LegalizeThe Genetically Modified Organisms (Contained Use) Regulations 2014
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 is to be read in substitution for the relevant measure in Table 1a;
- (b) additional, it is to be read as an addition to the measures in Table 1a, and any measure which has been substituted for a measure in Table 1a, in accordance with paragraph 2(a).
3
For the purposes of this Schedule—
- (a) Table 1a describes containment measures applicable to contained use involving micro-organisms in laboratories;
- (b) Table 1a, read with Table 1b, describes containment measures applicable to contained use involving micro-organisms in plant growth facilities;
- (c) Table 1a, read with Table 1c, describes containment measures applicable to contained use involving micro-organisms in animal units;
- (d) Table 2 describes containment measures applicable to contained use involving micro-organisms in premises other than those referred to in Tables 1a, 1b and 1c.
PART 2 — Containment measures
| Containment Measures | Containment Levels | Containment Levels | Containment Levels | Containment Levels | |
|---|---|---|---|---|---|
| Containment Measures | 1 | 2 | 3 | 4 | |
| (1) “isolation” means, in relation to a laboratory, separation of the laboratory from other areas in the same building, or being in a separate building. | (1) “isolation” means, in relation to a laboratory, separation of the laboratory from other areas in the same building, or being in a separate building. | (1) “isolation” means, in relation to a laboratory, separation of the laboratory from other areas in the same building, or being in a separate building. | (1) “isolation” means, in relation to a laboratory, separation of the laboratory from other areas in the same building, or being in a separate building. | (1) “isolation” means, in relation to a laboratory, separation of the laboratory from other areas in the same building, or being in a separate building. | (1) “isolation” means, in relation to a laboratory, separation of the laboratory from other areas in the same building, or being in a separate building. |
| (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. | (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. | (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. | (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. | (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. | (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. | (3) Where viruses are not retained by the HEPA filters, extra requirements will be necessary for extract air. | (3) Where viruses are not retained by the HEPA filters, extra requirements will be necessary for extract air. | (3) Where viruses are not retained by the HEPA filters, extra requirements will be necessary for extract air. | (3) Where viruses are not retained by the HEPA filters, extra requirements will be necessary for extract air. | (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 contained use is being undertaken, but within the laboratory suite, there must 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. | (4) Where the autoclave is outside the laboratory in which the contained use is being undertaken, but within the laboratory suite, there must 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. | (4) Where the autoclave is outside the laboratory in which the contained use is being undertaken, but within the laboratory suite, there must 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. | (4) Where the autoclave is outside the laboratory in which the contained use is being undertaken, but within the laboratory suite, there must 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. | (4) Where the autoclave is outside the laboratory in which the contained use is being undertaken, but within the laboratory suite, there must 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. | (4) Where the autoclave is outside the laboratory in which the contained use is being undertaken, but within the laboratory suite, there must 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. |
| Facilities | Facilities | Facilities | Facilities | Facilities | Facilities |
| 1 | Laboratory suite: isolation[^f01000] | not required | not required | required | required |
| 2 | Laboratory: sealable for fumigation | not required | not required | required | required |
| Equipment | Equipment | Equipment | Equipment | Equipment | Equipment |
| 3 | Surfaces impervious to water, resistant to acids, alkalis, solvents, disinfectants and decontamination agents and easy to clean | required for any bench | required for any bench | required for any bench and floor | required for any bench, floor, ceiling and walls |
| 4 | Entry to laboratory via airlock[^f01001] | not required | not required | required where and to extent the risk assessment shows it is required | required |
| 5 | Negative pressure relative to the pressure of the immediate surroundings | not required | not required | required except for activities where transmission does not occur by the airborne route | required |
| 6 | Extract and input air from the laboratory must be HEPA filtered | not required | not required | HEPA filters required for extract air except for activities where transmission does not occur by the airborne route | HEPA filters required for input and extract air[^f01002] |
| 7 | Microbiological safety cabinet/enclosure | not required | required where and to extent the risk assessment shows it is required | required, and all procedures with infective materials required to be contained within a cabinet/ enclosure | required, and all procedures with infective materials required to be contained within a cabinet/ enclosure |
| 8 | Autoclave | required on site | required in the building | required in the laboratory suite[^f01003] | double ended autoclave required in laboratory |
| System of work | System of work | System of work | System of work | System of work | System of work |
| 9 | Access restricted to authorised personnel only | not required | required | required | required (via airlock key procedure) |
| 10 | Biohazard sign on door | not required | required | required | required |
| 11 | Specific measures to control aerosol dissemination | not required | required so as to minimise | required so as to prevent | required so as to prevent |
| 12 | Shower | not required | not required | required where and to extent the risk assessment shows it is required | required |
| 13 | Protective clothing | suitable protective clothing required | suitable protective clothing required | suitable protective clothing required; footwear required where and to extent the risk assessment shows it is required | complete change of clothing and footwear required before entry and exit |
| 14 | Gloves | not required | required where and to extent the risk assessment shows they are required | required | required |
| 15 | Efficient control of disease vectors (e.g. rodents and insects) which could disseminate GMMs | required where and to extent the risk assessment shows it is required | required | required | required |
| Waste | Waste | Waste | Waste | Waste | Waste |
| 16 | Inactivation of GMMs in effluent from hand-washing sinks and showers and similar effluents | not required | not required | required where and to extent the risk assessment shows it is required | required |
| 17 | Inactivation of GMMs in contaminated material and waste | required by validated means where and to extent the risk assessment shows it is required | required by validated means | required by validated means, with waste inactivated within the laboratory suite | required by validated means, with waste inactivated within the laboratory |
