Aquatic guidance document

If the active substance is a herbicide data are also required on an additional species of an alga as well as an aquatic plant. Full details of the appropriate studies are provided in Section 8.2 Directive 96/12/EC and the Aquatic Guidance Document. 

Data are also required on the toxicity of the plant protection product. Further details on when these data are required can be found in the Aquatic Guidance Document, as well as Section 10.2.1 of Directive 96/12/EC. 

Depending on the persistence of the active substance in the water phase of a sediment water study, toxicity data are required to address the possible chronic risk of an active substance. Guidance on when these data are needed and on appropriate studies is provided in Section 8.2 and 10.2.4 of Directive 96/12/EC as well as in the Aquatic Guidance Document. 

Depending upon the partitioning and persistence of an active substance in the sediment phase of natural water sediment study, data may be required on its toxicity to sediment dwelling invertebrates. Details of when this study is required and choice of test method are given in the Aquatic Guidance Document. Information is also given in Section 8.2.7 of Directive 96/12/EC. 

Data are required on the bioconcentration potential of an active substance when the log Pow is >3. Further details are given in Section 8.2.3 Directive 96/12/EC, together with the Aquatic Guidance Document. 

By comparison with the measured data presented above, it can be seen that the local PECs are generally below, or in the order of, the maximum values measured in the aquatic environment. By way of exception, the values reported for methyltins, and in particular dimeth-yltin dichloride, from stabilizer production using the Technical Guidance Document (CEC, 2003) equations are significantly higher than the maximum measured values reported in the environment. 

European Commission, Guidance Document on Aquatic Ecotoxicology, 8075WI/97 rev. 7, 08.07.2000 (Draft), European Commission, Brussels (2000). 

Giddings JM, Brock TCM, Heger W et al (2002) Guidance document on community level aquatic system studies - interpretation criteria. SETAC, Brussels... 

European Commission (2002) Guidance document on aquatic ecotoxicology., Health and Consumer Protection Directorate - General, Bmssels, Sanco/3268/2001 rev 4 (final), pp 62... 

Environment Canada (2004a) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms, Report EPS l/RM/44, Environment Canada,... 

EC (Environment Canada) (2001) Metal Mining Guidance Document for Aquatic Environmental Effects Monitoring, Environment Canada Report EEM/2001/1. 

The Community-Level Aquatic Systems Studies Interpretation Studies (CLASSIC) guidance document, which deals with the interpretation of results of microcosm and mesocosm tests in the risk assessment procedure of pesticides, recommends that regulatory model ecosystem experiments be conducted in spring to midsummer (Giddings et al. 2002). On the basis of the limited number of model ecosystem experiments described above, it seems that threshold concentrations for effects observed in early-season studies are reasonably predictive for threshold concentrations later in the season. Above these threshold concentrations, however, the intensity and duration of the responses (direct and indirect effects) may vary during different periods of the year. Consequently, the extrapolation of NOECcommunity values from one season to another seems to be possible with lower uncertainty than hazard estimates of higher concentrations in which both direct and indirect effects are involved. 

Campbell PJ, Arnold D, Brock T, Grandy N, Heger W, Heimbach F, Maund SJ, Streloke M, editors. 1999. Guidance document higher-tier aquatic risk assessment for pesticides. Brussels (Belgium) SETAC-Europe, 179 p. 

Organisation for Economic Co-Operation and Development [OECD], 2001. Guidance document on the use of the harmonized system for the classification of chemicals which are hazardous for the aquatic environment. OECD Series on Testing and Assessment. No. 27 ENV/JM/MONO. Paris (France) Organization of Economic Cooperation and Development, 8 p. 

Technical Guidance Document and Water Framework Directive approaches EU member state, North American, and other international approaches) and the way in which they are implemented (e.g., mandatory pass or fail probabilistic, e.g., 95th percentiles or tiered risk assessment frameworks). Soil and water standards were considered, as were values for the protection of human health and the natural environment. The focus was on European regulatory frameworks, although expert input was sought from other jurisdictions internationally. Chemical standards for aquatic (water and sediment) and terrestrial (soil and groundwater) systems were the main focus for the meeting. This workshop built on, and included some participants from, a 1998 SETAC workshop Re-evaluation of the State of the Science for Water-Quality Criteria Development (Reiley et al. 2003). 

A9.6.4.7 The Nordic Council of Ministers issued a report (Pederson et al, 1995) entitled Environmental Hazard Classification, that includes information on data collection and interpretation, as well as a section (5.2.8) entitled QSAR estimates of water solubility and acute aquatic toxicity . This section also discusses the estimation of physicochemical properties, including log Kow For the sake of classification purposes, estimation methods are recommended for prediction of minimum acute aquatic toxicity, for ...neutral, organic, non-reactive and non-ionizable compounds such as alcohols, ketones, ethers, alkyl, and aryl halides, and can also be used for aromatic hydrocarbons, halogenated aromatic and aliphatic hydrocarbons as well as sulphides and disulphides, as cited in an earlier OECD Guidance Document (OECD, 1995). The Nordic document also includes diskettes for a computerized application of some of these methods. 

OECD 2000. Revised Draft Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures, OECD, Paris... 

OECD (1995). Environment Monographs No. 92. Guidance Document for Aquatic Effects Assessment. OECD, Paris... 

In general, the sustainability of populations of non-target organisms should be ensured (Guidance Document on Aquatic Ecotoxicology European Commission 2002a). 

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