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Biosafety in the laboratory - VIB

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Def<strong>in</strong>ition of a GMO<br />

GMOs are organisms whose genetic material has been altered <strong>in</strong> a way that<br />

is not possible by reproduction or natural recomb<strong>in</strong>ation. Techniques that<br />

lead to <strong>the</strong> formation of a GMO <strong>in</strong>clude:<br />

*recomb<strong>in</strong>ant-DNA- and RNA-techniques <strong>in</strong>volv<strong>in</strong>g <strong>the</strong> use of host/vector<br />

systems<br />

* techniques <strong>in</strong>volv<strong>in</strong>g <strong>the</strong> direct <strong>in</strong>troduction <strong>in</strong>to a micro-organism of<br />

heritable material prepared outside <strong>the</strong> micro-organism, <strong>in</strong>clud<strong>in</strong>g micro<strong>in</strong>jection,<br />

macro-<strong>in</strong>jection and micro-encapsulation<br />

* cell fusion or hybridisation techniques where liv<strong>in</strong>g cells conta<strong>in</strong><strong>in</strong>g new<br />

comb<strong>in</strong>ations of heritable genetic material are formed through <strong>the</strong> fusion<br />

of two or more cells by means of methods that do not occur naturally<br />

The follow<strong>in</strong>g techniques are not considered to result <strong>in</strong> genetic modification,<br />

on condition that <strong>the</strong>y do not <strong>in</strong>volve <strong>the</strong> use of recomb<strong>in</strong>ant-DNA<br />

molecules or genetically modified organisms<br />

* <strong>in</strong>-vitro fertilisation<br />

* natural processes such as: conjugation, transduction, viral <strong>in</strong>fection,<br />

transformation<br />

* polyploidy <strong>in</strong>duction.<br />

Exceptions to <strong>the</strong> guidel<strong>in</strong>es<br />

The follow<strong>in</strong>g GMOs are excluded from <strong>the</strong> regulations and also from <strong>the</strong> scope of this<br />

booklet if <strong>the</strong>y have been made us<strong>in</strong>g <strong>the</strong> techniques listed below, on <strong>the</strong> condition that<br />

<strong>the</strong>y do not <strong>in</strong>volve <strong>the</strong> use of recomb<strong>in</strong>ant-nucleic acid molecules or GMOs o<strong>the</strong>r than<br />

those produced by one or more of <strong>the</strong> techniques listed below:<br />

* Mutagenesis.<br />

* Cell fusion (<strong>in</strong>clud<strong>in</strong>g protoplast fusion) of prokaryotic species that exchange genetic<br />

material by known physiological processes.<br />

* Cell fusion (<strong>in</strong>clud<strong>in</strong>g protoplast fusion) of cells of any eukaryotic species, <strong>in</strong>clud<strong>in</strong>g<br />

production of hybridomas and plant cell fusions.<br />

* Self-clon<strong>in</strong>g consist<strong>in</strong>g <strong>in</strong> <strong>the</strong> removal of nucleic acid sequences from a cell of an organism<br />

which may or may not be followed by re<strong>in</strong>sertion of all or part of that nucleic acid<br />

(or a syn<strong>the</strong>tic equivalent) with or without prior enzymatic or mechanical steps, <strong>in</strong>to<br />

cells of <strong>the</strong> same species or <strong>in</strong>to cells of phylogenetically closely related species which<br />

can exchange genetic material by natural physiological processes where <strong>the</strong> result<strong>in</strong>g<br />

micro-organism is unlikely to cause disease to humans, animals or plants. Self-clon<strong>in</strong>g<br />

may <strong>in</strong>clude <strong>the</strong> use of recomb<strong>in</strong>ant vectors with an extended history of safe use <strong>in</strong> <strong>the</strong><br />

particular microorganisms.<br />

Recomb<strong>in</strong>ant-DNA GMO’s<br />

Today a whole range of organisms can already be genetically modified, a.o bacteria, yeasts,<br />

fungi, <strong>in</strong>sects (fruit fly), parasites, nematodes, plants, frogs, mammals (mice, rats, rabbits,<br />

goats, sheep, pigs, cattle). Genetic modification <strong>in</strong> general <strong>in</strong>volves <strong>the</strong> follow<strong>in</strong>g components:<br />

Classification and risk assessment 11

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