©2002 CRC Press LLC European Approaches to Coastal and Estuarine Risk Assessment Mark Crane, Neal Sorokin, James Wheeler, Albania Grosso, Paul Whitehouse, and David Morritt CONTENTS 2.1 Introduction 2.2 Legislative Procedure in The European Union 2.3 Principles of Chemical Risk Assessment in the EU 2.4. Prospective Risk Assessment in the EU 2.4.1 New Chemical Substances 2.4.2 Existing Chemical Substances 2.4.3 The Technical Guidance Document 2.4.4 The Precautionary Principle 2.4.4.1 What Is the Precautionary Principle? 2.4.4.2 When and How Should the Precautionary Principle Be Applied? 2.4.4.3 Remaining Problems with the Precautionary Principle 2.4.5 Prospective Risk Assessment for Saltwater Environments in the EU 2.4.5.1 Perceived Problems with Marine Risk Assessment in the EU 2.4.5.2 Estimating a Saltwater PNEC 2.4.5.3 Factors Potentially Affecting Correlations between Freshwater and Saltwater Toxicity Data 2.4.5.4 Saltwater Species Sensitivity Distributions 2.5 Retrospective Risk Assessments 2.5.1 The Dangerous Substances Directive and Other Marine Regulations 2.5.2 The Water Framework Directive 2.5.2.1 Principles of the Water Framework Directive 2 ©2002 CRC Press LLC 2.5.2.2 What Is “Good Status” for Marine Waters? 2.5.2.3 Direct Biological Assessment of the Tees Estuary — A Case Study 2.6 Conclusions Acknowledgments References 2.1 INTRODUCTION The European Union (EU) is neither a national legislature, such as the U.S. federal government, nor an international organization, such as the United Nations (UN). European Union members are completely sovereign states that have surrendered some law-making and enforcing powers, so that the powers of the EU go consid- erably beyond those of international organizations such as the UN, but not as far as those of the U.S. government. 1 This chapter briefly describes the political structure of the EU and the environmental regulations that have emerged from this structure. Much of the environmental legislation from the EU has been fragmen- tary, addressing single issues, or has focused on freshwater environments. There is now an increasing move toward an integrated approach to the environment, epitomized by the Water Framework Directive (WFD). Marine and estuarine waters, although not entirely ignored by earlier legislation, are now explicitly considered within the WFD. However, there is a recurrent practical problem. What are the fate, behavior, and toxicity of the many thousands of chemicals used in the EU for which we have little or no data for saltwater species? Must we test every chemical and every taxonomic group, or can we extrapolate between chem- icals, biological species, and ecosystems? This is currently an important debate within the EU, with some environmental regulators proposing that toxicity to marine species must always be tested, while others believe that toxicity to fresh- water species can be used to predict toxicity to marine species. There is also a recurring conceptual problem in most EU legislation. How can we define “high ecological status” for estuaries and coastal waters when we have difficulties in defining this for freshwater systems that have been more intensively studied? This chapter discusses these problems and provides some examples of ways in which they are being addressed by European researchers. 2.2 LEGISLATIVE PROCEDURE IN THE EUROPEAN UNION After the devastation of two World Wars in the space of just over 30 years, the leaders of continental Europe finally recognized that new political structures were needed to avoid further bloodshed. The 1957 Treaty of Rome was a tool to establish a common market, expand economic activity, promote living standards, and, perhaps most importantly, encourage political stability in Western Europe. The European Community formed by the Treaty of Rome unified the European Economic Com- munity, the European Atomic Energy Community, and the European Coal and Steel ©2002 CRC Press LLC Community. 2 This common market has expanded in both membership and aims over the decades since its formation. The postwar organization, set up primarily for economic and security reasons, has now evolved into the EU, a body with legislative powers that penetrate deeply into the daily life of every member state. Currently, the EU has 15 member states: Belgium, Luxembourg, the Netherlands, France, Germany, Italy, the United Kingdom, Ireland, Denmark, Greece, Spain, Portugal, Finland, Sweden, and Austria. More countries, principally from the former Soviet bloc, are likely to join the EU in the near future, with “Accession States” such as Poland due to join within the next 5 years. Four major EU institutions are responsible for legislation under the Treaty of Rome: the European Commission, European Parliament, Council of Ministers, and European Court. The Commission is the supreme EU executive, comprising 20 independent members appointed by individual member states. Members of the Commission are charged with operating in the interests of the community as a whole, not as national representatives. Each commissioner has responsibility for an area of community policy, which includes a commissioner for the environment, and their main function is to propose EU legislation. The Commission civil servants are divided among 25 different directorates that report to the Council of Ministers. The most important directorates involved in chemicals and environmental legislation are Directorate General (DG) III (Enterprise), DGVI (Agriculture), and DG XI (Envi- ronment). 