destination, and

(ii)justification for not applying any containment measure at containment level 2;

(m)a copy of the assessment carried out pursuant to regulation 6(1);

(n)any advice received in relation to that assessment from the genetic modification safety committee established pursuant to regulation 16;

(o)the information necessary for the competent authority to evaluate any emergency plan; and

(p)confirmation that the emergency services and any body or authority liable to be affected by an accident to which any emergency plan relates will be informed of the contents of the plan and of any relevant revisions made in pursuance of regulation 20(3).

Part IIInformation required for a notification under regulation 11(1)

2.  A notification required for the purposes of regulation 11(1) shall contain the following information—

(a)the name, address and telephone number and any fax number and any e-mail address of the notifier;

(b)the centre number allocated by the competent authority in respect of the premises at which the activity involving genetic modification of micro-organisms is to be undertaken and the date of the notification required by regulation 9(1) relating to those premises;

(c)the name of the employee of the notifier with specific responsibility for supervision and safety;

(d)information on the training and qualifications of that employee;

(e)the recipient or parental micro-organism to be used;

(f)the donor micro-organism to be used;

(g)where applicable, the host-vector system to be used;

(h)the source and intended function of the genetic material involved in the modification;

(i)the identity and characteristics of the genetically modified micro-organism;

(j)the culture volumes to be used;

(k)a description of the containment and other protective measures to be applied, including—

(i)information on waste management, including the type and form of wastes to be generated, their treatment, ultimate form and destination,

(ii)in the case of activities involving genetic modification of micro-organisms in class 3, justification for not applying any containment measure at containment level 3, and

(iii)in the case of activities involving genetic modification of micro-organisms in class 4, justification for not applying any containment measure at containment level 4;

(l)the purpose of the activity involving genetic modification of micro-organisms, including its expected results;

(m) a description of the parts of the installation;

(n)information on any accident prevention and emergency plans, including—

(i)any specific hazards arising from the location of the installation,

(ii)the preventive measures applied, including safety equipment, alarm systems and containment methods,

(iii)procedures and plans for verifying the continuing effectiveness of the containment measures,

(iv)a description of the information provided to workers,

(v)the information necessary for the competent authority to evaluate any emergency plan, and

(vi)confirmation that the emergency services and any body or authority liable to be affected by an accident to which any emergency plan relates will be informed of the contents of the plan and of any relevant revisions made in pursuance of regulation 20(3); and

(o)a copy of the assessment referred to in regulation 6(1).

Part IIIInformation required for a notification under regulation 12(1)

3.  A notification required for the purposes of regulation 12(1) shall contain the following information—

(a)the name, address and telephone number and any fax number and any e-mail address of the notifier;

(b)the centre number allocated by the competent authority in respect of the premises at which the activity involving genetic modification of organisms other than micro-organisms is to be undertaken and the date of the notification required by regulation 9(1) relating to those premises;

(c)the name of the employee of the notifier with specific responsibility for supervision and safety;

(d)information on the training and qualifications of that employee;

(e)the recipient or parental organism to be used;

(f)the donor organism to be used;

(g)where applicable, the host-vector system to be used;

(h)the sources and intended functions of the genetic material involved in the modification;

(i)the identity and characteristics of the genetically modified organism;

(j)the purpose of the activity involving genetic modification of organisms other than micro-organisms, including its expected results;

(k)a description of the containment and other protective measures to be applied, including information on waste management, including the type and form of wastes to be generated, their treatment, ultimate form and destination;

(l)a copy of the assessment referred to in regulation 7(1);

(m)the information necessary for the competent authority to evaluate any emergency plan; and

(n)confirmation that the emergency services and any body or authority liable to be affected by an accident to which any emergency plan relates will be informed of the contents of that plan and of any relevant revisions made in pursuance of regulation 20(3).

Regulation 17(2) and (3)

SCHEDULE 7General principles of good microbiological practice and of good occupational safety and hygiene

The general principles of good microbiological practice and of good occupational safety and hygiene are as follows—

(a)keeping workplace and environmental exposure to any genetically modified micro-organism to the lowest reasonably practicable level;

(b)exercising engineering control measures at source and supplementing these with appropriate personal protective clothing and equipment where necessary;

(c)testing adequately and maintaining control measures and equipment;

(d)testing, where necessary, for the presence of viable process organisms outside the primary physical containment;

(e)providing appropriate training of personnel;

(f)formulating and implementing local codes of practice for the safety of personnel, as required;

(g)displaying biohazard signs where appropriate;

(h)providing washing and decontamination facilities for personnel;

(i)keeping adequate records;

(j)prohibiting in the work area eating, drinking, smoking, applying cosmetics or the storing of food for human consumption;

(k)prohibiting mouth pipetting;

(l)providing written standard operating procedures where appropriate to ensure safety;

(m)having effective disinfectants and specified disinfection procedures available in case of spillage of genetically modified micro-organisms; and

(n)providing safe storage for contaminated laboratory equipment and materials where appropriate.

Regulations 2(3) and 18(1)

SCHEDULE 8Containment measures

Part I

1.  In this Schedule—

GMMs” means genetically modified micro-organisms;

HEPA” means High Efficiency Particulate Air;

“inactivation” means the complete or partial destruction of GMMs so as to ensure that any contact between the GMMs and humans or the environment is limited to an extent commensurate with the risks identified in the risk assessment and to provide a high level of protection for humans and the environment;

“plant growth facilities” means a structure, whether permanent or impermanent, designed and used principally for growing plants in a controlled and protected environment; and

“risk assessment” means the assessment carried out in accordance with regulation 6.

