The Genetically Modified Organisms(Contained Use) Regulations 2000
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ARRANGEMENT OF REGULATIONS
PART I INTERPRETATION AND GENERAL
PART II RISK ASSESSMENT AND NOTIFICATION OF ACTIVITIES INVOLVING GENETIC MODIFICATION
PART III CONDUCT OF ACTIVITIES INVOLVING GENETIC MODIFICATION
PART IV DISCLOSURE OF INFORMATION AND PUBLICITY
PART V MISCELLANEOUS AND GENERAL
SCHEDULES
The Secretary of State, being the Minister designated[1]
under section 2(2) of the European Communities Act 1972[2]
in relation to the control and regulation of genetically modified organisms
and in the exercise of the powers conferred on him by the said section
2(2)[3]
and by sections 15(1), (2), (3)(b) and (c), (4)(a), (5)(b) and (9), 43(2),
(4), (5) and (6), 52(2) and (3) and 82(3)(a) of, and paragraphs 1(1)(b)
and (c), (2), (4) and (5), 4(1), 5, 6(1), 8(2), 9, 11, 13(1) and (3), 14,
15(1), 16 and 20 of Schedule 3 to, the Health and Safety at Work etc. Act
1974[4]
("the 1974 Act") and of all other powers enabling him in that behalf and
for the purpose of giving effect without modifications to proposals submitted
to him by the Health and Safety Commission under section 11(2)(d) of the
1974 Act after the carrying out by the said Commission of consultations
in accordance with section 50(3) of that Act, hereby makes the following
Regulations:
PART I INTERPRETATION AND GENERAL Citation and commencement
Interpretation
(b) as regards Scotland, the Scottish Ministers and the Executive,
acting jointly,
(b) the techniques listed in Part II of Schedule 2 are not considered
to result in genetic modification,
(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; and (c) in relation to a notification submitted in accordance with regulation
13(1), any reference to the competent authority shall be construed as a
reference to the joint competent authority.
(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.
(b) a reference to a numbered paragraph is a reference to the paragraph
so numbered in the regulation or Schedule in which that reference occurs.
3. - (1) These Regulations shall have effect with a view to -
(b) protecting the environment against harm from activities involving
genetic modification of micro-organisms.
(3) These Regulations shall not apply to any activity
in which -
(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[9]
on the deliberate release into the environment of genetically modified
organisms,
(ii) a medicinal product for human or veterinary use marketed in accordance with Council Regulation (EEC) No. 2309/93[10], 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[11];
or
(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) These Regulations shall not extend to Northern Ireland. (7) 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"
Modification of the Health and Safety at Work etc. Act 1974
(2) Section 3(2) of the 1974 Act 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 -
(b) "student" means any person studying at an educational establishment.
RISK ASSESSMENT AND NOTIFICATION OF ACTIVITIES INVOLVING GENETIC MODIFICATION Risk assessment of activities involving genetically modified micro-organisms
(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
(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
(b) there has been a significant change in the activity involving
genetic modification to which an assessment relates,
(2) The person undertaking an activity involving
genetic modification -
(b) shall make such record available to the competent authority when
requested to do so.
Notification of the intention to use premises for the first time
for activities involving genetic modification
(b) he has received an acknowledgement from the Executive of receipt
of that notification.
Notification of class 2 activities involving genetic modification
of micro-organisms
(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) No person shall undertake -
(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;
(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
(b) received the written consent of the competent authority to undertake
the activity in question.
(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
(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) No person shall 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. Notifications to the joint competent authority and of connected programmes
of work
(b) under regulation 10(1), 11(1) or 12(1) in respect of an activity
involving genetic modification which is to take place in both England and
Scotland,
(2) 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 -
(b) more than one site.
(4) In this regulation -
(b) "site" means premises of which the competent authority has been
notified in accordance with regulation 9(1).
14. - (1) The competent authority shall examine a notification submitted under regulation 9(1), 10(1), 11(1) or 12(1) for -
(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.
(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) -
(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.
(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 -
(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,
Additional provisions relating to notifications
(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,
(2) A notifier shall forthwith send to the competent
authority full details in writing of -
(b) any new building -
(ii) under his control;
(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) above; (g) 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, provided that a notification has been submitted by him in accordance with regulation 9(1) in respect of the additional premises; (h) any change in the information specified in -
(ii) paragraph 1(c) or (d) of Part I of Schedule 6 and provided by
him in accordance with regulation 10(1).