2 Legislation generally emerges from the commission in the form of pro- posals for Directives. Once accepted by the Council and Parliament these are usually enforceable across all member states and are the main basis for statutory controls in EU environmental legislation. Directives empower the commission to define objectives, standards, and procedures, but allow member states flexibility in imple- mentation, so they can use their own national legislative processes. A Directive is therefore binding about the ends to be achieved, but leaves the means to member states. This has led to a variety of national methods for achieving environmental objectives as defined by Directives. The European Parliament was originally a consultative and advisory body, but is gaining increasing legislative powers, and is the only part of the EU legislature that is truly open to public scrutiny. Its function is to assess proposals for legislation by commenting on the Commission’s proposals. It also has some control over EU budgets, and the Council of Ministers must consult with the European Parliament over all new legislation. Increasingly, the Parliament has to agree to legislation as part of a “co-decision” (Council and Parliament). The Council of Ministers comprises government ministers from each member state and is the primary decision-making body in the EU. Its main function is to consider proposals from the Commission. Voting in the Council must be unanimous to be accepted on some issues (e.g., tax and defense), although a form of majority voting is now frequently used in other areas. The main function of the European Court is to interpret and apply all com- munity law. All judgments are binding and member states must ensure that national legislation is compatible with EU law. This then is the political framework that currently generates Europe-wide envi- ronmental policy and regulation. These policies generally comply with several prin- ciples that have been agreed upon by member states. ©2002 CRC Press LLC 2.3 PRINCIPLES OF CHEMICAL RISK ASSESSMENT IN THE EU Environmental laws in the individual countries of the European Union date to the 1800s, with the Rivers Pollution Prevention Act 1876 in the United Kingdom. 1 Over the following 90 years, several pieces of environmental legislation were enacted in various European countries with, arguably, only limited success. In the 1960s, widespread public concern about environmental issues was aroused in Europe as well as in North America by books such as Rachel Carson’s Silent Spring, and by several dramatic environmental accidents, particularly oil spills at sea. As a result of this, the environment became accepted as a serious political issue in the 1970s. In 1972, the year of the first UN Conference on the Environment, the European Community established fundamental principles that were to guide future policies for a wide range of environmental problems. These principles have been carried forward and enhanced in subsequent programs. 1,3 The more familiar principles are as follows: • Polluters should pay for damage that they cause (the “Polluter Pays Principle”); • Prevention of environmental damage is more cost-effective and environ- mentally beneficial than dependence on subsequent remediation (“preven- tion is better than cure”); • Environmental action should be taken at the most appropriate level (regional, national, or international: the “Subsidiarity Principle”); and • Action to prevent environmental damage can be taken in the absence of complete scientific knowledge (the much-debated “Precautionary Princi- ple” discussed later in Section 2.4.4). Aquatic environmental legislation adopted by the EU over the past two decades and relevant to this chapter can be divided into four broad categories: 1. Directives that impose rules and obligations on the supply of chemicals; 2. Directives that try to limit or prohibit discharges of dangerous substances into waters by industrial plants; 3. Directives and regulations that set water quality objectives for various uses; and 4. Geographically specific regulations on marine pollution to help protect the North, Baltic, and Mediterranean Seas. Before turning to ways in which the EU performs chemical risk assessments, it is important to distinguish between the two main types of risk assessment that may be performed. Chemical risk assessments for any environmental medium may be prospective or retrospective. 