ECOTOXICOLOGY
AND
ENVIRONMENTAL
SAFETY
New Challenges
3,116-121
(1979)
to Ecotoxicologyl
J. SMEETS Commission
of the European
Communities, Received
I. LEGISLATIVE
200, Rue de la Loi. August
1049 Bruxelles,
Belgium
16, 1978
CONSIDERATIONS
The current international development legislation on chemical substances leads to new dimensions in operational ecotoxicology and research. Several countries, such as Japan, the United States, Canada, France, Sweden, and Switzerland, have already adopted legislative measurements in order to protect man and his environment against the risks caused by the use of hazardous chemical substances and mixtures. Others, like the United Kingdom, the European Community, and the Federal Republic of Germany, are in an advanced stage of preparation. It is not the aim of this presentation to discuss the many regulatory aspects involved, nor to compare in detail the contents, the field of application, the administrative procedures or the implications of these regulations on the world market of chemical substances and mixtures. I simply wish to draw the attention of scientists and experts to some points of major interest in order to orientate and stimulate work to be accomplished in a few years. As will be shown, there is a great need! Summarizing, it can be said that mandatory rules are established or envisaged to prevent the marketing of chemical substances or mixtures known to be dangerous or to present an unreasonable risk, in one way or another, to man or his environment. The general and wide-ranging coverage of these rules must be stressed; the regulatory concepts are no longer limited to certain products or groups of chemicals, such as pesticides, pharmaceuticals, food additives, etc. Some countries limit the field of application only to new chemicals, substances which have not been marketed before. Others, like the Toxic Substances Control Act (TSCA) of the USA covers all existing as well as new chemical substances. Control is often reflected through an obligatory notification system to a competent authority of the central government by the producer or importer of the substances in question. This notification requires information on the results of research and tests which characterize and identify the properties and the possible risks of the substances. The marketing or production of an incriminated product can be forbidden on the basis of this information. This characterization and identification concerns physical and chemical parameters and a study of the possible toxicological and ecotoxicological risks. Some legislations, such as the Japanese law and the proposed European Community directive, indicate, in the 1 Paper presented at the Environmental Chemicals.”
meeting August
0147-6513/79/020116-06$02.00/O Copyright All nghfs
0 1979 by Academic Press. Inc. of reproduction m any form reserved.
on “Scientific Basis 16-18, 1978, Vienna. 116
for
the
Ecotoxicological
Assessment
of
NEW
CHALLENGES
TO ECOTOXICOLOGY
117
notification scheme, the tests to be performed. Others leave the judgment for the tests to the producer or importer; TSCA foresees a guidance for testing, the draft of this guidance being now available. It is evident that these legislative measures require an important effort of man and will place important financial charges on the budget of the manufacturer of chemicals. The cost of testing might be considerable. On the other hand, this development is not surprising considering some very doubtful experiences with chemicals in the past. A major characteristic of this legislation is that it covers risks for man as well as for the total environment. Reference will be made among others in the following to the proposed directive of the Commission of the European Communities which was submitted to the Council of Ministers in 1976 and is now under discussion at policy level in expert groups. This directive envisages the harmonization of legislation with respect to chemical substances in the nine Common Market countries to avoid unacceptable trade barriers between the member states. Such a harmonization at the worldwide level is, for the time being, a utopia. In the framework of OECD important work is going on, which represents a first step in the direction of harmonizing policies in this field on a larger scale than the Community’s. II. NOTIFICATION The proposed Community Directive foresees a notification procedure providing a technical dossier, to be submitted by the producer or importer following given guidelines. This dossier should “supply the information necessary to evaluate the foreseeable immediate or differed risks, which the