"the 1974 Act" means the Health and Safety at Work etc. Act 1974;

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

"activity involving genetic modification" means a contained use;

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

"competent authority" means - 

(a) as regards England and Wales, the Secretary of State, the Minister of Agriculture, Fisheries and Food and the Executive, acting jointly; and

(b) as regards Scotland, the Scottish Ministers and the Executive, acting jointly,

and the expressions "competent authority as regards England and Wales" and "competent authority as regards Scotland" shall be construed accordingly;

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

(a) there is reason to suspect that an assessment is no longer valid; or

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

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

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

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

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

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

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

(a) any person or class of persons; or

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

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

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

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

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

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

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

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

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

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

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

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

(a) in vitro fertilisation;

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

(c) polyploidy induction.

(a) mutagenesis;

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

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

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

     4. In paragraph 3 - 

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

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

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


(i) the recipient micro-organism,

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

(iii) the vector,

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

(v) the resulting genetically modified micro-organism;



(b) the characteristics of the activity;

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

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

     2. In paragraph 1, "potentially harmful effects" includes - 

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

(b) disease to animals or plants;

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

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

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

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

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


(i) the recipient organism,

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

(iii) the vector,

(iv) the donor organism, and

(v) the resulting genetically modified organism;



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

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

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

     2. In paragraph 1, "potentially harmful effects" includes - 

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

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

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

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

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

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

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

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


(i) the provisional level of risk, and

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



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

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

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

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

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

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

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

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

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


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

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

(iii) information on waste management, and

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



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



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

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

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

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

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

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

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

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

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

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

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

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

(k) the approximate culture volumes to be used;

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


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

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



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

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

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

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

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

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

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

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

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

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

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

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

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

(j) the culture volumes to be used;

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


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

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

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



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

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

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



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

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

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

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

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

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



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

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

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

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

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

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

(f) the donor organism to be used;

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

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

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

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

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

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

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

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

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

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

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

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

(e) providing appropriate training of personnel;

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

(g) displaying biohazard signs where appropriate;

(h) providing washing and decontamination facilities for personnel;

(i) keeping adequate records;

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

(k) prohibiting mouth pipetting;

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

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

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

"GMMs" means genetically modified micro-organisms;

"HEPA" means High Efficiency Particulate Air;

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

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

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

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

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

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

     3. For the purposes of this Schedule - 

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

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

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

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