4 Prospective, or predictive, risk assessments are usually performed to assess the future, usually generic, risks from releases of chemicals into the environment. In contrast, retrospective risk assessments are performed when sites have been contaminated historically, and such assessments are therefore necessarily site specific. Prospective risk assessments tend to have received more attention at ©2002 CRC Press LLC the Commission because of the need to remove trade barriers through harmonization of all aspects of product testing. However, individual member states in the EU spend considerable resources on emission control and environmental monitoring within retrospective risk assessment frameworks. Section 2.4 discusses ways the EU addresses prospective risk assessment, and Section 2.5 looks at ways retrospective risk is assessed. Throughout both of these sections the reader should bear in mind that the term risk assessment is not used in the strict sense of “the probability of an adverse event occurring.” Instead, and in common with much of the rest of the world, the term is used rather loosely in the EU to cover regulatory processes that address chemical hazards and concentrations of chemicals in the environment, without necessarily combining them probabilistically. 2.4. PROSPECTIVE RISK ASSESSMENT IN THE EU 2.4.1 N EW C HEMICAL S UBSTANCES The 1967 Council Directive 67/548 on the Classification, Packaging and Labelling of Dangerous Substances was enacted to classify chemicals for dangerous properties, thereby ensuring adequate labeling at the point of supply. The approach taken was to use hazard labeling for substances over a certain threshold volume when these were supplied in member states. This was so EU citizens would be aware of any dangers if the chemical were released deliberately or accidentally, but also so that a market without trade barriers could be established in the EU. However, it was only with the sixth amendment to Council Directive 67/548 in 1979 (79/631/EEC) that a series of biological, physical, and chemical tests became a requirement before new chemicals could be marketed. The seventh amendment (92/32/EEC) in 1992 intro- duced hazard classification for the environment, and risk assessment was introduced through a daughter Directive (93/67/EEC) in 1993. The amount and type of information required for each chemical depends on its production volume. Testing within this scheme comprises three levels. Level 0 (or base level) is for production volumes of up to 10 tonnes/year and requires short- term toxicity data for the invertebrate Daphnia magna and for fish (e.g., rainbow trout, Oncorhynchus mykiss ). Algal growth inhibition tests were mandated by the seventh amendment in 1992. For higher production volumes of up to 1000 tonnes/year (Level 1), and greater than 1000 tonnes/year (Level 2), more thorough toxicological testing is required, such as long-term toxicity studies with Daphnia and freshwater fish. Marketing and environmental safety of plant protection products (pesticides) was treated separately in the 1991 Plant Protection Products Directive (PPPD, EU Directive 91/414/EEC). Many of the data requirements for the PPPD are similar to those required for new substances, e.g., toxicity profiles for fish, invertebrates, and algae. A deterministic risk assessment of product impacts on humans and wildlife must be carried out for both new and existing pesticides. This combines hazard assessments with rather simple environmental fate models to estimate toxicity expo- sure ratios. There is also a directive covering biocides, which contains many similar elements to the PPPD, including deterministic risk assessments. ©2002 CRC Press LLC 2.4.2 E XISTING C HEMICAL S UBSTANCES Of course, there are many thousands of existing substances in use within the EU that were never subject to testing under the Directives described above. Because of this, Council Regulation 793/93 on Existing Chemicals was developed to harmonize the different national systems for risk assessment within the member states. The regulation came into effect in 1993 and covers about 100,000 chemical substances that are thought to be used in the EU. Under this regulation, information must be provided to the Commission by industry for substances produced or imported into the EU in quantities over 1000 tonnes/year. The information col- lected by the Commission is then used for setting priorities on the basis of a preliminary risk assessment. The priority substances are assessed by distributing them among member states for