(b) becomes aware of any new information which may have significant
consequences for the risks arising from that activity,
(4) Subject to paragraph (5), 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 -
(b) he has received the written consent of the competent authority
pursuant to regulation 11(1)(b).
(6) 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. (7) In this regulation, the word "site" has the same meaning as it has in regulation 13. (8) 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 Magdalen House, Stanley
Precinct, Bootle, Merseyside L20 3QZ.
PART III CONDUCT OF ACTIVITIES INVOLVING GENETIC MODIFICATION Establishment of a genetic modification safety committee
Principles of occupational and environmental safety
(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.
(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
(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) -
(b) forthwith if that person suspects that -
(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.
Containment and control measures for activities involving genetic
modification of organisms other than micro-organisms
(2) That person shall review the containment measures
applied by him in accordance with paragraph (1) -
(b) forthwith if that person suspects that -
(ii) in the light of new scientific or technical knowledge, the assessment
referred to in paragraph (1) is no longer valid.
20. - (1) Where an assessment carried out pursuant to regulation 6(1) shows that, as a result of any reasonably foreseeable accident -
(b) there is a risk of serious damage to 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 -
(b) shall be reviewed and, where necessary, revised at suitably regular
intervals.
(b) make the plan and any such revisions publicly available.
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 -
(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.
(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 -
(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.
DISCLOSURE OF INFORMATION AND PUBLICITY Disclosure of information provided pursuant to regulations 9 to 15
(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) or 15(3), a person
indicates that he is providing information which should be kept confidential
on one or more of the grounds set out in regulation 4(2)(a) to (c) and
(e) of the Environmental Information Regulations 1992[12]
-
(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.
(b) in the case of a notification relating to an activity involving
genetic modification of a micro-organism -
(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.
(b) to the European Commission.
(b) to the European Commission.
(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(6). (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 -
(b) withholding information is necessary in order to protect his
intellectual property rights,
(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 -
(b) the notifier has informed the competent authority of any change
in circumstances pursuant to paragraph (9),
(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
(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 4(2)(a)
to (c) and (e) of the Environmental Information Regulations 1992 -
(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.
(b) in the case of an accident relating to an activity involving
genetic modification of a micro-organism -
(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.
(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 -
(b) withholding information is necessary in order to protect his
intellectual property rights,
(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 -
(b) the person who provided the information has informed the competent
authority of a change in circumstances pursuant to paragraph (8),
(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
(2) The register referred to in paragraph (1)
shall contain -
(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 (g) of regulation 15(2) or in regulation 15(3),
confirmation that such details have been received;
(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;
(c) in relation to each notification submitted under regulation 11(1)
-
(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 -
(b) be withheld in accordance with regulation 22(8),
(5) Where a person withdraws a notification under regulation 15(6), 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 -
(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.
(b) Magdalen House, Stanley Precinct, Bootle, Merseyside L20 3QZ.
(9) A copy of that part of the register which
relates to -
(b) an activity involving genetic modification, in respect of which
a notification has been submitted in accordance with regulation 10(1),
11(1) or 12(1), undertaken at such premises,
(10) The copies of the register shall be open
to inspection by members of the public at any reasonable time.
PART V MISCELLANEOUS AND GENERAL Exemption certificates
(b) any genetically modified organism or class of genetically modified
organisms,
(2) The competent authority shall not grant an
exemption unless, having regard to the circumstances of the case and in
particular to -
(b) any requirements imposed by or under any enactments which apply
to the case,
(3) The matters about which the competent authority
shall be satisfied for the purposes of paragraph (2) are -
(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.
