The Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 2015

Made: 18th September 2015

Coming into operation: 23rd October 2015

The Regulations give effect without modifications to proposals submitted to the Department by the Health and Safety Executive for Northern Ireland under Article 13(1A)[^f00007] of the 1978 Order after the Executive had carried out consultations in accordance with Article 46(3)[^f00008] of the 1978 Order.

PART 1 — Interpretation and General

Citation and commencement

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These Regulations may be cited as the Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 2015 and shall come into operation on 23rd October 2015.

Interpretation

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• (1) In these Regulations—

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

• “the 2001 Regulations” means the Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 2001[^f00009];

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

• “class” in relation to a contained use involving micro-organisms, means one of the four classes set out 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;

• “emergency plan” means a plan required by regulation 21;

• “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— genetic modification occurs at least through the use of the techniques listed in Part 1 of Schedule 2; and the techniques set out in Part 2 of Schedule 2 are not considered to result in genetic modification and “genetically modified” is to be construed accordingly;

• “larger GMO” means an organism which is genetically modified or is the subject of genetic modification which is not a micro-organism;

• “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, except in regulation 14, the person who submits or has submitted a notification to the competent authority under regulation 9(2), 10(2), 11(2), 12(2) or 33(3);

• “organism” means a biological entity capable of replication or of transferring genetic material and includes a micro-organism, but does not include a human, human embryo or human admixed embryo and for the purpose of this definition— “human admixed embryo” has the same meaning as in the Human Fertilisation and Embryology Act 1990[^f00010] by virtue of section 4A(6) and (11) of that Act; and “human embryo” has the same meaning as “embryo” in the Human Fertilisation and Embryology Act 1990 (apart from section 4A) by virtue of section 1(1) and (6) of that Act;

• “person responsible for contained use” or “person responsible for the contained use” means — a person who has the authority to determine whether a particular contained use takes place; or a person who has control of the planning or conduct (or both) of that contained use, and there may be more than one person responsible for the same contained use;

• “premises” means both single buildings and a site made up of more than one building;

• “risk assessment” means, in the context of contained use involving— genetically modified micro-organisms, an assessment carried out as required by regulation 5(1); or larger GMOs, an assessment carried out as required by regulation 6(1);

• “transboundary movement” has the meaning assigned to it by Article 3 of Regulation (EC) No. 1946/2003 of the European Parliament and the Council on transboundary movements of genetically modified organisms[^f00011];

• “user” means a person who undertakes or proposes to undertake a contained use;

• “working day” means any day other than a Saturday, a Sunday, Christmas Day or Good Friday, or a bank holiday specified in Schedule 1 to the Banking and Financial Dealings Act 1971[^f00012].

• (2) In these Regulations —

• (a) a reference to an appropriate containment level is a reference to the containment level assigned to a contained use involving micro-organisms in accordance with paragraphs 3(i) and 4 of Part 2 of Schedule 3;

• (b) any reference to a contained use in a numbered class is a reference to a contained use involving micro-organisms which has been classified as belonging to the class of that number in accordance with paragraph 3(j) and (k) of Part 2 of Schedule 3.

• (3) The measures in —

• (a) Part 2 of Schedule 8 are to be applied in accordance with Part 1 of that Schedule; and

• (b) Tables 1a, 1b and 1c in Part 2 of Schedule 8 are to be applied in accordance with the notes set out at the end of the table in question.

• (4) The Interpretation Act (Northern Ireland) 1954[^f00013] shall apply to these Regulations as it applies to an Act of the Northern Ireland Assembly.

Application

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• (1) These Regulations (except regulation 18) shall not apply to the genetic modification of organisms solely by any of the techniques referred to in Part 3 of Schedule 2 nor to any organisms so modified.

