HEALTH AND SAFETY PART I INTERPRETATION AND GENERAL Citation and commencement 1 These Regulations may be cited as the Genetically Modified Organisms (Contained Use) Regulations 1992 and shall come into force on 1st February 1993. Interpretation 2 1 In these Regulations, unless the context otherwise requires— “the 1989 Regulations ” means the Genetic Manipulation Regulations 1989 ; “accident” means any 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; “approved” means approved in writing for the time being by the Executive ; “activity involving genetic modification” means any operation involving the contained use of a genetically modified organism; “contained use” means any operation in which organisms are genetically modified or in which such genetically modified organisms are cultured, stored, used, transported, destroyed or disposed of and for which physical barriers or a combination of physical barriers with chemical or biological barriers or both, are used to limit their contact with the general population and the environment; “the contained use Directive ” means Council Directive No. 90/219/ EEC on the contained use of genetically modified micro-organisms; “the Executive” means the Health and Safety Executive; “genetic modification” in relation to an organism means the altering of the genetic material in that organism by a way that does not occur naturally by mating or natural recombination or both and within the terms of this definition— genetic modification occurs at least through the use of the techniques listed in Part I of Schedule 1; and the techniques listed in Part II of that Schedule are not considered to result in genetic modification, and “genetically modified” shall be construed accordingly; “genetic modification safety committee” means the committee established in accordance with regulation 11; “micro-organism” means a microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material including animal or plant cell cultures; “organism” means a biological entity capable of replication or of transferring genetic material and includes a micro-organism; “self-cloning” means the removal of nucleic acid from a cell or organism, followed by the re-insertion of all or part of that nucleic acid — with or without further enzymic, chemical or mechanical steps — into the same cell type (or cell-line) or into a phylogenetically closely related species which can naturally exchange genetic material with the donor species; “Type A operation” means any activity involving genetically modified microorganisms for the purposes of teaching, research, development, or for non-industrial or non-commercial purposes on a scale at which the practices and conditions of the operations relative to the culture, volume and numbers of organisms involved is such that— the system used to keep the organisms under containment reflects good microbiological practice and good occupational safety and hygiene; and it is possible easily to render the organisms inactive by standard laboratory decontamination techniques; “Type B operation” means any activity involving the genetic modification of microorganisms other than a Type A operation. 2 Genetically modified organisms shall be classified— a in the case of micro-organisms— i as Group I micro-organisms if they comply with such of the criteria set out in Part I of Schedule 2 as are applicable to the particular case, determined in accordance with the guidelines set out in Part II of that Schedule which gives effect to Commission Decision 91/448/EEC , or ii as Group II micro-organisms if they do not comply with the said criteria; or b in the case of genetically modified organisms other than micro-organisms, in accordance with the criteria set out in Part III of Schedule 2. 3 In these Regulations, unless the context otherwise requires— a a reference to a numbered Part, regulation or Schedule is a reference to the Part, regulation or Schedule in these Regulations so numbered; and 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. Application 3 1 These Regulations shall have effect with a view to protecting persons against risks to their health, whether immediate or delayed, and for the protection of the environment, arising from activities involving genetically modified organisms. 2 Regulations 8 to 12 shall not apply to the transport of genetically modified organisms by road, rail, inland waterway, sea or air. 3 These Regulations shall not apply to the genetic modification of organisms solely by any of the techniques referred to in Part III of Schedule 1 or to any organisms so modified. 4 Insofar as these Regulations relate to the protection of the environment, they shall only apply to genetically modified micro-organisms. 5 Nothing in these Regulations shall prejudice any requirement imposed by or under any enactment which relates to public health or the protection of the environment. 6 These Regulations shall not extend to Northern Ireland. Meaning of “work” “at work” 4 For the purpose of these Regulations and Part I of the Health and Safety at Work etc. Act 1974 the meaning of “work” shall be extended to include any activity involving genetic modification and the meaning of “at work” shall be extended accordingly. Modification of section 3(2) of the Health and Safety at Work etc. Act 1974 5 Section 3(2) of the Health and Safety at Work etc. Act 1974 shall be modified in relation to an activity involving genetic modification so as to have effect as if the reference to a self-employed person therein is a reference to any person who is not an employer or an employee and the reference in it to his undertaking includes a reference to such an activity. PART II NOTIFICATION OF AND CONSENT FOR ACTIVITIES INVOLVING GENETIC MODIFICATION Prohibition of certain work with genetically modified organisms outside containment 6 1 Subject to paragraph (2), any operation in which organisms are genetically modified or in which such genetically modified organisms are cultured, stored, used, transported, destroyed or disposed of is prohibited unless it is undertaken in conditions of contained use in accordance with these Regulations. 