| Other measures | Other measures | Other measures | Other measures | Other measures | Other measures |
| 18 | Laboratory to contain its own equipment | not required | not required | required, so far as is reasonably practicable | required |
| 19 | An observation window or alternative is to be present so that occupants can be seen | required where and to extent the risk assessment shows it is required | required where and to extent the risk assessment shows it is required | required where and to extent the risk assessment shows it is required | required |
| 20 | Safe storage of GMMs | required where and to extent the risk assessment shows it is required | required | required | secure storage required |
| 21 | Written records of staff training | not required | required where and to extent the risk assessment shows it is required | required | required |
| ¹ A permanent structure refers to a fixed structure with walls, a roof and a floor. Where the permanent structure is a greenhouse, that structure must also have a continuous waterproof covering and self-closing lockable outer doors, and be located on a site designed to prevent the entry of surface run-off water. | ¹ A permanent structure refers to a fixed structure with walls, a roof and a floor. Where the permanent structure is a greenhouse, that structure must also have a continuous waterproof covering and self-closing lockable outer doors, and be located on a site designed to prevent the entry of surface run-off water. | ¹ A permanent structure refers to a fixed structure with walls, a roof and a floor. Where the permanent structure is a greenhouse, that structure must also have a continuous waterproof covering and self-closing lockable outer doors, and be located on a site designed to prevent the entry of surface run-off water. | ¹ A permanent structure refers to a fixed structure with walls, a roof and a floor. Where the permanent structure is a greenhouse, that structure must also have a continuous waterproof covering and self-closing lockable outer doors, and be located on a site designed to prevent the entry of surface run-off water. | ¹ A permanent structure refers to a fixed structure with walls, a roof and a floor. Where the permanent structure is a greenhouse, that structure must also have a continuous waterproof covering and self-closing lockable outer doors, and be located on a site designed to prevent the entry of surface run-off water. | ¹ A permanent structure refers to a fixed structure with walls, a roof and a floor. Where the permanent structure is a greenhouse, that structure must also have a continuous waterproof covering and self-closing lockable outer doors, and be located on a site designed to prevent the entry of surface run-off water. |
| --- | --- | --- | --- | --- | --- |
| Containment Measures | Containment Levels | Containment Levels | Containment Levels | Containment Levels | |
| Containment Measures | 1 | 2 | 2 | 3 | |
| Facilities | Facilities | Facilities | Facilities | Facilities | Facilities |
| 1 | Permanent structure¹ | required where and to extent the risk assessment shows it is required | required | required | required |
| Equipment | Equipment | Equipment | Equipment | Equipment | Equipment |
| 2 | Entry via a separate room with two interlocking doors | not required | required where and to extent the risk assessment shows it is required | required where and to extent the risk assessment shows it is required | required where and to extent the risk assessment shows it is required |
| 3 | Control of contaminated run-off water | required where and to extent the risk assessment shows it is required | required so as to minimise run-off | required so as to prevent run-off | required so as to prevent run-off |
| System of work | System of work | System of work | System of work | System of work | System of work |
| 4 | Effective control of disease vectors such as insects, rodents and arthropods which could disseminate GMMs | required | required | required | required |
| 5 | Effective control of pollen, seeds and other plant material which could disseminate GMMs | required where and to extent the risk assessment shows it is required | required so as to minimise dissemination | required so as to prevent dissemination | required so as to prevent dissemination |
| 6 | Procedures for transfer of living material between the plant growth facilities, protective structure and laboratory must control dissemination of GMMs | required so as to minimise dissemination | required so as to minimise dissemination | required so as to prevent dissemination | required so as to prevent dissemination |
| ¹ “animal unit” means a building, or separate area within a building, containing an animal facility and other areas including changing rooms, showers, autoclaves and food storage areas. | ¹ “animal unit” means a building, or separate area within a building, containing an animal facility and other areas including changing rooms, showers, autoclaves and food storage areas. | ¹ “animal unit” means a building, or separate area within a building, containing an animal facility and other areas including changing rooms, showers, autoclaves and food storage areas. | ¹ “animal unit” means a building, or separate area within a building, containing an animal facility and other areas including changing rooms, showers, autoclaves and food storage areas. | ¹ “animal unit” means a building, or separate area within a building, containing an animal facility and other areas including changing rooms, showers, autoclaves and food storage areas. | ¹ “animal unit” means a building, or separate area within a building, containing an animal facility and other areas including changing rooms, showers, autoclaves and food storage areas. |
| --- | --- | --- | --- | --- | --- |
| ² “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. | ² “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. | ² “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. | ² “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. | ² “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. | ² “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 “isolators” means transparent boxes where small animals are contained within or outside a cage; for large animals, isolated rooms may be more appropriate. | ³ “isolators” means transparent boxes where small animals are contained within or outside a cage; for large animals, isolated rooms may be more appropriate. | ³ “isolators” means transparent boxes where small animals are contained within or outside a cage; for large animals, isolated rooms may be more appropriate. | ³ “isolators” means transparent boxes where small animals are contained within or outside a cage; for large animals, isolated rooms may be more appropriate. | ³ “isolators” means transparent boxes where small animals are contained within or outside a cage; for large animals, isolated rooms may be more appropriate. | ³ “isolators” means transparent boxes where small animals are contained within or outside a cage; for large animals, isolated rooms may be more appropriate. |
| Containment Measures | Containment Measures | Containment Levels | Containment Levels | Containment Levels | |
| Containment Measures | Containment Measures | 1 | 1 | 2 | |
| Facilities | Facilities | Facilities | Facilities | Facilities | Facilities |
| 1 | Isolation of animal unit¹ | required where and to extent the risk assessment shows it is required | required where and to extent the risk assessment shows it is required | required | required |
