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Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 2001

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Part IISteps 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 shall include—

(a)identification of any harmful properties of the recipient and, where appropriate, the donor micro-organism;

(b)identification of any harmful properties associated with the vector or inserted material, including any alteration in the recipient’s existing properties;

(c)consideration of relevant Community legislation, including Council Directive 90/679/EEC(1) on the protection of workers from risks related to exposure to biological agents at work, other classification schemes referring to plant and animal pathogens, and other international and national classification schemes for genetically modifed micro-organisms;

(d)identification of the provisional level of risk associated with the genetically modified micro-organism;

(e)consideration of—

(i)the characteristics of the environment likely to be exposed,

(ii)the characteristics of the activity involving genetic modification of micro-organisms, and

(iii)any activities involving genetic modification of micro-organisms which cannot be adequately controlled by standard laboratory procedures, and which present risks which require controls for each individual case;

(f)adjustment of the provisional level of risk in the light of the matters referred to in sub-paragraph (e);

(g)selection of the appropriate containment measures from those specified in the applicable Table in Schedule 8 on the basis of the provisional level of risk as adjusted in accordance with sub-paragraph (f);

(h)assignment of the activity involving genetic modification of micro-organisms to the appropriate containment level, in accordance with paragraph 4;

(i)classification of that activity in the class of the same number as that of the appropriate containment level; and

(j)review and reconsideration of that classification in the light of the completed assessment.

4.  To assign an activity involving genetic modification of micro-organisms to the appropriate containment level for the purposes of paragraph 3(h), the person carrying out the assessment for the purposes of regulation 6 shall—

(a)first identify for each selected containment measure the column in the applicable Table in Schedule 8 having the lowest number in which that selected containment measure is shown as being required, regardless of whether or not such requirement is subject to any qualification;

(b)then select the highest number of all the columns identified in accordance with sub-paragraph (a); and

(c)then assign the activity involving genetic modification in question to the containment level of that highest number.

5.  In paragraph 4, “selected containment measure” means an appropriate containment measure selected in accordance with paragraph 3(g).

(1)

OJ No. L 374, 31.12.90, p. 1, as amended by Council Directive 93/88/EEC (OJ No. L 268, 29.10.93, p. 71), Commission Directive 95/30/EC (OJ No. L 155, 6.7.95, p. 41), Commission Directive 97/59/EC (OJ No. L 282, 15.10.1997, p. 33) and Commission Directive 97/65/EC (OJ No. L 335, 6.12.1997, p. 17)

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