Legal Frameworks
Legal and Advisory Frameworks


Legal Frameworks
Building Frameworks


Although both the United States and the United Kingdom developed their regulatory systems following the Moratorium self-imposed by scientists in the 1970's, the regulatory systems moved apart significantly. In the United States it was decided not to impose new regulatory burdens on the biotechnology laboratory or industry. Guidelines for the safe use of modified organisms were introduced, in particular the NIH Guidelines, which imposed a set of safety precautions on those funded by the NIH for the safe use of modified organisms. Most industries, although not funded by NIH, followed these guidelines, at least in spirit.

In Europe, however, a statutory regulatory system is in force, which requires an assessment of the risks associated with the use of modified organisms in containment. The statutory system in Europe also depends on a Directive which defines the conditions in which biological agents (whether genetically modified or not) may be used in the workplace. Most of this discussion relates to the system in place in Europe, as it is not dissimilar to that expected but not required by law in many countries.

The original Directive which was produced for the European Union, 90/219 was clearly flawed. It worked on the basis type of work and of the hazard, rather than on the true risk.

The Directive defined two types of activity, Groups A and B. If the work was for research or development purposes, or non-commercial, or non-industrial, it was group A, otherwise B. The only purpose of these two groups was to identify the notification and consent requirements for the work. The separation is at least partially justified on the basis of the risk to workers - Group B work might involve less qualified or involved personnel who would not understand the risk, but takes little account of either risk or hazard.

Micro-organisms are then classified as type 1 or type 2. Type 1 organisms are those that pose no risk to human health or safety; type 2 organisms are all others. The classification is largely based on the host organism. I find it difficult to link the risk assessment with these classifications, which simply identify the needs of notification and consent once again. A risk assessment is still needed, but that which is closely defined is not the risk, but whether a consent is required.

Discussions concerning this Directive and possible modification have proceeded almost since it was first agreed in 1990. A change to a risk rather than hazard based system, with notification and consent based on risk rather than hazard or type of activity has been thought to be important, but it is not easy to implement these ideas. Some member states believe that the current Directive is working well, others would prefer a more logical approach.

This Directive is undergoing radical modification and a version has been sent to the European Parliament. The Commission is working on a draft that identifies the containment needed to minimize risk and links the risk assessment - risk management system with the consent - notification system.

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

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

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.

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.

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 minimize risks.
  • Risk Communication- the communication of information on the risk and on the decisions made to minimize or combat it
  • Risk Monitoring- the assessment of the effectiveness of control measures.

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.

Risk assessment identifies the hazards which might be encountered, and the probability of the hazards being realized. Risk management techniques are used to modify the probability of the hazard being realized 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.

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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