Ecotoxicology requirements

The guidance deals with each of these issues in turn. It addresses the basic data requirements and highlights appropriate risk assessment schemes and other sources of information that can be used in producing a good risk assessment. There may also be other references and information that can be used in support of the risk assessment. Notably, the use of such material should be scientifically justified. 

The European and Mediterranean Plant Protection Organisation (EPPO) have produced several schemes that can be used to assess the risk to non-target organisms. These schemes aim to provide a basis for undertaking an appropriate risk 

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. 

In certain instances it may be necessary for the product to have a buffer zone restriction added to the label to protect aquatic life. 

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Ecotoxicology is a natural extension of toxicology that studies the fate and effects of toxic substances on an ecosystem. It is based on scientiflc research that employs both laboratory and held methods. Ecotoxicology requires an understanding of ecologic principles and theories pertaining to how chemicals can affect individuals, populations, communities, and ecosystems. Individuals are single entities, whereas a... 

Reliable residue data are generated during the development of an a.i. to support the assessment of the consumer risk (residue data and toxicological data) and the impact on the environment (fate and behavior, efficacy and ecotoxicological data). It is critical that these analytical methods are reliably validated. In the guidance document SANCO/3029/99 rev. 4 (11/07/00), harmonized requirements for the residue analytical method are described. Validated analytical methods are required for the following studies ... 

Ecotoxicological data based on Organization for Economic Cooperation and Development (OECD) guidelines are also required, and the endpoints for aquatic organisms, such as fish, daphnia, algae and aquatic plants, are needed for utilization as part of the risk assessment process. 

Sometimes for some very potent pollutants analytical methodologies provide limits of detection (LODs) higher than the concentrations that cause effects, as derived from ecotoxicological studies. Therefore efforts in the field of analytical chemistry (see Sect. 2) are focused on making available the necessary analytical capabilities to detect pollutants at the required low levels found in the environment. This was the case of pharmaceuticals, illicit drugs, perfluorinated compounds (PFCs), sunscreens/UV filters, etc. few years ago. However, this list is likely to increase with new family candidates. 

Moreover, water quality is to be maintained or restored in such a way that human beings do not suffer any health damage as a result of the pollutant content of the fish they consume. The ecotoxicological data required in order to protect aquatic organisms and fish populations are the so-called No Observed Effect Concentration (NOEC) data. 

Ecotoxicological effects have been demonstrated for a number of surfactants or their metabolites, including some still currently in use, such as the nonylphenol ethoxylates [1], and as such there is a necessity to find more environmentally acceptable alternatives. Whilst the silicones are not the major surfactant type in use to date, the efficient properties and indications of low environmental persistence and toxicity demonstrate their potential for widespread use [2-4]. Relatively little is known about these new, rapidly emerging surfactants and the purpose of this chapter is thus to collate the available data, present new data, and identify the future research required in this area in order to evaluate the environmental relevance of this class of surfactants. 

Companies will be required to provide information on the identity and properties of a compound (including physical, chemical, toxicological, and ecotoxicological properties), the intended uses, the estimated human and environmental exposure, risks for humans and the environment, and proposals for risk management measures. Information requirements will depend largely on production volumes, but might be adjusted based on the intrinsic properties and conditions of use of individual substances. 

According to the Directive, an active substance cannot be used in a PPP unless it is included in an EU positive list. The Directive also requires very extensive risk assessments for effects on health and environment to be carried out, before a PPP can be placed on the market and used. In 1992, the European Commission started a Community-wide review process for aU active substances used in PPPs within the EU. Based on scientific assessments, each applicant had to prove that a substance could be used safely regarding human health, the environment, ecotoxicology and residues in the food chain. This program will be completed by 2008. From the end of 2003, the European Food Safety Authority (EFSA) deals with risk assessment issues and the European Commission retains the risk... 

Good Laboratory Practice and Quality Assurance procedures required for acute and chronic health effect studies can be used for acute and chronic mammalian, aquatic and avian ecotoxicology studies. 

The requirements for ecotoxicology studies vary little from the requirements for health effect studies. Laboratories that have adequate facilities, equipment, staff, and procedures for health effect studies, with adequate training of their staff in specific areas of ecotoxicology, could conduct these tests. 

With the exception of the special handling required for the test water, wild birds and fish, facilities that conduct routine mammalian toxicity studies should be adequate to conduct ecotoxicology testing. 

To reduce the inflow of toxic substances into basin waters efficiently, the Corporation required information on which effluents posed the greatest hazard to the river. While chemical data on many of the effluents were available, their diverse composition was difficult to interpret in terms of hazard potential. Moreover, hazard is not only linked to chemical composition of an effluent, but also on the toxic effects it can have on a variety of freshwater organisms. Adverse effects on biota are also influenced by the volume of wastewater discharged at different times of the year. Hence, the Corporation searched for a cost-effective approach, based on ecotoxicological principles, to rank the various effluents (there are several hundred sources), in terms of their toxic loading, so that subsequent efforts (such as clean up actions) could be prioritized. 

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