2.  For the purposes of this Schedule, where, in the final column of Table 1b or Table 1c, a measure is specified as—

(a)a modification, it shall be read in substitution for the relevant measure in Table 1a;

(b)additional, it shall be read as an addition to the measures in Table 1a, subject to the substitution, where appropriate, of an individual measure in Table 1a by a measure specified as a modification in the Table in question.

3.  For the purposes of this Schedule—

(a)Table 1a describes containment measures applicable to activities involving genetic modification of micro-organisms in laboratories;

(b)Table 1a, read with Table 1b, describes containment measures applicable to activities involving genetic modification of micro-organisms in plant growth facilities;

(c)Table 1a, read with Table 1c, describes containment measures applicable to activities involving genetic modification of micro-organisms in animal units;

(d)Table 2 describes containment measures applicable to activities involving genetic modification of micro-organisms in premises other than those referred to in Tables 1a, 1b and 1c.

Part II

Table 1a:

Containment measures for activities involving genetic modification of micro-organisms in laboratories

Containment MeasuresContainment Levels
1234

NOTES

1.

In the Table above, “isolation” means, in relation to a laboratory, separation of the laboratory from other areas in the same building, or being in a separate building.

2.

Entry must be through an airlock which is a chamber isolated from the laboratory. The clean side of the airlock must be separated from the restricted side by changing or showering facilities and preferably by interlocking doors.

3.

Where viruses are not retained by the HEPA filters, extra requirements will be necessary for extract air.

4.

Where the autoclave is outside the laboratory in which the activity involving genetic modification of micro-organisms is being undertaken, but within the laboratory suite, there shall be validated procedures for the safe transfer of material into that autoclave, which provide a level of protection equivalent to that which would be achieved by having an autoclave in that laboratory.

1  Laboratory suite: isolation (Note 1)

not requirednot requiredrequiredrequired

2  Laboratory: sealable for fumigation

not requirednot requiredrequiredrequired
Equipment

3  Surfaces impervious to water, resistant to acids, alkalis, solvents, disinfectants and decontamination agents and easy to clean

required for benchrequired for benchrequired for bench and floorrequired for bench, floor ceiling and walls

4  Entry to lab via airlock (Note 2)

not requirednot requiredrequired where and to extent the risk assessment shows it is requiredrequired

5  Negative pressure relative to the pressure of the immediate surroundings

not requiredrequired where and to extent the risk assessment shows it is requiredrequiredrequired

6  Extract and input air from the laboratory shall be HEPA filtered

not requirednot requiredHEPA filters required for extract airHEPA filters required for input and extract air (Note 3)

7  Microbiological safety cabinet/enclosure

not requiredrequired where and to extent the risk assessment shows it is requiredrequired, and all procedures with infective materials required to be contained within a cabinet/ enclosureClass III cabinet required

8  Autoclave

required on siterequired in the buildingrequired in the laboratory suite (Note 4)double ended autoclave required in laboratory
System of work

9  Access restricted to authorised personnel only

not requiredrequiredrequiredrequired (via airlock key procedure)

10  Specific measures to control aerosol dissemination

not requiredrequired so as to minimiserequired so as to preventrequired so as to prevent

11  Shower

not requirednot requiredrequired where and to extent the risk assessment shows it is requiredrequired

12  Protective clothing

suitable protective clothing requiredsuitable protective clothing requiredsuitable protective clothing required; footwear required where and to extent the risk assessment shows it is requiredcomplete change of clothing and footwear required before entry and exit

13  Gloves

not requiredrequired where and to extent the risk assessment shows they are requiredrequiredrequired

14  Efficient control of disease vectors (eg rodents and insects) which could disseminate GMMs

required where and to extent the risk assessment shows it is requiredrequiredrequiredrequired

15  Specified disinfection procedures in place

required where and to extent the risk assessment shows they are requiredrequiredrequiredrequired
Waste

16  Inactivation of GMMs in effluent from handwashing sinks and showers and similar effluents

not requirednot requiredrequired where and to extent the risk assessment shows it is requiredrequired

17  Inactivation of GMMs in contaminated material and waste

required by validated meansrequired by validated meansrequired by validated meansrequired by validated means
Other measures

18  Laboratory to contain its own equipment

not requirednot requiredrequired, so far as is reasonably practicablerequired

19  An observation window or alternative is to be present so that occupants can be seen

required where and to extent the risk assessment shows it is requiredrequired where and to extent the risk assessment shows it is requiredrequiredrequired

20  Safe storage of GMMs

required where and to extent the risk assessment shows it is requiredrequiredrequiredsecure storage required

21  Written records of staff training

not requiredrequired where and to extent the risk assessment shows they are requiredrequiredrequired

Table 1b:

Containment measures for activities involving genetic modification of micro-organisms in plant growth facilities (to be read with Table 1a as indicated in paragraph 3)

Containment MeasuresContainment LevelsAdditional/ modification
1234

NOTE

1.

A permanent structure refers to a fixed structure with walls, a roof and a floor. Where the permanent structure is a greenhouse, that structure shall also have a continuous waterproof covering and self-closing lockable outer doors, and be located on a site designed to prevent the entry of surface run-off water.

