Made | 6th August 2001 | ||
Coming into operation | 25th September 2001 |
1. | Citation and commencement |
2. | Interpretation |
3. | Application |
4. | Meaning of "work" and "at work" |
5. | Modification of the Health and Safety at Work (Northern Ireland) Order 1978 |
6. | Risk assessment of activities involving genetically modified micro-organisms |
7. | Risk assessment of activities involving genetically modified organisms other than micro-organisms |
8. | Review and recording of risk assessments |
9. | Notification of the intention to use premises for the first time for activities involving genetic modification |
10. | Notification of class 2 activities involving genetic modification of micro-organisms |
11. | Notification of class 3 or class 4 activities involving genetic modification of micro-organisms |
12. | Notification of activities involving genetic modification of organisms other than micro-organisms |
13. | Notification of connected programmes of work |
14. | Duties on receiving notifications and additional information |
15. | Additional provisions relating to notifications |
16. | Establishment of a genetic modification safety committee |
17. | Principles of occupational and environmental safety |
18. | Containment and control measures for activities involving genetic modification of micro-organisms |
19. | Containment and control measures for activities involving genetic modification of organisms other than micro-organisms |
20. | Emergency plans |
21. | Information relating to accidents |
22. | Disclosure of information provided pursuant to regulations 9 to 15 |
23. | Disclosure of information provided pursuant to regulation 21 |
24. | Register of notifications |
25. | Exemption certificates |
26. | Enforcement and civil liability |
27. | Fees for notifications and applications |
28. | Transitional provisions |
29. | Appeals |
30. | Application within territorial waters |
31. | Revocations, amendments and savings |
Schedule 1. | Classes of activity involving genetic modification |
Schedule 2. |
Part I: | Examples of techniques constituting genetic modification |
Part II: | Techniques which are not considered to result in genetic modification |
Part III: | Techniques to which these Regulations do not apply |
Schedule 3. |
Part I: | Matters to be taken into account in carrying out an assessment for the purposes of regulation 6 |
Part II: | Steps to be included when carrying out an assessment for the purposes of regulation 6 |
Schedule 4. |
Part I: | Matters to be taken into account in carrying out an assessment for the purposes of regulation 7 |
Part II: | Steps to be included when carrying out an assessment for the purposes of regulation 7 |
Schedule 5. | Information required for a notification under regulation 9(1) |
Schedule 6. |
Part I: | Information required for a notification under regulation 10(1) |
Part II: | Information required for a notification under regulation 11(1) |
Part III: | Information required for a notification under regulation 12(1) |
Schedule 7. | General principles of good microbiological practice and of good occupational safety and hygiene |
Schedule 8. | Containment measures |
Schedule 9. | Fees for notifications and applications |
Schedule 10. | Transitional provisions |
Schedule 11. | Premises and activities within territorial waters |
and "genetically modified" shall be construed accordingly;
(2) In these Regulations -
(3) The provisions in -
(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 -
(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 -
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 -
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 -
(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 -
(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 -
(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 -
(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 -
(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 -
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 -
(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) -
(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 -
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 -
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 -
(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 -
(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 -
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 -
(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.
(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) -
(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) -
Emergency plans
20.
- (1) Where an assessment carried out pursuant to regulation 6(1) shows that, as a result of any reasonably foreseeable accident -
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 -
(4) The person undertaking the activity involving genetic modification which is the subject of an emergency plan shall -
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 -
(2) Where the competent authority is informed of an accident in pursuance of paragraph (1), it shall -
(3) Subject to paragraph (8), paragraph (2) shall not apply to the following information, which shall not be kept confidential -
(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 -
(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 -
(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 -
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 -
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 -
(3) Subject to paragraph (7), paragraph (2) shall not apply to the following information, which shall not be kept confidential -
(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 -
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 -
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 -
(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 -
(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) -
(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 -
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 -
(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.
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 -
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 -
Enforcement and civil liability
26.
- (1) Subject to paragraph (2) and to the extent they would not otherwise do so, the provisions of -
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 -
may appeal to the Department of Enterprise, Trade and Investment.
(2) Any person who is aggrieved by -
may appeal to the Department of Enterprise, Trade and Investment.
(3) Any person who is aggrieved by a decision of the competent authority -
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 -
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 -
(b) if -
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 -
(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 -
(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
Class | Description |
1 | Activities of no or negligible risk, for which containment level 1 is appropriate to protect human health and the environment |
2 | Activities of low risk, for which containment level 2 is appropriate to protect human health and the environment |
3 | Activities of moderate risk, for which containment level 3 is appropriate to protect human health and the environment |
4 | Activities of high risk, for which containment level 4 is appropriate to protect human health and the environment. |
4.