| 2 | Animal facilities² separated by lockable doors | required where and to extent the risk assessment shows it is required | required where and to extent the risk assessment shows it is required | required | required |
| 3 | Animal facilities (cages, etc.) designed to facilitate decontamination (waterproof and easily washable material) | required where and to extent the risk assessment shows it is required | required where and to extent the risk assessment shows it is required | required where and to extent the risk assessment shows it is required | required where and to extent the risk assessment shows it is required |
| 4 | Floor, walls and ceiling easily washable | required where and to extent the risk assessment shows it is required | required where and to extent the risk assessment shows it is required | required for floor | required for floor |
| 5 | Appropriate filters on isolators or isolated rooms³ | not required | not required | required where and to extent the risk assessment shows it is required | required where and to extent the risk assessment shows it is required |
| 6 | Appropriate barriers at the room exit, and at drains or ventilation duct work | required | required | required | required |
| 7 | Animals kept in appropriate containment facilities, such as cages, pens or tanks but not isolators | required where and to extent the risk assessment shows it is required | required where and to extent the risk assessment shows it is required | required where and to extent the risk assessment shows it is required | required where and to extent the risk assessment shows it is required |
| 8 | Animals kept in isolators | not required | not required | required where and to extent the risk assessment shows it is required | required where and to extent the risk assessment shows it is required |
| Containment Measure | Containment Levels | Containment Levels | Containment Levels | Containment Levels | |
| --- | --- | --- | --- | --- | --- |
| Containment Measure | 1 | 2 | 3 | 4 | |
| General | General | General | General | General | General |
| 1 | Viable micro-organisms must be contained in a system which separates the process from the workplace and wider environment (closed system) | required where and to extent the risk assessment shows it is required | required | required | required |
| 2 | Closed systems located within a controlled area | not required | required where and to extent the risk assessment shows it is required | required | required |
| 3 | Control of exhaust gases from the closed system | not required | required so as to minimise release | required so as to prevent release | required so as to prevent release |
| 4 | Control of aerosols during sample collection, addition of material to a closed system or transfer of material to another closed system | required where and to extent the risk assessment shows it is required | required so as to minimise release | required so as to prevent release | required so as to prevent release |
| 5 | Inactivation of bulk culture fluids before removal from the closed system | required where and to extent the risk assessment shows it is required | required by validated means | required by validated means | required by validated means |
| 6 | Seals must be designed so as to minimise or prevent release | not required | required so as to minimise release | required so as to prevent release | required so as to prevent release |
| 7 | The controlled area designed to contain spillage of the entire contents of the closed system | required where and to extent the risk assessment shows it is required | required where and to extent the risk assessment shows it is required | required | required |
| 8 | The controlled area sealable to permit fumigation | not required | required where and to extent the risk assessment shows it is required | required where and to extent the risk assessment shows it is required | required |
| 9 | Biohazard signs posted | not required | required | required | required |
| Equipment | Equipment | Equipment | Equipment | Equipment | Equipment |
| 10 | Entry via airlock | not required | not required | required where and to extent the risk assessment shows it is required | required |
| 11 | Surfaces resistant to water, acids, alkalis, solvents, disinfectants and decontamination agents and easy to clean | required for any bench | required for any bench | required for any bench and floor | required for any bench, floor, ceilings and walls |
| 12 | Specific measures to ventilate adequately the controlled areas in order to minimise air contamination | required where and to extent the risk assessment shows they are required | required where and to extent the risk assessment shows they are required | required where and to extent the risk assessment shows they are required | required |
| 13 | The controlled area maintained at an air pressure negative to the immediate surroundings | not required | not required | required where and to extent the risk assessment shows it is required | required |
| 14 | Extract and input air from the controlled area must be HEPA filtered | not required | not required | required for extract air; required where and to extent the risk assessment shows it is required for input air | required for input and extract air |
| System of work | System of work | System of work | System of work | System of work | System of work |
| 15 | Access restricted to authorised personnel only | not required | required | required | required |
| 16 | Personnel must shower before leaving the controlled area | not required | not required | required where and to extent the risk assessment shows it is required | required |
| 17 | Personnel must wear protective clothing | work clothing required | work clothing required | required | complete change required before exit and entry |
| 18 | Written procedures and records of staff training | not required | required where and to extent the risk assessment shows they are required | required | required |
| Waste | Waste | Waste | Waste | Waste | Waste |
| 19 | Inactivation of GMMs in effluent from hand-washing sinks and showers or similar effluents | not required | not required | required where and to extent the risk assessment shows it is required | required |
| 20 | Inactivation of GMMs in contaminated material and waste including those in process effluent before final discharge | required by validated means where and to extent the risk assessment shows it to be required | required by validated means | required by validated means | required by validated means |
Signed
Signed by authority of the Secretary of State for Work and Pensions
Mike Penning — Minister of State — 2014-06-23
Explanatory note
(This note is not part of the Regulations)
1These Regulations consolidate, revoke and replace the Genetically Modified Organisms (Contained Use) Regulations 2000 (S.I. 2000/2831) and its amending instruments (S.I. 2002/63, S.I. 2005/2466, S.I. 2010/2840). The Regulations implement Directive (EC) No 2009/41 (O.J. No L 125, 21.5.2009, p. 75) which lays down measures for the contained use of genetically modified micro-organisms with a view to protecting human health and the environment. Section 2(2) of the European Communities Act 1972 is used to implement the aspects of the Directive which relate to protection of the environment. The Regulations also apply to the contained use of genetically modified organisms that are not micro-organisms, known as larger GMOs, but only in relation to risks to human health. Larger GMOs are not covered by the Directive.