2 Paragraph (1) shall not apply to any operation in which— a genetically modified organisms are cultured, stored, used, transported, destroyed or disposed of, where such organisms are or are contained in a product marketed in pursuance of— i a consent granted by the Secretary of State under section 111(1) of the Environmental Protection Act 1990 , or ii a written consent given by another competent authority of a member State in accordance with Article 13(4) of Council Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms, and in either case, the operation is conducted in accordance with any conditions or limitations attached to that consent b genetically modified organisms are released or marketed in circumstances in which the consent of the Secretary of State is required under section 111(1) of the Environmental Protection Act 1990. 3 In this regulation, “product” means a product consisting of or containing a genetically modified organism or a combination of genetically modified organisms. Risk assessment 7 1 A person shall not— a use any premises for activities involving genetic modification for the first time; or b undertake any activity involving genetic modification, unless he has ensured that, before commencing that use or activity, as the case may be, a suitable and sufficient assessment of the risks created thereby to human health and the environment has been made. 2 Without prejudice to the generality of paragraph (1), the purposes of the assessment undertaken under that paragraph shall include— a classifying any genetically modified organisms involved in the activity in accordance with the provisions of Schedule 2; and b where appropriate, making decisions about the levels of containment required for the activity concerned. 3 In making the assessment required by paragraph (1) the person undertaking that assessment shall— a in particular, take due account of the parameters set out in Schedule 3 in as far as they are relevant; and b in a case in which the Executive has approved a method in relation to the activity involving genetic modification concerned or in relation to a particular element of that assessment, undertake the assessment in accordance with that method. 4 The assessment shall be reviewed forthwith if— a there is reason to suspect that the assessment is no longer valid; or b there has been a significant change in the activity to which the assessment relates. 5 The person making the assessment shall make a record of it and of any subsequent review and shall keep that record for at least 10 years from the date on which use of the premises or the activity, as the case may be, to which the assessment related, ceased. Notification of the intention to use premises for activities involving genetic modification for the first time 8 1 Subject to the following paragraphs of this regulation and regulation 10, no person shall undertake any activity involving genetic modification at any premises for the first time, unless he has notified the Executive of his intention to do so at least 90 days in advance or before such shorter time as the Executive may approve and with that notification has furnished the particulars specified in Schedule 4. 2 In the case of activities involving the genetic modification of micro-organisms, separate notifications shall be made of an intention to use the premises for activities involving genetically modified micro-organisms of Group I or Group II. 3 In the case of activities involving genetically modified micro-organisms of Group II, the premises shall only be used for those activities after the Executive has given its consent. 4 In any other case, the use of the premises for the activity may be commenced at or after the end of the period of 90 days, or such shorter period as the Executive may have approved in pursuance of paragraph (1), unless the Executive objects in writing before the end of the relevant period. 5 In any case in which a consent is required under paragraph (3), the Executive shall communicate its decision on the application in writing within 90 days after the application was received. 6 Nothing in this regulation shall prevent a person from notifying under regulation 9 an individual activity which he intends to undertake in the premises at the same time as making a notification under this regulation; in such a case he shall not commence the activity except in accordance with the time periods specified in this regulation. Notification of individual activities involving genetic modification 9 1 Subject to the following paragraphs of this regulation and regulation 10, no person shall undertake any activity involving genetic modification unless he has notified the Executive of his intention to do so at least 60 days in advance or before such shorter time as the Executive may approve and has furnished the particulars specified in the following paragraphs of this regulation and, except in the case of an activity to which paragraph (5) applies, the activity may be commenced after the expiry of the relevant period if by then the Executive has not objected in writing. 2 In the case of an activity which is— a a Type A operation involving only micro-organisms classified as Group I; or b an activity involving genetically modified organisms other than micro-organisms and which satisfy the criteria set out in Part III of Schedule 2, it shall be a sufficient compliance with paragraph (1) if the person undertaking the activity keeps a record of such activities and forthwith after the end of each calendar year notifies the Executive— i of the total number of risk assessments under regulation 7 undertaken during that year; ii where appropriate, that he is intending to continue to undertake such activities; and iii that the information notified to the Executive in accordance with regulation 8 remains correct. 