In paragraph 3 -
(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 -
(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;
(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 -
5.
In paragraph 4, "selected containment measure" means an appropriate containment measure selected in accordance with paragraph 3(g).
(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 -
(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).
(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) -
(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).
(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 -
(o) a copy of the assessment referred to in regulation 6(1).
2.
For the purposes of this Schedule, where, in the final column of Table 1b or Table 1c, a measure is specified as -
3.
For the purposes of this Schedule -
Containment Measures | Containment Levels | |||
1 | 2 | 3 | 4 | |
1
Laboratory suite: isolation (Note 1) |
not required | not required | required | required |
2
Laboratory: sealable for fumigation |
not required | not required | required | required |
Equipment | ||||
3
Surfaces impervious to water, resistant to acids, alkalis, solvents, disinfectants and decontamination agents and easy to clean |
required for bench | required for bench | required for bench and floor | required for bench, floor ceiling and walls |
4
Entry to lab via airlock (Note 2) |
not required | not required | required where and to extent the risk assessment shows it is required | required |
5
Negative pressure relative to the pressure of the immediate surroundings |
not required | required where and to extent the risk assessment shows it is required | required | required |
6
Extract and input air from the laboratory shall be HEPA filtered |
not required | not required | HEPA filters required for extract air | HEPA filters required for input and extract air (Note 3) |
7
Microbiological safety cabinet/enclosure |
not required | required where and to extent the risk assessment shows it is required | required, and all procedures with infective materials required to be contained within a cabinet/ enclosure | Class III cabinet required |
8
Autoclave |
required on site | required in the building | required in the laboratory suite (Note 4) | double ended autoclave required in laboratory |
System of work | ||||
9
Access restricted to authorised personnel only |
not required | required | required | required (via airlock key procedure) |
10
Specific measures to control aerosol dissemination |
not required | required so as to minimise | required so as to prevent | required so as to prevent |
11
Shower |
not required | not required | required where and to extent the risk assessment shows it is required | required |
12
Protective clothing |
suitable protective clothing required | suitable protective clothing required | suitable protective clothing required; footwear required where and to extent the risk assessment shows it is required | complete change of clothing and footwear required before entry and exit |
13
Gloves |
not required | required where and to extent the risk assessment shows they are required | required | required |
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 required | required | required | required |
15
Specified disinfection procedures in place |
required where and to extent the risk assessment shows they are required | required | required | required |
Waste | ||||
16
Inactivation of GMMs in effluent from handwashing sinks and showers and similar effluents |
not required | not required | required where and to extent the risk assessment shows it is required | required |
17
Inactivation of GMMs in contaminated material and waste |
required by validated means | required by validated means | required by validated means | required by validated means |
Other measures | ||||
18
Laboratory to contain its own equipment |
not required | not required | required, so far as is reasonably practicable | required |
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 required | required where and to extent the risk assessment shows it is required | required | required |
20
Safe storage of GMMs |
required where and to extent the risk assessment shows it is required | required | required | secure storage required |
21
Written records of staff training |
not required | required where and to extent the risk assessment shows they are required | required | required |
Containment Measures | Containment Levels | Additional/ modification | |||
1 | 2 | 3 | 4 | ||
Building | |||||
1
Permanent structure (Note 1) |
required where and to extent the risk assessment shows it is required | required | required | required | Modification |
Equipment | |||||
2
Entry via a separate room with two interlocking doors |
not required | required where and to extent the risk assessment shows it is required | required where and to extent the risk assessment shows it is required | required (via airlock key procedure) | Additional |
3
Control of contaminated run-off water |
required where and to extent the risk assessment shows it is required | required so as to prevent run-off | required so as to prevent run-off | required so as to prevent run-off | Additional |
System of work | |||||
4
Effective control of disease vectors such as insects, rodents and arthropods which could disseminate GMMs |
required | required | required | required | Additional |
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 required | required so as to minimise dissemination | required so as to prevent dissemination | required so as to prevent dissemination | Additional |
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 dissemination | required so as to prevent dissemination | required so as to prevent dissemination | required so as to prevent dissemination | Additional |
Containment Measures | Containment Levels | Additional/modification | |||
1 | 2 | 3 | 4 | ||
Facilities | |||||
1
Isolation of animal unit (Note 1) |
required where and to extent the risk assessment shows it is required | required | required | required | Modification |
2
Animal facilities (Note 2) separatedwhere and by lockable doors |
required to extent the risk assessment shows they are required | required | required | required | Additional |
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 required | required where and to extent the risk assesment shows they are required | required | required | Additional |
4
Floor, walls and ceiling easily washable |
required where and to extent the risk assessment shows they are required | required for floor | required for floor and walls | required for floor, walls and ceiling | Modification |
5
Appropriate filters on isolators or isolated rooms (Note 3) |