26. - (1) Subject to paragraph (2) and to the extent they would not otherwise do so, the provisions of -
(b) the Health and Safety (Training for Employment) Regulations 1990[13],
(2) A failure to discharge a duty -
(b) placed on any other person by Schedule 11,
(3) Notwithstanding regulation 3 of the Health and Safety (Enforcing Authority) Regulations 1998[14], the enforcing authority for these Regulations shall be the Executive. Fees for notifications and applications
(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(6). Transitional provisions
Appeals
(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),
(2) Any person who is aggrieved by -
(b) an instruction given to him pursuant to regulation 14(3); (c) a notice given to him pursuant to regulation 15(1),
(3) Any person who is aggrieved by a decision
of the competent authority -
(b) made pursuant to regulation 22(8) or regulation 23(7), not to
withhold information,
(4) The provisions of Schedule 11 shall apply where an aggrieved person appeals to the appropriate person. (5) Where an appeal is brought under this regulation,
none of the following, that is to say -
(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),
(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
-
(ii) to the European Commission;
(ii) the information is required to be entered in the register maintained
in accordance with regulation 24,
(ii) an appeal under paragraph (2)(a) or (b) against a request or
instruction relating to -
(bb) premises which are the subject of a notification under regulation
9(1) and which are situate,
(ii) an appeal under paragraph 2(a) or (b) against a request or instruction
relating to -
(bb) premises which are the subject of a notification under regulation
9(1) and which are situate,
30. These Regulations shall apply in relation to premises and activities involving genetic modification outside Great Britain to which sections 1 to 59 and 80 to 82 of the 1974 Act apply by virtue of the Health and Safety at Work etc. Act 1974 (Application Outside Great Britain) Order 1995[15] as they apply to premises and activities involving genetic modification within Great Britain. Revocations, amendments and savings
(1) The following are revoked -
(b) the Genetically Modified Organisms (Contained Use) (Amendment) Regulations 1996[17]; (c) the Genetically Modified Organisms (Contained Use) (Amendment)
Regulations 1998[18].
(3) The Genetically Modified Organisms (Risk Assessment)
(Records and Exemptions) Regulations 1996[20]
shall be amended as follows -
(b) in paragraph (2)(b)(i) of regulation 3, for the words "Schedule 1", there shall be substituted the words "Schedule 2"; and (c) in paragraph (2)(b)(ii) of regulation 3, 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".
(5) In the Health and Safety (Fees) Regulations 2000[22], regulation 17 and Schedule 14 shall be omitted. (6) Every record required to be kept under regulation
7(5) of the Genetically Modified Organisms (Contained Use) Regulations
1992 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.
Signed by authority of the Secretary of State
Michael Meacher
17th October 2000
SCHEDULE 1
CLASSES OF ACTIVITY INVOLVING GENETIC MODIFICATION
SCHEDULE 2 PART I EXAMPLES 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 -
(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.
TECHNIQUES 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
-
(b) natural processes including conjugation, transduction or transformation; (c) polyploidy induction.
TECHNIQUES 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 -
(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.
(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.
PART I MATTERS TO BE TAKEN INTO ACCOUNT IN CARRYING OUT ANASSESSMENT 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 -
(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;
(c) the severity of the potentially harmful effects; and (d) the likelihood of the potentially harmful effects being realised.
(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.
STEPS 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 -
(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[23] 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 -
(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;
(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) above; (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.
(b) then select the highest number of all the columns identified in accordance with sub-paragraph (a) above; and (c) then assign the activity involving genetic modification in question
to the containment level of that highest number.
SCHEDULE 4 PART I MATTERS 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 -
(ii) the inserted genetic material (originating from the donor organism), (iii) the vector, (iv) the donor organism, and (v) the resulting genetically modified organism;
(c) the severity of the potentially harmful effects; and (d) the likelihood of the potentially harmful effects being realised.
(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.
STEPS 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 -
(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 -
(ii) the characteristics of the activity involving genetic modification;
(f) review and reconsideration of the containment and other protective
measures in the light of the steps required by sub-paragraphs (a) to (e)
above.
INFORMATION REQUIRED FOR A NOTIFICATION UNDER REGULATION 9(1)
A notification required for the purposes of regulation 9(1) shall
contain the following information -
(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 -
(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
(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).
PART I INFORMATION REQUIRED FOR A NOTIFICATION UNDERREGULATION 10(1) 1. A notification required for the purposes
of regulation 10(1) shall contain the following information -
(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 -
(ii) justification for not applying any containment measure at containment
level 2;
(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).
INFORMATION REQUIRED FOR A NOTIFICATION UNDER REGULATION 11(1) 2. A notification required for the purposes
of regulation 11(1) shall contain the following information -
(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 -
(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;
(m) a description of the parts of the installation; (n) information on any accident prevention and emergency plans, including
-
(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
INFORMATION REQUIRED FOR A NOTIFICATION UNDER REGULATION 12(1) 3. A notification required for the purposes
of regulation 12(1) shall contain the following information -
(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).
