Possible effects on aquatic species must be investigated except where the possibility that aquatic species will be exposed can be ruled out.
TER a and TER lt must be reported, where:
=
acute LC 50 (mg a.s./l)/realistic worst case PEC sw (initial or short-term, in mg a.s./l)
=
chronic NOEC (mg a.s./l)/long term PEC sw (mg a.s./l)
In principle tests should be carried out on one species from each of the three groups of aquatic organisms as referred to in Annex II, point 8.2 (fish, aquatic invertebrates and algae) in case the plant protection product itself can contaminate water. However where the available information permits to conclude that one of these groups is clearly more sensitive, tests on only the most sensitive species of the relevant group have to be performed.
The test must be performed where:
the acute toxicity of the plant protection product can not be predicted on the basis of the data for the active substance which is especially the case if the formulation contains two or more active substances or formulants such as solvents, emulgators, surfactants, dispersants, fertilizers which are able to increase the toxicity in comparison with the active substance, or
the intended use includes direct application on water
unless suitable studies referred to under point 10.2.4 are available.
The relevant provisions as under the corresponding paragraphs of Annex II, points 8.2.1, 8.2.4 and 8.2.6 apply.
The tests must provide sufficient data to evaluate the essential impact on aquatic organisms under field conditions.
Where TER a ≤ 100 or where TER lt ≤ 10, expert judgment must be used to decide whether a microcosm or mesocom study is appropriate. This judgment will take into account the results of any additional data over and above those required by the provisions of Annex II, point 8.2 and of point 10.2.1.
Before performing these studies the applicant shall seek the agreement of the competent authorities on the specific aims of the study to be performed and consequently on the type and conditions of the study to be performed.
The study should include at least the highest likely exposure rate, whether from direct applicaiton, drift, drainage or run-off. The duration of the study must be sufficient to permit evaluation of all effects.
Appropriate guidelines are included in:
Setac — Guidance document on testing procedures for pesticides in freshwater mesocosms/Workshop Huntingdon, 3 and 4 July 1991
or
Freshwater field tests for hazard assessment of chemicals — European Workshop on Freshwater Field Tests (EWOFFT).
The test will provide sufficient data to evaluate the potential for occurrence of residues in fish.
In general data are available from bioconcentration studies in fish.
Where bioconcentration has been observed in the study performed in accordance with Annex II, point 8.2.3 expert judgement is required to decide whether a long-term microcosm or mesocosm study has to be carried out in order to establish the maximum residues likely to be encountered.
Setac — Guidance document on testing procedures for pesticides in freshwater mesocosms/Workshop Huntingdon, 3 and 4 July 1991 .
The studies referred to in Annex II, points 8.2.2 and 8.2.5 may be required for particular plant protection products where it is not possible to extrapolate from data obtained in the corresponding studies on the active substance.]