not required | required where and to extent the risk assessment shows they are required | required | required | Additional |
6
Incinerator for disposal of animal carcasses |
required to be accessible | required to be accessible | required to be accessible | required to be on site | Additional |
7
Appropriate barriers at the room exit, and at drains or ventilation duct work |
required | required | required | required | Additional |
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 required | required where and to extent the risk assessment shows it is required | required where and to extent the risk assessment shows it is required | required where and to extent the risk assessment shows it is required | Additional |
Containment Measures | Containment Levels | |||
1 | 2 | 3 | 4 | |
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 required | required | required | required |
2
Closed systems located within a controlled area |
not required | required where and to extent the risk assessment shows they are required | required | required and required to be purpose built |
3
Control of exhaust gases from the closed system |
not required | required so as to minimise release | required so as to prevent release | required 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 required | required so as to minimise release | required so as to prevent release | required 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 required | required by validated means | required by validated means | required by validated means |
6
Seals shall be designed so as to minimise or prevent release |
not required | required so as to minimise release | required so as to prevent release | required 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 is | required where and to extent the risk assessment shows it is required | required required | required |
8
The controlled area sealable to permit fumigation |
not required | required where and to extent the risk assessment shows it is required | required where and to extent the risk assessment shows it is required | required |
9
Biohazard signs posted |
required where and to extent the risk assessment shows it is required | required | required | required |
Equipment | ||||
10
Entry via airlock |
not required | not required | required where and to extent the risk assessment shows it is required | required |
11
Surfaces resistant to water, acids, alkalis, solvents, disinfectants and decontamination agents and easy to clean |
required for any bench | required for any bench | required for floor and any bench | required 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 required | required where and to extent the risk assessment shows they are required | required where and to extent the risk assessment shows they are required | required |
13
The controlled area maintained at an air pressure negative to the immediate surroundings |
not required | not required | required where and to extent the risk assessment shows it is required | required |
14
Extract and input air from the controlled area shall be HEPA filtered |
not required | not required | required for extract air, optional for input air | required for input and extract air |
System of work | ||||
15
Access restricted to authorised personnel only |
not required | required | required | required |
16
Decontamination and washing facilities provided for personnel |
required | required | required | required |
17
Personnel shall shower before leaving the controlled area |
not required | not required | required where and to extent the risk assessment shows it is required | required |
18
Personnel shall wear protective clothing |
work clothing required | work clothing required | required | complete change required before exit and entry |
19
Written procedures and records of staff training |
not required | not required | required | required |
Waste | ||||
20
Inactivation of GMMs in effluent from handwashing sinks and showers or similar effluents |
not required | not required | required where and to extent the risk assessment shows it is required | required |
21
Inactivation of GMMs in contaminated material and waste including those in process effluent before final discharge |
required by validated means | required by validated means | required by validated means | required by validated means |
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 |
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 -
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 -
(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 -
(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 -
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 -
(c) in relation to a notification submitted in accordance with paragraph 5, the register shall contain -
(3) The competent authority shall include in the register -
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 -
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 -
the notification in question submitted under regulation 9(1) of the 1994 Regulations.
(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 -
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 -
(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 -
(3) For the purposes of sub-paragraph (2), the excepted structures are -
Wells
3.
- (1) This paragraph applies to -
(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 -
being in either case a vessel which is engaged in pipeline works.
(2) In this paragraph -
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;
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 -
(2) This paragraph does not apply to vessels which are registered outside the United Kingdom and are on passage through territorial waters.
[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)back
[4] See Article 2(2) of S.I. 1978/1039 (N.I. 9)back
[5] Article 17 must be read with S.I. 1992/1728 (N.I. 17), Articles 3(2) and 4(2)back
[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)back
[7] Article 13(1) was amended by S.I. 1998/2795 (N.I. 18), Article 4back
[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)back
[14] S.I. 1991/1714 (N.I. 19)back
[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)back
[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)back
[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)back
[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 1back
[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.back
[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)back
[32] S.R. 1994 No. 143, as amended by S.R. 1996 No. 250 , S.R. 1999 No. 14 and S.R. 1999 No. 150back
[33] 1964 c. 29; section 1(7) was amended by the Oil and Gas (Enterprise) Act 1982 (c. 23), Schedule 3, paragraph 1back