Containment, control & monitoring of GM organisms
The GMO Regulations requires all individuals undertaking activities involving genetic modification to reduce: a) exposure of humans and the environment to GMMs, and b) harm to humans arising from an activity involving genetic modification of organisms other than micro-organisms, to the lowest level that is reasonably practicable.
Clearly, containment and control measures must be chosen appropriate to the risk of the activity. For activities involving GMMs, control measures must include the principles of good microbiological practice (GMP) and good occupational safety and hygiene (GOSH). The general principles of GMP and GOSH involve not only physical containment, but also cover work practices and other non-physical methods of control. These control measures are in addition to the appropriate table of containment measures, determined during the classification of the activity. Where appropriate, these principles also apply for the genetic modification of organisms other than micro-organisms.
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Good microbiological practice and good occupational safety and hygiene
The principles are as follows:
- Keeping workplace and environment exposure to any genetically modified micro-organism to the lowest reasonably practicable level. The use of good practice will be applied to achieve a low level of exposure to GMMs.
- Exercising engineering control measures at source and supplementing these with appropriate personal protective clothing and equipment where necessary. This refers to the hierarchy of control measures used in COSHH, which requires that if exposure cannot be prevented (by elimination or substitution) exposure is controlled through primary containment in the first instance.
- Testing and adequately maintaining control measures and equipment. This is required to ensure the integrity of containment and that other control measures, including management and work methods, are being applied appropriately. Waste inactivation represents a particularly important aspect that needs to be monitored for effectiveness. The inactivation procedure used must be validated and monitoring data kept. Safety equipment must be examined at least every 14 months.
- Testing where necessary, for the presence of viable process organisms outside the primary physical containment. This must be applied where the risk assessment shows that monitoring outside the primary containment (e.g. culture vessel) is necessary to ensure effective control.
- Providing appropriate training of personnel.
- Formulating and implementing Code of Practice for Microbial Work (PDF , 131kb)/ for the safety of personnel, as required:
- Displaying biohazard signs where appropriate
- Providing washing and decontamination facilities for personnel
- Keeping adequate records: the GMO Regulations requires the keeping of records of risk assessments for 10 years from the date of cessation of that activity.
- Prohibiting in the work area eating, drinking, smoking, applying cosmetics or storing of food for human consumption
- Prohibiting mouth pipetting
- Providing written standard operating procedures where appropriate to ensure safety
- Having effective disinfectants and specified disinfection procedures available in case of spillage of genetically modified organisms. Refer to the ACGM CoG for further advice about disinfection methods. Disinfection should reduce numbers of live GMMs by at least 99.999% - i.e. a 5 log reduction.
- Providing safe storage for contaminated laboratory equipment and materials where appropriate. Appropriateness is again based on the level of risk associated with the activity
Control and containment measures for Class 1-4 activities involving genetic modification of micro-organisms
Containment and control measures must be chosen appropriate to the risk of the activity to protect both human health and the environment. These are in addition to applying the principles of GMP and GOSH. The risk assessment process must be used to determine the level of containment required for the genetic manipulation activity. Each of the Class 1-4 activities are related to the containment measures identified by the risk assessment as being necessary to control the risk. In turn, the activity Class feeds back into the level of containment that must be used.
Those undertaking an activity involving GMMs must apply the containment measures of the appropriate containment level set out in the applicable Table in Schedule 8 to the GMO Regulations 2000.
The regulations allow for a reduction in control measures from the appropriate containment level where the risk assessment shows that a particular containment measure(s) is not necessary. The person undertaking the activity must provide full justification to not apply a measure(s), supported by the risk assessment, to the competent authority (HSE). However, the full containment level must be applied until written agreement has been received from the HSE.
Containment measures must be reviewed at suitable regular intervals (depends on risk and nature of the particular activity) and in specific instances, when:
- it is suspected that they are no longer adequate
- the activity classification has changed
- there is scientific knowledge which shows that the risk assessment is inadequate
Control and containment measures for activities involving genetic modification of organisms other than micro-organisms
A different approach is taken for the containment of GM animals and plants. The GMO Regulations 2000 do not provide detailed containment levels for GM plants and animals, other than requiring that GMP and GOSH principles be applied where appropriate. The ACGM guidance is that a basic level of containment should be applied to all GM plants and animals (suitable for low risk GMOs). A higher level of containment should be applied to higher risk GM plants and animals. Refer to ACGM CoG, Parts 3B and 3D for details.
Waste inactivation and disposal
Prior to final discharge / disposal of waste from contained use activities, any risks to humans and the environment associated with any GMO must be removed by use of validated inactivation methods. Inactivation refers to the complete or partial destruction of GMMs so as to ensure that any contact between the GMMs and humans or the environment is limited to provide a high level of protection to both humans and the environment. Clearly, the degree of "kill" is related to the level of risk identified by the risk assessment.
In the case of GMMs, this refers to material and waste contaminated with GMMs from all containment level activities. The only exception to this is if the user has the explicit agreement of the competent authority (HSE) to dispose of waste without inactivation. The Authority requires evidence that GMMs will not survive to any appreciable extent in the environment and that there are no associated hazards.
For more hazardous GMMs, methods giving 100% kill are required such as incineration or autoclaving. However, for less hazardous GMMs, methods giving less than 100% kill may be acceptable, such as chemical disinfection which typically gives a 5 log reduction in viability, or 99.999% kill.