new substances may entail for man and the environment.” In Annex VII to the proposed Directive, the so-called “base-set” of notifiable information is summarized. This basic information contains six chapters: 1. The identity of the substance, i.e., its chemical name, its empirical and structural formulae, and its composition, including impurities and methods of detection and determination; 2. Information on the substance-proposed uses, estimated production and imports, field of application, etc. ; 3. The physico-chemical properties, i.e., melting and boiling point, relative density, water and fat solubility, partition coefficient, etc.; 4. Toxicological studies, i.e., acute toxicity, subacute toxicity, and mutagenic and carcinogenic effects; 5. Ecotoxicologicaf studies, i.e., acute lethal concentrations for fish and daphnia, biotic and abiotic degradation tests; and 6. Means of Neutralizing the substance for industry, craft trades, and the public at large. The required tests must be conducted according to methods recognized by existing good laboratory practice and recommended by the competent international bodies where such recommendations exist. For the time being, only the Japanese law recognizes standard tests for degradability, bioaccumulation, and toxicity. In the European Community
118
J. SMEETS
directive, only the nature of the information to be notified is indicated, not the methodology to be used. Sometimes the requirements for more detailed informations are defined, e.g., the information on acute toxicity should concern both male and female rats and one of the tests should be made orally. For the degradation test, the BOD/COD ration is the minimum requirement. Other examples could also be given. The notification dossier must also present the competent authority with a declaration on the unfavorable effects of the various uses and make proposals for any measure relating to thecondition of use, which is recommended to limit these. unfavorable effects. One of the basic problems of a notification scheme is the introduction of a certain flexibility in testing. The diversity of chemical substances and products manufactured and the wide range of their potential effects on human health and environment make it impossible to require universally applicable testing for all chemical substances. A certain flexibility should be considered. But how flexible should the system be and what are the criteria for controlling flexibility without allowing the system to become arbitrary? Manpower and cost are particularly important factors to be taken in consideration, on the one hand, in relation to the quantity of the chemical in question to be produced or imported and, on the other hand, considering the possible harmfulness of the product. Some legislators have considered this problem thoroughly; they propose or will apply a so-called hierarchical test scheme, also referred to as step-sequence testing or, to use the common German expression, “Stufenplan.” Following a defined trigger mechanism a certain degree of automaticity for step-sequential tests has been developed. The first step is the information to be considered in the so-called base-set dossier: this mechanism can be expressed in yearly production quantities or in accumulated import quantities. In relation herewith the next test steps should be performed, if preceding tests demonstrate the presence of risks. The Japanese law is a good example of this procedure. Thefirst test step to be performed is biodegradability testing; the second test step is bioaccumulation, but this step is only required ifthe chemical substance has proved with the first test to have a low degradability. The third test step, fish toxicity testing, is required only for a substance which has proved during the second test to be highly bioaccumulative. In fact, the Japanese law only forsees information on these three tests in its notification scheme: The factual data of PCB for degradability, accumulation, and toxicity are used as quantitative references. Another problem of importance is the definition of risk or unfavorable effects of certain parameters. Certainly, past experience in toxicology and ecotoxicology has made it possible to establish certain guidelines for experts and competent authorities. However, much more expertise, experience, and objective criteria will be needed for the application of this legislation to avoid decisions with an arbitrary character. III. ECOTOXICOLOGICAL TESTING Concerning the contents of the notification scheme and the different parameters to be considered, the state of the art can be summarized as follows.
