Contained use of of

genetically modified organisms

What is this leaflet about?
This leaflet tells you about the controls on contained use of genetically modified organisms. These controls are set out in the Genetically Modified Organisms (Contained Use) Regulations 2000, which replaced the Genetically Modified Organisms (Contained Use) Regulations 1992, as amended in 1996 and 1998. These Regulations are supplemented by the sections of the Environmental Protection Act 1990 and the Genetically Modified Organisms (Risk Assessment) (Records and Exemptions) Regulations (as amended in 1997) which specifically cover the control of risks to the environment from genetically modified animals and plants.

What are genetically modified organisms?
All living organisms – animals, plants and micro–organisms (such as bacteria or fungi) – carry copies of all their genes in their cells. Those genes hold the infor­ mation that determines the organism’s particular form and function. Specific characteristics of an organism may be linked to particular genes or combinations of genes. Genetically modified organisms (GMOs), therefore, are organisms whose genes have been artificially altered to modify their characteristics in some way or other. For example, medicinal products such as insulin, blood factor VIII and human growth hormone, were formerly produced from humans and animals and some carried a slight risk of transmitting disease. Now, with the use of genetic modification (GM) technology, pure and safe equivalents can be produced using GMOs.

What is contained use?
The term ‘contained use’ covers any activity involving GMOs in which measures are taken to limit contact between them and people or the environment. It relates to the actual process of genetic modification, and also to the use, storage, transport and destruction of GMOs. Typical contained use facilities would be microbiology laboratories, animal houses, greenhouses

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Contained use of genetically modified organisms

or industrial production facilities. GMOs that are deliberately introduced into the environment for experimental purposes, or placed on the market, for example, as food or for medical purposes, are obviously not contained. They are outside the scope of the Regulations on contained use and regulated under other legislation; the section ‘Where can I find out about other aspects of genetic modification?’ tells you where you can find out more about other aspects of GMOs.

Why did the previous Regulations have to be replaced?
They needed to be brought up to date to reflect developments in GM technology. Also, experience of operating the previous Regulations indicated ways in which the administrative procedures might be made more straightforward. The overriding objective was to maintain and improve standards of protection for human health and the environment. The revision also reflects a major amendment of the European Community Directive on contained use of genetically modified micro-organisms (Directive 90/219/EEC as amended by Directive 98/81/EC).

Why do we need controls and Regulations?
Most contained use activities involve organisms which do not cause disease and are very unlikely to survive in the environment outside a containment facility. A small proportion of work is carried out with more hazardous organisms whose escape from contain­ ment could damage human health or the environment. It is, therefore, very important to assess the risks of all activities and to make sure that any necessary controls are put in place to protect people and the environment. Risk assessments must take account of what could happen if GMOs came into contact with other organisms in the environment. The Regulations provide a framework for making these judgments, and place clear legal obligations on people who work with GMOs.

What changes do the new Regulations introduce?
The main changes are: removal of the previous requirement to categorize activities involving genetically modified micro-organisms (GMMs) as Type A or B, according to their purpose and scale; removal of the scheme for classifying GMMs into Group I and II, according to their inherent properties; establishing a structured approach to risk assessment which incorporates elements covered by the previous

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Contained use of genetically modified organisms

categorization (Type A/Type B) and classification (Group I/Group II) and places activities involving GMMs into 4 different classes (class1 covers activities of no or negligible risk and class 4 those of high risk to people and the environment); shorter and simplified notification procedures based directly on the outcome of risk assessment; more detailed specifications of the control measures appropriate to different types of activity; and much more information about contained use premises and activities to be included in the public register of notifications.

classify all activities as described under ‘How are activities classified?’ and notify them where required; apply the necessary containment and control measures indicated by the risk assessment; and draw up emergency plans for riskier activities, and notify any accidents that occur.

How are activities classified?
The risk assessment, which must be carried out for any contained use activity, indicates the containment and control measures needed. For activities involving micro-organisms, it is necessary to decide which of the four standard containment levels applies to the work. The containment and control measures which define those levels are set out in a Schedule to the Regulations. Anyone carrying out a risk assessment, therefore, will need to check which level matches the measures indicated by the assessment. The classification of the activity is simply read across from the containment level: Containment level 1 Containment level 2 Containment level 3 Containment level 4 — — — — Class 1 Class 2 Class 3 Class 4

What are the main duties under the Regulations?
Anyone carrying out contained use work must comply with the Regulations and, in particular: notify the authorities* of their intention to use their premises for contained use activities for the first time; carry out an assessment of the risks to human health and the environment of every contained use activity before it begins, reviewing and revising the assess­ ment as necessary, and keeping records; establish a genetic modification safety committee to advise on risk assessments; *

HSE has lead responsibility for administration of the Regulations, but the Department for Environment, Food and Rural

Affairs (DEFRA), the Scottish Executive, and the National Assembly for Wales are also involved in the scrutiny of notifications. Notifications and other communications need be sent only to the Health and Safety Executive which will arrange circulation to other bodies as necessary.