Building

1  Permanent structure (Note 1)

required where and to extent the risk assessment shows it is requiredrequiredrequiredrequiredModification
Equipment

2  Entry via a separate room with two interlocking doors

not requiredrequired where and to extent the risk assessment shows it is requiredrequired where and to extent the risk assessment shows it is requiredrequired (via airlock key procedure)Additional

3  Control of contaminated run-off water

required where and to extent the risk assessment shows it is requiredrequired so as to prevent run-offrequired so as to prevent run-offrequired so as to prevent run-offAdditional
System of work

4  Effective control of disease vectors such as insects, rodents and arthropods which could disseminate GMMs

requiredrequiredrequiredrequiredAdditional

5  Effective control of pollen, seeds and other plant material which could disseminate GMMs

required where and to extent the risk assessment shows it is requiredrequired so as to minimise disseminationrequired so as to prevent disseminationrequired so as to prevent disseminationAdditional

6  Procedures for transfer of living material between the plant growth facilities, protective structure and laboratory shall control dissemination of GMMs

required so as to minimise disseminationrequired so as to prevent disseminationrequired so as to prevent disseminationrequired so as to prevent disseminationAdditional

Table 1c:

Containment measures for activities involving genetic modification of micro-organisms in animal units (to be read with Table 1a as indicated in paragraph 3)

Containment MeasuresContainment LevelsAdditional/modification
1234

NOTES

1.

In the Table above, “animal unit” means a building, or separate area within a building, containing an animal facility and other areas including changing rooms, showers, autoclaves and food storage areas.

2.

In the Table above and in Note 1 above, “animal facility” means a facility normally used to house stock, breeding or experimental animals or one which is used for the performance of minor surgical procedures on animals.

3.

In the Table above, “isolators” means transparent boxes where small animals are contained within or outside a cage; for large animals, isolated rooms may be more appropriate.

Facilities

1  Isolation of animal unit (Note 1)

required where and to extent the risk assessment shows it is requiredrequiredrequiredrequiredModification

2  Animal facilities (Note 2) separatedwhere and by lockable doors

required to extent the risk assessment shows they are requiredrequiredrequiredrequiredAdditional

3  Animal facilities (cages, etc) designed to facilitate decontamination (waterproof and easily washable material)

required where and to extent the risk assessment shows they are requiredrequired where and to extent the risk assesment shows they are requiredrequiredrequiredAdditional

4  Floor, walls and ceiling easily washable

required where and to extent the risk assessment shows they are requiredrequired for floorrequired for floor and wallsrequired for floor, walls and ceilingModification

5  Appropriate filters on isolators or isolated rooms (Note 3)

not requiredrequired where and to extent the risk assessment shows they are requiredrequiredrequiredAdditional

6  Incinerator for disposal of animal carcasses

required to be accessiblerequired to be accessiblerequired to be accessiblerequired to be on siteAdditional

7  Appropriate barriers at the room exit, and at drains or ventilation duct work

requiredrequiredrequiredrequiredAdditional

8  Animals kept in appropriate containment facilities, such as cages, pens, tanks or isolators

required where and to extent the risk assessment shows it is requiredrequired where and to extent the risk assessment shows it is requiredrequired where and to extent the risk assessment shows it is requiredrequired where and to extent the risk assessment shows it is requiredAdditional

Table 2:

Containment measures for activities involving genetic modification of micro-organisms in premises other than those referred to in Tables 1a, 1b and 1c

Containment MeasuresContainment Levels
1234
General

1  Viable micro-organisms shall be contained in a system which separates the process from the workplace and wider environment (closed system)

required where and to extent the risk assessment shows it is requiredrequiredrequiredrequired

2  Closed systems located within a controlled area

not requiredrequired where and to extent the risk assessment shows they are requiredrequiredrequired and required to be purpose built

3  Control of exhaust gases from the closed system

not requiredrequired so as to minimise releaserequired so as to prevent releaserequired so as to prevent release

4  Control of aerosols during sample collection, addition of material to a closed system or transfer of material to another closed system

required where and to extent the risk assessment shows it is requiredrequired so as to minimise releaserequired so as to prevent releaserequired so as to prevent release

5  Inactivation of bulk culture fluids before removal from the closed system

required where and to extent the risk assessment shows it is requiredrequired by validated meansrequired by validated meansrequired by validated means

6  Seals shall be designed so as to minimise or prevent release

not requiredrequired so as to minimise releaserequired so as to prevent releaserequired so as to prevent release

7  The controlled area designed to contain spillage of the entire contents of the closed system

required where and to extent the risk assessment shows it isrequired where and to extent the risk assessment shows it is requiredrequired requiredrequired

8  The controlled area sealable to permit fumigation

not requiredrequired where and to extent the risk assessment shows it is requiredrequired where and to extent the risk assessment shows it is requiredrequired

9  Biohazard signs posted

required where and to extent the risk assessment shows it is requiredrequiredrequiredrequired
Equipment

10  Entry via airlock

not requirednot requiredrequired where and to extent the risk assessment shows it is requiredrequired

11  Surfaces resistant to water, acids, alkalis, solvents, disinfectants and decontamination agents and easy to clean

required for any benchrequired for any benchrequired for floor and any benchrequired for bench, floor, ceiling and walls

12  Specific measures to adequately ventilate the controlled areas in order to minimise air contamination

required where and to extent the risk assessment shows they are requiredrequired where and to extent the risk assessment shows they are requiredrequired where and to extent the risk assessment shows they are requiredrequired

13  The controlled area maintained at an air pressure negative to the immediate surroundings

not requirednot requiredrequired where and to extent the risk assessment shows it is requiredrequired

