Select Committee on European Communities Second Report - Written Evidence

Memorandum by the Health and Safety Executive


Health and Safety Commission and Health and Safety Executive

  1. The Health and Safety Commission (HSC) and the Health and Safety Executive (HSE) are both statutory non-departmental public bodies. The HSC's 10 members are appointed by the Secretary of State for the Environment, Transport and the Regions after consultation with organisations representing employers, employees, local authorities and others as appropriate. The HSC's statutory responsibilities under the Health and Safety at Work, etc. Act 1974 include proposing health and safety regulations and standards to Ministers. The Health and Safety Executive is a body of three people appointed by the HSC with the consent of the Secretary of State for the Environment, Transport and the Regions. The Executive is supported by about 4,000 staff (HSE), including inspectors, policy advisors, and scientific, technological and medical experts. Of these some 350 are in the Health and Safety Laboratory, an in-house Agency of HSE.

  2. The HSC relies on the policy advice of HSE, and also advice from a wide variety of interests including trade unions, employers' organisations and scientific and technological experts. Much of this advice is managed through a network of advisory committees. Some of these deal with particular hazard areas and some with particular industries. Each includes a balance of employer and employee representatives and, where appropriate, technological and professional experts. Their main function is to recommend standards and guidance on health and safety matters to HSC. Advisory committees are serviced by HSE.

Advisory Committee on Genetic Modification

  3. The Advisory Committee on Genetic Modification (ACGM) is one of HSC's subject advisory committees and was established in 1984. Its original remit was to advise the HSC/E and interested Ministers on all aspects of work with genetically modified organisms (GMOs). After the Advisory Committee on Releases into the Environment (ACRE) was established to advise the Secretary of State and HSC/E on aspects of human and environmental safety of the release of GMOs and other novel organisms into the environment, ACGM confined itself to GMO activities under conditions of containment (e.g., work in laboratories and industrial installations). ACGM's remit is to advise on any aspect of contained use. Since 1993 this has included the Genetically Modified Organisms (Contained Use) Regulations 1992, as amended in 1996.

  4. ACGM comprises 13 members appointed by HSC. This includes a chairman who is an independent expert; four nominees of employers' organisations; and four nominees of employees' organisations; and four independent experts of whom one must specialise in environmental safety. The current chairman is Professor Kay Davies, CBE, of Oxford University. ACGM has a Technical Sub-Committee comprising a chairman and 12 members (representing an appropriate balance of expertise and employer and employee interests) who provide specialised technical advice in all aspects of the human and environmental safety of the contained use of GMOs. ACGM's focus is on safety aspects of genetic modification; it does not consider social or ethical aspects. It is also not involved in consideration of product safety which is handled under deliberate release or product based legislation.


  5. Regulations to control the safety of genetic modification (GM) work have been in place in Great Britain (GB) since 1978. In 1989 the Regulations were extended to cover experimental releases of GMOs into the environment, though the purpose of the legislation was restricted to the protection of human health. Specific provision for environmental safety of GMOs was addressed in Part VI of the Environmental Protection Act 1990[22] (EPA). At the same time there were moves in the European Community to establish common human health and environmental standards for all GM work including the marketing of GM products. These standards are specified in two Directives which were adopted in 1990. They deal respectively with the contained use of genetically modified micro-organisms (GMMs) (90/219/EEC)[23] and the deliberate release into the environment of GMOs (90/220/EEC)[24]. ACGM's interests do not extend to Directive 90/220/EEC.

Legislation on contained use of genetically modified organisms

  6. "Contained Use" means any operation in which organisms are genetically modified or in which GMOs 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 people and the environment. This definition covers activities such as laboratory operations, housing and breeding of GM animals in animal houses or farm animals restrained by fencing, the use of growth rooms and glasshouses, and the use of fermenters.

  7. The Contained Use Directive is implemented in Great Britain through regulations made under the powers of the Health and Safety at Work, etc., Act 1974, and the European Communities Act 1972. The regulations are concerned with protecting both human health and the environment. They comprise the Genetically Modified Organisms (Contained Use) Regulations 1992[25] and the Genetically Modified Organisms (Contained Use) (Amendment) Regulations 1996[26] They require, with certain exceptions, that anyone carrying out any activity involving genetic modification does so in conditions of contained use which satisfy the Regulations. All contained use activities must be risk-assessed, and containment and control measures must be applied. The Regulations require notification in advance to HSE before any premises are used for GM activities for the first time. Where higher risk GMOs are involved individual activities must also be notified to HSE. In some cases a specific consent from HSE is required before the work can begin. HSE may only grant such a consent with the agreement of the SoS.

