National Frameworks
Legal Frameworks


International Frameworks
Regional Frameworks
National Frameworks

The legal process which regulates the use of genetically modified organisms is concerned with the health and safety of those in the workplace and with the possible harm that may be caused to the environment by the modified organism. A formal risk assessment is required to identify any likely risks and management procedures must be designed to minimize them

  1. Risk Assessment depends on an assessment of the hazard associated with the modified organisms or the procedures used in handling the organism, and on the likelihood of the hazard occurring.
  2. For CONTAINED USE, where it is presumed there are both physical and biological barriers which limit the likely impact on the environment, it is almost solely the health and safety of those who are likely to enter the laboratory or factory that causes concern. The assessment of risk considers the likely effects of the modified organism on the humans using it, including those who enter the facility but are not aware of the sort of work being done (cleaners, secretaries...). It must also take into account both the incidental release of the organisms into a wider environment (waste streams, rubbish) and accidental release - what are the likely effects if the organism escapes from its physical containment, not only on human health and safety outside the containment facility but also on the environment?

This is crucially important where the 'micro-organism' being used is a plant or animal pathogen, or even a plant or animal cell. The initial test, for risk to humans, indicates lack of problem and hence safe usage in relatively light containment, but the impact on the environment may be severe should they escape, and hence the need for greater containment (both physical and biological) is indicated.

  1. Where the organism in containment is an animal or plant, the risk to the environment on escape is the most crucial, although risk to humans remains a consideration. If 'animals' are mentioned, it is often assumed that large farm or domestic animals - cats, dogs, sheep, pigs or cows are involved. It is these animals where the risk is probably least, and to some extent, biologically contained (There is little risk of genes inserted into a cow 'escaping' into the environment, but there is risk associated with the escape of such genes from a tom-cat). Modified animals which might pose a real threat to humans might be mites or insects and a consideration of the likely effects of escape or infestation becomes more important as the biological containment is less effective.
  2. Where the organism constitutes a risk to public health, special considerations apply. A report recently published by the Advisory Committee on Dangerous Pathogens in the UK on Microbiological Risk Assessment tabulates a risk assessment procedure as follows for risk assessment, not specifically for genetically modified organisms, but in general (summarised): A United States Presidential and Congressional Commission has recently reported in similar terms:
    • A statement of why a risk analysis is needed - the cause of concern. This may include questions relating to uncertainties that need resolution
    • Risk Assessment- (i) identification of the source of the hazard and the conditions under which adverse consequences could occur; and (ii) reviewing and quantifying the risk consequent on each hazard. The consequences of failure to identify a serious hazard may be grave. The procedure would involve
      • Assembly of available information from relevant data sources
      • Definition of the hazard and its potential harm (qualitatively expressed), explicitly stating any essential assumptions made and the circumstances in which its harm may be expected. This definition might include consideration of the life cycle of the organism, route of transmission, susceptibility to infection, available treatment or prophylaxis, consequences of infection...
    • Risk Importance- a judgement of the significance of the risk and the probability of the hazard being expressed. Information which might be available includes experimental evidence, epidemiological information, predictive modelling, information on pathogenic mechanism, route and consequences of infection, susceptibility of the population and the natural history of the disease.
    • Production of a formal record - a clear; comprehensive and concise record should be accompanied by a summary of the data on which the assessment was made and an appraisal of its quality.
    • Testing of the robustness of the scenario of the risk assessment - to challenge the susceptibility of the outcomes of the assessment to changes or errors in the data and assumptions on which the assessment was made.
    • Risk Management- the decision on and implementation of action to eliminate or minimise risks.
    • Risk Communication- the communication of information on the risk and on the decisions made to minimise or combat it
    • Risk Monitoring- the assessment of the effectiveness of control measures.
      1. Where the organism is DELIBERATELY RELEASED INTO THE ENVIRONMENT, or where the physical containment is not likely to be completely effective, the environmental effects of the organism become more important, and a detailed assessment of the risk to the environment is needed.
      2. Risk assessment identifies the hazards which might be encountered, and the probability of the hazards being realised. Risk management techniques are used to modify the probability of the hazard being realised so that the risk is minimized. In some cases this might require significant changes to the design of the system. This process is effectively a filter system, which may allow an undesirable product through.
      3. Whether for contained use or for deliberate release the hazard identification concentrates on four factors, which will be discussed in some detail in the chapter on risk assessment methodology:
        • the genetic alteration
        • the phenotype of the wild-type host and donor organisms, and of the vector used to transfer the information
        • the phenotype of the modified organism
        • the specific environment into which the organism is to be placed.

Last Modified: May 21, 2001
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