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The Genetically Modified Organisms (Contained Use) Regulations 2014

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This is the original version (as it was originally made).

Regulation 6

SCHEDULE 4

This schedule has no associated Explanatory Memorandum

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).

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