The definition of ‘contained use’
“Contained use” is defined as any activity in which micro-organisms are genetically modified or in which such genetically modified micro-organisms (GMMs) are cultured, stored, transported, destroyed, disposed of or used in any other way, and for which specific containment measures are used to limit their contact with the general population and the environment.
An introduction to contained use
The term ‘contained use’ covers any activity involving genetically modified micro-organisms (GMMs) carried out under containment and in which measures are taken to limit contact between these organisms, people and the environment. It relates to the actual process of genetic modification, as well as to the use, storage, transport and destruction of GMOs.
Typical contained use facilities can be microbiology laboratories, animal houses, greenhouses or industrial production facilities. For example, before GMOs where invented, medicinal products such as insulin, blood factor VIII and human growth hormone, were formerly collected from dead humans and animals. These were collected in small amounts and always carried the risk of transmitting disease. Now, with the use of genetic modification (GM) technology, pure and safe equivalents can be produced in larger quantities using GM bacteria.
Why do we need controls and legislation?
A considerable number of contained use activities involve organisms that do not cause disease and are very unlikely to survive in the environment outside a containment facility. However, some contained use activities are carried out with more hazardous organisms whose escape from containment could result in adverse effects on human health and / or the environment. Therefore, it is very important to assess the risks of all activities and to make sure that any necessary controls are put in place to protect people and the environment.
Consequently, there is legislation in Malta and the EU to control and lay down measures for contained use activities. The Contained use of genetically modified micro-organisms regulations (S.L. 549.49) give effect to Directive 2009/41/EC on the contained use of genetically modified micro-organisms (Recast). The Environment and Resources Authority (ERA) is the designated Competent Authority in Malta for the implementation of these Regulations.
The legislation requires the applicant to carry out a thorough risk assessment, which is then reviewed by ERA. S.L. 549.49 outlines the risk assessment procedure that should be followed to determine which containment level is necessary and into which classification category the GMM and the proposed activity fall.
In some cases, there will not be an exact match between the containment and control measures, which the risk assessment indicates, and those specified for a particular class; i.e. the measures will effectively fall between two classes. In such cases, the activity applied for would be under the higher class.
Obligations under S.L. 549.49
Anyone carrying out contained use activities must comply with S.L. 549.49, particularly:
- Notify ERA of their intention to use their premises for contained use activities for the first time;
- Carry out an assessment of the risks to human health and the environment of every contained use activity before it begins, reviewing and revising the assessment as necessary, and keeping records;
- Establish a genetic modification safety committee to advise on risk assessments;
- Classify all activities as described in the 4. Regulations;
- Apply the necessary containment and control measures indicated by the risk assessment, and;
- Draw up emergency plans for riskier activities, and notify any accidents that occur.
Classification of GMMs
|Local and EU legislation classify GMMs into four classes:|
|Class 1||Activities of no or negligible risk, for which level 1 containment is appropriate|
|Class 2||Activities of low risk; for which level 2 containment is appropriate|
|Class 3||Activities of moderate risk, for which level 3 containment is appropriate|
|Class 4||Activities of high risk, for which level 4 containment is appropriate|
Most genetically modified plants are considered Class 1 because they are not usually modified to contain DNA sequences from human disease-causing organisms. Class 4 is reserved for highly dangerous human or animal pathogens such as small pox, which are highly transmissible and for which there is no prophylaxis.
For application procedures, click here.