2Contained use includes any activity or other action (for example storage) involving a genetically modified organism within a controlled environment where there are physical barriers and/or other controls in place to ensure that any genetically modified organism is not released into the environment. Certain techniques are or are not regarded as genetic modification and the Regulations do not apply to genetically modified organisms in a number of circumstances, for example, where there is a consent for use under other legislation. Some of the regulations are disapplied to genetically modified organisms when they are being transported (regulation 3 and Schedule 2).
3The Regulations extend to England, Scotland and Wales but not to Northern Ireland. The competent authority in relation to contained use in England and Wales is the Secretary of State and the Health and Safety Executive (“the Executive”) acting jointly. The competent authority in relation to contained use in Scotland is the Scottish Ministers and the Executive acting jointly. The joint competent authority is the two competent authorities acting jointly (regulation 2). The Regulations impose duties on people who are undertaking or proposing to undertake contained use (users) and persons responsible for contained use. These are people who either have the authority to determine whether contained use can take place, or people with control over the planning or conduct of the contained use.
4The meaning of some terms within the Health and Safety at Work etc. Act 1974 is modified so that the Regulations apply to educational institutions as if they were workplaces and students as if they were employees of the educational institution. They also apply to any person who is not an employee undertaking contained use (except a student) as if they were self-employed within the meaning of that Act (regulation 4).
5Before contained use involving micro-organisms can commence, a person responsible for the contained use must ensure that an assessment of the risks to human health and the environment has been carried out. The person carrying out the risk assessment must classify the contained use (from class 1 to class 4) depending on the seriousness of the risks posed, with 4 being the highest risk (regulation 5, Schedule 1 and Schedule 3). Contained use involving larger GMOs cannot commence until the person responsible has ensured that an assessment is carried out in relation to risks to human health (regulation 6 and Schedule 4) although there is no requirement to assign a class of use. There are specific requirements relating to the review, recording and keeping of risk assessments (regulation 7). A person responsible for contained use must obtain advice on the risk assessment either from an individual or a genetic modification safety committee with relevant expertise (regulation 8).
6Before premises are used for the first time, for contained use, a person responsible for the first contained use must notify the competent authority and provide information specified by regulation 9 and Schedule 5. One notification can include more than one premises. Where a notification contains premises situated in both Scotland and in England, or in both Scotland and in Wales the notification must be made to the joint competent authority.
7Before class 2 contained use can commence, a person responsible for the contained use must notify the competent authority of the contained use and provide information specified in Schedule 6 (regulation 10). A period of time must then elapse before contained use can begin. Class 3 or 4 contained use cannot commence unless the competent authority has given consent for the contained use. A person responsible must submit a notification for the contained use and provide the information specified in Schedule 6. Consent must be notified within a specified period that is dependent on whether the notifier already has consent for class 3 or class 4 contained use (regulation 11).
8Before contained use can commence involving a larger GMO (and the contained use will result in a more hazardous organism than its parent organism) a person responsible for that contained use must notify the competent authority of that contained use and provide the information specified in Schedule 6 (regulation 12).
9A notification for contained use where the premises notification had to be made to the joint competent authority must also be made to the joint competent authority. In certain circumstances the competent authority or joint competent authority may accept single notifications for a connected programme of work or contained use at more than one premises (regulation 13). There are various duties to notify the competent authority of changes of circumstances and changes that affect risks (regulations 14 and 15).
10If the competent authority asks for further information about a notification, the contained use must not commence or continue, except to store or destroy the genetically modified organisms, until the competent authority has agreed in writing that it may (regulation 16). A notifier may withdraw their application as long as the contained use has not commenced (regulation 17).
11Users are required to ensure that occupational and environmental safety principles are observed (Schedule 7) and that risks are kept to the lowest level reasonably practicable (regulation 18).
12A user carrying out contained use involving genetically modified micro-organisms is required to apply the containment measures which are appropriate to that contained use in accordance with the risk assessment. The containment measures are classified into different containment levels which largely correspond with the class assigned to the contained use, with level 4 being the highest level of containment. The measures are set out in Schedule 8 (regulation 19). A user carrying out contained use involving a larger GMO must apply the containment measures applicable in accordance with the risk assessment for that contained use (regulation 20).
13Where a risk assessment shows it is warranted, an emergency plan must be prepared before contained use can commence. In the case of genetically modified micro-organisms the plan must address risks to human health and the protection of the environment, in the case of larger GMOs the plan need only address human health, (regulation 21). If an accident occurs the person responsible for the contained use must notify the competent authority immediately and provide specified information (regulation 22).
