CONTAINED USE OF GENETICALLY MODIFIED ORGANISMS

CONTENTS

WHAT THIS LEAFLET TELLS YOU

This leaflet summarises the main requirements of two sets of Regulations concerned with the contained use of genetically modified organisms: the Genetically Modified Organisms (Contained Use) Regulations 1992 and the Genetically Modified Organisms (Contained Use) (Amendment) Regulations 1996. It also briefly outlines the responsibilities of other Government organisations dealing with biotechnology, giving their addresses and telephone numbers for further information.

WHY WE NEED THE REGULATIONS AND WHY ARE THEY BEING AMENDED?

The main purpose of the Regulations is the protection of people's health and the environment from risks associated with the contained use of genetically modified organisms. Advances in scientific knowledge and experience of genetic modification techniques have led to the need for various amendments, which update the 1992 Regulations.

WHAT ARE THE AMENDMENTS?

The 1992 Regulations have been updated and amended by the Genetically Modified Organisms (Contained Use) (Amendment) Regulations 1996. The main changes are:

  • a new organism classification scheme;
  • removal of people from the definition of organism (which brings the Regulations into line with other existing GB legislation on GMOs);
  • exemption of certain marketed products which have been cleared through relevant product legislation;
  • simplification of procedures to allow joint first use notification of both Group I and Group II activities to be made;
  • notification of Group I genetically modified micro-organisms (GMMs) for the first time is not required if premises have already obtained consent for the more hazardous Group II activities.

These changes will benefit users by introducing a simpler and more practical GMM classification scheme and a more sensible notification system for first use.

WHAT DO THE REGULATIONS COVER?

The Regulations define genetic modification in relation to any organism as 'the altering of the genetic material in that organism by a way that does not occur naturally by mating or natural recombination or both'. Three examples of techniques covered by this definition are listed in the Regulations:

  • recombinant DNA techniques using viral or bacterial vectors;
  • the direct introduction of DNA into an organism, eg by micro-injection; and cell fusion or hybridisation.

Some genetic modification techniques are exempt from the Regulations, including:

  • somatic hybridoma cells, eg for the production of monoclonal antibodies; mutagenesis;
  • plant cell fusion where the resulting organisms can be produced by traditional breeding methods;
  • self-cloning of Group I GMMs;
  • GMOs released or marketed in circumstances which require a consent to release.

WHAT IS CONTAINED USE?

Contained use is defined as any operation in which organisms are genetically modified or in which genetically modified organisms are cultured, stored, used, transported, destroyed or disposed of, and where physical barriers (possibly combined with chemical and/or biological barriers) are used to limit their contact with the general population and the environment.

This definition covers activities such as laboratory operations, housing and breeding of genetically modified animals in animal houses or farm animals restrained by fencing, the use of growth rooms and glasshouses, and the use of fermenters.

WHAT ARE THE MAIN DUTIES UNDER THE REGULATIONS?

The Regulations apply to anybody carrying out contained use work, whether the person concerned is an employer, an employee, a self-employed person or someone who is not employed, such as a student. Any person carrying out contained use work is required to:

  • carry out an assessment of the risks to human health and to the environment* and keep records;
  • establish a local genetic modification safety committee to advise on risk assessments;
  • classify all operations and organisms used, according to the scheme described in section 8 of this leaflet;
  • *Assessments of environmental risks associated with genetically modified non micro-organisms (eg whole plants and animals) are covered by section 1OS(1)(a) of the Environmental Protection Act 1990 together with the Genetically Modified Organisms (Risk Assessment) (Records and Exemptions) Regulations 1996.
  • notify the Health and Safety Executive (HSE) of the intention to use premises for contained use work for the first time, or of subsequent individual activities, and in some cases seek consent from HSE;
  • adopt controls, including suitable containment measures;
  • draw up emergency plans where necessary, and notify HSE of accidents involving genetically modified organisms.

There are provisions for the public to have access to some information notified to HSE, however, safeguards have been built in for the protection of information that is commercially sensitive.

WHO ENFORCES THE REGULATIONS?

The Regulations are enforced by specialist inspectors from HSE's Directorate of Science and Technology.

HOW IS THE WORK CLASSIFIED?

The Regulations set out a framework for classifying genetically modified micro-organisms (GMMs) into two groups and genetic modification activities into two types. Non micro-organisms are classified separately.