NEW CHALLENGES
TO ECOTOXICOLOGY
119
In general, there is good agreement on the definitions and methodology used to characterize physico-chemical properties of a substance. The parameters concerned are well known and many standardized methods are available. This is the result of many years of experience. It is not surprising that this state has not yet been reached in a much younger science, namely, toxicology, notwithstanding its great progress and developments the last decennium. Still much work has to be performed to arrive on international levels upon generally accepted methods to evaluate the risks of chemical substances for man. An intermediate phase must thoroughly be consideredin this context, i.e., the improvement of the comparability of toxicological data submitted by different laboratories and harmonization of the applied testing methodologies. In the European Community, an interlaboratory comparison study has been organized for acute toxicity testing. More than 60 experienced laboratories have participated. It appears that the results of this test are far from comparable among laboratories and that the methods used are far from harmonized. In ecotoxicology the drawback is even more important, not by a lack of research or goodwill, but more by a lack of imperative pressure. Until now, the need for a systematic approach was less urgent; the legislative pressure was less strong than in toxicology. Until recently, toxicological research was considered as the major and often the only prerequisite to judge the use and applications of a chemical product. Ecotoxicological studies were only required for specific products, compounds, or situations. Therefore great experience has been gained with work performed in radioecology and with respect to the use of pesticides, etc. At the European level there is still some controversy with respect to the notification scheme on the question as to whether or not environmental testing, like toxicological testing, should be mandatory for the base-set dossier. Some feel that environmental testing should not be part of the base-set dossier but should be included in subsequent test steps. They bear in mind, among others, the test costs. This point of view seems to be unrealistic if legislation requires the control of chemical substances to protect the environment as well as man. As long as insufficient data are available or experience is gained, at least some well-chosen environmental tests should be part of the base-set dossier. We must recognize that a choice is necessary since the number of susceptible media and matrices to be considered for environmental testing is enormous. On.the other hand, the currently available information on bioindicators, critical pathways, critical biota or groups of biota, and ways of transfer is very limited; such a choice will still have a certain arbitrary character. Nevertheless, the field has to be covered in an unbiased way. Another aspect is the difference in priorities given to aquatic and terrestrial ecosystems, the latter often considered of secondary importance. It is true that there is a greater risk from aquatic pollutants, through their direct or indirect dispersion in aquatic ecosystems, than for pollutants in terrestrial ecosystems. However, here again, if one envisages protection of the environment, one must consider both ecosystems. The proposed directive of the Commission does not foresee tests for studying toxicological effects of chemical substances on birds, higher or lower plants, and microorganisms or concerning adsorption or desorption
120
J. SMEETS
in soil, etc., but only considers the aquatic environment, i.e., testing concerning lethal concentrations for fish and daphniae. Since there was a general feeling on the expert level that more consideration should be given to the testing of terrestrial ecotoxicological matrices studies for routine base terrestrial ecotoxicological testing are now underway, using of the earthworm (Lumbricus terrestris), the honeybee (Apis melliferu), and the Japanese quail (Coturnix coturnix). The recently published preliminary draf guidance for premanufacture notification in the framework of USA-TSCA calls for manufacturers’ notifications including acute and clinic effects on terrestrial and on aquatic ecosystems and their conponents. The initial responsibility for selecting and conducting a testing scheme adequate to support such an evaluation must be borne by the manufacturer. In this draft guidance the following ecological effects and tests organisms have been selected: -Microbial effects: Cellulose decomposition, nitrogen transformation, sulfate reduction test, respiration (CO, evolution) test; -Plant effect tests: Algal inhibition, Lemna inhibition, seed germination and early growth; -Animal effect tests: Duphnia life cycle, fish acute toxicity, quail dietary LC50, fish bioconcentration test. Apart from these fundamental aspects, there is a need on a national as well as an international level to improve the quality of test results and to render the data from different laboratories more comparable. The Commission of the European Communities has taken some initiatives by establishing collaborative programs among laboratories in the member states. Intercomparison studies are now under way with respect to the testing of degradability, acute toxicity for daphnia and fish, and bioaccumulation. A similar intercomparison program is under way for the testing of some phsico-chemical properties such as water and fat solubility, partition coefficient (n-OctanoYwater), adsoption/desorption of different soils and sediments, etc. We hope to inform you about the results of