evaluation by national experts. The experts in these member states can ask for additional information from manufacturers and importers if the substance is sus- pected to be dangerous. On the basis of these data and more refined risk assessments, a substance may be deemed as dangerous by the Commission and be banned or restricted. The risk assessment methodology that should be used is described in the Technical Guidance Document, 5 described in more detail below. The EU existing substances regulations are coordinated with the Organisation for Economic Coop- eration and Development (OECD) Chemicals Program. The OECD is the main coordinating body for the development of new ecotoxicity testing strategies and agrees on tests that then become mandatory data requirements in EU Directives. 2.4.3 T HE T ECHNICAL G UIDANCE D OCUMENT EU directives and regulations generally state some of the basic principles of risk assessment for new and existing chemicals, but lack detail. Because of this, the European Commission, the member states, and the European chemical industries produced a Technical Guidance Document (TGD) on risk assessment. This rather lengthy set of guidelines condenses to a series of deterministic equations for esti- mating chemical hazard and exposure in various environmental compartments, and the comparison of these using a quotient approach. A predicted environmental concentration (PEC) is estimated from data or models on chemical emissions and distribution in the environment. A predicted no effect concentration (PNEC) is estimated by adding a safety factor, usually 10, 100, or 1000 depending on the level of uncertainty and availability of data, to ecotoxicity data, although for marine and estuarine systems, a further assessment factor of 10,000 has been suggested. 11 In the risk characterization phase, PEC and PNEC values are compared to decide whether there is a risk from a substance or whether further information and testing are needed to refine the risk quotients. The TGD requires the calculation of PEC/PNEC ratios for aquatic eco- systems, terrestrial ecosystems, sediment ecosystems, top predators, and microbes in sewage treatment systems. The TGD has also been implemented in a computerized system: the European Union System for the Evaluation of Substances (EUSES), which includes algorithms for the deterministic equations plus conservative default values that can be used in the absence of data. This means that EUSES calculations ©2002 CRC Press LLC can be made with limited data, such as the base set for new chemicals, 6 four physicochemical properties of the substance under consideration, and the tonnage that is likely to be present in the EU. 7 PEC values are derived for local as well as regional situations, each based on a number of time- and scale-specific emission characteristics. As a consequence, several different exposure scenarios are estimated, leading to different PEC/PNEC ratios, some of which may exceed a threshold of 1 and some of which may not. If the PEC/PNEC ratio is greater than 1, the substance is considered to be of concern and further action must be taken. This may be through consulting with industry to see whether additional data on exposure or toxicity can be obtained to refine the risk assessment. If the PEC/PNEC ratio remains above 1 after the generation of further information, risk reduction measures will be imposed. This risk assessment procedure should be performed within the spirit of the Precautionary Principle. 2.4.4 T HE P RECAUTIONARY P RINCIPLE 2.4.4.1 What Is the Precautionary Principle? The conventional form of the Precautionary Principle states: “preventative action must be taken when there is reason to believe that harm is likely to be caused, even when there is no conclusive evidence to link cause with effect: if the likely conse- quences of inaction are high, one should initiate action even if there is scientific uncertainty.” 8 This principle has been increasingly adopted in Europe over recent years, as in the 1987 Ministerial Declaration on the North Sea, and the 1992 Convention for the Protection of the Marine Environment of the North East Atlantic. Although the European Commission has embraced the Precautionary Principle in its approach to environmental regulation, it recently felt that there was a need to explain exactly what it meant by precaution . This is because of criticisms from scientists that the Precautionary Principle, as defined by some environmentalists, seems to be an illogical tool with no place in science-based decision making. On the other hand, the commission has suffered criticism from environmentalists that it was acting in an insufficiently precautionary manner by following a slow risk assessment process when there was a priori evidence of damage caused by the substance being assessed. According to the Commission, the Precautionary Principle should be considered as part of a structured approach to the analysis of risk. It assumes that the potentially dangerous effects of a chemical substance have been identified through scientific procedures, but scientific evaluation does not allow the risk to be quantified with sufficient certainty. 