14The competent authority is placed under a duty to examine a notification submitted to it under regulations 9(2), 10(2), 11(2) and 12(2) (regulation 23) and the Executive may ask the notifier for additional information on behalf of the competent authority (regulation 24). The competent authority has power to impose time limits or conditions on contained use, to suspend or terminate contained use or require that the contained use is not commenced. The competent authority may also vary or revoke any consent previously granted under regulation 11 (regulation 25). 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 an exemption (regulation 26).
15The competent authority is to maintain a register of all notifications and copies of the register are to be made available by the Executive for public inspection by appropriate means (regulation 28). Certain information may not be published if it would be contrary to the interests of national security (regulation 29).
16Provision is made for the enforcement of the Regulations under the Health and Safety at Work etc. Act 1974 (regulation 30).
17There is a right of appeal for any person who is aggrieved by certain decisions or actions of the competent authority or the Executive (regulation 31).
18Anything that must be submitted to the competent authority under the regulations must be submitted to the Executive at the address it publishes on its website for the purpose (regulation 32).
19There are various transitional, saving and consequential provisions and a number of instruments are revoked (see paragraph 1 above) (regulations 33 to 35).
20A Transposition Note has been produced and is published on the website of the Health and Safety Executive www.hse.gov.uk.
21A copy of the impact assessment prepared in respect of these Regulations can be obtained from www.legislation.gov.uk.
Footnotes
[^f00001]: 1972 c. 68. Section 2(2) was amended by section 27(1)(a) of the Legislative and Regulatory Reform Act 2006 (c. 51) and Part 1 of the Schedule to the European Union (Amendment) Act 2008 (c. 7) In relation to Scotland, see also section 57(1) of the Scotland Act 1998 (c. 46) which provides that, despite the transfer to the Scottish Ministers of functions in relation to observing and implementing European Union law, any function of a Minister of the Crown in relation to any matter shall continue to be exercisable in relation to Scotland by that Minister, for the purposes specified in section 2(2) of the 1972 Act.
[^f00002]: S.I. 1991/755.
[^f00003]: 1974 c. 37. Section 15(1) was substituted by paragraph 6 of Schedule 15 to the Employment Protection Act 1975 (c. 71) and amended by S.I. 2002/794. Section 15(2) was amended by paragraphs 1 and 5(3) of Schedule 12 to the Energy Act 2013 (c. 32). Section 52(3) was substituted by paragraph 17 of Schedule 15 to the Employment Protection Act 1975 and amended by S.I. 2002/794.
[^f00004]: Section 11(3) was substituted by S.I. 2008/960.
[^f00005]: Section 50(3) was amended by paragraph 16 of Schedule 15 to the Employment Protection Act 1975, S.I. 2008/960, paragraphs 4 and 6 of Schedule 7 to the Health and Social Care Act 2012 (c. 7) and by paragraphs 1 and 11(1) of Schedule 12 to the Energy Act 2013.
[^f00006]: S.I. 2000/2831. The 2000 Regulations and all its amending instruments are revoked by these Regulations (see regulation 35).
[^f00007]: 1990 c. 37. Sections 1(1) and (6) were substituted by section 1(2) and (5) of the Human Fertilisation and Embryology Act 2008 (c. 22) and section 4A was inserted by section 4(2) of that Act.
[^f00008]: OJ No L 287, 5.11.2003, p1.
[^f00009]: 1971 c. 80. Schedule 1 was amended by section 1 of the St Andrew’s Day Bank Holiday (Scotland) Act 2007 (2007 asp.2).
[^f00010]: 1990 c. 43. The functions of the Secretary of State under section 111(1) are exercisable in relation to Scotland by the Scottish Ministers, by virtue of section 53 of the Scotland Act 1998 (c. 46). The functions of the Secretary of State under section 111(1) are exercisable in relation to Wales by the Welsh Ministers. Those functions were originally conferred on the National Assembly for Wales under S.I. 1999/672, which was an Order in Council made under section 22 of the Government of Wales Act 1998 (c. 38). Functions which had been conferred on the Assembly under an Order in Council under section 22 were transferred to the Welsh Ministers by virtue of paragraph 30 of Schedule 11 to the Government of Wales Act 2006 (c. 32).
[^f00011]: S.I. 1991/1714 (N.I.19).
[^f00012]: OJ No L 106, 17.04.2001, p1. Under Article 4.4 member States must designate a competent authority responsible for complying with the requirements of the Directive.
[^f00013]: OJ No L 136, 30.4.2004, p1 as amended by Regulation (EC) No 1901/2006 (OJ No L 378, 27.12.2006, p1), Regulation (EC) No 1394/2007 (OJ No L 324, 10.12.2007, p121), Regulation (EC) No 219/2009 (OJ No L 87, 31.3.2009, p109), Regulation (EC) No 470/2009 (OJ No L 152, 16.6.2009, p11), Regulation (EU) No 1235/2010 (OJ No L 348, 31.12.2010, p1) (which was corrected by Corrigendum, OJ No L 201, 27.7.2012, p138) and Regulation (EU) No 1027/2012 (OJ No L 316, 14.11.2012, p38).
