SCHEDULE 3
PART IMATTERS TO BE TAKEN INTO ACCOUNT IN CARRYING OUT ANASSESSMENT FOR THE PURPOSES OF REGULATION 6
1
The following matters shall be taken into account in carrying out an assessment for the purposes of regulation 6—
a
any potentially harmful effects, in particular those associated with—
i
the recipient micro-organism,
ii
the inserted genetic material (originating from the donor organism),
iii
the vector,
iv
the donor micro-organism (where that donor micro-organism is used during the activity involving genetic modification), and
v
the resulting genetically modified micro-organism;
b
the characteristics of the activity;
c
the severity of the potentially harmful effects; and
d
the likelihood of the potentially harmful effects being realised.
2
In paragraph 1, “potentially harmful effects” includes—
a
disease to humans including allergenic or toxic effects;
b
disease to animals or plants;
c
adverse effects resulting from the inability to treat disease or offer an effective prophylaxis;
d
adverse effects resulting from establishment or dissemination of the genetically modified micro-organisms in the environment;
e
adverse effects resulting from the natural transfer of genetic material to or from other organisms;
f
adverse effects resulting from the likely interaction of the genetically modified micro-organism with other organisms at the premises where the activity involving genetic modification is to be conducted.