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Contained Use of GMOs

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The definition of 'contained use' 
An introduction to contained use
Why do we need controls and legislation?
Obligations under Legal Notice 127 of 2008
Classification of GMOs 
Public register and confidentiality claims 
Application procedures


The definition of 'contained use'

Contained Use is defined as "any activity in which micro-organisms are genetically modified or in which such 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 which 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. It is, therefore, 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, 2008, (Legal Notice 127 of 2008), as amended, give effect to EC Directive 2009/41/EC on the contained use of genetically modified micro-organisms. The Malta Environment and Planning Authority (MEPA) 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 MEPA with the help of its advisory committee, the Biosafety Co-ordinating Committee (BCC). LN 127/08 outlines, in Annex III and IV, 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 Legal Notice 127 of 2008

Anyone carrying out contained use activities must comply with Legal Notice 127 of 2008, particularly:
  1. Notify MEPA of their intention to use their premises for contained use activities for the first time;
  2. 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;
  3. Establish a genetic modification safety committee to advise on risk assessments;
  4. Classify all activities as described in Annex IV and notify them;
  5. Apply the necessary containment and control measures indicated by the risk assessment; and
  6. Draw up emergency plans for riskier activities, and notify any accidents that occur.


Classification of GMOs

Local and EU legislation classify GMOs into four classes:
Class 1 - activities of no or negligible risk
Class 2 - activities of low risk
Class 3 - activities of moderate risk
Class 4 - activities of high risk

Most genetically modified plants are considered to be 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.


Public register and confidentialy claims

Legal Notice 127 of 2008 has provisions for public access to notifications of both premises and activities. All information is accessible to the public, except where a specific confidentiality claim is made by the applicant and deemed valid by MEPA. However, no confidentiality claims may be made on information listed in Article 14 (3) of Legal Notice 127 of 2008.


Application procedures

When undertaking genetic modification procedures for the first time, premises must be registered with MEPA specifying their first activity by submitting an application for first time use. Activities of Class 1 and above need to notify MEPA of each new activity through an application for individual contained use activities. However, those premises that undertake Class 1 need only notify the information listed in Schedule V Part B, but are required to keep record of each risk assessments, which will be made available to MEPA on request.

The following table gives a summary of the different notification processes required for different classes of micro-organisms.

CLASS 1
Negligible Risk

CLASS 2
Low Risk

CLASSES 3 & 4
Moderate & High Risk

PREMISES ALREADY NOTIFIED


PREMISES
NOT
NOTIFIED

PREMISES ALREADY NOTIFIED


PREMISES
NOT
NOTIFIED

PREMISES ALREADY NOTIFIED


PREMISES
NOT
NOTIFIED

Class 1

submit notification with registration fee and proceed

always keep record of each assessment to be available on request

Class 1

submit First Time use notification with registration fee

once approved, proceed with experiment

always keep record of each assessment to be available on request

Class 2

submit individual contained use notification with registration fee and proceed

or

OPTIONAL

request decision on a formal authorisation by the competent authority (within 45 days)

Class 2

submit First Time use notification with registration fee

then proceed 45 days after submission or earlier with the agreement of the competent authority

Class 3 & 4

submit individual contained use notification with registration fee

then proceed after written decision at least 45 days after submission

Class 3 & 4

submit First Time use notification with registration fee

then proceed after written decision at least 90 days after submission

Application form for Notification for First Time Use

Application form for Individual Contained Use Activities

The application forms can be filled in and submitted to: GMOs, Ecosystems Management Unit, Malta Environment and Planning Authority, St. Francis Ravelin, Floriana, FRN 1230.

 

 

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