2.4.4.2 When and How Should the Precautionary Principle Be Applied? The Commission wishes to apply the Precautionary Principle when there is evi- dence for a potential risk, even if this risk cannot be fully demonstrated or quantified because of insufficient scientific data. It should be triggered when ©2002 CRC Press LLC scientific evaluation has shown a potential danger, and efforts have been made to reduce scientific uncertainty and fill gaps in knowledge that could allow a scien- tifically based decision to be made. When the Precautionary Principle is invoked, the view of the Commission is that measures should be: • Proportional (measures should be chosen to provide a specific level of protection to humans or wildlife); • Nondiscriminatory (comparable situations should not be treated differ- ently, and different situations should not be treated in the same way, unless there are objective grounds for doing so); • Consistent (measures taken should be of a comparable scope and nature to those already taken in equivalent areas); • Cognizant of costs and benefits (the overall cost of action and lack of action should be compared, in both the long and short term); • Subject to review (measures based on the Precautionary Principle should be maintained so long as scientific information is incomplete or inconclu- sive, and the risk is still considered too high to be imposed on society); and • Capable of assigning responsibility for producing the scientific evidence necessary for altering conclusions based upon the Precautionary Principle (for chemicals this will usually be the company that wishes to manufacture or market the chemicals). 2.4.4.3 Remaining Problems with the Precautionary Principle Despite the Commission’s valiant attempts to define the Precautionary Principle accurately and sensibly, and thereby defuse arguments about its applicability, these arguments still remain and are likely to gather force whenever a decision about a potentially dangerous chemical needs to be made. Santillo et al. 10 summarize the views of many European environmentalists who believe that the spirit of the Pre- cautionary Principle is not being implemented fully in the EU. The main disagree- ment appears to be over when the Precautionary Principle should be invoked, rather than over whether it should be invoked. Santillo et al. 10 argue that too often a decision to regulate a substance is deferred until the results of further research become available. In their view this approach is based upon two flawed assumptions: 1. That greater understanding of the system under study will always result from further scientific study, allowing risks to be more accurately defined and quantified; and 2. That risks (usually commercial) arising from precautionary action taken now are greater than the currently undefined risks (usually human health or environmental) of inaction until the results of further investigations become available. Of relevance to the subject of this book is the Santillo et al. view that the Precautionary Principle is in opposition to approaches based upon risk assessment. ©2002 CRC Press LLC This is because of the inherent uncertainty of risk assessment approaches based upon limited data, usually from laboratory tests on only a few species, and the use of arbitrary safety factors. The views of environmentalists such as Santillo and co- workers arguably carry more weight in Europe than in North America, because Green political parties have over the past decade been quite successful in European elections. However, it is still not entirely clear what factors should, in their view, trigger the invocation of the Precautionary Principle and, perhaps more importantly, what types of scientific evidence would allow such a decision to be reversed. 2.4.5 P ROSPECTIVE R ISK A SSESSMENT FOR S ALTWATER E NVIRONMENTS IN THE EU 2.4.5.1 Perceived Problems with Marine Risk Assessment in the EU Despite the theme of this book, readers of this chapter will so far have encountered rather few references to coastal or estuarine systems. This is in part because there are problems in using the approaches described in the TGD for saltwater prospective risk assessments, as that document deals mostly with freshwater and terrestrial habitats. For example, the TGD provides guidance for the calculation of local PECs for several different environmental compartments. However, releases into coastal or estuarine waters are not specifically considered. There is a view, in Europe at least, that experience of risk assessment in the marine environment is insufficient to give sound practical guidance in the TGD. There are fears that large dilution factors, low biodegradation rates, and possible long-term exposure with consequent prolonged effects on saltwater organisms may produce quite different scenarios in marine systems when compared with freshwater systems. 