[^f00014]: OJ No L 268 18.10.2003, p1 as amended by Regulation (EC) No 1981/2006 (OJ No L 368, 23.12.2006, p[99) and Regulation (EC) No 298/2008 (OJ No L 97 9.4.2008, p64).
[^f00015]: S.I. 2004/3391.
[^f00016]: S.S.I. 2004/520.
[^f00017]: Section 16 of the 1974 Act was amended by paragraph 9 of Schedule 3 to the Railways Act 2005 (c. 14) and paragraphs 4 and 5 of Schedule 7 to the Health and Social Care Act 2012 (c. 7). Section 18 was amended by Schedules 15 and 18 to the Employment Protection Act 1975 (c. 71), paragraph 10(3) of Schedule 3 and Part 1 of Schedule 13 to the Railways Act 2005 and paragraphs 1 and 6 of Schedule 12 to the Energy Act 2013 (c. 32). Section 20 was amended by paragraph 49 of Schedule 27 to the Civil Partnership Act 2004 (c. 33). Section 22 was amended by Schedule 3 to the Consumer Protection Act 1987 (c. 43). Section 23 was amended in relation to England and Wales by paragraph 44 of Schedule 1 to the Fire and Rescue Services Act 2004 (c. 21) and S.I. 2005/1541. In relation to Scotland section 23 was amended by S.S.I. 2005/383, S.S.I. 2006/475 and paragraph 49 of Schedule 7 to the Police and Fire Reform (Scotland) Act 2012 (asp. 8). Section 24 was amended by section 1(2)(a) of the Employment Rights (Dispute Resolution) Act 1998 (c. 8). Section 25A was inserted by paragraph 3 of Schedule 3 to the Consumer Protection Act 1987 (c. 43). In addition sections 16, 17 and 18 were amended by S.I. 2008/960.
[^f00018]: Section 33 was amended by Schedules 15 and 18 to the Employment Protection Act 1975, Part 1 of the Schedule to the Forgery and Counterfeiting Act 1981 (c. 45), Schedule 3 to the Consumer Protection Act 1987, sections 4(5) and (6) of, and Schedule 2 to, the Offshore Safety Act 1992 (c. 15) and section 1(1) of the Health and Safety (Offences) Act 2008 (c. 20). Section 34 was amended by S.I. 2008/960, paragraph 25 of Schedule 21 to the Coroners and Justice Act 2009 (c. 25) and, in its application to Scotland, by paragraph 51 of Schedule 9 to the Criminal Procedure (Scotland) Act 1975 (c. 21) and paragraph 18 of Schedule 7 to the Gas Act 1986 (c. 44). Section 36 has been modified by S.I. 2007/1353 to the effect that references to the Crown are treated as including references to the National Assembly for Wales Commission. Section 38 was amended by paragraph 30(7) of Schedule 22 to the Environmental Act 1995 (c. 25) and S.I. 2013/755. Section 36 was amended by paragraph 2(2) and (3) of Schedule 3 to the Health and Safety (Offences) Act 2008.
[^f00019]: S.I. 1990/1380.
[^f00020]: S.I. 1998/494, to which there are amendments not relevant to these Regulations.
[^f00021]: S.I. 2012/1652 as amended by S.I. 2013/448, 2013/1512 and 2013/1948.
[^f00022]: S.I. 2002/63.
[^f00023]: S.I. 2005/2466.
[^f00024]: S.I. 2010/2840.
[^f00025]: OJ No L 262, 17.10.2000, p21.
A notification required for the purposes of regulation 9(2) must contain the following information—
- (a) the name, address and telephone number and any fax number and any e-mail address of the notifier;
- (b) the name of the person with specific responsibility for the supervision and safety of contained use;
- (c) information on the training and qualifications of that person;
- (d) details of the arrangements for obtaining advice on risk assessments in accordance with regulation 8, including details of any genetic modification safety committee if established;
- (e) the address of the premises where the contained use is to be carried out and a general description of the premises, together with, if required by regulation 9(6), the principal address of the premises;
- (f) the nature of the work to be undertaken;
- (g) the class of any contained use involving micro-organisms;
- (h) where the first contained use to be carried out in those premises is a class 1 contained use—
- (i) a summary of the risk assessment of that contained use;
- (ii) any advice received in relation to the risk assessment from a person or genetic modification safety committee in accordance with regulation 8;
- (iii) information on waste management;
- (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;
- (i) where the first contained use to be carried out in those premises is a contained use involving larger GMOs and that contained use is not notifiable under regulation 12(2)—
- (i) a copy of the risk assessment; 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 emergency plan and of any relevant revisions.