14  Extract and input air from the controlled area shall be HEPA filtered

not requirednot requiredrequired for extract air, optional for input airrequired for input and extract air
System of work

15  Access restricted to authorised personnel only

not requiredrequiredrequiredrequired

16  Decontamination and washing facilities provided for personnel

requiredrequiredrequiredrequired

17  Personnel shall shower before leaving the controlled area

not requirednot requiredrequired where and to extent the risk assessment shows it is requiredrequired

18  Personnel shall wear protective clothing

work clothing requiredwork clothing requiredrequiredcomplete change required before exit and entry

19  Written procedures and records of staff training

not requirednot requiredrequiredrequired
Waste

20  Inactivation of GMMs in effluent from handwashing sinks and showers or similar effluents

not requirednot requiredrequired where and to extent the risk assessment shows it is requiredrequired

21  Inactivation of GMMs in contaminated material and waste including those in process effluent before final discharge

required by validated meansrequired by validated meansrequired by validated meansrequired by validated means

Regulation 27(1)

SCHEDULE 9Fees for notifications and applications

Notification of the intention to use premises for the first time for the purpose of undertaking activities involving genetic modification under regulation 9(1).£200
Notification of an activity involving genetic modification in class 2 under regulation 10(1), except a notification to which paragraph 4(1) or paragraph 5(1) of Schedule 10 applies.£400
Notification of the intention to use premises for the first time for the purpose of undertaking activities involving genetic modification under regulation 9(1) at the same time as notification of an activity involving genetic modification in class 2 under regulation 10(1).£400
Notification of an activity involving genetic modification in class 3 under regulation 11(1), except a notification to which paragraph 4(2) or paragraph 5(2) of Schedule 10 applies.£430
Notification of the intention to use premises for the first time for the purpose of undertaking activities involving genetic modification under regulation 9(1) at the same time as notification of an activity involving genetic modification in class 3 under regulation 11(1).£430
Notification of an activity involving genetic modification in class 4 under regulation 11(1), except a notification to which paragraph 4(2) or paragraph 5(2) of Schedule 10 applies.£500
Notification of the intention to use premises for the first time for the purpose of undertaking activities involving genetic modification under regulation 9(1) at the same time as notification of an activity involving genetic modification in class 4 under regulation 11(1).£500
Notification of an activity involving genetic modification of organisms other than micro-organisms under regulation 12(1).£400
Notification of the intention to use premises for the first time for the purpose of undertaking activities involving genetic modification under regulation 9(1) at the same time as notification of an activity involving genetic modification of organisms other than micro-organisms under regulation 12(1).£400
Notification of additional information under regulation 15(4).£300
Application for the written agreement of the competent authority under regulation 18(2) where the application is made after a notification has been submitted pursuant to regulation 9(1), 10(1), 11(1) or 12(1).£300

Regulation 28

SCHEDULE 10Transitional provisions

Interpretation

1.  In this Schedule—

(a)“the 1994 Regulations” means the Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 1994(32); and

(b)“the relevant date” means the date on which these Regulations come into operation.

Risk assessment

2.—(1) Where a person undertakes an activity involving genetic modification of micro-organisms which he commenced before the relevant date, he shall ensure that an assessment is carried out in accordance with regulation 6 as if the date of the commencement of that activity were 25th October 2001.

(2) Where a person undertakes an activity involving genetic modification of organisms other than micro-organisms which he commenced before the relevant date, he shall ensure that an assessment is carried out in accordance with regulation 7 as if the date of the commencement of that activity were 25th October 2001.

Notification of premises

3.  Where before the relevant date a person had notified the Executive in accordance with regulation 8(1) of the 1994 Regulations of his intention to undertake an activity involving genetic modification at premises for the first time, the requirements of regulation 9 shall be deemed to be satisfied, provided that, before 27th December 2001, that person submits to the competent authority a notification containing—

(a)the information specified in paragraph (g) of Schedule 5; and

(b)the information specified in paragraph (h)(iii) and (iv) of Schedule 5 where the activity involving genetic modification is a class 1 activity to be undertaken on or after 27th December 2001 at the premises referred to in the notification submitted pursuant to regulation 8(1) of the 1994 Regulations.

Notification of activities involving genetic modification

4.—(1) Where a person had notified the Executive of his intention to undertake an activity involving genetic modification of micro-organisms in accordance with regulation 9(1) of the 1994 Regulations and immediately before the relevant date that person was entitled under the 1994 Regulations to undertake that activity, and where that activity involving genetic modification of micro-organisms is in class 2, the requirements of regulation 10 shall be deemed to be satisfied in relation to that activity, provided that before 27th December 2001 that person submits to the competent authority a notification containing—

(a)in the case of an activity referred to in regulation 9(2)(a) of the 1994 Regulations, the information specified in Part I of Schedule 6;

(b)in the case of an activity referred to in regulation 9(3) or regulation 9(4)(a) of the 1994 Regulations, the information specified in paragraphs (c), (d), (l), (m), (o) and (p) of Part I of Schedule 6; and

(c)in the case of an activity referred to in regulation 9(5) of the 1994 Regulations, the information specified in paragraphs (c), (d), (l)(ii) and (p) of Part I of Schedule 6.