Genetically modified micro-organisms (including animal and plant cells) must be classified into one of two groups: Group I or Group II, based on characteristics set out in the Regulations. The 1996 Regulations update the criteria so that they take account of current scientific knowledge. In general, Group I micro-organisms are considered to be unlikely to cause harm to people, animals, plants or the environment, while those in Group II are potentially harmful.

Activities involving genetically modified micro-organisms must be categorised as either Type A or Type B. Type A operations are those for teaching, research or development, or for non-industrial or non-commercial purposes. They must be on a scale at which the containment system reflects good microbiological practice and good occupational safety and hygiene, and the micro-organisms can be easily inactivated by standard laboratory decontamination techniques.

Type B operations are all those that fail to meet the required criteria of Type A. They will usually be large scale and carried out under industrial conditions, producing a commercial product. However, some non-commercial work may also be categorised as Type B, eg where the scale is such that standard laboratory decontamination techniques would be insufficient. Small-scale industrial production for commercial reasons will also be Type B.

Genetically modified non micro-organisms (including whole plants and animals) must also be classified into one of two hazard groups: those which are as safe as the parental organism in conditions of containment, and those which are not. They do not need to be categorised as Type A or Type B.

NOTIFICATIONS AND CONSENTS

The information given in notifications helps HSE and other Government departments to ensure that genetically modified organisms are being properly assessed and handled under the correct conditions. To do this, HSE will consult with the Department of the Environment (DoE), the Ministry of Agriculture, Fisheries and Food (MAFF), the Scottish Office and the Welsh Office, who together will evaluate the notification in terms of human health and environmental safety. HSE will also seek the advice of the Advisory Committee on Genetic Modification (ACGM). Advance notification is required whenever premises are going to be used for genetic modification for the first time. Certain individual activities involving genetically modified organisms must also be notified in advance. In some cases a specific 'consent' from HSE is required before the work can begin. HSE can only grant a consent with the agreement of the Secretary of State.

Table 1 sets out the notification requirements for each class of organism and type of activity.

It may be necessary for HSE to ask for additional information to help evaluate a notification. This 'stops the clock' as far as the specified time periods are concerned, and in such cases work can begin only with HSE's written agreement.

HOW SHOULD NOTIFICATION BE MADE?

The information required for notification is set out in the Schedules to the Regulations.

Notifications and annual returns must be made on forms approved by HSE. Forms are available from HSE's Directorate of Science and Technology (see section 13 of this leaflet) and completed forms should be sent to the same address.

FEES

A fee must be paid with each notification (except annual returns). Details of current charges are available from the Directorate of Science and Technology.

OTHER RELEVANT LEGISLATION AND ORGANISATIONS

Other regulatory organisations are also involved in work connected with biotechnology and you may find it useful to know who they are and what they do. Department of the Environment (DoE) is a consultee on notifications for contained use of GMOs and deals with legislation concerning the release and marketing of genetically modified organisms. The legislation concerned is the Genetically Modified Organisms (Deliberate Release) Regulations 1992 and 1995 made under the Environmental Protection Act 1990. Department of the Environment, Biotechnology Unit, Room B351, Romney House, 43 Marsham Street, London SW1P 3PY. Tel: 020 7276 8187 Fax: 020 7276 8333.

Ministry of Agriculture, Fisheries and Food (MAFF) is responsible for food safety and labelling, pesticides, plant health, animal health, welfare of farm animals and veterinary medicines. Legislation and guidelines cover the use of GMOs in food, animal feeds, fertilisers and veterinary medicinal products.

Other controls exist on the use of pesticides and on the use and import of plants and plant/animal/fish pathogens.

Ministry of Agriculture, Additives and Novel Foods (Branch D), Room 239c, Ergon House, c/o Nobel House, Smith Square, London SW1P 3JR. Tel: 020 7238 6224 Fax: 020 7238 6382, or MAFF Helpline Tel: 0645 33 55 77 (local call rate).

Department of Health (DH) is actively involved in aspects of biotechnology where it relates to human health and food. This includes the secretariat to the Gene Therapy Advisory Committee (GTAC) which assesses gene therapy trial protocols. The Medicines Control Agency (MCA) has responsibility for matters relating to the safety, quality and efficacy of medicines. The legislation concerned for clinical trials of gene therapy is the Medicines Act 1968 and secondary legislation.

