UK Focal Point on Access to Genetic Resources and Benefit Sharing

Introduction | Legal Summary | Access To Resources | Related Links

Legal Summary

Health and Safety legislation

The Health and Safety Executive operates and enforces legislation in Great Britain designed to ensure that risks to people's health and safety from work activities are properly controlled. (For general information, see http://www.hse.gov.uk/enforce/index.htm ) Certain legislation may also affect access to genetic resources. In the UK, health and safety legislation requires employers to look after the health and safety of their employees; employees and the self-employed have to look after their own health and safety; and all employers and employees must take care of the health and safety of third parties such as members of the public who may be affected by their work activities.

Several areas of health and safety legislation have direct influence on access to genetic resources. These are listed below.

The Health and Safety at Work etc. Act 1974 (HSWA)

All work except domestic service is subject to regulation under the HSWA. Employers have general duties to ensure, so far as is reasonably practicable, the health, safety and welfare at work of employees, and to conduct their undertakings in such a way as to ensure, so far as is reasonably practicable, that other persons who may be affected by the work are not exposed to risks to their health and safety. Self-employed people have general duties to conduct their undertakings in such a way as to ensure, so far as is reasonably practicable, that they and other persons are not exposed to risks to their health and safety from the work. Employees have a general duty to take reasonable care for the health and safety of themselves and of other persons who may be affected by their work, and to co-operate with their employer or any other person to enable them to comply with any health and safety duties.

The Management of Health and Safety at Work Regulations 1999 (MHSWR)

The MHSWR provide a framework for controlling health and safety at work. As well as calling for risk assessments, they also require employers to have access to competent help in applying the provisions of health and safety law; to establish procedures to be followed by any worker if situations presenting serious and imminent danger were to arise; and for co operation and co ordination where two or more employers or self employed persons share a workplace.

Control of Substances Hazardous to Health (COSHH)

The COSHH Regulations (Statutory Instrument 1999 No. 437 - see http://www.hmso.gov.uk/si/si1999/19990437.htm) provide a framework of actions designed to control the risk from a range of hazardous substances including biological agents. Schedule 3 of COSHH contains provisions specifically relating to biological agents. The essential elements of the COSHH Regulations as they relate to work with biological agents are:

• risk assessment;
• prevention of exposure or substitution of an agent with one that is less hazardous (where the nature of the activity permits);
• selection of control measures;
• maintenance, examination and testing of control measures, e.g. protective equipment such as safety cabinets;
• provision of information, instruction and training for employees;
• monitoring exposure at the workplace (if a suitable procedure is available);
• health surveillance of employees (where appropriate, and if there are valid techniques for detecting indications of disease) when it can lead to action that will be of benefit to the health of employees;
• notification of ‘first use’ of biological agents in Hazard Groups 2, 3 and 4
• notification of the consignment or importation of biological agents listed in Part V of Schedule 3 of COSHH.

Hazardous substances are anything that can harm health when a person works with them if they are not properly controlled (eg by using adequate ventilation) and can include substances used directly in work activities (eg glues, paints, cleaning agents), substances generated during work activities (eg fumes from soldering and welding), naturally occurring substances (eg grain dust, blood, bacteria and other genetic resources). Biological agents may be hazardous substances. Biological agents are bacteria and other micro-organisms. They are controlled by COSHH if they are directly connected with the work or if exposure is incidental, such as with farming, sewage treatment or healthcare. Under COSHH, biological agents are categorised according to hazard and categories of containment

For further information, see http://www.hse.gov.uk/coshh

The Reporting of Incidents, Diseases and Dangerous Occurrences Regulations 1995 (RIDDOR)

RIDDOR requires employers, the self-employed and people in control of premises to report certain dangerous occurrences, occupational injuries and diseases.

The Carriage of Dangerous Goods (Classification, Packaging and Labelling) Regulations 1996

The legislative controls for the domestic carriage of dangerous goods, including biological agents are contained in these Regulations.

Further information on any of the above can be obtained from the Health and Safety Executive website http://www.hse.gov.uk

Advisory Committee on Dangerous Pathogens

The Advisory Committee on Dangerous Pathogens (ACDP) is a non-statutory advisory non-Departmental Public Body comprising a tripartite membership of 8 scientific experts, 4 employer representatives and 4 employee representatives. Its current terms of reference are:

"To advise the Health and Safety Commission, the Health and Safety Executive, Health and Agriculture Ministers and their counterparts under devolution in Scotland, Wales and Northern Ireland, as required, on all aspects of hazards and risks to workers and others from exposure to pathogens".

The ACDP Secretariat can be contacted via email at: acdp.secretariat@hse.gov.uk or via the DH website http://www.advisorybodies.doh.gov.uk/acdp/contact.htm

Legislative controls over the safety of GMOs used in containment.

The Health and Safety Executive operates and enforces legislation in Great Britain that controls the safety, to humans and the environment, of activities involving genetically modified organisms (GMOs) in containment. GMOs are micro-organisms, plants and animals that have had their genetic material altered by artificial means. This is variously known as genetic modification, modern biotechnology, genetic engineering, gene technology, or recombinant DNA technology. ‘Containment’ covers the contact of the GMOs with humans and the environment is limited by the use of barriers so that harm is avoided. Contained use includes facilities such as:

• laboratories;
• animal houses used, eg for breeding modified mice;
• fencing to restrain farm animals;
• plant growth rooms and glasshouses;
• industrial fermentors used for large scale production of things such as enzymes for washing powders.

Further information on contained use of GMOs can found in the HSE publication 'A Guide to the Genetically Modified Organisms (Contained Use) Regulations 2000. ISBN No 0-7176-1758-0, price £13.50 available from HSE Books, PO Box 1999, Sudbury, Suffolk, CO 10 , 6FS.

The current legislation which applies to the contained use of GMOs is the Genetically Modified Organisms (Contained Use) Regulations 2000 (SI 2000/2831), the main requirements of which include risk assessment; establishment of a local Genetic Modification Safety Committee; notification to the Competent Authorities (via HSE acting as a post box) of all premises where GMOs are used; notification to the Competent Authorities via HSE of activities of low, medium or high risk; and application of suitable containment and control. One implication of these Regulations is that any individual or organisation seeking access to various categories of GMO would not be entitled to access and use GMOs unless these Regulations were followed with respect to a range of activities including their acquisition, safe storage, handling and use. For example, people planning to work with a GM virus will have to follow certain steps before they can begin working. They need to:

• carefully assess risks to human health and safety and the environment,
• prepare a notification and have it reviewed by a GM Safety Committee, and
• obtain a consent from the Competent Authority if the activity is of sufficiently high risk to require one.

When products are to be released deliberately, including those first developed in containment and then subsequently released, legislation on the deliberate release of GMOs must be taken into account. Deliberate release and the marketing and approval of products is regulated in the Deliberate Release Regulations (EU Council Directive 90/220/EEC - to be replaced by Directive 2001/18/EC - on the Deliberate Release into the Environment of Genetically Modified Organisms). These Regulations are the responsibility of the Department of the Environment, Food and Rural Affairs.

Further information on the effect of this and other legislation relevant to the use of GMOs can be found on http://www.hse.gov.uk/biosafety/gmo/index.htm.