A notification required for the purposes of regulation 10(2), 11(2) or 12(2) must contain the following information except where it is required only for a specified regulation—
- (a) the name, address and telephone number and any fax number and any e-mail address of the notifier;
- (b) any centre number allocated by the competent authority in respect of the premises at which the contained use is to be undertaken and the date of the notification required by regulation 9(2) relating to those premises;
- (c) the name of the person with specific responsibility for supervision and safety of contained use;
- (d) information on the training and qualifications of that person;
- (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 organism;
- (j) the purpose of the contained use, including its expected results;
- (k) for regulation 10(2) the approximate culture volumes to be used;
- (l) for regulation 11(2) the culture volumes to be used;
- (m) 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) for regulation 10(2) justification for not applying any containment measure at containment level 2;
- (iii) for regulation 11(2), for class 3 contained use, justification for not applying any containment measure at containment level 3;
- (iv) for regulation 11(2), for class 4 contained use, justification for not applying any containment measure at containment level 4;
- (n) for regulations 10(2) and 11(2) a copy of the risk assessment;
- (o) for regulations 10(2) and 11(2) the advice received in relation to that assessment from a genetic modification safety committee;
- (p) for regulation 12(2) a copy of the risk assessment;
- (q) information in relation to any accident prevention and emergency plans including—
- (i) the information necessary for the competent authority to evaluate any emergency plan;
- (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 emergency plan and of any relevant revisions;
- (iii) for regulation 11(2), in addition—
- (aa) any specific hazards arising from the location of the installation;
- (bb) the preventive measures applied, including safety equipment, alarm systems and containment methods;
- (cc) procedures and plans for verifying the continuing effectiveness of the containment measures;
- (dd) a description of the information provided to workers;
- (r) for regulation 11(2) a description of the parts of the installation;
- (s) for regulation 11(2) whether the genetically modified organism is likely to be subject to transboundary movement.
The general principles of good microbiological practice and of good occupational safety and hygiene are as follows—
- (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) establishing a genetic modification safety committee, if required;
- (g) formulating and implementing local codes of practice for the safety of personnel, as required;
- (h) displaying biohazard signs where appropriate;
- (i) providing washing and decontamination facilities for personnel;
- (j) keeping adequate records;
- (k) prohibiting in the work area eating, drinking, smoking, applying cosmetics or the storing of food for human consumption;
- (l) prohibiting mouth pipetting;
- (m) providing written standard operating procedures where appropriate to ensure safety;
- (n) having effective disinfectants and specified disinfection procedures available in case of spillage of genetically modified micro-organisms;
- (o) providing safe storage for contaminated laboratory equipment and materials where appropriate.
Editorial notes
[^c22149351]: 1972 c. 68. Section 2(2) was amended by section 27(1)(a) of the Legislative and Regulatory Reform Act 2006 (c. 51) and Part 1 of the Schedule to the European Union (Amendment) Act 2008 (c. 7) In relation to Scotland, see also section 57(1) of the Scotland Act 1998 (c. 46) which provides that, despite the transfer to the Scottish Ministers of functions in relation to observing and implementing European Union law, any function of a Minister of the Crown in relation to any matter shall continue to be exercisable in relation to Scotland by that Minister, for the purposes specified in section 2(2) of the 1972 Act.
[^c22149361]: S.I. 1991/755.
[^c22149371]: 1974 c. 37. Section 15(1) was substituted by paragraph 6 of Schedule 15 to the Employment Protection Act 1975 (c. 71) and amended by S.I. 2002/794. Section 15(2) was amended by paragraphs 1 and 5(3) of Schedule 12 to the Energy Act 2013 (c. 32). Section 52(3) was substituted by paragraph 17 of Schedule 15 to the Employment Protection Act 1975 and amended by S.I. 2002/794.
[^c22149381]: Section 11(3) was substituted by S.I. 2008/960.
[^c22149391]: Section 50(3) was amended by paragraph 16 of Schedule 15 to the Employment Protection Act 1975, S.I. 2008/960, paragraphs 4 and 6 of Schedule 7 to the Health and Social Care Act 2012 (c. 7) and by paragraphs 1 and 11(1) of Schedule 12 to the Energy Act 2013.
[^c22149401]: S.I. 2000/2831. The 2000 Regulations and all its amending instruments are revoked by these Regulations (see regulation 35).
[^c22149411]: 1990 c. 37. Sections 1(1) and (6) were substituted by section 1(2) and (5) of the Human Fertilisation and Embryology Act 2008 (c. 22) and section 4A was inserted by section 4(2) of that Act.
[^c22149421]: OJ No L 287, 5.11.2003, p1.
[^c22149431]: 1971 c. 80. Schedule 1 was amended by section 1 of the St Andrew's Day Bank Holiday (Scotland) Act 2007 (2007 asp.2).
[^c22149441]: 1990 c. 43. The functions of the Secretary of State under section 111(1) are exercisable in relation to Scotland by the Scottish Ministers, by virtue of section 53 of the Scotland Act 1998 (c. 46). The functions of the Secretary of State under section 111(1) are exercisable in relation to Wales by the Welsh Ministers. Those functions were originally conferred on the National Assembly for Wales under S.I. 1999/672, which was an Order in Council made under section 22 of the Government of Wales Act 1998 (c. 38). Functions which had been conferred on the Assembly under an Order in Council under section 22 were transferred to the Welsh Ministers by virtue of paragraph 30 of Schedule 11 to the Government of Wales Act 2006 (c. 32).
[^c22149451]: S.I. 1991/1714 (N.I.19).
[^c22149481]: OJ No L 268 18.10.2003, p1 as amended by Regulation (EC) No 1981/2006 (OJ No L 368, 23.12.2006, p[99) and Regulation (EC) No 298/2008 (OJ No L 97 9.4.2008, p64).
[^c22149491]: S.I. 2004/3391.
[^c22149501]: S.S.I. 2004/520.