3 In the case of an activity which is a Type B operation involving only microorganisms classified as Group I, the specified particulars for the purposes of paragraph (1) shall be those specified in Part I of Schedule 5. 4 In the case of an activity which is— a a Type A operation involving genetically modified micro-organisms classified as Group II; or b an activity involving genetically modified organisms other than micro-organisms and which do not satisfy the criteria set out in Part III of Schedule 2, the specified particulars for the purposes of paragraph (1) shall be those specified in Parts I and II of Schedule 5. 5 In the case of an activity which is a Type B operation involving genetically modified micro-organisms classified as Group II, the specified particulars for the purposes of paragraph (1) shall be those specified in Parts I, II and III of Schedule 5 and the activity shall only be commenced with the consent of the Executive. 6 In any case in which a consent is required under paragraph (5), the Executive shall communicate its decision on the application in writing within 90 days after the application was received. 7 The Executive may accept as a single notification a connected programme of work covering more than one activity involving genetic modification at one site, or a single activity carried on by the same person at more than one site. Additional provisions relating to notifications and consents 10 1 Where necessary for the purpose of evaluating a notification made under regulation 8 or 9, the Executive may require in writing the person making the notification to give such additional information relating to the proposal as it may specify and, in such a case, the person making the notification shall not proceed with the activity involving genetic modification, until the Executive gives its approval, and the period between the time when the Executive requires the information and the notifier responds to the satisfaction of the Executive shall not be taken into account in calculating the periods of days referred to in the provisions concerned. 2 Any consent granted by the Executive under regulation 8 or 9 may be granted subject to conditions or to a limit of time and may be revoked or varied at any time and in such a case the person undertaking the activity shall comply with those conditions. 3 In so far as they relate to the protection of the environment, the Executive shall not grant, vary or revoke a consent under regulation 8 or 9, or give its approval under paragraph (1), without the agreement of the Secretary of State. 4 Where a person making a notification in pursuance of regulation 8 or 9 subsequently makes a significant change in any premises or activity to which the notification relates or becomes aware of any new information which would affect the particulars previously notified, he shall forthwith notify the Executive thereof. 5 If information subsequently becomes available to the Executive which could have significant consequences for the risks to health or the environment created by an activity involving genetic modification which has been notified to it, it may require the notifier to modify the conditions under which the activity is carried out, or to suspend or terminate the activity. 6 Notifications made in pursuance of regulations 8 and 9 shall be in a form approved by the Executive. Establishment of a genetic modification safety committee 11 A person who undertakes an assessment made for the purposes of regulation 7(1) shall establish a genetic modification safety committee to advise him in relation to that assessment. PART III CONDUCT OF ACTIVITIES INVOLVING GENETIC MODIFICATION Standards of occupational and environmental safety and containment 12 1 For any activity involving genetically modified micro-organisms of Group I, the principles of good microbiological practice and the following principles of good occupational safety and hygiene shall apply— a to keep workplace and environmental exposure to any physical, chemical and biological agent adequately controlled; b to exercise engineering control methods at source and to supplement these with appropriate personal protective clothing and equipment where necessary; c to test and maintain control measures and equipment; d to test, when necessary, for the presence of viable process organisms outside the primary physical containment; e to provide training of personnel; and f to formulate and implement local rules for the safety of personnel. 2 For the purpose of paragraph (1) “adequate” in relation to the control of an agent means adequate having regard only to the nature of the agent and the nature and degree of exposure to such an agent and “adequately” shall be construed accordingly. 3 For any activities involving genetically modified micro-organisms of Group II in Type A operations, in addition to the principles set out in paragraph (1) the containment measures shall be determined by a method approved by the Executive. 4 For any activities involving genetically modified micro-organisms of Group II in Type B operations, in addition to the principles set out in paragraph (1) the containment measures set out in Schedule 6 shall be applied at an appropriate level so as to ensure a high level of health and safety and environmental protection. 5 For any activities involving genetically modified organisms other than microorganisms, the principles set out in paragraph (1) shall be applied in as far as they are appropriate. Emergency plans 13 1 Where the assessment made in accordance with 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 carried on is liable to be affected or there is a risk of damage to the environment, the person undertaking the activity shall ensure that a suitable emergency plan is prepared with a view to securing the health and safety of those persons and the protection of the environment. 