• (2) 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, a product marketed in accordance with—

• (i) the consent of any of the following granted under section 111(1) of the Environmental Protection Act 1990[^f00014]—

• (aa) the Secretary of State;

• (bb) the Scottish Ministers, as regards Scotland;

• (cc) the Welsh Ministers, as regards Wales;

• (ii) a consent granted by the Department of the Environment under Article 8(1) of the Genetically Modified Organisms (Northern Ireland) Order 1991[^f00015], or

• (iii) a written consent given by the competent authority of an EEA State in accordance with Article 15(3), 17(6), or 18(2) of Directive (EC) No 2001/18 of the European Parliament and the Council on the deliberate release into the environment of genetically modified organisms[^f00016],

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

• (b) genetically modified organisms are cultured, stored, transported, destroyed, disposed of or used, where such organisms are, or are contained in—

• (i) a medicinal product for human or veterinary use marketed in accordance with Regulation (EC) No 726/2004 of the European Parliament and the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency[^f00017]; or

• (ii) food or feed authorised in accordance with the provisions of Regulation (EC) No 1829/2003 of the European Parliament and the Council on genetically modified food and feed[^f00018]...

• (iii) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

; or

• (iv) a medicinal product for human use marketed in accordance with the Human Medicines Regulations 2012 ; or

• (v) a medicinal product for veterinary use marketed in accordance with the Veterinary Medicines Regulations 2013;

• (c) genetically modified organisms are released or marketed in cases or circumstances in which—

• (i) the consent of any of the following is required under section 111(1) of the Environmental Protection Act 1990—

• (aa) the Secretary of State;

• (bb) the Scottish Ministers, as regards Scotland;

• (cc) the Welsh Ministers, as regards Wales; or

• (ii) the consent of the Department of the Environment is required under Article 8(1) of the Genetically Modified Organisms (Northern Ireland) Order 1991.

• (3) Regulations 7, 9 to 17, 18(2) and (4), 19, 20 and 23 to 25 shall not apply to the transport of genetically modified organisms by road, rail, inland waterway, sea or air.

• (4) Regulation 5 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 5(1), the person undertaking that assessment shall not be required to include the steps set out in paragraph 3(i) to (k) of Part 2 of Schedule 3.

• (5) 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” and modification of the 1978 Order

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• (1) For the purpose of these Regulations and Part I of the 1978 Order, the meaning of “work” shall be extended to include any contained use and the meaning of “at work” shall be extended accordingly.

• (2) Articles 4(1), (2) and (3) and 8 of the 1978 Order shall be modified in relation to contained use as follows—

• (a) those Articles have effect as if a reference to —

• (i) an employer includes a reference to an educational establishment providing a course of study; and

• (ii) an employee includes a reference to a student undertaking contained use in that educational establishment to the extent that the contained use is under the control of that educational establishment.

• (3) Article 5(2) of the 1978 Order shall be modified in relation to contained use so as to have effect as if the reference in that Article—

• (a) to a self-employed person were a reference to any person (except a student) undertaking contained use who is not an employer or an employee; and

• (b) to that person’s undertaking includes a reference to that contained use.

• (4) In this regulation—

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

• “student” means any person studying at an educational establishment.

PART 2 — Risk Assessment and Notification of Contained Use

Risk assessment of contained use involving micro-organisms

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• (1) Before any contained use involving micro-organisms is commenced, a person responsible for the contained use shall ensure that a suitable and sufficient assessment of the risks to human health and the environment created by the contained use is carried out.

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

Risk assessment of contained use involving larger GMOs

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• (1) Before any contained use involving larger GMOs is commenced, a person responsible for the contained use shall ensure that a suitable and sufficient assessment of the risks to human health created by the contained use is carried out.

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

Review and recording of risk assessments

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• (1) A person responsible for contained use shall ensure that the risk assessment is reviewed immediately where—

• (a) there is reason to suspect that the risk assessment is no longer valid; or

• (b) there has been a significant change in the contained use to which the risk assessment relates.

• (2) A person responsible for contained use shall—

• (a) keep a record of the risk assessment and any review of the risk assessment, for at least 10 years from the date the contained use stops; and

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

Advice from a genetic modification safety committee

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• (1) Subject to paragraph (2), a person responsible for contained use shall obtain advice on a risk assessment from either—

• (a) a person; or

• (b) a genetic modification safety committee,

with expertise in risk assessment relating to contained use.