Department of Health, Biotechnology Unit, Room 537B, Skipton House, 80 London Road, Elephant and Castle, London SE1 6LW. Tel: 020 7972 5347 Fax: 020 7972 5365/5155. GTAC Secretariat Tel: 020 7972 4021 Fax: 020 7972 4196 MCA, Guidance on Clinical Trials Tel: 020 7273 0327/0328 Fax: 020 7273 0443.

The Home Office is responsible for regulating scientific procedures (including experiments) on protected animals. This includes the production, breeding and use of all transgenic vertebrates (and Octopus vulgaris). Regulation is implemented through a series of certificates and licences. The legislation concerned is the Animals (Scientific Procedures) Act 1986.

Home Office, Animals, Bylaws and Coroners Unit, 50 Queen Anne's Gate, London SW1 9AT. Tel: 020 7273 2861 Fax: 020 7273 2423.

Department of Trade and Industry (DTI) has overall responsibility for sponsoring the industrial application of biotechnology and for ensuring that Government policies take account of their impact on industrial competitiveness in this area. An important component of this is to encourage the development of biotechnology through support for innovation through schemes such as LINK, SMART, SPUR, EUREKA and the EU Framework programme on biotechnology. DTI publishes a BioGuide providing the biotechnology community with an essential summary of current regulations and procedures and of support available to the sector, both from Government and elsewhere. Copies are available from DTI.

Department of Trade and Industry, Chemicals and Biotechnology Directorate, 151 Buckingham Palace Road, London SWIW 9SS. Tel: 020 7215 2914 Fax: 020 72151379.

The Scottish Office is responsible for the release and marketing of genetically modified organisms in Scotland and is a consultee for applications for contained use of such organisms in Scotland. It is also responsible for any related plant health aspects.

The Scottish Office Agriculture, Environment and Fisheries Department, Room 356, Pentland House, 47 Robb's Loan, Edinburgh EH14 1TY. Tel: 0131 244 6185 Fax: 0131 244 6445.

The Welsh Office is responsible for legislation concerning the release and marketing of genetically modified organisms in Wales, and is a consultee for applications for their contained use.

Welsh Office, Environment Division, Cathays Park, Cardiff CF1 3NQ. Tel: 01222 825111 Fax: 01222 823658.

USEFUL ADDRESSES IN HSE FOR ADVICE

Advice on matters concerning contained use of genetically modified organisms is dealt with by the HSE organisations listed below.

Directorate of Science and Technology (DST) Health and Safety Executive, Directorate of Science and Technology, Unit E4, Magdalen House, Stanley Precinct, Bootle L20 3QZ. Tel: 0151 951 4772 Fax: 0151 951 3474. Contact DST for: notification forms; copies of AGGM/HSE/DoE guidance notes and newsletters; technical enquiries; general procedures concerning notifications. Health Directorate (HD) Health and Safety Executive, Health Directorate B2, Floor 7SW, Rose Court, 2 Southwark Bridge, London SE1 9HB. Tel: 020 7717 6348 Fax: 020 7717 6199. Contact HD for: copies of ACGM/HSE/DoE guidance notes and newsletters; general information about legislation.

FURTHER INFORMATION

The full text of the Regulations, accompanied by comprehensive guidance, is contained in an HSE booklet A guide to the Genetically Modified Organisms (Contained Use) Regulations 1992, as amended in 1996 (HSE Books 1996 ISBN 0 7176 1186 8, price £10.50). Copies of the Guide can be obtained from HSE Books using the order form in this leaflet. HSE priced and free publications are available by mail order from HSE Books, PO Box 1999, Sudbury, Suffolk CO10 6FS Tel: 01787 881165 Fax: 01787 313995. HSE priced publications are also available from good booksellers. For other enquiries, ring HSE's InfoLine Tel: 0541 545500, or write to HSE's Information Centre, Broad Lane, Sheffield S3 7HQ. This guidance is issued by the Health and Safety Executive. Following the guidance is not compulsory and you are free to take other action. But if you do follow the guidance you will normally be doing enough to comply with the law. Health and safety inspectors seek to secure compliance with the law and may refer to this guidance as illustrating good practice. This publication may be freely reproduced, except for advertising, endorsement or commercial purposes. The information it contains is current at 5/96. Please acknowledge the source as HSE. IND(G)86(L) (rev) 10/96 C130

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