(2) Where a person had notified the Executive of his intention to undertake an activity involving genetic modification of micro-organisms in accordance with regulation 9(1) of the 1994 Regulations and immediately before the relevant date that person was entitled under the 1994 Regulations to undertake that activity, and where that activity involving genetic modification of micro-organisms is in class 3 or class 4, the requirements of regulation 11 shall be deemed to be satisfied in relation to that activity, provided that—

(a)before 25th November 2001, that person submits to the competent authority a notification containing the information specified in Part II of Schedule 6; and

(b)before 27th December 2001, the competent authority gives its consent in writing to continue to undertake the activity involving genetic modification of micro-organisms in question.

(3) Where a person had notified the Executive of his intention to undertake an activity involving the genetic modification of organisms other than micro-organisms in accordance with regulation 9(1) of the 1994 Regulations and immediately before the relevant date that person was entitled under the 1994 Regulations to undertake that activity, the requirements of regulation 12 shall be deemed to be satisfied.

(4) Where a person submits a notification in accordance with this paragraph, he shall at the same time provide the competent authority with a short description of the activity involving genetic modification to which the notification relates.

Notification of proposed activities involving genetic modification

5.—(1) Where a person had notified the Executive of his intention to undertake an activity involving genetic modification of micro-organisms in accordance with regulation 9(1) of the 1994 Regulations but immediately before the relevant date that person was not entitled under the 1994 Regulations to undertake that activity for any reason other than the reason mentioned in sub-paragraph (4), and where that activity involving genetic modification of micro-organisms is in class 2, that person may submit to the competent authority a notification containing—

(a)in the case of an activity referred to in regulation 9(2)(a) of the 1994 Regulations, the information specified in Part I of Schedule 6;

(b)in the case of an activity referred to in regulation 9(3) or regulation 9(4)(a) of the 1994 Regulations, the information specified in paragraphs (c), (d), (l), (m), (o) and (p) of Part I of Schedule 6; and

(c)in the case of an activity referred to in regulation 9(5) of the 1994 Regulations, the information specified in paragraphs (c), (d), (l)(ii) and (p) of Part I of Schedule 6,

in which case the provisions of these Regulations shall apply as if that person had submitted a notification pursuant to regulation 10(1) on the date he submitted the notification pursuant to this sub-paragraph, save that regulation 24 shall apply as modified in accordance with paragraph 10.

(2) Where a person had notified the Executive of his intention to undertake an activity involving genetic modification of micro-organisms in accordance with regulation 9(1) of the 1994 Regulations but immediately before the relevant date that person was not entitled under the 1994 Regulations to undertake that activity for any reason other than the reason mentioned in sub-paragraph (4), and where that activity involving genetic modification of micro-organisms is in class 3 or class 4, that person may submit a notification containing the information specified in Part II of Schedule 6, in which case the provisions of these Regulations shall apply as if that person had submitted a notification pursuant to regulation 11(1) on the date he submitted the notification pursuant to this sub-paragraph, save that regulation 24 shall apply as modified in accordance with paragraph 10.

(3) Where a person had notified the Executive of his intention to undertake an activity involving the genetic modification of organisms other than micro-organisms in accordance with regulation 9(1) of the 1994 Regulations but immediately before the relevant date that person was not entitled under the 1994 Regulations to undertake that activity for any reason other than the reason referred to in sub-paragraph (4), the provisions of these Regulations shall apply as if that person had submitted a notification in accordance with regulation 12 on the relevant date, save that regulation 24 shall apply as modified in accordance with paragraph 10.

(4) The reason referred to in sub-paragraphs (1), (2) and (3) is that the Executive has informed the person who submitted the notification in question that he may not commence the activity involving genetic modification to which the notification relates.

(5) Where a person submits a notification in accordance with this paragraph, he shall at the same time provide the competent authority with a short description of the activity involving genetic modification to which the notification relates.

Duties on receiving notifications and additional information

6.  Regulation 14(1) to (5) shall apply to a notification submitted pursuant to the 1994 Regulations which, by virtue of paragraph 4 of this Schedule, is treated as satisfying the requirements of these Regulations as it applies to a notification submitted pursuant to these Regulations.

Additional provisions relating to notification

7.  Regulation 15 shall apply in cases where a notification has been submitted pursuant to regulation 8 or 9 of the 1994 Regulations as it applies where a notification has been submitted pursuant to these Regulations.

Emergency plans

8.  Where before the relevant date a person had ensured that a plan had been prepared in accordance with regulation 13 of the 1994 Regulations, that plan shall be treated as satisfying the requirements of regulation 20, provided that, immediately following the assessment to be carried out in accordance with paragraph 2, the plan is reviewed and, where necessary, revised pursuant to regulation 20(3).

Disclosure of information

9.  Regulations 22 and 23 shall apply to information notified or provided under the 1994 Regulations as they apply to information provided under these Regulations.

Register of notifications

10.—(1) Subject to sub-paragraph (2), regulation 24 shall apply to a notification submitted in accordance with paragraphs 3, 4 and 5 as it applies to a notification submitted in accordance with regulations 9(1), 10(1), 11(1) and 12(1).

