Risk assessment & classification of GM activities

All work activities, including those concerned with genetic modification, are covered by Control of Substances Hazardous to Health (COSHH) Regulations and Management of Health and Safety at Work Regulations (MHSWR). However, the GMO Regulations also require a specific risk assessment to be made which can form part of the overall COSHH assessment (avoiding any duplication).

A 'suitable and sufficient' risk assessment must be carried out and approved by the GMSC before the start of any activity involving genetic modification of:

• micro-organisms
• organisms other than micro-organisms

The University has set in place a GMO risk assessment form and accompanying instructions which have been approved by the GMSC. Although the person undertaking the activities does not necessarily have to perform the risk assessment, that person has the responsibility of ensuring that it is suitable and sufficient.

The process of getting a GM risk assessment approved before commencing the GM work activity is outlined in GM Flow Chart 2 (PDF , 15kb). Copies of a GM risk assessments should initially be sent to The Chairman of the  Biological Agents Safety Committee (BASC). Further copies are then distributed to 2 other members of the Committee for review. It is the intention of the BASC to give feedback on risk assessments within 2 weeks of submission for all GMM activities that are provisionally classified as Class 1, and other GM activities (e.g. work with transgenic plants and animals) provisionally classified at Containment Level A. Work can commence for those activities approved by the BASC sub-group, although final approval will still be required at the next scheduled BASC meeting. All other GM activities require the full approval of the BASC before work can commence.

The main purpose of the risk assessment process is to assess the risks to human health and to the environment. The environment can be defined as "land, air and water" and the organisms and systems which are associated with these components. Damage or harm to the environment could be caused by the presence in the environment of GMOs which have escaped from containment and are capable of causing harm to any living organisms supported by the environment. For example, if pollen from a glasshouse, or transgenic animals accidentally escaped from containment, the unintentional transfer of genes to a farmer's crops or livestock is a potential hazard and could cause harm if realised. The toxic or allergenic effects arising from the expression of genes in pollen would also present a potential hazard to human health.

The GMO Regulations 2000 require human health and safety must be considered for all activities involving genetically modified organisms (including micro-organisms), whilst environmental safety must be considered for activities involving genetically modified micro-organisms. The environmental provisions for activities involving GM animals and plants are covered by the EPA1990 and its associated Regulations.

The process of preparing a risk assessment for activities involving GMMs essentially involves an assessment of human health and environmental risks, before determining the containment measures required to control the identified risks. The containment measures selected decide the classification which determines notification requirements. GM Flow Chart 3 (PDF , 6kb) summarises the process of risk assessment, containment measures and classification for GMMs.

The amount of detail required in a risk assessment will obviously vary depending on the type of work. Most routine work, for example cloning work with disabled Escherichia coli K12 derivatives will require only a brief assessment. For other activities involving more hazardous organisms, a more detailed assessment will clearly be required. The level of detail for individual cases will vary, dependent on the nature of the hazards or level of uncertainty.

It is no longer appropriate or sufficient to carry out a "Brenner Scheme" assessment, which employs a system for ranking hazards and assigning probability ratings to three aspects of the GMO; Access, Expression and Damage. The scheme was essentially a method for determining whether a host strain might be made more hazardous by cloning in a foreign gene. In many cases it did not reliably indicate the level of containment required, especially in more recent years when more complex and novel genetic modifications became available. The new guidance provides a more workable approach to assessing GM activities and should be used for all GMO risk assessments.

Details of matters to be considered and steps to be included when carrying out an assessment for genetically modified micro-organisms are outlined in the GM risk assessment form and accompanying instructions.

Further details are also given in Schedule 3 (Parts 1 and 2) of the GMO 2000 Regulations and Schedule 4 (Parts 1 and 2) for genetically modified organisms other than micro-organisms. Further information is also included in Part 2 of the Advisory Committee on Genetic Modification Compendium of Guidance (ACGM CoG), which also provides detailed guidance and worked examples of risk assessment on different GMOs and activities.

The ACGM recommend that the risk assessment and the assignment of containment and control measures follows six basic stages for activities using GMMs. This forms a guide as to the procedure to follow and the factors to consider. The six basic stages include:

Stage I

Consideration of the predicted properties of the GMM to determine if there are any potential mechanisms by which it could represent a hazard to human health and how severe the consequence might be

Stage II

Consideration of the likelihood that, in the event of exposure, the GMM could actually cause harm to human health

Stage III

Assignment to the provisional containment level

Stage IV

Consideration of the nature of the work and a detailed review of controls necessary to safeguard human health

Stage V

The identification of any hazards to the environment and the assignment of any additional containment measures

Stage VI

Assignment of the final activity Class (1,2,3 or 4)

The activity classes are based largely on the Advisory Committee on Dangerous Pathogens (ACDP) levels of control. Although no definitions are given, Table 1 describes activity classes 1-4, as adapted from the ACDP categorisation of human pathogens.

The completed risk assessment must be approved by the BASC. A review of the initial assessment is required if there is reason to suspect it is no longer valid because of a significant change in the activity. A record of the assessment relating to that activity must be kept for at least 10 years after finishing that activity. A copy of the risk assessments will be kept with the HSA(BS).

The GMO Regulations 2000 only requires an assessment of risks to human health for GM plants and animals. An assessment of environmental risks must also be carried out, although this is a requirement of the EPA 1990 and associated regulations. Records of the environmental risk assessment must be kept for 10 years after completion of the work. In this case, records will be kept with the HSA(BS). Details of the risk assessment requirements for GM plants and animals is given in Parts 2D and 2E of the ACGM CoG (available from the HSA(BS)).

The process of assessing the risks to human health and the environment for genetically modified plants and animals is essentially the same as that for micro-organisms, although classification into Class 1-4 activities and associated containment levels does not apply. In outline, the recommended procedure involves:

1. risk assessment for environmental protection (hazard identification, assessment of likelihood and consequences; determination of risk; assignment of risk management measures to protect the environment)
2. risk assessment for human health and safety
3. assignment of final containment and control requirements, adjusting 1 to take account of 2

The ACGM guidance recommends that a basic level of containment should be applied to all plants and animals. A basic level of containment is suitable for GMOs where the risk is assessed to be low or zero. Higher risk GM plants and animals require additional measures to control specific risks. Higher level containment should be used for where the risk assessment identifies a hazard to humans or the environment, and the risks cannot be reduced to an acceptable level (i.e. low or negligible) by the basic containment facilities.