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Contained use of genetically modified organisms

In some cases, there will not be an exact match between the containment and control measures the risk assess­ ment indicates and those specified for any of the containment levels; the measures will effectively fall between two levels. In such cases, the activity must be classified at the higher level. For activities involving GMOs that are not micro-organisms (ie animals and plants), there are no standard containment levels. Such activities are simply classified as ‘notifiable’ or ‘non­ notifiable’ according to the nature of the GMO itself.

activity varies depending on the activity’s classification. Also, the riskier activities may not begin without explicit consent. The requirements are summarized overleaf.

How is the disposal of GMOs controlled?
The Regulations require all GMMs to be inactivated before they are disposed of. The Regulations define ‘inactivation’ as ‘the complete or partial destruction of GMMs … to provide a high level of protection for humans and the environ­ ment’. The definition of ‘contained use’, however, recognizes that containment could be achieved by biological barriers, eg a live GMM may be discharged from a contained use facility, but would be biologically incapable of survival. So, discharge of GMMs without inactivation may be allowed if the person carrying out the activity can demonstrate that adequate biological barriers are in place. No discharge of non-inactivated waste may take place unless and until the authorities have evaluated the adequacy of the barriers and given their permission.

Notifiable activity
Activity involving a GM animal or plant which poses a greater risk to human health than its unmodified parental organism

Non-notifiable activity
Activity involving a GM animal or plant which poses no greater risk to human health than its unmodified parental organism

How are premises and activities notified?
The information which must be notified is set out in Schedules to the Regulations. HSE provides forms (also available on the Internet at HSE’s website) to use for the submission of notifications. The notification period applicable to an

Can anyone see notified data?
Yes, but the Regulations have to maintain a balance between the public’s right of access to data and the right of GM practitioners to protect their work from

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Contained use of genetically modified organisms

their competitors. Any notified information may be disclosed to the public on request, but notifiers may claim confidentiality for specific data, especially if they can demonstrate that disclosure could compromise their competitive position or intellectual property rights. The authorities will decide whether confidentiality claims are justified. Furthermore, the Regulations specify certain core data for which confidentiality cannot be claimed on any grounds, except harm to intellectual property rights. To facilitate public access to notified data, HSE maintains a public register of notifications. This contains all (non­ confidential) information notified on premises and individual activities, including the nature of work to be carried out at premises, the purpose of individual activities and the characteristics of the GMOs involved. Simply to save space, the full risk assessment of an activity is not placed on the register, but may be viewed on request. The public register is held at the following addresses: Rose Court, 2 Southwark Bridge, London SE1 9HS Tel: 020 7717 6278

Type of notification
First use of premises

GMMs: Class 1

GMMs: Class 2 (first at premises)

GMMs: Class 2 (subsequent)

GMMs: Class 3 or Class 4 (first at premises)

GMMs: Class 3 or Class 4 (subsequent)

Non-notifiable GM animals/plants

Magdalen House, Stanley Precinct, Bootle L20 3QZ Tel: 0151 951 4772

Also, each main office of HSE will hold those entries in the register for premises and activities notified in its area. If you do not know where your nearest office is, look up ‘Health and Safety Executive’ in the

Notifiable GM animals/plants

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Contained use of genetically modified organisms

Notification period
None; the premises may begin undertaking contained use work as soon as HSE acknowledges receipt of the notification and the premises have complied with the notification requirements for the first intended activity. Class 1 activities do not have to be notified. If, however, the first intended activity at new premises is Class 1, the premises notification must include a risk assessment and some other information specific to that activity. Must be notified 45 days before it is intended to begin (unless consent has already been granted for Class 3 or Class 4 activities, in which case the activity may begin as soon as HSE acknowledges receipt of the notification). Must be notified, but may begin as soon as HSE acknowledges receipt of the notification.

Consent required?
No.

No.

No; the activity may begin 45 days after submission of the notification unless the authorities have written within that period agreeing to an earlier start.

No.

Must be notified 90 days before it is intended to begin.

Yes; the authorities must issue a consent - or let the notifier know why consent is being withheld - within 30 to 90 days.

Must be notified 45 days before they are intended to begin.

Yes; the authorities must issue a consent - or let the notifier know why consent is being withheld - within 30 to 45 days.

Activities involving non-notifiable animals or plants do not have to be notified. If, however, such an activity is to be the first at new premises, the premises notification must include a risk assessment and some other information specific to that activity. Must be notified 45 days before it is intended to begin.

No.

No; the activity may begin 45 days after submission of the notification unless the authorities have written within that period agreeing to an earlier start.

