SCHEDULE 3
Regulations 2(3), 3(4) and 5
PART 1

Matters to be taken into account in carrying out an assessment for the purposes of regulation 5
1
The following matters must be taken into account in carrying out an assessment for the purposes of regulation 5—
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 contained use);
v
the resulting genetically modified micro-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;
e
the disposal of waste and effluents.
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 contained use is to be conducted.
PART 2

Steps to be included when carrying out an assessment for the purposes of regulation 5
3
An assessment carried out for the purposes of regulation 5 must 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 existing properties of the recipient;
c
recognition that, in general, only contained use which shows the following characteristics is appropriate for inclusion in class 1 as described in Schedule 1—
i
the recipient or parental micro-organism is unlikely to cause disease to humans, animals or plants;
ii
the nature of the vector and the insert is such that they do not endow the genetically modified micro-organism with a phenotype likely to cause disease to humans, animals or plants, or likely to cause deleterious effects on the environment; and
iii
the genetically modified micro-organism is unlikely to cause disease to humans, animals or plants and is unlikely to have deleterious effects on the environment;
d
consideration of relevant EU legislation, including Directive (EC) No 2000/54 of the European Parliament and the Council 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 modified micro-organisms;
e
identification of the provisional level of risk associated with the genetically modified micro-organism;
f
consideration of—
i
the characteristics of the environment likely to be exposed;
ii
the characteristics of the contained use involving micro-organisms;
iii
any contained use of micro-organisms which cannot be controlled adequately by standard laboratory procedures, and which presents risks which require controls for each individual case;
g
adjustment of the provisional level of risk in the light of the matters referred to in sub-paragraph (f);
h
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 (g);
i
assignment of the contained use to the appropriate containment level, in accordance with paragraph 4;
j
classification of the contained use in the class of the same number as that of the appropriate containment level;
k
review and reconsideration of that classification in the light of the completed risk assessment.
4
To assign a contained use to the appropriate containment level for the purposes of paragraph 3(i), the person carrying out the risk assessment must—
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 contained use 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(h).
OJ No L 262, 17.10.2000, p21.