(2) Paragraphs (2), (3) and (4) of regulation 24 shall not apply to a notification submitted in accordance with paragraphs 3, 4 and 5 and shall be replaced by the following provisions, namely—

(a)in relation to a notification submitted in accordance with paragraph 3, the register shall contain the name and address of the person who submitted that notification, and the reference number given by the Executive to the notification under the 1994 Regulations of the premises in question;

(b)in relation to a notification submitted in accordance with paragraph 4, the register shall contain—

(i)the name and address of the person who submitted that notification,

(ii)a short description of the activity involving genetic modification to which the notification relates, and any reference number given by the Executive to the notification of that activity under the 1994 Regulations,

(iii)the date on which any information had been notified under regulation 10(4) of the 1994 Regulations, and

(iv)where appropriate, confirmation that a consent has been granted under paragraph 4(2)(b); and

(c)in relation to a notification submitted in accordance with paragraph 5, the register shall contain—

(i)the name and address of the person who submitted that notification,

(ii)a short description of the activity involving genetic modification to which the notification relates, and any reference number given by the Executive to the notification of that activity under the 1994 Regulations,

(iii)the date on which any information had been notified under regulation 10(4) of the 1994 Regulations, and

(iv)where appropriate, confirmation that a consent has been granted under regulation 11(3) or 11(4).

(3) The competent authority shall include in the register—

(a)by 25th January 2002, the information referred to in sub-paragraph (2)(a);

(b)by 25th February 2002, the information referred to in sub-paragraph (2)(b); and

(c)within fourteen days of the receipt of a notification submitted under paragraph 5, the information referred to in sub-paragraph (2)(c).

Reference to previous notification

11.  Where a person submits a notification in accordance with paragraph 3, 4 or 5, he shall at the same time provide the competent authority with the following information—

(a)his name, address and telephone number and any fax number and any e-mail address; and either

(b)in the case of a notification submitted in accordance with paragraph 3—

(i)the date of,

(ii)any reference number given by the Executive to, and

(iii)the date of any information notified to the Executive under regulation 10 of the 1994 Regulations relating to,

the notification in question submitted under regulation 8(1) of the 1994 Regulations; or

(c)in the case of a notification submitted in accordance with paragraph 4 or 5—

(i)the date of,

(ii)any reference number given by the Executive to, and

(iii)the date of any information notified to the Executive under regulation 10 of the 1994 Regulations relating to,

the notification in question submitted under regulation 9(1) of the 1994 Regulations.

Regulation 30

SCHEDULE 11Premises and activities within territorial waters

Interpretation

1.—(1) In this Schedule—

“designated area” means any area designated by order under section 1(7) of the Continental Shelf Act 1964(33) and “within a designated area” includes over and under it;

“offshore installation” shall be construed in accordance with paragraph 2(4) and (5);

“stand-by vessel” means a vessel which is ready to give assistance in the event of an emergency on or near an offshore installation;

“vessel” includes a hovercraft and any floating structure which is capable of being staffed.

(2) For the purposes of this Schedule, any structures and devices on top of a well shall be treated as forming part of the well.

(3) For the purposes of this Schedule, a person shall be deemed to be engaged in diving operations throughout any period from the time when he commences to prepare for diving until the time when—

(a)he is no longer subjected to raised pressure;

(b) he has normal inert gas partial pressure in his tissues; and

(c)if he entered the water, he has left it,

and diving operations include the activity of any person in connection with the health and safety of a person who is, or is deemed to be, engaged in diving operations.

(4) Any reference in this Schedule to premises and activities (howsoever described) includes a reference to any person, article or substance on those premises or engaged in or, as the case may be, used or for use in connection with any such activity but does not include a reference to an aircraft which is airborne.

Offshore installations

2.—(1) This paragraph applies to—

(a)any offshore installation and any activity on it;

(b)any activity, including diving operations, in connection with an offshore installation, or any activity which is immediately preparatory thereto, whether carried on from the installation itself, on or from a vessel or in any other manner, other than—

(i)transporting, towing or navigating the installation; or

(ii)any activity on or from a vessel being used as a stand-by vessel; or

(c)diving operations involving the survey and preparation of the sea bed for an offshore installation.

(2) Subject to sub-paragraph (3), in this Schedule “offshore installation” means a structure which is, or is to be, or has been, used while standing or stationed in water, or on the foreshore or other land intermittently covered with water—

(a)for the exploitation, or exploration with a view to exploitation, of mineral resources by means of a well;

(b)for the storage of gas in or under the shore or bed of any water or the recovery of gas so stored;

(c)for the conveyance of things by means of a pipe; or

(d)mainly for the provision of accommodation for persons who work on or from a structure falling within any of the provisions of this sub-paragraph,and which is not an excepted structure.

(3) For the purposes of sub-paragraph (2), the excepted structures are—

(a)a structure which is connected with dry land by a permanent structure providing access at all times and for all purposes;

(b)a well;

(c)a structure which has ceased to be used for any of the purposes specified in sub-paragraph (2) and has since been used for a purpose not so specified;

(d)a mobile structure which has been taken out of use and is not for the time being intended to be used for any of the purposes specified in sub-paragraph (2); and

(e)any part of a pipeline.

Wells

3.—(1) This paragraph applies to—

(a)a well and any activity in connection with it; or

(b)an activity which is immediately preparatory to any activity in head (a).

(2) Sub-paragraph (1) includes keeping a vessel on station for the purpose of working on a well but otherwise does not include navigation or an activity connected with navigation.

Pipelines

4.—(1) This paragraph applies to—

(a)a pipeline;

(b)any pipeline works; or

(c)any of the following activities in connection with pipeline works—

(i)the loading, unloading, fuelling or provisioning of a vessel;

(ii)the loading, unloading, fuelling, repair and maintenance of an aircraft on a vessel,

being in either case a vessel which is engaged in pipeline works.