GENERAL 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 -
(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.
CONTAINMENT MEASURES
PART I 1. In this Schedule -
(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.
(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.
Table 1a: Containment Measures for Activities Involving Genetic Modification of Micro-organisms in Laboratories
NOTES
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.
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)
NOTE
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)
NOTES
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.
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
SCHEDULE 9
FEES FOR NOTIFICATIONS AND APPLICATIONS
SCHEDULE 10
TRANSITIONAL PROVISIONS
Interpretation
(b) "the relevant date" means the date on which these Regulations come into force; and (c) a reference to a numbered sub-paragraph is a reference to the
sub-paragraph so numbered in the paragraph in which that reference occurs.
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 15th December 2000. (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 15th December 2000. Notification of premises
(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 15th February 2001 at the premises referred
to in the notification submitted pursuant to regulation 8(1) of the 1992
Regulations.
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 1992 Regulations and immediately before the relevant date that person was entitled under the 1992 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 15th February 2001 that person submits to the competent authority a notification containing -
(b) in the case of an activity referred to in regulation 9(3) or regulation 9(4)(a) of the 1992 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 1992 Regulations, the information specified in paragraphs (c), (d),
(l)(ii) and (p) of Part I of Schedule 6.
(b) before 15th February 2001, the competent authority gives its
consent in writing to continue to undertake the activity involving genetic
modification of micro-organisms in question.
(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
(b) in the case of an activity referred to in regulation 9(3) or regulation 9(4)(a) of the 1992 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 1992 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 1992 Regulations but immediately before the relevant date that person was not entitled under the 1992 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 1992 Regulations but immediately before the relevant date that person was not entitled under the 1992 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
Additional provisions relating to notification
Emergency Plans
Disclosure of information
Register of notifications
(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 -
(b) in relation to a notification submitted in accordance with paragraph
4, the register shall contain -
(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 1992 Regulations, (iii) the date on which any information had been notified under regulation 10(4) of the 1992 Regulations, and (iv) where appropriate, confirmation that a consent has been granted
under paragraph 4(2)(b); and
(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 1992 Regulations, (iii) the date on which any information had been notified under regulation 10(4) of the 1992 Regulations, and (iv) where appropriate, confirmation that a consent has been granted
under regulation 11(3) or 11(4).
(b) by 15th April 2001, 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).
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 -
(b) in the case of a notification submitted in accordance with paragraph
3 -
(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 1992 Regulations relating to,
(c) in the case of a notification submitted in accordance with paragraph
4 or 5 -
(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 1992 Regulations relating to,
SCHEDULE 11
APPEALS
PART I 1. In this Schedule -
"appellant" means a person who has brought an appeal; "appointed person" means a person appointed in accordance with paragraph 2; "appropriate person" has the same meaning as in regulation 29; "authority" means the competent authority in the case of an appeal under regulation 29(1), (2)(c) or (3) and the Executive in the case of an appeal under regulation 29(2)(a) or (b); "hearing" means a hearing to which Part II of this Schedule applies; "the parties" means the appellant and the authority; "site" means premises at which the activity involving genetic modification to which the appeal relates is, or is proposed to be, undertaken; and (b) a reference to a numbered sub-paragraph is a reference to the
sub-paragraph so numbered in the paragraph in which that reference occurs.
3. Before the determination of an appeal,
the appointed person shall ask the parties whether they wish to appear
and be heard on the appeal and -
(b) the appointed person shall, if either of the parties expresses
a wish to appear and be heard, afford both of them an opportunity of so
doing, in which case the provisions of Part II of this Schedule shall apply.
5. The appropriate person may pay to an
appointed person such remuneration and allowances as the appropriate person
may, with the approval of the Minister for the Civil Service, determine.