these studies during the next meeting of SECOTOX in the spring of 1979. Summarizing, it can be said that the ecotoxicologist is now confronted with important questions in order: -to develop adequate and representative test methodology techniques; -to simplify test procedures; -to advise legislators to establish appropriate notification schemes; and -finally, after enough experience has been gained, to propose appropriate standard methods. In this respect it can be noted that for aquatic ecosystems much more progress has been made for international standardization than for the terrestrial ecosystems. IV. CONCLUSION Under TSCA it is estimated that 200 to 400 notifications will be submitted yearly in the United States by industry and importers. The same order of magnitude might be expected in Europe. It is important to emphasize the enormous efforts in terms of manpower and financial and technical resources to deal properly with the aims
NEW CHALLENGES
TO ECOTOXICOLOGY
121
defined by the legislators. The total test cost for one substance is estimated between 100,000 and 500,000 dollars for the whole notification scheme. This variation can be attributed to differences in point of view and appreciation. For the time being it is impossible to evaluate the large number of experts and technicians needed to perform all the technical and scientific work. The administrative aspects will also require a considerable input of personnel and expertise. Neither this expertise nor suitable personnel to accomplish the industrial, scientific, or administrative tasks are available in all instances at this time. Therefore, there is an urgent need to fill these gaps in which the training of experts is certainly not of minor importance. Rationalization at worldwide level must be achieved by the exchange and pooling of available information, by the establishment of adequate, but not exaggerated, notification schemes, by the simplification and harmonization of test procedures, by the mutual recognition at the international level of test data, etc. There is a need to find procedures for sharing existing costs between industries and to harmonize inventories of approved chemical substances while still respecting industrial confidentiality. The establishment of internationally accepted procedures is required to improve the comparability of data obtained by different laboratories. From the foregoing it is clear that, once again, legislators have thrown down the gauntlet and issued the challenge; it has shown what needs to be done. It is now up to experts to give the appropriate answers to the many open-ended questions that have been posed. Our society has an important duty to fulfill in the area of ecotoxicology to ensure that the questions are duly answered and that the necessary mechanisms and training are available to ensure the smooth and efficient operation of a complex but necessary system for the protection of man and his environment.
AND
ENVIRONMENTAL
SAFETY
New Challenges
3,116-121
(1979)
to Ecotoxicologyl
J. SMEETS Commission
of the European
Communities, Received
I. LEGISLATIVE
200, Rue de la Loi. August
1049 Bruxelles,
Belgium
16, 1978
CONSIDERATIONS
The current international development legislation on chemical substances leads to new dimensions in operational ecotoxicology and research. Several countries, such as Japan, the United States, Canada, France, Sweden, and Switzerland, have already adopted legislative measurements in order to protect man and his environment against the risks caused by the use of hazardous chemical substances and mixtures. Others, like the United Kingdom, the European Community, and the Federal Republic of Germany, are in an advanced stage of preparation. It is not the aim of this presentation to discuss the many regulatory aspects involved, nor to compare in detail the contents, the field of application, the administrative procedures or the implications of these regulations on the world market of chemical substances and mixtures. I simply wish to draw the attention of scientists and experts to some points of major interest in order to orientate and stimulate work to be accomplished in a few years. As will be shown, there is a great need! Summarizing, it can be said that mandatory rules are established or envisaged to prevent the marketing of chemical substances or mixtures known to be dangerous or to present an unreasonable risk, in one way or another, to man or his environment. The general and wide-ranging coverage of these rules must be stressed; the regulatory concepts are no longer limited to certain products or groups of chemicals, such as pesticides, pharmaceuticals, food additives, etc. Some countries limit the field of application only to new chemicals, substances which have not been marketed before. Others, like the Toxic Substances Control Act (TSCA) of the USA covers all existing as well as new chemical substances. Control is often reflected through an obligatory notification system to a competent authority of the central government by the producer or importer of the substances in question. This notification requires information on the results of research and tests which characterize and identify the properties and the possible risks of the substances. The marketing or production of an incriminated product can be forbidden on the basis of this information. This characterization and identification concerns physical and chemical parameters and a study of the possible toxicological and ecotoxicological risks. Some legislations, such as the Japanese law and the proposed European Community directive, indicate, in the 1 Paper presented at the Environmental Chemicals.”