[^c22149511]: Section 16 of the 1974 Act was amended by paragraph 9 of Schedule 3 to the Railways Act 2005 (c. 14) and paragraphs 4 and 5 of Schedule 7 to the Health and Social Care Act 2012 (c. 7). Section 18 was amended by Schedules 15 and 18 to the Employment Protection Act 1975 (c. 71), paragraph 10(3) of Schedule 3 and Part 1 of Schedule 13 to the Railways Act 2005 and paragraphs 1 and 6 of Schedule 12 to the Energy Act 2013 (c. 32). Section 20 was amended by paragraph 49 of Schedule 27 to the Civil Partnership Act 2004 (c. 33). Section 22 was amended by Schedule 3 to the Consumer Protection Act 1987 (c. 43). Section 23 was amended in relation to England and Wales by paragraph 44 of Schedule 1 to the Fire and Rescue Services Act 2004 (c. 21) and S.I. 2005/1541. In relation to Scotland section 23 was amended by S.S.I. 2005/383, S.S.I. 2006/475 and paragraph 49 of Schedule 7 to the Police and Fire Reform (Scotland) Act 2012 (asp. 8). Section 24 was amended by section 1(2)(a) of the Employment Rights (Dispute Resolution) Act 1998 (c. 8). Section 25A was inserted by paragraph 3 of Schedule 3 to the Consumer Protection Act 1987 (c. 43). In addition sections 16, 17 and 18 were amended by S.I. 2008/960.
[^c22149521]: Section 33 was amended by Schedules 15 and 18 to the Employment Protection Act 1975, Part 1 of the Schedule to the Forgery and Counterfeiting Act 1981 (c. 45), Schedule 3 to the Consumer Protection Act 1987, sections 4(5) and (6) of, and Schedule 2 to, the Offshore Safety Act 1992 (c. 15) and section 1(1) of the Health and Safety (Offences) Act 2008 (c. 20). Section 34 was amended by S.I. 2008/960, paragraph 25 of Schedule 21 to the Coroners and Justice Act 2009 (c. 25) and, in its application to Scotland, by paragraph 51 of Schedule 9 to the Criminal Procedure (Scotland) Act 1975 (c. 21) and paragraph 18 of Schedule 7 to the Gas Act 1986 (c. 44). Section 36 has been modified by S.I. 2007/1353 to the effect that references to the Crown are treated as including references to the National Assembly for Wales Commission. Section 38 was amended by paragraph 30(7) of Schedule 22 to the Environmental Act 1995 (c. 25) and S.I. 2013/755. Section 36 was amended by paragraph 2(2) and (3) of Schedule 3 to the Health and Safety (Offences) Act 2008.
[^c22149531]: S.I. 1990/1380.
[^c22149541]: S.I. 1998/494, to which there are amendments not relevant to these Regulations.
[^c22149551]: S.I. 2012/1652 as amended by S.I. 2013/448, 2013/1512 and 2013/1948.
[^c22149561]: S.I. 2002/63.
[^c22149571]: S.I. 2005/2466.
[^c22149581]: S.I. 2010/2840.
[^key-a23fbd303dd6590b0d1b31baf0c73d21]: Words in reg. 4(3)(a) inserted (1.10.2015) by The Deregulation Act 2015 (Health and Safety at Work) (General Duties of Self-Employed Persons) (Consequential Amendments) Order 2015 (S.I. 2015/1637), art. 1, Sch. para. 12(a)
[^key-48bbf0f7b127bc9998c859bd8e723d8c]: Words in reg. 4(3)(b) substituted (1.10.2015) by The Deregulation Act 2015 (Health and Safety at Work) (General Duties of Self-Employed Persons) (Consequential Amendments) Order 2015 (S.I. 2015/1637), art. 1, Sch. para. 12(b)
[^key-13b40627aea7e94e1857fbb16c69445e]: Reg. 33A inserted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 1 para. 40(3) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 1 para. 19); 2020 c. 1, Sch. 5 para. 1(1)
[^key-1a3af7ccf40e96409e6bb6f32c4a2288]: Reg. 3(2)(a)(iii) omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 1 para. 40(2)(a); 2020 c. 1, Sch. 5 para. 1(1)
[^key-45fa2f6f26219a231bab82b0dfc2aaa8]: Word in reg. 3(2)(b)(i) inserted (31.12.2020) by The Health and Safety (Amendment) (EU Exit) Regulations 2018 (S.I. 2018/1370), regs. 1(1), 9(2)(a); 2020 c. 1, Sch. 5 para. 1(1)
[^key-07013c409514416bc2b107ac68b40bd4]: Reg. 3(2)(b)(i) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 1 para. 40(2)(b); 2020 c. 1, Sch. 5 para. 1(1)
[^key-476085e7f970cb1cd5675283e20927c8]: Words in reg. 3(2)(b)(ii) omitted (31.12.2020) by virtue of The Health and Safety (Amendment) (EU Exit) Regulations 2018 (S.I. 2018/1370), regs. 1(1), 9(2)(b); 2020 c. 1, Sch. 5 para. 1(1)
[^key-6b267e6e88d33e6e8cfd71dcc3e9bfd2]: Reg. 3(2)(b)(iii) omitted (31.12.2020) by virtue of The Health and Safety (Amendment) (EU Exit) Regulations 2018 (S.I. 2018/1370), regs. 1(1), 9(2)(c); 2020 c. 1, Sch. 5 para. 1(1)
[^key-53db087aee861b127d590b350ffeb2af]: Reg. 3(2)(b)(iv) and word inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 8 para. 12; 2020 c. 1, Sch. 5 para. 1(1)
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