PART II 6. An appeal brought pursuant to regulation 29(3) shall be heard in private. 7. - (1) Subject to the following sub-paragraphs of this paragraph, a date, time and place for the holding of the hearing shall be fixed, and may be varied, by the appointed person, who shall give not less than 42 days' notice in writing of such date, time and place to the parties. (2) With the consent of the parties, the appointed person may give such lesser period of notice as shall be agreed with the parties and in that event he may specify a date for service of the statement referred to in paragraph 8(1) later than the date determined in accordance with that paragraph. (3) Where it becomes necessary or advisable to vary the time or place fixed for the hearing, the appointed person shall give such notice of the variation as may appear to him to be reasonable in the circumstances. (4) Without prejudice to the foregoing provisions
of this paragraph, the appointed person may require the authority to take
one or more of the following steps, namely: -
(b) to serve such notice of the hearing, in such form and on such persons or classes of persons as he may direct; (c) to give such other notice of the hearing and in such form as
he may direct,
8. - (1) Not later than 28 days before the date of the hearing, or such later date as the appointed person may specify in accordance with paragraph 7(2), the authority shall serve on the appellant a written statement of any submission which the authority proposes to put forward at the hearing and shall supply a copy of the statement to the appointed person. (2) Where a government department has expressed in writing to the authority a view in support of the decision of the authority and the authority proposes to rely on such expression of view in its submission at the hearing, the authority shall include the expression of view in its statement and shall supply a copy of the statement to the government department concerned. (3) Where the authority intends to refer to or put in evidence at the hearing, documents (including photographs, maps and plans), the statement of the authority shall be accompanied by a list of such documents, together with a written notice stating the times and place at which the documents may be inspected by the appellant; and the authority shall afford the appellant a reasonable opportunity to inspect and, where practicable, to take copies of the documents. (4) If so required by the appointed person, the
appellant shall -
(b) afford the authority a reasonable opportunity to inspect and,
where practicable, to take copies of such documents as are referred to
in the foregoing provision.
(2) Any other person may appear at the discretion of the appointed person provided that he has, not later than 7 days before the date of the hearing, served on the authority a statement of his proposed submissions. (3) The authority shall send a copy of every statement served on it in accordance with sub-paragraph (2) to the appointed person and to the appellant. (4) A body corporate may appear by its clerk or secretary or by any other officer appointed for the purpose by that body, or by counsel or a solicitor. (5) A person may appear on his own behalf or be represented by counsel, a solicitor or any other person. (6) Where there are two or more persons having a similar interest in the subject matter of the hearing, the appointed person may allow one or more persons to appear for the benefit of some or all persons so interested. 10. - (1) Where a government department has expressed in writing to the authority a view in support of the decision of the authority and the authority has included this view in the statement referred to in paragraph 8(1), the appellant may apply in writing to the appointed person, not later than 14 days before the date of the hearing, for a representative of the government department concerned to be made available at the hearing. (2) The appointed person shall send any application made to him under sub-paragraph (1) to the government department concerned who shall make a representative of the department available to attend the hearing. (3) A representative of a government department who, in pursuance of this paragraph, attends a hearing shall be called as a witness by the authority and shall state the reasons for the view expressed by his department and included in the statement of the authority under paragraph 8(1) and shall give evidence and be subject to cross-examination to the same extent as any other witness. (4) Nothing in the last foregoing paragraph shall require a representative of a government department to answer any question which in the opinion of the appointed person is directed to the merits of government policy or to matters which affect the safety of the State and the appointed person shall disallow any such question. 11. - (1) Except as otherwise provided
in this Part of this Schedule, the procedure at the hearing shall be such
as the appointed person shall in his discretion determine and the appointed
person shall -
(b) shall inform the parties what he proposes as regards any site
inspection arising out of the hearing.
(b) in the case of an appeal to the Secretary of State and the Scottish
Ministers acting jointly -
(ii) the other persons entitled or permitted to appear shall be heard in such order as the appointed person may determine, and (iii) any closing statements shall be made in the same order, unless
the appointed person otherwise determines.