11 Furthermore, information on releases to saltwater systems is scarce for some substances, making it difficult to estimate a PEC. Despite this, modifications of EUSES to permit its use for risk assessment for the marine environment have been proposed. 12 These are being developed by the OSPAR (Oslo Paris Commission) DYNAMEC group, which has also developed a modification of the COMMPS (Combined Monitoring-based and Modelling-based Priority Setting) approach to prioritize those substances for which marine risk assessment is urgently required. The remaining part of this section outlines some of the problems that researchers and environmental regulators in the EU currently have in attempting to estimate the toxicity of chemicals to saltwater biota. 2.4.5.2 Estimating a Saltwater PNEC A key step in chemical risk assessment is the estimation of a PNEC. In practice, risk assessors must extrapolate from a relatively small data set, usually containing data from fewer than ten species, to estimate the PNEC. 13 This is normally achieved by applying safety factors to the lowest effects concentrations from reliable studies, although species sensitivity distribution models are considered by some regulatory authorities. 14 There are generally fewer data available for saltwater species than for ©2002 CRC Press LLC freshwater species, especially for organic compounds, 15 largely because there are fewer standard test methods in the EU for saltwater species and because aquatic risk assessments have traditionally tended to focus on freshwater systems. Because of this paucity of data, many saltwater PNECs rely on extrapolations from freshwater data. This surrogate approach assumes that freshwater species respond like marine species, and that the distributions of freshwater and saltwater species sensitivities are similar — assumptions that are only now being addressed in current research programs. 2.4.5.3 Factors Potentially Affecting Correlations between Freshwater and Saltwater Toxicity Data The degree of correlation between freshwater and saltwater toxicity data could potentially be influenced by two main factors. 1. Biological differences between saltwater and freshwater animals . For example, saltwater and freshwater invertebrates differ in their physiology, phylogeny, and life histories, which has implications for their sensitivity to toxicants. Most important is the greater phylogenetic diversity in marine environments compared with freshwater environments, with some com- ponents of marine assemblages absent from fresh waters (e.g., Echino- dermata, Cephalopoda, and Ctenophora). Conversely, freshwater data sets may of course include insects, higher plants, and amphibians that are generally absent from the marine environment. Differences in physiology may also be responsible for differences in the uptake and toxicity of certain chemicals to freshwater and marine crustaceans and fish. 16–19 Many more saltwater species have pelagic planktonic stages that can exhibit markedly different sensitivities to chemicals. 20,21 Finally, reproductive strategies of marine invertebrates are less responsive to changing environmental con- ditions, which might lead to differences in sensitivity to toxicants. 22 Some studies show good correlations between the sensitivities of particular freshwater and saltwater invertebrates, fish, and algae. 26,27 After reviewing the European Chemical Industry ECETOC Aquatic Toxicity Database, Hutchinson et al. 22 concluded that freshwater to saltwater toxicity could be predicted with greater confidence for fish than for invertebrates. 2. Differences in chemical behavior, especially speciation and bioavailabil- ity . Differences in bioavailability in fresh and salt waters can be expected for a number of inorganic substances and can have a major impact on toxicity. 23 When reviewing toxicity data, it is important to recognize the possible differences between total concentrations of a substance and con- centrations that are bioavailable or are biologically active. 24 Differences in solubility of organic chemicals between fresh water and salt water can influence partitioning between water and tissues, with the effect that differences in uptake or the time required to attain a critical body burden may occur. Such differences are often acknowledged in water quality standards (which may be regarded as PNECs), with different standards for salt and fresh waters. [...]... 12 Zinc FW 28 SW 12 1. 