(2) In this paragraph—

  • “pipeline” means a pipe or system of pipes for the conveyance of any thing, together with—

    (a)

    any apparatus for inducing or facilitating the flow of any thing through, or through a part of, the pipe or system;

    (b)

    any apparatus for treating or cooling any thing which is to flow through, or through part of, the pipe or system;

    (c)

    valves, valve chambers and similar works which are annexed to, or incorporated in the course of, the pipe or system;

    (d)

    apparatus for supplying energy for the operation of any such apparatus or works as are mentioned in heads (a) to (c);

    (e)

    apparatus for the transmission of information for the operation of the pipe or system;

    (f)

    apparatus for the cathodic protection of the pipe or system; and

    (g)

    a structure used or to be used solely for the support of a part of the pipe or system;

    but not including a pipeline of which no initial or terminal point is situated in the United Kingdom or within territorial waters, United Kingdom territorial waters adjacent to Great Britain or a designated area;

  • “pipeline works” means—

    (a)

    assembling or placing a pipeline or length of pipeline including the provision of internal or external protection for it;

    (b)

    inspecting, testing, maintaining, adjusting, repairing, altering or renewing a pipeline or length of pipeline;

    (c)

    changing the position of or dismantling or removing a pipeline or length of pipeline;

    (d)

    opening the bed of the sea for the purposes of the works mentioned in heads (a) to (c), and tunnelling or boring for those purposes;

    (e)

    any activities incidental to the activities described in heads (a) to (d);

    (f)

    diving operations in connection with any of the works mentioned in heads (a) to (e) or for the purpose of determining whether a place is suitable as part of the site of a proposed pipeline and the carrying out of surveying operations for settling the route of a proposed pipeline.

Mines

5.—(1) This paragraph applies to the working of a mine and work for the purpose of, or in connection with, the working of any part of a mine.

(2) In this paragraph “mine” and “working of a mine” have the same meaning as in the Mines Act (Northern Ireland) 1969(34).

Other activities

6.—(1) Subject to sub-paragraph (2), this paragraph applies to—

(a)the construction, reconstruction, alteration, repair, maintenance, cleaning, demolition and dismantling of any building or other structure not being a vessel, or any preparation for any such activity;

(b)the loading, unloading, fuelling or provisioning of a vessel;

(c)diving operations;

(d)the construction, reconstruction, finishing, refitting, repair, maintenance, cleaning or breaking up of a vessel except when carried out by the master or any officer or member of the crew of that vessel; or

(e)the maintaining on a station of a vessel which would be an offshore installation were it not a structure to which paragraph 2(3)(d) relates.

(2) This paragraph does not apply to vessels which are registered outside the United Kingdom and are on passage through territorial waters.

Explanatory Note

(This note is not part of the Regulations.)

1.  These Regulations have effect with a view to protecting persons and the environment from risks arising from activities involving the contained use of genetically modified micro-organisms and protecting persons from risks arising from activities involving the contained use of genetically modified organisms which are not micro-organisms.

2.  Save as regards the matters referred to in regulations 7, 12, 17(1)(b), 17(3), 19, 20(2), 24, 25, 27 and 29, Schedule 4, Part III of Schedule 6 and Schedule 9, these Regulations implement as respects Northern Ireland Council Directive 90/219/EEC of 23rd April 1990 on the contained use of genetically modified micro-organisms (O.J. No. L117, 8.5.90, p. 1), as amended by Commission Directive 94/51/EC of 7 November 1994 (O.J. L297, 18.11.94, p. 29) and Council Directive 98/81/EC of 26th October 1998 (O.J. No. L330, 5.12.98, p. 13).

3.  The Regulations revoke and replace the Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 1994, as amended. The principal provisions are as follows.

4.  Any activity involving genetic modification of micro-organisms is prohibited unless the person intending to undertake the activity in question has ensured that an assessment of the risks created by that activity to human health and the environment has been carried out. Any activity involving genetic modification of organisms other than micro-organisms is prohibited unless the person intending to undertake the activity in question has ensured that an assessment of the risks created by that activity to human health has been carried out. A person who carries out such an assessment is required to establish a safety committee to advise him. (Regulations 6, 7 and 16.) (The terms “activity involving genetic modification”, “micro-organism” and “organism” are defined in regulation 2(1).)

5.  A person shall not use premises for the first time for the purpose of undertaking an activity involving genetic modification unless he has notified the competent authority (also defined in regulation 2(1)) of his intention to do so and provided to the competent authority certain information. (Regulation 9 and Schedule 5.)

6.  The Regulations prohibit the undertaking of certain types of activity involving the genetic modification of micro-organisms and the genetic modification of organisms other than micro-organisms unless the competent authority has been given prior notification together with certain information and, in specified circumstances, the competent authority has given its consent. (Regulations 10, 11 and 12 and Schedule 6.)

7.  The competent authority is placed under a duty to examine a notification submitted to it under regulations 9, 10, 11 and 12 and the Health and Safety Executive for Northern Ireland may ask the notifier for additional information. (Regulation 14.)

8.  The competent authority has power to vary or revoke any consent under regulation 11, and a notifier is required to inform the competent authority of changes in the information supplied with the notification submitted by him or other changes in circumstances relating to the undertaking of the activity involving genetic modification. (Regulation 15.)

9.  The Regulations impose on a person who undertakes an activity involving genetic modification a requirement to ensure that safety principles are observed. (Regulation 17.)

10.  A person who undertakes an activity involving genetic modification of micro-organisms is required to apply the containment measures which are appropriate to that activity as set out in the relevant table in Schedule 8. (Regulation 18.)