  8. The information given in notifications assists HSE and other government departments to ensure that GMOs are being properly assessed and handled under the correct conditions. To do this, HSE consults with Department of Environment, Transport and the Regions (DETR), Ministry of Agriculture Fisheries and Food (MAFF), Scottish Office and Welsh Office; together these organisations evaluate the notification in terms of human health and environmental safety. HSE may also seek the advice of ACGM.

  9. The Contained Use Directive covers only genetically modified micro-organisms (GMMs). However, the GB legislation which implements the Directive also covers GM animals and plants insofar as they may present risks to human health. For GMMs the Regulations cover both human health and environmental risks. The environmental risks associated with work with larger organisms (GMOs) are covered separately by section 108(1)(a) of the EPA. This section requires anyone acquiring a GMO which is not an approved product under the Genetically Modified Organisms (Deliberate Release) Regulations 1991 to carry out a risk assessment of the environmental risks.

  10. The Genetically Modified Organisms (Risk Assessment) (Records and Exemptions) Regulations 1996[27] require records on the risk assessment to be kept for 10 years. These were amended by the Genetically Modified Organism (Deliberate Release and Risk Assessment—Amendment) Regulations 1997.[28]

Proposed amendment to Contained Use Directive (90/219/EEC)

  11. A proposal for fundamental revision of the Contained Use Directive (90/219/EEC) has been under negotiation in the European Council of Ministers since May 1996. The initiative began with a 1993 House of Lords Select Committee on Science and Technology,[29] and a European Commission White Paper[30] on competitiveness suggesting a review of the biotechnology regulatory framework in order to simplify it. It was also necessary to match controls more scientifically to the kind of GMO activities now carried out and to what is known about the risks.

  12. The proposed revision streamlines administrative procedures and places greater emphasis on risk assessment and containment and control measures. It is currently at Second Reading stage in the European Parliament, and it is hoped to achieve final adoption by about September 1998. Implementation in Great Britain is likely to be in March/April 2000.

Operation of the GB contained use legislation

  13. The HSE and the Secretary of State are joint competent authorities (HSE is given the decision-making power, but cannot act on environmental issues without the agreement of the Secretary of State). HSE receives all notifications and other information submitted under the legislation. Under a Memorandum of Understanding all of this information is circulated to DETR, MAFF, Scottish Office and Welsh Office for their comment. This system works very well and allows HSE to draw on the experience and knowledge of other Government Departments as well as ACGM's advice when appropriate.

Enforcement of the contained use legislation

  14. The contained use legislation is enforced by HSE specialist inspectors. In enforcing environmental aspects of GM animals and plants controlled under Part VI of the EPA and associated regulations, HSE operates under an Agency Agreement with DETR.

Relevance of contained use legislation to genetic modification in agriculture

  15. Research and development leading to agricultural products is a step-wise process. It will typically form a continuum from laboratory-based studies, to growthrooms and glasshouses, to small-scale field trails, and finally to commercialisation. The initial (contained) stages are controlled under the contained use legislation. The sorts of studies include initial insertion of new genes into plants, creation of animal embryos with new genes, development and production of novel veterinary medicines and growth studies in glasshouses. Field trials and production involving deliberate release, and product approval do not fall under the continued use legislation. DETR lead on matters concerning deliberate release of GMOs under the Environmental Protection Act 1990 and the Genetically Modified Organisms (Deliberate Release) Regulations 1992 (as amended in 1995 and 1997). MAFF have responsibility for all aspects of the use of GM technology for the production of foods under the Novel Foods and Novel Food Ingredients Regulations 1997.[31]

29 May 1998

22   (SI 1996/967). Back

23   (SI 1996/1106). Back

24   (SI 1997/1900). Back

25   (Regulation of the UK Biotechnology Industry and Global Competitiveness; HL Paper 80). Back

26   (XI/506/94). Back

27   OJ No. L43 14 February 1997 pl. Back

28   Draft-permits are published in the official journal of the authority and in two national dailies. Back

29   Permits are published in the official journal of the authority. Back

30   The procedure for hybrid registration is not included in the table, as this procedure exists only in given countries. Back

31   Novartis Seeds had already indicated that its product, the seeds of Bt-maize, would be labelled. Back

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