SCHEDULE 4

Regulation 6

PART 1Matters 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 2Steps 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).