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Contained use of genetically modified organisms

telephone directory for your area or tele­ phone HSE’s InfoLine on 08701 545500. That part of the register covering premises and activities in Scotland is also held at: Belford House, 59 Belford Rd, Edinburgh EH4 3UE Tel: 0131 247 2000

Where can I find out about other aspects of genetic modification?
Other government departments also have responsibilities for genetic modification activities. The Department for Environment,

What further information is available?
The full text of the Regulations is contained in A guide to the Genetically

Food and Rural Affairs (DEFRA) is responsible for the control of environ­ mental risks caused by contained use of GM animals or plants. It also operates the Genetically Modified Organisms (Deliberate Release) Regulations which govern experimental release and marketing of GMOs. DEFRA is also responsible for the agricultural implications of GMOs (eg plant variety and seeds legislation, plant and animal health aspects, pesticide controls and general impact on agriculture). The Department for Environment, Food and Rural Affairs GM Policy and Regulatory Unit Ashdown House 123 Victoria Street London SW1E 6DE The Food Standards Agency (FSA) was established in April 2000 and is responsibie for the safety and labelling of GM food and

Modified Organisms (Contained Use) Regulations 2000 (HSE Books 2000,
ISBN 0 7176 1758 0) which also provides fuller explanation of the Regulations’ requirements in non-legal language. Copies of the guide can be purchased by completing and sending off the order form on the back cover of this leaflet. You can also place orders by telephoning HSE Books on 01787 881165. The Health and Safety Executive and the Advisory Committee on Genetic Modification have produced a Compen­ dium of Guidance for people carrying out contained use activities. This offers detailed technical advice on risk assess­ ment and control for different sorts of activity. For details of how to obtain a copy of the Compendium, please contact the Secretariat of the Advisory Committee on 020 7717 6245.

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Order form

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Contained use of genetically modified organisms

the application of the EC Regulation on Novel Foods and Novel Food Ingredients which governs the marketing of GM foods. FSA Novel Foods Division, Room 239c, Ergon House, PO Box 31037, Horseferry Road, London SW1P 3WG Tel: 020 7238 6379 Fax: 020 7238 6382 The Department of Health (DH) has responsibility for the general human health and food safety aspects of GMOs, including medical applications of GM technology. It provides the secretariats for the Gene Therapy Advisory Committee (GTAC) which assesses protocols for gene therapy trials and for the United Kingdom Xenotransplantation Interim Regulatory Authority (UKXIRA) which regulates all activities involving the transplants from one species to another. The Medicines Control Agency (MCA) has responsibility for the safety, quality and efficacy of medicines. DH Biotechnology Unit, Skipton House, 80 London Road, Elephant and Castle, London, SE1 6LW Tel: 020 7972 5347 Fax: 020 7972 5155 GTAC Secretariat, DH, Wellington House, 135–155 Waterloo Road, London, SE1 8UG Tel: 020 7972 4021 Fax: 020 7972 4196 UKXIRA Secretariat, DH, Wellington House, 133–155 Waterloo Road, London, SE1 8UG Tel: 020 7972 4921/4822 Fax: 020 7972 4852

MCA, c/o Information Centre Central Enquiry Point Tel: 020 7273 0000 Fax: 020 7273 0353 The Home Office regulates the use of protected animals (ie all vertebrates and

Octopus vulgaris), including those that
have been genetically modified, for experimental or other scientific purposes. The relevant legislation is the Animals (Scientific Procedures) Act 1986. Home Office Animals By-Laws and Coroners Unit, 50 Queen Anne’s Gate, London, SW1 9AT Tel: 020 7273 2861 Fax: 020 7273 2423 The Department of Trade and Industry (DTI) has overall responsibility for sponsoring the industrial application of biotechnology. It is also responsible for ensuring that the implications for industrial competitiveness are taken into account in the formulation of Government policy in this area. DTI publishes the BioGuide which provides the biotechnology community with an essential summary of current regulations and procedures and of the support available from the Government and elsewhere. DTI Chemicals and Biotechnology Directorate, 151 Buckingham Palace Road, London, SW1W 9SS Tel: 020 7215 2914 Fax: 020 7215 1379

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HSE priced and free publications are available by mail order from HSE Books, PO Box 1999, Sudbury, Suffolk CO10 2WA Tel: 01787 881165 Fax: 01787 313995 Website: www.hsebooks.co.uk This leaflet is available in priced packs of 15, ISBN 0 7176 1771 8 from HSE Books. It is also available as free single copies from HSE Books. HSE priced publications are also available from bookshops. For information about health and safety ring HSE's InfoLine Tel: 08701 545500 Fax: 02920 859260 e-mail: hseinformationservices@natbrit.com or write to HSE Information Services, Caerphilly Business Park, Caerphilly CF83 3GG. You can also visit HSE’s website: www.hse.gov.uk

This publication may be freely reproduced, except for advertising, endorsement or commercial purposes. The information is current at 11/00. Please acknowledge the source as HSE. Printed and published by the Health and Safety Executive INDG86(rev2) 8/01 C150

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