SCHEDULE 4
Regulation 6
PART 1

Matters to be taken into account in carrying out an assessment for the purposes of regulation 6
1
The following matters must 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 organism;
ii
the inserted genetic material (originating from the donor organism);
iii
the vector;
iv
the donor organism;
v
the resulting genetically modified organism;
b
the characteristics of the contained use;
c
the severity of the potentially harmful effects;
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
acting as a human disease vector or reservoir;
c
adverse effects to humans arising from change in behaviour or in physical nature;
d
adverse effects arising from the inability to treat human disease or offer effective prophylaxis.
PART 2

Steps to be included when carrying out an assessment for the purposes of regulation 6
3
An assessment carried out for the purposes of regulation 6 must include—
a
identification of any harmful properties of the recipient and, where appropriate, the donor organism;
b
identification of any harmful properties associated with the vector or inserted material, including any alteration in the existing properties of the recipient;
c
identification of the provisional level of risk associated with the genetically modified organisms;
d
selection of containment and other protective measures on the basis of—
i
the provisional level of risk; and
ii
the characteristics of the contained use;
e
adjustment of the level of risk in the light of the matters referred to in sub-paragraph (d);
f
review and reconsideration of the containment and other protective measures in the light of the steps required by sub-paragraphs (a) to (e).