(4) Subject to sub-paragraph (5), any evidence may be admitted at the discretion of the appointed person, who may direct that documents tendered in evidence may be inspected by any person entitled or permitted to appear at the hearing and that facilities be afforded him to take or obtain copies thereof. (5) The appointed person shall not require or permit the giving or production of any evidence, whether written or oral, which would be contrary to the public interest. (6) The appointed person may allow the authority or the appellant, or both of them, to alter or add to the submissions contained in any statement served under paragraph 8(1) or (4), or to any list of documents which accompanied such statement, so far as may be necessary for the purpose of determining the questions in controversy between the parties, but shall (if necessary by adjourning the hearing) give the appellant or the authority, as the case may be, an adequate opportunity of considering any such fresh submission or document. (7) If any person entitled to appear at the hearing fails to appear, the appointed person may proceed with the hearing at his discretion. (8) The appointed person shall be entitled (subject to disclosure thereof at the hearing) to take into account any written representations or statements received by him before the hearing from any person. (9) The appointed person may from time to time adjourn the hearing, and where he does so, shall give reasonable notice to every person entitled or permitted to appear at the hearing of the date, time and place of the adjourned hearing. 12. - (1) The appointed person may make an inspection of the site before or during the hearing after having given notice to the parties of the date and time at which he proposes to do so. (2) The appointed person may, and shall if so requested by either party before or during the hearing, inspect the site after the close of the hearing and, in all cases where he intends to make such an inspection, shall announce during the hearing the date and time at which he proposes to do so. (3) The parties shall be entitled to accompany the appointed person on any inspection under this paragraph, but the appointed person shall not be bound to defer his inspection if any person entitled to accompany him is not present at the time appointed. 13. - (1) Where, after the close of
the hearing, the appointed person proposes to take into consideration -
(b) any new issue of fact, not being a matter of government policy
or a matter affecting the safety of the State,
(2) If he thinks fit, the appointed person may cause the hearing to be re-opened and shall cause it to be re-opened if asked to do so in accordance with sub-paragraph (1). (3) Where the hearing is re-opened, paragraphs 7(1) and 7(4) shall apply as they applied to the original hearing with the substitution in paragraph 7(1) of "28" for "42". 14. The appointed person shall notify the
decision on the appeal, and the reasons therefor, in writing to the parties
and to any person who, having appeared at the hearing, has asked to be
notified of the decision.
(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, Schedule 9 and Schedule 11, these Regulations implement as respects Great Britain Council Directive 90/219/EEC of 23 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 26 October 1998 (O.J. No. L330, 5.12.98, p. 13). 3. The Regulations revoke and replace the Genetically Modified Organisms (Contained Use) Regulations 1992, 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. No person shall 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 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 certain offices of the Health and Safety Executive. 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. (Regulation 29 and Schedule 11.) 19. A copy of the regulatory impact assessment prepared in respect of these Regulations can be obtained from the Health and Safety Executive, Economic Adviser's Unit, Rose Court, 2, Southwark Bridge, London SE1 9HS. A copy has been placed in the Library of each House of Parliament.
Notes: [1] S.I. 1991/755.back [2] 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 [3] As regards Scotland, see also section 57(1) of the Scotland Act 1998 (c. 46), which provides that, despite the transfer to the Scottish Ministers by virtue of that Act of functions in relation to observing and implementing obligations under Community law, any function of a Minister of the Crown in relation to any matter shall continue to be exerciseable by him as regards Scotland for the purposes specified in section 2(2) of the European Communities Act 1972.back [4] 1974 c. 37; sections 11(2), 15(1), 43(6), 50 and 52(3) were amended by section 116 of, and paragraphs 4, 6, 12, 16 and 17 respectively of Schedule 15 to, the Employment Protection Act 1975 (c. 71).back [5] Cm 2073 and 2183.back [6] 1993 c. 51.back [7] 1971 c. 80.back [8] 1990 c. 43.back [9] OJ No. L117, 8.5.90, p. 15, as amended by Commission Directive 94/15/EC (OJ No. L103, 22.4.94, p. 20) and Commission Directive 97/35/EC (OJ No. L 169, 27.6.97, p. 72).back [10] OJ No. L 124, 24.8.93, p. 1, as amended by Commission Regulation (EC) 649/98 (OJ No. L 88, 24.3.98, p. 7).back [11] OJ No. L 43, 14.2.97, p. 1 (to be read with Corrigenda published in OJ L 173, 1.7.97, p. 12 and OJ L 187, 20.7.99, p. 74.back [12] S.I. 1992/3240, as amended by S.I. 1998/1447.back [13] S.I. 1990/1380.back [14] S.I. 1998/494.back [15] S.I. 1995/263.back [16] S.I. 1992/3217.back [17] S.I. 1996/967.back [18] S.I. 1998/1548.back [19] S.I. 1992/3280. Paragraph (3) of regulation 8 was amended by S.I. 1995/304; there are other amendments not relevant to these Regulations.back [20] S.I. 1996/1106, to which there are amendments not relevant to these Regulations.back [21] S.I. 1999/437.back [22] S.I. 2000/2482.back [23] 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 [24] S.I. 1992/3217, as amended by S.I. 1996/967, 1998/1548.back
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