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Standard Guide for Assessing the Hazard of a Material to Aquatic Organisms and Their Uses 评估材料对水生生物及其用途的危害的标准指南
发布日期: 2023-01-01
1.1 本指南描述了使用材料的生物、化学、物理和毒理学财产相关信息的逐步过程,以确定材料释放到环境中可能对水生生物及其用途产生的不利影响。材料通常是一种特定的化学品,尽管它可能是一组具有非常相似的生物、化学、物理和毒理财产的化学品,并且通常一起生产、使用和丢弃。 1.2 危险评估过程很复杂,需要在多个方面做出决定;因此,危险评估的有效性取决于这些决策的可靠性以及所用信息的准确性。 所有决策都应基于合理的最坏情况分析,以便以符合科学有效性的最低成本完成适当的评估。 1.3 本指南假设读者熟悉水生毒理学和相关领域。提供了一般参考文献列表 ( 1. ) . 2. 1.4 本指南未描述或参考估算或测量环境浓度的详细程序,或确定水生生物捕食者食物中可接受的测试材料最大浓度的程序。然而,本指南确实描述了在评估材料对水生生物的危害及其用途时应如何使用此类信息。 1.5 由于对水生生物及其用途的危害评估是水生毒理学中一项相对较新的活动,因此本文提供的大多数指南都是定性而非定量的。如果可能,应计算并考虑置信限。 1.6 本指南为评估危险提供了指导,但未提供如何考虑社会因素以判断危险的可接受性的指导。关于可接受性的判断是社会的,也是科学的,不在本指南的范围之内。 1.7 本指南安排如下: 部分 参考文件 2. 本标准专用术语说明 3. 指南摘要 4. 意义和用途 5. 四个基本概念 6. 迭代 6.1 两个要素 6.2 可能的决定 6.3 分阶段方法 6.4 第一阶段-使用低成本(现有)信息 7. 可用数据的收集 7.1 环境浓度的初步估算 7.2 对水生生物毒性的初步估计 7.3 水生器官生物累积的初步估计- 主义 7.4 第一阶段危险评估 7.5 第二阶段使用中等成本信息 8. 环境浓度的改进估计 8.2 对水生动物的急性毒性 8.3 对藻类的毒性 8.4 短期测试的扩展 8.5 生物累积性 8.6 第二阶段危险评估 8. 7. 第三阶段高成本信息的使用 9 环境浓度的精确估算 9.2 对水生动物的慢性毒性 9.3 急性慢性比率的使用 9.4 水生植物毒性 9.5 生物浓缩 9.6 食物中的生物累积 9.7 第三阶段危险评估 9.8 附录 附录X1 生产、使用、处置和其他释放 附录X2 生物学考虑因素 附录X3 化学因素 附录X4 物理注意事项 附录X5 毒理学考虑 附录X6 估算环境浓度 附录X7 试验物种的选择 附录X8 长期毒性试验 1.8 本标准并不旨在解决与其使用相关的所有安全问题(如有)。 本标准的使用者有责任在使用前建立适当的安全、健康和环境实践,并确定监管限制的适用性。 1.9 本国际标准是根据世界贸易组织技术性贸易壁垒(TBT)委员会发布的《国际标准、指南和建议制定原则决定》中确立的国际公认标准化原则制定的。 =====意义和用途====== 5.1 对水生生物自然种群及其用途的不利影响表明,需要评估许多新材料和一些目前使用的材料的危害。 本文所述的过程将有助于生产商、用户、监管机构和其他人有效和充分地比较替代材料,全面评估最终候选材料,或重新评估已使用材料的危害。 5.2 顺序评估和反馈允许对资源的有效使用进行适当的判断,从而最大限度地减少不必要的测试,并将精力集中在与每种材料最相关的信息上。对于不同的材料和情况,危险评估将适当地基于不同数量和种类的生物、化学、物理和毒理学数据。 5.3 对材料对水生生物的危害及其用途的评估永远不应被认为是完整的。 如果生产、使用或处置量增加,发现了新用途,或获得了有关生物、化学、物理或毒理学财产的新信息,则应考虑重新评估。定期审查将有助于确保新情况和信息得到及时的适当关注。 5.4 如果对另一种材料有实质性转化,则可能需要评估这两种材料的危害。 5.5 在许多情况下,对不利影响的考虑不应随着危险评估的完成而结束。其他步骤通常应包括风险评估、关于已识别危险和风险的可接受性的决定以及缓解措施。 5.6 由于这一做法主要涉及对水生生物及其用途的不利影响,因此,缓解措施(如改善废水处理)不会对非水生生物造成不可接受的影响是很重要的。因此,本标准应与其他信息一起使用,以评估对水生和非水生生物的危害。
1.1 This guide describes a stepwise process for using information concerning the biological, chemical, physical, and toxicological properties of a material to identify adverse effects likely to occur to aquatic organisms and their uses as a result of release of the material to the environment. The material will usually be a specific chemical, although it might be a group of chemicals that have very similar biological, chemical, physical, and toxicological properties and are usually produced, used, and discarded together. 1.2 The hazard assessment process is complex and requires decisions at a number of points; thus, the validity of a hazard assessment depends on the soundness of those decisions, as well as the accuracy of the information used. All decisions should be based on reasonable worst-case analyses so that an appropriate assessment can be completed for the least cost that is consistent with scientific validity. 1.3 This guide assumes that the reader is knowledgeable in aquatic toxicology and related pertinent areas. A list of general references is provided ( 1 ) . 2 1.4 This guide does not describe or reference detailed procedures for estimating or measuring environmental concentrations, or procedures for determining the maximum concentration of test material that is acceptable in the food of predators of aquatic life. However, this guide does describe how such information should be used when assessing the hazard of a material to aquatic organisms and their uses. 1.5 Because assessment of hazard to aquatic organisms and their uses is a relatively new activity within aquatic toxicology, most of the guidance provided herein is qualitative rather than quantitative. When possible, confidence limits should be calculated and taken into account. 