2 The person preparing the plan shall consult such persons, bodies and authorities as are appropriate and shall inform the emergency services in writing of the plan and of the hazards to which the plan relates. 3 The person undertaking the activity involving genetic modification which is the subject of the emergency plan shall take appropriate measures to inform persons who are liable to be affected by an accident of the safety measures and the correct behaviour to adopt in the event of an accident. 4 The information required to be given in pursuance of paragraph (3) shall be repeated and brought up to date at appropriate intervals and shall be made publicly available. Notification of accidents 14 1 Where an accident occurs, the person undertaking the activity involving genetically modified organisms shall forthwith notify the Executive of it and shall provide the following information— a the circumstances of the accident; b the identity and quantity of genetically modified organisms released; c any information necessary to assess the effects of the accident on the health of the general population and on the environment; and d the emergency measures taken. 2 Where the Executive receives a notification in pursuance of paragraph (1), the Executive shall— a ensure that any emergency, medium and long term measures are taken; b immediately inform any other member State that 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 the information provided for under paragraph (1), together with an analysis of the accident and details of any recommendations made to avoid similar accidents in the future and to limit their effects. PART IV DISCLOSURE OF INFORMATION NOTIFIED AND PUBLICITY Disclosure of information notified 15 1 The information notified in pursuance of regulations 8 to 10 shall not be treated as relevant information for the purposes of section 28 of the Health and Safety at Work etc. Act 1974. 2 Where a person making a notification in pursuance of regulations 8 to 10 indicates that it contains certain information the disclosure of which might harm his competitive position and should be kept confidential, full justification for that indication shall be given and in such a case after consulting the notifier the Executive shall decide which information shall be kept confidential and shall inform the notifier of its decision. 3 Nothing in paragraph (2) shall apply to the following information which shall not be kept confidential— a the name and address of the notifier and the location of the activity involving genetic modification; b the purpose of the activity; c the description of the genetically modified organism involved; d methods and plans for monitoring the genetically modified organism and for emergency response; and e the evaluation of foreseeable effects and in particular pathogenic effects and ecologically disruptive effects. 4 Notwithstanding paragraph (3), where the Executive is satisfied on the basis of detailed 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 Executive shall withhold that information to the extent and for so long as it is necessary to protect those rights. 5 Information which is kept confidential in accordance with paragraph (2) or withheld in accordance with paragraph (4) shall be disclosed only— a to the Secretary of State; b to the European Commission or the competent authority for Northern Ireland or another member State; c for the purpose of any legal proceedings; d with the consent of the notifier; or e to the extent necessary to evaluate the notification. 6 A person who receives information in accordance with sub-paragraph (e) of paragraph (5) shall not use that information except for a purpose of the Executive or the Secretary of State. 7 Where the notifier has requested that certain information in the notification shall be kept confidential in accordance with paragraph (2) or withheld in accordance with paragraph (4), the Executive shall not disclose any of that information (except in accordance with paragraph (5)) until at least 14 days after it has reached a decision under the relevant paragraph. 8 After consulting the notifier, the Executive may review any decision made under paragraph (2) or (4) and shall inform the notifier of the result of that review. 9 Where, for whatever reason, the notifier withdraws the notification, the Executive shall not thereafter disclose any of the information supplied. Register of notifications 16 1 The Executive shall maintain a register of notifications to which regulation 8(3) or 9(5) relate (for which the consent of the Executive is required) and that register shall be open to inspection by members of the public at any reasonable time. 2 The register referred to in paragraph (1) shall contain in relation to each such notification— a such of the information referred to in regulation 15(3) as has not been withheld in accordance with paragraph (4) of that regulation; and b a statement as to whether or not the consent of the Executive has been granted. 3 The information referred to in sub-paragraph (a) of paragraph (2) shall be entered in the register within 14 days of its receipt by the Executive and the information referred to in sub-paragraph (b) of that paragraph within 14 days of the decision whether to grant the consent or not having been made, except that where the notifier has requested that certain information specified in regulation 15(3) be withheld in accordance with regulation 15(4), that information shall only be entered in the register not less that 14 days but not more than 28 days after the Executive has made a decision not to withhold that information. 