Contained Use of Genetically Modified Micro-Organisms

L.N. 168 of 2004

ENVIRONMENT PROTECTION ACT

(CAP. 435)

Contained Use of Genetically Modified Micro-Organisms

(Amendment) Regulations, 2004

IN exercise of the powers conferred by article 9 of the

Environment Protection Act, the Minister responsible for Rural

Affairs and the Environment has made the following regulations>-

The title of these regulations is the Contained Use of

Genetically Modified Micro-Organisms (Amendment) Regulations,

2004 and they shall be read and construed as one with the Contained

Use of Genetically Modified Micro-Organisms Regulations, 2002,

hereinafter referred to as “the principal regulations”.

For Annex II to the principal regulations there shall be

substituted the following new Annex II>

“ANNEX II

PART A

Techniques or methods of genetic modification yielding

micro-organisms to be excluded from the Regulation on the

condition that they do not involve the use of recombinant-

nucleic acid molecules or GMMs other than those produced by

one or more of the techniques#methods listed below>

1. Mutagenesis.

2. Cell fusion (including protoplast fusion) of prokaryotic

species that exchange genetic material by known physiological

processes.

Cell fusion (including protoplast fusion) of cells of

any eukaryotic species, including production of hybridomas and

plant cell fusions.

Self-cloning consisting in the removal of nucleic acid

sequences from a cell of an organism which may or may not be

followed by reinsertion of all or part of that nucleic acid (or a

synthetic equivalent) with or without prior enzymic or

mechanical steps, into cells of the same species or into cells of

phylogenetically closely related species which can exchange

genetic material by natural physiological processes where the

resulting micro-organism is unlikely to cause disease to humans,

animals or plants.

Self-cloning may include the use of recombinant vectors

with an extended history of safe use in the particular micro-

organisms.

PART B

Criteria establishing the safety of GMMs for human

health and the environment

This Annex describes in general terms the criteria to be

met when establishing the safety of types of GMMs for human

health and the environment.

1. GENERAL CRITERIA

2.1.

Strain verification#authentication

Identity of the strain must be precisely established.

Modification must be known and verified.

2.2.

Documented and established evidence of safety

Documented evidence of the safety of the organism must

be provided.

2.3.

Genetic stability

Where any instability could adversely affect safety,

evidence of stability is required.

2. SPECIFIC CRITERIA

3.1.

Non-pathogenic

The GMM should not be capable of causing disease or harm

to a healthy human, plant or animal. Since pathogenicity

includes both toxigenicity and allergenicity, the GMM should

therefore be>

3.1.1.

Non-toxigenic

The GMM should not produce increased toxigenicity as a

result of the genetic modification nor be noted for its toxigenic

properties.

3.1.2.

Non-allergenic

The GMM should not produce increased allergenicity as a

result of the genetic modification nor be a noted allergen,

having, for example, allergenicity comparable in particular with

that of the micro-organisms identified in Legal Notice 228 of

2003 on the protection of workers from risks related to exposure

to biological agents at work.

3.2.

No harmful adventitious agents

The GMM should not harbour known harmful adventitious

agents such as other micro-organisms, active or latent, existing

alongside or inside the GMM that could cause harm to human

health and the environment.

3.3.

Transfer of genetic material

The modified genetic material must not give rise to harm

if transferred nor should it be self-transmissible or transferable

at a frequency greater than other genes of the recipient or

parental micro-organism.

3.4. Safety for the environment in the event of a

significant and unintended release

GMMs must not produce adverse effects on the

environment, immediate or delayed, should any incident

involving a significant and unintended release occur.”.

Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press