meeting August
0147-6513/79/020116-06$02.00/O Copyright All nghfs
0 1979 by Academic Press. Inc. of reproduction m any form reserved.
on “Scientific Basis 16-18, 1978, Vienna. 116
for
the
Ecotoxicological
Assessment
of
NEW
CHALLENGES
TO ECOTOXICOLOGY
117
notification scheme, the tests to be performed. Others leave the judgment for the tests to the producer or importer; TSCA foresees a guidance for testing, the draft of this guidance being now available. It is evident that these legislative measures require an important effort of man and will place important financial charges on the budget of the manufacturer of chemicals. The cost of testing might be considerable. On the other hand, this development is not surprising considering some very doubtful experiences with chemicals in the past. A major characteristic of this legislation is that it covers risks for man as well as for the total environment. Reference will be made among others in the following to the proposed directive of the Commission of the European Communities which was submitted to the Council of Ministers in 1976 and is now under discussion at policy level in expert groups. This directive envisages the harmonization of legislation with respect to chemical substances in the nine Common Market countries to avoid unacceptable trade barriers between the member states. Such a harmonization at the worldwide level is, for the time being, a utopia. In the framework of OECD important work is going on, which represents a first step in the direction of harmonizing policies in this field on a larger scale than the Community’s. II. NOTIFICATION The proposed Community Directive foresees a notification procedure providing a technical dossier, to be submitted by the producer or importer following given guidelines. This dossier should “supply the information necessary to evaluate the foreseeable immediate or differed risks, which the new substances may entail for man and the environment.” In Annex VII to the proposed Directive, the so-called “base-set” of notifiable information is summarized. This basic information contains six chapters: 1. The identity of the substance, i.e., its chemical name, its empirical and structural formulae, and its composition, including impurities and methods of detection and determination; 2. Information on the substance-proposed uses, estimated production and imports, field of application, etc. ; 3. The physico-chemical properties, i.e., melting and boiling point, relative density, water and fat solubility, partition coefficient, etc.; 4. Toxicological studies, i.e., acute toxicity, subacute toxicity, and mutagenic and carcinogenic effects; 5. Ecotoxicologicaf studies, i.e., acute lethal concentrations for fish and daphnia, biotic and abiotic degradation tests; and 6. Means of Neutralizing the substance for industry, craft trades, and the public at large. The required tests must be conducted according to methods recognized by existing good laboratory practice and recommended by the competent international bodies where such recommendations exist. For the time being, only the Japanese law recognizes standard tests for degradability, bioaccumulation, and toxicity. In the European Community
118
J. SMEETS
directive, only the nature of the information to be notified is indicated, not the methodology to be used. Sometimes the requirements for more detailed informations are defined, e.g., the information on acute toxicity should concern both male and female rats and one of the tests should be made orally. For the degradation test, the BOD/COD ration is the minimum requirement. Other examples could also be given. The notification dossier must also present the competent authority with a declaration on the unfavorable effects of the various uses and make proposals for any measure relating to thecondition of use, which is recommended to limit these. unfavorable effects. One of the basic problems of a notification scheme is the introduction of a certain flexibility in testing. The diversity of chemical substances and products manufactured and the wide range of their potential effects on human health and environment make it impossible to require universally applicable testing for all chemical substances. A certain flexibility should be considered. But how flexible should the system be and what are the criteria for controlling flexibility without allowing the system to become arbitrary? Manpower and cost are particularly important factors to be taken in consideration, on the one hand, in relation to the quantity of the chemical in question to be produced or imported and, on the other hand, considering the possible harmfulness of the product. Some legislators have considered this problem thoroughly; they propose or will apply a so-called hierarchical test scheme, also referred to as step-sequence testing or, to use the common German expression, “Stufenplan.” Following a defined trigger mechanism a certain degree of automaticity for step-sequential tests has been developed. The first step is the information to be