027 6 0.844 3.438 4.093 0.564 0.464 0.957 0.986 1.898 2. 409 79.07 25 6.45 75.97 25 0.67 1.094 0.649 2. 720 2. 767 0.6 02 0.357 0.976 0.990 1. 423 1.456 28 .58 28 .58 23 .81 26 .51 0.967 0.654 4.857 4.549 0.5 32 0.359 0.987 0.980 3.347 3.387 22 23.31 24 37.81 1577.69 24 15.65 0.91 0.959 0.587 4.153 4.178 0. 528 0. 323 0.985 0.975 2. 675 2. 927 473.15 845 .28 457. 12 8 32. 28 0.56 0. 520 0 .25 9 3.379 2. 6 42. .. 0. 729 3.609 4.460 0.4 92 0.401 0.958 0.984 2. 493 3 .20 7 311.17 1610.66 301. 12 15 92. 58 0.19 28 6 0. 520 0.863 4.893 4.5 72 0 .28 6 0.475 0.987 0. 926 3.815 3 .22 7 6531.30 1686.55 6513.54 16 82. 97 3.87 42 31 1 .28 4 1.339 2. 960 3.083 0.706 0.737 0.989 0.9 72 0.3 52 1.075 2. 25 11.89 nc 0.005 0.19 25 8 0.778 0.666 1.760 0.837 0. 428 0.367 0.9 62 0.969 0.470 –0.358 2. 95 0.44 2. 68 0. 42 6.7 90 19 1 .22 6 1.566 0. 928 0.8 72. .. 0.496 0. 523 0.9 82 0.966 –0 .23 0 –0.104 0.589 0.787 0.376 0. 622 0.75 76 25 1.3 62 1.506 1 .23 1 0.604 0.749 0.578 0.9 52 0.949 –0.879 2. 1 42 0.1 32 0.007 0.051 0.006 18.85 11 6 1.117 0.1 82 3 .26 1 3.880 0.614 0.100 0.886 0.971 1.334 3.510 97 35 1.049 1.339 2. 309 1.909 0.577 0.670 0.9 92 0.957 0 .26 1 –0 .29 6 1. 824 0.506 0.658 0.495 3.60 150 28 1.377 1 .23 1 2. 767 2. 287 0.757 0.677 0.984 0.9 82 –0.036 0. 124 0. 92 1.33... 0.56 0. 520 0 .25 9 3.379 2. 6 42 0 .29 6 0.1 42 0.991 0.938 2. 423 2. 149 26 4.85 140.93 26 1.15 140.47 1.88 0.555 0.700 4.838 4.767 0.305 0.385 0.987 0.980 3.764 3.085 5807.64 121 6.19 5791.86 120 9.53 4.78 0. 321 0. 321 4.963 4.831 0.118 0.177 0.974 0.854 4.4 72 4.139 29 648.34 137 72. 10 29 645.56 13767.83 2. 15 1.0 92 0.538 3 .28 4 3.513 0.600 0 .29 6 0.983 0.980 1.351 2. 458 22 .44 28 7.08 15.08 28 4.86 FW = freshwater, SW... –1. 422 –1.816 0.038 0.015 0.001 0.014 2. 53 15 7 1.139 0.887 3.0 02 4 .20 4 0. 626 0.488 0.976 0.930 0.66 1.913 4.57 81.85 2. 25 78.34 0.056 42 24 1.014 0.6 02 2.368 2. 333 0.558 0.331 0.974 0.9 92 0. 521 1.091 3. 32 12. 33 2. 09 11.53 0 .27 Chemical Ammonia FW SW Benzene FW SW Cadmium FW SW Chlordane FW SW Chlorpyrifos FW SW Chromium FW SW Copper FW SW n HC5 (␮g/l) Lower 95% CI (␮g/l) Ratio FW:SW HC5 (continued) 20 02. .. 15 13 1.150 0.803 2. 2 42 2 .22 3 0.6 32 0.4 42 0.983 0.958 –0.034 0.569 0. 925 3.707 0.611 3.363 0 .25 Chemical Dichloroaniline FW SW Dieldrin FW SW Endosulfan FW SW Lead FW SW Lindane FW SW Malathion FW SW Mercury FW SW n 20 02 CRC Press LLC 21 .58 323 5.94 19.41 323 4.96 0.006 Nickel FW 11 SW 9 Pentachlorophenol FW 80 SW 30 Phenol FW 144 SW 28 Potassium dichromate FW 79 SW 33 Thiobenocarb FW 28 SW 6 Toluene... 671, 1999 8 Eduljee, G.H., Trends in risk assessment and risk management, Sci Total Environ., 24 9, 13, 20 00 9 European Commission, Precautionary Principle communique of 02/ 02/ 2000 COM (20 00)1, 20 00 10 Santillo, D et al., The Precautionary Principle: protecting against failures of scientific method and risk assessment Mar Pollut Bull., 36, 939, 1998 11 BUA Project Group Assessment criteria for the marine... FW:SW HC5 (continued) 20 02 CRC Press LLC TABLE 2. 1 (CONTINUED) Summary Statistics from Log-Logistic Species Sensitivity Distributions Generated with Data on the Toxicity of 22 Chemicals to Freshwater and Saltwater Organisms STD (log) ␣ ␤ r2 HC5 (log ␮g/l) HC5 (␮g/l) Lower 95% CI (␮g/l) Ratio FW:SW HC5 14 11 0.959 0.587 3.497 3.717 0.539 0 .26 9 0.960 0.941 2. 398 2. 6 72 250.04 469.89 24 4.71 467.11 0.53 58... prospective risk assessment of chemicals still depends largely on PEC/PNEC approaches, but there is increasing research activity and regulatory interest in the use of species sensitivity distributions and probabilistic risk assessment approaches There is also a recognition that coastal and estuarine environments have been neglected during the development of EU prospective risk assessment strategies, and that... Biology, 2nd ed., Taylor & Francis, London, 1996 4 Suter, G.W II, Ecological Risk Assessment, Lewis Publishers, Boca Raton, FL, 1993 5 European Union, Technical Guidance Document on Risk Assessment for New and Existing Substances, Part 2, Environmental Risk Assessment Office for Official Publications of the European Community, Luxembourg, 1996 6 Jager, T and de Bruijn, J.H.M., The EU-TDG for new and existing . 2. 287 0.677 0.9 82 0. 124 1.33 0.767 0.69 Mercury FW 15 1.150 2. 2 42 0.6 32 0.983 –0.034 0. 925 0.611 SW 13 0.803 2. 223 0.4 42 0.958 0.569 3.707 3.363 0 .25 20 02 CRC Press LLC Nickel FW 11 1. 027 6. 0.986 2. 409 25 6.45 25 0.67 0.31 Pentachlorophenol FW 80 1.094 2. 720 0.6 02 0.976 1. 423 28 .58 23 .81 SW 30 0.649 2. 767 0.357 0.990 1.456 28 .58 26 .51 1 Phenol FW 144 0.967 4.857 0.5 32 0.987 3.347 22 23.31. 0. 926 3 .22 7 1686.55 16 82. 97 3.87 Cadmium FW 42 1 .28 4 2. 960 0.706 0.989 0.3 52 2 .25 nc SW 31 1.339 3.083 0.737 0.9 72 1.075 11.89 0.005 0.19 Chlordane FW 25 0.778 1.760 0. 428 0.9 62 0.470 2. 95 2. 68 SW