4 Copies of the register shall be maintained at— a the area office of the Executive in whose area the notifier is situated; and b Baynards House, 1, Chepstow Place, Westbourne Grove, London W2 4TF, and c Magdalen House, Stanley Precinct, Bootle, Merseyside, L20 3QZ. PART V ADDITIONAL DUTIES PLACED ON THE EXECUTIVE Duties on receiving notifications 17 The Executive shall examine a notification under regulation 8 or 9 for— a the conformity with the requirements of these Regulations; b the accuracy and completeness of the information given; c the correctness of the classification of the organisms to which the notification relates in accordance with Schedule 2; and d where appropriate, the adequacy of the waste management, safety and emergency response measures. Information to be sent to the Secretary of State 18 Forthwith after receipt, the Executive shall send to the Secretary of State a copy in each case of— a any notification received under regulation 8 or 9; b any requirement for further information under regulation 10(1) and the response thereto; and c any notification relating to an accident under regulation 14, and if requested to do so by the Secretary of State shall require additional information under regulation 10(1). Reports to the European Commission 19 The Executive shall send to the European Commission reports of notifications for which a consent is required under regulation 9(5) and summary reports of the application of these Regulations in accordance with Article 18 of the contained use Directive. PART VI MISCELLANEOUS AND GENERAL Exemption certificates 20 1 Subject to paragraph (2) and to any provisions imposed by the Communities in respect of the control and regulation of genetically modified organisms, the Executive may, with the agreement of the Secretary of State in so far as the exemption relates to the environment, by a certificate in writing, exempt any person or class of persons, genetically modified organism or class of genetically modified organisms from all or any of the requirements 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 Executive shall not grant any such 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 that the health and safety of persons who are likely to be affected by the exemption or the protection of the environment will not be prejudiced in consequence of it. Enforcement and civil liability 21 1 Insofar as any provision of regulations 6 to 14 is made under section 2 of the European Communities Act 1972 — a the provisions of the Health and Safety at Work etc. Act 1974 relating to enforcement and offences shall apply to that provision as if that provision had been made under section 15 of that Act; and b in the event of a breach of duty imposed by that provision, it shall confer a right of action in civil proceedings if that breach of duty causes damage. 2 Notwithstanding regulation 3 of the Health and Safety (Enforcing Authority) Regulations 1989 , the enforcing authority for these Regulations shall be the Executive. Fees for notifications 22 1 Fees shall be payable in accordance with paragraph (2) by a notifier to the Executive in relation to any matter referred to in that paragraph. 2 The fees referred to in paragraph (1) shall be— a subject to sub-paragraph (b), on each notification of the intention to use premises for activities involving genetic modification for the first time under regulation 8, £100; b on each notification of the intention to use premises for activities involving genetic modification for the first time, where a consent is required under regulation 8(3), £130; c subject to sub-paragraph (d), on each notification of individual activities involving genetic modification under regulation 9, £180; d on each notification of individual activities involving genetic modification for which a consent is required under regulation 9(5), £270. 3 This regulation shall not apply to any notification made for the purposes of regulation 23(1) or (3) (which relates to transitional provisions). Transitional provisions 23 1 Where before 1st February 1993 a person had notified the Executive of his intention to undertake activities involving genetic modification which complied with regulation 5(1) and (2)(a) of the 1989 Regulations as then in force, that notification shall be treated as satisfying the requirements of regulation 8 except that regulation 8(3) shall apply to that activity on or after 1st February 1994. 2 Before 2nd May 1993 it shall be a sufficient compliance with regulation 8 if the notifier commences the activity having notified his intention to do so 30 days in advance or such shorter time in advance as the Executive may approve and regulation 8(3) shall not apply to activities commenced before 2nd May 1993 until 1st February 1994. 3 Where before 1st February 1993 a person had notified the Executive of his intention to undertake activities involving genetic modification which complied with regulation 5(1) and (2)(b) of the 1989 Regulations as then in force, that notification shall be treated as satisfying the requirements of regulation 9 except that regulation 9(5) shall apply to that activity on or after 1st February 1994. 4 Before 2nd April 1993 it shall be a sufficient compliance with regulation 9 if the notifier of an activity involving genetic modification had notified it in accordance with that regulation 30 days in advance or such shorter time in advance as the Executive may approve and regulation 9(5) shall not apply to activities commenced before 2nd April 1993 until 1st February 1994. 5 Regulation 10 shall apply to any notification made on or after 1st February 1993. Extension outside Great Britain 24 These Regulations shall apply in relation to premises and activities outside Great Britain to which sections 1 to 59 and 80 to 82 of the Health and Safety at Work etc. Act 1974 apply by virtue of the Health and Safety at Work etc. Act 1974 (Application Outside Great Britain) Order 1989 as they apply to premises and activities within Great Britain. Revocation 25 The 1989 Regulations are revoked. Signed by order of the Secretary of State. Patrick McLoughlin Parliamentary Under Secretary of State, Department of Employment 15th December 1992