considered in the so-called base-set dossier: this mechanism can be expressed in yearly production quantities or in accumulated import quantities. In relation herewith the next test steps should be performed, if preceding tests demonstrate the presence of risks. The Japanese law is a good example of this procedure. Thefirst test step to be performed is biodegradability testing; the second test step is bioaccumulation, but this step is only required ifthe chemical substance has proved with the first test to have a low degradability. The third test step, fish toxicity testing, is required only for a substance which has proved during the second test to be highly bioaccumulative. In fact, the Japanese law only forsees information on these three tests in its notification scheme: The factual data of PCB for degradability, accumulation, and toxicity are used as quantitative references. Another problem of importance is the definition of risk or unfavorable effects of certain parameters. Certainly, past experience in toxicology and ecotoxicology has made it possible to establish certain guidelines for experts and competent authorities. However, much more expertise, experience, and objective criteria will be needed for the application of this legislation to avoid decisions with an arbitrary character. III. ECOTOXICOLOGICAL TESTING Concerning the contents of the notification scheme and the different parameters to be considered, the state of the art can be summarized as follows.
NEW CHALLENGES
TO ECOTOXICOLOGY
119
In general, there is good agreement on the definitions and methodology used to characterize physico-chemical properties of a substance. The parameters concerned are well known and many standardized methods are available. This is the result of many years of experience. It is not surprising that this state has not yet been reached in a much younger science, namely, toxicology, notwithstanding its great progress and developments the last decennium. Still much work has to be performed to arrive on international levels upon generally accepted methods to evaluate the risks of chemical substances for man. An intermediate phase must thoroughly be consideredin this context, i.e., the improvement of the comparability of toxicological data submitted by different laboratories and harmonization of the applied testing methodologies. In the European Community, an interlaboratory comparison study has been organized for acute toxicity testing. More than 60 experienced laboratories have participated. It appears that the results of this test are far from comparable among laboratories and that the methods used are far from harmonized. In ecotoxicology the drawback is even more important, not by a lack of research or goodwill, but more by a lack of imperative pressure. Until now, the need for a systematic approach was less urgent; the legislative pressure was less strong than in toxicology. Until recently, toxicological research was considered as the major and often the only prerequisite to judge the use and applications of a chemical product. Ecotoxicological studies were only required for specific products, compounds, or situations. Therefore great experience has been gained with work performed in radioecology and with respect to the use of pesticides, etc. At the European level there is still some controversy with respect to the notification scheme on the question as to whether or not environmental testing, like toxicological testing, should be mandatory for the base-set dossier. Some feel that environmental testing should not be part of the base-set dossier but should be included in subsequent test steps. They bear in mind, among others, the test costs. This point of view seems to be unrealistic if legislation requires the control of chemical substances to protect the environment as well as man. As long as insufficient data are available or experience is gained, at least some well-chosen environmental tests should be part of the base-set dossier. We must recognize that a choice is necessary since the number of susceptible media and matrices to be considered for environmental testing is enormous. On.the other hand, the currently available information on bioindicators, critical pathways, critical biota or groups of biota, and ways of transfer is very limited; such a choice will still have a certain arbitrary character. Nevertheless, the field has to be covered in an unbiased way. Another aspect is the difference in priorities given to aquatic and terrestrial ecosystems, the latter often considered of secondary importance. It is true that there is a greater risk from aquatic pollutants, through their direct or indirect dispersion in aquatic ecosystems, than for pollutants in terrestrial ecosystems. However, here again, if one envisages protection of the environment, one must consider both ecosystems. The proposed directive of the Commission does not foresee tests for studying toxicological effects of chemical substances on birds, higher or lower plants, and microorganisms or concerning adsorption or desorption