• (2) Where the risk assessment indicates that the contained use is classified as class 2 or above the advice shall be obtained from a genetic modification safety committee.

Notification of premises to be used for contained use

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• (1) A user shall not use premises for contained use unless the premises have been notified to the competent authority in accordance with this regulation.

• (2) Before premises are used for contained use for the first time, a person responsible for the contained use shall—

• (a) submit a notification to the competent authority containing the information specified in Schedule 5; and

• (b) have received an acknowledgement of receipt of the notification from the Executive.

• (3) The Executive shall send an acknowledgement of receipt to the notifier within 10 working days of the competent authority receiving the notification.

• (4) A single notification may include more than one premises.

• (5) The notifier shall nominate one address which is to be the principal address for the purposes of a notification under paragraph (4).

Notification of class 2 contained use

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• (1) A user shall not undertake a contained use involving micro-organisms classified as class 2 unless the provisions of this regulation have been complied with.

• (2) A person responsible for the contained use shall submit a notification to the competent authority containing the information specified in Schedule 6.

• (3) The Executive shall send an acknowledgement of receipt to the notifier within 10 working days of the competent authority receiving the notification.

• (4) Where the premises in the notification have not previously been notified for class 2 or a higher class of contained use, a user may undertake the class 2 contained use if—

• (a) 45 days have elapsed since the acknowledgement of receipt was received, provided that the competent authority has not informed the notifier that the class 2 contained use may not be undertaken; or

• (b) the competent authority has agreed in writing that the class 2 contained use may commence sooner.

• (5) Where the premises in the notification have—

• (a) previously been notified for class 2 contained use; or

• (b) already been granted consent for class 3 or class 4 contained use,

a user may undertake the class 2 contained use if the notifier has received the acknowledgement of receipt.

• (6) Where a notifier submits a notification for a class 2 contained use which is to be undertaken for the second or subsequent time at the premises in the notification, the notifier may request that the competent authority provide a written agreement that the contained use may be undertaken.

• (7) The competent authority shall make a decision and, if they agree, provide the written agreement requested under paragraph (6), within 45 days of the date on which the acknowledgement of receipt was sent to the notifier.

Notification of class 3 or class 4 contained use

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• (1) A user shall not undertake a contained use involving micro-organisms classified as class 3 or class 4 unless written consent for that contained use has been granted by the competent authority.

• (2) A person responsible for the contained use shall submit a notification to the competent authority containing the information specified in Schedule 6.

• (3) The Executive shall send an acknowledgement of receipt to the notifier within 10 working days of the competent authority receiving the notification.

• (4) Where the premises in the notification have not previously been notified for class 3 or class 4 contained use, the competent authority shall inform the notifier, in writing, of its decision to grant or refuse consent for the class 3 or class 4 contained use, within 90 days of the date on which the acknowledgement of receipt was sent to the notifier.

• (5) Where the premises in the notification have previously been notified for class 3 or class 4 contained use and all relevant conditions of existing consents have been complied with, the competent authority shall inform the notifier, in writing, of its decision to grant or refuse consent for the class 3 or class 4 contained use, within 45 days of the date on which the acknowledgement of receipt was sent to the notifier.

• (6) Before granting consent, the competent authority shall ensure that an emergency plan has been prepared where the risk assessment shows an emergency plan is required.

• (7) Before deciding whether to grant or refuse consent, the competent authority shall take into account any representations made to it by any person within 30 days of the date on which the acknowledgement of receipt was sent to the notifier.

• (8) A consent granted under this regulation may be granted subject to conditions.

Notification of contained use involving larger GMOs

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• (1) A user shall not undertake a contained use involving larger GMOs unless the provisions of this regulation have been complied with.

• (2) A person responsible for the contained use shall submit a notification to the competent authority containing the information specified in Schedule 6.