1.6 This guide provides guidance for assessing hazard but does not provide guidance on how to take into account social considerations in order to judge the acceptability of the hazard. Judgments concerning acceptability are social as well as scientific, and are outside the scope of this guide. 1.7 This guide is arranged as follows: Section Referenced Documents 2 Descriptions of Terms Specific to This Standard 3 Summary of Guide 4 Significance and Use 5 Four Basic Concepts 6 The Iteration 6.1 The Two Elements 6.2 The Possible Decisions 6.3 The Phased Approach 6.4 Phase I—Use of Low-Cost (Existing) Information 7 Collection of Available Data 7.1 Initial Estimates of Environmental Concentrations 7.2 Initial Estimate of Toxicity to Aquatic Organisms 7.3 Initial Estimate of Bioaccumulation by Aquatic Organ- isms 7.4 Phase I Hazard Assessment 7.5 Phase II—Use of Medium-Cost Information 8 Improved Estimates of Environmental Concentrations 8.2 Acute Toxicity to Aquatic Animals 8.3 Toxicity to Algae 8.4 Expansion of Short-Term Testing 8.5 Bioaccumulation 8.6 Phase II Hazard Assessment 8.7 Phase III—Use of High-Cost Information 9 Refined Estimates of Environmental Concentrations 9.2 Chronic Toxicity to Aquatic Animals 9.3 Use of Acute-Chronic Ratios 9.4 Toxicity to Aquatic Plants 9.5 Bioconcentration 9.6 Bioaccumulation from Food 9.7 Phase III Hazard Assessment 9.8 Appendixes Appendix X1 Production, Use, Disposal, and Other Release Appendix X2 Biological Considerations Appendix X3 Chemical Considerations Appendix X4 Physical Considerations Appendix X5 Toxicological Considerations Appendix X6 Estimating Environmental Concentrations Appendix X7 Selection of Test Species Appendix X8 Long-Term Toxicity Tests 1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.9 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. ====== Significance And Use ====== 5.1 Adverse effects on natural populations of aquatic organisms and their uses have demonstrated the need to assess the hazards of many new, and some presently used, materials. The process described herein will help producers, users, regulatory agencies, and others to efficiently and adequately compare alternative materials, completely assess a final candidate material, or reassess the hazard of a material already in use. 5.2 Sequential assessment and feedback allow appropriate judgments concerning efficient use of resources, thereby minimizing unnecessary testing and focusing effort on the information most pertinent to each material. For different materials and situations, assessment of hazard will appropriately be based on substantially different amounts and kinds of biological, chemical, physical, and toxicological data. 5.3 Assessment of the hazard of a material to aquatic organisms and their uses should never be considered complete for all time. Reassessment should be considered if the amount of production, use, or disposal increases, new uses are discovered, or new information on biological, chemical, physical, or toxicological properties becomes available. Periodic review will help assure that new circumstances and information receive prompt appropriate attention. 5.4 If there is substantial transformation to another material, the hazard of both materials may need to be assessed. 5.5 In many cases, consideration of adverse effects should not end with completion of the hazard assessment. Additional steps should often include risk assessment, decisions concerning acceptability of identified hazards and risks, and mitigative actions. 5.6 Because this practice deals mostly with adverse effects on aquatic organisms and their uses, it is important that mitigative actions, such as improved treatment of aqueous effluents, not result in unacceptable effects on non-aquatic organisms. Thus, this standard should be used with other information in order to assess hazard to both aquatic and non-aquatic organisms.
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