Biosafety in the laboratory - VIB

ANNEX 2:
GUIDELINES FOR THE
CLASSIFICATION OF
GMO-ACTIVITIES
Introduction
These guidelines are meant to offer help in the determination of the appropriate containment measures
for activities with genetically modified organisms. In this annex a distinction is made between activities
involving micro-organisms and cells (chapter A), activities with plants (chapter B) and activities with animals
(chapter C). The transformation of plants using Agrobacterium tumefaciens is classified as an activity
with the micro-organism.
The use of these guidelines
These guidelines offer especially help for determining the necessary containment measures for activities
with micro-organisms and cells (chapter A of these guidelines). In chapter A there is a description of how
to use the classification schemes. Also, the necessary definitions of T1, T2 and T3 toxins are given as
well as the requirements for risk class 1 hostorganisms and vectors. For activities with transgenic plants,
chapter B gives some guidance. Activities with transgenic animals and especially the combination of the
use of genetically modified micro-organisms or cells with animals are difficult to classify. Chapter C gives
some guidance for these activities.
Of course there are cases that are not described in these guidelines. In such cases it is best to contact
internal or external biosafety experts as given in annex 5 in this booklet.
Sources
These guidelines have been developed from the guidelines from the dutch genetic modification advisory
committee (COGEM), as far as applicable in Belgium, and from the classification guidelines in the
annexes of section 51 of Vlarem II.
CHAPTER A. GUIDELINES FOR THE CLASSIFICATION OF ACTIVITIES INVOLVING
GENETICALLY MODIFIED MICRO-ORGANISMS AND CELLS
Classification rules
On the following pages classification schemes are presented that can be used to determine a first indication
of the necessary containment level. As already explained in chapter 3 and in the example in chapter
7 of this booklet, this is only a first, but important step. To come to a final conclusion one still has to
consider: (1) the environment to which the GMO would be exposed, (2) the type and the scale of the
activity, and (3) possible non-standard manipulations.
The classification scheme is divided into four parts:
• Part 1: activities with host/vectorsystems that do or do not fulfill the criteria for categorisation in risk
class 1 and activities with non-viral pathogenic hostorganisms
• Part 2: activities involving animal cells without viral vectors and with baculoviruses
• Part 3: activities involving animal cells in combination with viruses or viral vectors
• Part 4: activities in plant cells
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Biosafety in the laboratory