11.  A person who undertakes an activity involving genetic modification of organisms other than micro-organisms is required to apply the containment measures selected in accordance with the assessment made under regulation 7. (Regulation 19.)

12.  In certain circumstances, before a person undertakes an activity involving genetic modification of micro-organisms, he must prepare an emergency plan to secure the health of persons and the protection of the environment. In certain circumstances, before a person undertakes an activity involving genetic modification of genetically modified organisms other than micro-organisms, he must prepare an emergency plan to secure the health of persons. (Regulation 20.)

13.  A person who undertakes an activity involving genetic modification of organisms must report to the competent authority every accident and provide that authority with information about the accident. (Regulation 21.) (The term “accident” is defined in regulation 2(1).)

14.  The Regulations contain provisions relating to the confidentiality of information provided to the competent authority. (Regulations 22 and 23.)

15.  The competent authority is to maintain a register of the notifications made under regulations 9 to 12 and copies of the register are to be kept at the offices of the Health and Safety Executive for Northern Ireland at 83 Ladas Drive, Belfast BT6 9FR. The register is to be open to public inspection at any reasonable time and is to contain certain information. (Regulation 24.)

16.  The competent authority may grant an exemption from the requirements of the Regulations but only if it is satisfied that the health and safety of persons and the environment are not prejudiced by the granting of such an exemption. (Regulation 25.)

17.  Provision is made for the enforcement of the Regulations, for the payment of fees and for transitional measures. (Regulations 26, 27 and 28 and Schedules 9 and 10.)

18.  There is a right of appeal for any person who is aggrieved by certain decisions of the competent authority, a request for information or an instruction given to him by the Health and Safety Executive for Northern Ireland. (Regulation 29.)

19.  The Regulations specify the premises and activities within United Kingdom territorial waters adjacent to Northern Ireland to which the Regulations apply. (Regulation 30 and Schedule 11.)

20.  In Great Britain, the corresponding Regulations are the Genetically Modified Organisms (Contained Use) Regulations 2000 (S.I. 2000/2831). The Great Britain Health and Safety Executive has prepared a regulatory impact assessment in relation to those Regulations and a copy of that assessment together with a Northern Ireland Supplement prepared by the Health and Safety Executive for Northern Ireland is held at the offices of that Executive at 83 Ladas Drive, Belfast BT6 9FR from where a copy may be obtained on request.

21.  A person who contravenes the Regulations is guilty of an offence under Article 31 of the Health and Safety at Work (Northern Ireland) Order 1978 and is liable, on summary conviction, to a fine not exceeding the statutory maximum (currently £5,000) or, on conviction on indictment, to a fine.

(1)

Formerly the Department of Economic Development; see S.I. 1999/283 (N.I. 1), Article 3(5)

(2)

S.I. 1991/755

(3)

1972 c. 68; the enabling powers conferred by section 2(2) were extended by virtue of section 1 of the European Economic Area Act 1993 (c. 51)

(4)

See Article 2(2) of S.I. 1978/1039 (N.I. 9)

(5)

Article 17 must be read with S.I. 1992/1728 (N.I. 17), Articles 3(2) and 4(2)

(6)

S.I. 1978/1039 (N.I. 9); the general purposes of Part II referred to in Article 17(1) were extended by S.I. 1992/1728 (N.I. 17), Article 3(1). Article 47A was inserted by Article 3, and Article 2 was amended by Articles 4 and 8, of S.I. 1997/1774 (N.I. 16)

(7)

Article 13(1) was amended by S.I. 1998/2795 (N.I. 18), Article 4

(8)

Article 46(3) was amended by S.I. 1998/2795 (N.I. 18), Article 6(1) and Schedule 1, paragraphs 8 and 18(c)

(9)

Cm 2073 and 2183

(11)

S.I. 2000/2831

(15)

O.J. No. L117, 8.5.90, p. 15, as amended by Commission Directive 94/15/EC (O.J. No. L103, 22.4.94, p. 20) and Commission Directive 97/35/EC (O.J. No. L169, 27.6.97, p. 72)

(16)

O.J. No. L124, 24.8.93, p. 1, as amended by Commission Regulation (EC) 649/98 (OJ No. L88, 24.3.98, p. 7)

(17)

O.J. No. L43, 14.2.97, p. 1 (to be read with Corrigenda published in O.J. No. L173, 1.7.97, p. 12 and O.J. No. L187, 20.7.99, p. 74)

(18)

S.I. 1978/1039 (N.I. 9); Article 30 was amended by S.I. 1998/2795 (N.I. 18), Article 6(1) and Schedule 1, paragraph 1

(20)

S.I. 1978/1039 (N.I. 9); Articles 18 to 20 and 31 were amended by, and Article 34A was inserted by, S.I. 1998/2795 (N.I. 18), Article 6(1) and Schedule 1.

(31)

OJ No. L 374, 31.12.90, p. 1, as amended by Council Directive 93/88/EEC (OJ No. L 268, 29.10.93, p. 71), Commission Directive 95/30/EC (OJ No. L 155, 6.7.95, p. 41), Commission Directive 97/59/EC (OJ No. L 282, 15.10.1997, p. 33) and Commission Directive 97/65/EC (OJ No. L 335, 6.12.1997, p. 17)

(33)

1964 c. 29; section 1(7) was amended by the Oil and Gas (Enterprise) Act 1982 (c. 23), Schedule 3, paragraph 1

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