120
J. SMEETS
in soil, etc., but only considers the aquatic environment, i.e., testing concerning lethal concentrations for fish and daphniae. Since there was a general feeling on the expert level that more consideration should be given to the testing of terrestrial ecotoxicological matrices studies for routine base terrestrial ecotoxicological testing are now underway, using of the earthworm (Lumbricus terrestris), the honeybee (Apis melliferu), and the Japanese quail (Coturnix coturnix). The recently published preliminary draf guidance for premanufacture notification in the framework of USA-TSCA calls for manufacturers’ notifications including acute and clinic effects on terrestrial and on aquatic ecosystems and their conponents. The initial responsibility for selecting and conducting a testing scheme adequate to support such an evaluation must be borne by the manufacturer. In this draft guidance the following ecological effects and tests organisms have been selected: -Microbial effects: Cellulose decomposition, nitrogen transformation, sulfate reduction test, respiration (CO, evolution) test; -Plant effect tests: Algal inhibition, Lemna inhibition, seed germination and early growth; -Animal effect tests: Duphnia life cycle, fish acute toxicity, quail dietary LC50, fish bioconcentration test. Apart from these fundamental aspects, there is a need on a national as well as an international level to improve the quality of test results and to render the data from different laboratories more comparable. The Commission of the European Communities has taken some initiatives by establishing collaborative programs among laboratories in the member states. Intercomparison studies are now under way with respect to the testing of degradability, acute toxicity for daphnia and fish, and bioaccumulation. A similar intercomparison program is under way for the testing of some phsico-chemical properties such as water and fat solubility, partition coefficient (n-OctanoYwater), adsoption/desorption of different soils and sediments, etc. We hope to inform you about the results of these studies during the next meeting of SECOTOX in the spring of 1979. Summarizing, it can be said that the ecotoxicologist is now confronted with important questions in order: -to develop adequate and representative test methodology techniques; -to simplify test procedures; -to advise legislators to establish appropriate notification schemes; and -finally, after enough experience has been gained, to propose appropriate standard methods. In this respect it can be noted that for aquatic ecosystems much more progress has been made for international standardization than for the terrestrial ecosystems. IV. CONCLUSION Under TSCA it is estimated that 200 to 400 notifications will be submitted yearly in the United States by industry and importers. The same order of magnitude might be expected in Europe. It is important to emphasize the enormous efforts in terms of manpower and financial and technical resources to deal properly with the aims
NEW CHALLENGES
TO ECOTOXICOLOGY
121
defined by the legislators. The total test cost for one substance is estimated between 100,000 and 500,000 dollars for the whole notification scheme. This variation can be attributed to differences in point of view and appreciation. For the time being it is impossible to evaluate the large number of experts and technicians needed to perform all the technical and scientific work. The administrative aspects will also require a considerable input of personnel and expertise. Neither this expertise nor suitable personnel to accomplish the industrial, scientific, or administrative tasks are available in all instances at this time. Therefore, there is an urgent need to fill these gaps in which the training of experts is certainly not of minor importance. Rationalization at worldwide level must be achieved by the exchange and pooling of available information, by the establishment of adequate, but not exaggerated, notification schemes, by the simplification and harmonization of test procedures, by the mutual recognition at the international level of test data, etc. There is a need to find procedures for sharing existing costs between industries and to harmonize inventories of approved chemical substances while still respecting industrial confidentiality. The establishment of internationally accepted procedures is required to improve the comparability of data obtained by different laboratories. From the foregoing it is clear that, once again, legislators have thrown down the gauntlet and issued the challenge; it has shown what needs to be done. It is now up to experts to give the appropriate answers to the many open-ended questions that have been posed. Our society has an important duty to fulfill in the area of ecotoxicology to ensure that the questions are duly answered and that the necessary mechanisms and training are available to ensure the smooth and efficient operation of a complex but necessary system for the protection of man and his environment.
